Final rule.
CFR Part: "45 CFR Part 102"
RIN Number: "RIN 0991-AC0"
Citation: "83 FR 51369"
Page Number: "51369"
"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"), 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.
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 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
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
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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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 circumventingStark 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
[FR Doc. 2018-22005 Filed 10-10-18; 8:45 am]
BILLING CODE 4150-24-P
Medicare-for-all discussion presents golden opportunity for small business
Title 3–The President – Fire Prevention Week, 2018 – By the President of the United States of America
Advisor News
- SEC To Vote June 5 On Regulation Best Interest
- Securities America Recruits Three Groups With About $245M In Client Assets
- Triad Advisors Recruits D.C.-Area Hybrid RIA Argent Bridge Advisors
- LPL Financial To Acquire Allen & Company
- Harris Poll Shows Military Members, Families Rely On Gig Economy
More Advisor NewsAnnuity News
- AmeriLife Direct And One Resource Group Partner On Medicare, Other Products
- First-Quarter Pension Buy-Out Product Sales Up 240%: LIMRA
- Allianz Bolsters Its Top-Selling 222 Fixed Indexed Annuity Line
- 1Q Annuity Sales Up 38% Year Over Year, LIMRA Reports
- The Impact Partnership Targets High-Net-Worth Clients With Lincoln Annuity
More Annuity NewsHealth/Employee Benefits
- Court Will Hear ACA Appeal Arguments July 9
- Bill Expanding Annuity Options In Retirement Plans Passes The House
- Why Aren’t Workers Buying DI?
- First-Quarter Pension Buy-Out Product Sales Up 240%: LIMRA
- Milliman: Multi-Employer Plans Over 90% Funded Despite 2018 Investment Losses
More Health/Employee BenefitsLife Insurance
- Florida Man Gets Life In Wife’s 1993 Murder After Son Dug Up Skull In Backyard
- Washington Drug Testing Delays Lead To Delays In Life Insurance Benefits
- Total U.S. Voluntary Market Grows 3% in 2018, LIMRA Reports
- North American Offers Classic Term Life Insurance
- NAIC Group Aims To Finalize ‘Policy Overview’ Idea By Summer Meeting
More Life Insurance