[Federal Register Volume 85, Number 12 (Friday, January 17, 2020)]
[Rules and Regulations]
[Pages 2869-2887]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-00738]
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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.
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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 to make changes to reflect an amendment to the Federal Food,
Drug, and Cosmetic Act by the Further Consolidated Appropriations Act,
2020 (effective January 1, 2020).
DATES: This rule is effective January 17, 2020.
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
[[Page 2870]]
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), October 11, 2018 (83 FR 51369), and
on November 5, 2019 (84 FR 59549).
The Further Consolidated Appropriations Act, 2020 (hereafter, 2020
Appropriations Act), created a new section 906(d)(5) in the Federal
Food, Drug, and Cosmetic Act, codified at 21 U.S.C. 387f(d)(5), which
increases the minimum age of sale of tobacco products and makes it
unlawful for a retailer to sell a tobacco product to any person younger
than 21 years old. H.R. 1865 Sec. 603. The 2020 Appropriations Act also
amended the civil money penalty schedule codified in 21 U.S.C. 333 note
to apply to violations of new section 906(d)(5). Accordingly, the
description of 21 U.S.C. 333 note has been modified in the table to
reflect these amendments. In addition, a technical error for an
incorrect description of 42 U.S.C. 299c-(3)(d) was identified and is
corrected below.
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 16, 2019, Office of Management
and Budget (OMB) Memorandum for the Heads of Executive Agencies and
Departments, M-20-05, Implementation of the Penalty Inflation
Adjustments for 2020, 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 2020, based on the CPI-U for the month of October 2019,
not seasonally adjusted, is 1.01764. The multiplier is applied to each
applicable penalty amount that was updated and published for FY 2019
and is rounded to the nearest dollar.
Using the 2020 multiplier, HHS adjusted all its applicable monetary
penalties in 45 CFR 102.3.
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-20-05, the phrase ``notwithstanding section 553'' in
section 4(b)(2) of the 2015 Act means that ``the public procedure the
APA 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. Additionally, HHS finds good cause for issuing technical
changes as a final rule without notice and comment because these
changes only update the implementing regulation to restate the statute
in light of amendments recently enacted into law.
Pursuant to OMB Memorandum M-20-05, HHS has determined that the
annual inflation adjustment to the civil monetary penalties in its
regulations does not trigger any requirements under procedural statutes
and Executive Orders that govern rulemaking procedures.
IV. Effective Date
This rule is effective January 17, 2020. A delayed effective date
for the technical changes to the table made to reflect the 2020
Appropriations Act is unnecessary because the new requirements are
already effective as a matter of law (5 U.S.C. 553(d)(3)) and they do
not establish additional regulatory obligations or impose additional
burden on regulated entities. The adjusted civil monetary penalty
amounts apply to penalties assessed on or after January 17, 2020, 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.
* * * * *
[[Page 2871]]
Table 1 to Sec. 102.3--Civil Monetary Penalty Authorities Administered by HHS Agencies and Penalty Amounts
January 17, 2020
----------------------------------------------------------------------------------------------------------------
Date of
last 2019 2020
HHS penalty Maximum Maximum
CFR \1\ agency Description \2\ figure or adjusted adjusted
adjustment penalty penalty
\3\ ($) ($) \4\
----------------------------------------------------------------------------------------------------------------
21 U.S.C.:
333(b)(2)(A)............. ............... FDA Penalty for 2019 105,194 107,050
violations
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 2019 2,146,800 2,184,670
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.
333(b)(3)................ ............... FDA Penalty for 2019 210,386 214,097
failure to
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 2019 28,413 28,914
person who
violates a
requirement
related to
devices for
each such
violation.
Penalty for 2019 1,894,261 1,927,676
aggregate of
all violations
related to
devices in a
single
proceeding.
333(f)(2)(A)............. ............... FDA Penalty for any 2019 79,875 81,284
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 2019 399,374 406,419
case of any
other person
other than an
individual)
for such
introduction
or delivery of
adulterated
food.
Penalty for 2019 798,747 812,837
aggregate of
all such
violations
related to
adulterated
food
adjudicated in
a single
proceeding.
333(f)(3)(A)............. ............... FDA Penalty for all 2019 12,103 12,316
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 2019 12,103 12,316
each day any
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 2019 302,585 307,923
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).
Penalty for 2019 1,210,340 1,231,690
aggregate of
all such above
violations in
a single
proceeding.
333(f)(4)(A)(ii)......... ............... FDA Penalty for 2019 302,585 307,923
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 2019 1,210,340 1,231,690
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 2019 12,103,404 12,316,908
aggregate of
all such above
violations
adjudicated in
a single
proceeding.
333(f)(9)(A)............. ............... FDA Penalty for any 2019 17,547 17,857
person who
violates a
requirement
which relates
to tobacco
products for
each such
violation.
Penalty for 2019 1,169,798 1,190,433
aggregate of
all such
violations of
tobacco
product
requirement
adjudicated in
a single
proceeding.
333(f)(9)(B)(i)(I)....... ............... FDA Penalty per 2019 292,450 297,609
violation
related to
violations of
tobacco
requirements.
[[Page 2872]]
Penalty for 2019 1,169,798 1,190,433
aggregate of
all such
violations of
tobacco
product
requirements
adjudicated in
a single
proceeding.
333(f)(9)(B)(i)(II).......... ............... FDA Penalty in the 2019 292,450 297,609
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 2019 1,169,798 1,190,433
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 2019 11,697,983 11,904,335
aggregate of
all such
violations
related to
tobacco
product
requirements
adjudicated in
a single
proceeding.
333(f)(9)(B)(ii)(I)...... ............... FDA Penalty for any 2019 292,450 297,609
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 2019 1,169,798 1,190,433
aggregate of
for all such
above
violations
adjudicated in
a single
proceeding.
333(f)(9)(B)(ii)(II)..... ............... FDA Penalty for 2019 292,450 297,609
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 2019 1,169,798 1,190,433
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 2019 11,697,983 11,904,335
aggregate
above tobacco
product
requirement
violations
adjudicated in
a single
proceeding.
333(g)(1)................ ............... FDA Penalty for any 2019 302,585 307,923
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.
Penalty for 2019 605,171 615,846
each
subsequent
above
violation in
any 3-year
period.
333 note................. ............... FDA Penalty to be 2019 292 297
applied for
violations of
21 U.S.C.
387f(d)(5) or
of violations
of
restrictions
on the sale or
distribution
of tobacco
products
promulgated
under 21
U.S.C. 387f(d)
(e.g.,
violations of
regulations in
21 CFR part
1140) with
respect to a
retailer with
an approved
training
program in the
case of a
second
regulation
violation
within a 12-
month period.
Penalty in the 2019 584 594
case of a
third
violation of
21 U.S.C.
387f(d)(5) or
of the tobacco
product
regulations
within a 24-
month period.
Penalty in the 2019 2,340 2,381
case of a
fourth
violation of
21 U.S.C.
387f(d)(5) or
of the tobacco
product
regulations
within a 24-
month period.
Penalty in the 2019 5,849 5,952
case of a
fifth
violation of
21 U.S.C.
387f(d)(5) or
of the tobacco
product
regulations
within a 36-
month period.
[[Page 2873]]
Penalty in the 2019 11,698 11,904
case of a
sixth or
subsequent
violation of
21 U.S.C.
387f(d)(5) or
of the tobacco
product
regulations
within a 48-
month period
as determined
on a case-by-
case basis.
Penalty to be 2019 292 297
applied for
violations of
21 U.S.C.
387f(d)(5) or
of violations
of
restrictions
on the sale or
distribution
of tobacco
products
promulgated
under 21
U.S.C. 387f(d)
(e.g.,
violations of
regulations in
21 CFR part
1140) with
respect to a
retailer that
does not have
an approved
training
program in the
case of the
first
regulation
violation.
Penalty in the 2019 584 594
case of a
second
violation of
21 U.S.C.
387f(d)(5) or
of the tobacco
product
regulations
within a 12-
month period.
Penalty in the 2019 1,170 1,191
case of a
third
violation of
21 U.S.C.
387f(d)(5) or
of the tobacco
product
regulations
within a 24-
month period.
Penalty in the 2019 2,340 2,381
case of a
fourth
violation of
21 U.S.C.
387f(d)(5) or
of the tobacco
product
regulations
within a 24-
month period.
Penalty in the 2019 5,849 5,952
case of a
fifth
violation of
21 U.S.C.
387f(d)(5) or
of the tobacco
product
regulations
within a 36-
month period.
Penalty in the 2019 11,698 11,904
case of a
sixth or
subsequent
violation of
21 U.S.C.
387f(d)(5) or
of the tobacco
product
regulations
within a 48-
month period
as determined
on a case-by-
case basis.
335b(a).................. ............... FDA Penalty for 2019 445,846 453,711
each violation
for any
individual who
made a false
statement or
misrepresentat
ion 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 2019 1,783,384 1,814,843
case of any
other person
(other than an
individual)
per above
violation.
360pp(b)(1).................. ............... FDA Penalty for any 2019 2,924 2,976
person who
violates any
such
requirements
for electronic
products, with
each unlawful
act or
omission
constituting a
separate
violation.
Penalty imposed 2019 996,806 1,014,390
for any
related series
of violations
of
requirements
relating to
electronic
products.
42 U.S.C..................... ............... ........ ............... 2019 ........... ...........
262(d)................... ............... FDA Penalty per day 2019 229,269 233,313
for violation
of order of
recall of
biological
product
presenting
imminent or
substantial
hazard.
263b(h)(3)............... ............... FDA Penalty for 2019 17,834 18,149
failure to
obtain a
mammography
certificate as
required.
300aa-28(b)(1)........... ............... FDA Penalty per 2019 229,269 233,313
occurrence for
any vaccine
manufacturer
that
intentionally
destroys,
alters,
falsifies, or
conceals any
record or
report
required.
256b(d)(1)(B)(vi)........ ............... HRSA Penalty for 2019 5,781 5,883
each instance
of
overcharging a
340B covered
entity.
299c-(3)(d).............. ............... AHRQ Penalty for an 2019 15,034 15,299
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 ACF Penalty for 2019 1,542 1,569
303.21(f). Misuse of
Information in
the National
Directory of
New Hires.
262a(i)(1)............... 42 CFR 1003.910 OIG Penalty for 2019 348,708 354,859
each
individual who
violates
safety and
security
procedures
related to
handling
dangerous
biological
agents and
toxins.
[[Page 2874]]
Penalty for any 2019 697,418 709,720
other person
who violates
safety and
security
procedures
related to
handling
dangerous
biological
agents and
toxins.
300jj-51................. ............... OIG Penalty per 2019 1,063,260 1,082,016
violation for
committing
information
blocking.
1320a-7a(a).............. 42 CFR OIG Penalty for 2019 20,504 20,866
1003.210(a)(1). knowingly
presenting or
causing to be
presented to
an officer,
employee, or
agent of the
United States
a false claim.
Penalty for 2019 20,504 20,866
knowingly
presenting or
causing to be
presented a
request for
payment which
violates the
terms of an
assignment,
agreement, or
PPS agreement.
42 CFR ........ Penalty for 2019 30,757 31,300
1003.210(a)(2). 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.
42 CFR ........ Penalty for an 2019 20,504 20,866
1003.210(a)(3). excluded party
retaining
ownership or
control
interest in a
participating
entity.
42 CFR ........ Penalty for 2019 20,504 20,866
1003.1010. remuneration
offered to
induce program
beneficiaries
to use
particular
providers,
practitioners,
or suppliers.
42 CFR ........ Penalty for 2019 20,504 20,866
1003.210(a)(4). employing or
contracting
with an
excluded
individual.
42 CFR ........ Penalty for 2019 102,522 104,330
1003.310(a)(3). 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.
42 CFR ........ Penalty for 2019 20,504 20,866
1003.210(a)(1). ordering or
prescribing
medical or
other item or
service during
a period in
which the
person was
excluded.
42 CFR ........ Penalty for 2019 102,522 104,330
1003.210(a)(6). knowingly
making or
causing to be
made a false
statement,
omission or
misrepresentat
ion of a
material fact
in any
application,
bid, or
contract to
participate or
enroll as a
provider or
supplier.
42 CFR ........ Penalty for 2019 20,504 20,866
1003.210(a)(8). knowing of an
overpayment
and failing to
report and
return.
42 CFR ........ Penalty for 2019 57,812 58,832
1003.210(a)(7). making or
using a false
record or
statement that
is material to
a false or
fraudulent
claim.
42 CFR ........ Penalty for 2019 30,757 31,300
1003.210(a)(9). failure to
grant timely
access to HHS
OIG for
audits,
investigations
, evaluations,
and other
statutory
functions of
HHS OIG.
1320a-7a(b).............. ............... OIG Penalty for 2019 5,126 5,216
payments by a
hospital or
critical
access
hospital to
induce a
physician to
reduce or
limit services
to individuals
under direct
care of
physician or
who are
entitled to
certain
medical
assistance
benefits.
Penalty for 2019 5,126 5,216
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.
42 CFR ........ Penalty for a 2019 10,252 10,433
1003.210(a)(10 physician who
). executes a
document that
falsely
certifies home
health needs
for Medicare
beneficiaries.
1320a-7a(o).............. ............... OIG Penalty for 2016 10,000 10,176
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.
[[Page 2875]]
Penalty for 2016 50,000 50,882
knowingly
making, using,
or causing to
be made or
used any false
statement,
omission, or
misrepresentat
ion of a
material fact
in any
application,
proposal, bid,
progress
report, or
other document
required to
directly or
indirectly
receive or
retain funds
provided
pursuant to
grant,
contract, or
other
agreement.
Penalty for 2016 50,000 50,882
Knowingly
making, using,
or causing to
be made or
used, a false
record or
statement
material to a
false or
fraudulent
specified
claim under
grant,
contract, or
other
agreement.
Penalty for 2016 50,000 for 53,231 for
knowingly each false each false
making, using, record or record
or causing to statement, statement,
be made or 10,000 per 10,646 per
used, a false day. day.
record or
statement
material to an
obligation to
pay or
transmit funds
or property
with respect
to grant,
contract, or
other
agreement, or
knowingly
conceals or
improperly
avoids or
decreases any
such
obligation.
Penalty for 2016 15,000 15,265
failure to
grant timely
access, upon
reasonable
request, to
the Inspector
General (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 2019 39,121 39,811
failure to
report any
final adverse
action taken
against a
health care
provider,
supplier, or
practitioner.
1320b-10(b)(1)........... 42 CFR OIG Penalty for the 2019 10,519 10,705
1003.610(a). 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.
1320b-10(b)(2)........... 42 CFR OIG Penalty for the 2019 52,596 53,524
1003.610(a). 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.
1395i-3(b)(3)(B)(ii)(1).. 42 CFR OIG Penalty for 2019 2,194 2,233
1003.210(a)(11 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 OIG Penalty for 2019 10,967 11,160
1003.210(a)(11 causing
). 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 OIG Penalty for any 2019 4,388 4,465
1003.1310. 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 2019 39,936 40,640
Medicare
Advantage
organization
that
substantially
fails to
provide
medically
necessary,
required items
and services.
Penalty for a 2019 39,121 39,811
Medicare
Advantage
organization
that charges
excessive
premiums.
Penalty for a 2019 39,121 39,811
Medicare
Advantage
organization
that
improperly
expels or
refuses to
reenroll a
beneficiary.
Penalty for a 2019 156,488 159,248
Medicare
Advantage
organization
that engages
in practice
that would
reasonably be
expected to
have the
effect of
denying or
discouraging
enrollment.
Penalty per 2019 23,473 23,887
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 2019 156,488 159,248
Medicare
Advantage
organization
misrepresentin
g or
falsifying
information to
Secretary.
[[Page 2876]]
Penalty for a 2019 39,121 39,811
Medicare
Advantage
organization
misrepresentin
g or
falsifying
information to
individual or
other entity.
Penalty for 2019 39,121 39,811
Medicare
Advantage
organization
interfering
with
provider's
advice to
enrollee and
non-managed
care
organization
(MCO)
affiliated
providers that
balance bill
enrollees.
Penalty for a 2019 39,121 39,811
Medicare
Advantage
organization
that employs
or contracts
with excluded
individual or
entity.
Penalty for a 2019 39,121 39,811
Medicare
Advantage
organization
enrolling an
individual in
without prior
written
consent.
Penalty for a 2019 39,121 39,811
Medicare
Advantage
organization
transferring
an enrollee to
another plan
without
consent or
solely for the
purpose of
earning a
commission.
Penalty for a 2019 39,121 39,811
Medicare
Advantage
organization
failing to
comply with
marketing
restrictions
or applicable
implementing
regulations or
guidance.
Penalty for a 2019 39,121 39,811
Medicare
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 2019 13,669 13,910
prescription
drug card
sponsor that
falsifies or
misrepresents
marketing
materials,
overcharges
program
enrollees, or
misuse
transitional
assistance
funds.
1395cc(g)................ ............... OIG Penalty for 2019 5,317 5,411
improper
billing by
Hospitals,
Critical
Access
Hospitals, or
Skilled
Nursing
Facilities.
1395dd(d)(1)............. 42 CFR 1003.510 OIG Penalty for a 2019 109,663 111,597
hospital or
responsible
physician
dumping
patients
needing
emergency
medical care,
if the
hospital has
100 beds or
more.
Penalty for a 2019 54,833 55,800
hospital or
responsible
physician
dumping
patients
needing
emergency
medical care,
if the
hospital has
less than 100
beds.
1395mm(i)(6)(B)(i)....... 42 CFR 1003.410 OIG Penalty for a 2019 54,833 55,800
health
maintenance
organization
(HMO) or
competitive
plan is such
plan
substantially
fails to
provide
medically
necessary,
required items
or services.
Penalty for 2019 54,833 55,800
HMOs/
competitive
medical plans
that charge
premiums in
excess of
permitted
amounts.
Penalty for a 2019 54,833 55,800
HMO or
competitive
medical plan
that expels or
refuses to
reenroll an
individual per
prescribed
conditions.
Penalty for a 2019 219,327 223,196
HMO or
competitive
medical plan
that
implements
practices to
discourage
enrollment of
individuals
needing
services in
future.
Penalty per 2019 31,558 32,115
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 2019 219,327 223,196
HMO or
competitive
medical plan
that
misrepresents
or falsifies
information to
the Secretary.
Penalty for a 2019 54,833 55,800
HMO or
competitive
medical plan
that
misrepresents
or falsifies
information to
an individual
or any other
entity.
Penalty for 2019 54,833 55,800
failure by HMO
or competitive
medical plan
to assure
prompt payment
of Medicare
risk sharing
contracts or
incentive plan
provisions.
Penalty for HMO 2019 50,334 51,222
that employs
or contracts
with excluded
individual or
entity.
[[Page 2877]]
1395nn(g)(3)............. 42 CFR 1003.310 OIG Penalty for 2019 25,372 25,820
submitting 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 2019 169,153 172,137
circumventing
Stark Law's
restrictions
on physician
self-referrals.
1395ss(d)(1)............. 42 CFR OIG Penalty for a 2019 10,519 10,705
1003.1110. material
misrepresentat
ion regarding
Medigap
compliance
policies.
1395ss(d)(2)............. 42 CFR OIG Penalty for 2019 10,519 10,705
1003.1110. selling
Medigap policy
under false
pretense.
1395ss(d)(3)(A)(ii)...... 42 CFR OIG Penalty for an 2019 47,357 48,192
1003.1110. issuer that
sells health
insurance
policy that
duplicates
benefits.
Penalty for 2019 28,413 28,914
someone other
than issuer
that sells
health
insurance that
duplicates
benefits.
1395ss(d)(4)(A).......... 42 CFR OIG Penalty for 2019 10,519 10,705
1003.1110. using mail to
sell a non-
approved
Medigap
insurance
policy.
1396b(m)(5)(B)(i)........ 42 CFR 1003.410 OIG Penalty for a 2019 52,596 53,524
Medicaid MCO
that
substantially
fails to
provide
medically
necessary,
required items
or services.
Penalty for a 2019 52,596 53,524
Medicaid MCO
that charges
excessive
premiums.
Penalty for a 2019 210,386 214,097
Medicaid MCO
that
improperly
expels or
refuses to
reenroll a
beneficiary.
Penalty per 2019 31,558 32,115
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 2019 210,386 214,097
Medicaid MCO
misrepresentin
g or
falsifying
information to
the Secretary.
Penalty for a 2019 52,596 53,524
Medicaid MCO
misrepresentin
g or
falsifying
information to
an individual
or another
entity.
Penalty for a 2019 47,357 48,192
Medicaid MCO
that fails to
comply with
contract
requirements
with respect
to physician
incentive
plans.
1396r(b)(3)(B)(ii)(I).... 42 CFR OIG Penalty for 2019 2,194 2,233
1003.210(a)(11 willfully and
). knowingly
certifying a
material and
false
statement in a
Skilled
Nursing
Facility
resident
assessment.
1396r(b)(3)(B)(ii)(II)... 42 CFR OIG Penalty for 2019 10,967 11,160
1003.210(a)(11 willfully 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 OIG Penalty for 2019 4,388 4,465
1003.1310. notifying or
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 OIG Penalty for the 2019 189,427 192,768
1003.1210. knowing
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 OIG Penalty per day 2019 18,943 19,277
1003.1210. for failure to
timely provide
information by
drug
manufacturer
with rebate
agreement.
1396r-8(b)(3)(C)(ii)..... 42 CFR OIG Penalty for 2019 189,427 192,768
1003.1210. knowing
provision of
false
information by
drug
manufacturer
with rebate
agreement.
1396t(i)(3)(A)........... 42 CFR OIG Penalty for 2019 3,788 3,855
1003.1310. notifying home
and community-
based
providers or
settings of
survey.
11131(c)................. 42 CFR 1003.810 OIG Penalty for 2019 22,927 23,331
failing to
report a
medical
malpractice
claim to
National
Practitioner
Data Bank.
11137(b)(2).............. 42 CFR 1003.810 OIG Penalty for 2019 22,927 23,331
breaching
confidentialit
y of
information
reported to
National
Practitioner
Data Bank.
299b-22(f)(1)............ 42 CFR 3.404... OCR Penalty for 2019 12,695 12,919
violation of
confidentialit
y provision of
the Patient
Safety and
Quality
Improvement
Act.
45 CFR OCR Penalty for 2019 159 162
160.404(b)(1)( each pre-
i), (ii). February 18,
2009 violation
of the Health
Insurance
Portability
and
Accountability
Act (HIPAA)
administrative
simplification
provisions.
Calendar Year 2019 39,936 40,640
Cap.
[[Page 2878]]
1320(d)-5(a)............. 45 CFR OCR Penalty for
160.404(b)(2)( each February
i)(A), (B). 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...... 2019 117 119
Maximum...... 2019 58,490 59,522
Calendar Year 2019 1,754,698 1,785,651
Cap.
45 CFR OCR Penalty for
160.404(b)(2)( each February
ii)(A), (B). 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...... 2019 1,170 1,191
Maximum...... 2019 58,490 59,522
Calendar Year 2019 1,754,698 1,785,651
Cap.
45 CFR OCR Penalty for
160.404(b)(2)( each February
iii)(A), (B). 18, 2009 or
later
violation of a
HIPAA
administrative
simplification
provision in
which it is
established
that the
violation was
due to willful
neglect and
was corrected
during the 30-
day period
beginning on
the first date
the covered
entity or
business
associate
knew, or, by
exercising
reasonable
diligence,
would have
known that the
violation
occurred:
Minimum...... 2019 11,698 11,904
Maximum...... 2019 58,490 59,522
Calendar Year 2019 1,754,698 1,785,651
Cap.
45 CFR OCR Penalty for
160.404(b)(2)( each February
iv)(A), (B). 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...... 2019 58,490 59,522
Maximum...... 2019 1,754,698 1,785,651
Calendar Year 2019 1,754,698 1,785,651
Cap.
263a(h)(2)(B) & 1395w- 42 CFR CMS Penalty for a
2(b)(2)(A)(ii). 493.1834(d)(2) clinical
(i). laboratory's
failure to
meet
participation
and
certification
requirements
and poses
immediate
jeopardy:
Minimum...... 2019 6,417 6,530
Maximum...... 2019 21,039 21,410
42 CFR CMS Penalty for a
493.1834(d)(2) clinical
(ii). laboratory's
failure to
meet
participation
and
certification
requirements
and the
failure does
not pose
immediate
jeopardy:
Minimum...... 2019 106 108
Maximum...... 2019 6,311 6,422
300gg-15(f).............. 45 CFR CMS Failure to 2019 1,156 1,176
147.200(e). provide the
Summary of
Benefits and
Coverage.
300gg-18................. 45 CFR 158.606. CMS Penalty for 2019 116 118
violations of
regulations
related to the
medical loss
ratio
reporting and
rebating.
1320a-7h(b)(1)........... 42 CFR CMS Penalty for
402.105(d)(5), manufacturer
42 CFR or group
403.912(a) & purchasing
(c). organization
failing to
report
information
required under
42 U.S.C.
1320a-7h(a),
relating to
physician
ownership or
investment
interests:
Minimum...... 2019 1,156 1,176
Maximum...... 2019 11,562 11,766
Calendar Year 2019 173,436 176,495
Cap.
1320a-7h(b)(2)........... 42 CFR CMS Penalty for
402.105(h), 42 manufacturer
CFR 403.912(b) or group
& (c). purchasing
organization
knowingly
failing to
report
information
required under
42 U.S.C.
1320a-7h(a),
relating to
physician
ownership or
investment
interests:
[[Page 2879]]
Minimum...... 2019 11,562 11,766
Maximum...... 2019 115,624 117,664
Calendar Year 2019 1,156,242 1,176,638
Cap.
CMS Penalty for an 2019 115,624 117,664
administrator
of a facility
that fails to
comply with
notice
requirements
for the
closure of a
facility.
1320a-7j(h)(3)(A)........ 42 CFR CMS Minimum penalty 2019 578 588
488.446(a)(1), for the first
(2), & (3). offense of an
administrator
who fails to
provide notice
of facility
closure.
Minimum penalty 2019 1,735 1,766
for the second
offense of an
administrator
who fails to
provide notice
of facility
closure.
Minimum penalty 2019 3,468 3,529
for the third
and subsequent
offenses of an
administrator
who fails to
provide notice
of facility
closure.
1320a-8(a)(1)............ ............... CMS Penalty for an 2019 8,457 8,606
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 2019 7,975 8,116
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.
1320a-8(a)(3)............ ............... CMS Penalty for a 2019 6,623 6,740
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 2019 231,249 235,328
failure of
covered
individuals to
report to the
Secretary and
1 or more law
enforcement
officials any
reasonable
suspicion of a
crime against
a resident, or
individual
receiving
care, from a
long-term care
facility.
1320b-25(c)(2)(A)........ ............... CMS Penalty for 2019 346,872 352,991
failure of
covered
individuals to
report to the
Secretary and
1 or more law
enforcement
officials any
reasonable
suspicion of a
crime against
a resident, or
individual
receiving
care, from a
long-term care
facility if
such failure
exacerbates
the harm to
the victim of
the crime or
results in the
harm to
another
individual.
1320b-25(d)(2)........... ............... CMS Penalty for a 2019 231,249 235,328
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.
1395b-7(b)(2)(B)......... 42 CFR CMS Penalty for any 2019 156 159
402.105(g). 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.
1395i-3(h)(2)(B)(ii)(I).. 42 CFR CMS Penalty per day
488.408(d)(1)( for a Skilled
iii). Nursing
Facility that
has a Category
2 violation of
certification
requirements:
Minimum...... 2019 110 112
Maximum...... 2019 6,579 6,695
42 CFR CMS Penalty per
488.408(d)(1)( instance of
iv). Category 2
noncompliance
by a Skilled
Nursing
Facility:
Minimum...... 2019 2,194 2,233
Maximum...... 2019 21,933 22,320
[[Page 2880]]
42 CFR CMS Penalty per day
488.408(e)(1)( for a Skilled
iii). Nursing
Facility that
has a Category
3 violation of
certification
requirements:
Minimum...... 2019 6,690 6,808
Maximum...... 2019 21,933 22,320
42 CFR CMS Penalty per
488.408(e)(1)( instance of
iv). Category 3
noncompliance
by a Skilled
Nursing
Facility:
Minimum...... 2019 2,194 2,233
Maximum...... 2019 21,933 22,320
42 CFR CMS Penalty per day
488.408(e)(2)( and per
ii). instance for a
Skilled
Nursing
Facility that
has Category 3
noncompliance
with Immediate
Jeopardy:
Per Day 2019 6,690 6,808
(Minimum).
Per Day 2019 21,933 22,320
(Maximum).
Per Instance 2019 2,194 2,233
(Minimum).
Per Instance 2019 21,933 22,320
(Maximum).
42 CFR CMS Penalty per day
488.438(a)(1)( of a Skilled
i). Nursing
Facility that
fails to meet
certification
requirements.
These amounts
represent the
upper range
per day:
Minimum...... 2019 6,690 6,808
Maximum...... 2019 21,933 22,320
42 CFR CMS Penalty per day
488.438(a)(1)( of a Skilled
ii). Nursing
Facility that
fails to meet
certification
requirements.
These amounts
represent the
lower range
per day:
Minimum...... 2019 110 112
Maximum...... 2019 6,579 6,695
42 CFR CMS Penalty per
488.438(a)(2). instance of a
Skilled
Nursing
Facility that
fails to meet
certification
requirements:
Minimum...... 2019 2,194 2,233
Maximum...... 2019 21,933 22,320
1395l(h)(5)(D)........... 42 CFR CMS Penalty for 2019 15,975 16,257
402.105(d)(2)( knowingly,
i). 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 2019 4,208 4,282
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.
1395l(q)(2)(B)(i)........ 42 CFR CMS Penalty for 2019 4,027 4,098
402.105(a). knowingly and
willfully
failing to
provide
information
about a
referring
physician when
seeking
payment on an
unassigned
basis.
1395m(a)(11)(A).......... 42 CFR CMS Penalty for any 2019 15,975 16,257
402.1(c)(4), durable
402.105(d)(2)( medical
ii). equipment
supplier that
knowingly and
willfully
charges for a
covered
service that
is furnished
on a rental
basis after
the rental
payments may
no longer be
made.
(Penalties are
assessed in
the same
manner as 42
U.S.C.
1395u(j)(2)(B)
, which is
assessed
according to
1320a-7a(a)).
1395m(a)(18)(B).......... 42 CFR CMS Penalty for any 2019 15,975 16,257
402.1(c)(5), nonparticipati
402.105(d)(2)( ng durable
iii). medical
equipment
supplier that
knowingly and
willfully
fails to make
a refund to
Medicare
beneficiaries
for a covered
service for
which payment
is precluded
due to an
unsolicited
telephone
contact from
the supplier.
(Penalties are
assessed in
the same
manner as 42
U.S.C.
1395u(j)(2)(B)
, which is
assessed
according to
1320a-7a(a)).
[[Page 2881]]
1395m(b)(5)(C)........... 42 CFR CMS Penalty for any 2019 15,975 16,257
402.1(c)(6), nonparticipati
402.105(d)(2)( ng physician
iv). 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 CMS Penalty for any 2019 15,975 16,257
402.1(c)(8), supplier of
402.105(d)(2)( prosthetic
vi). devices,
orthotics, and
prosthetics
that knowing
and willfully
charges for a
covered
prosthetic
device,
orthotic, or
prosthetic
that is
furnished on a
rental basis
after the
rental payment
may no longer
be made.
(Penalties are
assessed in
the same
manner as 42
U.S.C.
1395m(a)(11)(A
), that is in
the same
manner as
1395u(j)(2)(B)
, which is
assessed
according to
1320a-7a(a)).
1395m(j)(2)(A)(iii)...... ............... CMS Penalty for any 2019 1,692 1,722
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.
1395m(j)(4).............. 42 CFR CMS Penalty for any 2019 15,975 16,257
402.1(c)(10), supplier of
402.105(d)(2)( durable
vii). medical
equipment,
including a
supplier of
prosthetic
devices,
prosthetics,
orthotics, or
supplies that
knowingly and
willfully
fails to make
refunds in a
timely manner
to Medicare
beneficiaries
for series
billed other
than on as
assignment-
related basis
under certain
conditions.
(Penalties are
assessed in
the same
manner as 42
U.S.C.
1395m(j)(4)
and
1395u(j)(2)(B)
, which is
assessed
according to
1320a-7a(a)).
1395m(k)(6).............. 42 CFR CMS Penalty for any 2019 15,975 16,257
402.1(c)(31), person or
402.105(d)(3). 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 CMS Penalty for any 2019 15,975 16,257
402.1(c)(32), supplier of
402.105(d)(4). 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 CMS Penalty for any 2019 15,975 16,257
402.1(c)(11), practitioner
402.105(d)(2)( specified in
viii). Section
1842(b)(18)(C)
of the Act or
other person
that knowingly
and willfully
bills or
collects for
any services
by the
practitioners
on other than
an assignment-
related basis.
(Penalties are
assessed in
the same
manner as 42
U.S.C.
1395u(j)(2)(B)
, which is
assessed
according to
1320a-7a(a)).
1395u(j)(2)(B)........... 42 CFR 402.1(c) CMS Penalty for any 2019 15,975 16,257
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)).
[[Page 2882]]
1395u(k)................. 42 CFR CMS Penalty for any 2019 15,975 16,257
402.1(c)(12), physician who
402.105(d)(2)( knowingly and
ix). 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 CMS Penalty for any 2019 15,975 16,257
402.1(c)(13), nonparticipati
402.105(d)(2)( ng physician
x). 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 CMS Penalty for any 2019 15,975 16,257
402.1(c)(14), nonparticipati
402.105(d)(2)( ng physician
xi). 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 CMS Penalty for any 2019 15,975 16,257
402.1(c)(15), physician who
402.105(d)(2)( knowingly,
xii). willfully, and
repeatedly
bills one or
more
beneficiaries
for purchased
diagnostic
tests any
amount other
than the
payment amount
specified by
the Act.
(Penalties are
assessed in
the same
manner as 42
U.S.C.
1395u(j)(2)(B)
, which is
assessed
according to
1320a-7a(a)).
1395u(o)(3)(B)........... 42 CFR CMS Penalty for any 2019 15,975 16,257
414.707(b). 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 2019 4,208 4,282
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 2019 13,669 13,910
pharmaceutical
manufacturer's
misrepresentat
ion of average
sales price of
a drug, or
biologic.
1395w-4(g)(1)(B)......... 42 CFR CMS Penalty for any 2019 15,975 16,257
402.1(c)(17), nonparticipati
402.105(d)(2)( ng physician,
xiii). 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)).
[[Page 2883]]
1395w-4(g)(3)(B)......... 42 CFR CMS Penalty for any 2019 15,975 16,257
402.1(c)(18), person that
402.105(d)(2)( knowingly and
xiv). willfully
bills for
statutorily
defined State-
plan approved
physicians'
services on
any other
basis than an
assignment-
related basis
for a Medicare/
Medicaid dual
eligible
beneficiary.
(Penalties are
assessed in
the same
manner as 42
U.S.C.
1395u(j)(2)(B)
, which is
assessed
according to
1320a-7a(a)).
1395w-27(g)(3)(A); 42 CFR CMS Penalty for 2019 39,121 39,811
1857(g)(3). 422.760(b); 42 each
CFR 423.760(b). 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); ............... CMS Penalty for 2019 15,649 15,925
1857(g)(3). 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.
1395w-27(g)(3)(D); ............... CMS Penalty for a 2019 145,335 147,899
1857(g)(3). Medicare
Advantage
organization's
or Part D
sponsor's
early
termination of
its contract.
1395y(b)(3)(C)........... 42 CFR CMS Penalty for an 2019 9,472 9,639
411.103(b). 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.
1395y(b)(5)(C)(ii)....... 42 CFR CMS Penalty for any 2019 1,542 1,569
402.1(c)(20), non-
42 CFR governmental
402.105(b)(2). 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 CMS Penalty for any 2019 3,383 3,443
402.1(c)(21), entity that
402.105(a). 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 2019 1,211 1,232
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.
1395y(b)(8)(E)........... ............... CMS Penalty for any 2019 1,211 1,232
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.
1395nn(g)(5)............. 42 CFR 411.361. CMS Penalty for any 2019 20,134 20,489
person that
fails to
report
information
required by
HHS under
Section
1877(f)
concerning
ownership,
investment,
and
compensation
arrangements.
1395pp(h)................ 42 CFR CMS Penalty for any 2019 15,975 16,257
402.1(c)(23), durable
402.105(d)(2)( medical
xv). 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 CMS Penalty for any 2019 54,832 55,799
402.1(c)(24), person that
405.105(f)(1). 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.
[[Page 2884]]
1395ss(d)(3)(A)(vi)(II).. CMS Penalty for 2019 28,413 28,914
someone other
than issuer
that sells or
issues a
Medicare
supplemental
policy to
beneficiary
without a
disclosure
statement.
Penalty for an 2019 47,357 48,192
issuer that
sells or
issues a
Medicare
supplemental
policy without
disclosure
statement.
1395ss(d)(3)(B)(iv)...... ............... CMS Penalty for 2019 28,413 28,914
someone other
than issuer
that sells or
issues a
Medicare
supplemental
policy without
acknowledgemen
t form.
Penalty for 2019 47,357 48,192
issuer that
sells or
issues a
Medicare
supplemental
policy without
an
acknowledgemen
t form.
1395ss(p)(8)............. 42 CFR CMS Penalty for any 2019 28,413 28,914
402.1(c)(25), person that
402.105(e). sells or
issues
Medicare
supplemental
polices after
a given date
that fail to
conform to the
National
Association of
Insurance
Commissioners
(NAIC) or
Federal
standards
established by
statute.
42 CFR CMS Penalty for any 2019 47,357 48,192
402.1(c)(25), person that
405.105(f)(2). 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 CMS Penalty for any 2019 28,413 28,914
402.1(c)(26), person that
402.105(e). 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 ........ Penalty for any 2019 47,357 48,192
402.1(c)(26), person that
405.105(f)(3), sells a
(4). 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 CMS Penalty for any 2019 47,357 48,192
402.1(c)(27), person that
405.105(f)(5). 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 CMS Penalty for any 2019 47,357 48,192
402.1(c)(28), person that
405.105(f)(6). fails to
provide
refunds or
credits as
required by
section
1882(r)(1)(B).
1395ss(s)(4)............. 42 CFR CMS Penalty for any 2019 20,104 20,459
402.1(c)(29), issuer of a
405.105(c). 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 CMS Penalty for any 2019 47,357 48,192
402.1(c)(30), issuer of a
405.105(f)(7). Medicare
supplemental
policy that
fails to
fulfill listed
responsibiliti
es.
1395ss(v)(4)(A).......... ............... CMS Penalty someone 2019 20,503 20,865
other than
issuer who
sells, issues,
or renews a
Medigap Rx
policy to an
individual who
is a Part D
enrollee.
Penalty for an 2019 34,174 34,777
issuer who
sells, issues,
or renews a
Medigap Rx
policy who is
a Part D
enrollee.
1395bbb(c)(1)............ 42 CFR CMS Penalty for any 2019 4,388 4,465
488.725(c). 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 CMS Maximum daily 2019 21,039 21,410
488.845(b)(2)( penalty amount
iii) 42 CFR for each day a
488.845(b)(3)- home health
(6); and 42 agency is not
CFR in compliance
488.845(d)(1)( with statutory
ii). requirements.
[[Page 2885]]
42 CFR ........ Penalty per day
488.845(b)(3). for home
health
agency's
noncompliance
(Upper Range):
Minimum...... 2019 17,883 18,198
Maximum...... 2019 21,039 21,410
42 CFR ........ Penalty for a 2019 21,039 21,410
488.845(b)(3)( home health
i). agency's
deficiency or
deficiencies
that cause
immediate
jeopardy and
result in
actual harm.
42 CFR ........ Penalty for a 2019 18,934 19,268
488.845(b)(3)( home health
ii). agency's
deficiency or
deficiencies
that cause
immediate
jeopardy and
result in
potential for
harm.
42 CFR ........ Penalty for an 2019 17,883 18,198
488.845(b)(3)( isolated
iii). incident of
noncompliance
in violation
of established
home health
agency (HHA)
policy.
42 CFR ........ Penalty for a
488.845(b)(4). 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...... 2019 3,157 3,213
Maximum...... 2019 17,883 18,198
42 CFR ........ Penalty for a
488.845(b)(5). 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...... 2019 1,052 1,071
Maximum...... 2019 8,415 8,563
42 CFR ........ Penalty imposed
488.845(b)(6). 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...... 2019 2,104 2,141
Maximum...... 2019 21,039 21,410
Penalty for 2019 21,039 21,410
each day of
noncompliance
(Maximum).
42 CFR Penalty for 2019 21,039 21,410
488.845(d)(1)( each day of
ii). noncompliance
(Maximum).
1396b(m)(5)(B)........... 42 CFR 460.46.. CMS Penalty for
Programs of
All-Inclusive
Care for the
Elderly (PACE)
organization's
practice that
would
reasonably be
expected to
have the
effect of
denying or
discouraging
enrollment:
Minimum...... 2019 23,473 23,887
Maximum...... 2019 156,488 159,248
Penalty for a 2019 39,121 39,811
PACE
organization
that charges
excessive
premiums.
Penalty for a 2019 156,488 159,248
PACE
organization
misrepresentin
g or
falsifying
information to
CMS, the
State, or an
individual or
other entity.
Penalty for 2019 39,121 39,811
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 2019 39,121 39,811
involuntarily
disenrolling a
participant.
Penalty for 2019 39,121 39,811
discriminating
or
discouraging
enrollment or
disenrollment
of
participants
on the basis
of an
individual's
health status
or need for
health care
services.
1396r(h)(3)(C)(ii)(I).... 42 CFR CMS Penalty per day
488.408(d)(1)( for a nursing
iii). facility's
failure to
meet a
Category 2
Certification:
Minimum...... 2019 110 112
Maximum...... 2019 6,579 6,695
42 CFR CMS Penalty per
488.408(d)(1)( instance for a
iv). nursing
facility's
failure to
meet Category
2
certification:
Minimum...... 2019 2,194 2,233
Maximum...... 2019 21,933 22,320
42 CFR CMS Penalty per day
488.408(e)(1)( for a nursing
iii). facility's
failure to
meet Category
3
certification:
[[Page 2886]]
Minimum...... 2019 6,690 6,808
Maximum...... 2019 21,933 22,320
42 CFR CMS Penalty per
488.408(e)(1)( instance for a
iv). nursing
facility's
failure to
meet Category
3
certification:
Minimum...... 2019 2,194 2,233
Maximum...... 2019 21,933 22,320
42 CFR CMS Penalty per
488.408(e)(2)( instance for a
ii). nursing
facility's
failure to
meet Category
3
certification,
which results
in immediate
jeopardy:
Minimum...... 2019 2,194 2,233
Maximum...... 2019 21,933 22,320
42 CFR CMS Penalty per day
488.438(a)(1)( for nursing
i). facility's
failure to
meet
certification
(Upper Range):
Minimum...... 2019 6,690 6,808
Maximum...... 2019 21,933 22,320
42 CFR CMS Penalty per day
488.438(a)(1)( for nursing
ii). facility's
failure to
meet
certification
(Lower Range):
Minimum...... 2019 110 112
Maximum...... 2019 6,579 6,695
42 CFR CMS Penalty per
488.438(a)(2). instance for
nursing
facility's
failure to
meet
certification:
Minimum...... 2019 2,194 2,233
Maximum...... 2019 21,933 22,320
1396r(f)(2)(B)(iii)(I)(c) 42 CFR CMS Grounds to 2019 10,967 11,160
483.151(b)(2)( prohibit
iv) and approval of
(b)(3)(iii). 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
civil monetary
penalties
(CMPs)
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 CMS Grounds to 2019 10,967 11,160
483.151(c)(2). waive
disapproval of
nurse aide
training
program--refer
ence to
disapproval
based on
imposition of
CMP ``not less
than $5,000''
[Not CMP
authority but
CMP imposition
at this level
determines
eligibility to
seek waiver of
disapproval of
nurse aide
training
program].
1396t(j)(2)(C)........... ............... CMS Penalty for
each day of
noncompliance
for a home or
community care
provider that
no longer
meets the
minimum
requirements
for home and
community
care:
Minimum...... 2019 2 2
Maximum...... 2019 18,943 19,277
1396u-2(e)(2)(A)(i)...... 42 CFR 438.704. CMS Penalty for a 2019 39,121 39,811
Medicaid
managed care
organization
that fails
substantially
to provide
medically
necessary
items and
services.
Penalty for 2019 39,121 39,811
Medicaid
managed care
organization
that imposes
premiums or
charges on
enrollees in
excess of the
premiums or
charges
permitted.
Penalty for a 2019 39,121 39,811
Medicaid
managed care
organization
that
misrepresents
or falsifies
information to
another
individual or
entity.
Penalty for a 2019 39,121 39,811
Medicaid
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 2019 156,488 159,248
Medicaid
managed care
organization
that
misrepresents
or falsifies
information to
the HHS
Secretary.
Penalty for 2019 156,488 159,248
Medicaid
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 2019 23,473 23,887
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.
1396u(h)(2).............. 42 CFR Part CMS Penalty for a 2019 21,933 22,320
441, Subpart I. 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.
[[Page 2887]]
1396w-2(c)(1)............ ............... CMS Penalty for 2019 11,698 11,904
disclosing
information
related to
eligibility
determinations
for medical
assistance
programs.
18041(c)(2).............. 45 CFR 150.315; CMS Failure to 2019 159 162
45 CFR comply with
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 2019 28,906 29,416
providing
false
information on
Exchange
application.
18081(h)(1)(B)........... 42 CFR 155.285. CMS Penalty for 2019 289,060 294,159
knowingly or
willfully
providing
false
information on
Exchange
application.
18081(h)(2).............. 42 CFR 155.260. CMS Penalty for 2019 28,906 29,416
knowingly or
willfully
disclosing
protected
information
from Exchange.
31 U.S.C.:
1352..................... 45 CFR HHS Penalty for the 2019 20,134 20,489
93.400(e). 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...... 2019 20,134 20,489
Maximum...... 2019 201,340 204,892
Penalty for the 2019 20,134 20,489
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...... 2019 20,134 20,489
Maximum...... 2019 201,340 204,892
45 CFR Part 93, HHS Penalty for
Appendix A. failure to
provide
certification
regarding
lobbying in
the award
documents for
all sub-awards
of all tiers:
Minimum...... 2019 20,134 20,489
Maximum...... 2019 201,340 204,892
Penalty for
failure to
provide
statement
regarding
lobbying for
loan guarantee
and loan
insurance
transactions:
Minimum...... 2019 20,134 20,489
Maximum...... 2019 201,340 204,892
3801-3812................ 45 CFR HHS Penalty against 2019 10,520 10,706
79.3(a)(1)(iv). any individual
who--with
knowledge or
reason to
know--makes,
presents or
submits a
false,
fictitious or
fraudulent
claim to the
Department.
45 CFR ........ Penalty against 2019 10,520 10,706
79.3(b)(1)(ii). any 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 2020, based on the Consumer Price Index for all Urban Consumers (CPI-U)
for the month of October 2019, not seasonally adjusted, is 1.01764, as indicated in OMB Memorandum M-20-05,
``Implementation of Penalty Inflation Adjustments for 2019, Pursuant to the Federal Civil Penalties Adjustment
Act Improvements Act of 2015'' (December 16, 2019).
Alex M. Azar II,
Secretary, Department of Health and Human Services.
[FR Doc. 2020-00738 Filed 1-15-20; 4:15 pm]
BILLING CODE 4150-24-P