Regulations last checked for updates: Feb 07, 2026

Title 45 - Public Welfare last revised: Jan 28, 2026
§ 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
2024
Maximum
adjusted
penalty
($)
2025
Maximum
adjusted
penalty
($) 4
21 U.S.C.:
333(b)(2)(A)FDAPenalty for violations related to drug samples resulting in a conviction of any representative of manufacturer or distributor in any 10-year period2024127,983131,308
333(b)(2)(B)FDAPenalty for violation related to drug samples resulting in a conviction of any representative of manufacturer or distributor after the second conviction in any 10-yr period20242,559,6362,626,135
333(b)(3)FDAPenalty for failure to make a report required by 21 U.S.C. 353(d)(3)(E) relating to drug samples2024255,964262,614
333(f)(1)(A)FDAPenalty for any person who violates a requirement related to devices for each such violation202434,56835,466
FDAPenalty for aggregate of all violations related to devices in a single proceeding20242,304,6292,364,503
333(f)(2)(A)FDAPenalty for any individual who introduces or delivers for introduction into interstate commerce food that is adulterated per 21 U.S.C. 342(a)(2)(B) or any individual who does not comply with a recall order under 21 U.S.C. 350l202497,17999,704
FDAPenalty in the case of any other person (other than an individual) for such introduction or delivery of adulterated food2024485,893498,517
FDAPenalty for aggregate of all such violations related to adulterated food adjudicated in a single proceeding2024971,787997,034
333(f)(3)(A)FDAPenalty for all violations adjudicated in a single proceeding for any person who violates 21 U.S.C. 331(jj) by failing to submit the certification required by 42 U.S.C. 282(j)(5)(B) or knowingly submitting a false certification; by failing to submit clinical trial information under 42 U.S.C. 282(j); or by submitting clinical trial information under 42 U.S.C. 282(j) that is false or misleading in any particular under 42 U.S.C. 282(j)(5)(D)202414,72415,107
333(f)(3)(B)FDAPenalty for each day any above violation is not corrected after a 30-day period following notification until the violation is corrected202414,72415,107
333(f)(4)(A)(i)FDAPenalty for any responsible person that violates a requirement of 21 U.S.C. 355(o) (post-marketing studies, clinical trials, labeling), 21 U.S.C. 355(p) (risk evaluation and mitigation (REMS)), or 21 U.S.C. 355-1 (REMS)2024368,137377,701
FDAPenalty for aggregate of all such above violations in a single proceeding20241,472,5461,510,803
333(f)(4)(A)(ii)FDAPenalty for REMS violation that continues after written notice to the responsible person for the first 30-day period (or any portion thereof) the responsible person continues to be in violation2024368,137377,701
FDAPenalty 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 period20241,472,5461,510,803
FDAPenalty for aggregate of all such above violations adjudicated in a single proceeding202414,725,45615,108,023
333(f)(9)(A)FDAPenalty for any person who violates a requirement which relates to tobacco products for each such violation202421,34821,903
FDAPenalty for aggregate of all such violations of tobacco product requirement adjudicated in a single proceeding20241,423,2201,460,195
333(f)(9)(B)(i)(I)FDAPenalty per violation related to violations of tobacco requirements2024355,806365,050
FDAPenalty for aggregate of all such violations of tobacco product requirements adjudicated in a single proceeding20241,423,2201,460,195
333(f)(9)(B)(i)(II)FDAPenalty in the case of a violation of tobacco product requirements that continues after written notice to such person, for the first 30-day period (or any portion thereof) the person continues to be in violation2024355,806365,050
FDAPenalty 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 period20241,423,2201,460,195
FDAPenalty for aggregate of all such violations related to tobacco product requirements adjudicated in a single proceeding202414,232,20514,601,958
333(f)(9)(B)(ii)(I)FDAPenalty for any person who either does not conduct post-market surveillance and studies to determine impact of a modified risk tobacco product for which the HHS Secretary has provided them an order to sell, or who does not submit a protocol to the HHS Secretary after being notified of a requirement to conduct post-market surveillance of such tobacco products2024355,806365,050
FDAPenalty for aggregate of for all such above violations adjudicated in a single proceeding20241,423,2201,460,195
333(f)(9)(B)(ii)(II)FDAPenalty for violation of modified risk tobacco product post-market surveillance that continues after written notice to such person for the first 30-day period (or any portion thereof) that the person continues to be in violation2024355,806365,050
FDAPenalty 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 period20241,423,2201,460,195
Penalty for aggregate above tobacco product requirement violations adjudicated in a single proceeding202414,232,20514,601,958
333(g)(1)FDAPenalty for any person who disseminates or causes another party to disseminate a direct-to-consumer advertisement that is false or misleading for the first such violation in any 3-year period2024368,137377,701
Penalty for each subsequent above violation in any 3-year period2024736,274755,402
333 noteFDAPenalty 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.2024356365
FDAPenalty 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 period2024709727
FDAPenalty 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 period20242,8462,920
FDAPenalty 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 period20247,1157,300
FDAPenalty 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 basis202414,23214,602
FDAPenalty 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 violation2024356365
FDAPenalty 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 period2024709727
FDAPenalty 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 period20241,4241,461
FDAPenalty 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 period20242,8462,920
FDAPenalty 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 period20247,1157,300
FDAPenalty 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 basis202414,23214,602
335b(a)FDAPenalty for each violation for any individual who made a false statement or misrepresentation of a material fact, bribed, destroyed, altered, removed, or secreted, or procured the destruction, alteration, removal, or secretion of, any material document, failed to disclose a material fact, obstructed an investigation, employed a consultant who was debarred, debarred individual provided consultant services2024542,434556,526
FDAPenalty in the case of any other person (other than an individual) per above violation20242,169,7312,226,101
360pp(b)(1)FDAPenalty for any person who violates any such requirements for electronic products, with each unlawful act or omission constituting a separate violation20243,5583,650
FDAPenalty imposed for any related series of violations of requirements relating to electronic products20241,212,7511,244,258
42 U.S.C2024
262(d)FDAPenalty per day for violation of order of recall of biological product presenting imminent or substantial hazard2024278,937286,184
263b(h)(3)FDAPenalty for failure to obtain a mammography certificate as required202421,69922,263
300aa-28(b)(1)FDAPenalty per occurrence for any vaccine manufacturer that intentionally destroys, alters, falsifies, or conceals any record or report required2024278,937286,184
56b(d)(1)(B)(vi)HRSAPenalty for each instance of overcharging a 340B covered entity20247,0347,217
299c-3(d)AHRQPenalty 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 so202418,29118,766
653(l)(2)45 CFR 303.21(f)ACFPenalty for Misuse of Information in the National Directory of New Hires20241,8771,926
262a(i)(1)42 CFR 1003.910OIGPenalty for each individual who violates safety and security procedures related to handling dangerous biological agents and toxins2024424,250435,272
42 CFR 1003.1410OIGPenalty for any other person who violates safety and security procedures related to handling dangerous biological agents and toxins2024848,505870,549
300jj-51OIGPenalty per violation for committing information blocking20241,293,6011,327,209
1320a-7a(a)42 CFR 1003.210(a)(1)OIGPenalty for knowingly presenting or causing to be presented to an officer, employee, or agent of the United States a false claim202424,94725,595
OIGPenalty for knowingly presenting or causing to be presented a request for payment which violates the terms of an assignment, agreement, or PPS agreement202424,94725,595
42 CFR 1003.210(a)(2)OIGPenalty 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 decision202437,42138,393
42 CFR 1003.210(a)(3)OIGPenalty for an excluded party retaining ownership or control interest in a participating entity202424,94725,595
42 CFR 1003.1010OIGPenalty for remuneration offered to induce program beneficiaries to use particular providers, practitioners, or suppliers202424,94725,595
42 CFR 1003.210(a)(4)OIGPenalty for employing or contracting with an excluded individual202424,94725,595
42 CFR 1003.310(a)(3)OIGPenalty 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 program2024124,732127,973
42 CFR 1003.210(a)(1)OIGPenalty for ordering or prescribing medical or other item or service during a period in which the person was excluded202424,94725,595
42 CFR 1003.210(a)(6)OIGPenalty 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 supplier2024124,732127,973
42 CFR 1003.210(a)(8)OIGPenalty for knowing of an overpayment and failing to report and return202424,94725,595
42 CFR 1003.210(a)(7)OIGPenalty for making or using a false record or statement that is material to a false or fraudulent claim202470,33672,163
42 CFR 1003.210(a)(9)OIGPenalty for failure to grant timely access to HHS OIG for audits, investigations, evaluations, and other statutory functions of HHS OIG202437,42138,393
1320a-7a(b)OIGPenalty for payments by a hospital or critical access hospital to induce a physician to reduce or limit services to individuals under direct care of physician or who are entitled to certain medical assistance benefits20246,2366,398
OIGPenalty 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 benefits20246,2366,398
42 CFR 1003.210(a)(10)OIGPenalty for a physician who executes a document that falsely certifies home health needs for Medicare beneficiaries202412,47312,797
1320a-7a(o)42 CFR 1003.710(a)(1)OIGPenalty for knowingly presenting or causing to be presented a false or fraudulent specified claim under a grant, contract, or other agreement for which the Secretary provides funding202412,16612,482
42 CFR 1003.710(a)(2)OIGPenalty 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 agreement202460,83162,411
42 CFR 1003.710(a)(3)OIGPenalty 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 agreement202460,83162,411
42 CFR 1003.710(a)(4)OIGPenalty 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 statement202463,45065,098
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 day202412,70713,037
42 CFR 1003.710(a)(5)OIGPenalty 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 agreements202418,25018,724
1320a-7e(b)(6)(A)42 CFR 1003.810OIGPenalty for failure to report any final adverse action taken against a health care provider, supplier, or practitioner202447,59648,833
1320b-10(b)(1)42 CFR 1003.610(a)OIGPenalty for the misuse of words, symbols, or emblems in communications in a manner in which a person could falsely construe that such item is approved, endorsed, or authorized by HHS202412,79913,132
1320b-10(b)(2)42 CFR 1003.610(a)OIGPenalty for the misuse of words, symbols, or emblems in a broadcast or telecast in a manner in which a person could falsely construe that such item is approved, endorsed, or authorized by HHS202463,99165,653
1395i-3(b)(3)(B)(ii)(1)42 CFR 1003.210(a)(11)OIGPenalty for certification of a false statement in assessment of functional capacity of a Skilled Nursing Facility resident assessment20242,6702,739
1395i-3(b)(3)(B)(ii)(2)42 CFR 1003.210(a)(11)OIGPenalty for causing another to certify or make a false statement in assessment of functional capacity of a Skilled Nursing Facility resident assessment202413,34313,690
1395i-3(g)(2)(A)42 CFR 1003.1310OIGPenalty for any individual who notifies or causes to be notified a Skilled Nursing Facility of the time or date on which a survey is to be conducted20245,3395,478
1395w-27(g)(2)(A)42 CFR 1003.410OIGPenalty for a Medicare Advantage organization that substantially fails to provide medically necessary, required items and services202448,58649,848
OIGPenalty for a Medicare Advantage organization that charges excessive premiums202447,59648,833
OIGPenalty for a Medicare Advantage organization that improperly expels or refuses to reenroll a beneficiary202447,59648,833
OIGPenalty for a Medicare Advantage organization that engages in practice that would reasonably be expected to have the effect of denying or discouraging enrollment2024190,389195,335
OIGPenalty 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 enrollment202428,55729,299
OIGPenalty for a Medicare Advantage organization misrepresenting or falsifying information to Secretary2024190,389195,335
OIGPenalty for a Medicare Advantage organization misrepresenting or falsifying information to individual or other entity202447,59648,833
OIGPenalty for Medicare Advantage organization interfering with provider's advice to enrollee and non-MCO affiliated providers that balance bill enrollees202447,59648,833
OIGPenalty for a Medicare Advantage organization that employs or contracts with excluded individual or entity202447,59648,833
OIGPenalty for a Medicare Advantage organization enrolling an individual in without prior written consent202447,59648,833
OIGPenalty for a Medicare Advantage organization transferring an enrollee to another plan without consent or solely for the purpose of earning a commission202447,59648,833
OIGPenalty for a Medicare Advantage organization failing to comply with marketing restrictions or applicable implementing regulations or guidance202447,59648,833
OIGPenalty for a Medicare Advantage organization employing or contracting with an individual or entity who violates 1395w-27(g)(1)(A)-(J)202447,59648,833
1395w-141(i)(3)OIGPenalty for a prescription drug card sponsor that falsifies or misrepresents marketing materials, overcharges program enrollees, or misuse transitional assistance funds202416,63017,062
1395cc(g)42 CFR 1003.210(a)(5)OIGPenalty for improper billing by Hospitals, Critical Access Hospitals, or Skilled Nursing Facilities20246,4696,637
1395dd(d)(1)42 CFR 1003.510OIGPenalty for a hospital with 100 beds or more or responsible physician dumping patients needing emergency medical care2024133,420136,886
OIGPenalty for a hospital with less than 100 beds dumping patients needing emergency medical care202466,71268,445
1395mm(i)(6)(B)(i)42 CFR 1003.410OIGPenalty for a HMO or competitive medical plan if such plan substantially fails to provide medically necessary, required items or services202466,71268,445
OIGPenalty for HMOs/competitive medical plans that charge premiums in excess of permitted amounts202466,71268,445
OIGPenalty for a HMO or competitive medical plan that expels or refuses to reenroll an individual per prescribed conditions202466,71268,445
OIGPenalty for a HMO or competitive medical plan that implements practices to discourage enrollment of individuals needing services in future2024266,841273,774
OIGPenalty 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 future202438,39539,393
OIGPenalty for a HMO or competitive medical plan that misrepresents or falsifies information to the Secretary2024266,841273,774
OIGPenalty for a HMO or competitive medical plan that misrepresents or falsifies information to an individual or any other entity202466,71268,445
OIGPenalty for failure by HMO or competitive medical plan to assure prompt payment of Medicare risk sharing contracts or incentive plan provisions202466,71268,445
OIGPenalty for HMO that employs or contracts with excluded individual or entity202461,23862,829
1395nn(g)(3)42 CFR 1003.310OIGPenalty for submitting or causing to be submitted claims in violation of the Stark Law's restrictions on physician self-referrals202430,86831,670
1395nn(g)(4)42 CFR 1003.310OIGPenalty for circumvention schemes in violation of the Stark Law's restrictions on physician self-referrals2024205,799211,146
1395ss(d)(1)42 CFR 1003.1110OIGPenalty for a material misrepresentation regarding Medigap compliance policies202412,79913,132
1395ss(d)(2)42 CFR 1003.1110OIGPenalty for selling Medigap policy under false pretense202412,79913,132
1395ss(d)(3)(A)(ii)42 CFR 1003.1110OIGPenalty for an issuer that sells health insurance policy that duplicates benefits202457,61759,114
OIGPenalty for someone other than issuer that sells health insurance that duplicates benefits202434,56835,466
1395ss(d)(4)(A)42 CFR 1003.1110OIGPenalty for using mail to sell a non-approved Medigap insurance policy202412,79913,132
1396b(m)(5)(B)(i)42 CFR 1003.410OIGPenalty for a Medicaid MCO that substantially fails to provide medically necessary, required items or services202463,99165,653
OIGPenalty for a Medicaid MCO that charges excessive premiums202463,99165,653
OIGPenalty for a Medicaid MCO that improperly expels or refuses to reenroll a beneficiary2024255,964262,614
OIGPenalty 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 enrollment202438,39539,393
OIGPenalty for a Medicaid MCO misrepresenting or falsifying information to the Secretary2024255,964262,614
OIGPenalty for a Medicaid MCO misrepresenting or falsifying information to an individual or another entity202463,99165,653
OIGPenalty for a Medicaid MCO that fails to comply with contract requirements with respect to physician incentive plans202457,61759,114
1396r(b)(3)(B)(ii)(I)42 CFR 1003.210(a)(11)OIGPenalty for willfully and knowingly certifying a material and false statement in a Skilled Nursing Facility resident assessment20242,6702,739
1396r(b)(3)(B)(ii)(II)42 CFR 1003.210(a)(11)OIGPenalty for willfully and knowingly causing another individual to certify a material and false statement in a Skilled Nursing Facility resident assessment202413,34313,690
1396r(g)(2)(A)(i)42 CFR 1003.1310OIGPenalty for notifying or causing to be notified a Skilled Nursing Facility of the time or date on which a survey is to be conducted20245,3395,478
1396r-8(b)(3)(B)42 CFR 1003.1210OIGPenalty for the knowing provision of false information or refusing to provide information about charges or prices of a covered outpatient drug2024230,464236,451
1396r-8(b)(3)(C)(i)42 CFR 1003.1210OIGPenalty per day for failure to timely provide information by drug manufacturer with rebate agreement202423,04823,647
1396r-8(b)(3)(C)(ii)42 CFR 1003.1210OIGPenalty for knowing provision of false information by drug manufacturer with rebate agreement2024230,464236,451
1396t(i)(3)(A)42 CFR 1003.1310OIGPenalty for notifying home and community-based providers or settings of survey20244,6104,730
11131(c)42 CFR 1003.810OIGPenalty for failing to report a medical malpractice claim to National Practitioner Data Bank202427,89428,619
11137(b)(2)42 CFR 1003.810OIGPenalty for breaching confidentiality of information reported to National Practitioner Data Bank202427,89428,619
299b-22(f)(1)42 CFR 3.404OCRPenalty for violation of confidentiality provision of the Patient Safety and Quality Improvement Act202415,44515,846
1320(d)-5(a)45 CFR 160.404(b)(1)(i), (ii)OCRPenalty for each pre-February 18, 2009 violation of the HIPAA administrative simplification provisions2024193198
OIGCalendar Year Cap202448,58649,848
1320(d)-5(a)45 CFR 160.404(b)(2)(i)(A), (B)OCRPenalty for each February 18, 2009 or later violation of a HIPAA administrative simplification provision in which it is established that the covered entity or business associate did not know and by exercising reasonable diligence, would not have known that the covered entity or business associate violated such a provision2024
Minimum2024141145
Maximum202471,16273,011
Calendar Year Cap20242,134,8312,190,294
45 CFR 160.404(b)(2)(ii)(A), (B)OCRPenalty for each February 18, 2009 or later violation of a HIPAA administrative simplification provision in which it is established that the violation was due to reasonable cause and not to willful neglect2024
Minimum20241,4241,461
Maximum202471,16273,011
Calendar Year Cap20242,134,8312,190,294
45 CFR 160.404(b)(2)(iii)(A), (B)OCRPenalty for each February 18, 2009 or later violation of a HIPAA administrative simplification provision in which it is established that the violation was due to willful neglect and was corrected during the 30-day period beginning on the first date the covered entity or business associate knew, or, by exercising reasonable diligence, would have known that the violation occurred2024
Minimum202414,23214,602
Maximum202471,16273,011
Calendar Year Cap20242,134,8312,190,294
45 CFR 160.404(b)(2)(iv)(A), (B)OCRPenalty for each February 18, 2009 or later violation of a HIPAA administrative simplification provision in which it is established that the violation was due to willful neglect and was not corrected during the 30-day period beginning on the first date the covered entity or business associate knew, or, by exercising reasonable diligence, would have known that the violation occurred2024
Minimum202471,16273,011
Maximum20242,134,8312,190,294
Calendar Year Cap20242,134,8312,190,294
290dd-2(f)42 CFR 2.3(a) and (c)OCRPenalty 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 provision2024
Minimum2024100103
Maximum202450,00051,299
Calendar Year Cap20241,500,0001,538,970
42 CFR 2.3(a) and (c)OCRPenalty 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 neglect2024
Minimum20241,0001,026
Maximum202450,00051,299
Calendar Year Cap20241,500,0001,538,970
42 CFR 2.3(a) and (c)OCRPenalty 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 occurred2024
Minimum202410,00010,260
Maximum202450,00051,299
Calendar Year Cap20241,500,0001,538,970
42 CFR 2.3(a) and (c)OCRPenalty 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 occurred2024
Minimum202450,00051,299
Maximum20241,500,0001,538,970
Calendar Year Cap20241,500,0001,538,970
42 U.S.C. 300gg-18,42.S.C. 130245 CFR 180.90CMSPenalty for a hospital's non-compliance with making public standard charges for hospital items and services2024333342
Per Day (Maximum)20246,1186,277
45 CFR 180.90(c)(2)(i)CMSApplicable solely to CY 2021 penalties, per day penalty for a hospital's noncompliance with making public standard charges for hospital items and services2024339348
45 CFR 180.90(c)(2)(ii)(A)CMSPer day penalty for hospitals with equal to or less than 30 beds2024333342
45 CFR 180.90(c)(2)(ii)(B)CMSPer day, per bed penalty for hospitals having at least 31 and up to and including 550 beds20241111
45 CFR 180.90(c)(2)(ii)(C)CMSPer day penalty for hospitals having greater than 550 beds20246,1186,277
CARES Act, Public Law 116-136, section 3202(b)(2)45 CFR 182.70CMSPenalty for a provider's non-compliance with price transparency requirements regarding diagnostic tests for COVID-192024
Per Day (Maximum)2024N/AN/A
263a(h)(2)(B) & 1395w-2(b)(2)(A)(ii)42 CFR 493.1834(d)(2)(i)CMSPenalty for a clinical laboratory's failure to meet participation and certification requirements and poses immediate jeopardy2024
Minimum20247,8078,010
Maximum202425,59726,262
42 CFR 493.1834(d)(2)(ii).CMSPenalty for a clinical laboratory's failure to meet participation and certification requirements and the failure does not pose immediate jeopardy2024
Minimum2024129132
Maximum20247,6787,877
42 CFR 493.1834(d)(2)(iii)CMSPenalty for a clinical laboratory's failure to meet SARS-CoV-2 test reporting requirements2024
First day of noncompliance2024
Each additional day of noncompliance2024
300gg-15(f)45 CFR 147.200(e)CMSFailure to provide the Summary of Benefits and Coverage20241,4061,443
300gg-1845 CFR 158.606CMSPenalty for violations of regulations related to the medical loss ratio reporting and rebating2024140144
45 CFR 180.70CMSPenalty against hospital identified by CMS as noncompliant according to § 182.50 with respect to price transparency requirements regarding diagnostic tests for COVID-192024
42 U.S.C. 300gg-118 note, 300gg-134CMSPenalties for failure to comply with No Surprises Act requirements on providers, facilities, providers of air ambulance services202411,81612,123
1320a-7h(b)(1)42 CFR 402.105(d)(5), 42 CFR 403.912(a) & (c)CMSPenalty for manufacturer or group purchasing organization failing to report information required under 42 U.S.C. 1320a-7h(a), relating to physician ownership or investment interests2024
Minimum20241,4061,443
Maximum202414,06714,432
Calendar Year Cap2024211,008216,490
1320a-7h(b)(2)42 CFR 402.105(h), 42 CFR 403.912(b) & (c)CMSPenalty for manufacturer or group purchasing organization knowingly failing to report information required under 42 U.S.C. 1320a-7h(a), relating to physician ownership or investment interests2024
Minimum202414,06714,432
Maximum2024140,674144,329
Calendar Year Cap20241,406,7281,443,275
1320a-7j(h)(3)(A)CMSMaximum penalty for an administrator of a facility that fails to comply with notice requirements for the closure of a facility2024140,674144,329
1320a-7j(h)(3)(A)42 CFR 488.446(a)(1), (2), & (3)CMSMinimum penalty for the first offense of an administrator who fails to provide notice of facility closure2024703721
Minimum penalty for the second offense of an administrator who fails to provide notice of facility closure20242,1112,166
Minimum penalty for the third and subsequent offenses of an administrator who fails to provide notice of facility closure20244,2194,329
1320a-8(a)(1)CMSPenalty for an entity knowingly making a false statement or representation of material fact in the determination of the amount of benefits or payments related to old-age, survivors, and disability insurance benefits, special benefits for certain World War II veterans, or supplemental security income for the aged, blind, and disabled202410,28910,556
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 determination20249,7049,956
1320a-8(a)(3)CMSPenalty for a representative payee (under 42 U.S.C. 405(j), 1007, or 1383(a)(2)) converting any part of a received payment from the benefit programs described in the previous civil monetary penalty to a use other than for the benefit of the beneficiary20248,0588,267
1320b-25(c)(1)(A)CMSPenalty for failure of covered individuals to report to the Secretary and 1 or more law enforcement officials any reasonable suspicion of a crime against a resident, or individual receiving care, from a long-term care facility2024281,346288,655
1320b-25(c)(2)(A)CMSPenalty for failure of covered individuals to report to the Secretary and 1 or more law enforcement officials any reasonable suspicion of a crime against a resident, or individual receiving care, from a long-term care facility if such failure exacerbates the harm to the victim of the crime or results in the harm to another individual2024422,017432,981
1320b-25(d)(2)CMSPenalty for a long-term care facility that retaliates against any employee because of lawful acts done by the employee, or files a complaint or report with the State professional disciplinary agency against an employee or nurse for lawful acts done by the employee or nurse2024281,346288,655
1395b-7(b)(2)(B)42 CFR 402.105(g)CMSPenalty for any person who knowingly and willfully fails to furnish a beneficiary with an itemized statement of items or services within 30 days of the beneficiary's request2024190195
1395i-3(h)(2)(B)(ii)(I)42 CFR 488.408(d)(1)(iii)CMSPenalty per day for a Skilled Nursing Facility that has a Category 2 violation of certification requirements2024
Minimum2024133136
Maximum20248,0038,211
42 CFR 488.408(d)(1)(iv)CMSPenalty per instance of Category 2 noncompliance by a Skilled Nursing Facility2024
Minimum20242,6702,739
Maximum202426,68527,378
42 CFR 488.408(e)(1)(iii)CMSPenalty per day for a Skilled Nursing Facility that has a Category 3 violation of certification requirements2024
Minimum20248,1408,351
Maximum202426,68527,378
42 CFR 488.408(e)(1)(iv)CMSPenalty per instance of Category 3 noncompliance by a Skilled Nursing Facility2024
Minimum20242,6702,739
Maximum202426,68527,378
42 CFR 488.408(e)(2)(ii)CMSPenalty per day and per instance for a Skilled Nursing Facility that has Category 3 noncompliance with Immediate Jeopardy20240
Per Day (Minimum)20248,1408,351
Per Day (Maximum)202426,68527,378
Per Instance (Minimum)20242,6702,739
Per Instance (Maximum)202426,68527,378
42 CFR 488.438(a)(1)(i)CMSPenalty per day of a Skilled Nursing Facility that fails to meet certification requirements. These amounts represent the upper range per day20240
Minimum20248,1408,351
Maximum202426,68527,378
42 CFR 488.438(a)(1)(ii)CMSPenalty per day of a Skilled Nursing Facility that fails to meet certification requirements. These amounts represent the lower range per day20240
Minimum2024133136
Maximum20248,0038,211
42 CFR 488.438(a)(2)CMSPenalty per instance of a Skilled Nursing Facility that fails to meet certification requirements20240
Minimum20242,6702,739
Maximum202426,68527,378
42 CFR 488.447CMSPenalty imposed for failure to comply with infection control weekly reporting requirements at 42 CFR 483.80(g)(1) and (2)2024
First occurrence20241,1961,227
Incremental increases for each subsequent occurrence2024598614
1395i-6(c)(5)(B)(i)42 CFR 488.1245CMSPenalty for noncompliance by hospice program with requirements specified in section 1395x(dd) of 42 U.S.C.202411,12411,413
42 CFR 488.1245(b)(2)(iii)CMSAdjustment to penalties. Maximum penalty assessment for each day a hospice is not in substantial compliance with one or more conditions of participation202411,12411,413
42 CFR 488.1245(b)(3)CMSPenalty imposed for hospice condition-level deficiency that is immediate jeopardy. These amounts represent the upper range of penalty2024
Minimum20249,4559,701
Maximum202411,12411,413
42 CFR 488.1245(b)(3)(i)CMSPenalty imposed for hospice condition-level deficiency that is immediate jeopardy. These amounts represent the upper range of penalty202411,12411,413
42 CFR 488.1245(b)(3)(ii)CMSPenalty imposed for hospice condition-level deficiency that is immediate jeopardy. These amounts represent the upper range of penalty202410,01110,271
42 CFR 488.1245(b)(3)(iii)CMSPenalty imposed for hospice condition-level deficiency that is immediate jeopardy. These amounts represent the upper range of penalty20249,4559,701
42 CFR 488.1245(b)(4)CMSPenalty 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 penalty2024
Minimum20241,6681,711
Maximum20249,4559,701
42 CFR 488.1245(b)(5)CMSPenalty 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 penalty2024
Minimum2024556570
Maximum20244,4504,566
42 CFR 488.1245(b)(6)CMSPenalty range imposed for per instance of hospice noncompliance2024
Minimum20241,1121,141
Maximum202411,12411,413
42 CFR 488.1245(d)(1)(ii)CMSPenalty for each per instance of hospice noncompliance, maximum per day per hospice program202411,12411,413
2024
1395l(h)(5)(D)42 CFR 402.105(d)(2)(i)CMSPenalty for knowingly, willfully, and repeatedly billing for a clinical diagnostic laboratory test other than on an assignment-related basis. (Penalties are assessed in the same manner as 42 U.S.C. 1395u(j)(2)(B), which is assessed according to 1320a-7a(a))202419,43519,940
1395l(i)(6)CMSPenalty for knowingly and willfully presenting or causing to be presented a bill or request for payment for an intraocular lens inserted during or after cataract surgery for which the Medicare payment rate includes the cost of acquiring the class of lens involved20245,1215,254
1395l(q)(2)(B)(i)42 CFR 402.105(a)CMSPenalty for knowingly and willfully failing to provide information about a referring physician when seeking payment on an unassigned basis20244,8995,026
1395m(a)(11)(A)42 CFR 402.1(c)(4), 402.105(d)(2)(ii)CMSPenalty for any durable medical equipment supplier that knowingly and willfully charges for a covered service that is furnished on a rental basis after the rental payments may no longer be made. (Penalties are assessed in the same manner as 42 U.S.C. 1395u(j)(2)(B), which is assessed according to 1320a-7a(a))202419,43519,940
1395m(a)(18)(B)42 CFR 402.1(c)(5), 402.105(d)(2)(iii)CMSPenalty for any nonparticipating durable medical equipment supplier that knowingly and willfully fails to make a refund to Medicare beneficiaries for a covered service for which payment is precluded due to an unsolicited telephone contact from the supplier. (Penalties are assessed in the same manner as 42 U.S.C. 1395u(j)(2)(B), which is assessed according to 1320a-7a(a))202419,43519,940
1395m(b)(5)(C)42 CFR 402.1(c)(6), 402.105(d)(2)(iv)CMSPenalty for any nonparticipating physician or supplier that knowingly and willfully charges a Medicare beneficiary more than the limiting charge for radiologist services. (Penalties are assessed in the same manner as 42 U.S.C. 1395u(j)(2)(B), which is assessed according to 1320a-7a(a))202419,43519,940
1395m(h)(3)42 CFR 402.1(c)(8), 402.105(d)(2)(vi)CMSPenalty for any supplier of prosthetic devices, orthotics, and prosthetics that knowing and willfully charges for a covered prosthetic device, orthotic, or prosthetic that is furnished on a rental basis after the rental payment may no longer be made. (Penalties are assessed in the same manner as 42 U.S.C. 1395m(a)(11)(A), that is in the same manner as 1395u(j)(2)(B), which is assessed according to 1320a-7a(a))202419,43519,940
1395m(j)(2)(A)(iii)CMSPenalty for any supplier of durable medical equipment including a supplier of prosthetic devices, prosthetics, orthotics, or supplies that knowingly and willfully distributes a certificate of medical necessity in violation of Section 1834(j)(2)(A)(i) of the Act or fails to provide the information required under Section 1834(j)(2)(A)(ii) of the Act20242,0582,111
1395m(j)(4)42 CFR 402.1(c)(10), 402.105(d)(2)(vii)CMSPenalty for any supplier of durable medical equipment, including a supplier of prosthetic devices, prosthetics, orthotics, or supplies that knowingly and willfully fails to make refunds in a timely manner to Medicare beneficiaries for series billed other than on as assignment-related basis under certain conditions. (Penalties are assessed in the same manner as 42 U.S.C. 1395m(j)(4) and 1395u(j)(2)(B), which is assessed according to 1320a-7a(a))202419,43519,940
1395m-1(a)42 CFR. 414.504(e)CMSPenalty 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 test202412,95813,295
42 CFR 402.1(c)(31), 402.105(d)(3)CMSPenalty for any person or entity who knowingly and willfully bills or collects for any outpatient therapy services or comprehensive outpatient rehabilitation services on other than an assignment-related basis. (Penalties are assessed in the same manner as 42 U.S.C. 1395m(k)(6) and 1395u(j)(2)(B), which is assessed according to 1320a-7a(a))202419,43519,940
1395m(l)(6)42 CFR 402.1(c)(32), 402.105(d)(4)CMSPenalty for any supplier of ambulance services who knowingly and willfully fills or collects for any services on other than an assignment-related basis. (Penalties are assessed in the same manner as 42 U.S.C. 1395u(b)(18)(B), which is assessed according to 1320a-7a(a))202419,43519,940
1395u(b)(18)(B)42 CFR 402.1(c)(11), 402.105(d)(2)(viii)CMSPenalty for any practitioner specified in Section 1842(b)(18)(C) of the Act or other person that knowingly and willfully bills or collects for any services by the practitioners on other than an assignment-related basis. (Penalties are assessed in the same manner as 42 U.S.C. 1395u(j)(2)(B), which is assessed according to 1320a-7a(a))202419,43519,940
1395u(j)(2)(B)42 CFR 402.1(c)CMSPenalty for any physician who charges more than 125% for a non-participating referral. (Penalties are assessed in the same manner as 42 U.S.C. 1320a-7a(a))202419,43519,940
1395u(k)42 CFR 402.1(c)(12), 402.105(d)(2)(ix) 1834A(a)(9) and 42 CFR 414.504(e)CMSPenalty for any physician who knowingly and willfully presents or causes to be presented a claim for bill for an assistant at a cataract surgery performed on or after March 1, 1987, for which payment may not be made because of section 1862(a)(15). (Penalties are assessed in the same manner as 42 U.S.C. 1395u(j)(2)(B), which is assessed according to 1320a-7a(a))202419,43519,940
1395u(l)(3)42 CFR 402.1(c)(13), 402.105(d)(2)(x)CMSPenalty for any nonparticipating physician who does not accept payment on an assignment-related basis and who knowingly and willfully fails to refund on a timely basis any amounts collected for services that are not reasonable or medically necessary or are of poor quality under 1842(l)(1)(A). (Penalties are assessed in the same manner as 42 U.S.C. 1395u(j)(2)(B), which is assessed according to 1320a-7a(a))202419,43519,940
1395u(m)(3)42 CFR 402.1(c)(14), 402.105(d)(2)(xi)CMSPenalty for any nonparticipating physician charging more than $500 who does not accept payment for an elective surgical procedure on an assignment related basis and who knowingly and willfully fails to disclose the required information regarding charges and coinsurance amounts and fails to refund on a timely basis any amount collected for the procedure in excess of the charges recognized and approved by the Medicare program. (Penalties are assessed in the same manner as 42 U.S.C. 1395u(j)(2)(B), which is assessed according to 1320a-7a(a))202419,43519,940
1395u(n)(3)42 CFR 402.1(c)(15), 402.105(d)(2)(xii)CMSPenalty for any physician who knowingly, willfully, and repeatedly bills one or more beneficiaries for purchased diagnostic tests any amount other than the payment amount specified by the Act. (Penalties are assessed in the same manner as 42 U.S.C. 1395u(j)(2)(B), which is assessed according to 1320a-7a(a))202419,43519,940
1395u(o)(3)(B)42 CFR 414.707(b)CMSPenalty for any practitioner specified in Section 1842(b)(18)(C) of the Act or other person that knowingly and willfully bills or collects for any services pertaining to drugs or biologics by the practitioners on other than an assignment-related basis. (Penalties are assessed in the same manner as 42 U.S.C. 1395u(b)(18)(B) and 1395u(j)(2)(B), which is assessed according to 1320a-7a(a))202419,43519,940
1395u(p)(3)(A)CMSPenalty for any physician or practitioner who knowingly and willfully fails promptly to provide the appropriate diagnosis codes upon CMS or Medicare administrative contractor request for payment or bill not submitted on an assignment-related basis20245,1215,254
1395w-3a(d)(4)(A)42 CFR 414.806CMSPenalty for a pharmaceutical manufacturer's misrepresentation of average sales price of a drug, or biologic202416,63017,062
1395w-4(g)(1)(B)42 CFR 402.1(c)(17), 402.105(d)(2)(xiii)CMSPenalty for any nonparticipating physician, supplier, or other person that furnishes physician services not on an assignment-related basis who either knowingly and willfully bills or collects in excess of the statutorily-defined limiting charge or fails to make a timely refund or adjustment. (Penalties are assessed in the same manner as 42 U.S.C. 1395u(j)(2)(B), which is assessed according to 1320a-7a(a))202419,43519,940
1395w-4(g)(3)(B)42 CFR 402.1(c)(18), 402.105(d)(2)(xiv)CMSPenalty for any person that knowingly and willfully bills for statutorily defined State-plan approved physicians' services on any other basis than an assignment-related basis for a Medicare/Medicaid dual eligible beneficiary. (Penalties are assessed in the same manner as 42 U.S.C. 1395u(j)(2)(B), which is assessed according to 1320a-7a(a))202419,43519,940
1395w-27(g)(3)(A); 1857(g)(3); 1860D-12(b)(3)(E)42 CFR 422.760(b); 42 CFR 423.760(b)CMSPenalty for each termination determination the Secretary makes that is the result of actions by a Medicare Advantage organization or Part D sponsor that has adversely affected (or has the substantial likelihood of adversely affecting) an individual covered under the organization's contract202447,59648,833
1395w-27(g)(3)(B); 1857(g)(3); 1860D-12(b)(3)(E)CMSPenalty for each week beginning after the initiation of civil money penalty procedures by the Secretary because a Medicare Advantage organization or Part D sponsor has failed to carry out a contract, or has carried out a contract inconsistently with regulations202419,04019,535
1395w-27(g)(3)(D); 1857(g)(3): 1860D-12(b)(3)(E)CMSPenalty for a Medicare Advantage organization's or Part D sponsor's early termination of its contract2024176,807181,400
1395y(b)(3)(C)42 CFR 411.103(b)CMSPenalty for an employer or other entity to offer any financial or other incentive for an individual entitled to benefits not to enroll under a group health plan or large group health plan which would be a primary plan202411,52411,823
1395y(b)(5)(C)(ii)42 CFR 402.1(c)(20), 42 CFR 402.105(b)(2)CMSPenalty for any non-governmental employer that, before October 1, 1998, willfully or repeatedly failed to provide timely and accurate information requested relating to an employee's group health insurance coverage20241,8771,926
1395y(b)(6)(B)42 CFR 402.1(c)(20), 402.105(a)CMSPenalty for any entity that knowingly, willfully, and repeatedly fails to complete a claim form relating to the availability of other health benefits in accordance with statute or provides inaccurate information relating to such on the claim form20244,1174,224
1395y(b)(7)(B)(i)42 CFR 402.1(c)(21), 402.105(a)CMSPenalty for any entity serving as insurer, third party administrator, or fiduciary for a group health plan that fails to provide information that identifies situations where the group health plan is or was a primary plan to Medicare to the HHS Secretary20241,4741,512
1395y(b)(8)(E)CMSPenalty for any non-group health plan that fails to identify claimants who are Medicare beneficiaries and provide information to the HHS Secretary to coordinate benefits and pursue any applicable recovery claim20241,4741,512
1395nn(g)(5)42 CFR 411.361CMSPenalty for any person that fails to report information required by HHS under Section 1877(f) concerning ownership, investment, and compensation arrangements202424,49625,132
1395pp(h)42 CFR 402.1(c)(23), 402.105(d)(2)(xv)CMSPenalty for any durable medical equipment supplier, including a supplier of prosthetic devices, prosthetics, orthotics, or supplies, that knowingly and willfully fails to make refunds in a timely manner to Medicare beneficiaries under certain conditions. (42 U.S.C. 1395(m)(18) sanctions apply here in the same manner, which is under 1395u(j)(2) and 1320a-7a(a))202419,43519,940
1395ss(a)(2)402.102(f)(1)CMSPenalty for any person that issues a Medicare supplemental policy that has not been approved by the State regulatory program or does not meet Federal standards after a statutorily defined effective date202466,71168,444
1395ss(d)(3)(A)(vi)(II)42 CFR 402.1(c)(25), 402.105(e),402.105(f)(2)CMSPenalty for someone other than issuer that sells or issues a Medicare supplemental policy to beneficiary without a disclosure statement202434,56835,466
CMSPenalty for an issuer that sells or issues a Medicare supplemental policy without disclosure statement202457,61759,114
1395ss(d)(3)(B)(iv)CMSPenalty for someone other than issuer that sells or issues a Medicare supplemental policy without acknowledgement form202434,56835,466
CMSPenalty for issuer that sells or issues a Medicare supplemental policy without an acknowledgement form202457,61759,114
1395ss(p)(8)42 CFR 402.1(c)(25), 402.105(e)CMSPenalty 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 statute202434,56835,466
42 CFR 402.1(c)(25), 405402.105(f)(2)CMSPenalty 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 statute202457,61759,114
1395ss(p)(9)(C)42 CFR 402.1(c)(26), 402.105(e), 402.105(f)(3), (4)CMSPenalty 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 benefits202434,56835,466
42 CFR 402.105(f)(3), (4)CMSPenalty 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 benefits202457,61759,114
1395ss(q)(5)(C)42 CFR 402.105(f)(5)CMSPenalty for any person that fails to suspend the policy of a policyholder made eligible for medical assistance or automatically reinstates the policy of a policyholder who has lost eligibility for medical assistance, under certain circumstances202457,61759,114
1395ss(r)(6)(A)42 CFR 402.105(f)(6)CMSPenalty for any person that fails to provide refunds or credits as required by section 1882(r)(1)(B)202457,61759,114
1395ss(s)(4)42 CFR 402.1(c)(29), 402.105(c)CMSPenalty for any issuer of a Medicare supplemental policy that does not waive listed time periods if they were already satisfied under a proceeding Medicare supplemental policy, or denies a policy, or conditions the issuances or effectiveness of the policy, or discriminates in the pricing of the policy base on health status or other specified criteriaC202424,46025,095
1395ss(t)(2)42 CFR 402.1(c)(30), 402.105(f)(7)CMSPenalty for any issuer of a Medicare supplemental policy that fails to fulfill listed responsibilities202457,61759,114
1395ss(v)(4)(A)CMSPenalty someone other than issuer who sells, issues, or renews a medigap Rx policy to an individual who is a Part D enrollee202424,94625,594
CMSPenalty for an issuer who sells, issues, or renews a Medigap Rx policy who is a Part D enrollee202441,57742,657
1395bbb(c)(1)42 CFR 488.725(c)CMSPenalty for any individual who notifies or causes to be notified a home health agency of the time or date on which a survey of such agency is to be conducted20245,3395,478
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)CMSMaximum daily penalty amount for each day a home health agency is not in compliance with statutory requirements202425,59726,262
42 CFR 488.845(b)(3)CMSPenalty per day for home health agency's noncompliance (Upper Range)20240
Minimum202421,75722,322
Maximum202425,59726,262
42 CFR 488.845(b)(3)(i)CMSPenalty for a home health agency's deficiency or deficiencies that cause immediate jeopardy and result in actual harm202425,59726,262
42 CFR 488.845(b)(3)(ii)CMSPenalty for a home health agency's deficiency or deficiencies that cause immediate jeopardy and result in potential for harm202423,03623,634
42 CFR 488.845(b)(3)(iii)CMSPenalty for an isolated incident of noncompliance in violation of established HHA policy202421,75722,322
42 CFR 488.845(b)(4)CMSPenalty 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)20240
Minimum20243,8413,941
Maximum202421,75722,322
42 CFR 488.845(b)(5)CMSPenalty 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)20240
Minimum20241,2801,313
Maximum20242,5592,625
42 CFR 488.845(b)(6)CMSPenalty 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 survey20240
Penalty for each day of noncompliance (Minimum)20242,5592,625
Penalty for each day of noncompliance (Maximum)202425,59726,262
42 CFR 488.845(d)(1)(ii)CMSPenalty for each day of noncompliance (Maximum)202425,59726,262
1395eee(e)(6)(B); 1396u-4(e)(6)(B)42 CFR 460.46CMSPenalty 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 services202447,59648,833
CMSFor each individual not enrolled as a result of the PACE organization's discrimination in enrollment or disenrollment or practice that would deny or discourage enrollment2024
Minimum202417,93318,399
Maximum2024119,555122,661
CMSPenalty for a PACE organization that charges excessive premiums202447,59648,833
CMSPenalty for a PACE organization misrepresenting or falsifying information to CMS or the State2024190,389195,335
CMSPenalty for any other violation specified in 42 CFR 460.40202447,59648,833
1396r(h)(3)(C)(ii)(I)42 CFR 488.408(d)(1)(iii)CMSPenalty per day for a nursing facility's failure to meet a Category 2 Certification20240
Minimum2024133136
Maximum20248,0038,211
42 CFR 488.408(d)(1)(iv)CMSPenalty per instance for a nursing facility's failure to meet Category 2 certification2024
Minimum20242,6702,739
Maximum202426,68527,378
42 CFR 488.408(e)(1)(iii)CMSPenalty per day for a nursing facility's failure to meet Category 3 certification2024
Minimum20248,1408,351
Maximum202426,68527,378
42 CFR 488.408(e)(1)(iv)CMSPenalty per instance for a nursing facility's failure to meet Category 3 certification20240
Minimum20242,6702,739
Maximum202426,68527,378
42 CFR 488.408(e)(2)(ii)CMSPenalty per instance for a nursing facility's failure to meet Category 3 certification, which results in immediate jeopardy20240
Minimum20242,6702,739
Maximum202426,68527,378
42 CFR 488.438(a)(1)(i)CMSPenalty per day for nursing facility's failure to meet certification (Upper Range)20240
Minimum20248,1408,351
Maximum202426,68527,378
42 CFR 488.438(a)(1)(ii)CMSPenalty per day for nursing facility's failure to meet certification (Lower Range)20240
Minimum2024133136
Maximum20248,0038,211
42 CFR 488.438(a)(2)CMSPenalty per instance for nursing facility's failure to meet certification20240
Minimum20242,6702,739
Maximum202426,68527,378
42 CFR 488.447CMSPenalty imposed for failure to comply with infection control weekly reporting requirements at 42 CFR 483.80(g)(1) and (2)2024
First occurrence (Minimum)20241,1961,227
Incremental increases for each subsequent occurrence2024598614
1396r(f)(2)(B)(iii)(I)(c)42 CFR 483.151(b)(2)(iv) and (b)(3)(iii)CMSGrounds to prohibit approval of Nurse Aide Training Program—if assessed a penalty in 1819(h)(2)(B)(i) or 1919(h)(2)(A)(ii) of “not less than $5,000” [Not CMP authority, but a specific CMP amount (CMP at this level) that is the triggering condition for disapproval]202413,34313,690
1396r(h)(3)(C)(ii)(I)42 CFR 483.151(c)(2)CMSGrounds to waive disapproval of nurse aide training program—reference to disapproval based on imposition of CMP “not less than $5,000” [Not CMP authority but CMP imposition at this level determines eligibility to seek waiver of disapproval of nurse aide training program]202413,34313,690
1396t(j)(2)(C)CMSPenalty for each day of noncompliance for a home or community care provider that no longer meets the minimum requirements for home and community care20240
Minimum202422
Maximum202423,04823,647
1396u-2(e)(2)(A)(i)42 CFR 438.704CMSPenalty for a Medicaid managed care organization that fails substantially to provide medically necessary items and services202447,59648,833
CMSPenalty for Medicaid managed care organization that imposes premiums or charges on enrollees in excess of the premiums or charges permitted202447,59648,833
CMSPenalty for a Medicaid managed care organization that misrepresents or falsifies information to another individual or entity202447,59648,833
CMSPenalty for a Medicaid managed care organization that fails to comply with the applicable statutory requirements for such organizations.202447,59648,833
1396u-2(e)(2)(A)(ii)42 CFR 438.704CMSPenalty for a Medicaid managed care organization that misrepresents or falsifies information to the HHS Secretary2024190,389195,335
CMSPenalty for Medicaid managed care organization that acts to discriminate among enrollees on the basis of their health status2024190,389195,335
1396u-2(e)(2)(A)(iv)42 CFR 438.704CMSPenalty for each individual that does not enroll as a result of a Medicaid managed care organization that acts to discriminate among enrollees on the basis of their health status202428,55729,299
1396u(h)(2)42 CFR Part 441, Subpart ICMSPenalty for a provider not meeting one of the requirements relating to the protection of the health, safety, and welfare of individuals receiving community supported living arrangements services202426,68527,378
1396w-2(c)(1)42 U.S.C. 300gg-22(b)(2)(C)(i) 45 CFR 150.315CMSPenalty 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|177202414,23214,602
18041(c)(2)45 CFR 156.805(c)CMSFailure 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 standards2024193198
42 U.S.C. 300gg-22(b)(2)(C)(i)45 CFR 150.315CMSPenalty 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 Act2024183188
18081(h)(1)(A)(i)(II)45 CFR 155.285CMSPenalty for providing false information on Exchange application202435,16936,083
18081(h)(1)(B)45 CFR 155.285CMSPenalty for knowingly or willfully providing false information on Exchange application2024351,681360,818
18081(h)(2)45 CFR 155.260CMSPenalty for knowingly or willfully disclosing protected information from Exchange20240
CMSMaximum202435,16936,083
CMSMinimum2024359368
18041(c)(2)45 CFR 155.206(i)CMSPenalties for violation of applicable Exchange standards by consumer assistance entities in Federally-facilitated Exchanges202443,12844,248
Maximum (Per Day)2024119122
31 U.S.C45 CFR 93.400(e)HHS2024359368
Penalty for the first time an individual makes an expenditure prohibited by regulations regarding lobbying disclosure, absent aggravating circumstances202424,49625,132
Penalty for second and subsequent offenses by individuals who make an expenditure prohibited by regulations regarding lobbying disclosure20240
Minimum202424,49625,132
Maximum2024244,958251,322
1352HHSPenalty for the first time an individual fails to file or amend a lobbying disclosure form, absent aggravating circumstances202424,49625,132
Penalty for second and subsequent offenses by individuals who fail to file or amend a lobbying disclosure form, absent aggravating circumstances20240
Minimum202424,49625,132
Maximum2024244,958251,322
45 CFR Part 93, Appendix AHHSPenalty for failure to provide certification regarding lobbying in the award documents for all sub-awards of all tiers20240
Minimum202424,49625,132
Maximum2024244,958251,322
HHSPenalty for failure to provide statement regarding lobbying for loan guarantee and loan insurance transactions20240
Minimum202424,49625,132
Maximum2024244,958251,322
3801-381245 CFR 79.3(a)(1)(iv)HHSPenalty against any individual who—with knowledge or reason to know—makes, presents or submits a false, fictitious or fraudulent claim to the Department202412,80013,133
45 CFR 79.3(b)(1)(ii)HHSPenalty against any individual who—with knowledge or reason to know—makes, presents or submits a false, fictitious or fraudulent claim to the Department202412,80013,133

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.

[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; 91 FR 3666, Jan. 28, 2026]

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 102.3