Adjustment of Civil Monetary Penalties for Inflation and the Annual Civil Monetary Penalties Inflation Adjustment for 2021, 62928-62943 [2021-24672]
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Federal Register / Vol. 86, No. 217 / Monday, November 15, 2021 / Rules and Regulations
V. Congressional Review Act
Pursuant to the Congressional Review
Act (5 U.S.C. 801 et seq.), EPA will
submit a report containing this rule and
other required information to the U.S.
Senate, the U.S. House of
Representatives, and the Comptroller
General of the United States prior to
publication of the rule in the Federal
Register. This action is not a ‘‘major
rule’’ as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Dated: October 26, 2021.
Edward Messina,
Director, Office of Pesticide Programs.
PART 180—TOLERANCES AND
EXEMPTIONS FOR PESTICIDE
CHEMICAL RESIDUES IN FOOD
1. The authority citation for part 180
continues to read as follows:
2. Add § 180.1385 to subpart D to read
as follows:
■
§ 180.1385 Methylorubrum populi strain
NLS0089; exemption from the requirement
of a tolerance.
An exemption from the requirement
of a tolerance is established for residues
of Methylorubrum populi strain
NLS0089 in or on all food commodities
when used in accordance with label
directions and good agricultural
practices.
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42 CFR Parts 402, 403, 411, 412, 422,
423, 460, 483, 488, and 493
42 CFR Part 1003
Office of the Secretary
45 CFR Parts 79, 93, 102, 147, 150, 155,
156, 158, and 160
45 CFR Part 303
RIN 0991–AC0
Office of the Assistant
Secretary for Financial Resources,
Department of Health and Human
Services (HHS).
ACTION: Final rule.
AGENCY:
Authority: 21 U.S.C. 321(q), 346a and 371.
16:01 Nov 12, 2021
Centers for Medicare & Medicaid
Services
Adjustment of Civil Monetary Penalties
for Inflation and the Annual Civil
Monetary Penalties Inflation
Adjustment for 2021
■
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42 CFR Part 3
Administration for Children and
Families
Therefore, for the reasons stated in the
preamble, EPA is amending 40 CFR
chapter I as follows:
BILLING CODE 6560–50–P
Office of the Secretary
Office of the Inspector General
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
[FR Doc. 2021–24794 Filed 11–12–21; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
This final rule finalizes the
provisions of the September 6, 2016
interim final rule that adjusts for
inflation the maximum civil monetary
penalty (CMP) amounts for all agencies
within the Department of Health and
Human Services (HHS) and updates
certain agency-specific regulations. It
also updates our required annual
inflation-related increases to the CMP
amounts in our regulations, under the
Federal Civil Penalties Inflation
Adjustment Act Improvements Act of
2015; adds references to new penalty
authorities; and reflects technical
changes to correct errors.
DATES:
Effective date: This final rule is
effective November 15, 2021.
Applicability date: The adjusted civil
monetary penalty amounts apply to
penalties assessed on or after November
15, 2021, if the violation occurred on or
after November 2, 2015.
FOR FURTHER INFORMATION CONTACT:
David Dasher, Deputy Assistant
Secretary, Office of Acquisitions, Office
of the Assistant Secretary for Financial
Resources, Room 536–H, Hubert
SUMMARY:
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Humphrey Building, 200 Independence
Avenue SW, Washington DC 20201;
202–205–0706.
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 civil
monetary penalties 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), and
January 17, 2020 (85 FR 2869).
II. Provisions of the Final Rule
A. Finalization of the September 6, 2016
Interim Final Rule
In the September 6, 2016 Federal
Register (81 FR 61538), HHS issued a
department-wide interim final rule (IFR)
titled ‘‘Adjustment of Civil Monetary
Penalties for Inflation’’ that established
new regulations at 45 CFR part 102 to
adjust for inflation the maximum CMP
amounts for the various CMP authorities
for all agencies within the Department.
HHS took this action to comply with the
Federal Civil Penalties Inflation
Adjustment Act of 1990 (the Inflation
Adjustment Act) (28 U.S.C. 2461 note
2(a)), as amended by the Federal Civil
Penalties Inflation Adjustment Act
Improvements Act of 2015 (section 701
of the Bipartisan Budget Act of 2015,
(Pub. L.114–74), enacted on November
2, 2015). In addition, the September
2016 IFR included updates to certain
agency-specific regulations to reflect the
new provisions governing the
adjustment of civil monetary penalties
for inflation in 45 CFR part 102.
One of the purposes of the Inflation
Adjustment Act was to create a
mechanism to allow for regular
inflationary adjustments to federal civil
monetary penalties. Section 2(b)(1) of
the Inflation Adjustment Act. The 2015
amendments removed an inflation
update exclusion that previously
applied to the Social Security Act as
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well as to the Occupational Safety and
Health Act. The 2015 amendments also
‘‘reset’’ the inflation calculations by
excluding prior inflationary adjustments
under the Inflation Adjustment Act and
requiring agencies to identify, for each
penalty, the year and corresponding
amount(s) for which the maximum
penalty level or range of minimum and
maximum penalties was established
(that is, originally enacted by Congress)
or last adjusted other than pursuant to
the Inflation Adjustment Act. In
accordance with section 4 of the
Inflation Adjustment Act, agencies were
required to: (1) Adjust the level of civil
monetary penalties with an initial
‘‘catch-up’’ adjustment through an
interim final rulemaking to take effect
by August 1, 2016; and (2) make
subsequent annual adjustments for
inflation.
In the September 2016 interim final
rule, HHS adopted new regulations at 45
CFR part 102 to govern adjustment of
civil monetary penalties for inflation.
The regulation at 45 CFR 102.1 provides
that part 102 applies to each statutory
provision under the laws administered
by HHS (including the Centers for
Medicare & Medicaid Services (CMS))
concerning CMPs, and that the
regulations in part 102 supersede
existing HHS regulations setting forth
CMP amounts. The CMPs and the
adjusted penalty amounts administered
by all HHS agencies are listed in tabular
form in 45 CFR 102.3. In addition to
codifying the adjusted penalty amounts
identified in § 102.3, the HHS-wide
interim final rule included several
technical conforming updates to certain
agency-specific regulations, including
various CMS regulations, to identify
their updated information, and
incorporate a cross-reference to the
location of HHS-wide regulations.
In the September 12, 2017 Federal
Register (82 FR 42748), CMS published
a correcting amendment that corrected a
limited number of technical and
typographical errors identified in the
CMS provisions of the September 6,
2016 IFR.
The Medicare provisions included in
the September 2016 IFR are subject to
requirements of section 1871(a) of the
Social Security Act (the Act) which sets
forth certain procedures for
promulgating regulations necessary to
carry out the administration of the
insurance programs under Title XVIII of
the Act. Section 1871(a)(3)(A) of the Act
requires the Secretary, in consultation
with the Director of the Office of
Management and Budget (OMB), to
establish a regular timeline for the
publication of final regulations based on
the previous publication of a proposed
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rule or an interim final rule. In
accordance with section 1871(a)(3)(B) of
the Act, such timeline may vary among
different rules, based on the complexity
of the rule, the number and scope of the
comments received, and other relevant
factors. However, the timeline for
publishing the final rule cannot exceed
3 years from the date of publication of
the proposed or interim final rule,
unless there are exceptional
circumstances. After consultation with
the Director of OMB, the Secretary
published a notice, which appeared in
the December 30, 2004 Federal Register
(69 FR 78442), establishing a general 3year timeline for publishing Medicare
final rules after the publication of a
proposed or interim final rule.
Because the conforming changes to
the Medicare provisions were part of a
larger, omnibus departmental interim
final rule, we inadvertently missed
setting a target date for the final rule to
make permanent the changes to the
Medicare regulations in accordance
with section 1871(a)(3)(A) of the Act
and the procedures outlined in the
December 2004 notice. Consistent with
section 1871(a)(3)(C) of the Act, we
published notices of continuation
extending the effectiveness of the
technical conforming changes to the
Medicare regulations that were
implemented through interim final rule
and to allow time to publish a final rule
(see the January 2, 2020 (85 FR 7) and
September 8, 2020 (85 FR 55385)
continuation documents). The extended
time was needed to allow for
coordination between CMS and the
Department to issue a final rule and to
avoid the potential for confusion
between 45 CFR part 102, which
established the civil monetary payment
amounts, and the Medicare regulations
subject to the timing requirements in
section 1871(a)(3)(C) of the Act, which
would otherwise cause the regulation to
revert to the language that was used
prior to the Inflation Adjustment Act.
In this final rule, we are finalizing the
provisions of the September 6, 2016 IFR
without modification. Because the
provisions were established via interim
final rulemaking, finalizing the
provisions is pro forma for all agencies
except CMS. Given the statutory
requirements specified previously,
finalization of the September 2016 IFR
permanently establishes the interim
final regulatory provisions for the
Medicare program.
B. Calculation of Annual Inflation
Adjustment
The annual inflation adjustment for
each applicable CMP is determined
using the percent increase in the
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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 23, 2020, Office of
Management and Budget (OMB)
Memorandum for the Heads of
Executive Agencies and Departments,
M–21–10, ‘‘Implementation of the
Penalty Inflation Adjustments for 2021,
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 2021, based
on the CPI–U for the month of October
2020, not seasonally adjusted, is
1.01182. The multiplier is applied to
each applicable penalty amount that
was updated and published for fiscal
year (FY) 2020 and is rounded to the
nearest dollar.
C. Other Revisions
In addition to the inflation
adjustments for 2021, 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 January 17, 2020
update and that are being updated in
this rule. The rule also corrects several
technical errors to regulatory references
in the table and updates descriptions for
clarification and accuracy.
First, a CMS final rule, ‘‘Medicare and
Medicaid Programs: CY 2020 Hospital
Outpatient PPS Policy Changes and
Payment Rates and Ambulatory Surgical
Center Payment System Policy Changes
and Payment Rates. Price Transparency
Requirements for Hospitals to Make
Standard Charges Public’’ (84 FR 65524,
November 27, 2019), effective January 1,
2021, finalized a new provision,
codified at 45 CFR 180.90. That section
establishes CMPs associated with a
hospital’s noncompliance with price
transparency disclosure and display
requirements, and the table has been
modified to reflect this requirement.
Second, section 3202(b) of the
Coronavirus Aid, Relief, and Economic
Security Act (CARES Act) (Pub. L. 116–
136) added a requirement that each
provider of a diagnostic test for COVID–
19 make public the cash price for such
test on the provider’s public internet
site, and authorized the Secretary to
impose a CMP on a provider that fails
to comply. Rulemaking entitled
‘‘Additional Policy and Regulatory
Revisions in Response to the COVID–19
Public Health Emergency’’ (85 FR
71142, November 6, 2020) implemented
this statutory requirement by
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establishing a provision at 45 CFR
182.70, allowing for imposition of a
CMP, and the table has been modified
to reflect this requirement.
Third, in a CMS interim final rule
with comment period entitled
‘‘Medicare and Medicaid Programs,
Clinical Laboratory Improvement
Amendments (CLIA), and Patient
Protection and Affordable Care Act;
Additional Policy and Regulatory
Revisions in Response to the COVID–19
Public Health Emergency’’ (85 FR 54873
through 54874, September 2, 2020),
CMS established requirements for all
CLIA laboratories to report COVID–19
test results to the Secretary in such form
and manner, and at such timing and
frequency, as the Secretary may
prescribe during the COVID–19 Public
Health Emergency. Failure to report test
results as required results in condition
level deficiencies for which CMPs or
other penalties may apply. The table has
been modified to reflect this
requirement. Also in this interim final
rule, CMS codified new enforcement
requirements at 42 CFR 488.447
establishing CMP amounts that may be
imposed against long term care facilities
that fail to report COVID–19 related data
as required in 42 CFR 483.80(g)(1) and
(2). The table has been modified to
reflect these requirements.
Finally, the following technical errors
were identified and are corrected in the
table at 45 CFR 102.3:
• 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 two descriptions of 42 U.S.C.
1395dd(d)(1) are revised for more
accuracy because penalties for a
responsible physician, unlike penalties
for a hospital, are not tied to the number
of beds in the hospital (see 42 U.S.C.
1395dd(d)(1)(B)).
• 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 references tied to 42
U.S.C. 1395ss(a)(2), (p)(8), (p)(9)(C),
(q)(5)(C), (r)(6)(A), (s)(4), (t)(2)
incorrectly referred to 42 CFR part 405
and are corrected to refer to 42 CFR part
402.
• The first set of regulatory references
tied to 42 U.S.C. 1395ss(p)(8) are
expanded to also include 42 CFR
402.105(f)(2), which was inadvertently
omitted, and the corresponding
description is revised to replace ‘‘any
person’’ with ‘‘someone other than
issuer’’ for greater accuracy and
clarification.
• The description for the second set
of regulatory references tied to 42 U.S.C.
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1395ss(p)(8) is revised to replace ‘‘any
person’’ with ‘‘an issuer’’ for greater
accuracy and clarification.
• The first set of regulatory references
tied to 42 U.S.C. 1395ss(p)(9)(C) are
expanded to also include 42 CFR
402.105(f)(3) and (4), which were
inadvertently omitted, and the
corresponding description is revised to
replace ‘‘any person’’ with ‘‘someone
other than issuer’’ for greater accuracy
and clarification.
• The description for the second set
of regulatory references tied to 42 U.S.C.
1395ss(p)(9)(C) is revised to replace
‘‘any person’’ with ‘‘an issuer’’ for
greater accuracy and clarification.
• The description for 42 U.S.C.
18081(c)(2) is being revised to ‘‘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. (42
U.S.C. 300gg-22(b)(2)(C))’’ for greater
accuracy and clarification.
• Reference to the existing CMPs
authorized under 42 U.S.C. 1395m-1(a)
and 42 CFR 414.504(e) for a reporting
entity that has failed to report or made
a misrepresentation or omission in
reporting applicable information was
inadvertently omitted from the prior
annual updates and the regulation is
modified to include this authority and
the 2021 adjusted amount. CMS, in
separate rulemaking, made the initial
catch-up adjustment for this amount in
accordance with the 2015 Act on June
23, 2016 (81 FR 41036, 41069) which
was $10,017, and noted that subsequent
inflationary adjustments would be made
to this amount annually.
++ The adjusted amounts applying
the multiplier for each year beginning in
2017 through 2020 1 are as follows:
—The 2017 adjusted amount is $10,181
($10,017 × 1.01636).
1 The published multiplier for 2017 is 1.01636
(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); for 2018 it is
1.02041 (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); for 2019 it is 1.02522 (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); and for 2020
it is 1.01764 (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).
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—The 2018 adjusted amount is $10,389
($10,181 × 1.02041).
—The 2019 adjusted amount is $10,651
($10,389 × 1.02522).
—The 2020 adjusted amount is $10,839
($10,651 × 1.01764).
++ The 2021 adjusted amount is
calculated by applying the 2021
multiplier to $10,839 and this adjusted
amount is reflected in the table of the
regulation at 45 CFR 102.3.
III. Statutory and Executive Order
Reviews and Waiver of Proposed
Rulemaking
The 2015 Act requires Federal
agencies to publish annual penalty
inflation adjustments notwithstanding
section 553 of the Administrative
Procedure Act (APA).
Section 4(a) of the 2015 Act directs
Federal agencies to publish annual
adjustments no later than January 15th
of each year thereafter. In accordance
with section 553 of the APA, most rules
are subject to notice and comment and
are effective no earlier than 30 days after
publication in the Federal Register.
However, section 4(b)(2) of the 2015 Act
provides that each agency shall make
the annual inflation adjustments
‘‘notwithstanding 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 is 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 and to add additional
technical clarifying edits to descriptions
and correcting inadvertent omissions
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assessed on or after date specified in the
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.
FR 61537, as final with the following
changes to 45 CFR part 102:
List of Subjects in 45 CFR Part 102
Authority: Public Law 101–410, Sec. 701 of
Public Law 114–74, 31 U.S.C. 3801–3812.
IV. Effective and Applicability Dates
Administrative practice and
procedure, Penalties.
■
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
For reasons discussed in the
preamble, the Department of Health and
Human Services adopts the interim final
rule published September 6, 2016, at 81
and typographical errors. For these same
reasons HHS also finds good cause to
make the final rule effective upon
publication.
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.
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DATES
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PART 102—ADJUSTMENT OF CIVIL
MONETARY PENALTIES FOR
INFLATION
1. The authority citation for part 102
continues to read as follows:
■
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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TABLE 1 TO §102.3 -- CIVIL MONETARY PENALTY AUTHORITIES
ADMINISTERED BY HHS
CFR1
HHS
Agency
333(b)(2)(A)
FDA
333{b){2)(B)
FDA
333{b)(3)
FDA
FDA
333(n(1)(A)
FDA
FDA
333(n(2){A)
FDA
FDA
333(n(3)(A)
FDA
333(n(3)(B)
FDA
FDA
333(n(4)(A)(i)
FDA
FDA
333(n(4)(A)(ii)
FDA
FDA
FDA
333(n(9)(A)
FDA
FDA
333(n(9)(B)(i)(I)
FDA
FDA
333(n(9)(B)(i)(II)
FDA
FDA
FDA
333(n(9)(B)(ii)(I)
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FDA
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Description'
Penalty for violations related to drug samples resulting in a conviction of any
representative of manufacturer or distributor in any 10-vear period.
Penalty for violation related to drug samples resulting in a conviction of any representative
of manufacturer or distributor after the second conviction in anv 10-vear period.
Penalty for failure to make a repori 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.
Penaltv for aaareaate of all violations related to devices in a sinale Proceedina.
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 complv 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
deliverv 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(jj) 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 misleadina in anv particular under 42 U.S.C. 282(il(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) (postmarketing 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 aaareaate of all such above violations in a sinale proceedina.
Penalty for REMS violation that continues after written notice to the responsible person for
the first 30-day period (or any portion thereon 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 anv 30--0av 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 sinale proceedina.
Penalty per violation related to violations of tobacco requirements.
Penalty for aggregate of all such violations of tobacco product requirements adjudicated in
a sinale proceedina.
Penalty in the case of a violation of tobacco product requirements that continues after
written notice to such person, for the first 30--0ay period (or any portion thereon 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 sinale proceedina.
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 post-market surveillance of such tobacco
Products.
Penaltv for aaareaate of for all such above violations adiudicated in a sinale Proceedina.
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2021
Maximum
Adjusted
Penalty4
(in$)
2020
107,050
108,315
2020
2,184,670
2,210,493
2020
214,097
216,628
E:\FR\FM\15NOR1.SGM
15NOR1
2020
28,914
29,256
2020
1,927,676
1,950,461
2020
81,284
82,245
2020
406,419
411,223
2020
812,837
822,445
2020
12,316
12,462
2020
12,316
12,462
2020
307,923
311,563
2020
1,231,690
1,246,249
2020
307,923
311,563
2020
1,231,690
1,246,249
2020
12,316,908
2020
17,857
18,068
2020
1,190,433
1,204,504
2020
297,609
301,127
2020
1,190,433
1,204,504
2020
297,609
301,127
2020
1,190,433
1,204,504
2020
11,904,335
2020
297,609
301,127
2020
1,190,433
1,204,504
12,462,494
12,045,044
ER15NO21.001</GPH>
U.S.C. Section(s)
21 U.S.C.:
2020
Maximum
Adjusted
Penalty
(in$)
Date of Last
Penalty
Figure or
Adjustment•
Federal Register / Vol. 86, No. 217 / Monday, November 15, 2021 / Rules and Regulations
U.S.C. Sectionlsl
CFR1
HHS
Aoencv
FDA
333(D(9}(B}(ii}(II}
FDA
FDA
333(g}(1}
FDA
FDA
FDA
FDA
FDA
333 note
FDA
FDA
FDA
FDA
FDA
FDA
FDA
335b(a)
FDA
FDA
360pp(b}(1)
FDA
Description'
Penalty for violation ol 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 30day period.
Penalty for aggregate above tobacco product requirement violations adjudicated in a
sinole proceedino.
Penalty for any person who disseminates or causes another party to disseminate a directto-consumer advertisement that is false or misleading for the first such violation in any 3year period.
Penalty for each subsequent above violation in any 3-year 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 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. 387f(d)(5) or of the tobacco product
reoulations within a 24-month oeriod.
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 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 under21 U.S.C. 387/(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
reoulations within a 24-month oeriod.
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) per 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
oroducts.
khammond on DSKJM1Z7X2PROD with RULES
2020
297,609
301,127
2020
1,190,433
1,204,504
2020
11,904,335
2020
307,923
311,563
2020
615,846
623,125
2020
297
301
2020
594
601
2020
2,381
2,409
2020
5,952
6,022
2020
11,904
12,045
2020
297
301
2020
594
601
2020
1,191
1,205
2020
2,381
2,409
2020
5,952
6,022
2020
11,904
12,045
2020
453,711
459,074
2020
1,814,843
1,836,294
2020
2,976
3,011
2020
1,014,390
1,026,380
2020
233,313
236,071
2020
18,149
18,364
2020
233,313
236,071
2020
5,883
5,953
2020
15,299
15,480
2020
1,569
1,588
12,045,044
263b(hl(3)
FDA
300aa-28(b)(1)
FDA
256b(dl(1l<Bl(vil
HRSA
299c-(3}(d)
AHRQ
45 CFR 303.21 (f)
16:01 Nov 12, 2021
ACF
Jkt 256001
Penalty per day for violation of order of recall of biological product presenting imminent or
substantial hazard.
Penaltv for failure to obtain a mammoaraohv certificate as reauired.
Penalty per occurrence for any vaccine manufacturer that intentionally destroys, alters,
falsifies, or conceals anv record or reoort reauired.
Penaltv for each instance of overcharaina a 3408 covered entitv.
Penalty for an establishment or person supplying information obtained in the course of
activities for any purpose other than the purpose for which it was supplied.
Penalty for Misuse of Information in the National Directory of New Hires.
PO 00000
Frm 00039
Fmt 4700
Sfmt 4725
E:\FR\FM\15NOR1.SGM
15NOR1
ER15NO21.002</GPH>
FDA
VerDate Sep<11>2014
2021
Maximum
Adjusted
Penalty•
lin $1
2020
262(d)
653(1)(2)
2020
Maximum
Adjusted
Penalty
(in$}
Date of Last
Penalty
Figure or
Adiustment•
42 u.s.c.
62933
Federal Register / Vol. 86, No. 217 / Monday, November 15, 2021 / Rules and Regulations
U.S.C. Sectionfsl
CFR1
HHS
Aaencv
42 CFR 1003.910
OIG
262a(i)(1)
OIG
300ii-51
OIG
42 CFR
1003.210falf1l
OIG
OIG
1320a-7a(a)
42 CFR
1003.210(a)(2)
OIG
42 CFR
1003.210(a)(3)
OIG
42 CFR 1003.1010
OIG
42 CFR
1003.210(a)(4)
OIG
42 CFR
1003.310(a)(3)
OIG
42 CFR
1003210(8)(1)
OIG
42 CFR
1003.210(a)(6)
OIG
42 CFR
1003.210(a)(8)
42 CFR
1003.210(a)(7)
42 CFR
1003.210(a)(9)
OIG
OIG
OIG
OIG
1320a-7a(b)
OIG
42 CFR
1003.21O(a)(10)
OIG
OIG
OIG
OIG
1320a-7a(o)
OIG
OIG
khammond on DSKJM1Z7X2PROD with RULES
1320a-7e(b)(6)(A)
VerDate Sep<11>2014
42 CFR 1003.810
16:01 Nov 12, 2021
OIG
Jkt 256001
Descriotion2
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.
Penaltv oerviolation for committina information blockina.
Penalty for knowingly presenting or causing to be presented to an officer, employee, or
aaent 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 assianment, aareement, or PPS aareement.
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
discharqe decision.
Penalty for an excluded party retaining ownership or control interest in a participating
entitv.
Penalty for remuneration offered to induce program beneficiaries to use particular
oroviders, oractitioners, or suooliers.
Date of Last
Penalty
Figure or
Adiustment•
Penalty for employing or contracting with an excluded individual.
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
oaid for bv a Federal health care oroaram.
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.
Penalty for knowing of an overpayment and failing to report and return.
Penalty for making or using a false record or statement that is material to a false or
fraudulent claim.
Penalty for failure to grant timely access to HHS OIG for audits, investigations,
evaluations, and other statutorv 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.
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 Secretary provides
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 arant, contract, or other aareement.
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
agreement.
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 anv such obliaation.
Maximum for each false record statement
Maximum per day
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 agreements.
Penalty for failure to report any final adverse action taken against a health care provider,
supolier, or oractitioner
PO 00000
Frm 00040
Fmt 4700
Sfmt 4725
E:\FR\FM\15NOR1.SGM
15NOR1
2020
2020
Maximum
Adjusted
Penalty
tin $1
2021
Maximum
Adjusted
Penalty'
tin $1
354,859
359,053
2020
709,720
718,109
2020
1,082,016
1,094,805
2020
20,866
21,113
2020
20,866
21,113
2020
31,300
31,670
2020
20,866
21,113
2020
20,866
21,113
2020
20,866
21,113
2020
104,330
105,563
2020
20,866
21,113
2020
104,330
105,563
2020
20,866
21,113
2020
58,832
59,527
2020
31,300
31,670
2020
5,216
5,278
2020
5,216
5,278
2020
10,433
10,556
2020
10,176
10,296
2020
50,882
51,483
2020
50,882
51,483
53,231
10,646
53772
10,646
2020
15,265
15,445
2020
39,811
40,282
2020
ER15NO21.003</GPH>
62934
HHS
Aaencv
U.S.C. Sectionlsl
CFR1
1320b-10(b)(1)
42 CFR
1003.610(a)
OIG
1320b-10(b){2)
42 CFR
1003.610(a)
OIG
1395i-3(b)(3)(B)(ii)(1)
1395i-3(b)(3)(B)(ii)(2)
1395i-3(g)(2)(A)
42 CFR
1003.210(8)(11)
42 CFR
1003.21 0(a)(11)
OIG
OIG
42 CFR 1003.1310
OIG
OIG
OIG
OIG
OIG
OIG
OIG
1395w-27(g)(2)(A)
42 CFR 1003.410
OIG
OIG
OIG
OIG
OIG
OIG
OIG
1395w-141(i)(3)
OIG
1395cc(g)
OIG
1395dd{d){1)
42 CFR 1003.510
OIG
OIG
OIG
OIG
OIG
1395mm(i)(6)(B)(i)
42 CFR 1003.410
OIG
OIG
OIG
khammond on DSKJM1Z7X2PROD with RULES
OIG
VerDate Sep<11>2014
16:01 Nov 12, 2021
Jkt 256001
Descriotion 2
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
bvHHS
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 approved, 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 dale on which a survey is to be conducted
Penalty for a Medicare Advantage organization that substantially fails to provide medically
necessarv, reauired items and services
Penaltv for a Medicare Advantaae omanization that chames excessive premiums.
Penalty for a Medicare Advantage organization that improperly expels or refuses to
reenroll a beneficiarv.
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 denying or
discouraaina enrollment.
Penalty for a Medicare Advantage organization misrepresenting or falsifying information to
Secretary.
Penalty for a Medicare Advantage organization misrepresenting or falsifying information to
individual or other entity.
Penalty for Medicare Advantage organization interfering with provide(s advice to enrollee
and non-MCO affiliated providers that balance bill enrollees.
Penalty for a Medicare Advantage organization that employs or contracts with excluded
individual or entitv.
Penalty for a Medicare Advantage organization enrolling an individual in without prior
written consent.
Penalty for a Medicare Advantage organization transferring an enrollee to another plan
without consent or solely for the purpose of eamina a commission.
Penalty for a Medicare Advantage organization failing to comply with marketing
restrictions or applicable implementina reaulations or auidance.
Penalty for a Medicare Advantage organization employing or contracting with an individual
or entitv who violates 1395w-27(al(1l(Al-(Jl.
Penalty for a prescription drug card sponsor that falsifies or misrepresents marketing
materials, overcharges program enrollees, or misuse transitional assistance funds
Penalty for improper billing by Hospitals, Critical Access Hospitals, or Skilled Nursing
Facilities
Penalty for a hospital with 100 beds or more or responsible physician dumping patients
needina emeraencv medical care.
Penalty for a hospital with less than 100 beds dumping patients needing emergency
medical care.
Penalty for an HMO or competitive medical plan is such plan substantially fails to provide
medically necessary, required items or services
Penalty for HMOs/competitive medical plans that charge premiums in excess of permitted
amounts.
Penalty for an HMO or competitive medical plan that expels or refuses to reenroll an
individual Per Prescribed conditions.
Penalty for an 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 an HMO or competitive medical plan that misrepresents or falsifies information
to an individual or any other entitv.
Penalty for failure by HMO or competitive medical plan to assure prompt payment of
Medicare risk sharina contracts or incentive plan provisions.
PO 00000
Frm 00041
Fmt 4700
Sfmt 4725
E:\FR\FM\15NOR1.SGM
2020
2021
Maximum
Adjusted
Penalty
tin$!
Maximum
Adjusted
Penalty•
tin $1
2020
10,705
10,832
2020
53,524
54,157
2020
2,233
2,259
2020
11,160
11,292
2020
4,465
4,518
2020
40,640
41,120
2020
39,811
40,282
2020
39,811
40,282
2020
159,248
161,130
2020
23,887
24,169
2020
159,248
161,130
2020
39,811
40,282
2020
39,811
40,282
2020
39,811
40,282
2020
39,811
40,282
2020
39,811
40,282
2020
39,811
40,282
2020
39,811
40,282
2020
13,910
14,074
2020
5,411
5,475
2020
111,597
112,916
2020
55,800
56,460
2020
55,800
56,460
2020
55,800
56,460
2020
55,800
56,460
2020
223,196
225,834
2020
32,115
32,495
2020
223,196
225,834
2020
55,800
56,460
2020
55,800
56,460
Date of Last
Penalty
Figure or
Adiustment•
15NOR1
62935
ER15NO21.004</GPH>
Federal Register / Vol. 86, No. 217 / Monday, November 15, 2021 / Rules and Regulations
Federal Register / Vol. 86, No. 217 / Monday, November 15, 2021 / Rules and Regulations
U.S.C. Sectionlsl
CFR1
HHS
Aaencv
OIG
1395nn(g)(3)
42 CFR 1003.310
OIG
1395nn(g)(4)
42 CFR 1003.310
OIG
1395ss/d)/ 1)
1395ss/d)/2)
1395ss/d)/3)/A)/iil
42 CFR 1003.1110
42 CFR 1003.1110
42 CFR 1003.1110
1395ss(dl(4l(Al
42 CFR 1003.1110
OIG
OIG
OIG
OIG
OIG
OIG
OIG
OIG
1396b(m)(5)(B)(i)
42 CFR 1003.410
OIG
OIG
OIG
OIG
1396r(b)(3)(B)(ii)(I)
1396r(b)(3)(B)(ii)(II)
42 CFR
1003.21 0(al(11 l
42 CFR
1003.21 0(al(11 l
OIG
OIG
1396r(g)(2)(A)(i)
42 CFR 1003.1310
OIG
1396r-8(b)(3)(B)
42 CFR 1003.1210
OIG
1396r-8(b)(3)(C)(i)
42 CFR 1003.1210
OIG
1396r-8(b)(3)(C)(ii)
42 CFR 1003.1210
OIG
1396l(i)(3)(Al
11131(c)
42 CFR 1003.1310
42 CFR 1003.810
OIG
OIG
11137(b)(2)
42 CFR 1003.810
OIG
299b-22m(1)
42 CFR 3.404
OCR
45 CFR
160.404(b)(1)(i) and
OCR
(ii)
45 CFR
160.404(b)(2)(i)(A),
(B)
khammond on DSKJM1Z7X2PROD with RULES
1320(d)-5(a)
VerDate Sep<11>2014
OCR
45 CFR
160.404(b)(2)(ii)(A),
(B)
OCR
45 CFR
160.404(b)(2)(iii)(A),
(B)
OCR
16:01 Nov 12, 2021
Jkt 256001
Descriotion'
Penaltv for HMO that emplovs or contracts with excluded individual or entitv.
Penalty for submitting or causing to be submitted claims in violation of the Stark Law's
restrictions on Phvsician self-referrals
Penalty for circumvention schemes in violation of the Stark Law's restrictions on physician
self-refenrals
Penaltv for a material misrePresentation reaardina MediaaP comPliance Policies
Penaltv for sellina Mediaap policv under false pretense
Penaltv for an issuer that sells health insurance policv that duplicates benefits
Penaltv for someone other than issuer that sells health insurance that duplicates benefits.
Penaltv for usina mail to sell a non-approved Mediaap insurance policy
Penalty for a Medicaid MCO that substantially fails to provide medically necessary,
reauired items or seivices
Penaltv for a Medicaid MCO that chames excessive premiums.
Penaltv 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 denvina or discouraaina enrollment.
Penaltv for a Medicaid MCO misrepresentina or lalsilvina inlonnation to the Secretary.
Penalty for a Medicaid MCO misrepresenting or falsifying infonnation to an individual or
another entitv.
Penalty for a Medicaid MCO that fails to comply with contract requirements with respect to
Phvsician incentive Plans.
Penalty for willfully and knowingly certifying a material and false statement in a Skilled
Nursina Facilitv resident assessment
Penalty for willfully and knowingly causing another individual to certify a material and false
statement in a Skilled Nursina Facilitv resident assessment
Penalty for notifying or causing to be notified a Skilled Nursing Facility of the time or date
on which a suivev 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 drug
Penalty per day for failure to timely provide infonnation by drug manufacturer with rebate
aareement
Penalty for knowing provision of false inlonnation by drug manufacturer with rebate
aareement
Penaltv for notilvina home and communitv-based providers or settinas of suivev
Penaltv for failina to report a medical malpractice claim to National Practitioner Data Bank
Penalty for breaching confidentiality of infonnation reported to National Practitioner Data
Bank
Penalty for violation of confidentiality provision of the Patient Safety and Quality
Improvement Act
Penalty for each pre-February 18, 2009 violation of the HIPAA administrative simplification
provisions
Calendar Year Cap
Penalty for each February 18, 2009 or later violation of a HIPAA administrative
simplification provision in which ii is established that the covered entity or business
associate did not know and by exercising reasonable diligence, would not have known that
the covered entity or business associate violated such a provision:
Minimum
Maximum
Calendar Year Cap
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 reasonable
cause and not to willful nealect:
Minimum
Maximum
Calendar Year Cap
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:
Minimum
Maximum
PO 00000
Frm 00042
Fmt 4700
Sfmt 4725
E:\FR\FM\15NOR1.SGM
2020
2021
Maximum
Adjusted
Penalty
fin$}
51,222
Maximum
Adjusted
Penalty4
fin $1
51,827
2020
25,820
26,125
2020
172,137
174,172
2020
2020
2020
2020
2020
10,705
10,705
48,192
28,914
10,705
10,832
10,832
48,762
29,256
10,832
2020
53,524
54,157
2020
2020
53,524
214,097
54,157
216,628
Date of Last
Penalty
Figure or
Adiustment•
2020
15NOR1
2020
32,115
32,495
2020
214,097
216,628
2020
53,524
54,157
2020
48,192
48,762
2020
2,233
2,259
2020
11,160
11,292
2020
4,465
4,518
2020
192,768
195,047
2020
19,277
19,505
2020
192,768
195,047
2020
2020
3,855
23,331
3,901
23,607
2020
23,331
23,607
2020
12,919
13,072
2020
162
64
2020
40,640
41,120
119
59,522
1,785,651
120
60,226
1,806,757
1,191
59,522
1,785,651
1,205
60,226
1,806,757
11,904
59,522
12,045
60,226
2020
2020
2020
2020
2020
2020
2020
2020
2020
2020
2020
ER15NO21.005</GPH>
62936
Federal Register / Vol. 86, No. 217 / Monday, November 15, 2021 / Rules and Regulations
HHS
Aaencv
CFR1
45 CFR
160.404(b)(2)(iv)(A),
(B)
OCR
42 U.S.C. 300gg-18,
42 u.s.c. 1302
45 CFR 180.90
CMS
CARES Act, Pub. L.
116-136, section
3202(b)(2)
(See 85 FR 71142
November 6, 2020)
42 CFR
493.1834(d)(2)(i).
263a(h)(2)(B) &
1395w-2(b)(2)(A)(ii)
300aa-15(f)
300aa-18
1320a-7h(b)(1)
CMS
CMS
42 CFR
493.1834(d)(2)(ii).
CMS
42 CFR
493.1834(d)(2)(iii)
CMS
45 CFR 147.200(e)
45 CFR 158.606
CMS
CMS
45 CFR 180.90
CMS
42 CFR
402.105(d)(5) and
403.912(a) and (c)
CMS
42 CFR402.105(h)
and 403.912(b) and
/cl
CMS
1320a-7h(b)(2)
CMS
42 CFR
488.446(8)(1), (2), &
(3)
khammond on DSKJM1Z7X2PROD with RULES
VerDate Sep<11>2014
16:01 Nov 12, 2021
Penalty for a provider's non-compliance with price transparency requirements regarding
diagnostic tests for COVID-19
2020
CMS
PO 00000
Frm 00043
Fmt 4700
Sfmt 4725
E:\FR\FM\15NOR1.SGM
15NOR1
60,226
1,806,757
1,806,757
300
304
6,530
21,410
6,607
21,663
108
6,422
N/A
N/A
N/A
1,176
118
109
6,498
2020
2020
Minimum penalty for the second offense of an administrator who fails to provide notice of
facilitv 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 Worfd War II veterans, or
supplemental security income for the aged, 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.
59,522
1,785,651
1,785,651
2020
Maximum penalty per day
Minimum penalty for the first offense of an administrator who fails to provide notice of
facility closure.
Jkt 256001
2020
2020
2020
2020
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:
Minimum
Maximum
Calendar Year Cap
Penalty for manufacturer or group purchasing organization knowingly failing to report
information required under42 U.S.C. 1320a-7h(a), relating to physician ownership or
investment interests:
Minimum
Maximum
Calendar Year Cap
Penalty for an administrator of a facility that fails to comply with notice requirements for the
closure of a facilitv.
2021
Maximum
Adjusted
Penalty4
lin $1
1,806,757
2020
Per Day (Maximum)
Penalty for a clinical laboratory's failure to meet participation and certification requirements
and poses immediate ieopardv:
Minimum
Maximum
Penalty for a clinical laboratory's failure to meet participation and certification requirements
and the failure does not pose immediate ieopardv:
Minimum
Maximum
Penalty for a clinical laboratory's failure to meet SARS-CoV-2 test reporting requirements:
First dav of noncomoliance.
Each additional dav of noncompliance.
Failure to provide the Summarv of Benefits and Coveraoe.
Penaltv for violations of reoulations related to the medical loss ratio reportino and rebatino
Price against hospital identified by CMS as noncompliant according to 45 CFR 182.50 with
respect to Price transparencv reauirements reaardina diaanostic tests for COVID-19.
CMS
1320a-7j(h)(3)(A)
1320a-8(a)(1)
Descriation'
Calendar Year Cap
Penalty for each February 18, 2009 or later violation of a HIPAA administrative
simplification provision in which ii is established that the violation was due to willful neglect
and was not corrected during the 30-day period beginning on the first date the covered
entity or business associate knew, or by exercising reasonable diligence, would have
known that the violation occurred:
Minimum
Maximum
Calendar Year Cap
Penalty for a hospital's non-compliance with making public standard charges for hospital
items and services
Per Dav !Maximum}
2020
Maximum
Adjusted
Penalty
lin$l
1,785,651
2020
2020
2020
2020
2020
2020
2020
2020
2020
2020
2020
1,190
119
2020
Effective
2021
2020
1,176
11,766
176,495
1,190
11,905
178,581
2020
2020
2020
11,766
117,664
1,176,638
11,905
119,055
1,190,546
2020
117,664
119,055
2020
588
595
2020
1,766
1,787
2020
3,529
3,571
2020
8,606
8,708
2020
8,116
8,212
2020
2020
2020
2020
ER15NO21.006</GPH>
U.S.C. Sectionlsl
Date of Last
Penalty
Figure or
Adiustment•
2020
62937
Federal Register / Vol. 86, No. 217 / Monday, November 15, 2021 / Rules and Regulations
U.S.C. Sectionlsl
HHS
Aaencv
CFR1
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)
42 CFR402.105(g)
CMS
1395i-3(h)(2)(B)(ii)(I)
42 CFR
488.408/ dl/ 1)(iii\
CMS
42 CFR
488.408(d)(1)(iv)
42 CFR
488.408/ el/ 1)(iii\
42 CFR
488.408(e)(1)(iv)
1395I(h)(5)(D)
khammond on DSKJM1Z7X2PROD with RULES
1395I(q)(2)(B)(i)
VerDate Sep<11>2014
6,740
6,820
2020
235,328
238,110
2020
352,991
357,163
2020
235,328
238,110
2020
159
161
112
6,695
113
6,774
2,233
22,320
2,259
22,584
6,808
22,320
6,888
22,584
2,233
22,320
2,259
22,584
6,808
22,320
2,233
22,320
6,888
22,584
2,259
22,584
6,808
22,320
6,888
22,584
112
6,695
113
6,774
2,233
22,320
2,259
22,584
2020
2020
1,000
500
1,012
506
2020
16,257
16,449
2020
4,282
4,333
2020
4,098
4,146
2020
2020
2020
2020
2020
2020
CMS
Minimum
Maximum
Penalty per day for a Skilled Nursing Facility that has a Category 3 violation of certification
reauirements:
Minimum
Maximum
Penalty per instance of Category 3 noncompliance by a Skilled Nursing Facility:
2020
Minimum
Maximum
Penalty per day and per instance for a Skilled Nursing Facility that has Category 3
noncomcliance with Immediate Jeocardv:
Per Dav (Minimum)
Per Dav /Maximum)
Per Instance /Minimum)
Per Instance /Maximum)
Penalty per day of a Skilled Nursing Facility that fails to meet certification requirements.
These amounts recresent the uccer ranae cer dav:
Minimum
Maximum
Penalty per day of a Skilled Nursing Facility that fails to meet certification requirements.
These amounts recresent the lower ranae cer dav:
Minimum
Maximum
Penalty per instance of a Skilled Nursing Facility that fails to meet certification
reauirements:
Minimum
Maximum
Penalty imposed for failure to comply with infection control weekly reporting requirements
at42 CFR483.80lnl/1) and (2).
First occurrence
Incremental increases for each subseauent occurrence.
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. 1395u0)(2)(B), which is assessed according to 42 U.S.C. 320a7a/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 cavment 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 seekina cavment on an unassianed basis.
2020
2020
CMS
42 CFR
488.438(a)(1)(i)
CMS
42 CFR
488.438(a)(1)(ii)
CMS
42 CFR
488.438(a)(2)
CMS
42 CFR 488.447
CMS
42 CFR
402.105(d)(2)(i)
CMS
CMS
16:01 Nov 12, 2021
2020
Penalty per instance of Category 2 noncompliance by a Skilled Nursing Facility:
42 CFR
488.408(e)(2)(ii)
42 CFR402.105(a)
2021
Maximum
Adjusted
Penalty•
lin $1
CMS
CMS
1395I(i)(6)
Descriotion 2
Penalty for a representative payee (under 42 U.S.C. 405U), 1007, or 1383(a)(2))
converting any part of a received payment from the benefit programs described in the
crevious civil monetarv cenaltv 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
receivinq care, from a lonq-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 employee 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 davs of the beneficiarv's reauest.
Penalty per day for a Skilled Nursing Facility that has a Category 2 violation of certification
reauirements:
Minimum
Maximum
2020
Maximum
Adjusted
Penalty
lin$1
Date of Last
Penalty
Figure or
Adiustment•
CMS
Jkt 256001
PO 00000
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E:\FR\FM\15NOR1.SGM
15NOR1
2020
2020
2020
2020
2020
2020
2020
2020
2020
2020
2020
2020
2020
2020
2020
2020
2020
2020
ER15NO21.007</GPH>
62938
HHS
Agency
U.S.C. Section(sl
CFR1
1395m(a)(11 )(A)
42 CFR402.1(c)(4)
and
402.105(d)(2)(ii)
CMS
1395m(a)(18)(8)
42 CFR402.1(c)(5)
and
402.105(d){2)(iii)
CMS
1395m(b)(5)(C)
42 CFR402.1(c)(6)
and
402.105(d)(2)(iv)
CMS
1395m{h){3)
42 CFR402.1(c)(8)
and
402 .105(d)(2)(vi)
CMS
khammond on DSKJM1Z7X2PROD with RULES
1395m(j)(2){A)(iii)
CMS
1395m(j)(4)
42 CFR
402.1 (c)(10) and
402.105(d)(2)(vii)
CMS
1395m-1(a)
42 CFR 414.504(e)
CMS
42 CFR
402.1(c)(31) and
402.105{d)(3)
CMS
1395m(l)(6)
42 CFR
402.1 (c)(32) and
402.105{d)(4)
CMS
1395u(b)(18)(8)
42 CFR
402.1(c)(11) and
402.105{d)(2)(viii)
CMS
1395u(j)(2)(8)
42 CFR402.1(c)
CMS
1395u(k)
42 CFR
402.1(c)(12),
402.105(d)(2)(ix),
section 1834A(a)(9)
of the Act, and 42
CFR 414.504(e)
1395u(l)(3)
42 CFR
402.1 (c)(13) and
402.105(d)(2)(x)
CMS
1395u(m)(3)
42 CFR
402.1 (c)(14) and
402.105(d)(2)(xi)
CMS
VerDate Sep<11>2014
16:01 Nov 12, 2021
CMS
Jkt 256001
Description'
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. 1395u(j)(2)(8),
which is assessed according to 42 U.S.C. 1320a-7a(a).)
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. (Penalties
are assessed in the same manner as 42 U.S.C. 1395u(j)(2)(8), which is assessed
accordina to 42 U.S.C. 320a-7a/al.l
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. 1395u(j)(2)(B), which is assessed
accordina to 1320a-7a/all
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 42 U.S.C.
395u/il(2)/Bl, which is assessed according to 42 U.S.C. 1320a-7a(a).l
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 1834(j)(2)(A)(i) of the Act or fails to
provide the information reauired under section 1834/il/2)/A)/ii) of the Act.
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 assignmentrelated basis under certain conditions. (Penalties are assessed in the same manner as 42
U.S.C. 1395m(j)(4) and 1395u(j)(2)(8), which is assessed according to 42 U.S.C. 1320a7a(a).)
Penalty for an applicable entity that has failed to report or made a misrepresentation or
omission in reporting applicable information with respect to a clinical diagnostic laboratory
test.
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 1395u(j)(2)(8), which is assessed according to 42 U.S.C. 1320a7a(al.l
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 1320a7a(a).l
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 assignment-related basis. (Penalties are assessed in the same manner as 42
U.S.C. 1395u/il(2l(Bl, which is assessed according to 42 U.S.C. 1320a-7a(al.l
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. 1320a-7atal.l
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(1)(1 )(A). (Penalties are assessed in the same manner as 42
U.S.C. 1395u(il(2l(Bl, which is assessed according to 42 U.S.C. 1320a-7a(a.l)
Penalty for any nonparticipating physician charging more than $500 who does not accept
payment for an elective surgical procedure on an assignment related basis and who
knowingly and willfully fails to disclose the required information regarding charges and
coinsurance amounts and fails to refund on a timely basis any amount collected for the
procedure in excess of the charges recognized and approved by the Medicare program.
(Penalties are assessed in the same manner as 42 U.S.C. 1395u(j)(2)(8), which is
assessed accordina to 42 U.S.C. 1320a-7a(al.l
PO 00000
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E:\FR\FM\15NOR1.SGM
2020
2021
Maximum
Adjusted
Penalty
(in$)
Maximum
Adjusted
Penalty4
(in$)
2020
16,257
16,449
2020
16,257
16,449
2020
16,257
16,449
2020
16,257
16,449
2020
1,722
1,742
2020
16,257
16,449
2020
10,839
10,967
2020
16,257
16,449
2020
16,257
16,449
2020
16,257
16,449
2020
16,257
16,449
2020
16,257
16,449
2020
16,257
16,449
2020
16,257
16,449
Date of Last
Penalty
Figure or
Adjustment•
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) of the Act. (Penalties
are assessed in the same manner as 42 U.S.C. 1395u(j)(2)(8), which is assessed
according to 42 U.S.C. 1320a-7a(a).)
15NOR1
62939
ER15NO21.008</GPH>
Federal Register / Vol. 86, No. 217 / Monday, November 15, 2021 / Rules and Regulations
Federal Register / Vol. 86, No. 217 / Monday, November 15, 2021 / Rules and Regulations
HHS
Aaencv
U.S.C. Sectionlsl
CFR1
1395u(n)(3)
42 CFR
402.1 (c)(15) and
402.105(d)(2)(xii)
CMS
1395u(o)(3)(8)
42 CFR 414.707(b)
CMS
1395u(p)(3)(A)
CMS
1395w-3a(d)(4)(A)
42 CFR 414.806
CMS
1395w-4(g)(1)(B)
42 CFR
402.1 (c)(17) and
402.105(d}(2)(xiii)
CMS
1395w-4(g)(3)(B)
42 CFR
402.1 (c)(18) and
402.105{d}(2)(xiv)
CMS
1395w-27(g)(3)(A);
1857(g)(3); 1860D12(b}(3)(E)
42 CFR 422.760(b}
and 423.760(b)
CMS
1395w-27(g)(3)(B);
1857(g)(3); 1860D12/bl/3)/El
1395w-27(g)(3)(D);
1857(g)(3): 1860D12(bl(3)(E)
1395y(b)(3)(C)
CMS
42 CFR411.103(b)
1395y(b}(5)(C)(ii)
1395y(b)(6)(B)
42 CFR
402.1 (c)(20) and
402105/bl/2)
42 CFR
402.1(c)(21) and
402.105(a)
CMS
CMS
CMS
1395y(b)(7)(B)(i)
CMS
1395y(b}(8)(E)
CMS
1395nn(g)(5)
42CFR411.361
CMS
1395pp{h}
42 CFR
402.1 (c)(23) and
402.105(d}{2)(xv)
CMS
1395ss(a)(2)
1395ss(d}(3)(A)(vi)
(II)
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CMS
VerDate Sep<11>2014
42 CFR
402.1 (c)(24) and
405.105(1)(1 l
42 CFR
402.1 (c)(25) and
402.105(e) and
(1)(2)
16:01 Nov 12, 2021
CMS
Descriation'
Penalty for any physician who knowingly, willlully, and repeatedly bills one or more
beneficiaries for purchased diagnostic tests any amount other than the payment amount
specified by the Act. (Penalties are assessed in the same manner as 42 U.S.C.
1395u/il/2l/Bl, which is assessed accordina to 1320a-7a/all
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)(8) and 1395uQ)(2)(8), which is assessed
accordina to 42 U.S.C. 1320a-7a/a).)
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.
Penalty for a pharmaceutical manufacturers misrepresentation of average sales price of a
drua, or bioloaic.
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 statutorily-defined limiting charge or fails to make a timely
refund or adjustment. (Penalties are assessed in the same manner as 42 U.S.C.
1395u/il/2l/Bl, which is assessed accordina to 42 U.S.C. 1320a-7a/al.l
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. 1395u/il/2)/B), which is assessed accordina to 42 U.S.C. 1320a-7a/a).)
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 oraanization's contract.
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
carrv out a contract, or has carried out a contract inconsistently with reaulations.
2020
2021
Maximum
Adjusted
Penalty
lin$l
Maximum
Adjusted
Penalty4
lin $1
2020
16,257
16,449
2020
16,257
16,449
2020
4,282
4,333
2020
13,910
14,074
2020
16,257
16,449
2020
16,257
16,449
2020
39,811
40,282
2020
15,925
16,113
2020
147,889
149,637
2020
9,639
9,753
2020
1,569
1,588
2020
3,443
3,484
2020
1,232
1,247
2020
1,232
1,247
2020
20,489
20,731
2020
16,257
16,449
2020
55,799
56,459
Date of Last
Penalty
Figure or
Adiustment•
Penalty for a Medicare Advantage organization's or Part D sponsors early termination of
its contract.
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
clan which would be a crimarv clan.
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
emclovee's arouc health insurance coveraae.
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.
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
clan is or was a crimarv clan to Medicare to the HHS Secretarv.
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
cursue anv acclicable recoverv claim.
Penalty for any person that fails to report information required by HHS under section
1877/f) of the Act concemina ownershic, investment, and comcensation arranaements.
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 42
U.S.C.1395u(il(2l and 1320a-7a(all.
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.
CMS
Penalty for someone other than issuer that sells or issues a Medicare supplemental policy
to beneficiary without a disclosure statement.
2020
28,914
29,256
CMS
Penalty for an issuer that sells or issues a Medicare supplemental policy without
disclosure statement.
2020
48,192
48,762
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15NOR1
ER15NO21.009</GPH>
62940
Federal Register / Vol. 86, No. 217 / Monday, November 15, 2021 / Rules and Regulations
HHS
Aaencv
CFR1
1395ss(d)(3)(B)(iv)
CMS
CMS
42 CFR
402.1(c)(25) and
402.105/el
42 CFR
402.1(c)(25) and
402.105/fl/2)
42 CFR
402.1 (c)(26),
402.105(e),
402.105/fl/3), /4)
1395ss(p)(8)
1395ss(p)(9)(C)
CMS
CMS
CMS
42 CFR
402.1 (c)(26),
402.105(1)(3), (4)
CMS
42 CFR
402.1(c)(27) and
402.105/fl/5)
42 CFR
402.1(c)(28) and
402.105(1)(6)
1395ss(q)(5)(C)
CMS
2021
Maximum
Adjusted
Penalty•
(in$)
2020
28,914
29,256
2020
48,192
48,762
2020
28,914
29,256
Penalty for an issuer that sells or issues Medicare supplemental polices after a given dale
that fail to conform to the NAIC or Federal standards established by statute.
2020
48,192
48,762
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
sellina the policv, an outline of coveraae describina benefits.
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 coveraae describina benefits.
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
eliaibilitv for medical assistance, under certain circumstances.
2020
28,914
29,256
2020
48,192
48,762
2020
48,192
48,762
CMS
Penalty for any person that fails to provide refunds or credits as required by section
1882(r)(1 )(B) of the Act.
2020
48,192
48,762
1395ss(s)(4)
42 CFR
402.1(c)(29) and
402.105(c)
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 pricina of the policv base on health status or other specified criteria.
2020
20,459
20,701
1395ss(t)(2)
42 CFR
402.1(c)(30) and
402.105(1)(7)
CMS
Penalty for any issuer of a Medicare supplemental policy that fails to fulfill listed
responsibilities.
2020
48,192
48,762
2020
20,865
21,112
2020
34,777
35,188
2020
4,465
4,518
21,410
21,663
1395ss(r)(6)(A)
1395ss(v)(4)(A)
CMS
CMS
1395bbb(c)(1)
42 CFR 488.725(c)
1395bbb(f)(2)(A)(i)
42 CFR
488.845(b)(2)(iii),
(b)(3) - (6), and
(dl(1l(iil
42 CFR
488.845(b){3)
42 CFR
488.845(b)(3)(i)
42 CFR
488.845/bl/3)(ii)
42 CFR
488.845(b)(3)(iiil
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Description'
Penalty for someone other than issuer that sells or issues a Medicare supplemental policy
without acknowledaement form.
Penalty for issuer that sells or issues a Medicare supplemental policy without an
acknowledgement form.
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.
2020
Maximum
Adjusted
Penalty
(in$)
Date of last
Penalty
Figure or
Adiustment3
VerDate Sep<11>2014
CMS
CMS
Maximum daily penalty amount for each day a home health agency is not in compliance
with statutory requirements
2020
CMS
Penalty per day for home health agency's noncompliance (Upper Range):
2020
2020
2020
18,198
21,410
18,413
21,663
CMS
Minimum
Maximum
Penalty for a home health agency's deficiency or deficiencies that cause immediate
ieopardv and result in actual harm
Penalty for a home health agency's deficiency or deficiencies that cause immediate
ieopardv and result in polential for harm
2020
21,410
21,663
2020
19,268
19,496
Penalty for an isolated incident of noncompliance in violation of established HHA policy
2020
18,198
18,413
3,213
18,198
3,251
18,413
1,071
2,141
1,084
2,166
CMS
CMS
42 CFR
488.845(b)(4)
CMS
42 CFR
488.845(b)(5)
CMS
42 CFR
488.845(b)(6)
CMS
16:01 Nov 12, 2021
Penalty someone other than issuer who sells, issues, or renews a Medigap Rx policy to an
individual who is a Part D enrollee.
Penalty for an issuer who sells, issues, or renews a Medigap Rx policy who is a Part D
enrollee.
Penalty for any individual who notifies or causes to be notified a home health agency of
the time or dale on which a survey of such agency is to be conducted
Jkt 256001
Penalty for a repeat and/or condition-level deficiency that does not constitute immediate
ieopardv, but is directlv related to poor aualilv patient care outcomes (Lower Ranae):
Minimum
Maximum
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 Ranae):
Minimum
Maximum
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
noncomplianoe was corrected durina the onsite survev:
PO 00000
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2020
2020
2020
2020
2020
2020
2020
ER15NO21.010</GPH>
U.S.C. Section(sl
62941
Federal Register / Vol. 86, No. 217 / Monday, November 15, 2021 / Rules and Regulations
U.S.C. Section(s)
CFR1
42 CFR
488.845(d)(1)(ii)
1395eee(e)(6)(B);
1396u-4(e)(6)(B)
42 CFR 460.46
HHS
Agency
CMS
CMS
CMS
CMS
CMS
CMS
42 CFR
488.408(d)(1 )(iii)
CMS
42 CFR
488.408(d)(1)(iv)
CMS
42 CFR
488.408( e)( 1)(iii)
CMS
42 CFR
488.408(e)(1)(iv)
CMS
42 CFR
488.408(e)(2)(ii)
CMS
42 CFR
488.438(a)(1)(i)
CMS
42 CFR
488.438(a)(1)(ii)
CMS
42 CFR
488.438(a)(2)
CMS
42 CFR 488.447
CMS
1396rm(2)(B)(iii)(l)(c)
42 CFR
483.151 (b)(2)(iv)
and (b)(3)(iiil
CMS
1396r(h)(3)(C)(ii)(I)
42 CFR
483.151(c)(2)
CMS
1396r(h)(3)(C)(ii)(I)
1396tG)(2)(C)
CMS
CMS
1396u-2(e)(2)(A)(i)
42 CFR 438. 704
CMS
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CMS
VerDate Sep<11>2014
16:01 Nov 12, 2021
Jkt 256001
2020
2021
Maximum
Adjusted
Penalty
(in$)
2,141
21,410
21,410
Maximum
Adjusted
Penalty•
(in$)
2,166
21,663
21,663
Description'
Minimum
Maximum
Penaltv for each dav of noncomoliance /Maximum).
Date of Last
Penalty
Figure or
Adjustment•
2020
2020
2020
Penalty for each day of noncompliance (Maximum)
2020
21,410
21,663
2020
39,811
40,282
2020
2020
2020
15,000
100,000
39,811
15,177
101,182
40,282
2020
159,248
161,130
2020
2020
2020
2020
2020
2020
2020
2020
2020
2020
2020
2020
2020
39,811
40,282
112
6,695
113
6,774
2,233
22,320
2,259
22,584
6,808
22,320
6,888
22,584
2,233
22,320
2,259
22,584
2,233
22,320
2,259
22,584
6,808
22,320
6,888
22,584
112
6,695
113
6,774
2,233
22,320
2,259
22,584
2020
2020
1,000
500
1,012
506
2020
11,160
11,292
2020
11,160
11,292
2020
2020
2
19,277
2
19,505
2020
39,811
40,282
2020
39,811
40,282
2020
39,811
40,282
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 discouraaina enrollment, on the basis of health status or the need for services:
For each individual not enrolled as a result of the PACE organization's discrimination in
enrollment or disenrollment or oractice that would denv or discouraae enrollment.
Minimum
Maximum
Penaltv for a PACE oraanization that charaes excessive oremiums.
Penalty for a PACE organization misrepresenting or falsifying information to CMS or the
State.
Penaltv for anv other violation soecified in 42 CFR 460.40.
Penaltv per dav for a nursina facilitv's failure to meet a Cateaorv 2 Certification:
Minimum
Maximum
Penalty per instance for a nursing facility's failure to meet Category 2 certification:
Minimum
Maximum
Penaltv per dav for a nursina facilitv's failure to meet Cateaorv 3 certification:
Minimum
Maximum
Penaltv per instance for a nursing facility's failure to meet Category 3 certification:
Minimum
Maximum
Penalty per instance for a nursing facility's failure to meet Category 3 certification, which
results in immediate jeopardy:
Minimum
Maximum
Penaltv oer dav for nursina facilitv's failure to meet certification /Uooer Ranae):
Minimum
Maximum
Penaltv per dav for nursina facilitv's failure to meet certification (Lower Ranae):
Minimum
Maximum
Penalty per instance for nursing facility's failure to meet certification:
Minimum
Maximum
Penalty imposed for failure to comply with infection control weekly reporting requirements
at42 CFR483.80/al/1) and (2)
First occurrence /Minimuml
Incremental increases for each subseauent occurrence
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 "notless than $5,000" [Not CMP authority, but a
specific CMP amount (CMP at this level) that is the triaaerinq condition for disapproval]
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
traininq proaraml
Penalty for each day of noncompliance for a home or community care provider that no
lonaer meets the minimum reauirements for home and communitv care:
Minimum
Maximum
Penalty for a Medicaid managed care organization that fails substantially to provide
medicallv necessarv items and services
Penalty for Medicaid managed care organization that imposes premiums or charges on
enrollees in excess of the premiums or charaes permitted.
Penalty for a Medicaid managed care organization that misrepresents or falsifies
information to another individual or entitv.
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2020
2020
2020
2020
2020
2020
2020
2020
2020
2020
2020
2020
2020
2020
2020
ER15NO21.011</GPH>
62942
Federal Register / Vol. 86, No. 217 / Monday, November 15, 2021 / Rules and Regulations
U.S.C. Section(sl
HHS
Agency
CFR1
CMS
CMS
1396u-2(e)(2)(A)(ii)
42 CFR 438. 704
CMS
1396u-2(e)(2)(A)(iv)
1396u(h)(2)
42 CFR 438. 704
CMS
CMS
42 CFR part 441,
Subpart I
1396w-2(c)(1)
CMS
18041(c)(2)
45 CFR 156.805(c)
CMS
18081 (h)(1)(A)(i)(II)
18081(h)(1)(8)
45 CFR 155.285
45 CFR 155.285
18081(h)(2)
45 CFR 155.260
CMS
CMS
CMS
CMS
CMS
18041(c)(2)
45 CFR 155.206(i)
CMS
Description'
Penalty for a Medicaid managed care organization that fails to comply with the applicable
statutory requirements for such orqanizations.
Penalty for a Medicaid managed care organization that misrepresents or falsifies
information to the HHS Secretary
Penalty for Medicaid managed care organization that acts to discriminate among enrollees
on the basis of their health status.
Penalty for each individual that does not enroll as a result of a Medicaid managed care
orqanization that acts to discriminate amonq 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 supported living
arranaements services
Penalty for disclosing information related to eligibility determinations for medical
assistance proqrams
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.
Penaltv for providino false information on Exchanoe application
Penalty for knowinqly or willfully providinq false information on Exchanqe application
Penalty for knowinqly or willfully disclosinq protected information from Exchanqe
Minimum
Maximum
Penalties for violation of applicable Exchange standards by consumer assistance entities
in Federally-facilitated Exchanqes
Maximum (Per Day)
2020
2021
Maximum
Adjusted
Penalty
(in$)
Maximum
Adjusted
Penalty4
(in$)
2020
39,811
40,282
2020
159,248
161,130
2020
159,248
161,130
2020
23,887
24,169
2020
22,320
22,584
2020
11,904
12,045
2020
162
164
2020
2020
2020
2020
2020
29,416
294,159
29,764
297,636
29,416
300
29,764
304
100
300
101
304
20,489
20,731
20,489
204,892
20,731
207,314
20,489
20,731
20,489
204,892
20,731
207,314
20,489
204,892
20,731
207,314
20,489
204,892
20,731
207,314
10,706
10,833
10,706
10,833
Date of Last
Penalty
Figure or
Adjustment•
31 U.S.C.
62943
2020
2020
2020
Penalty for the first time an individual makes an expenditure prohibited by regulations
2020
reqardinq lobbyinq disclosure, absent aqqravatinq circumstances
Penalty for second and subsequent offenses by individuals who make an expenditure
2020
HHS
prohibited by reoulations reoardino lobbyino disclosure:
Minimum
2020
Maximum
2020
45 CFR 93.400(e)
Penalty for the first time an individual fails to file or amend a lobbying disclosure form,
2020
absent aaoravatina circumstances
Penalty for second and subsequent offenses by individuals who fail to file or amend a
2020
HHS
lobbvina disclosure form, absent aqqravatina circumstances:
1352
Minimum
2020
Maximum
2020
Penalty for failure to provide certification regarding lobbying in the award documents for all
HHS
2020
sub-awards of all tiers:
Minimum
2020
Maximum
2020
45 CFR part 93,
Appendix A
Penalty for failure to provide statement regarding lobbying for loan guarantee and loan
HHS
2020
insurance transactions:
Minimum
2020
Maximum
2020
Penalty against any individual who-with knowledge or reason to know-makes, presents
45 CFR
3801-3812
HHS
2020
79.3(a)(1)(iv)
or submits a false, fictitious or fraudulent claim to the Department
Penalty against any individual who-with knowledge or reason to know-makes, presents
45 CFR
HHS
2020
79.3(b)(1)fii)
or submits a false, fictitious or fraudulent claim to the Deoartment
''
"
1 Some HHS components have not promulgated regulations regarding their c1v1I
monetary penalty-spec1f1c statutory authont1es.
2 The description is not intended to be a comprehensive explanation of the underlying violation; the statute and corresponding regulation, if applicable, should
consulted.
3 Statutory or Inflation Act Adjustment.
4 The cost of living multiplier for 2021, based on the Consumer Price Index for all Urban Consumers (CPI-U) for the month of October 2020, not seasonally
adjusted, is 1.01182, as indicated in 0MB Memorandum M-21-10, "Implementation of Penalty Inflation Adjustments for 2021, Pursuant to the Federal Civil
Penalties Adjustment Act Improvements Act of 2015" (December 23, 2020).
be
Dated: November 8, 2021.
Xavier Becerra,
Secretary, Department of Health and Human
Services.
[FR Doc. 2021–24672 Filed 11–12–21; 8:45 am]
VerDate Sep<11>2014
16:01 Nov 12, 2021
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BILLING CODE 4150–24–C
]]>Agencies
[Federal Register Volume 86, Number 217 (Monday, November 15, 2021)]
[Rules and Regulations]
[Pages 62928-62943]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-24672]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
42 CFR Part 3
Centers for Medicare & Medicaid Services
42 CFR Parts 402, 403, 411, 412, 422, 423, 460, 483, 488, and 493
Office of the Inspector General
42 CFR Part 1003
Office of the Secretary
45 CFR Parts 79, 93, 102, 147, 150, 155, 156, 158, and 160
Administration for Children and Families
45 CFR Part 303
RIN 0991-AC0
Adjustment of Civil Monetary Penalties for Inflation and the
Annual Civil Monetary Penalties Inflation Adjustment for 2021
AGENCY: Office of the Assistant Secretary for Financial Resources,
Department of Health and Human Services (HHS).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This final rule finalizes the provisions of the September 6,
2016 interim final rule that adjusts for inflation the maximum civil
monetary penalty (CMP) amounts for all agencies within the Department
of Health and Human Services (HHS) and updates certain agency-specific
regulations. It also updates our required annual inflation-related
increases to the CMP amounts in our regulations, under the Federal
Civil Penalties Inflation Adjustment Act Improvements Act of 2015; adds
references to new penalty authorities; and reflects technical changes
to correct errors.
DATES:
Effective date: This final rule is effective November 15, 2021.
Applicability date: The adjusted civil monetary penalty amounts
apply to penalties assessed on or after November 15, 2021, if the
violation occurred on or after November 2, 2015.
FOR FURTHER INFORMATION CONTACT: David Dasher, 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; 202-205-0706.
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
civil monetary penalties 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), and January 17, 2020 (85 FR 2869).
II. Provisions of the Final Rule
A. Finalization of the September 6, 2016 Interim Final Rule
In the September 6, 2016 Federal Register (81 FR 61538), HHS issued
a department-wide interim final rule (IFR) titled ``Adjustment of Civil
Monetary Penalties for Inflation'' that established new regulations at
45 CFR part 102 to adjust for inflation the maximum CMP amounts for the
various CMP authorities for all agencies within the Department. HHS
took this action to comply with the Federal Civil Penalties Inflation
Adjustment Act of 1990 (the Inflation Adjustment Act) (28 U.S.C. 2461
note 2(a)), as amended by the Federal Civil Penalties Inflation
Adjustment Act Improvements Act of 2015 (section 701 of the Bipartisan
Budget Act of 2015, (Pub. L.114-74), enacted on November 2, 2015). In
addition, the September 2016 IFR included updates to certain agency-
specific regulations to reflect the new provisions governing the
adjustment of civil monetary penalties for inflation in 45 CFR part
102.
One of the purposes of the Inflation Adjustment Act was to create a
mechanism to allow for regular inflationary adjustments to federal
civil monetary penalties. Section 2(b)(1) of the Inflation Adjustment
Act. The 2015 amendments removed an inflation update exclusion that
previously applied to the Social Security Act as
[[Page 62929]]
well as to the Occupational Safety and Health Act. The 2015 amendments
also ``reset'' the inflation calculations by excluding prior
inflationary adjustments under the Inflation Adjustment Act and
requiring agencies to identify, for each penalty, the year and
corresponding amount(s) for which the maximum penalty level or range of
minimum and maximum penalties was established (that is, originally
enacted by Congress) or last adjusted other than pursuant to the
Inflation Adjustment Act. In accordance with section 4 of the Inflation
Adjustment Act, agencies were required to: (1) Adjust the level of
civil monetary penalties with an initial ``catch-up'' adjustment
through an interim final rulemaking to take effect by August 1, 2016;
and (2) make subsequent annual adjustments for inflation.
In the September 2016 interim final rule, HHS adopted new
regulations at 45 CFR part 102 to govern adjustment of civil monetary
penalties for inflation. The regulation at 45 CFR 102.1 provides that
part 102 applies to each statutory provision under the laws
administered by HHS (including the Centers for Medicare & Medicaid
Services (CMS)) concerning CMPs, and that the regulations in part 102
supersede existing HHS regulations setting forth CMP amounts. The CMPs
and the adjusted penalty amounts administered by all HHS agencies are
listed in tabular form in 45 CFR 102.3. In addition to codifying the
adjusted penalty amounts identified in Sec. 102.3, the HHS-wide
interim final rule included several technical conforming updates to
certain agency-specific regulations, including various CMS regulations,
to identify their updated information, and incorporate a cross-
reference to the location of HHS-wide regulations.
In the September 12, 2017 Federal Register (82 FR 42748), CMS
published a correcting amendment that corrected a limited number of
technical and typographical errors identified in the CMS provisions of
the September 6, 2016 IFR.
The Medicare provisions included in the September 2016 IFR are
subject to requirements of section 1871(a) of the Social Security Act
(the Act) which sets forth certain procedures for promulgating
regulations necessary to carry out the administration of the insurance
programs under Title XVIII of the Act. Section 1871(a)(3)(A) of the Act
requires the Secretary, in consultation with the Director of the Office
of Management and Budget (OMB), to establish a regular timeline for the
publication of final regulations based on the previous publication of a
proposed rule or an interim final rule. In accordance with section
1871(a)(3)(B) of the Act, such timeline may vary among different rules,
based on the complexity of the rule, the number and scope of the
comments received, and other relevant factors. However, the timeline
for publishing the final rule cannot exceed 3 years from the date of
publication of the proposed or interim final rule, unless there are
exceptional circumstances. After consultation with the Director of OMB,
the Secretary published a notice, which appeared in the December 30,
2004 Federal Register (69 FR 78442), establishing a general 3-year
timeline for publishing Medicare final rules after the publication of a
proposed or interim final rule.
Because the conforming changes to the Medicare provisions were part
of a larger, omnibus departmental interim final rule, we inadvertently
missed setting a target date for the final rule to make permanent the
changes to the Medicare regulations in accordance with section
1871(a)(3)(A) of the Act and the procedures outlined in the December
2004 notice. Consistent with section 1871(a)(3)(C) of the Act, we
published notices of continuation extending the effectiveness of the
technical conforming changes to the Medicare regulations that were
implemented through interim final rule and to allow time to publish a
final rule (see the January 2, 2020 (85 FR 7) and September 8, 2020 (85
FR 55385) continuation documents). The extended time was needed to
allow for coordination between CMS and the Department to issue a final
rule and to avoid the potential for confusion between 45 CFR part 102,
which established the civil monetary payment amounts, and the Medicare
regulations subject to the timing requirements in section 1871(a)(3)(C)
of the Act, which would otherwise cause the regulation to revert to the
language that was used prior to the Inflation Adjustment Act.
In this final rule, we are finalizing the provisions of the
September 6, 2016 IFR without modification. Because the provisions were
established via interim final rulemaking, finalizing the provisions is
pro forma for all agencies except CMS. Given the statutory requirements
specified previously, finalization of the September 2016 IFR
permanently establishes the interim final regulatory provisions for the
Medicare program.
B. 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 23, 2020, Office of Management and Budget (OMB)
Memorandum for the Heads of Executive Agencies and Departments, M-21-
10, ``Implementation of the Penalty Inflation Adjustments for 2021,
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 2021, based on the CPI-U for the month of October 2020, not
seasonally adjusted, is 1.01182. The multiplier is applied to each
applicable penalty amount that was updated and published for fiscal
year (FY) 2020 and is rounded to the nearest dollar.
C. Other Revisions
In addition to the inflation adjustments for 2021, 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 January 17, 2020 update and that are being
updated in this rule. The rule also corrects several technical errors
to regulatory references in the table and updates descriptions for
clarification and accuracy.
First, a CMS final rule, ``Medicare and Medicaid Programs: CY 2020
Hospital Outpatient PPS Policy Changes and Payment Rates and Ambulatory
Surgical Center Payment System Policy Changes and Payment Rates. Price
Transparency Requirements for Hospitals to Make Standard Charges
Public'' (84 FR 65524, November 27, 2019), effective January 1, 2021,
finalized a new provision, codified at 45 CFR 180.90. That section
establishes CMPs associated with a hospital's noncompliance with price
transparency disclosure and display requirements, and the table has
been modified to reflect this requirement.
Second, section 3202(b) of the Coronavirus Aid, Relief, and
Economic Security Act (CARES Act) (Pub. L. 116-136) added a requirement
that each provider of a diagnostic test for COVID-19 make public the
cash price for such test on the provider's public internet site, and
authorized the Secretary to impose a CMP on a provider that fails to
comply. Rulemaking entitled ``Additional Policy and Regulatory
Revisions in Response to the COVID-19 Public Health Emergency'' (85 FR
71142, November 6, 2020) implemented this statutory requirement by
[[Page 62930]]
establishing a provision at 45 CFR 182.70, allowing for imposition of a
CMP, and the table has been modified to reflect this requirement.
Third, in a CMS interim final rule with comment period entitled
``Medicare and Medicaid Programs, Clinical Laboratory Improvement
Amendments (CLIA), and Patient Protection and Affordable Care Act;
Additional Policy and Regulatory Revisions in Response to the COVID-19
Public Health Emergency'' (85 FR 54873 through 54874, September 2,
2020), CMS established requirements for all CLIA laboratories to report
COVID-19 test results to the Secretary in such form and manner, and at
such timing and frequency, as the Secretary may prescribe during the
COVID-19 Public Health Emergency. Failure to report test results as
required results in condition level deficiencies for which CMPs or
other penalties may apply. The table has been modified to reflect this
requirement. Also in this interim final rule, CMS codified new
enforcement requirements at 42 CFR 488.447 establishing CMP amounts
that may be imposed against long term care facilities that fail to
report COVID-19 related data as required in 42 CFR 483.80(g)(1) and
(2). The table has been modified to reflect these requirements.
Finally, the following technical errors were identified and are
corrected in the table at 45 CFR 102.3:
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 two descriptions of 42 U.S.C. 1395dd(d)(1) are revised
for more accuracy because penalties for a responsible physician, unlike
penalties for a hospital, are not tied to the number of beds in the
hospital (see 42 U.S.C. 1395dd(d)(1)(B)).
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 references tied to 42 U.S.C. 1395ss(a)(2),
(p)(8), (p)(9)(C), (q)(5)(C), (r)(6)(A), (s)(4), (t)(2) incorrectly
referred to 42 CFR part 405 and are corrected to refer to 42 CFR part
402.
The first set of regulatory references tied to 42 U.S.C.
1395ss(p)(8) are expanded to also include 42 CFR 402.105(f)(2), which
was inadvertently omitted, and the corresponding description is revised
to replace ``any person'' with ``someone other than issuer'' for
greater accuracy and clarification.
The description for the second set of regulatory
references tied to 42 U.S.C. 1395ss(p)(8) is revised to replace ``any
person'' with ``an issuer'' for greater accuracy and clarification.
The first set of regulatory references tied to 42 U.S.C.
1395ss(p)(9)(C) are expanded to also include 42 CFR 402.105(f)(3) and
(4), which were inadvertently omitted, and the corresponding
description is revised to replace ``any person'' with ``someone other
than issuer'' for greater accuracy and clarification.
The description for the second set of regulatory
references tied to 42 U.S.C. 1395ss(p)(9)(C) is revised to replace
``any person'' with ``an issuer'' for greater accuracy and
clarification.
The description for 42 U.S.C. 18081(c)(2) is being revised
to ``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. (42 U.S.C. 300gg-
22(b)(2)(C))'' for greater accuracy and clarification.
Reference to the existing CMPs authorized under 42 U.S.C.
1395m-1(a) and 42 CFR 414.504(e) for a reporting entity that has failed
to report or made a misrepresentation or omission in reporting
applicable information was inadvertently omitted from the prior annual
updates and the regulation is modified to include this authority and
the 2021 adjusted amount. CMS, in separate rulemaking, made the initial
catch-up adjustment for this amount in accordance with the 2015 Act on
June 23, 2016 (81 FR 41036, 41069) which was $10,017, and noted that
subsequent inflationary adjustments would be made to this amount
annually.
++ The adjusted amounts applying the multiplier for each year
beginning in 2017 through 2020 \1\ are as follows:
---------------------------------------------------------------------------
\1\ The published multiplier for 2017 is 1.01636 (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); for 2018 it is 1.02041 (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); for 2019 it is 1.02522
(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); and for 2020
it is 1.01764 (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).
--The 2017 adjusted amount is $10,181 ($10,017 x 1.01636).
--The 2018 adjusted amount is $10,389 ($10,181 x 1.02041).
--The 2019 adjusted amount is $10,651 ($10,389 x 1.02522).
--The 2020 adjusted amount is $10,839 ($10,651 x 1.01764).
++ The 2021 adjusted amount is calculated by applying the 2021
multiplier to $10,839 and this adjusted amount is reflected in the
table of the regulation at 45 CFR 102.3.
III. Statutory and Executive Order Reviews and Waiver of Proposed
Rulemaking
The 2015 Act requires Federal agencies to publish annual penalty
inflation adjustments notwithstanding section 553 of the Administrative
Procedure Act (APA).
Section 4(a) of the 2015 Act directs Federal agencies to publish
annual adjustments no later than January 15th of each year thereafter.
In accordance with section 553 of the APA, most rules are subject to
notice and comment and are effective no earlier than 30 days after
publication in the Federal Register. However, section 4(b)(2) of the
2015 Act provides that each agency shall make the annual inflation
adjustments ``notwithstanding 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
is 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 and to add additional technical clarifying edits to descriptions
and correcting inadvertent omissions
[[Page 62931]]
and typographical errors. For these same reasons HHS also finds good
cause to make the final rule effective upon publication.
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.
IV. Effective and Applicability Dates
This rule is effective on the date specified in the DATES section
of this final rule. The adjusted civil monetary penalty amounts apply
to penalties assessed on or after date specified in the DATES section
of this final rule, if the violation occurred on or after November 2,
2015. If the violation occurred before November 2, 2015, or a penalty
was assessed before September 6, 2016, the pre-adjustment civil penalty
amounts in effect before September 6, 2016, will apply.
List of Subjects in 45 CFR Part 102
Administrative practice and procedure, Penalties.
For reasons discussed in the preamble, the Department of Health and
Human Services adopts the interim final rule published September 6,
2016, at 81 FR 61537, as final with the following changes to 45 CFR
part 102:
PART 102--ADJUSTMENT OF CIVIL MONETARY PENALTIES FOR INFLATION
0
1. The authority citation for part 102 continues to read as follows:
Authority: Public Law 101-410, Sec. 701 of Public Law 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.
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Dated: November 8, 2021.
Xavier Becerra,
Secretary, Department of Health and Human Services.
[FR Doc. 2021-24672 Filed 11-12-21; 8:45 am]
BILLING CODE 4150-24-C
