Federal Register, Volume 89 Issue 153 (Thursday, August 8, 2024)

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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

45 CFR Part 102

RIN 0991-AC34

Annual Civil Monetary Penalties Inflation Adjustment

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

ACTION: Final rule.

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

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

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

SUPPLEMENTARY INFORMATION:

I. Background

The Federal Civil Penalties Inflation Adjustment Act Improvements
Act of 2015 (section 701 of Pub. L. 114-74) (the ``2015 Act'') amended
the Federal Civil Penalties Inflation Adjustment Act of 1990 (Pub. L.
101-410, 104 Stat. 890 (1990)), which is intended to improve the
effectiveness of CMPs and to maintain the deterrent effect of such
penalties, requires agencies to adjust the CMPs for inflation annually.
HHS lists the CMP authorities and the amounts administered by all
of its agencies in tabular form in 45 CFR 102.3, which was issued in an
interim final rule published in the September 6, 2016, issue of the
Federal Register (81 FR 61538). Annual adjustments were subsequently
published in the Federal Register on February 3, 2017 (82 FR 9175),
October 11, 2018 (83 FR 51369), November 5, 2019 (84 FR 59549), January
17, 2020 (85 FR 2869), November 15, 2021 (86 FR 62928), March 17, 2022
(87 FR 15100), and October 6, 2023 (88 FR 69531).

II. Calculation of Annual Inflation Adjustment and Other Updates

The annual inflation adjustment for each applicable CMP is
determined using the percent increase in the Consumer Price Index for
all Urban Consumers (CPI-U) for the month of October of the year in
which the amount of each CMP was most recently established or modified.
In the December 19, 2023, Office of Management and Budget (OMB)
Memorandum for the Heads of Executive Agencies and Departments, M-24-
07, ``Implementation of Penalty Inflation Adjustments for 2024,
Pursuant to the Federal Civil Penalties Inflation Adjustment Act
Improvements Act of 2015,'' OMB published the multiplier for the
required annual adjustment. The cost-of-living adjustment multiplier
for 2024, based on the CPI-U for the month of October 2023, not
seasonally adjusted, is 1.03241. The multiplier is applied to each
applicable penalty amount that was updated and published for fiscal
year (FY) 2023 and is rounded to the nearest dollar.
In addition to the inflation adjustments for 2023, this final rule
makes a few non-substantive changes to punctuation in the table in 45
CFR 102.3.

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

The 2015 Act requires Federal agencies to publish annual penalty
inflation adjustments notwithstanding section 553 of the Administrative
Procedure Act (APA). Section 4(a) of the 2015 Act directs Federal
agencies to publish annual adjustments no later than January 15th of
each year thereafter. In accordance with section 553 of the APA, most
rules are subject to notice and comment and are effective no earlier
than 30 days after publication in the Federal Register. However,
section 4(b)(2) of the 2015 Act provides that each agency shall make
the annual inflation adjustments ``notwithstanding

[[Page 64816]]

section 553'' of the APA. According to OMB's Memorandum M-24-07, the
phrase ``notwithstanding section 553'' in section 4(b)(2) of the 2015
Act means that ``the public procedure the APA generally requires--
notice, an opportunity for comment, and a delay in effective date--is
not required for agencies to issue regulations implementing the annual
adjustment.''
Consistent with the language of the 2015 Act and OMB's
implementation guidance, the inflation adjustments set out in this rule
are not subject to notice and an opportunity for public comment and
will be effective immediately upon publication.
Pursuant to OMB Memorandum M-24-07, HHS has determined that the
annual inflation adjustment to the civil monetary penalties in its
regulations does not trigger any requirements under procedural statutes
and Executive Orders that govern rulemaking procedures.

IV. Effective and Applicability Dates

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

List of Subjects in 45 CFR Part 102

Administrative practice and procedure, Penalties.

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

PART 102--ADJUSTMENT OF CIVIL MONETARY PENALTIES FOR INFLATION

0
1. The authority citation for part 102 continues to read as follows:

Authority: Pub. L. 101-410, Sec. 701 of Pub. L. 114-74, 31
U.S.C. 3801-3812.

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

Sec. 102.3 Penalty adjustment and table.

* * * * *

[[Page 64817]]

Table 1 to Sec. 102.3--Civil Monetary Penalty Authorities Administered by HHS
--------------------------------------------------------------------------------------------------------------------------------------------------------
Date of
last 2023 2024
penalty Maximum Maximum
U.S.C. section(s) CFR \1\ HHS agency Description \2\ figure or adjusted adjusted
adjustment penalty ($) penalty ($)
\3\ \4\
--------------------------------------------------------------------------------------------------------------------------------------------------------
21 U.S.C.:
333(b)(2)(A).............. ...................... FDA........... Penalty for violations related to drug 2023 123,965 127,983
samples resulting in a conviction of any
representative of manufacturer or
distributor in any 10-year period.
333(b)(2)(B).............. ...................... FDA........... Penalty for violation related to drug 2023 2,479,282 2,559,636
samples resulting in a conviction of any
representative of manufacturer or
distributor after the second conviction
in any 10-yr period.
333(b)(3)................. ...................... FDA........... Penalty for failure to make a report 2023 247,929 255,964
required by 21 U.S.C. 353(d)(3)(E)
relating to drug samples.
333(f)(1)(A).............. ...................... FDA........... Penalty for any person who violates a 2023 33,483 34,568
requirement related to devices for each
such violation.
FDA........... Penalty for aggregate of all violations 2023 2,232,281 2,304,629
related to devices in a single
proceeding.
333(f)(2)(A).............. ...................... FDA........... Penalty for any individual who introduces 2023 94,128 97,179
or delivers for introduction into
interstate commerce food that is
adulterated per 21 U.S.C. 342(a)(2)(B)
or any individual who does not comply
with a recall order under 21 U.S.C. 350l.
FDA........... Penalty in the case of any other person 2023 470,640 485,893
(other than an individual) for such
introduction or delivery of adulterated
food.
FDA........... Penalty for aggregate of all such 2023 941,280 971,787
violations related to adulterated food
adjudicated in a single proceeding.
333(f)(3)(A).............. ...................... FDA........... Penalty for all violations adjudicated in 2023 14,262 14,724
a single proceeding for any person who
violates 21 U.S.C. 331(jj) by failing to
submit the certification required by 42
U.S.C. 282(j)(5)(B) or knowingly
submitting a false certification; by
failing to submit clinical trial
information under 42 U.S.C. 282(j); or
by submitting clinical trial information
under 42 U.S.C. 282(j) that is false or
misleading in any particular under 42
U.S.C. 282(j)(5)(D).
333(f)(3)(B).............. ...................... FDA........... Penalty for each day any above violation 2023 14,262 14,724
is not corrected after a 30-day period
following notification until the
violation is corrected.
333(f)(4)(A)(i)........... ...................... FDA........... Penalty for any responsible person that 2023 356,580 368,137
violates a requirement of 21 U.S.C.
355(o) (post-marketing studies, clinical
trials, labeling), 21 U.S.C. 355(p)
(risk evaluation and mitigation (REMS)),
or 21 U.S.C. 355-1 (REMS).
FDA........... Penalty for aggregate of all such above 2023 1,426,319 1,472,546
violations in a single proceeding.
333(f)(4)(A)(ii).......... ...................... FDA........... Penalty for REMS violation that continues 2023 356,580 368,137
after written notice to the responsible
person for the first 30-day period (or
any portion thereof) the responsible
person continues to be in violation.
FDA........... Penalty for REMS violation that continues 2023 1,426,319 1,472,546
after written notice to responsible
person doubles for every 30-day period
thereafter the violation continues, but
may not exceed penalty amount for any 30-
day period.
FDA........... Penalty for aggregate of all such above 2023 14,263,186 14,725,456
violations adjudicated in a single
proceeding.
333(f)(9)(A).............. ...................... FDA........... Penalty for any person who violates a 2023 20,678 21,348
requirement which relates to tobacco
products for each such violation.
FDA........... Penalty for aggregate of all such 2023 1,378,541 1,423,220
violations of tobacco product
requirement adjudicated in a single
proceeding.
333(f)(9)(B)(i)(I)........ ...................... FDA........... Penalty per violation related to 2023 344,636 355,806
violations of tobacco requirements.
FDA........... Penalty for aggregate of all such 2023 1,378,541 1,423,220
violations of tobacco product
requirements adjudicated in a single
proceeding.
333(f)(9)(B)(i)(II)....... ...................... FDA........... Penalty in the case of a violation of 2023 344,636 355,806
tobacco product requirements that
continues after written notice to such
person, for the first 30-day period (or
any portion thereof) the person
continues to be in violation.
FDA........... Penalty for violation of tobacco product 2023 1,378,541 1,423,220
requirements that continues after
written notice to such person shall
double for every 30-day period
thereafter the violation continues, but
may not exceed penalty amount for any 30-
day period.
FDA........... Penalty for aggregate of all such 2023 13,785,420 14,232,205
violations related to tobacco product
requirements adjudicated in a single
proceeding.

[[Page 64818]]

333(f)(9)(B)(ii)(I)....... ...................... FDA........... Penalty for any person who either does 2023 344,636 355,806
not conduct post-market surveillance and
studies to determine impact of a
modified risk tobacco product for which
the HHS Secretary has provided them an
order to sell, or who does not submit a
protocol to the HHS Secretary after
being notified of a requirement to
conduct post-market surveillance of such
tobacco products.
FDA........... Penalty for aggregate of for all such 2023 1,378,541 1,423,220
above violations adjudicated in a single
proceeding.
333(f)(9)(B)(ii)(II)...... ...................... FDA........... Penalty for violation of modified risk 2023 344,636 355,806
tobacco product post-market surveillance
that continues after written notice to
such person for the first 30-day period
(or any portion thereof) that the person
continues to be in violation.
FDA........... Penalty for post-notice violation of 2023 1,378,541 1,423,220
modified risk tobacco product post-
market surveillance shall double for
every 30-day period thereafter that the
tobacco product requirement violation
continues for any 30-day period, but may
not exceed penalty amount for any 30-day
period.
Penalty for aggregate above tobacco 2023 13,785,420 14,232,205
product requirement violations
adjudicated in a single proceeding.
333(g)(1)................. ...................... FDA........... Penalty for any person who disseminates 2023 356,580 368,137
or causes another party to disseminate a
direct-to-consumer advertisement that is
false or misleading for the first such
violation in any 3-year period.
Penalty for each subsequent above 2023 713,160 736,274
violation in any 3-year period.
333 note.................. ...................... FDA........... Penalty to be applied for violations of 2023 345 356
21 U.S.C. 387f(d)(5) or of violations of
restrictions on the sale or distribution
of tobacco products promulgated under 21
U.S.C. 387f(d) (e.g., violations of
regulations in 21 CFR part 1140) with
respect to a retailer with an approved
training program in the case of a second
regulation violation within a 12-month
period.
FDA........... Penalty in the case of a third violation 2023 687 709
of 21 U.S.C. 387f(d)(5) or of the
tobacco product regulations within a 24-
month period.
FDA........... Penalty in the case of a fourth violation 2023 2,757 2,846
of 21 U.S.C. 387f(d)(5) or of the
tobacco product regulations within a 24-
month period.
FDA........... Penalty in the case of a fifth violation 2023 6,892 7,115
of 21 U.S.C. 387f(d)(5) or of the
tobacco product regulations within a 36-
month period.
FDA........... Penalty in the case of a sixth or 2023 13,785 14,232
subsequent violation of 21 U.S.C.
387f(d)(5) or of the tobacco product
regulations within a 48-month period as
determined on a case-by-case basis.
FDA........... Penalty to be applied for violations of 2023 345 356
21 U.S.C. 387f(d)(5) or of violations of
restrictions on the sale or distribution
of tobacco products promulgated under 21
U.S.C. 387f(d) (e.g., violations of
regulations in 21 CFR part 1140) with
respect to a retailer that does not have
an approved training program in the case
of the first regulation violation.
FDA........... Penalty in the case of a second violation 2023 687 709
of 21 U.S.C. 387f(d)(5) or of the
tobacco product regulations within a 12-
month period.
FDA........... Penalty in the case of a third violation 2023 1,379 1,424
of 21 U.S.C. 387f(d)(5) or of the
tobacco product regulations within a 24-
month period.
FDA........... Penalty in the case of a fourth violation 2023 2,757 2,846
of 21 U.S.C. 387f(d)(5) or of the
tobacco product regulations within a 24-
month period.
FDA........... Penalty in the case of a fifth violation 2023 6,892 7,115
of 21 U.S.C. 387f(d)(5) or of the
tobacco product regulations within a 36-
month period.
FDA........... Penalty in the case of a sixth or 2023 13,785 14,232
subsequent violation of 21 U.S.C.
387f(d)(5) or of the tobacco product
regulations within a 48-month period as
determined on a case-by-case basis.
335b(a)................... ...................... FDA........... Penalty for each violation for any 2023 525,406 542,434
individual who made a false statement or
misrepresentation of a material fact,
bribed, destroyed, altered, removed, or
secreted, or procured the destruction,
alteration, removal, or secretion of,
any material document, failed to
disclose a material fact, obstructed an
investigation, employed a consultant who
was debarred, debarred individual
provided consultant services.

[[Page 64819]]

FDA........... Penalty in the case of any other person 2023 2,101,618 2,169,731
(other than an individual) per above
violation.
360pp(b)(1)............... ...................... FDA........... Penalty for any person who violates any 2023 3,446 3,558
such requirements for electronic
products, with each unlawful act or
omission constituting a separate
violation.
FDA........... Penalty imposed for any related series of 2023 1,174,680 1,212,751
violations of requirements relating to
electronic products.
42 U.S.C...................... ...................... .............. ......................................... 2023 ........... ...........
262(d).................... ...................... FDA........... Penalty per day for violation of order of 2023 270,180 278,937
recall of biological product presenting
imminent or substantial hazard.
263b(h)(3)................ ...................... FDA........... Penalty for failure to obtain a 2023 21,018 21,699
mammography certificate as required.
300aa-28(b)(1)............ ...................... FDA........... Penalty per occurrence for any vaccine 2023 270,180 278,937
manufacturer that intentionally
destroys, alters, falsifies, or conceals
any record or report required.
256b(d)(1)(B)(vi)......... ...................... HRSA.......... Penalty for each instance of overcharging 2023 6,813 7,034
a 340B covered entity.
299c-3(d)................. ...................... AHRQ.......... Penalty for using or disclosing 2023 17,717 18,291
identifiable information obtained in the
course of activities undertaken pursuant
to Title IX of the Public Health Service
Act, for a purpose other than that for
which the information was supplied,
without consent to do so.
653(l)(2)................. 45 CFR 303.21(f)...... ACF........... Penalty for Misuse of Information in the 2023 1,818 1,877
National Directory of New Hires.
262a(i)(1)................ 42 CFR 1003.910....... OIG........... Penalty for each individual who violates 2023 410,932 424,250
safety and security procedures related
to handling dangerous biological agents
and toxins.
42 CFR 1003.1410...... OIG........... Penalty for any other person who violates 2023 821,868 848,505
safety and security procedures related
to handling dangerous biological agents
and toxins.
300jj-51.................. OIG........... Penalty per violation for committing 2023 1,252,992 1,293,601
information blocking.
1320a-7a(a)............... 42 CFR 1003.210(a)(1). OIG........... Penalty for knowingly presenting or 2023 24,164 24,947
causing to be presented to an officer,
employee, or agent of the United States
a false claim.
OIG........... Penalty for knowingly presenting or 2023 24,164 24,947
causing to be presented a request for
payment which violates the terms of an
assignment, agreement, or PPS agreement.
42 CFR 1003.210(a)(2). OIG........... Penalty for knowingly giving or causing 2023 36,246 37,421
to be presented to a participating
provider or supplier false or misleading
information that could reasonably be
expected to influence a discharge
decision.
42 CFR 1003.210(a)(3). OIG........... Penalty for an excluded party retaining 2023 24,164 24,947
ownership or control interest in a
participating entity.
42 CFR 1003.1010...... OIG........... Penalty for remuneration offered to 2023 24,164 24,947
induce program beneficiaries to use
particular providers, practitioners, or
suppliers.
42 CFR 1003.210(a)(4). OIG........... Penalty for employing or contracting with 2023 24,164 24,947
an excluded individual.
42 CFR 1003.310(a)(3). OIG........... Penalty for knowing and willful 2023 120,816 124,732
solicitation, receipt, offer, or payment
of remuneration for referring an
individual for a service or for
purchasing, leasing, or ordering an item
to be paid for by a Federal health care
program.
42 CFR 1003.210(a)(1). OIG........... Penalty for ordering or prescribing 2023 24,164 24,947
medical or other item or service during
a period in which the person was
excluded.
42 CFR 1003.210(a)(6). OIG........... Penalty for knowingly making or causing 2023 120,816 124,732
to be made a false statement, omission
or misrepresentation of a material fact
in any application, bid, or contract to
participate or enroll as a provider or
supplier.
42 CFR 1003.210(a)(8). OIG........... Penalty for knowing of an overpayment and 2023 24,164 24,947
failing to report and return.
42 CFR 1003.210(a)(7). OIG........... Penalty for making or using a false 2023 68,128 70,336
record or statement that is material to
a false or fraudulent claim.
42 CFR 1003.210(a)(9). OIG........... Penalty for failure to grant timely 2023 36,246 37,421
access to HHS OIG for audits,
investigations, evaluations, and other
statutory functions of HHS OIG.
1320a-7a(b)............... ...................... OIG........... Penalty for payments by a hospital or 2023 6,040 6,236
critical access hospital to induce a
physician to reduce or limit services to
individuals under direct care of
physician or who are entitled to certain
medical assistance benefits.
OIG........... Penalty for physicians who knowingly 2023 6,040 6,236
receive payments from a hospital or
critical access hospital to induce such
physician to reduce or limit services to
individuals under direct care of
physician or who are entitled to certain
medical assistance benefits.
42 CFR 1003.210(a)(10) OIG........... Penalty for a physician who executes a 2023 12,081 12,473
document that falsely certifies home
health needs for Medicare beneficiaries.
1320a-7a(o)............... 42 CFR 1003.710(a)(1). OIG........... Penalty for knowingly presenting or 2023 11,784 12,166
causing to be presented a false or
fraudulent specified claim under a
grant, contract, or other agreement for
which the Secretary provides funding.

[[Page 64820]]

42 CFR 1003.710(a)(2). OIG........... Penalty for knowingly making, using, or 2023 58,921 60,831
causing to be made or used any false
statement, omission, or
misrepresentation of a material fact in
any application, proposal, bid, progress
report, or other document required to
directly or indirectly receive or retain
funds provided pursuant to grant,
contract, or other agreement.
42 CFR 1003.710(a)(3). OIG........... Penalty for Knowingly making, using, or 2023 58,921 60,831
causing to be made or used, a false
record or statement material to a false
or fraudulent specified claim under
grant, contract, or other agreement.
42 CFR 1003.710(a)(4). OIG........... Penalty for knowingly making, using, or 2023 61,458 63,450
causing to be made or used, a false
record or statement material to an
obligation to pay or transmit funds or
property with respect to grant,
contract, or other agreement, or
knowingly conceals or improperly avoids
or decreases any such obligation, per
each false record or statement.
Penalty for knowingly making, using, or 2023 12,308 12,707
causing to be made or used, a false
record or statement material to an
obligation to pay or transmit funds or
property with respect to grant,
contract, or other agreement, or
knowingly conceals or improperly avoids
or decreases any such obligation, per
day.
42 CFR 1003.710(a)(5). OIG........... Penalty for failure to grant timely 2023 17,677 18,250
access, upon reasonable request, to the
I.G. for purposes of audits,
investigations, evaluations, or other
statutory functions of I.G. in matters
involving grants, contracts, or other
agreements.
1320a-7e(b)(6)(A)......... 42 CFR 1003.810....... OIG........... Penalty for failure to report any final 2023 46,102 47,596
adverse action taken against a health
care provider, supplier, or practitioner.
1320b-10(b)(1)............ 42 CFR 1003.610(a).... OIG........... Penalty for the misuse of words, symbols, 2023 12,397 12,799
or emblems in communications in a manner
in which a person could falsely construe
that such item is approved, endorsed, or
authorized by HHS.
1320b-10(b)(2)............ 42 CFR 1003.610(a).... OIG........... Penalty for the misuse of words, symbols, 2023 61,982 63,991
or emblems in a broadcast or telecast in
a manner in which a person could falsely
construe that such item is approved,
endorsed, or authorized by HHS.
1395i-3(b)(3)(B)(ii)(1)... 42 CFR 1003.210(a)(11) OIG........... Penalty for certification of a false 2023 2,586 2,670
statement in assessment of functional
capacity of a Skilled Nursing Facility
resident assessment.
1395i-3(b)(3)(B)(ii)(2)... 42 CFR 1003.210(a)(11) OIG........... Penalty for causing another to certify or 2023 12,924 13,343
make a false statement in assessment of
functional capacity of a Skilled Nursing
Facility resident assessment.
1395i-3(g)(2)(A).......... 42 CFR 1003.1310...... OIG........... Penalty for any individual who notifies 2023 5,171 5,339
or causes to be notified a Skilled
Nursing Facility of the time or date on
which a survey is to be conducted.
1395w-27(g)(2)(A)......... 42 CFR 1003.410....... OIG........... Penalty for a Medicare Advantage 2023 47,061 48,586
organization that substantially fails to
provide medically necessary, required
items and services.
OIG........... Penalty for a Medicare Advantage 2023 46,102 47,596
organization that charges excessive
premiums.
OIG........... Penalty for a Medicare Advantage 2023 46,102 47,596
organization that improperly expels or
refuses to reenroll a beneficiary.
OIG........... Penalty for a Medicare Advantage 2023 184,412 190,389
organization that engages in practice
that would reasonably be expected to
have the effect of denying or
discouraging enrollment.
OIG........... Penalty per individual who does not 2023 27,661 28,557
enroll as a result of a Medicare
Advantage organization's practice that
would reasonably be expected to have the
effect of denying or discouraging
enrollment.
OIG........... Penalty for a Medicare Advantage 2023 184,412 190,389
organization misrepresenting or
falsifying information to Secretary.
OIG........... Penalty for a Medicare Advantage 2023 46,102 47,596
organization misrepresenting or
falsifying information to individual or
other entity.
OIG........... Penalty for Medicare Advantage 2023 46,102 47,596
organization interfering with provider's
advice to enrollee and non-MCO
affiliated providers that balance bill
enrollees.
OIG........... Penalty for a Medicare Advantage 2023 46,102 47,596
organization that employs or contracts
with excluded individual or entity.

[[Page 64821]]

OIG........... Penalty for a Medicare Advantage 2023 46,102 47,596
organization enrolling an individual in
without prior written consent.
OIG........... Penalty for a Medicare Advantage 2023 46,102 47,596
organization transferring an enrollee to
another plan without consent or solely
for the purpose of earning a commission.
OIG........... Penalty for a Medicare Advantage 2023 46,102 47,596
organization failing to comply with
marketing restrictions or applicable
implementing regulations or guidance.
OIG........... Penalty for a Medicare Advantage 2023 46,102 47,596
organization employing or contracting
with an individual or entity who
violates 1395w-27(g)(1)(A)-(J).
1395w-141(i)(3)........... ...................... OIG........... Penalty for a prescription drug card 2023 16,108 16,630
sponsor that falsifies or misrepresents
marketing materials, overcharges program
enrollees, or misuse transitional
assistance funds.
1395cc(g)................. 42 CFR 1003.210(a)(5). OIG........... Penalty for improper billing by 2023 6,266 6,469
Hospitals, Critical Access Hospitals, or
Skilled Nursing Facilities.
1395dd(d)(1).............. 42 CFR 1003.510....... OIG........... Penalty for a hospital with 100 beds or 2023 129,232 133,420
more or responsible physician dumping
patients needing emergency medical care.
OIG........... Penalty for a hospital with less than 100 2023 64,618 66,712
beds dumping patients needing emergency
medical care.
1395mm(i)(6)(B)(i)........ 42 CFR 1003.410....... OIG........... Penalty for a HMO or competitive medical 2023 64,618 66,712
plan if such plan substantially fails to
provide medically necessary, required
items or services.
OIG........... Penalty for HMOs/competitive medical 2023 64,618 66,712
plans that charge premiums in excess of
permitted amounts.
OIG........... Penalty for a HMO or competitive medical 2023 64,618 66,712
plan that expels or refuses to reenroll
an individual per prescribed conditions.
OIG........... Penalty for a HMO or competitive medical 2023 258,464 266,841
plan that implements practices to
discourage enrollment of individuals
needing services in future.
OIG........... Penalty per individual not enrolled in a 2023 37,190 38,395
plan as a result of a HMO or competitive
medical plan that implements practices
to discourage enrollment of individuals
needing services in the future.
OIG........... Penalty for a HMO or competitive medical 2023 258,464 266,841
plan that misrepresents or falsifies
information to the Secretary.
OIG........... Penalty for a HMO or competitive medical 2023 64,618 66,712
plan that misrepresents or falsifies
information to an individual or any
other entity.
OIG........... Penalty for failure by HMO or competitive 2023 64,618 66,712
medical plan to assure prompt payment of
Medicare risk sharing contracts or
incentive plan provisions.
OIG........... Penalty for HMO that employs or contracts 2023 59,316 61,238
with excluded individual or entity.
1395nn(g)(3).............. 42 CFR 1003.310....... OIG........... Penalty for submitting or causing to be 2023 29,899 30,868
submitted claims in violation of the
Stark Law's restrictions on physician
self-referrals.
1395nn(g)(4).............. 42 CFR 1003.310....... OIG........... Penalty for circumvention schemes in 2023 199,338 205,799
violation of the Stark Law's
restrictions on physician self-referrals.
1395ss(d)(1).............. 42 CFR 1003.1110...... OIG........... Penalty for a material misrepresentation 2023 12,397 12,799
regarding Medigap compliance policies.
1395ss(d)(2).............. 42 CFR 1003.1110...... OIG........... Penalty for selling Medigap policy under 2023 12,397 12,799
false pretense.
1395ss(d)(3)(A)(ii)....... 42 CFR 1003.1110...... OIG........... Penalty for an issuer that sells health 2023 55,808 57,617
insurance policy that duplicates
benefits.
OIG........... Penalty for someone other than issuer 2023 33,483 34,568
that sells health insurance that
duplicates benefits.
1395ss(d)(4)(A)........... 42 CFR 1003.1110...... OIG........... Penalty for using mail to sell a non- 2023 12,397 12,799
approved Medigap insurance policy.
1396b(m)(5)(B)(i)......... 42 CFR 1003.410....... OIG........... Penalty for a Medicaid MCO that 2023 61,982 63,991
substantially fails to provide medically
necessary, required items or services.
OIG........... Penalty for a Medicaid MCO that charges 2023 61,982 63,991
excessive premiums.
OIG........... Penalty for a Medicaid MCO that 2023 247,929 255,964
improperly expels or refuses to reenroll
a beneficiary.
OIG........... Penalty per individual who does not 2023 37,190 38,395
enroll as a result of a Medicaid MCO's
practice that would reasonably be
expected to have the effect of denying
or discouraging enrollment.
OIG........... Penalty for a Medicaid MCO 2023 247,929 255,964
misrepresenting or falsifying
information to the Secretary.
OIG........... Penalty for a Medicaid MCO 2023 61,982 63,991
misrepresenting or falsifying
information to an individual or another
entity.
OIG........... Penalty for a Medicaid MCO that fails to 2023 55,808 57,617
comply with contract requirements with
respect to physician incentive plans.
1396r(b)(3)(B)(ii)(I)..... 42 CFR 1003.210(a)(11) OIG........... Penalty for willfully and knowingly 2023 2,586 2,670
certifying a material and false
statement in a Skilled Nursing Facility
resident assessment.

[[Page 64822]]

1396r(b)(3)(B)(ii)(II).... 42 CFR 1003.210(a)(11) OIG........... Penalty for willfully and knowingly 2023 12,924 13,343
causing another individual to certify a
material and false statement in a
Skilled Nursing Facility resident
assessment.
1396r(g)(2)(A)(i)......... 42 CFR 1003.1310...... OIG........... Penalty for notifying or causing to be 2023 5,171 5,339
notified a Skilled Nursing Facility of
the time or date on which a survey is to
be conducted.
1396r-8(b)(3)(B).......... 42 CFR 1003.1210...... OIG........... Penalty for the knowing provision of 2023 223,229 230,464
false information or refusing to provide
information about charges or prices of a
covered outpatient drug.
1396r-8(b)(3)(C)(i)....... 42 CFR 1003.1210...... OIG........... Penalty per day for failure to timely 2023 22,324 23,048
provide information by drug manufacturer
with rebate agreement.
1396r-8(b)(3)(C)(ii)...... 42 CFR 1003.1210...... OIG........... Penalty for knowing provision of false 2023 223,229 230,464
information by drug manufacturer with
rebate agreement.
1396t(i)(3)(A)............ 42 CFR 1003.1310...... OIG........... Penalty for notifying home and community- 2023 4,465 4,610
based providers or settings of survey.
11131(c).................. 42 CFR 1003.810....... OIG........... Penalty for failing to report a medical 2023 27,018 27,894
malpractice claim to National
Practitioner Data Bank.
11137(b)(2)............... 42 CFR 1003.810....... OIG........... Penalty for breaching confidentiality of 2023 27,018 27,894
information reported to National
Practitioner Data Bank.
299b-22(f)(1)............. 42 CFR 3.404.......... OCR........... Penalty for violation of confidentiality 2023 14,960 15,445
provision of the Patient Safety and
Quality Improvement Act.
1320(d)-5(a).............. 45 CFR OCR........... Penalty for each pre-February 18, 2009 2023 187 193
160.404(b)(1)(i), violation of the HIPAA administrative
(ii). simplification provisions.
OCR........... Calendar Year Cap........................ 2023 47,061 48,586
1320(d)-5(a).............. 45 CFR OCR........... Penalty for each February 18, 2009 or 2023 ........... ...........
160.404(b)(2)(i)(A), later violation of a HIPAA
(B). administrative simplification provision
in which it is established that the
covered entity or business associate did
not know and, by exercising reasonable
diligence, would not have known that the
covered entity or business associate
violated such a provision.
Minimum.................................. 2023 137 141
Maximum.................................. 2023 68,928 71,162
Calendar Year Cap........................ 2023 2,067,813 2,134,831
45 CFR OCR........... Penalty for each February 18, 2009 or 2023 ........... ...........
160.404(b)(2)(ii)(A), later violation of a HIPAA
(B). administrative simplification provision
in which it is established that the
violation was due to reasonable cause
and not to willful neglect.
Minimum.................................. 2023 1,379 1,424
Maximum.................................. 2023 68,928 71,162
Calendar Year Cap........................ 2023 2,067,813 2,134,831
45 CFR OCR........... Penalty for each February 18, 2009 or 2023 ........... ...........
160.404(b)(2)(iii)(A) later violation of a HIPAA
, (B). administrative simplification provision
in which it is established that the
violation was due to willful neglect and
was corrected during the 30-day period
beginning on the first date the covered
entity or business associate knew, or,
by exercising reasonable diligence,
would have known that the violation
occurred.
Minimum.................................. 2023 13,785 14,232
Maximum.................................. 2023 68,928 71,162
Calendar Year Cap........................ 2023 2,067,813 2,134,831
45 CFR OCR........... Penalty for each February 18, 2009 or 2023 ........... ...........
160.404(b)(2)(iv)(A), later violation of a HIPAA
(B). administrative simplification provision
in which it is established that the
violation was due to willful neglect and
was not corrected during the 30-day
period beginning on the first date the
covered entity or business associate
knew, or, by exercising reasonable
diligence, would have known that the
violation occurred.
Minimum.................................. 2023 68,928 71,162
Maximum.................................. 2023 2,067,813 2,134,831
Calendar Year Cap........................ 2023 2,067,813 2,134,831
42 U.S.C. 300gg-18, 42 U.S.C. 45 CFR 180.90......... CMS........... Penalty for a hospital's non-compliance 2023 323 333
1302. with making public standard charges for
hospital items and services.
Per Day (Maximum)........................ 2023 5,926 6,118

[[Page 64823]]

45 CFR 180.90(c)(2)(i) CMS........... Per day penalty for a hospital's ........... 328 339
noncompliance with making public
standard charges for hospital items and
services.
45 CFR CMS........... Per day penalty for hospitals with equal ........... 323 333
180.90(c)(2)(ii)(A). to or less than 30 beds.
45 CFR CMS........... Per day, per bed penalty for hospitals ........... 11 11
180.90(c)(2)(ii)(B). having at least 31 and up to and
including 550 beds.
45 CFR CMS........... Per day penalty for hospitals having ........... 2,926 3,021
180.90(c)(2)(ii)(C). greater than 550 beds.
CARES Act, Public Law 116- 45 CFR 182.70......... CMS........... Penalty for a provider's non-compliance 2023 ........... ...........
136, section 3202(b)(2). with price transparency requirements
regarding diagnostic tests for COVID-19.
Per Day (Maximum)........................ 2023 323 333
263a(h)(2)(B) & 1395w- 42 CFR CMS........... Penalty for a clinical laboratory's 2023 ........... ...........
2(b)(2)(A)(ii). 493.1834(d)(2)(i). failure to meet participation and
certification requirements and poses
immediate jeopardy.
Minimum.................................. 2023 7,562 7,807
Maximum.................................. 2023 24,793 25,597
42 CFR CMS........... Penalty for a clinical laboratory's 2023 ........... ...........
493.1834(d)(2)(ii). failure to meet participation and
certification requirements and the
failure does not pose immediate jeopardy.
Minimum.................................. 2023 125 129
Maximum.................................. 2023 7,437 7,678
42 CFR CMS........... Penalty for a clinical laboratory's 2023 ........... ...........
493.1834(d)(2)(iii). failure to meet SARS-CoV-2 test
reporting requirements.
First day of noncompliance............... 2023 ........... ...........
Each additional day of noncompliance..... 2023 ........... ...........
300gg-15(f)............... 45 CFR 147.200(e)..... CMS........... Failure to provide the Summary of 2023 1,362 1,406
Benefits and Coverage.
300gg-18.................. 45 CFR 158.606........ CMS........... Penalty for violations of regulations 2023 136 140
related to the medical loss ratio
reporting and rebating.
45 CFR 180.90......... CMS........... Price against hospital identified by CMS 2023 ........... ...........
as noncompliant according to Sec.
182.50 with respect to price
transparency requirements regarding
diagnostic tests for COVID-19.
42 U.S.C. 300gg-118 note, ...................... CMS........... Penalties for failure to comply with No 2023 11,445 11,816
300gg-134. Surprises Act requirements on providers,
facilities, providers of air ambulance
services.
1320a-7h(b)(1)............ 42 CFR 402.105(d)(5), CMS........... Penalty for manufacturer or group 2023 ........... ...........
42 CFR 403.912(a) & purchasing organization failing to
(c). report information required under 42
U.S.C. 1320a-7h(a), relating to
physician ownership or investment
interests.
Minimum.................................. 2023 1,362 1,406
Maximum.................................. 2023 13,625 14,067
Calendar Year Cap........................ 2023 204,384 211,008
1320a-7h(b)(2)............ 42 CFR 402.105(h), 42 CMS........... Penalty for manufacturer or group 2023 ........... ...........
CFR 403.912(b) & (c). purchasing organization knowingly
failing to report information required
under 42 U.S.C. 1320a-7h(a), relating to
physician ownership or investment
interests.
Minimum.................................. 2023 13,625 14,067
Maximum.................................. 2023 136,258 140,674
Calendar Year Cap........................ 2023 1,362,567 1,406,728
CMS........... Penalty for an administrator of a 2023 136,258 140,674
facility that fails to comply with
notice requirements for the closure of a
facility.
1320a-7j(h)(3)(A)......... 42 CFR 488.446(a)(1), CMS........... Minimum penalty for the first offense of 2023 681 703
(2), & (3). an administrator who fails to provide
notice of facility closure.
Minimum penalty for the second offense of 2023 2,045 2,111
an administrator who fails to provide
notice of facility closure.
Minimum penalty for the third and 2023 4,087 4,219
subsequent offenses of an administrator
who fails to provide notice of facility
closure.
1320a-8(a)(1)............. CMS........... Penalty for an entity knowingly making a 2023 9,966 10,289
false statement or representation of
material fact in the determination of
the amount of benefits or payments
related to old-age, survivors, and
disability insurance benefits, special
benefits for certain World War II
veterans, or supplemental security
income for the aged, blind, and disabled.
Penalty for violation of 42 U.S.C. 1320a- 2023 9,399 9,704
8(a)(1) if the violator is a person who
receives a fee or other income for
services performed in connection with
determination of the benefit amount or
the person is a physician or other
health care provider who submits
evidence in connection with such a
determination.
1320a-8(a)(3)............. CMS........... Penalty for a representative payee (under 2023 7,805 8,058
42 U.S.C. 405(j), 1007, or 1383(a)(2))
converting any part of a received
payment from the benefit programs
described in the previous civil monetary
penalty to a use other than for the
benefit of the beneficiary.

[[Page 64824]]

1320b-25(c)(1)(A)......... CMS........... Penalty for failure of covered 2023 272,514 281,346
individuals to report to the Secretary
and 1 or more law enforcement officials
any reasonable suspicion of a crime
against a resident, or individual
receiving care, from a long-term care
facility.
1320b-25(c)(2)(A)......... CMS........... Penalty for failure of covered 2023 408,769 422,017
individuals to report to the Secretary
and 1 or more law enforcement officials
any reasonable suspicion of a crime
against a resident, or individual
receiving care, from a long-term care
facility if such failure exacerbates the
harm to the victim of the crime or
results in the harm to another
individual.
1320b-25(d)(2)............ CMS........... Penalty for a long-term care facility 2023 272,514 281,346
that retaliates against any employee
because of lawful acts done by the
employee, or files a complaint or report
with the State professional disciplinary
agency against an employee or nurse for
lawful acts done by the employee or
nurse.
1395b-7(b)(2)(B).......... 42 CFR 402.105(g)..... CMS........... Penalty for any person who knowingly and 2023 184 190
willfully fails to furnish a beneficiary
with an itemized statement of items or
services within 30 days of the
beneficiary's request.
1395i-3(h)(2)(B)(ii)(I)... 42 CFR CMS........... Penalty per day for a Skilled Nursing 2023 ........... ...........
488.408(d)(1)(iii). Facility that has a Category 2 violation
of certification requirements.
Minimum.................................. 2023 129 133
Maximum.................................. 2023 7,752 8,003
42 CFR CMS........... Penalty per instance of Category 2 2023 ........... ...........
488.408(d)(1)(iv). noncompliance by a Skilled Nursing
Facility.
Minimum.................................. 2023 2,586 2,670
Maximum.................................. 2023 25,847 26,685
42 CFR CMS........... Penalty per day for a Skilled Nursing 2023 ........... ...........
488.408(e)(1)(iii). Facility that has a Category 3 violation
of certification requirements.
Minimum.................................. 2023 7,884 8,140
Maximum.................................. 2023 25,847 26,685
42 CFR CMS........... Penalty per instance of Category 3 2023 ........... ...........
488.408(e)(1)(iv). noncompliance by a Skilled Nursing
Facility.
Minimum.................................. 2023 2,586 2,670
Maximum.................................. 2023 25,847 26,685
42 CFR CMS........... Penalty per day and per instance for a 2023 ........... ...........
488.408(e)(2)(ii). Skilled Nursing Facility that has
Category 3 noncompliance with Immediate
Jeopardy.
Per Day (Minimum)........................ 2023 7,884 8,140
Per Day (Maximum)........................ 2023 25,847 26,685
Per Instance (Minimum)................... 2023 2,586 2,670
Per Instance (Maximum)................... 2023 25,847 26,685
42 CFR CMS........... Penalty per day of a Skilled Nursing 2023 ........... ...........
488.438(a)(1)(i). Facility that fails to meet
certification requirements. These
amounts represent the upper range per
day.
Minimum.................................. 2023 7,884 8,140
Maximum.................................. 2023 25,847 26,685
42 CFR CMS........... Penalty per day of a Skilled Nursing 2023 ........... ...........
488.438(a)(1)(ii). Facility that fails to meet
certification requirements. These
amounts represent the lower range per
day.
Minimum.................................. 2023 129 133
Maximum.................................. 2023 7,752 8,003
42 CFR 488.438(a)(2).. CMS........... Penalty per instance of a Skilled Nursing 2023 ........... ...........
Facility that fails to meet
certification requirements.
Minimum.................................. 2023 2,586 2,670
Maximum.................................. 2023 25,847 26,685
42 CFR 488.447........ CMS........... Penalty imposed for failure to comply 2023 ........... ...........
with infection control weekly reporting
requirements at 42 CFR 483.80(g)(1) and
(2).
First occurrence......................... 2023 1,158 1,196
Incremental increases for each subsequent 2023 579 598
occurrences.
1395i-6(c)(5)(B)(i)....... 42 CFR 488.1245....... CMS........... Penalty for noncompliance by hospice 2023 10,775 11,124
program with requirements specified in
section 1395x(dd) of 42 U.S.C.

[[Page 64825]]

42 CFR CMS........... Adjustment to penalties. Maximum penalty 2023 10,775 11,124
488.1245(b)(2)(iii). assessment for each day a hospice is not
in substantial compliance with one or
more conditions of participation.
42 CFR 488.1245(b)(3). CMS........... Penalty imposed for hospice condition- ........... ........... ...........
level deficiency that is immediate
jeopardy. These amounts represent the
upper range of penalty.
Minimum.................................. 2023 9,158 9,455
Maximum.................................. 2023 10,775 11,124
42 CFR CMS........... Penalty imposed for hospice condition- 2023 10,775 11,124
488.1245(b)(3)(i). level deficiency that is immediate
jeopardy. These amounts represent the
upper range of penalty.
42 CFR CMS........... Penalty imposed for hospice condition- 2023 9,697 10,011
488.1245(b)(3)(ii). level deficiency that is immediate
jeopardy. These amounts represent the
upper range of penalty.
42 CFR CMS........... Penalty imposed for hospice condition- 2023 9,158 9,455
488.1245(b)(3)(iii). level deficiency that is immediate
jeopardy. These amounts represent the
upper range of penalty.
42 CFR 488.1245(b)(4). CMS........... Penalty imposed for hospice repeat or ........... ........... ...........
condition-level deficiency or both that
does not constitute immediate jeopardy
but is directly related to poor quality
patient care outcomes. These amounts
represent the middle range of penalty.
Minimum.................................. 2023 1,616 1,668
Maximum.................................. 2023 9,158 9,455
42 CFR 488.1245(b)(5). CMS........... Penalty imposed for hospice repeat or ........... ........... ...........
condition-level deficiency or both that
does not constitute immediate jeopardy
and are related predominantly to
structure or process-oriented conditions
rather than directly related to patient
outcomes. These amounts represent the
lower range of penalty.
Minimum.................................. 2023 539 556
Maximum.................................. 2023 4,310 4,450
42 CFR 488.1245(b)(6). CMS........... Penalty range imposed for per instance of ........... ........... ...........
hospice noncompliance.
Minimum.................................. 2023 1,077 1,112
Maximum.................................. 2023 10,775 11,124
42 CFR CMS........... Penalty for each per instance of hospice 2023 10,775 11,124
488.1245(d)(1)(ii). noncompliance, maximum per day per
hospice program.
1395l(h)(5)(D)............ 42 CFR CMS........... Penalty for knowingly, willfully, and 2023 18,825 19,435
402.105(d)(2)(i). repeatedly billing for a clinical
diagnostic laboratory test other than on
an assignment-related basis. (Penalties
are assessed in the same manner as 42
U.S.C. 1395u(j)(2)(B), which is assessed
according to 1320a-7a(a)).
1395l(i)(6)............... ...................... CMS........... Penalty for knowingly and willfully 2023 4,960 5,121
presenting or causing to be presented a
bill or request for payment for an
intraocular lens inserted during or
after cataract surgery for which the
Medicare payment rate includes the cost
of acquiring the class of lens involved.
1395l(q)(2)(B)(i)......... 42 CFR 402.105(a)..... CMS........... Penalty for knowingly and willfully 2023 4,745 4,899
failing to provide information about a
referring physician when seeking payment
on an unassigned basis.
1395m(a)(11)(A)........... 42 CFR 402.1(c)(4), CMS........... Penalty for any durable medical equipment 2023 18,825 19,435
402.105(d)(2)(ii). supplier that knowingly and willfully
charges for a covered service that is
furnished on a rental basis after the
rental payments may no longer be made.
(Penalties are assessed in the same
manner as 42 U.S.C. 1395u(j)(2)(B),
which is assessed according to 1320a-
7a(a)).
1395m(a)(18)(B)........... 42 CFR 402.1(c)(5), CMS........... Penalty for any nonparticipating durable 2023 18,825 19,435
402.105(d)(2)(iii). medical equipment supplier that
knowingly and willfully fails to make a
refund to Medicare beneficiaries for a
covered service for which payment is
precluded due to an unsolicited
telephone contact from the supplier.
(Penalties are assessed in the same
manner as 42 U.S.C. 1395u(j)(2)(B),
which is assessed according to 1320a-
7a(a)).
1395m(b)(5)(C)............ 42 CFR 402.1(c)(6), CMS........... Penalty for any nonparticipating 2023 18,825 19,435
402.105(d)(2)(iv). physician or supplier that knowingly and
willfully charges a Medicare beneficiary
more than the limiting charge for
radiologist services. (Penalties are
assessed in the same manner as 42 U.S.C.
1395u(j)(2)(B), which is assessed
according to 1320a-7a(a)).
1395m(h)(3)............... 42 CFR 402.1(c)(8), CMS........... Penalty for any supplier of prosthetic 2023 18,825 19,435
402.105(d)(2)(vi). devices, orthotics, and prosthetics that
knowing and willfully charges for a
covered prosthetic device, orthotic, or
prosthetic that is furnished on a rental
basis after the rental payment may no
longer be made. (Penalties are assessed
in the same manner as 42 U.S.C.
1395m(a)(11)(A), that is in the same
manner as 1395u(j)(2)(B), which is
assessed according to 1320a-7a(a)).

[[Page 64826]]

1395m(j)(2)(A)(iii)....... ...................... CMS........... Penalty for any supplier of durable 2023 1,993 2,058
medical equipment including a supplier
of prosthetic devices, prosthetics,
orthotics, or supplies that knowingly
and willfully distributes a certificate
of medical necessity in violation of
Section 1834(j)(2)(A)(i) of the Act or
fails to provide the information
required under Section 1834(j)(2)(A)(ii)
of the Act.
1395m(j)(4)............... 42 CFR 402.1(c)(10), CMS........... Penalty for any supplier of durable 2023 18,825 19,435
402.105(d)(2)(vii). medical equipment, including a supplier
of prosthetic devices, prosthetics,
orthotics, or supplies that knowingly
and willfully fails to make refunds in a
timely manner to Medicare beneficiaries
for series billed other than on as
assignment-related basis under certain
conditions. (Penalties are assessed in
the same manner as 42 U.S.C. 1395m(j)(4)
and 1395u(j)(2)(B), which is assessed
according to 1320a-7a(a)).
1395m-1(a)................ 42 CFR 414.504(e)..... CMS........... Penalty for an applicable entity that has 2023 12,551 12,958
failed to report or made a
misrepresentation or omission in
reporting applicable information with
respect to a clinical diagnostic
laboratory test.
42 CFR 402.1(c)(31), CMS........... Penalty for any person or entity who 2023 18,825 19,435
402.105(d)(3). knowingly and willfully bills or
collects for any outpatient therapy
services or comprehensive outpatient
rehabilitation services on other than an
assignment-related basis. (Penalties are
assessed in the same manner as 42 U.S.C.
1395m(k)(6) and 1395u(j)(2)(B), which is
assessed according to 1320a-7a(a)).
1395m(l)(6)............... 42 CFR 402.1(c)(32), CMS........... Penalty for any supplier of ambulance 2023 18,825 19,435
402.105(d)(4). services who knowingly and willfully
fills or collects for any services on
other than an assignment-related basis.
(Penalties are assessed in the same
manner as 42 U.S.C. 1395u(b)(18)(B),
which is assessed according to 1320a-
7a(a)).
1395u(b)(18)(B)........... 42 CFR 402.1(c)(11), CMS........... Penalty for any practitioner specified in 2023 18,825 19,435
402.105(d)(2)(viii). Section 1842(b)(18)(C) of the Act or
other person that knowingly and
willfully bills or collects for any
services by the practitioners on other
than an assignment-related basis.
(Penalties are assessed in the same
manner as 42 U.S.C. 1395u(j)(2)(B),
which is assessed according to 1320a-
7a(a)).
1395u(j)(2)(B)............ 42 CFR 402.1(c)....... CMS........... Penalty for any physician who charges 2023 18,825 19,435
more than 125% for a non-participating
referral. (Penalties are assessed in the
same manner as 42 U.S.C. 1320a-7a(a)).
1395u(k).................. 42 CFR 402.1(c)(12), CMS........... Penalty for any physician who knowingly 2023 18,825 19,435
402.105(d)(2)(ix) and willfully presents or causes to be
1834A(a)(9) and 42 presented a claim for bill for an
CFR 414.504(e). assistant at a cataract surgery
performed on or after March 1, 1987, for
which payment may not be made because of
section 1862(a)(15). (Penalties are
assessed in the same manner as 42 U.S.C.
1395u(j)(2)(B), which is assessed
according to 1320a-7a(a)).
1395u(l)(3)............... 42 CFR 402.1(c)(13), CMS........... Penalty for any nonparticipating 2023 18,825 19,435
402.105(d)(2)(x). physician who does not accept payment on
an assignment-related basis and who
knowingly and willfully fails to refund
on a timely basis any amounts collected
for services that are not reasonable or
medically necessary or are of poor
quality under 1842(l)(1)(A). (Penalties
are assessed in the same manner as 42
U.S.C. 1395u(j)(2)(B), which is assessed
according to 1320a-7a(a)).
1395u(m)(3)............... 42 CFR 402.1(c)(14), CMS........... Penalty for any nonparticipating 2023 18,825 19,435
402.105(d)(2)(xi). physician charging more than $500 who
does not accept payment for an elective
surgical procedure on an assignment
related basis and who knowingly and
willfully fails to disclose the required
information regarding charges and
coinsurance amounts and fails to refund
on a timely basis any amount collected
for the procedure in excess of the
charges recognized and approved by the
Medicare program. (Penalties are
assessed in the same manner as 42 U.S.C.
1395u(j)(2)(B), which is assessed
according to 1320a-7a(a)).
1395u(n)(3)............... 42 CFR 402.1(c)(15), CMS........... Penalty for any physician who knowingly, 2023 18,825 19,435
402.105(d)(2)(xii). willfully, and repeatedly bills one or
more beneficiaries for purchased
diagnostic tests any amount other than
the payment amount specified by the Act.
(Penalties are assessed in the same
manner as 42 U.S.C. 1395u(j)(2)(B),
which is assessed according to 1320a-
7a(a)).

[[Page 64827]]

1395u(o)(3)(B)............ 42 CFR 414.707(b)..... CMS........... Penalty for any practitioner specified in 2023 18,825 19,435
Section 1842(b)(18)(C) of the Act or
other person that knowingly and
willfully bills or collects for any
services pertaining to drugs or
biologics by the practitioners on other
than an assignment-related basis.
(Penalties are assessed in the same
manner as 42 U.S.C. 1395u(b)(18)(B) and
1395u(j)(2)(B), which is assessed
according to 1320a-7a(a)).
1395u(p)(3)(A)............ ...................... CMS........... Penalty for any physician or practitioner 2023 4,960 5,121
who knowingly and willfully fails
promptly to provide the appropriate
diagnosis codes upon CMS or Medicare
administrative contractor request for
payment or bill not submitted on an
assignment-related basis.
1395w-3a(d)(4)(A)......... 42 CFR 414.806........ CMS........... Penalty for a pharmaceutical 2023 16,108 16,630
manufacturer's misrepresentation of
average sales price of a drug, or
biologic.
1395w-4(g)(1)(B).......... 42 CFR 402.1(c)(17), CMS........... Penalty for any nonparticipating 2023 18,825 19,435
402.105(d)(2)(xiii). physician, supplier, or other person
that furnishes physician services not on
an assignment-related basis who either
knowingly and willfully bills or
collects in excess of the statutorily-
defined limiting charge or fails to make
a timely refund or adjustment.
(Penalties are assessed in the same
manner as 42 U.S.C. 1395u(j)(2)(B),
which is assessed according to 1320a-
7a(a)).
1395w-4(g)(3)(B).............. 42 CFR 402.1(c)(18), CMS........... Penalty for any person that knowingly and 2023 18,825 19,435
402.105(d)(2)(xiv). willfully bills for statutorily defined
State-plan approved physicians' services
on any other basis than an assignment-
related basis for a Medicare/Medicaid
dual eligible beneficiary. (Penalties
are assessed in the same manner as 42
U.S.C. 1395u(j)(2)(B), which is assessed
according to 1320a-7a(a)).
1395w-27(g)(3)(A); 42 CFR 422.760(b); 42 CMS........... Penalty for each termination 2023 46,102 47,596
1857(g)(3); 1860D- CFR 423.760(b). determination the Secretary makes that
12(b)(3)(E). is the result of actions by a Medicare
Advantage organization or Part D sponsor
that has adversely affected (or has the
substantial likelihood of adversely
affecting) an individual covered under
the organization's contract.
1395w-27(g)(3)(B); ...................... CMS........... Penalty for each week beginning after the 2023 18,442 19,040
1857(g)(3); 1860D- initiation of civil money penalty
12(b)(3)(E). procedures by the Secretary because a
Medicare Advantage organization or Part
D sponsor has failed to carry out a
contract, or has carried out a contract
inconsistently with regulations.
1395w-27(g)(3)(D); ...................... CMS........... Penalty for a Medicare Advantage 2023 171,257 176,807
1857(g)(3): 1860D- organizations or Part D sponsor's early
12(b)(3)(E). termination of its contract.
1395y(b)(3)(C)............ 42 CFR 411.103(b)..... CMS........... Penalty for an employer or other entity 2023 11,162 11,524
to offer any financial or other
incentive for an individual entitled to
benefits not to enroll under a group
health plan or large group health plan
which would be a primary plan.
1395y(b)(5)(C)(ii)........ 42 CFR 402.1(c)(20), CMS........... Penalty for any non-governmental employer 2023 1,818 1,877
42 CFR 402.105(b)(2). that, before October 1, 1998, willfully
or repeatedly failed to provide timely
and accurate information requested
relating to an employee's group health
insurance coverage.
1395y(b)(6)(B)............ 42 CFR 402.1(c)(20), CMS........... Penalty for any entity that knowingly, 2023 3,988 4,117
402.105(a). willfully, and repeatedly fails to
complete a claim form relating to the
availability of other health benefits in
accordance with statute or provides
inaccurate information relating to such
on the claim form.
1395y(b)(7)(B)(i)......... 42 CFR 402.1(c)(21), CMS........... Penalty for any entity serving as 2023 1,428 1,474
402.105(a). insurer, third party administrator, or
fiduciary for a group health plan that
fails to provide information that
identifies situations where the group
health plan is or was a primary plan to
Medicare to the HHS Secretary.
1395y(b)(8)(E)............ ...................... CMS........... Penalty for any non-group health plan 2023 1,428 1,474
that fails to identify claimants who are
Medicare beneficiaries and provide
information to the HHS Secretary to
coordinate benefits and pursue any
applicable recovery claim.
1395nn(g)(5).............. 42 CFR 411.361........ CMS........... Penalty for any person that fails to 2023 23,727 24,496
report information required by HHS under
Section 1877(f) concerning ownership,
investment, and compensation
arrangements.
1395pp(h)................. 42 CFR 402.1(c)(23), CMS........... Penalty for any durable medical equipment 2023 18,825 19,435
402.105(d)(2)(xv). supplier, including a supplier of
prosthetic devices, prosthetics,
orthotics, or supplies, that knowingly
and willfully fails to make refunds in a
timely manner to Medicare beneficiaries
under certain conditions. (42 U.S.C.
1395(m)(18) sanctions apply here in the
same manner, which is under 1395u(j)(2)
and 1320a-7a(a)).
1395ss(a)(2).............. 402.102(f)(1)......... CMS........... Penalty for any person that issues a 2023 64,617 66,711
Medicare supplemental policy that has
not been approved by the State
regulatory program or does not meet
Federal standards after a statutorily
defined effective date.
1395ss(d)(3)(A)(vi) (II).. 42 CFR 402.1(c)(25), CMS........... Penalty for someone other than issuer 2023 33,483 34,568
402.105(e), that sells or issues a Medicare
402.105(f)(2). supplemental policy to beneficiary
without a disclosure statement.
CMS........... Penalty for an issuer that sells or 2023 55,808 57,617
issues a Medicare supplemental policy
without disclosure statement.

[[Page 64828]]

1395ss(d)(3)(B)(iv)....... ...................... CMS........... Penalty for someone other than issuer 2023 33,483 34,568
that sells or issues a Medicare
supplemental policy without
acknowledgement form.
CMS........... Penalty for issuer that sells or issues a 2023 55,808 57,617
Medicare supplemental policy without an
acknowledgement form.
1395ss(p)(8).............. 42 CFR 402.1(c)(25), CMS........... Penalty for someone other than issuer 2023 33,483 34,568
402.105(e). that sells or issues Medicare
supplemental polices after a given date
that fail to conform to the NAIC or
Federal standards established by statute.
42 CFR 402.1(c)(25), CMS........... Penalty for an issuer that sells or 2023 55,808 57,617
405402.105(f)(2). issues Medicare supplemental polices
after a given date that fail to conform
to the NAIC or Federal standards
established by statute.
1395ss(p)(9)(C)........... 42 CFR 402.1(c)(26), CMS........... Penalty for someone other than issuer 2023 33,483 34,568
402.105(e), that sells a Medicare supplemental
402.105(f)(3), (4). policy and fails to make available for
sale the core group of basic benefits
when selling other Medicare supplemental
policies with additional benefits or
fails to provide the individual, before
selling the policy, an outline of
coverage describing benefits.
402.105(f)(3),(4)..... CMS........... Penalty for an issuer that sells a 2023 55,808 57,617
Medicare supplemental policy and fails
to make available for sale the core
group of basic benefits when selling
other Medicare supplemental policies
with additional benefits or fails to
provide the individual, before selling
the policy, an outline of coverage
describing benefits.
1395ss(q)(5)(C)........... 402.105(f)(5)......... CMS........... Penalty for any person that fails to 2023 55,808 57,617
suspend the policy of a policyholder
made eligible for medical assistance or
automatically reinstates the policy of a
policyholder who has lost eligibility
for medical assistance, under certain
circumstances.
1395ss(r)(6)(A)........... 402.105(f)(6)......... CMS........... Penalty for any person that fails to 2023 55,808 57,617
provide refunds or credits as required
by section 1882(r)(1)(B).
1395ss(s)(4).............. 42 CFR 402.1(c)(29), CMS........... Penalty for any issuer of a Medicare 2023 23,692 24,460
402.105(c). supplemental policy that does not waive
listed time periods if they were already
satisfied under a proceeding Medicare
supplemental policy, or denies a policy,
or conditions the issuances or
effectiveness of the policy, or
discriminates in the pricing of the
policy base on health status or other
specified criteria.
1395ss(t)(2).............. 42 CFR 402.1(c)(30), CMS........... Penalty for any issuer of a Medicare 2023 55,808 57,617
402.105(f)(7). supplemental policy that fails to
fulfill listed responsibilities.
1395ss(v)(4)(A)........... ...................... CMS........... Penalty someone other than issuer who 2023 24,163 24,946
sells, issues, or renews a medigap Rx
policy to an individual who is a Part D
enrollee.
CMS........... Penalty for an issuer who sells, issues, 2023 40,272 41,577
or renews a Medigap Rx policy who is a
Part D enrollee.
1395bbb(c)(1)............. 42 CFR 488.725(c)..... CMS........... Penalty for any individual who notifies 2023 5,171 5,339
or causes to be notified a home health
agency of the time or date on which a
survey of such agency is to be conducted.
1395bbb(f)(2)(A)(i)....... 42 CFR CMS........... Maximum daily penalty amount for each day 2023 24,793 25,597
488.845(b)(2)(iii) 42 a home health agency is not in
CFR 488.845(b)(3)- compliance with statutory requirements.
(6); and 42 CFR
488.845(d)(1)(ii).
42 CFR 488.845(b)(3).. CMS........... Penalty per day for home health agency's 2023 ........... ...........
noncompliance (Upper Range).
Minimum.................................. 2023 21,074 21,757
Maximum.................................. 2023 24,793 25,597
42 CFR CMS........... Penalty for a home health agency's 2023 24,793 25,597
488.845(b)(3)(i). deficiency or deficiencies that cause
immediate jeopardy and result in actual
harm.
42 CFR CMS........... Penalty for a home health agency's 2023 22,313 23,036
488.845(b)(3)(ii). deficiency or deficiencies that cause
immediate jeopardy and result in
potential for harm.
42 CFR CMS........... Penalty for an isolated incident of 2023 21,074 21,757
488.845(b)(3)(iii). noncompliance in violation of
established HHA policy.
42 CFR 488.845(b)(4).. CMS........... Penalty for a repeat and/or condition- 2023 ........... ...........
level deficiency that does not
constitute immediate jeopardy, but is
directly related to poor quality patient
care outcomes (Lower Range).
Minimum.................................. 2023 3,720 3,841
Maximum.................................. 2023 21,074 21,757

[[Page 64829]]

42 CFR 488.845(b)(5).. CMS........... Penalty for a repeat and/or condition- 2023 ........... ...........
level deficiency that does not
constitute immediate jeopardy and that
is related predominately to structure or
process-oriented conditions (Lower
Range).
Minimum.................................. 2023 1,240 1,280
Maximum.................................. 2023 2,479 2,559
42 CFR 488.845(b)(6).. CMS........... Penalty imposed for instance of 2023 ........... ...........
noncompliance that may be assessed for
one or more singular events of condition-
level noncompliance that are identified
and where the noncompliance was
corrected during the onsite survey.
Penalty for each day of noncompliance 2023 2,479 2,559
(Minimum).
Penalty for each day of noncompliance 2023 24,793 25,597
(Maximum).
42 CFR CMS........... Penalty for each day of noncompliance 2023 24,793 25,597
488.845(d)(1)(ii). (Maximum).
1395eee(e)(6)(B); 1396u- 42 CFR 460.46......... CMS........... Penalty for PACE organization that 2023 46,102 47,596
4(e)(6)(B). discriminates in enrollment or
disenrollment, or engages in any
practice that would reasonably be
expected to have the effect of denying
or discouraging enrollment, on the basis
of health status or the need for
services.
CMS........... For each individual not enrolled as a 2023 ........... ...........
result of the PACE organization's
discrimination in enrollment or
disenrollment or practice that would
deny or discourage enrollment.
Minimum.................................. 2023 17,370 17,933
Maximum.................................. 2023 115,802 119,555
CMS........... Penalty for a PACE organization that 2023 46,102 47,596
charges excessive premiums.
CMS........... Penalty for a PACE organization 2023 184,412 190,389
misrepresenting or falsifying
information to CMS or the State.
CMS........... Penalty for any other violation specified 2023 46,102 47,596
in 42 CFR 460.40.
1396r(h)(3)(C)(ii)(I)..... 42 CFR CMS........... Penalty per day for a nursing facility's 2023 ........... ...........
488.408(d)(1)(iii). failure to meet a Category 2
Certification.
Minimum.................................. 2023 129 133
Maximum.................................. 2023 7,752 8,003
42 CFR CMS........... Penalty per instance for a nursing 2023 ........... ...........
488.408(d)(1)(iv). facility's failure to meet Category 2
certification.
Minimum.................................. 2023 2,586 2,670
Maximum.................................. 2023 25,847 26,685
42 CFR CMS........... Penalty per day for a nursing facility's 2023 ........... ...........
488.408(e)(1)(iii). failure to meet Category 3 certification.
Minimum.................................. 2023 7,884 8,140
Maximum.................................. 2023 25,847 26,685
42 CFR CMS........... Penalty per instance for a nursing 2023 ........... ...........
488.408(e)(1)(iv). facility's failure to meet Category 3
certification.
Minimum.................................. 2023 2,586 2,670
Maximum.................................. 2023 25,847 26,685
42 CFR CMS........... Penalty per instance for a nursing 2023 ........... ...........
488.408(e)(2)(ii). facility's failure to meet Category 3
certification, which results in
immediate jeopardy.
Minimum.................................. 2023 2,586 2,670
Maximum.................................. 2023 25,847 26,685
42 CFR CMS........... Penalty per day for nursing facility's 2023 ........... ...........
488.438(a)(1)(i). failure to meet certification (Upper
Range).
Minimum.................................. 2023 7,884 8,140
Maximum.................................. 2023 25,847 26,685
42 CFR CMS........... Penalty per day for nursing facility's 2023 ........... ...........
488.438(a)(1)(ii). failure to meet certification (Lower
Range).
Minimum.................................. 2023 129 133
Maximum.................................. 2023 7,752 8,003
42 CFR 488.438(a)(2).. CMS........... Penalty per instance for nursing 2023 ........... ...........
facility's failure to meet certification.
Minimum.................................. 2023 2,586 2,670
Maximum.................................. 2023 25,847 26,685
42 CFR 488.447........ CMS........... Penalty imposed for failure to comply 2023 ........... ...........
with infection control weekly reporting
requirements at 42 CFR 483.80(g)(1) and
(2).
First occurrence (Minimum)............... 2023 1,158 1,196
Incremental increases for each subsequent 2023 579 598
occurrence.
1396r(f)(2)(B)(iii)(I)(c). 42 CFR CMS........... Grounds to prohibit approval of Nurse 2023 12,924 13,343
483.151(b)(2)(iv) and Aide Training Program--if assessed a
(b)(3)(iii). penalty in 1819(h)(2)(B)(i) or
1919(h)(2)(A)(ii) of ``not less than
$5,000'' [Not CMP authority, but a
specific CMP amount (CMP at this level)
that is the triggering condition for
disapproval].

[[Page 64830]]

1396r(h)(3)(C)(ii)(I)..... 42 CFR 483.151(c)(2).. CMS........... Grounds to waive disapproval of nurse 2023 12,924 13,343
aide training program--reference to
disapproval based on imposition of CMP
``not less than $5,000'' [Not CMP
authority but CMP imposition at this
level determines eligibility to seek
waiver of disapproval of nurse aide
training program].
1396t(j)(2)(C)............ ...................... CMS........... Penalty for each day of noncompliance for 2023 ........... ...........
a home or community care provider that
no longer meets the minimum requirements
for home and community care.
Minimum.................................. 2023 2 2
Maximum.................................. 2023 22,324 23,048
1396u-2(e)(2)(A)(i)....... 42 CFR 438.704........ CMS........... Penalty for a Medicaid managed care 2023 46,102 47,596
organization that fails substantially to
provide medically necessary items and
services.
CMS........... Penalty for Medicaid managed care 2023 46,102 47,596
organization that imposes premiums or
charges on enrollees in excess of the
premiums or charges permitted.
CMS........... Penalty for a Medicaid managed care 2023 46,102 47,596
organization that misrepresents or
falsifies information to another
individual or entity.
CMS........... Penalty for a Medicaid managed care 2023 46,102 47,596
organization that fails to comply with
the applicable statutory requirements
for such organizations.
1396u-2(e)(2)(A)(ii)...... 42 CFR 438.704........ CMS........... Penalty for a Medicaid managed care 2023 184,412 190,389
organization that misrepresents or
falsifies information to the HHS
Secretary.
CMS........... Penalty for Medicaid managed care 2023 184,412 190,389
organization that acts to discriminate
among enrollees on the basis of their
health status.
1396u-2(e)(2)(A)(iv)...... 42 CFR 438.704........ CMS........... Penalty for each individual that does not 2023 27,661 28,557
enroll as a result of a Medicaid managed
care organization that acts to
discriminate among enrollees on the
basis of their health status.
1396u(h)(2)............... 42 CFR part 441, CMS........... Penalty for a provider not meeting one of 2023 25,847 26,685
subpart I. the requirements relating to the
protection of the health, safety, and
welfare of individuals receiving
community supported living arrangements
services.
1396w-2(c)(1)............. 42 U.S.C. 300gg- CMS........... Penalty for each day, for each individual 2023 13,785 14,232
22(b)(2)(C)(i), 45 affected by the failure of a health
CFR 150.315. insurance issuer or non-Federal
governmental group health plan to comply
with federal market reform provisions in
part A or D of title XXVII of the PHS
Act 2022[bond]174[bond] 177.
18041(c)(2)............... 45 CFR 156.805(c)..... CMS........... Failure to comply with ACA requirements 2023 187 193
related to risk adjustment, reinsurance,
risk corridors, Exchanges (including QHP
standards) and other ACA Subtitle D
standards; Penalty for violations of
rules or standards of behavior
associated with issuer compliance with
risk adjustment, reinsurance, risk
corridors, Exchanges (including QHP
standards) and other ACA Subtitle D
standards.
42 U.S.C. 300gg- 45 CFR 150.315........ CMS........... Penalty for each day, for each individual 2023 177 183
22(b)(2)(C)(i). affected by the failure of a health
insurance issuer or non-Federal
governmental group health plan to comply
with federal market reform provisions in
part A or D of title XXVII of the PHS
Act.
18081(h)(1)(A)(i)(II)..... 45 CFR 155.285........ CMS........... Penalty for providing false information 2023 34,065 35,169
on Exchange application.
18081(h)(1)(B)............ 45 CFR 155.285........ CMS........... Penalty for knowingly or willfully 2023 340,641 351,681
providing false information on Exchange
application.
18081(h)(2)............... 45 CFR 155.260........ CMS........... Penalty for knowingly or willfully 2023 ........... ...........
disclosing protected information from
Exchange.
CMS........... Maximum.................................. 2023 34,065 35,169
CMS........... Minimum.................................. 2023 348 359
18041(c)(2)............... 45 CFR 155.206(i)..... CMS........... Penalties for violation of applicable 2023 41,774 43,128
Exchange standards by consumer
assistance entities in Federally-
facilitated Exchanges.
Maximum (Per Day)........................ 2023 115 119
31 U.S.C...................... ...................... .............. ......................................... 2023 348 359
1352...................... 45 CFR 93.400(e)...... HHS........... Penalty for the first time an individual 2023 23,727 24,496
makes an expenditure prohibited by
regulations regarding lobbying
disclosure, absent aggravating
circumstances.
Penalty for second and subsequent 2023 ........... ...........
offenses by individuals who make an
expenditure prohibited by regulations
regarding lobbying disclosure.
Minimum.................................. 2023 23,727 24,496

[[Page 64831]]

Maximum.................................. 2023 237,268 244,958
HHS........... Penalty for the first time an individual 2023 23,727 24,496
fails to file or amend a lobbying
disclosure form, absent aggravating
circumstances.
Penalty for second and subsequent 2023 ........... ...........
offenses by individuals who fail to file
or amend a lobbying disclosure form,
absent aggravating circumstances.
Minimum.................................. 2023 23,727 24,496
Maximum.................................. 2023 237,268 244,958
45 CFR part 93, HHS........... Penalty for failure to provide 2023 ........... ...........
Appendix A. certification regarding lobbying in the
award documents for all sub-awards of
all tiers.
Minimum.................................. 2023 23,727 24,496
Maximum.................................. 2023 237,268 244,958
HHS........... Penalty for failure to provide statement 2023 ........... ...........
regarding lobbying for loan guarantee
and loan insurance transactions.
Minimum.................................. 2023 23,727 24,496
Maximum.................................. 2023 237,268 244,958
3801-3812................. 45 CFR 79.3(a)(1)(iv). HHS........... Penalty against any individual who--with 2023 12,398 12,800
knowledge or reason to know--makes,
presents or submits a false, fictitious
or fraudulent claim to the Department.
45 CFR 79.3(b)(1)(ii). HHS........... Penalty against any individual who--with 2023 12,398 12,800
knowledge or reason to know--makes,
presents or submits a false, fictitious
or fraudulent claim to the Department.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Some HHS components have not promulgated regulations regarding their civil monetary penalty-specific statutory authorities.
\2\ The description is not intended to be a comprehensive explanation of the underlying violation; the statute and corresponding regulation, if
applicable, should be consulted.
\3\ Statutory or Inflation Act Adjustment.
\4\ OMB Memorandum M-16-06, Implementation of the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015, published February 24,
2016, guided agencies on initial ``catch-up'' adjustment requirements, and M-17-11, Implementation of the 2017 annual adjustment pursuant to the
Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015, published December 16, 2016; followed by M-18-03, M-19-04, M-20-05, M-21-
10, M-22-07, M-23-05, and M-24-07 guided agencies on annual adjustment requirements.
\5\ OMB Circular A-136, Financial Reporting Requirements, Section II.4.9, directs that agencies must make annual inflation adjustments to civil monetary
penalties and report on the adjustments in the Agency Financial Report (AFR) or Performance and Accountability Report (PAR).
\6\ Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015, Sec. 701(b)(1)(A) (codified as amended at 28 U.S.C. 2461 note).
\7\ Annual inflation adjustments are based on the percent change between each published October's CPI-U. In this case, October 2023 CPI-U (307.671)/
October 2022 CPI-U (298.012) = 1.03241.

[[Page 64832]]

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

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