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October 11, 2018 newswires No comments Views: 21

Annual Civil Monetary Penalties Inflation Adjustment

Federal Register

Final rule.

CFR Part: "45 CFR Part 102"

RIN Number: "RIN 0991-AC0"

Citation: "83 FR 51369"

Page Number: "51369"

"Rules and Regulations"

Agency: "Office of the Assistant Secretary for Financial Resources, Department of Health and Human Services."

SUMMARY: The Department of Health and Human Services is updating its regulations to reflect required annual inflation-related increases to the civil monetary penalties in its regulations, pursuant to the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015.

   DATES:

This rule is effective October 11, 2018.

   FOR FURTHER INFORMATION CONTACT: Shaunta Johnson, Office of Grants and Acquisition Policy and Accountability, Office of the Assistant Secretary for Financial Resources, Room 514-G, Hubert Humphrey Building, 200 Independence Avenue SW, Washington, DC 20201; 202-690-6396; FAX 202-690-5405.

   SUPPLEMENTARY INFORMATION:

I. Background The Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (Sec. 701 of Pub. L. 114-74) (the "2015 Act"), which is intended to improve the effectiveness of civil monetary penalties (CMPs) and to maintain the deterrent effect of such penalties, requires agencies to adjust the civil monetary penalties for inflation annually.

The Department of Health and Human Services (HHS) lists the civil monetary penalty authorities and the penalty amounts administered by all of its agencies in tabular form in 45 CFR 102.3.

II. Calculation of Adjustment

The annual inflation adjustment for each applicable civil monetary penalty is determined using the percent increase in the Consumer Price Index for all Urban Consumers (CPI-U) for the month of October of the year in which the amount of each civil penalty was most recently established or modified. In the December 15, 2017, Office of Management and Budget (OMB) Memorandum for the Heads of Executive Agencies and Departments, M-18-03, Implementation of the Penalty Inflation Adjustments for 2018, Pursuant to the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015, OMB published the multiplier for the required annual adjustment. The cost-of-living adjustment multiplier for 2018, based on the CPI-U for the month of October 2017, not seasonally adjusted, is 1.02041.

Using the 2018 multiplier, HHS adjusted all its applicable monetary penalties in 45 CFR 102.3.

III. Statutory and Executive Order Reviews

The 2015 Act requires federal agencies to publish annual penalty inflation adjustments notwithstanding section 553 of the Administrative Procedure Act (APA).

Section 4(a) of the 2015 Act directs federal agencies to publish annual adjustments no later than January 15th of each year thereafter. In accordance with section 553 of the APA, most rules are subject to notice and comment and are effective no earlier than 30 days after publication in the Federal Register. However, section 4(b)(2) of the 2015 Act provides that each agency shall make the annual inflation adjustments "notwithstanding section 553" of the APA.

According to OMB's Memorandum M-18-03, the phrase "notwithstanding section 553" means that "the public procedure the APA generally requires--notice, an opportunity for comment, and a delay in effective date--is not required for agencies to issue regulations implementing the annual adjustment." Consistent with the language of the 2015 Act and OMB's implementation guidance, this rule is not subject to notice and an opportunity for public comment and will be effective immediately upon publication.

Pursuant to OMB Memorandum M-18-03, HHS has determined that the annual inflation adjustment to the civil monetary penalties in its regulations does not trigger any requirements under procedural statutes and Executive Orders that govern rulemaking procedures.

IV. Effective Date

This rule is effective October 11 2018. The adjusted civil monetary penalty amounts apply to penalties assessed on or after October 11, 2018, if the violation occurred on or after November 2, 2015. If the violation occurred prior to November 2, 2015, or a penalty was assessed prior to September 6, 2016, the pre-adjustment civil penalty amounts in effect prior to September 6, 2016, will apply.

   List of Subjects in 45 CFR Part 102 Administrative practice and procedure, Penalties.

For reasons discussed in the preamble, the Department of Health and Human Services amends subtitle A, title 45 of the Code of Federal Regulations as follows:

   PART 102--ADJUSTMENT OF CIVIL MONETARY PENALTIES FOR INFLATION

   1. The authority citation for part 102 continues to read as follows:

Authority:Public Law 101-410, Sec. 701 of Public Law 114-74, 31 U.S.C. 3801-3812.

   2. Amend SEC 102.3 by revising the table to read as follows:

SEC 102.3 Penalty adjustment and table.

*****

 Civil Monetary Penalty Authorities Administered by HHS Agencies and Penalty Amounts                                                                                                                       Citation                                                                                                                                                                                                  U.S.C.                   CFR  fn1               HHS                      Description  fn2       Date of last             2016                     2017                     2018                                                                        agency                                            statutorily              Maximum                  Maximum                  Maximum                                                                                                                       established              adjusted                 adjusted                 adjusted                                                                                                                      penalty                  penalty                  penalty                  penalty                                                                                                                       figure  fn3            ( $ )                    ( $ )  fn4             ( $ ) 21 U.S.C.                                                                                                                                                                                                 333(b)(2)(A)             FDA                      Penalty for violations   2016                     98,935                   100,554                  102,606                                                                                              related to drug samples                                                                                                                                                                                  resulting in a                                                                                                                                                                                           conviction of any                                                                                                                                                                                        representative of                                                                                                                                                                                        manufacturer or                                                                                                                                                                                          distributor in any                                                                                                                                                                                       10-year period                                                                                                                                         333(b)(2)(B)             FDA                      Penalty for violation    2016                     1,978,690                2,011,061                2,052,107                                                                                            related to drug samples                                                                                                                                                                                  resulting in a                                                                                                                                                                                           conviction of any                                                                                                                                                                                        representative of                                                                                                                                                                                        manufacturer or                                                                                                                                                                                          distributor after the                                                                                                                                                                                    second conviction in any                                                                                                                                                                                 10-yr period                                                                                                                                           333(b)(3)                FDA                      Penalty for failure to   2016                     197,869                  201,106                  205,211                                                                                              make a report required                                                                                                                                                                                   by 21 U.S.C.                                                                                                                                                                                             353(d)(3)(E) relating to                                                                                                                                                                                 drug samples                                                                                                                                           333(f)(1)(A)             FDA                      Penalty for any person   2016                     26,723                   27,160                   27,714                                                                                               who violates a                                                                                                                                                                                           requirement related to                                                                                                                                                                                   devices for each such                                                                                                                                                                                    violation                                                                                                                                                                                                                       Penalty for aggregate of 2016                     1,781,560                1,810,706                1,847,663                                                                                            all violations related                                                                                                                                                                                   to devices in a single                                                                                                                                                                                   proceeding                                                                                                                    333(f)(2)(A)             FDA                      Penalty for any          2016                     75,123                   76,352                   77,910                                                                                               individual who                                                                                                                                                                                           introduces or delivers                                                                                                                                                                                   for introduction into                                                                                                                                                                                    interstate commerce food                                                                                                                                                                                 that is adulterated per                                                                                                                                                                                  21 U.S.C. 342(a)(2)(B)                                                                                                                                                                                   or any individual who                                                                                                                                                                                    does not comply with a                                                                                                                                                                                   recall order under 21                                                                                                                                                                                    U.S.C. 350l                                                                                                                                                                                                                     Penalty in the case of   2016                     375,613                  381,758                  389,550                                                                                              any other person other                                                                                                                                                                                   than an individual) for                                                                                                                                                                                  such introduction or                                                                                                                                                                                     delivery of adulterated                                                                                                                                                                                  food                                                                                                                                                                                                   Penalty for aggregate of 2016                     751,225                  763,515                  779,098                                                                                              all such violations                                                                                                                                                                                      related to adulterated                                                                                                                                                                                   food adjudicated in a                                                                                                                                                                                    single proceeding                                                                                                             333(f)(3)(A)             FDA                      Penalty for all          2016                     11,383                   11,569                   11,805                                                                                               violations adjudicated                                                                                                                                                                                   in a single proceeding                                                                                                                                                                                   for any person who                                                                                                                                                                                       violates 21 U.S.C.                                                                                                                                                                                       331(jj)(1) by failing to                                                                                                                                                                                 submit the certification                                                                                                                                                                                 required by 42 U.S.C.                                                                                                                                                                                    282(j)(5)(B) or                                                                                                                                                                                          knowingly submitting a                                                                                                                                                                                   false certification; by                                                                                                                                                                                  failing to submit                                                                                                                                                                                        clinical trial                                                                                                                                                                                           information under 42                                                                                                                                                                                     U.S.C 282(j); or by                                                                                                                                                                                      submitting clinical                                                                                                                                                                                      trial information under                                                                                                                                                                                  42 U.S.C. 282(j) that is                                                                                                                                                                                 false or misleading in                                                                                                                                                                                   any particular under 42                                                                                                                                                                                  U.S.C. 282(j)(5)(D)                                                                                                                                    333(f)(3)(B)             FDA                      Penalty for each day any 2016                     11,383                   11,569                   11,805                                                                                               above violation is not                                                                                                                                                                                   corrected after a 30-day                                                                                                                                                                                 period following                                                                                                                                                                                         notification until the                                                                                                                                                                                   violation is corrected                                                                                                                                 333(f)(4)(A)(i)          FDA                      Penalty for any          2016                     284,583                  289,239                  295,142                                                                                              responsible person that                                                                                                                                                                                  violates a requirement                                                                                                                                                                                   of 21 U.S.C. 355(o)                                                                                                                                                                                      (post-marketing studies,                                                                                                                                                                                 clinical trials,                                                                                                                                                                                         labeling), 21 U.S.C.                                                                                                                                                                                     355(p) (risk evaluation                                                                                                                                                                                  and mitigation (REMS)),                                                                                                                                                                                  or 21 U.S.C. 355-1                                                                                                                                                                                       (REMS)                                                                                                                                                                                                                          Penalty for aggregate of 2016                     1,138,330                1,156,953                1,180,566                                                                                            all such above                                                                                                                                                                                           violations in a single                                                                                                                                                                                   proceeding                                                                                                                    333(f)(4)(A)(ii)                                  FDA                      Penalty for REMS         2016                     284,583                  289,239                  295,142                                                                                              violation that continues                                                                                                                                                                                 after written notice to                                                                                                                                                                                  the responsible person                                                                                                                                                                                   for the first 30-day                                                                                                                                                                                     period (or any portion                                                                                                                                                                                   thereof) the responsible                                                                                                                                                                                 person continues to be                                                                                                                                                                                   in violation                                                                                                                                                                                           Penalty for REMS         2016                     1,138,330                1,156,953                1,180,566                                                                                            violation that continues                                                                                                                                                                                 after written notice to                                                                                                                                                                                  responsible person                                                                                                                                                                                       doubles for every 30-day                                                                                                                                                                                 period thereafter the                                                                                                                                                                                    violation continues, but                                                                                                                                                                                 may not exceed penalty                                                                                                                                                                                   amount for any 30-day                                                                                                                                                                                    period                                                                                                                                                                                                 Penalty for aggregate of 2016                     11,383,300               11,569,531               11,805,665                                                                                           all such above                                                                                                                                                                                           violations adjudicated                                                                                                                                                                                   in a single proceeding                                                                                                        333(f)(9)(A)             FDA                      Penalty for any person   2016                     16,503                   16,773                   17,115                                                                                               who violates a                                                                                                                                                                                           requirement which                                                                                                                                                                                        relates to tobacco                                                                                                                                                                                       products for each such                                                                                                                                                                                   violation                                                                                                                                                                                                                       Penalty for aggregate of 2016                     1,100,200                1,118,199                1,141,021                                                                                            all such violations of                                                                                                                                                                                   tobacco product                                                                                                                                                                                          requirement adjudicated                                                                                                                                                                                  in a single proceeding                                                                                                        333(f)(9)(B)(i)(I)                                FDA                      Penalty per violation    2016                     275,050                  279,550                  285,256                                                                                              related to violations of                                                                                                                                                                                 tobacco requirements                                                                                                                                                                                   Penalty for aggregate of 2016                     1,100,200                1,118,199                1,141,021                                                                                            all such violations of                                                                                                                                                                                   tobacco product                                                                                                                                                                                          requirements adjudicated                                                                                                                                                                                 in a single proceeding                                                                                                        333(f)(9)(B)(i)(II)      FDA                      Penalty in the case of a 2016                     275,050                  279,550                  285,256                                                                                              violation of tobacco                                                                                                                                                                                     product requirements                                                                                                                                                                                     that continues after                                                                                                                                                                                     written notice to such                                                                                                                                                                                   person, for the first                                                                                                                                                                                    30-day period (or any                                                                                                                                                                                    portion thereof) the                                                                                                                                                                                     person continues to be                                                                                                                                                                                   in violation                                                                                                                                                                                                                    Penalty for violation of 2016                     1,100,200                1,118,199                1,141,021                                                                                            tobacco product                                                                                                                                                                                          requirements that                                                                                                                                                                                        continues after written                                                                                                                                                                                  notice to such person                                                                                                                                                                                    shall double for every                                                                                                                                                                                   30-day period thereafter                                                                                                                                                                                 the violation continues,                                                                                                                                                                                 but may not exceed                                                                                                                                                                                       penalty amount for any                                                                                                                                                                                   30-day period                                                                                                                                                                                          Penalty for aggregate of 2016                     11,002,000               11,181,993               11,410,218                                                                                           all such violations                                                                                                                                                                                      related to tobacco                                                                                                                                                                                       product requirements                                                                                                                                                                                     adjudicated in a single                                                                                                                                                                                  proceeding                                                                                                                    333(f)(9)(B)(ii)(I)      FDA                      Penalty for any person   2016                     275,050                  279,550                  285,256                                                                                              who either does not                                                                                                                                                                                      conduct post-market                                                                                                                                                                                      surveillance and studies                                                                                                                                                                                 to determine impact of a                                                                                                                                                                                 modified risk tobacco                                                                                                                                                                                    product for which the                                                                                                                                                                                    HHS Secretary has                                                                                                                                                                                        provided them an order                                                                                                                                                                                   to sell, or who does not                                                                                                                                                                                 submit a protocol to the                                                                                                                                                                                 HHS Secretary after                                                                                                                                                                                      being notified of a                                                                                                                                                                                      requirement to conduct                                                                                                                                                                                   post-market surveillance                                                                                                                                                                                 of such tobacco products                                                                                                                                                                                                        Penalty for aggregate of 2016                     1,100,200                1,118,199                1,141,021                                                                                            for all such above                                                                                                                                                                                       violations adjudicated                                                                                                                                                                                   in a single proceeding                                                                                                        333(f)(9)(B)(ii)(II)     FDA                      Penalty for violation of 2016                     275,050                  279,550                  285,256                                                                                              modified risk tobacco                                                                                                                                                                                    product post-market                                                                                                                                                                                      surveillance that                                                                                                                                                                                        continues after written                                                                                                                                                                                  notice to such person                                                                                                                                                                                    for the first 30-day                                                                                                                                                                                     period (or any portion                                                                                                                                                                                   thereof) that the person                                                                                                                                                                                 continues to be in                                                                                                                                                                                       violation                                                                                                                                                                                                                       Penalty for post-notice  2016                     1,100,200                1,118,199                1,141,021                                                                                            violation of modified                                                                                                                                                                                    risk tobacco product                                                                                                                                                                                     post-market surveillance                                                                                                                                                                                 shall double for every                                                                                                                                                                                   30-day period thereafter                                                                                                                                                                                 that the tobacco product                                                                                                                                                                                 requirement violation                                                                                                                                                                                    continues for any 30-day                                                                                                                                                                                 period, but may not                                                                                                                                                                                      exceed penalty amount                                                                                                                                                                                    for any 30-day period                                                                                                                                                                                  Penalty for aggregate    2016                     11,002,000               11,181,993               11,410,218                                                                                           above tobacco product                                                                                                                                                                                    requirement violations                                                                                                                                                                                   adjudicated in a single                                                                                                                                                                                  proceeding                                                                                                                    333(g)(1)                FDA                      Penalty for any person   2016                     284,583                  289,239                  295,142                                                                                              who disseminates or                                                                                                                                                                                      causes another party to                                                                                                                                                                                  disseminate a                                                                                                                                                                                            direct-to-consumer                                                                                                                                                                                       advertisement that is                                                                                                                                                                                    false or misleading for                                                                                                                                                                                  the first such violation                                                                                                                                                                                 in any 3-year period                                                                                                                                                                                                            Penalty for each         2016                     569,165                  578,477                  590,284                                                                                              subsequent above                                                                                                                                                                                         violation in any 3-year                                                                                                                                                                                  period                                                                                                                        333 note                 FDA                      Penalty to be applied    2016                     275                      279                      285                                                                                                  for violations of                                                                                                                                                                                        restrictions on the sale                                                                                                                                                                                 or distribution of                                                                                                                                                                                       tobacco products                                                                                                                                                                                         promulgated under 21                                                                                                                                                                                     U.S.C. 387f(d) (e.g.,                                                                                                                                                                                    violations of                                                                                                                                                                                            regulations in 21 CFR                                                                                                                                                                                    Part 1140) with respect                                                                                                                                                                                  to a retailer with an                                                                                                                                                                                    approved training                                                                                                                                                                                        program in the case of a                                                                                                                                                                                 second regulation                                                                                                                                                                                        violation within a                                                                                                                                                                                       12-month period                                                                                                                                                                                                                 Penalty in the case of a 2016                     550                      559                      570                                                                                                  third tobacco product                                                                                                                                                                                    regulation violation                                                                                                                                                                                     within a 24-month period                                                                                                                                                                               Penalty in the case of a 2016                     2,200                    2,236                    2,282                                                                                                fourth tobacco product                                                                                                                                                                                   regulation violation                                                                                                                                                                                     within a 24-month period                                                                                                                                                                               Penalty in the case of a 2016                     5,501                    5,591                    5,705                                                                                                fifth tobacco product                                                                                                                                                                                    regulation violation                                                                                                                                                                                     within a 36-month period                                                                                                                                                                               Penalty in the case of a 2016                     11,002                   11,182                   11,410                                                                                               sixth or subsequent                                                                                                                                                                                      tobacco product                                                                                                                                                                                          regulation violation                                                                                                                                                                                     within a 48-month period                                                                                                                                                                                 as determined on a                                                                                                                                                                                       case-by-case basis                                                                                                                                                                                     Penalty to be applied    2016                     275                      279                      285                                                                                                  for violations of                                                                                                                                                                                        restrictions on the sale                                                                                                                                                                                 or distribution of                                                                                                                                                                                       tobacco products                                                                                                                                                                                         promulgated under 21                                                                                                                                                                                     U.S.C. 387f(d) (e.g.,                                                                                                                                                                                    violations of                                                                                                                                                                                            regulations in 21 CFR                                                                                                                                                                                    Part 1140) with respect                                                                                                                                                                                  to a retailer that does                                                                                                                                                                                  not have an approved                                                                                                                                                                                     training program in the                                                                                                                                                                                  case of the first                                                                                                                                                                                        regulation violation                                                                                                                                                                                   Penalty in the case of a 2016                     550                      559                      570                                                                                                  second tobacco product                                                                                                                                                                                   regulation violation                                                                                                                                                                                     within a 12-month period                                                                                                                                                                               Penalty in the case of a 2016                     1,100                    1,118                    1,141                                                                                                third tobacco product                                                                                                                                                                                    regulation violation                                                                                                                                                                                     within a 24-month period                                                                                                                                                                               Penalty in the case of a 2016                     2,200                    2,236                    2,282                                                                                                fourth tobacco product                                                                                                                                                                                   regulation violation                                                                                                                                                                                     within a 24-month period                                                                                                                                                                               Penalty in the case of a 2016                     5,501                    5,591                    5,705                                                                                                fifth tobacco product                                                                                                                                                                                    regulation violation                                                                                                                                                                                     within a 36-month period                                                                                                                                                                               Penalty in the case of a 2016                     11,002                   11,182                   11,410                                                                                               sixth or subsequent                                                                                                                                                                                      tobacco product                                                                                                                                                                                          regulation violation                                                                                                                                                                                     within a 48-month period                                                                                                                                                                                 as determined on a                                                                                                                                                                                       case-by-case basis                                                                                                            335b(a)                  FDA                      Penalty for each         2016                     419,320                  426,180                  434,878                                                                                              violation for any                                                                                                                                                                                        individual who made a                                                                                                                                                                                    false statement or                                                                                                                                                                                       misrepresentation of a                                                                                                                                                                                   material fact, bribed,                                                                                                                                                                                   destroyed, altered,                                                                                                                                                                                      removed, or secreted, or                                                                                                                                                                                 procured the                                                                                                                                                                                             destruction, alteration,                                                                                                                                                                                 removal, or secretion                                                                                                                                                                                    of, any material                                                                                                                                                                                         document, failed to                                                                                                                                                                                      disclose a material                                                                                                                                                                                      fact, obstructed an                                                                                                                                                                                      investigation, employed                                                                                                                                                                                  a consultant who was                                                                                                                                                                                     debarred, debarred                                                                                                                                                                                       individual provided                                                                                                                                                                                      consultant services                                                                                                                                                                                                             Penalty in the case of   2016                     1,677,280                1,704,720                1,739,513                                                                                            any other person (other                                                                                                                                                                                  than an individual) per                                                                                                                                                                                  above violation                                                                                                               360pp(b)(1)              FDA                      Penalty for any person   2016                     2,750                    2,795                    2,852                                                                                                who violates any such                                                                                                                                                                                    requirements for                                                                                                                                                                                         electronic products,                                                                                                                                                                                     with each unlawful act                                                                                                                                                                                   or omission constituting                                                                                                                                                                                 a separate violation                                                                                                                                                                                                            Penalty imposed for any  2016                     937,500                  952,838                  972,285                                                                                              related series of                                                                                                                                                                                        violations of                                                                                                                                                                                            requirements relating to                                                                                                                                                                                 electronic products                                                                                                           42 U.S.C.                                                                                                                                                                                                 262(d)                   FDA                      Penalty per day for      2016                     215,628                  219,156                  223,629                                                                                              violation of order of                                                                                                                                                                                    recall of biological                                                                                                                                                                                     product presenting                                                                                                                                                                                       imminent or substantial                                                                                                                                                                                  hazard                                                                                                                                                 263b(h)(3)               FDA                      Penalty for failure to   2016                     16,773                   17,047                   17,395                                                                                               obtain a mammography                                                                                                                                                                                     certificate as required                                                                                                                                300aa-28(b)(1)           FDA                      Penalty per occurrence   2016                     215,628                  219,156                  223,629                                                                                              for any vaccine                                                                                                                                                                                          manufacturer that                                                                                                                                                                                        intentionally destroys,                                                                                                                                                                                  alters, falsifies, or                                                                                                                                                                                    conceals any record or                                                                                                                                                                                   report required                                                                                                                                        256b(d)(1)(B)(vi)        HRSA                     Penalty for each         2016                     5,437                    5,526                    5,639                                                                                                instance of overcharging                                                                                                                                                                                 a 340B covered entity                                                                                                                                  299c-3(d)                AHRQ                     Penalty for an           2016                     14,140                   14,371                   14,664                                                                                               establishment or person                                                                                                                                                                                  supplying information                                                                                                                                                                                    obtained in the course                                                                                                                                                                                   of activities for any                                                                                                                                                                                    purpose other than the                                                                                                                                                                                   purpose for which it was                                                                                                                                                                                 supplied                                                                                                                                               653(l)(2)                45 CFR 303.21(f)         ACF                      Penalty for Misuse of    2016                     1,450                    1,474                    1,504                                                                                                Information in the                                                                                                                                                                                       National Directory of                                                                                                                                                                                    New Hires                                                                                                                     262a(i)(1)               42 CFR 1003.910          OIG                      Penalty for each         2016                     327,962                  333,327                  340,130                                                                                              individual who violates                                                                                                                                                                                  safety and security                                                                                                                                                                                      procedures related to                                                                                                                                                                                    handling dangerous                                                                                                                                                                                       biological agents and                                                                                                                                                                                    toxins                                                                                                                                                                                                 Penalty for any other    2016                     655,925                  666,656                  680,262                                                                                              person who violates                                                                                                                                                                                      safety and security                                                                                                                                                                                      procedures related to                                                                                                                                                                                    handling dangerous                                                                                                                                                                                       biological agents and                                                                                                                                                                                    toxins                                                                                                                        300jj-51                 OIG                      Penalty per violation    2016                     1,000,000                1,016,360                1,037,104                                                                                            for committing                                                                                                                                                                                           information blocking                                                                                                                                   1320a-7a(a)  fn5       42 CFR 1003.210(a)(1)    OIG                      Penalty for knowingly    2018                     15,024                   15,270                   20,000                                                                                               presenting or causing to                                                                                                                                                                                 be presented to an                                                                                                                                                                                       officer, employee, or                                                                                                                                                                                    agent of the United                                                                                                                                                                                      States a false claim                                                                                                                                                                                   Penalty for knowingly    2018                     15,024                   15,270                   20,000                                                                                               presenting or causing to                                                                                                                                                                                 be presented a request                                                                                                                                                                                   for payment which                                                                                                                                                                                        violates the terms of an                                                                                                                                                                                 assignment, agreement,                                                                                                                                                                                   or PPS agreement                                                                                                                                     42 CFR 1003.210(a)(2)    Penalty for knowingly    2018                     22,537                   22,906                   30,000                                                                                               giving or causing to be                                                                                                                                                                                  presented to a                                                                                                                                                                                           participating provider                                                                                                                                                                                   or supplier false or                                                                                                                                                                                     misleading information                                                                                                                                                                                   that could reasonably be                                                                                                                                                                                 expected to influence a                                                                                                                                                                                  discharge decision                                                                                                                                                            42 CFR 1003.210(a)(3)    Penalty for an excluded  2018                     15,024                   15,270                   20,000                                                                                               party retaining                                                                                                                                                                                          ownership or control                                                                                                                                                                                     interest in a                                                                                                                                                                                            participating entity                                                                                                                                                          42 CFR 1003.1010         Penalty for remuneration 2018                     15,024                   15,270                   20,000                                                                                               offered to induce                                                                                                                                                                                        program beneficiaries to                                                                                                                                                                                 use particular                                                                                                                                                                                           providers,                                                                                                                                                                                               practitioners, or                                                                                                                                                                                        suppliers                                                                                                                                                                     42 CFR 1003.210(a)(4)    Penalty for employing or 2018                     14,718                   14,959                   20,000                                                                                               contracting with an                                                                                                                                                                                      excluded individual                                                                                                                                                           42 CFR 1003.310(a)(3)    Penalty for knowing and  2018                     73,588                   74,792                   100,000                                                                                              willful solicitation,                                                                                                                                                                                    receipt, offer, or                                                                                                                                                                                       payment of remuneration                                                                                                                                                                                  for referring an                                                                                                                                                                                         individual for a service                                                                                                                                                                                 or for purchasing,                                                                                                                                                                                       leasing, or ordering an                                                                                                                                                                                  item to be paid for by a                                                                                                                                                                                 Federal health care                                                                                                                                                                                      program                                                                                                                                                                       42 CFR 1003.210(a)(1)    Penalty for ordering or  2018                     10,874                   11,052                   20,000                                                                                               prescribing medical or                                                                                                                                                                                   other item or service                                                                                                                                                                                    during a period in which                                                                                                                                                                                 the person was excluded                                                                                                                                                       42 CFR 1003.210(a)(6)    Penalty for knowingly    2018                     54,372                   55,262                   100,000                                                                                              making or causing to be                                                                                                                                                                                  made a false statement,                                                                                                                                                                                  omission or                                                                                                                                                                                              misrepresentation of a                                                                                                                                                                                   material fact in any                                                                                                                                                                                     application, bid, or                                                                                                                                                                                     contract to participate                                                                                                                                                                                  or enroll as a provider                                                                                                                                                                                  or supplier                                                                                                                                                                   42 CFR 1003.210(a)(8)    Penalty for knowing of   2018                     10,874                   11,052                   20,000                                                                                               an overpayment and                                                                                                                                                                                       failing to report and                                                                                                                                                                                    return                                                                                                                                                                        42 CFR 1003.210(a)(7)    Penalty for making or    2018                     54,372                   55,262                   100,000                                                                                              using a false record or                                                                                                                                                                                  statement that is                                                                                                                                                                                        material to a false or                                                                                                                                                                                   fraudulent claim                                                                                                                                                              42 CFR 1003.210(a)(9)    Penalty for failure to   2018                     16,312                   16,579                   30,000                                                                                               grant timely access to                                                                                                                                                                                   HHS OIG for audits,                                                                                                                                                                                      investigations,                                                                                                                                                                                          evaluations, and other                                                                                                                                                                                   statutory functions of                                                                                                                                                                                   HHS OIG                                                                                                                                                1320a-7a(b)  fn5       OIG                      Penalty for payments by  2018                     4,313                    4,384                    5,000                                                                                                a hospital or critical                                                                                                                                                                                   access hospital to                                                                                                                                                                                       induce a physician to                                                                                                                                                                                    reduce or limit services                                                                                                                                                                                 to individuals under                                                                                                                                                                                     direct care of physician                                                                                                                                                                                 or who are entitled to                                                                                                                                                                                   certain medical                                                                                                                                                                                          assistance benefits                                                                                                                                                           Penalty for physicians   2018                     4,313                    4,384                    5,000                                                                                                who knowingly receive                                                                                                                                                                                    payments from a hospital                                                                                                                                                                                 or critical access                                                                                                                                                                                       hospital to induce such                                                                                                                                                                                  physician to reduce or                                                                                                                                                                                   limit services to                                                                                                                                                                                        individuals under direct                                                                                                                                                                                 care of physician or who                                                                                                                                                                                 are entitled to certain                                                                                                                                                                                  medical assistance                                                                                                                                                                                       benefits                                                                                                                                                                                               42 CFR 1003.210(a)(10)   Penalty for a physician  2018                     7,512                    7,635                    10,000                                                                                               who executes a document                                                                                                                                                                                  that falsely certifies                                                                                                                                                                                   home health needs for                                                                                                                                                                                    Medicare beneficiaries                                                                                                                                 1320a-7e(b)(6)(A)        42 CFR 1003.810          OIG                      Penalty for failure to   2016                     36,794                   37,396                   38,159                                                                                               report any final adverse                                                                                                                                                                                 action taken against a                                                                                                                                                                                   health care provider,                                                                                                                                                                                    supplier, or                                                                                                                                                                                             practitioner                                                                                                                  1320b-10(b)(1)           42 CFR 1003.610(a)       OIG                      Penalty for the misuse   2016                     9,893                    10,055                   10,260                                                                                               of words, symbols, or                                                                                                                                                                                    emblems in                                                                                                                                                                                               communications in a                                                                                                                                                                                      manner in which a person                                                                                                                                                                                 could falsely construe                                                                                                                                                                                   that such item is                                                                                                                                                                                        approved, endorsed, or                                                                                                                                                                                   authorized by HHS                                                                                                             1320b-10(b)(2)           42 CFR 1003.610(a)       OIG                      Penalty for the misuse   2016                     49,467                   50,276                   51,302                                                                                               of words, symbols, or                                                                                                                                                                                    emblems in a broadcast                                                                                                                                                                                   or telecast in a manner                                                                                                                                                                                  in which a person could                                                                                                                                                                                  falsely construe that                                                                                                                                                                                    such item is approved,                                                                                                                                                                                   endorsed, or authorized                                                                                                                                                                                  by HHS                                                                                                                        1395i-3(b)(3)(B)(ii)(1)  42 CFR 1003.210(a)(11)   OIG                      Penalty for              2016                     2,063                    2,097                    2,140                                                                                                certification of a false                                                                                                                                                                                 statement in assessment                                                                                                                                                                                  of functional capacity                                                                                                                                                                                   of a Skilled Nursing                                                                                                                                                                                     Facility resident                                                                                                                                                                                        assessment                                                                                                                    1395i-3(b)(3)(B)(ii)(2)  42 CFR 1003.210(a)(11)   OIG                      Penalty for causing      2016                     10,314                   10,483                   10,697                                                                                               another to certify or                                                                                                                                                                                    make a false statement                                                                                                                                                                                   in assessment of                                                                                                                                                                                         functional capacity of a                                                                                                                                                                                 Skilled Nursing Facility                                                                                                                                                                                 resident assessment                                                                                                           1395i-3(g)(2)(A)         42 CFR 1003.1310         OIG                      Penalty for any          2016                     4,126                    4,194                    4,280                                                                                                individual who notifies                                                                                                                                                                                  or causes to be notified                                                                                                                                                                                 a Skilled Nursing                                                                                                                                                                                        Facility of the time or                                                                                                                                                                                  date on which a survey                                                                                                                                                                                   is to be conducted                                                                                                            1395w-27(g)(2)(A)        42 CFR 1003.410          OIG                      Penalty for a Medicare   2016                     37,561                   38,175                   38,954                                                                                               Advantage organization                                                                                                                                                                                   that substantially fails                                                                                                                                                                                 to provide medically                                                                                                                                                                                     necessary, required                                                                                                                                                                                      items and services                                                                                                                                                            Penalty for a Medicare   2016                     36,794                   37,396                   38,159                                                                                               Advantage organization                                                                                                                                                                                   that charges excessive                                                                                                                                                                                   premiums                                                                                                                                                                                                                        Penalty for a Medicare   2016                     36,794                   37,396                   38,159                                                                                               Advantage organization                                                                                                                                                                                   that improperly expels                                                                                                                                                                                   or refuses to reenroll a                                                                                                                                                                                 beneficiary                                                                                                                                                                                            Penalty for a Medicare   2016                     147,177                  149,585                  152,638                                                                                              Advantage organization                                                                                                                                                                                   that engages in practice                                                                                                                                                                                 that would reasonably be                                                                                                                                                                                 expected to have the                                                                                                                                                                                     effect of denying or                                                                                                                                                                                     discouraging enrollment                                                                                                                                                                                Penalty per individual   2016                     22,077                   22,438                   22,896                                                                                               who does not enroll as a                                                                                                                                                                                 result of a Medicare                                                                                                                                                                                     Advantage organization's                                                                                                                                                                                 practice that would                                                                                                                                                                                      reasonably be expected                                                                                                                                                                                   to have the effect of                                                                                                                                                                                    denying or discouraging                                                                                                                                                                                  enrollment                                                                                                                                                                                             Penalty for a Medicare   2016                     147,177                  149,585                  152,638                                                                                              Advantage organization                                                                                                                                                                                   misrepresenting or                                                                                                                                                                                       falsifying information                                                                                                                                                                                   to Secretary                                                                                                                                                                                           Penalty for a Medicare   2016                     36,794                   37,396                   38,159                                                                                               Advantage organization                                                                                                                                                                                   misrepresenting or                                                                                                                                                                                       falsifying information                                                                                                                                                                                   to individual or other                                                                                                                                                                                   entity                                                                                                                                                                                                 Penalty for Medicare     2016                     36,794                   37,396                   38,159                                                                                               Advantage organization                                                                                                                                                                                   interfering with                                                                                                                                                                                         provider's advice to                                                                                                                                                                                     enrollee and non-MCO                                                                                                                                                                                     affiliated providers                                                                                                                                                                                     that balance bill                                                                                                                                                                                        enrollees                                                                                                                                                                                              Penalty for a Medicare   2016                     36,794                   37,396                   38,159                                                                                               Advantage organization                                                                                                                                                                                   that employs or                                                                                                                                                                                          contracts with excluded                                                                                                                                                                                  individual or entity                                                                                                                                                                                   Penalty for a Medicare   2016                     36,794                   37,396                   38,159                                                                                               Advantage organization                                                                                                                                                                                   enrolling an individual                                                                                                                                                                                  in without prior written                                                                                                                                                                                 consent                                                                                                                                                                                                Penalty for a Medicare   2016                     36,794                   37,396                   38,159                                                                                               Advantage organization                                                                                                                                                                                   transferring an enrollee                                                                                                                                                                                 to another plan without                                                                                                                                                                                  consent or solely for                                                                                                                                                                                    the purpose of earning a                                                                                                                                                                                 commission                                                                                                                                                                                             Penalty for a Medicare   2016                     36,794                   37,396                   38,159                                                                                               Advantage organization                                                                                                                                                                                   failing to comply with                                                                                                                                                                                   marketing restrictions                                                                                                                                                                                   or applicable                                                                                                                                                                                            implementing regulations                                                                                                                                                                                 or guidance                                                                                                                                                                                            Penalty for a Medicare   2016                     36,794                   37,396                   38,159                                                                                               Advantage organization                                                                                                                                                                                   employing or contracting                                                                                                                                                                                 with an individual or                                                                                                                                                                                    entity who violates                                                                                                                                                                                      1395w-27(g)(1)(A)-(J)                                                                                                         1395w-141(i)(3)                                   OIG                      Penalty for a            2016                     12,856                   13,066                   13,333                                                                                               prescription drug card                                                                                                                                                                                   sponsor that falsifies                                                                                                                                                                                   or misrepresents                                                                                                                                                                                         marketing materials,                                                                                                                                                                                     overcharges program                                                                                                                                                                                      enrollees, or misuse                                                                                                                                                                                     transitional assistance                                                                                                                                                                                  funds                                                                                                                         1395cc(g)                                         OIG                      Penalty for improper     2016                     5,000                    5,082                    5,186                                                                                                billing by Hospitals,                                                                                                                                                                                    Critical Access                                                                                                                                                                                          Hospitals, or Skilled                                                                                                                                                                                    Nursing Facilities                                                                                                            1395dd(d)(1)             42 CFR 1003.510          OIG                      Penalty for a hospital   2016                     103,139                  104,826                  106,965                                                                                              or responsible physician                                                                                                                                                                                 dumping patients needing                                                                                                                                                                                 emergency medical care,                                                                                                                                                                                  if the hospital has 100                                                                                                                                                                                  beds or more                                                                                                                                                                                           Penalty for a hospital   2016                     51,570                   52,414                   53,484                                                                                               or responsible physician                                                                                                                                                                                 dumping patients needing                                                                                                                                                                                 emergency medical care,                                                                                                                                                                                  if the hospital has less                                                                                                                                                                                 than 100 beds                                                                                                                 1395mm(i)(6)(B)(i)       42 CFR 1003.410          OIG                      Penalty for a HMO or     2016                     51,570                   52,414                   53,484                                                                                               competitive plan is such                                                                                                                                                                                 plan substantially fails                                                                                                                                                                                 to provide medically                                                                                                                                                                                     necessary, required                                                                                                                                                                                      items or services                                                                                                                                                                                      Penalty for              2016                     51,570                   52,414                   53,484                                                                                               HMOs/competitive medical                                                                                                                                                                                 plans that charge                                                                                                                                                                                        premiums in excess of                                                                                                                                                                                    permitted amounts                                                                                                                                                                                      Penalty for a HMO or     2016                     51,570                   52,414                   53,484                                                                                               competitive medical plan                                                                                                                                                                                 that expels or refuses                                                                                                                                                                                   to reenroll an                                                                                                                                                                                           individual per                                                                                                                                                                                           prescribed conditions                                                                                                                                                                                  Penalty for a HMO or     2016                     206,278                  209,653                  213,932                                                                                              competitive medical plan                                                                                                                                                                                 that implements                                                                                                                                                                                          practices to discourage                                                                                                                                                                                  enrollment of                                                                                                                                                                                            individuals needing                                                                                                                                                                                      services in future                                                                                                                                                                                     Penalty per individual   2016                     29,680                   30,166                   30,782                                                                                               not enrolled in a plan                                                                                                                                                                                   as a result of a HMO or                                                                                                                                                                                  competitive medical plan                                                                                                                                                                                 that implements                                                                                                                                                                                          practices to discourage                                                                                                                                                                                  enrollment of                                                                                                                                                                                            individuals needing                                                                                                                                                                                      services in the future                                                                                                                                                                                 Penalty for a HMO or     2016                     206,278                  209,653                  213,932                                                                                              competitive medical plan                                                                                                                                                                                 that misrepresents or                                                                                                                                                                                    falsifies information to                                                                                                                                                                                 the Secretary                                                                                                                                                                                          Penalty for a HMO or     2016                     51,570                   52,414                   53,484                                                                                               competitive medical plan                                                                                                                                                                                 that misrepresents or                                                                                                                                                                                    falsifies information to                                                                                                                                                                                 an individual or any                                                                                                                                                                                     other entity                                                                                                                                                                                           Penalty for failure by   2016                     51,570                   52,414                   53,484                                                                                               HMO or competitive                                                                                                                                                                                       medical plan to assure                                                                                                                                                                                   prompt payment of                                                                                                                                                                                        Medicare risk sharing                                                                                                                                                                                    contracts or incentive                                                                                                                                                                                   plan provisions                                                                                                                                                                                        Penalty for HMO that     2016                     47,340                   48,114                   49,096                                                                                               employs or contracts                                                                                                                                                                                     with excluded individual                                                                                                                                                                                 or entity                                                                                                                     1395nn(g)(3)             42 CFR 1003.310          OIG                      Penalty for submitting   2016                     23,863                   24,253                   24,748                                                                                               or causing to be                                                                                                                                                                                         submitted claims in                                                                                                                                                                                      violation of the Stark                                                                                                                                                                                   Law's restrictions on                                                                                                                                                                                    physician self-referrals                                                                                                      1395nn(g)(4)             42 CFR 1003.310          OIG                      Penalty for              2016                     159,089                  161,692                  164,992                                                                                              circumventing Stark                                                                                                                                                                                      Law's restrictions on                                                                                                                                                                                    physician self-referrals                                                                                                      1395ss(d)(1)             42 CFR 1003.1110         OIG                      Penalty for a material   2016                     9,893                    10,055                   10,260                                                                                               misrepresentation                                                                                                                                                                                        regarding Medigap                                                                                                                                                                                        compliance policies                                                                                                           1395ss(d)(2)             42 CFR 1003.1110         OIG                      Penalty for selling      2016                     9,893                    10,055                   10,260                                                                                               Medigap policy under                                                                                                                                                                                     false pretense                                                                                                                1395ss(d)(3)(A)(ii)      42 CFR 1003.1110         OIG                      Penalty for an issuer    2016                     44,539                   45,268                   46,192                                                                                               that sells health                                                                                                                                                                                        insurance policy that                                                                                                                                                                                    duplicates benefits                                                                                                                                                                                    Penalty for someone      2016                     26,723                   27,160                   27,714                                                                                               other than issuer that                                                                                                                                                                                   sells health insurance                                                                                                                                                                                   that duplicates benefits                                                                                                      1395ss(d)(4)(A)          42 CFR 1003.1110         OIG                      Penalty for using mail   2016                     9,893                    10,055                   10,260                                                                                               to sell a non-approved                                                                                                                                                                                   Medigap insurance policy                                                                                                      1396b(m)(5)(B)(i)        42 CFR 1003.410          OIG                      Penalty for a Medicaid   2016                     49,467                   50,276                   51,302                                                                                               MCO that substantially                                                                                                                                                                                   fails to provide                                                                                                                                                                                         medically necessary,                                                                                                                                                                                     required items or                                                                                                                                                                                        services                                                                                                                                                                                               Penalty for a Medicaid   2016                     49,467                   50,276                   51,302                                                                                               MCO that charges                                                                                                                                                                                         excessive premiums                                                                                                                                                                                     Penalty for a Medicaid   2016                     197,869                  201,106                  205,211                                                                                              MCO that improperly                                                                                                                                                                                      expels or refuses to                                                                                                                                                                                     reenroll a beneficiary                                                                                                                                                                                 Penalty per individual   2016                     29,680                   30,166                   30,782                                                                                               who does not enroll as a                                                                                                                                                                                 result of a Medicaid                                                                                                                                                                                     MCO's practice that                                                                                                                                                                                      would reasonably be                                                                                                                                                                                      expected to have the                                                                                                                                                                                     effect of denying or                                                                                                                                                                                     discouraging enrollment                                                                                                                                                                                Penalty for a Medicaid   2016                     197,869                  201,106                  205,211                                                                                              MCO misrepresenting or                                                                                                                                                                                   falsifying information                                                                                                                                                                                   to the Secretary                                                                                                                                                                                       Penalty for a Medicaid   2016                     49,467                   50,276                   51,302                                                                                               MCO misrepresenting or                                                                                                                                                                                   falsifying information                                                                                                                                                                                   to an individual or                                                                                                                                                                                      another entity                                                                                                                                                                                         Penalty for a Medicaid   2016                     44,539                   45,268                   46,192                                                                                               MCO that fails to comply                                                                                                                                                                                 with contract                                                                                                                                                                                            requirements with                                                                                                                                                                                        respect to physician                                                                                                                                                                                     incentive plans                                                                                                               1396r(b)(3) (B)(ii)(I)   42 CFR 1003.210(a)(11)   OIG                      Penalty for willfully    2016                     2,063                    2,097                    2,140                                                                                                and knowingly certifying                                                                                                                                                                                 a material and false                                                                                                                                                                                     statement in a Skilled                                                                                                                                                                                   Nursing Facility                                                                                                                                                                                         resident assessment                                                                                                           1396r(b)(3)(B)(ii)(II)   42 CFR 1003.210(a)(11)   OIG                      Penalty for willfully    2016                     10,314                   10,483                   10,697                                                                                               and knowingly causing                                                                                                                                                                                    another individual to                                                                                                                                                                                    certify a material and                                                                                                                                                                                   false statement in a                                                                                                                                                                                     Skilled Nursing Facility                                                                                                                                                                                 resident assessment                                                                                                           1396r(g)(2)(A)(i)        42 CFR 1003.1310         OIG                      Penalty for notifying or 2016                     4,126                    4,194                    4,280                                                                                                causing to be notified a                                                                                                                                                                                 Skilled Nursing Facility                                                                                                                                                                                 of the time or date on                                                                                                                                                                                   which a survey is to be                                                                                                                                                                                  conducted                                                                                                                     1396r-8(b)(3)(B)         42 CFR 1003.1210         OIG                      Penalty for the knowing  2016                     178,156                  181,071                  184,767                                                                                              provision of false                                                                                                                                                                                       information or refusing                                                                                                                                                                                  to provide information                                                                                                                                                                                   about charges or prices                                                                                                                                                                                  of a covered outpatient                                                                                                                                                                                  drug                                                                                                                          1396r-8(b)(3)(C)(i)      42 CFR 1003.1210         OIG                      Penalty per day for      2016                     17,816                   18,107                   18,477                                                                                               failure to timely                                                                                                                                                                                        provide information by                                                                                                                                                                                   drug manufacturer with                                                                                                                                                                                   rebate agreement                                                                                                              1396r-8(b)(3)(C)(ii)     42 CFR 1003.1210         OIG                      Penalty for knowing      2016                     178,156                  181,071                  184,767                                                                                              provision of false                                                                                                                                                                                       information by drug                                                                                                                                                                                      manufacturer with rebate                                                                                                                                                                                 agreement                                                                                                                     1396t(i)(3)(A)           42 CFR 1003.1310         OIG                      Penalty for notifying    2016                     3,563                    3,621                    3,695                                                                                                home and community-based                                                                                                                                                                                 providers or settings of                                                                                                                                                                                 survey                                                                                                                        11131(c)                 42 CFR 1003.810          OIG                      Penalty for failing to   2016                     21,563                   21,916                   22,363                                                                                               report a medical                                                                                                                                                                                         malpractice claim to                                                                                                                                                                                     National Practitioner                                                                                                                                                                                    Data Bank                                                                                                                     11137(b)(2)              42 CFR 1003.810          OIG                      Penalty for breaching    2016                     21,563                   21,916                   22,363                                                                                               confidentiality of                                                                                                                                                                                       information reported to                                                                                                                                                                                  National Practitioner                                                                                                                                                                                    Data Bank                                                                                                                     299b-22(f)(1)            42 CFR 3.404             OCR                      Penalty for violation of 2016                     11,940                   12,135                   12,383                                                                                               confidentiality                                                                                                                                                                                          provision of the Patient                                                                                                                                                                                 Safety and Quality                                                                                                                                                                                       Improvement Act                                                                                                               1320(d)-5(a)             45 CFR 160.404(b)(1)(i), OCR                      Penalty for each         2016                     150                      152                      155                                                (ii)                                              pre-February 18, 2009                                                                                                                                                                                    violation of the HIPAA                                                                                                                                                                                   administrative                                                                                                                                                                                           simplification                                                                                                                                                                                           provisions                                                                                                                                                                                             Calendar Year Cap        2016                     37,561                   38,175                   38,954                                           45 CFR                   OCR                      Penalty for each                                                                                                                                       160.404(b)(2)(i)(A), (B)                          February 18, 2009 or                                                                                                                                                                                     later violation of a                                                                                                                                                                                     HIPAA administrative                                                                                                                                                                                     simplification provision                                                                                                                                                                                 in which it is                                                                                                                                                                                           established that the                                                                                                                                                                                     covered entity or                                                                                                                                                                                        business associate did                                                                                                                                                                                   not know and by                                                                                                                                                                                          exercising reasonable                                                                                                                                                                                    diligence, would not                                                                                                                                                                                     have known that the                                                                                                                                                                                      covered entity or                                                                                                                                                                                        business associate                                                                                                                                                                                       violated such a                                                                                                                                                                                          provision                                                                                                                                                                                              Minimum                  2016                     110                      112                      114                                                                                                Maximum                  2016                     55,010                   55,910                   57,051                                                                                             Calendar Year Cap        2016                     1,650,300                1,677,299                1,711,533                                        45 CFR                   OCR                      Penalty for each                                                                                                                                       160.404(b)(2)(ii)(A),                             February 18, 2009 or                                                                                                                                   (B)                                               later violation of a                                                                                                                                                                                     HIPAA administrative                                                                                                                                                                                     simplification provision                                                                                                                                                                                 in which it is                                                                                                                                                                                           established that the                                                                                                                                                                                     violation was due to                                                                                                                                                                                     reasonable cause and not                                                                                                                                                                                 to willful neglect                                                                                                                                                                                     Minimum                  2016                     1,100                    1,118                    1,141                                                                                              Maximum                  2016                     55,010                   55,910                   57,051                                                                                             Calendar Year Cap        2016                     1,650,300                1,677,299                1,711,533                                        45 CFR                   OCR                      Penalty for each                                                                                                                                       160.404(b)(2)(iii)(A),                            February 18, 2009 or                                                                                                                                   (B)                                               later violation of a                                                                                                                                                                                     HIPAA administrative                                                                                                                                                                                     simplification provision                                                                                                                                                                                 in which it is                                                                                                                                                                                           established that the                                                                                                                                                                                     violation was due to                                                                                                                                                                                     willful neglect and was                                                                                                                                                                                  corrected during the                                                                                                                                                                                     30-day period beginning                                                                                                                                                                                  on the first date the                                                                                                                                                                                    covered entity or                                                                                                                                                                                        business associate knew,                                                                                                                                                                                 or, by exercising                                                                                                                                                                                        reasonable diligence,                                                                                                                                                                                    would have known that                                                                                                                                                                                    the violation occurred                                                                                                                                                                                 Minimum                  2016                     11,002                   11,182                   11,410                                                                                             Maximum                  2016                     55,010                   55,910                   57,051                                                                                             Calendar Year Cap        2016                     1,650,300                1,677,299                1,711,533                                        45 CFR                   OCR                      Penalty for each                                                                                                                                       160.404(b)(2)(iv)(A),                             February 18, 2009 or                                                                                                                                   (B)                                               later violation of a                                                                                                                                                                                     HIPAA administrative                                                                                                                                                                                     simplification provision                                                                                                                                                                                 in which it is                                                                                                                                                                                           established that the                                                                                                                                                                                     violation was due to                                                                                                                                                                                     willful neglect and was                                                                                                                                                                                  not corrected during the                                                                                                                                                                                 30-day period beginning                                                                                                                                                                                  on the first date the                                                                                                                                                                                    covered entity or                                                                                                                                                                                        business associate knew,                                                                                                                                                                                 or by exercising                                                                                                                                                                                         reasonable diligence,                                                                                                                                                                                    would have known that                                                                                                                                                                                    the violation occurred                                                                                                                                                                                 Minimum                  2016                     55,010                   55,910                   57,051                                                                                             Maximum                  2016                     1,650,300                1,677,299                1,711,533                                                                                          Calendar Year Cap        2016                     1,650,300                1,677,299                1,711,533                 263a(h)(2)(B) &          42 CFR 493.1834(d)(2)(i) CMS                      Penalty for a clinical                                                                                                        1395w-2(b)(2)(A)(ii)                                                       laboratory's failure to                                                                                                                                                                                  meet participation and                                                                                                                                                                                   certification                                                                                                                                                                                            requirements and poses                                                                                                                                                                                   immediate jeopardy                                                                                                                                                                                     Minimum                  2016                     6,035                    6,134                    6,259                                                                                              Maximum                  2016                     19,787                   20,111                   20,521                                           42 CFR                   CMS                      Penalty for a clinical   -                                                                                                                             493.1834(d)(2)(ii)                                laboratory's failure to                                                                                                                                                                                  meet participation and                                                                                                                                                                                   certification                                                                                                                                                                                            requirements and the                                                                                                                                                                                     failure does not pose                                                                                                                                                                                    immediate jeopardy                                                                                                                                                                                     Minimum                  2016                     99                       101                      103                                                                                                Maximum                  2016                     5,936                    6,033                    6,156                     300gg-15(f)              45 CFR 147.200(e)        CMS                      Failure to provide the   2016                     1,087                    1,105                    1,128                                                                                                Summary of Benefits and                                                                                                                                                                                  Coverage                                                                                                                      300gg-18                 45 CFR 158.606           CMS                      Penalty for violations   2016                     109                      111                      113                                                                                                  of regulations related                                                                                                                                                                                   to the medical loss                                                                                                                                                                                      ratio reporting and                                                                                                                                                                                      rebating                                                                                                                      1320a-7h(b)(1)           42 CFR 402.105(d)(5), 42 CMS                      Penalty for manufacturer                                                                                                                               CFR 403.912(a) & (c)                              or group purchasing                                                                                                                                                                                      organization failing to                                                                                                                                                                                  report information                                                                                                                                                                                       required under 42 U.S.C.                                                                                                                                                                                 1320a-7h(a), relating to                                                                                                                                                                                 physician ownership or                                                                                                                                                                                   investment interests                                                                                                                                                                                   Minimum                  2016                     1,087                    1,105                    1,128                                                                                              Maximum                  2016                     10,874                   11,052                   11,278                                                                                             Calendar Year Cap        2016                     163,117                  165,786                  169,170                   1320a-7h(b)(2)           42 CFR 402.105(h), 42    CMS                      Penalty for manufacturer                                                                                                                               CFR 403 912(b) & (c)                              or group purchasing                                                                                                                                                                                      organization knowingly                                                                                                                                                                                   failing to report                                                                                                                                                                                        information required                                                                                                                                                                                     under 42 U.S.C.                                                                                                                                                                                          1320a-7h(a) , relating                                                                                                                                                                                   to physician ownership                                                                                                                                                                                   or investment interests                                                                                                                                                                                Minimum                  2016                     10,874                   11,052                   11,278                                                                                             Maximum                  2016                     108,745                  110,524                  112,780                                                                                            Calendar Year Cap        2016                     1,087,450                1,105,241                1,127,799                 1320a-7j(h)(3)(A)                                 CMS                      Penalty for an           2016                     108,745                  110,524                  112,780                                                                                              administrator of a                                                                                                                                                                                       facility that fails to                                                                                                                                                                                   comply with notice                                                                                                                                                                                       requirements for the                                                                                                                                                                                     closure of a facility                                                                                                                                42 CFR                   CMS                      Minimum penalty for the  2016                     544                      553                      564                                                488.446(a)(1),(2), & (3)                          first offense of an                                                                                                                                                                                      administrator who fails                                                                                                                                                                                  to provide notice of                                                                                                                                                                                     facility closure                                                                                                                                                                                       Minimum penalty for the  2016                     1,631                    1,658                    1,692                                                                                                second offense of an                                                                                                                                                                                     administrator who fails                                                                                                                                                                                  to provide notice of                                                                                                                                                                                     facility closure                                                                                                                                                                                       Minimum penalty for the  2016                     3,262                    3,315                    3,383                                                                                                third and subsequent                                                                                                                                                                                     offenses of an                                                                                                                                                                                           administrator who fails                                                                                                                                                                                  to provide notice of                                                                                                                                                                                     facility closure                                                                                                              1320a-8(a)(1)                                     CMS                      Penalty for an entity    2016                     7,954                    8,084                    8,249                                                                                                knowingly making a false                                                                                                                                                                                 statement or                                                                                                                                                                                             representation of                                                                                                                                                                                        material fact in the                                                                                                                                                                                     determination of the                                                                                                                                                                                     amount of benefits or                                                                                                                                                                                    payments related to                                                                                                                                                                                      old-age, survivors, and                                                                                                                                                                                  disability insurance                                                                                                                                                                                     benefits, special                                                                                                                                                                                        benefits for certain                                                                                                                                                                                     World War II veterans,                                                                                                                                                                                   or supplemental security                                                                                                                                                                                 income for the aged,                                                                                                                                                                                     blind, and disabled                                                                                                                                                                                    Penalty for violation of 2016                     7,500                    7,623                    7,779                                                                                                42 U.S.C. 1320a-8(a)(1)                                                                                                                                                                                  if the violator is a                                                                                                                                                                                     person who receives a                                                                                                                                                                                    fee or other income for                                                                                                                                                                                  services performed in                                                                                                                                                                                    connection with                                                                                                                                                                                          determination of the                                                                                                                                                                                     benefit amount or the                                                                                                                                                                                    person is a physician or                                                                                                                                                                                 other health care                                                                                                                                                                                        provider who submits                                                                                                                                                                                     evidence in connection                                                                                                                                                                                   with such a                                                                                                                                                                                              determination                                                                                                                 1320a-8(a)(3)                                     CMS                      Penalty for a            2016                     6,229                    6,331                    6,460                                                                                                representative payee                                                                                                                                                                                     (under 42 U.S.C. 405(j),                                                                                                                                                                                 1007, or 1383(a)(2))                                                                                                                                                                                     converting any part of a                                                                                                                                                                                 received payment from                                                                                                                                                                                    the benefit programs                                                                                                                                                                                     described in the                                                                                                                                                                                         previous civil monetary                                                                                                                                                                                  penalty to a use other                                                                                                                                                                                   than for the benefit of                                                                                                                                                                                  the beneficiary                                                                                                               1320b-25(c)(1)(A)                                 CMS                      Penalty for failure of   2016                     217,490                  221,048                  225,560                                                                                              covered individuals to                                                                                                                                                                                   report to the Secretary                                                                                                                                                                                  and 1 or more law                                                                                                                                                                                        enforcement officials                                                                                                                                                                                    any reasonable suspicion                                                                                                                                                                                 of a crime against a                                                                                                                                                                                     resident, or individual                                                                                                                                                                                  receiving care, from a                                                                                                                                                                                   long-term care facility                                                                                                       1320b-25(c)(2)(A)                                 CMS                      Penalty for failure of   2016                     326,235                  331,572                  338,339                                                                                              covered individuals to                                                                                                                                                                                   report to the Secretary                                                                                                                                                                                  and 1 or more law                                                                                                                                                                                        enforcement officials                                                                                                                                                                                    any reasonable suspicion                                                                                                                                                                                 of a crime against a                                                                                                                                                                                     resident, or individual                                                                                                                                                                                  receiving care, from a                                                                                                                                                                                   long-term care facility                                                                                                                                                                                  if such failure                                                                                                                                                                                          exacerbates the harm to                                                                                                                                                                                  the victim of the crime                                                                                                                                                                                  or results in the harm                                                                                                                                                                                   to another individual                                                                                                         1320b-25(d)(2)                                    CMS                      Penalty for a long-term  2016                     217,490                  221,048                  225,560                                                                                              care facility that                                                                                                                                                                                       retaliates against any                                                                                                                                                                                   employee because of                                                                                                                                                                                      lawful acts done by the                                                                                                                                                                                  employee, or files a                                                                                                                                                                                     complaint or report with                                                                                                                                                                                 the State professional                                                                                                                                                                                   disciplinary agency                                                                                                                                                                                      against an employee or                                                                                                                                                                                   nurse for lawful acts                                                                                                                                                                                    done by the employee or                                                                                                                                                                                  nurse                                                                                                                         1395b-7(b)(2)(B)         42 CFR 402.105(g)        CMS                      Penalty for any person   2016                     147                      149                      152                                                                                                  who knowingly and                                                                                                                                                                                        willfully fails to                                                                                                                                                                                       furnish a beneficiary                                                                                                                                                                                    with an itemized                                                                                                                                                                                         statement of items or                                                                                                                                                                                    services within 30 days                                                                                                                                                                                  of the beneficiary's                                                                                                                                                                                     request                                                                                                                       1395i-3(h)(2)(B)(ii)(I)  42 CFR                   CMS                      Penalty per day for a                                                                                                                                  488.408(d)(1)(iii)                                Skilled Nursing Facility                                                                                                                                                                                 that has a Category 2                                                                                                                                                                                    violation of                                                                                                                                                                                             certification                                                                                                                                                                                            requirements                                                                                                                                                                                           Minimum                  2016                     103                      105                      107                                                                                                Maximum                  2016                     6,188                    6,289                    6,417                                            42 CFR 488.408(d)(1)(iv) CMS                      Penalty per instance of                                                                                                                                                                                  Category 2 noncompliance                                                                                                                                                                                 by a Skilled Nursing                                                                                                                                                                                     Facility                                                                                                                                                                                               Minimum                  2016                     2,063                    2,097                    2,140                                                                                              Maximum                  2016                     20,628                   20,965                   21,393                                           42 CFR                   CMS                      Penalty per day for a                                                                                                                                  488.408(e)(1)(iii)                                Skilled Nursing Facility                                                                                                                                                                                 that has a Category 3                                                                                                                                                                                    violation of                                                                                                                                                                                             certification                                                                                                                                                                                            requirements                                                                                                                                                                                           Minimum                  2016                     6,291                    6,394                    6,525                                                                                              Maximum                  2016                     20,628                   20,965                   21,393                                           42 CFR 488.408(e)(1)(iv) CMS                      Penalty per instance of                                                                                                                                                                                  Category 3 noncompliance                                                                                                                                                                                 by a Skilled Nursing                                                                                                                                                                                     Facility                                                                                                                                                                                               Minimum                  2016                     2,063                    2,097                    2,140                                                                                              Maximum                  2016                     20,628                   20,965                   21,393                                           42 CFR 488.408           CMS                      Penalty per day and per                                                                                                                                (e)(2)(ii)                                        instance for a Skilled                                                                                                                                                                                   Nursing Facility that                                                                                                                                                                                    has Category 3                                                                                                                                                                                           noncompliance with                                                                                                                                                                                       Immediate Jeopardy                                                                                                                                                                                     Per Day (Minimum)        2016                     6,291                    6,394                    6,525                                                                                              Per Day (Maximum)        2016                     20,628                   20,965                   21,393                                                                                             Per Instance (Minimum)   2016                     2,063                    2,097                    2,140                                                                                              Per Instance (Maximum)   2016                     20,628                   20,965                   21,393                                           42 CFR 488.438(a)(1)(i)  CMS                      Penalty per day of a                                                                                                                                                                                     Skilled Nursing Facility                                                                                                                                                                                 that fails to meet                                                                                                                                                                                       certification                                                                                                                                                                                            requirements. These                                                                                                                                                                                      amounts represent the                                                                                                                                                                                    upper range per day                                                                                                                                                                                    Minimum                  2016                     6,291                    6,394                    6,524                                                                                              Maximum                  2016                     20,628                   20,965                   21,393                                           42 CFR 488.438(a)(1)(ii) CMS                      Penalty per day of a                                                                                                                                                                                     Skilled Nursing Facility                                                                                                                                                                                 that fails to meet                                                                                                                                                                                       certification                                                                                                                                                                                            requirements. These                                                                                                                                                                                      amounts represent the                                                                                                                                                                                    lower range per day                                                                                                                                                                                    Minimum                  2016                     103                      105                      107                                                                                                Maximum                  2016                     6,188                    6,289                    6,418                                            42 CFR 488.438(a)(2)     CMS                      Penalty per instance of                                                                                                                                                                                  a Skilled Nursing                                                                                                                                                                                        Facility that fails to                                                                                                                                                                                   meet certification                                                                                                                                                                                       requirements                                                                                                                                                                                           Minimum                  2016                     2,063                    2,097                    2,140                                                                                              Maximum                  2016                     20,628                   20,965                   21,393                    1395l(h)(5)(D)  fn5    42 CFR 402.105(d)(2)(i)  CMS                      Penalty for knowingly,   2018                     15,024                   15,270                   30,000                                                                                               willfully, and                                                                                                                                                                                           repeatedly billing for a                                                                                                                                                                                 clinical diagnostic                                                                                                                                                                                      laboratory test other                                                                                                                                                                                    than on an                                                                                                                                                                                               assignment-related                                                                                                                                                                                       basis. (Penalties are                                                                                                                                                                                    assessed in the same                                                                                                                                                                                     manner as 42 U.S.C.                                                                                                                                                                                      1395u(j)(2)(B), which is                                                                                                                                                                                 assessed according to                                                                                                                                                                                    1320a-7a(a))                                                                                                                  1395l(i)(6)                                       CMS                      Penalty for knowingly    2016                     3,957                    4,022                    4,104                                                                                                and willfully presenting                                                                                                                                                                                 or causing to be                                                                                                                                                                                         presented a bill or                                                                                                                                                                                      request for payment for                                                                                                                                                                                  an intraocular lens                                                                                                                                                                                      inserted during or after                                                                                                                                                                                 cataract surgery for                                                                                                                                                                                     which the Medicare                                                                                                                                                                                       payment rate includes                                                                                                                                                                                    the cost of acquiring                                                                                                                                                                                    the class of lens                                                                                                                                                                                        involved                                                                                                                      1395l(q)(2)(B)(i)        42 CFR 402.105(a)        CMS                      Penalty for knowingly    2016                     3,787                    3,849                    3,928                                                                                                and willfully failing to                                                                                                                                                                                 provide information                                                                                                                                                                                      about a referring                                                                                                                                                                                        physician when seeking                                                                                                                                                                                   payment on an unassigned                                                                                                                                                                                 basis                                                                                                                         1395m(a)(11)(A) fn5      42 CFR 402.1(c)(4),      CMS                      Penalty for any durable  2018                     15,024                   15,270                   30,000                                             402.105(d)(2)(ii)                                 medical equipment                                                                                                                                                                                        supplier that knowingly                                                                                                                                                                                  and willfully charges                                                                                                                                                                                    for a covered service                                                                                                                                                                                    that is furnished on a                                                                                                                                                                                   rental basis after the                                                                                                                                                                                   rental payments may no                                                                                                                                                                                   longer be made.                                                                                                                                                                                          (Penalties are assessed                                                                                                                                                                                  in the same manner as 42                                                                                                                                                                                 U.S.C. 1395u(j)(2)(B),                                                                                                                                                                                   which is assessed                                                                                                                                                                                        according to                                                                                                                                                                                             1320a-7a(a))                                                                                                                  1395m(a)(18)(B)  fn5   42 CFR 402.1(c)(5),      CMS                      Penalty for any          2018                     15,024                   15,270                   30,000                                             402.105(d)(2)(iii)                                nonparticipating durable                                                                                                                                                                                 medical equipment                                                                                                                                                                                        supplier that knowingly                                                                                                                                                                                  and willfully fails to                                                                                                                                                                                   make a refund to                                                                                                                                                                                         Medicare beneficiaries                                                                                                                                                                                   for a covered service                                                                                                                                                                                    for which payment is                                                                                                                                                                                     precluded due to an                                                                                                                                                                                      unsolicited telephone                                                                                                                                                                                    contact from the                                                                                                                                                                                         supplier. (Penalties are                                                                                                                                                                                 assessed in the same                                                                                                                                                                                     manner as 42 U.S.C.                                                                                                                                                                                      1395u(j)(2)(B), which is                                                                                                                                                                                 assessed according to                                                                                                                                                                                    1320a-7a(a))                                                                                                                  1395m(b)(5)(C)  fn5    42 CFR 402.1(c)(6),      CMS                      Penalty for any          2018                     15,024                   15,270                   30,000                                             402.105(d)(2)(iv)                                 nonparticipating                                                                                                                                                                                         physician or supplier                                                                                                                                                                                    that knowingly and                                                                                                                                                                                       willfully charges a                                                                                                                                                                                      Medicare beneficiary                                                                                                                                                                                     more than the limiting                                                                                                                                                                                   charge for radiologist                                                                                                                                                                                   services. (Penalties are                                                                                                                                                                                 assessed in the same                                                                                                                                                                                     manner as 42 U.S.C.                                                                                                                                                                                      1395u(j)(2)(B), which is                                                                                                                                                                                 assessed according to                                                                                                                                                                                    1320a-7a(a))                                                                                                                  1395m(h)(3)  fn5       42 CFR 402.1(c)(8),      CMS                      Penalty for any supplier 2018                     15,024                   15,270                   30,000                                             402.105(d)(2)(vi)                                 of prosthetic devices,                                                                                                                                                                                   orthotics, and                                                                                                                                                                                           prosthetics that knowing                                                                                                                                                                                 and willfully charges                                                                                                                                                                                    for a covered prosthetic                                                                                                                                                                                 device, orthotic, or                                                                                                                                                                                     prosthetic that is                                                                                                                                                                                       furnished on a rental                                                                                                                                                                                    basis after the rental                                                                                                                                                                                   payment may no longer be                                                                                                                                                                                 made. (Penalties are                                                                                                                                                                                     assessed in the same                                                                                                                                                                                     manner as 42 U.S.C.                                                                                                                                                                                      1395m(a)(11)(A), that is                                                                                                                                                                                 in the same manner as                                                                                                                                                                                    1395u(j)(2)(B), which is                                                                                                                                                                                 assessed according to                                                                                                                                                                                    1320a-7a(a))                                                                                                                  1395m(j)(2)(A)(iii)                               CMS                      Penalty for any supplier 2016                     1,591                    1,617                    1,650                                                                                                of durable medical                                                                                                                                                                                       equipment including a                                                                                                                                                                                    supplier of prosthetic                                                                                                                                                                                   devices, prosthetics,                                                                                                                                                                                    orthotics, or supplies                                                                                                                                                                                   that knowingly and                                                                                                                                                                                       willfully distributes a                                                                                                                                                                                  certificate of medical                                                                                                                                                                                   necessity in violation                                                                                                                                                                                   of Section                                                                                                                                                                                               1834(j)(2)(A)(i) of the                                                                                                                                                                                  Act or fails to provide                                                                                                                                                                                  the information required                                                                                                                                                                                 under Section                                                                                                                                                                                            1834(j)(2)(A)(ii) of the                                                                                                                                                                                 Act                                                                                                                           1395m(j)(4)  fn5       42 CFR 402.1(c)(10),     CMS                      Penalty for any supplier 2018                     15,024                   15,270                   30,000                                             402.105(d)(2)(vii)                                of durable medical                                                                                                                                                                                       equipment, including a                                                                                                                                                                                   supplier of prosthetic                                                                                                                                                                                   devices, prosthetics,                                                                                                                                                                                    orthotics, or supplies                                                                                                                                                                                   that knowingly and                                                                                                                                                                                       willfully fails to make                                                                                                                                                                                  refunds in a timely                                                                                                                                                                                      manner to Medicare                                                                                                                                                                                       beneficiaries for series                                                                                                                                                                                 billed other than on as                                                                                                                                                                                  assignment-related basis                                                                                                                                                                                 under certain                                                                                                                                                                                            conditions. (Penalties                                                                                                                                                                                   are assessed in the same                                                                                                                                                                                 manner as 42 U.S.C.                                                                                                                                                                                      1395m(j)(4) and                                                                                                                                                                                          1395u(j)(2)(B), which is                                                                                                                                                                                 assessed according to                                                                                                                                                                                    1320a-7a(a))                                                                                                                  1395m(k)(6)  fn5       42 CFR 402.1(c)(31),     CMS                      Penalty for any person   2018                     15,024                   15,270                   30,000                                             402.105(d)(3)                                     or entity who knowingly                                                                                                                                                                                  and willfully bills or                                                                                                                                                                                   collects for any                                                                                                                                                                                         outpatient therapy                                                                                                                                                                                       services or                                                                                                                                                                                              comprehensive outpatient                                                                                                                                                                                 rehabilitation services                                                                                                                                                                                  on other than an                                                                                                                                                                                         assignment-related                                                                                                                                                                                       basis. (Penalties are                                                                                                                                                                                    assessed in the same                                                                                                                                                                                     manner as 42 U.S.C.                                                                                                                                                                                      1395m(k)(6) and                                                                                                                                                                                          1395u(j)(2)(B), which is                                                                                                                                                                                 assessed according to                                                                                                                                                                                    1320a-7a(a))                                                                                                                  1395m(l)(6) fn5          42 CFR 402.1(c)(32),     CMS                      Penalty for any supplier 2018                     15,024                   15,270                   30,000                                             402.105(d)(4)                                     of ambulance services                                                                                                                                                                                    who knowingly and                                                                                                                                                                                        willfully fills or                                                                                                                                                                                       collects for any                                                                                                                                                                                         services on other than                                                                                                                                                                                   an assignment-related                                                                                                                                                                                    basis. (Penalties are                                                                                                                                                                                    assessed in the same                                                                                                                                                                                     manner as 42 U.S.C.                                                                                                                                                                                      1395u(b)(18)(B), which                                                                                                                                                                                   is assessed according to                                                                                                                                                                                 1320a-7a(a))                                                                                                                  1395u(b)(18)(B)  fn5   42 CFR 402.1(c)(11),     CMS                      Penalty for any          2018                     15,024                   15,270                   30,000                                             402.105(d)(2)(viii)                               practitioner specified                                                                                                                                                                                   in Section                                                                                                                                                                                               1842(b)(18)(C) of the                                                                                                                                                                                    Act or other person that                                                                                                                                                                                 knowingly and willfully                                                                                                                                                                                  bills or collects for                                                                                                                                                                                    any services by the                                                                                                                                                                                      practitioners on other                                                                                                                                                                                   than an                                                                                                                                                                                                  assignment-related                                                                                                                                                                                       basis. (Penalties are                                                                                                                                                                                    assessed in the same                                                                                                                                                                                     manner as 42 U.S.C.                                                                                                                                                                                      1395u(j)(2)(B), which is                                                                                                                                                                                 assessed according to                                                                                                                                                                                    1320a-7a(a))                                                                                                                  1395u(j)(2)(B)  fn5    42 CFR 402.1(c)          CMS                      Penalty for any          2018                     15,024                   15,270                   30,000                                                                                               physician who charges                                                                                                                                                                                    more than 125% for a                                                                                                                                                                                     non-participating                                                                                                                                                                                        referral. (Penalties are                                                                                                                                                                                 assessed in the same                                                                                                                                                                                     manner as 42 U.S.C.                                                                                                                                                                                      1320a-7a(a))                                                                                                                  1395u(k)  fn5          42 CFR 402.1(c)(12),     CMS                      Penalty for any          2018                     15,024                   15,270                   30,000                                             402.105(d)(2)(ix)                                 physician who knowingly                                                                                                                                                                                  and willfully presents                                                                                                                                                                                   or causes to be                                                                                                                                                                                          presented a claim for                                                                                                                                                                                    bill for an assistant at                                                                                                                                                                                 a cataract surgery                                                                                                                                                                                       performed on or after                                                                                                                                                                                    March 1, 1987, for which                                                                                                                                                                                 payment may not be made                                                                                                                                                                                  because of section                                                                                                                                                                                       1862(a)(15). (Penalties                                                                                                                                                                                  are assessed in the same                                                                                                                                                                                 manner as 42 U.S.C.                                                                                                                                                                                      1395u(j)(2)(B), which is                                                                                                                                                                                 assessed according to                                                                                                                                                                                    1320a-7a(a))                                                                                                                  1395u(l)(3)  fn5       42 CFR 402.1(c)(13),     CMS                      Penalty for any          2018                     15,024                   15,270                   30,000                                             402.105(d)(2)(x)                                  nonparticipating                                                                                                                                                                                         physician who does not                                                                                                                                                                                   accept payment on an                                                                                                                                                                                     assignment-related basis                                                                                                                                                                                 and who knowingly and                                                                                                                                                                                    willfully fails to                                                                                                                                                                                       refund on a timely basis                                                                                                                                                                                 any amounts collected                                                                                                                                                                                    for services that are                                                                                                                                                                                    not reasonable or                                                                                                                                                                                        medically necessary or                                                                                                                                                                                   are of poor quality                                                                                                                                                                                      under 1842(l)(1)(A).                                                                                                                                                                                     (Penalties are assessed                                                                                                                                                                                  in the same manner as 42                                                                                                                                                                                 U.S.C. 1395u(j)(2)(B),                                                                                                                                                                                   which is assessed                                                                                                                                                                                        according to                                                                                                                                                                                             1320a-7a(a))                                                                                                                  1395u(m)(3)  fn5       42 CFR 402.1(c)(14),     CMS                      Penalty for any          2018                     15,024                   15,270                   30,000                                             402.105(d)(2)(xi)                                 nonparticipating                                                                                                                                                                                         physician charging more                                                                                                                                                                                  than $ 500 who does not                                                                                                                                                                                  accept payment for an                                                                                                                                                                                    elective surgical                                                                                                                                                                                        procedure on an                                                                                                                                                                                          assignment related basis                                                                                                                                                                                 and who knowingly and                                                                                                                                                                                    willfully fails to                                                                                                                                                                                       disclose the required                                                                                                                                                                                    information regarding                                                                                                                                                                                    charges and coinsurance                                                                                                                                                                                  amounts and fails to                                                                                                                                                                                     refund on a timely basis                                                                                                                                                                                 any amount collected for                                                                                                                                                                                 the procedure in excess                                                                                                                                                                                  of the charges                                                                                                                                                                                           recognized and approved                                                                                                                                                                                  by the Medicare program.                                                                                                                                                                                 (Penalties are assessed                                                                                                                                                                                  in the same manner as 42                                                                                                                                                                                 U.S.C. 1395u(j)(2)(B),                                                                                                                                                                                   which is assessed                                                                                                                                                                                        according to                                                                                                                                                                                             1320a-7a(a))                                                                                                                  1395u(n)(3)  fn5       42 CFR 402.1(c)(15),     CMS                      Penalty for any          2018                     15,024                   15,270                   30,000                                             402.105(d)(2)(xii)                                physician who knowingly,                                                                                                                                                                                 willfully, and                                                                                                                                                                                           repeatedly bills one or                                                                                                                                                                                  more beneficiaries for                                                                                                                                                                                   purchased diagnostic                                                                                                                                                                                     tests any amount other                                                                                                                                                                                   than the payment amount                                                                                                                                                                                  specified by the Act.                                                                                                                                                                                    (Penalties are assessed                                                                                                                                                                                  in the same manner as 42                                                                                                                                                                                 U.S.C. 1395u(j)(2)(B),                                                                                                                                                                                   which is assessed                                                                                                                                                                                        according to                                                                                                                                                                                             1320a-7a(a))                                                                                                                  1395u(o)(3)(B)  fn5    42 CFR 414.707(b)        CMS                      Penalty for any          2018                     15,024                   15,270                   30,000                                                                                               practitioner specified                                                                                                                                                                                   in Section                                                                                                                                                                                               1842(b)(18)(C) of the                                                                                                                                                                                    Act or other person that                                                                                                                                                                                 knowingly and willfully                                                                                                                                                                                  bills or collects for                                                                                                                                                                                    any services pertaining                                                                                                                                                                                  to drugs or biologics by                                                                                                                                                                                 the practitioners on                                                                                                                                                                                     other than an                                                                                                                                                                                            assignment-related                                                                                                                                                                                       basis. (Penalties are                                                                                                                                                                                    assessed in the same                                                                                                                                                                                     manner as 42 U.S.C.                                                                                                                                                                                      1395u(b)(18)(B) and                                                                                                                                                                                      1395u(j)(2)(B), which is                                                                                                                                                                                 assessed according to                                                                                                                                                                                    1320a-7a(a))                                                                                                                  1395u(p)(3)(A)           CMS                      Penalty for any          2016                     3,957                    4,022                    4,104                                                                                                physician or                                                                                                                                                                                             practitioner who                                                                                                                                                                                         knowingly and willfully                                                                                                                                                                                  fails promptly to                                                                                                                                                                                        provide the appropriate                                                                                                                                                                                  diagnosis codes upon CMS                                                                                                                                                                                 or Medicare                                                                                                                                                                                              administrative                                                                                                                                                                                           contractor request for                                                                                                                                                                                   payment or bill not                                                                                                                                                                                      submitted on an                                                                                                                                                                                          assignment-related basis                                                                                                                               1395w-3a(d)(4)(A)        42 CFR 414.806           CMS                      Penalty for a            2016                     12,856                   13,066                   13,333                                                                                               pharmaceutical                                                                                                                                                                                           manufacturer's                                                                                                                                                                                           misrepresentation of                                                                                                                                                                                     average sales price of a                                                                                                                                                                                 drug, or biologic                                                                                                             1395w-4(g)(1)(B)  fn5  42 CFR 402.1(c)(17),     CMS                      Penalty for any          2018                     15,024                   15,270                   30,000                                             402.105(d)(2)(xiii)                               nonparticipating                                                                                                                                                                                         physician, supplier, or                                                                                                                                                                                  other person that                                                                                                                                                                                        furnishes physician                                                                                                                                                                                      services not on an                                                                                                                                                                                       assignment-related basis                                                                                                                                                                                 who either knowingly and                                                                                                                                                                                 willfully bills or                                                                                                                                                                                       collects in excess of                                                                                                                                                                                    the statutorily-defined                                                                                                                                                                                  limiting charge or fails                                                                                                                                                                                 to make a timely refund                                                                                                                                                                                  or adjustment.                                                                                                                                                                                           (Penalties are assessed                                                                                                                                                                                  in the same manner as 42                                                                                                                                                                                 U.S.C. 1395u(j)(2)(B),                                                                                                                                                                                   which is assessed                                                                                                                                                                                        according to                                                                                                                                                                                             1320a-7a(a))                                                                                                                  1395w-4(g)(3)(B)  fn5  42 CFR 402.1(c)(18),     CMS                      Penalty for any person   2018                     15,024                   15,270                   30,000                                             402.105(d)(2)(xiv)                                that knowingly and                                                                                                                                                                                       willfully bills for                                                                                                                                                                                      statutorily defined                                                                                                                                                                                      State-plan approved                                                                                                                                                                                      physicians' services on                                                                                                                                                                                  any other basis than an                                                                                                                                                                                  assignment-related basis                                                                                                                                                                                 for a Medicare/Medicaid                                                                                                                                                                                  dual eligible                                                                                                                                                                                            beneficiary. (Penalties                                                                                                                                                                                  are assessed in the same                                                                                                                                                                                 manner as 42 U.S.C.                                                                                                                                                                                      1395u(j)(2)(B), which is                                                                                                                                                                                 assessed according to                                                                                                                                                                                    1320a-7a(a))                                                                                                                  1395w-27(g)(3)(A);       42 CFR 422.760(b); 42    CMS                      Penalty for each         2016                     36,794                   37,396                   38,159                    1857(g)(3)               CFR 423.760(b)                                    termination                                                                                                                                                                                              determination the                                                                                                                                                                                        Secretary makes that is                                                                                                                                                                                  the result of actions by                                                                                                                                                                                 a Medicare Advantage                                                                                                                                                                                     organization or Part D                                                                                                                                                                                   sponsor that has                                                                                                                                                                                         adversely affected an                                                                                                                                                                                    individual covered under                                                                                                                                                                                 the organization's                                                                                                                                                                                       contract                                                                                                                      1395w-27(g)(3)(B);       CMS                      Penalty for each week    2016                     14,718                   14,959                   15,264                                             1857(g)(3)                                        beginning after the                                                                                                                                                                                      initiation of civil                                                                                                                                                                                      money penalty procedures                                                                                                                                                                                 by the Secretary because                                                                                                                                                                                 a Medicare Advantage                                                                                                                                                                                     organization or Part D                                                                                                                                                                                   sponsor has failed to                                                                                                                                                                                    carry out a contract, or                                                                                                                                                                                 has carried out a                                                                                                                                                                                        contract inconsistently                                                                                                                                                                                  with regulations                                                                                                                                       1395w-27(g)(3)(D);       CMS                      Penalty for a Medicare   2016                     136,689                  138,925                  141,760                                            1857(g)(3)                                        Advantage organization's                                                                                                                                                                                 or Part D sponsor's                                                                                                                                                                                      early termination of its                                                                                                                                                                                 contract                                                                                                                                               1395y(b)(3)(C)           42 CFR 411.103(b)        CMS                      Penalty for an employer  2016                     8,908                    9,054                    9,239                                                                                                or other entity to offer                                                                                                                                                                                 any financial or other                                                                                                                                                                                   incentive for an                                                                                                                                                                                         individual entitled to                                                                                                                                                                                   benefits not to enroll                                                                                                                                                                                   under a group health                                                                                                                                                                                     plan or large group                                                                                                                                                                                      health plan which would                                                                                                                                                                                  be a primary plan                                                                                                             1395y(b)(5)(C)(ii)       42 CFR 402.1(c)(20), 42  CMS                      Penalty for any          2016                     1,450                    1,474                    1,504                                              CFR 402.105(b)(2)                                 non-governmental                                                                                                                                                                                         employer that, before                                                                                                                                                                                    October 1, 1998,                                                                                                                                                                                         willfully or repeatedly                                                                                                                                                                                  failed to provide timely                                                                                                                                                                                 and accurate information                                                                                                                                                                                 requested relating to an                                                                                                                                                                                 employee's group health                                                                                                                                                                                  insurance coverage                                                                                                            1395y(b)(6)(B)           42 CFR 402.1(c)(21),     CMS                      Penalty for any entity   2016                     3,182                    3,234                    3,300                                              402.105(a)                                        that knowingly,                                                                                                                                                                                          willfully, and                                                                                                                                                                                           repeatedly fails to                                                                                                                                                                                      complete a claim form                                                                                                                                                                                    relating to the                                                                                                                                                                                          availability of other                                                                                                                                                                                    health benefits in                                                                                                                                                                                       accordance with statute                                                                                                                                                                                  or provides inaccurate                                                                                                                                                                                   information relating to                                                                                                                                                                                  such on the claim form                                                                                                        1395y(b)(7)(B)(i)        CMS                      Penalty for any entity   2016                     1,138                    1,157                    1,181                                                                                                serving as insurer,                                                                                                                                                                                      third party                                                                                                                                                                                              administrator, or                                                                                                                                                                                        fiduciary for a group                                                                                                                                                                                    health plan that fails                                                                                                                                                                                   to provide information                                                                                                                                                                                   that identifies                                                                                                                                                                                          situations where the                                                                                                                                                                                     group health plan is or                                                                                                                                                                                  was a primary plan to                                                                                                                                                                                    Medicare to the HHS                                                                                                                                                                                      Secretary                                                                                                                                              1395pp(h)  fn5         42 CFR 402.1(c)(23),     CMS                      Penalty for any durable  2018                     15,024                   15,270                   30,000                                             402.105(d)(2)(xv)                                 medical equipment                                                                                                                                                                                        supplier, including a                                                                                                                                                                                    supplier of prosthetic                                                                                                                                                                                   devices, prosthetics,                                                                                                                                                                                    orthotics, or supplies,                                                                                                                                                                                  that knowingly and                                                                                                                                                                                       willfully fails to make                                                                                                                                                                                  refunds in a timely                                                                                                                                                                                      manner to Medicare                                                                                                                                                                                       beneficiaries under                                                                                                                                                                                      certain conditions. (42                                                                                                                                                                                  U.S.C. 1395(m)(18)                                                                                                                                                                                       sanctions apply here in                                                                                                                                                                                  the same manner, which                                                                                                                                                                                   is under 1395u(j)(2) and                                                                                                                                                                                 1320a-7a(a))                                                                                                                  1395nn(g)(5)             42 CFR 411.361           CMS                      Penalty for any person   2016                     18,936                   19,246                   19,639                                                                                               that fails to report                                                                                                                                                                                     information required by                                                                                                                                                                                  HHS under Section                                                                                                                                                                                        1877(f) concerning                                                                                                                                                                                       ownership, investment,                                                                                                                                                                                   and compensation                                                                                                                                                                                         arrangements                                                                                                                  1395pp(h)                42 CFR 402.1(c)(23),     CMS                      Penalty for any durable  2016                     15,024                   15,270                   15,582                                             402.105(d)(2)(xv)                                 medical equipment                                                                                                                                                                                        supplier, including a                                                                                                                                                                                    supplier of prosthetic                                                                                                                                                                                   devices, prosthetics,                                                                                                                                                                                    orthotics, or supplies,                                                                                                                                                                                  that knowingly and                                                                                                                                                                                       willfully fails to make                                                                                                                                                                                  refunds in a timely                                                                                                                                                                                      manner to Medicare                                                                                                                                                                                       beneficiaries under                                                                                                                                                                                      certain conditions. (42                                                                                                                                                                                  U.S.C. 1395(m)(18)                                                                                                                                                                                       sanctions apply here in                                                                                                                                                                                  the same manner, which                                                                                                                                                                                   is under 1395u(j)(2) and                                                                                                                                                                                 1320a-7a(a))                                                                                                                  1395ss(a)(2)             42 CFR 402.1(c)(24),     CMS                      Penalty for any person   2016                     51,569                   52,413                   53,483                                             405.105(f)(1)                                     that issues a Medicare                                                                                                                                                                                   supplemental policy that                                                                                                                                                                                 has not been approved by                                                                                                                                                                                 the State regulatory                                                                                                                                                                                     program or does not meet                                                                                                                                                                                 Federal standards after                                                                                                                                                                                  a statutorily defined                                                                                                                                                                                    effective date                                                                                                                1395ss(d)(3)(A)(vi)(II)  CMS                      Penalty for someone      2016                     26,723                   27,160                   27,714                                                                                               other than issuer that                                                                                                                                                                                   sells or issues a                                                                                                                                                                                        Medicare supplemental                                                                                                                                                                                    policy to beneficiary                                                                                                                                                                                    without a disclosure                                                                                                                                                                                     statement                                                                                                                                                                                                                       Penalty for an issuer    2016                     44,539                   45,268                   46,192                                                                                               that sells or issues a                                                                                                                                                                                   Medicare supplemental                                                                                                                                                                                    policy without                                                                                                                                                                                           disclosure statement                                                                                                          1395ss(d)(3)(B)(iv)      CMS                      Penalty for someone      2016                     26,723                   27,160                   27,714                                                                                               other than issuer that                                                                                                                                                                                   sells or issues a                                                                                                                                                                                        Medicare supplemental                                                                                                                                                                                    policy without                                                                                                                                                                                           acknowledgement form.                                                                                                                                                                                                           Penalty for issuer that  2016                     44,539                   45,268                   46,192                                                                                               sells or issues a                                                                                                                                                                                        Medicare supplemental                                                                                                                                                                                    policy without an                                                                                                                                                                                        acknowledgement form                                                                                                          1395ss(p)(8)             42 CFR 402.1(c)(25),     CMS                      Penalty for any person   2016                     26,723                   27,160                   27,714                                             402.105(e)                                        that sells or issues                                                                                                                                                                                     Medicare supplemental                                                                                                                                                                                    polices after a given                                                                                                                                                                                    date that fail to                                                                                                                                                                                        conform to the NAIC or                                                                                                                                                                                   Federal standards                                                                                                                                                                                        established by statute                                                                                                                               42 CFR 402.1(c)(25),     CMS                      Penalty for any person   2016                     44,539                   45,268                   46,192                                             405.105(f)(2)                                     that sells or issues                                                                                                                                                                                     Medicare supplemental                                                                                                                                                                                    polices after a given                                                                                                                                                                                    date that fail to                                                                                                                                                                                        conform to the NAIC or                                                                                                                                                                                   Federal standards                                                                                                                                                                                        established by statute                                                                                                        1395ss(p)(9)(C)          42 CFR 402.1(c)(26),     CMS                      Penalty for any person   2016                     26,723                   27,160                   27,714                                             402.105(e)                                        that sells a Medicare                                                                                                                                                                                    supplemental policy and                                                                                                                                                                                  fails to make available                                                                                                                                                                                  for sale the core group                                                                                                                                                                                  of basic benefits when                                                                                                                                                                                   selling other Medicare                                                                                                                                                                                   supplemental policies                                                                                                                                                                                    with additional benefits                                                                                                                                                                                 or fails to provide the                                                                                                                                                                                  individual, before                                                                                                                                                                                       selling the policy, an                                                                                                                                                                                   outline of coverage                                                                                                                                                                                      describing benefits                                                                                                                                  42 CFR 402.1(c)(26),     Penalty for any person   2016                     44,539                   45,268                   46,192                                                                      405.105(f)(3), (4)       that sells a Medicare                                                                                                                                                                                    supplemental policy and                                                                                                                                                                                  fails to make available                                                                                                                                                                                  for sale the core group                                                                                                                                                                                  of basic benefits when                                                                                                                                                                                   selling other Medicare                                                                                                                                                                                   supplemental policies                                                                                                                                                                                    with additional benefits                                                                                                                                                                                 or fails to provide the                                                                                                                                                                                  individual, before                                                                                                                                                                                       selling the policy, an                                                                                                                                                                                   outline of coverage                                                                                                                                                                                      describing benefits                                                                                                                                    1395ss(q)(5)(C)          42 CFR 402.1(c)(27),     CMS                      Penalty for any person   2016                     44,539                   45,268                   46,192                                             405.105(f)(5)                                     that fails to suspend                                                                                                                                                                                    the policy of a                                                                                                                                                                                          policyholder made                                                                                                                                                                                        eligible for medical                                                                                                                                                                                     assistance or                                                                                                                                                                                            automatically reinstates                                                                                                                                                                                 the policy of a                                                                                                                                                                                          policyholder who has                                                                                                                                                                                     lost eligibility for                                                                                                                                                                                     medical assistance,                                                                                                                                                                                      under certain                                                                                                                                                                                            circumstances                                                                                                                 1395ss(r)(6)(A)          42 CFR 402.1(c)(28),     CMS                      Penalty for any person   2016                     44,539                   45,268                   46,192                                             405.105(f)(6)                                     that fails to provide                                                                                                                                                                                    refunds or credits as                                                                                                                                                                                    required by section                                                                                                                                                                                      1882(r)(1)(B)                                                                                                                 1395ss(s)(4)             42 CFR 402.1(c)(29),     CMS                      Penalty for any issuer   2016                     18,908                   19,217                   19,609                                             405.105(c)                                        of a Medicare                                                                                                                                                                                            supplemental policy that                                                                                                                                                                                 does not waive listed                                                                                                                                                                                    time periods if they                                                                                                                                                                                     were already satisfied                                                                                                                                                                                   under a proceeding                                                                                                                                                                                       Medicare supplemental                                                                                                                                                                                    policy, or denies a                                                                                                                                                                                      policy, or conditions                                                                                                                                                                                    the issuances or                                                                                                                                                                                         effectiveness of the                                                                                                                                                                                     policy, or discriminates                                                                                                                                                                                 in the pricing of the                                                                                                                                                                                    policy base on health                                                                                                                                                                                    status or other                                                                                                                                                                                          specified criteria                                                                                                            1395ss(t)(2)             42 CFR 402.1(c)(30),     CMS                      Penalty for any issuer   2016                     44,539                   45,268                   46,192                                             405.105(f)(7)                                     of a Medicare                                                                                                                                                                                            supplemental policy that                                                                                                                                                                                 fails to fulfill listed                                                                                                                                                                                  responsibilities                                                                                                              1395ss(v)(4)(A)          CMS                      Penalty someone other    2016                     19,284                   19,599                   19,999                                                                                               than issuer who sells,                                                                                                                                                                                   issues, or renews a                                                                                                                                                                                      Medigap Rx policy to an                                                                                                                                                                                  individual who is a Part                                                                                                                                                                                 D enrollee                                                                                                                                                                                                                      Penalty for an issuer    2016                     32,140                   32,666                   33,333                                                                                               who sells, issues, or                                                                                                                                                                                    renews a Medigap Rx                                                                                                                                                                                      policy who is a Part D                                                                                                                                                                                   enrollee                                                                                                                      1395bbb(c)(1)            42 CFR 488.725(c)        CMS                      Penalty for any          2016                     4,126                    4,194                    4,280                                                                                                individual who notifies                                                                                                                                                                                  or causes to be notified                                                                                                                                                                                 a home health agency of                                                                                                                                                                                  the time or date on                                                                                                                                                                                      which a survey of such                                                                                                                                                                                   agency is to be                                                                                                                                                                                          conducted                                                                                                                     1395bbb(f)(2)(A)(i)      42 CFR                   CMS                      Maximum daily penalty    2016                     19,787                   20,111                   20,521                                             488.845(b)(2)(iii); 42                            amount for each day a                                                                                                                                  CFR 488.845(b)(3)-(6);                            home health agency is                                                                                                                                  and 42 CFR                                        not in compliance with                                                                                                                                 488.845(d)(1)(ii)                                 statutory requirements                                                                                                                               42 CFR 488.845(b)(3)     Penalty per day for home                                                                                                                                                                                 health agency's                                                                                                                                                                                          noncompliance (Upper                                                                                                                                                                                     Range)                                                                                                                                                                                                                          Minimum                  2016                     16,819                   17,094                   17,443                                                                                             Maximum                  2016                     19,787                   20,111                   20,521                                           42 CFR 488.845(b)(3)(i)  Penalty for a home       2016                     19,787                   20,111                   20,521                                                                                               health agency's                                                                                                                                                                                          deficiency or                                                                                                                                                                                            deficiencies that cause                                                                                                                                                                                  immediate jeopardy and                                                                                                                                                                                   result in actual harm                                                                                                                                                         42 CFR 488.845(b)(3)(ii) Penalty for a home       2016                     17,808                   18,099                   18,468                                                                                               health agency's                                                                                                                                                                                          deficiency or                                                                                                                                                                                            deficiencies that cause                                                                                                                                                                                  immediate jeopardy and                                                                                                                                                                                   result in potential for                                                                                                                                                                                  harm                                                                                                                                                                          42 CFR                   Penalty for an isolated  2016                     16,819                   17,094                   17,443                                                                      488.845(b)(3)(iii)       incident of                                                                                                                                                                                              noncompliance in                                                                                                                                                                                         violation of established                                                                                                                                                                                 HHA policy                                                                                                                                                                    42 CFR 488.845(b)(4)     Penalty for a repeat                                                                                                                                                                                     and/or condition-level                                                                                                                                                                                   deficiency that does not                                                                                                                                                                                 constitute immediate                                                                                                                                                                                     jeopardy, but is                                                                                                                                                                                         directly related to poor                                                                                                                                                                                 quality patient care                                                                                                                                                                                     outcomes (Lower Range)                                                                                                                                                                                                          Minimum                  2016                     2,968                    3,017                    3,079                                                                                              Maximum                  2016                     16,819                   17,094                   17,443                                           42 CFR 488.845(b)(5)     Penalty for a repeat                                                                                                                                                                                     and/or condition-level                                                                                                                                                                                   deficiency that does not                                                                                                                                                                                 constitute immediate                                                                                                                                                                                     jeopardy and that is                                                                                                                                                                                     related predominately to                                                                                                                                                                                 structure or                                                                                                                                                                                             process-oriented                                                                                                                                                                                         conditions (Lower Range)                                                                                                                                                                                                        Minimum                  2016                     989                      1,005                    1,026                                                                                              Maximum                  2016                     7,915                    8,044                    8,208                                            42 CFR 488.845(b)(6)     Penalty imposed for                                                                                                                                                                                      instance of                                                                                                                                                                                              noncompliance that may                                                                                                                                                                                   be assessed for one or                                                                                                                                                                                   more singular events of                                                                                                                                                                                  condition-level                                                                                                                                                                                          noncompliance that are                                                                                                                                                                                   identified and where the                                                                                                                                                                                 noncompliance was                                                                                                                                                                                        corrected during the                                                                                                                                                                                     onsite survey                                                                                                                                                                                                                   Minimum                  2016                     1,979                    2,011                    2,052                                                                                              Maximum                  2016                     19,787                   20,111                   20,521                                                                                             Penalty for each day of  2016                     19,787                   20,111                   20,521                                                                                               noncompliance (Maximum)                                                                                                                              42 CFR 488.845(d)(1)(ii) Penalty for each day of  2016                     19,787                   20,111                   20,521                                                                                               noncompliance (Maximum)                                                                                                                                1396b(m)(5)(B)           42 CFR 460.46            CMS                      Penalty for PACE                                                                                                                                                                                         organization's practice                                                                                                                                                                                  that would reasonably be                                                                                                                                                                                 expected to have the                                                                                                                                                                                     effect of denying or                                                                                                                                                                                     discouraging enrollment                                                                                                                                                                                Minimum                  2016                     22,077                   22,438                   22,896                                                                                             Maximum                  2016                     147,177                  149,585                  152,638                                                                                            Penalty for a PACE       2016                     36,794                   37,396                   38,159                                                                                               organization that                                                                                                                                                                                        charges excessive                                                                                                                                                                                        premiums                                                                                                                                                                                               Penalty for a PACE       2016                     147,177                  149,585                  152,638                                                                                              organization                                                                                                                                                                                             misrepresenting or                                                                                                                                                                                       falsifying information                                                                                                                                                                                   to CMS, the State, or an                                                                                                                                                                                 individual or other                                                                                                                                                                                      entity                                                                                                                                                                                                 Penalty for each         2016                     36,794                   37,396                   38,159                                                                                               determination the CMS                                                                                                                                                                                    makes that the PACE                                                                                                                                                                                      organization has failed                                                                                                                                                                                  to provide medically                                                                                                                                                                                     necessary items and                                                                                                                                                                                      services of the failure                                                                                                                                                                                  has adversely affected                                                                                                                                                                                   (or has the substantial                                                                                                                                                                                  likelihood of adversely                                                                                                                                                                                  affecting) a PACE                                                                                                                                                                                        participant                                                                                                                                                                                            Penalty for              2016                     36,794                   37,396                   38,159                                                                                               involuntarily                                                                                                                                                                                            disenrolling a                                                                                                                                                                                           participant                                                                                                                                                                                            Penalty for              2016                     36,794                   37,396                   38,159                                                                                               discriminating or                                                                                                                                                                                        discouraging enrollment                                                                                                                                                                                  or disenrollment of                                                                                                                                                                                      participants on the                                                                                                                                                                                      basis of an individual's                                                                                                                                                                                 health status or need                                                                                                                                                                                    for health care services                                                                                                      1396r(h)(3)(C)(ii)(I)    42 CFR                   CMS                      Penalty per day for a                                                                                                                                  488.408(d)(1)(iii)                                nursing facility's                                                                                                                                                                                       failure to meet a                                                                                                                                                                                        Category 2 Certification                                                                                                                                                                               Minimum                  2016                     103                      105                      107                                                                                                Maximum                  2016                     6,188                    6,289                    6,417                                            42 CFR 488.408(d)(1)(iv) CMS                      Penalty per instance for                                                                                                                                                                                 a nursing facility's                                                                                                                                                                                     failure to meet Category                                                                                                                                                                                 2 certification                                                                                                                                                                                        Minimum                  2016                     2,063                    2,097                    2,140                                                                                              Maximum                  2016                     20,628                   20,965                   21,393                                           42 CFR                   CMS                      Penalty per day for a                                                                                                                                  488.408(e)(1)(iii)                                nursing facility's                                                                                                                                                                                       failure to meet Category                                                                                                                                                                                 3 certification                                                                                                                                                                                        Minimum                  2016                     6,291                    6,394                    6,525                                                                                              Maximum                  2016                     20,628                   20,965                   21,393                                           42 CFR 488.408(e)(1)(iv) CMS                      Penalty per instance for                                                                                                                                                                                 a nursing facility's                                                                                                                                                                                     failure to meet Category                                                                                                                                                                                 3 certification                                                                                                                                                                                        Minimum                  2016                     2,063                    2,097                    2,140                                                                                              Maximum                  2016                     20,628                   20,965                   21,393                                           42 CFR 488.408(e)(2)(ii) CMS                      Penalty per instance for                                                                                                                                                                                 a nursing facility's                                                                                                                                                                                     failure to meet Category                                                                                                                                                                                 3 certification, which                                                                                                                                                                                   results in immediate                                                                                                                                                                                     jeopardy                                                                                                                                                                                               Minimum                  2016                     2,063                    2,097                    2,140                                                                                              Maximum                  2016                     20,628                   20,965                   21,393                                           42 CFR 488.438(a)(1)(i)  CMS                      Penalty per day for                                                                                                                                                                                      nursing facility's                                                                                                                                                                                       failure to meet                                                                                                                                                                                          certification (Upper                                                                                                                                                                                     Range)                                                                                                                                                                                                 Minimum                  2016                     6,291                    6,394                    6,525                                                                                              Maximum                  2016                     20,628                   20,965                   21,393                                           42 CFR 488.438(a)(1)(ii) CMS                      Penalty per day for                                                                                                                                                                                      nursing facility's                                                                                                                                                                                       failure to meet                                                                                                                                                                                          certification (Lower                                                                                                                                                                                     Range)                                                                                                                                                                                                 Minimum                  2016                     103                      105                      107                                                                                                Maximum                  2016                     6,188                    6,289                    6,417                                            42 CFR 488.438(a)(2)     CMS                      Penalty per instance for                                                                                                                                                                                 nursing facility's                                                                                                                                                                                       failure to meet                                                                                                                                                                                          certification                                                                                                                                                                                          Minimum                  2016                     2,063                    2,097                    2,140                                                                                              Maximum                  2016                     20,628                   20,965                   21,393                    1396r(f)(2)              42 CFR 483.151(b)(2)(iv) CMS                      Grounds to prohibit      2016                     10,314                   10,483                   10,697                    (B)(iii)(I)(c)           and (b)(3)(iii)                                   approval of Nurse Aide                                                                                                                                                                                   Training Program-if                                                                                                                                                                                    assessed a penalty in                                                                                                                                                                                    1819(h)(2)(B)(i) or                                                                                                                                                                                      1919(h)(2)(A)(ii) of                                                                                                                                                                                     "not less than                                                                                                                                                                                         $ 5,000" $(Not CMP                                                                                                                                                                                      authority, but a                                                                                                                                                                                         specific CMP amount (CMP                                                                                                                                                                                 at this level) that is                                                                                                                                                                                   the triggering condition                                                                                                                                                                                 for disapproval$)                                                                                                              1396r(h)(3)(C)(ii)(I)    42 CFR 483.151(c)(2)     CMS                      Grounds to waive         2016                     10,314                   10,483                   10,697                                                                                               disapproval of nurse                                                                                                                                                                                     aide training                                                                                                                                                                                            program-reference to                                                                                                                                                                                   disapproval based on                                                                                                                                                                                     imposition of CMP "not                                                                                                                                                                                 less than $ 5,000"                                                                                                                                                                                     $(Not CMP authority but                                                                                                                                                                                   CMP imposition at this                                                                                                                                                                                   level determines                                                                                                                                                                                         eligibility to seek                                                                                                                                                                                      waiver of disapproval of                                                                                                                                                                                 nurse aide training                                                                                                                                                                                      program$)                                                                                                                      1396t(j)(2)(C)           CMS                      Penalty for each day of                                                                                                                                                                                  noncompliance for a home                                                                                                                                                                                 or community care                                                                                                                                                                                        provider that no longer                                                                                                                                                                                  meets the minimum                                                                                                                                                                                        requirements for home                                                                                                                                                                                    and community care                                                                                                                                                                                                              Minimum                  2016                     2                        2                        2                                                                                                  Maximum                  2016                     17,816                   18,107                   18,477                    1396u-2(e)(2)(A)(i)      42 CFR 438.704           CMS                      Penalty for a Medicaid   2016                     36,794                   37,396                   38,159                                                                                               managed care                                                                                                                                                                                             organization that fails                                                                                                                                                                                  substantially to provide                                                                                                                                                                                 medically necessary                                                                                                                                                                                      items and services                                                                                                                                                                                     Penalty for Medicaid     2016                     36,794                   37,396                   38,159                                                                                               managed care                                                                                                                                                                                             organization that                                                                                                                                                                                        imposes premiums or                                                                                                                                                                                      charges on enrollees in                                                                                                                                                                                  excess of the premiums                                                                                                                                                                                   or charges permitted                                                                                                                                                                                   Penalty for a Medicaid   2016                     36,794                   37,396                   38,159                                                                                               managed care                                                                                                                                                                                             organization that                                                                                                                                                                                        misrepresents or                                                                                                                                                                                         falsifies information to                                                                                                                                                                                 another individual or                                                                                                                                                                                    entity                                                                                                                                                                                                 Penalty for a Medicaid   2016                     36,794                   37,396                   38,159                                                                                               managed care                                                                                                                                                                                             organization that fails                                                                                                                                                                                  to comply with the                                                                                                                                                                                       applicable statutory                                                                                                                                                                                     requirements for such                                                                                                                                                                                    organizations                                                                                                                 1396u-2(e)(2)(A)(ii)     42 CFR 438.704           CMS                      Penalty for a Medicaid   2016                     147,177                  149,585                  152,638                                                                                              managed care                                                                                                                                                                                             organization that                                                                                                                                                                                        misrepresents or                                                                                                                                                                                         falsifies information to                                                                                                                                                                                 the HHS Secretary                                                                                                                                                                                      Penalty for Medicaid     2016                     147,177                  149,585                  152,638                                                                                              managed care                                                                                                                                                                                             organization that acts                                                                                                                                                                                   to discriminate among                                                                                                                                                                                    enrollees on the basis                                                                                                                                                                                   of their health status                                                                                                        1396u-2(e)(2)(A)(iv)     42 CFR 438.704           CMS                      Penalty for each         2016                     22,077                   22,438                   22,896                                                                                               individual that does not                                                                                                                                                                                 enroll as a result of a                                                                                                                                                                                  Medicaid managed care                                                                                                                                                                                    organization that acts                                                                                                                                                                                   to discriminate among                                                                                                                                                                                    enrollees on the basis                                                                                                                                                                                   of their health status                                                                                                        1396u(h)(2)              42 CFR Part 441, Subpart CMS                      Penalty for a provider   2016                     20,628                   20,965                   21,393                                             I                                                 not meeting one of the                                                                                                                                                                                   requirements relating to                                                                                                                                                                                 the protection of the                                                                                                                                                                                    health, safety, and                                                                                                                                                                                      welfare of individuals                                                                                                                                                                                   receiving community                                                                                                                                                                                      supported living                                                                                                                                                                                         arrangements services                                                                                                         1396w-2(c)(1)                                     CMS                      Penalty for disclosing   2016                     11,002                   11,182                   11,410                                                                                               information related to                                                                                                                                                                                   eligibility                                                                                                                                                                                              determinations for                                                                                                                                                                                       medical assistance                                                                                                                                                                                       programs                                                                                                                      18041(c)(2)              45 CFR 150.315; 45 CFR   CMS                      Failure to comply with   2016                     150                      152                      155                                                156.805(c)                                        requirements of the                                                                                                                                                                                      Public Health Services                                                                                                                                                                                   Act; Penalty for                                                                                                                                                                                         violations of rules or                                                                                                                                                                                   standards of behavior                                                                                                                                                                                    associated with issuer                                                                                                                                                                                   participation in the                                                                                                                                                                                     Federally-facilitated                                                                                                                                                                                    Exchange. (42 U.S.C.                                                                                                                                                                                     300gg-22(b)(2)(C))                                                                                                            18081(h)(1)(A)(i)(II)    42 CFR 155.285           CMS                      Penalty for providing    2016                     27,186                   27,631                   28,195                                                                                               false information on                                                                                                                                                                                     Exchange application                                                                                                          18081(h)(1)(B)           42 CFR 155.285           CMS                      Penalty for knowingly or 2016                     271,862                  276,310                  281,949                                                                                              willfully providing                                                                                                                                                                                      false information on                                                                                                                                                                                     Exchange application                                                                                                          18081(h)(2)              42 CFR 155.260           CMS                      Penalty for knowingly or 2016                     27,186                   27,631                   28,195                                                                                               willfully disclosing                                                                                                                                                                                     protected information                                                                                                                                                                                    from Exchange                                                                                                                 31 U.S.C.                                                                                                                                                                                                 1352                     45 CFR 93.400(e)         HHS                      Penalty for the first    2016                     18,936                   19,246                   19,639                                                                                               time an individual makes                                                                                                                                                                                 an expenditure                                                                                                                                                                                           prohibited by                                                                                                                                                                                            regulations regarding                                                                                                                                                                                    lobbying disclosure,                                                                                                                                                                                     absent aggravating                                                                                                                                                                                       circumstances                                                                                                                                                                                          Penalty for second and                                                                                                                                                                                   subsequent offenses by                                                                                                                                                                                   individuals who make an                                                                                                                                                                                  expenditure prohibited                                                                                                                                                                                   by regulations regarding                                                                                                                                                                                 lobbying disclosure                                                                                                                                                                                    Minimum                  2016                     18,936                   19,246                   19,639                                                                                             Maximum                  2016                     189,361                  192,459                  196,387                                                                                            Penalty for the first    2016                     18,936                   19,246                   19,639                                                                                               time an individual fails                                                                                                                                                                                 to file or amend a                                                                                                                                                                                       lobbying disclosure                                                                                                                                                                                      form, absent aggravating                                                                                                                                                                                 circumstances                                                                                                                                                                                          Penalty for second and                                                                                                                                                                                   subsequent offenses by                                                                                                                                                                                   individuals who fail to                                                                                                                                                                                  file or amend a lobbying                                                                                                                                                                                 disclosure form, absent                                                                                                                                                                                  aggravating                                                                                                                                                                                              circumstances                                                                                                                                                                                          Minimum                  2016                     18,936                   19,246                   19,639                                                                                             Maximum                  2016                     189,361                  192,459                  196,387                                          45 CFR Part 93, Appendix HHS                      Penalty for failure to                                                                                                                                 A                                                 provide certification                                                                                                                                                                                    regarding lobbying in                                                                                                                                                                                    the award documents for                                                                                                                                                                                  all sub-awards of all                                                                                                                                                                                    tiers                                                                                                                                                                                                  Minimum                  2016                     18,936                   19,246                   19,639                                                                                             Maximum                  2016                     189,361                  192,459                  196,387                                                                                            Penalty for failure to                                                                                                                                                                                   provide statement                                                                                                                                                                                        regarding lobbying for                                                                                                                                                                                   loan guarantee and loan                                                                                                                                                                                  insurance transactions                                                                                                                                                                                 Minimum                  2016                     18,936                   19,246                   19,639                                                                                             Maximum                  2016                     189,361                  192,459                  196,387                   3801-3812                45 CFR 79.3(a)(1)(iv)    HHS                      Penalty against any      2016                     9,894                    10,056                   10,261                                                                                               individual who-with                                                                                                                                                                                    knowledge or reason to                                                                                                                                                                                   know-makes, presents                                                                                                                                                                                   or submits a false,                                                                                                                                                                                      fictitious or fraudulent                                                                                                                                                                                 claim to the Department                                                                                                                              45 CFR 79.3(b)(1(ii)     HHS                      Penalty against any      2016                     9,894                    10,056                   10,261                                                                                               individual who-with                                                                                                                                                                                    knowledge or reason to                                                                                                                                                                                   know-makes, presents                                                                                                                                                                                   or submits a false,                                                                                                                                                                                      fictitious or fraudulent                                                                                                                                                                                 claim to the Department                                                                                                        fn1  Some HHS components have not promulgated regulations regarding their civil monetary penalty-specific statutory authorities. fn2  The description is not intended to be a comprehensive explanation of the underlying violation; the statute and corresponding regulation, if applicable, should be consulted. fn3  Statutory or Inflation Act Adjustment. fn4  The cost of living multiplier for 2018, based on the CPI-U for the month of October 2017, not seasonally adjusted, is 1.02041, as indicated in OMB Memorandum M-18-03, "Implementation of Penalty Inflation Adjustments for 2018, Pursuant to the Federal Civil Penalties Adjustment Act Improvements Act of 2015" (December 15, 2017). fn5  2018 Maximum Adjusted Penalty column adjusted based on changes to the Bipartisan Budget Act of 2018 for 42 U.S.C.1320a-7a(a),1320a-7a(b), 1395l(h)(5)(D),1395m(a)(11)(A),1395m(a)(18)(B), 1395m(b)(5)(C), 1395m(h)(3), 1395m(j)(4), 1395m(k)(6), 1395m(l)(6), 1395u(b)(18)(B), 1395u(j)(2)(B), 1395u(k), 1395u(l)(3), 1395u(m)(3), 1395u(n)(3), 1395u(o)(3)(B), 1395w-4(g)(1)(B), 1395w-4(g)(3)(B),1395pp(h). 

   Dated: October 3, 2018.

Alex M. Azar II,

Secretary, Department of Health and Human Services.

[FR Doc. 2018-22005 Filed 10-10-18; 8:45 am]

BILLING CODE 4150-24-P

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