[Federal Register Volume 89, Number 153 (Thursday, August 8, 2024)]
[Rules and Regulations]
[Pages 64815-64832]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-17466]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

45 CFR Part 102

RIN 0991-AC34


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 August 8, 2024.
    Applicability date: The adjusted civil monetary penalty amounts 
apply to penalties assessed on or after August 8, 2024, if the 
violation occurred on or after November 2, 2015.

FOR FURTHER INFORMATION CONTACT: Katrina Brisbon, Deputy Assistant 
Secretary, Office of Acquisitions, Office of the Assistant Secretary 
for Financial Resources, Room 536-H, Hubert Humphrey Building, 200 
Independence Avenue SW, Washington, DC 20201; (202) 260-6677.

SUPPLEMENTARY INFORMATION:

I. Background

    The Federal Civil Penalties Inflation Adjustment Act Improvements 
Act of 2015 (section 701 of Pub. L. 114-74) (the ``2015 Act'') amended 
the Federal Civil Penalties Inflation Adjustment Act of 1990 (Pub. L. 
101-410, 104 Stat. 890 (1990)), which is intended to improve the 
effectiveness of CMPs and to maintain the deterrent effect of such 
penalties, requires agencies to adjust the CMPs for inflation annually.
    HHS lists the CMP authorities and the amounts administered by all 
of its agencies in tabular form in 45 CFR 102.3, which was issued in an 
interim final rule published in the September 6, 2016, issue of the 
Federal Register (81 FR 61538). Annual adjustments were subsequently 
published in the Federal Register 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), and October 6, 2023 (88 FR 69531).

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 19, 2023, Office of Management and Budget (OMB) 
Memorandum for the Heads of Executive Agencies and Departments, M-24-
07, ``Implementation of Penalty Inflation Adjustments for 2024, 
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 2024, based on the CPI-U for the month of October 2023, not 
seasonally adjusted, is 1.03241. The multiplier is applied to each 
applicable penalty amount that was updated and published for fiscal 
year (FY) 2023 and is rounded to the nearest dollar.
    In addition to the inflation adjustments for 2023, this final rule 
makes a few non-substantive changes to punctuation in the table in 45 
CFR 102.3.

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

[[Page 64816]]

section 553'' of the APA. According to OMB's Memorandum M-24-07, the 
phrase ``notwithstanding section 553'' in section 4(b)(2) of the 2015 
Act means that ``the public procedure the APA generally requires--
notice, an opportunity for comment, and a delay in effective date--is 
not required for agencies to issue regulations implementing the annual 
adjustment.''
    Consistent with the language of the 2015 Act and OMB's 
implementation guidance, the inflation adjustments set out in this rule 
are not subject to notice and an opportunity for public comment and 
will be effective immediately upon publication.
    Pursuant to OMB Memorandum M-24-07, 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 64817]]



                                     Table 1 to Sec.   102.3--Civil Monetary Penalty Authorities Administered by HHS
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                     Date of
                                                                                                                       last         2023         2024
                                                                                                                     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            2023      123,965      127,983
                                                                         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             2023    2,479,282    2,559,636
                                                                         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              2023      247,929      255,964
                                                                         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             2023       33,483       34,568
                                                                         requirement related to devices for each
                                                                         such violation.
                                                        FDA...........  Penalty for aggregate of all violations           2023    2,232,281    2,304,629
                                                                         related to devices in a single
                                                                         proceeding.
    333(f)(2)(A)..............  ......................  FDA...........  Penalty for any individual who introduces         2023       94,128       97,179
                                                                         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           2023      470,640      485,893
                                                                         (other than an individual) for such
                                                                         introduction or delivery of adulterated
                                                                         food.
                                                        FDA...........  Penalty for aggregate of all such                 2023      941,280      971,787
                                                                         violations related to adulterated food
                                                                         adjudicated in a single proceeding.
    333(f)(3)(A)..............  ......................  FDA...........  Penalty for all violations adjudicated in         2023       14,262       14,724
                                                                         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          2023       14,262       14,724
                                                                         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           2023      356,580      368,137
                                                                         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           2023    1,426,319    1,472,546
                                                                         violations in a single proceeding.
    333(f)(4)(A)(ii)..........  ......................  FDA...........  Penalty for REMS violation that continues         2023      356,580      368,137
                                                                         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         2023    1,426,319    1,472,546
                                                                         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           2023   14,263,186   14,725,456
                                                                         violations adjudicated in a single
                                                                         proceeding.
    333(f)(9)(A)..............  ......................  FDA...........  Penalty for any person who violates a             2023       20,678       21,348
                                                                         requirement which relates to tobacco
                                                                         products for each such violation.
                                                        FDA...........  Penalty for aggregate of all such                 2023    1,378,541    1,423,220
                                                                         violations of tobacco product
                                                                         requirement adjudicated in a single
                                                                         proceeding.
    333(f)(9)(B)(i)(I)........  ......................  FDA...........  Penalty per violation related to                  2023      344,636      355,806
                                                                         violations of tobacco requirements.
                                                        FDA...........  Penalty for aggregate of all such                 2023    1,378,541    1,423,220
                                                                         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             2023      344,636      355,806
                                                                         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          2023    1,378,541    1,423,220
                                                                         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                 2023   13,785,420   14,232,205
                                                                         violations related to tobacco product
                                                                         requirements adjudicated in a single
                                                                         proceeding.

[[Page 64818]]

 
    333(f)(9)(B)(ii)(I).......  ......................  FDA...........  Penalty for any person who either does            2023      344,636      355,806
                                                                         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             2023    1,378,541    1,423,220
                                                                         above violations adjudicated in a single
                                                                         proceeding.
    333(f)(9)(B)(ii)(II)......  ......................  FDA...........  Penalty for violation of modified risk            2023      344,636      355,806
                                                                         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              2023    1,378,541    1,423,220
                                                                         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               2023   13,785,420   14,232,205
                                                                         product requirement violations
                                                                         adjudicated in a single proceeding.
    333(g)(1).................  ......................  FDA...........  Penalty for any person who disseminates           2023      356,580      368,137
                                                                         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                 2023      713,160      736,274
                                                                         violation in any 3-year period.
    333 note..................  ......................  FDA...........  Penalty to be applied for violations of           2023          345          356
                                                                         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          2023          687          709
                                                                         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         2023        2,757        2,846
                                                                         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          2023        6,892        7,115
                                                                         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                 2023       13,785       14,232
                                                                         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           2023          345          356
                                                                         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         2023          687          709
                                                                         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          2023        1,379        1,424
                                                                         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         2023        2,757        2,846
                                                                         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          2023        6,892        7,115
                                                                         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                 2023       13,785       14,232
                                                                         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                2023      525,406      542,434
                                                                         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 64819]]

 
                                                        FDA...........  Penalty in the case of any other person           2023    2,101,618    2,169,731
                                                                         (other than an individual) per above
                                                                         violation.
    360pp(b)(1)...............  ......................  FDA...........  Penalty for any person who violates any           2023        3,446        3,558
                                                                         such requirements for electronic
                                                                         products, with each unlawful act or
                                                                         omission constituting a separate
                                                                         violation.
                                                        FDA...........  Penalty imposed for any related series of         2023    1,174,680    1,212,751
                                                                         violations of requirements relating to
                                                                         electronic products.
42 U.S.C......................  ......................  ..............  .........................................         2023  ...........  ...........
    262(d)....................  ......................  FDA...........  Penalty per day for violation of order of         2023      270,180      278,937
                                                                         recall of biological product presenting
                                                                         imminent or substantial hazard.
    263b(h)(3)................  ......................  FDA...........  Penalty for failure to obtain a                   2023       21,018       21,699
                                                                         mammography certificate as required.
    300aa-28(b)(1)............  ......................  FDA...........  Penalty per occurrence for any vaccine            2023      270,180      278,937
                                                                         manufacturer that intentionally
                                                                         destroys, alters, falsifies, or conceals
                                                                         any record or report required.
    256b(d)(1)(B)(vi).........  ......................  HRSA..........  Penalty for each instance of overcharging         2023        6,813        7,034
                                                                         a 340B covered entity.
    299c-3(d).................  ......................  AHRQ..........  Penalty for using or disclosing                   2023       17,717       18,291
                                                                         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          2023        1,818        1,877
                                                                         National Directory of New Hires.
    262a(i)(1)................  42 CFR 1003.910.......  OIG...........  Penalty for each individual who violates          2023      410,932      424,250
                                                                         safety and security procedures related
                                                                         to handling dangerous biological agents
                                                                         and toxins.
                                42 CFR 1003.1410......  OIG...........  Penalty for any other person who violates         2023      821,868      848,505
                                                                         safety and security procedures related
                                                                         to handling dangerous biological agents
                                                                         and toxins.
    300jj-51..................                          OIG...........  Penalty per violation for committing              2023    1,252,992    1,293,601
                                                                         information blocking.
    1320a-7a(a)...............  42 CFR 1003.210(a)(1).  OIG...........  Penalty for knowingly presenting or               2023       24,164       24,947
                                                                         causing to be presented to an officer,
                                                                         employee, or agent of the United States
                                                                         a false claim.
                                                        OIG...........  Penalty for knowingly presenting or               2023       24,164       24,947
                                                                         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           2023       36,246       37,421
                                                                         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           2023       24,164       24,947
                                                                         ownership or control interest in a
                                                                         participating entity.
                                42 CFR 1003.1010......  OIG...........  Penalty for remuneration offered to               2023       24,164       24,947
                                                                         induce program beneficiaries to use
                                                                         particular providers, practitioners, or
                                                                         suppliers.
                                42 CFR 1003.210(a)(4).  OIG...........  Penalty for employing or contracting with         2023       24,164       24,947
                                                                         an excluded individual.
                                42 CFR 1003.310(a)(3).  OIG...........  Penalty for knowing and willful                   2023      120,816      124,732
                                                                         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               2023       24,164       24,947
                                                                         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           2023      120,816      124,732
                                                                         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         2023       24,164       24,947
                                                                         failing to report and return.
                                42 CFR 1003.210(a)(7).  OIG...........  Penalty for making or using a false               2023       68,128       70,336
                                                                         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               2023       36,246       37,421
                                                                         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             2023        6,040        6,236
                                                                         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              2023        6,040        6,236
                                                                         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            2023       12,081       12,473
                                                                         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               2023       11,784       12,166
                                                                         causing to be presented a false or
                                                                         fraudulent specified claim under a
                                                                         grant, contract, or other agreement for
                                                                         which the Secretary provides funding.

[[Page 64820]]

 
                                42 CFR 1003.710(a)(2).  OIG...........  Penalty for knowingly making, using, or           2023       58,921       60,831
                                                                         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           2023       58,921       60,831
                                                                         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           2023       61,458       63,450
                                                                         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           2023       12,308       12,707
                                                                         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               2023       17,677       18,250
                                                                         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           2023       46,102       47,596
                                                                         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,         2023       12,397       12,799
                                                                         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,         2023       61,982       63,991
                                                                         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              2023        2,586        2,670
                                                                         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         2023       12,924       13,343
                                                                         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           2023        5,171        5,339
                                                                         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                  2023       47,061       48,586
                                                                         organization that substantially fails to
                                                                         provide medically necessary, required
                                                                         items and services.
                                                        OIG...........  Penalty for a Medicare Advantage                  2023       46,102       47,596
                                                                         organization that charges excessive
                                                                         premiums.
                                                        OIG...........  Penalty for a Medicare Advantage                  2023       46,102       47,596
                                                                         organization that improperly expels or
                                                                         refuses to reenroll a beneficiary.
                                                        OIG...........  Penalty for a Medicare Advantage                  2023      184,412      190,389
                                                                         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               2023       27,661       28,557
                                                                         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                  2023      184,412      190,389
                                                                         organization misrepresenting or
                                                                         falsifying information to Secretary.
                                                        OIG...........  Penalty for a Medicare Advantage                  2023       46,102       47,596
                                                                         organization misrepresenting or
                                                                         falsifying information to individual or
                                                                         other entity.
                                                        OIG...........  Penalty for Medicare Advantage                    2023       46,102       47,596
                                                                         organization interfering with provider's
                                                                         advice to enrollee and non-MCO
                                                                         affiliated providers that balance bill
                                                                         enrollees.
                                                        OIG...........  Penalty for a Medicare Advantage                  2023       46,102       47,596
                                                                         organization that employs or contracts
                                                                         with excluded individual or entity.

[[Page 64821]]

 
                                                        OIG...........  Penalty for a Medicare Advantage                  2023       46,102       47,596
                                                                         organization enrolling an individual in
                                                                         without prior written consent.
                                                        OIG...........  Penalty for a Medicare Advantage                  2023       46,102       47,596
                                                                         organization transferring an enrollee to
                                                                         another plan without consent or solely
                                                                         for the purpose of earning a commission.
                                                        OIG...........  Penalty for a Medicare Advantage                  2023       46,102       47,596
                                                                         organization failing to comply with
                                                                         marketing restrictions or applicable
                                                                         implementing regulations or guidance.
                                                        OIG...........  Penalty for a Medicare Advantage                  2023       46,102       47,596
                                                                         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              2023       16,108       16,630
                                                                         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                   2023        6,266        6,469
                                                                         Hospitals, Critical Access Hospitals, or
                                                                         Skilled Nursing Facilities.
    1395dd(d)(1)..............  42 CFR 1003.510.......  OIG...........  Penalty for a hospital with 100 beds or           2023      129,232      133,420
                                                                         more or responsible physician dumping
                                                                         patients needing emergency medical care.
                                                        OIG...........  Penalty for a hospital with less than 100         2023       64,618       66,712
                                                                         beds dumping patients needing emergency
                                                                         medical care.
    1395mm(i)(6)(B)(i)........  42 CFR 1003.410.......  OIG...........  Penalty for a HMO or competitive medical          2023       64,618       66,712
                                                                         plan if such plan substantially fails to
                                                                         provide medically necessary, required
                                                                         items or services.
                                                        OIG...........  Penalty for HMOs/competitive medical              2023       64,618       66,712
                                                                         plans that charge premiums in excess of
                                                                         permitted amounts.
                                                        OIG...........  Penalty for a HMO or competitive medical          2023       64,618       66,712
                                                                         plan that expels or refuses to reenroll
                                                                         an individual per prescribed conditions.
                                                        OIG...........  Penalty for a HMO or competitive medical          2023      258,464      266,841
                                                                         plan that implements practices to
                                                                         discourage enrollment of individuals
                                                                         needing services in future.
                                                        OIG...........  Penalty per individual not enrolled in a          2023       37,190       38,395
                                                                         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          2023      258,464      266,841
                                                                         plan that misrepresents or falsifies
                                                                         information to the Secretary.
                                                        OIG...........  Penalty for a HMO or competitive medical          2023       64,618       66,712
                                                                         plan that misrepresents or falsifies
                                                                         information to an individual or any
                                                                         other entity.
                                                        OIG...........  Penalty for failure by HMO or competitive         2023       64,618       66,712
                                                                         medical plan to assure prompt payment of
                                                                         Medicare risk sharing contracts or
                                                                         incentive plan provisions.
                                                        OIG...........  Penalty for HMO that employs or contracts         2023       59,316       61,238
                                                                         with excluded individual or entity.
    1395nn(g)(3)..............  42 CFR 1003.310.......  OIG...........  Penalty for submitting or causing to be           2023       29,899       30,868
                                                                         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              2023      199,338      205,799
                                                                         violation of the Stark Law's
                                                                         restrictions on physician self-referrals.
    1395ss(d)(1)..............  42 CFR 1003.1110......  OIG...........  Penalty for a material misrepresentation          2023       12,397       12,799
                                                                         regarding Medigap compliance policies.
    1395ss(d)(2)..............  42 CFR 1003.1110......  OIG...........  Penalty for selling Medigap policy under          2023       12,397       12,799
                                                                         false pretense.
    1395ss(d)(3)(A)(ii).......  42 CFR 1003.1110......  OIG...........  Penalty for an issuer that sells health           2023       55,808       57,617
                                                                         insurance policy that duplicates
                                                                         benefits.
                                                        OIG...........  Penalty for someone other than issuer             2023       33,483       34,568
                                                                         that sells health insurance that
                                                                         duplicates benefits.
    1395ss(d)(4)(A)...........  42 CFR 1003.1110......  OIG...........  Penalty for using mail to sell a non-             2023       12,397       12,799
                                                                         approved Medigap insurance policy.
    1396b(m)(5)(B)(i).........  42 CFR 1003.410.......  OIG...........  Penalty for a Medicaid MCO that                   2023       61,982       63,991
                                                                         substantially fails to provide medically
                                                                         necessary, required items or services.
                                                        OIG...........  Penalty for a Medicaid MCO that charges           2023       61,982       63,991
                                                                         excessive premiums.
                                                        OIG...........  Penalty for a Medicaid MCO that                   2023      247,929      255,964
                                                                         improperly expels or refuses to reenroll
                                                                         a beneficiary.
                                                        OIG...........  Penalty per individual who does not               2023       37,190       38,395
                                                                         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                        2023      247,929      255,964
                                                                         misrepresenting or falsifying
                                                                         information to the Secretary.
                                                        OIG...........  Penalty for a Medicaid MCO                        2023       61,982       63,991
                                                                         misrepresenting or falsifying
                                                                         information to an individual or another
                                                                         entity.
                                                        OIG...........  Penalty for a Medicaid MCO that fails to          2023       55,808       57,617
                                                                         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               2023        2,586        2,670
                                                                         certifying a material and false
                                                                         statement in a Skilled Nursing Facility
                                                                         resident assessment.

[[Page 64822]]

 
    1396r(b)(3)(B)(ii)(II)....  42 CFR 1003.210(a)(11)  OIG...........  Penalty for willfully and knowingly               2023       12,924       13,343
                                                                         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            2023        5,171        5,339
                                                                         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              2023      223,229      230,464
                                                                         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             2023       22,324       23,048
                                                                         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            2023      223,229      230,464
                                                                         information by drug manufacturer with
                                                                         rebate agreement.
    1396t(i)(3)(A)............  42 CFR 1003.1310......  OIG...........  Penalty for notifying home and community-         2023        4,465        4,610
                                                                         based providers or settings of survey.
    11131(c)..................  42 CFR 1003.810.......  OIG...........  Penalty for failing to report a medical           2023       27,018       27,894
                                                                         malpractice claim to National
                                                                         Practitioner Data Bank.
    11137(b)(2)...............  42 CFR 1003.810.......  OIG...........  Penalty for breaching confidentiality of          2023       27,018       27,894
                                                                         information reported to National
                                                                         Practitioner Data Bank.
    299b-22(f)(1).............  42 CFR 3.404..........  OCR...........  Penalty for violation of confidentiality          2023       14,960       15,445
                                                                         provision of the Patient Safety and
                                                                         Quality Improvement Act.
    1320(d)-5(a)..............  45 CFR                  OCR...........  Penalty for each pre-February 18, 2009            2023          187          193
                                 160.404(b)(1)(i),                       violation of the HIPAA administrative
                                 (ii).                                   simplification provisions.
                                                        OCR...........  Calendar Year Cap........................         2023       47,061       48,586
    1320(d)-5(a)..............  45 CFR                  OCR...........  Penalty for each February 18, 2009 or             2023  ...........  ...........
                                 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..................................         2023          137          141
                                                                        Maximum..................................         2023       68,928       71,162
                                                                        Calendar Year Cap........................         2023    2,067,813    2,134,831
                                45 CFR                  OCR...........  Penalty for each February 18, 2009 or             2023  ...........  ...........
                                 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..................................         2023        1,379        1,424
                                                                        Maximum..................................         2023       68,928       71,162
                                                                        Calendar Year Cap........................         2023    2,067,813    2,134,831
                                45 CFR                  OCR...........  Penalty for each February 18, 2009 or             2023  ...........  ...........
                                 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..................................         2023       13,785       14,232
                                                                        Maximum..................................         2023       68,928       71,162
                                                                        Calendar Year Cap........................         2023    2,067,813    2,134,831
                                45 CFR                  OCR...........  Penalty for each February 18, 2009 or             2023  ...........  ...........
                                 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..................................         2023       68,928       71,162
                                                                        Maximum..................................         2023    2,067,813    2,134,831
                                                                        Calendar Year Cap........................         2023    2,067,813    2,134,831
42 U.S.C. 300gg-18, 42 U.S.C.   45 CFR 180.90.........  CMS...........  Penalty for a hospital's non-compliance           2023          323          333
 1302.                                                                   with making public standard charges for
                                                                         hospital items and services.
                                                                        Per Day (Maximum)........................         2023        5,926        6,118

[[Page 64823]]

 
                                45 CFR 180.90(c)(2)(i)  CMS...........  Per day penalty for a hospital's           ...........          328          339
                                                                         noncompliance with making public
                                                                         standard charges for hospital items and
                                                                         services.
                                45 CFR                  CMS...........  Per day penalty for hospitals with equal   ...........          323          333
                                 180.90(c)(2)(ii)(A).                    to or less than 30 beds.
                                45 CFR                  CMS...........  Per day, per bed penalty for hospitals     ...........           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       ...........        2,926        3,021
                                 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           2023  ...........  ...........
     136, section 3202(b)(2).                                            with price transparency requirements
                                                                         regarding diagnostic tests for COVID-19.
                                                                        Per Day (Maximum)........................         2023          323          333
    263a(h)(2)(B) & 1395w-      42 CFR                  CMS...........  Penalty for a clinical laboratory's               2023  ...........  ...........
     2(b)(2)(A)(ii).             493.1834(d)(2)(i).                      failure to meet participation and
                                                                         certification requirements and poses
                                                                         immediate jeopardy.
                                                                        Minimum..................................         2023        7,562        7,807
                                                                        Maximum..................................         2023       24,793       25,597
                                42 CFR                  CMS...........  Penalty for a clinical laboratory's               2023  ...........  ...........
                                 493.1834(d)(2)(ii).                     failure to meet participation and
                                                                         certification requirements and the
                                                                         failure does not pose immediate jeopardy.
                                                                        Minimum..................................         2023          125          129
                                                                        Maximum..................................         2023        7,437        7,678
                                42 CFR                  CMS...........  Penalty for a clinical laboratory's               2023  ...........  ...........
                                 493.1834(d)(2)(iii).                    failure to meet SARS-CoV-2 test
                                                                         reporting requirements.
                                                                        First day of noncompliance...............         2023  ...........  ...........
                                                                        Each additional day of noncompliance.....         2023  ...........  ...........
    300gg-15(f)...............  45 CFR 147.200(e).....  CMS...........  Failure to provide the Summary of                 2023        1,362        1,406
                                                                         Benefits and Coverage.
    300gg-18..................  45 CFR 158.606........  CMS...........  Penalty for violations of regulations             2023          136          140
                                                                         related to the medical loss ratio
                                                                         reporting and rebating.
                                45 CFR 180.90.........  CMS...........  Price against hospital identified by CMS          2023  ...........  ...........
                                                                         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           2023       11,445       11,816
     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                 2023  ...........  ...........
                                 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..................................         2023        1,362        1,406
                                                                        Maximum..................................         2023       13,625       14,067
                                                                        Calendar Year Cap........................         2023      204,384      211,008
    1320a-7h(b)(2)............  42 CFR 402.105(h), 42   CMS...........  Penalty for manufacturer or group                 2023  ...........  ...........
                                 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.
                                                                        Minimum..................................         2023       13,625       14,067
                                                                        Maximum..................................         2023      136,258      140,674
                                                                        Calendar Year Cap........................         2023    1,362,567    1,406,728
                                                        CMS...........  Penalty for an administrator of a                 2023      136,258      140,674
                                                                         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          2023          681          703
                                 (2), & (3).                             an administrator who fails to provide
                                                                         notice of facility closure.
                                                                        Minimum penalty for the second offense of         2023        2,045        2,111
                                                                         an administrator who fails to provide
                                                                         notice of facility closure.
                                                                        Minimum penalty for the third and                 2023        4,087        4,219
                                                                         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          2023        9,966       10,289
                                                                         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-         2023        9,399        9,704
                                                                         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         2023        7,805        8,058
                                                                         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.

[[Page 64824]]

 
    1320b-25(c)(1)(A).........                          CMS...........  Penalty for failure of covered                    2023      272,514      281,346
                                                                         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                    2023      408,769      422,017
                                                                         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.
    1320b-25(d)(2)............                          CMS...........  Penalty for a long-term care facility             2023      272,514      281,346
                                                                         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          2023          184          190
                                                                         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             2023  ...........  ...........
                                 488.408(d)(1)(iii).                     Facility that has a Category 2 violation
                                                                         of certification requirements.
                                                                        Minimum..................................         2023          129          133
                                                                        Maximum..................................         2023        7,752        8,003
                                42 CFR                  CMS...........  Penalty per instance of Category 2                2023  ...........  ...........
                                 488.408(d)(1)(iv).                      noncompliance by a Skilled Nursing
                                                                         Facility.
                                                                        Minimum..................................         2023        2,586        2,670
                                                                        Maximum..................................         2023       25,847       26,685
                                42 CFR                  CMS...........  Penalty per day for a Skilled Nursing             2023  ...........  ...........
                                 488.408(e)(1)(iii).                     Facility that has a Category 3 violation
                                                                         of certification requirements.
                                                                        Minimum..................................         2023        7,884        8,140
                                                                        Maximum..................................         2023       25,847       26,685
                                42 CFR                  CMS...........  Penalty per instance of Category 3                2023  ...........  ...........
                                 488.408(e)(1)(iv).                      noncompliance by a Skilled Nursing
                                                                         Facility.
                                                                        Minimum..................................         2023        2,586        2,670
                                                                        Maximum..................................         2023       25,847       26,685
                                42 CFR                  CMS...........  Penalty per day and per instance for a            2023  ...........  ...........
                                 488.408(e)(2)(ii).                      Skilled Nursing Facility that has
                                                                         Category 3 noncompliance with Immediate
                                                                         Jeopardy.
                                                                        Per Day (Minimum)........................         2023        7,884        8,140
                                                                        Per Day (Maximum)........................         2023       25,847       26,685
                                                                        Per Instance (Minimum)...................         2023        2,586        2,670
                                                                        Per Instance (Maximum)...................         2023       25,847       26,685
                                42 CFR                  CMS...........  Penalty per day of a Skilled Nursing              2023  ...........  ...........
                                 488.438(a)(1)(i).                       Facility that fails to meet
                                                                         certification requirements. These
                                                                         amounts represent the upper range per
                                                                         day.
                                                                        Minimum..................................         2023        7,884        8,140
                                                                        Maximum..................................         2023       25,847       26,685
                                42 CFR                  CMS...........  Penalty per day of a Skilled Nursing              2023  ...........  ...........
                                 488.438(a)(1)(ii).                      Facility that fails to meet
                                                                         certification requirements. These
                                                                         amounts represent the lower range per
                                                                         day.
                                                                        Minimum..................................         2023          129          133
                                                                        Maximum..................................         2023        7,752        8,003
                                42 CFR 488.438(a)(2)..  CMS...........  Penalty per instance of a Skilled Nursing         2023  ...........  ...........
                                                                         Facility that fails to meet
                                                                         certification requirements.
                                                                        Minimum..................................         2023        2,586        2,670
                                                                        Maximum..................................         2023       25,847       26,685
                                42 CFR 488.447........  CMS...........  Penalty imposed for failure to comply             2023  ...........  ...........
                                                                         with infection control weekly reporting
                                                                         requirements at 42 CFR 483.80(g)(1) and
                                                                         (2).
                                                                        First occurrence.........................         2023        1,158        1,196
                                                                        Incremental increases for each subsequent         2023          579          598
                                                                         occurrences.
    1395i-6(c)(5)(B)(i).......  42 CFR 488.1245.......  CMS...........  Penalty for noncompliance by hospice              2023       10,775       11,124
                                                                         program with requirements specified in
                                                                         section 1395x(dd) of 42 U.S.C.

[[Page 64825]]

 
                                42 CFR                  CMS...........  Adjustment to penalties. Maximum penalty          2023       10,775       11,124
                                 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-     ...........  ...........  ...........
                                                                         level deficiency that is immediate
                                                                         jeopardy. These amounts represent the
                                                                         upper range of penalty.
                                                                        Minimum..................................         2023        9,158        9,455
                                                                        Maximum..................................         2023       10,775       11,124
                                42 CFR                  CMS...........  Penalty imposed for hospice condition-            2023       10,775       11,124
                                 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-            2023        9,697       10,011
                                 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-            2023        9,158        9,455
                                 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      ...........  ...........  ...........
                                                                         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..................................         2023        1,616        1,668
                                                                        Maximum..................................         2023        9,158        9,455
                                42 CFR 488.1245(b)(5).  CMS...........  Penalty imposed for hospice repeat or      ...........  ...........  ...........
                                                                         condition-level deficiency or both that
                                                                         does not constitute immediate jeopardy
                                                                         and are related predominantly to
                                                                         structure or process-oriented conditions
                                                                         rather than directly related to patient
                                                                         outcomes. These amounts represent the
                                                                         lower range of penalty.
                                                                        Minimum..................................         2023          539          556
                                                                        Maximum..................................         2023        4,310        4,450
                                42 CFR 488.1245(b)(6).  CMS...........  Penalty range imposed for per instance of  ...........  ...........  ...........
                                                                         hospice noncompliance.
                                                                        Minimum..................................         2023        1,077        1,112
                                                                        Maximum..................................         2023       10,775       11,124
                                42 CFR                  CMS...........  Penalty for each per instance of hospice          2023       10,775       11,124
                                 488.1245(d)(1)(ii).                     noncompliance, maximum per day per
                                                                         hospice program.
    1395l(h)(5)(D)............  42 CFR                  CMS...........  Penalty for knowingly, willfully, and             2023       18,825       19,435
                                 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               2023        4,960        5,121
                                                                         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               2023        4,745        4,899
                                                                         failing to provide information about a
                                                                         referring physician when seeking payment
                                                                         on an unassigned basis.
    1395m(a)(11)(A)...........  42 CFR 402.1(c)(4),     CMS...........  Penalty for any durable medical equipment         2023       18,825       19,435
                                 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          2023       18,825       19,435
                                 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                  2023       18,825       19,435
                                 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            2023       18,825       19,435
                                 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)).

[[Page 64826]]

 
    1395m(j)(2)(A)(iii).......  ......................  CMS...........  Penalty for any supplier of durable               2023        1,993        2,058
                                                                         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               2023       18,825       19,435
                                 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         2023       12,551       12,958
                                                                         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              2023       18,825       19,435
                                 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             2023       18,825       19,435
                                 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         2023       18,825       19,435
                                 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             2023       18,825       19,435
                                                                         more than 125% for a non-participating
                                                                         referral. (Penalties are assessed in the
                                                                         same manner as 42 U.S.C. 1320a-7a(a)).
    1395u(k)..................  42 CFR 402.1(c)(12),    CMS...........  Penalty for any physician who knowingly           2023       18,825       19,435
                                 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                  2023       18,825       19,435
                                 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                  2023       18,825       19,435
                                 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,          2023       18,825       19,435
                                 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)).

[[Page 64827]]

 
    1395u(o)(3)(B)............  42 CFR 414.707(b).....  CMS...........  Penalty for any practitioner specified in         2023       18,825       19,435
                                                                         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         2023        4,960        5,121
                                                                         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                      2023       16,108       16,630
                                                                         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                  2023       18,825       19,435
                                 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         2023       18,825       19,435
                                 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                      2023       46,102       47,596
     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         2023       18,442       19,040
     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                  2023      171,257      176,807
     1857(g)(3): 1860D-                                                  organizations 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           2023       11,162       11,524
                                                                         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         2023        1,818        1,877
                                 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.
    1395y(b)(6)(B)............  42 CFR 402.1(c)(20),    CMS...........  Penalty for any entity that knowingly,            2023        3,988        4,117
                                 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                 2023        1,428        1,474
                                 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             2023        1,428        1,474
                                                                         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              2023       23,727       24,496
                                                                         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         2023       18,825       19,435
                                 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              2023       64,617       66,711
                                                                         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             2023       33,483       34,568
                                 402.105(e),                             that sells or issues a Medicare
                                 402.105(f)(2).                          supplemental policy to beneficiary
                                                                         without a disclosure statement.
                                                        CMS...........  Penalty for an issuer that sells or               2023       55,808       57,617
                                                                         issues a Medicare supplemental policy
                                                                         without disclosure statement.

[[Page 64828]]

 
    1395ss(d)(3)(B)(iv).......  ......................  CMS...........  Penalty for someone other than issuer             2023       33,483       34,568
                                                                         that sells or issues a Medicare
                                                                         supplemental policy without
                                                                         acknowledgement form.
                                                        CMS...........  Penalty for issuer that sells or issues a         2023       55,808       57,617
                                                                         Medicare supplemental policy without an
                                                                         acknowledgement form.
    1395ss(p)(8)..............  42 CFR 402.1(c)(25),    CMS...........  Penalty for someone other than issuer             2023       33,483       34,568
                                 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               2023       55,808       57,617
                                 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             2023       33,483       34,568
                                 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.
                                402.105(f)(3),(4).....  CMS...........  Penalty for an issuer that sells a                2023       55,808       57,617
                                                                         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)...........  402.105(f)(5).........  CMS...........  Penalty for any person that fails to              2023       55,808       57,617
                                                                         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)...........  402.105(f)(6).........  CMS...........  Penalty for any person that fails to              2023       55,808       57,617
                                                                         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              2023       23,692       24,460
                                 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.
    1395ss(t)(2)..............  42 CFR 402.1(c)(30),    CMS...........  Penalty for any issuer of a Medicare              2023       55,808       57,617
                                 402.105(f)(7).                          supplemental policy that fails to
                                                                         fulfill listed responsibilities.
    1395ss(v)(4)(A)...........  ......................  CMS...........  Penalty someone other than issuer who             2023       24,163       24,946
                                                                         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,          2023       40,272       41,577
                                                                         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           2023        5,171        5,339
                                                                         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         2023       24,793       25,597
                                 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          2023  ...........  ...........
                                                                         noncompliance (Upper Range).
                                                                        Minimum..................................         2023       21,074       21,757
                                                                        Maximum..................................         2023       24,793       25,597
                                42 CFR                  CMS...........  Penalty for a home health agency's                2023       24,793       25,597
                                 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                2023       22,313       23,036
                                 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               2023       21,074       21,757
                                 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-            2023  ...........  ...........
                                                                         level deficiency that does not
                                                                         constitute immediate jeopardy, but is
                                                                         directly related to poor quality patient
                                                                         care outcomes (Lower Range).
                                                                        Minimum..................................         2023        3,720        3,841
                                                                        Maximum..................................         2023       21,074       21,757

[[Page 64829]]

 
                                42 CFR 488.845(b)(5)..  CMS...........  Penalty for a repeat and/or condition-            2023  ...........  ...........
                                                                         level deficiency that does not
                                                                         constitute immediate jeopardy and that
                                                                         is related predominately to structure or
                                                                         process-oriented conditions (Lower
                                                                         Range).
                                                                        Minimum..................................         2023        1,240        1,280
                                                                        Maximum..................................         2023        2,479        2,559
                                42 CFR 488.845(b)(6)..  CMS...........  Penalty imposed for instance of                   2023  ...........  ...........
                                                                         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             2023        2,479        2,559
                                                                         (Minimum).
                                                                        Penalty for each day of noncompliance             2023       24,793       25,597
                                                                         (Maximum).
                                42 CFR                  CMS...........  Penalty for each day of noncompliance             2023       24,793       25,597
                                 488.845(d)(1)(ii).                      (Maximum).
    1395eee(e)(6)(B); 1396u-    42 CFR 460.46.........  CMS...........  Penalty for PACE organization that                2023       46,102       47,596
     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             2023  ...........  ...........
                                                                         result of the PACE organization's
                                                                         discrimination in enrollment or
                                                                         disenrollment or practice that would
                                                                         deny or discourage enrollment.
                                                                        Minimum..................................         2023       17,370       17,933
                                                                        Maximum..................................         2023      115,802      119,555
                                                        CMS...........  Penalty for a PACE organization that              2023       46,102       47,596
                                                                         charges excessive premiums.
                                                        CMS...........  Penalty for a PACE organization                   2023      184,412      190,389
                                                                         misrepresenting or falsifying
                                                                         information to CMS or the State.
                                                        CMS...........  Penalty for any other violation specified         2023       46,102       47,596
                                                                         in 42 CFR 460.40.
    1396r(h)(3)(C)(ii)(I).....  42 CFR                  CMS...........  Penalty per day for a nursing facility's          2023  ...........  ...........
                                 488.408(d)(1)(iii).                     failure to meet a Category 2
                                                                         Certification.
                                                                        Minimum..................................         2023          129          133
                                                                        Maximum..................................         2023        7,752        8,003
                                42 CFR                  CMS...........  Penalty per instance for a nursing                2023  ...........  ...........
                                 488.408(d)(1)(iv).                      facility's failure to meet Category 2
                                                                         certification.
                                                                        Minimum..................................         2023        2,586        2,670
                                                                        Maximum..................................         2023       25,847       26,685
                                42 CFR                  CMS...........  Penalty per day for a nursing facility's          2023  ...........  ...........
                                 488.408(e)(1)(iii).                     failure to meet Category 3 certification.
                                                                        Minimum..................................         2023        7,884        8,140
                                                                        Maximum..................................         2023       25,847       26,685
                                42 CFR                  CMS...........  Penalty per instance for a nursing                2023  ...........  ...........
                                 488.408(e)(1)(iv).                      facility's failure to meet Category 3
                                                                         certification.
                                                                        Minimum..................................         2023        2,586        2,670
                                                                        Maximum..................................         2023       25,847       26,685
                                42 CFR                  CMS...........  Penalty per instance for a nursing                2023  ...........  ...........
                                 488.408(e)(2)(ii).                      facility's failure to meet Category 3
                                                                         certification, which results in
                                                                         immediate jeopardy.
                                                                        Minimum..................................         2023        2,586        2,670
                                                                        Maximum..................................         2023       25,847       26,685
                                42 CFR                  CMS...........  Penalty per day for nursing facility's            2023  ...........  ...........
                                 488.438(a)(1)(i).                       failure to meet certification (Upper
                                                                         Range).
                                                                        Minimum..................................         2023        7,884        8,140
                                                                        Maximum..................................         2023       25,847       26,685
                                42 CFR                  CMS...........  Penalty per day for nursing facility's            2023  ...........  ...........
                                 488.438(a)(1)(ii).                      failure to meet certification (Lower
                                                                         Range).
                                                                        Minimum..................................         2023          129          133
                                                                        Maximum..................................         2023        7,752        8,003
                                42 CFR 488.438(a)(2)..  CMS...........  Penalty per instance for nursing                  2023  ...........  ...........
                                                                         facility's failure to meet certification.
                                                                        Minimum..................................         2023        2,586        2,670
                                                                        Maximum..................................         2023       25,847       26,685
                                42 CFR 488.447........  CMS...........  Penalty imposed for failure to comply             2023  ...........  ...........
                                                                         with infection control weekly reporting
                                                                         requirements at 42 CFR 483.80(g)(1) and
                                                                         (2).
                                                                        First occurrence (Minimum)...............         2023        1,158        1,196
                                                                        Incremental increases for each subsequent         2023          579          598
                                                                         occurrence.
    1396r(f)(2)(B)(iii)(I)(c).  42 CFR                  CMS...........  Grounds to prohibit approval of Nurse             2023       12,924       13,343
                                 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].

[[Page 64830]]

 
    1396r(h)(3)(C)(ii)(I).....  42 CFR 483.151(c)(2)..  CMS...........  Grounds to waive disapproval of nurse             2023       12,924       13,343
                                                                         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         2023  ...........  ...........
                                                                         a home or community care provider that
                                                                         no longer meets the minimum requirements
                                                                         for home and community care.
                                                                        Minimum..................................         2023            2            2
                                                                        Maximum..................................         2023       22,324       23,048
    1396u-2(e)(2)(A)(i).......  42 CFR 438.704........  CMS...........  Penalty for a Medicaid managed care               2023       46,102       47,596
                                                                         organization that fails substantially to
                                                                         provide medically necessary items and
                                                                         services.
                                                        CMS...........  Penalty for Medicaid managed care                 2023       46,102       47,596
                                                                         organization that imposes premiums or
                                                                         charges on enrollees in excess of the
                                                                         premiums or charges permitted.
                                                        CMS...........  Penalty for a Medicaid managed care               2023       46,102       47,596
                                                                         organization that misrepresents or
                                                                         falsifies information to another
                                                                         individual or entity.
                                                        CMS...........  Penalty for a Medicaid managed care               2023       46,102       47,596
                                                                         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               2023      184,412      190,389
                                                                         organization that misrepresents or
                                                                         falsifies information to the HHS
                                                                         Secretary.
                                                        CMS...........  Penalty for Medicaid managed care                 2023      184,412      190,389
                                                                         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         2023       27,661       28,557
                                                                         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         2023       25,847       26,685
                                 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         2023       13,785       14,232
                                 22(b)(2)(C)(i), 45                      affected by the failure of a health
                                 CFR 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 2022[bond]174[bond] 177.
    18041(c)(2)...............  45 CFR 156.805(c).....  CMS...........  Failure to comply with ACA requirements           2023          187          193
                                                                         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         2023          177          183
     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           2023       34,065       35,169
                                                                         on Exchange application.
    18081(h)(1)(B)............  45 CFR 155.285........  CMS...........  Penalty for knowingly or willfully                2023      340,641      351,681
                                                                         providing false information on Exchange
                                                                         application.
    18081(h)(2)...............  45 CFR 155.260........  CMS...........  Penalty for knowingly or willfully                2023  ...........  ...........
                                                                         disclosing protected information from
                                                                         Exchange.
                                                        CMS...........  Maximum..................................         2023       34,065       35,169
                                                        CMS...........  Minimum..................................         2023          348          359
    18041(c)(2)...............  45 CFR 155.206(i).....  CMS...........  Penalties for violation of applicable             2023       41,774       43,128
                                                                         Exchange standards by consumer
                                                                         assistance entities in Federally-
                                                                         facilitated Exchanges.
                                                                        Maximum (Per Day)........................         2023          115          119
31 U.S.C......................  ......................  ..............  .........................................         2023          348          359
    1352......................  45 CFR 93.400(e)......  HHS...........  Penalty for the first time an individual          2023       23,727       24,496
                                                                         makes an expenditure prohibited by
                                                                         regulations regarding lobbying
                                                                         disclosure, absent aggravating
                                                                         circumstances.
                                                                        Penalty for second and subsequent                 2023  ...........  ...........
                                                                         offenses by individuals who make an
                                                                         expenditure prohibited by regulations
                                                                         regarding lobbying disclosure.
                                                                        Minimum..................................         2023       23,727       24,496

[[Page 64831]]

 
                                                                        Maximum..................................         2023      237,268      244,958
                                                        HHS...........  Penalty for the first time an individual          2023       23,727       24,496
                                                                         fails to file or amend a lobbying
                                                                         disclosure form, absent aggravating
                                                                         circumstances.
                                                                        Penalty for second and subsequent                 2023  ...........  ...........
                                                                         offenses by individuals who fail to file
                                                                         or amend a lobbying disclosure form,
                                                                         absent aggravating circumstances.
                                                                        Minimum..................................         2023       23,727       24,496
                                                                        Maximum..................................         2023      237,268      244,958
                                45 CFR part 93,         HHS...........  Penalty for failure to provide                    2023  ...........  ...........
                                 Appendix A.                             certification regarding lobbying in the
                                                                         award documents for all sub-awards of
                                                                         all tiers.
                                                                        Minimum..................................         2023       23,727       24,496
                                                                        Maximum..................................         2023      237,268      244,958
                                                        HHS...........  Penalty for failure to provide statement          2023  ...........  ...........
                                                                         regarding lobbying for loan guarantee
                                                                         and loan insurance transactions.
                                                                        Minimum..................................         2023       23,727       24,496
                                                                        Maximum..................................         2023      237,268      244,958
    3801-3812.................  45 CFR 79.3(a)(1)(iv).  HHS...........  Penalty against any individual who--with          2023       12,398       12,800
                                                                         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          2023       12,398       12,800
                                                                         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, and M-24-07 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 2023 CPI-U (307.671)/
  October 2022 CPI-U (298.012) = 1.03241.



[[Page 64832]]

Xavier Becerra,
Secretary, Department of Health and Human Services.

[FR Doc. 2024-17466 Filed 8-7-24; 8:45 am]
BILLING CODE 4150-24-P