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 Department of Health and Human Services 45 CFR Part 102
RIN 0991-AC34
 AGENCY: Office of the Assistant Secretary for Financial Resources, Department of Health and Human Services.
 ACTION: Final rule.
 SUMMARY: The Department of Health and Human Services (HHS) is updating its regulations to reflect required annual inflation-related increases to the civil monetary penalty (CMP) amounts in its regulations, under the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 and adds references to new penalty authorities.
 DATES:  *Effective date:*
                         This final rule is effective October 6, 2023. *Applicability date:*
                         The adjusted civil monetary penalty amounts apply to penalties assessed on or after the date of publication to the 
                        **Federal Register**
                        , if the violation occurred on or after November 2, 2015.
 FOR FURTHER INFORMATION CONTACT: Katrina Brisbon, Deputy Assistant Secretary, Office of Acquisitions, Office of the Assistant Secretary for Financial Resources, Room 536-H, Hubert Humphrey Building, 200 Independence Avenue SW, Washington DC 20201; (202)260-6677.


SUPPLEMENTARY INFORMATION: I. Background The Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (section 701 of Pub. L. 114-74) (the “2015 Act”) amended the Federal Civil Penalties Inflation Adjustment Act of 1990 (Pub. L. 101-410, 104 Stat. 890 (1990)), which is intended to improve the effectiveness of CMPs and to maintain the deterrent effect of such penalties, requires agencies to adjust the CMPs for inflation annually. HHS lists the CMP authorities and the amounts administered by all of its agencies in tabular form in 45 CFR 102.3, which was issued in an interim final rule published in the September 6, 2016, 
                    **Federal Register**
                     (81 FR 61538). Annual adjustments were subsequently published on February 3, 2017 (82 FR 9175), October 11, 2018 (83 FR 51369), November 5, 2019 (84 FR 59549), January 17, 2020 (85 FR 2869), November 15, 2021 (86 FR 62928), and March 17, 2022 (87 FR 15100)
                    *.* II. Calculation of Annual Inflation Adjustment and Other Updates The annual inflation adjustment for each applicable CMP is determined using the percent increase in the Consumer Price Index for all Urban Consumers (CPI-U) for the month of October of the year in which the amount of each CMP was most recently established or modified. In the December 15, 2022, Office of Management and Budget (OMB) Memorandum for the Heads of Executive Agencies and Departments, M-23-05, “Implementation of Penalty Inflation Adjustments for 2023, Pursuant to the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015,” OMB published the multiplier for the required annual adjustment. The cost-of-living adjustment multiplier for 2023, based on the CPI-U for the month of October 2022, not seasonally adjusted, is 1.07745. The multiplier is applied to each applicable penalty amount that was updated and published for fiscal year (FY) 2022 and is rounded to the nearest dollar. In addition to the inflation adjustments for 2023, this final rule updates the table in 45 CFR 102.3 to add references to new, applicable CMP authorities that were established or implemented since the publication of the March 17, 2022, update and that are being updated in this rule. First, in the final rule, “Medicare and Medicaid Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Price Transparency of Hospital Standard Charges; Radiation Oncology Model” final rule with comment period (86 FR 63548, November 16, 2021), the Centers for Medicare & Medicaid Services (CMS) finalized a new provision, effective January 1, 2022, at 45 CFR 180.90(c)(ii) to increase the CMP amounts associated with a hospital's noncompliance with 
                    ( print page 69532)
                    price transparency disclosure and display requirements at 45 CFR 180.40, 180.50, and 180.60. Second, in the final rule, “Medicare and Medicaid Programs; CY 2022 Home Health Prospective Payment System Rate Update; Home Health Value-Based Purchasing Model Requirements and Model Expansion; Home Health and Other Quality Reporting Program Requirements; Home Infusion Therapy Services Requirements; Survey and Enforcement Requirements for Hospice Programs; Medicare Provider Enrollment Requirements; and COVID-19 Reporting Requirements for Long-Term Care Facilities” final rule (86 FR 62240, November 9, 2021), CMS finalized a new provision, effective January 1, 2022, establishing enforcement remedies for noncompliant hospice programs, including a CMP remedy at 42 CFR 488.1245. This final rule implemented Division CC, section 407 of the Consolidated Appropriations Act, 2021 which added a new section 1822 of the Social Security Act for hospice program survey and enforcement requirements, specifically authorizing the Secretary to establish CMPs in an amount not to exceed $10,000 for each day of noncompliance by a hospice program (see 42 U.S.C. 1395i-6(c)(5)(B)(i)). The table has been modified to reflect these new regulatory and statutory amounts. III. Statutory and Executive Order Reviews and Waiver of Proposed Rulemaking The 2015 Act requires Federal agencies to publish annual penalty inflation adjustments notwithstanding section 553 of the Administrative Procedure Act (APA). Section 4(a) of the 2015 Act directs Federal agencies to publish annual adjustments no later than January 15th of each year thereafter. In accordance with section 553 of the APA, most rules are subject to notice and comment and are effective no earlier than 30 days after publication in the 
                    **Federal Register**
                    . However, section 4(b)(2) of the 2015 Act provides that each agency shall make the annual inflation adjustments “notwithstanding section 553” of the APA. According to OMB's Memorandum M-23-05, the phrase “notwithstanding section 553” in section 4(b)(2) of the 2015 Act means that “the public procedure the APA generally requires—notice, an opportunity for comment, and a delay in effective date—is not required for agencies to issue regulations implementing the annual adjustment.” Consistent with the language of the 2015 Act and OMB's implementation guidance, the inflation adjustments set out in this rule are not subject to notice and an opportunity for public comment and will be effective immediately upon publication. Additionally, HHS finds that notice and comment procedures would be impracticable and unnecessary under the APA for making the statutorily required inflation updates to newly established penalty amounts. Pursuant to OMB Memorandum M-23-05, HHS has determined that the annual inflation adjustment to the civil monetary penalties in its regulations does not trigger any requirements under procedural statutes and Executive Orders that govern rulemaking procedures. IV. Effective and Applicability Dates This rule is effective on the date specified in the 
                    **DATES**
                     section of this final rule. The adjusted civil monetary penalty amounts apply to penalties assessed on or after the date specified in the 
                    **DATES**
                     section of this final rule, if the violation occurred on or after November 2, 2015. If the violation occurred before November 2, 2015, or a penalty was assessed before September 6, 2016, the pre-adjustment civil penalty amounts in effect before September 6, 2016, will apply. List of Subjects in 45 CFR Part 102 Administrative practice and procedure
Penalties
 For reasons discussed in the preamble, the Department of Health and Human Services amends subtitle A, title 45 of the Code of Federal Regulations as follows: PART 102—ADJUSTMENT OF CIVIL MONETARY PENALTIES FOR INFLATION
 1.The authority citation for part 102 continues to read as follows: Authority:
                        Pub. L. 101-410, Sec. 701 of Pub. L. 114-74, 31 U.S.C. 3801-3812. 2.Amend §  102.3 by revising table 1 to read as follows: § 102.3
  
 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
2022 
                                     Maximum  
                                     adjusted  
                                     penalty  
                                     ($)
2023 
                                     Maximum  
                                     adjusted  
                                     penalty  
                                     
                                        ($) 421 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
2022
115,054
123,965333(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
2022
2,301,065
2,479,282333(b)(3)

FDA
Penalty for failure to make a report required by 21 U.S.C. 353(d)(3)(E) relating to drug samples
2022
230,107
247,929333(f)(1)(A)

FDA
Penalty for any person who violates a requirement related to devices for each such violation
2022
31,076
33,483FDA
Penalty for aggregate of all violations related to devices in a single proceeding
2022
2,071,819
2,232,281( print page 69533)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
2022
87,362
94,128FDA
Penalty in the case of any other person (other than an individual) for such introduction or delivery of adulterated food
2022
436,809
470,640FDA
Penalty for aggregate of all such violations related to adulterated food adjudicated in a single proceeding
2022
873,618
941,280333(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)
2022
13,237
14,262333(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
2022
13,237
14,262333(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)
2022
330,948
356,580FDA
Penalty for aggregate of all such above violations in a single proceeding
2022
1,323,791
1,426,319333(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
2022
330,948
356,580FDA
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
2022
1,323,791
1,426,319FDA
Penalty for aggregate of all such above violations adjudicated in a single proceeding
2022
13,237,910
14,263,186333(f)(9)(A)

FDA
Penalty for any person who violates a requirement which relates to tobacco products for each such violation
2022
19,192
20,678FDA
Penalty for aggregate of all such violations of tobacco product requirement adjudicated in a single proceeding
2022
1,279,448
1,378,541333(f)(9)(B)(i)(I)

FDA
Penalty per violation related to violations of tobacco requirements
2022
319,863
344,636FDA
Penalty for aggregate of all such violations of tobacco product requirements adjudicated in a single proceeding
2022
1,279,448
1,378,541333(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
2022
319,863
344,636( print page 69534)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
2022
1,279,448
1,378,541FDA
Penalty for aggregate of all such violations related to tobacco product requirements adjudicated in a single proceeding
2022
12,794,487
13,785,420333(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
2022
319,863
344,636FDA
Penalty for aggregate of for all such above violations adjudicated in a single proceeding
2022
1,279,448
1,378,541333(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
2022
319,863
344,636FDA
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
2022
1,279,448
1,378,541Penalty for aggregate above tobacco product requirement violations adjudicated in a single proceeding
2022
12,794,487
13,785,420333(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
2022
330,948
356,580Penalty for each subsequent above violation in any 3-year period
2022
661,896
713,160333 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
2022
320
345FDA
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
2022
638
687FDA
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
2022
2,559
2,757FDA
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
2022
6,397
6,892( print page 69535)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
2022
12,794
13,785FDA
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
2022
320
345FDA
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
2022
638
687FDA
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
2022
1,280
1,379FDA
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
2022
2,559
2,757FDA
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
2022
6,397
6,892FDA
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
2022
12,794
13,785335b(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
2022
487,638
525,406FDA
Penalty in the case of any other person (other than an individual) per above violation
2022
1,950,548
2,101,618360pp(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
2022
3,198
3,446FDA
Penalty imposed for any related series of violations of requirements relating to electronic products
2022
1,090,241
1,174,68042 U.S.C.



2022
0262(d)

FDA
Penalty per day for violation of order of recall of biological product presenting imminent or substantial hazard
2022
250,759
270,180263b(h)(3)

FDA
Penalty for failure to obtain a mammography certificate as required
2022
19,507
21,018300aa-28(b)(1)

FDA
Penalty per occurrence for any vaccine manufacturer that intentionally destroys, alters, falsifies, or conceals any record or report required
2022
250,759
270,180256b(d)(1)(B)(vi)

HRSA
Penalty for each instance of overcharging a 340B covered entity
2022
6,323
6,813( print page 69536)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
2022
16,443
17,717653(l)(2)
45 CFR 303.21(f)
ACF
Penalty for Misuse of Information in the National Directory of New Hires
2022
1,687
1,818262a(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
2022
381,393
410,932OIG
Penalty for any other person who violates safety and security procedures related to handling dangerous biological agents and toxins
2022
762,790
821,868300jj-51

OIG
Penalty per violation for committing information blocking
2022
1,162,924
1,252,9921320a-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
2022
22,427
24,164OIG
Penalty for knowingly presenting or causing to be presented a request for payment which violates the terms of an assignment, agreement, or PPS agreement
2022
22,427
24,16442 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
2022
33,641
36,24642 CFR 1003.210(a)(3)
OIG
Penalty for an excluded party retaining ownership or control interest in a participating entity
2022
22,427
24,16442 CFR 1003.1010
OIG
Penalty for remuneration offered to induce program beneficiaries to use particular providers, practitioners, or suppliers
2022
22,427
24,16442 CFR 1003.210(a)(4)
OIG
Penalty for employing or contracting with an excluded individual
2022
22,427
24,16442 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
2022
112,131
120,81642 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
2022
22,427
24,16442 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
2022
112,131
120,81642 CFR 1003.210(a)(8)
OIG
Penalty for knowing of an overpayment and failing to report and return
2022
22,427
24,16442 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
2022
63,231
68,12842 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
2022
33,641
36,2461320a-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
2022
5,606
6,040( print page 69537)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
2022
5,606
6,04042 CFR 1003.210(a)(10)
OIG
Penalty for a physician who executes a document that falsely certifies home health needs for Medicare beneficiaries
2022
11,213
12,0811320a-7a(o)

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
2022
10,937
11,784OIG
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
2022
54,686
58,921OIG
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
2022
54,686
58,921OIG
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
2022
53,772 each false record or statement, 10,754 per day
61,458 each false record or statement, 12,308 per dayOIG
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
2022
16,406
17,6771320a-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
2022
42,788
46,1021320b-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
2022
11,506
12,3971320b-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
2022
57,527
61,9821395i-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
2022
2,400
2,5861395i-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
2022
11,995
12,924( print page 69538)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
2022
4,799
5,1711395w-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
2022
43,678
47,061OIG
Penalty for a Medicare Advantage organization that charges excessive premiums
2022
42,788
46,102OIG
Penalty for a Medicare Advantage organization that improperly expels or refuses to reenroll a beneficiary
2022
42,788
46,102OIG
Penalty for a Medicare Advantage organization that engages in practice that would reasonably be expected to have the effect of denying or discouraging enrollment
2022
171,156
184,412OIG
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
2022
25,673
27,661OIG
Penalty for a Medicare Advantage organization misrepresenting or falsifying information to Secretary
2022
171,156
184,412OIG
Penalty for a Medicare Advantage organization misrepresenting or falsifying information to individual or other entity
2022
42,788
46,102OIG
Penalty for Medicare Advantage organization interfering with provider's advice to enrollee and non-MCO affiliated providers that balance bill enrollees
2022
42,788
46,102OIG
Penalty for a Medicare Advantage organization that employs or contracts with excluded individual or entity
2022
42,788
46,102OIG
Penalty for a Medicare Advantage organization enrolling an individual in without prior written consent
2022
42,788
46,102OIG
Penalty for a Medicare Advantage organization transferring an enrollee to another plan without consent or solely for the purpose of earning a commission
2022
42,788
46,102OIG
Penalty for a Medicare Advantage organization failing to comply with marketing restrictions or applicable implementing regulations or guidance
2022
42,788
46,102OIG
Penalty for a Medicare Advantage organization employing or contracting with an individual or entity who violates 1395w-27(g)(1)(A)-(J)
2022
42,788
46,1021395w-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
2022
14,950
16,1081395cc(g)
42 CFR 1003.210(a)(5)
OIG
Penalty for improper billing by Hospitals, Critical Access Hospitals, or Skilled Nursing Facilities
2022
5,816
6,2661395dd(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
2022
119,942
129,232Penalty for a hospital with less than 100 beds dumping patients needing emergency medical care
2022
59,973
64,6181395mm(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
2022
59,973
64,618( print page 69539)OIG
Penalty for HMOs/competitive medical plans that charge premiums in excess of permitted amounts
2022
59,973
64,618OIG
Penalty for a HMO or competitive medical plan that expels or refuses to reenroll an individual per prescribed conditions
2022
59,973
64,618OIG
Penalty for a HMO or competitive medical plan that implements practices to discourage enrollment of individuals needing services in future
2022
239,885
258,464OIG
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
2022
34,517
37,190OIG
Penalty for a HMO or competitive medical plan that misrepresents or falsifies information to the Secretary
2022
239,885
258,464OIG
Penalty for a HMO or competitive medical plan that misrepresents or falsifies information to an individual or any other entity
2022
59,973
64,618OIG
Penalty for failure by HMO or competitive medical plan to assure prompt payment of Medicare risk sharing contracts or incentive plan provisions
2022
59,973
64,618OIG
Penalty for HMO that employs or contracts with excluded individual or entity
2022
55,052
59,3161395nn(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
2022
27,750
29,8991395nn(g)(4)
42 CFR 1003.310
OIG
Penalty for circumvention schemes in violation of the Stark Law's restrictions on physician self-referrals
2022
185,009
199,3381395ss(d)(1)
42 CFR 1003.1110
OIG
Penalty for a material misrepresentation regarding Medigap compliance policies
2022
11,506
12,3971395ss(d)(2)
42 CFR 1003.1110
OIG
Penalty for selling Medigap policy under false pretense
2022
11,506
12,3971395ss(d)(3)(A)(ii)
42 CFR 1003.1110
OIG
Penalty for an issuer that sells health insurance policy that duplicates benefits
2022
51,796
55,808OIG
Penalty for someone other than issuer that sells health insurance that duplicates benefits
2022
31,076
33,4831395ss(d)(4)(A)
42 CFR 1003.1110
OIG
Penalty for using mail to sell a non-approved Medigap insurance policy
2022
11,506
12,3971396b(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
2022
57,527
61,982OIG
Penalty for a Medicaid MCO that charges excessive premiums
2022
57,527
61,982OIG
Penalty for a Medicaid MCO that improperly expels or refuses to reenroll a beneficiary
2022
230,107
247,929OIG
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
2022
34,517
37,190OIG
Penalty for a Medicaid MCO misrepresenting or falsifying information to the Secretary
2022
230,107
247,929OIG
Penalty for a Medicaid MCO misrepresenting or falsifying information to an individual or another entity
2022
57,527
61,982OIG
Penalty for a Medicaid MCO that fails to comply with contract requirements with respect to physician incentive plans
2022
51,796
55,808( print page 69540)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
2022
2,400
2,5861396r(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
2022
11,995
12,9241396r(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
2022
4,799
5,1711396r-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
2022
207,183
223,2291396r-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
2022
20,719
22,3241396r-8(b)(3)(C)(ii)
42 CFR 1003.1210
OIG
Penalty for knowing provision of false information by drug manufacturer with rebate agreement
2022
207,183
223,2291396t(i)(3)(A)
42 CFR 1003.1310
OIG
Penalty for notifying home and community-based providers or settings of survey
2022
4,144
4,46511131(c)
42 CFR 1003.810
OIG
Penalty for failing to report a medical malpractice claim to National Practitioner Data Bank
2022
25,076
27,01811137(b)(2)
42 CFR 1003.810
OIG
Penalty for breaching confidentiality of information reported to National Practitioner Data Bank
2022
25,076
27,018299b-22(f)(1)
42 CFR 3.404
OCR
Penalty for violation of confidentiality provision of the Patient Safety and Quality Improvement Act
2022
13,885
14,96045 CFR 160.404(b)(1)(i), (ii)
OCR
Penalty for each pre-February 18, 2009 violation of the HIPAA administrative simplification provisions
2022
174
187Calendar Year Cap
2022
43,678
47,0611320(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:
2022Minimum
2022
127
137Maximum
2022
63,973
68,928Calendar Year Cap
2022
1,919,173
2,067,81345 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:
2022Minimum
2022
1,280
1,379Maximum
2022
63,973
68,928Calendar Year Cap
2022
1,919,173
2,067,81345 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:
2022Minimum
2022
12,794
13,785Maximum
2022
63,973
68,928Calendar Year Cap
2022
1,919,173
2,067,813( print page 69541)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:
2022Minimum
2022
63,973
68,928Maximum
2022
1,919,173
2,067,813Calendar Year Cap
2022
1,919,173
2,067,81342 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
2022
300
323Per Day (Maximum)
2022
5,500
5,92645 CFR 180.90(c)(2)(i)
CMS
Per day penalty for a hospital's noncompliance with making public standard charges for hospital items and services
2022
304
32845 CFR 180.90(c)(2)(ii)(A)
CMS
Per day penalty for hospitals with equal to or less than 30 beds
2022
300
32345 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
2022
10
1145 CFR 180.90(c)(2)(ii)(C)
CMS
Per day penalty for hospitals having greater than 550 beds
2022
5,500
5,926CARES 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
2022Per Day (Maximum)
2022
300
323263a(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:
2022Minimum
2022
7,018
7,562Maximum
2022
23,011
24,79342 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:
2022Minimum
2022
116
125Maximum
2022
6,902
7,43742 CFR 493.1834(d)(2)(iii)
CMS
Penalty for a clinical laboratory's failure to meet SARS-CoV-2 test reporting requirements:
2022First day of noncompliance
2022Each additional day of noncompliance
2022300gg-15(f)
45 CFR 147.200(e)
CMS
Failure to provide the Summary of Benefits and Coverage
2022
1,264
1,362300gg-18
45 CFR 158.606
CMS
Penalty for violations of regulations related to the medical loss ratio reporting and rebating
2022
126
13645 CFR 180.90
CMS
Price against hospital identified by CMS as noncompliant according to § 182.50 with respect to price transparency requirements regarding diagnostic tests for COVID-19
202242 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
2022
10,622
11,4451320a-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:
2022Minimum
2022
1,264
1,362Maximum
2022
12,646
13,625Calendar Year Cap
2022
189,692
204,384( print page 69542)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:
2022Minimum
2022
12,646
13,625Maximum
2022
126,463
136,258Calendar Year Cap
2022
1,264,622
1,362,567CMS
Penalty for an administrator of a facility that fails to comply with notice requirements for the closure of a facility
2022
126,463
136,2581320a-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
2022
632
681Minimum penalty for the second offense of an administrator who fails to provide notice of facility closure
2022
1,898
2,045Minimum penalty for the third and subsequent offenses of an administrator who fails to provide notice of facility closure
2022
3,793
4,0871320a-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
2022
9,250
9,966Penalty 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
2022
8,723
9,3991320a-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
2022
7,244
7,8051320b-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
2022
252,925
272,5141320b-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
2022
379,386
408,7691320b-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
2022
252,925
272,514( print page 69543)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
2022
171
1841395i-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:
2022Minimum
2022
120
129Maximum
2022
7,195
7,75242 CFR 488.408(d)(1)(iv)
CMS
Penalty per instance of Category 2 noncompliance by a Skilled Nursing Facility:
2022Minimum
2022
2,400
2,586Maximum
2022
23,989
25,84742 CFR 488.408(e)(1)(iii)
CMS
Penalty per day for a Skilled Nursing Facility that has a Category 3 violation of certification requirements:
2022Minimum
2022
7,317
7,884Maximum
2022
23,989
25,84742 CFR 488.408(e)(1)(iv)
CMS
Penalty per instance of Category 3 noncompliance by a Skilled Nursing Facility:
2022Minimum
2022
2,400
2,586Maximum
2022
23,989
25,84742 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:
2022Per Day (Minimum)
2022
7,317
7,884Per Day (Maximum)
2022
23,989
25,847Per Instance (Minimum)
2022
2,400
2,586Per Instance (Maximum)
2022
23,989
25,84742 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:
2022Minimum
2022
7,317
7,884Maximum
2022
23,989
25,84742 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:
2022Minimum
2022
120
129Maximum
2022
7,195
7,75242 CFR 488.438(a)(2)
CMS
Penalty per instance of a Skilled Nursing Facility that fails to meet certification requirements:
2022Minimum
2022
2,400
2,586Maximum
2022
23,989
25,84742 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)
2022First occurrence
2022
1,075
1,158Incremental increases for each subsequent occurrence
2022
537
5791395i-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 USC
2022
10,000
10,77542 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
2022
10,000
10,77542 CFR 488.1245(b)(3)
CMS
Penalty imposed for hospice condition-level deficiency that is immediate jeopardy. These amounts represent the upper range of penaltyCMS
Minimum
2022
8,500
9,158Maximum
2022
10,000
10,77542 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
2022
10,000
10,775( print page 69544)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
2022
9,000
9,69742 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
2022
8,500
9,15842 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
2022Minimum
2022
1,500
1,616Maximum
2022
8,500
9,15842 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
2022Minimum
2022
500
539Maximum
2022
4,000
4,31042 CFR 488.1245(b)(6)
CMS
Penalty range imposed for per instance of hospice noncompliance
2022CMS
Minimum
2022
1,000
1,077Maximum
2022
10,000
10,77542 CFR 488.1245(d)(1)(ii)
CMS
Penalty for each per instance of hospice noncompliance, maximum per day per hospice program
2022
10,000
10,7751395l(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))
2022
17,472
18,8251395l(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
2022
4,603
4,9601395l(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
2022
4,404
4,7451395m(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))
2022
17,472
18,8251395m(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))
2022
17,472
18,825( print page 69545)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))
2022
17,472
18,8251395m(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))
2022
17,472
18,8251395m(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
2022
1,850
1,9931395m(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))
2022
17,472
18,8251395m-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
2022
11,649
12,55142 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))
2022
17,472
18,8251395m(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))
2022
17,472
18,825( print page 69546)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))
2022
17,472
18,8251395u(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))
2022
17,472
18,8251395u(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))
2022
17,472
18,8251395u(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))
2022
17,472
18,8251395u(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))
2022
17,472
18,8251395u(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))
2022
17,472
18,8251395u(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))
2022
17,472
18,825( print page 69547)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
2022
4,603
4,9601395w-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
2022
14,950
16,1081395w-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))
2022
17,472
18,8251395w-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))
2022
17,472
18,8251395w-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
2022
42,788
46,1021395w-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
2022
17,116
18,4421395w-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
2022
158,947
171,2571395y(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
2022
10,360
11,1621395y(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
2022
1,687
1,8181395y(b)(6)(B)
42 CFR 402.1(c)(21), 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
2022
3,701
3,988( print page 69548)1395y(b)(7)(B)(i)

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
2022
1,325
1,4281395y(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
2022
1,325
1,4281395nn(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
2022
22,021
23,7271395pp(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))
2022
17,472
18,8251395ss(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
2022
59,972
64,6171395ss(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
2022
31,076
33,483CMS
Penalty for an issuer that sells or issues a Medicare supplemental policy without disclosure statement
2022
51,796
55,8081395ss(d)(3)(B)(iv)

CMS
Penalty for someone other than issuer that sells or issues a Medicare supplemental policy without acknowledgement form
2022
31,076
33,483CMS
Penalty for issuer that sells or issues a Medicare supplemental policy without an acknowledgement form
2022
51,796
55,8081395ss(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
2022
31,076
33,48342 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
2022
51,796
55,8081395ss(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
2022
31,076
33,483( print page 69549)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
2022
51,796
55,8081395ss(q)(5)(C)
402.105(f)(5)
CMS
Penalty for any person that fails to suspend the policy of a policyholder made eligible for medical assistance or automatically reinstates the policy of a policyholder who has lost eligibility for medical assistance, under certain circumstances
2022
51,796
55,8081395ss(r)(6)(A)
402.105(f)(6)
CMS
Penalty for any person that fails to provide refunds or credits as required by section 1882(r)(1)(B)
2022
51,796
55,8081395ss(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
2022
21,989
23,6921395ss(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
2022
51,796
55,8081395ss(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
2022
22,426
24,163CMS
Penalty for an issuer who sells, issues, or renews a Medigap Rx policy who is a Part D enrollee
2022
37,377
40,2721395bbb(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
2022
4,799
5,1711395bbb(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
2022
23,011
24,79342 CFR 488.845(b)(3)
CMS
Penalty per day for home health agency's noncompliance (Upper Range):
2022Minimum
2022
19,559
21,074Maximum
2022
23,011
24,79342 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
2022
23,011
24,79342 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
2022
20,709
22,31342 CFR 488.845(b)(3)(iii)
CMS
Penalty for an isolated incident of noncompliance in violation of established HHA policy
2022
19,559
21,07442 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):
2022Minimum
2022
3,453
3,720Maximum
2022
19,559
21,07442 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):
2022Minimum
2022
1,151
1,240( print page 69550)Maximum
2022
2,301
2,47942 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:
2022Penalty for each day of noncompliance (Minimum)
2022
2,301
2,479Penalty for each day of noncompliance (Maximum)
2022
23,011
24,79342 CFR 488.845(d)(1)(ii)
CMS
Penalty for each day of noncompliance (Maximum)
2022
23,011
24,7931395eee(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:
2022
42,788
46,102CMS
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
2022Minimum
2022
16,121
17,370Maximum
2022
107,478
115,802CMS
Penalty for a PACE organization that charges excessive premiums
2022
42,788
46,102CMS
Penalty for a PACE organization misrepresenting or falsifying information to CMS or the State
2022
171,156
184,412CMS
Penalty for any other violation specified in 42 C.F.R. 460.40
2022
42,788
46,1021396r(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:
2022Minimum
2022
120
129Maximum
2022
7,195
7,75242 CFR 488.408(d)(1)(iv)
CMS
Penalty per instance for a nursing facility's failure to meet Category 2 certification:
2022Minimum
2022
2,400
2,586Maximum
2022
23,989
25,84742 CFR 488.408(e)(1)(iii)
CMS
Penalty per day for a nursing facility's failure to meet Category 3 certification:
2022Minimum
2022
7,317
7,884Maximum
2022
23,989
25,84742 CFR 488.408(e)(1)(iv)
CMS
Penalty per instance for a nursing facility's failure to meet Category 3 certification:
2022Minimum
2022
2,400
2,586Maximum
2022
23,989
25,84742 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:
2022Minimum
2022
2,400
2,586Maximum
2022
23,989
25,84742 CFR 488.438(a)(1)(i)
CMS
Penalty per day for nursing facility's failure to meet certification (Upper Range):
2022Minimum
2022
7,317
7,884Maximum
2022
23,989
25,84742 CFR 488.438(a)(1)(ii)
CMS
Penalty per day for nursing facility's failure to meet certification (Lower Range):
2022Minimum
2022
120
129Maximum
2022
7,195
7,75242 CFR 488.438(a)(2)
CMS
Penalty per instance for nursing facility's failure to meet certification:
2022Minimum
2022
2,400
2,586Maximum
2022
23,989
25,847( print page 69551)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)
2022First occurrence (Minimum)
2022
1,075
1,158Incremental increases for each subsequent occurrence
2022
537
5791396r(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]
2022
11,995
12,9241396r(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]
2022
11,995
12,9241396t(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:
2022Minimum
2022
2
2Maximum
2022
20,719
22,3241396u-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
2022
42,788
46,102CMS
Penalty for Medicaid managed care organization that imposes premiums or charges on enrollees in excess of the premiums or charges permitted
2022
42,788
46,102CMS
Penalty for a Medicaid managed care organization that misrepresents or falsifies information to another individual or entity
2022
42,788
46,102CMS
Penalty for a Medicaid managed care organization that fails to comply with the applicable statutory requirements for such organizations
2022
42,788
46,1021396u-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
2022
171,156
184,412CMS
Penalty for Medicaid managed care organization that acts to discriminate among enrollees on the basis of their health status
2022
171,156
184,4121396u-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
2022
25,673
27,6611396u(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
2022
23,989
25,8471396w-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
2022
12,794
13,785( print page 69552)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
17718041(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
2022
174
18718081(h)(1)(A)(i)(II)
45 CFR 155.285
CMS
Penalty for providing false information on Exchange application
2022
31,616
34,06518081(h)(1)(B)
45 CFR 155.285
CMS
Penalty for knowingly or willfully providing false information on Exchange application
2022
316,155
340,64118081(h)(2)
45 CFR 155.260
CMS
Penalty for knowingly or willfully disclosing protected information from Exchange
2022CMS
Minimum
2022
31,616
34,065CMS
Maximum
2022
323
34818041(c)(2)
45 CFR 155.206(i)
CMS
Penalties for violation of applicable Exchange standards by consumer assistance entities in Federally-facilitated Exchanges
2022
38,771
41,774Maximum (Per Day)
2022
107
11531 U.S.C.



2022
323
3481352
45 CFR 93.400(e)
HHS
Penalty for the first time an individual makes an expenditure prohibited by regulations regarding lobbying disclosure, absent aggravating circumstances
2022
22,021
23,727Penalty for second and subsequent offenses by individuals who make an expenditure prohibited by regulations regarding lobbying disclosure:
2022Minimum
2022
22,021
23,727Maximum
2022
220,213
237,268HHS
Penalty for the first time an individual fails to file or amend a lobbying disclosure form, absent aggravating circumstances
2022
22,021
23,727Penalty for second and subsequent offenses by individuals who fail to file or amend a lobbying disclosure form, absent aggravating circumstances:
2022Minimum
2022
22,021
23,727Maximum
2022
220,213
237,26845 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:
2022Minimum
2022
22,021
23,727Maximum
2022
220,213
237,268HHS
Penalty for failure to provide statement regarding lobbying for loan guarantee and loan insurance transactions:
2022Minimum
2022
22,021
23,727Maximum
2022
220,213
237,2683801-3812
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
2022
11,507
12,398( print page 69553)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
2022
11,507
12,3981
                                 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,*
                                 and 
                                *M-23-05*
                                 guided agencies on annual adjustment requirements5
                                 
                                *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 2022 CPI-U (298.012) 
                                */*
                                 October 2021 CPI-U (276.589) = 1.07745.
 Dated: October 2, 2023. Xavier Becerra, Secretary, Department of Health and Human Services.


[FR Doc. 2023-22264 Filed 10-5-23; 8:45 am] BILLING CODE 4150-24-P