Annual Civil Monetary Penalties Inflation Adjustment, 59549-59567 [2019-23955]
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Federal Register / Vol. 84, No. 214 / Tuesday, November 5, 2019 / Rules and Regulations
59549
Paperwork Reduction Act, 44 U.S.C.
3501 et seq.
PART 64—[AMENDED]
1978 Comp.; p. 329; E.O. 12127, 44 FR 19367,
3 CFR, 1979 Comp.; p. 376.
List of Subjects in 44 CFR Part 64
Flood insurance, Floodplains.
Accordingly, 44 CFR part 64 is
amended as follows:
■
1. The authority citation for Part 64
continues to read as follows:
§ 64.6
Authority: 42 U.S.C. 4001 et seq.;
Reorganization Plan No. 3 of 1978, 3 CFR,
Community
no.
State and location
Region VIII
Montana:
Rosebud County, Unincorporated Areas
300069
Roundup, City of, Musselshell County ..
300050
[Amended]
2. The tables published under the
authority of § 64.6 are amended as
follows:
■
Effective date authorization/cancellation of
sale of flood insurance in community
Current effective
map date
April 9, 1997, Emerg; September 1, 1997,
Reg; November 15, 2019, Susp
March 12, 1975, Emerg; March 18, 1986,
Reg; November 15, 2019, Susp
November 15,
2019.
......do ...............
Date
certain Federal
assistance no
longer
available in
SFHAs
November 15,
2019.
Do.
*......do = Ditto.
Code for reading third column: Emerg.—Emergency; Reg.—Regular; Susp.—Suspension.
Dated: October 29, 2019.
Eric Letvin,
Deputy Assistant Administrator for
Mitigation, Federal Insurance and Mitigation
Administration—FEMA Resilience,
Department of Homeland Security, Federal
Emergency Management Agency.
[FR Doc. 2019–24077 Filed 11–4–19; 8:45 am]
BILLING CODE 9111–12–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
45 CFR Part 102
RIN 0991–AC0
Annual Civil Monetary Penalties
Inflation Adjustment
Office of the Assistant
Secretary for Financial Resources,
Department of Health and Human
Services.
ACTION: Final rule.
AGENCY:
The Department of Health and
Human Services is updating its
regulations to reflect required annual
inflation-related increases to the civil
monetary penalties in its regulations,
pursuant to the Federal Civil Penalties
Inflation Adjustment Act Improvements
Act of 2015 and is making a technical
change to correct an error in the
regulation.
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SUMMARY:
This rule is effective November
5, 2019.
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
DATES:
VerDate Sep<11>2014
16:18 Nov 04, 2019
Jkt 250001
Avenue SW, Washington DC 20201;
202–205–0706.
SUPPLEMENTARY INFORMATION:
I. Background
The Federal Civil Penalties Inflation
Adjustment Act Improvements Act of
2015 (Sec. 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 civil monetary
penalty authorities and the penalty
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) and on October 11, 2018 (83 FR
51369).
II. Calculation of Adjustment
The annual inflation adjustment for
each applicable civil monetary penalty
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 civil penalty was most
recently established or modified. In the
December 14, 2018, Office of
Management and Budget (OMB)
Memorandum for the Heads of
Executive Agencies and Departments,
M–19–04, Implementation of the
PO 00000
Frm 00025
Fmt 4700
Sfmt 4700
Penalty Inflation Adjustments for 2019,
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 2019, based
on the CPI–U for the month of October
2018, not seasonally adjusted, is
1.02522. The multiplier is applied to
each applicable penalty amount that
was updated and published for FY 2018
and is rounded to the nearest dollar.
Using the 2019 multiplier, HHS
adjusted all its applicable monetary
penalties in 45 CFR 102.3. In addition
to the adjustment, a technical error for
an incorrect citation in the description
of 21 U.S.C. 333(f)(3)(A) was identified
and is corrected below.
III. Statutory and Executive Order
Reviews
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–19–04, the phrase
‘‘notwithstanding section 553’’ in
section 4(b)(2) of the 2015 Act means
that ‘‘the public procedure the APA
E:\FR\FM\05NOR1.SGM
05NOR1
59550
Federal Register / Vol. 84, No. 214 / Tuesday, November 5, 2019 / Rules and Regulations
generally requires (i.e., 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, this rule is not subject to
notice and an opportunity for public
comment and will be effective
immediately upon publication.
Pursuant to OMB Memorandum M–
19–04, 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 Date
This rule is effective November 5,
2019. The adjusted civil monetary
penalty amounts apply to penalties
assessed on or after November 5, 2019,
if the violation occurred on or after
November 2, 2015. If the violation
occurred prior to November 2, 2015, or
a penalty was assessed prior to
September 6, 2016, the pre-adjustment
civil penalty amounts in effect prior to
September 6, 2016, will apply.
List of Subjects in 45 CFR Part 102
Administrative practice and
procedure, Penalties.
For reasons discussed in the
preamble, the Department of Health and
Human Services amends 45 CFR part
102 as follows:
PART 102—ADJUSTMENT OF CIVIL
MONETARY PENALTIES FOR
INFLATION
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.
2. Amend § 102.3 by revising the table
to read as follows:
■
§ 102.3
*
*
Penalty adjustment and table.
*
*
*
CIVIL MONETARY PENALTY AUTHORITIES ADMINISTERED BY HHS AGENCIES AND PENALTY AMOUNTS
[Effective November 5, 2019]
U.S.C.
CFR 1
HHS
agency
Description 2
21 U.S.C.:
333(b)(2)(A) .....................
.................................................
FDA .......
333(b)(2)(B) .....................
.................................................
FDA .......
333(b)(3) ..........................
.................................................
FDA .......
333(f)(1)(A) ......................
.................................................
FDA .......
Penalty for violations related to drug samples resulting in a conviction of any representative of manufacturer or distributor
in any 10-year period.
Penalty for violation related to drug samples resulting in a conviction of any representative of manufacturer or distributor
after the second conviction in any 10-yr
period.
Penalty for failure to make a report required by 21 U.S.C. 353(d)(3)(E) relating
to drug samples.
Penalty for any person who violates a requirement related to devices for each
such violation.
Penalty for aggregate of all violations related to devices in a single proceeding.
Penalty for any individual who introduces
or delivers for introduction into interstate
commerce food that is adulterated per
21 U.S.C. 342(a)(2)(B) or any individual
who does not comply with a recall order
under 21 U.S.C. 350l.
Penalty in the case of any other person
other than an individual) for such introduction or delivery of adulterated food.
Penalty for aggregate of all such violations
related to adulterated food adjudicated in
a single proceeding.
Penalty for all violations adjudicated in a
single proceeding for any person who
violates 21 U.S.C. 331(jj) by failing to
submit the certification required by 42
U.S.C. 282(j)(5)(B) or knowingly submitting a false certification; by failing to submit clinical trial information under 42
U.S.C. 282(j); or by submitting clinical
trial information under 42 U.S.C. 282(j)
that is false or misleading in any particular under 42 U.S.C. 282(j)(5)(D).
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(o) (post-marketing studies, clinical
trials, labeling), 21 U.S.C. 355(p) (risk
evaluation and mitigation (REMS)), or 21
U.S.C. 355–1 (REMS).
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333(f)(2)(A) ......................
.................................................
FDA .......
333(f)(3)(A) ......................
.................................................
FDA .......
333(f)(3)(B) ......................
.................................................
FDA .......
333(f)(4)(A)(i) ...................
.................................................
FDA .......
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E:\FR\FM\05NOR1.SGM
Date of last
statutorily
established
penalty
figure 3
05NOR1
2018
Maximum
adjusted
penalty
($)
2019
Maximum
adjusted
penalty
($) 4
2018
102,606
105,194
2018
2,052,107
2,103,861
2018
205,211
210,386
2018
27,714
28,413
2018
1,847,663
1,894,261
2018
77,910
79,875
2018
389,550
399,374
2018
779,098
798,747
2018
11,805
12,103
2018
11,805
12,103
2018
295,142
302,585
Federal Register / Vol. 84, No. 214 / Tuesday, November 5, 2019 / Rules and Regulations
59551
CIVIL MONETARY PENALTY AUTHORITIES ADMINISTERED BY HHS AGENCIES AND PENALTY AMOUNTS—Continued
[Effective November 5, 2019]
U.S.C.
333(f)(4)(A)(ii) ..................
333(f)(9)(A) ......................
333(f)(9)(B)(i)(I) ................
333(f)(9)(B)(i)(II) ...............
333(f)(9)(B)(ii)(I) ...............
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333(f)(9)(B)(ii)(II) ..............
333(g)(1) ..........................
VerDate Sep<11>2014
HHS
agency
CFR 1
.................................................
.................................................
.................................................
.................................................
.................................................
.................................................
.................................................
16:18 Nov 04, 2019
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PO 00000
FDA .......
FDA .......
FDA .......
FDA .......
FDA .......
FDA .......
FDA .......
Frm 00027
Description 2
Date of last
statutorily
established
penalty
figure 3
Penalty for aggregate of all such above
violations in a single proceeding.
Penalty for REMS violation that continues
after written notice to the responsible
person for the first 30-day period (or any
portion thereof) the responsible person
continues to be in violation.
Penalty for REMS violation that continues
after written notice to responsible person
doubles for every 30-day period thereafter the violation continues, but may not
exceed penalty amount for any 30-day
period.
Penalty for aggregate of all such above
violations adjudicated in a single proceeding.
Penalty for any person who violates a requirement which relates to tobacco products for each such violation.
Penalty for aggregate of all such violations
of tobacco product requirement adjudicated in a single proceeding.
Penalty per violation related to violations of
tobacco requirements.
Penalty for aggregate of all such violations
of tobacco product requirements adjudicated in a single proceeding.
Penalty in the case of a violation of tobacco product requirements that continues after written notice to such person, for the first 30-day period (or any
portion thereof) the person continues to
be in violation.
Penalty for violation of tobacco product requirements that continues after written
notice to such person shall double for
every 30-day period thereafter the violation continues, but may not exceed penalty amount for any 30-day period.
Penalty for aggregate of all such violations
related to tobacco product requirements
adjudicated in a single proceeding.
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.
Penalty for aggregate of for all such above
violations adjudicated in a single proceeding.
Penalty for violation of modified risk tobacco product post-market surveillance
that continues after written notice to such
person for the first 30-day period (or any
portion thereof) that the person continues to be in violation.
Penalty for post-notice violation of modified
risk tobacco product post-market surveillance shall double for every 30-day period thereafter that the tobacco product
requirement violation continues for any
30-day period, but may not exceed penalty amount for any 30-day period.
Penalty for aggregate above tobacco product requirement violations adjudicated in
a single proceeding.
Penalty for any person who disseminates
or causes another party to disseminate a
direct-to-consumer advertisement that is
false or misleading for the first such violation in any 3-year period.
Fmt 4700
Sfmt 4700
E:\FR\FM\05NOR1.SGM
05NOR1
2018
Maximum
adjusted
penalty
($)
2019
Maximum
adjusted
penalty
($) 4
2018
1,180,566
1,210,340
2018
295,142
302,585
2018
1,180,566
1,210,340
2018
11,805,665
12,103,404
2018
17,115
17,547
2018
1,141,021
1,169,798
2018
285,256
292,450
2018
1,141,021
1,169,798
2018
285,256
292,450
2018
1,141,021
1,169,798
2018
11,410,217
11,697,983
2018
285,256
292,450
2018
1,141,021
1,169,798
2018
285,256
292,450
2018
1,141,021
1,169,798
2018
11,410,217
11,697,983
2018
295,142
302,585
59552
Federal Register / Vol. 84, No. 214 / Tuesday, November 5, 2019 / Rules and Regulations
CIVIL MONETARY PENALTY AUTHORITIES ADMINISTERED BY HHS AGENCIES AND PENALTY AMOUNTS—Continued
[Effective November 5, 2019]
U.S.C.
333 note ...........................
335b(a) .............................
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360pp(b)(1) ......................
42 U.S.C:
262(d) ...............................
VerDate Sep<11>2014
HHS
agency
CFR 1
.................................................
.................................................
.................................................
.................................................
16:18 Nov 04, 2019
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PO 00000
FDA .......
FDA .......
FDA .......
FDA .......
Frm 00028
Description 2
Date of last
statutorily
established
penalty
figure 3
Penalty for each subsequent above violation in any 3-year period.
Penalty to be applied for 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 tobacco product regulation violation within a 24-month
period.
Penalty in the case of a fourth tobacco
product regulation violation within a 24month period.
Penalty in the case of a fifth tobacco product regulation violation within a 36-month
period.
Penalty in the case of a sixth or subsequent tobacco product regulation violation within a 48-month period as determined on a case-by-case basis.
Penalty to be applied for violations of restrictions on the sale or distribution of tobacco products promulgated under 21
U.S.C. 387f(d) (e.g., violations of regulations in 21 CFR part 1140) with respect
to a retailer that does not have an approved training program in the case of
the first regulation violation.
Penalty in the case of a second tobacco
product regulation violation within a 12month period.
Penalty in the case of a third tobacco product regulation violation within a 24-month
period.
Penalty in the case of a fourth tobacco
product regulation violation within a 24month period.
Penalty in the case of a fifth tobacco product regulation violation within a 36-month
period.
Penalty in the case of a fifth tobacco product regulation violation within a 36-month
period.
Penalty in the case of a sixth or subsequent tobacco product regulation violation 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 products..
Penalty per day for violation of order of recall of biological product presenting imminent or substantial hazard.
Fmt 4700
Sfmt 4700
E:\FR\FM\05NOR1.SGM
05NOR1
2018
Maximum
adjusted
penalty
($)
2019
Maximum
adjusted
penalty
($) 4
2018
590,284
605,171
2018
284.69439
292
2018
570.40919
584
2018
2,282
2,340
2018
5,705
5,849
2018
11,410
11,698
2018
284.69439
292
2018
570.40919
584
2018
1,141
1,170
2018
2,282
2,340
2018
5,705
5,849
2018
5,705
5,849
2018
11,410
11,698
2018
434,878
445,846
2018
1,739,513
1,783,384
2018
2,852
2,924
2018
972,285
996,806
2018
223,629
229,269
Federal Register / Vol. 84, No. 214 / Tuesday, November 5, 2019 / Rules and Regulations
59553
CIVIL MONETARY PENALTY AUTHORITIES ADMINISTERED BY HHS AGENCIES AND PENALTY AMOUNTS—Continued
[Effective November 5, 2019]
HHS
agency
Description 2
263b(h)(3) ........................
.................................................
FDA .......
300aa–28(b)(1) ................
.................................................
FDA .......
256b(d)(1)(B)(vi) ..............
.................................................
HRSA ....
299c–(3)(d) ......................
.................................................
AHRQ ....
653(l)(2) ...........................
45 CFR 303.21(f) ...................
ACF .......
262a(i)(1) .........................
42 CFR 1003.910 ...................
OIG .......
Penalty for failure to obtain a mammography certificate as required.
Penalty per occurrence for any vaccine
manufacturer that intentionally destroys,
alters, falsifies, or conceals any record or
report required.
Penalty for each instance of overcharging
a 340B covered entity.
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.
Penalty for each individual who violates
safety and security procedures related to
handling dangerous biological agents
and toxins.
Penalty for any other person who violates
safety and security procedures related to
handling dangerous biological agents
and toxins.
Penalty per violation for committing information blocking.
Penalty for knowingly presenting or causing to be presented to an officer, employee, or agent of the United States a
false claim.
Penalty for knowingly presenting or causing to be presented a request for payment which violates the terms of an assignment, agreement, or PPS agreement.
Penalty for knowingly giving or causing to
be presented to a participating provider
or supplier false or misleading information that could reasonably be expected
to influence a discharge decision.
Penalty for an excluded party retaining
ownership or control interest in a participating entity.
Penalty for remuneration offered to induce
program beneficiaries to use particular
providers, practitioners, or suppliers.
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 paid for by a Federal
health care program.
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 statutory functions of
HHS OIG.
Penalty for payments by a hospital or critical access hospital to induce a physician to reduce or limit services to individuals under direct care of physician or
who are entitled to certain medical assistance benefits
U.S.C.
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Date of last
statutorily
established
penalty
figure 3
CFR 1
300jj–51 ...........................
.................................................
OIG .......
1320a–7a(a) .....................
42 CFR 1003.210(a)(1) ..........
OIG .......
1320a–7a(b) .....................
VerDate Sep<11>2014
42 CFR 1003.210(a)(2) ..........
...............
42 CFR 1003.210(a)(3) ..........
...............
42 CFR 1003.1010 .................
...............
42 CFR 1003.210(a)(4) ..........
...............
42 CFR 1003.310(a)(3) ..........
...............
42 CFR 1003.210(a)(1) ..........
...............
42 CFR 1003.210(a)(6) ..........
...............
42 CFR 1003.210(a)(8) ..........
...............
42 CFR 1003.210(a)(7) ..........
...............
42 CFR 1003.210(a)(9) ..........
...............
.................................................
OIG .......
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E:\FR\FM\05NOR1.SGM
05NOR1
2018
Maximum
adjusted
penalty
($)
2019
Maximum
adjusted
penalty
($) 4
2018
17,395
17,834
2018
223,629
229,269
2018
5,639
5,781
2018
14,664
15,034
2018
1,504
1,542
2018
340,130
348,708
2018
680,262
697,418
2018
1,037,104
1,063,260
2018
20,000
20,504
2018
20,000
20,504
2018
30,000
30,757
2018
20,000
20,504
2018
20,000
20,504
2018
20,000
20,504
2018
100,000
102,522
2018
20,000
20,504
2018
100,000
102,522
2018
20,000
20,504
2018
100,000
102,522
2018
30,000
30,757
2018
5,000
5,126
59554
Federal Register / Vol. 84, No. 214 / Tuesday, November 5, 2019 / Rules and Regulations
CIVIL MONETARY PENALTY AUTHORITIES ADMINISTERED BY HHS AGENCIES AND PENALTY AMOUNTS—Continued
[Effective November 5, 2019]
U.S.C.
khammond on DSKJM1Z7X2PROD with RULES
1320a–7a(o) .....................
HHS
agency
CFR 1
42 CFR 1003.210(a)(10) ........
...............
.................................................
OIG .......
1320a–7e(b)(6)(A) ...........
42 CFR 1003.810 ...................
OIG .......
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) ......
42 CFR 1003.210(a)(11) ........
OIG .......
1395i–3(b)(3)(B)(ii)(2) ......
42 CFR 1003.210(a)(11) ........
OIG .......
1395i–3(g)(2)(A) ...............
42 CFR 1003.1310 .................
OIG .......
1395w–27(g)(2)(A) ...........
42 CFR 1003.410 ...................
OIG .......
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16:18 Nov 04, 2019
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Frm 00030
Description 2
Date of last
statutorily
established
penalty
figure 3
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 funding
Knowingly makes, uses, or causes to be
made or used any false statement, omission, or misrepresentation of a material
fact in any application, proposal, bid,
progress report, or other document required to directly or indirectly receive or
retain funds provided pursuant to grant,
contract, or other agreement
Knowingly makes, uses, or causes to be
made or used, a false record or statement material to a false or fraudulent
specified claim under grant, contract, or
other agreement.
Knowingly makes, uses, or causes to be
made or used, a false record or statement material to an obligation to pay or
transmit funds or property with respect to
grant, contract, or other agreement, or
knowingly conceals or improperly avoids
or decreases any such obligation..
Fails 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, supplier, or practitioner.
Penalty for the misuse of words, symbols,
or emblems in communications in a
manner in which a person could falsely
construe that such item is approved, endorsed, or authorized by HHS.
Penalty for the misuse of words, symbols,
or emblems in a broadcast or telecast in
a manner in which a person could falsely
construe that such item is approved, endorsed, or authorized by HHS.
Penalty for certification of a false statement
in assessment of functional capacity of a
Skilled Nursing Facility resident assessment.
Penalty for causing another to certify or
make a false statement in assessment of
functional capacity of a Skilled Nursing
Facility resident assessment.
Penalty for any individual who notifies or
causes to be notified a Skilled Nursing
Facility of the time or date on which a
survey is to be conducted.
Penalty for a Medicare Advantage organization that substantially fails to provide
medically necessary, required items and
services.
Penalty for a Medicare Advantage organization that charges excessive premiums.
Penalty for a Medicare Advantage organization that improperly expels or refuses
to reenroll a beneficiary.
Fmt 4700
Sfmt 4700
E:\FR\FM\05NOR1.SGM
05NOR1
2018
Maximum
adjusted
penalty
($)
2019
Maximum
adjusted
penalty
($) 4
2018
5,000
5,126
2018
10,000
10,252
2016
10,000
10,461
2016
50,000
52,308
2016
50,000
52,308
2016
* 50,000
** 52,308
2016
15,000
15,692
2018
38,159
39,121
2018
10,260
10,519
2018
51,302
52,596
2018
2,140
2,194
2018
10,697
10,967
2018
4,280
4,388
2018
38,954
39,936
2018
38,159
39,121
2018
38,159
39,121
Federal Register / Vol. 84, No. 214 / Tuesday, November 5, 2019 / Rules and Regulations
59555
CIVIL MONETARY PENALTY AUTHORITIES ADMINISTERED BY HHS AGENCIES AND PENALTY AMOUNTS—Continued
[Effective November 5, 2019]
U.S.C.
1395w–141(i)(3) ...............
.................................................
OIG .......
1395cc(g) .........................
42 CFR 1003.210(a)(5) ..........
OIG .......
1395dd(d)(1) ....................
42 CFR 1003.510 ...................
OIG .......
1395mm(i)(6)(B)(i) ...........
khammond on DSKJM1Z7X2PROD with RULES
HHS
agency
CFR 1
VerDate Sep<11>2014
42 CFR 1003.410 ...................
16:18 Nov 04, 2019
Jkt 250001
PO 00000
OIG .......
Frm 00031
Description 2
Date of last
statutorily
established
penalty
figure 3
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 discouraging 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 provider’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 entity.
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 earning a commission.
Penalty for a Medicare Advantage organization failing to comply with marketing
restrictions or applicable implementing
regulations or guidance.
Penalty for a Medicare Advantage organization employing or contracting with an
individual or entity who violates 1395w–
27(g)(1)(A)–(J).
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 needing emergency medical
care.
Penalty for a hospital with less than 100
beds dumping patients needing emergency medical care.
Penalty for a HMO or competitive plan if
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 a HMO or competitive medical
plan that expels or refuses to reenroll an
individual per prescribed conditions.
Penalty for a HMO or competitive medical
plan that implements practices to discourage enrollment of individuals needing services in future.
Penalty per individual not enrolled in a plan
as a result of a HMO or competitive
medical plan that implements practices
to discourage enrollment of individuals
needing services in the future.
Penalty for a HMO or competitive medical
plan that misrepresents or falsifies information to the Secretary.
Fmt 4700
Sfmt 4700
E:\FR\FM\05NOR1.SGM
05NOR1
2018
Maximum
adjusted
penalty
($)
2019
Maximum
adjusted
penalty
($) 4
2018
152,638
156,488
2018
22,896
23,473
2018
152,638
156,488
2018
38,159
39,121
2018
38,159
39,121
2018
38,159
39,121
2018
38,159
39,121
2018
38,159
39,121
2018
38,159
39,121
2018
38,159
39,121
2018
13,333
13,669
2018
5,186
5,317
2018
106,965
109,663
2018
53,484
54,833
2018
53,484
54,833
2018
53,484
54,833
2018
53,484
54,833
2018
213,932
219,327
2018
30,782
31,558
2018
213,932
219,327
59556
Federal Register / Vol. 84, No. 214 / Tuesday, November 5, 2019 / Rules and Regulations
CIVIL MONETARY PENALTY AUTHORITIES ADMINISTERED BY HHS AGENCIES AND PENALTY AMOUNTS—Continued
[Effective November 5, 2019]
U.S.C.
khammond on DSKJM1Z7X2PROD with RULES
HHS
agency
CFR 1
1395nn(g)(3) ....................
42 CFR 1003.310 ...................
OIG .......
1395nn(g)(4) ....................
42 CFR 1003.310 ...................
OIG .......
1395ss(d)(1) .....................
42 CFR 1003.1110 .................
OIG .......
1395ss(d)(2) .....................
42 CFR 1003.1110 .................
OIG .......
1395ss(d)(3)(A)(ii) ............
42 CFR 1003.1110 .................
OIG .......
1395ss(d)(4)(A) ................
42 CFR 1003.1110 .................
OIG .......
1396b(m)(5)(B)(i) .............
42 CFR 1003.410 ...................
OIG .......
1396r(b)(3)(B)(ii)(I) ...........
42 CFR 1003.210(a)(11) ........
OIG .......
1396r(b)(3)(B)(ii)(II) ..........
42 CFR 1003.210(a)(11) ........
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 .......
1396t(i)(3)(A) ....................
42 CFR 1003.1310 .................
OIG .......
11131(c) ...........................
42 CFR 1003.810 ...................
OIG .......
VerDate Sep<11>2014
16:18 Nov 04, 2019
Jkt 250001
PO 00000
Frm 00032
Description 2
Date of last
statutorily
established
penalty
figure 3
Penalty for a HMO or competitive medical
plan that misrepresents or falsifies information to an individual or any other entity.
Penalty for failure by HMO or competitive
medical plan to assure prompt payment
of Medicare risk sharing contracts or incentive plan provisions.
Penalty for HMO that employs or contracts
with excluded individual or entity.
Penalty for submitting or causing to be
submitted claims in violation of the Stark
Law’s restrictions on physician self-referrals.
Penalty for circumventing Stark Law’s restrictions on physician self-referrals.
Penalty for a material misrepresentation regarding Medigap compliance policies.
Penalty for selling Medigap policy under
false pretense.
Penalty for an issuer that sells health insurance policy that duplicates benefits.
Penalty for someone other than issuer that
sells health insurance that duplicates
benefits.
Penalty for using mail to sell a non-approved Medigap insurance policy.
Penalty for a Medicaid MCO that substantially fails to provide medically necessary, required items or services.
Penalty for a Medicaid MCO that charges
excessive premiums.
Penalty for a Medicaid MCO that improperly expels or refuses to reenroll a beneficiary.
Penalty per individual who does not enroll
as a result of a Medicaid MCO’s practice
that would reasonably be expected to
have the effect of denying or discouraging enrollment.
Penalty for a Medicaid MCO misrepresenting or falsifying information to the
Secretary.
Penalty for a Medicaid MCO misrepresenting or falsifying information to an individual or another entity.
Penalty for a Medicaid MCO that fails to
comply with contract requirements with
respect to physician incentive plans.
Penalty for willfully and knowingly certifying
a material and false statement in a
Skilled Nursing Facility resident assessment.
Penalty for willfully and knowingly causing
another individual to certify a material
and false statement in a Skilled Nursing
Facility resident assessment.
Penalty for notifying or causing to be notified a Skilled Nursing Facility of the time
or date on which a survey is to be conducted.
Penalty for the knowing provision of false
information or refusing to provide information about charges or prices of a covered outpatient drug.
Penalty per day for failure to timely provide
information by drug manufacturer with
rebate agreement.
Penalty for knowing provision of false information by drug manufacturer with rebate
agreement.
Penalty for notifying home and communitybased providers or settings of survey.
Penalty for failing to report a medical malpractice claim to National Practitioner
Data Bank.
Fmt 4700
Sfmt 4700
E:\FR\FM\05NOR1.SGM
05NOR1
2018
Maximum
adjusted
penalty
($)
2019
Maximum
adjusted
penalty
($) 4
2018
53,484
54,833
2018
53,484
54,833
2018
49,096
50,334
2018
24,748
25,372
2018
164,992
169,153
2018
10,260
10,519
2018
10,260
10,519
2018
46,192
47,357
2018
27,714
28,413
2018
10,260
10,519
2018
51,302
52,596
2018
51,302
52,596
2018
205,211
210,386
2018
30,782
31,558
2018
205,211
210,386
2018
51,302
52,596
2018
46,192
47,357
2018
2,140
2,194
2018
10,697
10,967
2018
4,280
4,388
2018
184,767
189,427
2018
18,477
18,943
2018
184,767
189,427
2018
3,695
3,788
2018
22,363
22,927
Federal Register / Vol. 84, No. 214 / Tuesday, November 5, 2019 / Rules and Regulations
59557
CIVIL MONETARY PENALTY AUTHORITIES ADMINISTERED BY HHS AGENCIES AND PENALTY AMOUNTS—Continued
[Effective November 5, 2019]
CFR 1
HHS
agency
Description 2
11137(b)(2) ......................
42 CFR 1003.810 ...................
OIG .......
299b–22(f)(1) ...................
42 CFR 3.404 .........................
OCR ......
45 CFR 160.404(b)(1)(i), (ii) ...
OCR ......
45 CFR 160.404(b)(2)(i)(A),
(B).
OCR ......
Penalty for breaching confidentiality of information 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 it is established that the covered entity or business
associate did not know and by exercising
reasonable diligence, would not have
known that the covered entity or business associate violated such a provision:
Minimum ......................................................
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 reasonable cause and not to willful neglect:
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 30day 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 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 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 clinical laboratory’s failure to
meet participation and certification requirements and poses immediate jeopardy:
Minimum ......................................................
Maximum .....................................................
Penalty for a clinical laboratory’s failure to
meet participation and certification requirements and the failure does not pose
immediate jeopardy:
Minimum ......................................................
Maximum .....................................................
Failure to provide the Summary of Benefits
and Coverage.
Penalty for violations of regulations related
to the medical loss ratio reporting and
rebating.
U.S.C.
1320(d)–5(a) ....................
45 CFR 160.404(b)(2)(ii)(A),
(B).
OCR ......
45 CFR 160.404(b)(2)(iii)(A),
(B).
45 CFR 160.404(b)(2)(iv)(A),
(B).
263a(h)(2)(B) & 1395w–
2(b)(2)(A)(ii).
42 CFR 493.1834(d)(2)(i) .......
khammond on DSKJM1Z7X2PROD with RULES
42 CFR 493.1834(d)(2)(ii) ......
OCR ......
OCR ......
CMS ......
CMS ......
300gg–15(f) ......................
45 CFR 147.200(e) ................
CMS ......
300gg–18 .........................
45 CFR 158.606 .....................
CMS ......
VerDate Sep<11>2014
16:18 Nov 04, 2019
Jkt 250001
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Frm 00033
Fmt 4700
Sfmt 4700
E:\FR\FM\05NOR1.SGM
Date of last
statutorily
established
penalty
figure 3
05NOR1
2018
Maximum
adjusted
penalty
($)
2019
Maximum
adjusted
penalty
($) 4
2018
22,363
22,927
2018
12,383
12,695
2018
155.10232
159
2018
2018
38,954
....................
39,936
....................
2018
2018
2018
2018
114.28592
57,051
1,711,533
....................
117
58,490
1,754,698
....................
2018
2018
2018
2018
1,141
57,051
1,711,533
....................
1,170
58,490
1,754,698
....................
2018
2018
2018
2018
11,410
57,051
1,711,533
....................
11,698
58,490
1,754,698
....................
2018
2018
2018
2018
57,051
1,711,533
1,711,533
....................
58,490
1,754,698
1,754,698
....................
2018
2018
2018
6,259
20,521
....................
6,417
21,039
....................
2018
2018
2018
103
6,156
1,128
106
6,311
1,156
2018
113
116
59558
Federal Register / Vol. 84, No. 214 / Tuesday, November 5, 2019 / Rules and Regulations
CIVIL MONETARY PENALTY AUTHORITIES ADMINISTERED BY HHS AGENCIES AND PENALTY AMOUNTS—Continued
[Effective November 5, 2019]
CFR 1
U.S.C.
1320a–7h(b)(1) ................
1320a–7h(b)(2) ................
42 CFR 402.105(d)(5), 42
CFR 403.912(a) & (c).
42 CFR 402.105(h), 42 CFR
403.912(b) & (c).
HHS
agency
Description 2
CMS ......
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 under 42
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 facility.
Minimum penalty for the first offense of an
administrator who fails to provide notice
of facility closure.
Minimum penalty for the second offense of
an administrator who fails to provide notice of facility closure.
Minimum penalty for the third and subsequent offenses of an administrator who
fails to provide notice of facility closure.
Penalty for an entity knowingly making a
false statement or representation of material fact in the determination of the
amount of benefits or payments related
to old-age, survivors, and disability insurance benefits, special benefits for certain
World War II veterans, or supplemental
security income for the 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.
Penalty for a representative payee (under
42 U.S.C. 405(j), 1007, or 1383(a)(2))
converting any part of a received payment from the benefit programs described in the previous civil monetary
penalty to a use other than for the benefit of the beneficiary.
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 longterm 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 longterm 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.
CMS ......
CMS ......
1320a–7j(h)(3)(A) .............
khammond on DSKJM1Z7X2PROD with RULES
1320a–8(a)(1) ..................
42 CFR 488.446(a)(1), (2), &
(3).
.................................................
CMS ......
CMS ......
1320a–8(a)(3) ..................
.................................................
CMS ......
1320b–25(c)(1)(A) ............
.................................................
CMS ......
1320b–25(c)(2)(A) ............
.................................................
CMS ......
1320b–25(d)(2) ................
.................................................
CMS ......
VerDate Sep<11>2014
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Frm 00034
Fmt 4700
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E:\FR\FM\05NOR1.SGM
2018
Maximum
adjusted
penalty
($)
2019
Maximum
adjusted
penalty
($) 4
2018
....................
....................
2018
2018
2018
2018
1,128
11,278
169,170
....................
1,156
11,562
173,436
....................
2018
2018
2018
2018
11,278
112,780
1,127,799
112,780
11,562
115,624
1,156,242
115,624
2018
564.28673
578
2018
1,692
1,735
2018
3,383
3,468
2018
8,249
8,457
2018
7,779
7,975
2018
6,460
6,623
2018
225,560
231,249
2018
338,339
346,872
2018
225,560
231,249
Date of last
statutorily
established
penalty
figure 3
05NOR1
Federal Register / Vol. 84, No. 214 / Tuesday, November 5, 2019 / Rules and Regulations
59559
CIVIL MONETARY PENALTY AUTHORITIES ADMINISTERED BY HHS AGENCIES AND PENALTY AMOUNTS—Continued
[Effective November 5, 2019]
CFR 1
HHS
agency
Description 2
1395b–7(b)(2)(B) .............
42 CFR 402.105(g) ................
CMS ......
1395i–3(h)(2)(B)(ii)(I) .......
42 CFR 488.408(d)(1)(iii) .......
CMS ......
Penalty for any person who knowingly and
willfully fails to furnish a beneficiary with
an itemized statement of items or services within 30 days of the beneficiary’s
request.
Penalty per day for a Skilled Nursing Facility that has a Category 2 violation of certification requirements:
Minimum ......................................................
Maximum .....................................................
Penalty per instance of Category 2 noncompliance by a Skilled Nursing Facility:
Minimum ......................................................
Maximum .....................................................
Penalty per day for a Skilled Nursing Facility that has a Category 3 violation of certification requirements:
Minimum ......................................................
Maximum .....................................................
Penalty per instance of Category 3 noncompliance by a Skilled Nursing Facility:
Minimum ......................................................
Maximum .....................................................
Penalty per day and per instance for a
Skilled Nursing Facility that has Category
3 noncompliance with Immediate Jeopardy:
Per Day (Minimum) .....................................
Per Day (Maximum) ....................................
Per Instance (Minimum) ..............................
Per Instance (Maximum) .............................
Penalty per day of a Skilled Nursing Facility that fails to meet certification requirements. These amounts represent the
upper range per day:
Minimum ......................................................
Maximum .....................................................
Penalty per day of a Skilled Nursing Facility that fails to meet certification requirements. These amounts represent the
lower range per day:
Minimum ......................................................
Maximum .....................................................
Penalty per instance of a Skilled Nursing
Facility that fails to meet certification requirements:
Minimum ......................................................
Maximum .....................................................
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. 1395u(j)(2)(B), which is assessed
according to 1320a–7a(a)).
Penalty for knowingly and willfully presenting or causing to be presented a bill
or request for payment for an intraocular
lens inserted during or after cataract surgery for which the Medicare payment
rate includes the cost of acquiring the
class of lens involved.
Penalty for knowingly and willfully failing to
provide information about a referring
physician when seeking payment on an
unassigned basis.
Penalty for any durable medical equipment
supplier that knowingly and willfully
charges for a covered service that is furnished on a rental basis after the rental
payments may no longer be made. (Penalties are assessed in the same manner
as 42 U.S.C. 1395u(j)(2)(B), which is assessed according to 1320a–7a(a)).
U.S.C.
42 CFR 488.408(d)(1)(iv) .......
42 CFR 488.408(e)(1)(iii) .......
42 CFR 488.408(e)(1)(iv) .......
42 CFR 488.408(e)(2)(ii) ........
42 CFR 488.438(a)(1)(i) .........
42 CFR 488.438(a)(1)(ii) ........
khammond on DSKJM1Z7X2PROD with RULES
42 CFR 488.438(a)(2) ............
CMS ......
CMS ......
CMS ......
CMS ......
CMS ......
CMS ......
CMS ......
1395l(h)(5)(D) ..................
42 CFR 402.105(d)(2)(i) .........
CMS ......
1395l(i)(6) .........................
.................................................
CMS ......
1395l(q)(2)(B)(i) ...............
42 CFR 402.105(a) ................
CMS ......
1395m(a)(11)(A) ..............
42 CFR 402.1(c)(4),
402.105(d)(2)(ii).
CMS ......
VerDate Sep<11>2014
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E:\FR\FM\05NOR1.SGM
Date of last
statutorily
established
penalty
figure 3
05NOR1
2018
Maximum
adjusted
penalty
($)
2019
Maximum
adjusted
penalty
($) 4
2018
152
156
2018
....................
....................
2018
2018
2018
107
6,417
....................
110
6,579
....................
2018
2018
2018
2,140
21,393
....................
2,194
21,933
....................
2018
2018
2018
6,525
21,393
....................
6,690
21,933
....................
2018
2018
2018
2,140
21,393
....................
2,194
21,933
....................
2018
2018
2018
2018
2018
6,525
21,393
2,140
21,393
....................
6,690
21,933
2,194
21,933
....................
2018
2018
2018
6,525
21,393
....................
6,690
21,933
....................
2018
2018
2018
107
6,417
....................
110
6,579
....................
2018
2018
2018
2,140
21,393
15,582
2,194
21,933
15,975
2018
4,104
4,208
2018
3,928
4,027
2018
15,582
15,975
59560
Federal Register / Vol. 84, No. 214 / Tuesday, November 5, 2019 / Rules and Regulations
CIVIL MONETARY PENALTY AUTHORITIES ADMINISTERED BY HHS AGENCIES AND PENALTY AMOUNTS—Continued
[Effective November 5, 2019]
CFR 1
khammond on DSKJM1Z7X2PROD with RULES
U.S.C.
HHS
agency
Description 2
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)(B), which is assessed
according to 1320a–7a(a)).
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 according to 1320a–7a(a)).
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 1395u(j)(2)(B), which is assessed according to 1320a–7a(a)).
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
required under Section 1834(j)(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 assignment-related
basis under certain conditions. (Penalties
are assessed in the same manner as 42
U.S.C. 1395m(j)(4) and 1395u(j)(2)(B),
which is assessed according to 1320a–
7a(a)).
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)(B), which is assessed
according to 1320a–7a(a)).
Penalty for any supplier of ambulance
services who knowingly and willfully fills
or collects for any services on other than
an assignment-related basis. (Penalties
are assessed in the same manner as 42
U.S.C. 1395u(b)(18)(B), which is assessed according to 1320a–7a(a)).
Penalty for any practitioner specified in
Section 1842(b)(18)(C) of the Act or
other person that knowingly and willfully
bills or collects for any services by the
practitioners on other than an assignment-related basis. (Penalties are assessed in the same manner as 42
U.S.C. 1395u(j)(2)(B), which is assessed
according to 1320a–7a(a)).
1395m(a)(18)(B) ..............
42 CFR 402.1(c)(5),
402.105(d)(2)(iii).
CMS ......
1395m(b)(5)(C) ................
42 CFR 402.1(c)(6),
402.105(d)(2)(iv).
CMS ......
1395m(h)(3) .....................
42 CFR 402.1(c)(8),
402.105(d)(2)(vi).
CMS ......
1395m(j)(2)(A)(iii) .............
.................................................
CMS ......
1395m(j)(4) ......................
42 CFR 402.1(c)(10),
402.105(d)(2)(vii).
CMS ......
1395m(k)(6) .....................
42 CFR 402.1(c)(31),
402.105(d)(3).
CMS ......
1395m(l)(6) ......................
42 CFR 402.1(c)(32),
402.105(d)(4).
CMS ......
1395u(b)(18)(B) ...............
42 CFR 402.1(c)(11),
402.105(d)(2)(viii).
CMS ......
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Frm 00036
Fmt 4700
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E:\FR\FM\05NOR1.SGM
Date of last
statutorily
established
penalty
figure 3
05NOR1
2018
Maximum
adjusted
penalty
($)
2019
Maximum
adjusted
penalty
($) 4
2018
15,582
15,975
2018
15,582
15,975
2018
15,582
15,975
2018
1,650
1,692
2018
15,582
15,975
2018
15,582
15,975
2018
15,582
15,975
2018
15,582
15,975
Federal Register / Vol. 84, No. 214 / Tuesday, November 5, 2019 / Rules and Regulations
59561
CIVIL MONETARY PENALTY AUTHORITIES ADMINISTERED BY HHS AGENCIES AND PENALTY AMOUNTS—Continued
[Effective November 5, 2019]
CFR 1
HHS
agency
Description 2
1395u(j)(2)(B) ...................
42 CFR 402.1(c) .....................
CMS ......
1395u(k) ...........................
42 CFR 402.1(c)(12),
402.105(d)(2)(ix).
CMS ......
1395u(l)(3) .......................
42 CFR 402.1(c)(13),
402.105(d)(2)(x).
CMS ......
1395u(m)(3) .....................
42 CFR 402.1(c)(14),
402.105(d)(2)(xi).
CMS ......
1395u(n)(3) ......................
42 CFR 402.1(c)(15),
402.105(d)(2)(xii).
CMS ......
1395u(o)(3)(B) .................
42 CFR 414.707(b) ................
CMS ......
1395u(p)(3)(A) .................
.................................................
CMS ......
1395w–3a(d)(4)(A) ...........
42 CFR 414.806 .....................
CMS ......
Penalty for any physician who charges
more than 125% for a non-participating
referral. (Penalties are assessed in the
same manner as 42 U.S.C. 1320a–
7a(a)).
Penalty for any physician who knowingly
and willfully presents or causes to be
presented a claim for bill for an assistant
at a cataract surgery performed on or
after March 1, 1987, for which payment
may not be made because of section
1862(a)(15). (Penalties are assessed in
the same manner as 42 U.S.C.
1395u(j)(2)(B), which is assessed according to 1320a–7a(a)).
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(l)(1)(A). (Penalties are assessed in the same manner as 42
U.S.C. 1395u(j)(2)(B), which is assessed
according to 1320a–7a(a)).
Penalty for any nonparticipating physician
charging more than $500 who does not
accept payment for an elective surgical
procedure on an assignment related
basis and who knowingly and willfully
fails to disclose the required information
regarding charges and coinsurance
amounts and fails to refund on a timely
basis any amount collected for the procedure in excess of the charges recognized and approved by the Medicare
program. (Penalties are assessed in the
same
manner
as
42
U.S.C.
1395u(j)(2)(B), which is assessed according to 1320a–7a(a)).
Penalty for any physician who knowingly,
willfully, and repeatedly bills one or more
beneficiaries for purchased diagnostic
tests any amount other than the payment
amount specified by the Act. (Penalties
are assessed in the same manner as 42
U.S.C. 1395u(j)(2)(B), which is assessed
according to 1320a–7a(a)).
Penalty for any practitioner specified in
Section 1842(b)(18)(C) of the Act or
other person that knowingly and willfully
bills or collects for any services pertaining to drugs or biologics by the practitioners on other than an assignment-related basis. (Penalties are assessed in
the same manner as 42 U.S.C.
1395u(b)(18)(B)
and
1395u(j)(2)(B),
which is assessed according to 1320a–
7a(a)).
Penalty for any physician or practitioner
who knowingly and willfully fails promptly
to provide the appropriate diagnosis
codes upon CMS or Medicare administrative contractor request for payment or
bill not submitted on an assignment-related basis.
Penalty for a pharmaceutical manufacturer’s misrepresentation of average sales
price of a drug, or biologic.
khammond on DSKJM1Z7X2PROD with RULES
U.S.C.
VerDate Sep<11>2014
16:18 Nov 04, 2019
Jkt 250001
PO 00000
Frm 00037
Fmt 4700
Sfmt 4700
E:\FR\FM\05NOR1.SGM
Date of last
statutorily
established
penalty
figure 3
05NOR1
2018
Maximum
adjusted
penalty
($)
2019
Maximum
adjusted
penalty
($) 4
2018
15,582
15,975
2018
15,582
15,975
2018
15,582
15,975
2018
15,582
15,975
2018
15,582
15,975
2018
15,582
15,975
2018
4,104
4,208
2018
13,333
13,669
59562
Federal Register / Vol. 84, No. 214 / Tuesday, November 5, 2019 / Rules and Regulations
CIVIL MONETARY PENALTY AUTHORITIES ADMINISTERED BY HHS AGENCIES AND PENALTY AMOUNTS—Continued
[Effective November 5, 2019]
CFR 1
khammond on DSKJM1Z7X2PROD with RULES
U.S.C.
HHS
agency
Description 2
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(j)(2)(B), which is assessed according to 1320a–7a(a)).
Penalty for any person that knowingly and
willfully bills for statutorily defined Stateplan approved physicians’ services on
any other basis than an assignment-related basis for a Medicare/Medicaid dual
eligible beneficiary. (Penalties are assessed in the same manner as 42
U.S.C. 1395u(j)(2)(B), which is assessed
according to 1320a–7a(a)).
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 an individual covered
under the organization’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 carry out a contract, or has carried out a contract inconsistently with regulations.
Penalty for a Medicare Advantage organization’s or Part D sponsor’s 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 plan which would be a primary plan.
Penalty for any non-governmental employer that, before October 1, 1998, willfully or repeatedly failed to provide timely
and accurate information requested relating to an employee’s group health insurance coverage.
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 plan is or was a
primary plan to Medicare to the HHS
Secretary.
Penalty for any non-group health plan that
fails to identify claimants who are Medicare beneficiaries and provide information to the HHS Secretary to coordinate
benefits and pursue any applicable recovery claim.
Penalty for any person that fails to report
information required by HHS under Section 1877(f) concerning ownership, investment, and compensation arrangements.
1395w–4(g)(1)(B) .............
42 CFR 402.1(c)(17),
402.105(d)(2)(xiii).
CMS ......
1395w–4(g)(3)(B) .............
42 CFR 402.1(c)(18),
402.105(d)(2)(xiv).
CMS ......
1395w–27(g)(3)(A);
1857(g)(3) (A).
42 CFR 422.760(b)(1)–(2); 42
CFR 423.760(b)(1)–(2).
CMS ......
1395w–27(g)(3)(B);
1857(g)(3)(B).
42 CFR 422.760(b)(3); 42
CFR 423.760(b)(3).
CMS ......
1395w–27(g)(3)(D);
1857(g)(3)(D).
.................................................
CMS ......
1395y(b)(3)(C) .................
42 CFR 411.103(b) ................
CMS ......
1395y(b)(5)(C)(ii) .............
42 CFR 402.1(c)(20), 42 CFR
402.105(b)(2).
CMS ......
1395y(b)(6)(B) ..................
42 CFR 402.1(c)(21),
402.105(a).
CMS ......
1395y(b)(7)(B)(i) ..............
.................................................
CMS ......
1395y(b)(8)(E) ..................
.................................................
CMS ......
1395nn(g)(5) ....................
42 CFR 411.361 .....................
CMS ......
VerDate Sep<11>2014
16:18 Nov 04, 2019
Jkt 250001
PO 00000
Frm 00038
Fmt 4700
Sfmt 4700
E:\FR\FM\05NOR1.SGM
Date of last
statutorily
established
penalty
figure 3
05NOR1
2018
Maximum
adjusted
penalty
($)
2019
Maximum
adjusted
penalty
($) 4
2018
15,582
15,975
2018
15,582
15,975
2018
38,159
39,121
2018
15,264
15,649
2018
141,760
145,335
2018
9,239
9,472
2018
1,504
1,542
2018
3,300
3,383
2018
1,181
1,211
2018
1,181
1,211
2018
19,639
20,134
Federal Register / Vol. 84, No. 214 / Tuesday, November 5, 2019 / Rules and Regulations
59563
CIVIL MONETARY PENALTY AUTHORITIES ADMINISTERED BY HHS AGENCIES AND PENALTY AMOUNTS—Continued
[Effective November 5, 2019]
CFR 1
U.S.C.
Description 2
Penalty for any durable medical equipment
supplier, including a supplier of prosthetic devices, prosthetics, orthotics, or
supplies, that knowingly and willfully fails
to make refunds in a timely manner to
Medicare beneficiaries under certain
conditions. (42 U.S.C. 1395(m)(18) sanctions apply here in the same manner,
which is under 1395u(j)(2) and 1320a–
7a(a)).
Penalty for any person that issues a Medicare supplemental policy that has not
been approved by the State regulatory
program or does not meet Federal
standards after a statutorily defined effective date.
Penalty for someone other than issuer that
sells or issues a Medicare supplemental
policy to beneficiary without a disclosure
statement.
Penalty for an issuer that sells or issues a
Medicare supplemental policy without
disclosure statement.
Penalty for someone other than issuer that
sells or issues a Medicare supplemental
policy without acknowledgement form.
Penalty for issuer that sells or issues a
Medicare supplemental policy without an
acknowledgement form.
Penalty for any person that sells or issues
Medicare supplemental polices after a
given date that fail to conform to the
NAIC or Federal standards established
by statute.
Penalty for any person that sells or issues
Medicare supplemental polices after a
given date that fail to conform to the
NAIC or Federal standards established
by statute.
Penalty for any person that sells a Medicare supplemental policy and fails to
make available for sale the core group of
basic benefits when selling other Medicare supplemental policies with additional benefits or fails to provide the individual, before selling the policy, an outline of coverage describing benefits.
Penalty for any person that sells a Medicare supplemental policy and fails to
make available for sale the core group of
basic benefits when selling other Medicare supplemental policies with additional benefits or fails to provide the individual, before selling the policy, an outline of coverage describing benefits.
Penalty for any person that fails to suspend the policy of a policyholder made
eligible for medical assistance or automatically reinstates the policy of a policyholder who has lost eligibility for medical
assistance, under certain circumstances.
Penalty for any person that fails to provide
refunds or credits as required by section
1882(r)(1)(B).
Penalty for any issuer of a Medicare supplemental policy that does not waive listed time periods if they were already satisfied under a proceeding Medicare supplemental policy, or denies a policy, or
conditions the issuances or effectiveness
of the policy, or discriminates in the pricing of the policy base on health status or
other specified criteria.
Penalty for any issuer of a Medicare supplemental policy that fails to fulfill listed
responsibilities.
1395pp(h) .........................
42 CFR 402.1(c)(23),
402.105(d)(2)(xv).
CMS ......
1395ss(a)(2) .....................
42 CFR 402.1(c)(24),
405.105(f)(1).
CMS ......
1395ss(d)(3)(A)(vi) (II) .....
.................................................
CMS ......
1395ss(d)(3)(B)(iv) ...........
1395ss(p)(8) .....................
.................................................
CMS ......
42 CFR 402.1(c)(25),
402.105(e).
CMS ......
42 CFR 402.1(c)(25),
405.105(f)(2).
CMS ......
42 CFR 402.1(c)(26),
402.105(e).
CMS ......
42 CFR 402.1(c)(26),
405.105(f)(3), (4).
...............
1395ss(q)(5)(C) ................
42 CFR 402.1(c)(27),
405.105(f)(5).
CMS ......
1395ss(r)(6)(A) .................
42 CFR 402.1(c)(28),
405.105(f)(6).
CMS ......
1395ss(s)(4) .....................
42 CFR 402.1(c)(29),
405.105(c).
CMS ......
1395ss(t)(2) ......................
42 CFR 402.1(c)(30),
405.105(f)(7).
CMS ......
1395ss(p)(9)(C) ................
khammond on DSKJM1Z7X2PROD with RULES
HHS
agency
VerDate Sep<11>2014
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Frm 00039
Fmt 4700
Sfmt 4700
E:\FR\FM\05NOR1.SGM
Date of last
statutorily
established
penalty
figure 3
05NOR1
2018
Maximum
adjusted
penalty
($)
2019
Maximum
adjusted
penalty
($) 4
2018
15,582
15,975
2018
53,483
54,832
2018
27,714
28,413
2018
46,192
47,357
2018
27,714
28,413
2018
46,192
47,357
2018
27,714
28,413
2018
46,192
47,357
2018
27,714
28,413
2018
46,192
47,357
2018
46,192
47,357
2018
46,192
47,357
2018
19,609
20,104
2018
46,192
47,357
59564
Federal Register / Vol. 84, No. 214 / Tuesday, November 5, 2019 / Rules and Regulations
CIVIL MONETARY PENALTY AUTHORITIES ADMINISTERED BY HHS AGENCIES AND PENALTY AMOUNTS—Continued
[Effective November 5, 2019]
CFR 1
HHS
agency
Description 2
.................................................
CMS ......
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 date on which a
survey of such agency is to be conducted.
Maximum daily penalty amount for each
day a home health agency is not in compliance with statutory requirements.
Penalty per day for home health agency’s
noncompliance (Upper Range):
Minimum ......................................................
Maximum .....................................................
Penalty for a home health agency’s deficiency or deficiencies that cause immediate jeopardy and result in actual harm.
Penalty for a home health agency’s deficiency or deficiencies that cause immediate jeopardy and result in potential for
harm.
Penalty for an isolated incident of noncompliance in violation of established
HHA policy.
Penalty for a repeat and/or condition-level
deficiency that does not constitute immediate jeopardy, but is directly related to
poor quality patient care outcomes
(Lower Range):
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 Range):
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 noncompliance was corrected
during the onsite survey:
Minimum ......................................................
Maximum .....................................................
Penalty for each day of noncompliance
(Maximum).
Penalty for each day of noncompliance
(Maximum).
Penalty for discriminating or discouraging
enrollment or disenrollment of participants on the basis of an individual’s
health status or need for health care
services.
Minimum ......................................................
Maximum .....................................................
Penalty for a PACE organization that
charges excessive premiums.
Penalty for a PACE organization misrepresenting or falsifying information to CMS,
the State, or an individual or other entity.
Penalty for each determination the CMS
makes that the PACE organization has
failed to provide medically necessary
items and services of the failure has adversely affected (or has the substantial
likelihood of adversely affecting) a PACE
participant.
Penalty for involuntarily disenrolling a participant.
U.S.C.
1395ss(v)(4)(A) ................
1395bbb(c)(1) ..................
42 CFR 488.725(c) ................
CMS ......
1395bbb(f)(2)(A)(i) ...........
42 CFR 488.845(b)(2)(iii) 42
CFR 488.845(b)(3)–(6); and
42 CFR 488.845(d)(1)(ii).
42 CFR 488.845(b)(3) ............
CMS ......
42 CFR 488.845(b)(3)(i) .........
...............
42 CFR 488.845(b)(3)(ii) ........
...............
42 CFR 488.845(b)(3)(iii) .......
...............
42 CFR 488.845(b)(4) ............
...............
42 CFR 488.845(b)(5) ............
42 CFR 488.845(b)(6) ............
khammond on DSKJM1Z7X2PROD with RULES
1396b(m)(5)(B) ................
VerDate Sep<11>2014
...............
...............
...............
42 CFR 488.845(d)(1)(ii) ........
...............
42 CFR 460.46 (a)(1) .............
CMS ......
42 CFR 460.46 (a)(1) .............
42 CFR 460.46 (a)(1) .............
42 CFR 460.46 (a)(2) .............
...............
...............
...............
42 CFR 460.46 (a)(3) .............
...............
42 CFR 460.46 (a)(4) .............
...............
42 CFR 460.46 (a)(4) .............
...............
17:22 Nov 04, 2019
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PO 00000
Frm 00040
Fmt 4700
Sfmt 4700
E:\FR\FM\05NOR1.SGM
Date of last
statutorily
established
penalty
figure 3
05NOR1
2018
Maximum
adjusted
penalty
($)
2019
Maximum
adjusted
penalty
($) 4
2018
19,999
20,503
2018
33,333
34,174
2018
4,280
4,388
2018
20,521
21,039
2018
....................
....................
2018
2018
2018
17,443
20,521
20,521
17,883
21,039
21,039
2018
18,468
18,934
2018
17,443
17,883
2018
....................
....................
2018
2018
2018
3,079
17,443
....................
3,157
17,883
....................
2018
2018
2018
1,026
8,208
....................
1,052
8,415
....................
2018
2018
2018
2,052
20,521
20,521
2,104
21,039
21,039
2018
20,521
21,039
2018
....................
....................
2018
2018
2018
22,896
152,638
38,159
23,473
156,488
39,121
2018
152,638
156,488
2018
38,159
39,121
2018
38,159
39,121
Federal Register / Vol. 84, No. 214 / Tuesday, November 5, 2019 / Rules and Regulations
59565
CIVIL MONETARY PENALTY AUTHORITIES ADMINISTERED BY HHS AGENCIES AND PENALTY AMOUNTS—Continued
[Effective November 5, 2019]
CFR 1
HHS
agency
Description 2
42 CFR 460.46 (a)(4) .............
...............
42 CFR 488.408(d)(1)(iii) .......
CMS ......
Penalty for PACE organization’s practice
that would reasonably be expected to
have the effect of denying or discouraging enrollment.
Penalty per day for a nursing facility’s failure to meet a Category 2 Certification:
Minimum ......................................................
Maximum .....................................................
Penalty per instance for a nursing facility’s
failure to meet Category 2 certification:
Minimum ......................................................
Maximum .....................................................
Penalty per day 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:
Minimum ......................................................
Maximum .....................................................
Penalty per instance for a nursing facility’s
failure to meet Category 3 certification,
which results in immediate jeopardy:
Minimum ......................................................
Maximum .....................................................
Penalty per day for nursing facility’s failure
to meet certification (Upper Range):
Minimum ......................................................
Maximum .....................................................
Penalty per day for nursing facility’s failure
to meet certification (Lower Range):
Minimum ......................................................
Maximum .....................................................
Penalty per instance for nursing facility’s
failure to meet certification:
Minimum ......................................................
Maximum .....................................................
Grounds to prohibit approval of Nurse Aide
Training Program—if assessed a penalty
in 1819(h)(2)(B)(i) or 1919(h)(2)(A)(ii) of
‘‘not less than $5,000’’ [Not CMP authority, but a specific CMP amount (CMP at
this level) that is the triggering condition
for disapproval].
Grounds to waive disapproval of nurse
aide training program—reference to disapproval based on imposition of CMP
‘‘not less than $5,000’’ [Not CMP authority but CMP imposition at this level determines eligibility to seek waiver of disapproval of nurse aide training program].
Penalty for each day of noncompliance for
a home or community care provider that
no longer meets the minimum requirements for home and community care:
Minimum ......................................................
Maximum .....................................................
Penalty for a Medicaid managed care organization that fails substantially to provide
medically necessary items and services.
Penalty for Medicaid managed care organization that imposes premiums or
charges on enrollees in excess of the
premiums or charges permitted.
Penalty for a Medicaid managed care organization that misrepresents or falsifies information to another individual or entity.
Penalty for a Medicaid managed care organization that fails to comply with the applicable statutory requirements for such
organizations.
Penalty for a Medicaid managed care organization that misrepresents or falsifies information to the HHS Secretary.
U.S.C.
1396r(h)(3)(C)(ii)(I) ...........
42 CFR 488.408(d)(1)(iv) .......
42 CFR 488.408(e)(1)(iii) .......
42 CFR 488.408(e)(1)(iv) .......
42 CFR 488.408(e)(2)(ii) ........
42 CFR 488.438(a)(1)(i) .........
42 CFR 488.438(a)(1)(ii) ........
42 CFR 488.438(a)(2) ............
CMS ......
CMS ......
CMS ......
CMS ......
CMS ......
CMS ......
1396r(f)(2)(B)(iii)(I)(c) .......
42 CFR 483.151(b)(2)(iv) and
(b)(3)(iii).
CMS ......
1396r(h)(3)(C)(ii)(I) ...........
42 CFR 483.151(c)(2) ............
CMS ......
1396t(j)(2)(C) ...................
.................................................
CMS ......
1396u–2(e)(2)(A)(i) ..........
khammond on DSKJM1Z7X2PROD with RULES
CMS ......
1396u–2(e)(2)(A)(ii) .........
VerDate Sep<11>2014
42 CFR 438.704 .....................
42 CFR 438.704 .....................
17:58 Nov 04, 2019
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CMS ......
CMS ......
Frm 00041
Fmt 4700
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E:\FR\FM\05NOR1.SGM
Date of last
statutorily
established
penalty
figure 3
05NOR1
2018
Maximum
adjusted
penalty
($)
2019
Maximum
adjusted
penalty
($) 4
2018
38,159
39,121
2018
....................
....................
2018
2018
2018
107.14305
6,417
....................
110
6,579
....................
2018
2018
2018
2,140
21,393
....................
2,194
21,933
....................
2018
2018
2018
6,525
21,393
....................
6,690
21,933
....................
2018
2018
2018
2,140
21,393
....................
2,194
21,933
....................
2018
2018
2018
2,140
21,393
....................
2,194
21,933
....................
2018
2018
2018
6,525
21,393
....................
6,690
21,933
....................
2018
2018
2018
107.14305
6,417
....................
110
6,579
....................
2018
2018
2018
2,140
21,393
10,697
2,194
21,933
10,967
2018
10,697
10,967
2018
....................
....................
2018
2018
2018
2
18,477
38,159
2
18,943
39,121
2018
38,159
39,121
2018
38,159
39,121
2018
38,159
39,121
2018
152,638
156,488
59566
Federal Register / Vol. 84, No. 214 / Tuesday, November 5, 2019 / Rules and Regulations
CIVIL MONETARY PENALTY AUTHORITIES ADMINISTERED BY HHS AGENCIES AND PENALTY AMOUNTS—Continued
[Effective November 5, 2019]
HHS
agency
CFR 1
U.S.C.
1396u–2(e)(2)(A)(iv) ........
42 CFR 438.704 .....................
CMS ......
1396u(h)(2) ......................
42 CFR Part 441, Subpart I ...
CMS ......
1396w–2(c)(1) ..................
.................................................
CMS ......
18041(c)(2) ......................
45 CFR 150.315; 45 CFR
156.805(c).
CMS ......
18081(h)(1)(A)(i)(II) ..........
42 CFR 155.285 .....................
CMS ......
18081(h)(1)(B) .................
42 CFR 155.285 .....................
CMS ......
18081(h)(2) ......................
42 CFR 155.260 .....................
CMS ......
31 U.S.C.:
1352 .................................
45 CFR 93.400(e) ..................
HHS ......
45 CFR Part 93, Appendix A
khammond on DSKJM1Z7X2PROD with RULES
3801–3812 .......................
HHS ......
45 CFR 79.3(a)(1)(iv) .............
HHS ......
45 CFR 79.3(b)(1)(ii) ..............
...............
Description 2
Date of last
statutorily
established
penalty
figure 3
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 organization that acts to discriminate among enrollees on the basis of
their health status.
Penalty for a provider not meeting one of
the requirements relating to the protection of the health, safety, and welfare of
individuals receiving community supported living arrangements services.
Penalty for disclosing information related to
eligibility determinations for medical assistance programs.
Failure to comply with requirements of the
Public Health Services Act; Penalty for
violations of rules or standards of behavior associated with issuer participation in
the Federally-facilitated Exchange. (42
U.S.C. 300gg–22(b)(2)(C)).
Penalty for providing false information on
Exchange application.
Penalty for knowingly or willfully providing
false information on Exchange application.
Penalty for knowingly or willfully disclosing
protected information from Exchange.
Penalty for the first time an individual
makes an expenditure prohibited by regulations regarding lobbying disclosure,
absent aggravating circumstances.
Penalty for second and subsequent offenses by individuals who make an expenditure prohibited by regulations regarding lobbying disclosure:
Minimum ......................................................
Maximum .....................................................
Penalty for the first time an individual fails
to file or amend a lobbying disclosure
form, absent aggravating circumstances.
Penalty for second and subsequent offenses by individuals who fail to file or
amend a lobbying disclosure form, absent aggravating circumstances:
Minimum ......................................................
Maximum .....................................................
Penalty for failure to provide certification
regarding lobbying in the award documents for all sub-awards of all tiers:
Minimum ......................................................
Maximum .....................................................
Penalty for failure to provide statement regarding lobbying for loan guarantee and
loan insurance transactions:
Minimum ......................................................
Maximum .....................................................
Penalty against any individual who—with
knowledge or reason to know—makes,
presents or submits a false, fictitious or
fraudulent claim to the Department.
Penalty against any individual who—with
knowledge or reason to know—makes,
presents or submits a false, fictitious or
fraudulent claim to the Department.
1 Some
2018
Maximum
adjusted
penalty
($)
2019
Maximum
adjusted
penalty
($) 4
2018
152,638
156,488
2018
22,896
23,473
2018
21,393
21,933
2018
11,410
11,698
2018
155.10232
159
2018
28,195
28,906
2018
281,949
289,060
2018
28,195
28,906
2018
19,639
20,134
2018
....................
....................
2018
2018
2018
19,639
196,387
19,639
20,134
201,340
20,134
2018
....................
....................
2018
2018
2018
19,639
196,387
....................
20,134
201,340
....................
2018
2018
2018
19,639
196,387
....................
20,134
201,340
....................
2018
2018
2018
19,639
196,387
10,261
20,134
201,340
10,520
2018
10,261
10,520
HHS components have not promulgated regulations regarding their civil monetary penalty-specific statutory authorities.
description is not intended to be a comprehensive explanation of the underlying violation; the statute and corresponding regulation, if applicable, should be
consulted.
3 Statutory or Inflation Act Adjustment.
4 The cost of living multiplier for 2019, based on the CPI–U for the month of October 2018, not seasonally adjusted, is 1.02522, as indicated in OMB Memorandum
M–19–04, ‘‘Implementation of Penalty Inflation Adjustments for 2018, Pursuant to the Federal Civil Penalties Adjustment Act Improvements Act of 2015’’ (December
14, 2018).
* For each false record or statement, 10,000 per day.
** For each false record statement, 10,461 per day.
2 The
VerDate Sep<11>2014
17:22 Nov 04, 2019
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E:\FR\FM\05NOR1.SGM
05NOR1
Federal Register / Vol. 84, No. 214 / Tuesday, November 5, 2019 / Rules and Regulations
Dated: October 28, 2019.
Alex M. Azar II,
Secretary, Department of Health and Human
Services.
[FR Doc. 2019–23955 Filed 11–4–19; 8:45 am]
BILLING CODE 4150–24–P
FEDERAL COMMUNICATIONS
COMMISSION
47 CFR Part 1
[WT Docket No. 17–79; DA 19–1024]
Accelerating Wireless Broadband
Deployment by Removing Barriers to
Infrastructure Investment
Federal Communications
Commission.
ACTION: Final rule.
AGENCY:
The Federal Communications
Commission (Commission) repeals a
section of the Commission’s rules
implementing the small wireless
facilities exemption and deletes a crossreference to that section contained
elsewhere in the Commission’s rules.
DATES: Effective December 5, 2019.
FOR FURTHER INFORMATION CONTACT:
Belinda Nixon, Belinda.Nixon@fcc.gov,
of the Wireless Telecommunications
Bureau, Competition & Infrastructure
Policy Division, 202–418–1382.
SUPPLEMENTARY INFORMATION: This is a
summary of the Commission’s Order in
WT Docket No. 17–79; DA 19–1024,
adopted and released on October 8,
2019. The complete text of this
document is available for download at
https://fjallfoss.fcc.gov/edocs_public/.
The complete text of this document is
also available for inspection and
copying during normal business hours
in the FCC Reference Information
Center, Portals II, 445 12th Street SW,
Room CY–A257, Washington, DC 20554.
To request materials in accessible
formats for people with disabilities
(Braille, large print, electronic files,
audio format), send an email to
FCC504@fcc.gov or call the Consumer &
Governmental Affairs Bureau at 202–
418–0530 (voice), 202–418–0432 (TTY).
1. In United Keetoowah Band of
Cherokee Indians v. FCC, No. 18–1129,
2019 WL 3756373 (D.C. Cir Aug. 9,
2019) (United Keetoowah), the U.S.
Court of Appeals for the District of
Columbia Circuit vacated those portions
of the Commission’s 2018 Accelerating
Wireless Broadband Deployment by
Removing Barriers to Infrastructure
Investment (Second Report and Order),
83 FR 19440, May 3, 2018, that
exempted certain small wireless
khammond on DSKJM1Z7X2PROD with RULES
SUMMARY:
VerDate Sep<11>2014
16:18 Nov 04, 2019
Jkt 250001
facilities from federal environmental
and historic preservation review.
Pursuant to F.R. App. P. 41(b), the court
issued its mandate on October 7, 2019.
Consistent with the court’s mandate,
this Order repeals the section of the
Commission’s rules implementing the
small wireless facilities exemption and
deletes a cross-reference to that section
contained elsewhere in the
Commission’s rules.
2. The Bureau finds that notice and
comment are unnecessary for these rule
amendments under 5 U.S.C. 553(b),
because this ministerial order merely
implements the mandate of the United
States Court of Appeals for the District
of Columbia Circuit, and the
Commission lacks discretion to depart
from this mandate.
3. Accordingly, It Is Ordered that
§ 1.1312(e)(2) of the Commission’s rules,
47 CFR 1.1312(e)(2), Is Repealed and
§ 1.6002, 47 CFR 1.6002, is amended as
set forth in Appendix A of the Order,
effective December 5, 2019.
4. This action is taken pursuant to
sections 4(i), 4(j), 5(c), 303, and 309(j) of
the Communications Act of 1934, as
amended, 47 U.S.C. 154(i), 154(j),
155(c), 303 and 309(j) and § 0.331(d) of
the Commission’s rules, 47 CFR
0.331(d).
5. The Bureau has determined, and
the Administrator of the Office of
Information and Regulatory Affairs,
Office of Management and Budget,
concurs that these rules are major under
the Congressional Review Act, 5 U.S.C.
804(2). The Bureau will send a copy of
this Order to Congress and the
Government Accountability Office
pursuant to 5 U.S.C. 801(a)(1)(A). The
Bureau finds good cause to make this
rule effective earlier than 60 days after
the Order is submitted to Congress and
the Government Accountability Office,
pursuant to 5 U.S.C. 808(2), because this
ministerial order merely implements the
mandate of the United States Court of
Appeals for the District of Columbia
Circuit, and the Commission lacks
discretion to depart from this mandate.
List of Subjects in 47 CFR Part 1
Communications equipment,
Environmental protection, Historic
preservation, Radio,
Telecommunications.
Federal Communications Commission.
Amy Brett,
Associate Chief, Competition and
Infrastructure Policy Division, Wireless
Telecommunications Bureau.
Final Rules
For the reasons discussed in the
preamble, the Federal Communications
PO 00000
Frm 00043
Fmt 4700
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59567
Commission amends 47 CFR part 1 as
follows:
PART 1—PRACTICE AND
PROCEDURE
1. The authority citation for part 1
continues to read as follows:
■
Authority: 47 U.S.C. chs. 2, 5, 9, 13; 28
U.S.C. 2461 note, unless otherwise noted.
2. Section 1.1312 is amended by
revising paragraph (e) to read as follows:
■
§ 1.1312 Facilities for which no
preconstruction authorization is required.
*
*
*
*
*
(e) Paragraphs (a) through (d) of this
section shall not apply to the
construction of mobile stations.
3. Section 1.6002 is amended by
revising paragraph (l) to read as follows:
■
§ 1.6002
*
*
Definitions.
*
*
*
(l) Small wireless facilities are
facilities that meet each of the following
conditions:
(1) The facilities—
(i) Are mounted on structures 50 feet
or less in height including their
antennas as defined in § 1.1320(d); or
(ii) Are mounted on structures no
more than 10 percent taller than other
adjacent structures; or
(iii) Do not extend existing structures
on which they are located to a height of
more than 50 feet or by more than 10
percent, whichever is greater;
(2) Each antenna associated with the
deployment, excluding associated
antenna equipment (as defined in the
definition of antenna in § 1.1320(d)), is
no more than three cubic feet in volume;
(3) All other wireless equipment
associated with the structure, including
the wireless equipment associated with
the antenna and any pre-existing
associated equipment on the structure,
is no more than 28 cubic feet in volume;
(4) The facilities do not require
antenna structure registration under part
17 of this chapter;
(5) The facilities are not located on
Tribal lands, as defined under 36 CFR
800.16(x); and
(6) The facilities do not result in
human exposure to radiofrequency
radiation in excess of the applicable
safety standards specified in § 1.1307(b).
*
*
*
*
*
[FR Doc. 2019–24071 Filed 11–4–19; 8:45 am]
BILLING CODE 6712–01–P
E:\FR\FM\05NOR1.SGM
05NOR1
]]>Agencies
[Federal Register Volume 84, Number 214 (Tuesday, November 5, 2019)]
[Rules and Regulations]
[Pages 59549-59567]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-23955]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
45 CFR Part 102
RIN 0991-AC0
Annual Civil Monetary Penalties Inflation Adjustment
AGENCY: Office of the Assistant Secretary for Financial Resources,
Department of Health and Human Services.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Department of Health and Human Services is updating its
regulations to reflect required annual inflation-related increases to
the civil monetary penalties in its regulations, pursuant to the
Federal Civil Penalties Inflation Adjustment Act Improvements Act of
2015 and is making a technical change to correct an error in the
regulation.
DATES: This rule is effective November 5, 2019.
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 (Sec. 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 civil
monetary penalty authorities and the penalty 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) and on October 11, 2018 (83 FR 51369).
II. Calculation of Adjustment
The annual inflation adjustment for each applicable civil monetary
penalty 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 civil penalty was most recently
established or modified. In the December 14, 2018, Office of Management
and Budget (OMB) Memorandum for the Heads of Executive Agencies and
Departments, M-19-04, Implementation of the Penalty Inflation
Adjustments for 2019, 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 2019, based on the CPI-U for the month of October 2018,
not seasonally adjusted, is 1.02522. The multiplier is applied to each
applicable penalty amount that was updated and published for FY 2018
and is rounded to the nearest dollar.
Using the 2019 multiplier, HHS adjusted all its applicable monetary
penalties in 45 CFR 102.3. In addition to the adjustment, a technical
error for an incorrect citation in the description of 21 U.S.C.
333(f)(3)(A) was identified and is corrected below.
III. Statutory and Executive Order Reviews
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-19-04, the phrase ``notwithstanding section 553'' in
section 4(b)(2) of the 2015 Act means that ``the public procedure the
APA
[[Page 59550]]
generally requires (i.e., 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, this rule is not subject to notice and an
opportunity for public comment and will be effective immediately upon
publication.
Pursuant to OMB Memorandum M-19-04, 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 Date
This rule is effective November 5, 2019. The adjusted civil
monetary penalty amounts apply to penalties assessed on or after
November 5, 2019, if the violation occurred on or after November 2,
2015. If the violation occurred prior to November 2, 2015, or a penalty
was assessed prior to September 6, 2016, the pre-adjustment civil
penalty amounts in effect prior to September 6, 2016, will apply.
List of Subjects in 45 CFR Part 102
Administrative practice and procedure, Penalties.
For reasons discussed in the preamble, the Department of Health and
Human Services amends 45 CFR part 102 as follows:
PART 102--ADJUSTMENT OF CIVIL MONETARY PENALTIES FOR INFLATION
0
1. The authority citation for part 102 continues to read as follows:
Authority: 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 the table to read as follows:
Sec. 102.3 Penalty adjustment and table.
* * * * *
Civil Monetary Penalty Authorities Administered by HHS Agencies and Penalty Amounts
[Effective November 5, 2019]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Date of
last 2018 2019
statutorily Maximum Maximum
U.S.C. CFR \1\ HHS agency Description \2\ established adjusted adjusted
penalty penalty ($) penalty ($)
figure \3\ \4\
--------------------------------------------------------------------------------------------------------------------------------------------------------
21 U.S.C.:
333(b)(2)(A)...................... ......................... FDA................. Penalty for violations 2018 102,606 105,194
related to drug samples
resulting in a
conviction of any
representative of
manufacturer or
distributor in any 10-
year period.
333(b)(2)(B)...................... ......................... FDA................. Penalty for violation 2018 2,052,107 2,103,861
related to drug samples
resulting in a
conviction of any
representative of
manufacturer or
distributor after the
second conviction in
any 10-yr period.
333(b)(3)......................... ......................... FDA................. Penalty for failure to 2018 205,211 210,386
make a report required
by 21 U.S.C.
353(d)(3)(E) relating
to drug samples.
333(f)(1)(A)...................... ......................... FDA................. Penalty for any person 2018 27,714 28,413
who violates a
requirement related to
devices for each such
violation.
Penalty for aggregate of 2018 1,847,663 1,894,261
all violations related
to devices in a single
proceeding.
333(f)(2)(A)...................... ......................... FDA................. Penalty for any 2018 77,910 79,875
individual who
introduces or delivers
for introduction into
interstate commerce
food that is
adulterated per 21
U.S.C. 342(a)(2)(B) or
any individual who does
not comply with a
recall order under 21
U.S.C. 350l.
Penalty in the case of 2018 389,550 399,374
any other person other
than an individual) for
such introduction or
delivery of adulterated
food.
Penalty for aggregate of 2018 779,098 798,747
all such violations
related to adulterated
food adjudicated in a
single proceeding.
333(f)(3)(A)...................... ......................... FDA................. Penalty for all 2018 11,805 12,103
violations adjudicated
in a single proceeding
for any person who
violates 21 U.S.C.
331(jj) by failing to
submit the
certification required
by 42 U.S.C.
282(j)(5)(B) or
knowingly submitting a
false certification; by
failing to submit
clinical trial
information under 42
U.S.C. 282(j); or by
submitting clinical
trial information under
42 U.S.C. 282(j) that
is false or misleading
in any particular under
42 U.S.C. 282(j)(5)(D).
333(f)(3)(B)...................... ......................... FDA................. Penalty for each day any 2018 11,805 12,103
above violation is not
corrected after a 30-
day period following
notification until the
violation is corrected.
333(f)(4)(A)(i)................... ......................... FDA................. Penalty for any 2018 295,142 302,585
responsible person that
violates a requirement
of 21 U.S.C. 355(o)
(post-marketing
studies, clinical
trials, labeling), 21
U.S.C. 355(p) (risk
evaluation and
mitigation (REMS)), or
21 U.S.C. 355-1 (REMS).
[[Page 59551]]
Penalty for aggregate of 2018 1,180,566 1,210,340
all such above
violations in a single
proceeding.
333(f)(4)(A)(ii).................. ......................... FDA................. Penalty for REMS 2018 295,142 302,585
violation that
continues after written
notice to the
responsible person for
the first 30-day period
(or any portion
thereof) the
responsible person
continues to be in
violation.
Penalty for REMS 2018 1,180,566 1,210,340
violation that
continues after written
notice to responsible
person doubles for
every 30-day period
thereafter the
violation continues,
but may not exceed
penalty amount for any
30-day period.
Penalty for aggregate of 2018 11,805,665 12,103,404
all such above
violations adjudicated
in a single proceeding.
333(f)(9)(A)...................... ......................... FDA................. Penalty for any person 2018 17,115 17,547
who violates a
requirement which
relates to tobacco
products for each such
violation.
Penalty for aggregate of 2018 1,141,021 1,169,798
all such violations of
tobacco product
requirement adjudicated
in a single proceeding.
333(f)(9)(B)(i)(I)................ ......................... FDA................. Penalty per violation 2018 285,256 292,450
related to violations
of tobacco requirements.
Penalty for aggregate of 2018 1,141,021 1,169,798
all such violations of
tobacco product
requirements
adjudicated in a single
proceeding.
333(f)(9)(B)(i)(II)............... ......................... FDA................. Penalty in the case of a 2018 285,256 292,450
violation of tobacco
product requirements
that continues after
written notice to such
person, for the first
30-day period (or any
portion thereof) the
person continues to be
in violation.
Penalty for violation of 2018 1,141,021 1,169,798
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 2018 11,410,217 11,697,983
all such violations
related to tobacco
product requirements
adjudicated in a single
proceeding.
333(f)(9)(B)(ii)(I)............... ......................... FDA................. Penalty for any person 2018 285,256 292,450
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.
Penalty for aggregate of 2018 1,141,021 1,169,798
for all such above
violations adjudicated
in a single proceeding.
333(f)(9)(B)(ii)(II).............. ......................... FDA................. Penalty for violation of 2018 285,256 292,450
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 2018 1,141,021 1,169,798
violation of modified
risk tobacco product
post-market
surveillance shall
double for every 30-day
period thereafter that
the tobacco product
requirement violation
continues for any 30-
day period, but may not
exceed penalty amount
for any 30-day period.
Penalty for aggregate 2018 11,410,217 11,697,983
above tobacco product
requirement violations
adjudicated in a single
proceeding.
333(g)(1)......................... ......................... FDA................. Penalty for any person 2018 295,142 302,585
who disseminates or
causes another party to
disseminate a direct-to-
consumer advertisement
that is false or
misleading for the
first such violation in
any 3-year period.
[[Page 59552]]
Penalty for each 2018 590,284 605,171
subsequent above
violation in any 3-year
period.
333 note.......................... ......................... FDA................. Penalty to be applied 2018 284.69439 292
for 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 2018 570.40919 584
third tobacco product
regulation violation
within a 24-month
period.
Penalty in the case of a 2018 2,282 2,340
fourth tobacco product
regulation violation
within a 24-month
period.
Penalty in the case of a 2018 5,705 5,849
fifth tobacco product
regulation violation
within a 36-month
period.
Penalty in the case of a 2018 11,410 11,698
sixth or subsequent
tobacco product
regulation violation
within a 48-month
period as determined on
a case-by-case basis.
Penalty to be applied 2018 284.69439 292
for violations of
restrictions on the
sale or distribution of
tobacco products
promulgated under 21
U.S.C. 387f(d) (e.g.,
violations of
regulations in 21 CFR
part 1140) with respect
to a retailer that does
not have an approved
training program in the
case of the first
regulation violation.
Penalty in the case of a 2018 570.40919 584
second tobacco product
regulation violation
within a 12-month
period.
Penalty in the case of a 2018 1,141 1,170
third tobacco product
regulation violation
within a 24-month
period.
Penalty in the case of a 2018 2,282 2,340
fourth tobacco product
regulation violation
within a 24-month
period.
Penalty in the case of a 2018 5,705 5,849
fifth tobacco product
regulation violation
within a 36-month
period.
Penalty in the case of a 2018 5,705 5,849
fifth tobacco product
regulation violation
within a 36-month
period.
Penalty in the case of a 2018 11,410 11,698
sixth or subsequent
tobacco product
regulation violation
within a 48-month
period as determined on
a case-by-case basis.
335b(a)........................... ......................... FDA................. Penalty for each 2018 434,878 445,846
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 2018 1,739,513 1,783,384
any other person (other
than an individual) per
above violation..
360pp(b)(1)....................... ......................... FDA................. Penalty for any person 2018 2,852 2,924
who violates any such
requirements for
electronic products,
with each unlawful act
or omission
constituting a separate
violation.
Penalty imposed for any 2018 972,285 996,806
related series of
violations of
requirements relating
to electronic products..
42 U.S.C:
262(d)............................ ......................... FDA................. Penalty per day for 2018 223,629 229,269
violation of order of
recall of biological
product presenting
imminent or substantial
hazard.
[[Page 59553]]
263b(h)(3)........................ ......................... FDA................. Penalty for failure to 2018 17,395 17,834
obtain a mammography
certificate as required.
300aa-28(b)(1).................... ......................... FDA................. Penalty per occurrence 2018 223,629 229,269
for any vaccine
manufacturer that
intentionally destroys,
alters, falsifies, or
conceals any record or
report required.
256b(d)(1)(B)(vi)................. ......................... HRSA................ Penalty for each 2018 5,639 5,781
instance of
overcharging a 340B
covered entity.
299c-(3)(d)....................... ......................... AHRQ................ Penalty for an 2018 14,664 15,034
establishment or person
supplying information
obtained in the course
of activities for any
purpose other than the
purpose for which it
was supplied.
653(l)(2)......................... 45 CFR 303.21(f)......... ACF................. Penalty for Misuse of 2018 1,504 1,542
Information in the
National Directory of
New Hires.
262a(i)(1)........................ 42 CFR 1003.910.......... OIG................. Penalty for each 2018 340,130 348,708
individual who violates
safety and security
procedures related to
handling dangerous
biological agents and
toxins.
Penalty for any other 2018 680,262 697,418
person who violates
safety and security
procedures related to
handling dangerous
biological agents and
toxins.
300jj-51.......................... ......................... OIG................. Penalty per violation 2018 1,037,104 1,063,260
for committing
information blocking.
1320a-7a(a)....................... 42 CFR 1003.210(a)(1).... OIG................. Penalty for knowingly 2018 20,000 20,504
presenting or causing
to be presented to an
officer, employee, or
agent of the United
States a false claim.
Penalty for knowingly 2018 20,000 20,504
presenting or causing
to be presented a
request for payment
which violates the
terms of an assignment,
agreement, or PPS
agreement.
42 CFR 1003.210(a)(2).... .................... Penalty for knowingly 2018 30,000 30,757
giving or causing to be
presented to a
participating provider
or supplier false or
misleading information
that could reasonably
be expected to
influence a discharge
decision.
42 CFR 1003.210(a)(3).... .................... Penalty for an excluded 2018 20,000 20,504
party retaining
ownership or control
interest in a
participating entity.
42 CFR 1003.1010......... .................... Penalty for remuneration 2018 20,000 20,504
offered to induce
program beneficiaries
to use particular
providers,
practitioners, or
suppliers.
42 CFR 1003.210(a)(4).... .................... Penalty for employing or 2018 20,000 20,504
contracting with an
excluded individual.
42 CFR 1003.310(a)(3).... .................... Penalty for knowing and 2018 100,000 102,522
willful solicitation,
receipt, offer, or
payment of remuneration
for referring an
individual for a
service or for
purchasing, leasing, or
ordering an item to be
paid for by a Federal
health care program.
42 CFR 1003.210(a)(1).... .................... Penalty for ordering or 2018 20,000 20,504
prescribing medical or
other item or service
during a period in
which the person was
excluded.
42 CFR 1003.210(a)(6).... .................... Penalty for knowingly 2018 100,000 102,522
making or causing to be
made a false statement,
omission or
misrepresentation of a
material fact in any
application, bid, or
contract to participate
or enroll as a provider
or supplier.
42 CFR 1003.210(a)(8).... .................... Penalty for knowing of 2018 20,000 20,504
an overpayment and
failing to report and
return.
42 CFR 1003.210(a)(7).... .................... Penalty for making or 2018 100,000 102,522
using a false record or
statement that is
material to a false or
fraudulent claim.
42 CFR 1003.210(a)(9).... .................... Penalty for failure to 2018 30,000 30,757
grant timely access to
HHS OIG for audits,
investigations,
evaluations, and other
statutory functions of
HHS OIG.
1320a-7a(b)....................... ......................... OIG................. Penalty for payments by 2018 5,000 5,126
a hospital or critical
access hospital to
induce a physician to
reduce or limit
services to individuals
under direct care of
physician or who are
entitled to certain
medical assistance
benefits
[[Page 59554]]
Penalty for physicians 2018 5,000 5,126
who knowingly receive
payments from a
hospital or critical
access hospital to
induce such physician
to reduce or limit
services to individuals
under direct care of
physician or who are
entitled to certain
medical assistance
benefits.
42 CFR 1003.210(a)(10)... .................... Penalty for a physician 2018 10,000 10,252
who executes a document
that falsely certifies
home health needs for
Medicare beneficiaries
1320a-7a(o)....................... ......................... OIG................. Penalty for knowingly 2016 10,000 10,461
presenting or causing
to be presented a false
or fraudulent specified
claim under a grant,
contract, or other
agreement for which the
Secretary provides
funding
Knowingly makes, uses, 2016 50,000 52,308
or causes to be made or
used any false
statement, omission, or
misrepresentation of a
material fact in any
application, proposal,
bid, progress report,
or other document
required to directly or
indirectly receive or
retain funds provided
pursuant to grant,
contract, or other
agreement
Knowingly makes, uses, 2016 50,000 52,308
or causes to be made or
used, a false record or
statement material to a
false or fraudulent
specified claim under
grant, contract, or
other agreement.
Knowingly makes, uses, 2016 * 50,000 ** 52,308
or causes to be made or
used, a false record or
statement material to
an obligation to pay or
transmit funds or
property with respect
to grant, contract, or
other agreement, or
knowingly conceals or
improperly avoids or
decreases any such
obligation..
Fails to grant timely 2016 15,000 15,692
access, upon reasonable
request, to the I.G.
for purposes of audits,
investigations,
evaluations, or other
statutory functions of
I.G. in matters
involving grants,
contracts, or other
agreements..
1320a-7e(b)(6)(A)................. 42 CFR 1003.810.......... OIG................. Penalty for failure to 2018 38,159 39,121
report any final
adverse action taken
against a health care
provider, supplier, or
practitioner.
1320b-10(b)(1).................... 42 CFR 1003.610(a)....... OIG................. Penalty for the misuse 2018 10,260 10,519
of words, symbols, or
emblems in
communications in a
manner in which a
person could falsely
construe that such item
is approved, endorsed,
or authorized by HHS.
1320b-10(b)(2).................... 42 CFR 1003.610(a)....... OIG................. Penalty for the misuse 2018 51,302 52,596
of words, symbols, or
emblems in a broadcast
or telecast in a manner
in which a person could
falsely construe that
such item is approved,
endorsed, or authorized
by HHS.
1395i-3(b)(3)(B)(ii)(1)........... 42 CFR 1003.210(a)(11)... OIG................. Penalty for 2018 2,140 2,194
certification of a
false statement in
assessment of
functional capacity of
a Skilled Nursing
Facility resident
assessment.
1395i-3(b)(3)(B)(ii)(2)........... 42 CFR 1003.210(a)(11)... OIG................. Penalty for causing 2018 10,697 10,967
another to certify or
make a false statement
in assessment of
functional capacity of
a Skilled Nursing
Facility resident
assessment.
1395i-3(g)(2)(A).................. 42 CFR 1003.1310......... OIG................. Penalty for any 2018 4,280 4,388
individual who notifies
or causes to be
notified a Skilled
Nursing Facility of the
time or date on which a
survey is to be
conducted.
1395w-27(g)(2)(A)................. 42 CFR 1003.410.......... OIG................. Penalty for a Medicare 2018 38,954 39,936
Advantage organization
that substantially
fails to provide
medically necessary,
required items and
services.
Penalty for a Medicare 2018 38,159 39,121
Advantage organization
that charges excessive
premiums.
Penalty for a Medicare 2018 38,159 39,121
Advantage organization
that improperly expels
or refuses to reenroll
a beneficiary.
[[Page 59555]]
Penalty for a Medicare 2018 152,638 156,488
Advantage organization
that engages in
practice that would
reasonably be expected
to have the effect of
denying or discouraging
enrollment.
Penalty per individual 2018 22,896 23,473
who does not enroll as
a result of a Medicare
Advantage
organization's practice
that would reasonably
be expected to have the
effect of denying or
discouraging enrollment.
Penalty for a Medicare 2018 152,638 156,488
Advantage organization
misrepresenting or
falsifying information
to Secretary.
Penalty for a Medicare 2018 38,159 39,121
Advantage organization
misrepresenting or
falsifying information
to individual or other
entity.
Penalty for Medicare 2018 38,159 39,121
Advantage organization
interfering with
provider's advice to
enrollee and non-MCO
affiliated providers
that balance bill
enrollees.
Penalty for a Medicare 2018 38,159 39,121
Advantage organization
that employs or
contracts with excluded
individual or entity.
Penalty for a Medicare 2018 38,159 39,121
Advantage organization
enrolling an individual
in without prior
written consent.
Penalty for a Medicare 2018 38,159 39,121
Advantage organization
transferring an
enrollee to another
plan without consent or
solely for the purpose
of earning a commission.
Penalty for a Medicare 2018 38,159 39,121
Advantage organization
failing to comply with
marketing restrictions
or applicable
implementing
regulations or guidance.
Penalty for a Medicare 2018 38,159 39,121
Advantage organization
employing or
contracting with an
individual or entity
who violates 1395w-
27(g)(1)(A)-(J).
1395w-141(i)(3)................... ......................... OIG................. Penalty for a 2018 13,333 13,669
prescription drug card
sponsor that falsifies
or misrepresents
marketing materials,
overcharges program
enrollees, or misuse
transitional assistance
funds.
1395cc(g)......................... 42 CFR 1003.210(a)(5).... OIG................. Penalty for improper 2018 5,186 5,317
billing by Hospitals,
Critical Access
Hospitals, or Skilled
Nursing Facilities.
1395dd(d)(1)...................... 42 CFR 1003.510.......... OIG................. Penalty for a hospital 2018 106,965 109,663
with 100 beds or more
or responsible
physician dumping
patients needing
emergency medical care.
Penalty for a hospital 2018 53,484 54,833
with less than 100 beds
dumping patients
needing emergency
medical care.
1395mm(i)(6)(B)(i)................ 42 CFR 1003.410.......... OIG................. Penalty for a HMO or 2018 53,484 54,833
competitive plan if
such plan substantially
fails to provide
medically necessary,
required items or
services.
Penalty for HMOs/ 2018 53,484 54,833
competitive medical
plans that charge
premiums in excess of
permitted amounts.
Penalty for a HMO or 2018 53,484 54,833
competitive medical
plan that expels or
refuses to reenroll an
individual per
prescribed conditions.
Penalty for a HMO or 2018 213,932 219,327
competitive medical
plan that implements
practices to discourage
enrollment of
individuals needing
services in future.
Penalty per individual 2018 30,782 31,558
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 2018 213,932 219,327
competitive medical
plan that misrepresents
or falsifies
information to the
Secretary.
[[Page 59556]]
Penalty for a HMO or 2018 53,484 54,833
competitive medical
plan that misrepresents
or falsifies
information to an
individual or any other
entity.
Penalty for failure by 2018 53,484 54,833
HMO or competitive
medical plan to assure
prompt payment of
Medicare risk sharing
contracts or incentive
plan provisions.
Penalty for HMO that 2018 49,096 50,334
employs or contracts
with excluded
individual or entity.
1395nn(g)(3)...................... 42 CFR 1003.310.......... OIG................. Penalty for submitting 2018 24,748 25,372
or causing to be
submitted claims in
violation of the Stark
Law's restrictions on
physician self-
referrals.
1395nn(g)(4)...................... 42 CFR 1003.310.......... OIG................. Penalty for 2018 164,992 169,153
circumventing Stark
Law's restrictions on
physician self-
referrals.
1395ss(d)(1)...................... 42 CFR 1003.1110......... OIG................. Penalty for a material 2018 10,260 10,519
misrepresentation
regarding Medigap
compliance policies.
1395ss(d)(2)...................... 42 CFR 1003.1110......... OIG................. Penalty for selling 2018 10,260 10,519
Medigap policy under
false pretense.
1395ss(d)(3)(A)(ii)............... 42 CFR 1003.1110......... OIG................. Penalty for an issuer 2018 46,192 47,357
that sells health
insurance policy that
duplicates benefits.
Penalty for someone 2018 27,714 28,413
other than issuer that
sells health insurance
that duplicates
benefits.
1395ss(d)(4)(A)................... 42 CFR 1003.1110......... OIG................. Penalty for using mail 2018 10,260 10,519
to sell a non-approved
Medigap insurance
policy.
1396b(m)(5)(B)(i)................. 42 CFR 1003.410.......... OIG................. Penalty for a Medicaid 2018 51,302 52,596
MCO that substantially
fails to provide
medically necessary,
required items or
services.
Penalty for a Medicaid 2018 51,302 52,596
MCO that charges
excessive premiums.
Penalty for a Medicaid 2018 205,211 210,386
MCO that improperly
expels or refuses to
reenroll a beneficiary.
Penalty per individual 2018 30,782 31,558
who does not enroll as
a result of a Medicaid
MCO's practice that
would reasonably be
expected to have the
effect of denying or
discouraging enrollment.
Penalty for a Medicaid 2018 205,211 210,386
MCO misrepresenting or
falsifying information
to the Secretary.
Penalty for a Medicaid 2018 51,302 52,596
MCO misrepresenting or
falsifying information
to an individual or
another entity.
Penalty for a Medicaid 2018 46,192 47,357
MCO that fails to
comply with contract
requirements with
respect to physician
incentive plans.
1396r(b)(3)(B)(ii)(I)............. 42 CFR 1003.210(a)(11)... OIG................. Penalty for willfully 2018 2,140 2,194
and knowingly
certifying a material
and false statement in
a Skilled Nursing
Facility resident
assessment.
1396r(b)(3)(B)(ii)(II)............ 42 CFR 1003.210(a)(11)... OIG................. Penalty for willfully 2018 10,697 10,967
and knowingly causing
another individual to
certify a material and
false statement in a
Skilled Nursing
Facility resident
assessment.
1396r(g)(2)(A)(i)................. 42 CFR 1003.1310......... OIG................. Penalty for notifying or 2018 4,280 4,388
causing to be notified
a Skilled Nursing
Facility of the time or
date on which a survey
is to be conducted.
1396r-8(b)(3)(B).................. 42 CFR 1003.1210......... OIG................. Penalty for the knowing 2018 184,767 189,427
provision of false
information or refusing
to provide information
about charges or prices
of a covered outpatient
drug.
1396r-8(b)(3)(C)(i)............... 42 CFR 1003.1210......... OIG................. Penalty per day for 2018 18,477 18,943
failure to timely
provide information by
drug manufacturer with
rebate agreement.
1396r-8(b)(3)(C)(ii).............. 42 CFR 1003.1210......... OIG................. Penalty for knowing 2018 184,767 189,427
provision of false
information by drug
manufacturer with
rebate agreement.
1396t(i)(3)(A).................... 42 CFR 1003.1310......... OIG................. Penalty for notifying 2018 3,695 3,788
home and community-
based providers or
settings of survey.
11131(c).......................... 42 CFR 1003.810.......... OIG................. Penalty for failing to 2018 22,363 22,927
report a medical
malpractice claim to
National Practitioner
Data Bank.
[[Page 59557]]
11137(b)(2)....................... 42 CFR 1003.810.......... OIG................. Penalty for breaching 2018 22,363 22,927
confidentiality of
information reported to
National Practitioner
Data Bank.
299b-22(f)(1)..................... 42 CFR 3.404............. OCR................. Penalty for violation of 2018 12,383 12,695
confidentiality
provision of the
Patient Safety and
Quality Improvement Act.
45 CFR 160.404(b)(1)(i), OCR................. Penalty for each pre- 2018 155.10232 159
(ii). February 18, 2009
violation of the HIPAA
administrative
simplification
provisions.
Calendar Year Cap....... 2018 38,954 39,936
1320(d)-5(a)...................... 45 CFR OCR................. Penalty for each 2018 ........... ...........
160.404(b)(2)(i)(A), (B). February 18, 2009 or
later violation of a
HIPAA administrative
simplification
provision in which it
is established that the
covered entity or
business associate did
not know and by
exercising reasonable
diligence, would not
have known that the
covered entity or
business associate
violated such a
provision:
Minimum................. 2018 114.28592 117
Maximum................. 2018 57,051 58,490
Calendar Year Cap....... 2018 1,711,533 1,754,698
45 CFR OCR................. Penalty for each 2018 ........... ...........
160.404(b)(2)(ii)(A), February 18, 2009 or
(B). later violation of a
HIPAA administrative
simplification
provision in which it
is established that the
violation was due to
reasonable cause and
not to willful neglect:
Minimum................. 2018 1,141 1,170
Maximum................. 2018 57,051 58,490
Calendar Year Cap....... 2018 1,711,533 1,754,698
45 CFR OCR................. Penalty for each 2018 ........... ...........
160.404(b)(2)(iii)(A), February 18, 2009 or
(B). later violation of a
HIPAA administrative
simplification
provision in which it
is established that the
violation was due to
willful neglect and was
corrected during the 30-
day period beginning on
the first date the
covered entity or
business associate
knew, or, by exercising
reasonable diligence,
would have known that
the violation occurred:
Minimum................. 2018 11,410 11,698
Maximum................. 2018 57,051 58,490
Calendar Year Cap....... 2018 1,711,533 1,754,698
45 CFR OCR................. Penalty for each 2018 ........... ...........
160.404(b)(2)(iv)(A), February 18, 2009 or
(B). later violation of a
HIPAA administrative
simplification
provision in which it
is established that the
violation was due to
willful neglect and was
not corrected during
the 30-day period
beginning on the first
date the covered entity
or business associate
knew, or by exercising
reasonable diligence,
would have known that
the violation occurred:
Minimum................. 2018 57,051 58,490
Maximum................. 2018 1,711,533 1,754,698
Calendar Year Cap....... 2018 1,711,533 1,754,698
263a(h)(2)(B) & 1395w- 42 CFR 493.1834(d)(2)(i). CMS................. Penalty for a clinical 2018 ........... ...........
2(b)(2)(A)(ii). laboratory's failure to
meet participation and
certification
requirements and poses
immediate jeopardy:
Minimum................. 2018 6,259 6,417
Maximum................. 2018 20,521 21,039
42 CFR 493.1834(d)(2)(ii) CMS................. Penalty for a clinical 2018 ........... ...........
laboratory's failure to
meet participation and
certification
requirements and the
failure does not pose
immediate jeopardy:
Minimum................. 2018 103 106
Maximum................. 2018 6,156 6,311
300gg-15(f)....................... 45 CFR 147.200(e)........ CMS................. Failure to provide the 2018 1,128 1,156
Summary of Benefits and
Coverage.
300gg-18.......................... 45 CFR 158.606........... CMS................. Penalty for violations 2018 113 116
of regulations related
to the medical loss
ratio reporting and
rebating.
[[Page 59558]]
1320a-7h(b)(1).................... 42 CFR 402.105(d)(5), 42 CMS................. Penalty for manufacturer 2018 ........... ...........
CFR 403.912(a) & (c). or group purchasing
organization failing to
report information
required under 42
U.S.C. 1320a-7h(a),
relating to physician
ownership or investment
interests:
Minimum................. 2018 1,128 1,156
Maximum................. 2018 11,278 11,562
Calendar Year Cap....... 2018 169,170 173,436
1320a-7h(b)(2).................... 42 CFR 402.105(h), 42 CFR CMS................. Penalty for manufacturer 2018 ........... ...........
403.912(b) & (c). or group purchasing
organization knowingly
failing to report
information required
under 42 U.S.C. 1320a-
7h(a), relating to
physician ownership or
investment interests:
Minimum................. 2018 11,278 11,562
Maximum................. 2018 112,780 115,624
Calendar Year Cap....... 2018 1,127,799 1,156,242
CMS................. Penalty for an 2018 112,780 115,624
administrator of a
facility that fails to
comply with notice
requirements for the
closure of a facility.
1320a-7j(h)(3)(A)................. 42 CFR 488.446(a)(1), CMS................. Minimum penalty for the 2018 564.28673 578
(2), & (3). first offense of an
administrator who fails
to provide notice of
facility closure.
Minimum penalty for the 2018 1,692 1,735
second offense of an
administrator who fails
to provide notice of
facility closure.
Minimum penalty for the 2018 3,383 3,468
third and subsequent
offenses of an
administrator who fails
to provide notice of
facility closure.
1320a-8(a)(1)..................... ......................... CMS................. Penalty for an entity 2018 8,249 8,457
knowingly making a
false statement or
representation of
material fact in the
determination of the
amount of benefits or
payments related to old-
age, survivors, and
disability insurance
benefits, special
benefits for certain
World War II veterans,
or supplemental
security income for the
aged, blind, and
disabled.
Penalty for violation of 2018 7,779 7,975
42 U.S.C. 1320a-8(a)(1)
if the violator is a
person who receives a
fee or other income for
services performed in
connection with
determination of the
benefit amount or the
person is a physician
or other health care
provider who submits
evidence in connection
with such a
determination.
1320a-8(a)(3)..................... ......................... CMS................. Penalty for a 2018 6,460 6,623
representative payee
(under 42 U.S.C.
405(j), 1007, or
1383(a)(2)) converting
any part of a received
payment from the
benefit programs
described in the
previous civil monetary
penalty to a use other
than for the benefit of
the beneficiary.
1320b-25(c)(1)(A)................. ......................... CMS................. Penalty for failure of 2018 225,560 231,249
covered individuals to
report to the Secretary
and 1 or more law
enforcement officials
any reasonable
suspicion of a crime
against a resident, or
individual receiving
care, from a long-term
care facility.
1320b-25(c)(2)(A)................. ......................... CMS................. Penalty for failure of 2018 338,339 346,872
covered individuals to
report to the Secretary
and 1 or more law
enforcement officials
any reasonable
suspicion of a crime
against a resident, or
individual receiving
care, from a long-term
care facility if such
failure exacerbates the
harm to the victim of
the crime or results in
the harm to another
individual.
1320b-25(d)(2).................... ......................... CMS................. Penalty for a long-term 2018 225,560 231,249
care facility that
retaliates against any
employee because of
lawful acts done by the
employee, or files a
complaint or report
with the State
professional
disciplinary agency
against an employee or
nurse for lawful acts
done by the employee or
nurse.
[[Page 59559]]
1395b-7(b)(2)(B).................. 42 CFR 402.105(g)........ CMS................. Penalty for any person 2018 152 156
who knowingly and
willfully fails to
furnish a beneficiary
with an itemized
statement of items or
services within 30 days
of the beneficiary's
request.
1395i-3(h)(2)(B)(ii)(I)........... 42 CFR 488.408(d)(1)(iii) CMS................. Penalty per day for a 2018 ........... ...........
Skilled Nursing
Facility that has a
Category 2 violation of
certification
requirements:
Minimum................. 2018 107 110
Maximum................. 2018 6,417 6,579
42 CFR 488.408(d)(1)(iv). CMS................. Penalty per instance of 2018 ........... ...........
Category 2
noncompliance by a
Skilled Nursing
Facility:
Minimum................. 2018 2,140 2,194
Maximum................. 2018 21,393 21,933
42 CFR 488.408(e)(1)(iii) CMS................. Penalty per day for a 2018 ........... ...........
Skilled Nursing
Facility that has a
Category 3 violation of
certification
requirements:
Minimum................. 2018 6,525 6,690
Maximum................. 2018 21,393 21,933
42 CFR 488.408(e)(1)(iv). CMS................. Penalty per instance of 2018 ........... ...........
Category 3
noncompliance by a
Skilled Nursing
Facility:
Minimum................. 2018 2,140 2,194
Maximum................. 2018 21,393 21,933
42 CFR 488.408(e)(2)(ii). CMS................. Penalty per day and per 2018 ........... ...........
instance for a Skilled
Nursing Facility that
has Category 3
noncompliance with
Immediate Jeopardy:
Per Day (Minimum)....... 2018 6,525 6,690
Per Day (Maximum)....... 2018 21,393 21,933
Per Instance (Minimum).. 2018 2,140 2,194
Per Instance (Maximum).. 2018 21,393 21,933
42 CFR 488.438(a)(1)(i).. CMS................. Penalty per day of a 2018 ........... ...........
Skilled Nursing
Facility that fails to
meet certification
requirements. These
amounts represent the
upper range per day:
Minimum................. 2018 6,525 6,690
Maximum................. 2018 21,393 21,933
42 CFR 488.438(a)(1)(ii). CMS................. Penalty per day of a 2018 ........... ...........
Skilled Nursing
Facility that fails to
meet certification
requirements. These
amounts represent the
lower range per day:
Minimum................. 2018 107 110
Maximum................. 2018 6,417 6,579
42 CFR 488.438(a)(2)..... CMS................. Penalty per instance of 2018 ........... ...........
a Skilled Nursing
Facility that fails to
meet certification
requirements:
Minimum................. 2018 2,140 2,194
Maximum................. 2018 21,393 21,933
1395l(h)(5)(D).................... 42 CFR 402.105(d)(2)(i).. CMS................. Penalty for knowingly, 2018 15,582 15,975
willfully, and
repeatedly billing for
a clinical diagnostic
laboratory test other
than on an assignment-
related basis.
(Penalties are assessed
in the same manner as
42 U.S.C.
1395u(j)(2)(B), which
is assessed according
to 1320a-7a(a)).
1395l(i)(6)....................... ......................... CMS................. Penalty for knowingly 2018 4,104 4,208
and willfully
presenting or causing
to be presented a bill
or request for payment
for an intraocular lens
inserted during or
after cataract surgery
for which the Medicare
payment rate includes
the cost of acquiring
the class of lens
involved.
1395l(q)(2)(B)(i)................. 42 CFR 402.105(a)........ CMS................. Penalty for knowingly 2018 3,928 4,027
and willfully failing
to provide information
about a referring
physician when seeking
payment on an
unassigned basis.
1395m(a)(11)(A)................... 42 CFR 402.1(c)(4), CMS................. Penalty for any durable 2018 15,582 15,975
402.105(d)(2)(ii). medical equipment
supplier that knowingly
and willfully charges
for a covered service
that is furnished on a
rental basis after the
rental payments may no
longer be made.
(Penalties are assessed
in the same manner as
42 U.S.C.
1395u(j)(2)(B), which
is assessed according
to 1320a-7a(a)).
[[Page 59560]]
1395m(a)(18)(B)................... 42 CFR 402.1(c)(5), CMS................. Penalty for any 2018 15,582 15,975
402.105(d)(2)(iii). nonparticipating
durable medical
equipment supplier that
knowingly and willfully
fails to make a refund
to Medicare
beneficiaries for a
covered service for
which payment is
precluded due to an
unsolicited telephone
contact from the
supplier. (Penalties
are assessed in the
same manner as 42
U.S.C. 1395u(j)(2)(B),
which is assessed
according to 1320a-
7a(a)).
1395m(b)(5)(C).................... 42 CFR 402.1(c)(6), CMS................. Penalty for any 2018 15,582 15,975
402.105(d)(2)(iv). nonparticipating
physician or supplier
that knowingly and
willfully charges a
Medicare beneficiary
more than the limiting
charge for radiologist
services. (Penalties
are assessed in the
same manner as 42
U.S.C. 1395u(j)(2)(B),
which is assessed
according to 1320a-
7a(a)).
1395m(h)(3)....................... 42 CFR 402.1(c)(8), CMS................. Penalty for any supplier 2018 15,582 15,975
402.105(d)(2)(vi). of prosthetic devices,
orthotics, and
prosthetics that
knowing and willfully
charges for a covered
prosthetic device,
orthotic, or prosthetic
that is furnished on a
rental basis after the
rental payment may no
longer be made.
(Penalties are assessed
in the same manner as
42 U.S.C.
1395m(a)(11)(A), that
is in the same manner
as 1395u(j)(2)(B),
which is assessed
according to 1320a-
7a(a)).
1395m(j)(2)(A)(iii)............... ......................... CMS................. Penalty for any supplier 2018 1,650 1,692
of durable medical
equipment including a
supplier of prosthetic
devices, prosthetics,
orthotics, or supplies
that knowingly and
willfully distributes a
certificate of medical
necessity in violation
of Section
1834(j)(2)(A)(i) of the
Act or fails to provide
the information
required under Section
1834(j)(2)(A)(ii) of
the Act.
1395m(j)(4)....................... 42 CFR 402.1(c)(10), CMS................. Penalty for any supplier 2018 15,582 15,975
402.105(d)(2)(vii). of durable medical
equipment, including a
supplier of prosthetic
devices, prosthetics,
orthotics, or supplies
that knowingly and
willfully fails to make
refunds in a timely
manner to Medicare
beneficiaries for
series billed other
than on as assignment-
related basis under
certain conditions.
(Penalties are assessed
in the same manner as
42 U.S.C. 1395m(j)(4)
and 1395u(j)(2)(B),
which is assessed
according to 1320a-
7a(a)).
1395m(k)(6)....................... 42 CFR 402.1(c)(31), CMS................. Penalty for any person 2018 15,582 15,975
402.105(d)(3). or entity who knowingly
and willfully bills or
collects for any
outpatient therapy
services or
comprehensive
outpatient
rehabilitation services
on other than an
assignment-related
basis. (Penalties are
assessed in the same
manner as 42 U.S.C.
1395m(k)(6) and
1395u(j)(2)(B), which
is assessed according
to 1320a-7a(a)).
1395m(l)(6)....................... 42 CFR 402.1(c)(32), CMS................. Penalty for any supplier 2018 15,582 15,975
402.105(d)(4). of ambulance services
who knowingly and
willfully fills or
collects for any
services on other than
an assignment-related
basis. (Penalties are
assessed in the same
manner as 42 U.S.C.
1395u(b)(18)(B), which
is assessed according
to 1320a-7a(a)).
1395u(b)(18)(B)................... 42 CFR 402.1(c)(11), CMS................. Penalty for any 2018 15,582 15,975
402.105(d)(2)(viii). practitioner specified
in Section
1842(b)(18)(C) of the
Act or other person
that knowingly and
willfully bills or
collects for any
services by the
practitioners on other
than an assignment-
related basis.
(Penalties are assessed
in the same manner as
42 U.S.C.
1395u(j)(2)(B), which
is assessed according
to 1320a-7a(a)).
[[Page 59561]]
1395u(j)(2)(B).................... 42 CFR 402.1(c).......... CMS................. Penalty for any 2018 15,582 15,975
physician who charges
more than 125% for a
non-participating
referral. (Penalties
are assessed in the
same manner as 42
U.S.C. 1320a-7a(a)).
1395u(k).......................... 42 CFR 402.1(c)(12), CMS................. Penalty for any 2018 15,582 15,975
402.105(d)(2)(ix). physician who knowingly
and willfully presents
or causes to be
presented a claim for
bill for an assistant
at a cataract surgery
performed on or after
March 1, 1987, for
which payment may not
be made because of
section 1862(a)(15).
(Penalties are assessed
in the same manner as
42 U.S.C.
1395u(j)(2)(B), which
is assessed according
to 1320a-7a(a)).
1395u(l)(3)....................... 42 CFR 402.1(c)(13), CMS................. Penalty for any 2018 15,582 15,975
402.105(d)(2)(x). nonparticipating
physician who does not
accept payment on an
assignment-related
basis and who knowingly
and willfully fails to
refund on a timely
basis any amounts
collected for services
that are not reasonable
or medically necessary
or are of poor quality
under 1842(l)(1)(A).
(Penalties are assessed
in the same manner as
42 U.S.C.
1395u(j)(2)(B), which
is assessed according
to 1320a-7a(a)).
1395u(m)(3)....................... 42 CFR 402.1(c)(14), CMS................. Penalty for any 2018 15,582 15,975
402.105(d)(2)(xi). nonparticipating
physician charging more
than $500 who does not
accept payment for an
elective surgical
procedure on an
assignment related
basis and who knowingly
and willfully fails to
disclose the required
information regarding
charges and coinsurance
amounts and fails to
refund on a timely
basis any amount
collected for the
procedure in excess of
the charges recognized
and approved by the
Medicare program.
(Penalties are assessed
in the same manner as
42 U.S.C.
1395u(j)(2)(B), which
is assessed according
to 1320a-7a(a)).
1395u(n)(3)....................... 42 CFR 402.1(c)(15), CMS................. Penalty for any 2018 15,582 15,975
402.105(d)(2)(xii). physician who
knowingly, willfully,
and repeatedly bills
one or more
beneficiaries for
purchased diagnostic
tests any amount other
than the payment amount
specified by the Act.
(Penalties are assessed
in the same manner as
42 U.S.C.
1395u(j)(2)(B), which
is assessed according
to 1320a-7a(a)).
1395u(o)(3)(B).................... 42 CFR 414.707(b)........ CMS................. Penalty for any 2018 15,582 15,975
practitioner specified
in Section
1842(b)(18)(C) of the
Act or other person
that knowingly and
willfully bills or
collects for any
services pertaining to
drugs or biologics by
the practitioners on
other than an
assignment-related
basis. (Penalties are
assessed in the same
manner as 42 U.S.C.
1395u(b)(18)(B) and
1395u(j)(2)(B), which
is assessed according
to 1320a-7a(a)).
1395u(p)(3)(A).................... ......................... CMS................. Penalty for any 2018 4,104 4,208
physician or
practitioner who
knowingly and willfully
fails promptly to
provide the appropriate
diagnosis codes upon
CMS or Medicare
administrative
contractor request for
payment or bill not
submitted on an
assignment-related
basis.
1395w-3a(d)(4)(A)................. 42 CFR 414.806........... CMS................. Penalty for a 2018 13,333 13,669
pharmaceutical
manufacturer's
misrepresentation of
average sales price of
a drug, or biologic.
[[Page 59562]]
1395w-4(g)(1)(B).................. 42 CFR 402.1(c)(17), CMS................. Penalty for any 2018 15,582 15,975
402.105(d)(2)(xiii). nonparticipating
physician, supplier, or
other person that
furnishes physician
services not on an
assignment-related
basis who either
knowingly and willfully
bills or collects in
excess of the
statutorily-defined
limiting charge or
fails to make a timely
refund or adjustment.
(Penalties are assessed
in the same manner as
42 U.S.C.
1395u(j)(2)(B), which
is assessed according
to 1320a-7a(a)).
1395w-4(g)(3)(B).................. 42 CFR 402.1(c)(18), CMS................. Penalty for any person 2018 15,582 15,975
402.105(d)(2)(xiv). that knowingly and
willfully bills for
statutorily defined
State-plan approved
physicians' services on
any other basis than an
assignment-related
basis for a Medicare/
Medicaid dual eligible
beneficiary. (Penalties
are assessed in the
same manner as 42
U.S.C. 1395u(j)(2)(B),
which is assessed
according to 1320a-
7a(a)).
1395w-27(g)(3)(A); 1857(g)(3) (A). 42 CFR 422.760(b)(1)-(2); CMS................. Penalty for each 2018 38,159 39,121
42 CFR 423.760(b)(1)-(2). termination
determination the
Secretary makes that is
the result of actions
by a Medicare Advantage
organization or Part D
sponsor that has
adversely affected an
individual covered
under the
organization's contract.
1395w-27(g)(3)(B); 1857(g)(3)(B).. 42 CFR 422.760(b)(3); 42 CMS................. Penalty for each week 2018 15,264 15,649
CFR 423.760(b)(3). beginning after the
initiation of civil
money penalty
procedures by the
Secretary because a
Medicare Advantage
organization or Part D
sponsor has failed to
carry out a contract,
or has carried out a
contract inconsistently
with regulations.
1395w-27(g)(3)(D); 1857(g)(3)(D).. ......................... CMS................. Penalty for a Medicare 2018 141,760 145,335
Advantage
organization's or Part
D sponsor's early
termination of its
contract.
1395y(b)(3)(C).................... 42 CFR 411.103(b)........ CMS................. Penalty for an employer 2018 9,239 9,472
or other entity to
offer any financial or
other incentive for an
individual entitled to
benefits not to enroll
under a group health
plan or large group
health plan which would
be a primary plan.
1395y(b)(5)(C)(ii)................ 42 CFR 402.1(c)(20), 42 CMS................. Penalty for any non- 2018 1,504 1,542
CFR 402.105(b)(2). governmental employer
that, before October 1,
1998, willfully or
repeatedly failed to
provide timely and
accurate information
requested relating to
an employee's group
health insurance
coverage.
1395y(b)(6)(B).................... 42 CFR 402.1(c)(21), CMS................. Penalty for any entity 2018 3,300 3,383
402.105(a). that knowingly,
willfully, and
repeatedly fails to
complete a claim form
relating to the
availability of other
health benefits in
accordance with statute
or provides inaccurate
information relating to
such on the claim form.
1395y(b)(7)(B)(i)................. ......................... CMS................. Penalty for any entity 2018 1,181 1,211
serving as insurer,
third party
administrator, or
fiduciary for a group
health plan that fails
to provide information
that identifies
situations where the
group health plan is or
was a primary plan to
Medicare to the HHS
Secretary.
1395y(b)(8)(E).................... ......................... CMS................. Penalty for any non- 2018 1,181 1,211
group health plan that
fails to identify
claimants who are
Medicare beneficiaries
and provide information
to the HHS Secretary to
coordinate benefits and
pursue any applicable
recovery claim.
1395nn(g)(5)...................... 42 CFR 411.361........... CMS................. Penalty for any person 2018 19,639 20,134
that fails to report
information required by
HHS under Section
1877(f) concerning
ownership, investment,
and compensation
arrangements.
[[Page 59563]]
1395pp(h)......................... 42 CFR 402.1(c)(23), CMS................. Penalty for any durable 2018 15,582 15,975
402.105(d)(2)(xv). medical equipment
supplier, including a
supplier of prosthetic
devices, prosthetics,
orthotics, or supplies,
that knowingly and
willfully fails to make
refunds in a timely
manner to Medicare
beneficiaries under
certain conditions. (42
U.S.C. 1395(m)(18)
sanctions apply here in
the same manner, which
is under 1395u(j)(2)
and 1320a-7a(a)).
1395ss(a)(2)...................... 42 CFR 402.1(c)(24), CMS................. Penalty for any person 2018 53,483 54,832
405.105(f)(1). that issues a Medicare
supplemental policy
that has not been
approved by the State
regulatory program or
does not meet Federal
standards after a
statutorily defined
effective date.
1395ss(d)(3)(A)(vi) (II).......... ......................... CMS................. Penalty for someone 2018 27,714 28,413
other than issuer that
sells or issues a
Medicare supplemental
policy to beneficiary
without a disclosure
statement.
Penalty for an issuer 2018 46,192 47,357
that sells or issues a
Medicare supplemental
policy without
disclosure statement.
1395ss(d)(3)(B)(iv)............... ......................... CMS................. Penalty for someone 2018 27,714 28,413
other than issuer that
sells or issues a
Medicare supplemental
policy without
acknowledgement form.
Penalty for issuer that 2018 46,192 47,357
sells or issues a
Medicare supplemental
policy without an
acknowledgement form.
1395ss(p)(8)...................... 42 CFR 402.1(c)(25), CMS................. Penalty for any person 2018 27,714 28,413
402.105(e). that sells or issues
Medicare supplemental
polices after a given
date that fail to
conform to the NAIC or
Federal standards
established by statute.
42 CFR 402.1(c)(25), CMS................. Penalty for any person 2018 46,192 47,357
405.105(f)(2). that sells or issues
Medicare supplemental
polices after a given
date that fail to
conform to the NAIC or
Federal standards
established by statute.
1395ss(p)(9)(C)................... 42 CFR 402.1(c)(26), CMS................. Penalty for any person 2018 27,714 28,413
402.105(e). that sells a Medicare
supplemental policy and
fails to make available
for sale the core group
of basic benefits when
selling other Medicare
supplemental policies
with additional
benefits or fails to
provide the individual,
before selling the
policy, an outline of
coverage describing
benefits.
42 CFR 402.1(c)(26), .................... Penalty for any person 2018 46,192 47,357
405.105(f)(3), (4). that sells a Medicare
supplemental policy and
fails to make available
for sale the core group
of basic benefits when
selling other Medicare
supplemental policies
with additional
benefits or fails to
provide the individual,
before selling the
policy, an outline of
coverage describing
benefits.
1395ss(q)(5)(C)................... 42 CFR 402.1(c)(27), CMS................. Penalty for any person 2018 46,192 47,357
405.105(f)(5). that fails to suspend
the policy of a
policyholder made
eligible for medical
assistance or
automatically
reinstates the policy
of a policyholder who
has lost eligibility
for medical assistance,
under certain
circumstances.
1395ss(r)(6)(A)................... 42 CFR 402.1(c)(28), CMS................. Penalty for any person 2018 46,192 47,357
405.105(f)(6). that fails to provide
refunds or credits as
required by section
1882(r)(1)(B).
1395ss(s)(4)...................... 42 CFR 402.1(c)(29), CMS................. Penalty for any issuer 2018 19,609 20,104
405.105(c). of a Medicare
supplemental policy
that does not waive
listed time periods if
they were already
satisfied under a
proceeding Medicare
supplemental policy, or
denies a policy, or
conditions the
issuances or
effectiveness of the
policy, or
discriminates in the
pricing of the policy
base on health status
or other specified
criteria.
1395ss(t)(2)...................... 42 CFR 402.1(c)(30), CMS................. Penalty for any issuer 2018 46,192 47,357
405.105(f)(7). of a Medicare
supplemental policy
that fails to fulfill
listed responsibilities.
[[Page 59564]]
1395ss(v)(4)(A)................... ......................... CMS................. Penalty someone other 2018 19,999 20,503
than issuer who sells,
issues, or renews a
medigap Rx policy to an
individual who is a
Part D enrollee.
Penalty for an issuer 2018 33,333 34,174
who sells, issues, or
renews a Medigap Rx
policy who is a Part D
enrollee.
1395bbb(c)(1)..................... 42 CFR 488.725(c)........ CMS................. Penalty for any 2018 4,280 4,388
individual who notifies
or causes to be
notified a home health
agency of the time or
date on which a survey
of such agency is to be
conducted.
1395bbb(f)(2)(A)(i)............... 42 CFR 488.845(b)(2)(iii) CMS................. Maximum daily penalty 2018 20,521 21,039
42 CFR 488.845(b)(3)- amount for each day a
(6); and 42 CFR home health agency is
488.845(d)(1)(ii). not in compliance with
statutory requirements.
42 CFR 488.845(b)(3)..... .................... Penalty per day for home 2018 ........... ...........
health agency's
noncompliance (Upper
Range):
Minimum................. 2018 17,443 17,883
Maximum................. 2018 20,521 21,039
42 CFR 488.845(b)(3)(i).. .................... Penalty for a home 2018 20,521 21,039
health agency's
deficiency or
deficiencies that cause
immediate jeopardy and
result in actual harm.
42 CFR 488.845(b)(3)(ii). .................... Penalty for a home 2018 18,468 18,934
health agency's
deficiency or
deficiencies that cause
immediate jeopardy and
result in potential for
harm.
42 CFR 488.845(b)(3)(iii) .................... Penalty for an isolated 2018 17,443 17,883
incident of
noncompliance in
violation of
established HHA policy.
42 CFR 488.845(b)(4)..... .................... Penalty for a repeat and/ 2018 ........... ...........
or condition-level
deficiency that does
not constitute
immediate jeopardy, but
is directly related to
poor quality patient
care outcomes (Lower
Range):
Minimum................. 2018 3,079 3,157
Maximum................. 2018 17,443 17,883
42 CFR 488.845(b)(5)..... .................... Penalty for a repeat and/ 2018 ........... ...........
or condition-level
deficiency that does
not constitute
immediate jeopardy and
that is related
predominately to
structure or process-
oriented conditions
(Lower Range):
Minimum................. 2018 1,026 1,052
Maximum................. 2018 8,208 8,415
42 CFR 488.845(b)(6)..... .................... Penalty imposed for 2018 ........... ...........
instance of
noncompliance that may
be assessed for one or
more singular events of
condition-level
noncompliance that are
identified and where
the noncompliance was
corrected during the
onsite survey:
Minimum................. 2018 2,052 2,104
Maximum................. 2018 20,521 21,039
Penalty for each day of 2018 20,521 21,039
noncompliance (Maximum).
42 CFR 488.845(d)(1)(ii). .................... Penalty for each day of 2018 20,521 21,039
noncompliance (Maximum).
1396b(m)(5)(B).................... 42 CFR 460.46 (a)(1)..... CMS................. Penalty for 2018 ........... ...........
discriminating or
discouraging enrollment
or disenrollment of
participants on the
basis of an
individual's health
status or need for
health care services.
42 CFR 460.46 (a)(1)..... .................... Minimum................. 2018 22,896 23,473
42 CFR 460.46 (a)(1)..... .................... Maximum................. 2018 152,638 156,488
42 CFR 460.46 (a)(2)..... .................... Penalty for a PACE 2018 38,159 39,121
organization that
charges excessive
premiums.
42 CFR 460.46 (a)(3)..... .................... Penalty for a PACE 2018 152,638 156,488
organization
misrepresenting or
falsifying information
to CMS, the State, or
an individual or other
entity.
42 CFR 460.46 (a)(4)..... .................... Penalty for each 2018 38,159 39,121
determination the CMS
makes that the PACE
organization has failed
to provide medically
necessary items and
services of the failure
has adversely affected
(or has the substantial
likelihood of adversely
affecting) a PACE
participant.
42 CFR 460.46 (a)(4)..... .................... Penalty for 2018 38,159 39,121
involuntarily
disenrolling a
participant.
[[Page 59565]]
42 CFR 460.46 (a)(4)..... .................... Penalty for PACE 2018 38,159 39,121
organization's practice
that would reasonably
be expected to have the
effect of denying or
discouraging enrollment.
1396r(h)(3)(C)(ii)(I)............. 42 CFR 488.408(d)(1)(iii) CMS................. Penalty per day for a 2018 ........... ...........
nursing facility's
failure to meet a
Category 2
Certification:
Minimum................. 2018 107.14305 110
Maximum................. 2018 6,417 6,579
42 CFR 488.408(d)(1)(iv). CMS................. Penalty per instance for 2018 ........... ...........
a nursing facility's
failure to meet
Category 2
certification:
Minimum................. 2018 2,140 2,194
Maximum................. 2018 21,393 21,933
42 CFR 488.408(e)(1)(iii) CMS................. Penalty per day for a 2018 ........... ...........
nursing facility's
failure to meet
Category 3
certification:
Minimum................. 2018 6,525 6,690
Maximum................. 2018 21,393 21,933
42 CFR 488.408(e)(1)(iv). CMS................. Penalty per instance for 2018 ........... ...........
a nursing facility's
failure to meet
Category 3
certification:
Minimum................. 2018 2,140 2,194
Maximum................. 2018 21,393 21,933
42 CFR 488.408(e)(2)(ii). CMS................. Penalty per instance for 2018 ........... ...........
a nursing facility's
failure to meet
Category 3
certification, which
results in immediate
jeopardy:
Minimum................. 2018 2,140 2,194
Maximum................. 2018 21,393 21,933
42 CFR 488.438(a)(1)(i).. CMS................. Penalty per day for 2018 ........... ...........
nursing facility's
failure to meet
certification (Upper
Range):
Minimum................. 2018 6,525 6,690
Maximum................. 2018 21,393 21,933
42 CFR 488.438(a)(1)(ii). CMS................. Penalty per day for 2018 ........... ...........
nursing facility's
failure to meet
certification (Lower
Range):
Minimum................. 2018 107.14305 110
Maximum................. 2018 6,417 6,579
42 CFR 488.438(a)(2)..... CMS................. Penalty per instance for 2018 ........... ...........
nursing facility's
failure to meet
certification:
Minimum................. 2018 2,140 2,194
Maximum................. 2018 21,393 21,933
1396r(f)(2)(B)(iii)(I)(c)......... 42 CFR 483.151(b)(2)(iv) CMS................. Grounds to prohibit 2018 10,697 10,967
and (b)(3)(iii). approval of Nurse Aide
Training Program--if
assessed a penalty in
1819(h)(2)(B)(i) or
1919(h)(2)(A)(ii) of
``not less than
$5,000'' [Not CMP
authority, but a
specific CMP amount
(CMP at this level)
that is the triggering
condition for
disapproval].
1396r(h)(3)(C)(ii)(I)............. 42 CFR 483.151(c)(2)..... CMS................. Grounds to waive 2018 10,697 10,967
disapproval of nurse
aide training program--
reference to
disapproval based on
imposition of CMP ``not
less than $5,000'' [Not
CMP authority but CMP
imposition at this
level determines
eligibility to seek
waiver of disapproval
of nurse aide training
program].
1396t(j)(2)(C).................... ......................... CMS................. Penalty for each day of 2018 ........... ...........
noncompliance for a
home or community care
provider that no longer
meets the minimum
requirements for home
and community care:
Minimum................. 2018 2 2
Maximum................. 2018 18,477 18,943
1396u-2(e)(2)(A)(i)............... 42 CFR 438.704........... CMS................. Penalty for a Medicaid 2018 38,159 39,121
managed care
organization that fails
substantially to
provide medically
necessary items and
services.
Penalty for Medicaid 2018 38,159 39,121
managed care
organization that
imposes premiums or
charges on enrollees in
excess of the premiums
or charges permitted.
Penalty for a Medicaid 2018 38,159 39,121
managed care
organization that
misrepresents or
falsifies information
to another individual
or entity.
Penalty for a Medicaid 2018 38,159 39,121
managed care
organization that fails
to comply with the
applicable statutory
requirements for such
organizations.
1396u-2(e)(2)(A)(ii).............. 42 CFR 438.704........... CMS................. Penalty for a Medicaid 2018 152,638 156,488
managed care
organization that
misrepresents or
falsifies information
to the HHS Secretary.
[[Page 59566]]
Penalty for Medicaid 2018 152,638 156,488
managed care
organization that acts
to discriminate among
enrollees on the basis
of their health status.
1396u-2(e)(2)(A)(iv).............. 42 CFR 438.704........... CMS................. Penalty for each 2018 22,896 23,473
individual that does
not enroll as a result
of a Medicaid managed
care organization that
acts to discriminate
among enrollees on the
basis of their health
status.
1396u(h)(2)....................... 42 CFR Part 441, Subpart CMS................. Penalty for a provider 2018 21,393 21,933
I. not meeting one of the
requirements relating
to the protection of
the health, safety, and
welfare of individuals
receiving community
supported living
arrangements services.
1396w-2(c)(1)..................... ......................... CMS................. Penalty for disclosing 2018 11,410 11,698
information related to
eligibility
determinations for
medical assistance
programs.
18041(c)(2)....................... 45 CFR 150.315; 45 CFR CMS................. Failure to comply with 2018 155.10232 159
156.805(c). requirements of the
Public Health Services
Act; Penalty for
violations of rules or
standards of behavior
associated with issuer
participation in the
Federally-facilitated
Exchange. (42 U.S.C.
300gg-22(b)(2)(C)).
18081(h)(1)(A)(i)(II)............. 42 CFR 155.285........... CMS................. Penalty for providing 2018 28,195 28,906
false information on
Exchange application.
18081(h)(1)(B).................... 42 CFR 155.285........... CMS................. Penalty for knowingly or 2018 281,949 289,060
willfully providing
false information on
Exchange application.
18081(h)(2)....................... 42 CFR 155.260........... CMS................. Penalty for knowingly or 2018 28,195 28,906
willfully disclosing
protected information
from Exchange.
31 U.S.C.:
1352.............................. 45 CFR 93.400(e)......... HHS................. Penalty for the first 2018 19,639 20,134
time an individual
makes an expenditure
prohibited by
regulations regarding
lobbying disclosure,
absent aggravating
circumstances.
Penalty for second and 2018 ........... ...........
subsequent offenses by
individuals who make an
expenditure prohibited
by regulations
regarding lobbying
disclosure:
Minimum................. 2018 19,639 20,134
Maximum................. 2018 196,387 201,340
Penalty for the first 2018 19,639 20,134
time an individual
fails to file or amend
a lobbying disclosure
form, absent
aggravating
circumstances.
Penalty for second and 2018 ........... ...........
subsequent offenses by
individuals who fail to
file or amend a
lobbying disclosure
form, absent
aggravating
circumstances:
Minimum................. 2018 19,639 20,134
Maximum................. 2018 196,387 201,340
45 CFR Part 93, Appendix HHS................. Penalty for failure to 2018 ........... ...........
A. provide certification
regarding lobbying in
the award documents for
all sub-awards of all
tiers:
Minimum................. 2018 19,639 20,134
Maximum................. 2018 196,387 201,340
Penalty for failure to 2018 ........... ...........
provide statement
regarding lobbying for
loan guarantee and loan
insurance transactions:
Minimum................. 2018 19,639 20,134
Maximum................. 2018 196,387 201,340
3801-3812......................... 45 CFR 79.3(a)(1)(iv).... HHS................. Penalty against any 2018 10,261 10,520
individual who--with
knowledge or reason to
know--makes, presents
or submits a false,
fictitious or
fraudulent claim to the
Department.
45 CFR 79.3(b)(1)(ii).... .................... Penalty against any 2018 10,261 10,520
individual who--with
knowledge or reason to
know--makes, presents
or submits a false,
fictitious or
fraudulent claim to the
Department.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Some HHS components have not promulgated regulations regarding their civil monetary penalty-specific statutory authorities.
\2\ The description is not intended to be a comprehensive explanation of the underlying violation; the statute and corresponding regulation, if
applicable, should be consulted.
\3\ Statutory or Inflation Act Adjustment.
\4\ The cost of living multiplier for 2019, based on the CPI-U for the month of October 2018, not seasonally adjusted, is 1.02522, as indicated in OMB
Memorandum M-19-04, ``Implementation of Penalty Inflation Adjustments for 2018, Pursuant to the Federal Civil Penalties Adjustment Act Improvements
Act of 2015'' (December 14, 2018).
* For each false record or statement, 10,000 per day.
** For each false record statement, 10,461 per day.
[[Page 59567]]
Dated: October 28, 2019.
Alex M. Azar II,
Secretary, Department of Health and Human Services.
[FR Doc. 2019-23955 Filed 11-4-19; 8:45 am]
BILLING CODE 4150-24-P
