法律人 LawPlayer logo

資料由法律人 LawPlayer整理提供·U.S. federal law / curated by LawPlayer from GPO govinfo & eCFR

CFR Regulation

ADJUSTMENT OF CIVIL MONETARY PENALTIES FOR INFLATION

Citation
45 CFR Part 102
Current through
Sections
3
§ 102.1Applicability.

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.

§ 102.2Applicability 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.

§ 102.3Penalty 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)

FDA

Penalty for violations related to drug samples resulting in a conviction of any representative of manufacturer or distributor in any 10-year period

2024

127,983

131,308

333(b)(2)(B)

FDA

Penalty for violation related to drug samples resulting in a conviction of any representative of manufacturer or distributor after the second conviction in any 10-yr period

2024

2,559,636

2,626,135

333(b)(3)

FDA

Penalty for failure to make a report required by 21 U.S.C. 353(d)(3)(E) relating to drug samples

2024

255,964

262,614

333(f)(1)(A)

FDA

Penalty for any person who violates a requirement related to devices for each such violation

2024

34,568

35,466

FDA

Penalty for aggregate of all violations related to devices in a single proceeding

2024

2,304,629

2,364,503

333(f)(2)(A)

FDA

Penalty for any individual who introduces or delivers for introduction into interstate commerce food that is adulterated per 21 U.S.C. 342(a)(2)(B) or any individual who does not comply with a recall order under 21 U.S.C. 350l

2024

97,179

99,704

FDA

Penalty in the case of any other person (other than an individual) for such introduction or delivery of adulterated food

2024

485,893

498,517

FDA

Penalty for aggregate of all such violations related to adulterated food adjudicated in a single proceeding

2024

971,787

997,034

333(f)(3)(A)

FDA

Penalty for all violations adjudicated in a single proceeding for any person who violates 21 U.S.C. 331(jj) by failing to submit the certification required by 42 U.S.C. 282(j)(5)(B) or knowingly submitting a false certification; by failing to submit clinical trial information under 42 U.S.C. 282(j); or by submitting clinical trial information under 42 U.S.C. 282(j) that is false or misleading in any particular under 42 U.S.C. 282(j)(5)(D)

2024

14,724

15,107

333(f)(3)(B)

FDA

Penalty for each day any above violation is not corrected after a 30-day period following notification until the violation is corrected

2024

14,724

15,107

333(f)(4)(A)(i)

FDA

Penalty for any responsible person that violates a requirement of 21 U.S.C. 355(o) (post-marketing studies, clinical trials, labeling), 21 U.S.C. 355(p) (risk evaluation and mitigation (REMS)), or 21 U.S.C. 355-1 (REMS)

2024

368,137

377,701

FDA

Penalty for aggregate of all such above violations in a single proceeding

2024

1,472,546

1,510,803

333(f)(4)(A)(ii)

FDA

Penalty for REMS violation that continues after written notice to the responsible person for the first 30-day period (or any portion thereof) the responsible person continues to be in violation

2024

368,137

377,701

FDA

Penalty for REMS violation that continues after written notice to responsible person doubles for every 30-day period thereafter the violation continues, but may not exceed penalty amount for any 30-day period

2024

1,472,546

1,510,803

FDA

Penalty for aggregate of all such above violations adjudicated in a single proceeding

2024

14,725,456

15,108,023

333(f)(9)(A)

FDA

Penalty for any person who violates a requirement which relates to tobacco products for each such violation

2024

21,348

21,903

FDA

Penalty for aggregate of all such violations of tobacco product requirement adjudicated in a single proceeding

2024

1,423,220

1,460,195

333(f)(9)(B)(i)(I)

FDA

Penalty per violation related to violations of tobacco requirements

2024

355,806

365,050

FDA

Penalty for aggregate of all such violations of tobacco product requirements adjudicated in a single proceeding

2024

1,423,220

1,460,195

333(f)(9)(B)(i)(II)

FDA

Penalty in the case of a violation of tobacco product requirements that continues after written notice to such person, for the first 30-day period (or any portion thereof) the person continues to be in violation

2024

355,806

365,050

FDA

Penalty for violation of tobacco product requirements that continues after written notice to such person shall double for every 30-day period thereafter the violation continues, but may not exceed penalty amount for any 30-day period

2024

1,423,220

1,460,195

FDA

Penalty for aggregate of all such violations related to tobacco product requirements adjudicated in a single proceeding

2024

14,232,205

14,601,958

333(f)(9)(B)(ii)(I)

FDA

Penalty for any person who either does not conduct post-market surveillance and studies to determine impact of a modified risk tobacco product for which the HHS Secretary has provided them an order to sell, or who does not submit a protocol to the HHS Secretary after being notified of a requirement to conduct post-market surveillance of such tobacco products

2024

355,806

365,050

FDA

Penalty for aggregate of for all such above violations adjudicated in a single proceeding

2024

1,423,220

1,460,195

333(f)(9)(B)(ii)(II)

FDA

Penalty for violation of modified risk tobacco product post-market surveillance that continues after written notice to such person for the first 30-day period (or any portion thereof) that the person continues to be in violation

2024

355,806

365,050

FDA

Penalty for post-notice violation of modified risk tobacco product post-market surveillance shall double for every 30-day period thereafter that the tobacco product requirement violation continues for any 30-day period, but may not exceed penalty amount for any 30-day period

2024

1,423,220

1,460,195

Penalty for aggregate above tobacco product requirement violations adjudicated in a single proceeding

2024

14,232,205

14,601,958

333(g)(1)

FDA

Penalty for any person who disseminates or causes another party to disseminate a direct-to-consumer advertisement that is false or misleading for the first such violation in any 3-year period

2024

368,137

377,701

Penalty for each subsequent above violation in any 3-year period

2024

736,274

755,402

333 note

FDA

Penalty to be applied for violations of 21 U.S.C. 387f(d)(5) or of violations of restrictions on the sale or distribution of tobacco products promulgated under 21 U.S.C. 387f(d) ( e.g., violations of regulations in 21 CFR part 1140) with respect to a retailer with an approved training program in the case of a second regulation violation within a 12-month period.

2024

356

365

FDA

Penalty in the case of a third violation of 21 U.S.C. 387f(d)(5) or of the tobacco product regulations within a 24-month period

2024

709

727

FDA

Penalty in the case of a fourth violation of 21 U.S.C. 387f(d)(5) or of the tobacco product regulations within a 24-month period

2024

2,846

2,920

FDA

Penalty in the case of a fifth violation of 21 U.S.C. 387f(d)(5) or of the tobacco product regulations within a 36-month period

2024

7,115

7,300

FDA

Penalty in the case of a sixth or subsequent violation of 21 U.S.C. 387f(d)(5) or of the tobacco product regulations within a 48-month period as determined on a case-by-case basis

2024

14,232

14,602

FDA

Penalty to be applied for violations of 21 U.S.C. 387f(d)(5) or of violations of restrictions on the sale or distribution of tobacco products promulgated under 21 U.S.C. 387f(d) ( e.g., violations of regulations in 21 CFR part 1140) with respect to a retailer that does not have an approved training program in the case of the first regulation violation

2024

356

365

FDA

Penalty in the case of a second violation of 21 U.S.C. 387f(d)(5) or of the tobacco product regulations within a 12-month period

2024

709

727

FDA

Penalty in the case of a third violation of 21 U.S.C. 387f(d)(5) or of the tobacco product regulations within a 24-month period

2024

1,424

1,461

FDA

Penalty in the case of a fourth violation of 21 U.S.C. 387f(d)(5) or of the tobacco product regulations within a 24-month period

2024

2,846

2,920

FDA

Penalty in the case of a fifth violation of 21 U.S.C. 387f(d)(5) or of the tobacco product regulations within a 36-month period

2024

7,115

7,300

FDA

Penalty in the case of a sixth or subsequent violation of 21 U.S.C. 387f(d)(5) or of the tobacco product regulations within a 48-month period as determined on a case-by-case basis

2024

14,232

14,602

335b(a)

FDA

Penalty for each violation for any individual who made a false statement or misrepresentation of a material fact, bribed, destroyed, altered, removed, or secreted, or procured the destruction, alteration, removal, or secretion of, any material document, failed to disclose a material fact, obstructed an investigation, employed a consultant who was debarred, debarred individual provided consultant services

2024

542,434

556,526

FDA

Penalty in the case of any other person (other than an individual) per above violation

2024

2,169,731

2,226,101

360pp(b)(1)

FDA

Penalty for any person who violates any such requirements for electronic products, with each unlawful act or omission constituting a separate violation

2024

3,558

3,650

FDA

Penalty imposed for any related series of violations of requirements relating to electronic products

2024

1,212,751

1,244,258

42 U.S.C

2024

262(d)

FDA

Penalty per day for violation of order of recall of biological product presenting imminent or substantial hazard

2024

278,937

286,184

263b(h)(3)

FDA

Penalty for failure to obtain a mammography certificate as required

2024

21,699

22,263

300aa-28(b)(1)

FDA

Penalty per occurrence for any vaccine manufacturer that intentionally destroys, alters, falsifies, or conceals any record or report required

2024

278,937

286,184

56b(d)(1)(B)(vi)

HRSA

Penalty for each instance of overcharging a 340B covered entity

2024

7,034

7,217

299c-3(d)

AHRQ

Penalty for using or disclosing identifiable information obtained in the course of activities undertaken pursuant to Title IX of the Public Health Service Act, for a purpose other than that for which the information was supplied, without consent to do so

2024

18,291

18,766

653(l)(2)

45 CFR 303.21(f)

ACF

Penalty for Misuse of Information in the National Directory of New Hires

2024

1,877

1,926

262a(i)(1)

42 CFR 1003.910

OIG

Penalty for each individual who violates safety and security procedures related to handling dangerous biological agents and toxins

2024

424,250

435,272

42 CFR 1003.1410

OIG

Penalty for any other person who violates safety and security procedures related to handling dangerous biological agents and toxins

2024

848,505

870,549

300jj-51

OIG

Penalty per violation for committing information blocking

2024

1,293,601

1,327,209

1320a-7a(a)

42 CFR 1003.210(a)(1)

OIG

Penalty for knowingly presenting or causing to be presented to an officer, employee, or agent of the United States a false claim

2024

24,947

25,595

OIG

Penalty for knowingly presenting or causing to be presented a request for payment which violates the terms of an assignment, agreement, or PPS agreement

2024

24,947

25,595

42 CFR 1003.210(a)(2)

OIG

Penalty for knowingly giving or causing to be presented to a participating provider or supplier false or misleading information that could reasonably be expected to influence a discharge decision

2024

37,421

38,393

42 CFR 1003.210(a)(3)

OIG

Penalty for an excluded party retaining ownership or control interest in a participating entity

2024

24,947

25,595

42 CFR 1003.1010

OIG

Penalty for remuneration offered to induce program beneficiaries to use particular providers, practitioners, or suppliers

2024

24,947

25,595

42 CFR 1003.210(a)(4)

OIG

Penalty for employing or contracting with an excluded individual

2024

24,947

25,595

42 CFR 1003.310(a)(3)

OIG

Penalty for knowing and willful solicitation, receipt, offer, or payment of remuneration for referring an individual for a service or for purchasing, leasing, or ordering an item to be paid for by a Federal health care program

2024

124,732

127,973

42 CFR 1003.210(a)(1)

OIG

Penalty for ordering or prescribing medical or other item or service during a period in which the person was excluded

2024

24,947

25,595

42 CFR 1003.210(a)(6)

OIG

Penalty for knowingly making or causing to be made a false statement, omission or misrepresentation of a material fact in any application, bid, or contract to participate or enroll as a provider or supplier

2024

124,732

127,973

42 CFR 1003.210(a)(8)

OIG

Penalty for knowing of an overpayment and failing to report and return

2024

24,947

25,595

42 CFR 1003.210(a)(7)

OIG

Penalty for making or using a false record or statement that is material to a false or fraudulent claim

2024

70,336

72,163

42 CFR 1003.210(a)(9)

OIG

Penalty for failure to grant timely access to HHS OIG for audits, investigations, evaluations, and other statutory functions of HHS OIG

2024

37,421

38,393

1320a-7a(b)

OIG

Penalty for payments by a hospital or critical access hospital to induce a physician to reduce or limit services to individuals under direct care of physician or who are entitled to certain medical assistance benefits

2024

6,236

6,398

OIG

Penalty for physicians who knowingly receive payments from a hospital or critical access hospital to induce such physician to reduce or limit services to individuals under direct care of physician or who are entitled to certain medical assistance benefits

2024

6,236

6,398

42 CFR 1003.210(a)(10)

OIG

Penalty for a physician who executes a document that falsely certifies home health needs for Medicare beneficiaries

2024

12,473

12,797

1320a-7a(o)

42 CFR 1003.710(a)(1)

OIG

Penalty for knowingly presenting or causing to be presented a false or fraudulent specified claim under a grant, contract, or other agreement for which the Secretary provides funding

2024

12,166

12,482

42 CFR 1003.710(a)(2)

OIG

Penalty for knowingly making, using, or causing to be made or used any false statement, omission, or misrepresentation of a material fact in any application, proposal, bid, progress report, or other document required to directly or indirectly receive or retain funds provided pursuant to grant, contract, or other agreement

2024

60,831

62,411

42 CFR 1003.710(a)(3)

OIG

Penalty for Knowingly making, using, or causing to be made or used, a false record or statement material to a false or fraudulent specified claim under grant, contract, or other agreement

2024

60,831

62,411

42 CFR 1003.710(a)(4)

OIG

Penalty for knowingly making, using, or causing to be made or used, a false record or statement material to an obligation to pay or transmit funds or property with respect to grant, contract, or other agreement, or knowingly conceals or improperly avoids or decreases any such obligation, per each false record or statement

2024

63,450

65,098

Penalty for knowingly making, using, or causing to be made or used, a false record or statement material to an obligation to pay or transmit funds or property with respect to grant, contract, or other agreement, or knowingly conceals or improperly avoids or decreases any such obligation, per day

2024

12,707

13,037

42 CFR 1003.710(a)(5)

OIG

Penalty for failure to grant timely access, upon reasonable request, to the I.G. for purposes of audits, investigations, evaluations, or other statutory functions of I.G. in matters involving grants, contracts, or other agreements

2024

18,250

18,724

1320a-7e(b)(6)(A)

42 CFR 1003.810

OIG

Penalty for failure to report any final adverse action taken against a health care provider, supplier, or practitioner

2024

47,596

48,833

1320b-10(b)(1)

42 CFR 1003.610(a)

OIG

Penalty for the misuse of words, symbols, or emblems in communications in a manner in which a person could falsely construe that such item is approved, endorsed, or authorized by HHS

2024

12,799

13,132

1320b-10(b)(2)

42 CFR 1003.610(a)

OIG

Penalty for the misuse of words, symbols, or emblems in a broadcast or telecast in a manner in which a person could falsely construe that such item is approved, endorsed, or authorized by HHS

2024

63,991

65,653

1395i-3(b)(3)(B)(ii)(1)

42 CFR 1003.210(a)(11)

OIG

Penalty for certification of a false statement in assessment of functional capacity of a Skilled Nursing Facility resident assessment

2024

2,670

2,739

1395i-3(b)(3)(B)(ii)(2)

42 CFR 1003.210(a)(11)

OIG

Penalty for causing another to certify or make a false statement in assessment of functional capacity of a Skilled Nursing Facility resident assessment

2024

13,343

13,690

1395i-3(g)(2)(A)

42 CFR 1003.1310

OIG

Penalty for any individual who notifies or causes to be notified a Skilled Nursing Facility of the time or date on which a survey is to be conducted

2024

5,339

5,478

1395w-27(g)(2)(A)

42 CFR 1003.410

OIG

Penalty for a Medicare Advantage organization that substantially fails to provide medically necessary, required items and services

2024

48,586

49,848

OIG

Penalty for a Medicare Advantage organization that charges excessive premiums

2024

47,596

48,833

OIG

Penalty for a Medicare Advantage organization that improperly expels or refuses to reenroll a beneficiary

2024

47,596

48,833

OIG

Penalty for a Medicare Advantage organization that engages in practice that would reasonably be expected to have the effect of denying or discouraging enrollment

2024

190,389

195,335

OIG

Penalty per individual who does not enroll as a result of a Medicare Advantage organization's practice that would reasonably be expected to have the effect of denying or discouraging enrollment

2024

28,557

29,299

OIG

Penalty for a Medicare Advantage organization misrepresenting or falsifying information to Secretary

2024

190,389

195,335

OIG

Penalty for a Medicare Advantage organization misrepresenting or falsifying information to individual or other entity

2024

47,596

48,833

OIG

Penalty for Medicare Advantage organization interfering with provider's advice to enrollee and non-MCO affiliated providers that balance bill enrollees

2024

47,596

48,833

OIG

Penalty for a Medicare Advantage organization that employs or contracts with excluded individual or entity

2024

47,596

48,833

OIG

Penalty for a Medicare Advantage organization enrolling an individual in without prior written consent

2024

47,596

48,833

OIG

Penalty for a Medicare Advantage organization transferring an enrollee to another plan without consent or solely for the purpose of earning a commission

2024

47,596

48,833

OIG

Penalty for a Medicare Advantage organization failing to comply with marketing restrictions or applicable implementing regulations or guidance

2024

47,596

48,833

OIG

Penalty for a Medicare Advantage organization employing or contracting with an individual or entity who violates 1395w-27(g)(1)(A)-(J)

2024

47,596

48,833

1395w-141(i)(3)

OIG

Penalty for a prescription drug card sponsor that falsifies or misrepresents marketing materials, overcharges program enrollees, or misuse transitional assistance funds

2024

16,630

17,062

1395cc(g)

42 CFR 1003.210(a)(5)

OIG

Penalty for improper billing by Hospitals, Critical Access Hospitals, or Skilled Nursing Facilities

2024

6,469

6,637

1395dd(d)(1)

42 CFR 1003.510

OIG

Penalty for a hospital with 100 beds or more or responsible physician dumping patients needing emergency medical care

2024

133,420

136,886

OIG

Penalty for a hospital with less than 100 beds dumping patients needing emergency medical care

2024

66,712

68,445

1395mm(i)(6)(B)(i)

42 CFR 1003.410

OIG

Penalty for a HMO or competitive medical plan if such plan substantially fails to provide medically necessary, required items or services

2024

66,712

68,445

OIG

Penalty for HMOs/competitive medical plans that charge premiums in excess of permitted amounts

2024

66,712

68,445

OIG

Penalty for a HMO or competitive medical plan that expels or refuses to reenroll an individual per prescribed conditions

2024

66,712

68,445

OIG

Penalty for a HMO or competitive medical plan that implements practices to discourage enrollment of individuals needing services in future

2024

266,841

273,774

OIG

Penalty per individual not enrolled in a plan as a result of a HMO or competitive medical plan that implements practices to discourage enrollment of individuals needing services in the future

2024

38,395

39,393

OIG

Penalty for a HMO or competitive medical plan that misrepresents or falsifies information to the Secretary

2024

266,841

273,774

OIG

Penalty for a HMO or competitive medical plan that misrepresents or falsifies information to an individual or any other entity

2024

66,712

68,445

OIG

Penalty for failure by HMO or competitive medical plan to assure prompt payment of Medicare risk sharing contracts or incentive plan provisions

2024

66,712

68,445

OIG

Penalty for HMO that employs or contracts with excluded individual or entity

2024

61,238

62,829

1395nn(g)(3)

42 CFR 1003.310

OIG

Penalty for submitting or causing to be submitted claims in violation of the Stark Law's restrictions on physician self-referrals

2024

30,868

31,670

1395nn(g)(4)

42 CFR 1003.310

OIG

Penalty for circumvention schemes in violation of the Stark Law's restrictions on physician self-referrals

2024

205,799

211,146

1395ss(d)(1)

42 CFR 1003.1110

OIG

Penalty for a material misrepresentation regarding Medigap compliance policies

2024

12,799

13,132

1395ss(d)(2)

42 CFR 1003.1110

OIG

Penalty for selling Medigap policy under false pretense

2024

12,799

13,132

1395ss(d)(3)(A)(ii)

42 CFR 1003.1110

OIG

Penalty for an issuer that sells health insurance policy that duplicates benefits

2024

57,617

59,114

OIG

Penalty for someone other than issuer that sells health insurance that duplicates benefits

2024

34,568

35,466

1395ss(d)(4)(A)

42 CFR 1003.1110

OIG

Penalty for using mail to sell a non-approved Medigap insurance policy

2024

12,799

13,132

1396b(m)(5)(B)(i)

42 CFR 1003.410

OIG

Penalty for a Medicaid MCO that substantially fails to provide medically necessary, required items or services

2024

63,991

65,653

OIG

Penalty for a Medicaid MCO that charges excessive premiums

2024

63,991

65,653

OIG

Penalty for a Medicaid MCO that improperly expels or refuses to reenroll a beneficiary

2024

255,964

262,614

OIG

Penalty per individual who does not enroll as a result of a Medicaid MCO's practice that would reasonably be expected to have the effect of denying or discouraging enrollment

2024

38,395

39,393

OIG

Penalty for a Medicaid MCO misrepresenting or falsifying information to the Secretary

2024

255,964

262,614

OIG

Penalty for a Medicaid MCO misrepresenting or falsifying information to an individual or another entity

2024

63,991

65,653

OIG

Penalty for a Medicaid MCO that fails to comply with contract requirements with respect to physician incentive plans

2024

57,617

59,114

1396r(b)(3)(B)(ii)(I)

42 CFR 1003.210(a)(11)

OIG

Penalty for willfully and knowingly certifying a material and false statement in a Skilled Nursing Facility resident assessment

2024

2,670

2,739

1396r(b)(3)(B)(ii)(II)

42 CFR 1003.210(a)(11)

OIG

Penalty for willfully and knowingly causing another individual to certify a material and false statement in a Skilled Nursing Facility resident assessment

2024

13,343

13,690

1396r(g)(2)(A)(i)

42 CFR 1003.1310

OIG

Penalty for notifying or causing to be notified a Skilled Nursing Facility of the time or date on which a survey is to be conducted

2024

5,339

5,478

1396r-8(b)(3)(B)

42 CFR 1003.1210

OIG

Penalty for the knowing provision of false information or refusing to provide information about charges or prices of a covered outpatient drug

2024

230,464

236,451

1396r-8(b)(3)(C)(i)

42 CFR 1003.1210

OIG

Penalty per day for failure to timely provide information by drug manufacturer with rebate agreement

2024

23,048

23,647

1396r-8(b)(3)(C)(ii)

42 CFR 1003.1210

OIG

Penalty for knowing provision of false information by drug manufacturer with rebate agreement

2024

230,464

236,451

1396t(i)(3)(A)

42 CFR 1003.1310

OIG

Penalty for notifying home and community-based providers or settings of survey

2024

4,610

4,730

11131(c)

42 CFR 1003.810

OIG

Penalty for failing to report a medical malpractice claim to National Practitioner Data Bank

2024

27,894

28,619

11137(b)(2)

42 CFR 1003.810

OIG

Penalty for breaching confidentiality of information reported to National Practitioner Data Bank

2024

27,894

28,619

299b-22(f)(1)

42 CFR 3.404

OCR

Penalty for violation of confidentiality provision of the Patient Safety and Quality Improvement Act

2024

15,445

15,846

1320(d)-5(a)

45 CFR 160.404(b)(1)(i), (ii)

OCR

Penalty for each pre-February 18, 2009 violation of the HIPAA administrative simplification provisions

2024

193

198

OIG

Calendar Year Cap

2024

48,586

49,848

1320(d)-5(a)

45 CFR 160.404(b)(2)(i)(A), (B)

OCR

Penalty for each February 18, 2009 or later violation of a HIPAA administrative simplification provision in which it is established that the covered entity or business associate did not know and by exercising reasonable diligence, would not have known that the covered entity or business associate violated such a provision

2024

Minimum

2024

141

145

Maximum

2024

71,162

73,011

Calendar Year Cap

2024

2,134,831

2,190,294

45 CFR 160.404(b)(2)(ii)(A), (B)

OCR

Penalty for each February 18, 2009 or later violation of a HIPAA administrative simplification provision in which it is established that the violation was due to reasonable cause and not to willful neglect

2024

Minimum

2024

1,424

1,461

Maximum

2024

71,162

73,011

Calendar Year Cap

2024

2,134,831

2,190,294

45 CFR 160.404(b)(2)(iii)(A), (B)

OCR

Penalty for each February 18, 2009 or later violation of a HIPAA administrative simplification provision in which it is established that the violation was due to willful neglect and was corrected during the 30-day period beginning on the first date the covered entity or business associate knew, or, by exercising reasonable diligence, would have known that the violation occurred

2024

Minimum

2024

14,232

14,602

Maximum

2024

71,162

73,011

Calendar Year Cap

2024

2,134,831

2,190,294

45 CFR 160.404(b)(2)(iv)(A), (B)

OCR

Penalty for each February 18, 2009 or later violation of a HIPAA administrative simplification provision in which it is established that the violation was due to willful neglect and was not corrected during the 30-day period beginning on the first date the covered entity or business associate knew, or, by exercising reasonable diligence, would have known that the violation occurred

2024

Minimum

2024

71,162

73,011

Maximum

2024

2,134,831

2,190,294

Calendar Year Cap

2024

2,134,831

2,190,294

290dd-2(f)

42 CFR 2.3(a) and (c)

OCR

Penalty for each violation of a 42 CFR part 2 provision in which it is established that the person did not know and by exercising reasonable diligence, would not have known that the person violated such a provision

2024

Minimum

2024

100

103

Maximum

2024

50,000

51,299

Calendar Year Cap

2024

1,500,000

1,538,970

42 CFR 2.3(a) and (c)

OCR

Penalty for each violation of a 42 CFR part 2 provision in which it is established that the violation was due to reasonable cause and not to willful neglect

2024

Minimum

2024

1,000

1,026

Maximum

2024

50,000

51,299

Calendar Year Cap

2024

1,500,000

1,538,970

42 CFR 2.3(a) and (c)

OCR

Penalty for each violation of a 42 CFR part 2 provision in which it is established that the violation was due to willful neglect and was corrected during the 30-day period beginning on the first date the person knew, or, by exercising reasonable diligence, would have known that the violation occurred

2024

Minimum

2024

10,000

10,260

Maximum

2024

50,000

51,299

Calendar Year Cap

2024

1,500,000

1,538,970

42 CFR 2.3(a) and (c)

OCR

Penalty for each violation of a 42 CFR part 2 provision in which it is established that the violation was due to willful neglect and was not corrected during the 30-day period beginning on the first date the person knew, or, by exercising reasonable diligence, would have known that the violation occurred

2024

Minimum

2024

50,000

51,299

Maximum

2024

1,500,000

1,538,970

Calendar Year Cap

2024

1,500,000

1,538,970

42 U.S.C. 300gg-18, 42 U.S.C. 1302

45 CFR 180.90

CMS

Penalty for a hospital's non-compliance with making public standard charges for hospital items and services

2024

333

342

Per Day (Maximum)

2024

6,118

6,277

45 CFR 180.90(c)(2)(i)

CMS

Applicable solely to CY 2021 penalties, per day penalty for a hospital's noncompliance with making public standard charges for hospital items and services

2024

339

348

45 CFR 180.90(c)(2)(ii)(A)

CMS

Per day penalty for hospitals with equal to or less than 30 beds

2024

333

342

45 CFR 180.90(c)(2)(ii)(B)

CMS

Per day, per bed penalty for hospitals having at least 31 and up to and including 550 beds

2024

11

11

45 CFR 180.90(c)(2)(ii)(C)

CMS

Per day penalty for hospitals having greater than 550 beds

2024

6,118

6,277

CARES Act, Public Law 116-136, section 3202(b)(2)

45 CFR 182.70

CMS

Penalty for a provider's non-compliance with price transparency requirements regarding diagnostic tests for COVID-19

2024

Per Day (Maximum)

2024

N/A

N/A

263a(h)(2)(B) & 1395w-2(b)(2)(A)(ii)

42 CFR 493.1834(d)(2)(i)

CMS

Penalty for a clinical laboratory's failure to meet participation and certification requirements and poses immediate jeopardy

2024

Minimum

2024

7,807

8,010

Maximum

2024

25,597

26,262

42 CFR 493.1834(d)(2)(ii).

CMS

Penalty for a clinical laboratory's failure to meet participation and certification requirements and the failure does not pose immediate jeopardy

2024

Minimum

2024

129

132

Maximum

2024

7,678

7,877

42 CFR 493.1834(d)(2)(iii)

CMS

Penalty for a clinical laboratory's failure to meet SARS-CoV-2 test reporting requirements

2024

First day of noncompliance

2024

Each additional day of noncompliance

2024

300gg-15(f)

45 CFR 147.200(e)

CMS

Failure to provide the Summary of Benefits and Coverage

2024

1,406

1,443

300gg-18

45 CFR 158.606

CMS

Penalty for violations of regulations related to the medical loss ratio reporting and rebating

2024

140

144

45 CFR 180.70

CMS

Penalty against hospital identified by CMS as noncompliant according to § 182.50 with respect to price transparency requirements regarding diagnostic tests for COVID-19

2024

42 U.S.C. 300gg-118 note, 300gg-134

CMS

Penalties for failure to comply with No Surprises Act requirements on providers, facilities, providers of air ambulance services

2024

11,816

12,123

1320a-7h(b)(1)

42 CFR 402.105(d)(5), 42 CFR 403.912(a) & (c)

CMS

Penalty for manufacturer or group purchasing organization failing to report information required under 42 U.S.C. 1320a-7h(a), relating to physician ownership or investment interests

2024

Minimum

2024

1,406

1,443

Maximum

2024

14,067

14,432

Calendar Year Cap

2024

211,008

216,490

1320a-7h(b)(2)

42 CFR 402.105(h), 42 CFR 403.912(b) & (c)

CMS

Penalty for manufacturer or group purchasing organization knowingly failing to report information required under 42 U.S.C. 1320a-7h(a), relating to physician ownership or investment interests

2024

Minimum

2024

14,067

14,432

Maximum

2024

140,674

144,329

Calendar Year Cap

2024

1,406,728

1,443,275

1320a-7j(h)(3)(A)

CMS

Maximum penalty for an administrator of a facility that fails to comply with notice requirements for the closure of a facility

2024

140,674

144,329

1320a-7j(h)(3)(A)

42 CFR 488.446(a)(1), (2), & (3)

CMS

Minimum penalty for the first offense of an administrator who fails to provide notice of facility closure

2024

703

721

Minimum penalty for the second offense of an administrator who fails to provide notice of facility closure

2024

2,111

2,166

Minimum penalty for the third and subsequent offenses of an administrator who fails to provide notice of facility closure

2024

4,219

4,329

1320a-8(a)(1)

CMS

Penalty for an entity knowingly making a false statement or representation of material fact in the determination of the amount of benefits or payments related to old-age, survivors, and disability insurance benefits, special benefits for certain World War II veterans, or supplemental security income for the aged, blind, and disabled

2024

10,289

10,556

Penalty for violation of 42 U.S.C. 1320a-8(a)(1) if the violator is a person who receives a fee or other income for services performed in connection with determination of the benefit amount or the person is a physician or other health care provider who submits evidence in connection with such a determination

2024

9,704

9,956

1320a-8(a)(3)

CMS

Penalty for a representative payee (under 42 U.S.C. 405(j), 1007, or 1383(a)(2)) converting any part of a received payment from the benefit programs described in the previous civil monetary penalty to a use other than for the benefit of the beneficiary

2024

8,058

8,267

1320b-25(c)(1)(A)

CMS

Penalty for failure of covered individuals to report to the Secretary and 1 or more law enforcement officials any reasonable suspicion of a crime against a resident, or individual receiving care, from a long-term care facility

2024

281,346

288,655

1320b-25(c)(2)(A)

CMS

Penalty for failure of covered individuals to report to the Secretary and 1 or more law enforcement officials any reasonable suspicion of a crime against a resident, or individual receiving care, from a long-term care facility if such failure exacerbates the harm to the victim of the crime or results in the harm to another individual

2024

422,017

432,981

1320b-25(d)(2)

CMS

Penalty for a long-term care facility that retaliates against any employee because of lawful acts done by the employee, or files a complaint or report with the State professional disciplinary agency against an employee or nurse for lawful acts done by the employee or nurse

2024

281,346

288,655

1395b-7(b)(2)(B)

42 CFR 402.105(g)

CMS

Penalty for any person who knowingly and willfully fails to furnish a beneficiary with an itemized statement of items or services within 30 days of the beneficiary's request

2024

190

195

1395i-3(h)(2)(B)(ii)(I)

42 CFR 488.408(d)(1)(iii)

CMS

Penalty per day for a Skilled Nursing Facility that has a Category 2 violation of certification requirements

2024

Minimum

2024

133

136

Maximum

2024

8,003

8,211

42 CFR 488.408(d)(1)(iv)

CMS

Penalty per instance of Category 2 noncompliance by a Skilled Nursing Facility

2024

Minimum

2024

2,670

2,739

Maximum

2024

26,685

27,378

42 CFR 488.408(e)(1)(iii)

CMS

Penalty per day for a Skilled Nursing Facility that has a Category 3 violation of certification requirements

2024

Minimum

2024

8,140

8,351

Maximum

2024

26,685

27,378

42 CFR 488.408(e)(1)(iv)

CMS

Penalty per instance of Category 3 noncompliance by a Skilled Nursing Facility

2024

Minimum

2024

2,670

2,739

Maximum

2024

26,685

27,378

42 CFR 488.408(e)(2)(ii)

CMS

Penalty per day and per instance for a Skilled Nursing Facility that has Category 3 noncompliance with Immediate Jeopardy

2024

0

Per Day (Minimum)

2024

8,140

8,351

Per Day (Maximum)

2024

26,685

27,378

Per Instance (Minimum)

2024

2,670

2,739

Per Instance (Maximum)

2024

26,685

27,378

42 CFR 488.438(a)(1)(i)

CMS

Penalty per day of a Skilled Nursing Facility that fails to meet certification requirements. These amounts represent the upper range per day

2024

0

Minimum

2024

8,140

8,351

Maximum

2024

26,685

27,378

42 CFR 488.438(a)(1)(ii)

CMS

Penalty per day of a Skilled Nursing Facility that fails to meet certification requirements. These amounts represent the lower range per day

2024

0

Minimum

2024

133

136

Maximum

2024

8,003

8,211

42 CFR 488.438(a)(2)

CMS

Penalty per instance of a Skilled Nursing Facility that fails to meet certification requirements

2024

0

Minimum

2024

2,670

2,739

Maximum

2024

26,685

27,378

42 CFR 488.447

CMS

Penalty imposed for failure to comply with infection control weekly reporting requirements at 42 CFR 483.80(g)(1) and (2)

2024

First occurrence

2024

1,196

1,227

Incremental increases for each subsequent occurrence

2024

598

614

1395i-6(c)(5)(B)(i)

42 CFR 488.1245

CMS

Penalty for noncompliance by hospice program with requirements specified in section 1395x(dd) of 42 U.S.C.

2024

11,124

11,413

42 CFR 488.1245(b)(2)(iii)

CMS

Adjustment to penalties. Maximum penalty assessment for each day a hospice is not in substantial compliance with one or more conditions of participation

2024

11,124

11,413

42 CFR 488.1245(b)(3)

CMS

Penalty imposed for hospice condition-level deficiency that is immediate jeopardy. These amounts represent the upper range of penalty

2024

Minimum

2024

9,455

9,701

Maximum

2024

11,124

11,413

42 CFR 488.1245(b)(3)(i)

CMS

Penalty imposed for hospice condition-level deficiency that is immediate jeopardy. These amounts represent the upper range of penalty

2024

11,124

11,413

42 CFR 488.1245(b)(3)(ii)

CMS

Penalty imposed for hospice condition-level deficiency that is immediate jeopardy. These amounts represent the upper range of penalty

2024

10,011

10,271

42 CFR 488.1245(b)(3)(iii)

CMS

Penalty imposed for hospice condition-level deficiency that is immediate jeopardy. These amounts represent the upper range of penalty

2024

9,455

9,701

42 CFR 488.1245(b)(4)

CMS

Penalty imposed for hospice repeat or condition-level deficiency or both that does not constitute immediate jeopardy but is directly related to poor quality patient care outcomes. These amounts represent the middle range of penalty

2024

Minimum

2024

1,668

1,711

Maximum

2024

9,455

9,701

42 CFR 488.1245(b)(5)

CMS

Penalty imposed for hospice repeat or condition-level deficiency or both that does not constitute immediate jeopardy and are related predominantly to structure or process-oriented conditions rather than directly related to patient outcomes. These amounts represent the lower range of penalty

2024

Minimum

2024

556

570

Maximum

2024

4,450

4,566

42 CFR 488.1245(b)(6)

CMS

Penalty range imposed for per instance of hospice noncompliance

2024

Minimum

2024

1,112

1,141

Maximum

2024

11,124

11,413

42 CFR 488.1245(d)(1)(ii)

CMS

Penalty for each per instance of hospice noncompliance, maximum per day per hospice program

2024

11,124

11,413

2024

1395l(h)(5)(D)

42 CFR 402.105(d)(2)(i)

CMS

Penalty for knowingly, willfully, and repeatedly billing for a clinical diagnostic laboratory test other than on an assignment-related basis. (Penalties are assessed in the same manner as 42 U.S.C. 1395u(j)(2)(B), which is assessed according to 1320a-7a(a))

2024

19,435

19,940

1395l(i)(6)

CMS

Penalty for knowingly and willfully presenting or causing to be presented a bill or request for payment for an intraocular lens inserted during or after cataract surgery for which the Medicare payment rate includes the cost of acquiring the class of lens involved

2024

5,121

5,254

1395l(q)(2)(B)(i)

42 CFR 402.105(a)

CMS

Penalty for knowingly and willfully failing to provide information about a referring physician when seeking payment on an unassigned basis

2024

4,899

5,026

1395m(a)(11)(A)

42 CFR 402.1(c)(4), 402.105(d)(2)(ii)

CMS

Penalty for any durable medical equipment supplier that knowingly and willfully charges for a covered service that is furnished on a rental basis after the rental payments may no longer be made. (Penalties are assessed in the same manner as 42 U.S.C. 1395u(j)(2)(B), which is assessed according to 1320a-7a(a))

2024

19,435

19,940

1395m(a)(18)(B)

42 CFR 402.1(c)(5), 402.105(d)(2)(iii)

CMS

Penalty for any nonparticipating durable medical equipment supplier that knowingly and willfully fails to make a refund to Medicare beneficiaries for a covered service for which payment is precluded due to an unsolicited telephone contact from the supplier. (Penalties are assessed in the same manner as 42 U.S.C. 1395u(j)(2)(B), which is assessed according to 1320a-7a(a))

2024

19,435

19,940

1395m(b)(5)(C)

42 CFR 402.1(c)(6), 402.105(d)(2)(iv)

CMS

Penalty for any nonparticipating physician or supplier that knowingly and willfully charges a Medicare beneficiary more than the limiting charge for radiologist services. (Penalties are assessed in the same manner as 42 U.S.C. 1395u(j)(2)(B), which is assessed according to 1320a-7a(a))

2024

19,435

19,940

1395m(h)(3)

42 CFR 402.1(c)(8), 402.105(d)(2)(vi)

CMS

Penalty for any supplier of prosthetic devices, orthotics, and prosthetics that knowing and willfully charges for a covered prosthetic device, orthotic, or prosthetic that is furnished on a rental basis after the rental payment may no longer be made. (Penalties are assessed in the same manner as 42 U.S.C. 1395m(a)(11)(A), that is in the same manner as 1395u(j)(2)(B), which is assessed according to 1320a-7a(a))

2024

19,435

19,940

1395m(j)(2)(A)(iii)

CMS

Penalty for any supplier of durable medical equipment including a supplier of prosthetic devices, prosthetics, orthotics, or supplies that knowingly and willfully distributes a certificate of medical necessity in violation of Section 1834(j)(2)(A)(i) of the Act or fails to provide the information required under Section 1834(j)(2)(A)(ii) of the Act

2024

2,058

2,111

1395m(j)(4)

42 CFR 402.1(c)(10), 402.105(d)(2)(vii)

CMS

Penalty for any supplier of durable medical equipment, including a supplier of prosthetic devices, prosthetics, orthotics, or supplies that knowingly and willfully fails to make refunds in a timely manner to Medicare beneficiaries for series billed other than on as assignment-related basis under certain conditions. (Penalties are assessed in the same manner as 42 U.S.C. 1395m(j)(4) and 1395u(j)(2)(B), which is assessed according to 1320a-7a(a))

2024

19,435

19,940

1395m-1(a)

42 CFR. 414.504(e)

CMS

Penalty for an applicable entity that has failed to report or made a misrepresentation or omission in reporting applicable information with respect to a clinical diagnostic laboratory test

2024

12,958

13,295

42 CFR 402.1(c)(31), 402.105(d)(3)

CMS

Penalty for any person or entity who knowingly and willfully bills or collects for any outpatient therapy services or comprehensive outpatient rehabilitation services on other than an assignment-related basis. (Penalties are assessed in the same manner as 42 U.S.C. 1395m(k)(6) and 1395u(j)(2)(B), which is assessed according to 1320a-7a(a))

2024

19,435

19,940

1395m(l)(6)

42 CFR 402.1(c)(32), 402.105(d)(4)

CMS

Penalty for any supplier of ambulance services who knowingly and willfully fills or collects for any services on other than an assignment-related basis. (Penalties are assessed in the same manner as 42 U.S.C. 1395u(b)(18)(B), which is assessed according to 1320a-7a(a))

2024

19,435

19,940

1395u(b)(18)(B)

42 CFR 402.1(c)(11), 402.105(d)(2)(viii)

CMS

Penalty for any practitioner specified in Section 1842(b)(18)(C) of the Act or other person that knowingly and willfully bills or collects for any services by the practitioners on other than an assignment-related basis. (Penalties are assessed in the same manner as 42 U.S.C. 1395u(j)(2)(B), which is assessed according to 1320a-7a(a))

2024

19,435

19,940

1395u(j)(2)(B)

42 CFR 402.1(c)

CMS

Penalty for any physician who charges more than 125% for a non-participating referral. (Penalties are assessed in the same manner as 42 U.S.C. 1320a-7a(a))

2024

19,435

19,940

1395u(k)

42 CFR 402.1(c)(12), 402.105(d)(2)(ix) 1834A(a)(9) and 42 CFR 414.504(e)

CMS

Penalty for any physician who knowingly and willfully presents or causes to be presented a claim for bill for an assistant at a cataract surgery performed on or after March 1, 1987, for which payment may not be made because of section 1862(a)(15). (Penalties are assessed in the same manner as 42 U.S.C. 1395u(j)(2)(B), which is assessed according to 1320a-7a(a))

2024

19,435

19,940

1395u(l)(3)

42 CFR 402.1(c)(13), 402.105(d)(2)(x)

CMS

Penalty for any nonparticipating physician who does not accept payment on an assignment-related basis and who knowingly and willfully fails to refund on a timely basis any amounts collected for services that are not reasonable or medically necessary or are of poor quality under 1842(l)(1)(A). (Penalties are assessed in the same manner as 42 U.S.C. 1395u(j)(2)(B), which is assessed according to 1320a-7a(a))

2024

19,435

19,940

1395u(m)(3)

42 CFR 402.1(c)(14), 402.105(d)(2)(xi)

CMS

Penalty for any nonparticipating physician charging more than $500 who does not accept payment for an elective surgical procedure on an assignment related basis and who knowingly and willfully fails to disclose the required information regarding charges and coinsurance amounts and fails to refund on a timely basis any amount collected for the procedure in excess of the charges recognized and approved by the Medicare program. (Penalties are assessed in the same manner as 42 U.S.C. 1395u(j)(2)(B), which is assessed according to 1320a-7a(a))

2024

19,435

19,940

1395u(n)(3)

42 CFR 402.1(c)(15), 402.105(d)(2)(xii)

CMS

Penalty for any physician who knowingly, willfully, and repeatedly bills one or more beneficiaries for purchased diagnostic tests any amount other than the payment amount specified by the Act. (Penalties are assessed in the same manner as 42 U.S.C. 1395u(j)(2)(B), which is assessed according to 1320a-7a(a))

2024

19,435

19,940

1395u(o)(3)(B)

42 CFR 414.707(b)

CMS

Penalty for any practitioner specified in Section 1842(b)(18)(C) of the Act or other person that knowingly and willfully bills or collects for any services pertaining to drugs or biologics by the practitioners on other than an assignment-related basis. (Penalties are assessed in the same manner as 42 U.S.C. 1395u(b)(18)(B) and 1395u(j)(2)(B), which is assessed according to 1320a-7a(a))

2024

19,435

19,940

1395u(p)(3)(A)

CMS

Penalty for any physician or practitioner who knowingly and willfully fails promptly to provide the appropriate diagnosis codes upon CMS or Medicare administrative contractor request for payment or bill not submitted on an assignment-related basis

2024

5,121

5,254

1395w-3a(d)(4)(A)

42 CFR 414.806

CMS

Penalty for a pharmaceutical manufacturer's misrepresentation of average sales price of a drug, or biologic

2024

16,630

17,062

1395w-4(g)(1)(B)

42 CFR 402.1(c)(17), 402.105(d)(2)(xiii)

CMS

Penalty for any nonparticipating physician, supplier, or other person that furnishes physician services not on an assignment-related basis who either knowingly and willfully bills or collects in excess of the statutorily-defined limiting charge or fails to make a timely refund or adjustment. (Penalties are assessed in the same manner as 42 U.S.C. 1395u(j)(2)(B), which is assessed according to 1320a-7a(a))

2024

19,435

19,940

1395w-4(g)(3)(B)

42 CFR 402.1(c)(18), 402.105(d)(2)(xiv)

CMS

Penalty for any person that knowingly and willfully bills for statutorily defined State-plan approved physicians' services on any other basis than an assignment-related basis for a Medicare/Medicaid dual eligible beneficiary. (Penalties are assessed in the same manner as 42 U.S.C. 1395u(j)(2)(B), which is assessed according to 1320a-7a(a))

2024

19,435

19,940

1395w-27(g)(3)(A); 1857(g)(3); 1860D-12(b)(3)(E)

42 CFR 422.760(b); 42 CFR 423.760(b)

CMS

Penalty for each termination determination the Secretary makes that is the result of actions by a Medicare Advantage organization or Part D sponsor that has adversely affected (or has the substantial likelihood of adversely affecting) an individual covered under the organization's contract

2024

47,596

48,833

1395w-27(g)(3)(B); 1857(g)(3); 1860D-12(b)(3)(E)

CMS

Penalty for each week beginning after the initiation of civil money penalty procedures by the Secretary because a Medicare Advantage organization or Part D sponsor has failed to carry out a contract, or has carried out a contract inconsistently with regulations

2024

19,040

19,535

1395w-27(g)(3)(D); 1857(g)(3): 1860D-12(b)(3)(E)

CMS

Penalty for a Medicare Advantage organization's or Part D sponsor's early termination of its contract

2024

176,807

181,400

1395y(b)(3)(C)

42 CFR 411.103(b)

CMS

Penalty for an employer or other entity to offer any financial or other incentive for an individual entitled to benefits not to enroll under a group health plan or large group health plan which would be a primary plan

2024

11,524

11,823

1395y(b)(5)(C)(ii)

42 CFR 402.1(c)(20), 42 CFR 402.105(b)(2)

CMS

Penalty for any non-governmental employer that, before October 1, 1998, willfully or repeatedly failed to provide timely and accurate information requested relating to an employee's group health insurance coverage

2024

1,877

1,926

1395y(b)(6)(B)

42 CFR 402.1(c)(20), 402.105(a)

CMS

Penalty for any entity that knowingly, willfully, and repeatedly fails to complete a claim form relating to the availability of other health benefits in accordance with statute or provides inaccurate information relating to such on the claim form

2024

4,117

4,224

1395y(b)(7)(B)(i)

42 CFR 402.1(c)(21), 402.105(a)

CMS

Penalty for any entity serving as insurer, third party administrator, or fiduciary for a group health plan that fails to provide information that identifies situations where the group health plan is or was a primary plan to Medicare to the HHS Secretary

2024

1,474

1,512

1395y(b)(8)(E)

CMS

Penalty for any non-group health plan that fails to identify claimants who are Medicare beneficiaries and provide information to the HHS Secretary to coordinate benefits and pursue any applicable recovery claim

2024

1,474

1,512

1395nn(g)(5)

42 CFR 411.361

CMS

Penalty for any person that fails to report information required by HHS under Section 1877(f) concerning ownership, investment, and compensation arrangements

2024

24,496

25,132

1395pp(h)

42 CFR 402.1(c)(23), 402.105(d)(2)(xv)

CMS

Penalty for any durable medical equipment supplier, including a supplier of prosthetic devices, prosthetics, orthotics, or supplies, that knowingly and willfully fails to make refunds in a timely manner to Medicare beneficiaries under certain conditions. (42 U.S.C. 1395(m)(18) sanctions apply here in the same manner, which is under 1395u(j)(2) and 1320a-7a(a))

2024

19,435

19,940

1395ss(a)(2)

402.102(f)(1)

CMS

Penalty for any person that issues a Medicare supplemental policy that has not been approved by the State regulatory program or does not meet Federal standards after a statutorily defined effective date

2024

66,711

68,444

1395ss(d)(3)(A)(vi)(II)

42 CFR 402.1(c)(25), 402.105(e),402.105(f)(2)

CMS

Penalty for someone other than issuer that sells or issues a Medicare supplemental policy to beneficiary without a disclosure statement

2024

34,568

35,466

CMS

Penalty for an issuer that sells or issues a Medicare supplemental policy without disclosure statement

2024

57,617

59,114

1395ss(d)(3)(B)(iv)

CMS

Penalty for someone other than issuer that sells or issues a Medicare supplemental policy without acknowledgement form

2024

34,568

35,466

CMS

Penalty for issuer that sells or issues a Medicare supplemental policy without an acknowledgement form

2024

57,617

59,114

1395ss(p)(8)

42 CFR 402.1(c)(25), 402.105(e)

CMS

Penalty for someone other than issuer that sells or issues Medicare supplemental polices after a given date that fail to conform to the NAIC or Federal standards established by statute

2024

34,568

35,466

42 CFR 402.1(c)(25), 405402.105(f)(2)

CMS

Penalty for an issuer that sells or issues Medicare supplemental polices after a given date that fail to conform to the NAIC or Federal standards established by statute

2024

57,617

59,114

1395ss(p)(9)(C)

42 CFR 402.1(c)(26), 402.105(e), 402.105(f)(3), (4)

CMS

Penalty for someone other than issuer that sells a Medicare supplemental policy and fails to make available for sale the core group of basic benefits when selling other Medicare supplemental policies with additional benefits or fails to provide the individual, before selling the policy, an outline of coverage describing benefits

2024

34,568

35,466

42 CFR 402.105(f)(3), (4)

CMS

Penalty for an issuer that sells a Medicare supplemental policy and fails to make available for sale the core group of basic benefits when selling other Medicare supplemental policies with additional benefits or fails to provide the individual, before selling the policy, an outline of coverage describing benefits

2024

57,617

59,114

1395ss(q)(5)(C)

42 CFR 402.105(f)(5)

CMS

Penalty for any person that fails to suspend the policy of a policyholder made eligible for medical assistance or automatically reinstates the policy of a policyholder who has lost eligibility for medical assistance, under certain circumstances

2024

57,617

59,114

1395ss(r)(6)(A)

42 CFR 402.105(f)(6)

CMS

Penalty for any person that fails to provide refunds or credits as required by section 1882(r)(1)(B)

2024

57,617

59,114

1395ss(s)(4)

42 CFR 402.1(c)(29), 402.105(c)

CMS

Penalty for any issuer of a Medicare supplemental policy that does not waive listed time periods if they were already satisfied under a proceeding Medicare supplemental policy, or denies a policy, or conditions the issuances or effectiveness of the policy, or discriminates in the pricing of the policy base on health status or other specified criteria

C2024

24,460

25,095

1395ss(t)(2)

42 CFR 402.1(c)(30), 402.105(f)(7)

CMS

Penalty for any issuer of a Medicare supplemental policy that fails to fulfill listed responsibilities

2024

57,617

59,114

1395ss(v)(4)(A)

CMS

Penalty someone other than issuer who sells, issues, or renews a medigap Rx policy to an individual who is a Part D enrollee

2024

24,946

25,594

CMS

Penalty for an issuer who sells, issues, or renews a Medigap Rx policy who is a Part D enrollee

2024

41,577

42,657

1395bbb(c)(1)

42 CFR 488.725(c)

CMS

Penalty for any individual who notifies or causes to be notified a home health agency of the time or date on which a survey of such agency is to be conducted

2024

5,339

5,478

1395bbb(f)(2)(A)(i)

42 CFR 488.845(b)(2)(iii) 42 CFR 488.845(b)(3)-(6); and 42 CFR 488.845(d)(1)(ii)

CMS

Maximum daily penalty amount for each day a home health agency is not in compliance with statutory requirements

2024

25,597

26,262

42 CFR 488.845(b)(3)

CMS

Penalty per day for home health agency's noncompliance (Upper Range)

2024

0

Minimum

2024

21,757

22,322

Maximum

2024

25,597

26,262

42 CFR 488.845(b)(3)(i)

CMS

Penalty for a home health agency's deficiency or deficiencies that cause immediate jeopardy and result in actual harm

2024

25,597

26,262

42 CFR 488.845(b)(3)(ii)

CMS

Penalty for a home health agency's deficiency or deficiencies that cause immediate jeopardy and result in potential for harm

2024

23,036

23,634

42 CFR 488.845(b)(3)(iii)

CMS

Penalty for an isolated incident of noncompliance in violation of established HHA policy

2024

21,757

22,322

42 CFR 488.845(b)(4)

CMS

Penalty for a repeat and/or condition-level deficiency that does not constitute immediate jeopardy, but is directly related to poor quality patient care outcomes (Lower Range)

2024

0

Minimum

2024

3,841

3,941

Maximum

2024

21,757

22,322

42 CFR 488.845(b)(5)

CMS

Penalty for a repeat and/or condition-level deficiency that does not constitute immediate jeopardy and that is related predominately to structure or process-oriented conditions (Lower Range)

2024

0

Minimum

2024

1,280

1,313

Maximum

2024

2,559

2,625

42 CFR 488.845(b)(6)

CMS

Penalty imposed for instance of noncompliance that may be assessed for one or more singular events of condition-level noncompliance that are identified and where the noncompliance was corrected during the onsite survey

2024

0

Penalty for each day of noncompliance (Minimum)

2024

2,559

2,625

Penalty for each day of noncompliance (Maximum)

2024

25,597

26,262

42 CFR 488.845(d)(1)(ii)

CMS

Penalty for each day of noncompliance (Maximum)

2024

25,597

26,262

1395eee(e)(6)(B); 1396u-4(e)(6)(B)

42 CFR 460.46

CMS

Penalty for PACE organization that discriminates in enrollment or disenrollment, or engages in any practice that would reasonably be expected to have the effect of denying or discouraging enrollment, on the basis of health status or the need for services

2024

47,596

48,833

CMS

For each individual not enrolled as a result of the PACE organization's discrimination in enrollment or disenrollment or practice that would deny or discourage enrollment

2024

Minimum

2024

17,933

18,399

Maximum

2024

119,555

122,661

CMS

Penalty for a PACE organization that charges excessive premiums

2024

47,596

48,833

CMS

Penalty for a PACE organization misrepresenting or falsifying information to CMS or the State

2024

190,389

195,335

CMS

Penalty for any other violation specified in 42 CFR 460.40

2024

47,596

48,833

1396r(h)(3)(C)(ii)(I)

42 CFR 488.408(d)(1)(iii)

CMS

Penalty per day for a nursing facility's failure to meet a Category 2 Certification

2024

0

Minimum

2024

133

136

Maximum

2024

8,003

8,211

42 CFR 488.408(d)(1)(iv)

CMS

Penalty per instance for a nursing facility's failure to meet Category 2 certification

2024

Minimum

2024

2,670

2,739

Maximum

2024

26,685

27,378

42 CFR 488.408(e)(1)(iii)

CMS

Penalty per day for a nursing facility's failure to meet Category 3 certification

2024

Minimum

2024

8,140

8,351

Maximum

2024

26,685

27,378

42 CFR 488.408(e)(1)(iv)

CMS

Penalty per instance for a nursing facility's failure to meet Category 3 certification

2024

0

Minimum

2024

2,670

2,739

Maximum

2024

26,685

27,378

42 CFR 488.408(e)(2)(ii)

CMS

Penalty per instance for a nursing facility's failure to meet Category 3 certification, which results in immediate jeopardy

2024

0

Minimum

2024

2,670

2,739

Maximum

2024

26,685

27,378

42 CFR 488.438(a)(1)(i)

CMS

Penalty per day for nursing facility's failure to meet certification (Upper Range)

2024

0

Minimum

2024

8,140

8,351

Maximum

2024

26,685

27,378

42 CFR 488.438(a)(1)(ii)

CMS

Penalty per day for nursing facility's failure to meet certification (Lower Range)

2024

0

Minimum

2024

133

136

Maximum

2024

8,003

8,211

42 CFR 488.438(a)(2)

CMS

Penalty per instance for nursing facility's failure to meet certification

2024

0

Minimum

2024

2,670

2,739

Maximum

2024

26,685

27,378

42 CFR 488.447

CMS

Penalty imposed for failure to comply with infection control weekly reporting requirements at 42 CFR 483.80(g)(1) and (2)

2024

First occurrence (Minimum)

2024

1,196

1,227

Incremental increases for each subsequent occurrence

2024

598

614

1396r(f)(2)(B)(iii)(I)(c)

42 CFR 483.151(b)(2)(iv) and (b)(3)(iii)

CMS

Grounds to prohibit approval of Nurse Aide Training Program—if assessed a penalty in 1819(h)(2)(B)(i) or 1919(h)(2)(A)(ii) of “not less than $5,000” [Not CMP authority, but a specific CMP amount (CMP at this level) that is the triggering condition for disapproval]

2024

13,343

13,690

1396r(h)(3)(C)(ii)(I)

42 CFR 483.151(c)(2)

CMS

Grounds to waive disapproval of nurse aide training program—reference to disapproval based on imposition of CMP “not less than $5,000” [Not CMP authority but CMP imposition at this level determines eligibility to seek waiver of disapproval of nurse aide training program]

2024

13,343

13,690

1396t(j)(2)(C)

CMS

Penalty for each day of noncompliance for a home or community care provider that no longer meets the minimum requirements for home and community care

2024

0

Minimum

2024

2

2

Maximum

2024

23,048

23,647

1396u-2(e)(2)(A)(i)

42 CFR 438.704

CMS

Penalty for a Medicaid managed care organization that fails substantially to provide medically necessary items and services

2024

47,596

48,833

CMS

Penalty for Medicaid managed care organization that imposes premiums or charges on enrollees in excess of the premiums or charges permitted

2024

47,596

48,833

CMS

Penalty for a Medicaid managed care organization that misrepresents or falsifies information to another individual or entity

2024

47,596

48,833

CMS

Penalty for a Medicaid managed care organization that fails to comply with the applicable statutory requirements for such organizations.

2024

47,596

48,833

1396u-2(e)(2)(A)(ii)

42 CFR 438.704

CMS

Penalty for a Medicaid managed care organization that misrepresents or falsifies information to the HHS Secretary

2024

190,389

195,335

CMS

Penalty for Medicaid managed care organization that acts to discriminate among enrollees on the basis of their health status

2024

190,389

195,335

1396u-2(e)(2)(A)(iv)

42 CFR 438.704

CMS

Penalty for each individual that does not enroll as a result of a Medicaid managed care organization that acts to discriminate among enrollees on the basis of their health status

2024

28,557

29,299

1396u(h)(2)

42 CFR Part 441, Subpart I

CMS

Penalty for a provider not meeting one of the requirements relating to the protection of the health, safety, and welfare of individuals receiving community supported living arrangements services

2024

26,685

27,378

1396w-2(c)(1)

42 U.S.C. 300gg-22(b)(2)(C)(i) 45 CFR 150.315

CMS

Penalty for each day, for each individual affected by the failure of a health insurance issuer or non-Federal governmental group health plan to comply with federal market reform provisions in part A or D of title XXVII of the PHS Act|2022|174|177

2024

14,232

14,602

18041(c)(2)

45 CFR 156.805(c)

CMS

Failure to comply with ACA requirements related to risk adjustment, reinsurance, risk corridors, Exchanges (including QHP standards) and other ACA Subtitle D standards; Penalty for violations of rules or standards of behavior associated with issuer compliance with risk adjustment, reinsurance, risk corridors, Exchanges (including QHP standards) and other ACA Subtitle D standards

2024

193

198

42 U.S.C. 300gg-22(b)(2)(C)(i)

45 CFR 150.315

CMS

Penalty for each day, for each individual affected by the failure of a health insurance issuer or non-Federal governmental group health plan to comply with federal market reform provisions in part A or D of title XXVII of the PHS Act

2024

183

188

18081(h)(1)(A)(i)(II)

45 CFR 155.285

CMS

Penalty for providing false information on Exchange application

2024

35,169

36,083

18081(h)(1)(B)

45 CFR 155.285

CMS

Penalty for knowingly or willfully providing false information on Exchange application

2024

351,681

360,818

18081(h)(2)

45 CFR 155.260

CMS

Penalty for knowingly or willfully disclosing protected information from Exchange

2024

0

CMS

Maximum

2024

35,169

36,083

CMS

Minimum

2024

359

368

18041(c)(2)

45 CFR 155.206(i)

CMS

Penalties for violation of applicable Exchange standards by consumer assistance entities in Federally-facilitated Exchanges

2024

43,128

44,248

Maximum (Per Day)

2024

119

122

31 U.S.C

45 CFR 93.400(e)

HHS

2024

359

368

Penalty for the first time an individual makes an expenditure prohibited by regulations regarding lobbying disclosure, absent aggravating circumstances

2024

24,496

25,132

Penalty for second and subsequent offenses by individuals who make an expenditure prohibited by regulations regarding lobbying disclosure

2024

0

Minimum

2024

24,496

25,132

Maximum

2024

244,958

251,322

1352

HHS

Penalty for the first time an individual fails to file or amend a lobbying disclosure form, absent aggravating circumstances

2024

24,496

25,132

Penalty for second and subsequent offenses by individuals who fail to file or amend a lobbying disclosure form, absent aggravating circumstances

2024

0

Minimum

2024

24,496

25,132

Maximum

2024

244,958

251,322

45 CFR Part 93, Appendix A

HHS

Penalty for failure to provide certification regarding lobbying in the award documents for all sub-awards of all tiers

2024

0

Minimum

2024

24,496

25,132

Maximum

2024

244,958

251,322

HHS

Penalty for failure to provide statement regarding lobbying for loan guarantee and loan insurance transactions

2024

0

Minimum

2024

24,496

25,132

Maximum

2024

244,958

251,322

3801-3812

45 CFR 79.3(a)(1)(iv)

HHS

Penalty against any individual who—with knowledge or reason to know—makes, presents or submits a false, fictitious or fraudulent claim to the Department

2024

12,800

13,133

45 CFR 79.3(b)(1)(ii)

HHS

Penalty against any individual who—with knowledge or reason to know—makes, presents or submits a false, fictitious or fraudulent claim to the Department

2024

12,800

13,133

1 Some HHS components have not promulgated regulations regarding their civil monetary penalty-specific statutory authorities.

2 The description is not intended to be a comprehensive explanation of the underlying violation; the statute and corresponding regulation, if applicable, should be consulted.

3 Statutory or Inflation Act Adjustment.

4 OMB Memorandum M-16-06, Implementation of the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015, published February 24, 2016, guided agencies on initial “catch-up” adjustment requirements, and M-17-11, Implementation of the 2017 annual adjustment pursuant to the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015, published December 16, 2016; followed by M-18-03, M-19-04, M-20-05, M-21-10, M-22-07, M-23-05, M-24-07, and M-25-02 guided agencies on annual adjustment requirements.

5 OMB Circular A-136, Financial Reporting Requirements, Section II.4.9, directs that agencies must make annual inflation adjustments to civil monetary penalties and report on the adjustments in the Agency Financial Report (AFR) or Performance and Accountability Report (PAR).

6 Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015, § 701(b)(1)(A) (codified as amended at 28 U.S.C. 2461 note).

7 Annual inflation adjustments are based on the percent change between each published October's CPI-U. In this case, October 2024 CPI-U (315.664) / October 2023 CPI-U (307.671) = 1.02598.

3 sections

Cite this law

ADJUSTMENT OF CIVIL MONETARY PENALTIES FOR INFLATION (U.S.C.). Retrieved via LawPlayer, https://lawplayer.com/us/act/cfr-title-45-part-102

United States government works (U.S. Code, Code of Federal Regulations) are in the public domain under 17 U.S.C. § 105.

US-Gov-PublicDomain

本頁資料來源:GPO govinfo / eCFR·整理提供:法律人 LawPlayer· lawplayer.com