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Annual Civil Monetary Penalties Inflation Adjustment

The Department of Health and Human Services (HHS) is updating its regulations to reflect required annual inflation-related increases to the civil monetary penalty (CMP) amounts ...

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Department of Health and Human Services

45 CFR Part 102
RIN 0991-AC38

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 (HHS) is updating its regulations to reflect required annual inflation-related increases to the civil monetary penalty (CMP) amounts in its statutes and regulations, under the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015.

DATES:

Effective date: This final rule is effective upon publication to the Federal Register .

Applicability date: The adjusted civil monetary penalty amounts apply to penalties assessed on or after the date of publication to the Federal Register , if the violation occurred on or after November 2, 2015.

FOR FURTHER INFORMATION CONTACT:

Jennifer Johnson, Acting, 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; (771) 215-0133.

SUPPLEMENTARY INFORMATION:

I. Background

The Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (section 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 CMPs and to maintain the deterrent effect of such penalties, requires agencies to adjust the CMPs for inflation annually.

HHS lists the CMP authorities and the 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), October 11, 2018 (83 FR 51369), November 5, 2019 (84 FR 59549), January 17, 2020 (85 FR 2869), November 15, 2021 (86 FR 62928), March 17, 2022 (87 FR 15100), October 6, 2023 (88 FR 69531), and August 8, 2024 (89 FR 64815) .

II. Calculation of Annual Inflation Adjustment and Other Updates

The annual inflation adjustment for each applicable CMP 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 CMP was most recently established or modified. In the December 17, 2024, Office of Management and Budget (OMB) Memorandum for the Heads of Executive Departments and Agencies, M-25-02, “Implementation of Penalty Inflation Adjustments for 2025, 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 2025, based on the CPI-U for the month of October 2024, not seasonally adjusted, is 1.02598. The multiplier is applied to each applicable penalty amount that was updated and published for fiscal year (FY) 2024 and is rounded to the nearest dollar.

In addition to the inflation adjustments for 2025, this final rule corrects several technical errors and updates descriptions for clarification and accuracy. The following non-substantive technical errors were identified and are corrected and following descriptions are updated in the table in 45 CFR 102.3:

The description of42 U.S.C. 1320a-7j(h)(3)(A) is revised to add the word “Maximum” to accurately reflect the statutory maximum penalty amount.
The regulatory cite associated with “Penalty against hospital identified by CMS as noncompliant according to § 182.50 with respect to price transparency requirements regarding diagnostic tests for COVID-19” was corrected from45 CFR 180.90 to 45 CFR 182.70.
The 2024 maximum penalty associated with45 CFR 180.90(c)(2)(ii)(C) was revised as it was cited incorrectly as $3,021 but should have been $6,118 in the last adjustment. In the 2024 adjustment, the amount reflected in the 2023 Maximum Adjusted Penalty column should have been $5,926, which was the actual adjusted amount in 2023 (see 88 FR at 69541). However, this amount was inadvertently mistyped as $2,926 in the last adjustment (see 89 FR at 64823). Applying the 2024 multiplier to the correct amount would have resulted in ( printed page 3666) $6,118 ($5,926 × 1.03241). Therefore, the 2024 Maximum Adjusted Penalty was revised in this rule to $6,118.

III. Statutory and Executive Order Reviews and Waiver of Proposed Rulemaking

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-25-02, the phrase “notwithstanding section 553” in section 4(b)(2) of the 2015 Act means that “the notice and comment process the APA generally 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, the inflation adjustments set out in this rule are not subject to notice and an opportunity for public comment and will be effective immediately upon publication. Also, HHS finds that notice and comment procedures would be impracticable and unnecessary under the APA for the ministerial and technical changes in this rule. In addition, HHS is waiving notice and comment for the non-substantive technical corrections set out in this final rule. HHS finds good cause for issuing these changes as a final rule without prior notice and comment because these changes make technical clarifying edits to descriptions and corrections to inadvertent typographical errors from the last update. For these same reasons, HHS also finds good cause to make the final rule effective upon publication.

Pursuant to OMB Memorandum M-25-02, 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 and Applicability Dates

This rule is effective on the date specified in the DATES section of this final rule. The adjusted civil monetary penalty amounts apply to penalties assessed on or after the date specified in the DATES section of this final rule, if the violation occurred on or after November 2, 2015 ( i.e., the date of enactment of the 2015 Act). If the violation occurred before November 2, 2015, or a penalty was assessed before September 6, 2016, the pre-adjustment civil penalty amounts in effect before September 6, 2016, will apply.

List of Subjects in 45 CFR Part 102

Administrative practice and procedure
Penalties

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

PART 102—ADJUSTMENT OF CIVIL MONETARY PENALTIES FOR INFLATION

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

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

2. Amend § 102.3 by revising table 1 to read as follows:

§ 102.3

Penalty adjustment and table.

( printed page 3667)

Table 1 to § 102.3—Civil Monetary Penalty Authorities Administered By HHS
U.S.C. section(s)	CFR ¹	HHS agency	Description ²	Date of last penalty figure or adjustment ³	2024 Maximum adjusted penalty ($)	2025 Maximum adjusted penalty ($) ⁴
21 U.S.C.:
333(b)(2)(A)		FDA	Penalty for violations related to drug samples resulting in a conviction of any representative of manufacturer or distributor in any 10-year period	2024	127,983	131,308
333(b)(2)(B)		FDA	Penalty 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 period	2024	2,559,636	2,626,135
333(b)(3)		FDA	Penalty for failure to make a report required by 21 U.S.C. 353(d)(3)(E) relating to drug samples	2024	255,964	262,614
333(f)(1)(A)		FDA	Penalty for any person who violates a requirement related to devices for each such violation	2024	34,568	35,466
		FDA	Penalty for aggregate of all violations related to devices in a single proceeding	2024	2,304,629	2,364,503
333(f)(2)(A)		FDA	Penalty 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. 350l	2024	97,179	99,704
		FDA	Penalty in the case of any other person (other than an individual) for such introduction or delivery of adulterated food	2024	485,893	498,517
		FDA	Penalty for aggregate of all such violations related to adulterated food adjudicated in a single proceeding	2024	971,787	997,034
333(f)(3)(A)		FDA	Penalty 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)	2024	14,724	15,107
333(f)(3)(B)		FDA	Penalty for each day any above violation is not corrected after a 30-day period following notification until the violation is corrected	2024	14,724	15,107
333(f)(4)(A)(i)		FDA	Penalty 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)	2024	368,137	377,701
		FDA	Penalty for aggregate of all such above violations in a single proceeding	2024	1,472,546	1,510,803
333(f)(4)(A)(ii)		FDA	Penalty 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 violation	2024	368,137	377,701
		FDA	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 period	2024	1,472,546	1,510,803
		FDA	Penalty for aggregate of all such above violations adjudicated in a single proceeding	2024	14,725,456	15,108,023
333(f)(9)(A)		FDA	Penalty for any person who violates a requirement which relates to tobacco products for each such violation	2024	21,348	21,903
		FDA	Penalty for aggregate of all such violations of tobacco product requirement adjudicated in a single proceeding	2024	1,423,220	1,460,195
333(f)(9)(B)(i)(I)		FDA	Penalty per violation related to violations of tobacco requirements	2024	355,806	365,050
		FDA	Penalty for aggregate of all such violations of tobacco product requirements adjudicated in a single proceeding	2024	1,423,220	1,460,195
333(f)(9)(B)(i)(II)		FDA	Penalty 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 violation	2024	355,806	365,050
		FDA	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 period	2024	1,423,220	1,460,195
		FDA	Penalty for aggregate of all such violations related to tobacco product requirements adjudicated in a single proceeding	2024	14,232,205	14,601,958
( printed page 3668)
333(f)(9)(B)(ii)(I)		FDA	Penalty 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 products	2024	355,806	365,050
		FDA	Penalty for aggregate of for all such above violations adjudicated in a single proceeding	2024	1,423,220	1,460,195
333(f)(9)(B)(ii)(II)		FDA	Penalty 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 violation	2024	355,806	365,050
		FDA	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 period	2024	1,423,220	1,460,195
			Penalty for aggregate above tobacco product requirement violations adjudicated in a single proceeding	2024	14,232,205	14,601,958
333(g)(1)		FDA	Penalty 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 period	2024	368,137	377,701
			Penalty for each subsequent above violation in any 3-year period	2024	736,274	755,402
333 note		FDA	Penalty to be applied for violations of 21 U.S.C. 387f(d)(5) or of violations of restrictions on the sale or distribution of tobacco products promulgated under 21 U.S.C. 387f(d) ( e.g., violations of regulations in 21 CFR part 1140) with respect to a retailer with an approved training program in the case of a second regulation violation within a 12-month period.	2024	356	365
		FDA	Penalty in the case of a third violation of 21 U.S.C. 387f(d)(5) or of the tobacco product regulations within a 24-month period	2024	709	727
		FDA	Penalty in the case of a fourth violation of 21 U.S.C. 387f(d)(5) or of the tobacco product regulations within a 24-month period	2024	2,846	2,920
		FDA	Penalty in the case of a fifth violation of 21 U.S.C. 387f(d)(5) or of the tobacco product regulations within a 36-month period	2024	7,115	7,300
		FDA	Penalty in the case of a sixth or subsequent violation of 21 U.S.C. 387f(d)(5) or of the tobacco product regulations within a 48-month period as determined on a case-by-case basis	2024	14,232	14,602
		FDA	Penalty to be applied for violations of 21 U.S.C. 387f(d)(5) or of violations of restrictions on the sale or distribution of tobacco products promulgated under 21 U.S.C. 387f(d) ( e.g., violations of regulations in 21 CFR part 1140) with respect to a retailer that does not have an approved training program in the case of the first regulation violation	2024	356	365
		FDA	Penalty in the case of a second violation of 21 U.S.C. 387f(d)(5) or of the tobacco product regulations within a 12-month period	2024	709	727
		FDA	Penalty in the case of a third violation of 21 U.S.C. 387f(d)(5) or of the tobacco product regulations within a 24-month period	2024	1,424	1,461
		FDA	Penalty in the case of a fourth violation of 21 U.S.C. 387f(d)(5) or of the tobacco product regulations within a 24-month period	2024	2,846	2,920
		FDA	Penalty in the case of a fifth violation of 21 U.S.C. 387f(d)(5) or of the tobacco product regulations within a 36-month period	2024	7,115	7,300
		FDA	Penalty in the case of a sixth or subsequent violation of 21 U.S.C. 387f(d)(5) or of the tobacco product regulations within a 48-month period as determined on a case-by-case basis	2024	14,232	14,602
335b(a)		FDA	Penalty 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 services	2024	542,434	556,526
( printed page 3669)
		FDA	Penalty in the case of any other person (other than an individual) per above violation	2024	2,169,731	2,226,101
360pp(b)(1)		FDA	Penalty for any person who violates any such requirements for electronic products, with each unlawful act or omission constituting a separate violation	2024	3,558	3,650
		FDA	Penalty imposed for any related series of violations of requirements relating to electronic products	2024	1,212,751	1,244,258
42 U.S.C				2024
262(d)		FDA	Penalty per day for violation of order of recall of biological product presenting imminent or substantial hazard	2024	278,937	286,184
263b(h)(3)		FDA	Penalty for failure to obtain a mammography certificate as required	2024	21,699	22,263
300aa-28(b)(1)		FDA	Penalty per occurrence for any vaccine manufacturer that intentionally destroys, alters, falsifies, or conceals any record or report required	2024	278,937	286,184
56b(d)(1)(B)(vi)		HRSA	Penalty for each instance of overcharging a 340B covered entity	2024	7,034	7,217
299c-3(d)		AHRQ	Penalty for using or disclosing identifiable information obtained in the course of activities undertaken pursuant to Title IX of the Public Health Service Act, for a purpose other than that for which the information was supplied, without consent to do so	2024	18,291	18,766
653(l)(2)	45 CFR 303.21(f)	ACF	Penalty for Misuse of Information in the National Directory of New Hires	2024	1,877	1,926
262a(i)(1)	42 CFR 1003.910	OIG	Penalty for each individual who violates safety and security procedures related to handling dangerous biological agents and toxins	2024	424,250	435,272
	42 CFR 1003.1410	OIG	Penalty for any other person who violates safety and security procedures related to handling dangerous biological agents and toxins	2024	848,505	870,549
300jj-51		OIG	Penalty per violation for committing information blocking	2024	1,293,601	1,327,209
1320a-7a(a)	42 CFR 1003.210(a)(1)	OIG	Penalty for knowingly presenting or causing to be presented to an officer, employee, or agent of the United States a false claim	2024	24,947	25,595
		OIG	Penalty for knowingly presenting or causing to be presented a request for payment which violates the terms of an assignment, agreement, or PPS agreement	2024	24,947	25,595
	42 CFR 1003.210(a)(2)	OIG	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 decision	2024	37,421	38,393
	42 CFR 1003.210(a)(3)	OIG	Penalty for an excluded party retaining ownership or control interest in a participating entity	2024	24,947	25,595
	42 CFR 1003.1010	OIG	Penalty for remuneration offered to induce program beneficiaries to use particular providers, practitioners, or suppliers	2024	24,947	25,595
	42 CFR 1003.210(a)(4)	OIG	Penalty for employing or contracting with an excluded individual	2024	24,947	25,595
	42 CFR 1003.310(a)(3)	OIG	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 program	2024	124,732	127,973
	42 CFR 1003.210(a)(1)	OIG	Penalty for ordering or prescribing medical or other item or service during a period in which the person was excluded	2024	24,947	25,595
	42 CFR 1003.210(a)(6)	OIG	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 supplier	2024	124,732	127,973
	42 CFR 1003.210(a)(8)	OIG	Penalty for knowing of an overpayment and failing to report and return	2024	24,947	25,595
	42 CFR 1003.210(a)(7)	OIG	Penalty for making or using a false record or statement that is material to a false or fraudulent claim	2024	70,336	72,163
	42 CFR 1003.210(a)(9)	OIG	Penalty for failure to grant timely access to HHS OIG for audits, investigations, evaluations, and other statutory functions of HHS OIG	2024	37,421	38,393
1320a-7a(b)		OIG	Penalty 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 benefits	2024	6,236	6,398
		OIG	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 benefits	2024	6,236	6,398
	42 CFR 1003.210(a)(10)	OIG	Penalty for a physician who executes a document that falsely certifies home health needs for Medicare beneficiaries	2024	12,473	12,797
1320a-7a(o)	42 CFR 1003.710(a)(1)	OIG	Penalty 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 funding	2024	12,166	12,482
( printed page 3670)
	42 CFR 1003.710(a)(2)	OIG	Penalty for knowingly making, using, or causing to be made or used any false statement, omission, or misrepresentation of a material fact in any application, proposal, bid, progress report, or other document required to directly or indirectly receive or retain funds provided pursuant to grant, contract, or other agreement	2024	60,831	62,411
	42 CFR 1003.710(a)(3)	OIG	Penalty for Knowingly making, using, or causing to be made or used, a false record or statement material to a false or fraudulent specified claim under grant, contract, or other agreement	2024	60,831	62,411
	42 CFR 1003.710(a)(4)	OIG	Penalty for knowingly making, using, or causing 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, per each false record or statement	2024	63,450	65,098
			Penalty for knowingly making, using, or causing 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, per day	2024	12,707	13,037
	42 CFR 1003.710(a)(5)	OIG	Penalty for failure 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	2024	18,250	18,724
1320a-7e(b)(6)(A)	42 CFR 1003.810	OIG	Penalty for failure to report any final adverse action taken against a health care provider, supplier, or practitioner	2024	47,596	48,833
1320b-10(b)(1)	42 CFR 1003.610(a)	OIG	Penalty 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 HHS	2024	12,799	13,132
1320b-10(b)(2)	42 CFR 1003.610(a)	OIG	Penalty 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 HHS	2024	63,991	65,653
1395i-3(b)(3)(B)(ii)(1)	42 CFR 1003.210(a)(11)	OIG	Penalty for certification of a false statement in assessment of functional capacity of a Skilled Nursing Facility resident assessment	2024	2,670	2,739
1395i-3(b)(3)(B)(ii)(2)	42 CFR 1003.210(a)(11)	OIG	Penalty for causing another to certify or make a false statement in assessment of functional capacity of a Skilled Nursing Facility resident assessment	2024	13,343	13,690
1395i-3(g)(2)(A)	42 CFR 1003.1310	OIG	Penalty 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 conducted	2024	5,339	5,478
1395w-27(g)(2)(A)	42 CFR 1003.410	OIG	Penalty for a Medicare Advantage organization that substantially fails to provide medically necessary, required items and services	2024	48,586	49,848
		OIG	Penalty for a Medicare Advantage organization that charges excessive premiums	2024	47,596	48,833
		OIG	Penalty for a Medicare Advantage organization that improperly expels or refuses to reenroll a beneficiary	2024	47,596	48,833
		OIG	Penalty for a Medicare Advantage organization that engages in practice that would reasonably be expected to have the effect of denying or discouraging enrollment	2024	190,389	195,335
		OIG	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 enrollment	2024	28,557	29,299
		OIG	Penalty for a Medicare Advantage organization misrepresenting or falsifying information to Secretary	2024	190,389	195,335
		OIG	Penalty for a Medicare Advantage organization misrepresenting or falsifying information to individual or other entity	2024	47,596	48,833
		OIG	Penalty for Medicare Advantage organization interfering with provider's advice to enrollee and non-MCO affiliated providers that balance bill enrollees	2024	47,596	48,833
		OIG	Penalty for a Medicare Advantage organization that employs or contracts with excluded individual or entity	2024	47,596	48,833
( printed page 3671)
		OIG	Penalty for a Medicare Advantage organization enrolling an individual in without prior written consent	2024	47,596	48,833
		OIG	Penalty for a Medicare Advantage organization transferring an enrollee to another plan without consent or solely for the purpose of earning a commission	2024	47,596	48,833
		OIG	Penalty for a Medicare Advantage organization failing to comply with marketing restrictions or applicable implementing regulations or guidance	2024	47,596	48,833
		OIG	Penalty for a Medicare Advantage organization employing or contracting with an individual or entity who violates 1395w-27(g)(1)(A)-(J)	2024	47,596	48,833
1395w-141(i)(3)		OIG	Penalty for a prescription drug card sponsor that falsifies or misrepresents marketing materials, overcharges program enrollees, or misuse transitional assistance funds	2024	16,630	17,062
1395cc(g)	42 CFR 1003.210(a)(5)	OIG	Penalty for improper billing by Hospitals, Critical Access Hospitals, or Skilled Nursing Facilities	2024	6,469	6,637
1395dd(d)(1)	42 CFR 1003.510	OIG	Penalty for a hospital with 100 beds or more or responsible physician dumping patients needing emergency medical care	2024	133,420	136,886
		OIG	Penalty for a hospital with less than 100 beds dumping patients needing emergency medical care	2024	66,712	68,445
1395mm(i)(6)(B)(i)	42 CFR 1003.410	OIG	Penalty for a HMO or competitive medical plan if such plan substantially fails to provide medically necessary, required items or services	2024	66,712	68,445
		OIG	Penalty for HMOs/competitive medical plans that charge premiums in excess of permitted amounts	2024	66,712	68,445
		OIG	Penalty for a HMO or competitive medical plan that expels or refuses to reenroll an individual per prescribed conditions	2024	66,712	68,445
		OIG	Penalty for a HMO or competitive medical plan that implements practices to discourage enrollment of individuals needing services in future	2024	266,841	273,774
		OIG	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 future	2024	38,395	39,393
		OIG	Penalty for a HMO or competitive medical plan that misrepresents or falsifies information to the Secretary	2024	266,841	273,774
		OIG	Penalty for a HMO or competitive medical plan that misrepresents or falsifies information to an individual or any other entity	2024	66,712	68,445
		OIG	Penalty for failure by HMO or competitive medical plan to assure prompt payment of Medicare risk sharing contracts or incentive plan provisions	2024	66,712	68,445
		OIG	Penalty for HMO that employs or contracts with excluded individual or entity	2024	61,238	62,829
1395nn(g)(3)	42 CFR 1003.310	OIG	Penalty for submitting or causing to be submitted claims in violation of the Stark Law's restrictions on physician self-referrals	2024	30,868	31,670
1395nn(g)(4)	42 CFR 1003.310	OIG	Penalty for circumvention schemes in violation of the Stark Law's restrictions on physician self-referrals	2024	205,799	211,146
1395ss(d)(1)	42 CFR 1003.1110	OIG	Penalty for a material misrepresentation regarding Medigap compliance policies	2024	12,799	13,132
1395ss(d)(2)	42 CFR 1003.1110	OIG	Penalty for selling Medigap policy under false pretense	2024	12,799	13,132
1395ss(d)(3)(A)(ii)	42 CFR 1003.1110	OIG	Penalty for an issuer that sells health insurance policy that duplicates benefits	2024	57,617	59,114
		OIG	Penalty for someone other than issuer that sells health insurance that duplicates benefits	2024	34,568	35,466
1395ss(d)(4)(A)	42 CFR 1003.1110	OIG	Penalty for using mail to sell a non-approved Medigap insurance policy	2024	12,799	13,132
1396b(m)(5)(B)(i)	42 CFR 1003.410	OIG	Penalty for a Medicaid MCO that substantially fails to provide medically necessary, required items or services	2024	63,991	65,653
		OIG	Penalty for a Medicaid MCO that charges excessive premiums	2024	63,991	65,653
		OIG	Penalty for a Medicaid MCO that improperly expels or refuses to reenroll a beneficiary	2024	255,964	262,614
		OIG	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 enrollment	2024	38,395	39,393
		OIG	Penalty for a Medicaid MCO misrepresenting or falsifying information to the Secretary	2024	255,964	262,614
		OIG	Penalty for a Medicaid MCO misrepresenting or falsifying information to an individual or another entity	2024	63,991	65,653
		OIG	Penalty for a Medicaid MCO that fails to comply with contract requirements with respect to physician incentive plans	2024	57,617	59,114
1396r(b)(3)(B)(ii)(I)	42 CFR 1003.210(a)(11)	OIG	Penalty for willfully and knowingly certifying a material and false statement in a Skilled Nursing Facility resident assessment	2024	2,670	2,739
( printed page 3672)
1396r(b)(3)(B)(ii)(II)	42 CFR 1003.210(a)(11)	OIG	Penalty for willfully and knowingly causing another individual to certify a material and false statement in a Skilled Nursing Facility resident assessment	2024	13,343	13,690
1396r(g)(2)(A)(i)	42 CFR 1003.1310	OIG	Penalty for notifying or causing to be notified a Skilled Nursing Facility of the time or date on which a survey is to be conducted	2024	5,339	5,478
1396r-8(b)(3)(B)	42 CFR 1003.1210	OIG	Penalty for the knowing provision of false information or refusing to provide information about charges or prices of a covered outpatient drug	2024	230,464	236,451
1396r-8(b)(3)(C)(i)	42 CFR 1003.1210	OIG	Penalty per day for failure to timely provide information by drug manufacturer with rebate agreement	2024	23,048	23,647
1396r-8(b)(3)(C)(ii)	42 CFR 1003.1210	OIG	Penalty for knowing provision of false information by drug manufacturer with rebate agreement	2024	230,464	236,451
1396t(i)(3)(A)	42 CFR 1003.1310	OIG	Penalty for notifying home and community-based providers or settings of survey	2024	4,610	4,730
11131(c)	42 CFR 1003.810	OIG	Penalty for failing to report a medical malpractice claim to National Practitioner Data Bank	2024	27,894	28,619
11137(b)(2)	42 CFR 1003.810	OIG	Penalty for breaching confidentiality of information reported to National Practitioner Data Bank	2024	27,894	28,619
299b-22(f)(1)	42 CFR 3.404	OCR	Penalty for violation of confidentiality provision of the Patient Safety and Quality Improvement Act	2024	15,445	15,846
1320(d)-5(a)	45 CFR 160.404(b)(1)(i), (ii)	OCR	Penalty for each pre-February 18, 2009 violation of the HIPAA administrative simplification provisions	2024	193	198
		OIG	Calendar Year Cap	2024	48,586	49,848
1320(d)-5(a)	45 CFR 160.404(b)(2)(i)(A), (B)	OCR	Penalty 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	2024
			Minimum	2024	141	145
			Maximum	2024	71,162	73,011
			Calendar Year Cap	2024	2,134,831	2,190,294
	45 CFR 160.404(b)(2)(ii)(A), (B)	OCR	Penalty 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	2024
			Minimum	2024	1,424	1,461
			Maximum	2024	71,162	73,011
			Calendar Year Cap	2024	2,134,831	2,190,294
	45 CFR 160.404(b)(2)(iii)(A), (B)	OCR	Penalty 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	2024
			Minimum	2024	14,232	14,602
			Maximum	2024	71,162	73,011
			Calendar Year Cap	2024	2,134,831	2,190,294
	45 CFR 160.404(b)(2)(iv)(A), (B)	OCR	Penalty 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	2024
			Minimum	2024	71,162	73,011
			Maximum	2024	2,134,831	2,190,294
			Calendar Year Cap	2024	2,134,831	2,190,294
290dd-2(f)	42 CFR 2.3(a) and (c)	OCR	Penalty for each violation of a 42 CFR part 2 provision in which it is established that the person did not know and by exercising reasonable diligence, would not have known that the person violated such a provision	2024
			Minimum	2024	100	103
( printed page 3673)
			Maximum	2024	50,000	51,299
			Calendar Year Cap	2024	1,500,000	1,538,970
	42 CFR 2.3(a) and (c)	OCR	Penalty for each violation of a 42 CFR part 2 provision in which it is established that the violation was due to reasonable cause and not to willful neglect	2024
			Minimum	2024	1,000	1,026
			Maximum	2024	50,000	51,299
			Calendar Year Cap	2024	1,500,000	1,538,970
	42 CFR 2.3(a) and (c)	OCR	Penalty for each violation of a 42 CFR part 2 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 person knew, or, by exercising reasonable diligence, would have known that the violation occurred	2024
			Minimum	2024	10,000	10,260
			Maximum	2024	50,000	51,299
			Calendar Year Cap	2024	1,500,000	1,538,970
	42 CFR 2.3(a) and (c)	OCR	Penalty for each violation of a 42 CFR part 2 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 person knew, or, by exercising reasonable diligence, would have known that the violation occurred	2024
			Minimum	2024	50,000	51,299
			Maximum	2024	1,500,000	1,538,970
			Calendar Year Cap	2024	1,500,000	1,538,970
42 U.S.C. 300gg-18, 42 U.S.C. 1302	45 CFR 180.90	CMS	Penalty for a hospital's non-compliance with making public standard charges for hospital items and services	2024	333	342
			Per Day (Maximum)	2024	6,118	6,277
	45 CFR 180.90(c)(2)(i)	CMS	Applicable solely to CY 2021 penalties, per day penalty for a hospital's noncompliance with making public standard charges for hospital items and services	2024	339	348
	45 CFR 180.90(c)(2)(ii)(A)	CMS	Per day penalty for hospitals with equal to or less than 30 beds	2024	333	342
	45 CFR 180.90(c)(2)(ii)(B)	CMS	Per day, per bed penalty for hospitals having at least 31 and up to and including 550 beds	2024	11	11
	45 CFR 180.90(c)(2)(ii)(C)	CMS	Per day penalty for hospitals having greater than 550 beds	2024	6,118	6,277
CARES Act, Public Law 116-136, section 3202(b)(2)	45 CFR 182.70	CMS	Penalty for a provider's non-compliance with price transparency requirements regarding diagnostic tests for COVID-19	2024
			Per Day (Maximum)	2024	N/A	N/A
263a(h)(2)(B) & 1395w-2(b)(2)(A)(ii)	42 CFR 493.1834(d)(2)(i)	CMS	Penalty for a clinical laboratory's failure to meet participation and certification requirements and poses immediate jeopardy	2024
			Minimum	2024	7,807	8,010
			Maximum	2024	25,597	26,262
	42 CFR 493.1834(d)(2)(ii).	CMS	Penalty for a clinical laboratory's failure to meet participation and certification requirements and the failure does not pose immediate jeopardy	2024
			Minimum	2024	129	132
			Maximum	2024	7,678	7,877
	42 CFR 493.1834(d)(2)(iii)	CMS	Penalty for a clinical laboratory's failure to meet SARS-CoV-2 test reporting requirements	2024
			First day of noncompliance	2024
			Each additional day of noncompliance	2024
300gg-15(f)	45 CFR 147.200(e)	CMS	Failure to provide the Summary of Benefits and Coverage	2024	1,406	1,443
300gg-18	45 CFR 158.606	CMS	Penalty for violations of regulations related to the medical loss ratio reporting and rebating	2024	140	144
	45 CFR 180.70	CMS	Penalty against hospital identified by CMS as noncompliant according to § 182.50 with respect to price transparency requirements regarding diagnostic tests for COVID-19	2024
42 U.S.C. 300gg-118 note, 300gg-134		CMS	Penalties for failure to comply with No Surprises Act requirements on providers, facilities, providers of air ambulance services	2024	11,816	12,123
1320a-7h(b)(1)	42 CFR 402.105(d)(5), 42 CFR 403.912(a) & (c)	CMS	Penalty 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	2024
			Minimum	2024	1,406	1,443
			Maximum	2024	14,067	14,432
			Calendar Year Cap	2024	211,008	216,490
1320a-7h(b)(2)	42 CFR 402.105(h), 42 CFR 403.912(b) & (c)	CMS	Penalty 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	2024
( printed page 3674)
			Minimum	2024	14,067	14,432
			Maximum	2024	140,674	144,329
			Calendar Year Cap	2024	1,406,728	1,443,275
1320a-7j(h)(3)(A)		CMS	Maximum penalty for an administrator of a facility that fails to comply with notice requirements for the closure of a facility	2024	140,674	144,329
1320a-7j(h)(3)(A)	42 CFR 488.446(a)(1), (2), & (3)	CMS	Minimum penalty for the first offense of an administrator who fails to provide notice of facility closure	2024	703	721
			Minimum penalty for the second offense of an administrator who fails to provide notice of facility closure	2024	2,111	2,166
			Minimum penalty for the third and subsequent offenses of an administrator who fails to provide notice of facility closure	2024	4,219	4,329
1320a-8(a)(1)		CMS	Penalty 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 disabled	2024	10,289	10,556
			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 determination	2024	9,704	9,956
1320a-8(a)(3)		CMS	Penalty 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 beneficiary	2024	8,058	8,267
1320b-25(c)(1)(A)		CMS	Penalty 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	2024	281,346	288,655
1320b-25(c)(2)(A)		CMS	Penalty 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 individual	2024	422,017	432,981
1320b-25(d)(2)		CMS	Penalty 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 nurse	2024	281,346	288,655
1395b-7(b)(2)(B)	42 CFR 402.105(g)	CMS	Penalty 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 request	2024	190	195
1395i-3(h)(2)(B)(ii)(I)	42 CFR 488.408(d)(1)(iii)	CMS	Penalty per day for a Skilled Nursing Facility that has a Category 2 violation of certification requirements	2024
			Minimum	2024	133	136
			Maximum	2024	8,003	8,211
	42 CFR 488.408(d)(1)(iv)	CMS	Penalty per instance of Category 2 noncompliance by a Skilled Nursing Facility	2024
			Minimum	2024	2,670	2,739
			Maximum	2024	26,685	27,378
	42 CFR 488.408(e)(1)(iii)	CMS	Penalty per day for a Skilled Nursing Facility that has a Category 3 violation of certification requirements	2024
			Minimum	2024	8,140	8,351
			Maximum	2024	26,685	27,378
	42 CFR 488.408(e)(1)(iv)	CMS	Penalty per instance of Category 3 noncompliance by a Skilled Nursing Facility	2024
			Minimum	2024	2,670	2,739
			Maximum	2024	26,685	27,378
( printed page 3675)
	42 CFR 488.408(e)(2)(ii)	CMS	Penalty per day and per instance for a Skilled Nursing Facility that has Category 3 noncompliance with Immediate Jeopardy	2024		0
			Per Day (Minimum)	2024	8,140	8,351
			Per Day (Maximum)	2024	26,685	27,378
			Per Instance (Minimum)	2024	2,670	2,739
			Per Instance (Maximum)	2024	26,685	27,378
	42 CFR 488.438(a)(1)(i)	CMS	Penalty per day of a Skilled Nursing Facility that fails to meet certification requirements. These amounts represent the upper range per day	2024		0
			Minimum	2024	8,140	8,351
			Maximum	2024	26,685	27,378
	42 CFR 488.438(a)(1)(ii)	CMS	Penalty per day of a Skilled Nursing Facility that fails to meet certification requirements. These amounts represent the lower range per day	2024		0
			Minimum	2024	133	136
			Maximum	2024	8,003	8,211
	42 CFR 488.438(a)(2)	CMS	Penalty per instance of a Skilled Nursing Facility that fails to meet certification requirements	2024		0
			Minimum	2024	2,670	2,739
			Maximum	2024	26,685	27,378
	42 CFR 488.447	CMS	Penalty imposed for failure to comply with infection control weekly reporting requirements at 42 CFR 483.80(g)(1) and (2)	2024
			First occurrence	2024	1,196	1,227
			Incremental increases for each subsequent occurrence	2024	598	614
1395i-6(c)(5)(B)(i)	42 CFR 488.1245	CMS	Penalty for noncompliance by hospice program with requirements specified in section 1395x(dd) of 42 U.S.C.	2024	11,124	11,413
	42 CFR 488.1245(b)(2)(iii)	CMS	Adjustment to penalties. Maximum penalty assessment for each day a hospice is not in substantial compliance with one or more conditions of participation	2024	11,124	11,413
	42 CFR 488.1245(b)(3)	CMS	Penalty imposed for hospice condition-level deficiency that is immediate jeopardy. These amounts represent the upper range of penalty	2024
			Minimum	2024	9,455	9,701
			Maximum	2024	11,124	11,413
	42 CFR 488.1245(b)(3)(i)	CMS	Penalty imposed for hospice condition-level deficiency that is immediate jeopardy. These amounts represent the upper range of penalty	2024	11,124	11,413
	42 CFR 488.1245(b)(3)(ii)	CMS	Penalty imposed for hospice condition-level deficiency that is immediate jeopardy. These amounts represent the upper range of penalty	2024	10,011	10,271
	42 CFR 488.1245(b)(3)(iii)	CMS	Penalty imposed for hospice condition-level deficiency that is immediate jeopardy. These amounts represent the upper range of penalty	2024	9,455	9,701
	42 CFR 488.1245(b)(4)	CMS	Penalty imposed for hospice repeat or condition-level deficiency or both that does not constitute immediate jeopardy but is directly related to poor quality patient care outcomes. These amounts represent the middle range of penalty	2024
			Minimum	2024	1,668	1,711
			Maximum	2024	9,455	9,701
	42 CFR 488.1245(b)(5)	CMS	Penalty imposed for hospice repeat or condition-level deficiency or both that does not constitute immediate jeopardy and are related predominantly to structure or process-oriented conditions rather than directly related to patient outcomes. These amounts represent the lower range of penalty	2024
			Minimum	2024	556	570
			Maximum	2024	4,450	4,566
	42 CFR 488.1245(b)(6)	CMS	Penalty range imposed for per instance of hospice noncompliance	2024
			Minimum	2024	1,112	1,141
			Maximum	2024	11,124	11,413
	42 CFR 488.1245(d)(1)(ii)	CMS	Penalty for each per instance of hospice noncompliance, maximum per day per hospice program	2024	11,124	11,413
				2024
1395l(h)(5)(D)	42 CFR 402.105(d)(2)(i)	CMS	Penalty 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))	2024	19,435	19,940
1395l(i)(6)		CMS	Penalty 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 involved	2024	5,121	5,254
1395l(q)(2)(B)(i)	42 CFR 402.105(a)	CMS	Penalty for knowingly and willfully failing to provide information about a referring physician when seeking payment on an unassigned basis	2024	4,899	5,026
( printed page 3676)
1395m(a)(11)(A)	42 CFR 402.1(c)(4), 402.105(d)(2)(ii)	CMS	Penalty 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))	2024	19,435	19,940
1395m(a)(18)(B)	42 CFR 402.1(c)(5), 402.105(d)(2)(iii)	CMS	Penalty 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))	2024	19,435	19,940
1395m(b)(5)(C)	42 CFR 402.1(c)(6), 402.105(d)(2)(iv)	CMS	Penalty 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))	2024	19,435	19,940
1395m(h)(3)	42 CFR 402.1(c)(8), 402.105(d)(2)(vi)	CMS	Penalty 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))	2024	19,435	19,940
1395m(j)(2)(A)(iii)		CMS	Penalty 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 Act	2024	2,058	2,111
1395m(j)(4)	42 CFR 402.1(c)(10), 402.105(d)(2)(vii)	CMS	Penalty 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))	2024	19,435	19,940
1395m-1(a)	42 CFR. 414.504(e)	CMS	Penalty for an applicable entity that has failed to report or made a misrepresentation or omission in reporting applicable information with respect to a clinical diagnostic laboratory test	2024	12,958	13,295
	42 CFR 402.1(c)(31), 402.105(d)(3)	CMS	Penalty 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))	2024	19,435	19,940
1395m(l)(6)	42 CFR 402.1(c)(32), 402.105(d)(4)	CMS	Penalty 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))	2024	19,435	19,940
1395u(b)(18)(B)	42 CFR 402.1(c)(11), 402.105(d)(2)(viii)	CMS	Penalty 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))	2024	19,435	19,940
1395u(j)(2)(B)	42 CFR 402.1(c)	CMS	Penalty 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))	2024	19,435	19,940
( printed page 3677)
1395u(k)	42 CFR 402.1(c)(12), 402.105(d)(2)(ix) 1834A(a)(9) and 42 CFR 414.504(e)	CMS	Penalty 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))	2024	19,435	19,940
1395u(l)(3)	42 CFR 402.1(c)(13), 402.105(d)(2)(x)	CMS	Penalty 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))	2024	19,435	19,940
1395u(m)(3)	42 CFR 402.1(c)(14), 402.105(d)(2)(xi)	CMS	Penalty 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))	2024	19,435	19,940
1395u(n)(3)	42 CFR 402.1(c)(15), 402.105(d)(2)(xii)	CMS	Penalty 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))	2024	19,435	19,940
1395u(o)(3)(B)	42 CFR 414.707(b)	CMS	Penalty 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))	2024	19,435	19,940
1395u(p)(3)(A)		CMS	Penalty 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 basis	2024	5,121	5,254
1395w-3a(d)(4)(A)	42 CFR 414.806	CMS	Penalty for a pharmaceutical manufacturer's misrepresentation of average sales price of a drug, or biologic	2024	16,630	17,062
1395w-4(g)(1)(B)	42 CFR 402.1(c)(17), 402.105(d)(2)(xiii)	CMS	Penalty 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))	2024	19,435	19,940
1395w-4(g)(3)(B)	42 CFR 402.1(c)(18), 402.105(d)(2)(xiv)	CMS	Penalty 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))	2024	19,435	19,940
1395w-27(g)(3)(A); 1857(g)(3); 1860D-12(b)(3)(E)	42 CFR 422.760(b); 42 CFR 423.760(b)	CMS	Penalty 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 (or has the substantial likelihood of adversely affecting) an individual covered under the organization's contract	2024	47,596	48,833
1395w-27(g)(3)(B); 1857(g)(3); 1860D-12(b)(3)(E)		CMS	Penalty 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 regulations	2024	19,040	19,535
1395w-27(g)(3)(D); 1857(g)(3): 1860D-12(b)(3)(E)		CMS	Penalty for a Medicare Advantage organization's or Part D sponsor's early termination of its contract	2024	176,807	181,400
1395y(b)(3)(C)	42 CFR 411.103(b)	CMS	Penalty 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 plan	2024	11,524	11,823
1395y(b)(5)(C)(ii)	42 CFR 402.1(c)(20), 42 CFR 402.105(b)(2)	CMS	Penalty 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 coverage	2024	1,877	1,926
( printed page 3678)
1395y(b)(6)(B)	42 CFR 402.1(c)(20), 402.105(a)	CMS	Penalty 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 form	2024	4,117	4,224
1395y(b)(7)(B)(i)	42 CFR 402.1(c)(21), 402.105(a)	CMS	Penalty 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 Secretary	2024	1,474	1,512
1395y(b)(8)(E)		CMS	Penalty 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 claim	2024	1,474	1,512
1395nn(g)(5)	42 CFR 411.361	CMS	Penalty for any person that fails to report information required by HHS under Section 1877(f) concerning ownership, investment, and compensation arrangements	2024	24,496	25,132
1395pp(h)	42 CFR 402.1(c)(23), 402.105(d)(2)(xv)	CMS	Penalty 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))	2024	19,435	19,940
1395ss(a)(2)	402.102(f)(1)	CMS	Penalty 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 date	2024	66,711	68,444
1395ss(d)(3)(A)(vi)(II)	42 CFR 402.1(c)(25), 402.105(e),402.105(f)(2)	CMS	Penalty for someone other than issuer that sells or issues a Medicare supplemental policy to beneficiary without a disclosure statement	2024	34,568	35,466
		CMS	Penalty for an issuer that sells or issues a Medicare supplemental policy without disclosure statement	2024	57,617	59,114
1395ss(d)(3)(B)(iv)		CMS	Penalty for someone other than issuer that sells or issues a Medicare supplemental policy without acknowledgement form	2024	34,568	35,466
		CMS	Penalty for issuer that sells or issues a Medicare supplemental policy without an acknowledgement form	2024	57,617	59,114
1395ss(p)(8)	42 CFR 402.1(c)(25), 402.105(e)	CMS	Penalty for someone other than issuer that sells or issues Medicare supplemental polices after a given date that fail to conform to the NAIC or Federal standards established by statute	2024	34,568	35,466
	42 CFR 402.1(c)(25), 405402.105(f)(2)	CMS	Penalty for an issuer that sells or issues Medicare supplemental polices after a given date that fail to conform to the NAIC or Federal standards established by statute	2024	57,617	59,114
1395ss(p)(9)(C)	42 CFR 402.1(c)(26), 402.105(e), 402.105(f)(3), (4)	CMS	Penalty for someone other than issuer that sells a Medicare supplemental policy and fails to make available for sale the core group of basic benefits when selling other Medicare supplemental policies with additional benefits or fails to provide the individual, before selling the policy, an outline of coverage describing benefits	2024	34,568	35,466
	42 CFR 402.105(f)(3), (4)	CMS	Penalty for an issuer that sells a Medicare supplemental policy and fails to make available for sale the core group of basic benefits when selling other Medicare supplemental policies with additional benefits or fails to provide the individual, before selling the policy, an outline of coverage describing benefits	2024	57,617	59,114
1395ss(q)(5)(C)	42 CFR 402.105(f)(5)	CMS	Penalty 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 circumstances	2024	57,617	59,114
1395ss(r)(6)(A)	42 CFR 402.105(f)(6)	CMS	Penalty for any person that fails to provide refunds or credits as required by section 1882(r)(1)(B)	2024	57,617	59,114
1395ss(s)(4)	42 CFR 402.1(c)(29), 402.105(c)	CMS	Penalty 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 criteria	C2024	24,460	25,095
( printed page 3679)
1395ss(t)(2)	42 CFR 402.1(c)(30), 402.105(f)(7)	CMS	Penalty for any issuer of a Medicare supplemental policy that fails to fulfill listed responsibilities	2024	57,617	59,114
1395ss(v)(4)(A)		CMS	Penalty someone other than issuer who sells, issues, or renews a medigap Rx policy to an individual who is a Part D enrollee	2024	24,946	25,594
		CMS	Penalty for an issuer who sells, issues, or renews a Medigap Rx policy who is a Part D enrollee	2024	41,577	42,657
1395bbb(c)(1)	42 CFR 488.725(c)	CMS	Penalty 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 conducted	2024	5,339	5,478
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)	CMS	Maximum daily penalty amount for each day a home health agency is not in compliance with statutory requirements	2024	25,597	26,262
	42 CFR 488.845(b)(3)	CMS	Penalty per day for home health agency's noncompliance (Upper Range)	2024		0
			Minimum	2024	21,757	22,322
			Maximum	2024	25,597	26,262
	42 CFR 488.845(b)(3)(i)	CMS	Penalty for a home health agency's deficiency or deficiencies that cause immediate jeopardy and result in actual harm	2024	25,597	26,262
	42 CFR 488.845(b)(3)(ii)	CMS	Penalty for a home health agency's deficiency or deficiencies that cause immediate jeopardy and result in potential for harm	2024	23,036	23,634
	42 CFR 488.845(b)(3)(iii)	CMS	Penalty for an isolated incident of noncompliance in violation of established HHA policy	2024	21,757	22,322
	42 CFR 488.845(b)(4)	CMS	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)	2024		0
			Minimum	2024	3,841	3,941
			Maximum	2024	21,757	22,322
	42 CFR 488.845(b)(5)	CMS	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)	2024		0
			Minimum	2024	1,280	1,313
			Maximum	2024	2,559	2,625
	42 CFR 488.845(b)(6)	CMS	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	2024		0
			Penalty for each day of noncompliance (Minimum)	2024	2,559	2,625
			Penalty for each day of noncompliance (Maximum)	2024	25,597	26,262
	42 CFR 488.845(d)(1)(ii)	CMS	Penalty for each day of noncompliance (Maximum)	2024	25,597	26,262
1395eee(e)(6)(B); 1396u-4(e)(6)(B)	42 CFR 460.46	CMS	Penalty for PACE organization that discriminates in enrollment or disenrollment, or engages in any practice that would reasonably be expected to have the effect of denying or discouraging enrollment, on the basis of health status or the need for services	2024	47,596	48,833
		CMS	For each individual not enrolled as a result of the PACE organization's discrimination in enrollment or disenrollment or practice that would deny or discourage enrollment	2024
			Minimum	2024	17,933	18,399
			Maximum	2024	119,555	122,661
		CMS	Penalty for a PACE organization that charges excessive premiums	2024	47,596	48,833
		CMS	Penalty for a PACE organization misrepresenting or falsifying information to CMS or the State	2024	190,389	195,335
		CMS	Penalty for any other violation specified in 42 CFR 460.40	2024	47,596	48,833
1396r(h)(3)(C)(ii)(I)	42 CFR 488.408(d)(1)(iii)	CMS	Penalty per day for a nursing facility's failure to meet a Category 2 Certification	2024		0
			Minimum	2024	133	136
			Maximum	2024	8,003	8,211
	42 CFR 488.408(d)(1)(iv)	CMS	Penalty per instance for a nursing facility's failure to meet Category 2 certification	2024
			Minimum	2024	2,670	2,739
			Maximum	2024	26,685	27,378
	42 CFR 488.408(e)(1)(iii)	CMS	Penalty per day for a nursing facility's failure to meet Category 3 certification	2024
			Minimum	2024	8,140	8,351
			Maximum	2024	26,685	27,378
	42 CFR 488.408(e)(1)(iv)	CMS	Penalty per instance for a nursing facility's failure to meet Category 3 certification	2024		0
			Minimum	2024	2,670	2,739
			Maximum	2024	26,685	27,378
( printed page 3680)
	42 CFR 488.408(e)(2)(ii)	CMS	Penalty per instance for a nursing facility's failure to meet Category 3 certification, which results in immediate jeopardy	2024		0
			Minimum	2024	2,670	2,739
			Maximum	2024	26,685	27,378
	42 CFR 488.438(a)(1)(i)	CMS	Penalty per day for nursing facility's failure to meet certification (Upper Range)	2024		0
			Minimum	2024	8,140	8,351
			Maximum	2024	26,685	27,378
	42 CFR 488.438(a)(1)(ii)	CMS	Penalty per day for nursing facility's failure to meet certification (Lower Range)	2024		0
			Minimum	2024	133	136
			Maximum	2024	8,003	8,211
	42 CFR 488.438(a)(2)	CMS	Penalty per instance for nursing facility's failure to meet certification	2024		0
			Minimum	2024	2,670	2,739
			Maximum	2024	26,685	27,378
	42 CFR 488.447	CMS	Penalty imposed for failure to comply with infection control weekly reporting requirements at 42 CFR 483.80(g)(1) and (2)	2024
			First occurrence (Minimum)	2024	1,196	1,227
			Incremental increases for each subsequent occurrence	2024	598	614
1396r(f)(2)(B)(iii)(I)(c)	42 CFR 483.151(b)(2)(iv) and (b)(3)(iii)	CMS	Grounds 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]	2024	13,343	13,690
1396r(h)(3)(C)(ii)(I)	42 CFR 483.151(c)(2)	CMS	Grounds 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]	2024	13,343	13,690
1396t(j)(2)(C)		CMS	Penalty for each day of noncompliance for a home or community care provider that no longer meets the minimum requirements for home and community care	2024		0
			Minimum	2024	2	2
			Maximum	2024	23,048	23,647
1396u-2(e)(2)(A)(i)	42 CFR 438.704	CMS	Penalty for a Medicaid managed care organization that fails substantially to provide medically necessary items and services	2024	47,596	48,833
		CMS	Penalty for Medicaid managed care organization that imposes premiums or charges on enrollees in excess of the premiums or charges permitted	2024	47,596	48,833
		CMS	Penalty for a Medicaid managed care organization that misrepresents or falsifies information to another individual or entity	2024	47,596	48,833
		CMS	Penalty for a Medicaid managed care organization that fails to comply with the applicable statutory requirements for such organizations.	2024	47,596	48,833
1396u-2(e)(2)(A)(ii)	42 CFR 438.704	CMS	Penalty for a Medicaid managed care organization that misrepresents or falsifies information to the HHS Secretary	2024	190,389	195,335
		CMS	Penalty for Medicaid managed care organization that acts to discriminate among enrollees on the basis of their health status	2024	190,389	195,335
1396u-2(e)(2)(A)(iv)	42 CFR 438.704	CMS	Penalty 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 status	2024	28,557	29,299
1396u(h)(2)	42 CFR Part 441, Subpart I	CMS	Penalty 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 services	2024	26,685	27,378
1396w-2(c)(1)	42 U.S.C. 300gg-22(b)(2)(C)(i) 45 CFR 150.315	CMS	Penalty for each day, for each individual affected by the failure of a health insurance issuer or non-Federal governmental group health plan to comply with federal market reform provisions in part A or D of title XXVII of the PHS Act\|2022\|174\|177	2024	14,232	14,602
( printed page 3681)
18041(c)(2)	45 CFR 156.805(c)	CMS	Failure to comply with ACA requirements related to risk adjustment, reinsurance, risk corridors, Exchanges (including QHP standards) and other ACA Subtitle D standards; Penalty for violations of rules or standards of behavior associated with issuer compliance with risk adjustment, reinsurance, risk corridors, Exchanges (including QHP standards) and other ACA Subtitle D standards	2024	193	198
42 U.S.C. 300gg-22(b)(2)(C)(i)	45 CFR 150.315	CMS	Penalty for each day, for each individual affected by the failure of a health insurance issuer or non-Federal governmental group health plan to comply with federal market reform provisions in part A or D of title XXVII of the PHS Act	2024	183	188
18081(h)(1)(A)(i)(II)	45 CFR 155.285	CMS	Penalty for providing false information on Exchange application	2024	35,169	36,083
18081(h)(1)(B)	45 CFR 155.285	CMS	Penalty for knowingly or willfully providing false information on Exchange application	2024	351,681	360,818
18081(h)(2)	45 CFR 155.260	CMS	Penalty for knowingly or willfully disclosing protected information from Exchange	2024		0
		CMS	Maximum	2024	35,169	36,083
		CMS	Minimum	2024	359	368
18041(c)(2)	45 CFR 155.206(i)	CMS	Penalties for violation of applicable Exchange standards by consumer assistance entities in Federally-facilitated Exchanges	2024	43,128	44,248
			Maximum (Per Day)	2024	119	122
31 U.S.C	45 CFR 93.400(e)	HHS		2024	359	368
			Penalty for the first time an individual makes an expenditure prohibited by regulations regarding lobbying disclosure, absent aggravating circumstances	2024	24,496	25,132
			Penalty for second and subsequent offenses by individuals who make an expenditure prohibited by regulations regarding lobbying disclosure	2024		0
			Minimum	2024	24,496	25,132
			Maximum	2024	244,958	251,322
1352		HHS	Penalty for the first time an individual fails to file or amend a lobbying disclosure form, absent aggravating circumstances	2024	24,496	25,132
			Penalty for second and subsequent offenses by individuals who fail to file or amend a lobbying disclosure form, absent aggravating circumstances	2024		0
			Minimum	2024	24,496	25,132
			Maximum	2024	244,958	251,322
	45 CFR Part 93, Appendix A	HHS	Penalty for failure to provide certification regarding lobbying in the award documents for all sub-awards of all tiers	2024		0
			Minimum	2024	24,496	25,132
			Maximum	2024	244,958	251,322
		HHS	Penalty for failure to provide statement regarding lobbying for loan guarantee and loan insurance transactions	2024		0
			Minimum	2024	24,496	25,132
			Maximum	2024	244,958	251,322
3801-3812	45 CFR 79.3(a)(1)(iv)	HHS	Penalty against any individual who—with knowledge or reason to know—makes, presents or submits a false, fictitious or fraudulent claim to the Department	2024	12,800	13,133
	45 CFR 79.3(b)(1)(ii)	HHS	Penalty against any individual who—with knowledge or reason to know—makes, presents or submits a false, fictitious or fraudulent claim to the Department	2024	12,800	13,133
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 OMB Memorandum M-16-06, Implementation of the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015, published February 24, 2016, guided agencies on initial “catch-up” adjustment requirements, and M-17-11, Implementation of the 2017 annual adjustment pursuant to the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015, published December 16, 2016; followed by M-18-03, M-19-04,M-20-05, M-21-10,M-22-07, M-23-05,M-24-07, and M-25-02 guided agencies on annual adjustment requirements.
⁵ OMB Circular A-136, Financial Reporting Requirements, Section II.4.9, directs that agencies must make annual inflation adjustments to civil monetary penalties and report on the adjustments in the Agency Financial Report (AFR) or Performance and Accountability Report (PAR).
⁶ Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015, § 701(b)(1)(A) (codified as amended at 28 U.S.C. 2461 note).
⁷ Annual inflation adjustments are based on the percent change between each published October's CPI-U. In this case, October 2024 CPI-U (315.664) / October 2023 CPI-U (307.671) = 1.02598.

( printed page 3682)

Robert F. Kennedy, Jr.,

Secretary, Department of Health and Human Services.

[FR Doc. 2026-01688 Filed 1-27-26; 8:45 am]

BILLING CODE 4150-24-P

Legal Citation

Federal Register Citation

Use this for formal legal and research references to the published document.

91 FR 3665

Web Citation

Suggested Web Citation

Use this when citing the archival web version of the document.

“Annual Civil Monetary Penalties Inflation Adjustment,” thefederalregister.org (January 28, 2026), https://thefederalregister.org/documents/2026-01688/annual-civil-monetary-penalties-inflation-adjustment.