[Federal Register Volume 91, Number 18 (Wednesday, January 28, 2026)]
[Rules and Regulations]
[Pages 3665-3682]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2026-01688]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

45 CFR Part 102

RIN 0991-AC38


Annual Civil Monetary Penalties Inflation Adjustment

AGENCY: Office of the Assistant Secretary for Financial Resources, 
Department of Health and Human Services.

ACTION: Final rule.

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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 statutes and 
regulations, under the Federal Civil Penalties Inflation Adjustment Act 
Improvements Act of 2015.

DATES: 
    Effective date: This final rule is effective upon publication to 
the Federal Register.
    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: Jennifer Johnson, Acting, 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; (771) 215-
0133.

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), March 17, 2022 (87 FR 15100), October 6, 2023 (88 FR 
69531), and August 8, 2024 (89 FR 64815).

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 17, 2024, Office of Management and Budget (OMB) 
Memorandum for the Heads of Executive Departments and Agencies, M-25-
02, ``Implementation of Penalty Inflation Adjustments for 2025, 
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 2025, based on the CPI-U for the month of October 2024, not 
seasonally adjusted, is 1.02598. The multiplier is applied to each 
applicable penalty amount that was updated and published for fiscal 
year (FY) 2024 and is rounded to the nearest dollar.
    In addition to the inflation adjustments for 2025, this final rule 
corrects several technical errors and updates descriptions for 
clarification and accuracy. The following non-substantive technical 
errors were identified and are corrected and following descriptions are 
updated in the table in 45 CFR 102.3:
     The description of 42 U.S.C. 1320a-7j(h)(3)(A) is revised 
to add the word ``Maximum'' to accurately reflect the statutory maximum 
penalty amount.
     The regulatory cite associated with ``Penalty against 
hospital identified by CMS as noncompliant according to Sec.  182.50 
with respect to price transparency requirements regarding diagnostic 
tests for COVID-19'' was corrected from 45 CFR 180.90 to 45 CFR 182.70.
     The 2024 maximum penalty associated with 45 CFR 
180.90(c)(2)(ii)(C) was revised as it was cited incorrectly as $3,021 
but should have been $6,118 in the last adjustment. In the 2024 
adjustment, the amount reflected in the 2023 Maximum Adjusted Penalty 
column should have been $5,926, which was the actual adjusted amount in 
2023 (see 88 FR at 69541). However, this amount was inadvertently 
mistyped as $2,926 in the last adjustment (see 89 FR at 64823). 
Applying the 2024 multiplier to the correct amount would have resulted 
in

[[Page 3666]]

$6,118 ($5,926 x 1.03241). Therefore, the 2024 Maximum Adjusted Penalty 
was revised in this rule to $6,118.

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-25-02, the phrase 
``notwithstanding section 553'' in section 4(b)(2) of the 2015 Act 
means that ``the notice and comment process the APA generally 
requires--i.e., 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. Also, HHS finds that 
notice and comment procedures would be impracticable and unnecessary 
under the APA for the ministerial and technical changes in this rule. 
In addition, HHS is waiving notice and comment for the non-substantive 
technical corrections set out in this final rule. HHS finds good cause 
for issuing these changes as a final rule without prior notice and 
comment because these changes make technical clarifying edits to 
descriptions and corrections to inadvertent typographical errors from 
the last update. For these same reasons, HHS also finds good cause to 
make the final rule effective upon publication.
    Pursuant to OMB Memorandum M-25-02, 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 (i.e., the date of enactment of the 2015 Act). 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

0
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.


0
2. Amend Sec.  102.3 by revising table 1 to read as follows:


Sec.  102.3  Penalty adjustment and table.

* * * * *

[[Page 3667]]



                                     Table 1 to Sec.   102.3--Civil Monetary Penalty Authorities Administered By HHS
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                     Date of
                                                                                                                       last         2024         2025
                                                                                                                     penalty      Maximum      Maximum
       U.S.C. section(s)                CFR \1\           HHS agency                 Description \2\                figure or     adjusted     adjusted
                                                                                                                    adjustment  penalty ($)  penalty ($)
                                                                                                                       \3\                       \4\
--------------------------------------------------------------------------------------------------------------------------------------------------------
21 U.S.C.:
    333(b)(2)(A)..............  ......................  FDA...........  Penalty for violations related to drug            2024      127,983      131,308
                                                                         samples resulting in a conviction of any
                                                                         representative of manufacturer or
                                                                         distributor in any 10-year period.
    333(b)(2)(B)..............  ......................  FDA...........  Penalty for violation related to drug             2024    2,559,636    2,626,135
                                                                         samples resulting in a conviction of any
                                                                         representative of manufacturer or
                                                                         distributor after the second conviction
                                                                         in any 10-yr period.
    333(b)(3).................  ......................  FDA...........  Penalty for failure to make a report              2024      255,964      262,614
                                                                         required by 21 U.S.C. 353(d)(3)(E)
                                                                         relating to drug samples.
    333(f)(1)(A)..............  ......................  FDA...........  Penalty for any person who violates a             2024       34,568       35,466
                                                                         requirement related to devices for each
                                                                         such violation.
                                                        FDA...........  Penalty for aggregate of all violations           2024    2,304,629    2,364,503
                                                                         related to devices in a single
                                                                         proceeding.
    333(f)(2)(A)..............  ......................  FDA...........  Penalty for any individual who introduces         2024       97,179       99,704
                                                                         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.
                                                        FDA...........  Penalty in the case of any other person           2024      485,893      498,517
                                                                         (other than an individual) for such
                                                                         introduction or delivery of adulterated
                                                                         food.
                                                        FDA...........  Penalty for aggregate of all such                 2024      971,787      997,034
                                                                         violations related to adulterated food
                                                                         adjudicated in a single proceeding.
    333(f)(3)(A)..............  ......................  FDA...........  Penalty for all violations adjudicated in         2024       14,724       15,107
                                                                         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).
    333(f)(3)(B)..............  ......................  FDA...........  Penalty for each day any above violation          2024       14,724       15,107
                                                                         is not corrected after a 30-day period
                                                                         following notification until the
                                                                         violation is corrected.
    333(f)(4)(A)(i)...........  ......................  FDA...........  Penalty for any responsible person that           2024      368,137      377,701
                                                                         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).
                                                        FDA...........  Penalty for aggregate of all such above           2024    1,472,546    1,510,803
                                                                         violations in a single proceeding.
    333(f)(4)(A)(ii)..........  ......................  FDA...........  Penalty for REMS violation that continues         2024      368,137      377,701
                                                                         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.
                                                        FDA...........  Penalty for REMS violation that continues         2024    1,472,546    1,510,803
                                                                         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.
                                                        FDA...........  Penalty for aggregate of all such above           2024   14,725,456   15,108,023
                                                                         violations adjudicated in a single
                                                                         proceeding.
    333(f)(9)(A)..............  ......................  FDA...........  Penalty for any person who violates a             2024       21,348       21,903
                                                                         requirement which relates to tobacco
                                                                         products for each such violation.
                                                        FDA...........  Penalty for aggregate of all such                 2024    1,423,220    1,460,195
                                                                         violations of tobacco product
                                                                         requirement adjudicated in a single
                                                                         proceeding.
    333(f)(9)(B)(i)(I)........  ......................  FDA...........  Penalty per violation related to                  2024      355,806      365,050
                                                                         violations of tobacco requirements.
                                                        FDA...........  Penalty for aggregate of all such                 2024    1,423,220    1,460,195
                                                                         violations of tobacco product
                                                                         requirements adjudicated in a single
                                                                         proceeding.
    333(f)(9)(B)(i)(II).......  ......................  FDA...........  Penalty in the case of a violation of             2024      355,806      365,050
                                                                         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.
                                                        FDA...........  Penalty for violation of tobacco product          2024    1,423,220    1,460,195
                                                                         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.
                                                        FDA...........  Penalty for aggregate of all such                 2024   14,232,205   14,601,958
                                                                         violations related to tobacco product
                                                                         requirements adjudicated in a single
                                                                         proceeding.

[[Page 3668]]

 
    333(f)(9)(B)(ii)(I).......  ......................  FDA...........  Penalty for any person who either does            2024      355,806      365,050
                                                                         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.
                                                        FDA...........  Penalty for aggregate of for all such             2024    1,423,220    1,460,195
                                                                         above violations adjudicated in a single
                                                                         proceeding.
    333(f)(9)(B)(ii)(II)......  ......................  FDA...........  Penalty for violation of modified risk            2024      355,806      365,050
                                                                         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.
                                                        FDA...........  Penalty for post-notice violation of              2024    1,423,220    1,460,195
                                                                         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.
                                                                        Penalty for aggregate above tobacco               2024   14,232,205   14,601,958
                                                                         product requirement violations
                                                                         adjudicated in a single proceeding.
    333(g)(1).................                          FDA...........  Penalty for any person who disseminates           2024      368,137      377,701
                                                                         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.
                                                                        Penalty for each subsequent above                 2024      736,274      755,402
                                                                         violation in any 3-year period.
    333 note..................  ......................  FDA...........  Penalty to be applied for violations of           2024          356          365
                                                                         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..
                                                        FDA...........  Penalty in the case of a third violation          2024          709          727
                                                                         of 21 U.S.C. 387f(d)(5) or of the
                                                                         tobacco product regulations within a 24-
                                                                         month period.
                                                        FDA...........  Penalty in the case of a fourth violation         2024        2,846        2,920
                                                                         of 21 U.S.C. 387f(d)(5) or of the
                                                                         tobacco product regulations within a 24-
                                                                         month period.
                                                        FDA...........  Penalty in the case of a fifth violation          2024        7,115        7,300
                                                                         of 21 U.S.C. 387f(d)(5) or of the
                                                                         tobacco product regulations within a 36-
                                                                         month period.
                                                        FDA...........  Penalty in the case of a sixth or                 2024       14,232       14,602
                                                                         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.
                                                        FDA...........  Penalty to be applied for violations of           2024          356          365
                                                                         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.
                                                        FDA...........  Penalty in the case of a second violation         2024          709          727
                                                                         of 21 U.S.C. 387f(d)(5) or of the
                                                                         tobacco product regulations within a 12-
                                                                         month period.
                                                        FDA...........  Penalty in the case of a third violation          2024        1,424        1,461
                                                                         of 21 U.S.C. 387f(d)(5) or of the
                                                                         tobacco product regulations within a 24-
                                                                         month period.
                                                        FDA...........  Penalty in the case of a fourth violation         2024        2,846        2,920
                                                                         of 21 U.S.C. 387f(d)(5) or of the
                                                                         tobacco product regulations within a 24-
                                                                         month period.
                                                        FDA...........  Penalty in the case of a fifth violation          2024        7,115        7,300
                                                                         of 21 U.S.C. 387f(d)(5) or of the
                                                                         tobacco product regulations within a 36-
                                                                         month period.
                                                        FDA...........  Penalty in the case of a sixth or                 2024       14,232       14,602
                                                                         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.
    335b(a)...................  ......................  FDA...........  Penalty for each violation for any                2024      542,434      556,526
                                                                         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.

[[Page 3669]]

 
                                                        FDA...........  Penalty in the case of any other person           2024    2,169,731    2,226,101
                                                                         (other than an individual) per above
                                                                         violation.
    360pp(b)(1)...............  ......................  FDA...........  Penalty for any person who violates any           2024        3,558        3,650
                                                                         such requirements for electronic
                                                                         products, with each unlawful act or
                                                                         omission constituting a separate
                                                                         violation.
                                                        FDA...........  Penalty imposed for any related series of         2024    1,212,751    1,244,258
                                                                         violations of requirements relating to
                                                                         electronic products.
    42 U.S.C..................  ......................  ..............  .........................................         2024  ...........  ...........
    262(d)....................  ......................  FDA...........  Penalty per day for violation of order of         2024      278,937      286,184
                                                                         recall of biological product presenting
                                                                         imminent or substantial hazard.
    263b(h)(3)................  ......................  FDA...........  Penalty for failure to obtain a                   2024       21,699       22,263
                                                                         mammography certificate as required.
    300aa-28(b)(1)............  ......................  FDA...........  Penalty per occurrence for any vaccine            2024      278,937      286,184
                                                                         manufacturer that intentionally
                                                                         destroys, alters, falsifies, or conceals
                                                                         any record or report required.
    56b(d)(1)(B)(vi)..........  ......................  HRSA..........  Penalty for each instance of overcharging         2024        7,034        7,217
                                                                         a 340B covered entity.
    299c-3(d).................  ......................  AHRQ..........  Penalty for using or disclosing                   2024       18,291       18,766
                                                                         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.
    653(l)(2).................  45 CFR 303.21(f)......  ACF...........  Penalty for Misuse of Information in the          2024        1,877        1,926
                                                                         National Directory of New Hires.
    262a(i)(1)................  42 CFR 1003.910.......  OIG...........  Penalty for each individual who violates          2024      424,250      435,272
                                                                         safety and security procedures related
                                                                         to handling dangerous biological agents
                                                                         and toxins.
                                42 CFR 1003.1410......  OIG...........  Penalty for any other person who violates         2024      848,505      870,549
                                                                         safety and security procedures related
                                                                         to handling dangerous biological agents
                                                                         and toxins.
    300jj-51..................                          OIG...........  Penalty per violation for committing              2024    1,293,601    1,327,209
                                                                         information blocking.
    1320a-7a(a)...............  42 CFR 1003.210(a)(1).  OIG...........  Penalty for knowingly presenting or               2024       24,947       25,595
                                                                         causing to be presented to an officer,
                                                                         employee, or agent of the United States
                                                                         a false claim.
                                                        OIG...........  Penalty for knowingly presenting or               2024       24,947       25,595
                                                                         causing to be presented a request for
                                                                         payment which violates the terms of an
                                                                         assignment, agreement, or PPS agreement.
                                42 CFR 1003.210(a)(2).  OIG...........  Penalty for knowingly giving or causing           2024       37,421       38,393
                                                                         to be presented to a participating
                                                                         provider or supplier false or misleading
                                                                         information that could reasonably be
                                                                         expected to influence a discharge
                                                                         decision.
                                42 CFR 1003.210(a)(3).  OIG...........  Penalty for an excluded party retaining           2024       24,947       25,595
                                                                         ownership or control interest in a
                                                                         participating entity.
                                42 CFR 1003.1010......  OIG...........  Penalty for remuneration offered to               2024       24,947       25,595
                                                                         induce program beneficiaries to use
                                                                         particular providers, practitioners, or
                                                                         suppliers.
                                42 CFR 1003.210(a)(4).  OIG...........  Penalty for employing or contracting with         2024       24,947       25,595
                                                                         an excluded individual.
                                42 CFR 1003.310(a)(3).  OIG...........  Penalty for knowing and willful                   2024      124,732      127,973
                                                                         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.
                                42 CFR 1003.210(a)(1).  OIG...........  Penalty for ordering or prescribing               2024       24,947       25,595
                                                                         medical or other item or service during
                                                                         a period in which the person was
                                                                         excluded.
                                42 CFR 1003.210(a)(6).  OIG...........  Penalty for knowingly making or causing           2024      124,732      127,973
                                                                         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.
                                42 CFR 1003.210(a)(8).  OIG...........  Penalty for knowing of an overpayment and         2024       24,947       25,595
                                                                         failing to report and return.
                                42 CFR 1003.210(a)(7).  OIG...........  Penalty for making or using a false               2024       70,336       72,163
                                                                         record or statement that is material to
                                                                         a false or fraudulent claim.
                                42 CFR 1003.210(a)(9).  OIG...........  Penalty for failure to grant timely               2024       37,421       38,393
                                                                         access to HHS OIG for audits,
                                                                         investigations, evaluations, and other
                                                                         statutory functions of HHS OIG.
    1320a-7a(b)...............  ......................  OIG...........  Penalty for payments by a hospital or             2024        6,236        6,398
                                                                         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.
                                                        OIG...........  Penalty for physicians who knowingly              2024        6,236        6,398
                                                                         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.
                                42 CFR 1003.210(a)(10)  OIG...........  Penalty for a physician who executes a            2024       12,473       12,797
                                                                         document that falsely certifies home
                                                                         health needs for Medicare beneficiaries.
    1320a-7a(o)...............  42 CFR 1003.710(a)(1).  OIG...........  Penalty for knowingly presenting or               2024       12,166       12,482
                                                                         causing to be presented a false or
                                                                         fraudulent specified claim under a
                                                                         grant, contract, or other agreement for
                                                                         which the Secretary provides funding.

[[Page 3670]]

 
                                42 CFR 1003.710(a)(2).  OIG...........  Penalty for knowingly making, using, or           2024       60,831       62,411
                                                                         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.
                                42 CFR 1003.710(a)(3).  OIG...........  Penalty for Knowingly making, using, or           2024       60,831       62,411
                                                                         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.
                                42 CFR 1003.710(a)(4).  OIG...........  Penalty for knowingly making, using, or           2024       63,450       65,098
                                                                         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.
                                                                        Penalty for knowingly making, using, or           2024       12,707       13,037
                                                                         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.
                                42 CFR 1003.710(a)(5).  OIG...........  Penalty for failure to grant timely               2024       18,250       18,724
                                                                         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.
    1320a-7e(b)(6)(A).........  42 CFR 1003.810.......  OIG...........  Penalty for failure to report any final           2024       47,596       48,833
                                                                         adverse action taken against a health
                                                                         care provider, supplier, or practitioner.
    1320b-10(b)(1)............  42 CFR 1003.610(a)....  OIG...........  Penalty for the misuse of words, symbols,         2024       12,799       13,132
                                                                         or emblems in communications in a manner
                                                                         in which a person could falsely construe
                                                                         that such item is approved, endorsed, or
                                                                         authorized by HHS.
    1320b-10(b)(2)............  42 CFR 1003.610(a)....  OIG...........  Penalty for the misuse of words, symbols,         2024       63,991       65,653
                                                                         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.
    1395i-3(b)(3)(B)(ii)(1)...  42 CFR 1003.210(a)(11)  OIG...........  Penalty for certification of a false              2024        2,670        2,739
                                                                         statement in assessment of functional
                                                                         capacity of a Skilled Nursing Facility
                                                                         resident assessment.
    1395i-3(b)(3)(B)(ii)(2)...  42 CFR 1003.210(a)(11)  OIG...........  Penalty for causing another to certify or         2024       13,343       13,690
                                                                         make a false statement in assessment of
                                                                         functional capacity of a Skilled Nursing
                                                                         Facility resident assessment.
    1395i-3(g)(2)(A)..........  42 CFR 1003.1310......  OIG...........  Penalty for any individual who notifies           2024        5,339        5,478
                                                                         or causes to be notified a Skilled
                                                                         Nursing Facility of the time or date on
                                                                         which a survey is to be conducted.
    1395w-27(g)(2)(A).........  42 CFR 1003.410.......  OIG...........  Penalty for a Medicare Advantage                  2024       48,586       49,848
                                                                         organization that substantially fails to
                                                                         provide medically necessary, required
                                                                         items and services.
                                                        OIG...........  Penalty for a Medicare Advantage                  2024       47,596       48,833
                                                                         organization that charges excessive
                                                                         premiums.
                                                        OIG...........  Penalty for a Medicare Advantage                  2024       47,596       48,833
                                                                         organization that improperly expels or
                                                                         refuses to reenroll a beneficiary.
                                                        OIG...........  Penalty for a Medicare Advantage                  2024      190,389      195,335
                                                                         organization that engages in practice
                                                                         that would reasonably be expected to
                                                                         have the effect of denying or
                                                                         discouraging enrollment.
                                                        OIG...........  Penalty per individual who does not               2024       28,557       29,299
                                                                         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.
                                                        OIG...........  Penalty for a Medicare Advantage                  2024      190,389      195,335
                                                                         organization misrepresenting or
                                                                         falsifying information to Secretary.
                                                        OIG...........  Penalty for a Medicare Advantage                  2024       47,596       48,833
                                                                         organization misrepresenting or
                                                                         falsifying information to individual or
                                                                         other entity.
                                                        OIG...........  Penalty for Medicare Advantage                    2024       47,596       48,833
                                                                         organization interfering with provider's
                                                                         advice to enrollee and non-MCO
                                                                         affiliated providers that balance bill
                                                                         enrollees.
                                                        OIG...........  Penalty for a Medicare Advantage                  2024       47,596       48,833
                                                                         organization that employs or contracts
                                                                         with excluded individual or entity.

[[Page 3671]]

 
                                                        OIG...........  Penalty for a Medicare Advantage                  2024       47,596       48,833
                                                                         organization enrolling an individual in
                                                                         without prior written consent.
                                                        OIG...........  Penalty for a Medicare Advantage                  2024       47,596       48,833
                                                                         organization transferring an enrollee to
                                                                         another plan without consent or solely
                                                                         for the purpose of earning a commission.
                                                        OIG...........  Penalty for a Medicare Advantage                  2024       47,596       48,833
                                                                         organization failing to comply with
                                                                         marketing restrictions or applicable
                                                                         implementing regulations or guidance.
                                                        OIG...........  Penalty for a Medicare Advantage                  2024       47,596       48,833
                                                                         organization employing or contracting
                                                                         with an individual or entity who
                                                                         violates 1395w-27(g)(1)(A)-(J).
    1395w-141(i)(3)...........  ......................  OIG...........  Penalty for a prescription drug card              2024       16,630       17,062
                                                                         sponsor that falsifies or misrepresents
                                                                         marketing materials, overcharges program
                                                                         enrollees, or misuse transitional
                                                                         assistance funds.
    1395cc(g).................  42 CFR 1003.210(a)(5).  OIG...........  Penalty for improper billing by                   2024        6,469        6,637
                                                                         Hospitals, Critical Access Hospitals, or
                                                                         Skilled Nursing Facilities.
    1395dd(d)(1)..............  42 CFR 1003.510.......  OIG...........  Penalty for a hospital with 100 beds or           2024      133,420      136,886
                                                                         more or responsible physician dumping
                                                                         patients needing emergency medical care.
                                                        OIG...........  Penalty for a hospital with less than 100         2024       66,712       68,445
                                                                         beds dumping patients needing emergency
                                                                         medical care.
    1395mm(i)(6)(B)(i)........  42 CFR 1003.410.......  OIG...........  Penalty for a HMO or competitive medical          2024       66,712       68,445
                                                                         plan if such plan substantially fails to
                                                                         provide medically necessary, required
                                                                         items or services.
                                                        OIG...........  Penalty for HMOs/competitive medical              2024       66,712       68,445
                                                                         plans that charge premiums in excess of
                                                                         permitted amounts.
                                                        OIG...........  Penalty for a HMO or competitive medical          2024       66,712       68,445
                                                                         plan that expels or refuses to reenroll
                                                                         an individual per prescribed conditions.
                                                        OIG...........  Penalty for a HMO or competitive medical          2024      266,841      273,774
                                                                         plan that implements practices to
                                                                         discourage enrollment of individuals
                                                                         needing services in future.
                                                        OIG...........  Penalty per individual not enrolled in a          2024       38,395       39,393
                                                                         plan as a result of a HMO or competitive
                                                                         medical plan that implements practices
                                                                         to discourage enrollment of individuals
                                                                         needing services in the future.
                                                        OIG...........  Penalty for a HMO or competitive medical          2024      266,841      273,774
                                                                         plan that misrepresents or falsifies
                                                                         information to the Secretary.
                                                        OIG...........  Penalty for a HMO or competitive medical          2024       66,712       68,445
                                                                         plan that misrepresents or falsifies
                                                                         information to an individual or any
                                                                         other entity.
                                                        OIG...........  Penalty for failure by HMO or competitive         2024       66,712       68,445
                                                                         medical plan to assure prompt payment of
                                                                         Medicare risk sharing contracts or
                                                                         incentive plan provisions.
                                                        OIG...........  Penalty for HMO that employs or contracts         2024       61,238       62,829
                                                                         with excluded individual or entity.
    1395nn(g)(3)..............  42 CFR 1003.310.......  OIG...........  Penalty for submitting or causing to be           2024       30,868       31,670
                                                                         submitted claims in violation of the
                                                                         Stark Law's restrictions on physician
                                                                         self-referrals.
    1395nn(g)(4)..............  42 CFR 1003.310.......  OIG...........  Penalty for circumvention schemes in              2024      205,799      211,146
                                                                         violation of the Stark Law's
                                                                         restrictions on physician self-referrals.
    1395ss(d)(1)..............  42 CFR 1003.1110......  OIG...........  Penalty for a material misrepresentation          2024       12,799       13,132
                                                                         regarding Medigap compliance policies.
    1395ss(d)(2)..............  42 CFR 1003.1110......  OIG...........  Penalty for selling Medigap policy under          2024       12,799       13,132
                                                                         false pretense.
    1395ss(d)(3)(A)(ii).......  42 CFR 1003.1110......  OIG...........  Penalty for an issuer that sells health           2024       57,617       59,114
                                                                         insurance policy that duplicates
                                                                         benefits.
                                                        OIG...........  Penalty for someone other than issuer             2024       34,568       35,466
                                                                         that sells health insurance that
                                                                         duplicates benefits.
    1395ss(d)(4)(A)...........  42 CFR 1003.1110......  OIG...........  Penalty for using mail to sell a non-             2024       12,799       13,132
                                                                         approved Medigap insurance policy.
    1396b(m)(5)(B)(i).........  42 CFR 1003.410.......  OIG...........  Penalty for a Medicaid MCO that                   2024       63,991       65,653
                                                                         substantially fails to provide medically
                                                                         necessary, required items or services.
                                                        OIG...........  Penalty for a Medicaid MCO that charges           2024       63,991       65,653
                                                                         excessive premiums.
                                                        OIG...........  Penalty for a Medicaid MCO that                   2024      255,964      262,614
                                                                         improperly expels or refuses to reenroll
                                                                         a beneficiary.
                                                        OIG...........  Penalty per individual who does not               2024       38,395       39,393
                                                                         enroll as a result of a Medicaid MCO's
                                                                         practice that would reasonably be
                                                                         expected to have the effect of denying
                                                                         or discouraging enrollment.
                                                        OIG...........  Penalty for a Medicaid MCO                        2024      255,964      262,614
                                                                         misrepresenting or falsifying
                                                                         information to the Secretary.
                                                        OIG...........  Penalty for a Medicaid MCO                        2024       63,991       65,653
                                                                         misrepresenting or falsifying
                                                                         information to an individual or another
                                                                         entity.
                                                        OIG...........  Penalty for a Medicaid MCO that fails to          2024       57,617       59,114
                                                                         comply with contract requirements with
                                                                         respect to physician incentive plans.
    1396r(b)(3)(B)(ii)(I).....  42 CFR 1003.210(a)(11)  OIG...........  Penalty for willfully and knowingly               2024        2,670        2,739
                                                                         certifying a material and false
                                                                         statement in a Skilled Nursing Facility
                                                                         resident assessment.

[[Page 3672]]

 
    1396r(b)(3)(B)(ii)(II)....  42 CFR 1003.210(a)(11)  OIG...........  Penalty for willfully and knowingly               2024       13,343       13,690
                                                                         causing another individual to certify a
                                                                         material and false statement in a
                                                                         Skilled Nursing Facility resident
                                                                         assessment.
    1396r(g)(2)(A)(i).........  42 CFR 1003.1310......  OIG...........  Penalty for notifying or causing to be            2024        5,339        5,478
                                                                         notified a Skilled Nursing Facility of
                                                                         the time or date on which a survey is to
                                                                         be conducted.
    1396r-8(b)(3)(B)..........  42 CFR 1003.1210......  OIG...........  Penalty for the knowing provision of              2024      230,464      236,451
                                                                         false information or refusing to provide
                                                                         information about charges or prices of a
                                                                         covered outpatient drug.
    1396r-8(b)(3)(C)(i).......  42 CFR 1003.1210......  OIG...........  Penalty per day for failure to timely             2024       23,048       23,647
                                                                         provide information by drug manufacturer
                                                                         with rebate agreement.
    1396r-8(b)(3)(C)(ii)......  42 CFR 1003.1210......  OIG...........  Penalty for knowing provision of false            2024      230,464      236,451
                                                                         information by drug manufacturer with
                                                                         rebate agreement.
    1396t(i)(3)(A)............  42 CFR 1003.1310......  OIG...........  Penalty for notifying home and community-         2024        4,610        4,730
                                                                         based providers or settings of survey.
    11131(c)..................  42 CFR 1003.810.......  OIG...........  Penalty for failing to report a medical           2024       27,894       28,619
                                                                         malpractice claim to National
                                                                         Practitioner Data Bank.
    11137(b)(2)...............  42 CFR 1003.810.......  OIG...........  Penalty for breaching confidentiality of          2024       27,894       28,619
                                                                         information reported to National
                                                                         Practitioner Data Bank.
    299b-22(f)(1).............  42 CFR 3.404..........  OCR...........  Penalty for violation of confidentiality          2024       15,445       15,846
                                                                         provision of the Patient Safety and
                                                                         Quality Improvement Act.
    1320(d)-5(a)..............  45 CFR                  OCR...........  Penalty for each pre-February 18, 2009            2024          193          198
                                 160.404(b)(1)(i),                       violation of the HIPAA administrative
                                 (ii).                                   simplification provisions.
                                                        OIG...........  Calendar Year Cap........................         2024       48,586       49,848
    1320(d)-5(a)..............  45 CFR                  OCR...........  Penalty for each February 18, 2009 or             2024  ...........  ...........
                                 160.404(b)(2)(i)(A),                    later violation of a HIPAA
                                 (B).                                    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.
                                                                        Minimum..................................         2024          141          145
                                                                        Maximum..................................         2024       71,162       73,011
                                                                        Calendar Year Cap........................         2024    2,134,831    2,190,294
                                45 CFR                  OCR...........  Penalty for each February 18, 2009 or             2024  ...........  ...........
                                 160.404(b)(2)(ii)(A),                   later violation of a HIPAA
                                 (B).                                    administrative simplification provision
                                                                         in which it is established that the
                                                                         violation was due to reasonable cause
                                                                         and not to willful neglect.
                                                                        Minimum..................................         2024        1,424        1,461
                                                                        Maximum..................................         2024       71,162       73,011
                                                                        Calendar Year Cap........................         2024    2,134,831    2,190,294
                                45 CFR                  OCR...........  Penalty for each February 18, 2009 or             2024  ...........  ...........
                                 160.404(b)(2)(iii)(A)                   later violation of a HIPAA
                                 , (B).                                  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.
                                                                        Minimum..................................         2024       14,232       14,602
                                                                        Maximum..................................         2024       71,162       73,011
                                                                        Calendar Year Cap........................         2024    2,134,831    2,190,294
                                45 CFR                  OCR...........  Penalty for each February 18, 2009 or             2024  ...........  ...........
                                 160.404(b)(2)(iv)(A),                   later violation of a HIPAA
                                 (B).                                    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.
                                                                        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            2024  ...........  ...........
                                                                         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.
                                                                        Minimum..................................         2024          100          103

[[Page 3673]]

 
                                                                        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            2024  ...........  ...........
                                                                         part 2 provision in which it is
                                                                         established that the violation was due
                                                                         to reasonable cause and not to willful
                                                                         neglect.
                                                                        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            2024  ...........  ...........
                                                                         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.
                                                                        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            2024  ...........  ...........
                                                                         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.
                                                                        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      45 CFR 180.90.........  CMS...........  Penalty for a hospital's non-compliance           2024          333          342
     U.S.C. 1302.                                                        with making public standard charges for
                                                                         hospital items and services.
                                                                        Per Day (Maximum)........................         2024        6,118        6,277
                                45 CFR 180.90(c)(2)(i)  CMS...........  Applicable solely to CY 2021 penalties,           2024          339          348
                                                                         per day penalty for a hospital's
                                                                         noncompliance with making public
                                                                         standard charges for hospital items and
                                                                         services.
                                45 CFR                  CMS...........  Per day penalty for hospitals with equal          2024          333          342
                                 180.90(c)(2)(ii)(A).                    to or less than 30 beds.
                                45 CFR                  CMS...........  Per day, per bed penalty for hospitals            2024           11           11
                                 180.90(c)(2)(ii)(B).                    having at least 31 and up to and
                                                                         including 550 beds.
                                45 CFR                  CMS...........  Per day penalty for hospitals having              2024        6,118        6,277
                                 180.90(c)(2)(ii)(C).                    greater than 550 beds.
    CARES Act, Public Law 116-  45 CFR 182.70.........  CMS...........  Penalty for a provider's non-compliance           2024  ...........  ...........
     136, section 3202(b)(2).                                            with price transparency requirements
                                                                         regarding diagnostic tests for COVID-19.
                                                                        Per Day (Maximum)........................         2024          N/A          N/A
    263a(h)(2)(B) & 1395w-      42 CFR                  CMS...........  Penalty for a clinical laboratory's               2024  ...........  ...........
     2(b)(2)(A)(ii).             493.1834(d)(2)(i).                      failure to meet participation and
                                                                         certification requirements and poses
                                                                         immediate jeopardy.
                                                                        Minimum..................................         2024        7,807        8,010
                                                                        Maximum..................................         2024       25,597       26,262
                                42 CFR                  CMS...........  Penalty for a clinical laboratory's               2024  ...........  ...........
                                 493.1834(d)(2)(ii)..                    failure to meet participation and
                                                                         certification requirements and the
                                                                         failure does not pose immediate jeopardy.
                                                                        Minimum..................................         2024          129          132
                                                                        Maximum..................................         2024        7,678        7,877
                                42 CFR                  CMS...........  Penalty for a clinical laboratory's               2024  ...........  ...........
                                 493.1834(d)(2)(iii).                    failure to meet SARS-CoV-2 test
                                                                         reporting requirements.
                                                                        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                 2024        1,406        1,443
                                                                         Benefits and Coverage.
    300gg-18..................  45 CFR 158.606........  CMS...........  Penalty for violations of regulations             2024          140          144
                                                                         related to the medical loss ratio
                                                                         reporting and rebating.
                                45 CFR 180.70.........  CMS...........  Penalty against hospital identified by            2024  ...........  ...........
                                                                         CMS as noncompliant according to Sec.
                                                                         182.50 with respect to price
                                                                         transparency requirements regarding
                                                                         diagnostic tests for COVID-19.
    42 U.S.C. 300gg-118 note,   ......................  CMS...........  Penalties for failure to comply with No           2024       11,816       12,123
     300gg-134.                                                          Surprises Act requirements on providers,
                                                                         facilities, providers of air ambulance
                                                                         services.
    1320a-7h(b)(1)............  42 CFR 402.105(d)(5),   CMS...........  Penalty for manufacturer or group                 2024  ...........  ...........
                                 42 CFR 403.912(a) &                     purchasing organization failing to
                                 (c).                                    report information required under 42
                                                                         U.S.C. 1320a-7h(a), relating to
                                                                         physician ownership or investment
                                                                         interests.
                                                                        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   CMS...........  Penalty for manufacturer or group                 2024  ...........  ...........
                                 CFR 403.912(b) & (c).                   purchasing organization knowingly
                                                                         failing to report information required
                                                                         under 42 U.S.C. 1320a-7h(a), relating to
                                                                         physician ownership or investment
                                                                         interests.

[[Page 3674]]

 
                                                                        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         2024      140,674      144,329
                                                                         facility that fails to comply with
                                                                         notice requirements for the closure of a
                                                                         facility.
    1320a-7j(h)(3)(A).........  42 CFR 488.446(a)(1),   CMS...........  Minimum penalty for the first offense of          2024          703          721
                                 (2), & (3).                             an administrator who fails to provide
                                                                         notice of facility closure.
                                                                        Minimum penalty for the second offense of         2024        2,111        2,166
                                                                         an administrator who fails to provide
                                                                         notice of facility closure.
                                                                        Minimum penalty for the third and                 2024        4,219        4,329
                                                                         subsequent offenses of an administrator
                                                                         who fails to provide notice of facility
                                                                         closure.
    1320a-8(a)(1).............  ......................  CMS...........  Penalty for an entity knowingly making a          2024       10,289       10,556
                                                                         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.
                                                                        Penalty for violation of 42 U.S.C. 1320a-         2024        9,704        9,956
                                                                         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.
    1320a-8(a)(3).............  ......................  CMS...........  Penalty for a representative payee (under         2024        8,058        8,267
                                                                         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.
    1320b-25(c)(1)(A).........  ......................  CMS...........  Penalty for failure of covered                    2024      281,346      288,655
                                                                         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.
    1320b-25(c)(2)(A).........  ......................  CMS...........  Penalty for failure of covered                    2024      422,017      432,981
                                                                         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.
    11320b-25(d)(2)...........  ......................  CMS...........  Penalty for a long-term care facility             2024      281,346      288,655
                                                                         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.
    1395b-7(b)(2)(B)..........  42 CFR 402.105(g).....  CMS...........  Penalty for any person who knowingly and          2024          190          195
                                                                         willfully fails to furnish a beneficiary
                                                                         with an itemized statement of items or
                                                                         services within 30 days of the
                                                                         beneficiary's request.
    1395i-3(h)(2)(B)(ii)(I)...  42 CFR                  CMS...........  Penalty per day for a Skilled Nursing             2024  ...........  ...........
                                 488.408(d)(1)(iii).                     Facility that has a Category 2 violation
                                                                         of certification requirements.
                                                                        Minimum..................................         2024          133          136
                                                                        Maximum..................................         2024        8,003        8,211
                                42 CFR                  CMS...........  Penalty per instance of Category 2                2024  ...........  ...........
                                 488.408(d)(1)(iv).                      noncompliance by a Skilled Nursing
                                                                         Facility.
                                                                        Minimum..................................         2024        2,670        2,739
                                                                        Maximum..................................         2024       26,685       27,378
                                42 CFR                  CMS...........  Penalty per day for a Skilled Nursing             2024  ...........  ...........
                                 488.408(e)(1)(iii).                     Facility that has a Category 3 violation
                                                                         of certification requirements.
                                                                        Minimum..................................         2024        8,140        8,351
                                                                        Maximum..................................         2024       26,685       27,378
                                42 CFR                  CMS...........  Penalty per instance of Category 3                2024  ...........  ...........
                                 488.408(e)(1)(iv).                      noncompliance by a Skilled Nursing
                                                                         Facility.
                                                                        Minimum..................................         2024        2,670        2,739
                                                                        Maximum..................................         2024       26,685       27,378

[[Page 3675]]

 
                                42 CFR                  CMS...........  Penalty per day and per instance for a            2024  ...........            0
                                 488.408(e)(2)(ii).                      Skilled Nursing Facility that has
                                                                         Category 3 noncompliance with Immediate
                                                                         Jeopardy.
                                                                        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                  CMS...........  Penalty per day of a Skilled Nursing              2024  ...........            0
                                 488.438(a)(1)(i).                       Facility that fails to meet
                                                                         certification requirements. These
                                                                         amounts represent the upper range per
                                                                         day.
                                                                        Minimum..................................         2024        8,140        8,351
                                                                        Maximum..................................         2024       26,685       27,378
                                42 CFR                  CMS...........  Penalty per day of a Skilled Nursing              2024  ...........            0
                                 488.438(a)(1)(ii).                      Facility that fails to meet
                                                                         certification requirements. These
                                                                         amounts represent the lower range per
                                                                         day.
                                                                        Minimum..................................         2024          133          136
                                                                        Maximum..................................         2024        8,003        8,211
                                42 CFR 488.438(a)(2)..  CMS...........  Penalty per instance of a Skilled Nursing         2024  ...........            0
                                                                         Facility that fails to meet
                                                                         certification requirements.
                                                                        Minimum..................................         2024        2,670        2,739
                                                                        Maximum..................................         2024       26,685       27,378
                                42 CFR 488.447........  CMS...........  Penalty imposed for failure to comply             2024  ...........  ...........
                                                                         with infection control weekly reporting
                                                                         requirements at 42 CFR 483.80(g)(1) and
                                                                         (2).
                                                                        First occurrence.........................         2024        1,196        1,227
                                                                        Incremental increases for each subsequent         2024          598          614
                                                                         occurrence.
    1395i-6(c)(5)(B)(i).......  42 CFR 488.1245.......  CMS...........  Penalty for noncompliance by hospice              2024       11,124       11,413
                                                                         program with requirements specified in
                                                                         section 1395x(dd) of 42 U.S.C..
                                42 CFR                  CMS...........  Adjustment to penalties. Maximum penalty          2024       11,124       11,413
                                 488.1245(b)(2)(iii).                    assessment for each day a hospice is not
                                                                         in substantial compliance with one or
                                                                         more conditions of participation.
                                42 CFR 488.1245(b)(3).  CMS...........  Penalty imposed for hospice condition-            2024  ...........  ...........
                                                                         level deficiency that is immediate
                                                                         jeopardy. These amounts represent the
                                                                         upper range of penalty.
                                                                        Minimum..................................         2024        9,455        9,701
                                                                        Maximum..................................         2024       11,124       11,413
                                42 CFR                  CMS...........  Penalty imposed for hospice condition-            2024       11,124       11,413
                                 488.1245(b)(3)(i).                      level deficiency that is immediate
                                                                         jeopardy. These amounts represent the
                                                                         upper range of penalty.
                                42 CFR                  CMS...........  Penalty imposed for hospice condition-            2024       10,011       10,271
                                 488.1245(b)(3)(ii).                     level deficiency that is immediate
                                                                         jeopardy. These amounts represent the
                                                                         upper range of penalty.
                                42 CFR                  CMS...........  Penalty imposed for hospice condition-            2024        9,455        9,701
                                 488.1245(b)(3)(iii).                    level deficiency that is immediate
                                                                         jeopardy. These amounts represent the
                                                                         upper range of penalty.
                                42 CFR 488.1245(b)(4).  CMS...........  Penalty imposed for hospice repeat or             2024  ...........  ...........
                                                                         condition-level deficiency or both that
                                                                         does not constitute immediate jeopardy
                                                                         but is directly related to poor quality
                                                                         patient care outcomes. These amounts
                                                                         represent the middle range of penalty.
                                                                        Minimum..................................         2024        1,668        1,711
                                                                        Maximum..................................         2024        9,455        9,701
                                42 CFR 488.1245(b)(5).  CMS...........  Penalty imposed for hospice repeat or             2024  ...........  ...........
                                                                         condition-level deficiency or both that
                                                                         does not constitute immediate jeopardy
                                                                         and are related predominantly to
                                                                         structure or process-oriented conditions
                                                                         rather than directly related to patient
                                                                         outcomes. These amounts represent the
                                                                         lower range of penalty.
                                                                        Minimum..................................         2024          556          570
                                                                        Maximum..................................         2024        4,450        4,566
                                42 CFR 488.1245(b)(6).  CMS...........  Penalty range imposed for per instance of         2024  ...........  ...........
                                                                         hospice noncompliance.
                                                                        Minimum..................................         2024        1,112        1,141
                                                                        Maximum..................................         2024       11,124       11,413
                                42 CFR                  CMS...........  Penalty for each per instance of hospice          2024       11,124       11,413
                                 488.1245(d)(1)(ii).                     noncompliance, maximum per day per
                                                                         hospice program.
                                                                                                                          2024  ...........  ...........
    1395l(h)(5)(D)............  42 CFR                  CMS...........  Penalty for knowingly, willfully, and             2024       19,435       19,940
                                 402.105(d)(2)(i).                       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)).
    1395l(i)(6)...............  ......................  CMS...........  Penalty for knowingly and willfully               2024        5,121        5,254
                                                                         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.
    1395l(q)(2)(B)(i).........  42 CFR 402.105(a).....  CMS...........  Penalty for knowingly and willfully               2024        4,899        5,026
                                                                         failing to provide information about a
                                                                         referring physician when seeking payment
                                                                         on an unassigned basis.

[[Page 3676]]

 
    1395m(a)(11)(A)...........  42 CFR 402.1(c)(4),     CMS...........  Penalty for any durable medical equipment         2024       19,435       19,940
                                 402.105(d)(2)(ii).                      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)).
    1395m(a)(18)(B)...........  42 CFR 402.1(c)(5),     CMS...........  Penalty for any nonparticipating durable          2024       19,435       19,940
                                 402.105(d)(2)(iii).                     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)).
    1395m(b)(5)(C)............  42 CFR 402.1(c)(6),     CMS...........  Penalty for any nonparticipating                  2024       19,435       19,940
                                 402.105(d)(2)(iv).                      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)).
    1395m(h)(3)...............  42 CFR 402.1(c)(8),     CMS...........  Penalty for any supplier of prosthetic            2024       19,435       19,940
                                 402.105(d)(2)(vi).                      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)).
    1395m(j)(2)(A)(iii).......  ......................  CMS...........  Penalty for any supplier of durable               2024        2,058        2,111
                                                                         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.
    1395m(j)(4)...............  42 CFR 402.1(c)(10),    CMS...........  Penalty for any supplier of durable               2024       19,435       19,940
                                 402.105(d)(2)(vii).                     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)).
    1395m-1(a)................  42 CFR. 414.504(e)....  CMS...........  Penalty for an applicable entity that has         2024       12,958       13,295
                                                                         failed to report or made a
                                                                         misrepresentation or omission in
                                                                         reporting applicable information with
                                                                         respect to a clinical diagnostic
                                                                         laboratory test.
                                42 CFR 402.1(c)(31),    CMS...........  Penalty for any person or entity who              2024       19,435       19,940
                                 402.105(d)(3).                          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)).
    1395m(l)(6)...............  42 CFR 402.1(c)(32),    CMS...........  Penalty for any supplier of ambulance             2024       19,435       19,940
                                 402.105(d)(4).                          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)).
    1395u(b)(18)(B)...........  42 CFR 402.1(c)(11),    CMS...........  Penalty for any practitioner specified in         2024       19,435       19,940
                                 402.105(d)(2)(viii).                    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)).
    1395u(j)(2)(B)............  42 CFR 402.1(c).......  CMS...........  Penalty for any physician who charges             2024       19,435       19,940
                                                                         more than 125% for a non-participating
                                                                         referral. (Penalties are assessed in the
                                                                         same manner as 42 U.S.C. 1320a-7a(a)).

[[Page 3677]]

 
    1395u(k)..................  42 CFR 402.1(c)(12),    CMS...........  Penalty for any physician who knowingly           2024       19,435       19,940
                                 402.105(d)(2)(ix)                       and willfully presents or causes to be
                                 1834A(a)(9) and 42                      presented a claim for bill for an
                                 CFR 414.504(e).                         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)).
    1395u(l)(3)...............  42 CFR 402.1(c)(13),    CMS...........  Penalty for any nonparticipating                  2024       19,435       19,940
                                 402.105(d)(2)(x).                       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)).
    1395u(m)(3)...............  42 CFR 402.1(c)(14),    CMS...........  Penalty for any nonparticipating                  2024       19,435       19,940
                                 402.105(d)(2)(xi).                      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)).
    1395u(n)(3)...............  42 CFR 402.1(c)(15),    CMS...........  Penalty for any physician who knowingly,          2024       19,435       19,940
                                 402.105(d)(2)(xii).                     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)).
    1395u(o)(3)(B)............  42 CFR 414.707(b).....  CMS...........  Penalty for any practitioner specified in         2024       19,435       19,940
                                                                         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)).
    1395u(p)(3)(A)............  ......................  CMS...........  Penalty for any physician or practitioner         2024        5,121        5,254
                                                                         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.
    1395w-3a(d)(4)(A).........  42 CFR 414.806........  CMS...........  Penalty for a pharmaceutical                      2024       16,630       17,062
                                                                         manufacturer's misrepresentation of
                                                                         average sales price of a drug, or
                                                                         biologic.
    1395w-4(g)(1)(B)..........  42 CFR 402.1(c)(17),    CMS...........  Penalty for any nonparticipating                  2024       19,435       19,940
                                 402.105(d)(2)(xiii).                    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)).
    1395w-4(g)(3)(B)..........  42 CFR 402.1(c)(18),    CMS...........  Penalty for any person that knowingly and         2024       19,435       19,940
                                 402.105(d)(2)(xiv).                     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)).
    1395w-27(g)(3)(A);          42 CFR 422.760(b); 42   CMS...........  Penalty for each termination                      2024       47,596       48,833
     1857(g)(3); 1860D-          CFR 423.760(b).                         determination the Secretary makes that
     12(b)(3)(E).                                                        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.
    1395w-27(g)(3)(B);          ......................  CMS...........  Penalty for each week beginning after the         2024       19,040       19,535
     1857(g)(3); 1860D-                                                  initiation of civil money penalty
     12(b)(3)(E).                                                        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.
    1395w-27(g)(3)(D);          ......................  CMS...........  Penalty for a Medicare Advantage                  2024      176,807      181,400
     1857(g)(3): 1860D-                                                  organization's or Part D sponsor's early
     12(b)(3)(E).                                                        termination of its contract.
    1395y(b)(3)(C)............  42 CFR 411.103(b).....  CMS...........  Penalty for an employer or other entity           2024       11,524       11,823
                                                                         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.
    1395y(b)(5)(C)(ii)........  42 CFR 402.1(c)(20),    CMS...........  Penalty for any non-governmental employer         2024        1,877        1,926
                                 42 CFR 402.105(b)(2).                   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.

[[Page 3678]]

 
    1395y(b)(6)(B)............  42 CFR 402.1(c)(20),    CMS...........  Penalty for any entity that knowingly,            2024        4,117        4,224
                                 402.105(a).                             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.
    1395y(b)(7)(B)(i).........  42 CFR 402.1(c)(21),    CMS...........  Penalty for any entity serving as                 2024        1,474        1,512
                                 402.105(a).                             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.
    1395y(b)(8)(E)............  ......................  CMS...........  Penalty for any non-group health plan             2024        1,474        1,512
                                                                         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.
    1395nn(g)(5)..............  42 CFR 411.361........  CMS...........  Penalty for any person that fails to              2024       24,496       25,132
                                                                         report information required by HHS under
                                                                         Section 1877(f) concerning ownership,
                                                                         investment, and compensation
                                                                         arrangements.
    1395pp(h).................  42 CFR 402.1(c)(23),    CMS...........  Penalty for any durable medical equipment         2024       19,435       19,940
                                 402.105(d)(2)(xv).                      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)).
    1395ss(a)(2)..............  402.102(f)(1).........  CMS...........  Penalty for any person that issues a              2024       66,711       68,444
                                                                         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.
    1395ss(d)(3)(A)(vi)(II)...  42 CFR 402.1(c)(25),    CMS...........  Penalty for someone other than issuer             2024       34,568       35,466
                                 402.105(e),402.105(f)                   that sells or issues a Medicare
                                 (2).                                    supplemental policy to beneficiary
                                                                         without a disclosure statement.
                                                        CMS...........  Penalty for an issuer that sells or               2024       57,617       59,114
                                                                         issues a Medicare supplemental policy
                                                                         without disclosure statement.
    1395ss(d)(3)(B)(iv).......  ......................  CMS...........  Penalty for someone other than issuer             2024       34,568       35,466
                                                                         that sells or issues a Medicare
                                                                         supplemental policy without
                                                                         acknowledgement form.
                                                        CMS...........  Penalty for issuer that sells or issues a         2024       57,617       59,114
                                                                         Medicare supplemental policy without an
                                                                         acknowledgement form.
    1395ss(p)(8)..............  42 CFR 402.1(c)(25),    CMS...........  Penalty for someone other than issuer             2024       34,568       35,466
                                 402.105(e).                             that sells or issues Medicare
                                                                         supplemental polices after a given date
                                                                         that fail to conform to the NAIC or
                                                                         Federal standards established by statute.
                                42 CFR 402.1(c)(25),    CMS...........  Penalty for an issuer that sells or               2024       57,617       59,114
                                 405402.105(f)(2).                       issues Medicare supplemental polices
                                                                         after a given date that fail to conform
                                                                         to the NAIC or Federal standards
                                                                         established by statute.
    1395ss(p)(9)(C)...........  42 CFR 402.1(c)(26),    CMS...........  Penalty for someone other than issuer             2024       34,568       35,466
                                 402.105(e),                             that sells a Medicare supplemental
                                 402.105(f)(3), (4).                     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.
                                42 CFR 402.105(f)(3),   CMS...........  Penalty for an issuer that sells a                2024       57,617       59,114
                                 (4).                                    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.
    1395ss(q)(5)(C)...........  42 CFR 402.105(f)(5)..  CMS...........  Penalty for any person that fails to              2024       57,617       59,114
                                                                         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.
    1395ss(r)(6)(A)...........  42 CFR 402.105(f)(6)..  CMS...........  Penalty for any person that fails to              2024       57,617       59,114
                                                                         provide refunds or credits as required
                                                                         by section 1882(r)(1)(B).
    1395ss(s)(4)..............  42 CFR 402.1(c)(29),    CMS...........  Penalty for any issuer of a Medicare             C2024       24,460       25,095
                                 402.105(c).                             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.

[[Page 3679]]

 
    1395ss(t)(2)..............  42 CFR 402.1(c)(30),    CMS...........  Penalty for any issuer of a Medicare              2024       57,617       59,114
                                 402.105(f)(7).                          supplemental policy that fails to
                                                                         fulfill listed responsibilities.
    1395ss(v)(4)(A)...........  ......................  CMS...........  Penalty someone other than issuer who             2024       24,946       25,594
                                                                         sells, issues, or renews a medigap Rx
                                                                         policy to an individual who is a Part D
                                                                         enrollee.
                                                        CMS...........  Penalty for an issuer who sells, issues,          2024       41,577       42,657
                                                                         or renews a Medigap Rx policy who is a
                                                                         Part D enrollee.
    1395bbb(c)(1).............  42 CFR 488.725(c).....  CMS...........  Penalty for any individual who notifies           2024        5,339        5,478
                                                                         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.
    1395bbb(f)(2)(A)(i).......  42 CFR                  CMS...........  Maximum daily penalty amount for each day         2024       25,597       26,262
                                 488.845(b)(2)(iii) 42                   a home health agency is not in
                                 CFR 488.845(b)(3)-                      compliance with statutory requirements.
                                 (6); and 42 CFR
                                 488.845(d)(1)(ii).
                                42 CFR 488.845(b)(3)..  CMS...........  Penalty per day for home health agency's          2024  ...........            0
                                                                         noncompliance (Upper Range).
                                                                        Minimum..................................         2024       21,757       22,322
                                                                        Maximum..................................         2024       25,597       26,262
                                42 CFR                  CMS...........  Penalty for a home health agency's                2024       25,597       26,262
                                 488.845(b)(3)(i).                       deficiency or deficiencies that cause
                                                                         immediate jeopardy and result in actual
                                                                         harm.
                                42 CFR                  CMS...........  Penalty for a home health agency's                2024       23,036       23,634
                                 488.845(b)(3)(ii).                      deficiency or deficiencies that cause
                                                                         immediate jeopardy and result in
                                                                         potential for harm.
                                42 CFR                  CMS...........  Penalty for an isolated incident of               2024       21,757       22,322
                                 488.845(b)(3)(iii).                     noncompliance in violation of
                                                                         established HHA policy.
                                42 CFR 488.845(b)(4)..  CMS...........  Penalty for a repeat and/or condition-            2024  ...........            0
                                                                         level deficiency that does not
                                                                         constitute immediate jeopardy, but is
                                                                         directly related to poor quality patient
                                                                         care outcomes (Lower Range).
                                                                        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-            2024  ...........            0
                                                                         level deficiency that does not
                                                                         constitute immediate jeopardy and that
                                                                         is related predominately to structure or
                                                                         process-oriented conditions (Lower
                                                                         Range).
                                                                        Minimum..................................         2024        1,280        1,313
                                                                        Maximum..................................         2024        2,559        2,625
                                42 CFR 488.845(b)(6)..  CMS...........  Penalty imposed for instance of                   2024  ...........            0
                                                                         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.
                                                                        Penalty for each day of noncompliance             2024        2,559        2,625
                                                                         (Minimum).
                                                                        Penalty for each day of noncompliance             2024       25,597       26,262
                                                                         (Maximum).
                                42 CFR                  CMS...........  Penalty for each day of noncompliance             2024       25,597       26,262
                                 488.845(d)(1)(ii).                      (Maximum).
    1395eee(e)(6)(B); 1396u-    42 CFR 460.46.........  CMS...........  Penalty for PACE organization that                2024       47,596       48,833
     4(e)(6)(B).                                                         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.
                                                        CMS...........  For each individual not enrolled as a             2024  ...........  ...........
                                                                         result of the PACE organization's
                                                                         discrimination in enrollment or
                                                                         disenrollment or practice that would
                                                                         deny or discourage enrollment.
                                                                        Minimum..................................         2024       17,933       18,399
                                                                        Maximum..................................         2024      119,555      122,661
                                                        CMS...........  Penalty for a PACE organization that              2024       47,596       48,833
                                                                         charges excessive premiums.
                                                        CMS...........  Penalty for a PACE organization                   2024      190,389      195,335
                                                                         misrepresenting or falsifying
                                                                         information to CMS or the State.
                                                        CMS...........  Penalty for any other violation specified         2024       47,596       48,833
                                                                         in 42 CFR 460.40.
    1396r(h)(3)(C)(ii)(I).....  42 CFR                  CMS...........  Penalty per day for a nursing facility's          2024  ...........            0
                                 488.408(d)(1)(iii).                     failure to meet a Category 2
                                                                         Certification.
                                                                        Minimum..................................         2024          133          136
                                                                        Maximum..................................         2024        8,003        8,211
                                42 CFR                  CMS...........  Penalty per instance for a nursing                2024  ...........  ...........
                                 488.408(d)(1)(iv).                      facility's failure to meet Category 2
                                                                         certification.
                                                                        Minimum..................................         2024        2,670        2,739
                                                                        Maximum..................................         2024       26,685       27,378
                                42 CFR                  CMS...........  Penalty per day for a nursing facility's          2024  ...........  ...........
                                 488.408(e)(1)(iii).                     failure to meet Category 3 certification.
                                                                        Minimum..................................         2024        8,140        8,351
                                                                        Maximum..................................         2024       26,685       27,378
                                42 CFR                  CMS...........  Penalty per instance for a nursing                2024  ...........            0
                                 488.408(e)(1)(iv).                      facility's failure to meet Category 3
                                                                         certification.
                                                                        Minimum..................................         2024        2,670        2,739
                                                                        Maximum..................................         2024       26,685       27,378

[[Page 3680]]

 
                                42 CFR                  CMS...........  Penalty per instance for a nursing                2024  ...........            0
                                 488.408(e)(2)(ii).                      facility's failure to meet Category 3
                                                                         certification, which results in
                                                                         immediate jeopardy.
                                                                        Minimum..................................         2024        2,670        2,739
                                                                        Maximum..................................         2024       26,685       27,378
                                42 CFR                  CMS...........  Penalty per day for nursing facility's            2024  ...........            0
                                 488.438(a)(1)(i).                       failure to meet certification (Upper
                                                                         Range).
                                                                        Minimum..................................         2024        8,140        8,351
                                                                        Maximum..................................         2024       26,685       27,378
                                42 CFR                  CMS...........  Penalty per day for nursing facility's            2024  ...........            0
                                 488.438(a)(1)(ii).                      failure to meet certification (Lower
                                                                         Range).
                                                                        Minimum..................................         2024          133          136
                                                                        Maximum..................................         2024        8,003        8,211
                                42 CFR 488.438(a)(2)..  CMS...........  Penalty per instance for nursing                  2024  ...........            0
                                                                         facility's failure to meet certification.
                                                                        Minimum..................................         2024        2,670        2,739
                                                                        Maximum..................................         2024       26,685       27,378
                                42 CFR 488.447........  CMS...........  Penalty imposed for failure to comply             2024  ...........  ...........
                                                                         with infection control weekly reporting
                                                                         requirements at 42 CFR 483.80(g)(1) and
                                                                         (2).
                                                                        First occurrence (Minimum)...............         2024        1,196        1,227
                                                                        Incremental increases for each subsequent         2024          598          614
                                                                         occurrence.
    1396r(f)(2)(B)(iii)(I)(c).  42 CFR                  CMS...........  Grounds to prohibit approval of Nurse             2024       13,343       13,690
                                 483.151(b)(2)(iv) and                   Aide Training Program--if assessed a
                                 (b)(3)(iii).                            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].
    1396r(h)(3)(C)(ii)(I).....  42 CFR 483.151(c)(2)..  CMS...........  Grounds to waive disapproval of nurse             2024       13,343       13,690
                                                                         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].
    1396t(j)(2)(C)............  ......................  CMS...........  Penalty for each day of noncompliance for         2024  ...........            0
                                                                         a home or community care provider that
                                                                         no longer meets the minimum requirements
                                                                         for home and community care.
                                                                        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               2024       47,596       48,833
                                                                         organization that fails substantially to
                                                                         provide medically necessary items and
                                                                         services.
                                                        CMS...........  Penalty for Medicaid managed care                 2024       47,596       48,833
                                                                         organization that imposes premiums or
                                                                         charges on enrollees in excess of the
                                                                         premiums or charges permitted.
                                                        CMS...........  Penalty for a Medicaid managed care               2024       47,596       48,833
                                                                         organization that misrepresents or
                                                                         falsifies information to another
                                                                         individual or entity.
                                                        CMS...........  Penalty for a Medicaid managed care               2024       47,596       48,833
                                                                         organization that fails to comply with
                                                                         the applicable statutory requirements
                                                                         for such organizations..
    1396u-2(e)(2)(A)(ii)......  42 CFR 438.704........  CMS...........  Penalty for a Medicaid managed care               2024      190,389      195,335
                                                                         organization that misrepresents or
                                                                         falsifies information to the HHS
                                                                         Secretary.
                                                        CMS...........  Penalty for Medicaid managed care                 2024      190,389      195,335
                                                                         organization that acts to discriminate
                                                                         among enrollees on the basis of their
                                                                         health status.
    1396u-2(e)(2)(A)(iv)......  42 CFR 438.704........  CMS...........  Penalty for each individual that does not         2024       28,557       29,299
                                                                         enroll as a result of a Medicaid managed
                                                                         care organization that acts to
                                                                         discriminate among enrollees on the
                                                                         basis of their health status.
    1396u(h)(2)...............  42 CFR Part 441,        CMS...........  Penalty for a provider not meeting one of         2024       26,685       27,378
                                 Subpart I.                              the requirements relating to the
                                                                         protection of the health, safety, and
                                                                         welfare of individuals receiving
                                                                         community supported living arrangements
                                                                         services.
    1396w-2(c)(1).............  42 U.S.C. 300gg-        CMS...........  Penalty for each day, for each individual         2024       14,232       14,602
                                 22(b)(2)(C)(i) 45 CFR                   affected by the failure of a health
                                 150.315.                                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[verbar]2022[verbar]174[verbar]177.

[[Page 3681]]

 
    18041(c)(2)...............  45 CFR 156.805(c).....  CMS...........  Failure to comply with ACA requirements           2024          193          198
                                                                         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.
    42 U.S.C. 300gg-            45 CFR 150.315........  CMS...........  Penalty for each day, for each individual         2024          183          188
     22(b)(2)(C)(i).                                                     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.
    18081(h)(1)(A)(i)(II).....  45 CFR 155.285........  CMS...........  Penalty for providing false information           2024       35,169       36,083
                                                                         on Exchange application.
    18081(h)(1)(B)............  45 CFR 155.285........  CMS...........  Penalty for knowingly or willfully                2024      351,681      360,818
                                                                         providing false information on Exchange
                                                                         application.
    18081(h)(2)...............  45 CFR 155.260........  CMS...........  Penalty for knowingly or willfully                2024  ...........            0
                                                                         disclosing protected information from
                                                                         Exchange.
                                                        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             2024       43,128       44,248
                                                                         Exchange standards by consumer
                                                                         assistance entities in Federally-
                                                                         facilitated Exchanges.
                                                                        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          2024       24,496       25,132
                                                                         makes an expenditure prohibited by
                                                                         regulations regarding lobbying
                                                                         disclosure, absent aggravating
                                                                         circumstances.
                                                                        Penalty for second and subsequent                 2024  ...........            0
                                                                         offenses by individuals who make an
                                                                         expenditure prohibited by regulations
                                                                         regarding lobbying disclosure.
                                                                        Minimum..................................         2024       24,496       25,132
                                                                        Maximum..................................         2024      244,958      251,322
    1352......................  ......................  HHS...........  Penalty for the first time an individual          2024       24,496       25,132
                                                                         fails to file or amend a lobbying
                                                                         disclosure form, absent aggravating
                                                                         circumstances.
                                                                        Penalty for second and subsequent                 2024  ...........            0
                                                                         offenses by individuals who fail to file
                                                                         or amend a lobbying disclosure form,
                                                                         absent aggravating circumstances.
                                                                        Minimum..................................         2024       24,496       25,132
                                                                        Maximum..................................         2024      244,958      251,322
                                45 CFR Part 93,         HHS...........  Penalty for failure to provide                    2024  ...........            0
                                 Appendix A.                             certification regarding lobbying in the
                                                                         award documents for all sub-awards of
                                                                         all tiers.
                                                                        Minimum..................................         2024       24,496       25,132
                                                                        Maximum..................................         2024      244,958      251,322
                                                        HHS...........  Penalty for failure to provide statement          2024  ...........            0
                                                                         regarding lobbying for loan guarantee
                                                                         and loan insurance transactions.
                                                                        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          2024       12,800       13,133
                                                                         knowledge or reason to know--makes,
                                                                         presents or submits a false, fictitious
                                                                         or fraudulent claim to the Department.
                                45 CFR 79.3(b)(1)(ii).  HHS...........  Penalty against any individual who--with          2024       12,800       13,133
                                                                         knowledge or reason to know--makes,
                                                                         presents or submits a false, fictitious
                                                                         or fraudulent claim to the Department.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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, Sec.   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.



[[Page 3682]]

Robert F. Kennedy, Jr.,
Secretary, Department of Health and Human Services.
[FR Doc. 2026-01688 Filed 1-27-26; 8:45 am]
BILLING CODE 4150-24-P