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Rule

Annual Civil Monetary Penalties Inflation Adjustment

Document Details

Information about this document as published in the Federal Register.

Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

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.

DATES:

This rule is effective October 11, 2018.

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FOR FURTHER INFORMATION CONTACT:

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

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”), which is intended to improve the effectiveness of civil monetary penalties (CMPs) and to maintain the deterrent effect of such penalties, requires agencies to adjust the civil monetary penalties for inflation annually.

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

II. Calculation of Adjustment

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

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

III. Statutory and Executive Order Reviews

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

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

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

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

IV. Effective Date

This rule is effective October 11 2018. The adjusted civil monetary penalty amounts apply to penalties assessed on or after October 11, 2018, if the violation occurred on or after November 2, 2015. If the violation occurred prior to November 2, 2015, or a penalty was assessed prior to September 6, 2016, the pre-adjustment civil penalty amounts in Start Printed Page 51370effect 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 subtitle A, title 45 of the Code of Federal Regulations as follows:

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PART 102—ADJUSTMENT OF CIVIL MONETARY PENALTIES FOR INFLATION

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

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

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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 October 11, 2018]

CitationHHS agencyDescription 2Date of last statutorily established penalty figure 32016 Maximum adjusted penalty ($)2017 Maximum adjusted penalty ($) 42018 Maximum adjusted penalty ($)
U.S.C.CFR 1
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 period201698,935100,554102,606
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 period20161,978,6902,011,0612,052,107
333(b)(3)FDAPenalty for failure to make a report required by 21 U.S.C. 353(d)(3)(E) relating to drug samples2016197,869201,106205,211
333(f)(1)(A)FDAPenalty for any person who violates a requirement related to devices for each such violation201626,72327,16027,714
Penalty for aggregate of all violations related to devices in a single proceeding20161,781,5601,810,7061,847,663
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. 350l201675,12376,35277,910
Penalty in the case of any other person other than an individual) for such introduction or delivery of adulterated food2016375,613381,758389,550
Penalty for aggregate of all such violations related to adulterated food adjudicated in a single proceeding2016751,225763,515779,098
333(f)(3)(A)FDAPenalty for all 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)201611,38311,56911,805
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 corrected201611,38311,56911,805
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)2016284,583289,239295,142
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Penalty for aggregate of all such above violations in a single proceeding20161,138,3301,156,9531,180,566
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 violation2016284,583289,239295,142
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 period20161,138,3301,156,9531,180,566
Penalty for aggregate of all such above violations adjudicated in a single proceeding201611,383,30011,569,53111,805,665
333(f)(9)(A)FDAPenalty for any person who violates a requirement which relates to tobacco products for each such violation201616,50316,77317,115
Penalty for aggregate of all such violations of tobacco product requirement adjudicated in a single proceeding20161,100,2001,118,1991,141,021
333(f)(9)(B)(i)(I)FDAPenalty per violation related to violations of tobacco requirements2016275,050279,550285,256
Penalty for aggregate of all such violations of tobacco product requirements adjudicated in a single proceeding20161,100,2001,118,1991,141,021
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 violation2016275,050279,550285,256
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 period20161,100,2001,118,1991,141,021
Penalty for aggregate of all such violations related to tobacco product requirements adjudicated in a single proceeding201611,002,00011,181,99311,410,218
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 products2016275,050279,550285,256
Penalty for aggregate of for all such above violations adjudicated in a single proceeding20161,100,2001,118,1991,141,021
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 violation2016275,050279,550285,256
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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 period20161,100,2001,118,1991,141,021
Penalty for aggregate above tobacco product requirement violations adjudicated in a single proceeding201611,002,00011,181,99311,410,218
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 period2016284,583289,239295,142
Penalty for each subsequent above violation in any 3-year period2016569,165578,477590,284
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 period2016275279285
Penalty in the case of a third tobacco product regulation violation within a 24-month period2016550559570
Penalty in the case of a fourth tobacco product regulation violation within a 24-month period20162,2002,2362,282
Penalty in the case of a fifth tobacco product regulation violation within a 36-month period20165,5015,5915,705
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 basis201611,00211,18211,410
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 violation2016275279285
Penalty in the case of a second tobacco product regulation violation within a 12-month period2016550559570
Penalty in the case of a third tobacco product regulation violation within a 24-month period20161,1001,1181,141
Penalty in the case of a fourth tobacco product regulation violation within a 24-month period20162,2002,2362,282
Penalty in the case of a fifth tobacco product regulation violation within a 36-month period20165,5015,5915,705
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 basis201611,00211,18211,410
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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 services2016419,320426,180434,878
Penalty in the case of any other person (other than an individual) per above violation20161,677,2801,704,7201,739,513
360pp(b)(1)FDAPenalty for any person who violates any such requirements for electronic products, with each unlawful act or omission constituting a separate violation20162,7502,7952,852
Penalty imposed for any related series of violations of requirements relating to electronic products2016937,500952,838972,285
42 U.S.C.
262(d)FDAPenalty per day for violation of order of recall of biological product presenting imminent or substantial hazard2016215,628219,156223,629
263b(h)(3)FDAPenalty for failure to obtain a mammography certificate as required201616,77317,04717,395
300aa-28(b)(1)FDAPenalty per occurrence for any vaccine manufacturer that intentionally destroys, alters, falsifies, or conceals any record or report required2016215,628219,156223,629
256b(d)(1)(B)(vi)HRSAPenalty for each instance of overcharging a 340B covered entity20165,4375,5265,639
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 supplied201614,14014,37114,664
653(l)(2)45 CFR 303.21(f)ACFPenalty for Misuse of Information in the National Directory of New Hires20161,4501,4741,504
262a(i)(1)42 CFR 1003.910OIGPenalty for each individual who violates safety and security procedures related to handling dangerous biological agents and toxins2016327,962333,327340,130
Penalty for any other person who violates safety and security procedures related to handling dangerous biological agents and toxins2016655,925666,656680,262
300jj-51OIGPenalty per violation for committing information blocking20161,000,0001,016,3601,037,104
1320a-7a(a) 542 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 claim201815,02415,27020,000
Penalty for knowingly presenting or causing to be presented a request for payment which violates the terms of an assignment, agreement, or PPS agreement201815,02415,27020,000
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 decision201822,53722,90630,000
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42 CFR 1003.210(a)(3)Penalty for an excluded party retaining ownership or control interest in a participating entity201815,02415,27020,000
42 CFR 1003.1010Penalty for remuneration offered to induce program beneficiaries to use particular providers, practitioners, or suppliers201815,02415,27020,000
42 CFR 1003.210(a)(4)Penalty for employing or contracting with an excluded individual201814,71814,95920,000
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 program201873,58874,792100,000
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 excluded201810,87411,05220,000
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 supplier201854,37255,262100,000
42 CFR 1003.210(a)(8)Penalty for knowing of an overpayment and failing to report and return201810,87411,05220,000
42 CFR 1003.210(a)(7)Penalty for making or using a false record or statement that is material to a false or fraudulent claim201854,37255,262100,000
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 OIG201816,31216,57930,000
1320a-7a(b) 5OIGPenalty 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 benefits20184,3134,3845,000
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 benefits20184,3134,3845,000
42 CFR 1003.210(a)(10)Penalty for a physician who executes a document that falsely certifies home health needs for Medicare beneficiaries20187,5127,63510,000
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 practitioner201636,79437,39638,159
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 HHS20169,89310,05510,260
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 HHS201649,46750,27651,302
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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 assessment20162,0632,0972,140
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 assessment201610,31410,48310,697
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 conducted20164,1264,1944,280
1395w-27(g)(2)(A)42 CFR 1003.410OIGPenalty for a Medicare Advantage organization that substantially fails to provide medically necessary, required items and services201637,56138,17538,954
Penalty for a Medicare Advantage organization that charges excessive premiums201636,79437,39638,159
Penalty for a Medicare Advantage organization that improperly expels or refuses to reenroll a beneficiary201636,79437,39638,159
Penalty for a Medicare Advantage organization that engages in practice that would reasonably be expected to have the effect of denying or discouraging enrollment2016147,177149,585152,638
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 enrollment201622,07722,43822,896
Penalty for a Medicare Advantage organization misrepresenting or falsifying information to Secretary2016147,177149,585152,638
Penalty for a Medicare Advantage organization misrepresenting or falsifying information to individual or other entity201636,79437,39638,159
Penalty for Medicare Advantage organization interfering with provider's advice to enrollee and non-MCO affiliated providers that balance bill enrollees201636,79437,39638,159
Penalty for a Medicare Advantage organization that employs or contracts with excluded individual or entity201636,79437,39638,159
Penalty for a Medicare Advantage organization enrolling an individual in without prior written consent201636,79437,39638,159
Penalty for a Medicare Advantage organization transferring an enrollee to another plan without consent or solely for the purpose of earning a commission201636,79437,39638,159
Penalty for a Medicare Advantage organization failing to comply with marketing restrictions or applicable implementing regulations or guidance201636,79437,39638,159
Penalty for a Medicare Advantage organization employing or contracting with an individual or entity who violates 1395w-27(g)(1)(A)-(J)201636,79437,39638,159
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1395w-141(i)(3)OIGPenalty for a prescription drug card sponsor that falsifies or misrepresents marketing materials, overcharges program enrollees, or misuse transitional assistance funds201612,85613,06613,333
1395cc(g)OIGPenalty for improper billing by Hospitals, Critical Access Hospitals, or Skilled Nursing Facilities20165,0005,0825,186
1395dd(d)(1)42 CFR 1003.510OIGPenalty for a hospital or responsible physician dumping patients needing emergency medical care, if the hospital has 100 beds or more2016103,139104,826106,965
Penalty for a hospital or responsible physician dumping patients needing emergency medical care, if the hospital has less than 100 beds201651,57052,41453,484
1395mm(i)(6)(B)(i)42 CFR 1003.410OIGPenalty for a HMO or competitive plan is such plan substantially fails to provide medically necessary, required items or services201651,57052,41453,484
Penalty for HMOs/competitive medical plans that charge premiums in excess of permitted amounts201651,57052,41453,484
Penalty for a HMO or competitive medical plan that expels or refuses to reenroll an individual per prescribed conditions201651,57052,41453,484
Penalty for a HMO or competitive medical plan that implements practices to discourage enrollment of individuals needing services in future2016206,278209,653213,932
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 future201629,68030,16630,782
Penalty for a HMO or competitive medical plan that misrepresents or falsifies information to the Secretary2016206,278209,653213,932
Penalty for a HMO or competitive medical plan that misrepresents or falsifies information to an individual or any other entity201651,57052,41453,484
Penalty for failure by HMO or competitive medical plan to assure prompt payment of Medicare risk sharing contracts or incentive plan provisions201651,57052,41453,484
Penalty for HMO that employs or contracts with excluded individual or entity201647,34048,11449,096
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-referrals201623,86324,25324,748
1395nn(g)(4)42 CFR 1003.310OIGPenalty for circumventing Stark Law's restrictions on physician self-referrals2016159,089161,692164,992
1395ss(d)(1)42 CFR 1003.1110OIGPenalty for a material misrepresentation regarding Medigap compliance policies20169,89310,05510,260
1395ss(d)(2)42 CFR 1003.1110OIGPenalty for selling Medigap policy under false pretense20169,89310,05510,260
1395ss(d)(3)(A)(ii)42 CFR 1003.1110OIGPenalty for an issuer that sells health insurance policy that duplicates benefits201644,53945,26846,192
Penalty for someone other than issuer that sells health insurance that duplicates benefits201626,72327,16027,714
Start Printed Page 51377
1395ss(d)(4)(A)42 CFR 1003.1110OIGPenalty for using mail to sell a non-approved Medigap insurance policy20169,89310,05510,260
1396b(m)(5)(B)(i)42 CFR 1003.410OIGPenalty for a Medicaid MCO that substantially fails to provide medically necessary, required items or services201649,46750,27651,302
Penalty for a Medicaid MCO that charges excessive premiums201649,46750,27651,302
Penalty for a Medicaid MCO that improperly expels or refuses to reenroll a beneficiary2016197,869201,106205,211
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 enrollment201629,68030,16630,782
Penalty for a Medicaid MCO misrepresenting or falsifying information to the Secretary2016197,869201,106205,211
Penalty for a Medicaid MCO misrepresenting or falsifying information to an individual or another entity201649,46750,27651,302
Penalty for a Medicaid MCO that fails to comply with contract requirements with respect to physician incentive plans201644,53945,26846,192
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 assessment20162,0632,0972,140
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 assessment201610,31410,48310,697
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 conducted20164,1264,1944,280
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 drug2016178,156181,071184,767
1396r-8(b)(3)(C)(i)42 CFR 1003.1210OIGPenalty per day for failure to timely provide information by drug manufacturer with rebate agreement201617,81618,10718,477
1396r-8(b)(3)(C)(ii)42 CFR 1003.1210OIGPenalty for knowing provision of false information by drug manufacturer with rebate agreement2016178,156181,071184,767
1396t(i)(3)(A)42 CFR 1003.1310OIGPenalty for notifying home and community-based providers or settings of survey20163,5633,6213,695
11131(c)42 CFR 1003.810OIGPenalty for failing to report a medical malpractice claim to National Practitioner Data Bank201621,56321,91622,363
11137(b)(2)42 CFR 1003.810OIGPenalty for breaching confidentiality of information reported to National Practitioner Data Bank201621,56321,91622,363
299b-22(f)(1)42 CFR 3.404OCRPenalty for violation of confidentiality provision of the Patient Safety and Quality Improvement Act201611,94012,13512,383
1320(d)-5(a)45 CFR 160.404(b)(1)(i), (ii)OCRPenalty for each pre-February 18, 2009 violation of the HIPAA administrative simplification provisions2016150152155
Calendar Year Cap201637,56138,17538,954
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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
Minimum2016110112114
Maximum201655,01055,91057,051
Calendar Year Cap20161,650,3001,677,2991,711,533
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
Minimum20161,1001,1181,141
Maximum201655,01055,91057,051
Calendar Year Cap20161,650,3001,677,2991,711,533
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
Minimum201611,00211,18211,410
Maximum201655,01055,91057,051
Calendar Year Cap20161,650,3001,677,2991,711,533
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
Minimum201655,01055,91057,051
Maximum20161,650,3001,677,2991,711,533
Calendar Year Cap20161,650,3001,677,2991,711,533
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
Minimum20166,0356,1346,259
Maximum201619,78720,11120,521
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-
Minimum201699101103
Maximum20165,9366,0336,156
300gg-15(f)45 CFR 147.200(e)CMSFailure to provide the Summary of Benefits and Coverage20161,0871,1051,128
300gg-1845 CFR 158.606CMSPenalty for violations of regulations related to the medical loss ratio reporting and rebating2016109111113
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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
Minimum20161,0871,1051,128
Maximum201610,87411,05211,278
Calendar Year Cap2016163,117165,786169,170
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
Minimum201610,87411,05211,278
Maximum2016108,745110,524112,780
Calendar Year Cap20161,087,4501,105,2411,127,799
1320a-7j(h)(3)(A)CMSPenalty for an administrator of a facility that fails to comply with notice requirements for the closure of a facility2016108,745110,524112,780
42 CFR 488.446(a)(1),(2), & (3)CMSMinimum penalty for the first offense of an administrator who fails to provide notice of facility closure2016544553564
Minimum penalty for the second offense of an administrator who fails to provide notice of facility closure20161,6311,6581,692
Minimum penalty for the third and subsequent offenses of an administrator who fails to provide notice of facility closure20163,2623,3153,383
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 disabled20167,9548,0848,249
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 determination20167,5007,6237,779
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 beneficiary20166,2296,3316,460
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 facility2016217,490221,048225,560
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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 individual2016326,235331,572338,339
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 nurse2016217,490221,048225,560
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 request2016147149152
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
Minimum2016103105107
Maximum20166,1886,2896,417
42 CFR 488.408(d)(1)(iv)CMSPenalty per instance of Category 2 noncompliance by a Skilled Nursing Facility
Minimum20162,0632,0972,140
Maximum201620,62820,96521,393
42 CFR 488.408(e)(1)(iii)CMSPenalty per day for a Skilled Nursing Facility that has a Category 3 violation of certification requirements
Minimum20166,2916,3946,525
Maximum201620,62820,96521,393
42 CFR 488.408(e)(1)(iv)CMSPenalty per instance of Category 3 noncompliance by a Skilled Nursing Facility
Minimum20162,0632,0972,140
Maximum201620,62820,96521,393
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
Per Day (Minimum)20166,2916,3946,525
Per Day (Maximum)201620,62820,96521,393
Per Instance (Minimum)20162,0632,0972,140
Per Instance (Maximum)201620,62820,96521,393
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
Minimum20166,2916,3946,524
Maximum201620,62820,96521,393
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
Minimum2016103105107
Maximum20166,1886,2896,418
42 CFR 488.438(a)(2)CMSPenalty per instance of a Skilled Nursing Facility that fails to meet certification requirements
Minimum20162,0632,0972,140
Maximum201620,62820,96521,393
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1395l(h)(5)(D) 542 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))201815,02415,27030,000
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 involved20163,9574,0224,104
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 basis20163,7873,8493,928
1395m(a)(11)(A)542 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))201815,02415,27030,000
1395m(a)(18)(B) 542 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))201815,02415,27030,000
1395m(b)(5)(C) 542 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))201815,02415,27030,000
1395m(h)(3) 542 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))201815,02415,27030,000
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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 Act20161,5911,6171,650
1395m(j)(4) 542 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))201815,02415,27030,000
1395m(k)(6) 542 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))201815,02415,27030,000
1395m(l)(6)542 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))201815,02415,27030,000
1395u(b)(18)(B) 542 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))201815,02415,27030,000
1395u(j)(2)(B) 542 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))201815,02415,27030,000
1395u(k) 542 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))201815,02415,27030,000
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1395u(l)(3) 542 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))201815,02415,27030,000
1395u(m)(3) 542 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))201815,02415,27030,000
1395u(n)(3) 542 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))201815,02415,27030,000
1395u(o)(3)(B) 542 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))201815,02415,27030,000
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 basis20163,9574,0224,104
1395w-3a(d)(4)(A)42 CFR 414.806CMSPenalty for a pharmaceutical manufacturer's misrepresentation of average sales price of a drug, or biologic201612,85613,06613,333
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1395w-4(g)(1)(B) 542 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))201815,02415,27030,000
1395w-4(g)(3)(B) 542 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))201815,02415,27030,000
1395w-27(g)(3)(A); 1857(g)(3)42 CFR 422.760(b); 42 CFR 423.760(b)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 contract201636,79437,39638,159
1395w-27(g)(3)(B); 1857(g)(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 regulations201614,71814,95915,264
1395w-27(g)(3)(D); 1857(g)(3)CMSPenalty for a Medicare Advantage organization's or Part D sponsor's early termination of its contract2016136,689138,925141,760
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 plan20168,9089,0549,239
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 coverage20161,4501,4741,504
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 form20163,1823,2343,300
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 Secretary20161,1381,1571,181
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1395pp(h) 542 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))201815,02415,27030,000
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 arrangements201618,93619,24619,639
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))201615,02415,27015,582
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 date201651,56952,41353,483
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 statement201626,72327,16027,714
Penalty for an issuer that sells or issues a Medicare supplemental policy without disclosure statement201644,53945,26846,192
1395ss(d)(3)(B)(iv)CMSPenalty for someone other than issuer that sells or issues a Medicare supplemental policy without acknowledgement form.201626,72327,16027,714
Penalty for issuer that sells or issues a Medicare supplemental policy without an acknowledgement form201644,53945,26846,192
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 statute201626,72327,16027,714
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 statute201644,53945,26846,192
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 benefits201626,72327,16027,714
Start Printed Page 51386
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 benefits201644,53945,26846,192
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 circumstances201644,53945,26846,192
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)201644,53945,26846,192
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 criteria201618,90819,21719,609
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 responsibilities201644,53945,26846,192
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 enrollee201619,28419,59919,999
Penalty for an issuer who sells, issues, or renews a Medigap Rx policy who is a Part D enrollee201632,14032,66633,333
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 conducted20164,1264,1944,280
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 requirements201619,78720,11120,521
42 CFR 488.845(b)(3)Penalty per day for home health agency's noncompliance (Upper Range)
Minimum201616,81917,09417,443
Maximum201619,78720,11120,521
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 harm201619,78720,11120,521
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 harm201617,80818,09918,468
42 CFR 488.845(b)(3)(iii)Penalty for an isolated incident of noncompliance in violation of established HHA policy201616,81917,09417,443
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)
Minimum20162,9683,0173,079
Start Printed Page 51387
Maximum201616,81917,09417,443
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)
Minimum20169891,0051,026
Maximum20167,9158,0448,208
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
Minimum20161,9792,0112,052
Maximum201619,78720,11120,521
Penalty for each day of noncompliance (Maximum)201619,78720,11120,521
42 CFR 488.845(d)(1)(ii)Penalty for each day of noncompliance (Maximum)201619,78720,11120,521
1396b(m)(5)(B)42 CFR 460.46CMSPenalty for PACE organization's practice that would reasonably be expected to have the effect of denying or discouraging enrollment
Minimum201622,07722,43822,896
Maximum2016147,177149,585152,638
Penalty for a PACE organization that charges excessive premiums201636,79437,39638,159
Penalty for a PACE organization misrepresenting or falsifying information to CMS, the State, or an individual or other entity2016147,177149,585152,638
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 participant201636,79437,39638,159
Penalty for involuntarily disenrolling a participant201636,79437,39638,159
Penalty for discriminating or discouraging enrollment or disenrollment of participants on the basis of an individual's health status or need for health care services201636,79437,39638,159
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
Minimum2016103105107
Maximum20166,1886,2896,417
42 CFR 488.408(d)(1)(iv)CMSPenalty per instance for a nursing facility's failure to meet Category 2 certification
Minimum20162,0632,0972,140
Maximum201620,62820,96521,393
42 CFR 488.408(e)(1)(iii)CMSPenalty per day for a nursing facility's failure to meet Category 3 certification
Minimum20166,2916,3946,525
Maximum201620,62820,96521,393
42 CFR 488.408(e)(1)(iv)CMSPenalty per instance for a nursing facility's failure to meet Category 3 certification
Minimum20162,0632,0972,140
Maximum201620,62820,96521,393
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
Start Printed Page 51388
Minimum20162,0632,0972,140
Maximum201620,62820,96521,393
42 CFR 488.438(a)(1)(i)CMSPenalty per day for nursing facility's failure to meet certification (Upper Range)
Minimum20166,2916,3946,525
Maximum201620,62820,96521,393
42 CFR 488.438(a)(1)(ii)CMSPenalty per day for nursing facility's failure to meet certification (Lower Range)
Minimum2016103105107
Maximum20166,1886,2896,417
42 CFR 488.438(a)(2)CMSPenalty per instance for nursing facility's failure to meet certification
Minimum20162,0632,0972,140
Maximum201620,62820,96521,393
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]201610,31410,48310,697
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]201610,31410,48310,697
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
Minimum2016222
Maximum201617,81618,10718,477
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 services201636,79437,39638,159
Penalty for Medicaid managed care organization that imposes premiums or charges on enrollees in excess of the premiums or charges permitted201636,79437,39638,159
Penalty for a Medicaid managed care organization that misrepresents or falsifies information to another individual or entity201636,79437,39638,159
Penalty for a Medicaid managed care organization that fails to comply with the applicable statutory requirements for such organizations201636,79437,39638,159
1396u-2(e)(2)(A)(ii)42 CFR 438.704CMSPenalty for a Medicaid managed care organization that misrepresents or falsifies information to the HHS Secretary2016147,177149,585152,638
Penalty for Medicaid managed care organization that acts to discriminate among enrollees on the basis of their health status2016147,177149,585152,638
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 status201622,07722,43822,896
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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 services201620,62820,96521,393
1396w-2(c)(1)CMSPenalty for disclosing information related to eligibility determinations for medical assistance programs201611,00211,18211,410
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))2016150152155
18081(h)(1)(A)(i)(II)42 CFR 155.285CMSPenalty for providing false information on Exchange application201627,18627,63128,195
18081(h)(1)(B)42 CFR 155.285CMSPenalty for knowingly or willfully providing false information on Exchange application2016271,862276,310281,949
18081(h)(2)42 CFR 155.260CMSPenalty for knowingly or willfully disclosing protected information from Exchange201627,18627,63128,195
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 circumstances201618,93619,24619,639
Penalty for second and subsequent offenses by individuals who make an expenditure prohibited by regulations regarding lobbying disclosure
Minimum201618,93619,24619,639
Maximum2016189,361192,459196,387
Penalty for the first time an individual fails to file or amend a lobbying disclosure form, absent aggravating circumstances201618,93619,24619,639
Penalty for second and subsequent offenses by individuals who fail to file or amend a lobbying disclosure form, absent aggravating circumstances
Minimum201618,93619,24619,639
Maximum2016189,361192,459196,387
45 CFR Part 93, Appendix AHHSPenalty for failure to provide certification regarding lobbying in the award documents for all sub-awards of all tiers
Minimum201618,93619,24619,639
Maximum2016189,361192,459196,387
Penalty for failure to provide statement regarding lobbying for loan guarantee and loan insurance transactions
Minimum201618,93619,24619,639
Maximum2016189,361192,459196,387
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 Department20169,89410,05610,261
45 CFR 79.3(b)(1(ii)HHSPenalty against any individual who—with knowledge or reason to know—makes, presents or submits a false, fictitious or fraudulent claim to the Department20169,89410,05610,261
1 Some HHS components have not promulgated regulations regarding their civil monetary penalty-specific statutory authorities.Start Printed Page 51390
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 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).
5 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).
Start Signature

Dated: October 3, 2018.

Alex M. Azar II,

Secretary, Department of Health and Human Services.

End Signature End Supplemental Information

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

BILLING CODE 4150-24-P