Annual Civil Monetary Penalties Inflation Adjustment, 15100-15123 [2022-05648]
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15100
Federal Register / Vol. 87, No. 52 / Thursday, March 17, 2022 / Rules and Regulations
Dated: March 10, 2022.
Charles Smith,
Director, Biopesticides and Pollution
Prevention Division, Office of Pesticide
Programs.
Therefore, for the reasons stated in the
preamble, EPA is amending 40 CFR
chapter I as follows:
PART 180—TOLERANCES AND
EXEMPTIONS FOR PESTICIDE
CHEMICAL RESIDUES IN FOOD
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Revise § 180.1327 to read as
follows:
■
§ 180.1327 Tetraacetylethylenediamine
(TAED) and its metabolite
Diacetylethylenediamine (DAED);
Exemption from the Requirement of a
Tolerance.
An exemption from the requirement
of a tolerance is established for residues
of the pesticide,
tetraacetylethylenediamine (TAED), and
its metabolite diacetylethylenediamine
(DAED), in or on all food commodities,
when used as a fungicide and
bactericide in accordance with label
directions and good agricultural
practices.
[FR Doc. 2022–05530 Filed 3–16–22; 8:45 am]
BILLING CODE 6560–50–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
45 CFR Part 102
RIN 0991–AC33
Annual Civil Monetary Penalties
Inflation Adjustment
Office of the Assistant
Secretary for Financial Resources,
Department of Health and Human
Services (HHS).
ACTION: Final rule.
AGENCY:
The Department of Health and
Human Services is updating its
regulations to reflect required annual
inflation-related increases to the civil
monetary penalty amounts in its
regulations, under the Federal Civil
Penalties Inflation Adjustment Act
Improvements Act of 2015; adding
references to new penalty authorities;
and making technical changes to correct
errors in the regulation.
DATES:
Effective date: This final rule is
effective March 17, 2022.
Applicability date: The adjusted civil
monetary penalty amounts apply to
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SUMMARY:
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penalties assessed on March 17, 2022, r
if the violation occurred on or after
November 2, 2015.
FOR FURTHER INFORMATION CONTACT:
Katrina Brisbon, Acting Deputy
Assistant Secretary, Office of
Acquisitions, Office of the Assistant
Secretary for Financial Resources, Room
536–H, Hubert Humphrey Building, 200
Independence Avenue SW, Washington,
DC 20201; (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 civil monetary
penalties (CMPs) and to maintain the
deterrent effect of such penalties,
requires agencies to adjust the CMPs for
inflation annually.
The Department of Health and Human
Services (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), and
November 15, 2021 (86 FR 62928).
II. Calculation of Annual Inflation
Adjustment
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, 2021, Office of
Management and Budget (OMB)
Memorandum for the Heads of
Executive Agencies and Departments,
M–22–07, ‘‘Implementation of Penalty
Inflation Adjustments for 2022,
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 2022, based
on the CPI–U for the month of October
2021, not seasonally adjusted, is
1.06222. The multiplier is applied to
each applicable penalty amount that
was updated and published for fiscal
year (FY) 2021 and is rounded to the
nearest dollar.
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III. Other Revisions
In addition to the inflation
adjustments for 2022, this final rule
updates the table in 45 CFR 102.3 to add
references to new, applicable civil
money penalty authorities that were
established or implemented since the
publication of the November 15, 2021
update and that are being updated in
this rule. The rule also corrects several
technical errors to regulatory citations
in the table and updates descriptions for
clarification and accuracy. The
following technical errors were
identified and are corrected in the table
at 45 CFR 102.3:
• The citation to, and description of,
42 U.S.C. 299c–3(d) are revised for
accuracy.
• The regulatory reference of 42 CFR
1003.210(a)(5) implementing 42 U.S.C.
1395cc(g) which was inadvertently
omitted from the regulation and is
added.
• The description of the CMP at 42
U.S.C. 1320a–7a(o) is revised for
accuracy.
• The regulatory reference to 45 CFR
155.206(i) 1 implementing 42 U.S.C.
18041(c)(2) 2 which was inadvertently
omitted from the regulation is added.
Additionally, the amount for this CMP
was not included in the 2021 inflation
adjustment rule. 86 FR 62928, 62943
(Nov. 15, 2021). Thus, we are updating
the inflation amount at this time.
• The first description tied to 42
U.S.C. 1395mm(i)(6)(B)(i) is revised
from ‘‘is such plan’’ to ‘‘if such plan’’.
• The regulatory reference to 85 FR
71142 (Nov. 6, 2020) implementing
CARES Act, Pub. L. 116–136, section
3202(b)(2), is revised to read 45 CFR
182.70.
++ The 2022 adjusted amount is
calculated by applying the 2021
multiplier to 1.06222 percent and this
adjusted amount is reflected in the table
of the regulation at 45 CFR 102.3.
1 The Department recently proposed a technical
correction to 45 CFR 155.206(i) to add language that
would cross-reference to the authority to implement
annual inflation-related increases to CMPs pursuant
to the 2015 Act. See Patient Protection and
Affordable Care Act; HHS Notice of Benefit and
Payment Parameters for 2023; Proposed Rule, 87 FR
584 at 640–641, 721 (Jan. 5, 2022). To date, no
CMPs have been imposed under this authority, but
any that are would reflect the current inflationary
adjusted amount as required by the 2015 Act and
would be calculated in accordance with applicable
OMB guidance to all Executive Departments on the
implementation of the 2015 Act.
2 See, e.g., the Patient Protection and Affordable
Care Act; Exchange and Insurance Market
Standards for 2015 and Beyond; Final Rule, 79 FR
30239 at 30262–30270 (May 27, 2014).
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Federal Register / Vol. 87, No. 52 / Thursday, March 17, 2022 / Rules and Regulations
IV. Statutory and Executive Order
Reviews and Waiver of Proposed
Rulemaking
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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–21–10, the
phrase ‘‘notwithstanding section 553’’
in section 4(b)(2) of the 2015 Act means
that ‘‘the public procedure the APA
generally requires (that is, 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
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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 and for the ministerial and
technical changes in this rule. In
addition, HHS is waiving notice and
comment for the non-substantive
technical corrections set out in this final
rule. HHS finds good cause for issuing
these changes as a final rule without
prior notice and comment because these
changes only update the regulation to
add the new CMP authorities that will
be adjusted in accordance with the 2015
Act which were implemented since the
last update.
Pursuant to OMB Memorandum M–
21–10, 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.
V. Effective and Applicability Dates
This rule is effective on the date
specified in the DATES section of this
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15101
final rule. The adjusted civil monetary
penalty amounts apply to penalties
assessed on or after 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.
Accordingly, the Department of
Health and Human Services amends 45
CFR part 102 as follows:
PART 102—ADJUSTMENT OF CIVIL
MONETARY PENALTIES FOR
INFLATION
1. The authority citation for part 102
is revised to read as follows:
■
Authority: Pub. L. 101–410, Sec. 701 of
Pub. L. 114–74, 31 U.S.C. 3801–3812.
2. Amend § 102.3 by revising table 1
to read as follows:
■
§ 102.3
*
*
Penalty adjustment and table.
*
*
BILLING CODE 4150–24–P
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Federal Register / Vol. 87, No. 52 / Thursday, March 17, 2022 / Rules and Regulations
TABLE
U.S.C. Section(s)
1 TO §102.3 -- CIVIL MONETARY PENALTY AUTHORITIES ADMINISTERED BY HHS
CFR1
HHS
Agency
Date of Last
Penalty
Figure or
Adjustment3
Description 2
2021
2022
Maximum
adjusted
penalty
($)
Maximum
adjusted
penalty ($)4
2021
108,315
115,054
2021
2,166,279
2,301,065
2021
216,628
230,107
2021
29,256
31,076
2021
1,950,461
2,071,819
2021
82,245
87,362
2021
411,223
436,809
2021
822,445
873,618
2021
12,462
13,237
2021
12,462
13,237
2021
311,563
330,948
2021
1,246,249
1,323,791
333(b)(2)(A)
FDA
333(b)(2)(B)
FDA
333(b)(3)
FDA
333(f)(1)(A)
FDA
FDA
FDA
333(f)(2)(A)
FDA
FDA
333(f)(3)(A)
FDA
333(f)(3)(B)
FDA
FDA
333(f)(4)(A)(i)
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FDA
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Penalty for violations related to drug samples resulting
in a conviction of any representative of manufacturer or
distributor in anv 10-vear oeriod
Penalty for violation related to drug samples resulting in
a conviction of any representative of manufacturer or
distributor after the second conviction in any 10-yr
period
Penalty for failure to make a report required by 21
U.S.C. 353(d)(3)(E) relating to drug samples
Penalty for any person who violates a requirement
related to devices for each such violation
Penalty for aggregate of all violations related to devices
in a single proceeding
Penalty for any 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. 3501
Penalty in the case of any other person (other than an
individual) for such introduction or delivery of
adulterated food
Penalty for aggregate of all such violations related to
adulterated food adjudicated in a single proceeding
Penalty for all violations adjudicated in a single
proceeding for any person who violates 21 U.S.C.
331@ by failing to submit the certification required by
42 U.S.C. 2820)(5)(B) or knowingly submitting a false
certification; by failing to submit clinical trial information
under 42 U.S.C. 2820); or by submitting clinical trial
information under 42 U.S.C. 2820) that is false or
misleading in any particular under 42 U.S.C.
282(i)(5)(D)
Penalty for each day any above violation is not
corrected after a 30-day period following notification
until the violation is corrected
Penalty for any responsible person that violates a
requirement of 21 U.S.C. 355(0) (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)
Penalty for aggregate of all such above violations in a
sinale proceedina
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21 U.S.C.:
FDA
333(f)(4)(A)(ii)
FDA
FDA
FDA
333(f)(9)(A)
FDA
FDA
333(f)(9)(B)(i)(I)
FDA
FDA
333(f)(9)(B)(i)(I I)
FDA
FDA
333(f)(9)(B)(ii)(I)
FDA
FDA
FDA
333(f)(9)(B)(ii)(II)
FDA
333(g)(1)
FDA
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333 note
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FDA
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Penalty for REMS 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
Penalty for REMS 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
Penalty for aggregate of all such above violations
adjudicated in a single proceeding
Penalty for any person who violates a requirement
which relates to tobacco products for each such
violation
Penalty for aggregate of all such violations of tobacco
product requirement adjudicated in a single
proceedinq.
Penalty per violation related to violations of tobacco
requirements
Penalty for aggregate of all such violations of tobacco
product requirements adjudicated in a single
proceeding.
Penalty in the case of a 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
Penalty for violation of 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.
Penalty for aggregate of all such violations related to
tobacco product requirements adjudicated in a single
proceedinq.
Penalty for any person 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 postmarket surveillance of such tobacco products
Penalty for aggregate of for all such above violations
adiudicated in a sinale oroceedina.
Penalty for violation of 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
Penalty for post-notice 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 30dav oeriod.
Penalty for aggregate above tobacco product
requirement violations adjudicated in a single
proceedinq.
Penalty for any person who disseminates or causes
another party to disseminate a direct-to-consumer
advertisement that is false or misleading for the first
such violation in anv 3-vear oeriod
Penalty for each subsequent above violation in any 3year period.
Penalty to be applied 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
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15103
2021
311,563
330,948
2021
1,246,249
1,323,791
2021
12,462,49
4
13,237,910
2021
18,068
19,192
2021
1,204,504
1,279,448
2021
301,127
319,863
2021
1,204,504
1,279,448
2021
301,127
319,863
2021
1,204,504
1,279,448
2021
12,045,04
4
12,794,487
2021
301,127
319,863
2021
1,204,504
1,279,448
2021
301,127
319,863
2021
1,204,504
1,279,448
2021
12,045,04
4
12,794,487
2021
311,563
330,948
2021
623,125
661,896
2021
301
320
17MRR1
ER17MR22.011</GPH>
Federal Register / Vol. 87, No. 52 / Thursday, March 17, 2022 / Rules and Regulations
15104
Federal Register / Vol. 87, No. 52 / Thursday, March 17, 2022 / Rules and Regulations
training program in the case of a second regulation
violation within a 12-month period.
Penalty in the case of a third violation of 21 U.S.C.
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
FDA
335b(a)
FDA
FDA
360pp(b )( 1)
FDA
FDA
§ 387f(d)(5) or of the tobacco product regulations within
a 24-month period.
Penalty in the case of a fourth violation of 21 U.S.C.
§ 387f(d)(5) or of the tobacco product regulations within
a 24-month period.
Penalty in the case of a fifth violation of 21 U.S.C.
§ 387f(d)(5) or of the tobacco product regulations within
a 36-month period.
Penalty in the case of a 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-bv-case basis.
Penalty to be applied 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.
Penalty in the case of a second violation of 21 U.S.C.
§ 387f(d)(5) or of the tobacco product regulations within
a 12-month period.
Penalty in the case of a third violation of 21 U.S.C.
§ 387f(d)(5) or of the tobacco product regulations within
a 24-month period.
Penalty in the case of a fourth violation of 21 U.S.C.
§ 387f(d)(5) or of the tobacco product regulations within
a 24-month period.
Penalty in the case of a fifth violation of 21 U.S.C.
§ 387f(d)(5) or of the tobacco product regulations within
a 36-month period.
Penalty in the case of a 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.
Penalty for each 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
Penalty in the case of any other person (other than an
individual) oer above violation.
Penalty for any person who violates any such
requirements for electronic products, with each
unlawful act or omission constituting a separate
violation
Penalty imposed for any related series of violations of
requirements relating to electronic products.
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42 U.S.C.
601
638
2021
2,409
2,559
2021
6,022
6,397
2021
12,045
12,794
2021
301
320
2021
601
638
2021
1,205
1,280
2021
2,409
2,559
2021
6,022
6,397
2021
12,045
12,794
2021
459,074
487,638
2021
1,836,294
1,950,548
2021
3,011
3,198
2021
1,026,380
1,090,241
-
2021
262(d)
FDA
263b(h)(3)
FDA
300aa-28(b )( 1)
FDA
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16:41 Mar 16, 2022
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Penalty per day for violation of order of recall of
biological product presenting imminent or substantial
hazard
Penalty for failure to obtain a mammography certificate
as required
Penalty per occurrence for any vaccine manufacturer
that intentionally destroys, alters, falsifies, or conceals
any record or report required
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2021
236,071
250,759
2021
18,364
19,507
2021
236,071
250,759
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ER17MR22.012</GPH>
FDA
256b(d)(1 )(B)(vi)
HRSA
299c-3(d)
AHRQ
45CFR
303.21(f
653(1)(2)
ACF
)
42 CFR
1003.91
0
262a(i)(1)
OIG
OIG
300jj-51
OIG
42 CFR
1003.21
0(a)(1)
OIG
OIG
42 CFR
1003.21
0(a)(2)
42 CFR
1003.21
0(a\(3\
42 CFR
1003.10
10
42 CFR
1003.21
0(a)(4)
1320a-7a(a)
OIG
2021
15,480
16,443
2021
1,588
1,687
2021
359,053
381,393
2021
718,109
762,790
2021
1,094,805
1,162,924
2021
21,113
22,427
2021
21,113
22,427
2021
31,670
33,641
21,113
22,427
OIG
Penalty for remuneration offered to induce program
beneficiaries to use particular providers, practitioners,
or suppliers.
2021
21,113
22,427
OIG
Penalty for employing or contracting with an excluded
individual.
2021
21,113
22,427
2021
105,563
112,131
2021
21,113
22,427
2021
105,563
112,131
42 CFR
1003.21
0(a)(1)
OIG
42 CFR
1003.21
0(a)(6)
OIG
Penalty for knowing and 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
proaram.
Penalty for ordering or prescribing medical or other
item or service during a period in which the person was
excluded.
Penalty for knowingly 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.
OIG
Penalty for knowing of an overpayment and failing to
report and return.
2021
21,113
22,427
OIG
Penalty for making or using a false record or statement
that is material to a false or fraudulent claim.
2021
59,527
63,231
2021
31,670
33,641
2021
5,278
5,606
2021
5,278
5,606
OIG
1320a-7a(b)
OIG
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6,323
2021
OIG
16:41 Mar 16, 2022
Penalty for each individual who violates safety and
security procedures related to handling dangerous
biological agents and toxins
Penalty for any other person who violates safety and
security procedures related to handling dangerous
biological agents and toxins.
Penalty per violation for committing information
blocking
Penalty for knowingly presenting or causing to be
presented to an officer, employee, or agent of the
United States a false claim
Penalty for knowingly presenting or causing to be
presented a request for payment which violates the
terms of an assignment, agreement, or PPS agreement
Penalty for knowingly giving or causing to be presented
to a participating provider or supplier false or
misleading information that could reasonably be
expected to influence a discharae decision.
5,953
Penalty for an excluded party retaining ownership or
control interest in a participating entity.
OIG
VerDate Sep<11>2014
Penalty for Misuse of Information in the National
Directory of New Hires
2021
OIG
42 CFR
1003.31
0(a)(3)
42 CFR
1003.21
0(a\(81
42 CFR
1003.21
0(a\(71
42 CFR
1003.21
0(a)(9)
Penalty for each instance of overcharging a 340B
covered entity
Penalty for using or 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.
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Penalty for failure to grant timely access to HHS OIG
for audits, investigations, evaluations, and other
statutory functions of HHS OIG.
Penalty for payments by 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
Penalty for physicians 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.
PO 00000
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Federal Register / Vol. 87, No. 52 / Thursday, March 17, 2022 / Rules and Regulations
15106
42 CFR
1003.21
O(a)(10)
OIG
OIG
OIG
OIG
1320a-7a(o)
OIG
OIG
1320a-7e(b)(6)(A)
42 CFR
1003.81
0
OIG
1320b-1 O(b)(1)
42 CFR
1003.61
O(a)
OIG
1320b-10(b)(2)
42 CFR
1003.61
O(a)
OIG
1395i3(b)(3)(B)(ii)(1)
1395i3(b)(3)(B)(ii)(2)
1395i-3(g)(2)(A)
42 CFR
1003.21
O(a)(11)
42 CFR
1003.21
O(a)(11)
42 CFR
1003.13
10
OIG
OIG
OIG
OIG
OIG
OIG
1395w27(g)(2)(A)
42 CFR
1003.41
0
OIG
khammond on DSKJM1Z7X2PROD with RULES
OIG
OIG
VerDate Sep<11>2014
16:41 Mar 16, 2022
Jkt 256001
Penalty for a physician who executes a document that
falsely certifies home health needs for Medicare
beneficiaries.
Penalty for knowingly presenting or causing to be
presented a false or fraudulent specified claim under a
grant, contract, or other agreement for which the
Secretarv orovides fundina.
Penalty for knowingly 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.
Penalty for Knowingly 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 aareement.
Penalty for knowingly making, using, or 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.
Penalty for failure to 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
aareements.
Penalty for failure to report any final adverse action
taken against a health care provider, supplier, or
practitioner
Penalty for the misuse 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 bv HHS
Penalty for the misuse of words, symbols, or emblems
in a broadcast or telecast in a manner in which a
person could falsely construe that such item is
annroved, endorsed, or authorized bv HHS
Penalty for certification of a false statement in
assessment of functional capacity of a Skilled Nursing
Facility resident assessment
Penalty for causing another to certify or make a false
statement in assessment of functional capacity of a
Skilled Nursing Facility resident assessment
Penalty for any 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
Penalty for a Medicare Advantage organization that
substantially fails to provide medically necessary,
required items and services
Penalty for a Medicare Advantage organization that
charges excessive premiums.
Penalty for a Medicare Advantage organization that
improperly expels or refuses to reenroll a beneficiary.
Penalty for a Medicare Advantage organization that
engages in practice that would reasonably be expected
to have the effect of denying or discouraging
enrollment.
Penalty per individual who does not enroll as a result of
a Medicare Advantage organization's practice that
would reasonably be expected to have the effect of
denvina or discouraaina enrollment.
Penalty for a Medicare Advantage organization
misrepresenting or falsifying information to Secretary.
PO 00000
Frm 00076
Fmt 4700
Sfmt 4725
E:\FR\FM\17MRR1.SGM
2021
10,556
11,213
2021
10,296
10,937
2021
51,483
54,686
2021
51,483
54,686
2021
53,772
each false
record or
statement,
10,754 per
day
53,772 each
false record
or statement,
10,754 per
day
2021
15,445
16,406
2021
40,282
42,788
2021
10,832
11,506
2021
54,157
57,527
2021
2,259
2,400
2021
11,292
11,995
2021
4,518
4,799
2021
41,120
43,678
2021
40,282
42,788
2021
40,282
42,788
2021
161,130
171,156
2021
24,169
25,673
2021
161,130
171,156
17MRR1
ER17MR22.014</GPH>
Federal Register / Vol. 87, No. 52 / Thursday, March 17, 2022 / Rules and Regulations
OIG
OIG
1395dd(d)(1)
42,788
OIG
Penalty for a Medicare Advantage organization
enrolling an individual in without prior written consent.
2021
40,282
42,788
2021
40,282
42,788
2021
40,282
42,788
2021
40,282
42,788
2021
14,074
14,950
Penalty for a Medicare Advantage organization
transferring an enrollee to another plan without consent
or solely for the ouroose of earning a commission.
Penalty for a Medicare Advantage organization failing
to comply with marketing restrictions or applicable
imolementing regulations or guidance.
Penalty for a Medicare Advantage organization
employing or contracting with an individual or entity
who violates 1395w-27(a)(1)(A)-(J).
Penalty for a prescription drug card sponsor that
falsifies or misrepresents marketing materials,
overcharges program enrollees, or misuse transitional
assistance funds
OIG
Penalty for improper billing by Hospitals, Critical
Access Hospitals, or Skilled Nursing Facilities
2021
5,475
5,816
OIG
Penalty for a hospital with 100 beds or more or
responsible physician dumping patients needing
emergency medical care.
2021
112,916
119,942
Penalty for a hospital with less than 100 beds dumping
patients needing emergency medical care.
2021
56,460
59,973
Penalty for a HMO or competitive medical plan if such
plan substantially fails to provide medically necessary,
required items or services
2021
56,460
59,973
2021
56,460
59,973
2021
56,460
59,973
2021
225,834
239,885
2021
32,495
34,517
2021
225,834
239,885
2021
56,460
59,973
2021
56,460
59,973
2021
51,827
55,052
2021
26,125
27,750
OIG
OIG
OIG
OIG
OIG
OIG
OIG
OIG
khammond on DSKJM1Z7X2PROD with RULES
40,282
42,788
OIG
42 CFR
1003.41
0
2021
40,282
OIG
1395mm(i)(6)(B)(i
)
42,788
2021
OIG
42 CFR
1003.21
0(a)(5)
42 CFR
1003.51
0
40,282
Penalty for a Medicare Advantage organization that
employs or contracts with excluded individual or entity.
OIG
1395cc(g)
2021
OIG
OIG
1395w-141 (i)(3)
Penalty for a Medicare Advantage organization
misrepresenting or falsifying information to individual or
other entity.
Penalty for Medicare Advantage organization
interfering with provider's advice to enrollee and nonMCO affiliated oroviders that balance bill enrollees.
15107
Penalty for HMOs/compelitive medical plans that
charge premiums in excess of permitted amounts.
Penalty for a HMO or competitive medical plan that
expels or refuses to reenroll an individual per
orescribed conditions.
Penalty for a HMO or competitive medical plan that
implements practices to discourage enrollment of
individuals needing services in future.
Penalty per individual 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.
Penalty for a HMO or competitive medical plan that
misrepresents or falsifies information to the Secretary.
Penalty for a HMO or competitive medical plan that
misrepresents or falsifies information to an individual or
any other entitY.
Penalty for failure by HMO or competitive medical plan
to assure prompt payment of Medicare risk sharing
contracts or incentive clan orovisions.
Penalty for HMO that employs or contracts with
excluded individual or entitY.
Penalty for submitting or causing to be submitted
claims in violation of the Stark Law's restrictions on
ohysician self-referrals
1395nn(g)(3)
42 CFR
1003.31
0
OIG
1395nn(g)(4)
42 CFR
1003.31
0
OIG
Penalty for circumvention schemes in violation of the
Stark Law's restrictions on physician self-referrals
2021
174,172
185,009
1395ss(d)( 1)
42 CFR
1003.11
10
OIG
Penalty for a material misrepresentation regarding
Medigap compliance policies
2021
10,832
11,506
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16:41 Mar 16, 2022
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Federal Register / Vol. 87, No. 52 / Thursday, March 17, 2022 / Rules and Regulations
15108
1395ss(d)(2)
1395ss(d)(3)(A)(ii)
1395ss(d)(4 )(A)
42 CFR
1003.11
10
42 CFR
1003.11
10
42 CFR
1003.11
10
OIG
Penalty for selling Medigap policy under false pretense
2021
10,832
11,506
OIG
Penalty for an issuer that sells health insurance policy
that duplicates benefits
2021
48,762
51,796
OIG
Penalty for someone other than issuer that sells health
insurance that duplicates benefits.
2021
29,256
31,076
OIG
Penalty for using mail to sell a non-approved Medigap
insurance policy
2021
10,832
11,506
OIG
Penalty for a Medicaid MCO that substantially fails to
provide medically necessary, required items or services
2021
54,157
57,527
2021
54,157
57,527
2021
216,628
230,107
2021
32,495
34,517
2021
216,628
230,107
2021
54,157
57,527
2021
48,762
51,796
2021
2,259
2,400
2021
11,292
11,995
2021
4,518
4,799
2021
195,047
207,183
OIG
OIG
1396b(m)(5)(B)(i)
42 CFR
1003.41
0
OIG
OIG
OIG
OIG
1396r(b)(3)(B)(ii)(I
)
1396r(b)(3)(B)(ii)(I
I)
1396r(g)(2)(A)(i)
1396r-8(b)(3)(B)
1396r8(b)(3)(C)(i)
1396r8(b)(3)(C)(ii)
1396t(i)(3)(A)
11131(c)
11137(b)(2)
299b-22(f)( 1)
42 CFR
1003.21
0(a)(11)
42 CFR
1003.21
0(a)(11)
42 CFR
1003.13
10
42 CFR
1003.12
10
42 CFR
1003.12
10
42 CFR
1003.12
10
42 CFR
1003.13
10
42 CFR
1003.81
0
42 CFR
1003.81
0
42 CFR
3.404
khammond on DSKJM1Z7X2PROD with RULES
45CFR
160.404
(b)(1)(i),
(ii)
VerDate Sep<11>2014
16:41 Mar 16, 2022
OIG
OIG
OIG
OIG
Penalty for a Medicaid MCO that charges excessive
premiums.
Penalty for a Medicaid MCO that improperly expels or
refuses to reenroll a beneficiary.
Penalty per individual 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.
Penalty for a Medicaid MCO misrepresenting or
falsifvinQ information to the Secretary.
Penalty for a Medicaid MCO misrepresenting or
falsifying information to an individual or another entity.
Penalty for a Medicaid MCO that fails to comply with
contract requirements with respect to physician
incentive olans.
Penalty for willfully and knowingly certifying a material
and false statement in a Skilled Nursing Facility
resident assessment
Penalty for willfully and knowingly causing another
individual to certify a material and false statement in a
Skilled Nursing Facility resident assessment
Penalty for notifying or causing to be notified a Skilled
Nursing Facility of the time or date on which a survey is
to be conducted
Penalty for the knowing provision of false information or
refusing to provide information about charges or prices
of a covered outpatient druQ
OIG
Penalty per day for failure to timely provide information
by drug manufacturer with rebate agreement
2021
19,505
20,719
OIG
Penalty for knowing provision of false information by
drug manufacturer with rebate agreement
2021
195,047
207,183
OIG
Penalty for notifying home and community-based
providers or settings of survey
2021
3,901
4,144
OIG
Penalty for failing to report a medical malpractice claim
to National Practitioner Data Bank
2021
23,607
25,076
OIG
Penalty for breaching confidentiality of information
reported to National Practitioner Data Bank
2021
23,607
25,076
OCR
Penalty for violation of confidentiality provision of the
Patient Safety and Quality Improvement Act
2021
13,072
13,885
OCR
Penalty for each pre-February 18, 2009 violation of the
HIPAA administrative simplification provisions
2021
164
174
Calendar Year Cap
2021
41,120
43,678
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Federal Register / Vol. 87, No. 52 / Thursday, March 17, 2022 / Rules and Regulations
Federal Register / Vol. 87, No. 52 / Thursday, March 17, 2022 / Rules and Regulations
45CFR
160.404
(b)(2)(ii)
(A), (B)
OCR
45CFR
160.404
(b)(2)(iv
)(A), (B)
OCR
OCR
42 U.S.C. 300gg18, 42 U.S.C.
khammond on DSKJM1Z7X2PROD with RULES
CARES Act, P.L.
116-136, section
3202(b)(2)
VerDate Sep<11>2014
45CFR
182.70
16:41 Mar 16, 2022
2021
120
127
Maximum
2021
60,226
63,973
Calendar Year Cap
2021
1,806,757
1,919,173
Penalty for each February 18, 2009 or 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:
2021
Minimum
2021
1,205
1,280
Maximum
2021
60,226
63,973
Calendar Year Cap
2021
1,806,757
1,919,173
Penalty for each February 18, 2009 or 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 dale the covered entity or
business associate knew, or, by exercising reasonable
diligence, would have known that the violation
occurred:
2021
Minimum
2021
12,045
12,794
0
Maximum
2021
60,226
63,973
Calendar Year Cap
2021
1,806,757
1,919,173
Penalty for each February 18, 2009 or later violation of
a HIPAA administrative simplification provision in which
ii 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:
2021
Minimum
2021
60,226
63,973
Maximum
2021
1,806,757
1,919,173
Calendar Year Cap
2021
1,806,757
1,919,173
2021
304
300 per day
Per Day (Maximum)
2021
304
5500 per day
Penalty for a provider's non-compliance with price
transparency requirements regarding diagnostic tests
for COVID-19
2021
-
Per Day (Maximum)
2021
$300 per day
Penalty for a hospital's non-compliance with making
45 CFR
180.90
1302
Minimum
0
OCR
1320(d)-5(a)
45CFR
160.404
(b)(2)(iii
)(A), (B)
2021
CMS
CMS
Jkt 256001
public standard charges for hospital items and services
PO 00000
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17MRR1
ER17MR22.017</GPH>
45CFR
160.404
(b)(2)(i)(
A), (B)
Penalty for each 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:
15109
15110
Federal Register / Vol. 87, No. 52 / Thursday, March 17, 2022 / Rules and Regulations
42 CFR
493.183
4(d)(2)(i
).
263a(h)(2)(B) &
1395w2(b)(2)(A)(ii)
42 CFR
493.183
4(d)(2)(i
i).
42 CFR
493.183
4(d)(2)(i
ii)
300gg-15(f)
CMS
45CFR
147.200
CMS
CMS
CMS
(e)
45CFR
158.606
300gg-18
CMS
45CFR
180.90
Penalty for a clinical laboratory's failure to meet
participation and certification requirements and poses
immediate jeopardy:
2021
Minimum
2021
6,607
7,018
Maximum
2021
21,663
23,011
Penalty for a clinical laboratory's failure to meet
participation and certification requirements and the
failure does not pose immediate jeopardy:
2021
Minimum
2021
109
116
Maximum
2021
6,498
6,902
Penalty for a clinical laboratory's failure to meet SARSCoV-2 test reporting requirements:
2021
First day of noncompliance
2021
Each additional day of noncompliance
2021
Failure to provide the Summary of Benefits and
Coverage
2021
1,190
1,264
2021
119
126
10,000
10,622
Penalty for violations of regulations related to the
medical loss ratio reoortina and rebatina
Price against hospital identified by CMS as
noncompliant according to §182.50 with respect to
CMS
price transparency requirements regarding diagnostic
2021
tests for COVID-19.
USC
300gg-
Penalties for failure to comply with No Surprises
118 note,
CMS
300qq-134
1320a-7h(b )(2)
1320a-7j(h)(3)(A)
khammond on DSKJM1Z7X2PROD with RULES
2021
providers of air ambulance services.
1320a-7h(b)(1)
VerDate Sep<11>2014
Act requirements on providers, facilities,
42 CFR
402.105
(d)(5),
42 CFR
403.912
(a) & (c)
42 CFR
402.105
(h), 42
CFR
403.912
(b) & (c)
42 CFR
488.446
(a)(1),
(2), &
(3)
16:41 Mar 16, 2022
Penalty for manufacturer or group purchasing
organization failing to report information required under
42 U.S.C. 1320a-7h(a), relating to physician ownership
or investment interests:
2021
Minimum
2021
1,190
1,264
Maximum
2021
11,905
12,646
Calendar Year Cap
2021
178,581
189,692
Penalty for manufacturer 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:
2021
Minimum
2021
11,905
12,646
Maximum
2021
119,055
126,463
Calendar Year Cap
2021
1,190,546
1,264,622
CMS
Penalty for an administrator of a facility that fails to
comply with notice requirements for the closure of a
facility
2021
119,055
126,463
CMS
Minimum penalty for the first offense of an
administrator who fails to provide notice of facility
closure
2021
595
632
CMS
CMS
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42
Federal Register / Vol. 87, No. 52 / Thursday, March 17, 2022 / Rules and Regulations
1320a-8(a)(1)
CMS
1320a-8(a)(3)
CMS
1320b-25(c)(1)(A)
CMS
1320b-25(c)(2)(A)
CMS
1320b-25(d)(2)
CMS
1395b-7(b)(2)(B)
1395i3(h)(2)(B)(ii)(I)
42 CFR
402.105
(g)
42 CFR
488.408
(d)(1 )(iii
CMS
CMS
Minimum penalty for the second offense of an
administrator who fails to provide notice of facility
closure.
Minimum penalty for the third and subsequent offenses
of an administrator who fails to provide notice of facility
closure.
Penalty for an entity 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
aaed, blind, and disabled
Penalty for violation of 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.
Penalty for a 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 beneficiarv
Penalty for failure of 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
Penalty for failure of 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
Penalty for a long-term 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
emolovee or nurse
Penalty for any person who knowingly and willfully fails
to furnish a beneficiary with an itemized statement of
items or services within 30 days of the beneficiary's
reauest
15111
2021
1,787
1,898
2021
3,571
3,793
2021
8,708
9,250
2021
8,212
8,723
2021
6,820
7,244
2021
238,110
252,925
2021
357,163
379,386
2021
238,110
252,925
2021
161
171
Penalty per day for a Skilled Nursing Facility that has a
Category 2 violation of certification requirements:
2021
Minimum
2021
113
120
Maximum
2021
6,774
7,195
Penalty per instance of Category 2 noncompliance by a
Skilled Nursing Facility:
2021
Minimum
2021
2,259
2,400
Maximum
2021
22,584
23,989
Penalty per day for a Skilled Nursing Facility that has a
Category 3 violation of certification requirements:
2021
Minimum
2021
6,888
7,317
Maximum
2021
22,584
23,989
Penalty per instance of Category 3 noncompliance by a
Skilled Nursing Facility:
2021
)
42 CFR
488.408
(d)(1 )(iv
CMS
)
42 CFR
488.408
(e)(1 )(iii
CMS
42 CFR
488.408
VerDate Sep<11>2014
16:41 Mar 16, 2022
CMS
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khammond on DSKJM1Z7X2PROD with RULES
)
15112
Federal Register / Vol. 87, No. 52 / Thursday, March 17, 2022 / Rules and Regulations
42 CFR
488.408
(e)(2)(ii)
42 CFR
488.438
(a)(1 )(i)
42 CFR
488.438
(a)(1 )(ii)
42 CFR
488.438
(a)(2)
42 CFR
488.447
1395I(h)(5)(D)
42 CFR
402.105
(d)(2)(i)
khammond on DSKJM1Z7X2PROD with RULES
1395I(i)(6)
CMS
CMS
CMS
CMS
CMS
CMS
CMS
1395I(q)(2)(B)(i)
42 CFR
402.105
(a)
1395m (a)( 11 )(A)
42 CFR
402.1 (c)
(4),
402.105
(d)(2)(ii)
CMS
1395m(a)(18)(B)
42 CFR
402.1 (c)
(5),
402.105
CMS
VerDate Sep<11>2014
16:41 Mar 16, 2022
CMS
Jkt 256001
Minimum
2021
2,259
2,400
22,584
23,989
Maximum
2021
Penalty per day and per instance for a Skilled Nursing
Facility that has Category 3 noncompliance with
Immediate Jeopardy:
2021
Per Day (Minimum)
2021
6,888
7,317
Per Day (Maximum)
2021
22,584
23,989
Per Instance (Minimum)
2021
2,259
2,400
Per Instance (Maximum)
2021
22,584
23,989
Penalty per day of a Skilled Nursing Facility that fails to
meet certification requirements. These amounts
represent the upper ranQe per day:
2021
Minimum
2021
6,888
7,317
Maximum
2021
22,584
23,989
Penalty per day of a Skilled Nursing Facility that fails to
meet certification requirements. These amounts
represent the lower ranQe per day:
2021
Minimum
2021
113
120
6,774
7,195
Maximum
2021
Penalty per instance of a Skilled Nursing Facility that
fails to meet certification reQuirements:
2021
Minimum
2021
2,259
2,400
22,584
23,989
Maximum
2021
Penalty imposed for failure to comply with infection
control weekly reporting requirements at 42 CFR
483.80(a)(1) and (2)
2021
First occurrence
2021
1,012
1,075
2021
506
537
2021
16,449
17,472
2021
4,333
4,603
2021
4,146
4,404
2021
16,449
17,472
2021
16,449
17,472
Incremental increases for each subsequent
occurrences
Penalty for knowingly, 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. 1395uG)(2)(B), which is
assessed according to 1320a-7a(a))
Penalty for knowingly 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 acauirina the class of lens involved
Penalty for knowingly and willfully failing to provide
information about a referring physician when seeking
payment on an unassigned basis
Penalty for any durable 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.
1395u0)(2)(B), which is assessed according to 1320a7a(all
Penalty for any 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.
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(e)(1 )(iv
)
Federal Register / Vol. 87, No. 52 / Thursday, March 17, 2022 / Rules and Regulations
1395m(b)(5)(C)
(d)(2)(iii
)
(Penalties are assessed in the same manner as 42
U.S.C. 1395uU)(2)(B), which is assessed according to
1320a-7a(a))
42 CFR
402.1 (c)
(6),
402.105
(d)(2)(iv
CMS
Penalty for any 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. 1395uU)(2)(B), which is assessed
according to 1320a-7a(a))
2021
16,449
17,472
CMS
Penalty for any supplier 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 1395uU)(2)(B), which is assessed
according to 1320a-7a(a))
2021
16,449
17,472
CMS
Penalty for any supplier 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 1834U)(2)(A)(i) of the Act or fails to provide
the information required under Section 1834U)(2)(A)(ii)
of the Act
2021
1,742
1,850
CMS
Penalty for any supplier 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. 1395mU)(4) and 1395uU)(2)(B), which is
assessed according to 1320a-7a(a))
2021
16,449
17,472
2021
10,967
11,649
)
1395m(h)(3)
42 CFR
402.1 (c)
(8),
402.105
(d)(2)(vi
)
1395mU)(2)(A)(iii)
1395mU)(4)
42 CFR
402.1 (c)
(10),
402.105
(d)(2)(vi
i)
42 C.F.R.
1395m-1(a)
15113
Penalty for an applicable entity that has failed to report or made a
§
414.504(e
CMS
misrepresentation or omission in reporting applicable information
with respect to a clinical diagnostic laboratory test.
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)
15114
42 CFR
402.1 (c)
(31),
402.105
(d)(3)
CMS
Penalty for any supplier 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))
Penalty for any 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 assignmentrelated basis. (Penalties are assessed in the same
manner as 42 U.S.C. 1395uU)(2)(B), which is assessed
accordinq to 1320a-7a(a))
2021
16,449
17,472
2021
16,449
17,472
2021
16,449
17,472
1395m(l)(6)
42 CFR
402.1 (c)
(32),
402.105
(d)(4)
CMS
1395u(b)(18)(B)
42 CFR
402.1 (c)
(11),
402.105
(d)(2)(vi
ii)
CMS
1395uU)(2)(B)
42 CFR
402.1 (c)
CMS
Penalty for any physician who charges more than
125% for a non-participating referral. (Penalties are
assessed in the same manner as 42 U.S.C. 1320a7a(a))
2021
16,449
17,472
CMS
Penalty for any physician who knowingly and willfully
presents 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.
1395uU)(2)(B), which is assessed according to 1320a7a(a))
2021
16,449
17,472
2021
16,449
17,472
2021
16,449
17,472
2021
16,449
17,472
42 CFR
402.1 (c)
(12),
402.105
(d)(2)(ix
)
1395u(k)
1834A(
a)(9)
and 42
C.F.R.
§
414.504
€
1395u(l)(3)
1395u(m)(3)
42 CFR
402.1 (c)
(13),
402.105
(d)(2)(x)
42 CFR
402.1 (c)
(14),
402.105
(d)(2)(xi
CMS
CMS
)
1395u(n)(3)
khammond on DSKJM1Z7X2PROD with RULES
Penalty for any person 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 1395uU)(2)(B), which is
assessed according to 1320a-7a(a))
42 CFR
402.1 (c)
(15),
402.105
(d)(2)(xi
CMS
i)
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16:41 Mar 16, 2022
Jkt 256001
Penalty for any nonparticipating physician who does
not accept payment on an assignment-related basis
and who knowingly and willfully fails to refund on a
timely basis any amounts collected for services that are
not reasonable or medically necessary or are of poor
quality under 1842(I)(1)(A). (Penalties are assessed in
the same manner as 42 U.S.C. 1395uU)(2)(B), which is
assessed accordinq to 1320a-7a(a))
Penalty for any nonparticipating physician charging
more than $500 who does not accept payment for an
elective surgical procedure on an assignment related
basis and who knowingly and willfully fails to disclose
the required information regarding charges and
coinsurance amounts and fails to refund on a timely
basis any amount collected for the procedure in excess
of the charges recognized and approved by the
Medicare program. (Penalties are assessed in the
same manner as 42 U.S.C. 1395uU)(2)(B), which is
assessed accordinq to 1320a-7a(a))
Penalty for any physician who knowingly, willfully, and
repeatedly bills one or more beneficiaries for
purchased diagnostic tests any amount other than the
payment amount specified by the Act. (Penalties are
assessed in the same manner as 42 U.S.C.
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Federal Register / Vol. 87, No. 52 / Thursday, March 17, 2022 / Rules and Regulations
Federal Register / Vol. 87, No. 52 / Thursday, March 17, 2022 / Rules and Regulations
15115
1395u(o)(3)(B)
42 CFR
414.707
(b)
khammond on DSKJM1Z7X2PROD with RULES
1395u(p)(3)(A)
1395w3a(d)(4)(A)
42 CFR
414.806
1395w-4(g)(1)(B)
42CFR
402.1 (c)
(17),
402.105
(d)(2)(xi
ii)
1395w-4(g)(3)(B)
42 CFR
402.1 (c)
(18),
402.105
(d)(2)(xi
v)
1395w27(g)(3)(A);
1857(g)(3);
1860D12(b)(3)(E)
42 CFR
422.760
(b); 42
CFR
423.760
(b)
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CMS
Penalty for any practitioner specified in Section
1842(b)(18)(C) of the Act or other person that
knowingly and willfully bills or collects for any services
pertaining to drugs or biologics by the practitioners on
other than an assignment-related basis. (Penalties are
assessed in the same manner as 42 U.S.C.
1395u(b)(18)(B) and 1395uU)(2)(B), which is assessed
according to 1320a-7a(a))
2021
16,449
17,472
CMS
Penalty for any physician or practitioner who knowingly
and willfully fails promptly to provide the appropriate
diagnosis codes upon CMS or Medicare administrative
contractor request for payment or bill not submitted on
an assignment-related basis
2021
4,333
4,603
CMS
Penalty for a pharmaceutical manufacturer's
misrepresentation of average sales price of a drug, or
biologic
2021
14,074
14,950
CMS
Penalty for any nonparticipating physician, supplier, or
other person that furnishes physician services not on
an assignment-related basis who either knowingly and
willfully bills or collects in excess of the statutorilydefined limiting charge or fails to make a timely refund
or adjustment. (Penalties are assessed in the same
manner as 42 U.S.C. 1395uU)(2)(B), which is assessed
according to 1320a-7a(a))
2021
16,449
17,472
CMS
Penalty for any person that knowingly and willfully bills
for statutorily defined State-plan approved physicians'
services on any other basis than an assignment-related
basis for a Medicare/Medicaid dual eligible beneficiary.
(Penalties are assessed in the same manner as 42
U.S.C. 1395uU)(2)(B), which is assessed according to
1320a-7a(a))
2021
16,449
17,472
2021
40,282
42,788
CMS
Jkt 256001
Penalty for each termination determination the
Secretary makes that is the result of actions by a
Medicare Advantage organization or Part D sponsor
that has adversely affected (or has the substantial
likelihood of adversely affecting) an individual covered
under the organization's contract
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1395u0)(2)(B), which is assessed according to 1320a7a(a))
15116
Federal Register / Vol. 87, No. 52 / Thursday, March 17, 2022 / Rules and Regulations
1395w27(g)(3)(B);
1857(g)(3);
1860D12(b)(3)(E)
1395w27(g)(3)(D);
1857(g)(3):
1860D12(b)(3)(E)
1395y(b)(3)(C)
42 CFR
411.103
(b)
1395y(b)(5)(C)(ii)
42 CFR
402.1 (c)
(20), 42
CFR
402.105
(b)(2)
1395y(b)(6)(B)
42 CFR
402.1 (c)
(21),
402.105
(a)
1395y(b)(7)(B)(i)
2021
16,113
17,116
CMS
Penalty for a Medicare Advantage organization's or
Part D sponsor's early termination of its contract
2021
149,637
158,947
CMS
Penalty for an employer or other entity to offer any
financial or other incentive for an individual entitled to
benefits not to enroll under a group health plan or large
group health plan which would be a primary plan
2021
9,753
10,360
CMS
Penalty for any non-governmental employer that,
before October 1, 1998, willfully or repeatedly failed to
provide timely and accurate information requested
relating to an employee's group health insurance
coverage
2021
1,588
1,687
CMS
Penalty for any entity that knowingly, willfully, and
repeatedly fails to complete a claim form relating to the
availability of other health benefits in accordance with
statute or provides inaccurate information relating to
such on the claim form
2021
3,484
3,701
CMS
Penalty for any entity serving as insurer, third party
administrator, or fiduciary for a group health plan that
fails to provide information that identifies situations
where the group health plan is or was a primary plan to
Medicare to the HHS Secretary
2021
1,247
1,325
CMS
Penalty for any non-group health plan that fails to
identify claimants who are Medicare beneficiaries and
provide information to the HHS Secretary to coordinate
benefits and pursue any applicable recovery claim
2021
1,247
1,325
1395nn(g)(5)
42 CFR
411.361
CMS
1395pp(h)
42 CFR
402.1 (c)
(23),
402.105
(d)(2)(x
v)
CMS
1395ss(a)(2)
402.102
(1)(1)
CMS
1395ss(d)(3)(A)(vi
) (II)
42 CFR
402.1 (c)
(25),
402.105
(e),402.
105(1)(2
CMS
Penalty for any person that fails to report information
required by HHS under Section 1877(1) concerning
ownership, investment, and compensation
arrangements
Penalty for any durable medical equipment supplier,
including a supplier of prosthetic devices, prosthetics,
orthotics, or supplies, that knowingly and willfully fails
to make refunds in a timely manner to Medicare
beneficiaries under certain conditions. (42 U.S.C.
1395(m)(18) sanctions apply here in the same manner,
which is under 1395u/il(2) and 1320a-7a(a))
Penalty for any person that issues a Medicare
supplemental policy that has not been approved by the
State regulatory program or does not meet Federal
standards after a statutorily defined effective date
2021
20,731
22,021
2021
16,449
17,472
2021
56,459
59,972
Penalty for someone other than issuer that sells or
issues a Medicare supplemental policy to beneficiary
without a disclosure statement
2021
29,256
31,076
)
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1395y(b)(8)(E)
CMS
Penalty for each week beginning after the initiation of
civil money penalty procedures by the Secretary
because a Medicare Advantage organization or Part D
sponsor has failed to carry out a contract, or has
carried out a contract inconsistently with regulations
Federal Register / Vol. 87, No. 52 / Thursday, March 17, 2022 / Rules and Regulations
15117
CMS
Penalty for an issuer that sells or issues a Medicare
supplemental policy without disclosure statement.
2021
48,762
51,796
CMS
Penalty for someone other than issuer that sells or
issues a Medicare supplemental policy without
acknowledaement form
2021
29,256
31,076
CMS
Penalty for issuer that sells or issues a Medicare
supplemental policy without an acknowledgement form.
2021
48,762
51,796
42 CFR
402.1 (c)
(25),
402.105
(e)
CMS
Penalty for someone other than issuer that sells or
issues Medicare supplemental polices after a given
date that fail to conform to the NAIC or Federal
standards established by statute
2021
29,256
31,076
42 CFR
402.1 (c)
(25),
405402.
105(f)(2
)
CMS
Penalty for an issuer that sells or issues Medicare
supplemental polices after a given date that fail to
conform to the NAIC or Federal standards established
by statute
2021
48,762
51,796
CMS
Penalty for someone other than issuer that sells a
Medicare supplemental policy and fails to make
available for sale the core group of basic benefits when
selling other Medicare supplemental policies with
additional benefits or fails to provide the individual,
before selling the policy, an outline of coverage
describing benefits
2021
29,256
31,076
CMS
Penalty for an issuer that sells a Medicare
supplemental policy and fails to make available for sale
the core group of basic benefits when selling other
Medicare supplemental policies with additional benefits
or fails to provide the individual, before selling the
policy, an outline of coverage describing benefits
2021
48,762
51,796
1395ss(q)(5)(C)
402.105
(f)(5)
CMS
Penalty for any person that fails to suspend the policy
of a policyholder made eligible for medical assistance
or automatically reinstates the policy of a policyholder
who has lost eligibility for medical assistance, under
certain circumstances
2021
48,762
51,796
1395ss(r)(6)(A)
402.105
(f)(6)
CMS
Penalty for any person that fails to provide refunds or
credits as required by section 1882(r)(1 )(B)
2021
48,762
51,796
CMS
Penalty for any issuer of a Medicare supplemental
policy that does not waive listed time periods if they
were already satisfied under a proceeding Medicare
supplemental policy, or denies a policy, or conditions
the issuances or effectiveness of the policy, or
discriminates in the pricing of the policy base on health
status or other specified criteria
2021
20,701
21,989
CMS
Penalty for any issuer of a Medicare supplemental
policy that fails to fulfill listed responsibilities
2021
48,762
51,796
CMS
Penalty someone other than issuer who sells, issues,
or renews a medigap Rx policy to an individual who is a
Part D enrollee
2021
21,112
22,426
1395ss(d)(3)(B)(iv
)
1395ss(p)(8)
1395ss(p)(9)(C)
42CFR
402.1 (c)
(26),
402.105
(e),
402.105
(f)(3),
(4)
402.105
(f)(3),(4)
1395ss(s)(4)
1395ss(t)(2)
42 CFR
402.1 (c)
(29),
402.105
(c)
42 CFR
402.1 (c)
(30),
402.105
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1395ss(v)(4)(A)
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(f)(?)
15118
Federal Register / Vol. 87, No. 52 / Thursday, March 17, 2022 / Rules and Regulations
1395bbb(c)(1)
1395bbb(f)(2)(A)(i
)
42 CFR
488.725
(c)
42 CFR
488.845
(b)(2)(iii
) 42
CFR
488.845
(b)(3)(6); and
42CFR
488.845
(d)(1 )(ii)
42 CFR
488.845
(b)(3)
42 CFR
488.845
(b)(3)(i)
42 CFR
488.845
(b)(3)(ii)
42 CFR
488.845
(b)(3)(iii
CMS
Penalty for an issuer who sells, issues, or renews a
Medigap Rx policy who is a Part D enrollee.
2021
35,188
37,377
CMS
Penalty for any individual who notifies or causes to be
notified a home health agency of the time or date on
which a survey of such agency is to be conducted
2021
4,518
4,799
CMS
Maximum daily penalty amount for each day a home
health agency is not in compliance with statutory
requirements
2021
21,663
23,011
CMS
Penalty per day for home health agency's
noncompliance (Upper Range):
2021
Minimum
2021
18,413
19,559
Maximum
2021
21,663
23,011
2021
21,663
23,011
2021
19,496
20,709
Penalty for an isolated incident of noncompliance in
violation of established HHA policy
2021
18,413
19,559
Penalty for a repeat and/or condition-level deficiency
that does not constitute immediate jeopardy, but is
directly related to poor quality patient care outcomes
(Lower Range):
2021
Minimum
2021
3,251
3,453
Maximum
2021
18,413
19,559
Penalty for a repeat and/or condition-level deficiency
that does not constitute immediate jeopardy and that is
related predominately to structure or process-oriented
conditions (Lower Range):
2021
Minimum
2021
1,084
1,151
2,166
2,301
CMS
CMS
CMS
Penalty for a home health agency's deficiency or
deficiencies that cause immediate jeopardy and result
in actual harm
Penalty for a home health agency's deficiency or
deficiencies that cause immediate jeopardy and result
in potential for harm
42 CFR
488.845
(b)(4)
42 CFR
488.845
(b)(5)
khammond on DSKJM1Z7X2PROD with RULES
42 CFR
488.845
(b)(6)
42 CFR
488.845
(d)(1 )(ii)
VerDate Sep<11>2014
16:41 Mar 16, 2022
CMS
CMS
CMS
CMS
Jkt 256001
Maximum
2021
Penalty imposed for instance of noncompliance that
may be assessed for one or more singular events of
condition-level noncompliance that are identified and
where the noncompliance was corrected during the
onsite survey:
2021
Penalty for each day of noncompliance (Minimum).
2021
2,166
2,301
Penalty for each day of noncompliance (Maximum).
2021
21,663
23,011
Penalty for each day of noncompliance (Maximum)
2021
21,663
23,011
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)
1395eee(e)(6)(B);
1396u-4(e)(6)(B)
42 CFR
460.46
CMS
CMS
CMS
CMS
CMS
42 CFR
488.408
(d)(1 )(iii
)
42 CFR
488.408
(d)(1 )(iv
)
1396r(h)(3)(C)(ii)(I
)
42 CFR
488.408
(e)(1 )(iii
)
42 CFR
488.408
(e)(1 )(iv
)
khammond on DSKJM1Z7X2PROD with RULES
42 CFR
488.408
(e)(2)(ii)
42 CFR
488.438
(a)(1 )(i)
VerDate Sep<11>2014
16:41 Mar 16, 2022
CMS
CMS
CMS
CMS
CMS
CMS
Jkt 256001
Penalty for PACE organization that discriminates in
enrollment or disenrollment, or engages in any practice
that would reasonably be expected to have the effect of
denying or discouraging enrollment, on the basis of
health status or the need for services:
2021
For each individual not enrolled as a result of the PACE
organization's discrimination in enrollment or
disenrollment or practice that would deny or discourage
enrollment.
2021
Minimum
Maximum
15119
40,282
42,788
2021
15,177
16,121
2021
101,182
107,478
2021
40,282
42,788
2021
161,130
171,156
Penalty for any other violation specified in 42 C.F.R.
460.40.
2021
40,282
42,788
Penalty per day for a nursing facility's failure to meet a
Cateoorv 2 Certification:
2021
Minimum
2021
113
120
6,774
7,195
Penalty for a PACE organization that charges
excessive premiums.
Penalty for a PACE organization misrepresenting or
falsifying information to CMS or the State.
Maximum
2021
Penalty per instance for a nursing facility's failure to
meet Cateoorv 2 certification:
2021
Minimum
2021
2,259
2,400
22,584
23,989
Maximum
2021
Penalty per day for a nursing facility's failure to meet
Category 3 certification:
2021
Minimum
2021
6,888
7,317
22,584
23,989
Maximum
2021
Penalty per instance for a nursing facility's failure to
meet Cateoorv 3 certification:
2021
Minimum
2021
2,259
2,400
22,584
23,989
Maximum
2021
Penalty per instance for a nursing facility's failure to
meet Category 3 certification, which results in
immediate jeopardy:
2021
Minimum
2021
2,259
2,400
Maximum
2021
22,584
23,989
Penalty per day for nursing facility's failure to meet
certification (Upper Range):
2021
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Federal Register / Vol. 87, No. 52 / Thursday, March 17, 2022 / Rules and Regulations
15120
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42 CFR
488.438
(a)(1 )(ii)
42 CFR
488.438
(a)(2)
42 CFR
488.447
1396r(f)(2)(B)(iii)(I
)(c)
42 CFR
483.151
(b)(2)(iv
) and
(b)(3)(iii
)
1396r(h)(3)(C)(ii)(I
)
42 CFR
483.151
(c)(2)
1396tU)(2)(C)
VerDate Sep<11>2014
CMS
CMS
CMS
CMS
2021
6,888
7,317
Maximum
2021
22,584
23,989
Penalty per day for nursing facility's failure to meet
certification (Lower Range):
2021
Minimum
2021
113
120
Maximum
2021
6,774
7,195
Penalty per instance for nursing facility's failure to meet
certification:
2021
Minimum
2021
2,259
2,400
Maximum
2021
22,584
23,989
Penalty imposed for failure to comply with infection
control weekly reporting requirements at 42 CFR
483.80(g)(1) and (2)
2021
First occurrence (Minimum)
2021
1,012
1,075
Incremental increases for each subsequent occurrence
2021
506
537
Grounds to prohibit approval of Nurse Aide Training
Program-if assessed a penalty in 1819(h)(2)(B)(i) or
1919(h)(2)(A)(ii) of "not less than $5,000" [Not CMP
authority, but a specific CMP amount (CMP at this
level) that is the triggering condition for disapproval]
2021
11,292
11,995
2021
11,292
11,995
Grounds to waive disapproval of nurse aide training
program-reference to disapproval based on
imposition of CMP "not less than $5,000" [Not CMP
authority but CMP imposition at this level determines
eligibility to seek waiver of disapproval of nurse aide
training program]
Penalty for each day of noncompliance for a home or
community care provider that no longer meets the
minimum reQuirements for home and community care:
2021
Minimum
2021
2
2
Maximum
2021
19,505
20,719
CMS
Penalty for a Medicaid managed care organization that
fails substantially to provide medically necessary items
and services
2021
40,282
42,788
CMS
Penalty for Medicaid managed care organization that
imposes premiums or charges on enrollees in excess
of the premiums or charges permitted.
2021
40,282
42,788
CMS
42 CFR
438.704
16:41 Mar 16, 2022
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1396u2(e)(2)(A)(i)
CMS
Minimum
1396u2(e)(2)(A)(ii)
1396u2(e)(2)(A)(iv)
1396u(h)(2)
1396w-2(c)(1)
CMS
Penalty for a Medicaid managed care organization that
misrepresents or falsifies information to another
individual or entity.
2021
40,282
42,788
CMS
Penalty for a Medicaid managed care organization that
fails to comply with the applicable statutory
requirements for such organizations.
2021
40,282
42,788
CMS
Penalty for a Medicaid managed care organization that
misrepresents or falsifies information to the HHS
Secretary
2021
161,130
171,156
CMS
Penalty for Medicaid managed care organization that
acts to discriminate among enrollees on the basis of
their health status.
2021
161,130
171,156
2021
24,169
25,673
2021
22,584
23,989
42 CFR
438.704
42 CFR
438.704
42 CFR
Part
441,
Subpart
I
CMS
CMS
Penalty for each individual that does not enroll as a
result of a Medicaid managed care organization that
acts to discriminate among enrollees on the basis of
their health status
Penalty for a provider not meeting one of the
requirements relating to the protection of the health,
safety, and welfare of individuals receiving community
suooorted livinq arranqements services
CMS
Penalty for disclosing information related to eligibility
determinations for medical assistance programs
2021
12,045
12,794
2021
164
174
18041(c)(2)
45CFR
156.805
(c)
CMS
Failure to comply with ACA requirements related to risk
adjustment, reinsurance, risk corridors, Exchanges
(including QHP standards) and other ACA Subtitle D
standards; Penalty for violations of rules or standards
of behavior associated with issuer compliance with risk
adjustment, reinsurance, risk corridors, Exchanges
(including QHP standards) and other ACA Subtitle D
standards.
18081 (h)(1 )(A)(i)(I
I)
45CFR
155.285
CMS
Penalty for providing false information on Exchange
application
2021
29,764
31,616
18081 (h)(1 )(B)
45CFR
155.285
CMS
Penalty for knowingly or willfully providing false
information on Exchange application
2021
297,636
316,155
CMS
Penalty for knowingly or willfully disclosing protected
information from Exchange
2021
CMS
Minimum
2021
29,764
31,616
CMS
Maximum
2021
304
323
CMS
Penalties for violation of applicable Exchange
standards by consumer assistance entities in
Federally-facilitated Exchanges
2021
36,500
38,771
Maximum (Per Day)
2021
101
107
2021
304
323
18081 (h )(2)
18041(c)(2)
45CFR
155.260
45CFR
155.206
(i)
31 U.S.C.
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15122
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HHS
45CFR
93.400(
e)
HHS
Penalty for the first lime an individual makes an
expenditure prohibited by regulations regarding
lobbvina disclosure, absent aaaravatina circumstances
Penalty for second and subsequent offenses by
individuals who make an expenditure prohibited by
reaulations reaardina lobbvina disclosure:
2021
20,731
22,021
2021
Minimum
2021
20,731
22,021
Maximum
2021
207,314
220,213
2021
20,731
22,021
Penalty for the first lime an individual fails to file or
amend a lobbying disclosure form, absent aggravating
circumstances
Penalty for second and subsequent offenses by
individuals who fail to file or amend a lobbying
disclosure form, absent aggravating circumstances:
2021
Minimum
2021
20,731
22,021
Maximum
2021
207,314
220,213
Penalty for failure to provide certification regarding
lobbying in the award documents for all sub-awards of
all tiers:
2021
Minimum
2021
20,731
22,021
Maximum
2021
207,314
220,213
1352
HHS
45CFR
Part 93,
Appendi
xA
3801-3812
45CFR
79.3(a)(
1)(iv)
45CFR
79.3(b)(
1)(ii)
Penalty for failure to provide statement regarding
HHS
HHS
HHS
lobbying for loan guarantee and loan insurance
transactions:
2021
Minimum
2021
20,731
22,021
Maximum
2021
207,314
220,213
2021
10,833
11,507
2021
10,833
11,507
Penalty against any individual who-with knowledge or
reason to know-makes, presents or submits a false,
fictitious or fraudulent claim to the Deoartment
Penalty against any individual who-with knowledge or
reason to know-makes, presents or submits a false,
fictitious or fraudulent claim to the Deoartment
1 Some
HHS components have not promulgated regulations regarding their civil monetary penalty-specific statutory authorities.
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 0MB 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; M-18-03, Implementation of Penalty Inflation Adjustments for 2018 pursuant to the Federal
Civil Penalties Inflation Adjustment Act Improvements Act of 2015, published December 15, 2017; M-19-04, Implementation of Penalty Inflation Adjustments for 2019
pursuant to the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015, published December 14, 2018; M-20-05, Implementation of Penalty Inflation
Adjustments for 2020 pursuant to the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015, published December 16, 2019; M-21-10,
Implementation of Penalty Inflation Adjustments for 2021 pursuant to the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015, published
December 23, 2020; M-22-07, Implementation of Penalty Inflation Adjustments for 2022, Pursuant to the Federal Civil Penalties Inflation Adjustment Act Improvements
Act of 2015, published December 15, 2021, guided agencies on annual adjustment requirements.
5 0MB Circular A-136, Financial Reporting Requirements, Section 11.4.9, 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, § 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 2021 CPI-U (276.589) /October 2020
CPI-U (260.388) = 1.06222.
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2 The
Federal Register / Vol. 87, No. 52 / Thursday, March 17, 2022 / Rules and Regulations
Xavier Becerra,
Secretary, Department of Health and Human
Services.
[FR Doc. 2022–05648 Filed 3–16–22; 8:45 am]
BILLING CODE 4150–24–C
FEDERAL MARITIME COMMISSION
46 CFR Part 525
[Docket No. 21–06]
RIN 3072–AC87
Marine Terminal Operator Schedules
Federal Maritime Commission.
Final rule.
AGENCY:
ACTION:
This final rule adopts without
substantive change the proposed rule.
The Federal Maritime Commission
(FMC or Commission) seeks to update
outdated references to Commission
offices, modernize references to
technology, and clarify existing
requirements associated with the filing
of marine terminal operator (MTO)
schedules.
DATES: This final rule is effective: April
18, 2022.
FOR FURTHER INFORMATION CONTACT: For
technical questions, contact Kristen
Monaco, Director, Bureau of Trade
Analysis, Federal Maritime
Commission, 800 North Capitol Street
NW, Washington, DC 20573–0001.
Phone: (202) 523–5796. Email:
tradeanalysis@fmc.gov. For legal
questions, contact Steven Andersen,
General Counsel, Federal Maritime
Commission, 800 North Capitol Street
NW, Washington, DC 20573–0001.
Phone: (202) 523–5738. Email:
GeneralCounsel@fmc.gov.
SUPPLEMENTARY INFORMATION:
khammond on DSKJM1Z7X2PROD with RULES
SUMMARY:
I. Introduction
Pursuant to 46 U.S.C. 40501(f), MTOs
may make public a schedule of rates,
regulations, and practice. Additionally,
Congress directs the Commission to
prescribe the form and manner in which
MTO schedules shall be published. 46
U.S.C. 40501(g)(3). The Commission’s
regulations regarding MTO schedules
are outlined in 46 CFR part 525.
Consistent with the language in 46
U.S.C. 40501(f), part 525 states that an
MTO, at its discretion, may make
available to the public a schedule of its
rates, regulations, and practices. Part
525 also discusses the requirements
when an MTO decides to make terminal
schedules available to the public.
II. Summary of Proposed Changes
In Fiscal Year 2021, the Commission
reviewed its regulations regarding MTO
VerDate Sep<11>2014
16:41 Mar 16, 2022
Jkt 256001
schedules found in 46 CFR part 525. On
September 22, 2021, the Commission
issued a notice of proposed rulemaking
that proposed several changes to part
525 that are neither substantive nor
policy related. 86 FR 52627. The
proposed revisions updated references
to a Commission bureau and deleted
references to outdated technology.
Additionally, the FMC clarified
definitions or revised them to be
consistent with other parts of the
Commission’s regulations. The
Commission requested comments on
these proposed amendments.
III. Summary of Comments
One shipper filed comments in this
docket. However, these comments,
which relate to per diem charges,
detention and demurrage fees, and dual
transaction requirements at specific
terminals, do not address the proposed
revisions to part 525. The commenter
neither expressed support nor
opposition to the proposed part 525
revisions. Because the issues raised by
the commenter are outside the scope of
the proposed amendments and the
rulemaking, the FMC is not making
changes to the final rule based on these
comments. The FMC now adopts all of
the proposed amendments without
substantive change in this final rule.
IV. Final Rule
The proposed rule contained
revisions that were not policy related
and the Commission’s intent was
limited to modernizing outdated
requirements, clarifying existing
requirements and definitions, and
making the existing requirements and
definitions consistent with other parts
of the Commission’s regulations. For the
reasons stated in the NPRM and
described below, the Commission is
adopting the revisions in the proposed
rule with non-substantive changes.
1. Section 525.1.
The proposed rule revises references
to the Shipping Act of 1984 (the Act) to
remove specific cites to the Ocean
Shipping Reform Act of 1998 and the
Coast Guard Authorization Act of 1998
because several other laws also amend
the Shipping Act of 1984. See An Act
to Complete the Codification of Title 46,
United States Code, ‘‘Shipping,’’ as
Positive Law, Public Law 109–304, 120
Stat. 1485 (2006); Frank LoBiondo Coast
Guard Authorization Act of 2018, Public
Law 115–282, 132 Stat. 4192 (2018).
These revisions affect section 525.1(a)
and (c)(1). The proposed rule added
clarifying language to the definition of
‘‘bulk cargo’’ to explain that bulk
‘‘containerized cargo tendered by the
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15123
shipper’’ is subject to mark and count
and is, therefore, subject to the
requirements of this part. The proposed
rule amended the definition of ‘‘forest
products’’ to correct a typographical
error.
In addition, the proposed rule revised
the definition of ‘‘marine terminal
operator’’ to mean ‘‘a person engaged in
the United States in the business of
providing wharfage, dock, warehouse,
or other terminal facilities in connection
with a common carrier[.]’’ This language
is consistent with the statutory
definition of an MTO. See 46 U.S.C.
40102(15). The proposed rule also
added language to clarify that shippers
or consignees who exclusively provide
their own marine terminal facilities in
connection with providing marine
terminal services are not MTOs.
The proposed rule amended the
definition of ‘‘terminal facilities’’ by
adding ‘‘docks, berths, piers, [and]
aprons’’ to the list of structures
comprising a terminal unit. In addition,
the proposed language replaces the term
‘‘water carriers’’ with ‘‘ocean common
carriers.’’ As a result of these revisions,
the definition of ‘‘terminal facilities’’ is
consistent with the definition of
‘‘marine terminal facilities’’ in 46 CFR
part 535.
The proposed rule also introduced a
definition for the ‘‘United States’’ that is
consistent with the definition found in
46 U.S.C. 114. To accommodate the new
paragraph, the proposed rule
renumbered paragraphs 525.1(c)(21) to
(23) to be paragraphs 525.1(c)(22) to
(24). Additionally, the proposed rule
revised the definition of an MTO to
delete ‘‘or a commonwealth, territory, or
possession thereof,’’ because those
entities are now included in the
definition of ‘‘United States.’’
The comments received do not
address these proposed revisions.
The final rule adopts the revisions
described above without change.
A. Section 525.2
The proposed rule did not propose
revisions to section 525.2. The
comments do not address section 525.2.
Thus, the final rule does not revise
section 525.2.
B. Section 525.3
With respect to section 525.3,
Availability of marine terminal operator
schedules, the proposed rule removed
outdated and unnecessary language
relating to accessing electronically
published MTO schedules. The
proposed rule deleted the terms
‘‘personal computer (PC),’’ ‘‘dial-up
connection,’’ ‘‘the internet,’’ ‘‘Web
browser,’’ ‘‘Telnet session,’’ ‘‘modem,’’
E:\FR\FM\17MRR1.SGM
17MRR1
]]>Agencies
[Federal Register Volume 87, Number 52 (Thursday, March 17, 2022)]
[Rules and Regulations]
[Pages 15100-15123]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-05648]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
45 CFR Part 102
RIN 0991-AC33
Annual Civil Monetary Penalties Inflation Adjustment
AGENCY: Office of the Assistant Secretary for Financial Resources,
Department of Health and Human Services (HHS).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Department of Health and Human Services is updating its
regulations to reflect required annual inflation-related increases to
the civil monetary penalty amounts in its regulations, under the
Federal Civil Penalties Inflation Adjustment Act Improvements Act of
2015; adding references to new penalty authorities; and making
technical changes to correct errors in the regulation.
DATES:
Effective date: This final rule is effective March 17, 2022.
Applicability date: The adjusted civil monetary penalty amounts
apply to penalties assessed on March 17, 2022, r if the violation
occurred on or after November 2, 2015.
FOR FURTHER INFORMATION CONTACT: Katrina Brisbon, Acting Deputy
Assistant Secretary, Office of Acquisitions, Office of the Assistant
Secretary for Financial Resources, Room 536-H, Hubert Humphrey
Building, 200 Independence Avenue SW, Washington, DC 20201; (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 civil monetary penalties (CMPs) and to maintain the
deterrent effect of such penalties, requires agencies to adjust the
CMPs for inflation annually.
The Department of Health and Human Services (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), and November 15, 2021 (86 FR
62928).
II. Calculation of Annual Inflation Adjustment
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, 2021, Office of Management and Budget (OMB)
Memorandum for the Heads of Executive Agencies and Departments, M-22-
07, ``Implementation of Penalty Inflation Adjustments for 2022,
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 2022, based on the CPI-U for the month of October 2021, not
seasonally adjusted, is 1.06222. The multiplier is applied to each
applicable penalty amount that was updated and published for fiscal
year (FY) 2021 and is rounded to the nearest dollar.
III. Other Revisions
In addition to the inflation adjustments for 2022, this final rule
updates the table in 45 CFR 102.3 to add references to new, applicable
civil money penalty authorities that were established or implemented
since the publication of the November 15, 2021 update and that are
being updated in this rule. The rule also corrects several technical
errors to regulatory citations in the table and updates descriptions
for clarification and accuracy. The following technical errors were
identified and are corrected in the table at 45 CFR 102.3:
The citation to, and description of, 42 U.S.C. 299c-3(d)
are revised for accuracy.
The regulatory reference of 42 CFR 1003.210(a)(5)
implementing 42 U.S.C. 1395cc(g) which was inadvertently omitted from
the regulation and is added.
The description of the CMP at 42 U.S.C. 1320a-7a(o) is
revised for accuracy.
The regulatory reference to 45 CFR 155.206(i) \1\
implementing 42 U.S.C. 18041(c)(2) \2\ which was inadvertently omitted
from the regulation is added. Additionally, the amount for this CMP was
not included in the 2021 inflation adjustment rule. 86 FR 62928, 62943
(Nov. 15, 2021). Thus, we are updating the inflation amount at this
time.
---------------------------------------------------------------------------
\1\ The Department recently proposed a technical correction to
45 CFR 155.206(i) to add language that would cross-reference to the
authority to implement annual inflation-related increases to CMPs
pursuant to the 2015 Act. See Patient Protection and Affordable Care
Act; HHS Notice of Benefit and Payment Parameters for 2023; Proposed
Rule, 87 FR 584 at 640-641, 721 (Jan. 5, 2022). To date, no CMPs
have been imposed under this authority, but any that are would
reflect the current inflationary adjusted amount as required by the
2015 Act and would be calculated in accordance with applicable OMB
guidance to all Executive Departments on the implementation of the
2015 Act.
\2\ See, e.g., the Patient Protection and Affordable Care Act;
Exchange and Insurance Market Standards for 2015 and Beyond; Final
Rule, 79 FR 30239 at 30262-30270 (May 27, 2014).
---------------------------------------------------------------------------
The first description tied to 42 U.S.C. 1395mm(i)(6)(B)(i)
is revised from ``is such plan'' to ``if such plan''.
The regulatory reference to 85 FR 71142 (Nov. 6, 2020)
implementing CARES Act, Pub. L. 116-136, section 3202(b)(2), is revised
to read 45 CFR 182.70.
++ The 2022 adjusted amount is calculated by applying the 2021
multiplier to 1.06222 percent and this adjusted amount is reflected in
the table of the regulation at 45 CFR 102.3.
[[Page 15101]]
IV. 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-21-10, the phrase
``notwithstanding section 553'' in section 4(b)(2) of the 2015 Act
means that ``the public procedure the APA generally requires (that is,
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 and for the ministerial
and technical changes in this rule. In addition, HHS is waiving notice
and comment for the non-substantive technical corrections set out in
this final rule. HHS finds good cause for issuing these changes as a
final rule without prior notice and comment because these changes only
update the regulation to add the new CMP authorities that will be
adjusted in accordance with the 2015 Act which were implemented since
the last update.
Pursuant to OMB Memorandum M-21-10, 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.
V. 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 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.
Accordingly, the Department of Health and Human Services amends 45
CFR part 102 as follows:
PART 102--ADJUSTMENT OF CIVIL MONETARY PENALTIES FOR INFLATION
0
1. The authority citation for part 102 is revised 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.
* * * * *
BILLING CODE 4150-24-P
[[Page 15102]]
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Xavier Becerra,
Secretary, Department of Health and Human Services.
[FR Doc. 2022-05648 Filed 3-16-22; 8:45 am]
BILLING CODE 4150-24-C
