Rule2023-22264
Annual Civil Monetary Penalties Inflation Adjustment
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
October 6, 2023
Effective
October 6, 2023
Issuing agencies
Health and Human Services Department
Abstract
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.
Full Text
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<title>Federal Register, Volume 88 Issue 193 (Friday, October 6, 2023)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-22264]
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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.
-----------------------------------------------------------------------
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
assig
[…truncated; see source link]Indexed from Federal Register on October 6, 2023.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.