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.
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ADJUSTMENT OF CIVIL MONETARY PENALTIES FOR INFLATION
The increased penalty amounts set forth in the right-most column of the table in Section 102.3, “Maximum Adjusted Penalty ($)”, apply to all civil monetary penalties which are assessed after August 1, 2016, including those penalties whose associated violations occurred after November 2, 2015.
The adjusted statutory penalty provisions and their applicable amounts are set out in the following table. The right-most column in the table, “Maximum Adjusted Penalty ($)”, 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.
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
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