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Rule

Annual Civil Monetary Penalties Inflation Adjustment

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Start Preamble

AGENCY:

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

ACTION:

Final rule.

SUMMARY:

The Department of Health and Human Services is updating its regulations to reflect required annual inflation-related increases to the civil monetary penalties in its regulations, pursuant to the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 and is making a technical change to correct an error in the regulation.

DATES:

This rule is effective November 5, 2019.

Start Further Info

FOR FURTHER INFORMATION CONTACT:

David Dasher, Deputy Assistant Secretary, Office of Acquisitions, Office of the Assistant Secretary for Financial Resources, Room 536-H, Hubert Humphrey Building, 200 Independence Avenue SW, Washington DC 20201; 202-205-0706.

End Further Info End Preamble Start Supplemental Information

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 Department of Health and Human Services (HHS) lists the civil monetary penalty authorities and the penalty amounts administered by all of its agencies in tabular form in 45 CFR 102.3, which was issued in an interim final rule published in the September 6, 2016 Federal Register (81 FR 61538). Annual adjustments were subsequently published on February 3, 2017 (82 FR 9175) and on October 11, 2018 (83 FR 51369).

II. Calculation of Adjustment

The annual inflation adjustment for each applicable civil monetary penalty is determined using the percent increase in the Consumer Price Index for all Urban Consumers (CPI-U) for the month of October of the year in which the amount of each civil penalty was most recently established or modified. In the December 14, 2018, Office of Management and Budget (OMB) Memorandum for the Heads of Executive Agencies and Departments, M-19-04, Implementation of the Penalty Inflation Adjustments for 2019, Pursuant to the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015, OMB published the multiplier for the required annual adjustment. The cost-of-living adjustment multiplier for 2019, based on the CPI-U for the month of October 2018, not seasonally adjusted, is 1.02522. The multiplier is applied to each applicable penalty amount that was updated and published for FY 2018 and is rounded to the nearest dollar.

Using the 2019 multiplier, HHS adjusted all its applicable monetary penalties in 45 CFR 102.3. In addition to the adjustment, a technical error for an incorrect citation in the description of 21 U.S.C. 333(f)(3)(A) was identified and is corrected below.

III. Statutory and Executive Order Reviews

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

Section 4(a) of the 2015 Act directs federal agencies to publish annual adjustments no later than January 15th of each year thereafter. In accordance with section 553 of the APA, most rules are subject to notice and comment and are effective no earlier than 30 days after publication in the Federal Register. However, section 4(b)(2) of the 2015 Act provides that each agency shall make the annual inflation adjustments “notwithstanding section 553” of the APA. According to OMB's Memorandum M-19-04, the phrase “notwithstanding section 553” in section 4(b)(2) of the 2015 Act means that “the public procedure the APA Start Printed Page 59550generally requires (i.e., 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-19-04, 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 November 5, 2019. The adjusted civil monetary penalty amounts apply to penalties assessed on or after November 5, 2019, if the violation occurred on or after November 2, 2015. If the violation occurred prior to November 2, 2015, or a penalty was assessed prior to September 6, 2016, the pre-adjustment civil penalty amounts in effect prior to September 6, 2016, will apply.

Start List of Subjects

List of Subjects in 45 CFR Part 102

  • Administrative practice and procedure
  • Penalties
End List of Subjects

For reasons discussed in the preamble, the Department of Health and Human Services amends 45 CFR part 102 as follows:

Start Part

PART 102—ADJUSTMENT OF CIVIL MONETARY PENALTIES FOR INFLATION

End Part Start Amendment Part

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

End Amendment Part Start Authority

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

End Authority Start Amendment Part

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

End Amendment Part
Penalty adjustment and table.
* * * * *

Civil Monetary Penalty Authorities Administered by HHS Agencies and Penalty Amounts

[Effective November 5, 2019]

U.S.C.CFR 1HHS agencyDescription 2Date of last statutorily established penalty figure 32018 Maximum adjusted penalty ($)2019 Maximum adjusted penalty ($) 4
21 U.S.C.:
333(b)(2)(A)FDAPenalty for violations related to drug samples resulting in a conviction of any representative of manufacturer or distributor in any 10-year period2018102,606105,194
333(b)(2)(B)FDAPenalty for violation related to drug samples resulting in a conviction of any representative of manufacturer or distributor after the second conviction in any 10-yr period20182,052,1072,103,861
333(b)(3)FDAPenalty for failure to make a report required by 21 U.S.C. 353(d)(3)(E) relating to drug samples2018205,211210,386
333(f)(1)(A)FDAPenalty for any person who violates a requirement related to devices for each such violation201827,71428,413
Penalty for aggregate of all violations related to devices in a single proceeding20181,847,6631,894,261
333(f)(2)(A)FDAPenalty for any 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. 350l201877,91079,875
Penalty in the case of any other person other than an individual) for such introduction or delivery of adulterated food2018389,550399,374
Penalty for aggregate of all such violations related to adulterated food adjudicated in a single proceeding2018779,098798,747
333(f)(3)(A)FDAPenalty for all violations 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)201811,80512,103
333(f)(3)(B)FDAPenalty for each day any above violation is not corrected after a 30-day period following notification until the violation is corrected201811,80512,103
333(f)(4)(A)(i)FDAPenalty for any 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)2018295,142302,585
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Penalty for aggregate of all such above violations in a single proceeding20181,180,5661,210,340
333(f)(4)(A)(ii)FDAPenalty for REMS 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 violation2018295,142302,585
Penalty for REMS 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 period20181,180,5661,210,340
Penalty for aggregate of all such above violations adjudicated in a single proceeding201811,805,66512,103,404
333(f)(9)(A)FDAPenalty for any person who violates a requirement which relates to tobacco products for each such violation201817,11517,547
Penalty for aggregate of all such violations of tobacco product requirement adjudicated in a single proceeding20181,141,0211,169,798
333(f)(9)(B)(i)(I)FDAPenalty per violation related to violations of tobacco requirements2018285,256292,450
Penalty for aggregate of all such violations of tobacco product requirements adjudicated in a single proceeding20181,141,0211,169,798
333(f)(9)(B)(i)(II)FDAPenalty in the case of a 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 violation2018285,256292,450
Penalty for violation of 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 period20181,141,0211,169,798
Penalty for aggregate of all such violations related to tobacco product requirements adjudicated in a single proceeding201811,410,21711,697,983
333(f)(9)(B)(ii)(I)FDAPenalty for any person 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 products2018285,256292,450
Penalty for aggregate of for all such above violations adjudicated in a single proceeding20181,141,0211,169,798
333(f)(9)(B)(ii)(II)FDAPenalty for violation of 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 violation2018285,256292,450
Penalty for post-notice 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 period20181,141,0211,169,798
Penalty for aggregate above tobacco product requirement violations adjudicated in a single proceeding201811,410,21711,697,983
333(g)(1)FDAPenalty for any person 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 period2018295,142302,585
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Penalty for each subsequent above violation in any 3-year period2018590,284605,171
333 noteFDAPenalty to be applied 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 period2018284.69439292
Penalty in the case of a third tobacco product regulation violation within a 24-month period2018570.40919584
Penalty in the case of a fourth tobacco product regulation violation within a 24-month period20182,2822,340
Penalty in the case of a fifth tobacco product regulation violation within a 36-month period20185,7055,849
Penalty in the case of a sixth or subsequent tobacco product regulation violation within a 48-month period as determined on a case-by-case basis201811,41011,698
Penalty to be applied 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 violation2018284.69439292
Penalty in the case of a second tobacco product regulation violation within a 12-month period2018570.40919584
Penalty in the case of a third tobacco product regulation violation within a 24-month period20181,1411,170
Penalty in the case of a fourth tobacco product regulation violation within a 24-month period20182,2822,340
Penalty in the case of a fifth tobacco product regulation violation within a 36-month period20185,7055,849
Penalty in the case of a fifth tobacco product regulation violation within a 36-month period20185,7055,849
Penalty in the case of a sixth or subsequent tobacco product regulation violation within a 48-month period as determined on a case-by-case basis201811,41011,698
335b(a)FDAPenalty for each 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 services2018434,878445,846
Penalty in the case of any other person (other than an individual) per above violation.20181,739,5131,783,384
360pp(b)(1)FDAPenalty for any person who violates any such requirements for electronic products, with each unlawful act or omission constituting a separate violation20182,8522,924
Penalty imposed for any related series of violations of requirements relating to electronic products.2018972,285996,806
42 U.S.C:
262(d)FDAPenalty per day for violation of order of recall of biological product presenting imminent or substantial hazard2018223,629229,269
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263b(h)(3)FDAPenalty for failure to obtain a mammography certificate as required201817,39517,834
300aa-28(b)(1)FDAPenalty per occurrence for any vaccine manufacturer that intentionally destroys, alters, falsifies, or conceals any record or report required2018223,629229,269
256b(d)(1)(B)(vi)HRSAPenalty for each instance of overcharging a 340B covered entity20185,6395,781
299c-(3)(d)AHRQPenalty for an establishment or person supplying information obtained in the course of activities for any purpose other than the purpose for which it was supplied201814,66415,034
653(l)(2)45 CFR 303.21(f)ACFPenalty for Misuse of Information in the National Directory of New Hires20181,5041,542
262a(i)(1)42 CFR 1003.910OIGPenalty for each individual who violates safety and security procedures related to handling dangerous biological agents and toxins2018340,130348,708
Penalty for any other person who violates safety and security procedures related to handling dangerous biological agents and toxins2018680,262697,418
300jj-51OIGPenalty per violation for committing information blocking20181,037,1041,063,260
1320a-7a(a)42 CFR 1003.210(a)(1)OIGPenalty for knowingly presenting or causing to be presented to an officer, employee, or agent of the United States a false claim201820,00020,504
Penalty for knowingly presenting or causing to be presented a request for payment which violates the terms of an assignment, agreement, or PPS agreement201820,00020,504
42 CFR 1003.210(a)(2)Penalty for knowingly 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 decision201830,00030,757
42 CFR 1003.210(a)(3)Penalty for an excluded party retaining ownership or control interest in a participating entity201820,00020,504
42 CFR 1003.1010Penalty for remuneration offered to induce program beneficiaries to use particular providers, practitioners, or suppliers201820,00020,504
42 CFR 1003.210(a)(4)Penalty for employing or contracting with an excluded individual201820,00020,504
42 CFR 1003.310(a)(3)Penalty for knowing and 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 program2018100,000102,522
42 CFR 1003.210(a)(1)Penalty for ordering or prescribing medical or other item or service during a period in which the person was excluded201820,00020,504
42 CFR 1003.210(a)(6)Penalty for knowingly 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 supplier2018100,000102,522
42 CFR 1003.210(a)(8)Penalty for knowing of an overpayment and failing to report and return201820,00020,504
42 CFR 1003.210(a)(7)Penalty for making or using a false record or statement that is material to a false or fraudulent claim2018100,000102,522
42 CFR 1003.210(a)(9)Penalty for failure to grant timely access to HHS OIG for audits, investigations, evaluations, and other statutory functions of HHS OIG201830,00030,757
1320a-7a(b)OIGPenalty for payments by 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 benefits20185,0005,126
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Penalty for physicians 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 benefits20185,0005,126
42 CFR 1003.210(a)(10)Penalty for a physician who executes a document that falsely certifies home health needs for Medicare beneficiaries201810,00010,252
1320a-7a(o)OIGPenalty for knowingly presenting or causing to be presented a false or fraudulent specified claim under a grant, contract, or other agreement for which the Secretary provides funding201610,00010,461
Knowingly makes, uses, or causes 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 agreement201650,00052,308
Knowingly makes, uses, or causes to be made or used, a false record or statement material to a false or fraudulent specified claim under grant, contract, or other agreement201650,00052,308
Knowingly makes, uses, or causes to be made or used, a false 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.2016* 50,000** 52,308
Fails to grant timely access, upon reasonable request, to the I.G. for purposes of audits, investigations, evaluations, or other statutory functions of I.G. in matters involving grants, contracts, or other agreements.201615,00015,692
1320a-7e(b)(6)(A)42 CFR 1003.810OIGPenalty for failure to report any final adverse action taken against a health care provider, supplier, or practitioner201838,15939,121
1320b-10(b)(1)42 CFR 1003.610(a)OIGPenalty for the misuse 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 HHS201810,26010,519
1320b-10(b)(2)42 CFR 1003.610(a)OIGPenalty for the misuse 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 HHS201851,30252,596
1395i-3(b)(3)(B)(ii)(1)42 CFR 1003.210(a)(11)OIGPenalty for certification of a false statement in assessment of functional capacity of a Skilled Nursing Facility resident assessment20182,1402,194
1395i-3(b)(3)(B)(ii)(2)42 CFR 1003.210(a)(11)OIGPenalty for causing another to certify or make a false statement in assessment of functional capacity of a Skilled Nursing Facility resident assessment201810,69710,967
1395i-3(g)(2)(A)42 CFR 1003.1310OIGPenalty for any individual who notifies or causes to be notified a Skilled Nursing Facility of the time or date on which a survey is to be conducted20184,2804,388
1395w-27(g)(2)(A)42 CFR 1003.410OIGPenalty for a Medicare Advantage organization that substantially fails to provide medically necessary, required items and services201838,95439,936
Penalty for a Medicare Advantage organization that charges excessive premiums201838,15939,121
Penalty for a Medicare Advantage organization that improperly expels or refuses to reenroll a beneficiary201838,15939,121
Start Printed Page 59555
Penalty for a Medicare Advantage organization that engages in practice that would reasonably be expected to have the effect of denying or discouraging enrollment2018152,638156,488
Penalty per individual 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 enrollment201822,89623,473
Penalty for a Medicare Advantage organization misrepresenting or falsifying information to Secretary2018152,638156,488
Penalty for a Medicare Advantage organization misrepresenting or falsifying information to individual or other entity201838,15939,121
Penalty for Medicare Advantage organization interfering with provider's advice to enrollee and non-MCO affiliated providers that balance bill enrollees201838,15939,121
Penalty for a Medicare Advantage organization that employs or contracts with excluded individual or entity201838,15939,121
Penalty for a Medicare Advantage organization enrolling an individual in without prior written consent201838,15939,121
Penalty for a Medicare Advantage organization transferring an enrollee to another plan without consent or solely for the purpose of earning a commission201838,15939,121
Penalty for a Medicare Advantage organization failing to comply with marketing restrictions or applicable implementing regulations or guidance201838,15939,121
Penalty for a Medicare Advantage organization employing or contracting with an individual or entity who violates 1395w-27(g)(1)(A)-(J)201838,15939,121
1395w-141(i)(3)OIGPenalty for a prescription drug card sponsor that falsifies or misrepresents marketing materials, overcharges program enrollees, or misuse transitional assistance funds201813,33313,669
1395cc(g)42 CFR 1003.210(a)(5)OIGPenalty for improper billing by Hospitals, Critical Access Hospitals, or Skilled Nursing Facilities20185,1865,317
1395dd(d)(1)42 CFR 1003.510OIGPenalty for a hospital with 100 beds or more or responsible physician dumping patients needing emergency medical care2018106,965109,663
Penalty for a hospital with less than 100 beds dumping patients needing emergency medical care201853,48454,833
1395mm(i)(6)(B)(i)42 CFR 1003.410OIGPenalty for a HMO or competitive plan if such plan substantially fails to provide medically necessary, required items or services201853,48454,833
Penalty for HMOs/competitive medical plans that charge premiums in excess of permitted amounts201853,48454,833
Penalty for a HMO or competitive medical plan that expels or refuses to reenroll an individual per prescribed conditions201853,48454,833
Penalty for a HMO or competitive medical plan that implements practices to discourage enrollment of individuals needing services in future2018213,932219,327
Penalty per individual 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 future201830,78231,558
Penalty for a HMO or competitive medical plan that misrepresents or falsifies information to the Secretary2018213,932219,327
Start Printed Page 59556
Penalty for a HMO or competitive medical plan that misrepresents or falsifies information to an individual or any other entity201853,48454,833
Penalty for failure by HMO or competitive medical plan to assure prompt payment of Medicare risk sharing contracts or incentive plan provisions201853,48454,833
Penalty for HMO that employs or contracts with excluded individual or entity201849,09650,334
1395nn(g)(3)42 CFR 1003.310OIGPenalty for submitting or causing to be submitted claims in violation of the Stark Law's restrictions on physician self-referrals201824,74825,372
1395nn(g)(4)42 CFR 1003.310OIGPenalty for circumventing Stark Law's restrictions on physician self-referrals2018164,992169,153
1395ss(d)(1)42 CFR 1003.1110OIGPenalty for a material misrepresentation regarding Medigap compliance policies201810,26010,519
1395ss(d)(2)42 CFR 1003.1110OIGPenalty for selling Medigap policy under false pretense201810,26010,519
1395ss(d)(3)(A)(ii)42 CFR 1003.1110OIGPenalty for an issuer that sells health insurance policy that duplicates benefits201846,19247,357
Penalty for someone other than issuer that sells health insurance that duplicates benefits201827,71428,413
1395ss(d)(4)(A)42 CFR 1003.1110OIGPenalty for using mail to sell a non-approved Medigap insurance policy201810,26010,519
1396b(m)(5)(B)(i)42 CFR 1003.410OIGPenalty for a Medicaid MCO that substantially fails to provide medically necessary, required items or services201851,30252,596
Penalty for a Medicaid MCO that charges excessive premiums201851,30252,596
Penalty for a Medicaid MCO that improperly expels or refuses to reenroll a beneficiary2018205,211210,386
Penalty per individual 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 enrollment201830,78231,558
Penalty for a Medicaid MCO misrepresenting or falsifying information to the Secretary2018205,211210,386
Penalty for a Medicaid MCO misrepresenting or falsifying information to an individual or another entity201851,30252,596
Penalty for a Medicaid MCO that fails to comply with contract requirements with respect to physician incentive plans201846,19247,357
1396r(b)(3)(B)(ii)(I)42 CFR 1003.210(a)(11)OIGPenalty for willfully and knowingly certifying a material and false statement in a Skilled Nursing Facility resident assessment20182,1402,194
1396r(b)(3)(B)(ii)(II)42 CFR 1003.210(a)(11)OIGPenalty for willfully and knowingly causing another individual to certify a material and false statement in a Skilled Nursing Facility resident assessment201810,69710,967
1396r(g)(2)(A)(i)42 CFR 1003.1310OIGPenalty for notifying or causing to be notified a Skilled Nursing Facility of the time or date on which a survey is to be conducted20184,2804,388
1396r-8(b)(3)(B)42 CFR 1003.1210OIGPenalty for the knowing provision of false information or refusing to provide information about charges or prices of a covered outpatient drug2018184,767189,427
1396r-8(b)(3)(C)(i)42 CFR 1003.1210OIGPenalty per day for failure to timely provide information by drug manufacturer with rebate agreement201818,47718,943
1396r-8(b)(3)(C)(ii)42 CFR 1003.1210OIGPenalty for knowing provision of false information by drug manufacturer with rebate agreement2018184,767189,427
1396t(i)(3)(A)42 CFR 1003.1310OIGPenalty for notifying home and community-based providers or settings of survey20183,6953,788
11131(c)42 CFR 1003.810OIGPenalty for failing to report a medical malpractice claim to National Practitioner Data Bank201822,36322,927
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11137(b)(2)42 CFR 1003.810OIGPenalty for breaching confidentiality of information reported to National Practitioner Data Bank201822,36322,927
299b-22(f)(1)42 CFR 3.404OCRPenalty for violation of confidentiality provision of the Patient Safety and Quality Improvement Act201812,38312,695
45 CFR 160.404(b)(1)(i), (ii)OCRPenalty for each pre-February 18, 2009 violation of the HIPAA administrative simplification provisions2018155.10232159
Calendar Year Cap201838,95439,936
1320(d)-5(a)45 CFR 160.404(b)(2)(i)(A), (B)OCRPenalty for each 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:2018
Minimum2018114.28592117
Maximum201857,05158,490
Calendar Year Cap20181,711,5331,754,698
45 CFR 160.404(b)(2)(ii)(A), (B)OCRPenalty for each February 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:2018
Minimum20181,1411,170
Maximum201857,05158,490
Calendar Year Cap20181,711,5331,754,698
45 CFR 160.404(b)(2)(iii)(A), (B)OCRPenalty for each February 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:2018
Minimum201811,41011,698
Maximum201857,05158,490
Calendar Year Cap20181,711,5331,754,698
45 CFR 160.404(b)(2)(iv)(A), (B)OCRPenalty for each February 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:2018
Minimum201857,05158,490
Maximum20181,711,5331,754,698
Calendar Year Cap20181,711,5331,754,698
263a(h)(2)(B) & 1395w-2(b)(2)(A)(ii)42 CFR 493.1834(d)(2)(i)CMSPenalty for a clinical laboratory's failure to meet participation and certification requirements and poses immediate jeopardy:2018
Minimum20186,2596,417
Maximum201820,52121,039
42 CFR 493.1834(d)(2)(ii)CMSPenalty for a clinical laboratory's failure to meet participation and certification requirements and the failure does not pose immediate jeopardy:2018
Minimum2018103106
Maximum20186,1566,311
300gg-15(f)45 CFR 147.200(e)CMSFailure to provide the Summary of Benefits and Coverage20181,1281,156
300gg-1845 CFR 158.606CMSPenalty for violations of regulations related to the medical loss ratio reporting and rebating2018113116
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1320a-7h(b)(1)42 CFR 402.105(d)(5), 42 CFR 403.912(a) & (c)CMSPenalty for manufacturer or group purchasing organization failing to report information required under 42 U.S.C. 1320a-7h(a), relating to physician ownership or investment interests:2018
Minimum20181,1281,156
Maximum201811,27811,562
Calendar Year Cap2018169,170173,436
1320a-7h(b)(2)42 CFR 402.105(h), 42 CFR 403.912(b) & (c)CMSPenalty for manufacturer 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:2018
Minimum201811,27811,562
Maximum2018112,780115,624
Calendar Year Cap20181,127,7991,156,242
CMSPenalty for an administrator of a facility that fails to comply with notice requirements for the closure of a facility2018112,780115,624
1320a-7j(h)(3)(A)42 CFR 488.446(a)(1), (2), & (3)CMSMinimum penalty for the first offense of an administrator who fails to provide notice of facility closure2018564.28673578
Minimum penalty for the second offense of an administrator who fails to provide notice of facility closure20181,6921,735
Minimum penalty for the third and subsequent offenses of an administrator who fails to provide notice of facility closure20183,3833,468
1320a-8(a)(1)CMSPenalty for an entity 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 disabled20188,2498,457
Penalty for violation of 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 determination20187,7797,975
1320a-8(a)(3)CMSPenalty for a 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 beneficiary20186,4606,623
1320b-25(c)(1)(A)CMSPenalty for failure of 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 facility2018225,560231,249
1320b-25(c)(2)(A)CMSPenalty for failure of 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 individual2018338,339346,872
1320b-25(d)(2)CMSPenalty for a long-term 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 nurse2018225,560231,249
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1395b-7(b)(2)(B)42 CFR 402.105(g)CMSPenalty for any person who knowingly and willfully fails to furnish a beneficiary with an itemized statement of items or services within 30 days of the beneficiary's request2018152156
1395i-3(h)(2)(B)(ii)(I)42 CFR 488.408(d)(1)(iii)CMSPenalty per day for a Skilled Nursing Facility that has a Category 2 violation of certification requirements:2018
Minimum2018107110
Maximum20186,4176,579
42 CFR 488.408(d)(1)(iv)CMSPenalty per instance of Category 2 noncompliance by a Skilled Nursing Facility:2018
Minimum20182,1402,194
Maximum201821,39321,933
42 CFR 488.408(e)(1)(iii)CMSPenalty per day for a Skilled Nursing Facility that has a Category 3 violation of certification requirements:2018
Minimum20186,5256,690
Maximum201821,39321,933
42 CFR 488.408(e)(1)(iv)CMSPenalty per instance of Category 3 noncompliance by a Skilled Nursing Facility:2018
Minimum20182,1402,194
Maximum201821,39321,933
42 CFR 488.408(e)(2)(ii)CMSPenalty per day and per instance for a Skilled Nursing Facility that has Category 3 noncompliance with Immediate Jeopardy:2018
Per Day (Minimum)20186,5256,690
Per Day (Maximum)201821,39321,933
Per Instance (Minimum)20182,1402,194
Per Instance (Maximum)201821,39321,933
42 CFR 488.438(a)(1)(i)CMSPenalty per day of a Skilled Nursing Facility that fails to meet certification requirements. These amounts represent the upper range per day:2018
Minimum20186,5256,690
Maximum201821,39321,933
42 CFR 488.438(a)(1)(ii)CMSPenalty per day of a Skilled Nursing Facility that fails to meet certification requirements. These amounts represent the lower range per day:2018
Minimum2018107110
Maximum20186,4176,579
42 CFR 488.438(a)(2)CMSPenalty per instance of a Skilled Nursing Facility that fails to meet certification requirements:2018
Minimum20182,1402,194
Maximum201821,39321,933
1395l(h)(5)(D)42 CFR 402.105(d)(2)(i)CMSPenalty for knowingly, 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))201815,58215,975
1395l(i)(6)CMSPenalty for knowingly 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 involved20184,1044,208
1395l(q)(2)(B)(i)42 CFR 402.105(a)CMSPenalty for knowingly and willfully failing to provide information about a referring physician when seeking payment on an unassigned basis20183,9284,027
1395m(a)(11)(A)42 CFR 402.1(c)(4), 402.105(d)(2)(ii)CMSPenalty for any durable 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))201815,58215,975
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1395m(a)(18)(B)42 CFR 402.1(c)(5), 402.105(d)(2)(iii)CMSPenalty for any 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))201815,58215,975
1395m(b)(5)(C)42 CFR 402.1(c)(6), 402.105(d)(2)(iv)CMSPenalty for any 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))201815,58215,975
1395m(h)(3)42 CFR 402.1(c)(8), 402.105(d)(2)(vi)CMSPenalty for any supplier 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))201815,58215,975
1395m(j)(2)(A)(iii)CMSPenalty for any supplier 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 Act20181,6501,692
1395m(j)(4)42 CFR 402.1(c)(10), 402.105(d)(2)(vii)CMSPenalty for any supplier 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))201815,58215,975
1395m(k)(6)42 CFR 402.1(c)(31), 402.105(d)(3)CMSPenalty for any person 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))201815,58215,975
1395m(l)(6)42 CFR 402.1(c)(32), 402.105(d)(4)CMSPenalty for any supplier 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))201815,58215,975
1395u(b)(18)(B)42 CFR 402.1(c)(11), 402.105(d)(2)(viii)CMSPenalty for any 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))201815,58215,975
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1395u(j)(2)(B)42 CFR 402.1(c)CMSPenalty for any 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))201815,58215,975
1395u(k)42 CFR 402.1(c)(12), 402.105(d)(2)(ix)CMSPenalty for any 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))201815,58215,975
1395u(l)(3)42 CFR 402.1(c)(13), 402.105(d)(2)(x)CMSPenalty for any 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))201815,58215,975
1395u(m)(3)42 CFR 402.1(c)(14), 402.105(d)(2)(xi)CMSPenalty for any 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))201815,58215,975
1395u(n)(3)42 CFR 402.1(c)(15), 402.105(d)(2)(xii)CMSPenalty for any 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))201815,58215,975
1395u(o)(3)(B)42 CFR 414.707(b)CMSPenalty for any 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))201815,58215,975
1395u(p)(3)(A)CMSPenalty for any 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 basis20184,1044,208
1395w-3a(d)(4)(A)42 CFR 414.806CMSPenalty for a pharmaceutical manufacturer's misrepresentation of average sales price of a drug, or biologic201813,33313,669
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1395w-4(g)(1)(B)42 CFR 402.1(c)(17), 402.105(d)(2)(xiii)CMSPenalty for any 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))201815,58215,975
1395w-4(g)(3)(B)42 CFR 402.1(c)(18), 402.105(d)(2)(xiv)CMSPenalty for any person 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))201815,58215,975
1395w-27(g)(3)(A); 1857(g)(3) (A)42 CFR 422.760(b)(1)-(2); 42 CFR 423.760(b)(1)-(2)CMSPenalty for each 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 contract201838,15939,121
1395w-27(g)(3)(B); 1857(g)(3)(B)42 CFR 422.760(b)(3); 42 CFR 423.760(b)(3)CMSPenalty for each week 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 regulations201815,26415,649
1395w-27(g)(3)(D); 1857(g)(3)(D)CMSPenalty for a Medicare Advantage organization's or Part D sponsor's early termination of its contract2018141,760145,335
1395y(b)(3)(C)42 CFR 411.103(b)CMSPenalty for an employer 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 plan20189,2399,472
1395y(b)(5)(C)(ii)42 CFR 402.1(c)(20), 42 CFR 402.105(b)(2)CMSPenalty for any 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 coverage20181,5041,542
1395y(b)(6)(B)42 CFR 402.1(c)(21), 402.105(a)CMSPenalty for any entity 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 form20183,3003,383
1395y(b)(7)(B)(i)CMSPenalty for any entity 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 Secretary20181,1811,211
1395y(b)(8)(E)CMSPenalty for any non-group 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 claim20181,1811,211
1395nn(g)(5)42 CFR 411.361CMSPenalty for any person that fails to report information required by HHS under Section 1877(f) concerning ownership, investment, and compensation arrangements201819,63920,134
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1395pp(h)42 CFR 402.1(c)(23), 402.105(d)(2)(xv)CMSPenalty for any durable 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))201815,58215,975
1395ss(a)(2)42 CFR 402.1(c)(24), 405.105(f)(1)CMSPenalty for any person 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 date201853,48354,832
1395ss(d)(3)(A)(vi) (II)CMSPenalty for someone other than issuer that sells or issues a Medicare supplemental policy to beneficiary without a disclosure statement201827,71428,413
Penalty for an issuer that sells or issues a Medicare supplemental policy without disclosure statement201846,19247,357
1395ss(d)(3)(B)(iv)CMSPenalty for someone other than issuer that sells or issues a Medicare supplemental policy without acknowledgement form201827,71428,413
Penalty for issuer that sells or issues a Medicare supplemental policy without an acknowledgement form201846,19247,357
1395ss(p)(8)42 CFR 402.1(c)(25), 402.105(e)CMSPenalty for any person that sells or issues Medicare supplemental polices after a given date that fail to conform to the NAIC or Federal standards established by statute201827,71428,413
42 CFR 402.1(c)(25), 405.105(f)(2)CMSPenalty for any person that sells or issues Medicare supplemental polices after a given date that fail to conform to the NAIC or Federal standards established by statute201846,19247,357
1395ss(p)(9)(C)42 CFR 402.1(c)(26), 402.105(e)CMSPenalty for any person 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 benefits201827,71428,413
42 CFR 402.1(c)(26), 405.105(f)(3), (4)Penalty for any person 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 benefits201846,19247,357
1395ss(q)(5)(C)42 CFR 402.1(c)(27), 405.105(f)(5)CMSPenalty for any person 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 circumstances201846,19247,357
1395ss(r)(6)(A)42 CFR 402.1(c)(28), 405.105(f)(6)CMSPenalty for any person that fails to provide refunds or credits as required by section 1882(r)(1)(B)201846,19247,357
1395ss(s)(4)42 CFR 402.1(c)(29), 405.105(c)CMSPenalty for any issuer 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 criteria201819,60920,104
1395ss(t)(2)42 CFR 402.1(c)(30), 405.105(f)(7)CMSPenalty for any issuer of a Medicare supplemental policy that fails to fulfill listed responsibilities201846,19247,357
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1395ss(v)(4)(A)CMSPenalty someone other than issuer who sells, issues, or renews a medigap Rx policy to an individual who is a Part D enrollee201819,99920,503
Penalty for an issuer who sells, issues, or renews a Medigap Rx policy who is a Part D enrollee201833,33334,174
1395bbb(c)(1)42 CFR 488.725(c)CMSPenalty for any 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 conducted20184,2804,388
1395bbb(f)(2)(A)(i)42 CFR 488.845(b)(2)(iii) 42 CFR 488.845(b)(3)-(6); and 42 CFR 488.845(d)(1)(ii)CMSMaximum daily penalty amount for each day a home health agency is not in compliance with statutory requirements201820,52121,039
42 CFR 488.845(b)(3)Penalty per day for home health agency's noncompliance (Upper Range):2018
Minimum201817,44317,883
Maximum201820,52121,039
42 CFR 488.845(b)(3)(i)Penalty for a home health agency's deficiency or deficiencies that cause immediate jeopardy and result in actual harm201820,52121,039
42 CFR 488.845(b)(3)(ii)Penalty for a home health agency's deficiency or deficiencies that cause immediate jeopardy and result in potential for harm201818,46818,934
42 CFR 488.845(b)(3)(iii)Penalty for an isolated incident of noncompliance in violation of established HHA policy201817,44317,883
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):2018
Minimum20183,0793,157
Maximum201817,44317,883
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):2018
Minimum20181,0261,052
Maximum20188,2088,415
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:2018
Minimum20182,0522,104
Maximum201820,52121,039
Penalty for each day of noncompliance (Maximum)201820,52121,039
42 CFR 488.845(d)(1)(ii)Penalty for each day of noncompliance (Maximum)201820,52121,039
1396b(m)(5)(B)42 CFR 460.46 (a)(1)CMSPenalty for discriminating or discouraging enrollment or disenrollment of participants on the basis of an individual's health status or need for health care services.2018
42 CFR 460.46 (a)(1)Minimum201822,89623,473
42 CFR 460.46 (a)(1)Maximum2018152,638156,488
42 CFR 460.46 (a)(2)Penalty for a PACE organization that charges excessive premiums.201838,15939,121
42 CFR 460.46 (a)(3)Penalty for a PACE organization misrepresenting or falsifying information to CMS, the State, or an individual or other entity.2018152,638156,488
42 CFR 460.46 (a)(4)Penalty for each 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 participant201838,15939,121
42 CFR 460.46 (a)(4)Penalty for involuntarily disenrolling a participant.201838,15939,121
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42 CFR 460.46 (a)(4)Penalty for PACE organization's practice that would reasonably be expected to have the effect of denying or discouraging enrollment201838,15939,121
1396r(h)(3)(C)(ii)(I)42 CFR 488.408(d)(1)(iii)CMSPenalty per day for a nursing facility's failure to meet a Category 2 Certification:2018
Minimum2018107.14305110
Maximum20186,4176,579
42 CFR 488.408(d)(1)(iv)CMSPenalty per instance for a nursing facility's failure to meet Category 2 certification:2018
Minimum20182,1402,194
Maximum201821,39321,933
42 CFR 488.408(e)(1)(iii)CMSPenalty per day for a nursing facility's failure to meet Category 3 certification:2018
Minimum20186,5256,690
Maximum201821,39321,933
42 CFR 488.408(e)(1)(iv)CMSPenalty per instance for a nursing facility's failure to meet Category 3 certification:2018
Minimum20182,1402,194
Maximum201821,39321,933
42 CFR 488.408(e)(2)(ii)CMSPenalty per instance for a nursing facility's failure to meet Category 3 certification, which results in immediate jeopardy:2018
Minimum20182,1402,194
Maximum201821,39321,933
42 CFR 488.438(a)(1)(i)CMSPenalty per day for nursing facility's failure to meet certification (Upper Range):2018
Minimum20186,5256,690
Maximum201821,39321,933
42 CFR 488.438(a)(1)(ii)CMSPenalty per day for nursing facility's failure to meet certification (Lower Range):2018
Minimum2018107.14305110
Maximum20186,4176,579
42 CFR 488.438(a)(2)CMSPenalty per instance for nursing facility's failure to meet certification:2018
Minimum20182,1402,194
Maximum201821,39321,933
1396r(f)(2)(B)(iii)(I)(c)42 CFR 483.151(b)(2)(iv) and (b)(3)(iii)CMSGrounds to prohibit 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]201810,69710,967
1396r(h)(3)(C)(ii)(I)42 CFR 483.151(c)(2)CMSGrounds to waive 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]201810,69710,967
1396t(j)(2)(C)CMSPenalty for each day of noncompliance for a home or community care provider that no longer meets the minimum requirements for home and community care:2018
Minimum201822
Maximum201818,47718,943
1396u-2(e)(2)(A)(i)42 CFR 438.704CMSPenalty for a Medicaid managed care organization that fails substantially to provide medically necessary items and services201838,15939,121
Penalty for Medicaid managed care organization that imposes premiums or charges on enrollees in excess of the premiums or charges permitted201838,15939,121
Penalty for a Medicaid managed care organization that misrepresents or falsifies information to another individual or entity201838,15939,121
Penalty for a Medicaid managed care organization that fails to comply with the applicable statutory requirements for such organizations201838,15939,121
1396u-2(e)(2)(A)(ii)42 CFR 438.704CMSPenalty for a Medicaid managed care organization that misrepresents or falsifies information to the HHS Secretary2018152,638156,488
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Penalty for Medicaid managed care organization that acts to discriminate among enrollees on the basis of their health status2018152,638156,488
1396u-2(e)(2)(A)(iv)42 CFR 438.704CMSPenalty for each 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 status201822,89623,473
1396u(h)(2)42 CFR Part 441, Subpart ICMSPenalty for a provider not meeting one of the requirements relating to the protection of the health, safety, and welfare of individuals receiving community supported living arrangements services201821,39321,933
1396w-2(c)(1)CMSPenalty for disclosing information related to eligibility determinations for medical assistance programs201811,41011,698
18041(c)(2)45 CFR 150.315; 45 CFR 156.805(c)CMSFailure to comply with 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))2018155.10232159
18081(h)(1)(A)(i)(II)42 CFR 155.285CMSPenalty for providing false information on Exchange application201828,19528,906
18081(h)(1)(B)42 CFR 155.285CMSPenalty for knowingly or willfully providing false information on Exchange application2018281,949289,060
18081(h)(2)42 CFR 155.260CMSPenalty for knowingly or willfully disclosing protected information from Exchange201828,19528,906
31 U.S.C.:
135245 CFR 93.400(e)HHSPenalty for the first time an individual makes an expenditure prohibited by regulations regarding lobbying disclosure, absent aggravating circumstances201819,63920,134
Penalty for second and subsequent offenses by individuals who make an expenditure prohibited by regulations regarding lobbying disclosure:2018
Minimum201819,63920,134
Maximum2018196,387201,340
Penalty for the first time an individual fails to file or amend a lobbying disclosure form, absent aggravating circumstances201819,63920,134
Penalty for second and subsequent offenses by individuals who fail to file or amend a lobbying disclosure form, absent aggravating circumstances:2018
Minimum201819,63920,134
Maximum2018196,387201,340
45 CFR Part 93, Appendix AHHSPenalty for failure to provide certification regarding lobbying in the award documents for all sub-awards of all tiers:2018
Minimum201819,63920,134
Maximum2018196,387201,340
Penalty for failure to provide statement regarding lobbying for loan guarantee and loan insurance transactions:2018
Minimum201819,63920,134
Maximum2018196,387201,340
3801-381245 CFR 79.3(a)(1)(iv)HHSPenalty against any individual who—with knowledge or reason to know—makes, presents or submits a false, fictitious or fraudulent claim to the Department201810,26110,520
45 CFR 79.3(b)(1)(ii)Penalty against any individual who—with knowledge or reason to know—makes, presents or submits a false, fictitious or fraudulent claim to the Department201810,26110,520
1 Some HHS components have not promulgated regulations regarding their civil monetary penalty-specific statutory authorities.
2 The description is not intended to be a comprehensive explanation of the underlying violation; the statute and corresponding regulation, if applicable, should be consulted.
3 Statutory or Inflation Act Adjustment.
4 The cost of living multiplier for 2019, based on the CPI-U for the month of October 2018, not seasonally adjusted, is 1.02522, as indicated in OMB Memorandum M-19-04, “Implementation of Penalty Inflation Adjustments for 2018, Pursuant to the Federal Civil Penalties Adjustment Act Improvements Act of 2015” (December 14, 2018).
* For each false record or statement, 10,000 per day.
** For each false record statement, 10,461 per day.
Start Signature
Start Printed Page 59567

Dated: October 28, 2019.

Alex M. Azar II,

Secretary, Department of Health and Human Services.

End Signature End Supplemental Information

[FR Doc. 2019-23955 Filed 11-4-19; 8:45 am]

BILLING CODE 4150-24-P