Final rule.
CFR Part: "45 CFR Part 102"
RIN Number: "RIN 0991-AC0"
Citation: "85 FR 2869"
Page Number: "2869"
"Rules and Regulations"
Agency: "
SUMMARY:
DATES:
This rule is effective
FOR FURTHER INFORMATION CONTACT:
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") amended the Federal Civil Penalties Inflation Adjustment Act of 1990 (Pub. L. 101-410, 104 Stat. 890 (1990)), 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 Further Consolidated Appropriations Act, 2020 (hereafter, 2020 Appropriations Act), created a new section 906(d)(5) in the Federal Food, Drug, and Cosmetic Act, codified at 21 U.S.C. 387f(d)(5), which increases the minimum age of sale of tobacco products and makes it unlawful for a retailer to sell a tobacco product to any person younger than 21 years old. H.R. 1865 Sec. 603. The 2020 Appropriations Act also amended the civil money penalty schedule codified in 21 U.S.C. 333 note to apply to violations of new section 906(d)(5). Accordingly, the description of 21 U.S.C. 333 note has been modified in the table to reflect these amendments. In addition, a technical error for an incorrect description of 42 U.S.C. 299c-(3)(d) was identified and is corrected below.
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
Using the 2020 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
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. Additionally, HHS finds good cause for issuing technical changes as a final rule without notice and comment because these changes only update the implementing regulation to restate the statute in light of amendments recently enacted into law.
Pursuant to OMB Memorandum M-20-05, 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
List of Subjects in 45 CFR Part 102 Administrative practice and procedure, Penalties.
For reasons discussed in the preamble, the
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
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Table 1 to [Sec.] 102.3-Civil Monetary Penalty Authorities Administered by HHS Agencies and Penalty Amounts CFR fn1 HHS Description fn2 Date of last penalty 2019 2020 agency figure or Maximum Maximum adjustment fn3 adjusted adjusted penalty penalty ( $ ) ( $ ) fn4 21 U.S.C.: 333(b)(2)(A) FDA Penalty for violations 2019 105,194 107,050 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 2019 2,146,800 2,184,670 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 make 2019 210,386 214,097 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 who 2019 28,413 28,914 violates a requirement related to devices for each such violation Penalty for aggregate of 2019 1,894,261 1,927,676 all violations related to devices in a single proceeding 333(f)(2)(A) FDA Penalty for any individual 2019 79,875 81,284 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 any 2019 399,374 406,419 other person other than an individual) for such introduction or delivery of adulterated food Penalty for aggregate of 2019 798,747 812,837 all such violations related to adulterated food adjudicated in a single proceeding 333(f)(3)(A) FDA Penalty for all violations 2019 12,103 12,316 adjudicated in a single proceeding for any person who violates 21 U.S.C. 331(jj) 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 2019 12,103 12,316 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 responsible 2019 302,585 307,923 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 2019 1,210,340 1,231,690 all such above violations in a single proceeding 333(f)(4)(A)(ii) FDA Penalty for REMS violation 2019 302,585 307,923 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 violation 2019 1,210,340 1,231,690 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 2019 12,103,404 12,316,908 all such above violations adjudicated in a single proceeding 333(f)(9)(A) FDA Penalty for any person who 2019 17,547 17,857 violates a requirement which relates to tobacco products for each such violation Penalty for aggregate of 2019 1,169,798 1,190,433 all such violations of tobacco product requirement adjudicated in a single proceeding 333(f)(9)(B)(i)(I) FDA Penalty per violation 2019 292,450 297,609 related to violations of tobacco requirements Penalty for aggregate of 2019 1,169,798 1,190,433 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 2019 292,450 297,609 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 2019 1,169,798 1,190,433 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 2019 11,697,983 11,904,335 all such violations related to tobacco product requirements adjudicated in a single proceeding 333(f)(9)(B)(ii)(I) FDA Penalty for any person who 2019 292,450 297,609 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 2019 1,169,798 1,190,433 for all such above violations adjudicated in a single proceeding 333(f)(9)(B)(ii)(II) FDA Penalty for violation of 2019 292,450 297,609 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 2019 1,169,798 1,190,433 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 above 2019 11,697,983 11,904,335 tobacco product requirement violations adjudicated in a single proceeding 333(g)(1) FDA Penalty for any person who 2019 302,585 307,923 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 subsequent 2019 605,171 615,846 above violation in any 3-year period 333 note FDA Penalty to be applied for 2019 292 297 violations of 21 U.S.C. 387f(d)(5) or of 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 2019 584 594 third violation of 21 U.S.C. 387f(d)(5) or of the tobacco product regulations within a 24-month period Penalty in the case of a 2019 2,340 2,381 fourth violation of 21 U.S.C. 387f(d)(5) or of the tobacco product regulations within a 24-month period Penalty in the case of a 2019 5,849 5,952 fifth violation of 21 U.S.C. 387f(d)(5) or of the tobacco product regulations within a 36-month period Penalty in the case of a 2019 11,698 11,904 sixth or subsequent violation of 21 U.S.C. 387f(d)(5) or of the tobacco product regulations within a 48-month period as determined on a case-by-case basis Penalty to be applied for 2019 292 297 violations of 21 U.S.C. 387f(d)(5) or of 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 2019 584 594 second violation of 21 U.S.C. 387f(d)(5) or of the tobacco product regulations within a 12-month period Penalty in the case of a 2019 1,170 1,191 third violation of 21 U.S.C. 387f(d)(5) or of the tobacco product regulations within a 24-month period Penalty in the case of a 2019 2,340 2,381 fourth violation of 21 U.S.C. 387f(d)(5) or of the tobacco product regulations within a 24-month period Penalty in the case of a 2019 5,849 5,952 fifth violation of 21 U.S.C. 387f(d)(5) or of the tobacco product regulations within a 36-month period Penalty in the case of a 2019 11,698 11,904 sixth or subsequent violation of 21 U.S.C. 387f(d)(5) or of the tobacco product regulations within a 48-month period as determined on a case-by-case basis 335b(a) FDA Penalty for each violation 2019 445,846 453,711 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 any 2019 1,783,384 1,814,843 other person (other than an individual) per above violation 360pp(b)(1) FDA Penalty for any person who 2019 2,924 2,976 violates any such requirements for electronic products, with each unlawful act or omission constituting a separate violation Penalty imposed for any 2019 996,806 1,014,390 related series of violations of requirements relating to electronic products 42 U.S.C 2019 262(d) FDA Penalty per day for 2019 229,269 233,313 violation of order of recall of biological product presenting imminent or substantial hazard 263b(h)(3) FDA Penalty for failure to 2019 17,834 18,149 obtain a mammography certificate as required 300aa-28(b)(1) FDA Penalty per occurrence for 2019 229,269 233,313 any vaccine manufacturer that intentionally destroys, alters, falsifies, or conceals any record or report required 256b(d)(1)(B)(vi) HRSA Penalty for each instance 2019 5,781 5,883 of overcharging a 340B covered entity 299c-(3)(d) AHRQ Penalty for an 2019 15,034 15,299 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 2019 1,542 1,569 Information in the National Directory of New Hires 262a(i)(1) 42 CFR 1003.910 OIG Penalty for each individual 2019 348,708 354,859 who violates safety and security procedures related to handling dangerous biological agents and toxins Penalty for any other 2019 697,418 709,720 person who violates safety and security procedures related to handling dangerous biological agents and toxins 300jj-51 OIG Penalty per violation for 2019 1,063,260 1,082,016 committing information blocking 1320a-7a(a) 42 CFR 1003.210(a)(1) OIG Penalty for knowingly 2019 20,504 20,866 presenting or causing to be presented to an officer, employee, or agent of the United States a false claim Penalty for knowingly 2019 20,504 20,866 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 2019 30,757 31,300 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 2019 20,504 20,866 party retaining ownership or control interest in a participating entity 42 CFR 1003.1010 Penalty for remuneration 2019 20,504 20,866 offered to induce program beneficiaries to use particular providers, practitioners, or suppliers 42 CFR 1003.210(a)(4) Penalty for employing or 2019 20,504 20,866 contracting with an excluded individual 42 CFR 1003.310(a)(3) Penalty for knowing and 2019 102,522 104,330 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 2019 20,504 20,866 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 2019 102,522 104,330 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 an 2019 20,504 20,866 overpayment and failing to report and return 42 CFR 1003.210(a)(7) Penalty for making or using 2019 57,812 58,832 a false record or statement that is material to a false or fraudulent claim 42 CFR 1003.210(a)(9) Penalty for failure to 2019 30,757 31,300 grant timely access to HHS OIG for audits, investigations, evaluations, and other statutory functions of HHS OIG 1320a-7a(b) OIG Penalty for payments by a 2019 5,126 5,216 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 who 2019 5,126 5,216 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 who 2019 10,252 10,433 executes a document that falsely certifies home health needs for Medicare beneficiaries 1320a-7a(o) OIG Penalty for knowingly 2016 10,000 10,176 presenting or causing to be presented a false or fraudulent specified claim under a grant, contract, or other agreement for which the Secretary provides funding Penalty for knowingly 2016 50,000 50,882 making, using, or causing to be made or used any false statement, omission, or misrepresentation of a material fact in any application, proposal, bid, progress report, or other document required to directly or indirectly receive or retain funds provided pursuant to grant, contract, or other agreement Penalty for Knowingly 2016 50,000 50,882 making, using, or causing to be made or used, a false record or statement material to a false or fraudulent specified claim under grant, contract, or other agreement Penalty for knowingly 2016 50,000 for each false 53,231 for each false making, using, or causing record or statement, 10,000 record statement, 10,646 to be made or used, a false per day. per day. record or statement material to an obligation to pay or transmit funds or property with respect to grant, contract, or other agreement, or knowingly conceals or improperly avoids or decreases any such obligation Penalty for failure to 2016 15,000 15,265 grant timely access, upon reasonable request, to the Inspector General (I.G.) for purposes of audits, investigations, evaluations, or other statutory functions of I.G. in matters involving grants, contracts, or other agreements 1320a-7e(b)(6)(A) 42 CFR 1003.810 OIG Penalty for failure to 2019 39,121 39,811 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 of 2019 10,519 10,705 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 of 2019 52,596 53,524 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 certification 2019 2,194 2,233 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 another 2019 10,967 11,160 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 individual 2019 4,388 4,465 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 2019 39,936 40,640 Advantage organization that substantially fails to provide medically necessary, required items and services Penalty for a Medicare 2019 39,121 39,811 Advantage organization that charges excessive premiums Penalty for a Medicare 2019 39,121 39,811 Advantage organization that improperly expels or refuses to reenroll a beneficiary Penalty for a Medicare 2019 156,488 159,248 Advantage organization that engages in practice that would reasonably be expected to have the effect of denying or discouraging enrollment Penalty per individual who 2019 23,473 23,887 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 2019 156,488 159,248 Advantage organization misrepresenting or falsifying information to Secretary Penalty for a Medicare 2019 39,121 39,811 Advantage organization misrepresenting or falsifying information to individual or other entity Penalty for Medicare 2019 39,121 39,811 Advantage organization interfering with provider's advice to enrollee and non-managed care organization (MCO) affiliated providers that balance bill enrollees Penalty for a Medicare 2019 39,121 39,811 Advantage organization that employs or contracts with excluded individual or entity Penalty for a Medicare 2019 39,121 39,811 Advantage organization enrolling an individual in without prior written consent Penalty for a Medicare 2019 39,121 39,811 Advantage organization transferring an enrollee to another plan without consent or solely for the purpose of earning a commission Penalty for a Medicare 2019 39,121 39,811 Advantage organization failing to comply with marketing restrictions or applicable implementing regulations or guidance Penalty for a Medicare 2019 39,121 39,811 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 prescription 2019 13,669 13,910 drug card sponsor that falsifies or misrepresents marketing materials, overcharges program enrollees, or misuse transitional assistance funds 1395cc(g) OIG Penalty for improper 2019 5,317 5,411 billing by Hospitals, Critical Access Hospitals, or Skilled Nursing Facilities 1395dd(d)(1) 42 CFR 1003.510 OIG Penalty for a hospital or 2019 109,663 111,597 responsible physician dumping patients needing emergency medical care, if the hospital has 100 beds or more Penalty for a hospital or 2019 54,833 55,800 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 health 2019 54,833 55,800 maintenance organization (HMO) or competitive plan is such plan substantially fails to provide medically necessary, required items or services Penalty for 2019 54,833 55,800 HMOs/competitive medical plans that charge premiums in excess of permitted amounts Penalty for a HMO or 2019 54,833 55,800 competitive medical plan that expels or refuses to reenroll an individual per prescribed conditions Penalty for a HMO or 2019 219,327 223,196 competitive medical plan that implements practices to discourage enrollment of individuals needing services in future Penalty per individual not 2019 31,558 32,115 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 2019 219,327 223,196 competitive medical plan that misrepresents or falsifies information to the Secretary Penalty for a HMO or 2019 54,833 55,800 competitive medical plan that misrepresents or falsifies information to an individual or any other entity Penalty for failure by HMO 2019 54,833 55,800 or competitive medical plan to assure prompt payment of Medicare risk sharing contracts or incentive plan provisions Penalty for HMO that 2019 50,334 51,222 employs or contracts with excluded individual or entity 1395nn(g)(3) 42 CFR 1003.310 OIG Penalty for submitting or 2019 25,372 25,820 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 circumventing 2019 169,153 172,137Stark Law's restrictions on physician self-referrals 1395ss(d)(1) 42 CFR 1003.1110 OIG Penalty for a material 2019 10,519 10,705 misrepresentation regarding Medigap compliance policies 1395ss(d)(2) 42 CFR 1003.1110 OIG Penalty for selling Medigap 2019 10,519 10,705 policy under false pretense 1395ss(d)(3)(A)(ii) 42 CFR 1003.1110 OIG Penalty for an issuer that 2019 47,357 48,192 sells health insurance policy that duplicates benefits Penalty for someone other 2019 28,413 28,914 than issuer that sells health insurance that duplicates benefits 1395ss(d)(4)(A) 42 CFR 1003.1110 OIG Penalty for using mail to 2019 10,519 10,705 sell a non-approved Medigap insurance policy 1396b(m)(5)(B)(i) 42 CFR 1003.410 OIG Penalty for a Medicaid MCO 2019 52,596 53,524 that substantially fails to provide medically necessary, required items or services Penalty for a Medicaid MCO 2019 52,596 53,524 that charges excessive premiums Penalty for a Medicaid MCO 2019 210,386 214,097 that improperly expels or refuses to reenroll a beneficiary Penalty per individual who 2019 31,558 32,115 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 MCO 2019 210,386 214,097 misrepresenting or falsifying information to the Secretary Penalty for a Medicaid MCO 2019 52,596 53,524 misrepresenting or falsifying information to an individual or another entity Penalty for a Medicaid MCO 2019 47,357 48,192 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 and 2019 2,194 2,233 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 and 2019 10,967 11,160 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 2019 4,388 4,465 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 2019 189,427 192,768 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 failure 2019 18,943 19,277 to timely provide information by drug manufacturer with rebate agreement 1396r-8(b)(3)(C)(ii) 42 CFR 1003.1210 OIG Penalty for knowing 2019 189,427 192,768 provision of false information by drug manufacturer with rebate agreement 1396t(i)(3)(A) 42 CFR 1003.1310 OIG Penalty for notifying home 2019 3,788 3,855 and community-based providers or settings of survey 11131(c) 42 CFR 1003.810 OIG Penalty for failing to 2019 22,927 23,331 report a medical malpractice claim to National Practitioner Data Bank 11137(b)(2) 42 CFR 1003.810 OIG Penalty for breaching 2019 22,927 23,331 confidentiality of information reported to National Practitioner Data Bank 299b-22(f)(1) 42 CFR 3.404 OCR Penalty for violation of 2019 12,695 12,919 confidentiality provision of the Patient Safety and Quality Improvement Act 45 CFR 160.404(b)(1)(i), OCR Penalty for each 2019 159 162 (ii) pre-February 18, 2009 violation of the Health Insurance Portability and Accountability Act (HIPAA) administrative simplification provisions Calendar Year Cap 2019 39,936 40,640 1320(d)-5(a) 45 CFR 160.404(b)(2)(i)(A), OCR Penalty for each February (B) 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 2019 117 119 Maximum 2019 58,490 59,522 Calendar Year Cap 2019 1,754,698 1,785,651 45 CFR OCR Penalty for each February 160.404(b)(2)(ii)(A), (B) 18, 2009 or 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 2019 1,170 1,191 Maximum 2019 58,490 59,522 Calendar Year Cap 2019 1,754,698 1,785,651 45 CFR OCR Penalty for each February 160.404(b)(2)(iii)(A), (B) 18, 2009 or 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 2019 11,698 11,904 Maximum 2019 58,490 59,522 Calendar Year Cap 2019 1,754,698 1,785,651 45 CFR OCR Penalty for each February 160.404(b)(2)(iv)(A), (B) 18, 2009 or 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 2019 58,490 59,522 Maximum 2019 1,754,698 1,785,651 Calendar Year Cap 2019 1,754,698 1,785,651 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 2019 6,417 6,530 Maximum 2019 21,039 21,410 42 CFR 493.1834(d)(2)(ii) CMS Penalty for a clinical laboratory's failure to meet participation and certification requirements and the failure does not pose immediate jeopardy: Minimum 2019 106 108 Maximum 2019 6,311 6,422 300gg-15(f) 45 CFR 147.200(e) CMS Failure to provide the 2019 1,156 1,176 Summary of Benefits and Coverage 300gg-18 45 CFR 158.606 CMS Penalty for violations of 2019 116 118 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 or CFR 403.912(a) & (c) group purchasing organization failing to report information required under 42 U.S.C. 1320a-7h(a), relating to physician ownership or investment interests: Minimum 2019 1,156 1,176 Maximum 2019 11,562 11,766 Calendar Year Cap 2019 173,436 176,495 1320a-7h(b)(2) 42 CFR 402.105(h), 42 CFR CMS Penalty for manufacturer or 403.912(b) & (c) 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 2019 11,562 11,766 Maximum 2019 115,624 117,664 Calendar Year Cap 2019 1,156,242 1,176,638 CMS Penalty for an 2019 115,624 117,664 administrator of a facility that fails to comply with notice requirements for the closure of a facility 1320a-7j(h)(3)(A) 42 CFR 488.446(a)(1), (2), CMS Minimum penalty for the 2019 578 588 & (3) first offense of an administrator who fails to provide notice of facility closure Minimum penalty for the 2019 1,735 1,766 second offense of an administrator who fails to provide notice of facility closure Minimum penalty for the 2019 3,468 3,529 third and subsequent offenses of an administrator who fails to provide notice of facility closure 1320a-8(a)(1) CMS Penalty for an entity 2019 8,457 8,606 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 42 2019 7,975 8,116 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 2019 6,623 6,740 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 2019 231,249 235,328 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 2019 346,872 352,991 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 2019 231,249 235,328 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 who 2019 156 159 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 488.408(d)(1)(iii) CMS Penalty per day for a Skilled Nursing Facility that has a Category 2 violation of certification requirements: Minimum 2019 110 112 Maximum 2019 6,579 6,695 42 CFR 488.408(d)(1)(iv) CMS Penalty per instance of Category 2 noncompliance by a Skilled Nursing Facility: Minimum 2019 2,194 2,233 Maximum 2019 21,933 22,320 42 CFR 488.408(e)(1)(iii) CMS Penalty per day for a Skilled Nursing Facility that has a Category 3 violation of certification requirements: Minimum 2019 6,690 6,808 Maximum 2019 21,933 22,320 42 CFR 488.408(e)(1)(iv) CMS Penalty per instance of Category 3 noncompliance by a Skilled Nursing Facility: Minimum 2019 2,194 2,233 Maximum 2019 21,933 22,320 42 CFR 488.408(e)(2)(ii) CMS Penalty per day and per instance for a Skilled Nursing Facility that has Category 3 noncompliance with Immediate Jeopardy: Per Day (Minimum) 2019 6,690 6,808 Per Day (Maximum) 2019 21,933 22,320 Per Instance (Minimum) 2019 2,194 2,233 Per Instance (Maximum) 2019 21,933 22,320 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 2019 6,690 6,808 Maximum 2019 21,933 22,320 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 2019 110 112 Maximum 2019 6,579 6,695 42 CFR 488.438(a)(2) CMS Penalty per instance of a Skilled Nursing Facility that fails to meet certification requirements: Minimum 2019 2,194 2,233 Maximum 2019 21,933 22,320 1395l(h)(5)(D) 42 CFR 402.105(d)(2)(i) CMS Penalty for knowingly, 2019 15,975 16,257 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 and 2019 4,208 4,282 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 and 2019 4,027 4,098 willfully failing to provide information about a referring physician when seeking payment on an unassigned basis 1395m(a)(11)(A) 42 CFR 402.1(c)(4), CMS Penalty for any durable 2019 15,975 16,257 402.105(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) 42 CFR 402.1(c)(5), CMS Penalty for any 2019 15,975 16,257 402.105(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) 42 CFR 402.1(c)(6), CMS Penalty for any 2019 15,975 16,257 402.105(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) 42 CFR 402.1(c)(8), CMS Penalty for any supplier of 2019 15,975 16,257 402.105(d)(2)(vi) 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 of 2019 1,692 1,722 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) 42 CFR 402.1(c)(10), CMS Penalty for any supplier of 2019 15,975 16,257 402.105(d)(2)(vii) 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) 42 CFR 402.1(c)(31), CMS Penalty for any person or 2019 15,975 16,257 402.105(d)(3) 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) 42 CFR 402.1(c)(32), CMS Penalty for any supplier of 2019 15,975 16,257 402.105(d)(4) 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) 42 CFR 402.1(c)(11), CMS Penalty for any 2019 15,975 16,257 402.105(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) 42 CFR 402.1(c) CMS Penalty for any physician 2019 15,975 16,257 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) 42 CFR 402.1(c)(12), CMS Penalty for any physician 2019 15,975 16,257 402.105(d)(2)(ix) 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) 42 CFR 402.1(c)(13), CMS Penalty for any 2019 15,975 16,257 402.105(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) 42 CFR 402.1(c)(14), CMS Penalty for any 2019 15,975 16,257 402.105(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) 42 CFR 402.1(c)(15), CMS Penalty for any physician 2019 15,975 16,257 402.105(d)(2)(xii) 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) 42 CFR 414.707(b) CMS Penalty for any 2019 15,975 16,257 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 physician 2019 4,208 4,282 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 2019 13,669 13,910 pharmaceutical manufacturer's misrepresentation of average sales price of a drug, or biologic 1395w-4(g)(1)(B) 42 CFR 402.1(c)(17), CMS Penalty for any 2019 15,975 16,257 402.105(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) 42 CFR 402.1(c)(18), CMS Penalty for any person that 2019 15,975 16,257 402.105(d)(2)(xiv) 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 CFR CMS Penalty for each 2019 39,121 39,811 1857(g)(3) 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 2019 15,649 15,925 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 2019 145,335 147,899 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 or 2019 9,472 9,639 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 CFR CMS Penalty for any 2019 1,542 1,569 402.105(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 that 2019 3,383 3,443 402.105(a) 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 2019 1,211 1,232 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 1395y(b)(8)(E) CMS Penalty for any non-group 2019 1,211 1,232 health plan that fails to identify claimants who are Medicare beneficiaries and provide information to the HHS Secretary to coordinate benefits and pursue any applicable recovery claim 1395nn(g)(5) 42 CFR 411.361 CMS Penalty for any person that 2019 20,134 20,489 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 2019 15,975 16,257 402.105(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 that 2019 54,832 55,799 405.105(f)(1) 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 other 2019 28,413 28,914 than issuer that sells or issues a Medicare supplemental policy to beneficiary without a disclosure statement Penalty for an issuer that 2019 47,357 48,192 sells or issues a Medicare supplemental policy without disclosure statement 1395ss(d)(3)(B)(iv) CMS Penalty for someone other 2019 28,413 28,914 than issuer that sells or issues a Medicare supplemental policy without acknowledgement form Penalty for issuer that 2019 47,357 48,192 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 that 2019 28,413 28,914 402.105(e) sells or issues Medicare supplemental polices after a given date that fail to conform to the National Association of Insurance Commissioners (NAIC) or Federal standards established by statute 42 CFR 402.1(c)(25), CMS Penalty for any person that 2019 47,357 48,192 405.105(f)(2) 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 that 2019 28,413 28,914 402.105(e) 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 that 2019 47,357 48,192 405.105(f)(3), (4) 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 that 2019 47,357 48,192 405.105(f)(5) 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 that 2019 47,357 48,192 405.105(f)(6) 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 of a 2019 20,104 20,459 405.105(c) 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 of a 2019 47,357 48,192 405.105(f)(7) Medicare supplemental policy that fails to fulfill listed responsibilities 1395ss(v)(4)(A) CMS Penalty someone other than 2019 20,503 20,865 issuer who sells, issues, or renews a Medigap Rx policy to an individual who is a Part D enrollee Penalty for an issuer who 2019 34,174 34,777 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 individual 2019 4,388 4,465 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 488.845(b)(2)(iii) CMS Maximum daily penalty 2019 21,039 21,410 42 CFR 488.845(b)(3)-(6); amount for each day a home and 42 CFR health agency is not in 488.845(d)(1)(ii) compliance with statutory requirements 42 CFR 488.845(b)(3) Penalty per day for home health agency's noncompliance (Upper Range): Minimum 2019 17,883 18,198 Maximum 2019 21,039 21,410 42 CFR 488.845(b)(3)(i) Penalty for a home health 2019 21,039 21,410 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 health 2019 18,934 19,268 agency's deficiency or deficiencies that cause immediate jeopardy and result in potential for harm 42 CFR 488.845(b)(3)(iii) Penalty for an isolated 2019 17,883 18,198 incident of noncompliance in violation of established home health agency (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 2019 3,157 3,213 Maximum 2019 17,883 18,198 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 2019 1,052 1,071 Maximum 2019 8,415 8,563 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 2019 2,104 2,141 Maximum 2019 21,039 21,410 Penalty for each day of 2019 21,039 21,410 noncompliance (Maximum) 42 CFR 488.845(d)(1)(ii) Penalty for each day of 2019 21,039 21,410 noncompliance (Maximum) 1396b(m)(5)(B) 42 CFR 460.46 CMS Penalty for Programs of All-Inclusive Care for the Elderly (PACE) organization's practice that would reasonably be expected to have the effect of denying or discouraging enrollment: Minimum 2019 23,473 23,887 Maximum 2019 156,488 159,248 Penalty for a PACE 2019 39,121 39,811 organization that charges excessive premiums Penalty for a PACE 2019 156,488 159,248 organization misrepresenting or falsifying information to CMS, the State, or an individual or other entity Penalty for each 2019 39,121 39,811 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 involuntarily 2019 39,121 39,811 disenrolling a participant Penalty for discriminating 2019 39,121 39,811 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 488.408(d)(1)(iii) CMS Penalty per day for a nursing facility's failure to meet a Category 2 Certification: Minimum 2019 110 112 Maximum 2019 6,579 6,695 42 CFR 488.408(d)(1)(iv) CMS Penalty per instance for a nursing facility's failure to meet Category 2 certification: Minimum 2019 2,194 2,233 Maximum 2019 21,933 22,320 42 CFR 488.408(e)(1)(iii) CMS Penalty per day for a nursing facility's failure to meet Category 3 certification: Minimum 2019 6,690 6,808 Maximum 2019 21,933 22,320 42 CFR 488.408(e)(1)(iv) CMS Penalty per instance for a nursing facility's failure to meet Category 3 certification: Minimum 2019 2,194 2,233 Maximum 2019 21,933 22,320 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 2019 2,194 2,233 Maximum 2019 21,933 22,320 42 CFR 488.438(a)(1)(i) CMS Penalty per day for nursing facility's failure to meet certification (Upper Range): Minimum 2019 6,690 6,808 Maximum 2019 21,933 22,320 42 CFR 488.438(a)(1)(ii) CMS Penalty per day for nursing facility's failure to meet certification (Lower Range): Minimum 2019 110 112 Maximum 2019 6,579 6,695 42 CFR 488.438(a)(2) CMS Penalty per instance for nursing facility's failure to meet certification: Minimum 2019 2,194 2,233 Maximum 2019 21,933 22,320 1396r(f)(2)(B)(iii)(I)(c) 42 CFR 483.151(b)(2)(iv) CMS Grounds to prohibit 2019 10,967 11,160 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" $(Not civil monetary penalties (CMPs) authority, but a specific CMP amount (CMP at this level) that is the triggering condition for disapproval$) 1396r(h)(3)(C)(ii)(I) 42 CFR 483.151(c)(2) CMS Grounds to waive 2019 10,967 11,160 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 2019 2 2 Maximum 2019 18,943 19,277 1396u-2(e)(2)(A)(i) 42 CFR 438.704 CMS Penalty for a Medicaid 2019 39,121 39,811 managed care organization that fails substantially to provide medically necessary items and services Penalty for Medicaid 2019 39,121 39,811 managed care organization that imposes premiums or charges on enrollees in excess of the premiums or charges permitted Penalty for a Medicaid 2019 39,121 39,811 managed care organization that misrepresents or falsifies information to another individual or entity Penalty for a Medicaid 2019 39,121 39,811 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 2019 156,488 159,248 managed care organization that misrepresents or falsifies information to the HHS Secretary Penalty for Medicaid 2019 156,488 159,248 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 individual 2019 23,473 23,887 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 I CMS Penalty for a provider not 2019 21,933 22,320 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 2019 11,698 11,904 information related to eligibility determinations for medical assistance programs 18041(c)(2) 45 CFR 150.315; 45 CFR CMS Failure to comply with 2019 159 162 156.805(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 false 2019 28,906 29,416 information on Exchange application 18081(h)(1)(B) 42 CFR 155.285 CMS Penalty for knowingly or 2019 289,060 294,159 willfully providing false information on Exchange application 18081(h)(2) 42 CFR 155.260 CMS Penalty for knowingly or 2019 28,906 29,416 willfully disclosing protected information from Exchange 31 U.S.C.: 1352 45 CFR 93.400(e) HHS Penalty for the first time 2019 20,134 20,489 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 2019 20,134 20,489 Maximum 2019 201,340 204,892 Penalty for the first time 2019 20,134 20,489 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 2019 20,134 20,489 Maximum 2019 201,340 204,892 45 CFR Part 93, Appendix A HHS Penalty for failure to provide certification regarding lobbying in the award documents for all sub-awards of all tiers: Minimum 2019 20,134 20,489 Maximum 2019 201,340 204,892 Penalty for failure to provide statement regarding lobbying for loan guarantee and loan insurance transactions: Minimum 2019 20,134 20,489 Maximum 2019 201,340 204,892 3801-3812 45 CFR 79.3(a)(1)(iv) HHS Penalty against any 2019 10,520 10,706 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) Penalty against any 2019 10,520 10,706 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 2020, based on the Consumer Price Index for all Urban Consumers (CPI-U) for the month of October 2019, not seasonally adjusted, is 1.01764, as indicated in OMB Memorandum M-20-05, "Implementation of Penalty Inflation Adjustments for 2019, Pursuant to the Federal Civil Penalties Adjustment Act Improvements Act of 2015" (December 16, 2019).
Alex M. Azar II,
Secretary, Department of
[FR Doc. 2020-00738 Filed 1-15-20; 4:15 pm]
BILLING CODE 4150-24-P
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