[Federal Register Volume 83, Number 197 (Thursday, October 11, 2018)]
[Rules and Regulations]
[Pages 51369-51390]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-22005]
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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.
DATES: This rule is effective October 11, 2018.
FOR FURTHER INFORMATION CONTACT: Shaunta Johnson, Office of Grants and
Acquisition Policy and Accountability, Office of the Assistant
Secretary for Financial Resources, Room 514-G, Hubert Humphrey
Building, 200 Independence Avenue SW, Washington, DC 20201; 202-690-
6396; FAX 202-690-5405.
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''), 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.
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 15, 2017, Office of Management
and Budget (OMB) Memorandum for the Heads of Executive Agencies and
Departments, M-18-03, Implementation of the Penalty Inflation
Adjustments for 2018, 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 2018, based on the CPI-U for the month of October 2017,
not seasonally adjusted, is 1.02041.
Using the 2018 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-18-03, the phrase ``notwithstanding
section 553'' means that ``the public procedure the APA generally
requires--notice, an opportunity for comment, and a delay in effective
date--is not required for agencies to issue regulations implementing
the annual adjustment.'' Consistent with the language of the 2015 Act
and OMB's implementation guidance, 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-18-03, 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 October 11 2018. The adjusted civil monetary
penalty amounts apply to penalties assessed on or after October 11,
2018, 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
[[Page 51370]]
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 subtitle A, title 45 of the Code of Federal
Regulations as follows:
PART 102--ADJUSTMENT OF CIVIL MONETARY PENALTIES FOR INFLATION
0
1. The authority citation for part 102 continues to read as follows:
Authority: 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 October 11, 2018]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Citation Date of
---------------------------------------------------------- last 2016 2017 2018
statutorily Maximum Maximum Maximum
HHS agency Description \2\ established adjusted adjusted adjusted
U.S.C. CFR \1\ penalty penalty ($) penalty ($) penalty ($)
figure \3\ \4\
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21 U.S.C.
--------------------------------------------------------------------------------------------------------------------------------------------------------
333(b)(2)(A)...................... ..................... FDA Penalty for 2016 98,935 100,554 102,606
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 2016 1,978,690 2,011,061 2,052,107
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 failure 2016 197,869 201,106 205,211
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 2016 26,723 27,160 27,714
person who violates
a requirement
related to devices
for each such
violation.
Penalty for 2016 1,781,560 1,810,706 1,847,663
aggregate of all
violations related
to devices in a
single proceeding.
333(f)(2)(A)...................... ..................... FDA Penalty for any 2016 75,123 76,352 77,910
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 2016 375,613 381,758 389,550
of any other person
other than an
individual) for
such introduction
or delivery of
adulterated food.
Penalty for 2016 751,225 763,515 779,098
aggregate of all
such violations
related to
adulterated food
adjudicated in a
single proceeding.
333(f)(3)(A)...................... ..................... FDA Penalty for all 2016 11,383 11,569 11,805
violations
adjudicated in a
single proceeding
for any person who
violates 21 U.S.C.
331(jj)(1) 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 2016 11,383 11,569 11,805
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 2016 284,583 289,239 295,142
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 51371]]
Penalty for 2016 1,138,330 1,156,953 1,180,566
aggregate of all
such above
violations in a
single proceeding.
333(f)(4)(A)(ii).................. FDA Penalty for REMS 2016 284,583 289,239 295,142
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 2016 1,138,330 1,156,953 1,180,566
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 2016 11,383,300 11,569,531 11,805,665
aggregate of all
such above
violations
adjudicated in a
single proceeding.
333(f)(9)(A)...................... ..................... FDA Penalty for any 2016 16,503 16,773 17,115
person who violates
a requirement which
relates to tobacco
products for each
such violation.
Penalty for 2016 1,100,200 1,118,199 1,141,021
aggregate of all
such violations of
tobacco product
requirement
adjudicated in a
single proceeding.
333(f)(9)(B)(i)(I)................ FDA Penalty per 2016 275,050 279,550 285,256
violation related
to violations of
tobacco
requirements.
Penalty for 2016 1,100,200 1,118,199 1,141,021
aggregate of all
such violations of
tobacco product
requirements
adjudicated in a
single proceeding.
333(f)(9)(B)(i)(II)............... ..................... FDA Penalty in the case 2016 275,050 279,550 285,256
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 2016 1,100,200 1,118,199 1,141,021
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 2016 11,002,000 11,181,993 11,410,218
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 2016 275,050 279,550 285,256
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 2016 1,100,200 1,118,199 1,141,021
aggregate of for
all such above
violations
adjudicated in a
single proceeding.
333(f)(9)(B)(ii)(II).............. ..................... FDA Penalty for 2016 275,050 279,550 285,256
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.
[[Page 51372]]
Penalty for post- 2016 1,100,200 1,118,199 1,141,021
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 2016 11,002,000 11,181,993 11,410,218
aggregate above
tobacco product
requirement
violations
adjudicated in a
single proceeding.
333(g)(1)......................... ..................... FDA Penalty for any 2016 284,583 289,239 295,142
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 each 2016 569,165 578,477 590,284
subsequent above
violation in any 3-
year period.
333 note.......................... ..................... FDA Penalty to be 2016 275 279 285
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 2016 550 559 570
of a third tobacco
product regulation
violation within a
24-month period.
Penalty in the case 2016 2,200 2,236 2,282
of a fourth tobacco
product regulation
violation within a
24-month period.
Penalty in the case 2016 5,501 5,591 5,705
of a fifth tobacco
product regulation
violation within a
36-month period.
Penalty in the case 2016 11,002 11,182 11,410
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 2016 275 279 285
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 2016 550 559 570
of a second tobacco
product regulation
violation within a
12-month period.
Penalty in the case 2016 1,100 1,118 1,141
of a third tobacco
product regulation
violation within a
24-month period.
Penalty in the case 2016 2,200 2,236 2,282
of a fourth tobacco
product regulation
violation within a
24-month period.
Penalty in the case 2016 5,501 5,591 5,705
of a fifth tobacco
product regulation
violation within a
36-month period.
Penalty in the case 2016 11,002 11,182 11,410
of a sixth or
subsequent tobacco
product regulation
violation within a
48-month period as
determined on a
case-by-case basis.
[[Page 51373]]
335b(a)........................... ..................... FDA Penalty for each 2016 419,320 426,180 434,878
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 2016 1,677,280 1,704,720 1,739,513
of any other person
(other than an
individual) per
above violation.
360pp(b)(1)....................... ..................... FDA Penalty for any 2016 2,750 2,795 2,852
person who violates
any such
requirements for
electronic
products, with each
unlawful act or
omission
constituting a
separate violation.
Penalty imposed for 2016 937,500 952,838 972,285
any related series
of violations of
requirements
relating to
electronic products.
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42 U.S.C.
--------------------------------------------------------------------------------------------------------------------------------------------------------
262(d)............................ ..................... FDA Penalty per day for 2016 215,628 219,156 223,629
violation of order
of recall of
biological product
presenting imminent
or substantial
hazard.
263b(h)(3)........................ ..................... FDA Penalty for failure 2016 16,773 17,047 17,395
to obtain a
mammography
certificate as
required.
300aa-28(b)(1).................... ..................... FDA Penalty per 2016 215,628 219,156 223,629
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 each 2016 5,437 5,526 5,639
instance of
overcharging a 340B
covered entity.
299c-3(d)......................... ..................... AHRQ Penalty for an 2016 14,140 14,371 14,664
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 2016 1,450 1,474 1,504
of Information in
the National
Directory of New
Hires.
262a(i)(1)........................ 42 CFR 1003.910...... OIG Penalty for each 2016 327,962 333,327 340,130
individual who
violates safety and
security procedures
related to handling
dangerous
biological agents
and toxins.
Penalty for any 2016 655,925 666,656 680,262
other person who
violates safety and
security procedures
related to handling
dangerous
biological agents
and toxins.
300jj-51.......................... ..................... OIG Penalty per 2016 1,000,000 1,016,360 1,037,104
violation for
committing
information
blocking.
1320a-7a(a) \5\................... 42 CFR 1003.210(a)(1) OIG Penalty for 2018 15,024 15,270 20,000
knowingly
presenting or
causing to be
presented to an
officer, employee,
or agent of the
United States a
false claim.
Penalty for 2018 15,024 15,270 20,000
knowingly
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 2018 22,537 22,906 30,000
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.
[[Page 51374]]
42 CFR 1003.210(a)(3) ................... Penalty for an 2018 15,024 15,270 20,000
excluded party
retaining ownership
or control interest
in a participating
entity.
42 CFR 1003.1010..... ................... Penalty for 2018 15,024 15,270 20,000
remuneration
offered to induce
program
beneficiaries to
use particular
providers,
practitioners, or
suppliers.
42 CFR 1003.210(a)(4) ................... Penalty for 2018 14,718 14,959 20,000
employing or
contracting with an
excluded individual.
42 CFR 1003.310(a)(3) ................... Penalty for knowing 2018 73,588 74,792 100,000
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 1003.210(a)(1) ................... Penalty for ordering 2018 10,874 11,052 20,000
or prescribing
medical or other
item or service
during a period in
which the person
was excluded.
42 CFR 1003.210(a)(6) ................... Penalty for 2018 54,372 55,262 100,000
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.
42 CFR 1003.210(a)(8) ................... Penalty for knowing 2018 10,874 11,052 20,000
of an overpayment
and failing to
report and return.
42 CFR 1003.210(a)(7) ................... Penalty for making 2018 54,372 55,262 100,000
or using a false
record or statement
that is material to
a false or
fraudulent claim.
42 CFR 1003.210(a)(9) ................... Penalty for failure 2018 16,312 16,579 30,000
to grant timely
access to HHS OIG
for audits,
investigations,
evaluations, and
other statutory
functions of HHS
OIG.
1320a-7a(b) \5\................... ..................... OIG Penalty for payments 2018 4,313 4,384 5,000
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 2018 4,313 4,384 5,000
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 2018 7,512 7,635 10,000
1003.210(a)(10). physician who
executes a document
that falsely
certifies home
health needs for
Medicare
beneficiaries.
1320a-7e(b)(6)(A)................. 42 CFR 1003.810...... OIG Penalty for failure 2016 36,794 37,396 38,159
to 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 2016 9,893 10,055 10,260
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 1003.610(a)... OIG Penalty for the 2016 49,467 50,276 51,302
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.
[[Page 51375]]
1395i-3(b)(3)(B)(ii)(1)........... 42 CFR OIG Penalty for 2016 2,063 2,097 2,140
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 causing 2016 10,314 10,483 10,697
1003.210(a)(11). 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 2016 4,126 4,194 4,280
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 2016 37,561 38,175 38,954
Medicare Advantage
organization that
substantially fails
to provide
medically
necessary, required
items and services.
................... Penalty for a 2016 36,794 37,396 38,159
Medicare Advantage
organization that
charges excessive
premiums.
Penalty for a 2016 36,794 37,396 38,159
Medicare Advantage
organization that
improperly expels
or refuses to
reenroll a
beneficiary.
Penalty for a 2016 147,177 149,585 152,638
Medicare Advantage
organization that
engages in practice
that would
reasonably be
expected to have
the effect of
denying or
discouraging
enrollment.
Penalty per 2016 22,077 22,438 22,896
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 2016 147,177 149,585 152,638
Medicare Advantage
organization
misrepresenting or
falsifying
information to
Secretary.
Penalty for a 2016 36,794 37,396 38,159
Medicare Advantage
organization
misrepresenting or
falsifying
information to
individual or other
entity.
Penalty for Medicare 2016 36,794 37,396 38,159
Advantage
organization
interfering with
provider's advice
to enrollee and non-
MCO affiliated
providers that
balance bill
enrollees.
Penalty for a 2016 36,794 37,396 38,159
Medicare Advantage
organization that
employs or
contracts with
excluded individual
or entity.
Penalty for a 2016 36,794 37,396 38,159
Medicare Advantage
organization
enrolling an
individual in
without prior
written consent.
Penalty for a 2016 36,794 37,396 38,159
Medicare Advantage
organization
transferring an
enrollee to another
plan without
consent or solely
for the purpose of
earning a
commission.
Penalty for a 2016 36,794 37,396 38,159
Medicare Advantage
organization
failing to comply
with marketing
restrictions or
applicable
implementing
regulations or
guidance.
Penalty for a 2016 36,794 37,396 38,159
Medicare Advantage
organization
employing or
contracting with an
individual or
entity who violates
1395w-27(g)(1)(A)-(
J).
[[Page 51376]]
1395w-141(i)(3)................... OIG Penalty for a 2016 12,856 13,066 13,333
prescription drug
card sponsor that
falsifies or
misrepresents
marketing
materials,
overcharges program
enrollees, or
misuse transitional
assistance funds.
1395cc(g)......................... OIG Penalty for improper 2016 5,000 5,082 5,186
billing by
Hospitals, Critical
Access Hospitals,
or Skilled Nursing
Facilities.
1395dd(d)(1)...................... 42 CFR 1003.510...... OIG Penalty for a 2016 103,139 104,826 106,965
hospital or
responsible
physician dumping
patients needing
emergency medical
care, if the
hospital has 100
beds or more.
Penalty for a 2016 51,570 52,414 53,484
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 HMO or 2016 51,570 52,414 53,484
competitive plan is
such plan
substantially fails
to provide
medically
necessary, required
items or services.
Penalty for HMOs/ 2016 51,570 52,414 53,484
competitive medical
plans that charge
premiums in excess
of permitted
amounts.
Penalty for a HMO or 2016 51,570 52,414 53,484
competitive medical
plan that expels or
refuses to reenroll
an individual per
prescribed
conditions.
Penalty for a HMO or 2016 206,278 209,653 213,932
competitive medical
plan that
implements
practices to
discourage
enrollment of
individuals needing
services in future.
Penalty per 2016 29,680 30,166 30,782
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 2016 206,278 209,653 213,932
competitive medical
plan that
misrepresents or
falsifies
information to the
Secretary.
Penalty for a HMO or 2016 51,570 52,414 53,484
competitive medical
plan that
misrepresents or
falsifies
information to an
individual or any
other entity.
Penalty for failure 2016 51,570 52,414 53,484
by HMO or
competitive medical
plan to assure
prompt payment of
Medicare risk
sharing contracts
or incentive plan
provisions.
Penalty for HMO that 2016 47,340 48,114 49,096
employs or
contracts with
excluded individual
or entity.
1395nn(g)(3)...................... 42 CFR 1003.310...... OIG Penalty for 2016 23,863 24,253 24,748
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 2016 159,089 161,692 164,992
circumventing Stark
Law's restrictions
on physician self-
referrals.
1395ss(d)(1)...................... 42 CFR 1003.1110..... OIG Penalty for a 2016 9,893 10,055 10,260
material
misrepresentation
regarding Medigap
compliance policies.
1395ss(d)(2)...................... 42 CFR 1003.1110..... OIG Penalty for selling 2016 9,893 10,055 10,260
Medigap policy
under false
pretense.
1395ss(d)(3)(A)(ii)............... 42 CFR 1003.1110..... OIG Penalty for an 2016 44,539 45,268 46,192
issuer that sells
health insurance
policy that
duplicates benefits.
Penalty for someone 2016 26,723 27,160 27,714
other than issuer
that sells health
insurance that
duplicates benefits.
[[Page 51377]]
1395ss(d)(4)(A)................... 42 CFR 1003.1110..... OIG Penalty for using 2016 9,893 10,055 10,260
mail to sell a non-
approved Medigap
insurance policy.
1396b(m)(5)(B)(i)................. 42 CFR 1003.410...... OIG Penalty for a 2016 49,467 50,276 51,302
Medicaid MCO that
substantially fails
to provide
medically
necessary, required
items or services.
Penalty for a 2016 49,467 50,276 51,302
Medicaid MCO that
charges excessive
premiums.
Penalty for a 2016 197,869 201,106 205,211
Medicaid MCO that
improperly expels
or refuses to
reenroll a
beneficiary.
Penalty per 2016 29,680 30,166 30,782
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 2016 197,869 201,106 205,211
Medicaid MCO
misrepresenting or
falsifying
information to the
Secretary.
Penalty for a 2016 49,467 50,276 51,302
Medicaid MCO
misrepresenting or
falsifying
information to an
individual or
another entity.
Penalty for a 2016 44,539 45,268 46,192
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 2016 2,063 2,097 2,140
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 2016 10,314 10,483 10,697
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 1003.1310..... OIG Penalty for 2016 4,126 4,194 4,280
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 1003.1210..... OIG Penalty for the 2016 178,156 181,071 184,767
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 1003.1210..... OIG Penalty per day for 2016 17,816 18,107 18,477
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 2016 178,156 181,071 184,767
provision of false
information by drug
manufacturer with
rebate agreement.
1396t(i)(3)(A).................... 42 CFR 1003.1310..... OIG Penalty for 2016 3,563 3,621 3,695
notifying home and
community-based
providers or
settings of survey.
11131(c).......................... 42 CFR 1003.810...... OIG Penalty for failing 2016 21,563 21,916 22,363
to report a medical
malpractice claim
to National
Practitioner Data
Bank.
11137(b)(2)....................... 42 CFR 1003.810...... OIG Penalty for 2016 21,563 21,916 22,363
breaching
confidentiality of
information
reported to
National
Practitioner Data
Bank.
299b-22(f)(1)..................... 42 CFR 3.404......... OCR Penalty for 2016 11,940 12,135 12,383
violation of
confidentiality
provision of the
Patient Safety and
Quality Improvement
Act.
1320(d)-5(a)...................... 45 CFR OCR Penalty for each pre- 2016 150 152 155
160.404(b)(1)(i), February 18, 2009
(ii). violation of the
HIPAA
administrative
simplification
provisions.
Calendar Year Cap... 2016 37,561 38,175 38,954
[[Page 51378]]
45 CFR OCR Penalty for each ........... ........... ........... ...........
160.404(b)(2)(i)(A), February 18, 2009
(B). 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............. 2016 110 112 114
Maximum............. 2016 55,010 55,910 57,051
Calendar Year Cap... 2016 1,650,300 1,677,299 1,711,533
45 CFR OCR Penalty for each ........... ........... ........... ...........
160.404(b)(2)(ii)(A) February 18, 2009
, (B). 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............. 2016 1,100 1,118 1,141
Maximum............. 2016 55,010 55,910 57,051
Calendar Year Cap... 2016 1,650,300 1,677,299 1,711,533
45 CFR OCR Penalty for each ........... ........... ........... ...........
160.404(b)(2)(iii)(A February 18, 2009
), (B). 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............. 2016 11,002 11,182 11,410
Maximum............. 2016 55,010 55,910 57,051
Calendar Year Cap... 2016 1,650,300 1,677,299 1,711,533
45 CFR OCR Penalty for each ........... ........... ........... ...........
160.404(b)(2)(iv)(A) February 18, 2009
, (B). 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............. 2016 55,010 55,910 57,051
Maximum............. 2016 1,650,300 1,677,299 1,711,533
Calendar Year Cap... 2016 1,650,300 1,677,299 1,711,533
263a(h)(2)(B) & 1395w- 42 CFR CMS Penalty for a ........... ........... ........... ...........
2(b)(2)(A)(ii). 493.1834(d)(2)(i). clinical
laboratory's
failure to meet
participation and
certification
requirements and
poses immediate
jeopardy.
Minimum............. 2016 6,035 6,134 6,259
Maximum............. 2016 19,787 20,111 20,521
42 CFR CMS Penalty for a ........... ........... ........... -
493.1834(d)(2)(ii). clinical
laboratory's
failure to meet
participation and
certification
requirements and
the failure does
not pose immediate
jeopardy.
Minimum............. 2016 99 101 103
Maximum............. 2016 5,936 6,033 6,156
300gg-15(f)....................... 45 CFR 147.200(e).... CMS Failure to provide 2016 1,087 1,105 1,128
the Summary of
Benefits and
Coverage.
300gg-18.......................... 45 CFR 158.606....... CMS Penalty for 2016 109 111 113
violations of
regulations related
to the medical loss
ratio reporting and
rebating.
[[Page 51379]]
1320a-7h(b)(1).................... 42 CFR 402.105(d)(5), CMS Penalty for ........... ........... ........... ...........
42 CFR 403.912(a) & manufacturer or
(c). group purchasing
organization
failing to report
information
required under 42
U.S.C. 1320a-7h(a),
relating to
physician ownership
or investment
interests.
Minimum............. 2016 1,087 1,105 1,128
Maximum............. 2016 10,874 11,052 11,278
Calendar Year Cap... 2016 163,117 165,786 169,170
1320a-7h(b)(2).................... 42 CFR 402.105(h), 42 CMS Penalty for ........... ........... ........... ...........
CFR 403 912(b) & (c). 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............. 2016 10,874 11,052 11,278
Maximum............. 2016 108,745 110,524 112,780
Calendar Year Cap... 2016 1,087,450 1,105,241 1,127,799
1320a-7j(h)(3)(A)................. CMS Penalty for an 2016 108,745 110,524 112,780
administrator of a
facility that fails
to comply with
notice requirements
for the closure of
a facility.
42 CFR CMS Minimum penalty for 2016 544 553 564
488.446(a)(1),(2), & the first offense
(3). of an administrator
who fails to
provide notice of
facility closure.
Minimum penalty for 2016 1,631 1,658 1,692
the second offense
of an administrator
who fails to
provide notice of
facility closure.
Minimum penalty for 2016 3,262 3,315 3,383
the third and
subsequent offenses
of an administrator
who fails to
provide notice of
facility closure.
1320a-8(a)(1)..................... CMS Penalty for an 2016 7,954 8,084 8,249
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 2016 7,500 7,623 7,779
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 2016 6,229 6,331 6,460
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 2016 217,490 221,048 225,560
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.
[[Page 51380]]
1320b-25(c)(2)(A)................. CMS Penalty for failure 2016 326,235 331,572 338,339
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 long- 2016 217,490 221,048 225,560
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 402.105(g).... CMS Penalty for any 2016 147 149 152
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 for ........... ........... ........... ...........
488.408(d)(1)(iii). a Skilled Nursing
Facility that has a
Category 2
violation of
certification
requirements.
Minimum............. 2016 103 105 107
Maximum............. 2016 6,188 6,289 6,417
42 CFR CMS Penalty per instance ........... ........... ........... ...........
488.408(d)(1)(iv). of Category 2
noncompliance by a
Skilled Nursing
Facility.
Minimum............. 2016 2,063 2,097 2,140
Maximum............. 2016 20,628 20,965 21,393
42 CFR CMS Penalty per day for ........... ........... ........... ...........
488.408(e)(1)(iii). a Skilled Nursing
Facility that has a
Category 3
violation of
certification
requirements.
Minimum............. 2016 6,291 6,394 6,525
Maximum............. 2016 20,628 20,965 21,393
42 CFR CMS Penalty per instance ........... ........... ........... ...........
488.408(e)(1)(iv). of Category 3
noncompliance by a
Skilled Nursing
Facility.
Minimum............. 2016 2,063 2,097 2,140
Maximum............. 2016 20,628 20,965 21,393
42 CFR 488.408 CMS Penalty per day and ........... ........... ........... ...........
(e)(2)(ii). per instance for a
Skilled Nursing
Facility that has
Category 3
noncompliance with
Immediate Jeopardy.
Per Day (Minimum)... 2016 6,291 6,394 6,525
Per Day (Maximum)... 2016 20,628 20,965 21,393
Per Instance 2016 2,063 2,097 2,140
(Minimum).
Per Instance 2016 20,628 20,965 21,393
(Maximum).
42 CFR CMS Penalty per day of a ........... ........... ........... ...........
488.438(a)(1)(i). Skilled Nursing
Facility that fails
to meet
certification
requirements. These
amounts represent
the upper range per
day.
Minimum............. 2016 6,291 6,394 6,524
Maximum............. 2016 20,628 20,965 21,393
42 CFR CMS Penalty per day of a ........... ........... ........... ...........
488.438(a)(1)(ii). Skilled Nursing
Facility that fails
to meet
certification
requirements. These
amounts represent
the lower range per
day.
Minimum............. 2016 103 105 107
Maximum............. 2016 6,188 6,289 6,418
42 CFR 488.438(a)(2). CMS Penalty per instance ........... ........... ........... ...........
of a Skilled
Nursing Facility
that fails to meet
certification
requirements.
Minimum............. 2016 2,063 2,097 2,140
Maximum............. 2016 20,628 20,965 21,393
[[Page 51381]]
1395l(h)(5)(D) \5\................ 42 CFR CMS Penalty for 2018 15,024 15,270 30,000
402.105(d)(2)(i). 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)).
1395l(i)(6)....................... CMS Penalty for 2016 3,957 4,022 4,104
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 402.105(a).... CMS Penalty for 2016 3,787 3,849 3,928
knowingly and
willfully failing
to provide
information about a
referring physician
when seeking
payment on an
unassigned basis.
1395m(a)(11)(A) \5\............... 42 CFR 402.1(c)(4), CMS Penalty for any 2018 15,024 15,270 30,000
402.105(d)(2)(ii). 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)).
1395m(a)(18)(B) \5\............... 42 CFR 402.1(c)(5), CMS Penalty for any 2018 15,024 15,270 30,000
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) \5\................ 42 CFR 402.1(c)(6), CMS Penalty for any 2018 15,024 15,270 30,000
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) \5\................... 42 CFR 402.1(c)(8), CMS Penalty for any 2018 15,024 15,270 30,000
402.105(d)(2)(vi). 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)).
[[Page 51382]]
1395m(j)(2)(A)(iii)............... CMS Penalty for any 2016 1,591 1,617 1,650
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) \5\................... 42 CFR 402.1(c)(10), CMS Penalty for any 2018 15,024 15,270 30,000
402.105(d)(2)(vii). 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)).
1395m(k)(6) \5\................... 42 CFR 402.1(c)(31), CMS Penalty for any 2018 15,024 15,270 30,000
402.105(d)(3). 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)).
1395m(l)(6) \5\................... 42 CFR 402.1(c)(32), CMS Penalty for any 2018 15,024 15,270 30,000
402.105(d)(4). 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)).
1395u(b)(18)(B) \5\............... 42 CFR 402.1(c)(11), CMS Penalty for any 2018 15,024 15,270 30,000
402.105(d)(2)(viii). practitioner
specified in
Section
1842(b)(18)(C) of
the Act or other
person that
knowingly and
willfully bills or
collects for any
services by the
practitioners on
other than an
assignment-related
basis. (Penalties
are assessed in the
same manner as 42
U.S.C.
1395u(j)(2)(B),
which is assessed
according to 1320a-
7a(a)).
1395u(j)(2)(B) \5\................ 42 CFR 402.1(c)...... CMS Penalty for any 2018 15,024 15,270 30,000
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) \5\...................... 42 CFR 402.1(c)(12), CMS Penalty for any 2018 15,024 15,270 30,000
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)).
[[Page 51383]]
1395u(l)(3) \5\................... 42 CFR 402.1(c)(13), CMS Penalty for any 2018 15,024 15,270 30,000
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) \5\................... 42 CFR 402.1(c)(14), CMS Penalty for any 2018 15,024 15,270 30,000
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) \5\................... 42 CFR 402.1(c)(15), CMS Penalty for any 2018 15,024 15,270 30,000
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) \5\................ 42 CFR 414.707(b).... CMS Penalty for any 2018 15,024 15,270 30,000
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 2016 3,957 4,022 4,104
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 2016 12,856 13,066 13,333
pharmaceutical
manufacturer's
misrepresentation
of average sales
price of a drug, or
biologic.
[[Page 51384]]
1395w-4(g)(1)(B) \5\.............. 42 CFR 402.1(c)(17), CMS Penalty for any 2018 15,024 15,270 30,000
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) \5\.............. 42 CFR 402.1(c)(18), CMS Penalty for any 2018 15,024 15,270 30,000
402.105(d)(2)(xiv). person that
knowingly and
willfully bills for
statutorily defined
State-plan approved
physicians'
services on any
other basis than an
assignment-related
basis for a
Medicare/Medicaid
dual eligible
beneficiary.
(Penalties are
assessed in the
same manner as 42
U.S.C.
1395u(j)(2)(B),
which is assessed
according to 1320a-
7a(a)).
1395w-27(g)(3)(A); 1857(g)(3)..... 42 CFR 422.760(b); 42 CMS Penalty for each 2016 36,794 37,396 38,159
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); 1857(g)(3)..... ..................... CMS Penalty for each 2016 14,718 14,959 15,264
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); 1857(g)(3)..... ..................... CMS Penalty for a 2016 136,689 138,925 141,760
Medicare 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 2016 8,908 9,054 9,239
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 402.1(c)(20), CMS Penalty for any non- 2016 1,450 1,474 1,504
42 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 2016 3,182 3,234 3,300
402.105(a). 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.
1395y(b)(7)(B)(i)................. ..................... CMS Penalty for any 2016 1,138 1,157 1,181
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.
[[Page 51385]]
1395pp(h) \5\..................... 42 CFR 402.1(c)(23), CMS Penalty for any 2018 15,024 15,270 30,000
402.105(d)(2)(xv). 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)).
1395nn(g)(5)...................... 42 CFR 411.361....... CMS Penalty for any 2016 18,936 19,246 19,639
person that fails
to report
information
required by HHS
under Section
1877(f) concerning
ownership,
investment, and
compensation
arrangements.
1395pp(h)......................... 42 CFR 402.1(c)(23), CMS Penalty for any 2016 15,024 15,270 15,582
402.105(d)(2)(xv). 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)).
1395ss(a)(2)...................... 42 CFR 402.1(c)(24), CMS Penalty for any 2016 51,569 52,413 53,483
405.105(f)(1). 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.
1395ss(d)(3)(A)(vi)(II)........... ..................... CMS Penalty for someone 2016 26,723 27,160 27,714
other than issuer
that sells or
issues a Medicare
supplemental policy
to beneficiary
without a
disclosure
statement.
Penalty for an 2016 44,539 45,268 46,192
issuer that sells
or issues a
Medicare
supplemental policy
without disclosure
statement.
1395ss(d)(3)(B)(iv)............... ..................... CMS Penalty for someone 2016 26,723 27,160 27,714
other than issuer
that sells or
issues a Medicare
supplemental policy
without
acknowledgement
form..
Penalty for issuer 2016 44,539 45,268 46,192
that sells or
issues a Medicare
supplemental policy
without an
acknowledgement
form.
1395ss(p)(8)...................... 42 CFR 402.1(c)(25), CMS Penalty for any 2016 26,723 27,160 27,714
402.105(e). 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.
42 CFR 402.1(c)(25), CMS Penalty for any 2016 44,539 45,268 46,192
405.105(f)(2). 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.
1395ss(p)(9)(C)................... 42 CFR 402.1(c)(26), CMS Penalty for any 2016 26,723 27,160 27,714
402.105(e). 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.
[[Page 51386]]
42 CFR 402.1(c)(26), ................... Penalty for any 2016 44,539 45,268 46,192
405.105(f)(3), (4). 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.
1395ss(q)(5)(C)................... 42 CFR 402.1(c)(27), CMS Penalty for any 2016 44,539 45,268 46,192
405.105(f)(5). 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.
1395ss(r)(6)(A)................... 42 CFR 402.1(c)(28), CMS Penalty for any 2016 44,539 45,268 46,192
405.105(f)(6). person 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 2016 18,908 19,217 19,609
405.105(c). 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.
1395ss(t)(2)...................... 42 CFR 402.1(c)(30), CMS Penalty for any 2016 44,539 45,268 46,192
405.105(f)(7). issuer of a
Medicare
supplemental policy
that fails to
fulfill listed
responsibilities.
1395ss(v)(4)(A)................... ..................... CMS Penalty someone 2016 19,284 19,599 19,999
other than issuer
who sells, issues,
or renews a Medigap
Rx policy to an
individual who is a
Part D enrollee.
Penalty for an 2016 32,140 32,666 33,333
issuer 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 2016 4,126 4,194 4,280
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 2016 19,787 20,111 20,521
488.845(b)(2)(iii); penalty amount for
42 CFR 488.845(b)(3)- each day a home
(6); and 42 CFR 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 health
agency's
noncompliance
(Upper Range).
Minimum............. 2016 16,819 17,094 17,443
Maximum............. 2016 19,787 20,111 20,521
42 CFR ................... Penalty for a home 2016 19,787 20,111 20,521
488.845(b)(3)(i). health agency's
deficiency or
deficiencies that
cause immediate
jeopardy and result
in actual harm.
42 CFR ................... Penalty for a home 2016 17,808 18,099 18,468
488.845(b)(3)(ii). health agency's
deficiency or
deficiencies that
cause immediate
jeopardy and result
in potential for
harm.
42 CFR ................... Penalty for an 2016 16,819 17,094 17,443
488.845(b)(3)(iii). isolated incident
of noncompliance in
violation of
established HHA
policy.
42 CFR 488.845(b)(4). ................... 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............. 2016 2,968 3,017 3,079
[[Page 51387]]
Maximum............. 2016 16,819 17,094 17,443
42 CFR 488.845(b)(5). ................... 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............. 2016 989 1,005 1,026
Maximum............. 2016 7,915 8,044 8,208
42 CFR 488.845(b)(6). ................... 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............. 2016 1,979 2,011 2,052
Maximum............. 2016 19,787 20,111 20,521
Penalty for each day 2016 19,787 20,111 20,521
of noncompliance
(Maximum).
42 CFR ................... Penalty for each day 2016 19,787 20,111 20,521
488.845(d)(1)(ii). of noncompliance
(Maximum).
1396b(m)(5)(B).................... 42 CFR 460.46........ CMS Penalty for PACE ........... ........... ........... ...........
organization's
practice that would
reasonably be
expected to have
the effect of
denying or
discouraging
enrollment.
Minimum............. 2016 22,077 22,438 22,896
Maximum............. 2016 147,177 149,585 152,638
Penalty for a PACE 2016 36,794 37,396 38,159
organization that
charges excessive
premiums.
Penalty for a PACE 2016 147,177 149,585 152,638
organization
misrepresenting or
falsifying
information to CMS,
the State, or an
individual or other
entity.
Penalty for each 2016 36,794 37,396 38,159
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 2016 36,794 37,396 38,159
involuntarily
disenrolling a
participant.
Penalty for 2016 36,794 37,396 38,159
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 for ........... ........... ........... ...........
488.408(d)(1)(iii). a nursing
facility's failure
to meet a Category
2 Certification.
Minimum............. 2016 103 105 107
Maximum............. 2016 6,188 6,289 6,417
42 CFR CMS Penalty per instance ........... ........... ........... ...........
488.408(d)(1)(iv). for a nursing
facility's failure
to meet Category 2
certification.
Minimum............. 2016 2,063 2,097 2,140
Maximum............. 2016 20,628 20,965 21,393
42 CFR CMS Penalty per day for ........... ........... ........... ...........
488.408(e)(1)(iii). a nursing
facility's failure
to meet Category 3
certification.
Minimum............. 2016 6,291 6,394 6,525
Maximum............. 2016 20,628 20,965 21,393
42 CFR CMS Penalty per instance ........... ........... ........... ...........
488.408(e)(1)(iv). for a nursing
facility's failure
to meet Category 3
certification.
Minimum............. 2016 2,063 2,097 2,140
Maximum............. 2016 20,628 20,965 21,393
42 CFR CMS Penalty per instance ........... ........... ........... ...........
488.408(e)(2)(ii). for a nursing
facility's failure
to meet Category 3
certification,
which results in
immediate jeopardy.
[[Page 51388]]
Minimum............. 2016 2,063 2,097 2,140
Maximum............. 2016 20,628 20,965 21,393
42 CFR CMS Penalty per day for ........... ........... ........... ...........
488.438(a)(1)(i). nursing facility's
failure to meet
certification
(Upper Range).
Minimum............. 2016 6,291 6,394 6,525
Maximum............. 2016 20,628 20,965 21,393
42 CFR CMS Penalty per day for ........... ........... ........... ...........
488.438(a)(1)(ii). nursing facility's
failure to meet
certification
(Lower Range).
Minimum............. 2016 103 105 107
Maximum............. 2016 6,188 6,289 6,417
42 CFR 488.438(a)(2). CMS Penalty per instance ........... ........... ........... ...........
for nursing
facility's failure
to meet
certification.
Minimum............. 2016 2,063 2,097 2,140
Maximum............. 2016 20,628 20,965 21,393
1396r(f)(2)(B)(iii)(I)(c)......... 42 CFR CMS Grounds to prohibit 2016 10,314 10,483 10,697
483.151(b)(2)(iv) approval of Nurse
and (b)(3)(iii). 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 2016 10,314 10,483 10,697
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 noncompliance
for a home or
community care
provider that no
longer meets the
minimum
requirements for
home and community
care.
Minimum............. 2016 2 2 2
Maximum............. 2016 17,816 18,107 18,477
1396u-2(e)(2)(A)(i)............... 42 CFR 438.704....... CMS Penalty for a 2016 36,794 37,396 38,159
Medicaid managed
care organization
that fails
substantially to
provide medically
necessary items and
services.
Penalty for Medicaid 2016 36,794 37,396 38,159
managed care
organization that
imposes premiums or
charges on
enrollees in excess
of the premiums or
charges permitted.
Penalty for a 2016 36,794 37,396 38,159
Medicaid managed
care organization
that misrepresents
or falsifies
information to
another individual
or entity.
Penalty for a 2016 36,794 37,396 38,159
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 2016 147,177 149,585 152,638
Medicaid managed
care organization
that misrepresents
or falsifies
information to the
HHS Secretary.
Penalty for Medicaid 2016 147,177 149,585 152,638
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 2016 22,077 22,438 22,896
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.
[[Page 51389]]
1396u(h)(2)....................... 42 CFR Part 441, CMS Penalty for a 2016 20,628 20,965 21,393
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.
1396w-2(c)(1)..................... CMS Penalty for 2016 11,002 11,182 11,410
disclosing
information related
to eligibility
determinations for
medical assistance
programs.
18041(c)(2)....................... 45 CFR 150.315; 45 CMS Failure to comply 2016 150 152 155
CFR 156.805(c). 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)).
18081(h)(1)(A)(i)(II)............. 42 CFR 155.285....... CMS Penalty for 2016 27,186 27,631 28,195
providing false
information on
Exchange
application.
18081(h)(1)(B).................... 42 CFR 155.285....... CMS Penalty for 2016 271,862 276,310 281,949
knowingly or
willfully providing
false information
on Exchange
application.
18081(h)(2)....................... 42 CFR 155.260....... CMS Penalty for 2016 27,186 27,631 28,195
knowingly or
willfully
disclosing
protected
information from
Exchange.
--------------------------------------------------------------------------------------------------------------------------------------------------------
31 U.S.C.
--------------------------------------------------------------------------------------------------------------------------------------------------------
1352.............................. 45 CFR 93.400(e)..... HHS Penalty for the 2016 18,936 19,246 19,639
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............. 2016 18,936 19,246 19,639
Maximum............. 2016 189,361 192,459 196,387
Penalty for the 2016 18,936 19,246 19,639
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............. 2016 18,936 19,246 19,639
Maximum............. 2016 189,361 192,459 196,387
45 CFR Part 93, HHS Penalty for failure ........... ........... ........... ...........
Appendix A. to provide
certification
regarding lobbying
in the award
documents for all
sub-awards of all
tiers.
Minimum............. 2016 18,936 19,246 19,639
Maximum............. 2016 189,361 192,459 196,387
Penalty for failure ........... ........... ........... ...........
to provide
statement regarding
lobbying for loan
guarantee and loan
insurance
transactions.
Minimum............. 2016 18,936 19,246 19,639
Maximum............. 2016 189,361 192,459 196,387
3801-3812......................... 45 CFR 79.3(a)(1)(iv) HHS Penalty against any 2016 9,894 10,056 10,261
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). HHS Penalty against any 2016 9,894 10,056 10,261
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.
[[Page 51390]]
\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 2018, based on the CPI-U for the month of October 2017, not seasonally adjusted, is 1.02041, as indicated in OMB
Memorandum M-18-03, ``Implementation of Penalty Inflation Adjustments for 2018, Pursuant to the Federal Civil Penalties Adjustment Act Improvements
Act of 2015'' (December 15, 2017).
\5\ 2018 Maximum Adjusted Penalty column adjusted based on changes to the Bipartisan Budget Act of 2018 for 42 U.S.C.1320a-7a(a),1320a-7a(b),
1395l(h)(5)(D),1395m(a)(11)(A),1395m(a)(18)(B), 1395m(b)(5)(C), 1395m(h)(3), 1395m(j)(4), 1395m(k)(6), 1395m(l)(6), 1395u(b)(18)(B), 1395u(j)(2)(B),
1395u(k), 1395u(l)(3), 1395u(m)(3), 1395u(n)(3), 1395u(o)(3)(B), 1395w-4(g)(1)(B), 1395w-4(g)(3)(B),1395pp(h).
Dated: October 3, 2018.
Alex M. Azar II,
Secretary, Department of Health and Human Services.
[FR Doc. 2018-22005 Filed 10-10-18; 8:45 am]
BILLING CODE 4150-24-P