Adjustment of Civil Monetary Penalties for Inflation
Federal Register, Volume 81 Issue 172 (Tuesday, September 6, 2016)
Federal Register Volume 81, Number 172 (Tuesday, September 6, 2016)
Rules and Regulations
Pages 61537-61582
From the Federal Register Online via the Government Publishing Office www.gpo.gov
FR Doc No: 2016-18680
Page 61537
Vol. 81
Tuesday,
No. 172
September 6, 2016
Part IV
Department of Health and Human Services
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Centers for Medicare & Medicaid Services
Office of the Inspector General
Administration for Children and Families
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42 CFR Parts 3, 402, 403, et al.
45 CFR Parts 79, 93, 102, et al.
Adjustment of Civil Monetary Penalties for Inflation; Interim Final Rule
Page 61538
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
Centers for Medicare & Medicaid Services
42 CFR Parts 402, 403, 411, 412, 422, 423, 460, 483, 488, and 493
Office of the Inspector General
42 CFR Part 1003
Office of the Secretary
45 CFR Parts 79, 93, 102, 147, 150, 155, 156, 158, and 160
Administration for Children and Families
RIN 0991-AC0
Adjustment of Civil Monetary Penalties for Inflation
AGENCY: Department of Health and Human Services, Office of the Assistant Secretary for Financial Resources, Centers for Medicare & and Medicaid Services, Office of the Inspector General, Administration for Children and Families.
ACTION: Interim final rule.
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SUMMARY: The Department of Health and Human Services (HHS) is issuing a new regulation to adjust for inflation the maximum civil monetary penalty amounts for the various civil monetary penalty authorities for all agencies within HHS. We are taking this action to comply with the Federal Civil Penalties Inflation Adjustment Act of 1990 (the Inflation Adjustment Act), as amended by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015. In addition, this interim final rule includes updates to certain agency-specific regulations to identify their updated information, and note the location of HHS-wide regulations.
DATES: This rule is effective on September 6, 2016.
FOR FURTHER INFORMATION CONTACT: 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:
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Regulatory Information
The Department of Health and Human Services (HHS) is promulgating this interim final rule to ensure that the amount of civil monetary penalties authorized to be assessed or enforced by HHS reflect the statutorily mandated amounts and ranges as adjusted for inflation. Pursuant to Section 4(b) of the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (the 2015 Act), HHS is required to promulgate a ``catch-up adjustment'' through an interim final rule. Pursuant to the 2015 Act and 5 U.S.C. 553(b)(3)(B), HHS finds that good cause exists for immediate implementation of this interim final rule without prior notice and comment because it would be impracticable to delay publication of this rule for notice and comment. The 2015 Act specifies that the adjustments shall take effect not later than August 1, 2016. Additionally, the 2015 Act provides a clear formula for adjustment of the civil monetary penalties, leaving agencies little room for discretion. For these reasons, HHS finds that notice and comment would be impracticable in this situation. Additionally, if applicable, HHS agencies will update their civil monetary penalty-
specific regulations to include a cross-reference to the revised regulations located at 45 CFR part 102 reflecting the new adjusted penalty amounts set out by HHS.\1\
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\1\ All applicable civil monetary penalty authorities within the jurisdiction of HHS must be adjusted in accordance with the 2015 Act. Where existing HHS agency regulations setting forth civil monetary penalty amounts are not updated by this interim final rule, they will be amended in a separate action as soon as practicable.
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Background and Requirements of the Law
On November 2, 2015, the President signed into law the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (the 2015 Act) (Sec. 701 of the Bipartisan Budget Act of 2015, Public Law 114-74, November 2, 2015), which amended the Federal Civil Penalties Inflation Adjustment Act of 1990 (the Inflation Adjustment Act) (Pub. L. 101-410, 104 Stat. 890 (1990) (codified as amended at 28 U.S.C. 2461 note 2(a)), to improve the effectiveness of civil monetary penalties and to maintain their deterrent effect. The 2015 Act, which removed an inflation update exclusion that previously applied to the Social Security Act as well as the Occupational Safety and Health Act, requires agencies to: (1) Adjust the level of civil monetary penalties with an initial ``catch-up'' adjustment through an interim final rulemaking (IFR); and (2) make subsequent annual adjustments for inflation.
The method of calculating inflation adjustments in the 2015 Act differs substantially from the methods used in past inflation adjustment rulemakings conducted pursuant to the Inflation Adjustment Act. Previously, adjustments to civil monetary penalties were conducted under rules that required significant rounding of figures. While this allowed penalties to be kept at round numbers, it meant that penalties would often not be increased at all if the inflation factor was not large enough. Furthermore, increases to penalties were capped at 10 percent. Over time, this formula caused penalties to lose value relative to total inflation.
The 2015 Act has removed these rounding rules; now, penalties are simply rounded to the nearest dollar. While this creates penalty values that are no longer round numbers, it does ensure that penalties will be increased each year to a figure commensurate with the actual calculated inflation. Furthermore, the 2015 Act ``resets'' the inflation calculations by excluding prior inflationary adjustments under the Inflation Adjustment Act, which contributed to a decline in the real value of penalty levels. To do this, the 2015 Act requires agencies to identify, for each penalty, the year and corresponding amount(s) for which the maximum penalty level or range of minimum and maximum penalties was established (i.e., originally enacted by Congress) or last adjusted other than pursuant to the Inflation Adjustment Act.
In this rule, the adjusted civil penalty amounts are applicable only to civil penalties assessed after August 1, 2016, whose associated violations occurred after November 2, 2015, the date of enactment of the 2015 Amendments. Therefore, violations occurring on or before November 2, 2015, and assessments made prior to August 1, 2016, whose associated violations occurred after November 2, 2015, will continue to be subject to the civil monetary penalty amounts set forth in the Department's existing regulations or as set forth by statute if the amount has not yet been adjusted by regulation.
Pursuant to the 2015 Act, the Department of Health and Human Services (HHS) has undertaken a thorough review of civil monetary penalties administered by its various components. This IFR sets forth the initial ``catch-up'' adjustment for civil monetary penalties as well as any necessary technical conforming changes to the language of the various regulations affected by this IFR. For
Page 61539
each component, HHS has provided a table showing how the penalties are being increased pursuant to the 2015 Act. The first two columns (``Citation'') identify the United States Code (U.S.C.) statutory citation, and the applicable regulatory citation in the Code of Federal Regulations (CFR), if any. The third column (``Description'') provides a short description of the penalty. In the fourth column (``Pre-
Inflation Penalty''), HHS has listed the penalty amount as it exists prior to the inflationary adjustments made by the effective date of this rule, and in the fifth column (``Date of Last Penalty Figure or Adjustment''), HHS has provided the amount and year of the penalty as enacted by Congress or changed through a mechanism other than pursuant to the Inflation Adjustment Act. In column six (``Percentage Increase''), HHS has listed the percentage increase based on the multiplier used to adjust from the CPI-U \2\ of the year of enactment of the monetary penalty to the CPI-U for the current year, or a percentage equal to 150 percent, whichever is less. Multiplying the current penalty amount in column four by the percentage increase provides the ``Increase'' listed in column seven. The ``Maximum Adjusted Penalty'' in column eight is the sum of the current penalty amount and the ``increase''. Where applicable, some HHS agencies will make as soon as practicable conforming edits to regulatory text. Additionally, HHS is issuing new regulatory text including the table showing how the penalties are being increased under the 2015 Act, located at 45 CFR part 102, to implement the civil monetary penalty (CMP) amounts adjusted for inflation agency-wide. Additionally, the 2015 Act requires agencies to publish annual adjustments not later than January 15 of every year after publication of the initial adjustment.
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\2\ Based upon the Consumer Price Index (CPI-U) for the month of October 2015. The CPI-U is published by the Department of Labor, Bureau of Labor Statistics, and is available at its Web site: http://www.bls.gov/cpi/.
Calculation of CMP Adjustments
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Citation Date of
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Pre- penalty Percentage Increase Maximum
Description \2\ inflation figure or increase ($) \5\ adjusted
U.S.C. CFR \1\ penalty ($) adjustment \4\ penalty ($)
\3\
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21 U.S.C. (FDA):
333(b)(2)(A)................... ...................... Penalty for violations 50,000 1988 97.869 48,935 98,935
related to drug samples
resulting in a conviction
of any representative of
manufacturer or
distributor in any 10-
year period.
333(b)(2)(B)................... ...................... Penalty for violation 1,000,000 1988 97.869 978,690 1,978,690
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)...................... ...................... Penalty for failure to 100,000 1988 97.869 97,869 197,869
make a report required by
21 U.S.C. 353(d)(3)(E)
relating to drug samples.
333(f)(1)(A)................... ...................... Penalty for any person who 15,000 1990 78.156 11,723 26,723
violates a requirement
related to devices for
each such violation.
Penalty for aggregate of 1,000,000 1990 78.156 781,560 1,781,560
all violations related to
devices in a single
proceeding.
333(f)(2)(A)................... ...................... Penalty for any individual 50,000 1996 50.425 25,123 75,123
who introduces or
delivers for introduction
into interstate commerce
food that is adulterated
per 21 U.S.C.
342(a)(2)(B) or any
individual who does not
comply with a recall
order under 21 U.S.C.
350l.
Penalty in the case of any 250,000 1996 50.425 125,613 375,613
other person other than
an individual for such
introduction or delivery
of adulterated food.
Penalty for aggregate of 500,000 1996 50.425 251,225 751,225
all such violations
related to adulterated
food adjudicated in a
single proceeding.
333(f)(3)(A)................... ...................... Penalty for all violations 10,000 2007 13.833 1,383 11,383
adjudicated in a single
proceeding for any person
who fails to submit
certification required by
42 U.S.C. 282(j)(5)(B) or
knowingly submitting a
false certification.
333(f)(3)(B)................... ...................... Penalty for each day the 10,000 2007 13.833 1,383 11,383
above violation is not
corrected after a 30-day
period following
notification until the
violation is corrected.
Page 61540
333(f)(4)(A)(i)................ ...................... Penalty for any 250,000 2007 13.833 34,583 284,583
responsible person that
violates a requirement of
21 U.S.C. 355(o) (post-
marketing studies,
clinical trials,
labeling), 21 U.S.C.
355(p) (risk evaluation
and mitigation (REMS)),
or 21 U.S.C. 355-1 (REMS).
Penalty for aggregate of 1,000,000 2007 13.833 138,330 1,138,330
all such above violations
in a single proceeding.
333(f)(4)(A)(ii)............... ...................... Penalty for REMS violation 250,000 2007 13.833 34,583 284,583
that continues after
written notice to the
responsible person for
the first 30-day period
(or any portion thereof)
the responsible person
continues to be in
violation.
Penalty for REMS violation 1,000,000 2007 13.833 138,330 1,138,330
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 10,000,000 2007 13.833 1,383,300 11,383,300
all such above violations
adjudicated in a single
proceeding.
333(f)(9)(A)................... ...................... Penalty for any person who 15,000 2009 10.02 1,503 16,503
violates a requirement
which relates to tobacco
products for each such
violation.
Penalty for aggregate of 1,000,000 2009 10.02 100,200 1,100,200
all such violations of
tobacco product
requirement adjudicated
in a single proceeding.
333(f)(9)(B)(i)(I)............. ...................... Penalty per violation 250,000 2009 10.02 25,050 275,050
related to violations of
tobacco requirements.
Penalty for aggregate of 1,000,000 2009 10.02 100,200 1,100,200
all such violations of
tobacco product
requirements adjudicated
in a single proceeding.
333(f)(9)(B)(i)(II)............ ...................... Penalty in the case of a 250,000 2009 10.02 25,050 275,050
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 1,000,000 2009 10.02 100,200 1,100,200
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 10,000,000 2009 10.02 1,002,000 11,002,000
all such violations
related to tobacco
product requirements
adjudicated in a single
proceeding.
333(f)(9)(B)(ii)(I)............ ...................... Penalty for any person who 250,000 2009 10.02 25,050 275,050
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 1,000,000 2009 10.02 100,200 1,100,200
for all such above
violations adjudicated in
a single proceeding.
Page 61541
333(f)(9)(B)(ii)(II)........... ...................... Penalty for violation of 250,000 2009 10.02 25,050 275,050
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 1,000,000 2009 10.02 100,200 1,100,200
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 10,000,000 2009 10.02 1,002,000 11,002,000
above tobacco product
requirement violations
adjudicated in a single
proceeding.
333(g)(1)...................... ...................... Penalty for any person who 250,000 2007 13.833 34,583 284,583
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 500,000 2007 13.833 69165 569,165
subsequent above
violation in any 3-year
period.
333 note....................... ...................... Penalty to be applied for 250 2009 10.02 25 275
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 500 2009 10.02 50 550
third tobacco product
regulation violation
within a 24-month period.
Penalty in the case of a 2,000 2009 10.02 200 2,200
fourth tobacco product
regulation violation
within a 24-month period.
Penalty in the case of a 5,000 2009 10.02 501 5,501
fifth tobacco product
regulation violation
within a 36-month period.
Penalty in the case of a 10,000 2009 10.02 1,002 11,002
sixth or subsequent
tobacco product
regulation violation
within a 48-month period
as determined on a case-
by-case basis.
Penalty to be applied for 250 2009 10.02 25 275
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 500 2009 10.02 50 550
second tobacco product
regulation violation
within a 12-month period.
Penalty in the case of a 1,000 2009 10.02 100 1,100
third tobacco product
regulation violation
within a 24-month period.
Penalty in the case of a 2,000 2009 10.02 200 2,200
fourth tobacco product
regulation violation
within a 24-month period.
Penalty in the case of a 5,000 2009 10.02 501 5,501
fifth tobacco product
regulation violation
within a 36-month period.
Page 61542
Penalty in the case of a 10,000 2009 10.02 1002 11,002
sixth or subsequent
tobacco product
regulation violation
within a 48-month period
as determined on a case-
by-case basis.
335b(a)........................ ...................... Penalty for each violation 250,000 1992 67.728 169,320 419,320
for any individual who
made a false statement or
misrepresentation of a
material fact, bribed,
destroyed, altered,
removed, or secreted, or
procured the destruction,
alteration, removal, or
secretion of, any
material document, failed
to disclose a material
fact, obstructed an
investigation, employed a
consultant who was
debarred, debarred
individual provided
consultant services.
Penalty in the case of any 1,000,000 1992 67.728 677,280 1,677,280
other person (other than
an individual) per above
violation.
360pp(b)(1).................... ...................... Penalty for any person who 1,100 1968 150 1,500 2,750
violates any such
requirements for
electronic products, with
each unlawful act or
omission constituting a
separate violation.
Penalty imposed for any 375,000 1968 150 562,500 937,500
related series of
violations of
requirements relating to
electronic products.
42 U.S.C. (FDA):
262(d)......................... ...................... Penalty per day for 100,000 1986 115.628 115,628 215,628
violation of order of
recall of biological
product presenting
imminent or substantial
hazard.
263b(h)(3)..................... ...................... Penalty for failure to 10,000 1992 67.728 6,773 16,773
obtain a mammography
certificate as required.
300aa-28(b)(1)................. ...................... Penalty per occurrence for 100,000 1986 115.628 115,628 215,628
any vaccine manufacturer
that intentionally
destroys, alters,
falsifies, or conceals
any record or report
required.
42 U.S.C. (HRSA):
256b(d)(1)(B)(vi).............. ...................... Penalty for each instance 5,000 2010 8.745 437 5,437
of overcharging a 340B
covered entity.
42 U.S.C. (AHRQ):
299c-(3)(d).................... ...................... Penalty for an 10,000 1999 41.402 4,140 14,140
establishment or person
supplying information
obtained in the course of
activities for any
purpose other than the
purpose for which it was
supplied.
42 U.S.C. ACF:
653(l)(2)...................... 45 CFR 303.21(f)...... Penalty for Misuse of 1,000 1998 45.023 450 1,450
Information in the
National Directory of New
Hires.
42 U.S.C. (OIG):
262a(i)(1)..................... 42 CFR Part 1003...... Penalty for each 250,000 2002 31.185 77,962 327,962
individual who violates
safety and security
procedures related to
handling dangerous
biological agents and
toxins.
Penalty for any other 500,000 2002 31.185 155,925 655,925
person who violates
safety and security
procedures related to
handling dangerous
biological agents and
toxins.
1320a-7a(a).................... 42 CFR Part 1003...... Penalty for knowingly 10,000 1996 50.245 5,024 15,024
presenting or causing to
be presented to an
officer, employee, or
agent of the United
States a false claim.
Penalty for knowingly 10,000 1996 50.245 5,024 15,024
presenting or causing to
be presented a request
for payment which
violates the terms of an
assignment, agreement, or
PPS agreement.
Page 61543
Penalty for knowingly 15,000 1996 50.245 7,537 22,537
giving or causing to be
presented to a
participating provider or
supplier false or
misleading information
that could reasonably be
expected to influence a
discharge decision.
Penalty for an excluded 10,000 1996 50.245 5,024 15,024
party retaining ownership
or control interest in a
participating entity.
Penalty for remuneration 10,000 1996 50.245 5,024 15,024
offered to induce program
beneficiaries to use
particular providers,
practitioners, or
suppliers.
Penalty for employing or 10,000 1997 47.177 4,718 14,718
contracting with an
excluded individual.
Penalty for knowing and 50,000 1997 47.177 23,588 73,588
willful solicitation,
receipt, offer, or
payment of remuneration
for referring an
individual for a service
or for purchasing,
leasing, or ordering an
item to be paid for by a
Federal health care
program.
Penalty for ordering or 10,000 2010 8.745 874 10,874
prescribing medical or
other item or service
during a period in which
the person was excluded.
Penalty for knowingly 50,000 2010 8.745 4,372 54,372
making or causing to be
made a false statement,
omission or
misrepresentation of a
material fact in any
application, bid, or
contract to participate
or enroll as a provider
or supplier.
Penalty for knowing of an 10,000 2010 8.745 874 10,874
overpayment and failing
to report and return.
Penalty for making or 50,000 2010 8.745 4,372 54,372
using a false record or
statement that is
material to a false or
fraudulent claim.
Penalty for failure to 15,000 2010 8.745 1,312 16,312
grant timely access to
HHS OIG for audits,
investigations,
evaluations, and other
statutory functions of
HHS OIG.
1320a-7a(b).................... 42 CFR Part 1003...... Penalty for payments by a 2,000 1986 115.628 2,313 4,313
hospital or critical
access hospital to induce
a physician to reduce or
limit services to
individuals under direct
care of physician or who
are entitled to certain
medical assistance
benefits.
Penalty for physicians who 2,000 1986 115.628 2,313 4,313
knowingly receive
payments from a hospital
or critical access
hospital to induce such
physician to reduce or
limit services to
individuals under direct
care of physician or who
are entitled to certain
medical assistance
benefits.
Penalty for a physician 5,000 1996 50.245 2,512 7,512
who executes a document
that falsely certifies
home health needs for
Medicare beneficiaries.
1320a-7e(b)(6)(A).............. 42 CFR Part 1003...... Penalty for failure to 25,000 1997 47.177 11,794 36,794
report any final adverse
action taken against a
health care provider,
supplier, or practitioner.
1320b-10(b)(1)................. 42 CFR Part 1003...... Penalty for the misuse of 5,000 1988 97.869 4,893 9,893
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.
Page 61544
1320b-10(b)(2)................. 42 CFR Part 1003...... Penalty for the misuse of 25,000 1988 97.869 24,467 49,467
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)........ ...................... Penalty for certification 1,000 1987 106.278 1,063 2,063
of a false statement in
assessment of functional
capacity of a Skilled
Nursing Facility resident
assessment.
1395i-3(b)(3)(B)(ii)(2)........ ...................... Penalty for causing 5,000 1987 106.278 5,314 10,314
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)............... ...................... Penalty for any individual 2,000 1987 106.278 2,126 4,126
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 422.752; 42 CFR Penalty for a Medicare 25,000 1996 50.245 12,561 37,561
Part 1003. Advantage organization
that substantially fails
to provide medically
necessary, required items
and services.
Penalty for a Medicare 25,000 1997 47.177 11,794 36,794
Advantage organization
that charges excessive
premiums.
Penalty for a Medicare 25,000 1997 47.177 11,794 36,794
Advantage organization
that improperly expels or
refuses to reenroll a
beneficiary.
Penalty for a Medicare 100,000 1997 47.177 47,177 147,177
Advantage organization
that engages in practice
that would reasonably be
expected to have the
effect of denying or
discouraging enrollment.
Penalty per individual who 15,000 1997 47.177 7,077 22,077
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 100,000 1997 47.177 47,177 147,177
Advantage organization
misrepresenting or
falsifying information to
Secretary.
Penalty for a Medicare 25,000 1997 47.177 11,794 36,794
Advantage organization
misrepresenting or
falsifying information to
individual or other
entity.
Penalty for Medicare 25,000 1997 47.177 11,794 36,794
Advantage organization
interfering with
provider's advice to
enrollee and non-MCO
affiliated providers that
balance bill enrollees.
Penalty for a Medicare 25,000 1997 47.177 11,794 36,794
Advantage organization
that employs or contracts
with excluded individual
or entity.
Penalty for a Medicare 25,000 2010 47.177 11,794 36,794
Advantage organization
enrolling an individual
in without prior written
consent.
Penalty for a Medicare 25,000 2010 47.177 11,794 36,794
Advantage organization
transferring an enrollee
to another plan without
consent or solely for the
purpose of earning a
commission.
Penalty for a Medicare 25,000 2010 47.177 11,794 36,794
Advantage organization
failing to comply with
marketing restrictions or
applicable implementing
regulations or guidance.
Page 61545
Penalty for a Medicare 25,000 2010 47.177 11,794 36,794
Advantage organization
employing or contracting
with an individual or
entity who violates 1395w-
27(g)(1)(A)-(J).
1395w-141(i)(3)................ 42 CFR Part 1003...... Penalty for a prescription 10,000 2003 28.561 2,856 12,856
drug card sponsor that
falsifies or
misrepresents marketing
materials, overcharges
program enrollees, or
misuse transitional
assistance funds.
1395cc(g)...................... 42 CFR Part 1003...... Penalty for improper 2,000 1972 150 3,000 5,000
billing by Hospitals,
Critical Access
Hospitals, or Skilled
Nursing Facilities.
1395dd(d)(1)................... 42 CFR Part 1003...... Penalty for a hospital or 50,000 1987 106.278 53,139 103,139
responsible physician
dumping patients needing
emergency medical care,
if the hospital has 100
beds or more.
Penalty for a hospital or 25,000 1987 106.278 26,570 51,570
responsible physician
dumping patients needing
emergency care, if the
hospital has less than
100 beds.
1395mm(i)(6)(B)(i)............. 42 CFR Part 1003...... Penalty for a HMO or 25,000 1987 106.278 26,570 51,570
competitive plan is such
plan substantially fails
to provide medically
necessary, required items
or services.
Penalty for HMOs/ 25,000 1987 106.278 26,570 51,570
competitive medical plans
that charge premiums in
excess of permitted
amounts.
Penalty for a HMO or 25,000 1987 106.278 26,570 51,570
competitive medical plan
that expels or refuses to
reenroll an individual
per prescribed conditions.
Penalty for a HMO or 100,000 1987 106.278 106,278 206,278
competitive medical plan
that implements practices
to discourage enrollment
of individuals needing
services in future.
Penalty per individual not 15,000 1988 97.869 14,680 29,680
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 100,000 1987 106.278 106,278 206,278
competitive medical plan
that misrepresents or
falsifies information to
the Secretary.
Penalty for a HMO or 25,000 1987 106.278 26,570 51,570
competitive medical plan
that misrepresents or
falsifies information to
an individual or any
other entity.
Penalty for failure by HMO 25,000 1987 106.278 26,570 51,570
or competitive medical
plan to assure prompt
payment of Medicare risk
sharing contracts or
incentive plan provisions.
Penalty for HMO that 25,000 1989 89.361 22,340 47,340
employs or contracts with
excluded individual or
entity.
1395nn(g)(3)................... 42 CFR Part 1003...... Penalty for submitting or 15,000 1994 59.089 8,863 23,863
causing to be submitted
claims in violation of
the Stark Law's
restrictions on physician
self-referrals.
1395nn(g)(4)................... 42 CFR Part 1003...... Penalty for circumventing 100,000 1994 59.089 59,089 159,089
Stark Law's restrictions
on physician self-
referrals.
1395ss(d)(1)................... 42 CFR Part 1003...... Penalty for a material 5,000 1988 97.869 4,893 9,893
misrepresentation
regarding Medigap
compliance policies.
1395ss(d)(2)................... 42 CFR Part 1003...... Penalty for selling 5,000 1988 97.869 4,893 9,893
Medigap policy under
false pretense.
1395ss(d)(3)(A)(ii)............ 42 CFR Part 1003...... Penalty for an issuer that 25,000 1990 78.156 19,539 44,539
sells health insurance
policy that duplicates
benefits.
Page 61546
Penalty for someone other 15,000 1990 78.156 11,723 26,723
than issuer that sells
health insurance that
duplicates benefits.
1395ss(d)(4)(A)................ 42 CFR Part 1003...... Penalty for using mail to 5,000 1988 97.869 4,893 9,893
sell a non-approved
Medigap insurance policy.
1396b(m)(5)(B)(i).............. 42 CFR Part 1003...... Penalty for a Medicaid MCO 25,000 1988 97.869 24,467 49,467
that substantially fails
to provide medically
necessary, required items
or services.
Penalty for a Medicaid MCO 25,000 1988 97.869 24,467 49,467
that charges excessive
premiums.
Penalty for a Medicaid MCO 100,000 1988 97.869 97,869 197,869
that improperly expels or
refuses to reenroll a
beneficiary.
Penalty per individual who 15,000 1988 97.869 14,680 29,680
does not enroll as a
result of a Medicaid
MCO's practice that would
reasonably be expected to
have the effect of
denying or discouraging
enrollment.
Penalty for a Medicaid MCO 100,000 1988 97.869 97,869 197,869
misrepresenting or
falsifying information to
the Secretary.
Penalty for a Medicaid MCO 25,000 1988 97.869 24,467 49,467
misrepresenting or
falsifying information to
an individual or another
entity.
Penalty for a Medicaid MCO 25,000 1990 78.156 19,539 44,539
that fails to comply with
contract requirements
with respect to physician
incentive plans.
1396r(b)(3)(B)(ii)(I).......... 42 CFR Part 1003...... Penalty for willfully and 1,000 1987 106.278 1,063 2,063
knowingly certifying a
material and false
statement in a Skilled
Nursing Facility resident
assessment.
1396r(b)(3)(B)(ii)(II)......... 42 CFR Part 1003...... Penalty for willfully and 5,000 1987 106.278 5,314 10,314
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 Part 1003...... Penalty for notifying or 2,000 1987 106.278 2,126 4,126
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 Part 1003...... Penalty for the knowing 100,000 1990 78.156 78,156 178,156
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 Part 1003...... Penalty per day for 10,000 1990 78.156 7,816 17,816
failure to timely provide
information by drug
manufacturer with rebate
agreement.
1396r-8(b)(3)(C)(ii)........... 42 CFR Part 1003...... Penalty for knowing 100,000 1990 78.156 78,156 178,156
provision of false
information by drug
manufacturer with rebate
agreement.
1396t(i)(3)(A)................. 42 CFR Part 1003...... Penalty for notifying home 2,000 1990 78.156 1,563 3,563
and community-based
providers or settings of
survey.
11131(c)....................... 42 CFR Part 1003...... Penalty for failing to 10,000 1986 115.628 11,563 21,563
report a medical
malpractice claim to
National Practitioner
Data Bank.
11137(b)(2).................... 42 CFR Part 1003...... Penalty for breaching 10,000 1986 115.628 11,563 21,563
confidentiality of
information reported to
National Practitioner
Data Bank.
42 U.S.C. (OCR):
299b-22(f)(1).................. 42 CFR 3.404(b)....... Penalty for violation of 10,000 2005 19.40 1,940 11,940
confidentiality provision
of the Patient Safety and
Quality Improvement Act.
1320(d)-5(a)................... 45 CFR Penalty for each pre- 100 1996 50.245 50 150
160.404(b)(1)(i),(ii). February 18, 2009
violation of the HIPAA
administrative
simplification provisions.
Calendar Year Cap......... 25,000 1996 50.245 12,561 37,561
Page 61547
45 CFR Penalty for each February
160.404(b)(2)(i)(A),( 18, 2009 or later
B). 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................ 100 2009 10.02 10 110
Maximum................ 50,000 2009 10.02 5,010 55,010
Calendar Year Cap...... 1,500,000 2009 10.02 150,300 1,650,300
45 CFR Penalty for each February
160.404(b)(2)(ii)(A), 18, 2009 or later
(B). 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................ 1,000 2009 10.02 100 1100
Maximum................ 50,000 2009 10.02 5,010 55,010
Calendar Year Cap...... 1,500,000 2009 10.02 150,300 1,650,300
45 CFR Penalty for each February
160.404(b)(2)(iii)(A) 18, 2009 or later
, (B). 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................ 10,000 2009 10.02 100 11,002
Maximum................ 50,000 2009 10.02 5,010 55,010
Calendar Year Cap...... 1,500,000 2009 10.02 150,300 1,650,300
45 CFR Penalty for each February
160.404(b)(2)(iv)(A), 18, 2009 or later
(B). 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................ 50,000 2009 10.02 5,010 55,010
Maximum................ 1,500,000 2009 10.02 150,300 1,650,300
Calendar Year Cap...... 1,500,000 2009 10.02 150,300 1,650,300
42 U.S.C. (CMS):
263a(h)(2)(B) & 1395w- 42 CFR Penalty for a clinical
2(b)(2)(A)(ii). 493.1834(d)(2)(i). laboratory's failure to
meet participation and
certification
requirements and poses
immediate jeopardy:
Minimum................ 3,050 1988 97.869 2,985 6,035
Maximum................ 10,000 1988 97.869 9,787 19,787
42 CFR Penalty for a clinical
493.1834(d)(2)(ii). laboratory's failure to
meet participation and
certification
requirements and the
failure does not pose
immediate jeopardy:
Minimum................ 50 1988 97.869 49 99
Maximum................ 3,000 1988 97.869 2,936 5,936
300gg-15(f).................... 45 CFR 147.200(e)..... Failure to provide the 1,000 2010 8.745 87 1,087
Summary of Benefits and
Coverage (SBC).
300gg-18....................... 45 CFR 158.606........ Penalty for violations of 100 2010 8.745 9 109
regulations related to
the medical loss ratio
reporting and rebating.
Page 61548
1320a-7h(b)(1)................. 42 CFR 402.105(d)(5), Penalty for manufacturer
42 CFR 403.912(a) & or group purchasing
(c). organization failing to
report information
required under 42 U.S.C.
1320a-7h(a), relating to
physician ownership or
investment interests:
Minimum................ 1,000 2010 8.745 87 1,087
Maximum................ 10,000 2010 8.745 874 10,874
Calendar Year Cap...... 150,000 2010 8.745 13,117 163,117
1320a-7h(b)(2)................. 42 CFR 402.105(h), 42 Penalty for manufacturer
CFR 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................ 10,000 2010 8.745 874 10,874
Maximum................ 100,000 2010 8.745 8,745 108,745
Calendar Year Cap...... 1,000,000 2010 8.745 87,450 1,087,450
1320a-7j(h)(3)(A).............. ...................... Penalty for an 100,000 2010 8.745 8,745 108,745
administrator of a
facility that fails to
comply with notice
requirements for the
closure of a facility.
42 CFR Minimum penalty for the 500 2010 8.745 44 544
488.446(a)(1),(2), & first offense of an
(3). administrator who fails
to provide notice of
facility closure.
Minimum penalty for the 1,500 2010 8.745 131 1,631
second offense of an
administrator who fails
to provide notice of
facility closure.
Minimum penalty for the 3,000 2010 8.745 262 3,262
third and subsequent
offenses of an
administrator who fails
to provide notice of
facility closure.
1320a-8(a)(1).................. ...................... Penalty for an entity 5,000 1994 59.089 2,954 7,954
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 the violation 7,500 2015 1 4,431 7,500
of 42 U.S.C. 1320a-8a(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).................. ...................... Penalty for a 5,000 2004 24.588 1,229 6,229
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).............. ...................... Penalty for failure of 200,000 2010 8.745 17,490 217,490
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 61549
1320b-25(c)(2)(A).............. ...................... Penalty for failure of 300,000 2010 8.745 26,235 326,235
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)................. ...................... Penalty for a long-term 200,000 2010 8.745 17,490 217,490
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)..... Penalty for any person who 100 1997 47.177 47 147
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 Penalty per day for a
488.408(d)(1)(iii). Skilled Nursing Facility
that has a Category 2
violation of
certification
requirements:
Minimum................ 50 1987 106.278 53 103
Maximum................ 3,000 1987 106.278 3,188 6,188
42 CFR Penalty per instance of
488.408(d)(1)(iv). Category 2 noncompliance
by a Skilled Nursing
Facility:
Minimum................ 1,000 1987 106.278 1,063 2,063
Maximum................ 10,000 1987 106.278 10,628 20,628
42 CFR Penalty per day for a
488.408(e)(1)(iii). Skilled Nursing Facility
that has a Category 3
violation of
certification
requirements:
Minimum................ 3,050 1987 106.278 3,241 6,291
Maximum................ 10,000 1987 106.278 10,628 20,628
42 CFR Penalty per instance of
488.408(e)(1)(iv). Category 3 noncompliance
by a Skilled Nursing
Facility:
Minimum................ 1,000 1987 106.278 1,063 2,063
Maximum................ 10,000 1987 106.278 10,628 20,628
Penalty per day and per
instance for a Skilled
Nursing Facility that has
Category 3 noncompliance
with Immediate Jeopardy.
Per Day (Minimum)...... 3,050 1987 106.278 3,241 6,291
Per Day (Maximum)...... 10,000 1987 106.278 10,628 20,628
Per Instance (Minimum). 1,000 1987 106.278 1,063 2,063
Per Instance (Maximum). 10,000 1987 106.278 10,628 20,628
42 CFR 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................ 3,050 1987 106.278 3,241 6,291
Maximum................ 10,000 1987 106.278 10,628 20,628
42 CFR 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................ 50 1987 106.278 53 103
Maximum................ 3,000 1987 106.278 3,188 6,188
42 CFR 488.438(a)(2).. Penalty per instance of a
Skilled Nursing Facility
that fails to meet
certification
requirements:
Minimum................ 1,000 1987 106.278 1,063 2,063
Maximum................ 10,000 1987 106.278 10,628 20,628
Page 61550
1395l(h)(5)(D)................. 42 CFR Penalty for knowingly, 10,000 1996 50.245 5,024 15,024
402.105(d)(2)(i). willfully, and repeatedly
billing for a clinical
diagnostic laboratory
test other than on an
assignment-related basis.
(Penalties are assessed
in the same manner as 42
U.S.C. 1395u(j)(2)(B),
which is assessed
according to 1320a-7a(a)).
1395l(i)(6).................... ...................... Penalty for knowingly and 2,000 1988 197.869 1,957 3,957
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)..... Penalty for knowingly and 2,000 1989 89.361 1,787 3,787
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), Penalty for any durable 10,000 1996 50.245 5,024 15,024
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)).
1395m(a)(18)(B)................ 42 CFR 402.1(c)(5), Penalty for any 10,000 1996 50.245 5,024 15,024
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), Penalty for any 10,000 1996 50.245 5,024 15,024
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), Penalty for any supplier 10,000 1996 50.245 5,024 15,024
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)).
Page 61551
1395m(j)(2)(A)(iii)............ ...................... Penalty for any supplier 1,000 1994 59.089 591 1,591
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), Penalty for any supplier 10,000 1996 50.245 5,024 15,024
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), Penalty for any person or 10,000 1996 50.245 5,024 15,024
402.105(d)(3). entity who knowingly and
willfully bills or
collects for any
outpatient therapy
services or comprehensive
outpatient rehabilitation
services on other than an
assignment-related basis.
(Penalties are assessed
in the same manner as 42
U.S.C. 1395m(k)(6) and
1395u(j)(2)(B), which is
assessed according to
1320a-7a(a)).
1395m(l)(6).................... 42 CFR 402.1(c)(32), Penalty for any supplier 10,000 1996 50.245 5,024 15,024
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), Penalty for any 10,000 1996 50.245 5,024 15,024
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)................. 42 CFR 402.1(c)....... Penalty for any physician 10,000 1996 50.245 5,024 15,024
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), Penalty for any physician 10,000 1996 50.245 5,024 15,024
402.105(d)(2)(ix). 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 61552
1395u(l)(3).................... 42 CFR 402.1(c)(13), Penalty for any 10,000 1996 50.245 5,024 15,024
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), Penalty for any 10,000 1996 50.245 5,024 15,024
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), Penalty for any physician 10,000 1996 50.245 5,024 15,024
402.105(d)(2)(xii). 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)..... Penalty for any 10,000 1996 50.245 5,024 15,024
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)................. ...................... Penalty for any physician 2,000 1988 97.869 1,957 3,957
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........ Penalty for a 10,000 2003 28.561 2,856 12,856
pharmaceutical
manufacturer's
misrepresentation of
average sales price of a
drug, or biologic.
Page 61553
1395w-4(g)(1)(B)............... 42 CFR 402.1(c)(17), Penalty for any 10,000 1996 50.245 5,024 15,024
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), Penalty for any person 10,000 1996 50.245 5,024 15,024
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).. 42 CFR 422.760(b); 42 Penalty for each 25,000 1997 47.177 11,794 36,794
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).. ...................... Penalty for each week 10,000 1997 47.177 4,718 14,718
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).. ...................... Penalty for a Medicare 100,000 2000 36.689 36,689 136,689
Advantage organization's
or Part D sponsor's early
termination of its
contract.
1395y(b)(3)(C)................. 42 CFR 411.103(b)..... Penalty for an employer or 5,000 1990 78.156 3,908 8,908
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), Penalty for any non- 1,000 1998 89.361 450 1,450
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), Penalty for any entity 2,000 1994 59.089 1,182 3,182
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).............. ...................... Penalty for any entity 1,000 2007 13.833 138 1,138
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 61554
1395y(b)(8)(E)................. ...................... Penalty for any non-group 1,000 2007 13.833 138 1,138
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........ Penalty for any person 10,000 1989 89.361 8,936 18,936
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), Penalty for any durable 10,000 1996 50.245 5,024 15,024
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), Penalty for any person 25,000 1987 106.278 26,569 51,569
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)....... ...................... Penalty for someone other 15,000 1990 78.156 11,723 26,723
than issuer that sells or
issues a Medicare
supplemental policy to
beneficiary without a
disclosure statement.
Penalty for an issuer that 25,000 1990 78.156 19,539 44,539
sells or issues a
Medicare supplemental
policy without disclosure
statement.
1395ss(d)(3)(B)(iv)................ ...................... Penalty for someone other 15,000 1990 78.156 11,723 26,723
than issuer that sells or
issues a Medicare
supplemental policy
without acknowledgement
form.
Penalty for issuer that 25,000 1990 78.156 19,539 44,539
sells or issues a
Medicare supplemental
policy without an
acknowledgement form.
1395ss(p)(8)................... 42 CFR 402.1(c)(25), Penalty for any person 15,000 1990 78.156 11,723 26,723
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), Penalty for any person 25,000 1990 78.156 19,539 44,539
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), Penalty for any person 15,000 1990 78.156 11,723 26,723
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.
Page 61555
42 CFR 402.1(c)(26), Penalty for any person 25,000 1990 78.156 19,539 44,539
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), Penalty for any person 25,000 1990 78.156 19,539 44,539
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), Penalty for any person 25,000 1990 78.156 19,539 44,539
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), Penalty for any issuer of 5,000 1990 78.156 3,908 8,908
405.105(c). 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), Penalty for any issuer of 25,000 1990 78.156 19,539 44,539
405.105(f)(7). a Medicare supplemental
policy that fails to
fulfill listed
responsibilities.
1395ss(v)(4)(A).................... ...................... Penalty someone other than 15,000 2003 28.561 4,284 19,284
issuer who sells, issues,
or renews a medigap Rx
policy to an individual
who is a Part D enrollee.
Penalty for an issuer who 25,000 2003 28.561 7,140 32,140
sells, issues, or renews
a Medigap Rx policy who
is a Part D enrollee.
1395bbb(c)(1).................. 42 CFR 488.725(c)..... Penalty for any individual 2,000 1987 106.278 2,126 4,126
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 Maximum daily penalty 10,000 1988 97.869 9,787 19,787
488.845(b)(2)(iii). amount for each day a
home health agency is not
in compliance with
statutory requirements.
42 CFR 488.845(b)(3).. Penalty per day for home
health agency's
noncompliance (Upper
Range):
Minimum................ 8,500 1988 97.869 8,319 16,819
Maximum................ 10,000 1988 97.869 9,787 19,787
42 CFR Penalty for a home health 10,000 1988 97.869 9,787 19,787
488.845(b)(3)(i). agency's deficiency or
deficiencies that cause
immediate jeopardy and
result in actual harm.
42 CFR Penalty for a home health 9,000 1988 97.869 8,808 17,808
488.845(b)(3)(ii). agency's deficiency or
deficiencies that cause
immediate jeopardy and
result in potential for
harm.
42 CFR Penalty for an isolated 8,500 1988 97.869 8,319 16,819
488.845(b)(3)(iii). 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................ 1,500 1988 97.869 1,468 2,968
Maximum................ 8,500 1988 97.869 8,319 16,819
Page 61556
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................ 500 1988 97.869 489 989
Maximum................ 4,000 1988 97.869 3,915 7,915
......................
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................ 1,000 1988 97.869 979 1,979
Maximum................ 10,000 1988 97.869 9,787 19,787
Penalty for each day of 10,000 1988 97.869 9,787 19,787
noncompliance (Maximum).
42 CFR Penalty for each day of 10,000 1988 97.869 9,787 19,787
488.845(d)(1)(ii). noncompliance (Maximum).
1396b(m)(5)(B)................. 42 CFR 460.46......... Penalty for PACE
organization's practice
that would reasonably be
expected to have the
effect of denying or
discouraging enrollment:
Minimum................ 15,000 1997 47.177 7,077 22,077
Maximum................ 100,000 1997 47.177 47,177 147,177
Penalty for a PACE 25,000 1997 47.177 11,794 36,794
organization that charges
excessive premiums.
Penalty for a PACE 100,000 1997 47.177 47,177 147,177
organization
misrepresenting or
falsifying information to
CMS, the State, or an
individual or other
entity.
Penalty for each 25,000 1997 47.177 11,794 36,794
determination the CMS
makes that the PACE
organization has failed
to provide medically
necessary items and
services of the failure
has adversely affected
(or has the substantial
likelihood of adversely
affecting) a PACE
participant.
Penalty for involuntarily 25,000 1997 47.177 11,794 36,794
disenrolling a
participant.
Penalty for discriminating 25,000 1997 47.177 11,794 36,794
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 Penalty per day for a
488.408(d)(1)(iii). nursing facility's
failure to meet a
Category 2 Certification:
Minimum................ 50 1987 106.278 53 103
Maximum................ 3,000 1987 106.278 3,188 6,188
42 CFR Penalty per instance for a
488.408(d)(1)(iv). nursing facility's
failure to meet Category
2 certification:
Minimum................ 1,000 1987 106.278 1,063 2,063
Maximum................ 10,000 1987 106.278 10,628 20,628
42 CFR Penalty per day for a
488.408(e)(1)(iii). nursing facility's
failure to meet Category
3 certification:
Minimum................ 3,050 1987 106.278 3,241 6,291
Maximum................ 10,000 1987 106.278 10,628 20,628
42 CFR Penalty per instance for a
488.408(e)(1)(iv). nursing facility's
failure to meet Category
3 certification:
Minimum................ 1,000 1987 106.278 1,063 2,063
Maximum................ 10,000 1987 106.278 10,628 20,628
42 CFR Penalty per instance for a
488.408(e)(2)(ii). nursing facility's
failure to meet Category
3 certification, which
results in immediate
jeopardy:
Minimum................ 1,000 1987 106.278 1,063 2,063
Maximum................ 10,000 1987 106.278 10,628 20,628
Page 61557
42 CFR Penalty per day for
488.438(a)(1)(i). nursing facility's
failure to meet
certification (Upper
Range):
Minimum................ 3,050 1987 106.278 3,241 6,291
Maximum................ 10,000 1987 106.278 10,628 20,628
42 CFR Penalty per day for
488.438(a)(1)(ii). nursing facility's
failure to meet
certification (Lower
Range):
Minimum................ 50 1987 106.278 53 103
Maximum................ 3,000 1987 106.278 3,188 6,188
42 CFR 488.438(a)(2).. Penalty per instance for
nursing facility's
failure to meet
certification:
Minimum................ 1,000 1987 106.278 1,063 2,063
Maximum................ 10,000 1987 106.278 10,628 20,628
1396r(f)(2)(B)(iii)(I)(c)...... 42 CFR Grounds to prohibit 5,000 1987 106.278 5,314 10,314
483.151(b)(2)(iv) and approval of Nurse Aide
(b)(3)(iii). 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).. Grounds to waive 5,000 1987 106.278 5,314 10,314
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)................. ...................... 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................ 1 1990 78.156 1 2
Maximum................ 10,000 1990 78.156 7,816 17,816
1396u-2(e)(2)(A)(i)............ 42 CFR 438.704........ Penalty for a Medicaid 25,000 1997 47.177 11,794 36,794
managed care organization
that fails substantially
to provide medically
necessary items and
services.
Penalty for Medicaid 25,000 1997 47.177 11,794 36,794
managed care organization
that imposes premiums or
charges on enrollees in
excess of the premiums or
charges permitted.
Penalty for a Medicaid 25,000 1997 47.177 11,794 36,794
managed care organization
that misrepresents or
falsifies information to
another individual or
entity.
Penalty for a Medicaid 25,000 1997 47.177 11,794 36,794
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........ Penalty for a Medicaid 100,000 1997 47.177 47,177 147,177
managed care organization
that misrepresents or
falsifies information to
the HHS Secretary.
Penalty for Medicaid 100,000 1997 47.177 47,177 147,177
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........ Penalty for each 15,000 1997 47.177 7,077 22,077
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 441, Subpart I. Penalty for a provider not 10,000 1990 106.278 10,628 20,628
meeting one of the
requirements relating to
the protection of the
health, safety, and
welfare of individuals
receiving community
supported living
arrangements services.
Page 61558
1396w-2(c)(1).................. ...................... Penalty for disclosing 10,000 2009 10.02 1,002 11,002
information related to
eligibility
determinations for
medical assistance
programs.
1903(m)(5)(B).................. 42 CFR 460.46......... Penalty for PACE
organization's practice
that would reasonably be
expected to have the
effect of denying or
discouraging enrollment:
Minimum................ 15,000 1997 47.177 7,077 22,077
Maximum................ 100,000 1997 47.177 47,177 147,177
Penalty for a PACE 25,000 1997 47.177 11,794 36,794
organization that charges
excessive premiums.
Penalty for a PACE 100,000 1997 47.177 47,177 147,177
organization
misrepresenting or
falsifying information to
CMS, the State, or an
individual or other
entity.
Penalty for each 25,000 1997 47.177 11,794 36,794
determination the CMS
makes that the PACE
organization has failed
to provide medically
necessary items and
services of the failure
has adversely affected
(or has the substantial
likelihood of adversely
affecting) a PACE
participant.
Penalty for involuntarily 25,000 1997 47.177 11,794 36,794
disenrolling a
participant.
Penalty for discriminating 25,000 1997 47.177 11,794 36,794
or discouraging
enrollment or
disenrollment of
participants on the basis
of an individual's health
status or need for health
care services.
18041(c)(2).................... 45 CFR 150.315 and 45 Failure to comply with 100 1996 50.245 50 150
CFR 156.805(c). requirements of 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)(C)).
18081(h)(1)(A)(i)(II).......... 42 CFR 155.285........ Penalty for providing 25,000 2010 8.745 2,186 27,186
false information on
Exchange application.
18081(h)(1)(B)................. 42 CFR 155.285........ Penalty for knowingly or 250,000 2010 8.745 21,862 271,862
willfully providing false
information on Exchange
application.
18081(h)(2).................... 42 CFR 155.260........ Penalty for knowingly or 25,000 2010 8.745 2,186 27,186
willfully disclosing
protected information
from Exchange.
31 U.S.C. (HHS):
1352........................... 45 CFR 93.400(e)...... Penalty for the first time 10,000 1989 89.361 8,936 18,936
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................ 10,000 1989 89.361 8,936 18,936
Maximum................ 100,000 1989 89.361 89,361 189,361
Penalty for the first time 10,000 1989 89.361 8,936 18,936
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................ 10,000 1989 89.361 8,936 18,936
Maximum................ 100,000 1989 89.361 89,361 189,361
45 CFR 93, Appendix A. Penalty for failure to
provide certification
regarding lobbying in the
award documents for all
sub-awards of all tiers:
Minimum................ 10,000 1989 89.361 8,936 18,936
Maximum................ 100,000 1989 89.361 89,361 189,361
Page 61559
Penalty for failure to
provide statement
regarding lobbying for
loan guarantee and loan
insurance transactions:
Minimum................ 10,000 1989 89.361 8,936 18,936
Maximum................ 100,000 1989 89.361 89,361 189,361
3801-3812...................... 45 CFR 79.3(a)(1(iv).. Penalty against any 5,000 1988 97.869 4,894 9,894
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 5,000 1988 97.869 4,894 9,894
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 penalties-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 non-Inflation Act Adjustment.
\4\ Based on the lesser of the CPI-U multiplier for October 2015, or 150%.
\5\ Rounded to the nearest dollar.
-
Environmental Impact
HHS has determined that this interim final rule (IFR) does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental impact assessment nor an environmental impact statement is required.
-
Paperwork Reduction Act
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35) and its implementing regulations (5 CFR part 1320), HHS reviewed this IFR and determined that there are no new collections of information contained therein.
-
Regulatory Flexibility Act
When an agency promulgates a final rule under 5 U.S.C. 553, after being required by that section or any other law to publish a general notice of proposed rulemaking, the Regulatory Flexibility Act (RFA) mandates that the agency prepare an RFA analysis. 5 U.S.C. 604(a). An RFA analysis is not required when a rule is exempt from notice and comment rulemaking under 5 U.S.C. 553(b). This interim final rule is exempt from notice and comment rulemaking. Therefore, no RFA analysis is required under 5 U.S.C. 604 and none was prepared.
-
Executive Orders 12866 and 13563
Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. Agencies must prepare a regulatory impact analysis for major rules with economically significant effects ($100 million or more in any 1 year). HHS has determined that this IFR is not economically significant.
HHS analyzed the economic significance of this IFR, by collecting data for fiscal years 2010 through 2014 on the total value of civil monetary penalties collected by Operating/Staff Divisions, except in the case of CMS, for which HHS used collections data through FY 2015. Such data included the statutory authority for the civil monetary penalty, which HHS used to apply the appropriate multiplier for each of the penalties collected. With respect to CMS, HHS determined the multiplier for the CMS collections by pro rating all of the multipliers for the civil monetary penalty authorities attributed to CMS.
HHS then applied the multiplier to collections for each Fiscal Year (2010 through 2014) to calculate the collections for each Fiscal Year with the inflation adjustment. HHS also performed an additional calculation for FY 2014/2015 using the inflated collections amount for FY 2015 for CMS and using the inflated collections amount for all other Operating/Staff Divisions for FY 2014. When collections were adjusted for inflation, the Department's lowest collection amount was $58,332,000 for FY 2012 and the highest total was $168,000,000 for FY 2014/2015.
Finally, HHS subtracted the collections value for a Fiscal Year (for example, FY 2010) from the collections value for the same Fiscal Year with the inflation adjustment (for example, FY 2010 with inflation adjustment) to assess the economic significance of this IFR for that Fiscal Year (for example, FY 2010 Economic Significance). When the calculations were completed, the Fiscal Year Economic Significance values ranged from a low of $23,698,917 for FY 2013, to a high of $70,913,713 for FY 2014/2015. Based on these calculations, HHS does not believe this IFR will be economically significant as defined in Executive Order 12866.
-
Unfunded Mandates Reform Act of 1995 Determination
Section 202 of the Unfunded Mandates Reform Act of 1995 (Unfunded Mandates Act) (2 U.S.C. 1532) requires that covered agencies prepare a budgetary impact statement before promulgating a rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more in any one year. If a budgetary impact statement is required, section 205 of the Unfunded Mandates Act also requires covered agencies to identify and consider a reasonable number of regulatory alternatives before promulgating a rule. HHS has
Page 61560
determined that this IFR does not result in expenditures by State, local, and tribal governments, or by the private sector, of $100 million or more in any one year. Accordingly, HHS has not prepared a budgetary impact statement or specifically addressed the regulatory alternatives considered.
-
Executive Order 13132 Determination
HHS has determined that this IFR does not have any Federalism implications, as required by Executive Order 13132.
List of Subjects
Administrative practice and procedure, Conflicts of interests, Health records, Privacy, Reporting and recordkeeping requirements.
42 CFR Part 402
Administrative practice and procedure, Medicaid, Medicare, Penalties.
Grant programs--health, Health insurance, Hospitals, Intergovernmental relations, Medicare, Reporting and recordkeeping requirements.
42 CFR Part 411
Kidney diseases, Medicare, Physician referral, Reporting and recordkeeping requirements.
42 CFR Part 412
Administrative practice and procedure, Health facilities, Medicare, Puerto Rico, Reporting and recordkeeping requirements.
42 CFR Part 422
Administrative practice and procedure, Health facilities, Health maintenance organizations (HMO), Medicare, Penalties, Privacy, Reporting and recordkeeping requirements.
42 CFR Part 423
Administrative practice and procedure, Emergency medical services, Health facilities, Health maintenance organizations (HMO), Health professionals, Medicare, Penalties, Privacy, Reporting and recordkeeping requirements.
Grant programs--health, Medicaid, Reporting and recordkeeping requirements.
Aged, Health care, Health records, Medicaid, Medicare, Reporting and recordkeeping requirements.
Grant programs--health, Health facilities, Health professions, Health records, Medicaid, Medicare, Nursing homes, Nutrition, Reporting and recordkeeping requirements, Safety.
42 CFR Part 488
Administrative practice and procedure, Health facilities, Medicare, Reporting and recordkeeping requirements.
42 CFR Part 493
Administrative practice and procedure, Grant programs--health, Health facilities, Laboratories, Medicaid, Medicare, Penalties, Reporting and recordkeeping requirements.
42 CFR Part 1003
Fraud, Grant programs--health, Health facilities, Health professions, Medicaid, Reporting and recordkeeping.
Administrative practice and procedure, Claims, Fraud, Penalties.
Government contracts, Grants programs, Loan programs, Lobbying, Penalties.
Administrative practice and procedure, Penalties.
Health care, Health insurance, Reporting and recordkeeping requirements.
45 CFR Part 155
Administrative practice and procedure, Advertising, Brokers, Conflict of interest, Consumer protection, Grant programs--health, Grants administration, Health care, Health insurance, Health maintenance organization (HMO), Health records, Hospitals, Indians, Individuals with disabilities, Loan programs--health, Organization and functions (Government agencies), Medicaid, Public assistance programs, Reporting and recordkeeping requirements, Safety, State and local governments, Technical assistance, Women, and Youth.
45 CFR Part 156
Administrative practice and procedure, Advertising, Advisory committees, Brokers, Conflict of interest, Consumer protection, Grant programs--health, Grants administration, Health care, Health insurance, Health maintenance organization (HMO), Health records, Hospitals, Indians, Individuals with disabilities, Loan programs--health, Organization and functions (Government agencies), Medicaid, Public assistance programs, Reporting and recordkeeping requirements, Safety, State and local governments, Sunshine Act, Technical assistance, Women, and Youth.
Administrative practice and procedure, Claims, Health care, Health insurance, Health plans, penalties, Reporting and recordkeeping requirements, Premium revenues, Medical loss ratio, Rebating.
45 CFR Part 160
Administrative practice and procedures, Penalties, Records and recordkeeping requirements.
Child support, Standards for program operations, Penalties.
For the reasons set forth in the preamble, the Department of Health and Human Services amends 42 CFR chapter I and 45 CFR subtitle A, the Centers for Medicare & Medicaid Services amends 42 CFR chapter IV, the Office of the Inspector General amends 42 CFR chapter 42 CFR chapter V, and the Administration for Children and Families amends 45 CFR chapter III as follows:
Title 42--Public Health
Chapter I--Public Health Service, Department of Health and Human Services
PART 3--PATIENT SAFETY ORGANIZATIONS AND PATIENT SAFETY WORK PRODUCT
0
1. The authority citation for part 3 continues to read as follows:
Authority: 42 U.S.C. 216, 299b-21 through 299b-26; 42 U.S.C. 299c-6.
0
2. Section 3.404 is revised to read as follows:
Sec. 3.404 Amount of a civil money penalty.
(a) The amount of a civil money penalty will be determined in accordance with paragraph (b) of this section and Sec. 3.408.
(b) The Secretary may impose a civil monetary penalty in the amount of not more than $11,000. This amount has been updated and will be updated annually, in accordance with the Federal Civil Monetary penalty Inflation Adjustment Act of 1990 (Pub. L. 101-140), as amended by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (section 701 of Pub. L. 114-74). The amount, as
Page 61561
updated, is published at 45 CFR part 102.
CHAPTER IV--CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES
PART 402--CIVIL MONEY PENALTIES, ASSESSMENTS, AND EXCLUSIONS
0
3. The authority citation for part 402 continues to read as follows:
Authority: Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh).
Sec. 402.105 Amended
0
4. In the table below, Sec. 402.105 is amended in each paragraph indicated in the first column, by removing the phrase indicated in the second column and adding in its place the phrase in the third column:
------------------------------------------------------------------------
Paragraph Remove Add
------------------------------------------------------------------------
(a)........................... ``$2,000 for each ``$2,000 as adjusted
service''. annually under 45
CFR part 102 for
each service''.
(b) introductory text......... ``not more than ``not more than
$1,000 for''. $1,000 as adjusted
annually under 45
CFR part 102 for''.
(c) introductory text......... ``not more than ``not more than
$5,000 for''. $5,000 as adjusted
annually under 45
CFR part 102 for''.
(d)(1)........................ ``not more than ``not more than
$10,000 for''. $10,000 as adjusted
annually under 45
CFR part 102 for''.
(d)(2) introductory text...... ``not more than ``not more than
$10,000 for''. $10,000 as adjusted
annually under 45
CFR part 102 for''.
(d)(3)........................ ``not more than ``not more than
$10,000 for''. $10,000 as adjusted
annually under 45
CFR part 102 for''.
(d)(4)........................ ``not more than ``not more than
$10,000 for''. $10,000 as adjusted
annually under 45
CFR part 102 for''.
(d)(5)........................ ``not more than ``not more than
$10,000 for''. $10,000 as adjusted
annually under 45
CFR part 102 for''.
(d)(5)........................ ``will not exceed ``will not exceed
$150,000''. $150,000 as annually
adjusted under 45
CFR part 102''.
(e)........................... ``not more than ``not more than
$15,000 for''. $15,000 as adjusted
annually under 45
CFR part 102 for''.
(f) introductory text......... ``not more than ``not more than
$25,000 for''. $25,000 as adjusted
annually under 45
CFR part 102 for''.
(g)........................... ``not more than ``not more than $100
$100 for''. as adjusted annually
under 45 CFR part
102 for''.
(h)........................... ``not more than ``not more than
$100,000 for''. $10,000 as adjusted
annually under 45
CFR part 102 for''.
(h)........................... ``will not exceed ``will not exceed
$1,000,000''. $1,000,000 as
annually adjusted
under 45 CFR part
102''.
------------------------------------------------------------------------
PART 403--SPECIAL PROGRAMS AND PROJECTS
0
5. The authority citation for part 403 continues to read as follows:
Authority: 42 U.S.C. 1395b-3 and Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh).
Sec. 403.912 Amended
0
6. In the table below, Sec. 403.912 is amended in each paragraph indicated in the first column, by removing the phrase indicated in the third column and adding in its place the phrase indicated in the fourth column:
------------------------------------------------------------------------
Paragraph Remove Add
------------------------------------------------------------------------
(a)(1)........................ ``not less than ``not less than
$1,000, but not $10,000, but not
more than more than $100,000,
$10,000 for''. as adjusted annually
under 45 CFR part
102 for''.
(a)(2)........................ ``will not exceed ``will not exceed
$150,000''. $150,000 as adjusted
annually under 45
CFR part 102''.
(b)(1)........................ ``not less than ``not less than
$10,000, but not $10,000, but not
more than more than $100,000,
$100,000 for''. as adjusted annually
under 45 CFR part
102 for''.
(b)(2)........................ ``will not exceed ``will not exceed
$1,000,000''. $1,000,000 as
adjusted annually
under 45 CFR part
102''.
(c)(2)........................ ``with a maximum ``with a maximum
combined annual combined annual
total of total of $1,150,000
$1,150,000''. as adjusted annually
under 45 CFR part
102''.
------------------------------------------------------------------------
PART 411--EXCLUSIONS FROM MEDICARE AND LIMITATIONS ON MEDICARE PAYMENT
0
7. The authority citation for part 411 continues to read as follows:
Authority: Secs. 1102, 1860D-1 through 1860D-42, 1871, and 1877 of the Social Security Act (42 U.S.C. 1302, 1395w-101 through 1395w-
152, 1395hh, and 1395nn).
Sec. Sec. 411.103 and 411.361 Amended
0
8. In the table below, for each section and paragraph indicated in the first two columns, remove the phrase indicated in the third column and add in its place
Page 61562
the phrase indicated in the fourth column:
----------------------------------------------------------------------------------------------------------------
Section Paragraphs Remove Add
----------------------------------------------------------------------------------------------------------------
Sec. 411.103..................... (b)(1)................ ``up to $5,000 for''.. ``up to $5,000 as adjusted
annually under 45 CFR part
102 for''.
(b)(2)................ ``up to $5,000''...... ``up to $5,000 as adjusted
annually under 45 CFR part
102''.
Sec. 411.361..................... (f)................... ``up to $10,000 for''. ``up to $10,000 as adjusted
annually under 45 CFR part
102 for''.
----------------------------------------------------------------------------------------------------------------
PART 412--PROSPECTIVE PAYMENT SYSTEMS FOR INPATIENT HOSPITAL SERVICES
0
12. The authority citation for part 412 continues to read as follows:
Authority: Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh), sec. 124 of Pub. L. 106-113 (113 Stat. 1501A-332), sec. 1206 of Pub. L. 113-67, and sec. 112 of Pub. L. 113-93.
Sec. 412.612 Amended
0
13. Section 412.612 is amended as follows:
0
a. In paragraph (b)(1)(i), by removing the phrase ``not more than $1,000 for'' and adding in its place the phrase ``not more than $1,000 as adjusted annually under 45 CFR part 102 for''; and
0
b. In paragraph (b)(1)(ii), by removing the phrase ``not more than $5,000 for'' and adding in its place the phrase ``not more than $5,000 as adjusted annually under 45 CFR part 102 for''.
PART 422--MEDICARE ADVANTAGE PROGRAM
0
14. The authority citation for part 422 continues to read as follows:
Authority: Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh).
Sec. 422.760 Amended
0
15. In the table below, Sec. 422.760 is amended in each paragraph indicated in the first column, by removing the phrase indicated in the second column and add in its place the phrase indicated in the third column:
------------------------------------------------------------------------
Paragraph Remove Add
------------------------------------------------------------------------
(b)(1)........................ ``up to $25,000 ``up to $25,000 as
for each''. adjusted annually
under 45 CFR part
102 for each''.
(b)(2)........................ ``up to $25,000 ``up to $25,000 as
for each''. adjusted annually
under 45 CFR part
102 for each''.
(b)(3)........................ ``determination-- ``determination--up
up to $10,000''. to $10,000 as
adjusted annually
under 45 CFR part
102''.
(b)(4)........................ ``$250 per ``$250 as adjusted
Medicare annually under 45
enrollee''. CFR part 102 per
Medicare enrollee''.
(b)(4)........................ ``or $100,000, ``or $100,000 as
whichever is adjusted annually
greater''. under 45 CFR part
102, whichever is
greater''.
(c)(1)........................ ``not more than ``not more than
$25,000 for''. $25,000 as adjusted
annually under 45
CFR part 102 for''.
(c)(2)........................ ``not more than ``not more than
$100,000 for''. $100,000 as adjusted
annually under 45
CFR part 102 for''.
(c)(4)........................ ``$15,000 for ``$15,000 as adjusted
each annually under 45
individual''. CFR part 102 for
each individual''.
------------------------------------------------------------------------
PART 423--VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT
0
16. The authority citation for part 423 continues to read as follows:
Authority: Sections 1102, 1106, 1860D-1 through 1860D-42, and 1871 of the Social Security Act (42 U.S.C. 1302, 1306, 1395w-101 through 1395w-152, and 1395hh).
Sec. 423.760 Amended
0
17. In the table below, Sec. 423.760 is amended in each paragraph indicated by the first column, by removing the phrase indicated in the second column and add in its place the phrase indicated in the third column:
------------------------------------------------------------------------
Paragraph Remove Add
------------------------------------------------------------------------
(b)(1)........................ ``enrollees--up ``enrollees--up to
to $25,000 for $25,000 as adjusted
each annually under 45
determination''. CFR part 102 for
each
determination''.
(b)(2)........................ ``of up to ``of up to $25,000 as
$25,000 for each adjusted annually
Part D under 45 CFR part
enrollee''. 102 for each Part D
enrollee''.
(b)(3)........................ ``up to $10,000'' ``up to $10,000 as
adjusted annually
under 45 CFR part
102''.
(b)(4)........................ ``$250 per ``$250 as adjusted
Medicare annually under 45
enrollee''. CFR part 102 per
Medicare enrollee''.
(b)(4)........................ ``or $100,000, ``or $100,000 as
whichever is adjusted annually
greater''. under 45 CFR part
102, whichever is
greater''.
(c)(1)........................ ``of not more ``of not more than
than $25,000 for $25,000 as adjusted
each''. annually under 45
CFR part 102 for
each''.
Page 61563
(c)(2)........................ ``not more than ``not more than
$100,000 for $100,000 as adjusted
each''. annually under 45
CFR part 102 for
each''.
(c)(4)........................ ``$15,000 for ``$15,000 as adjusted
each annually under 45
individual''. CFR part 102 for
each individual''.
------------------------------------------------------------------------
PART 483--REQUIREMENTS FOR STATES AND LONG TERM CARE FACILITIES
0
18. The authority citation for part 483 continues to read as follows:
Authority: Secs. 1102, 1128I, 1819, 1871 and 1919 of the Social Security Act (42 U.S.C. 1302, 1320a-7, 1395i, 1395hh and 1396r).
Sec. 483.20 Amended
0
19. Section 483.20 is amended as follows:
0
a. In paragraph (j)(1)(i), by removing the phrase ``not more than $1,000 for'' and adding in its place the phrase ``not more than $1,000 as adjusted annually under 45 CFR part 102 for''; and
0
b. In paragraph (j)(1)(ii), by removing the phrase ``not more than $5,000 for'' and adding it its place the phrase ``not more than $5,000 as adjusted annually under 45 CFR part 102 for''.
Sec. 483.151 Amended
0
20. Section 483.151 is amended as follows:
0
a. In paragraph (b)(2)(iv), by removing the phrase ``not less than $5,000; or'' and adding in its place the phrase ``not less than $5,000 as adjusted annually under 45 CFR part 102; or'';
0
b. In paragraph (b)(3)(iii), by removing the phrase ``not less than $5,000 for'' and adding in its place the phrase ``not less than $5,000 as adjusted annually under 45 CFR part 102 for''; and
0
c. In paragraph (c)(1), by removing the phrase ``not less than $5,000'' and adding in its place the phrase ``not less than $5,000 as adjusted annually under 45 CFR part 102''.
PART 488--SURVEY, CERTIFICATION, AND ENFORCEMENT PROCEDURES
0
21. The authority citation for part 488 continues to read as follows:
Authority: Secs. 1102, 1128l, 1864, 1865, 1871 and 1875 of the Social Security Act, unless otherwise noted (42 U.S.C. 1302, 1320a-
7j, 1395aa, 1395bb, 1395hh) and 1395ll.
Sec. Sec. 488.307, 488.408, 488.438, 488.446, 488.725, and 488.845 Amended
0
22. In the table below, for each section and paragraph indicated in the first two columns, remove the phrase indicated in the third column and add in its place the phrase indicated in the fourth column:
----------------------------------------------------------------------------------------------------------------
Section Paragraph Remove Add
----------------------------------------------------------------------------------------------------------------
488.307............................ (c)................... ``not to exceed ``not to exceed $2,000 as
$2,000''. adjusted annually under 45
CFR part 102''.
488.408............................ (d)(1)(iii)........... ``$50-$3,000 per day'' ``$50-$3,000 as adjusted
annually under 45 CFR part
102 per day''.
(d)(1)(iv)............ ``$1,000-$10,000 per ``$1,000-$10,000 as
instance''. adjusted annually under 45
CFR part 102 per
instance''.
(e)(1)(iii)........... ``$3,050-$10,000 per ``$3,050-$10,000 as
day''. adjusted annually under 45
CFR part 102 per day''.
(e)(1)(iv)............ ``$1,000-$10,000 per ``$1,000-$10,000 as
instance''. adjusted annually under 45
CFR part 102 per
instance''.
(e)(2)(ii)............ ``3,050-$10,000 per ``3,050-$10,000 as adjusted
day or $1,000-$10,000 annually under 45 CFR part
per instance''. 102 per day or $1,000-
$10,000 as adjusted
annually under 45 CFR part
102 per instance''.
488.438............................ (a)(1)(i)............. ``Upper range--$3,050- ``Upper range''.
$10,000''.
(a)(1)(i)............. ``$3,050-$10,000 per ``$3,050-$10,000 as
day''. adjusted annually under 45
CFR part 102 per day''.
(a)(1)(ii)............ ``Lower range--$50- ``Upper range''.
$3,000''.
(a)(1)(ii)............ ``$50-$3,000 per day'' ``$50-$3,000 as adjusted
annually under 45 CFR part
102 per day''.
(a)(2)................ ``$1,000-$10,000 per ``$1,000-$10,000 as
instance''. adjusted annually under 45
CFR part 102 per
instance''.
488.446............................ (a)(1)................ ``A minimum of $500 ``A minimum of $500 as
for''. adjusted annually under 45
CFR part 102 for''.
(a)(2)................ ``A minimum of $1,500 ``A minimum of $1,500 as
for''. adjusted annually under 45
CFR part 102 for''.
(a)(3)................ ``A minimum of $3,000 ``A minimum of $3,000 as
for''. adjusted annually under 45
CFR part 102 for''.
488.725............................ (c)................... ``not to exceed ``not to exceed $2,000 as
$2,000''. adjusted annually under 45
CFR part 102''.
488.845............................ (b)(2)(iii)........... ``shall exceed $10,000 ``will exceed $10,000 as
for''. adjusted under 45 CFR part
102 for''.
(b)(3) introductory ``upper range of ``upper range of $8,500 to
text. $8,500 to $10,000 per $10,000 as adjusted
day''. annually under 45 CFR part
102 per day''.
(b)(3)(i)............. ``$10,000 per day''... ``$10,000 as adjusted
annually under 45 CFR part
102 per day''.
(b)(3))(ii)........... ``$9,000 per day''.... ``$9,000 as adjusted
annually under 45 CFR part
102 per day''.
Page 61564
(b)(3)(iii)........... ``$8,500 per day''.... ``$8,500 as adjusted
annually under 45 CFR part
102 per day''.
(b)(4)................ ``range of $1,500- ``range of $1,500-$8,500 as
$8,500 per day''. adjusted annually under 45
CFR part 102 per day''.
(b)(5)................ ``range of $500-$4,000 ``range of $500-$4,000 as
are imposed''. adjusted annually under 45
CFR part 102 are
imposed''.
(b)(6)................ ``range of $1,000 to ``range of $1,000 to
$10,000 per instance, $10,000 as adjusted
not to exceed $10,000 annually under 45 CFR part
each day''. 102 per instance, not to
exceed $10,000 as adjusted
annually under 45 CFR part
102 each day''.
(d)(1)(ii)............ ``maximum of $10,000 ``maximum of $10,000 as
per day''. adjusted annually under 45
CFR part 102 per day''.
----------------------------------------------------------------------------------------------------------------
PART 493--LABORATORY REQUIREMENTS
0
23. The authority citation for part 493 continues to read as follows:
Authority: Sec. 353 of the Public Health Service Act, secs. 1102, 1861(e), the sentence following sections 1861(s)(11) through 1861(s)(16) of the Social Security Act (42 U.S.C. 263a, 1302, 1395x(e), the sentence following 1395x(s)(11) through 1395x(s)(16)), and the Pub. L. 112-202 amendments to 42 U.S.C. 263a.
Sec. 493.1834 Amended
0
24. Section 493.1834 is amended as follows:
0
a. In paragraph (d)(2)(i), by removing the phrase ``$3,050-$10,000 per day'' and adding in its place the phrase ``$3,050-$10,000 as adjusted annually under 45 CFR part 102 per day''; and
0
b. In paragraph (d)(2)(ii), by removing the phrase ``$50-$3,000 per day'' and adding in its place the phrase ``$50-$3,000 as adjusted annually under 45 CFR part 102 per day''.
CHAPTER V--OFFICE OF INSPECTOR GENERAL--HEALTH CARE, DEPARTMENT OF HEALTH AND HUMAN SERVICES
PART 1003--CIVIL MONEY PENALTIES, ASSESSMENTS AND EXCLUSIONS
0
25. The authority citation for part 1003 continues to read as follows:
Authority: 42 U.S.C. 262a, 1302, 1320-7, 1320a-7a, 1320b-10, 1395u(j), 1395u(k), 1395cc(j), 1395w-141(i)(3), 1395dd(d)(1), 1395mm, 1395nn(g), 1395ss(d), 1396b(m), 11131(c), and 11137(b)(2).
Sec. 1003.103 Amended
0
26. Section 1003.103 is amended:
0
a. In paragraph (c)--
0
i. By removing the footnote in paragraph (c); and
0
ii. In paragraph (c) by removing the phrase ``not more than $11,000 for each payment'' and adding in its place the phrase ``not more than $10,000 for each payment''; and
0
b. In the table below, Sec. 1003.103 is further amended in each paragraph indicated by the first column by adding the footnote in the third column after the phrase in the second column:
------------------------------------------------------------------------
Paragraph Text Add footnote
------------------------------------------------------------------------
(a)(1)........................ ``$2,000''....... ``1. This penalty
amount is updated
annually, as
adjusted in
accordance with the
Federal Civil
Monetary Penalty
Inflation Adjustment
Act of 1990 (Pub. L.
101-140), as amended
by the Federal Civil
Penalties Inflation
Adjustment Act
Improvements Act of
2015 (section 701 of
Pub. L. 114-74).
Annually adjusted
amounts are
published at 45 CFR
part 102.''
(a)(2)........................ ``$10,000''...... ``2. This penalty
amount is adjusted
annually for
inflation, and is
published at 45 CFR
part 102.''
(b)........................... ``not more than ``3. This penalty
$15,000''. amount is adjusted
annually for
inflation, and is
published at 45 CFR
part 102.''
``not more than ``4. This penalty
$100,000''. amount is adjusted
annually for
inflation, and is
published at 45 CFR
part 102.''
(c)........................... ``not more than ``5. This penalty
$10,000''. amount is adjusted
annually for
inflation, and is
published at 45 CFR
part 102.''
(d)(1)........................ ``not more than ``6. This penalty
$5,000''. amount is adjusted
annually for
inflation, and is
published at 45 CFR
part 102.''
``not more than ``7. This penalty
$25,000''. amount is adjusted
annually for
inflation, and is
published at 45 CFR
part 102.''
(e)(1)........................ ``not more than ``8. This penalty
$50,000''. amount is adjusted
annually for
inflation, and is
published at 45 CFR
part 102.''
``will not exceed ``9. This penalty
$25,000;''. amount is adjusted
annually for
inflation, and is
published at 45 CFR
part 102.''
(e)(2)........................ ``not more than ``10. This penalty
$50,000''. amount is adjusted
annually for
inflation, and is
published at 45 CFR
part 102.''
(f)(1) introductory text...... ``up to $25,000'' ``11. This penalty
amount is adjusted
annually for
inflation, and is
published at 45 CFR
part 102.''
(f)(2) introductory text...... ``up to $25,000'' ``12. This penalty
amount is adjusted
annually for
inflation, and is
published at 45 CFR
part 102.''
(f)(3) introductory text...... ``up to ``13. This penalty
$100,000''. amount is adjusted
annually for
inflation, and is
published at 45 CFR
part 102.''
(f)(5)........................ ``an additional ``14. This penalty
$15,000''. amount is adjusted
annually for
inflation, and is
published at 45 CFR
part 102.''
(g)........................... ``not more than ``15. This penalty
$25,000''. amount is adjusted
annually for
inflation, and is
published at 45 CFR
part 102.''
Page 61565
(h)(1)........................ ``not more than ``16. This penalty
$50,000''. amount is adjusted
annually for
inflation, and is
published at 45 CFR
part 102.''
(h)(2)(i)(1).................. ``$5,000''....... ``17. This penalty
amount is adjusted
annually for
inflation, and is
published at 45 CFR
part 102.''
(j)........................... ``not more than ``18. This penalty
$10,000''. amount is adjusted
annually for
inflation, and is
published at 45 CFR
part 102.''
(k)........................... ``not more than ``19. This penalty
$2,000''. amount is adjusted
annually for
inflation, and is
published at 45 CFR
part 102.''
(l)........................... ``not more than ``20. This penalty
$250,000''. amount is adjusted
annually for
inflation, and is
published at 45 CFR
part 102.''
(l)........................... ``and not more ``21. This penalty
than $500,000''. amount is adjusted
annually for
inflation, and is
published at 45 CFR
part 102.''
(m)........................... ``not more than ``22. This penalty
$10,000''. amount is adjusted
annually for
inflation, and is
published at 45 CFR
part 102.''
------------------------------------------------------------------------
Title 45--Public Welfare
Subtitle A--Department of Health and Human Services
PART 79--PROGRAM FRAUD CIVIL PENALTIES
0
27. The authority for part 79 continues to read as follows:
Authority: 31 U.S.C. 3801-3812.
0
28. In Sec. 79.3, paragraph (a)(1)(iv) is amended by revising footnote 1 and paragraph (b)(1)(ii) is amended by revising footnote 2 to read as follows:
Sec. 79.3 Basis for civil penalties and assessments.
(a) * * *
(1) * * *
(iv) * * *
\1\ The amounts specified in this section are updated annually, as adjusted in accordance with the Federal Civil Monetary Penalty Inflation Adjustment Act of 1990 (Pub. L. 101-140), as amended by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (section 701 of Pub. L. 114-74). Annually adjusted amounts are published at 45 CFR part 102.
* * * * *
(b) * * *
(1) * * *
(ii) * * *
\2\ The amounts specified in this section are updated annually, as adjusted in accordance with the Federal Civil Monetary Penalty Inflation Adjustment Act of 1990 (Pub. L. 101-140), as amended by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (section 701 of Pub. L. 114-74). Annually adjusted amounts are published at 45 CFR part 102.
* * * * *
PART 93--NEW RESTRICTIONS ON LOBBYING
0
29. The authority for part 93 continues to read as follows:
Authority: Section 319, Public Law 101-121 (31 U.S.C. 1352); (5 U.S.C. 301).
0
30. Section Sec. 93.400 is amended in paragraph (a) by adding a footnote at the end of the phrase ``not less than $10,000 and not more than $100,000'' to read as follows:
Sec. 93.400 Penalties.
(a) * * *
\1\ The amounts specified in this section are updated annually, as adjusted in accordance with the Federal Civil Monetary Penalty Inflation Adjustment Act of 1990 (Pub. L. 101-140), as amended by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (section 701 of Pub. L. 114-74). Annually adjusted amounts are published at 45 CFR part 102.
* * * * *
0
31. Appendix A to part 93 is amended in the undesignated paragraph following paragraph (3), under ``Certification for Contracts, Grants, Loans, and Cooperative Agreements,'' by adding a footnote at the end of the phrase ``of not less than $10,000 and not more than 100,000'' to read as follows:
Appendix A--Certification Regarding Lobbying
Certification for Contracts, Grants, Loans, and Cooperative Agreements
* * * * *
(3) * * *
\1\ The amounts specified in Appendix A to Part 93 are updated annually, as adjusted in accordance with the Federal Civil Monetary Penalty Inflation Adjustment Act of 1990 (Pub. L. 101-140), as amended by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (section 701 of Pub. L. 114-74). Annually adjusted amounts are published at 45 CFR part 102.
* * * * *
0
32. Part 102 is added to subchapter A to read as follows:
PART 102--ADJUSTMENT OF CIVIL MONETARY PENALTIES FOR INFLATION
Sec.
102.1 Applicability.
102.2 Applicability date.
102.3 Penalty adjustment and table.
Authority: Public Law 101-410, Sec. 701 of Public Law 114-74, 31 U.S.C. 3801-3812.
Sec. 102.1 Applicability.
This part applies to each statutory provision under the laws administered by the Department of Health and Human Services concerning the civil monetary penalties which may be assessed or enforced by an agency pursuant to Federal law or is assessed or enforced pursuant to civil judicial actions in the Federal courts or administrative proceedings. The regulations cited in this part supersede existing HHS regulations setting forth civil monetary penalty amounts. If applicable, the HHS agencies responsible for specific civil monetary penalties will amend their regulations to reflect the adjusted amounts and/or a cross-reference to 45 CFR part 102 in separate actions as soon as practicable.
Sec. 102.2 Applicability date.
The increased penalty amounts set forth in the right-most column of the table in Section 102.3, ``Maximum Adjusted Penalty ($)'', apply to all civil monetary penalties which are assessed after August 1, 2016, including those penalties whose associated violations occurred after November 2, 2015.
Sec. 102.3 Penalty adjustment and table.
The adjusted statutory penalty provisions and their applicable amounts are set out in the following table. The right-most column in the table, ``Maximum Adjusted Penalty ($)'', provides the maximum adjusted civil penalty amounts. The civil monetary penalty amounts are adjusted annually.
Page 61566
Civil Monetary Penalty Authorities Administered by HHS Agencies and Penalty Amounts
Effective September 6, 2016
--------------------------------------------------------------------------------------------------------------------------------------------------------
Citation Date of
-------------------------------------------------------------- last Pre- Maximum
penalty inflation adjusted
HHS agency Description \2\ figure or penalty penalty
U.S.C. CFR \1\ adjustment ($) ($)
\3\
--------------------------------------------------------------------------------------------------------------------------------------------------------
21 U.S.C.:
333(b)(2)(A).................... ....................... FDA Penalty for violations related 1988 50,000 98,935
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 related to 1988 1,000,000 1,978,690
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 make a 1988 100,000 197,869
report required by 21 U.S.C.
353(d)(3)(E) relating to drug
samples.
333(f)(1)(A).................... ....................... FDA Penalty for any person who 1990 15,000 26,723
violates a requirement related
to devices for each such
violation.
Penalty for aggregate of all 1990 1,000,000 1,781,560
violations related to devices
in a single proceeding.
333(f)(2)(A).................... ....................... FDA Penalty for any individual who 1996 50,000 75,123
introduces or delivers for
introduction into interstate
commerce food that is
adulterated per 21 U.S.C.
342(a)(2)(B) or any individual
who does not comply with a
recall order under 21 U.S.C.
350l.
Penalty in the case of any other 1996 250,000 375,613
person other than an
individual) for such
introduction or delivery of
adulterated food.
Penalty for aggregate of all 1996 500,000 751,225
such violations related to
adulterated food adjudicated in
a single proceeding.
333(f)(3)(A).................... ....................... FDA Penalty for all violations 2007 10,000 11,383
adjudicated in a single
proceeding for any person who
fails to submit certification
required by 42 U.S.C.
282(j)(5)(B) or knowingly
submitting a false
certification.
333(f)(3)(B).................... ....................... FDA Penalty for each day the above 2007 10,000 11,383
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 responsible 2007 250,000 284,583
person that violates a
requirement of 21 U.S.C. 355(o)
(post-marketing studies,
clinical trials, labeling), 21
U.S.C. 355(p) (risk evaluation
and mitigation (REMS)), or 21
U.S.C. 355-1 (REMS).
Penalty for aggregate of all 2007 1,000,000 1,138,330
such above violations in a
single proceeding.
333(f)(4)(A)(ii)................ ....................... FDA Penalty for REMS violation that 2007 250,000 284,583
continues after written notice
to the responsible person for
the first 30-day period (or any
portion thereof) the
responsible person continues to
be in violation.
Penalty for REMS violation that 2007 1,000,000 1,138,330
continues after written notice
to responsible person doubles
for every 30-day period
thereafter the violation
continues, but may not exceed
penalty amount for any 30-day
period.
Penalty for aggregate of all 2007 10,000,000 11,383,300
such above violations
adjudicated in a single
proceeding.
333(f)(9)(A).................... ....................... FDA Penalty for any person who 2009 15,000 16,503
violates a requirement which
relates to tobacco products for
each such violation.
Penalty for aggregate of all 2009 1,000,000 1,100,200
such violations of tobacco
product requirement adjudicated
in a single proceeding.
333(f)(9)(B)(i)(I).............. ....................... FDA Penalty per violation related to 2009 250,000 275,050
violations of tobacco
requirements.
Penalty for aggregate of all 2009 1,000,000 1,100,200
such violations of tobacco
product requirements
adjudicated in a single
proceeding.
333(f)(9)(B)(i)(II)............. ....................... FDA Penalty in the case of a 2009 250,000 275,050
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.
Page 61567
Penalty for violation of tobacco 2009 1,000,000 1,100,200
product requirements that
continues after written notice
to such person shall double for
every 30-day period thereafter
the violation continues, but
may not exceed penalty amount
for any 30-day period.
Penalty for aggregate of all 2009 10,000,000 11,002,000
such violations related to
tobacco product requirements
adjudicated in a single
proceeding.
333(f)(9)(B)(ii)(I)............. ....................... FDA Penalty for any person who 2009 250,000 275,050
either does not conduct post-
market surveillance and studies
to determine impact of a
modified risk tobacco product
for which the HHS Secretary has
provided them an order to sell,
or who does not submit a
protocol to the HHS Secretary
after being notified of a
requirement to conduct post-
market surveillance of such
tobacco products.
Penalty for aggregate of for all 2009 1,000,000 1,100,200
such above violations
adjudicated in a single
proceeding.
333(f)(9)(B)(ii)(II)............ ....................... FDA Penalty for violation of 2009 250,000 275,050
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 2009 1,000,000 1,100,200
violation of modified risk
tobacco product post-market
surveillance shall double for
every 30-day period thereafter
that the tobacco product
requirement violation continues
for any 30-day period, but may
not exceed penalty amount for
any 30-day period.
Penalty for aggregate above 2009 10,000,000 11,002,000
tobacco product requirement
violations adjudicated in a
single proceeding.
333(g)(1)....................... ....................... FDA Penalty for any person who 2007 250,000 284,583
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 subsequent 2007 500,000 569,165
above violation in any 3-year
period.
333 note........................ ....................... FDA Penalty to be applied for 2009 250 275
violations of restrictions on
the sale or distribution of
tobacco products promulgated
under 21 U.S.C. 387f(d) (e.g.,
violations of regulations in 21
CFR Part 1140) with respect to
a retailer with an approved
training program in the case of
a second regulation violation
within a 12-month period.
Penalty in the case of a third 2009 500 550
tobacco product regulation
violation within a 24-month
period.
Penalty in the case of a fourth 2009 2,000 2,200
tobacco product regulation
violation within a 24-month
period.
Penalty in the case of a fifth 2009 5,000 5,501
tobacco product regulation
violation within a 36-month
period.
Penalty in the case of a sixth 2009 10,000 11,002
or subsequent tobacco product
regulation violation within a
48-month period as determined
on a case-by-case basis.
Penalty to be applied for 2009 250 275
violations of restrictions on
the sale or distribution of
tobacco products promulgated
under 21 U.S.C. 387f(d) (e.g.,
violations of regulations in 21
CFR Part 1140) with respect to
a retailer that does not have
an approved training program in
the case of the first
regulation violation.
Penalty in the case of a second 2009 500 550
tobacco product regulation
violation within a 12-month
period.
Page 61568
Penalty in the case of a third 2009 1,000 1,100
tobacco product regulation
violation within a 24-month
period.
Penalty in the case of a fourth 2009 2,000 2,200
tobacco product regulation
violation within a 24-month
period.
Penalty in the case of a fifth 2009 5,000 5,501
tobacco product regulation
violation within a 36-month
period.
Penalty in the case of a sixth 2009 10,000 11,002
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 violation for 1992 250,000 419,320
any individual who made a false
statement or misrepresentation
of a material fact, bribed,
destroyed, altered, removed, or
secreted, or procured the
destruction, alteration,
removal, or secretion of, any
material document, failed to
disclose a material fact,
obstructed an investigation,
employed a consultant who was
debarred, debarred individual
provided consultant services.
Penalty in the case of any other 1992 1,000,000 1,677,280
person (other than an
individual) per above violation.
360pp(b)(1)..................... ....................... FDA Penalty for any person who 1968 1,100 2,750
violates any such requirements
for electronic products, with
each unlawful act or omission
constituting a separate
violation.
Penalty imposed for any related 1968 375,000 937,500
series of violations of
requirements relating to
electronic products.
42 U.S.C.:
262(d).......................... ....................... FDA Penalty per day for violation of 1986 100,000 215,628
order of recall of biological
product presenting imminent or
substantial hazard.
263b(h)(3)...................... ....................... FDA Penalty for failure to obtain a 1992 10,000 16,773
mammography certificate as
required.
300aa-28(b)(1).................. ....................... FDA Penalty per occurrence for any 1986 100,000 215,628
vaccine manufacturer that
intentionally destroys, alters,
falsifies, or conceals any
record or report required.
256b(d)(1)(B)(vi)............... ....................... HRSA Penalty for each instance of 2010 5,000 5,437
overcharging a 340B covered
entity.
299c-(3)(d)..................... ....................... AHRQ Penalty for an establishment or 1999 10,000 14,140
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 1998 1,000 1,450
Information in the National
Directory of New Hires.
262a(i)(1)...................... 42 CFR Part 1003....... OIG Penalty for each individual who 2002 250,000 327,962
violates safety and security
procedures related to handling
dangerous biological agents and
toxins.
Penalty for any other person who 2002 500,000 655,925
violates safety and security
procedures related to handling
dangerous biological agents and
toxins..
1320a-7a(a)..................... 42 CFR Part 1003....... OIG Penalty for knowingly presenting 1996 10,000 15,024
or causing to be presented to
an officer, employee, or agent
of the United States a false
claim.
Penalty for knowingly presenting 1996 10,000 15,024
or causing to be presented a
request for payment which
violates the terms of an
assignment, agreement, or PPS
agreement.
Penalty for knowingly giving or 1996 15,000 22,537
causing to be presented to a
participating provider or
supplier false or misleading
information that could
reasonably be expected to
influence a discharge decision.
Penalty for an excluded party 1996 10,000 15,024
retaining ownership or control
interest in a participating
entity.
Penalty for remuneration offered 1996 10,000 15,024
to induce program beneficiaries
to use particular providers,
practitioners, or suppliers.
Page 61569
Penalty for employing or 1997 10,000 14,718
contracting with an excluded
individual.
Penalty for knowing and willful 1997 50,000 73,588
solicitation, receipt, offer,
or payment of remuneration for
referring an individual for a
service or for purchasing,
leasing, or ordering an item to
be paid for by a Federal health
care program.
Penalty for ordering or 2010 10,000 10,874
prescribing medical or other
item or service during a period
in which the person was
excluded.
Penalty for knowingly making or 2010 50,000 54,372
causing to be made a false
statement, omission or
misrepresentation of a material
fact in any application, bid,
or contract to participate or
enroll as a provider or
supplier.
Penalty for knowing of an 2010 10,000 10,874
overpayment and failing to
report and return.
Penalty for making or using a 2010 50,000 54,372
false record or statement that
is material to a false or
fraudulent claim.
Penalty for failure to grant 2010 15,000 16,312
timely access to HHS OIG for
audits, investigations,
evaluations, and other
statutory functions of HHS OIG.
1320a-7a(b)..................... 42 CFR Part 1003....... OIG Penalty for payments by a 1986 2,000 4,313
hospital or critical access
hospital to induce a physician
to reduce or limit services to
individuals under direct care
of physician or who are
entitled to certain medical
assistance benefits.
Penalty for physicians who 1986 2,000 4,313
knowingly receive payments from
a hospital or critical access
hospital to induce such
physician to reduce or limit
services to individuals under
direct care of physician or who
are entitled to certain medical
assistance benefits.
Penalty for a physician who 1996 5,000 7,512
executes a document that
falsely certifies home health
needs for Medicare
beneficiaries.
1320a-7e(b)(6)(A)............... 42 CFR Part 1003....... OIG Penalty for failure to report 1997 25,000 36,794
any final adverse action taken
against a health care provider,
supplier, or practitioner.
1320b-10(b)(1).................. 42 CFR Part 1003....... OIG Penalty for the misuse of words, 1988 5,000 9,893
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 Part 1003....... OIG Penalty for the misuse of words, 1988 25,000 49,467
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)......... ....................... OIG Penalty for certification of a 1987 1,000 2,063
false statement in assessment
of functional capacity of a
Skilled Nursing Facility
resident assessment.
1395i-3(b)(3)(B)(ii)(2)......... ....................... OIG Penalty for causing another to 1987 5,000 10,314
certify or make a false
statement in assessment of
functional capacity of a
Skilled Nursing Facility
resident assessment.
1395i-3(g)(2)(A)................ ....................... OIG Penalty for any individual who 1987 2,000 4,126
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 422.752; 42 CFR OIG Penalty for a Medicare Advantage 1996 25,000 37,561
Part 1003. organization that substantially
fails to provide medically
necessary, required items and
services.
Penalty for a Medicare Advantage 1997 25,000 36,794
organization that charges
excessive premiums.
Penalty for a Medicare Advantage 1997 25,000 36,794
organization that improperly
expels or refuses to reenroll a
beneficiary.
Penalty for a Medicare Advantage 1997 100,000 147,177
organization that engages in
practice that would reasonably
be expected to have the effect
of denying or discouraging
enrollment.
Page 61570
Penalty per individual who does 1997 15,000 22,077
not enroll as a result of a
Medicare Advantage
organization's practice that
would reasonably be expected to
have the effect of denying or
discouraging enrollment.
Penalty for a Medicare Advantage 1997 100,000 147,177
organization misrepresenting or
falsifying information to
Secretary.
Penalty for a Medicare Advantage 1997 25,000 36,794
organization misrepresenting or
falsifying information to
individual or other entity.
Penalty for Medicare Advantage 1997 25,000 36,794
organization interfering with
provider's advice to enrollee
and non-MCO affiliated
providers that balance bill
enrollees.
Penalty for a Medicare Advantage 1997 25,000 36,794
organization that employs or
contracts with excluded
individual or entity.
Penalty for a Medicare Advantage 2010 25,000 36,794
organization enrolling an
individual in without prior
written consent.
Penalty for a Medicare Advantage 2010 25,000 36,794
organization transferring an
enrollee to another plan
without consent or solely for
the purpose of earning a
commission.
Penalty for a Medicare Advantage 2010 25,000 36,794
organization failing to comply
with marketing restrictions or
applicable implementing
regulations or guidance.
Penalty for a Medicare Advantage 2010 25,000 36,794
organization employing or
contracting with an individual
or entity who violates 1395w-
27(g)(1)(A)-(J).
1395w-141(i)(3)................. 42 CFR Part 1003....... OIG Penalty for a prescription drug 2003 10,000 12,856
card sponsor that falsifies or
misrepresents marketing
materials, overcharges program
enrollees, or misuse
transitional assistance funds.
1395cc(g)....................... 42 CFR Part 1003....... OIG Penalty for improper billing by 1972 2,000 5,000
Hospitals, Critical Access
Hospitals, or Skilled Nursing
Facilities.
1395dd(d)(1).................... 42 CFR Part 1003....... OIG Penalty for a hospital or 1987 50,000 103,139
responsible physician dumping
patients needing emergency
medical care, if the hospital
has 100 beds or more.
Penalty for a hospital or 1987 25,000 51,570
responsible physician dumping
patients needing emergency
medical care, if the hospital
has less than 100 beds.
1395mm(i)(6)(B)(i).............. 42 CFR Part 1003....... OIG Penalty for a HMO or competitive 1987 25,000 51,570
plan is such plan substantially
fails to provide medically
necessary, required items or
services.
Penalty for HMOs/competitive 1987 25,000 51,570
medical plans that charge
premiums in excess of permitted
amounts.
Penalty for a HMO or competitive 1987 25,000 51,570
medical plan that expels or
refuses to reenroll an
individual per prescribed
conditions.
Penalty for a HMO or competitive 1987 100,000 206,278
medical plan that implements
practices to discourage
enrollment of individuals
needing services in future.
Penalty per individual not 1988 15,000 29,680
enrolled in a plan as a result
of a HMO or competitive medical
plan that implements practices
to discourage enrollment of
individuals needing services in
the future.
Penalty for a HMO or competitive 1987 100,000 206,278
medical plan that misrepresents
or falsifies information to the
Secretary.
Penalty for a HMO or competitive 1987 25,000 51,570
medical plan that misrepresents
or falsifies information to an
individual or any other entity.
Penalty for failure by HMO or 1987 25,000 51,570
competitive medical plan to
assure prompt payment of
Medicare risk sharing contracts
or incentive plan provisions.
Page 61571
Penalty for HMO that employs or 1989 25,000 47,340
contracts with excluded
individual or entity.
1395nn(g)(3).................... 42 CFR Part 1003....... OIG Penalty for submitting or 1994 15,000 23,863
causing to be submitted claims
in violation of the Stark Law's
restrictions on physician self-
referrals.
1395nn(g)(4).................... 42 CFR Part 1003....... OIG Penalty for circumventing Stark 1994 100,000 159,089
Law's restrictions on physician
self-referrals.
1395ss(d)(1).................... 42 CFR Part 1003....... OIG Penalty for a material 1988 5,000 9,893
misrepresentation regarding
Medigap compliance policies.
1395ss(d)(2).................... 42 CFR Part 1003....... OIG Penalty for selling Medigap 1988 5,000 9,893
policy under false pretense.
1395ss(d)(3)(A)(ii)............. 42 CFR Part 1003....... OIG Penalty for an issuer that sells 1990 25,000 44,539
health insurance policy that
duplicates benefits.
Penalty for someone other than 1990 15,000 26,723
issuer that sells health
insurance that duplicates
benefits.
1395ss(d)(4)(A)................. 42 CFR Part 1003....... OIG Penalty for using mail to sell a 1988 5,000 9,893
non-approved Medigap insurance
policy.
1396b(m)(5)(B)(i)............... 42 CFR Part 1003....... OIG Penalty for a Medicaid MCO that 1988 25,000 49,467
substantially fails to provide
medically necessary, required
items or services.
Penalty for a Medicaid MCO that 1988 25,000 49,467
charges excessive premiums.
Penalty for a Medicaid MCO that 1988 100,000 197,869
improperly expels or refuses to
reenroll a beneficiary.
Penalty per individual who does 1988 15,000 29,680
not enroll as a result of a
Medicaid MCO's practice that
would reasonably be expected to
have the effect of denying or
discouraging enrollment.
Penalty for a Medicaid MCO 1988 100,000 197,869
misrepresenting or falsifying
information to the Secretary.
Penalty for a Medicaid MCO 1988 25,000 49,467
misrepresenting or falsifying
information to an individual or
another entity.
Penalty for a Medicaid MCO that 1990 25,000 44,539
fails to comply with contract
requirements with respect to
physician incentive plans.
1396r(b)(3)(B)(ii)(I)........... 42 CFR Part 1003....... OIG Penalty for willfully and 1987 1,000 2,063
knowingly certifying a material
and false statement in a
Skilled Nursing Facility
resident assessment.
1396r(b)(3)(B)(ii)(II).......... 42 CFR Part 1003....... OIG Penalty for willfully and 1987 5,000 10,314
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 Part 1003....... OIG Penalty for notifying or causing 1987 2,000 4,126
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 Part 1003....... OIG Penalty for the knowing 1990 100,000 178,156
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 Part 1003....... Penalty per day for failure to 1990 10,000 17,816
timely provide information by
drug manufacturer with rebate
agreement.
1396r-8(b)(3)(C)(ii)............ 42 CFR Part 1003....... Penalty for knowing provision of 1990 100,000 178,156
false information by drug
manufacturer with rebate
agreement.
1396t(i)(3)(A).................. 42 CFR Part 1003....... OIG Penalty for notifying home and 1990 2,000 3,563
community-based providers or
settings of survey.
11131(c)........................ 42 CFR Part 1003....... OIG Penalty for failing to report a 1986 10,000 21,563
medical malpractice claim to
National Practitioner Data Bank.
11137(b)(2)..................... 42 CFR Part 1003....... OIG Penalty for breaching 1986 10,000 21,563
confidentiality of information
reported to National
Practitioner Data Bank.
299b-22(f)(1)................... 42 CFR 3.404........... OCR Penalty for violation of 2005 10,000 11,940
confidentiality provision of
the Patient Safety and Quality
Improvement Act.
1320(d)-5(a).................... 45 CFR OCR Penalty for each pre-February 1996 100 150
160.404(b)(1)(i),(ii). 18, 2009 violation of the HIPAA
administrative simplification
provisions.
Calendar Year Cap............ 1996 25,000 37,561
Page 61572
1320(d)-5(a).................... 45 CFR OCR Penalty for each February 18,
160.404(b)(2)(i)(A), 2009 or later violation of a
(B). 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...................... 2009 100 110
Maximum...................... 2009 50,000 55,010
Calendar Year Cap............ 2009 1,500,000 1,650,300
45 CFR OCR Penalty for each February 18,
160.404(b)(2)(ii)(A), 2009 or later violation of a
(B). HIPAA administrative
simplification provision in
which it is established that
the violation was due to
reasonable cause and not to
willful neglect:
Minimum...................... 2009 1,000 1,100
Maximum...................... 2009 50,000 55,010
Calendar Year Cap............ 2009 1,500,000 1,650,300
45 CFR OCR Penalty for each February 18,
160.404(b)(2)(iii)(A), 2009 or later violation of a
(B). 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...................... 2009 10,000 11,002
Maximum...................... 2009 50,000 55,010
Calendar Year Cap............ 2009 1,500,000 1,650,300
45 CFR OCR Penalty for each February 18,
160.404(b)(2)(iv)(A), 2009 or later violation of a
(B). 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...................... 2009 50,000 55,010
Maximum...................... 2009 1,500,000 1,650,300
Calendar Year Cap............ 2009 1,500,000 1,650,300
263a(h)(2)(B) & 1395w- 42 CFR CMS Penalty for a clinical
2(b)(2)(A)(ii). 493.1834(d)(2)(i). laboratory's failure to meet
participation and certification
requirements and poses
immediate jeopardy:
Minimum...................... 1988 3,050 6,035
Maximum...................... 1988 10,000 19,787
42 CFR CMS Penalty for a clinical
493.1834(d)(2)(ii). laboratory's failure to meet
participation and certification
requirements and the failure
does not pose immediate
jeopardy:
Minimum...................... 1988 50 99
Maximum...................... 1988 3,000 5,936
300gg-15(f)..................... 45 CFR 147.200(e)...... CMS Failure to provide the Summary 2010 1,000 1,087
of Benefits and Coverage.
300gg-18........................ 45 CFR 158.606......... CMS Penalty for violations of 2010 100 109
regulations related to the
medical loss ratio reporting
and rebating.
1320a-7h(b)(1).................. 42 CFR 402.105(d)(5); CMS Penalty for manufacturer or
42 CFR 403.912(a) & group purchasing organization
(c). failing to report information
required under 42 U.S.C. 1320a-
7h(a), relating to physician
ownership or investment
interests:
Minimum...................... 2010 1,000 1,087
Maximum...................... 2010 10,000 10,874
Calendar Year Cap............ 2010 150,000 163,117
1320a-7h(b)(2).................. 42 CFR 402.105(h); 42 CMS Penalty for manufacturer or
CFR 403 912(b) & (c). 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...................... 2010 10,000 10,874
Maximum...................... 2010 100,000 108,745
Calendar Year Cap............ 2010 1,000,000 1,087,450
Page 61573
1320a-7j(h)(3)(A)............... ....................... CMS Penalty for an administrator of 2010 100,000 108,745
a facility that fails to comply
with notice requirements for
the closure of a facility.
42 CFR CMS Minimum penalty for the first 2010 500 544
488.446(a)(1),(2), & offense of an administrator who
(3). fails to provide notice of
facility closure.
Minimum penalty for the second 2010 1,500 1,631
offense of an administrator who
fails to provide notice of
facility closure.
Minimum penalty for the third 2010 3,000 3,262
and subsequent offenses of an
administrator who fails to
provide notice of facility
closure.
1320a-8(a)(1)................... ....................... CMS Penalty for an entity knowingly 1994 5,000 7,954
making a false statement or
representation of material fact
in the determination of the
amount of benefits or payments
related to old-age, survivors,
and disability insurance
benefits, special benefits for
certain World War II veterans,
or supplemental security income
for the aged, blind, and
disabled.
Penalty for violation of 42 2015 7,500 7,500
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 representative 2004 5,000 6,229
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 covered 2010 200,000 217,490
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 covered 2010 300,000 326,235
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 care 2010 200,000 217,490
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 person who 1997 100 147
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 a Skilled
488.408(d)(1)(iii). Nursing Facility that has a
Category 2 violation of
certification requirements:
Minimum...................... 1987 50 103
Maximum...................... 1987 3,000 6,188
42 CFR CMS Penalty per instance of Category
488.408(d)(1)(iv). 2 noncompliance by a Skilled
Nursing Facility:
Minimum...................... 1987 1,000 2,063
Maximum...................... 1987 10,000 20,628
42 CFR CMS Penalty per day for a Skilled
488.408(e)(1)(iii). Nursing Facility that has a
Category 3 violation of
certification requirements:
Minimum...................... 1987 3,050 6,291
Maximum...................... 1987 10,000 20,628
42 CFR CMS Penalty per instance of Category
488.408(e)(1)(iv). 3 noncompliance by a Skilled
Nursing Facility:
Minimum...................... 1987 1,000 2,063
Maximum...................... 1987 10,000 20,628
Page 61574
42 CFR CMS Penalty per day and per instance
488.408(e)(2)(ii). for a Skilled Nursing Facility
that has Category 3
noncompliance with Immediate
Jeopardy:
Per Day (Minimum)............ 1987 3,050 6,291
Per Day (Maximum)............ 1987 10,000 20,628
Per Instance (Minimum)....... 1987 1,000 2,063
Per Instance (Maximum)....... 1987 10,000 20,628
42 CFR 488.438(a)(1)(i) CMS Penalty per day of a Skilled
Nursing Facility that fails to
meet certification
requirements. These amounts
represent the upper range per
day:
Minimum...................... 1987 3,050 6,291
Maximum...................... 1987 10,000 20,628
42 CFR CMS Penalty per day of a Skilled
488.438(a)(1)(ii). Nursing Facility that fails to
meet certification
requirements. These amounts
represent the lower range per
day:
Minimum...................... 1987 50 103
Maximum...................... 1987 3,000 6,188
42 CFR 488.438(a)(2)... CMS Penalty per instance of a
Skilled Nursing Facility that
fails to meet certification
requirements:
Minimum...................... 1987 1,000 2,063
Maximum...................... 1987 10,000 20,628
1395l(h)(5)(D).................. 42 CFR 402.105(d)(2)(i) CMS Penalty for knowingly, 1996 10,000 15,024
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 and 1988 2,000 3,957
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 and 1989 2,000 3,787
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 medical 1996 10,000 15,024
402.105(d)(2)(ii). equipment supplier that
knowingly and willfully charges
for a covered service that is
furnished on a rental basis
after the rental payments may
no longer be made. (Penalties
are assessed in the same manner
as 42 U.S.C. 1395u(j)(2)(B),
which is assessed according to
1320a-7a(a)).
1395m(a)(18)(B)................. 42 CFR 402.1(c)(5), CMS Penalty for any nonparticipating 1996 10,000 15,024
402.105(d)(2)(iii). 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 nonparticipating 1996 10,000 15,024
402.105(d)(2)(iv). 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 of 1996 10,000 15,024
402.105(d)(2)(vi). 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 61575
1395m(j)(2)(A)(iii)............. ....................... CMS Penalty for any supplier of 1994 1,000 1,591
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 of 1996 10,000 15,024
402.105(d)(2)(vii). 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 or entity 1996 10,000 15,024
402.105(d)(3). 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 of 1996 10,000 15,024
402.105(d)(4). ambulance services who
knowingly and willfully fills
or collects for any services on
other than an assignment-
related basis. (Penalties are
assessed in the same manner as
42 U.S.C. 1395u(b)(18)(B),
which is assessed according to
1320a-7a(a)).
1395u(b)(18)(B)................. 42 CFR 402.1(c)(11), CMS Penalty for any practitioner 1996 10,000 15,024
402.105(d)(2)(viii). 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).................. 42 CFR 402.1(c)........ CMS Penalty for any physician who 1996 10,000 15,024
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 physician who 1996 10,000 15,024
402.105(d)(2)(ix). 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 nonparticipating 1996 10,000 15,024
402.105(d)(2)(x). 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)).
Page 61576
1395u(m)(3)..................... 42 CFR 402.1(c)(14), CMS Penalty for any nonparticipating 1996 10,000 15,024
402.105(d)(2)(xi). 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 physician who 1996 10,000 15,024
402.105(d)(2)(xii). 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 practitioner 1996 10,000 15,024
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 physician or 1988 2,000 3,957
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 pharmaceutical 2003 10,000 12,856
manufacturer's
misrepresentation of average
sales price of a drug, or
biologic.
1395w-4(g)(1)(B)................ 42 CFR 402.1(c)(17), CMS Penalty for any nonparticipating 1996 10,000 15,024
402.105(d)(2)(xiii). 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 that 1996 10,000 15,024
402.105(d)(2)(xiv). 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 termination 1997 25,000 36,794
CFR 423.760(b). 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 week beginning 1997 10,000 14,718
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 Medicare Advantage 2000 100,000 136,689
organization's or Part D
sponsor's early termination of
its contract.
Page 61577
1395y(b)(3)(C).................. 42 CFR 411.103(b)...... CMS Penalty for an employer or other 1990 5,000 8,908
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-governmental 1998 1,000 1,450
CFR 402.105(b)(2). employer that, before October
1, 1998, willfully or
repeatedly failed to provide
timely and accurate information
requested relating to an
employee's group health
insurance coverage.
1395y(b)(6)(B).................. 42 CFR 402.1(c)(21), CMS Penalty for any entity that 1994 2,000 3,182
402.105(a). knowingly, willfully, and
repeatedly fails to complete a
claim form relating to the
availability of other health
benefits in accordance with
statute or provides inaccurate
information relating to such on
the claim form.
1395y(b)(7)(B)(i)............... ....................... CMS Penalty for any entity serving 2007 1,000 1,138
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-group health 2007 1,000 1,138
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 that 1989 10,000 18,936
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 durable medical 1996 10,000 15,024
402.105(d)(2)(xv). equipment supplier, including a
supplier of prosthetic devices,
prosthetics, orthotics, or
supplies, that knowingly and
willfully fails to make refunds
in a timely manner to Medicare
beneficiaries under certain
conditions. (42 U.S.C.
1395(m)(18) sanctions apply
here in the same manner, which
is under 1395u(j)(2) and 1320a-
7a(a)).
1395ss(a)(2).................... 42 CFR 402.1(c)(24), CMS Penalty for any person that 1987 25,000 51,569
405.105(f)(1). issues a Medicare supplemental
policy that has not been
approved by the State
regulatory program or does not
meet Federal standards after a
statutorily defined effective
date.
1395ss(d)(3)(A)(vi)(II)......... ....................... CMS Penalty for someone other than 1990 15,000 26,723
issuer that sells or issues a
Medicare supplemental policy to
beneficiary without a
disclosure statement.
Penalty for an issuer that sells 1990 25,000 44,539
or issues a Medicare
supplemental policy without
disclosure statement.
1395ss(d)(3)(B)(iv)............. ....................... CMS Penalty for someone other than 1990 15,000 26,723
issuer that sells or issues a
Medicare supplemental policy
without acknowledgement form.
Penalty for issuer that sells or 1990 25,000 44,539
issues a Medicare supplemental
policy without an
acknowledgement form.
1395ss(p)(8).................... 42 CFR 402.1(c)(25), CMS Penalty for any person that 1990 15,000 26,723
402.105(e). 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 that 1990 25,000 44,539
405.105(f)(2). sells or issues Medicare
supplemental polices after a
given date that fail to conform
to the NAIC or Federal
standards established by
statute.
1395ss(p)(9)(C)................. 42 CFR 402.1(c)(26), CMS Penalty for any person that 1990 15,000 26,723
402.105(e). sells a Medicare supplemental
policy and fails to make
available for sale the core
group of basic benefits when
selling other Medicare
supplemental policies with
additional benefits or fails to
provide the individual, before
selling the policy, an outline
of coverage describing benefits.
Page 61578
42 CFR 402.1(c)(26), Penalty for any person that 1990 25,000 44,539
405.105(f)(3), (4). 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 that 1990 25,000 44,539
405.105(f)(5). fails to suspend the policy of
a policyholder made eligible
for medical assistance or
automatically reinstates the
policy of a policyholder who
has lost eligibility for
medical assistance, under
certain circumstances.
1395ss(r)(6)(A)................. 42 CFR 402.1(c)(28), CMS Penalty for any person that 1990 25,000 44,539
405.105(f)(6). 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 of a 1990 5,000 18,908
405.105(c). Medicare supplemental policy
that does not waive listed time
periods if they were already
satisfied under a proceeding
Medicare supplemental policy,
or denies a policy, or
conditions the issuances or
effectiveness of the policy, or
discriminates in the pricing of
the policy base on health
status or other specified
criteria.
1395ss(t)(2).................... 42 CFR 402.1(c)(30), CMS Penalty for any issuer of a 1990 25,000 44,539
405.105(f)(7). Medicare supplemental policy
that fails to fulfill listed
responsibilities.
1395ss(v)(4)(A)................. ....................... CMS Penalty someone other than 2003 15,000 19,284
issuer who sells, issues, or
renews a medigap Rx policy to
an individual who is a Part D
enrollee.
Penalty for an issuer who sells, 2003 25,000 32,140
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 individual who 1987 2,000 4,126
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 penalty amount for 1988 10,000 19,787
488.845(b)(2)(iii); 42 each day a home health agency
CFR 488.845(b)(3)-(6); is not in compliance with
and 42 CFR statutory requirements.
488.845(d)(1)(ii).
42 CFR 488.845(b)(3)... ................ Penalty per day for home health
agency's noncompliance (Upper
Range):
Minimum...................... 1988 8,500 16,819
Maximum...................... 1988 10,000 19,787
42 CFR 488.845(b)(3)(i) Penalty for a home health 1988 10,000 19,787
agency's deficiency or
deficiencies that cause
immediate jeopardy and result
in actual harm.
42 CFR Penalty for a home health 1988 9,000 17,808
488.845(b)(3)(ii). agency's deficiency or
deficiencies that cause
immediate jeopardy and result
in potential for harm.
42 CFR Penalty for an isolated incident 1988 8,500 16,819
488.845(b)(3)(iii). 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...................... 1988 1,500 2,968
Maximum...................... 1988 8,500 16,819
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...................... 1988 500 989
Maximum...................... 1988 4,000 7,915
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:
Page 61579
Minimum...................... 1988 1,000 1,979
Maximum...................... 1988 10,000 19,787
Penalty for each day of 1988 10,000 19,787
noncompliance (Maximum).
42 CFR Penalty for each day of 1988 10,000 19,787
488.845(d)(1)(ii). 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...................... 1997 15,000 22,077
Maximum...................... 1997 100,000 147,177
Penalty for a PACE organization 1997 25,000 36,794
that charges excessive premiums.
Penalty for a PACE organization 1997 100,000 147,177
misrepresenting or falsifying
information to CMS, the State,
or an individual or other
entity.
Penalty for each determination 1997 25,000 36,794
the CMS makes that the PACE
organization has failed to
provide medically necessary
items and services of the
failure has adversely affected
(or has the substantial
likelihood of adversely
affecting) a PACE participant.
Penalty for involuntarily 1997 25,000 36,794
disenrolling a participant.
Penalty for discriminating or 1997 25,000 36,794
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 a nursing
488.408(d)(1)(iii). facility's failure to meet a
Category 2 Certification:
Minimum...................... 1987 50 103
Maximum...................... 1987 3,000 6,188
42 CFR CMS Penalty per instance for a
488.408(d)(1)(iv). nursing facility's failure to
meet Category 2 certification:
Minimum...................... 1987 1,000 2,063
Maximum...................... 1987 10,000 20,628
42 CFR CMS Penalty per day for a nursing
488.408(e)(1)(iii). facility's failure to meet
Category 3 certification:
Minimum...................... 1987 3,050 6,291
Maximum...................... 1987 10,000 20,628
42 CFR CMS Penalty per instance for a ........... ........... 2,063
488.408(e)(1)(iv). nursing facility's failure to
meet Category 3 certification:
Minimum...................... 1987 1,000 20,628
Maximum...................... 1987 10,000
42 CFR CMS Penalty per instance for a ........... ........... 2,063
488.408(e)(2)(ii). nursing facility's failure to
meet Category 3 certification,
which results in immediate
jeopardy:
Minimum...................... 1987 1,000 20,628
Maximum...................... 1987 10,000
42 CFR 488.438(a)(1)(i) CMS Penalty per day for nursing ........... ........... 6,291
facility's failure to meet
certification (Upper Range):
Minimum...................... 1987 3,050 20,628
Maximum...................... 1987 10,000 2,063
42 CFR CMS Penalty per day for nursing
488.438(a)(1)(ii). facility's failure to meet
certification (Lower Range):
Minimum...................... 1987 50 103
Maximum...................... 1987 3,000 6,188
42 CFR 488.438(a)(2)... CMS Penalty per instance for nursing
facility's failure to meet
certification:
Minimum...................... 1987 1,000 2,063
Maximum...................... 1987 10,000 20,628
1396r(f)(2)(B)(iii)(I)(c)....... 42 CFR CMS Grounds to prohibit approval of 1987 5,000 10,314
483.151(b)(2)(iv) and Nurse Aide Training Program--if
(b)(3)(iii). 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 disapproval of 1987 5,000 10,314
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.
Page 61580
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...................... 1990 1 2
Maximum...................... 1990 10,000 17,816
1396u-2(e)(2)(A)(i)............. 42 CFR 438.704......... CMS Penalty for a Medicaid managed 1997 25,000 36,794
care organization that fails
substantially to provide
medically necessary items and
services.
Penalty for Medicaid managed 1997 25,000 36,794
care organization that imposes
premiums or charges on
enrollees in excess of the
premiums or charges permitted.
Penalty for a Medicaid managed 1997 25,000 36,794
care organization that
misrepresents or falsifies
information to another
individual or entity.
Penalty for a Medicaid managed 1997 25,000 36,794
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 managed 1997 100,000 147,177
care organization that
misrepresents or falsifies
information to the HHS
Secretary.
Penalty for Medicaid managed 1997 100,000 147,177
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 individual that 1997 15,000 22,077
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 441, Subpart I.. CMS Penalty for a provider not 1990 10,000 20,628
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 2009 10,000 11,002
information related to
eligibility determinations for
medical assistance programs.
18041(c)(2)..................... 45 CFR 150.315; 45 CFR CMS Failure to comply with 1996 100 150
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 false 2010 25,000 27,186
information on Exchange
application.
18081(h)(1)(B).................. 42 CFR 155.285......... CMS Penalty for knowingly or 2010 250,000 271,862
willfully providing false
information on Exchange
application.
18081(h)(2)..................... 42 CFR 155.260......... CMS Penalty for knowingly or 2010 25,000 27,186
willfully disclosing protected
information from Exchange.
31 U.S.C.:
1352............................ 45 CFR 93.400(e)....... HHS Penalty for the first time an 1989 10,000 18,936
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...................... 1989 10,000 18,936
Maximum...................... 1989 100,000 189,361
Penalty for the first time an 1989 10,000 18,936
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...................... 1989 10,000 18,936
Maximum...................... 1989 100,000 189,361
45 CFR 93, Appendix A.. HHS Penalty for failure to provide
certification regarding
lobbying in the award documents
for all sub-awards of all
tiers:
Minimum...................... 1989 10,000 18,936
Maximum...................... 1989 100,000 189,361
Page 61581
Penalty for failure to provide
statement regarding lobbying
for loan guarantee and loan
insurance transactions:
Minimum...................... 1989 10,000 18,936
Maximum...................... 1989 100,000 189,361
3801-3812....................... 45 CFR 79.3(a)(1)(iv).. HHS Penalty against any individual 1988 5,000 9,894
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 individual 1988 5,000 9,894
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 non-Inflation Act Adjustment.
PART 147--HEALTH INSURANCE REFORM REQUIREMENTS FOR THE GROUP AND INDIVIDUAL HEALTH INSURANCE MARKETS
0
33. The authority citation for part 147 continues to read as follows:
Authority: Secs. 2701 through 2763, 2791, and 2792 of the Public Health Service Act (42 U.S.C. 300gg through 300gg-63, 300gg-91, and 300gg-92), as amended.
Sec. 147.200 Amended
0
34. Section 147.200(e) is amended by removing the phrase ``not more than $1,000 for'' and adding in its place the phrase ``not more than $1,000 as adjusted annually under 45 CFR part 102 for''.
PART 150--CMS ENFORCEMENT IN GROUP AND INDIVIDUAL INSURANCE MARKETS
0
35. The authority citation for part 150 continues to read as follows:
Authority: Secs. 2701 through 2763, 2791, and 2792 of the PHS Act (42 U.S.C. 300gg through 300gg-63, 300gg-91, and 300gg-92).
Sec. 150.315 Amended
0
36. Section 150.315 is amended by removing the phrase ``may not exceed $100 for'' and adding in its place the phrase ``may not exceed $100 as adjusted annually under 45 CFR part 102 for''.
PART 155--EXCHANGE ESTABLISHMENT STANDARDS AND OTHER RELATED STANDARDS UNDER THE AFFORDABLE CARE ACT
0
37. The authority citation for part 155 continues to read as follows:
Authority: Title I of the Affordable Care Act, sections 1301, 1302, 1303, 1304, 1311, 1312, 1313, 1321, 1322, 1331, 1332, 1334, 1402, 1411, 1412, 1413, Pub. L. 111-148, 124 Stat. 119 (42 U.S.C. 18021-18024, 18031-18033, 18041-18042, 18051, 18054, 18071, and 18081-18083).
Sec. 155.260 Amended
0
38. In Sec. 155.260, paragraph (g) is amended by removing the phrase ``not more than $25,000 per'' and adding in its place the phrase ``not more than $25,000 as adjusted annually under 45 CFR part 102 per''.
Sec. 155.285 Amended
0
39. Amend Sec. 155.285 as follows:
0
a. In paragraph (c)(1)(i), by removing the phrase ``of $25,000 for'' and adding in its place the phrase ``of $25,000 as adjusted annually under 45 CFR part 102 for'';
0
b. In paragraph (c)(1)(ii), removing the phrase ``of $250,000 for'' and adding in its place the phrase ``of $250,000 as adjusted annually under 45 CFR part 102 for''; and
0
c. In paragraph (c)(2)(i), removing the phrase ``not more than $25,000 per'' and adding in its place the phrase ``not more than $25,000 as adjusted annually under 45 CFR part 102 per''.
PART 156--HEALTH INSURANCE ISSUER STANDARDS UNDER THE AFFORDABLE CARE ACT, INCLUDING STANDARDS RELATED TO EXCHANGES
0
40. The authority citation for part 156 continues to read as follows:
Authority: Title I of the Affordable Care Act, sections 1301-
1304, 1311-1313, 1321-1322, 1324, 1334, 1342-1343, 1401-1402, Pub. L. 111-148, 124 Stat. 119 (42 U.S.C. 18021-18024, 18031-18032, 18041-18042, 18044, 18054, 18061, 18063, 18071, 18082, 26 U.S.C. 36B, and 31 U.S.C. 9701).
Sec. 156.805 Amended
0
41. In Sec. 156.805, paragraph (c) is amended by removing the phrase ``$100 for'' and adding in its place the phrase ``$100 as adjusted annually under 45 CFR part 102 for''.
PART 158--ISSUER USE OF PREMIUM REVENUE: REPORTING AND REBATE REQUIREMENTS
0
42. The authority citation for part 158 continues to read as follows:
Authority: Section 2718 of the Public Health Service Act (42 U.S.C. 300gg-18), as amended.
Sec. 158.606 Amended
0
43. Section 158.606 is amended by removing the phrase ``may not exceed $100 for'' and adding in its place the phrase ``may not exceed $100 as adjusted annually under 45 CFR part 102 for''.
PART 160--GENERAL ADMINISTRATIVE REQUIREMENTS
0
44. The authority for part 160 continues to read as follows:
Authority: 42 U.S.C. 1302(a); 42 U.S.C. 1320d-1320d-9; sec. 264, Pub. L. 104-191, 110 Stat. 2033-2034 (42 U.S.C. 1320d-2 (note)); 5 U.S.C. 552; secs. 13400-13424, Pub. L. 111-5, 123 Stat. 258-279; and sec. 1104 of Pub. L. 111-148, 124 Stat. 146-154.
0
45. Section 160.404 is amended by revising paragraph (a) to read as follows:
Sec. 160.404 Amount of a civil money penalty.
(a) The amount of a civil money penalty will be determined in accordance with paragraph (b) of this section, and Sec. Sec. 160.406, 160.408, and 160.412. These amounts were adjusted in accordance with the Federal Civil Monetary Penalty Inflation Adjustment
Page 61582
Act of 1990, (Pub. L. 101-140), as amended by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015, (section 701 of Pub. L. 114-74), and appear at 45 CFR part 102. These amounts will be updated annually and published at 45 CFR part 102.
* * * * *
Subtitle B--Regulations Related to Public Welfare
Chapter II--Office of Family Assistance (Assistance Programs), Administration for Children and Families, Department of Health and Human Services
PART 303--STANDARDS FOR PROGRAM OPERATIONS
0
46. The authority citation for part 303 continues to read as follows:
Authority: 42 U.S.C. 651 through 658, 659a, 660, 663, 664, 666, 667, 1302, 1396a(a)(25), 1396b(d)(2), 1396b(o), 1396b(p), and 1396(k).
0
47. Section 303.21 is amended by revising paragraph (f) to read as follows:
Sec. 303.21 Safeguarding and disclosure of confidential information.
* * * * *
(f) Penalties for unauthorized disclosure. Any disclosure or use of confidential information in violation of 42 U.S.C. 653(l)(2) and implementing regulations shall be subject to:
(1) Any State and Federal statutes that impose legal sanctions for such disclosure; and
(2) The maximum civil monetary penalties associated with the statutory provisions authorizing civil monetary penalties under 42 U.S.C. 653(l)(2) as shown in the table at 45 CFR 102.3.
Dated: July 21, 2016.
Sylvia M. Burwell,
Secretary, Department of Health and Human Services.
FR Doc. 2016-18680 Filed 9-2-16; 8:45 am
BILLING CODE 4150-24-P
