[Federal Register Volume 88, Number 193 (Friday, October 6, 2023)]
[Rules and Regulations]
[Pages 69531-69553]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-22264]


=======================================================================
-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

SUMMARY: The Department of Health and Human Services (HHS) is updating 
its regulations to reflect required annual inflation-related increases 
to the civil monetary penalty (CMP) amounts in its regulations, under 
the Federal Civil Penalties Inflation Adjustment Act Improvements Act 
of 2015 and adds references to new penalty authorities.

DATES: 
    Effective date: This final rule is effective October 6, 2023.
    Applicability date: The adjusted civil monetary penalty amounts 
apply to penalties assessed on or after the date of publication to the 
Federal Register, if the violation occurred on or after November 2, 
2015.

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

SUPPLEMENTARY INFORMATION:

I. Background

    The Federal Civil Penalties Inflation Adjustment Act Improvements 
Act of 2015 (section 701 of Pub. L. 114-74) (the ``2015 Act'') amended 
the Federal Civil Penalties Inflation Adjustment Act of 1990 (Pub. L. 
101-410, 104 Stat. 890 (1990)), which is intended to improve the 
effectiveness of CMPs and to maintain the deterrent effect of such 
penalties, requires agencies to adjust the CMPs for inflation annually.
    HHS lists the CMP authorities and the amounts administered by all 
of its agencies in tabular form in 45 CFR 102.3, which was issued in an 
interim final rule published in the September 6, 2016, Federal Register 
(81 FR 61538). Annual adjustments were subsequently published on 
February 3, 2017 (82 FR 9175), October 11, 2018 (83 FR 51369), November 
5, 2019 (84 FR 59549), January 17, 2020 (85 FR 2869), November 15, 2021 
(86 FR 62928), and March 17, 2022 (87 FR 15100).

II. Calculation of Annual Inflation Adjustment and Other Updates

    The annual inflation adjustment for each applicable CMP is 
determined using the percent increase in the Consumer Price Index for 
all Urban Consumers (CPI-U) for the month of October of the year in 
which the amount of each CMP was most recently established or modified. 
In the December 15, 2022, Office of Management and Budget (OMB) 
Memorandum for the Heads of Executive Agencies and Departments, M-23-
05, ``Implementation of Penalty Inflation Adjustments for 2023, 
Pursuant to the Federal Civil Penalties Inflation Adjustment Act 
Improvements Act of 2015,'' OMB published the multiplier for the 
required annual adjustment. The cost-of-living adjustment multiplier 
for 2023, based on the CPI-U for the month of October 2022, not 
seasonally adjusted, is 1.07745. The multiplier is applied to each 
applicable penalty amount that was updated and published for fiscal 
year (FY) 2022 and is rounded to the nearest dollar.
    In addition to the inflation adjustments for 2023, this final rule 
updates the table in 45 CFR 102.3 to add references to new, applicable 
CMP authorities that were established or implemented since the 
publication of the March 17, 2022, update and that are being updated in 
this rule.
    First, in the final rule, ``Medicare and Medicaid Program: Hospital 
Outpatient Prospective Payment and Ambulatory Surgical Center Payment 
Systems and Quality Reporting Programs; Price Transparency of Hospital 
Standard Charges; Radiation Oncology Model'' final rule with comment 
period (86 FR 63548, November 16, 2021), the Centers for Medicare & 
Medicaid Services (CMS) finalized a new provision, effective January 1, 
2022, at 45 CFR 180.90(c)(ii) to increase the CMP amounts associated 
with a hospital's noncompliance with

[[Page 69532]]

price transparency disclosure and display requirements at 45 CFR 
180.40, 180.50, and 180.60.
    Second, in the final rule, ``Medicare and Medicaid Programs; CY 
2022 Home Health Prospective Payment System Rate Update; Home Health 
Value-Based Purchasing Model Requirements and Model Expansion; Home 
Health and Other Quality Reporting Program Requirements; Home Infusion 
Therapy Services Requirements; Survey and Enforcement Requirements for 
Hospice Programs; Medicare Provider Enrollment Requirements; and COVID-
19 Reporting Requirements for Long-Term Care Facilities'' final rule 
(86 FR 62240, November 9, 2021), CMS finalized a new provision, 
effective January 1, 2022, establishing enforcement remedies for 
noncompliant hospice programs, including a CMP remedy at 42 CFR 
488.1245. This final rule implemented Division CC, section 407 of the 
Consolidated Appropriations Act, 2021 which added a new section 1822 of 
the Social Security Act for hospice program survey and enforcement 
requirements, specifically authorizing the Secretary to establish CMPs 
in an amount not to exceed $10,000 for each day of noncompliance by a 
hospice program (see 42 U.S.C. 1395i-6(c)(5)(B)(i)).
    The table has been modified to reflect these new regulatory and 
statutory amounts.

III. Statutory and Executive Order Reviews and Waiver of Proposed 
Rulemaking

    The 2015 Act requires Federal agencies to publish annual penalty 
inflation adjustments notwithstanding section 553 of the Administrative 
Procedure Act (APA). Section 4(a) of the 2015 Act directs Federal 
agencies to publish annual adjustments no later than January 15th of 
each year thereafter. In accordance with section 553 of the APA, most 
rules are subject to notice and comment and are effective no earlier 
than 30 days after publication in the Federal Register. However, 
section 4(b)(2) of the 2015 Act provides that each agency shall make 
the annual inflation adjustments ``notwithstanding section 553'' of the 
APA. According to OMB's Memorandum M-23-05, the phrase 
``notwithstanding section 553'' in section 4(b)(2) of the 2015 Act 
means that ``the public procedure the APA generally requires--notice, 
an opportunity for comment, and a delay in effective date--is not 
required for agencies to issue regulations implementing the annual 
adjustment.''
    Consistent with the language of the 2015 Act and OMB's 
implementation guidance, the inflation adjustments set out in this rule 
are not subject to notice and an opportunity for public comment and 
will be effective immediately upon publication. Additionally, HHS finds 
that notice and comment procedures would be impracticable and 
unnecessary under the APA for making the statutorily required inflation 
updates to newly established penalty amounts.
    Pursuant to OMB Memorandum M-23-05, HHS has determined that the 
annual inflation adjustment to the civil monetary penalties in its 
regulations does not trigger any requirements under procedural statutes 
and Executive Orders that govern rulemaking procedures.

IV. Effective and Applicability Dates

    This rule is effective on the date specified in the DATES section 
of this final rule. The adjusted civil monetary penalty amounts apply 
to penalties assessed on or after the date specified in the DATES 
section of this final rule, if the violation occurred on or after 
November 2, 2015. If the violation occurred before November 2, 2015, or 
a penalty was assessed before September 6, 2016, the pre-adjustment 
civil penalty amounts in effect before September 6, 2016, will apply.

List of Subjects in 45 CFR Part 102

    Administrative practice and procedure, Penalties.

    For reasons discussed in the preamble, the Department of Health and 
Human Services amends subtitle A, title 45 of the Code of Federal 
Regulations as follows:

PART 102--ADJUSTMENT OF CIVIL MONETARY PENALTIES FOR INFLATION

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.

* * * * *

                                     Table 1 to Sec.   102.3--Civil Monetary Penalty Authorities Administered by HHS
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                     Date of
                                                                                                                       last         2022         2023
                                                                                                                     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           2022      115,054      123,965
                                                                                          related to drug 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            2022    2,301,065    2,479,282
                                                                                          related to drug 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           2022      230,107      247,929
                                                                                          make a report required
                                                                                          by 21 U.S.C.
                                                                                          353(d)(3)(E) relating
                                                                                          to drug samples.
    333(f)(1)(A)......................  .........................  FDA                   Penalty for any person           2022       31,076       33,483
                                                                                          who violates a
                                                                                          requirement related to
                                                                                          devices for each such
                                                                                          violation.
                                                                   FDA                   Penalty for aggregate of         2022    2,071,819    2,232,281
                                                                                          all violations related
                                                                                          to devices in a single
                                                                                          proceeding.

[[Page 69533]]

 
    333(f)(2)(A)......................  .........................  FDA                   Penalty for any                  2022       87,362       94,128
                                                                                          individual who
                                                                                          introduces or delivers
                                                                                          for introduction into
                                                                                          interstate commerce
                                                                                          food that is
                                                                                          adulterated per 21
                                                                                          U.S.C. 342(a)(2)(B) or
                                                                                          any individual who does
                                                                                          not comply with a
                                                                                          recall order under 21
                                                                                          U.S.C. 350l.
                                                                   FDA                   Penalty in the case of           2022      436,809      470,640
                                                                                          any other person (other
                                                                                          than an individual) for
                                                                                          such introduction or
                                                                                          delivery of adulterated
                                                                                          food.
                                                                   FDA                   Penalty for aggregate of         2022      873,618      941,280
                                                                                          all such violations
                                                                                          related to adulterated
                                                                                          food adjudicated in a
                                                                                          single proceeding.
    333(f)(3)(A)......................  .........................  FDA                   Penalty for all                  2022       13,237       14,262
                                                                                          violations adjudicated
                                                                                          in a single proceeding
                                                                                          for any person who
                                                                                          violates 21 U.S.C.
                                                                                          331(jj) by failing to
                                                                                          submit the
                                                                                          certification required
                                                                                          by 42 U.S.C.
                                                                                          282(j)(5)(B) or
                                                                                          knowingly submitting a
                                                                                          false certification; by
                                                                                          failing to submit
                                                                                          clinical trial
                                                                                          information under 42
                                                                                          U.S.C. 282(j); or by
                                                                                          submitting clinical
                                                                                          trial information under
                                                                                          42 U.S.C. 282(j) that
                                                                                          is false or misleading
                                                                                          in any particular under
                                                                                          42 U.S.C. 282(j)(5)(D).
    333(f)(3)(B)......................  .........................  FDA                   Penalty for each day any         2022       13,237       14,262
                                                                                          above violation is not
                                                                                          corrected after a 30-
                                                                                          day period following
                                                                                          notification until the
                                                                                          violation is corrected.
    333(f)(4)(A)(i)...................  .........................  FDA                   Penalty for any                  2022      330,948      356,580
                                                                                          responsible person that
                                                                                          violates a requirement
                                                                                          of 21 U.S.C. 355(o)
                                                                                          (post-marketing
                                                                                          studies, clinical
                                                                                          trials, labeling), 21
                                                                                          U.S.C. 355(p) (risk
                                                                                          evaluation and
                                                                                          mitigation (REMS)), or
                                                                                          21 U.S.C. 355-1 (REMS).
                                                                   FDA                   Penalty for aggregate of         2022    1,323,791    1,426,319
                                                                                          all such above
                                                                                          violations in a single
                                                                                          proceeding.
    333(f)(4)(A)(ii)..................  .........................  FDA                   Penalty for REMS                 2022      330,948      356,580
                                                                                          violation that
                                                                                          continues after written
                                                                                          notice to the
                                                                                          responsible person for
                                                                                          the first 30-day period
                                                                                          (or any portion
                                                                                          thereof) the
                                                                                          responsible person
                                                                                          continues to be in
                                                                                          violation.
                                                                   FDA                   Penalty for REMS                 2022    1,323,791    1,426,319
                                                                                          violation that
                                                                                          continues after written
                                                                                          notice to responsible
                                                                                          person doubles for
                                                                                          every 30-day period
                                                                                          thereafter the
                                                                                          violation continues,
                                                                                          but may not exceed
                                                                                          penalty amount for any
                                                                                          30-day period.
                                                                   FDA                   Penalty for aggregate of         2022   13,237,910   14,263,186
                                                                                          all such above
                                                                                          violations adjudicated
                                                                                          in a single proceeding.
    333(f)(9)(A)......................  .........................  FDA                   Penalty for any person           2022       19,192       20,678
                                                                                          who violates a
                                                                                          requirement which
                                                                                          relates to tobacco
                                                                                          products for each such
                                                                                          violation.
                                                                   FDA                   Penalty for aggregate of         2022    1,279,448    1,378,541
                                                                                          all such violations of
                                                                                          tobacco product
                                                                                          requirement adjudicated
                                                                                          in a single proceeding.
    333(f)(9)(B)(i)(I)................  .........................  FDA                   Penalty per violation            2022      319,863      344,636
                                                                                          related to violations
                                                                                          of tobacco requirements.
                                                                   FDA                   Penalty for aggregate of         2022    1,279,448    1,378,541
                                                                                          all such violations of
                                                                                          tobacco product
                                                                                          requirements
                                                                                          adjudicated in a single
                                                                                          proceeding.
    333(f)(9)(B)(i)(II)...............  .........................  FDA                   Penalty in the case of a         2022      319,863      344,636
                                                                                          violation of tobacco
                                                                                          product requirements
                                                                                          that continues after
                                                                                          written notice to such
                                                                                          person, for the first
                                                                                          30-day period (or any
                                                                                          portion thereof) the
                                                                                          person continues to be
                                                                                          in violation.

[[Page 69534]]

 
                                                                   FDA                   Penalty for violation of         2022    1,279,448    1,378,541
                                                                                          tobacco product
                                                                                          requirements that
                                                                                          continues after written
                                                                                          notice to such person
                                                                                          shall double for every
                                                                                          30-day period
                                                                                          thereafter the
                                                                                          violation continues,
                                                                                          but may not exceed
                                                                                          penalty amount for any
                                                                                          30-day period.
                                                                   FDA                   Penalty for aggregate of         2022   12,794,487   13,785,420
                                                                                          all such violations
                                                                                          related to tobacco
                                                                                          product requirements
                                                                                          adjudicated in a single
                                                                                          proceeding.
    333(f)(9)(B)(ii)(I)...............  .........................  FDA                   Penalty for any person           2022      319,863      344,636
                                                                                          who either does not
                                                                                          conduct post-market
                                                                                          surveillance and
                                                                                          studies to determine
                                                                                          impact of a modified
                                                                                          risk tobacco product
                                                                                          for which the HHS
                                                                                          Secretary has provided
                                                                                          them an order to sell,
                                                                                          or who does not submit
                                                                                          a protocol to the HHS
                                                                                          Secretary after being
                                                                                          notified of a
                                                                                          requirement to conduct
                                                                                          post-market
                                                                                          surveillance of such
                                                                                          tobacco products.
                                                                   FDA                   Penalty for aggregate of         2022    1,279,448    1,378,541
                                                                                          for all such above
                                                                                          violations adjudicated
                                                                                          in a single proceeding.
    333(f)(9)(B)(ii)(II)..............  .........................  FDA                   Penalty for violation of         2022      319,863      344,636
                                                                                          modified risk tobacco
                                                                                          product post-market
                                                                                          surveillance that
                                                                                          continues after written
                                                                                          notice to such person
                                                                                          for the first 30-day
                                                                                          period (or any portion
                                                                                          thereof) that the
                                                                                          person continues to be
                                                                                          in violation.
                                                                   FDA                   Penalty for post-notice          2022    1,279,448    1,378,541
                                                                                          violation of modified
                                                                                          risk tobacco product
                                                                                          post-market
                                                                                          surveillance shall
                                                                                          double for every 30-day
                                                                                          period thereafter that
                                                                                          the tobacco product
                                                                                          requirement violation
                                                                                          continues for any 30-
                                                                                          day period, but may not
                                                                                          exceed penalty amount
                                                                                          for any 30-day period.
                                                                   ....................  Penalty for aggregate            2022   12,794,487   13,785,420
                                                                                          above tobacco product
                                                                                          requirement violations
                                                                                          adjudicated in a single
                                                                                          proceeding.
    333(g)(1).........................  .........................  FDA                   Penalty for any person           2022      330,948      356,580
                                                                                          who disseminates or
                                                                                          causes another party to
                                                                                          disseminate a direct-to-
                                                                                          consumer advertisement
                                                                                          that is false or
                                                                                          misleading for the
                                                                                          first such violation in
                                                                                          any 3-year period.
                                                                                         Penalty for each                 2022      661,896      713,160
                                                                                          subsequent above
                                                                                          violation in any 3-year
                                                                                          period.
    333 note..........................  .........................  FDA                   Penalty to be applied            2022          320          345
                                                                                          for violations of 21
                                                                                          U.S.C. 387f(d)(5) or of
                                                                                          violations of
                                                                                          restrictions on the
                                                                                          sale or distribution of
                                                                                          tobacco products
                                                                                          promulgated under 21
                                                                                          U.S.C. 387f(d) (e.g.,
                                                                                          violations of
                                                                                          regulations in 21 CFR
                                                                                          part 1140) with respect
                                                                                          to a retailer with an
                                                                                          approved training
                                                                                          program in the case of
                                                                                          a second regulation
                                                                                          violation within a 12-
                                                                                          month period.
                                                                   FDA                   Penalty in the case of a         2022          638          687
                                                                                          third violation 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         2022        2,559        2,757
                                                                                          fourth violation 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         2022        6,397        6,892
                                                                                          fifth violation of 21
                                                                                          U.S.C. 387f(d)(5) or of
                                                                                          the tobacco product
                                                                                          regulations within a 36-
                                                                                          month period.

[[Page 69535]]

 
                                                                   FDA                   Penalty in the case of a         2022       12,794       13,785
                                                                                          sixth or subsequent
                                                                                          violation of 21 U.S.C.
                                                                                          387f(d)(5) or of the
                                                                                          tobacco product
                                                                                          regulations within a 48-
                                                                                          month period as
                                                                                          determined on a case-by-
                                                                                          case basis.
                                                                   FDA                   Penalty to be applied            2022          320          345
                                                                                          for violations of 21
                                                                                          U.S.C. 387f(d)(5) or of
                                                                                          violations of
                                                                                          restrictions on the
                                                                                          sale or distribution of
                                                                                          tobacco products
                                                                                          promulgated under 21
                                                                                          U.S.C. 387f(d) (e.g.,
                                                                                          violations of
                                                                                          regulations in 21 CFR
                                                                                          part 1140) with respect
                                                                                          to a retailer that does
                                                                                          not have an approved
                                                                                          training program in the
                                                                                          case of the first
                                                                                          regulation violation.
                                                                   FDA                   Penalty in the case of a         2022          638          687
                                                                                          second violation 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         2022        1,280        1,379
                                                                                          third violation 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         2022        2,559        2,757
                                                                                          fourth violation 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         2022        6,397        6,892
                                                                                          fifth violation 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         2022       12,794       13,785
                                                                                          sixth or subsequent
                                                                                          violation of 21 U.S.C.
                                                                                          387f(d)(5) or of the
                                                                                          tobacco product
                                                                                          regulations within a 48-
                                                                                          month period as
                                                                                          determined on a case-by-
                                                                                          case basis.
    335b(a)...........................  .........................  FDA                   Penalty for each                 2022      487,638      525,406
                                                                                          violation for any
                                                                                          individual who made a
                                                                                          false statement or
                                                                                          misrepresentation of a
                                                                                          material fact, bribed,
                                                                                          destroyed, altered,
                                                                                          removed, or secreted,
                                                                                          or procured the
                                                                                          destruction,
                                                                                          alteration, removal, or
                                                                                          secretion of, any
                                                                                          material document,
                                                                                          failed to disclose a
                                                                                          material fact,
                                                                                          obstructed an
                                                                                          investigation, employed
                                                                                          a consultant who was
                                                                                          debarred, debarred
                                                                                          individual provided
                                                                                          consultant services.
                                                                   FDA                   Penalty in the case of           2022    1,950,548    2,101,618
                                                                                          any other person (other
                                                                                          than an individual) per
                                                                                          above violation.
    360pp(b)(1).......................  .........................  FDA                   Penalty for any person           2022        3,198        3,446
                                                                                          who violates any such
                                                                                          requirements for
                                                                                          electronic products,
                                                                                          with each unlawful act
                                                                                          or omission
                                                                                          constituting a separate
                                                                                          violation.
                                                                   FDA                   Penalty imposed for any          2022    1,090,241    1,174,680
                                                                                          related series of
                                                                                          violations of
                                                                                          requirements relating
                                                                                          to electronic products.
42 U.S.C..............................  .........................  ....................  ........................         2022            0  ...........
    262(d)............................  .........................  FDA                   Penalty per day for              2022      250,759      270,180
                                                                                          violation of order of
                                                                                          recall of biological
                                                                                          product presenting
                                                                                          imminent or substantial
                                                                                          hazard.
    263b(h)(3)........................  .........................  FDA                   Penalty for failure to           2022       19,507       21,018
                                                                                          obtain a mammography
                                                                                          certificate as required.
    300aa-28(b)(1)....................  .........................  FDA                   Penalty per occurrence           2022      250,759      270,180
                                                                                          for any vaccine
                                                                                          manufacturer that
                                                                                          intentionally destroys,
                                                                                          alters, falsifies, or
                                                                                          conceals any record or
                                                                                          report required.
    256b(d)(1)(B)(vi).................  .........................  HRSA                  Penalty for each                 2022        6,323        6,813
                                                                                          instance of
                                                                                          overcharging a 340B
                                                                                          covered entity.

[[Page 69536]]

 
    299c-3(d).........................  .........................  AHRQ                  Penalty for using or             2022       16,443       17,717
                                                                                          disclosing identifiable
                                                                                          information obtained in
                                                                                          the course of
                                                                                          activities undertaken
                                                                                          pursuant to Title IX of
                                                                                          the Public Health
                                                                                          Service Act, for a
                                                                                          purpose other than that
                                                                                          for which the
                                                                                          information was
                                                                                          supplied, without
                                                                                          consent to do so.
    653(l)(2).........................  45 CFR 303.21(f).........  ACF                   Penalty for Misuse of            2022        1,687        1,818
                                                                                          Information in the
                                                                                          National Directory of
                                                                                          New Hires.
    262a(i)(1)........................  42 CFR 1003.910..........  OIG                   Penalty for each                 2022      381,393      410,932
                                                                                          individual who violates
                                                                                          safety and security
                                                                                          procedures related to
                                                                                          handling dangerous
                                                                                          biological agents and
                                                                                          toxins.
                                                                   OIG                   Penalty for any other            2022      762,790      821,868
                                                                                          person who violates
                                                                                          safety and security
                                                                                          procedures related to
                                                                                          handling dangerous
                                                                                          biological agents and
                                                                                          toxins.
    300jj-51..........................  .........................  OIG                   Penalty per violation            2022    1,162,924    1,252,992
                                                                                          for committing
                                                                                          information blocking.
    1320a-7a(a).......................  42 CFR 1003.210(a)(1)....  OIG                   Penalty for knowingly            2022       22,427       24,164
                                                                                          presenting or causing
                                                                                          to be presented to an
                                                                                          officer, employee, or
                                                                                          agent of the United
                                                                                          States a false claim.
                                                                   OIG                   Penalty for knowingly            2022       22,427       24,164
                                                                                          presenting or 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            2022       33,641       36,246
                                                                                          giving or causing to be
                                                                                          presented to a
                                                                                          participating provider
                                                                                          or supplier false or
                                                                                          misleading information
                                                                                          that could reasonably
                                                                                          be expected to
                                                                                          influence a discharge
                                                                                          decision.
                                        42 CFR 1003.210(a)(3)....  OIG                   Penalty for an excluded          2022       22,427       24,164
                                                                                          party retaining
                                                                                          ownership or control
                                                                                          interest in a
                                                                                          participating entity.
                                        42 CFR 1003.1010.........  OIG                   Penalty for remuneration         2022       22,427       24,164
                                                                                          offered to induce
                                                                                          program beneficiaries
                                                                                          to use particular
                                                                                          providers,
                                                                                          practitioners, or
                                                                                          suppliers.
                                        42 CFR 1003.210(a)(4)....  OIG                   Penalty for employing or         2022       22,427       24,164
                                                                                          contracting with an
                                                                                          excluded individual.
                                        42 CFR 1003.310(a)(3)....  OIG                   Penalty for knowing and          2022      112,131      120,816
                                                                                          willful solicitation,
                                                                                          receipt, offer, or
                                                                                          payment of remuneration
                                                                                          for referring an
                                                                                          individual for a
                                                                                          service or for
                                                                                          purchasing, leasing, or
                                                                                          ordering an item to be
                                                                                          paid for by a Federal
                                                                                          health care program.
                                        42 CFR 1003.210(a)(1)....  OIG                   Penalty for ordering or          2022       22,427       24,164
                                                                                          prescribing 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            2022      112,131      120,816
                                                                                          making or causing to be
                                                                                          made a false statement,
                                                                                          omission or
                                                                                          misrepresentation of a
                                                                                          material fact in any
                                                                                          application, bid, or
                                                                                          contract to participate
                                                                                          or enroll as a provider
                                                                                          or supplier.
                                        42 CFR 1003.210(a)(8)....  OIG                   Penalty for knowing of           2022       22,427       24,164
                                                                                          an overpayment and
                                                                                          failing to report and
                                                                                          return.
                                        42 CFR 1003.210(a)(7)....  OIG                   Penalty for making or            2022       63,231       68,128
                                                                                          using a false record or
                                                                                          statement that is
                                                                                          material to a false or
                                                                                          fraudulent claim.
                                        42 CFR 1003.210(a)(9)....  OIG                   Penalty for failure to           2022       33,641       36,246
                                                                                          grant timely access to
                                                                                          HHS OIG for audits,
                                                                                          investigations,
                                                                                          evaluations, and other
                                                                                          statutory functions of
                                                                                          HHS OIG.
    1320a-7a(b).......................  .........................  OIG                   Penalty for payments by          2022        5,606        6,040
                                                                                          a hospital or critical
                                                                                          access hospital to
                                                                                          induce a physician to
                                                                                          reduce or limit
                                                                                          services to individuals
                                                                                          under direct care of
                                                                                          physician or who are
                                                                                          entitled to certain
                                                                                          medical assistance
                                                                                          benefits.

[[Page 69537]]

 
                                                                   OIG                   Penalty for physicians           2022        5,606        6,040
                                                                                          who knowingly receive
                                                                                          payments from a
                                                                                          hospital or critical
                                                                                          access hospital to
                                                                                          induce such physician
                                                                                          to reduce or limit
                                                                                          services to individuals
                                                                                          under direct care of
                                                                                          physician or who are
                                                                                          entitled to certain
                                                                                          medical assistance
                                                                                          benefits.
                                        42 CFR 1003.210(a)(10)...  OIG                   Penalty for a physician          2022       11,213       12,081
                                                                                          who executes a document
                                                                                          that falsely certifies
                                                                                          home health needs for
                                                                                          Medicare beneficiaries.
    1320a-7a(o).......................  .........................  OIG                   Penalty for knowingly            2022       10,937       11,784
                                                                                          presenting or causing
                                                                                          to be presented a false
                                                                                          or fraudulent specified
                                                                                          claim under a grant,
                                                                                          contract, or other
                                                                                          agreement for which the
                                                                                          Secretary provides
                                                                                          funding.
                                                                   OIG                   Penalty for knowingly            2022       54,686       58,921
                                                                                          making, using, or
                                                                                          causing to be made or
                                                                                          used any false
                                                                                          statement, omission, or
                                                                                          misrepresentation of a
                                                                                          material fact in any
                                                                                          application, proposal,
                                                                                          bid, progress report,
                                                                                          or other document
                                                                                          required to directly or
                                                                                          indirectly receive or
                                                                                          retain funds provided
                                                                                          pursuant to grant,
                                                                                          contract, or other
                                                                                          agreement.
                                                                   OIG                   Penalty for Knowingly            2022       54,686       58,921
                                                                                          making, using, or
                                                                                          causing to be made or
                                                                                          used, a false record or
                                                                                          statement material to a
                                                                                          false or fraudulent
                                                                                          specified claim under
                                                                                          grant, contract, or
                                                                                          other agreement.
                                                                   OIG                   Penalty for knowingly            2022  53,772 each  61,458 each
                                                                                          making, using, or                           false        false
                                                                                          causing to be made or                   record or    record or
                                                                                          used, a false record or                statement,   statement,
                                                                                          statement material to                  10,754 per   12,308 per
                                                                                          an obligation to pay or                       day          day
                                                                                          transmit funds or
                                                                                          property with respect
                                                                                          to grant, contract, or
                                                                                          other agreement, or
                                                                                          knowingly conceals or
                                                                                          improperly avoids or
                                                                                          decreases any such
                                                                                          obligation.
                                                                   OIG                   Penalty for failure to           2022       16,406       17,677
                                                                                          grant timely access,
                                                                                          upon reasonable
                                                                                          request, to the I.G.
                                                                                          for purposes of audits,
                                                                                          investigations,
                                                                                          evaluations, or other
                                                                                          statutory functions of
                                                                                          I.G. in matters
                                                                                          involving grants,
                                                                                          contracts, or other
                                                                                          agreements.
    1320a-7e(b)(6)(A).................  42 CFR 1003.810..........  OIG                   Penalty for failure to           2022       42,788       46,102
                                                                                          report any final
                                                                                          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           2022       11,506       12,397
                                                                                          of words, symbols, or
                                                                                          emblems in
                                                                                          communications in a
                                                                                          manner in which a
                                                                                          person could falsely
                                                                                          construe that such item
                                                                                          is approved, endorsed,
                                                                                          or authorized by HHS.
    1320b-10(b)(2)....................  42 CFR 1003.610(a).......  OIG                   Penalty for the misuse           2022       57,527       61,982
                                                                                          of words, symbols, or
                                                                                          emblems in a broadcast
                                                                                          or telecast in a manner
                                                                                          in which a person could
                                                                                          falsely construe that
                                                                                          such item is approved,
                                                                                          endorsed, or authorized
                                                                                          by HHS.
    1395i-3(b)(3)(B)(ii)(1)...........  42 CFR 1003.210(a)(11)...  OIG                   Penalty for                      2022        2,400        2,586
                                                                                          certification of a
                                                                                          false 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              2022       11,995       12,924
                                                                                          another to certify or
                                                                                          make a false statement
                                                                                          in assessment of
                                                                                          functional capacity of
                                                                                          a Skilled Nursing
                                                                                          Facility resident
                                                                                          assessment.

[[Page 69538]]

 
    1395i-3(g)(2)(A)..................  42 CFR 1003.1310.........  OIG                   Penalty for any                  2022        4,799        5,171
                                                                                          individual who notifies
                                                                                          or causes to be
                                                                                          notified a Skilled
                                                                                          Nursing Facility of the
                                                                                          time or date on which a
                                                                                          survey is to be
                                                                                          conducted.
    1395w-27(g)(2)(A).................  42 CFR 1003.410..........  OIG                   Penalty for a Medicare           2022       43,678       47,061
                                                                                          Advantage organization
                                                                                          that substantially
                                                                                          fails to provide
                                                                                          medically necessary,
                                                                                          required items and
                                                                                          services.
                                                                   OIG                   Penalty for a Medicare           2022       42,788       46,102
                                                                                          Advantage organization
                                                                                          that charges excessive
                                                                                          premiums.
                                                                   OIG                   Penalty for a Medicare           2022       42,788       46,102
                                                                                          Advantage organization
                                                                                          that improperly expels
                                                                                          or refuses to reenroll
                                                                                          a beneficiary.
                                                                   OIG                   Penalty for a Medicare           2022      171,156      184,412
                                                                                          Advantage organization
                                                                                          that engages in
                                                                                          practice that would
                                                                                          reasonably be expected
                                                                                          to have the effect of
                                                                                          denying or discouraging
                                                                                          enrollment.
                                                                   OIG                   Penalty per individual           2022       25,673       27,661
                                                                                          who does not enroll as
                                                                                          a result of a Medicare
                                                                                          Advantage
                                                                                          organization's practice
                                                                                          that would reasonably
                                                                                          be expected to have the
                                                                                          effect of denying or
                                                                                          discouraging enrollment.
                                                                   OIG                   Penalty for a Medicare           2022      171,156      184,412
                                                                                          Advantage organization
                                                                                          misrepresenting or
                                                                                          falsifying information
                                                                                          to Secretary.
                                                                   OIG                   Penalty for a Medicare           2022       42,788       46,102
                                                                                          Advantage organization
                                                                                          misrepresenting or
                                                                                          falsifying information
                                                                                          to individual or other
                                                                                          entity.
                                                                   OIG                   Penalty for Medicare             2022       42,788       46,102
                                                                                          Advantage organization
                                                                                          interfering with
                                                                                          provider's advice to
                                                                                          enrollee and non-MCO
                                                                                          affiliated providers
                                                                                          that balance bill
                                                                                          enrollees.
                                                                   OIG                   Penalty for a Medicare           2022       42,788       46,102
                                                                                          Advantage organization
                                                                                          that employs or
                                                                                          contracts with excluded
                                                                                          individual or entity.
                                                                   OIG                   Penalty for a Medicare           2022       42,788       46,102
                                                                                          Advantage organization
                                                                                          enrolling an individual
                                                                                          in without prior
                                                                                          written consent.
                                                                   OIG                   Penalty for a Medicare           2022       42,788       46,102
                                                                                          Advantage organization
                                                                                          transferring an
                                                                                          enrollee to another
                                                                                          plan without consent or
                                                                                          solely for the purpose
                                                                                          of earning a commission.
                                                                   OIG                   Penalty for a Medicare           2022       42,788       46,102
                                                                                          Advantage organization
                                                                                          failing to comply with
                                                                                          marketing restrictions
                                                                                          or applicable
                                                                                          implementing
                                                                                          regulations or guidance.
                                                                   OIG                   Penalty for a Medicare           2022       42,788       46,102
                                                                                          Advantage 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                    2022       14,950       16,108
                                                                                          prescription drug card
                                                                                          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             2022        5,816        6,266
                                                                                          billing by Hospitals,
                                                                                          Critical Access
                                                                                          Hospitals, or Skilled
                                                                                          Nursing Facilities.
    1395dd(d)(1)......................  42 CFR 1003.510..........  OIG                   Penalty for a hospital           2022      119,942      129,232
                                                                                          with 100 beds or more
                                                                                          or responsible
                                                                                          physician dumping
                                                                                          patients needing
                                                                                          emergency medical care.
                                                                                         Penalty for a hospital           2022       59,973       64,618
                                                                                          with less than 100 beds
                                                                                          dumping patients
                                                                                          needing emergency
                                                                                          medical care.
    1395mm(i)(6)(B)(i)................  42 CFR 1003.410..........  OIG                   Penalty for a HMO or             2022       59,973       64,618
                                                                                          competitive medical
                                                                                          plan if such plan
                                                                                          substantially fails to
                                                                                          provide medically
                                                                                          necessary, required
                                                                                          items or services.

[[Page 69539]]

 
                                                                   OIG                   Penalty for HMOs/                2022       59,973       64,618
                                                                                          competitive medical
                                                                                          plans that charge
                                                                                          premiums in excess of
                                                                                          permitted amounts.
                                                                   OIG                   Penalty for a HMO or             2022       59,973       64,618
                                                                                          competitive medical
                                                                                          plan that expels or
                                                                                          refuses to reenroll an
                                                                                          individual per
                                                                                          prescribed conditions.
                                                                   OIG                   Penalty for a HMO or             2022      239,885      258,464
                                                                                          competitive medical
                                                                                          plan that implements
                                                                                          practices to discourage
                                                                                          enrollment of
                                                                                          individuals needing
                                                                                          services in future.
                                                                   OIG                   Penalty per individual           2022       34,517       37,190
                                                                                          not enrolled in a plan
                                                                                          as a result of a HMO or
                                                                                          competitive medical
                                                                                          plan that implements
                                                                                          practices to discourage
                                                                                          enrollment of
                                                                                          individuals needing
                                                                                          services in the future.
                                                                   OIG                   Penalty for a HMO or             2022      239,885      258,464
                                                                                          competitive medical
                                                                                          plan that misrepresents
                                                                                          or falsifies
                                                                                          information to the
                                                                                          Secretary.
                                                                   OIG                   Penalty for a HMO or             2022       59,973       64,618
                                                                                          competitive medical
                                                                                          plan that misrepresents
                                                                                          or falsifies
                                                                                          information to an
                                                                                          individual or any other
                                                                                          entity.
                                                                   OIG                   Penalty for failure by           2022       59,973       64,618
                                                                                          HMO or competitive
                                                                                          medical plan to assure
                                                                                          prompt payment of
                                                                                          Medicare risk sharing
                                                                                          contracts or incentive
                                                                                          plan provisions.
                                                                   OIG                   Penalty for HMO that             2022       55,052       59,316
                                                                                          employs or contracts
                                                                                          with excluded
                                                                                          individual or entity.
    1395nn(g)(3)......................  42 CFR 1003.310..........  OIG                   Penalty for submitting           2022       27,750       29,899
                                                                                          or causing to be
                                                                                          submitted claims in
                                                                                          violation of the Stark
                                                                                          Law's restrictions on
                                                                                          physician self-
                                                                                          referrals.
    1395nn(g)(4)......................  42 CFR 1003.310..........  OIG                   Penalty for                      2022      185,009      199,338
                                                                                          circumvention schemes
                                                                                          in violation of the
                                                                                          Stark Law's
                                                                                          restrictions on
                                                                                          physician self-
                                                                                          referrals.
    1395ss(d)(1)......................  42 CFR 1003.1110.........  OIG                   Penalty for a material           2022       11,506       12,397
                                                                                          misrepresentation
                                                                                          regarding Medigap
                                                                                          compliance policies.
    1395ss(d)(2)......................  42 CFR 1003.1110.........  OIG                   Penalty for selling              2022       11,506       12,397
                                                                                          Medigap policy under
                                                                                          false pretense.
    1395ss(d)(3)(A)(ii)...............  42 CFR 1003.1110.........  OIG                   Penalty for an issuer            2022       51,796       55,808
                                                                                          that sells health
                                                                                          insurance policy that
                                                                                          duplicates benefits.
                                                                   OIG                   Penalty for someone              2022       31,076       33,483
                                                                                          other than issuer that
                                                                                          sells health insurance
                                                                                          that duplicates
                                                                                          benefits.
    1395ss(d)(4)(A)...................  42 CFR 1003.1110.........  OIG                   Penalty for using mail           2022       11,506       12,397
                                                                                          to sell a non-approved
                                                                                          Medigap insurance
                                                                                          policy.
    1396b(m)(5)(B)(i).................  42 CFR 1003.410..........  OIG                   Penalty for a Medicaid           2022       57,527       61,982
                                                                                          MCO that substantially
                                                                                          fails to provide
                                                                                          medically necessary,
                                                                                          required items or
                                                                                          services.
                                                                   OIG                   Penalty for a Medicaid           2022       57,527       61,982
                                                                                          MCO that charges
                                                                                          excessive premiums.
                                                                   OIG                   Penalty for a Medicaid           2022      230,107      247,929
                                                                                          MCO that improperly
                                                                                          expels or refuses to
                                                                                          reenroll a beneficiary.
                                                                   OIG                   Penalty per individual           2022       34,517       37,190
                                                                                          who does not enroll as
                                                                                          a result of a Medicaid
                                                                                          MCO's practice that
                                                                                          would reasonably be
                                                                                          expected to have the
                                                                                          effect of denying or
                                                                                          discouraging enrollment.
                                                                   OIG                   Penalty for a Medicaid           2022      230,107      247,929
                                                                                          MCO misrepresenting or
                                                                                          falsifying information
                                                                                          to the Secretary.
                                                                   OIG                   Penalty for a Medicaid           2022       57,527       61,982
                                                                                          MCO misrepresenting or
                                                                                          falsifying information
                                                                                          to an individual or
                                                                                          another entity.
                                                                   OIG                   Penalty for a Medicaid           2022       51,796       55,808
                                                                                          MCO that fails to
                                                                                          comply with contract
                                                                                          requirements with
                                                                                          respect to physician
                                                                                          incentive plans.

[[Page 69540]]

 
    1396r(b)(3)(B)(ii)(I).............  42 CFR 1003.210(a)(11)...  OIG                   Penalty for willfully            2022        2,400        2,586
                                                                                          and knowingly
                                                                                          certifying a material
                                                                                          and false statement in
                                                                                          a Skilled Nursing
                                                                                          Facility resident
                                                                                          assessment.
    1396r(b)(3)(B)(ii)(II)............  42 CFR 1003.210(a)(11)...  OIG                   Penalty for willfully            2022       11,995       12,924
                                                                                          and knowingly 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         2022        4,799        5,171
                                                                                          causing to be 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          2022      207,183      223,229
                                                                                          provision of 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              2022       20,719       22,324
                                                                                          failure to timely
                                                                                          provide information by
                                                                                          drug manufacturer with
                                                                                          rebate agreement.
    1396r-8(b)(3)(C)(ii)..............  42 CFR 1003.1210.........  OIG                   Penalty for knowing              2022      207,183      223,229
                                                                                          provision of false
                                                                                          information by drug
                                                                                          manufacturer with
                                                                                          rebate agreement.
    1396t(i)(3)(A)....................  42 CFR 1003.1310.........  OIG                   Penalty for notifying            2022        4,144        4,465
                                                                                          home and community-
                                                                                          based providers or
                                                                                          settings of survey.
    11131(c)..........................  42 CFR 1003.810..........  OIG                   Penalty for failing to           2022       25,076       27,018
                                                                                          report a medical
                                                                                          malpractice claim to
                                                                                          National Practitioner
                                                                                          Data Bank.
    11137(b)(2).......................  42 CFR 1003.810..........  OIG                   Penalty for breaching            2022       25,076       27,018
                                                                                          confidentiality of
                                                                                          information reported to
                                                                                          National Practitioner
                                                                                          Data Bank.
    299b-22(f)(1).....................  42 CFR 3.404.............  OCR                   Penalty for violation of         2022       13,885       14,960
                                                                                          confidentiality
                                                                                          provision of the
                                                                                          Patient Safety and
                                                                                          Quality Improvement Act.
                                        45 CFR 160.404(b)(1)(i),   OCR                   Penalty for each pre-            2022          174          187
                                         (ii).                                            February 18, 2009
                                                                                          violation of the HIPAA
                                                                                          administrative
                                                                                          simplification
                                                                                          provisions.
                                                                                         Calendar Year Cap.......         2022       43,678       47,061
    1320(d)-5(a)......................  45 CFR                     OCR                   Penalty for each                 2022  ...........  ...........
                                         160.404(b)(2)(i)(A), (B).                        February 18, 2009 or
                                                                                          later violation of a
                                                                                          HIPAA administrative
                                                                                          simplification
                                                                                          provision in which it
                                                                                          is established that the
                                                                                          covered entity or
                                                                                          business associate did
                                                                                          not know and, by
                                                                                          exercising reasonable
                                                                                          diligence, would not
                                                                                          have known that the
                                                                                          covered entity or
                                                                                          business associate
                                                                                          violated such a
                                                                                          provision:
                                                                                            Minimum..............         2022          127          137
                                                                                            Maximum..............         2022       63,973       68,928
                                                                                         Calendar Year Cap.......         2022    1,919,173    2,067,813
                                        45 CFR                     OCR                   Penalty for each                 2022  ...........  ...........
                                         160.404(b)(2)(ii)(A),                            February 18, 2009 or
                                         (B).                                             later violation of a
                                                                                          HIPAA administrative
                                                                                          simplification
                                                                                          provision in which it
                                                                                          is established that the
                                                                                          violation was due to
                                                                                          reasonable cause and
                                                                                          not to willful neglect:
                                                                                            Minimum..............         2022        1,280        1,379
                                                                                            Maximum..............         2022       63,973       68,928
                                                                                         Calendar Year Cap.......         2022    1,919,173    2,067,813
                                        45 CFR                     OCR                   Penalty for each                 2022  ...........  ...........
                                         160.404(b)(2)(iii)(A),                           February 18, 2009 or
                                         (B).                                             later violation of a
                                                                                          HIPAA administrative
                                                                                          simplification
                                                                                          provision in which it
                                                                                          is established that the
                                                                                          violation was due to
                                                                                          willful neglect and was
                                                                                          corrected during the 30-
                                                                                          day period beginning on
                                                                                          the first date the
                                                                                          covered entity or
                                                                                          business associate
                                                                                          knew, or, by exercising
                                                                                          reasonable diligence,
                                                                                          would have known that
                                                                                          the violation occurred:
                                                                                            Minimum..............         2022       12,794       13,785
                                                                                            Maximum..............         2022       63,973       68,928
                                                                                         Calendar Year Cap.......         2022    1,919,173    2,067,813

[[Page 69541]]

 
                                        45 CFR                     OCR                   Penalty for each                 2022  ...........  ...........
                                         160.404(b)(2)(iv)(A),                            February 18, 2009 or
                                         (B).                                             later violation of a
                                                                                          HIPAA administrative
                                                                                          simplification
                                                                                          provision in which it
                                                                                          is established that the
                                                                                          violation was due to
                                                                                          willful neglect and was
                                                                                          not corrected during
                                                                                          the 30-day period
                                                                                          beginning on the first
                                                                                          date the covered entity
                                                                                          or business associate
                                                                                          knew, or, by exercising
                                                                                          reasonable diligence,
                                                                                          would have known that
                                                                                          the violation occurred:
                                                                                            Minimum..............         2022       63,973       68,928
                                                                                            Maximum..............         2022    1,919,173    2,067,813
                                                                                         Calendar Year Cap.......         2022    1,919,173    2,067,813
    42 U.S.C. 300gg-18, 42 U.S.C. 1302  45 CFR 180.90............  CMS                   Penalty for a hospital's         2022          300          323
                                                                                          non-compliance with
                                                                                          making public standard
                                                                                          charges for hospital
                                                                                          items and services.
                                                                                         Per Day (Maximum).......         2022        5,500        5,926
                                        45 CFR 180.90(c)(2)(i)...  CMS                   Per day penalty for a            2022          304          328
                                                                                          hospital's
                                                                                          noncompliance with
                                                                                          making public standard
                                                                                          charges for hospital
                                                                                          items and services.
                                        45 CFR                     CMS                   Per day penalty for              2022          300          323
                                         180.90(c)(2)(ii)(A).                             hospitals with equal to
                                                                                          or less than 30 beds.
                                        45 CFR                     CMS                   Per day, per bed penalty         2022           10           11
                                         180.90(c)(2)(ii)(B).                             for hospitals having at
                                                                                          least 31 and up to and
                                                                                          including 550 beds.
                                        45 CFR                     CMS                   Per day penalty for              2022        5,500        5,926
                                         180.90(c)(2)(ii)(C).                             hospitals having
                                                                                          greater than 550 beds.
CARES Act, Public Law 116-136, section  45 CFR 182.70............  CMS                   Penalty for a provider's         2022  ...........  ...........
 3202(b)(2).                                                                              non-compliance with
                                                                                          price transparency
                                                                                          requirements regarding
                                                                                          diagnostic tests for
                                                                                          COVID-19.
                                                                                         Per Day (Maximum).......         2022          300          323
    263a(h)(2)(B) & 1395w-              42 CFR 493.1834(d)(2)(i).  CMS                   Penalty for a clinical           2022  ...........  ...........
     2(b)(2)(A)(ii).                                                                      laboratory's failure to
                                                                                          meet participation and
                                                                                          certification
                                                                                          requirements and poses
                                                                                          immediate jeopardy:
                                                                                            Minimum..............         2022        7,018        7,562
                                                                                            Maximum..............         2022       23,011       24,793
                                        42 CFR 493.1834(d)(2)(ii)  CMS                   Penalty for a clinical           2022  ...........  ...........
                                                                                          laboratory's failure to
                                                                                          meet participation and
                                                                                          certification
                                                                                          requirements and the
                                                                                          failure does not pose
                                                                                          immediate jeopardy:
                                                                                            Minimum..............         2022          116          125
                                                                                            Maximum..............         2022        6,902        7,437
                                        42 CFR                     CMS                   Penalty for a clinical           2022  ...........  ...........
                                         493.1834(d)(2)(iii).                             laboratory's failure to
                                                                                          meet SARS-CoV-2 test
                                                                                          reporting requirements:
                                                                                         First day of                     2022  ...........  ...........
                                                                                          noncompliance.
                                                                                         Each additional day of           2022  ...........  ...........
                                                                                          noncompliance.
    300gg-15(f).......................  45 CFR 147.200(e)........  CMS                   Failure to provide the           2022        1,264        1,362
                                                                                          Summary of Benefits and
                                                                                          Coverage.
    300gg-18..........................  45 CFR 158.606...........  CMS                   Penalty for violations           2022          126          136
                                                                                          of regulations related
                                                                                          to the medical loss
                                                                                          ratio reporting and
                                                                                          rebating.
                                        45 CFR 180.90............  CMS                   Price against hospital           2022  ...........  ...........
                                                                                          identified by CMS as
                                                                                          noncompliant according
                                                                                          to Sec.   182.50 with
                                                                                          respect to price
                                                                                          transparency
                                                                                          requirements regarding
                                                                                          diagnostic tests for
                                                                                          COVID-19.
    42 U.S.C. 300gg-118 note, 300gg-    .........................  CMS                   Penalties for failure to         2022       10,622       11,445
     134.                                                                                 comply with No
                                                                                          Surprises Act
                                                                                          requirements on
                                                                                          providers, facilities,
                                                                                          providers of air
                                                                                          ambulance services.
    1320a-7h(b)(1)....................  42 CFR 402.105(d)(5), 42   CMS                   Penalty for manufacturer         2022  ...........  ...........
                                         CFR 403.912(a) & (c).                            or group purchasing
                                                                                          organization failing to
                                                                                          report information
                                                                                          required under 42
                                                                                          U.S.C. 1320a-7h(a),
                                                                                          relating to physician
                                                                                          ownership or investment
                                                                                          interests:
                                                                                            Minimum..............         2022        1,264        1,362
                                                                                            Maximum..............         2022       12,646       13,625
                                                                                         Calendar Year Cap.......         2022      189,692      204,384

[[Page 69542]]

 
    1320a-7h(b)(2)....................  42 CFR 402.105(h), 42 CFR  CMS                   Penalty for manufacturer         2022  ...........  ...........
                                         403.912(b) & (c).                                or group purchasing
                                                                                          organization knowingly
                                                                                          failing to report
                                                                                          information required
                                                                                          under 42 U.S.C. 1320a-
                                                                                          7h(a), relating to
                                                                                          physician ownership or
                                                                                          investment interests:
                                                                                            Minimum..............         2022       12,646       13,625
                                                                                            Maximum..............         2022      126,463      136,258
                                                                                         Calendar Year Cap.......         2022    1,264,622    1,362,567
                                                                   CMS                   Penalty for an                   2022      126,463      136,258
                                                                                          administrator of a
                                                                                          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          2022          632          681
                                         (2), & (3).                                      first offense of an
                                                                                          administrator who fails
                                                                                          to provide notice of
                                                                                          facility closure.
                                                                                         Minimum penalty for the          2022        1,898        2,045
                                                                                          second offense of an
                                                                                          administrator who fails
                                                                                          to provide notice of
                                                                                          facility closure.
                                                                                         Minimum penalty for the          2022        3,793        4,087
                                                                                          third and subsequent
                                                                                          offenses of an
                                                                                          administrator who fails
                                                                                          to provide notice of
                                                                                          facility closure.
    1320a-8(a)(1).....................  .........................  CMS                   Penalty for an entity            2022        9,250        9,966
                                                                                          knowingly making a
                                                                                          false statement or
                                                                                          representation of
                                                                                          material fact in the
                                                                                          determination of the
                                                                                          amount of benefits or
                                                                                          payments related to old-
                                                                                          age, survivors, and
                                                                                          disability insurance
                                                                                          benefits, special
                                                                                          benefits for certain
                                                                                          World War II veterans,
                                                                                          or supplemental
                                                                                          security income for the
                                                                                          aged, blind, and
                                                                                          disabled.
                                                                                         Penalty for violation of         2022        8,723        9,399
                                                                                          42 U.S.C. 1320a-8(a)(1)
                                                                                          if the violator is a
                                                                                          person who receives a
                                                                                          fee or other income for
                                                                                          services performed in
                                                                                          connection with
                                                                                          determination of the
                                                                                          benefit amount or the
                                                                                          person is a physician
                                                                                          or other health care
                                                                                          provider who submits
                                                                                          evidence in connection
                                                                                          with such a
                                                                                          determination.
    1320a-8(a)(3).....................  .........................  CMS                   Penalty for a                    2022        7,244        7,805
                                                                                          representative payee
                                                                                          (under 42 U.S.C.
                                                                                          405(j), 1007, or
                                                                                          1383(a)(2)) converting
                                                                                          any part of a received
                                                                                          payment from the
                                                                                          benefit programs
                                                                                          described in the
                                                                                          previous civil monetary
                                                                                          penalty to a use other
                                                                                          than for the benefit of
                                                                                          the beneficiary.
    1320b-25(c)(1)(A).................  .........................  CMS                   Penalty for failure of           2022      252,925      272,514
                                                                                          covered individuals to
                                                                                          report to the Secretary
                                                                                          and 1 or more law
                                                                                          enforcement officials
                                                                                          any reasonable
                                                                                          suspicion of a crime
                                                                                          against a resident, or
                                                                                          individual receiving
                                                                                          care, from a long-term
                                                                                          care facility.
    1320b-25(c)(2)(A).................  .........................  CMS                   Penalty for failure of           2022      379,386      408,769
                                                                                          covered individuals to
                                                                                          report to the Secretary
                                                                                          and 1 or more law
                                                                                          enforcement officials
                                                                                          any reasonable
                                                                                          suspicion of a crime
                                                                                          against a resident, or
                                                                                          individual receiving
                                                                                          care, from a long-term
                                                                                          care facility if such
                                                                                          failure exacerbates the
                                                                                          harm to the victim of
                                                                                          the crime or results in
                                                                                          the harm to another
                                                                                          individual.
    1320b-25(d)(2)....................  .........................  CMS                   Penalty for a long-term          2022      252,925      272,514
                                                                                          care facility that
                                                                                          retaliates against any
                                                                                          employee because of
                                                                                          lawful acts done by the
                                                                                          employee, or files a
                                                                                          complaint or report
                                                                                          with the State
                                                                                          professional
                                                                                          disciplinary agency
                                                                                          against an employee or
                                                                                          nurse for lawful acts
                                                                                          done by the employee or
                                                                                          nurse.

[[Page 69543]]

 
    1395b-7(b)(2)(B)..................  42 CFR 402.105(g)........  CMS                   Penalty for any person           2022          171          184
                                                                                          who knowingly and
                                                                                          willfully fails to
                                                                                          furnish a beneficiary
                                                                                          with an itemized
                                                                                          statement of items or
                                                                                          services within 30 days
                                                                                          of the beneficiary's
                                                                                          request.
    1395i-3(h)(2)(B)(ii)(I)...........  42 CFR 488.408(d)(1)(iii)  CMS                   Penalty per day for a            2022  ...........  ...........
                                                                                          Skilled Nursing
                                                                                          Facility that has a
                                                                                          Category 2 violation of
                                                                                          certification
                                                                                          requirements:
                                                                                            Minimum..............         2022          120          129
                                                                                            Maximum..............         2022        7,195        7,752
                                        42 CFR 488.408(d)(1)(iv).  CMS                   Penalty per instance of          2022  ...........  ...........
                                                                                          Category 2
                                                                                          noncompliance by a
                                                                                          Skilled Nursing
                                                                                          Facility:
                                                                                            Minimum..............         2022        2,400        2,586
                                                                                            Maximum..............         2022       23,989       25,847
                                        42 CFR 488.408(e)(1)(iii)  CMS                   Penalty per day for a            2022  ...........  ...........
                                                                                          Skilled Nursing
                                                                                          Facility that has a
                                                                                          Category 3 violation of
                                                                                          certification
                                                                                          requirements:
                                                                                            Minimum..............         2022        7,317        7,884
                                                                                            Maximum..............         2022       23,989       25,847
                                        42 CFR 488.408(e)(1)(iv).  CMS                   Penalty per instance of          2022  ...........  ...........
                                                                                          Category 3
                                                                                          noncompliance by a
                                                                                          Skilled Nursing
                                                                                          Facility:
                                                                                            Minimum..............         2022        2,400        2,586
                                                                                            Maximum..............         2022       23,989       25,847
                                        42 CFR 488.408(e)(2)(ii).  CMS                   Penalty per day and per          2022  ...........  ...........
                                                                                          instance for a Skilled
                                                                                          Nursing Facility that
                                                                                          has Category 3
                                                                                          noncompliance with
                                                                                          Immediate Jeopardy:
                                                                                         Per Day (Minimum).......         2022        7,317        7,884
                                                                                         Per Day (Maximum).......         2022       23,989       25,847
                                                                                         Per Instance (Minimum)..         2022        2,400        2,586
                                                                                         Per Instance (Maximum)..         2022       23,989       25,847
                                        42 CFR 488.438(a)(1)(i)..  CMS                   Penalty per day of a             2022  ...........  ...........
                                                                                          Skilled Nursing
                                                                                          Facility that fails to
                                                                                          meet certification
                                                                                          requirements. These
                                                                                          amounts represent the
                                                                                          upper range per day:
                                                                                            Minimum..............         2022        7,317        7,884
                                                                                            Maximum..............         2022       23,989       25,847
                                        42 CFR 488.438(a)(1)(ii).  CMS                   Penalty per day of a             2022  ...........  ...........
                                                                                          Skilled Nursing
                                                                                          Facility that fails to
                                                                                          meet certification
                                                                                          requirements. These
                                                                                          amounts represent the
                                                                                          lower range per day:
                                                                                            Minimum..............         2022          120          129
                                                                                            Maximum..............         2022        7,195        7,752
                                        42 CFR 488.438(a)(2).....  CMS                   Penalty per instance of          2022  ...........  ...........
                                                                                          a Skilled Nursing
                                                                                          Facility that fails to
                                                                                          meet certification
                                                                                          requirements:
                                                                                            Minimum..............         2022        2,400        2,586
                                                                                            Maximum..............         2022       23,989       25,847
                                        42 CFR 488.447...........  CMS                   Penalty imposed for              2022  ...........  ...........
                                                                                          failure to comply with
                                                                                          infection control
                                                                                          weekly reporting
                                                                                          requirements at 42 CFR
                                                                                          483.80(g)(1) and (2).
                                                                                         First occurrence........         2022        1,075        1,158
                                                                                         Incremental increases            2022          537          579
                                                                                          for each subsequent
                                                                                          occurrence.
    1395i-6(c)(5)(B)(i)...............  42 CFR 488.1245..........  CMS                   Penalty for                      2022       10,000       10,775
                                                                                          noncompliance by
                                                                                          hospice program with
                                                                                          requirements specified
                                                                                          in section 1395x(dd) of
                                                                                          42 USC.
                                        42 CFR                     CMS                   Adjustment to penalties.         2022       10,000       10,775
                                         488.1245(b)(2)(iii).                             Maximum penalty
                                                                                          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.
                                                                   CMS                      Minimum..............         2022        8,500        9,158
                                                                                            Maximum..............         2022       10,000       10,775
                                        42 CFR 488.1245(b)(3)(i).  CMS                   Penalty imposed for              2022       10,000       10,775
                                                                                          hospice condition-level
                                                                                          deficiency that is
                                                                                          immediate jeopardy.
                                                                                          These amounts represent
                                                                                          the upper range of
                                                                                          penalty.

[[Page 69544]]

 
                                        42 CFR 488.1245(b)(3)(ii)  CMS                   Penalty imposed for              2022        9,000        9,697
                                                                                          hospice condition-level
                                                                                          deficiency that is
                                                                                          immediate jeopardy.
                                                                                          These amounts represent
                                                                                          the upper range of
                                                                                          penalty.
                                        42 CFR                     CMS                   Penalty imposed for              2022        8,500        9,158
                                         488.1245(b)(3)(iii).                             hospice condition-level
                                                                                          deficiency that is
                                                                                          immediate jeopardy.
                                                                                          These amounts represent
                                                                                          the upper range of
                                                                                          penalty.
                                        42 CFR 488.1245(b)(4)....  CMS                   Penalty imposed for              2022  ...........  ...........
                                                                                          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..............         2022        1,500        1,616
                                                                                            Maximum..............         2022        8,500        9,158
                                        42 CFR 488.1245(b)(5)....  CMS                   Penalty imposed for              2022  ...........  ...........
                                                                                          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..............         2022          500          539
                                                                                            Maximum..............         2022        4,000        4,310
                                        42 CFR 488.1245(b)(6)....  CMS                   Penalty range imposed            2022  ...........  ...........
                                                                                          for per instance of
                                                                                          hospice noncompliance.
                                                                   CMS                      Minimum..............         2022        1,000        1,077
                                                                                            Maximum..............         2022       10,000       10,775
                                        42 CFR 488.1245(d)(1)(ii)  CMS                   Penalty for each per             2022       10,000       10,775
                                                                                          instance of hospice
                                                                                          noncompliance, maximum
                                                                                          per day per hospice
                                                                                          program.
    1395l(h)(5)(D)....................  42 CFR 402.105(d)(2)(i)..  CMS                   Penalty for knowingly,           2022       17,472       18,825
                                                                                          willfully, and
                                                                                          repeatedly billing for
                                                                                          a clinical diagnostic
                                                                                          laboratory test other
                                                                                          than on an assignment-
                                                                                          related basis.
                                                                                          (Penalties are assessed
                                                                                          in the same manner as
                                                                                          42 U.S.C.
                                                                                          1395u(j)(2)(B), which
                                                                                          is assessed according
                                                                                          to 1320a-7a(a)).
    1395l(i)(6).......................  .........................  CMS                   Penalty for knowingly            2022        4,603        4,960
                                                                                          and willfully
                                                                                          presenting or causing
                                                                                          to be presented a bill
                                                                                          or request for payment
                                                                                          for an intraocular lens
                                                                                          inserted during or
                                                                                          after cataract surgery
                                                                                          for which the Medicare
                                                                                          payment rate includes
                                                                                          the cost of acquiring
                                                                                          the class of lens
                                                                                          involved.
    1395l(q)(2)(B)(i).................  42 CFR 402.105(a)........  CMS                   Penalty for knowingly            2022        4,404        4,745
                                                                                          and willfully 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          2022       17,472       18,825
                                         402.105(d)(2)(ii).                               medical equipment
                                                                                          supplier that knowingly
                                                                                          and willfully charges
                                                                                          for a covered service
                                                                                          that is furnished on a
                                                                                          rental basis after the
                                                                                          rental payments may no
                                                                                          longer be made.
                                                                                          (Penalties are assessed
                                                                                          in the same manner as
                                                                                          42 U.S.C.
                                                                                          1395u(j)(2)(B), which
                                                                                          is assessed according
                                                                                          to 1320a-7a(a)).
    1395m(a)(18)(B)...................  42 CFR 402.1(c)(5),        CMS                   Penalty for any                  2022       17,472       18,825
                                         402.105(d)(2)(iii).                              nonparticipating
                                                                                          durable medical
                                                                                          equipment supplier that
                                                                                          knowingly and willfully
                                                                                          fails to make a refund
                                                                                          to Medicare
                                                                                          beneficiaries for a
                                                                                          covered service for
                                                                                          which payment is
                                                                                          precluded due to an
                                                                                          unsolicited telephone
                                                                                          contact from the
                                                                                          supplier. (Penalties
                                                                                          are assessed in the
                                                                                          same manner as 42
                                                                                          U.S.C. 1395u(j)(2)(B),
                                                                                          which is assessed
                                                                                          according to 1320a-
                                                                                          7a(a)).

[[Page 69545]]

 
    1395m(b)(5)(C)....................  42 CFR 402.1(c)(6),        CMS                   Penalty for any                  2022       17,472       18,825
                                         402.105(d)(2)(iv).                               nonparticipating
                                                                                          physician or supplier
                                                                                          that knowingly and
                                                                                          willfully charges a
                                                                                          Medicare beneficiary
                                                                                          more than the limiting
                                                                                          charge for radiologist
                                                                                          services. (Penalties
                                                                                          are assessed in the
                                                                                          same manner as 42
                                                                                          U.S.C. 1395u(j)(2)(B),
                                                                                          which is assessed
                                                                                          according to 1320a-
                                                                                          7a(a)).
    1395m(h)(3).......................  42 CFR 402.1(c)(8),        CMS                   Penalty for any supplier         2022       17,472       18,825
                                         402.105(d)(2)(vi).                               of prosthetic devices,
                                                                                          orthotics, and
                                                                                          prosthetics that
                                                                                          knowing and willfully
                                                                                          charges for a covered
                                                                                          prosthetic device,
                                                                                          orthotic, or prosthetic
                                                                                          that is furnished on a
                                                                                          rental basis after the
                                                                                          rental payment may no
                                                                                          longer be made.
                                                                                          (Penalties are assessed
                                                                                          in the same manner as
                                                                                          42 U.S.C.
                                                                                          1395m(a)(11)(A), that
                                                                                          is in the same manner
                                                                                          as 1395u(j)(2)(B),
                                                                                          which is assessed
                                                                                          according to 1320a-
                                                                                          7a(a)).
    1395m(j)(2)(A)(iii)...............  .........................  CMS                   Penalty for any supplier         2022        1,850        1,993
                                                                                          of durable medical
                                                                                          equipment including a
                                                                                          supplier of prosthetic
                                                                                          devices, prosthetics,
                                                                                          orthotics, or supplies
                                                                                          that knowingly and
                                                                                          willfully distributes a
                                                                                          certificate of medical
                                                                                          necessity in violation
                                                                                          of Section
                                                                                          1834(j)(2)(A)(i) of the
                                                                                          Act or fails to provide
                                                                                          the information
                                                                                          required under Section
                                                                                          1834(j)(2)(A)(ii) of
                                                                                          the Act.
    1395m(j)(4).......................  42 CFR 402.1(c)(10),       CMS                   Penalty for any supplier         2022       17,472       18,825
                                         402.105(d)(2)(vii).                              of durable medical
                                                                                          equipment, including a
                                                                                          supplier of prosthetic
                                                                                          devices, prosthetics,
                                                                                          orthotics, or supplies
                                                                                          that knowingly and
                                                                                          willfully fails to make
                                                                                          refunds in a timely
                                                                                          manner to Medicare
                                                                                          beneficiaries for
                                                                                          series billed other
                                                                                          than on as assignment-
                                                                                          related basis under
                                                                                          certain conditions.
                                                                                          (Penalties are assessed
                                                                                          in the same manner as
                                                                                          42 U.S.C. 1395m(j)(4)
                                                                                          and 1395u(j)(2)(B),
                                                                                          which is assessed
                                                                                          according to 1320a-
                                                                                          7a(a)).
    1395m-1(a)........................  42 CFR 414.504(e)........  CMS                   Penalty for an                   2022       11,649       12,551
                                                                                          applicable entity that
                                                                                          has failed to report or
                                                                                          made a
                                                                                          misrepresentation or
                                                                                          omission in reporting
                                                                                          applicable information
                                                                                          with respect to a
                                                                                          clinical diagnostic
                                                                                          laboratory test.
                                        42 CFR 402.1(c)(31),       CMS                   Penalty for any person           2022       17,472       18,825
                                         402.105(d)(3).                                   or entity who knowingly
                                                                                          and willfully bills or
                                                                                          collects for any
                                                                                          outpatient therapy
                                                                                          services or
                                                                                          comprehensive
                                                                                          outpatient
                                                                                          rehabilitation services
                                                                                          on other than an
                                                                                          assignment-related
                                                                                          basis. (Penalties are
                                                                                          assessed in the same
                                                                                          manner as 42 U.S.C.
                                                                                          1395m(k)(6) and
                                                                                          1395u(j)(2)(B), which
                                                                                          is assessed according
                                                                                          to 1320a-7a(a)).
    1395m(l)(6).......................  42 CFR 402.1(c)(32),       CMS                   Penalty for any supplier         2022       17,472       18,825
                                         402.105(d)(4).                                   of ambulance services
                                                                                          who knowingly and
                                                                                          willfully fills or
                                                                                          collects for any
                                                                                          services on other than
                                                                                          an assignment-related
                                                                                          basis. (Penalties are
                                                                                          assessed in the same
                                                                                          manner as 42 U.S.C.
                                                                                          1395u(b)(18)(B), which
                                                                                          is assessed according
                                                                                          to 1320a-7a(a)).

[[Page 69546]]

 
    1395u(b)(18)(B)...................  42 CFR 402.1(c)(11),       CMS                   Penalty for any                  2022       17,472       18,825
                                         402.105(d)(2)(viii).                             practitioner specified
                                                                                          in Section
                                                                                          1842(b)(18)(C) of the
                                                                                          Act or other person
                                                                                          that knowingly and
                                                                                          willfully bills or
                                                                                          collects for any
                                                                                          services by the
                                                                                          practitioners on other
                                                                                          than an assignment-
                                                                                          related basis.
                                                                                          (Penalties are assessed
                                                                                          in the same manner as
                                                                                          42 U.S.C.
                                                                                          1395u(j)(2)(B), which
                                                                                          is assessed according
                                                                                          to 1320a-7a(a)).
    1395u(j)(2)(B)....................  42 CFR 402.1(c)..........  CMS                   Penalty for any                  2022       17,472       18,825
                                                                                          physician who charges
                                                                                          more than 125% for a
                                                                                          non-participating
                                                                                          referral. (Penalties
                                                                                          are assessed in the
                                                                                          same manner as 42
                                                                                          U.S.C. 1320a-7a(a)).
    1395u(k)..........................  42 CFR 402.1(c)(12),       CMS                   Penalty for any                  2022       17,472       18,825
                                         402.105(d)(2)(ix)                                physician who knowingly
                                         1834A(a)(9) and 42 CFR                           and willfully presents
                                         414.504(e).                                      or causes to be
                                                                                          presented a claim for
                                                                                          bill for an assistant
                                                                                          at a cataract surgery
                                                                                          performed on or after
                                                                                          March 1, 1987, for
                                                                                          which payment may not
                                                                                          be made because of
                                                                                          section 1862(a)(15).
                                                                                          (Penalties are assessed
                                                                                          in the same manner as
                                                                                          42 U.S.C.
                                                                                          1395u(j)(2)(B), which
                                                                                          is assessed according
                                                                                          to 1320a-7a(a)).
    1395u(l)(3).......................  42 CFR 402.1(c)(13),       CMS                   Penalty for any                  2022       17,472       18,825
                                         402.105(d)(2)(x).                                nonparticipating
                                                                                          physician who does not
                                                                                          accept payment on an
                                                                                          assignment-related
                                                                                          basis and who knowingly
                                                                                          and willfully fails to
                                                                                          refund on a timely
                                                                                          basis any amounts
                                                                                          collected for services
                                                                                          that are not reasonable
                                                                                          or medically necessary
                                                                                          or are of poor quality
                                                                                          under 1842(l)(1)(A).
                                                                                          (Penalties are assessed
                                                                                          in the same manner as
                                                                                          42 U.S.C.
                                                                                          1395u(j)(2)(B), which
                                                                                          is assessed according
                                                                                          to 1320a-7a(a)).
    1395u(m)(3).......................  42 CFR 402.1(c)(14),       CMS                   Penalty for any                  2022       17,472       18,825
                                         402.105(d)(2)(xi).                               nonparticipating
                                                                                          physician charging more
                                                                                          than $500 who does not
                                                                                          accept payment for an
                                                                                          elective surgical
                                                                                          procedure on an
                                                                                          assignment related
                                                                                          basis and who knowingly
                                                                                          and willfully fails to
                                                                                          disclose the required
                                                                                          information regarding
                                                                                          charges and coinsurance
                                                                                          amounts and fails to
                                                                                          refund on a timely
                                                                                          basis any amount
                                                                                          collected for the
                                                                                          procedure in excess of
                                                                                          the charges recognized
                                                                                          and approved by the
                                                                                          Medicare program.
                                                                                          (Penalties are assessed
                                                                                          in the same manner as
                                                                                          42 U.S.C.
                                                                                          1395u(j)(2)(B), which
                                                                                          is assessed according
                                                                                          to 1320a-7a(a)).
    1395u(n)(3).......................  42 CFR 402.1(c)(15),       CMS                   Penalty for any                  2022       17,472       18,825
                                         402.105(d)(2)(xii).                              physician who
                                                                                          knowingly, willfully,
                                                                                          and repeatedly bills
                                                                                          one or more
                                                                                          beneficiaries for
                                                                                          purchased diagnostic
                                                                                          tests any amount other
                                                                                          than the payment amount
                                                                                          specified by the Act.
                                                                                          (Penalties are assessed
                                                                                          in the same manner as
                                                                                          42 U.S.C.
                                                                                          1395u(j)(2)(B), which
                                                                                          is assessed according
                                                                                          to 1320a-7a(a)).
    1395u(o)(3)(B)....................  42 CFR 414.707(b)........  CMS                   Penalty for any                  2022       17,472       18,825
                                                                                          practitioner specified
                                                                                          in Section
                                                                                          1842(b)(18)(C) of the
                                                                                          Act or other person
                                                                                          that knowingly and
                                                                                          willfully bills or
                                                                                          collects for any
                                                                                          services pertaining to
                                                                                          drugs or biologics by
                                                                                          the practitioners on
                                                                                          other than an
                                                                                          assignment-related
                                                                                          basis. (Penalties are
                                                                                          assessed in the same
                                                                                          manner as 42 U.S.C.
                                                                                          1395u(b)(18)(B) and
                                                                                          1395u(j)(2)(B), which
                                                                                          is assessed according
                                                                                          to 1320a-7a(a)).

[[Page 69547]]

 
    1395u(p)(3)(A)....................  .........................  CMS                   Penalty for any                  2022        4,603        4,960
                                                                                          physician or
                                                                                          practitioner who
                                                                                          knowingly and willfully
                                                                                          fails promptly to
                                                                                          provide the appropriate
                                                                                          diagnosis codes upon
                                                                                          CMS or Medicare
                                                                                          administrative
                                                                                          contractor request for
                                                                                          payment or bill not
                                                                                          submitted on an
                                                                                          assignment-related
                                                                                          basis.
    1395w-3a(d)(4)(A).................  42 CFR 414.806...........  CMS                   Penalty for a                    2022       14,950       16,108
                                                                                          pharmaceutical
                                                                                          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                  2022       17,472       18,825
                                         402.105(d)(2)(xiii).                             nonparticipating
                                                                                          physician, supplier, or
                                                                                          other person that
                                                                                          furnishes physician
                                                                                          services not on an
                                                                                          assignment-related
                                                                                          basis who either
                                                                                          knowingly and willfully
                                                                                          bills or collects in
                                                                                          excess of the
                                                                                          statutorily-defined
                                                                                          limiting charge or
                                                                                          fails to make a timely
                                                                                          refund or adjustment.
                                                                                          (Penalties are assessed
                                                                                          in the same manner as
                                                                                          42 U.S.C.
                                                                                          1395u(j)(2)(B), which
                                                                                          is assessed according
                                                                                          to 1320a-7a(a)).
    1395w-4(g)(3)(B)..................  42 CFR 402.1(c)(18),       CMS                   Penalty for any person           2022       17,472       18,825
                                         402.105(d)(2)(xiv).                              that knowingly and
                                                                                          willfully bills for
                                                                                          statutorily defined
                                                                                          State-plan approved
                                                                                          physicians' services on
                                                                                          any other basis than an
                                                                                          assignment-related
                                                                                          basis for a Medicare/
                                                                                          Medicaid dual eligible
                                                                                          beneficiary. (Penalties
                                                                                          are assessed in the
                                                                                          same manner as 42
                                                                                          U.S.C. 1395u(j)(2)(B),
                                                                                          which is assessed
                                                                                          according to 1320a-
                                                                                          7a(a)).
    1395w-27(g)(3)(A); 1857(g)(3);      42 CFR 422.760(b); 42 CFR  CMS                   Penalty for each                 2022       42,788       46,102
     1860D-12(b)(3)(E).                  423.760(b).                                      termination
                                                                                          determination the
                                                                                          Secretary makes that is
                                                                                          the result of actions
                                                                                          by a Medicare Advantage
                                                                                          organization or Part D
                                                                                          sponsor that has
                                                                                          adversely affected (or
                                                                                          has the substantial
                                                                                          likelihood of adversely
                                                                                          affecting) an
                                                                                          individual covered
                                                                                          under the
                                                                                          organization's contract.
    1395w-27(g)(3)(B); 1857(g)(3);      .........................  CMS                   Penalty for each week            2022       17,116       18,442
     1860D-12(b)(3)(E).                                                                   beginning after the
                                                                                          initiation of civil
                                                                                          money penalty
                                                                                          procedures by the
                                                                                          Secretary because a
                                                                                          Medicare Advantage
                                                                                          organization or Part D
                                                                                          sponsor has failed to
                                                                                          carry out a contract,
                                                                                          or has carried out a
                                                                                          contract inconsistently
                                                                                          with regulations.
    1395w-27(g)(3)(D); 1857(g)(3):      .........................  CMS                   Penalty for a Medicare           2022      158,947      171,257
     1860D-12(b)(3)(E).                                                                   Advantage
                                                                                          organization's or Part
                                                                                          D sponsor's early
                                                                                          termination of its
                                                                                          contract.
    1395y(b)(3)(C)....................  42 CFR 411.103(b)........  CMS                   Penalty for an employer          2022       10,360       11,162
                                                                                          or other entity to
                                                                                          offer any financial or
                                                                                          other incentive for an
                                                                                          individual entitled to
                                                                                          benefits not to enroll
                                                                                          under a group health
                                                                                          plan or large group
                                                                                          health plan which would
                                                                                          be a primary plan.
    1395y(b)(5)(C)(ii)................  42 CFR 402.1(c)(20), 42    CMS                   Penalty for any non-             2022        1,687        1,818
                                         CFR 402.105(b)(2).                               governmental employer
                                                                                          that, before October 1,
                                                                                          1998, willfully or
                                                                                          repeatedly failed to
                                                                                          provide timely and
                                                                                          accurate information
                                                                                          requested relating to
                                                                                          an employee's group
                                                                                          health insurance
                                                                                          coverage.
    1395y(b)(6)(B)....................  42 CFR 402.1(c)(21),       CMS                   Penalty for any entity           2022        3,701        3,988
                                         402.105(a).                                      that knowingly,
                                                                                          willfully, and
                                                                                          repeatedly fails to
                                                                                          complete a claim form
                                                                                          relating to the
                                                                                          availability of other
                                                                                          health benefits in
                                                                                          accordance with statute
                                                                                          or provides inaccurate
                                                                                          information relating to
                                                                                          such on the claim form.

[[Page 69548]]

 
    1395y(b)(7)(B)(i).................  .........................  CMS                   Penalty for any entity           2022        1,325        1,428
                                                                                          serving as insurer,
                                                                                          third party
                                                                                          administrator, or
                                                                                          fiduciary for a group
                                                                                          health plan that fails
                                                                                          to provide information
                                                                                          that identifies
                                                                                          situations where the
                                                                                          group health plan is or
                                                                                          was a primary plan to
                                                                                          Medicare to the HHS
                                                                                          Secretary.
    1395y(b)(8)(E)....................  .........................  CMS                   Penalty for any non-             2022        1,325        1,428
                                                                                          group health plan that
                                                                                          fails to identify
                                                                                          claimants who are
                                                                                          Medicare beneficiaries
                                                                                          and provide information
                                                                                          to the HHS Secretary to
                                                                                          coordinate benefits and
                                                                                          pursue any applicable
                                                                                          recovery claim.
    1395nn(g)(5)......................  42 CFR 411.361...........  CMS                   Penalty for any person           2022       22,021       23,727
                                                                                          that fails to 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          2022       17,472       18,825
                                         402.105(d)(2)(xv).                               medical equipment
                                                                                          supplier, including a
                                                                                          supplier of prosthetic
                                                                                          devices, prosthetics,
                                                                                          orthotics, or supplies,
                                                                                          that knowingly and
                                                                                          willfully fails to make
                                                                                          refunds in a timely
                                                                                          manner to Medicare
                                                                                          beneficiaries under
                                                                                          certain conditions. (42
                                                                                          U.S.C. 1395(m)(18)
                                                                                          sanctions apply here in
                                                                                          the same manner, which
                                                                                          is under 1395u(j)(2)
                                                                                          and 1320a-7a(a)).
    1395ss(a)(2)......................  402.102(f)(1)............  CMS                   Penalty for any person           2022       59,972       64,617
                                                                                          that issues a Medicare
                                                                                          supplemental policy
                                                                                          that has not been
                                                                                          approved by the State
                                                                                          regulatory program or
                                                                                          does not meet Federal
                                                                                          standards after a
                                                                                          statutorily defined
                                                                                          effective date.
    1395ss(d)(3)(A)(vi)(II)...........  42 CFR 402.1(c)(25),       CMS                   Penalty for someone              2022       31,076       33,483
                                         402.105(e),                                      other than issuer that
                                         402.105(f)(2).                                   sells or issues a
                                                                                          Medicare supplemental
                                                                                          policy to beneficiary
                                                                                          without a disclosure
                                                                                          statement.
                                                                   CMS                   Penalty for an issuer            2022       51,796       55,808
                                                                                          that sells or issues a
                                                                                          Medicare supplemental
                                                                                          policy without
                                                                                          disclosure statement.
    1395ss(d)(3)(B)(iv)...............  .........................  CMS                   Penalty for someone              2022       31,076       33,483
                                                                                          other than issuer that
                                                                                          sells or issues a
                                                                                          Medicare supplemental
                                                                                          policy without
                                                                                          acknowledgement form.
                                                                   CMS                   Penalty for issuer that          2022       51,796       55,808
                                                                                          sells or issues a
                                                                                          Medicare supplemental
                                                                                          policy without an
                                                                                          acknowledgement form.
    1395ss(p)(8)......................  42 CFR 402.1(c)(25),       CMS                   Penalty for someone              2022       31,076       33,483
                                         402.105(e).                                      other than issuer that
                                                                                          sells or issues
                                                                                          Medicare supplemental
                                                                                          polices after a given
                                                                                          date that fail to
                                                                                          conform to the NAIC or
                                                                                          Federal standards
                                                                                          established by statute.
                                        42 CFR 402.1(c)(25),       CMS                   Penalty for an issuer            2022       51,796       55,808
                                         405402.105(f)(2).                                that sells or 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              2022       31,076       33,483
                                         402.105(e),                                      other than issuer that
                                         402.105(f)(3), (4).                              sells a Medicare
                                                                                          supplemental policy and
                                                                                          fails to make available
                                                                                          for sale the core group
                                                                                          of basic benefits when
                                                                                          selling other Medicare
                                                                                          supplemental policies
                                                                                          with additional
                                                                                          benefits or fails to
                                                                                          provide the individual,
                                                                                          before selling the
                                                                                          policy, an outline of
                                                                                          coverage describing
                                                                                          benefits.

[[Page 69549]]

 
                                        402.105(f)(3), (4).......  CMS                   Penalty for an issuer            2022       51,796       55,808
                                                                                          that sells a Medicare
                                                                                          supplemental policy and
                                                                                          fails to make available
                                                                                          for sale the core group
                                                                                          of basic benefits when
                                                                                          selling other Medicare
                                                                                          supplemental policies
                                                                                          with additional
                                                                                          benefits or fails to
                                                                                          provide the individual,
                                                                                          before selling the
                                                                                          policy, an outline of
                                                                                          coverage describing
                                                                                          benefits.
    1395ss(q)(5)(C)...................  402.105(f)(5)............  CMS                   Penalty for any person           2022       51,796       55,808
                                                                                          that fails to suspend
                                                                                          the policy of a
                                                                                          policyholder made
                                                                                          eligible for medical
                                                                                          assistance or
                                                                                          automatically
                                                                                          reinstates the policy
                                                                                          of a policyholder who
                                                                                          has lost eligibility
                                                                                          for medical assistance,
                                                                                          under certain
                                                                                          circumstances.
    1395ss(r)(6)(A)...................  402.105(f)(6)............  CMS                   Penalty for any person           2022       51,796       55,808
                                                                                          that fails to 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           2022       21,989       23,692
                                         402.105(c).                                      of a Medicare
                                                                                          supplemental policy
                                                                                          that does not waive
                                                                                          listed time periods if
                                                                                          they were already
                                                                                          satisfied under a
                                                                                          proceeding Medicare
                                                                                          supplemental policy, or
                                                                                          denies a policy, or
                                                                                          conditions the
                                                                                          issuances or
                                                                                          effectiveness of the
                                                                                          policy, or
                                                                                          discriminates in the
                                                                                          pricing of the policy
                                                                                          base on health status
                                                                                          or other specified
                                                                                          criteria.
    1395ss(t)(2)......................  42 CFR 402.1(c)(30),       CMS                   Penalty for any issuer           2022       51,796       55,808
                                         402.105(f)(7).                                   of a Medicare
                                                                                          supplemental policy
                                                                                          that fails to fulfill
                                                                                          listed responsibilities.
    1395ss(v)(4)(A)...................  .........................  CMS                   Penalty someone other            2022       22,426       24,163
                                                                                          than issuer who sells,
                                                                                          issues, or renews a
                                                                                          medigap Rx policy to an
                                                                                          individual who is a
                                                                                          Part D enrollee.
                                                                   CMS                   Penalty for an issuer            2022       37,377       40,272
                                                                                          who sells, issues, or
                                                                                          renews a Medigap Rx
                                                                                          policy who is a Part D
                                                                                          enrollee.
    1395bbb(c)(1).....................  42 CFR 488.725(c)........  CMS                   Penalty for any                  2022        4,799        5,171
                                                                                          individual who notifies
                                                                                          or causes to be
                                                                                          notified a home health
                                                                                          agency of the time or
                                                                                          date on which a survey
                                                                                          of such agency is to be
                                                                                          conducted.
    1395bbb(f)(2)(A)(i)...............  42 CFR                     CMS                   Maximum daily penalty            2022       23,011       24,793
                                         488.845(b)(2)(iii), 42                           amount for each day a
                                         CFR 488.845(b)(3)-(6);                           home health agency is
                                         and 42 CFR                                       not in compliance with
                                         488.845(d)(1)(ii).                               statutory requirements.
                                        42 CFR 488.845(b)(3).....  CMS                   Penalty per day for home         2022  ...........  ...........
                                                                                          health agency's
                                                                                          noncompliance (Upper
                                                                                          Range):
                                                                                            Minimum..............         2022       19,559       21,074
                                                                                            Maximum..............         2022       23,011       24,793
                                        42 CFR 488.845(b)(3)(i)..  CMS                   Penalty for a home               2022       23,011       24,793
                                                                                          health agency's
                                                                                          deficiency or
                                                                                          deficiencies that cause
                                                                                          immediate jeopardy and
                                                                                          result in actual harm.
                                        42 CFR 488.845(b)(3)(ii).  CMS                   Penalty for a home               2022       20,709       22,313
                                                                                          health agency's
                                                                                          deficiency or
                                                                                          deficiencies that cause
                                                                                          immediate jeopardy and
                                                                                          result in potential for
                                                                                          harm.
                                        42 CFR 488.845(b)(3)(iii)  CMS                   Penalty for an isolated          2022       19,559       21,074
                                                                                          incident of
                                                                                          noncompliance in
                                                                                          violation of
                                                                                          established HHA policy.
                                        42 CFR 488.845(b)(4).....  CMS                   Penalty for a repeat and/        2022  ...........  ...........
                                                                                          or condition-level
                                                                                          deficiency that does
                                                                                          not constitute
                                                                                          immediate jeopardy, but
                                                                                          is directly related to
                                                                                          poor quality patient
                                                                                          care outcomes (Lower
                                                                                          Range):
                                                                                            Minimum..............         2022        3,453        3,720
                                                                                            Maximum..............         2022       19,559       21,074
                                        42 CFR 488.845(b)(5).....  CMS                   Penalty for a repeat and/        2022  ...........  ...........
                                                                                          or condition-level
                                                                                          deficiency that does
                                                                                          not constitute
                                                                                          immediate jeopardy and
                                                                                          that is related
                                                                                          predominately to
                                                                                          structure or process-
                                                                                          oriented conditions
                                                                                          (Lower Range):
                                                                                            Minimum..............         2022        1,151        1,240

[[Page 69550]]

 
                                                                                            Maximum..............         2022        2,301        2,479
                                        42 CFR 488.845(b)(6).....  CMS                   Penalty imposed for              2022  ...........  ...........
                                                                                          instance of
                                                                                          noncompliance that may
                                                                                          be assessed for one or
                                                                                          more singular events of
                                                                                          condition-level
                                                                                          noncompliance that are
                                                                                          identified and where
                                                                                          the noncompliance was
                                                                                          corrected during the
                                                                                          onsite survey:
                                                                                         Penalty for each day of          2022        2,301        2,479
                                                                                          noncompliance (Minimum).
                                                                                         Penalty for each day of          2022       23,011       24,793
                                                                                          noncompliance (Maximum).
                                        42 CFR 488.845(d)(1)(ii).  CMS                   Penalty for each day of          2022       23,011       24,793
                                                                                          noncompliance (Maximum).
    1395eee(e)(6)(B); 1396u-4(e)(6)(B)  42 CFR 460.46............  CMS                   Penalty for PACE                 2022       42,788       46,102
                                                                                          organization that
                                                                                          discriminates in
                                                                                          enrollment or
                                                                                          disenrollment, or
                                                                                          engages in any practice
                                                                                          that would reasonably
                                                                                          be expected to have the
                                                                                          effect of denying or
                                                                                          discouraging
                                                                                          enrollment, on the
                                                                                          basis of health status
                                                                                          or the need for
                                                                                          services:
                                                                   CMS                   For each individual not          2022  ...........  ...........
                                                                                          enrolled as a result of
                                                                                          the PACE organization's
                                                                                          discrimination in
                                                                                          enrollment or
                                                                                          disenrollment or
                                                                                          practice that would
                                                                                          deny or discourage
                                                                                          enrollment.
                                                                                            Minimum..............         2022       16,121       17,370
                                                                                            Maximum..............         2022      107,478      115,802
                                                                   CMS                   Penalty for a PACE               2022       42,788       46,102
                                                                                          organization that
                                                                                          charges excessive
                                                                                          premiums.
                                                                   CMS                   Penalty for a PACE               2022      171,156      184,412
                                                                                          organization
                                                                                          misrepresenting or
                                                                                          falsifying information
                                                                                          to CMS or the State.
                                                                   CMS                   Penalty for any other            2022       42,788       46,102
                                                                                          violation specified in
                                                                                          42 C.F.R. 460.40.
    1396r(h)(3)(C)(ii)(I).............  42 CFR 488.408(d)(1)(iii)  CMS                   Penalty per day for a            2022  ...........  ...........
                                                                                          nursing facility's
                                                                                          failure to meet a
                                                                                          Category 2
                                                                                          Certification:
                                                                                            Minimum..............         2022          120          129
                                                                                            Maximum..............         2022        7,195        7,752
                                        42 CFR 488.408(d)(1)(iv).  CMS                   Penalty per instance for         2022  ...........  ...........
                                                                                          a nursing facility's
                                                                                          failure to meet
                                                                                          Category 2
                                                                                          certification:
                                                                                            Minimum..............         2022        2,400        2,586
                                                                                            Maximum..............         2022       23,989       25,847
                                        42 CFR 488.408(e)(1)(iii)  CMS                   Penalty per day for a            2022  ...........  ...........
                                                                                          nursing facility's
                                                                                          failure to meet
                                                                                          Category 3
                                                                                          certification:
                                                                                            Minimum..............         2022        7,317        7,884
                                                                                            Maximum..............         2022       23,989       25,847
                                        42 CFR 488.408(e)(1)(iv).  CMS                   Penalty per instance for         2022  ...........  ...........
                                                                                          a nursing facility's
                                                                                          failure to meet
                                                                                          Category 3
                                                                                          certification:
                                                                                            Minimum..............         2022        2,400        2,586
                                                                                            Maximum..............         2022       23,989       25,847
                                        42 CFR 488.408(e)(2)(ii).  CMS                   Penalty per instance for         2022  ...........  ...........
                                                                                          a nursing facility's
                                                                                          failure to meet
                                                                                          Category 3
                                                                                          certification, which
                                                                                          results in immediate
                                                                                          jeopardy:
                                                                                            Minimum..............         2022        2,400        2,586
                                                                                            Maximum..............         2022       23,989       25,847
                                        42 CFR 488.438(a)(1)(i)..  CMS                   Penalty per day for              2022  ...........  ...........
                                                                                          nursing facility's
                                                                                          failure to meet
                                                                                          certification (Upper
                                                                                          Range):
                                                                                            Minimum..............         2022        7,317        7,884
                                                                                            Maximum..............         2022       23,989       25,847
                                        42 CFR 488.438(a)(1)(ii).  CMS                   Penalty per day for              2022  ...........  ...........
                                                                                          nursing facility's
                                                                                          failure to meet
                                                                                          certification (Lower
                                                                                          Range):
                                                                                            Minimum..............         2022          120          129
                                                                                            Maximum..............         2022        7,195        7,752
                                        42 CFR 488.438(a)(2).....  CMS                   Penalty per instance for         2022  ...........  ...........
                                                                                          nursing facility's
                                                                                          failure to meet
                                                                                          certification:
                                                                                            Minimum..............         2022        2,400        2,586
                                                                                            Maximum..............         2022       23,989       25,847

[[Page 69551]]

 
                                        42 CFR 488.447...........  CMS                   Penalty imposed for              2022  ...........  ...........
                                                                                          failure to comply with
                                                                                          infection control
                                                                                          weekly reporting
                                                                                          requirements at 42 CFR
                                                                                          483.80(g)(1) and (2).
                                                                                         First occurrence                 2022        1,075        1,158
                                                                                          (Minimum).
                                                                                         Incremental increases            2022          537          579
                                                                                          for each subsequent
                                                                                          occurrence.
    1396r(f)(2)(B)(iii)(I)(c).........  42 CFR 483.151(b)(2)(iv)   CMS                   Grounds to prohibit              2022       11,995       12,924
                                         and (b)(3)(iii).                                 approval of Nurse Aide
                                                                                          Training Program--if
                                                                                          assessed a penalty in
                                                                                          1819(h)(2)(B)(i) or
                                                                                          1919(h)(2)(A)(ii) of
                                                                                          ``not less than
                                                                                          $5,000'' [Not CMP
                                                                                          authority, but a
                                                                                          specific CMP amount
                                                                                          (CMP at this level)
                                                                                          that is the triggering
                                                                                          condition for
                                                                                          disapproval].
    1396r(h)(3)(C)(ii)(I).............  42 CFR 483.151(c)(2).....  CMS                   Grounds to waive                 2022       11,995       12,924
                                                                                          disapproval of nurse
                                                                                          aide training program--
                                                                                          reference to
                                                                                          disapproval based on
                                                                                          imposition of CMP ``not
                                                                                          less than $5,000'' [Not
                                                                                          CMP authority but CMP
                                                                                          imposition at this
                                                                                          level determines
                                                                                          eligibility to seek
                                                                                          waiver of disapproval
                                                                                          of nurse aide training
                                                                                          program].
    1396t(j)(2)(C)....................  .........................  CMS                   Penalty for each day of          2022  ...........  ...........
                                                                                          noncompliance for a
                                                                                          home or community care
                                                                                          provider that no longer
                                                                                          meets the minimum
                                                                                          requirements for home
                                                                                          and community care:
                                                                                            Minimum..............         2022            2            2
                                                                                            Maximum..............         2022       20,719       22,324
    1396u-2(e)(2)(A)(i)...............  42 CFR 438.704...........  CMS                   Penalty for a Medicaid           2022       42,788       46,102
                                                                                          managed care
                                                                                          organization that fails
                                                                                          substantially to
                                                                                          provide medically
                                                                                          necessary items and
                                                                                          services.
                                                                   CMS                   Penalty for Medicaid             2022       42,788       46,102
                                                                                          managed care
                                                                                          organization that
                                                                                          imposes premiums or
                                                                                          charges on enrollees in
                                                                                          excess of the premiums
                                                                                          or charges permitted.
                                                                   CMS                   Penalty for a Medicaid           2022       42,788       46,102
                                                                                          managed care
                                                                                          organization that
                                                                                          misrepresents or
                                                                                          falsifies information
                                                                                          to another individual
                                                                                          or entity.
                                                                   CMS                   Penalty for a Medicaid           2022       42,788       46,102
                                                                                          managed care
                                                                                          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           2022      171,156      184,412
                                                                                          managed care
                                                                                          organization that
                                                                                          misrepresents or
                                                                                          falsifies information
                                                                                          to the HHS Secretary.
                                                                   CMS                   Penalty for Medicaid             2022      171,156      184,412
                                                                                          managed care
                                                                                          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                 2022       25,673       27,661
                                                                                          individual that does
                                                                                          not enroll as a result
                                                                                          of a Medicaid managed
                                                                                          care organization that
                                                                                          acts to discriminate
                                                                                          among enrollees on the
                                                                                          basis of their health
                                                                                          status.
    1396u(h)(2).......................  42 CFR Part 441, Subpart   CMS                   Penalty for a provider           2022       23,989       25,847
                                         I.                                               not meeting one of 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,            2022       12,794       13,785
                                         22(b)(2)(C)(i) 45 CFR                            for each individual
                                         150.315.                                         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
                                                                                          [bond] 2022 [bond] 174
                                                                                          [bond] 177.

[[Page 69552]]

 
    42 U.S.C. 300gg-22(b)(2)(C)(i)....  45 CFR 150.315...........  CMS                   Penalty for each day,            2022          174          177
                                                                                          for each individual
                                                                                          affected by the failure
                                                                                          of a health insurance
                                                                                          issuer or non-Federal
                                                                                          governmental group
                                                                                          health plan to comply
                                                                                          with federal market
                                                                                          reform provisions in
                                                                                          part A or D of title
                                                                                          XXVII of the PHS Act.
    18041(c)(2).......................  45 CFR 156.805(c)........  CMS                   Failure to comply with           2022          174          187
                                                                                          ACA requirements
                                                                                          related to risk
                                                                                          adjustment,
                                                                                          reinsurance, risk
                                                                                          corridors, Exchanges
                                                                                          (including QHP
                                                                                          standards) and other
                                                                                          ACA Subtitle D
                                                                                          standards; Penalty for
                                                                                          violations of rules or
                                                                                          standards of behavior
                                                                                          associated with issuer
                                                                                          compliance with risk
                                                                                          adjustment,
                                                                                          reinsurance, risk
                                                                                          corridors, Exchanges
                                                                                          (including QHP
                                                                                          standards) and other
                                                                                          ACA Subtitle D
                                                                                          standards.
    18081(h)(1)(A)(i)(II).............  45 CFR 155.285...........  CMS                   Penalty for providing            2022       31,616       34,065
                                                                                          false information on
                                                                                          Exchange application.
    18081(h)(1)(B)....................  45 CFR 155.285...........  CMS                   Penalty for knowingly or         2022      316,155      340,641
                                                                                          willfully providing
                                                                                          false information on
                                                                                          Exchange application.
    18081(h)(2).......................  45 CFR 155.260...........  CMS                   Penalty for knowingly or         2022  ...........  ...........
                                                                                          willfully disclosing
                                                                                          protected information
                                                                                          from Exchange.
                                                                   CMS                      Minimum..............         2022       31,616       34,065
                                                                   CMS                      Maximum..............         2022          323          348
    18041(c)(2).......................  45 CFR 155.206(i)........  CMS                   Penalties for violation          2022       38,771       41,774
                                                                                          of applicable Exchange
                                                                                          standards by consumer
                                                                                          assistance entities in
                                                                                          Federally-facilitated
                                                                                          Exchanges.
                                                                                            Maximum (Per Day)....         2022          107          115
31 U.S.C..............................                                                                                    2022          323          348
    1352..............................  45 CFR 93.400(e).........  HHS                   Penalty for the first            2022       22,021       23,727
                                                                                          time an individual
                                                                                          makes an expenditure
                                                                                          prohibited by
                                                                                          regulations regarding
                                                                                          lobbying disclosure,
                                                                                          absent aggravating
                                                                                          circumstances.
                                                                                         Penalty for second and           2022  ...........  ...........
                                                                                          subsequent offenses by
                                                                                          individuals who make an
                                                                                          expenditure prohibited
                                                                                          by regulations
                                                                                          regarding lobbying
                                                                                          disclosure:
                                                                                            Minimum..............         2022       22,021       23,727
                                                                                            Maximum..............         2022      220,213      237,268
                                                                   HHS                   Penalty for the first            2022       22,021       23,727
                                                                                          time an individual
                                                                                          fails to file or amend
                                                                                          a lobbying disclosure
                                                                                          form, absent
                                                                                          aggravating
                                                                                          circumstances.
                                                                                         Penalty for second and           2022  ...........  ...........
                                                                                          subsequent offenses by
                                                                                          individuals who fail to
                                                                                          file or amend a
                                                                                          lobbying disclosure
                                                                                          form, absent
                                                                                          aggravating
                                                                                          circumstances:
                                                                                            Minimum..............         2022       22,021       23,727
                                                                                            Maximum..............         2022      220,213      237,268
                                        45 CFR Part 93, Appendix   HHS                   Penalty for failure to           2022  ...........  ...........
                                         A.                                               provide certification
                                                                                          regarding lobbying in
                                                                                          the award documents for
                                                                                          all sub-awards of all
                                                                                          tiers:
                                                                                            Minimum..............         2022       22,021       23,727
                                                                                            Maximum..............         2022      220,213      237,268
                                                                   HHS                   Penalty for failure to           2022  ...........  ...........
                                                                                          provide statement
                                                                                          regarding lobbying for
                                                                                          loan guarantee and loan
                                                                                          insurance transactions:
                                                                                            Minimum..............         2022       22,021       23,727
                                                                                            Maximum..............         2022      220,213      237,268
    3801-3812.........................  45 CFR 79.3(a)(1)(iv)....  HHS                   Penalty against any              2022       11,507       12,398
                                                                                          individual who--with
                                                                                          knowledge or reason to
                                                                                          know--makes, presents
                                                                                          or submits a false,
                                                                                          fictitious or
                                                                                          fraudulent claim to the
                                                                                          Department.

[[Page 69553]]

 
                                        45 CFR 79.3(b)(1)(ii)....  HHS                   Penalty against any              2022       11,507       12,398
                                                                                          individual who--with
                                                                                          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, and M-23-05 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 2022 CPI-U (298.012) /
  October 2021 CPI-U (276.589) = 1.07745.


    Dated: October 2, 2023.
Xavier Becerra,
Secretary, Department of Health and Human Services.
[FR Doc. 2023-22264 Filed 10-5-23; 8:45 am]
BILLING CODE 4150-24-P