[Federal Register Volume 84, Number 214 (Tuesday, November 5, 2019)]
[Rules and Regulations]
[Pages 59549-59567]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-23955]
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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 is making a technical change to correct an error in the
regulation.
DATES: This rule is effective November 5, 2019.
FOR FURTHER INFORMATION CONTACT: David Dasher, Deputy Assistant
Secretary, Office of Acquisitions, Office of the Assistant Secretary
for Financial Resources, Room 536-H, Hubert Humphrey Building, 200
Independence Avenue SW, Washington DC 20201; 202-205-0706.
SUPPLEMENTARY INFORMATION:
I. Background
The Federal Civil Penalties Inflation Adjustment Act Improvements
Act of 2015 (Sec. 701 of Pub. L. 114-74) (the ``2015 Act'') amended the
Federal Civil Penalties Inflation Adjustment Act of 1990 (Pub. L. 101-
410, 104 Stat. 890 (1990)), which is intended to improve the
effectiveness of civil monetary penalties (CMPs) and to maintain the
deterrent effect of such penalties, requires agencies to adjust the
civil monetary penalties for inflation annually.
The Department of Health and Human Services (HHS) lists the civil
monetary penalty authorities and the penalty amounts administered by
all of its agencies in tabular form in 45 CFR 102.3, which was issued
in an interim final rule published in the September 6, 2016 Federal
Register (81 FR 61538). Annual adjustments were subsequently published
on February 3, 2017 (82 FR 9175) and on October 11, 2018 (83 FR 51369).
II. Calculation of Adjustment
The annual inflation adjustment for each applicable civil monetary
penalty is determined using the percent increase in the Consumer Price
Index for all Urban Consumers (CPI-U) for the month of October of the
year in which the amount of each civil penalty was most recently
established or modified. In the December 14, 2018, Office of Management
and Budget (OMB) Memorandum for the Heads of Executive Agencies and
Departments, M-19-04, Implementation of the Penalty Inflation
Adjustments for 2019, Pursuant to the Federal Civil Penalties Inflation
Adjustment Act Improvements Act of 2015, OMB published the multiplier
for the required annual adjustment. The cost-of-living adjustment
multiplier for 2019, based on the CPI-U for the month of October 2018,
not seasonally adjusted, is 1.02522. The multiplier is applied to each
applicable penalty amount that was updated and published for FY 2018
and is rounded to the nearest dollar.
Using the 2019 multiplier, HHS adjusted all its applicable monetary
penalties in 45 CFR 102.3. In addition to the adjustment, a technical
error for an incorrect citation in the description of 21 U.S.C.
333(f)(3)(A) was identified and is corrected below.
III. Statutory and Executive Order Reviews
The 2015 Act requires federal agencies to publish annual penalty
inflation adjustments notwithstanding section 553 of the Administrative
Procedure Act (APA).
Section 4(a) of the 2015 Act directs federal agencies to publish
annual adjustments no later than January 15th of each year thereafter.
In accordance with section 553 of the APA, most rules are subject to
notice and comment and are effective no earlier than 30 days after
publication in the Federal Register. However, section 4(b)(2) of the
2015 Act provides that each agency shall make the annual inflation
adjustments ``notwithstanding section 553'' of the APA. According to
OMB's Memorandum M-19-04, the phrase ``notwithstanding section 553'' in
section 4(b)(2) of the 2015 Act means that ``the public procedure the
APA
[[Page 59550]]
generally requires (i.e., notice, an opportunity for comment, and a
delay in effective date) is not required for agencies to issue
regulations implementing the annual adjustment.''
Consistent with the language of the 2015 Act and OMB's
implementation guidance, this rule is not subject to notice and an
opportunity for public comment and will be effective immediately upon
publication.
Pursuant to OMB Memorandum M-19-04, HHS has determined that the
annual inflation adjustment to the civil monetary penalties in its
regulations does not trigger any requirements under procedural statutes
and Executive Orders that govern rulemaking procedures.
IV. Effective Date
This rule is effective November 5, 2019. The adjusted civil
monetary penalty amounts apply to penalties assessed on or after
November 5, 2019, if the violation occurred on or after November 2,
2015. If the violation occurred prior to November 2, 2015, or a penalty
was assessed prior to September 6, 2016, the pre-adjustment civil
penalty amounts in effect prior to September 6, 2016, will apply.
List of Subjects in 45 CFR Part 102
Administrative practice and procedure, Penalties.
For reasons discussed in the preamble, the Department of Health and
Human Services amends 45 CFR part 102 as follows:
PART 102--ADJUSTMENT OF CIVIL MONETARY PENALTIES FOR INFLATION
0
1. The authority citation for part 102 continues to read as follows:
Authority: Public Law 101-410, Sec. 701 of Public Law 114-74, 31
U.S.C. 3801-3812.
0
2. Amend Sec. 102.3 by revising the table to read as follows:
Sec. 102.3 Penalty adjustment and table.
* * * * *
Civil Monetary Penalty Authorities Administered by HHS Agencies and Penalty Amounts
[Effective November 5, 2019]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Date of
last 2018 2019
statutorily Maximum Maximum
U.S.C. CFR \1\ HHS agency Description \2\ established adjusted adjusted
penalty penalty ($) penalty ($)
figure \3\ \4\
--------------------------------------------------------------------------------------------------------------------------------------------------------
21 U.S.C.:
333(b)(2)(A)...................... ......................... FDA................. Penalty for violations 2018 102,606 105,194
related to drug samples
resulting in a
conviction of any
representative of
manufacturer or
distributor in any 10-
year period.
333(b)(2)(B)...................... ......................... FDA................. Penalty for violation 2018 2,052,107 2,103,861
related to drug samples
resulting in a
conviction of any
representative of
manufacturer or
distributor after the
second conviction in
any 10-yr period.
333(b)(3)......................... ......................... FDA................. Penalty for failure to 2018 205,211 210,386
make a report required
by 21 U.S.C.
353(d)(3)(E) relating
to drug samples.
333(f)(1)(A)...................... ......................... FDA................. Penalty for any person 2018 27,714 28,413
who violates a
requirement related to
devices for each such
violation.
Penalty for aggregate of 2018 1,847,663 1,894,261
all violations related
to devices in a single
proceeding.
333(f)(2)(A)...................... ......................... FDA................. Penalty for any 2018 77,910 79,875
individual who
introduces or delivers
for introduction into
interstate commerce
food that is
adulterated per 21
U.S.C. 342(a)(2)(B) or
any individual who does
not comply with a
recall order under 21
U.S.C. 350l.
Penalty in the case of 2018 389,550 399,374
any other person other
than an individual) for
such introduction or
delivery of adulterated
food.
Penalty for aggregate of 2018 779,098 798,747
all such violations
related to adulterated
food adjudicated in a
single proceeding.
333(f)(3)(A)...................... ......................... FDA................. Penalty for all 2018 11,805 12,103
violations adjudicated
in a single proceeding
for any person who
violates 21 U.S.C.
331(jj) by failing to
submit the
certification required
by 42 U.S.C.
282(j)(5)(B) or
knowingly submitting a
false certification; by
failing to submit
clinical trial
information under 42
U.S.C. 282(j); or by
submitting clinical
trial information under
42 U.S.C. 282(j) that
is false or misleading
in any particular under
42 U.S.C. 282(j)(5)(D).
333(f)(3)(B)...................... ......................... FDA................. Penalty for each day any 2018 11,805 12,103
above violation is not
corrected after a 30-
day period following
notification until the
violation is corrected.
333(f)(4)(A)(i)................... ......................... FDA................. Penalty for any 2018 295,142 302,585
responsible person that
violates a requirement
of 21 U.S.C. 355(o)
(post-marketing
studies, clinical
trials, labeling), 21
U.S.C. 355(p) (risk
evaluation and
mitigation (REMS)), or
21 U.S.C. 355-1 (REMS).
[[Page 59551]]
Penalty for aggregate of 2018 1,180,566 1,210,340
all such above
violations in a single
proceeding.
333(f)(4)(A)(ii).................. ......................... FDA................. Penalty for REMS 2018 295,142 302,585
violation that
continues after written
notice to the
responsible person for
the first 30-day period
(or any portion
thereof) the
responsible person
continues to be in
violation.
Penalty for REMS 2018 1,180,566 1,210,340
violation that
continues after written
notice to responsible
person doubles for
every 30-day period
thereafter the
violation continues,
but may not exceed
penalty amount for any
30-day period.
Penalty for aggregate of 2018 11,805,665 12,103,404
all such above
violations adjudicated
in a single proceeding.
333(f)(9)(A)...................... ......................... FDA................. Penalty for any person 2018 17,115 17,547
who violates a
requirement which
relates to tobacco
products for each such
violation.
Penalty for aggregate of 2018 1,141,021 1,169,798
all such violations of
tobacco product
requirement adjudicated
in a single proceeding.
333(f)(9)(B)(i)(I)................ ......................... FDA................. Penalty per violation 2018 285,256 292,450
related to violations
of tobacco requirements.
Penalty for aggregate of 2018 1,141,021 1,169,798
all such violations of
tobacco product
requirements
adjudicated in a single
proceeding.
333(f)(9)(B)(i)(II)............... ......................... FDA................. Penalty in the case of a 2018 285,256 292,450
violation of tobacco
product requirements
that continues after
written notice to such
person, for the first
30-day period (or any
portion thereof) the
person continues to be
in violation.
Penalty for violation of 2018 1,141,021 1,169,798
tobacco product
requirements that
continues after written
notice to such person
shall double for every
30-day period
thereafter the
violation continues,
but may not exceed
penalty amount for any
30-day period.
Penalty for aggregate of 2018 11,410,217 11,697,983
all such violations
related to tobacco
product requirements
adjudicated in a single
proceeding.
333(f)(9)(B)(ii)(I)............... ......................... FDA................. Penalty for any person 2018 285,256 292,450
who either does not
conduct post-market
surveillance and
studies to determine
impact of a modified
risk tobacco product
for which the HHS
Secretary has provided
them an order to sell,
or who does not submit
a protocol to the HHS
Secretary after being
notified of a
requirement to conduct
post-market
surveillance of such
tobacco products.
Penalty for aggregate of 2018 1,141,021 1,169,798
for all such above
violations adjudicated
in a single proceeding.
333(f)(9)(B)(ii)(II).............. ......................... FDA................. Penalty for violation of 2018 285,256 292,450
modified risk tobacco
product post-market
surveillance that
continues after written
notice to such person
for the first 30-day
period (or any portion
thereof) that the
person continues to be
in violation.
Penalty for post-notice 2018 1,141,021 1,169,798
violation of modified
risk tobacco product
post-market
surveillance shall
double for every 30-day
period thereafter that
the tobacco product
requirement violation
continues for any 30-
day period, but may not
exceed penalty amount
for any 30-day period.
Penalty for aggregate 2018 11,410,217 11,697,983
above tobacco product
requirement violations
adjudicated in a single
proceeding.
333(g)(1)......................... ......................... FDA................. Penalty for any person 2018 295,142 302,585
who disseminates or
causes another party to
disseminate a direct-to-
consumer advertisement
that is false or
misleading for the
first such violation in
any 3-year period.
[[Page 59552]]
Penalty for each 2018 590,284 605,171
subsequent above
violation in any 3-year
period.
333 note.......................... ......................... FDA................. Penalty to be applied 2018 284.69439 292
for violations of
restrictions on the
sale or distribution of
tobacco products
promulgated under 21
U.S.C. 387f(d) (e.g.,
violations of
regulations in 21 CFR
part 1140) with respect
to a retailer with an
approved training
program in the case of
a second regulation
violation within a 12-
month period.
Penalty in the case of a 2018 570.40919 584
third tobacco product
regulation violation
within a 24-month
period.
Penalty in the case of a 2018 2,282 2,340
fourth tobacco product
regulation violation
within a 24-month
period.
Penalty in the case of a 2018 5,705 5,849
fifth tobacco product
regulation violation
within a 36-month
period.
Penalty in the case of a 2018 11,410 11,698
sixth or subsequent
tobacco product
regulation violation
within a 48-month
period as determined on
a case-by-case basis.
Penalty to be applied 2018 284.69439 292
for violations of
restrictions on the
sale or distribution of
tobacco products
promulgated under 21
U.S.C. 387f(d) (e.g.,
violations of
regulations in 21 CFR
part 1140) with respect
to a retailer that does
not have an approved
training program in the
case of the first
regulation violation.
Penalty in the case of a 2018 570.40919 584
second tobacco product
regulation violation
within a 12-month
period.
Penalty in the case of a 2018 1,141 1,170
third tobacco product
regulation violation
within a 24-month
period.
Penalty in the case of a 2018 2,282 2,340
fourth tobacco product
regulation violation
within a 24-month
period.
Penalty in the case of a 2018 5,705 5,849
fifth tobacco product
regulation violation
within a 36-month
period.
Penalty in the case of a 2018 5,705 5,849
fifth tobacco product
regulation violation
within a 36-month
period.
Penalty in the case of a 2018 11,410 11,698
sixth or subsequent
tobacco product
regulation violation
within a 48-month
period as determined on
a case-by-case basis.
335b(a)........................... ......................... FDA................. Penalty for each 2018 434,878 445,846
violation for any
individual who made a
false statement or
misrepresentation of a
material fact, bribed,
destroyed, altered,
removed, or secreted,
or procured the
destruction,
alteration, removal, or
secretion of, any
material document,
failed to disclose a
material fact,
obstructed an
investigation, employed
a consultant who was
debarred, debarred
individual provided
consultant services.
Penalty in the case of 2018 1,739,513 1,783,384
any other person (other
than an individual) per
above violation..
360pp(b)(1)....................... ......................... FDA................. Penalty for any person 2018 2,852 2,924
who violates any such
requirements for
electronic products,
with each unlawful act
or omission
constituting a separate
violation.
Penalty imposed for any 2018 972,285 996,806
related series of
violations of
requirements relating
to electronic products..
42 U.S.C:
262(d)............................ ......................... FDA................. Penalty per day for 2018 223,629 229,269
violation of order of
recall of biological
product presenting
imminent or substantial
hazard.
[[Page 59553]]
263b(h)(3)........................ ......................... FDA................. Penalty for failure to 2018 17,395 17,834
obtain a mammography
certificate as required.
300aa-28(b)(1).................... ......................... FDA................. Penalty per occurrence 2018 223,629 229,269
for any vaccine
manufacturer that
intentionally destroys,
alters, falsifies, or
conceals any record or
report required.
256b(d)(1)(B)(vi)................. ......................... HRSA................ Penalty for each 2018 5,639 5,781
instance of
overcharging a 340B
covered entity.
299c-(3)(d)....................... ......................... AHRQ................ Penalty for an 2018 14,664 15,034
establishment or person
supplying information
obtained in the course
of activities for any
purpose other than the
purpose for which it
was supplied.
653(l)(2)......................... 45 CFR 303.21(f)......... ACF................. Penalty for Misuse of 2018 1,504 1,542
Information in the
National Directory of
New Hires.
262a(i)(1)........................ 42 CFR 1003.910.......... OIG................. Penalty for each 2018 340,130 348,708
individual who violates
safety and security
procedures related to
handling dangerous
biological agents and
toxins.
Penalty for any other 2018 680,262 697,418
person who violates
safety and security
procedures related to
handling dangerous
biological agents and
toxins.
300jj-51.......................... ......................... OIG................. Penalty per violation 2018 1,037,104 1,063,260
for committing
information blocking.
1320a-7a(a)....................... 42 CFR 1003.210(a)(1).... OIG................. Penalty for knowingly 2018 20,000 20,504
presenting or causing
to be presented to an
officer, employee, or
agent of the United
States a false claim.
Penalty for knowingly 2018 20,000 20,504
presenting or causing
to be presented a
request for payment
which violates the
terms of an assignment,
agreement, or PPS
agreement.
42 CFR 1003.210(a)(2).... .................... Penalty for knowingly 2018 30,000 30,757
giving or causing to be
presented to a
participating provider
or supplier false or
misleading information
that could reasonably
be expected to
influence a discharge
decision.
42 CFR 1003.210(a)(3).... .................... Penalty for an excluded 2018 20,000 20,504
party retaining
ownership or control
interest in a
participating entity.
42 CFR 1003.1010......... .................... Penalty for remuneration 2018 20,000 20,504
offered to induce
program beneficiaries
to use particular
providers,
practitioners, or
suppliers.
42 CFR 1003.210(a)(4).... .................... Penalty for employing or 2018 20,000 20,504
contracting with an
excluded individual.
42 CFR 1003.310(a)(3).... .................... Penalty for knowing and 2018 100,000 102,522
willful solicitation,
receipt, offer, or
payment of remuneration
for referring an
individual for a
service or for
purchasing, leasing, or
ordering an item to be
paid for by a Federal
health care program.
42 CFR 1003.210(a)(1).... .................... Penalty for ordering or 2018 20,000 20,504
prescribing medical or
other item or service
during a period in
which the person was
excluded.
42 CFR 1003.210(a)(6).... .................... Penalty for knowingly 2018 100,000 102,522
making or causing to be
made a false statement,
omission or
misrepresentation of a
material fact in any
application, bid, or
contract to participate
or enroll as a provider
or supplier.
42 CFR 1003.210(a)(8).... .................... Penalty for knowing of 2018 20,000 20,504
an overpayment and
failing to report and
return.
42 CFR 1003.210(a)(7).... .................... Penalty for making or 2018 100,000 102,522
using a false record or
statement that is
material to a false or
fraudulent claim.
42 CFR 1003.210(a)(9).... .................... Penalty for failure to 2018 30,000 30,757
grant timely access to
HHS OIG for audits,
investigations,
evaluations, and other
statutory functions of
HHS OIG.
1320a-7a(b)....................... ......................... OIG................. Penalty for payments by 2018 5,000 5,126
a hospital or critical
access hospital to
induce a physician to
reduce or limit
services to individuals
under direct care of
physician or who are
entitled to certain
medical assistance
benefits
[[Page 59554]]
Penalty for physicians 2018 5,000 5,126
who knowingly receive
payments from a
hospital or critical
access hospital to
induce such physician
to reduce or limit
services to individuals
under direct care of
physician or who are
entitled to certain
medical assistance
benefits.
42 CFR 1003.210(a)(10)... .................... Penalty for a physician 2018 10,000 10,252
who executes a document
that falsely certifies
home health needs for
Medicare beneficiaries
1320a-7a(o)....................... ......................... OIG................. Penalty for knowingly 2016 10,000 10,461
presenting or causing
to be presented a false
or fraudulent specified
claim under a grant,
contract, or other
agreement for which the
Secretary provides
funding
Knowingly makes, uses, 2016 50,000 52,308
or causes to be made or
used any false
statement, omission, or
misrepresentation of a
material fact in any
application, proposal,
bid, progress report,
or other document
required to directly or
indirectly receive or
retain funds provided
pursuant to grant,
contract, or other
agreement
Knowingly makes, uses, 2016 50,000 52,308
or causes to be made or
used, a false record or
statement material to a
false or fraudulent
specified claim under
grant, contract, or
other agreement.
Knowingly makes, uses, 2016 * 50,000 ** 52,308
or causes to be made or
used, a false record or
statement material to
an obligation to pay or
transmit funds or
property with respect
to grant, contract, or
other agreement, or
knowingly conceals or
improperly avoids or
decreases any such
obligation..
Fails to grant timely 2016 15,000 15,692
access, upon reasonable
request, to the I.G.
for purposes of audits,
investigations,
evaluations, or other
statutory functions of
I.G. in matters
involving grants,
contracts, or other
agreements..
1320a-7e(b)(6)(A)................. 42 CFR 1003.810.......... OIG................. Penalty for failure to 2018 38,159 39,121
report any final
adverse action taken
against a health care
provider, supplier, or
practitioner.
1320b-10(b)(1).................... 42 CFR 1003.610(a)....... OIG................. Penalty for the misuse 2018 10,260 10,519
of words, symbols, or
emblems in
communications in a
manner in which a
person could falsely
construe that such item
is approved, endorsed,
or authorized by HHS.
1320b-10(b)(2).................... 42 CFR 1003.610(a)....... OIG................. Penalty for the misuse 2018 51,302 52,596
of words, symbols, or
emblems in a broadcast
or telecast in a manner
in which a person could
falsely construe that
such item is approved,
endorsed, or authorized
by HHS.
1395i-3(b)(3)(B)(ii)(1)........... 42 CFR 1003.210(a)(11)... OIG................. Penalty for 2018 2,140 2,194
certification of a
false statement in
assessment of
functional capacity of
a Skilled Nursing
Facility resident
assessment.
1395i-3(b)(3)(B)(ii)(2)........... 42 CFR 1003.210(a)(11)... OIG................. Penalty for causing 2018 10,697 10,967
another to certify or
make a false statement
in assessment of
functional capacity of
a Skilled Nursing
Facility resident
assessment.
1395i-3(g)(2)(A).................. 42 CFR 1003.1310......... OIG................. Penalty for any 2018 4,280 4,388
individual who notifies
or causes to be
notified a Skilled
Nursing Facility of the
time or date on which a
survey is to be
conducted.
1395w-27(g)(2)(A)................. 42 CFR 1003.410.......... OIG................. Penalty for a Medicare 2018 38,954 39,936
Advantage organization
that substantially
fails to provide
medically necessary,
required items and
services.
Penalty for a Medicare 2018 38,159 39,121
Advantage organization
that charges excessive
premiums.
Penalty for a Medicare 2018 38,159 39,121
Advantage organization
that improperly expels
or refuses to reenroll
a beneficiary.
[[Page 59555]]
Penalty for a Medicare 2018 152,638 156,488
Advantage organization
that engages in
practice that would
reasonably be expected
to have the effect of
denying or discouraging
enrollment.
Penalty per individual 2018 22,896 23,473
who does not enroll as
a result of a Medicare
Advantage
organization's practice
that would reasonably
be expected to have the
effect of denying or
discouraging enrollment.
Penalty for a Medicare 2018 152,638 156,488
Advantage organization
misrepresenting or
falsifying information
to Secretary.
Penalty for a Medicare 2018 38,159 39,121
Advantage organization
misrepresenting or
falsifying information
to individual or other
entity.
Penalty for Medicare 2018 38,159 39,121
Advantage organization
interfering with
provider's advice to
enrollee and non-MCO
affiliated providers
that balance bill
enrollees.
Penalty for a Medicare 2018 38,159 39,121
Advantage organization
that employs or
contracts with excluded
individual or entity.
Penalty for a Medicare 2018 38,159 39,121
Advantage organization
enrolling an individual
in without prior
written consent.
Penalty for a Medicare 2018 38,159 39,121
Advantage organization
transferring an
enrollee to another
plan without consent or
solely for the purpose
of earning a commission.
Penalty for a Medicare 2018 38,159 39,121
Advantage organization
failing to comply with
marketing restrictions
or applicable
implementing
regulations or guidance.
Penalty for a Medicare 2018 38,159 39,121
Advantage organization
employing or
contracting with an
individual or entity
who violates 1395w-
27(g)(1)(A)-(J).
1395w-141(i)(3)................... ......................... OIG................. Penalty for a 2018 13,333 13,669
prescription drug card
sponsor that falsifies
or misrepresents
marketing materials,
overcharges program
enrollees, or misuse
transitional assistance
funds.
1395cc(g)......................... 42 CFR 1003.210(a)(5).... OIG................. Penalty for improper 2018 5,186 5,317
billing by Hospitals,
Critical Access
Hospitals, or Skilled
Nursing Facilities.
1395dd(d)(1)...................... 42 CFR 1003.510.......... OIG................. Penalty for a hospital 2018 106,965 109,663
with 100 beds or more
or responsible
physician dumping
patients needing
emergency medical care.
Penalty for a hospital 2018 53,484 54,833
with less than 100 beds
dumping patients
needing emergency
medical care.
1395mm(i)(6)(B)(i)................ 42 CFR 1003.410.......... OIG................. Penalty for a HMO or 2018 53,484 54,833
competitive plan if
such plan substantially
fails to provide
medically necessary,
required items or
services.
Penalty for HMOs/ 2018 53,484 54,833
competitive medical
plans that charge
premiums in excess of
permitted amounts.
Penalty for a HMO or 2018 53,484 54,833
competitive medical
plan that expels or
refuses to reenroll an
individual per
prescribed conditions.
Penalty for a HMO or 2018 213,932 219,327
competitive medical
plan that implements
practices to discourage
enrollment of
individuals needing
services in future.
Penalty per individual 2018 30,782 31,558
not enrolled in a plan
as a result of a HMO or
competitive medical
plan that implements
practices to discourage
enrollment of
individuals needing
services in the future.
Penalty for a HMO or 2018 213,932 219,327
competitive medical
plan that misrepresents
or falsifies
information to the
Secretary.
[[Page 59556]]
Penalty for a HMO or 2018 53,484 54,833
competitive medical
plan that misrepresents
or falsifies
information to an
individual or any other
entity.
Penalty for failure by 2018 53,484 54,833
HMO or competitive
medical plan to assure
prompt payment of
Medicare risk sharing
contracts or incentive
plan provisions.
Penalty for HMO that 2018 49,096 50,334
employs or contracts
with excluded
individual or entity.
1395nn(g)(3)...................... 42 CFR 1003.310.......... OIG................. Penalty for submitting 2018 24,748 25,372
or causing to be
submitted claims in
violation of the Stark
Law's restrictions on
physician self-
referrals.
1395nn(g)(4)...................... 42 CFR 1003.310.......... OIG................. Penalty for 2018 164,992 169,153
circumventing Stark
Law's restrictions on
physician self-
referrals.
1395ss(d)(1)...................... 42 CFR 1003.1110......... OIG................. Penalty for a material 2018 10,260 10,519
misrepresentation
regarding Medigap
compliance policies.
1395ss(d)(2)...................... 42 CFR 1003.1110......... OIG................. Penalty for selling 2018 10,260 10,519
Medigap policy under
false pretense.
1395ss(d)(3)(A)(ii)............... 42 CFR 1003.1110......... OIG................. Penalty for an issuer 2018 46,192 47,357
that sells health
insurance policy that
duplicates benefits.
Penalty for someone 2018 27,714 28,413
other than issuer that
sells health insurance
that duplicates
benefits.
1395ss(d)(4)(A)................... 42 CFR 1003.1110......... OIG................. Penalty for using mail 2018 10,260 10,519
to sell a non-approved
Medigap insurance
policy.
1396b(m)(5)(B)(i)................. 42 CFR 1003.410.......... OIG................. Penalty for a Medicaid 2018 51,302 52,596
MCO that substantially
fails to provide
medically necessary,
required items or
services.
Penalty for a Medicaid 2018 51,302 52,596
MCO that charges
excessive premiums.
Penalty for a Medicaid 2018 205,211 210,386
MCO that improperly
expels or refuses to
reenroll a beneficiary.
Penalty per individual 2018 30,782 31,558
who does not enroll as
a result of a Medicaid
MCO's practice that
would reasonably be
expected to have the
effect of denying or
discouraging enrollment.
Penalty for a Medicaid 2018 205,211 210,386
MCO misrepresenting or
falsifying information
to the Secretary.
Penalty for a Medicaid 2018 51,302 52,596
MCO misrepresenting or
falsifying information
to an individual or
another entity.
Penalty for a Medicaid 2018 46,192 47,357
MCO that fails to
comply with contract
requirements with
respect to physician
incentive plans.
1396r(b)(3)(B)(ii)(I)............. 42 CFR 1003.210(a)(11)... OIG................. Penalty for willfully 2018 2,140 2,194
and knowingly
certifying a material
and false statement in
a Skilled Nursing
Facility resident
assessment.
1396r(b)(3)(B)(ii)(II)............ 42 CFR 1003.210(a)(11)... OIG................. Penalty for willfully 2018 10,697 10,967
and knowingly causing
another individual to
certify a material and
false statement in a
Skilled Nursing
Facility resident
assessment.
1396r(g)(2)(A)(i)................. 42 CFR 1003.1310......... OIG................. Penalty for notifying or 2018 4,280 4,388
causing to be notified
a Skilled Nursing
Facility of the time or
date on which a survey
is to be conducted.
1396r-8(b)(3)(B).................. 42 CFR 1003.1210......... OIG................. Penalty for the knowing 2018 184,767 189,427
provision of false
information or refusing
to provide information
about charges or prices
of a covered outpatient
drug.
1396r-8(b)(3)(C)(i)............... 42 CFR 1003.1210......... OIG................. Penalty per day for 2018 18,477 18,943
failure to timely
provide information by
drug manufacturer with
rebate agreement.
1396r-8(b)(3)(C)(ii).............. 42 CFR 1003.1210......... OIG................. Penalty for knowing 2018 184,767 189,427
provision of false
information by drug
manufacturer with
rebate agreement.
1396t(i)(3)(A).................... 42 CFR 1003.1310......... OIG................. Penalty for notifying 2018 3,695 3,788
home and community-
based providers or
settings of survey.
11131(c).......................... 42 CFR 1003.810.......... OIG................. Penalty for failing to 2018 22,363 22,927
report a medical
malpractice claim to
National Practitioner
Data Bank.
[[Page 59557]]
11137(b)(2)....................... 42 CFR 1003.810.......... OIG................. Penalty for breaching 2018 22,363 22,927
confidentiality of
information reported to
National Practitioner
Data Bank.
299b-22(f)(1)..................... 42 CFR 3.404............. OCR................. Penalty for violation of 2018 12,383 12,695
confidentiality
provision of the
Patient Safety and
Quality Improvement Act.
45 CFR 160.404(b)(1)(i), OCR................. Penalty for each pre- 2018 155.10232 159
(ii). February 18, 2009
violation of the HIPAA
administrative
simplification
provisions.
Calendar Year Cap....... 2018 38,954 39,936
1320(d)-5(a)...................... 45 CFR OCR................. Penalty for each 2018 ........... ...........
160.404(b)(2)(i)(A), (B). February 18, 2009 or
later violation of a
HIPAA administrative
simplification
provision in which it
is established that the
covered entity or
business associate did
not know and by
exercising reasonable
diligence, would not
have known that the
covered entity or
business associate
violated such a
provision:
Minimum................. 2018 114.28592 117
Maximum................. 2018 57,051 58,490
Calendar Year Cap....... 2018 1,711,533 1,754,698
45 CFR OCR................. Penalty for each 2018 ........... ...........
160.404(b)(2)(ii)(A), February 18, 2009 or
(B). later violation of a
HIPAA administrative
simplification
provision in which it
is established that the
violation was due to
reasonable cause and
not to willful neglect:
Minimum................. 2018 1,141 1,170
Maximum................. 2018 57,051 58,490
Calendar Year Cap....... 2018 1,711,533 1,754,698
45 CFR OCR................. Penalty for each 2018 ........... ...........
160.404(b)(2)(iii)(A), February 18, 2009 or
(B). later violation of a
HIPAA administrative
simplification
provision in which it
is established that the
violation was due to
willful neglect and was
corrected during the 30-
day period beginning on
the first date the
covered entity or
business associate
knew, or, by exercising
reasonable diligence,
would have known that
the violation occurred:
Minimum................. 2018 11,410 11,698
Maximum................. 2018 57,051 58,490
Calendar Year Cap....... 2018 1,711,533 1,754,698
45 CFR OCR................. Penalty for each 2018 ........... ...........
160.404(b)(2)(iv)(A), February 18, 2009 or
(B). later violation of a
HIPAA administrative
simplification
provision in which it
is established that the
violation was due to
willful neglect and was
not corrected during
the 30-day period
beginning on the first
date the covered entity
or business associate
knew, or by exercising
reasonable diligence,
would have known that
the violation occurred:
Minimum................. 2018 57,051 58,490
Maximum................. 2018 1,711,533 1,754,698
Calendar Year Cap....... 2018 1,711,533 1,754,698
263a(h)(2)(B) & 1395w- 42 CFR 493.1834(d)(2)(i). CMS................. Penalty for a clinical 2018 ........... ...........
2(b)(2)(A)(ii). laboratory's failure to
meet participation and
certification
requirements and poses
immediate jeopardy:
Minimum................. 2018 6,259 6,417
Maximum................. 2018 20,521 21,039
42 CFR 493.1834(d)(2)(ii) CMS................. Penalty for a clinical 2018 ........... ...........
laboratory's failure to
meet participation and
certification
requirements and the
failure does not pose
immediate jeopardy:
Minimum................. 2018 103 106
Maximum................. 2018 6,156 6,311
300gg-15(f)....................... 45 CFR 147.200(e)........ CMS................. Failure to provide the 2018 1,128 1,156
Summary of Benefits and
Coverage.
300gg-18.......................... 45 CFR 158.606........... CMS................. Penalty for violations 2018 113 116
of regulations related
to the medical loss
ratio reporting and
rebating.
[[Page 59558]]
1320a-7h(b)(1).................... 42 CFR 402.105(d)(5), 42 CMS................. Penalty for manufacturer 2018 ........... ...........
CFR 403.912(a) & (c). or group purchasing
organization failing to
report information
required under 42
U.S.C. 1320a-7h(a),
relating to physician
ownership or investment
interests:
Minimum................. 2018 1,128 1,156
Maximum................. 2018 11,278 11,562
Calendar Year Cap....... 2018 169,170 173,436
1320a-7h(b)(2).................... 42 CFR 402.105(h), 42 CFR CMS................. Penalty for manufacturer 2018 ........... ...........
403.912(b) & (c). or group purchasing
organization knowingly
failing to report
information required
under 42 U.S.C. 1320a-
7h(a), relating to
physician ownership or
investment interests:
Minimum................. 2018 11,278 11,562
Maximum................. 2018 112,780 115,624
Calendar Year Cap....... 2018 1,127,799 1,156,242
CMS................. Penalty for an 2018 112,780 115,624
administrator of a
facility that fails to
comply with notice
requirements for the
closure of a facility.
1320a-7j(h)(3)(A)................. 42 CFR 488.446(a)(1), CMS................. Minimum penalty for the 2018 564.28673 578
(2), & (3). first offense of an
administrator who fails
to provide notice of
facility closure.
Minimum penalty for the 2018 1,692 1,735
second offense of an
administrator who fails
to provide notice of
facility closure.
Minimum penalty for the 2018 3,383 3,468
third and subsequent
offenses of an
administrator who fails
to provide notice of
facility closure.
1320a-8(a)(1)..................... ......................... CMS................. Penalty for an entity 2018 8,249 8,457
knowingly making a
false statement or
representation of
material fact in the
determination of the
amount of benefits or
payments related to old-
age, survivors, and
disability insurance
benefits, special
benefits for certain
World War II veterans,
or supplemental
security income for the
aged, blind, and
disabled.
Penalty for violation of 2018 7,779 7,975
42 U.S.C. 1320a-8(a)(1)
if the violator is a
person who receives a
fee or other income for
services performed in
connection with
determination of the
benefit amount or the
person is a physician
or other health care
provider who submits
evidence in connection
with such a
determination.
1320a-8(a)(3)..................... ......................... CMS................. Penalty for a 2018 6,460 6,623
representative payee
(under 42 U.S.C.
405(j), 1007, or
1383(a)(2)) converting
any part of a received
payment from the
benefit programs
described in the
previous civil monetary
penalty to a use other
than for the benefit of
the beneficiary.
1320b-25(c)(1)(A)................. ......................... CMS................. Penalty for failure of 2018 225,560 231,249
covered individuals to
report to the Secretary
and 1 or more law
enforcement officials
any reasonable
suspicion of a crime
against a resident, or
individual receiving
care, from a long-term
care facility.
1320b-25(c)(2)(A)................. ......................... CMS................. Penalty for failure of 2018 338,339 346,872
covered individuals to
report to the Secretary
and 1 or more law
enforcement officials
any reasonable
suspicion of a crime
against a resident, or
individual receiving
care, from a long-term
care facility if such
failure exacerbates the
harm to the victim of
the crime or results in
the harm to another
individual.
1320b-25(d)(2).................... ......................... CMS................. Penalty for a long-term 2018 225,560 231,249
care facility that
retaliates against any
employee because of
lawful acts done by the
employee, or files a
complaint or report
with the State
professional
disciplinary agency
against an employee or
nurse for lawful acts
done by the employee or
nurse.
[[Page 59559]]
1395b-7(b)(2)(B).................. 42 CFR 402.105(g)........ CMS................. Penalty for any person 2018 152 156
who knowingly and
willfully fails to
furnish a beneficiary
with an itemized
statement of items or
services within 30 days
of the beneficiary's
request.
1395i-3(h)(2)(B)(ii)(I)........... 42 CFR 488.408(d)(1)(iii) CMS................. Penalty per day for a 2018 ........... ...........
Skilled Nursing
Facility that has a
Category 2 violation of
certification
requirements:
Minimum................. 2018 107 110
Maximum................. 2018 6,417 6,579
42 CFR 488.408(d)(1)(iv). CMS................. Penalty per instance of 2018 ........... ...........
Category 2
noncompliance by a
Skilled Nursing
Facility:
Minimum................. 2018 2,140 2,194
Maximum................. 2018 21,393 21,933
42 CFR 488.408(e)(1)(iii) CMS................. Penalty per day for a 2018 ........... ...........
Skilled Nursing
Facility that has a
Category 3 violation of
certification
requirements:
Minimum................. 2018 6,525 6,690
Maximum................. 2018 21,393 21,933
42 CFR 488.408(e)(1)(iv). CMS................. Penalty per instance of 2018 ........... ...........
Category 3
noncompliance by a
Skilled Nursing
Facility:
Minimum................. 2018 2,140 2,194
Maximum................. 2018 21,393 21,933
42 CFR 488.408(e)(2)(ii). CMS................. Penalty per day and per 2018 ........... ...........
instance for a Skilled
Nursing Facility that
has Category 3
noncompliance with
Immediate Jeopardy:
Per Day (Minimum)....... 2018 6,525 6,690
Per Day (Maximum)....... 2018 21,393 21,933
Per Instance (Minimum).. 2018 2,140 2,194
Per Instance (Maximum).. 2018 21,393 21,933
42 CFR 488.438(a)(1)(i).. CMS................. Penalty per day of a 2018 ........... ...........
Skilled Nursing
Facility that fails to
meet certification
requirements. These
amounts represent the
upper range per day:
Minimum................. 2018 6,525 6,690
Maximum................. 2018 21,393 21,933
42 CFR 488.438(a)(1)(ii). CMS................. Penalty per day of a 2018 ........... ...........
Skilled Nursing
Facility that fails to
meet certification
requirements. These
amounts represent the
lower range per day:
Minimum................. 2018 107 110
Maximum................. 2018 6,417 6,579
42 CFR 488.438(a)(2)..... CMS................. Penalty per instance of 2018 ........... ...........
a Skilled Nursing
Facility that fails to
meet certification
requirements:
Minimum................. 2018 2,140 2,194
Maximum................. 2018 21,393 21,933
1395l(h)(5)(D).................... 42 CFR 402.105(d)(2)(i).. CMS................. Penalty for knowingly, 2018 15,582 15,975
willfully, and
repeatedly billing for
a clinical diagnostic
laboratory test other
than on an assignment-
related basis.
(Penalties are assessed
in the same manner as
42 U.S.C.
1395u(j)(2)(B), which
is assessed according
to 1320a-7a(a)).
1395l(i)(6)....................... ......................... CMS................. Penalty for knowingly 2018 4,104 4,208
and willfully
presenting or causing
to be presented a bill
or request for payment
for an intraocular lens
inserted during or
after cataract surgery
for which the Medicare
payment rate includes
the cost of acquiring
the class of lens
involved.
1395l(q)(2)(B)(i)................. 42 CFR 402.105(a)........ CMS................. Penalty for knowingly 2018 3,928 4,027
and willfully failing
to provide information
about a referring
physician when seeking
payment on an
unassigned basis.
1395m(a)(11)(A)................... 42 CFR 402.1(c)(4), CMS................. Penalty for any durable 2018 15,582 15,975
402.105(d)(2)(ii). medical equipment
supplier that knowingly
and willfully charges
for a covered service
that is furnished on a
rental basis after the
rental payments may no
longer be made.
(Penalties are assessed
in the same manner as
42 U.S.C.
1395u(j)(2)(B), which
is assessed according
to 1320a-7a(a)).
[[Page 59560]]
1395m(a)(18)(B)................... 42 CFR 402.1(c)(5), CMS................. Penalty for any 2018 15,582 15,975
402.105(d)(2)(iii). nonparticipating
durable medical
equipment supplier that
knowingly and willfully
fails to make a refund
to Medicare
beneficiaries for a
covered service for
which payment is
precluded due to an
unsolicited telephone
contact from the
supplier. (Penalties
are assessed in the
same manner as 42
U.S.C. 1395u(j)(2)(B),
which is assessed
according to 1320a-
7a(a)).
1395m(b)(5)(C).................... 42 CFR 402.1(c)(6), CMS................. Penalty for any 2018 15,582 15,975
402.105(d)(2)(iv). nonparticipating
physician or supplier
that knowingly and
willfully charges a
Medicare beneficiary
more than the limiting
charge for radiologist
services. (Penalties
are assessed in the
same manner as 42
U.S.C. 1395u(j)(2)(B),
which is assessed
according to 1320a-
7a(a)).
1395m(h)(3)....................... 42 CFR 402.1(c)(8), CMS................. Penalty for any supplier 2018 15,582 15,975
402.105(d)(2)(vi). of prosthetic devices,
orthotics, and
prosthetics that
knowing and willfully
charges for a covered
prosthetic device,
orthotic, or prosthetic
that is furnished on a
rental basis after the
rental payment may no
longer be made.
(Penalties are assessed
in the same manner as
42 U.S.C.
1395m(a)(11)(A), that
is in the same manner
as 1395u(j)(2)(B),
which is assessed
according to 1320a-
7a(a)).
1395m(j)(2)(A)(iii)............... ......................... CMS................. Penalty for any supplier 2018 1,650 1,692
of durable medical
equipment including a
supplier of prosthetic
devices, prosthetics,
orthotics, or supplies
that knowingly and
willfully distributes a
certificate of medical
necessity in violation
of Section
1834(j)(2)(A)(i) of the
Act or fails to provide
the information
required under Section
1834(j)(2)(A)(ii) of
the Act.
1395m(j)(4)....................... 42 CFR 402.1(c)(10), CMS................. Penalty for any supplier 2018 15,582 15,975
402.105(d)(2)(vii). of durable medical
equipment, including a
supplier of prosthetic
devices, prosthetics,
orthotics, or supplies
that knowingly and
willfully fails to make
refunds in a timely
manner to Medicare
beneficiaries for
series billed other
than on as assignment-
related basis under
certain conditions.
(Penalties are assessed
in the same manner as
42 U.S.C. 1395m(j)(4)
and 1395u(j)(2)(B),
which is assessed
according to 1320a-
7a(a)).
1395m(k)(6)....................... 42 CFR 402.1(c)(31), CMS................. Penalty for any person 2018 15,582 15,975
402.105(d)(3). or entity who knowingly
and willfully bills or
collects for any
outpatient therapy
services or
comprehensive
outpatient
rehabilitation services
on other than an
assignment-related
basis. (Penalties are
assessed in the same
manner as 42 U.S.C.
1395m(k)(6) and
1395u(j)(2)(B), which
is assessed according
to 1320a-7a(a)).
1395m(l)(6)....................... 42 CFR 402.1(c)(32), CMS................. Penalty for any supplier 2018 15,582 15,975
402.105(d)(4). of ambulance services
who knowingly and
willfully fills or
collects for any
services on other than
an assignment-related
basis. (Penalties are
assessed in the same
manner as 42 U.S.C.
1395u(b)(18)(B), which
is assessed according
to 1320a-7a(a)).
1395u(b)(18)(B)................... 42 CFR 402.1(c)(11), CMS................. Penalty for any 2018 15,582 15,975
402.105(d)(2)(viii). practitioner specified
in Section
1842(b)(18)(C) of the
Act or other person
that knowingly and
willfully bills or
collects for any
services by the
practitioners on other
than an assignment-
related basis.
(Penalties are assessed
in the same manner as
42 U.S.C.
1395u(j)(2)(B), which
is assessed according
to 1320a-7a(a)).
[[Page 59561]]
1395u(j)(2)(B).................... 42 CFR 402.1(c).......... CMS................. Penalty for any 2018 15,582 15,975
physician who charges
more than 125% for a
non-participating
referral. (Penalties
are assessed in the
same manner as 42
U.S.C. 1320a-7a(a)).
1395u(k).......................... 42 CFR 402.1(c)(12), CMS................. Penalty for any 2018 15,582 15,975
402.105(d)(2)(ix). physician who knowingly
and willfully presents
or causes to be
presented a claim for
bill for an assistant
at a cataract surgery
performed on or after
March 1, 1987, for
which payment may not
be made because of
section 1862(a)(15).
(Penalties are assessed
in the same manner as
42 U.S.C.
1395u(j)(2)(B), which
is assessed according
to 1320a-7a(a)).
1395u(l)(3)....................... 42 CFR 402.1(c)(13), CMS................. Penalty for any 2018 15,582 15,975
402.105(d)(2)(x). nonparticipating
physician who does not
accept payment on an
assignment-related
basis and who knowingly
and willfully fails to
refund on a timely
basis any amounts
collected for services
that are not reasonable
or medically necessary
or are of poor quality
under 1842(l)(1)(A).
(Penalties are assessed
in the same manner as
42 U.S.C.
1395u(j)(2)(B), which
is assessed according
to 1320a-7a(a)).
1395u(m)(3)....................... 42 CFR 402.1(c)(14), CMS................. Penalty for any 2018 15,582 15,975
402.105(d)(2)(xi). nonparticipating
physician charging more
than $500 who does not
accept payment for an
elective surgical
procedure on an
assignment related
basis and who knowingly
and willfully fails to
disclose the required
information regarding
charges and coinsurance
amounts and fails to
refund on a timely
basis any amount
collected for the
procedure in excess of
the charges recognized
and approved by the
Medicare program.
(Penalties are assessed
in the same manner as
42 U.S.C.
1395u(j)(2)(B), which
is assessed according
to 1320a-7a(a)).
1395u(n)(3)....................... 42 CFR 402.1(c)(15), CMS................. Penalty for any 2018 15,582 15,975
402.105(d)(2)(xii). physician who
knowingly, willfully,
and repeatedly bills
one or more
beneficiaries for
purchased diagnostic
tests any amount other
than the payment amount
specified by the Act.
(Penalties are assessed
in the same manner as
42 U.S.C.
1395u(j)(2)(B), which
is assessed according
to 1320a-7a(a)).
1395u(o)(3)(B).................... 42 CFR 414.707(b)........ CMS................. Penalty for any 2018 15,582 15,975
practitioner specified
in Section
1842(b)(18)(C) of the
Act or other person
that knowingly and
willfully bills or
collects for any
services pertaining to
drugs or biologics by
the practitioners on
other than an
assignment-related
basis. (Penalties are
assessed in the same
manner as 42 U.S.C.
1395u(b)(18)(B) and
1395u(j)(2)(B), which
is assessed according
to 1320a-7a(a)).
1395u(p)(3)(A).................... ......................... CMS................. Penalty for any 2018 4,104 4,208
physician or
practitioner who
knowingly and willfully
fails promptly to
provide the appropriate
diagnosis codes upon
CMS or Medicare
administrative
contractor request for
payment or bill not
submitted on an
assignment-related
basis.
1395w-3a(d)(4)(A)................. 42 CFR 414.806........... CMS................. Penalty for a 2018 13,333 13,669
pharmaceutical
manufacturer's
misrepresentation of
average sales price of
a drug, or biologic.
[[Page 59562]]
1395w-4(g)(1)(B).................. 42 CFR 402.1(c)(17), CMS................. Penalty for any 2018 15,582 15,975
402.105(d)(2)(xiii). nonparticipating
physician, supplier, or
other person that
furnishes physician
services not on an
assignment-related
basis who either
knowingly and willfully
bills or collects in
excess of the
statutorily-defined
limiting charge or
fails to make a timely
refund or adjustment.
(Penalties are assessed
in the same manner as
42 U.S.C.
1395u(j)(2)(B), which
is assessed according
to 1320a-7a(a)).
1395w-4(g)(3)(B).................. 42 CFR 402.1(c)(18), CMS................. Penalty for any person 2018 15,582 15,975
402.105(d)(2)(xiv). that knowingly and
willfully bills for
statutorily defined
State-plan approved
physicians' services on
any other basis than an
assignment-related
basis for a Medicare/
Medicaid dual eligible
beneficiary. (Penalties
are assessed in the
same manner as 42
U.S.C. 1395u(j)(2)(B),
which is assessed
according to 1320a-
7a(a)).
1395w-27(g)(3)(A); 1857(g)(3) (A). 42 CFR 422.760(b)(1)-(2); CMS................. Penalty for each 2018 38,159 39,121
42 CFR 423.760(b)(1)-(2). termination
determination the
Secretary makes that is
the result of actions
by a Medicare Advantage
organization or Part D
sponsor that has
adversely affected an
individual covered
under the
organization's contract.
1395w-27(g)(3)(B); 1857(g)(3)(B).. 42 CFR 422.760(b)(3); 42 CMS................. Penalty for each week 2018 15,264 15,649
CFR 423.760(b)(3). beginning after the
initiation of civil
money penalty
procedures by the
Secretary because a
Medicare Advantage
organization or Part D
sponsor has failed to
carry out a contract,
or has carried out a
contract inconsistently
with regulations.
1395w-27(g)(3)(D); 1857(g)(3)(D).. ......................... CMS................. Penalty for a Medicare 2018 141,760 145,335
Advantage
organization's or Part
D sponsor's early
termination of its
contract.
1395y(b)(3)(C).................... 42 CFR 411.103(b)........ CMS................. Penalty for an employer 2018 9,239 9,472
or other entity to
offer any financial or
other incentive for an
individual entitled to
benefits not to enroll
under a group health
plan or large group
health plan which would
be a primary plan.
1395y(b)(5)(C)(ii)................ 42 CFR 402.1(c)(20), 42 CMS................. Penalty for any non- 2018 1,504 1,542
CFR 402.105(b)(2). governmental employer
that, before October 1,
1998, willfully or
repeatedly failed to
provide timely and
accurate information
requested relating to
an employee's group
health insurance
coverage.
1395y(b)(6)(B).................... 42 CFR 402.1(c)(21), CMS................. Penalty for any entity 2018 3,300 3,383
402.105(a). that knowingly,
willfully, and
repeatedly fails to
complete a claim form
relating to the
availability of other
health benefits in
accordance with statute
or provides inaccurate
information relating to
such on the claim form.
1395y(b)(7)(B)(i)................. ......................... CMS................. Penalty for any entity 2018 1,181 1,211
serving as insurer,
third party
administrator, or
fiduciary for a group
health plan that fails
to provide information
that identifies
situations where the
group health plan is or
was a primary plan to
Medicare to the HHS
Secretary.
1395y(b)(8)(E).................... ......................... CMS................. Penalty for any non- 2018 1,181 1,211
group health plan that
fails to identify
claimants who are
Medicare beneficiaries
and provide information
to the HHS Secretary to
coordinate benefits and
pursue any applicable
recovery claim.
1395nn(g)(5)...................... 42 CFR 411.361........... CMS................. Penalty for any person 2018 19,639 20,134
that fails to report
information required by
HHS under Section
1877(f) concerning
ownership, investment,
and compensation
arrangements.
[[Page 59563]]
1395pp(h)......................... 42 CFR 402.1(c)(23), CMS................. Penalty for any durable 2018 15,582 15,975
402.105(d)(2)(xv). medical equipment
supplier, including a
supplier of prosthetic
devices, prosthetics,
orthotics, or supplies,
that knowingly and
willfully fails to make
refunds in a timely
manner to Medicare
beneficiaries under
certain conditions. (42
U.S.C. 1395(m)(18)
sanctions apply here in
the same manner, which
is under 1395u(j)(2)
and 1320a-7a(a)).
1395ss(a)(2)...................... 42 CFR 402.1(c)(24), CMS................. Penalty for any person 2018 53,483 54,832
405.105(f)(1). that issues a Medicare
supplemental policy
that has not been
approved by the State
regulatory program or
does not meet Federal
standards after a
statutorily defined
effective date.
1395ss(d)(3)(A)(vi) (II).......... ......................... CMS................. Penalty for someone 2018 27,714 28,413
other than issuer that
sells or issues a
Medicare supplemental
policy to beneficiary
without a disclosure
statement.
Penalty for an issuer 2018 46,192 47,357
that sells or issues a
Medicare supplemental
policy without
disclosure statement.
1395ss(d)(3)(B)(iv)............... ......................... CMS................. Penalty for someone 2018 27,714 28,413
other than issuer that
sells or issues a
Medicare supplemental
policy without
acknowledgement form.
Penalty for issuer that 2018 46,192 47,357
sells or issues a
Medicare supplemental
policy without an
acknowledgement form.
1395ss(p)(8)...................... 42 CFR 402.1(c)(25), CMS................. Penalty for any person 2018 27,714 28,413
402.105(e). that sells or issues
Medicare supplemental
polices after a given
date that fail to
conform to the NAIC or
Federal standards
established by statute.
42 CFR 402.1(c)(25), CMS................. Penalty for any person 2018 46,192 47,357
405.105(f)(2). that sells or issues
Medicare supplemental
polices after a given
date that fail to
conform to the NAIC or
Federal standards
established by statute.
1395ss(p)(9)(C)................... 42 CFR 402.1(c)(26), CMS................. Penalty for any person 2018 27,714 28,413
402.105(e). that sells a Medicare
supplemental policy and
fails to make available
for sale the core group
of basic benefits when
selling other Medicare
supplemental policies
with additional
benefits or fails to
provide the individual,
before selling the
policy, an outline of
coverage describing
benefits.
42 CFR 402.1(c)(26), .................... Penalty for any person 2018 46,192 47,357
405.105(f)(3), (4). that sells a Medicare
supplemental policy and
fails to make available
for sale the core group
of basic benefits when
selling other Medicare
supplemental policies
with additional
benefits or fails to
provide the individual,
before selling the
policy, an outline of
coverage describing
benefits.
1395ss(q)(5)(C)................... 42 CFR 402.1(c)(27), CMS................. Penalty for any person 2018 46,192 47,357
405.105(f)(5). that fails to suspend
the policy of a
policyholder made
eligible for medical
assistance or
automatically
reinstates the policy
of a policyholder who
has lost eligibility
for medical assistance,
under certain
circumstances.
1395ss(r)(6)(A)................... 42 CFR 402.1(c)(28), CMS................. Penalty for any person 2018 46,192 47,357
405.105(f)(6). that fails to provide
refunds or credits as
required by section
1882(r)(1)(B).
1395ss(s)(4)...................... 42 CFR 402.1(c)(29), CMS................. Penalty for any issuer 2018 19,609 20,104
405.105(c). of a Medicare
supplemental policy
that does not waive
listed time periods if
they were already
satisfied under a
proceeding Medicare
supplemental policy, or
denies a policy, or
conditions the
issuances or
effectiveness of the
policy, or
discriminates in the
pricing of the policy
base on health status
or other specified
criteria.
1395ss(t)(2)...................... 42 CFR 402.1(c)(30), CMS................. Penalty for any issuer 2018 46,192 47,357
405.105(f)(7). of a Medicare
supplemental policy
that fails to fulfill
listed responsibilities.
[[Page 59564]]
1395ss(v)(4)(A)................... ......................... CMS................. Penalty someone other 2018 19,999 20,503
than issuer who sells,
issues, or renews a
medigap Rx policy to an
individual who is a
Part D enrollee.
Penalty for an issuer 2018 33,333 34,174
who sells, issues, or
renews a Medigap Rx
policy who is a Part D
enrollee.
1395bbb(c)(1)..................... 42 CFR 488.725(c)........ CMS................. Penalty for any 2018 4,280 4,388
individual who notifies
or causes to be
notified a home health
agency of the time or
date on which a survey
of such agency is to be
conducted.
1395bbb(f)(2)(A)(i)............... 42 CFR 488.845(b)(2)(iii) CMS................. Maximum daily penalty 2018 20,521 21,039
42 CFR 488.845(b)(3)- amount for each day a
(6); and 42 CFR home health agency is
488.845(d)(1)(ii). not in compliance with
statutory requirements.
42 CFR 488.845(b)(3)..... .................... Penalty per day for home 2018 ........... ...........
health agency's
noncompliance (Upper
Range):
Minimum................. 2018 17,443 17,883
Maximum................. 2018 20,521 21,039
42 CFR 488.845(b)(3)(i).. .................... Penalty for a home 2018 20,521 21,039
health agency's
deficiency or
deficiencies that cause
immediate jeopardy and
result in actual harm.
42 CFR 488.845(b)(3)(ii). .................... Penalty for a home 2018 18,468 18,934
health agency's
deficiency or
deficiencies that cause
immediate jeopardy and
result in potential for
harm.
42 CFR 488.845(b)(3)(iii) .................... Penalty for an isolated 2018 17,443 17,883
incident of
noncompliance in
violation of
established HHA policy.
42 CFR 488.845(b)(4)..... .................... Penalty for a repeat and/ 2018 ........... ...........
or condition-level
deficiency that does
not constitute
immediate jeopardy, but
is directly related to
poor quality patient
care outcomes (Lower
Range):
Minimum................. 2018 3,079 3,157
Maximum................. 2018 17,443 17,883
42 CFR 488.845(b)(5)..... .................... Penalty for a repeat and/ 2018 ........... ...........
or condition-level
deficiency that does
not constitute
immediate jeopardy and
that is related
predominately to
structure or process-
oriented conditions
(Lower Range):
Minimum................. 2018 1,026 1,052
Maximum................. 2018 8,208 8,415
42 CFR 488.845(b)(6)..... .................... Penalty imposed for 2018 ........... ...........
instance of
noncompliance that may
be assessed for one or
more singular events of
condition-level
noncompliance that are
identified and where
the noncompliance was
corrected during the
onsite survey:
Minimum................. 2018 2,052 2,104
Maximum................. 2018 20,521 21,039
Penalty for each day of 2018 20,521 21,039
noncompliance (Maximum).
42 CFR 488.845(d)(1)(ii). .................... Penalty for each day of 2018 20,521 21,039
noncompliance (Maximum).
1396b(m)(5)(B).................... 42 CFR 460.46 (a)(1)..... CMS................. Penalty for 2018 ........... ...........
discriminating or
discouraging enrollment
or disenrollment of
participants on the
basis of an
individual's health
status or need for
health care services.
42 CFR 460.46 (a)(1)..... .................... Minimum................. 2018 22,896 23,473
42 CFR 460.46 (a)(1)..... .................... Maximum................. 2018 152,638 156,488
42 CFR 460.46 (a)(2)..... .................... Penalty for a PACE 2018 38,159 39,121
organization that
charges excessive
premiums.
42 CFR 460.46 (a)(3)..... .................... Penalty for a PACE 2018 152,638 156,488
organization
misrepresenting or
falsifying information
to CMS, the State, or
an individual or other
entity.
42 CFR 460.46 (a)(4)..... .................... Penalty for each 2018 38,159 39,121
determination the CMS
makes that the PACE
organization has failed
to provide medically
necessary items and
services of the failure
has adversely affected
(or has the substantial
likelihood of adversely
affecting) a PACE
participant.
42 CFR 460.46 (a)(4)..... .................... Penalty for 2018 38,159 39,121
involuntarily
disenrolling a
participant.
[[Page 59565]]
42 CFR 460.46 (a)(4)..... .................... Penalty for PACE 2018 38,159 39,121
organization's practice
that would reasonably
be expected to have the
effect of denying or
discouraging enrollment.
1396r(h)(3)(C)(ii)(I)............. 42 CFR 488.408(d)(1)(iii) CMS................. Penalty per day for a 2018 ........... ...........
nursing facility's
failure to meet a
Category 2
Certification:
Minimum................. 2018 107.14305 110
Maximum................. 2018 6,417 6,579
42 CFR 488.408(d)(1)(iv). CMS................. Penalty per instance for 2018 ........... ...........
a nursing facility's
failure to meet
Category 2
certification:
Minimum................. 2018 2,140 2,194
Maximum................. 2018 21,393 21,933
42 CFR 488.408(e)(1)(iii) CMS................. Penalty per day for a 2018 ........... ...........
nursing facility's
failure to meet
Category 3
certification:
Minimum................. 2018 6,525 6,690
Maximum................. 2018 21,393 21,933
42 CFR 488.408(e)(1)(iv). CMS................. Penalty per instance for 2018 ........... ...........
a nursing facility's
failure to meet
Category 3
certification:
Minimum................. 2018 2,140 2,194
Maximum................. 2018 21,393 21,933
42 CFR 488.408(e)(2)(ii). CMS................. Penalty per instance for 2018 ........... ...........
a nursing facility's
failure to meet
Category 3
certification, which
results in immediate
jeopardy:
Minimum................. 2018 2,140 2,194
Maximum................. 2018 21,393 21,933
42 CFR 488.438(a)(1)(i).. CMS................. Penalty per day for 2018 ........... ...........
nursing facility's
failure to meet
certification (Upper
Range):
Minimum................. 2018 6,525 6,690
Maximum................. 2018 21,393 21,933
42 CFR 488.438(a)(1)(ii). CMS................. Penalty per day for 2018 ........... ...........
nursing facility's
failure to meet
certification (Lower
Range):
Minimum................. 2018 107.14305 110
Maximum................. 2018 6,417 6,579
42 CFR 488.438(a)(2)..... CMS................. Penalty per instance for 2018 ........... ...........
nursing facility's
failure to meet
certification:
Minimum................. 2018 2,140 2,194
Maximum................. 2018 21,393 21,933
1396r(f)(2)(B)(iii)(I)(c)......... 42 CFR 483.151(b)(2)(iv) CMS................. Grounds to prohibit 2018 10,697 10,967
and (b)(3)(iii). approval of Nurse Aide
Training Program--if
assessed a penalty in
1819(h)(2)(B)(i) or
1919(h)(2)(A)(ii) of
``not less than
$5,000'' [Not CMP
authority, but a
specific CMP amount
(CMP at this level)
that is the triggering
condition for
disapproval].
1396r(h)(3)(C)(ii)(I)............. 42 CFR 483.151(c)(2)..... CMS................. Grounds to waive 2018 10,697 10,967
disapproval of nurse
aide training program--
reference to
disapproval based on
imposition of CMP ``not
less than $5,000'' [Not
CMP authority but CMP
imposition at this
level determines
eligibility to seek
waiver of disapproval
of nurse aide training
program].
1396t(j)(2)(C).................... ......................... CMS................. Penalty for each day of 2018 ........... ...........
noncompliance for a
home or community care
provider that no longer
meets the minimum
requirements for home
and community care:
Minimum................. 2018 2 2
Maximum................. 2018 18,477 18,943
1396u-2(e)(2)(A)(i)............... 42 CFR 438.704........... CMS................. Penalty for a Medicaid 2018 38,159 39,121
managed care
organization that fails
substantially to
provide medically
necessary items and
services.
Penalty for Medicaid 2018 38,159 39,121
managed care
organization that
imposes premiums or
charges on enrollees in
excess of the premiums
or charges permitted.
Penalty for a Medicaid 2018 38,159 39,121
managed care
organization that
misrepresents or
falsifies information
to another individual
or entity.
Penalty for a Medicaid 2018 38,159 39,121
managed care
organization that fails
to comply with the
applicable statutory
requirements for such
organizations.
1396u-2(e)(2)(A)(ii).............. 42 CFR 438.704........... CMS................. Penalty for a Medicaid 2018 152,638 156,488
managed care
organization that
misrepresents or
falsifies information
to the HHS Secretary.
[[Page 59566]]
Penalty for Medicaid 2018 152,638 156,488
managed care
organization that acts
to discriminate among
enrollees on the basis
of their health status.
1396u-2(e)(2)(A)(iv).............. 42 CFR 438.704........... CMS................. Penalty for each 2018 22,896 23,473
individual that does
not enroll as a result
of a Medicaid managed
care organization that
acts to discriminate
among enrollees on the
basis of their health
status.
1396u(h)(2)....................... 42 CFR Part 441, Subpart CMS................. Penalty for a provider 2018 21,393 21,933
I. not meeting one of the
requirements relating
to the protection of
the health, safety, and
welfare of individuals
receiving community
supported living
arrangements services.
1396w-2(c)(1)..................... ......................... CMS................. Penalty for disclosing 2018 11,410 11,698
information related to
eligibility
determinations for
medical assistance
programs.
18041(c)(2)....................... 45 CFR 150.315; 45 CFR CMS................. Failure to comply with 2018 155.10232 159
156.805(c). requirements of the
Public Health Services
Act; Penalty for
violations of rules or
standards of behavior
associated with issuer
participation in the
Federally-facilitated
Exchange. (42 U.S.C.
300gg-22(b)(2)(C)).
18081(h)(1)(A)(i)(II)............. 42 CFR 155.285........... CMS................. Penalty for providing 2018 28,195 28,906
false information on
Exchange application.
18081(h)(1)(B).................... 42 CFR 155.285........... CMS................. Penalty for knowingly or 2018 281,949 289,060
willfully providing
false information on
Exchange application.
18081(h)(2)....................... 42 CFR 155.260........... CMS................. Penalty for knowingly or 2018 28,195 28,906
willfully disclosing
protected information
from Exchange.
31 U.S.C.:
1352.............................. 45 CFR 93.400(e)......... HHS................. Penalty for the first 2018 19,639 20,134
time an individual
makes an expenditure
prohibited by
regulations regarding
lobbying disclosure,
absent aggravating
circumstances.
Penalty for second and 2018 ........... ...........
subsequent offenses by
individuals who make an
expenditure prohibited
by regulations
regarding lobbying
disclosure:
Minimum................. 2018 19,639 20,134
Maximum................. 2018 196,387 201,340
Penalty for the first 2018 19,639 20,134
time an individual
fails to file or amend
a lobbying disclosure
form, absent
aggravating
circumstances.
Penalty for second and 2018 ........... ...........
subsequent offenses by
individuals who fail to
file or amend a
lobbying disclosure
form, absent
aggravating
circumstances:
Minimum................. 2018 19,639 20,134
Maximum................. 2018 196,387 201,340
45 CFR Part 93, Appendix HHS................. Penalty for failure to 2018 ........... ...........
A. provide certification
regarding lobbying in
the award documents for
all sub-awards of all
tiers:
Minimum................. 2018 19,639 20,134
Maximum................. 2018 196,387 201,340
Penalty for failure to 2018 ........... ...........
provide statement
regarding lobbying for
loan guarantee and loan
insurance transactions:
Minimum................. 2018 19,639 20,134
Maximum................. 2018 196,387 201,340
3801-3812......................... 45 CFR 79.3(a)(1)(iv).... HHS................. Penalty against any 2018 10,261 10,520
individual who--with
knowledge or reason to
know--makes, presents
or submits a false,
fictitious or
fraudulent claim to the
Department.
45 CFR 79.3(b)(1)(ii).... .................... Penalty against any 2018 10,261 10,520
individual who--with
knowledge or reason to
know--makes, presents
or submits a false,
fictitious or
fraudulent claim to the
Department.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Some HHS components have not promulgated regulations regarding their civil monetary penalty-specific statutory authorities.
\2\ The description is not intended to be a comprehensive explanation of the underlying violation; the statute and corresponding regulation, if
applicable, should be consulted.
\3\ Statutory or Inflation Act Adjustment.
\4\ The cost of living multiplier for 2019, based on the CPI-U for the month of October 2018, not seasonally adjusted, is 1.02522, as indicated in OMB
Memorandum M-19-04, ``Implementation of Penalty Inflation Adjustments for 2018, Pursuant to the Federal Civil Penalties Adjustment Act Improvements
Act of 2015'' (December 14, 2018).
* For each false record or statement, 10,000 per day.
** For each false record statement, 10,461 per day.
[[Page 59567]]
Dated: October 28, 2019.
Alex M. Azar II,
Secretary, Department of Health and Human Services.
[FR Doc. 2019-23955 Filed 11-4-19; 8:45 am]
BILLING CODE 4150-24-P