45 CFR 102.2 - Applicability date.

Regulations last checked for updates: Oct 16, 2024

Title 45 - Public Welfare last revised: Oct 02, 2024

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§ 102.1 - Applicability.

This part applies to each statutory provision under the laws administered by the Department of Health and Human Services concerning the civil monetary penalties which may be assessed or enforced by an agency pursuant to Federal law or is assessed or enforced pursuant to civil judicial actions in the Federal courts or administrative proceedings. The regulations cited in this part supersede existing HHS regulations setting forth civil monetary penalty amounts. If applicable, the HHS agencies responsible for specific civil monetary penalties will amend their regulations to reflect the adjusted amounts and/or a cross-reference to 45 CFR part 102 in separate actions as soon as practicable.

§ 102.2 - Applicability date.

The increased penalty amounts set forth in the right-most column of the table in Section 102.3, “Maximum Adjusted Penalty ($)”, apply to all civil monetary penalties which are assessed after August 1, 2016, including those penalties whose associated violations occurred after November 2, 2015.

§ 102.3 - Penalty adjustment and table.

The adjusted statutory penalty provisions and their applicable amounts are set out in the following table. The right-most column in the table, “Maximum Adjusted Penalty ($)”, provides the maximum adjusted civil penalty amounts. The civil monetary penalty amounts are adjusted annually.

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	2023 Maximum adjusted penalty ($)	2024 Maximum adjusted penalty ($) 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	2023	123,965	127,983
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	2023	2,479,282	2,559,636
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	2023	247,929	255,964
333(f)(1)(A)		FDA	Penalty for any person who violates a requirement related to devices for each such violation	2023	33,483	34,568
		FDA	Penalty for aggregate of all violations related to devices in a single proceeding	2023	2,232,281	2,304,629
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	2023	94,128	97,179
		FDA	Penalty in the case of any other person (other than an individual) for such introduction or delivery of adulterated food	2023	470,640	485,893
		FDA	Penalty for aggregate of all such violations related to adulterated food adjudicated in a single proceeding	2023	941,280	971,787
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)	2023	14,262	14,724
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	2023	14,262	14,724
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)	2023	356,580	368,137
		FDA	Penalty for aggregate of all such above violations in a single proceeding	2023	1,426,319	1,472,546
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	2023	356,580	368,137
		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	2023	1,426,319	1,472,546
		FDA	Penalty for aggregate of all such above violations adjudicated in a single proceeding	2023	14,263,186	14,725,456
333(f)(9)(A)		FDA	Penalty for any person who violates a requirement which relates to tobacco products for each such violation	2023	20,678	21,348
		FDA	Penalty for aggregate of all such violations of tobacco product requirement adjudicated in a single proceeding	2023	1,378,541	1,423,220
333(f)(9)(B)(i)(I)		FDA	Penalty per violation related to violations of tobacco requirements	2023	344,636	355,806
		FDA	Penalty for aggregate of all such violations of tobacco product requirements adjudicated in a single proceeding	2023	1,378,541	1,423,220
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	2023	344,636	355,806
		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	2023	1,378,541	1,423,220
		FDA	Penalty for aggregate of all such violations related to tobacco product requirements adjudicated in a single proceeding	2023	13,785,420	14,232,205
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	2023	344,636	355,806
		FDA	Penalty for aggregate of for all such above violations adjudicated in a single proceeding	2023	1,378,541	1,423,220
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	2023	344,636	355,806
		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	2023	1,378,541	1,423,220
			Penalty for aggregate above tobacco product requirement violations adjudicated in a single proceeding	2023	13,785,420	14,232,205
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	2023	356,580	368,137
			Penalty for each subsequent above violation in any 3-year period	2023	713,160	736,274
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	2023	345	356
		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	2023	687	709
		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	2023	2,757	2,846
		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	2023	6,892	7,115
		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	2023	13,785	14,232
		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	2023	345	356
		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	2023	687	709
		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	2023	1,379	1,424
		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	2023	2,757	2,846
		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	2023	6,892	7,115
		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	2023	13,785	14,232
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	2023	525,406	542,434
		FDA	Penalty in the case of any other person (other than an individual) per above violation	2023	2,101,618	2,169,731
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	2023	3,446	3,558
		FDA	Penalty imposed for any related series of violations of requirements relating to electronic products	2023	1,174,680	1,212,751
42 U.S.C				2023
262(d)		FDA	Penalty per day for violation of order of recall of biological product presenting imminent or substantial hazard	2023	270,180	278,937
263b(h)(3)		FDA	Penalty for failure to obtain a mammography certificate as required	2023	21,018	21,699
300aa-28(b)(1)		FDA	Penalty per occurrence for any vaccine manufacturer that intentionally destroys, alters, falsifies, or conceals any record or report required	2023	270,180	278,937
256b(d)(1)(B)(vi)		HRSA	Penalty for each instance of overcharging a 340B covered entity	2023	6,813	7,034
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	2023	17,717	18,291
653(l)(2)	45 CFR 303.21(f)	ACF	Penalty for Misuse of Information in the National Directory of New Hires	2023	1,818	1,877
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	2023	410,932	424,250
	42 CFR 1003.1410	OIG	Penalty for any other person who violates safety and security procedures related to handling dangerous biological agents and toxins	2023	821,868	848,505
300jj-51		OIG	Penalty per violation for committing information blocking	2023	1,252,992	1,293,601
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	2023	24,164	24,947
		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	2023	24,164	24,947
	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	2023	36,246	37,421
	42 CFR 1003.210(a)(3)	OIG	Penalty for an excluded party retaining ownership or control interest in a participating entity	2023	24,164	24,947
	42 CFR 1003.1010	OIG	Penalty for remuneration offered to induce program beneficiaries to use particular providers, practitioners, or suppliers	2023	24,164	24,947
	42 CFR 1003.210(a)(4)	OIG	Penalty for employing or contracting with an excluded individual	2023	24,164	24,947
	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	2023	120,816	124,732
	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	2023	24,164	24,947
	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	2023	120,816	124,732
	42 CFR 1003.210(a)(8)	OIG	Penalty for knowing of an overpayment and failing to report and return	2023	24,164	24,947
	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	2023	68,128	70,336
	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	2023	36,246	37,421
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	2023	6,040	6,236
		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	2023	6,040	6,236
	42 CFR 1003.210(a)(10)	OIG	Penalty for a physician who executes a document that falsely certifies home health needs for Medicare beneficiaries	2023	12,081	12,473
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	2023	11,784	12,166
	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	2023	58,921	60,831
	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	2023	58,921	60,831
	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	2023	61,458	63,450
			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	2023	12,308	12,707
	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	2023	17,677	18,250
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	2023	46,102	47,596
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	2023	12,397	12,799
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	2023	61,982	63,991
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	2023	2,586	2,670
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	2023	12,924	13,343
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	2023	5,171	5,339
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	2023	47,061	48,586
		OIG	Penalty for a Medicare Advantage organization that charges excessive premiums	2023	46,102	47,596
		OIG	Penalty for a Medicare Advantage organization that improperly expels or refuses to reenroll a beneficiary	2023	46,102	47,596
		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	2023	184,412	190,389
		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	2023	27,661	28,557
		OIG	Penalty for a Medicare Advantage organization misrepresenting or falsifying information to Secretary	2023	184,412	190,389
		OIG	Penalty for a Medicare Advantage organization misrepresenting or falsifying information to individual or other entity	2023	46,102	47,596
		OIG	Penalty for Medicare Advantage organization interfering with provider's advice to enrollee and non-MCO affiliated providers that balance bill enrollees	2023	46,102	47,596
		OIG	Penalty for a Medicare Advantage organization that employs or contracts with excluded individual or entity	2023	46,102	47,596
		OIG	Penalty for a Medicare Advantage organization enrolling an individual in without prior written consent	2023	46,102	47,596
		OIG	Penalty for a Medicare Advantage organization transferring an enrollee to another plan without consent or solely for the purpose of earning a commission	2023	46,102	47,596
		OIG	Penalty for a Medicare Advantage organization failing to comply with marketing restrictions or applicable implementing regulations or guidance	2023	46,102	47,596
		OIG	Penalty for a Medicare Advantage organization employing or contracting with an individual or entity who violates 1395w-27(g)(1)(A)-(J)	2023	46,102	47,596
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	2023	16,108	16,630
1395cc(g)	42 CFR 1003.210(a)(5)	OIG	Penalty for improper billing by Hospitals, Critical Access Hospitals, or Skilled Nursing Facilities	2023	6,266	6,469
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	2023	129,232	133,420
		OIG	Penalty for a hospital with less than 100 beds dumping patients needing emergency medical care	2023	64,618	66,712
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	2023	64,618	66,712
		OIG	Penalty for HMOs/competitive medical plans that charge premiums in excess of permitted amounts	2023	64,618	66,712
		OIG	Penalty for a HMO or competitive medical plan that expels or refuses to reenroll an individual per prescribed conditions	2023	64,618	66,712
		OIG	Penalty for a HMO or competitive medical plan that implements practices to discourage enrollment of individuals needing services in future	2023	258,464	266,841
		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	2023	37,190	38,395
		OIG	Penalty for a HMO or competitive medical plan that misrepresents or falsifies information to the Secretary	2023	258,464	266,841
		OIG	Penalty for a HMO or competitive medical plan that misrepresents or falsifies information to an individual or any other entity	2023	64,618	66,712
		OIG	Penalty for failure by HMO or competitive medical plan to assure prompt payment of Medicare risk sharing contracts or incentive plan provisions	2023	64,618	66,712
		OIG	Penalty for HMO that employs or contracts with excluded individual or entity	2023	59,316	61,238
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	2023	29,899	30,868
1395nn(g)(4)	42 CFR 1003.310	OIG	Penalty for circumvention schemes in violation of the Stark Law's restrictions on physician self-referrals	2023	199,338	205,799
1395ss(d)(1)	42 CFR 1003.1110	OIG	Penalty for a material misrepresentation regarding Medigap compliance policies	2023	12,397	12,799
1395ss(d)(2)	42 CFR 1003.1110	OIG	Penalty for selling Medigap policy under false pretense	2023	12,397	12,799
1395ss(d)(3)(A)(ii)	42 CFR 1003.1110	OIG	Penalty for an issuer that sells health insurance policy that duplicates benefits	2023	55,808	57,617
		OIG	Penalty for someone other than issuer that sells health insurance that duplicates benefits	2023	33,483	34,568
1395ss(d)(4)(A)	42 CFR 1003.1110	OIG	Penalty for using mail to sell a non-approved Medigap insurance policy	2023	12,397	12,799
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	2023	61,982	63,991
		OIG	Penalty for a Medicaid MCO that charges excessive premiums	2023	61,982	63,991
		OIG	Penalty for a Medicaid MCO that improperly expels or refuses to reenroll a beneficiary	2023	247,929	255,964
		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	2023	37,190	38,395
		OIG	Penalty for a Medicaid MCO misrepresenting or falsifying information to the Secretary	2023	247,929	255,964
		OIG	Penalty for a Medicaid MCO misrepresenting or falsifying information to an individual or another entity	2023	61,982	63,991
		OIG	Penalty for a Medicaid MCO that fails to comply with contract requirements with respect to physician incentive plans	2023	55,808	57,617
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	2023	2,586	2,670
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	2023	12,924	13,343
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	2023	5,171	5,339
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	2023	223,229	230,464
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	2023	22,324	23,048
1396r-8(b)(3)(C)(ii)	42 CFR 1003.1210	OIG	Penalty for knowing provision of false information by drug manufacturer with rebate agreement	2023	223,229	230,464
1396t(i)(3)(A)	42 CFR 1003.1310	OIG	Penalty for notifying home and community-based providers or settings of survey	2023	4,465	4,610
11131(c)	42 CFR 1003.810	OIG	Penalty for failing to report a medical malpractice claim to National Practitioner Data Bank	2023	27,018	27,894
11137(b)(2)	42 CFR 1003.810	OIG	Penalty for breaching confidentiality of information reported to National Practitioner Data Bank	2023	27,018	27,894
299b-22(f)(1)	42 CFR 3.404	OCR	Penalty for violation of confidentiality provision of the Patient Safety and Quality Improvement Act	2023	14,960	15,445
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	2023	187	193
		OCR	Calendar Year Cap	2023	47,061	48,586
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	2023
			Minimum	2023	137	141
			Maximum	2023	68,928	71,162
			Calendar Year Cap	2023	2,067,813	2,134,831
	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	2023
			Minimum	2023	1,379	1,424
			Maximum	2023	68,928	71,162
			Calendar Year Cap	2023	2,067,813	2,134,831
	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	2023
			Minimum	2023	13,785	14,232
			Maximum	2023	68,928	71,162
			Calendar Year Cap	2023	2,067,813	2,134,831
	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	2023
			Minimum	2023	68,928	71,162
			Maximum	2023	2,067,813	2,134,831
			Calendar Year Cap	2023	2,067,813	2,134,831
42 U.S.C. 300gg-18,42.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	2023	323	333
			Per Day (Maximum)	2023	5,926	6,118
	45 CFR 180.90(c)(2)(i)	CMS	Per day penalty for a hospital's noncompliance with making public standard charges for hospital items and services		328	339
	45 CFR 180.90(c)(2)(ii)(A)	CMS	Per day penalty for hospitals with equal to or less than 30 beds		323	333
	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		11	11
	45 CFR 180.90(c)(2)(ii)(C)	CMS	Per day penalty for hospitals having greater than 550 beds		2,926	3,021
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	2023
			Per Day (Maximum)	2023	323	333
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	2023
			Minimum	2023	7,562	7,807
			Maximum	2023	24,793	25,597
	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	2023
			Minimum	2023	125	129
			Maximum	2023	7,437	7,678
	42 CFR 493.1834(d)(2)(iii)	CMS	Penalty for a clinical laboratory's failure to meet SARS-CoV-2 test reporting requirements	2023
			First day of noncompliance	2023
			Each additional day of noncompliance	2023
300gg-15(f)	45 CFR 147.200(e)	CMS	Failure to provide the Summary of Benefits and Coverage	2023	1,362	1,406
300gg-18	45 CFR 158.606	CMS	Penalty for violations of regulations related to the medical loss ratio reporting and rebating	2023	136	140
	45 CFR 180.90	CMS	Price against hospital identified by CMS as noncompliant according to § 182.50 with respect to price transparency requirements regarding diagnostic tests for COVID-19	2023
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	2023	11,445	11,816
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	2023
			Minimum	2023	1,362	1,406
			Maximum	2023	13,625	14,067
			Calendar Year Cap	2023	204,384	211,008
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	2023
			Minimum	2023	13,625	14,067
			Maximum	2023	136,258	140,674
			Calendar Year Cap	2023	1,362,567	1,406,728
		CMS	Penalty for an administrator of a facility that fails to comply with notice requirements for the closure of a facility	2023	136,258	140,674
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	2023	681	703
			Minimum penalty for the second offense of an administrator who fails to provide notice of facility closure	2023	2,045	2,111
			Minimum penalty for the third and subsequent offenses of an administrator who fails to provide notice of facility closure	2023	4,087	4,219
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	2023	9,966	10,289
			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	2023	9,399	9,704
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	2023	7,805	8,058
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	2023	272,514	281,346
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	2023	408,769	422,017
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	2023	272,514	281,346
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	2023	184	190
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	2023
			Minimum	2023	129	133
			Maximum	2023	7,752	8,003
	42 CFR 488.408(d)(1)(iv)	CMS	Penalty per instance of Category 2 noncompliance by a Skilled Nursing Facility	2023
			Minimum	2023	2,586	2,670
			Maximum	2023	25,847	26,685
	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	2023
			Minimum	2023	7,884	8,140
			Maximum	2023	25,847	26,685
	42 CFR 488.408(e)(1)(iv)	CMS	Penalty per instance of Category 3 noncompliance by a Skilled Nursing Facility	2023
			Minimum	2023	2,586	2,670
			Maximum	2023	25,847	26,685
	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	2023
			Per Day (Minimum)	2023	7,884	8,140
			Per Day (Maximum)	2023	25,847	26,685
			Per Instance (Minimum)	2023	2,586	2,670
			Per Instance (Maximum)	2023	25,847	26,685
	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	2023
			Minimum	2023	7,884	8,140
			Maximum	2023	25,847	26,685
	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	2023
			Minimum	2023	129	133
			Maximum	2023	7,752	8,003
	42 CFR 488.438(a)(2)	CMS	Penalty per instance of a Skilled Nursing Facility that fails to meet certification requirements	2023
			Minimum	2023	2,586	2,670
			Maximum	2023	25,847	26,685
	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)	2023
			First occurrence	2023	1,158	1,196
			Incremental increases for each subsequent occurrences	2023	579	598
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	2023	10,775	11,124
	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	2023	10,775	11,124
	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
			Minimum	2023	9,158	9,455
			Maximum	2023	10,775	11,124
	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	2023	10,775	11,124
	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	2023	9,697	10,011
	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	2023	9,158	9,455
	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
			Minimum	2023	1,616	1,668
			Maximum	2023	9,158	9,455
	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
			Minimum	2023	539	556
			Maximum	2023	4,310	4,450
	42 CFR 488.1245(b)(6)	CMS	Penalty range imposed for per instance of hospice noncompliance
			Minimum	2023	1,077	1,112
			Maximum	2023	10,775	11,124
	42 CFR 488.1245(d)(1)(ii)	CMS	Penalty for each per instance of hospice noncompliance, maximum per day per hospice program	2023	10,775	11,124
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))	2023	18,825	19,435
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	2023	4,960	5,121
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	2023	4,745	4,899
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))	2023	18,825	19,435
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))	2023	18,825	19,435
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))	2023	18,825	19,435
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))	2023	18,825	19,435
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	2023	1,993	2,058
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))	2023	18,825	19,435
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	2023	12,551	12,958
	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))	2023	18,825	19,435
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))	2023	18,825	19,435
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))	2023	18,825	19,435
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))	2023	18,825	19,435
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))	2023	18,825	19,435
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))	2023	18,825	19,435
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))	2023	18,825	19,435
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))	2023	18,825	19,435
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))	2023	18,825	19,435
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	2023	4,960	5,121
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	2023	16,108	16,630
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))	2023	18,825	19,435
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))	2023	18,825	19,435
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	2023	46,102	47,596
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	2023	18,442	19,040
1395w-27(g)(3)(D); 1857(g)(3): 1860D-12(b)(3)(E)		CMS	Penalty for a Medicare Advantage organizations or Part D sponsor's early termination of its contract	2023	171,257	176,807
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	2023	11,162	11,524
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	2023	1,818	1,877
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	2023	3,988	4,117
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	2023	1,428	1,474
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	2023	1,428	1,474
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	2023	23,727	24,496
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))	2023	18,825	19,435
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	2023	64,617	66,711
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	2023	33,483	34,568
		CMS	Penalty for an issuer that sells or issues a Medicare supplemental policy without disclosure statement	2023	55,808	57,617
1395ss(d)(3)(B)(iv)		CMS	Penalty for someone other than issuer that sells or issues a Medicare supplemental policy without acknowledgement form	2023	33,483	34,568
		CMS	Penalty for issuer that sells or issues a Medicare supplemental policy without an acknowledgement form	2023	55,808	57,617
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	2023	33,483	34,568
	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	2023	55,808	57,617
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	2023	33,483	34,568
	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	2023	55,808	57,617
1395ss(q)(5)(C)	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	2023	55,808	57,617
1395ss(r)(6)(A)	402.105(f)(6)	CMS	Penalty for any person that fails to provide refunds or credits as required by section 1882(r)(1)(B)	2023	55,808	57,617
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	2023	23,692	24,460
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	2023	55,808	57,617
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	2023	24,163	24,946
		CMS	Penalty for an issuer who sells, issues, or renews a Medigap Rx policy who is a Part D enrollee	2023	40,272	41,577
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	2023	5,171	5,339
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	2023	24,793	25,597
	42 CFR 488.845(b)(3)	CMS	Penalty per day for home health agency's noncompliance (Upper Range)	2023
			Minimum	2023	21,074	21,757
			Maximum	2023	24,793	25,597
	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	2023	24,793	25,597
	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	2023	22,313	23,036
	42 CFR 488.845(b)(3)(iii)	CMS	Penalty for an isolated incident of noncompliance in violation of established HHA policy	2023	21,074	21,757
	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)	2023
			Minimum	2023	3,720	3,841
			Maximum	2023	21,074	21,757
	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)	2023
			Minimum	2023	1,240	1,280
			Maximum	2023	2,479	2,559
	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	2023
			Penalty for each day of noncompliance (Minimum)	2023	2,479	2,559
			Penalty for each day of noncompliance (Maximum)	2023	24,793	25,597
	42 CFR 488.845(d)(1)(ii)	CMS	Penalty for each day of noncompliance (Maximum)	2023	24,793	25,597
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	2023	46,102	47,596
		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	2023
			Minimum	2023	17,370	17,933
			Maximum	2023	115,802	119,555
		CMS	Penalty for a PACE organization that charges excessive premiums	2023	46,102	47,596
		CMS	Penalty for a PACE organization misrepresenting or falsifying information to CMS or the State	2023	184,412	190,389
		CMS	Penalty for any other violation specified in 42 CFR 460.40	2023	46,102	47,596
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	2023
			Minimum	2023	129	133
			Maximum	2023	7,752	8,003
	42 CFR 488.408(d)(1)(iv)	CMS	Penalty per instance for a nursing facility's failure to meet Category 2 certification	2023
			Minimum	2023	2,586	2,670
			Maximum	2023	25,847	26,685
	42 CFR 488.408(e)(1)(iii)	CMS	Penalty per day for a nursing facility's failure to meet Category 3 certification	2023
			Minimum	2023	7,884	8,140
			Maximum	2023	25,847	26,685
	42 CFR 488.408(e)(1)(iv)	CMS	Penalty per instance for a nursing facility's failure to meet Category 3 certification	2023
			Minimum	2023	2,586	2,670
			Maximum	2023	25,847	26,685
	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	2023
			Minimum	2023	2,586	2,670
			Maximum	2023	25,847	26,685
	42 CFR 488.438(a)(1)(i)	CMS	Penalty per day for nursing facility's failure to meet certification (Upper Range)	2023
			Minimum	2023	7,884	8,140
			Maximum	2023	25,847	26,685
	42 CFR 488.438(a)(1)(ii)	CMS	Penalty per day for nursing facility's failure to meet certification (Lower Range)	2023
			Minimum	2023	129	133
			Maximum	2023	7,752	8,003
	42 CFR 488.438(a)(2)	CMS	Penalty per instance for nursing facility's failure to meet certification	2023
			Minimum	2023	2,586	2,670
			Maximum	2023	25,847	26,685
	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)	2023
			First occurrence (Minimum)	2023	1,158	1,196
			Incremental increases for each subsequent occurrence	2023	579	598
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]	2023	12,924	13,343
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]	2023	12,924	13,343
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	2023
			Minimum	2023	2	2
			Maximum	2023	22,324	23,048
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	2023	46,102	47,596
		CMS	Penalty for Medicaid managed care organization that imposes premiums or charges on enrollees in excess of the premiums or charges permitted	2023	46,102	47,596
		CMS	Penalty for a Medicaid managed care organization that misrepresents or falsifies information to another individual or entity	2023	46,102	47,596
		CMS	Penalty for a Medicaid managed care organization that fails to comply with the applicable statutory requirements for such organizations	2023	46,102	47,596
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	2023	184,412	190,389
		CMS	Penalty for Medicaid managed care organization that acts to discriminate among enrollees on the basis of their health status	2023	184,412	190,389
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	2023	27,661	28,557
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	2023	25,847	26,685
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	2023	13,785	14,232
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	2023	187	193
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	2023	177	183
18081(h)(1)(A)(i)(II)	45 CFR 155.285	CMS	Penalty for providing false information on Exchange application	2023	34,065	35,169
18081(h)(1)(B)	45 CFR 155.285	CMS	Penalty for knowingly or willfully providing false information on Exchange application	2023	340,641	351,681
18081(h)(2)	45 CFR 155.260	CMS	Penalty for knowingly or willfully disclosing protected information from Exchange	2023
		CMS	Maximum	2023	34,065	35,169
		CMS	Minimum	2023	348	359
18041(c)(2)	45 CFR 155.206(i)	CMS	Penalties for violation of applicable Exchange standards by consumer assistance entities in Federally-facilitated Exchanges	2023	41,774	43,128
			Maximum (Per Day)	2023	115	119
31 U.S.C				2023	348	359
1352	45 CFR 93.400(e)	HHS	Penalty for the first time an individual makes an expenditure prohibited by regulations regarding lobbying disclosure, absent aggravating circumstances	2023	23,727	24,496
			Penalty for second and subsequent offenses by individuals who make an expenditure prohibited by regulations regarding lobbying disclosure	2023
			Minimum	2023	23,727	24,496
			Maximum	2023	237,268	244,958
		HHS	Penalty for the first time an individual fails to file or amend a lobbying disclosure form, absent aggravating circumstances	2023	23,727	24,496
			Penalty for second and subsequent offenses by individuals who fail to file or amend a lobbying disclosure form, absent aggravating circumstances	2023
			Minimum	2023	23,727	24,496
			Maximum	2023	237,268	244,958
	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	2023
			Minimum	2023	23,727	24,496
			Maximum	2023	237,268	244,958
		HHS	Penalty for failure to provide statement regarding lobbying for loan guarantee and loan insurance transactions	2023
			Minimum	2023	23,727	24,496
			Maximum	2023	237,268	244,958
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	2023	12,398	12,800
	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	2023	12,398	12,800

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, and M-24-07 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 2023 CPI-U (307.671)/October 2022 CPI-U (298.012) = 1.03241.

[81 FR 61565, Sept. 6, 2016, as amended at 87 FR 15101, Mar. 17, 2022; 88 FR 69532, Oct. 6, 2023; 88 FR 70373, Oct. 11, 2023; 88 FR 82787, Nov. 27, 2023; 89 FR 64816, Aug. 8, 2024]

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

source: 81 FR 61565, Sept. 6, 2016, unless otherwise noted.

cite as: 45 CFR 102.2