[Federal Register Volume 85, Number 12 (Friday, January 17, 2020)]
[Rules and Regulations]
[Pages 2869-2887]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-00738]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

45 CFR Part 102

RIN 0991-AC0


Annual Civil Monetary Penalties Inflation Adjustment

AGENCY: Office of the Assistant Secretary for Financial Resources, 
Department of Health and Human Services.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Department of Health and Human Services is updating its 
regulations to reflect required annual inflation-related increases to 
the civil monetary penalties in its regulations, pursuant to the 
Federal Civil Penalties Inflation Adjustment Act Improvements Act of 
2015, and to make changes to reflect an amendment to the Federal Food, 
Drug, and Cosmetic Act by the Further Consolidated Appropriations Act, 
2020 (effective January 1, 2020).

DATES: This rule is effective January 17, 2020.

FOR FURTHER INFORMATION CONTACT: David Dasher, Deputy Assistant 
Secretary, Office of Acquisitions, Office of the Assistant Secretary 
for Financial Resources, Room 536-H, Hubert Humphrey Building, 200 
Independence Avenue SW, Washington DC 20201; 202-205-0706.

SUPPLEMENTARY INFORMATION: 

I. Background

    The Federal Civil Penalties Inflation Adjustment Act Improvements 
Act of 2015 (Sec. 701 of Pub. L. 114-74) (the ``2015 Act'') amended the 
Federal Civil Penalties Inflation Adjustment Act of 1990 (Pub. L. 101-
410, 104 Stat. 890 (1990)), which is intended to improve the 
effectiveness of civil monetary

[[Page 2870]]

penalties (CMPs) and to maintain the deterrent effect of such 
penalties, requires agencies to adjust the civil monetary penalties for 
inflation annually.
    The Department of Health and Human Services (HHS) lists the civil 
monetary penalty authorities and the penalty amounts administered by 
all of its agencies in tabular form in 45 CFR 102.3, which was issued 
in an interim final rule published in the September 6, 2016 Federal 
Register (81 FR 61538). Annual adjustments were subsequently published 
on February 3, 2017 (82 FR 9175), October 11, 2018 (83 FR 51369), and 
on November 5, 2019 (84 FR 59549).
    The Further Consolidated Appropriations Act, 2020 (hereafter, 2020 
Appropriations Act), created a new section 906(d)(5) in the Federal 
Food, Drug, and Cosmetic Act, codified at 21 U.S.C. 387f(d)(5), which 
increases the minimum age of sale of tobacco products and makes it 
unlawful for a retailer to sell a tobacco product to any person younger 
than 21 years old. H.R. 1865 Sec. 603. The 2020 Appropriations Act also 
amended the civil money penalty schedule codified in 21 U.S.C. 333 note 
to apply to violations of new section 906(d)(5). Accordingly, the 
description of 21 U.S.C. 333 note has been modified in the table to 
reflect these amendments. In addition, a technical error for an 
incorrect description of 42 U.S.C. 299c-(3)(d) was identified and is 
corrected below.

II. Calculation of Adjustment

    The annual inflation adjustment for each applicable civil monetary 
penalty is determined using the percent increase in the Consumer Price 
Index for all Urban Consumers (CPI-U) for the month of October of the 
year in which the amount of each civil penalty was most recently 
established or modified. In the December 16, 2019, Office of Management 
and Budget (OMB) Memorandum for the Heads of Executive Agencies and 
Departments, M-20-05, Implementation of the Penalty Inflation 
Adjustments for 2020, Pursuant to the Federal Civil Penalties Inflation 
Adjustment Act Improvements Act of 2015, OMB published the multiplier 
for the required annual adjustment. The cost-of-living adjustment 
multiplier for 2020, based on the CPI-U for the month of October 2019, 
not seasonally adjusted, is 1.01764. The multiplier is applied to each 
applicable penalty amount that was updated and published for FY 2019 
and is rounded to the nearest dollar.
    Using the 2020 multiplier, HHS adjusted all its applicable monetary 
penalties in 45 CFR 102.3.

III. Statutory and Executive Order Reviews

    The 2015 Act requires Federal agencies to publish annual penalty 
inflation adjustments notwithstanding section 553 of the Administrative 
Procedure Act (APA).
    Section 4(a) of the 2015 Act directs Federal agencies to publish 
annual adjustments no later than January 15th of each year thereafter. 
In accordance with section 553 of the APA, most rules are subject to 
notice and comment and are effective no earlier than 30 days after 
publication in the Federal Register. However, section 4(b)(2) of the 
2015 Act provides that each agency shall make the annual inflation 
adjustments ``notwithstanding section 553'' of the APA. According to 
OMB's Memorandum M-20-05, the phrase ``notwithstanding section 553'' in 
section 4(b)(2) of the 2015 Act means that ``the public procedure the 
APA generally requires (i.e., notice, an opportunity for comment, and a 
delay in effective date) is not required for agencies to issue 
regulations implementing the annual adjustment.''
    Consistent with the language of the 2015 Act and OMB's 
implementation guidance, this rule is not subject to notice and an 
opportunity for public comment and will be effective immediately upon 
publication. Additionally, HHS finds good cause for issuing technical 
changes as a final rule without notice and comment because these 
changes only update the implementing regulation to restate the statute 
in light of amendments recently enacted into law.
    Pursuant to OMB Memorandum M-20-05, HHS has determined that the 
annual inflation adjustment to the civil monetary penalties in its 
regulations does not trigger any requirements under procedural statutes 
and Executive Orders that govern rulemaking procedures.

IV. Effective Date

    This rule is effective January 17, 2020. A delayed effective date 
for the technical changes to the table made to reflect the 2020 
Appropriations Act is unnecessary because the new requirements are 
already effective as a matter of law (5 U.S.C. 553(d)(3)) and they do 
not establish additional regulatory obligations or impose additional 
burden on regulated entities. The adjusted civil monetary penalty 
amounts apply to penalties assessed on or after January 17, 2020, if 
the violation occurred on or after November 2, 2015. If the violation 
occurred prior to November 2, 2015, or a penalty was assessed prior to 
September 6, 2016, the pre-adjustment civil penalty amounts in effect 
prior to September 6, 2016, will apply.

List of Subjects in 45 CFR Part 102

    Administrative practice and procedure, Penalties.
    For reasons discussed in the preamble, the Department of Health and 
Human Services amends 45 CFR part 102 as follows:

PART 102--ADJUSTMENT OF CIVIL MONETARY PENALTIES FOR INFLATION

0
1. The authority citation for part 102 continues to read as follows:

    Authority: Public Law 101-410, Sec. 701 of Public Law 114-74, 31 
U.S.C. 3801-3812.


0
2. Amend Sec.  102.3 by revising the table to read as follows:


Sec.  102.3   Penalty adjustment and table.

* * * * *

[[Page 2871]]



  Table 1 to Sec.   102.3--Civil Monetary Penalty Authorities Administered by HHS Agencies and Penalty Amounts
                                                January 17, 2020
----------------------------------------------------------------------------------------------------------------
                                                                             Date of
                                                                               last         2019         2020
                                                   HHS                       penalty      Maximum      Maximum
                                   CFR \1\       agency   Description \2\   figure or     adjusted     adjusted
                                                                            adjustment    penalty      penalty
                                                                               \3\          ($)        ($) \4\
----------------------------------------------------------------------------------------------------------------
21 U.S.C.:
    333(b)(2)(A).............  ...............  FDA       Penalty for             2019      105,194      107,050
                                                           violations
                                                           related to
                                                           drug samples
                                                           resulting in a
                                                           conviction of
                                                           any
                                                           representative
                                                           of
                                                           manufacturer
                                                           or distributor
                                                           in any 10-year
                                                           period.
    333(b)(2)(B).............  ...............  FDA       Penalty for             2019    2,146,800    2,184,670
                                                           violation
                                                           related to
                                                           drug samples
                                                           resulting in a
                                                           conviction of
                                                           any
                                                           representative
                                                           of
                                                           manufacturer
                                                           or distributor
                                                           after the
                                                           second
                                                           conviction in
                                                           any 10-yr
                                                           period.
    333(b)(3)................  ...............  FDA       Penalty for             2019      210,386      214,097
                                                           failure to
                                                           make a report
                                                           required by 21
                                                           U.S.C.
                                                           353(d)(3)(E)
                                                           relating to
                                                           drug samples.
    333(f)(1)(A).............  ...............  FDA       Penalty for any         2019       28,413       28,914
                                                           person who
                                                           violates a
                                                           requirement
                                                           related to
                                                           devices for
                                                           each such
                                                           violation.
                                                          Penalty for             2019    1,894,261    1,927,676
                                                           aggregate of
                                                           all violations
                                                           related to
                                                           devices in a
                                                           single
                                                           proceeding.
    333(f)(2)(A).............  ...............  FDA       Penalty for any         2019       79,875       81,284
                                                           individual who
                                                           introduces or
                                                           delivers for
                                                           introduction
                                                           into
                                                           interstate
                                                           commerce food
                                                           that is
                                                           adulterated
                                                           per 21 U.S.C.
                                                           342(a)(2)(B)
                                                           or any
                                                           individual who
                                                           does not
                                                           comply with a
                                                           recall order
                                                           under 21
                                                           U.S.C. 350l.
                                                          Penalty in the          2019      399,374      406,419
                                                           case of any
                                                           other person
                                                           other than an
                                                           individual)
                                                           for such
                                                           introduction
                                                           or delivery of
                                                           adulterated
                                                           food.
                                                          Penalty for             2019      798,747      812,837
                                                           aggregate of
                                                           all such
                                                           violations
                                                           related to
                                                           adulterated
                                                           food
                                                           adjudicated in
                                                           a single
                                                           proceeding.
    333(f)(3)(A).............  ...............  FDA       Penalty for all         2019       12,103       12,316
                                                           violations
                                                           adjudicated in
                                                           a single
                                                           proceeding for
                                                           any person who
                                                           violates 21
                                                           U.S.C. 331(jj)
                                                           by failing to
                                                           submit the
                                                           certification
                                                           required by 42
                                                           U.S.C.
                                                           282(j)(5)(B)
                                                           or knowingly
                                                           submitting a
                                                           false
                                                           certification;
                                                           by failing to
                                                           submit
                                                           clinical trial
                                                           information
                                                           under 42
                                                           U.S.C. 282(j);
                                                           or by
                                                           submitting
                                                           clinical trial
                                                           information
                                                           under 42
                                                           U.S.C. 282(j)
                                                           that is false
                                                           or misleading
                                                           in any
                                                           particular
                                                           under 42
                                                           U.S.C.
                                                           282(j)(5)(D).
    333(f)(3)(B).............  ...............  FDA       Penalty for             2019       12,103       12,316
                                                           each day any
                                                           above
                                                           violation is
                                                           not corrected
                                                           after a 30-day
                                                           period
                                                           following
                                                           notification
                                                           until the
                                                           violation is
                                                           corrected.
    333(f)(4)(A)(i)..........  ...............  FDA       Penalty for any         2019      302,585      307,923
                                                           responsible
                                                           person that
                                                           violates a
                                                           requirement of
                                                           21 U.S.C.
                                                           355(o) (post-
                                                           marketing
                                                           studies,
                                                           clinical
                                                           trials,
                                                           labeling), 21
                                                           U.S.C. 355(p)
                                                           (risk
                                                           evaluation and
                                                           mitigation
                                                           (REMS)), or 21
                                                           U.S.C. 355-1
                                                           (REMS).
                                                          Penalty for             2019    1,210,340    1,231,690
                                                           aggregate of
                                                           all such above
                                                           violations in
                                                           a single
                                                           proceeding.
    333(f)(4)(A)(ii).........  ...............  FDA       Penalty for             2019      302,585      307,923
                                                           REMS violation
                                                           that continues
                                                           after written
                                                           notice to the
                                                           responsible
                                                           person for the
                                                           first 30-day
                                                           period (or any
                                                           portion
                                                           thereof) the
                                                           responsible
                                                           person
                                                           continues to
                                                           be in
                                                           violation.
                                                          Penalty for             2019    1,210,340    1,231,690
                                                           REMS violation
                                                           that continues
                                                           after written
                                                           notice to
                                                           responsible
                                                           person doubles
                                                           for every 30-
                                                           day period
                                                           thereafter the
                                                           violation
                                                           continues, but
                                                           may not exceed
                                                           penalty amount
                                                           for any 30-day
                                                           period.
                                                          Penalty for             2019   12,103,404   12,316,908
                                                           aggregate of
                                                           all such above
                                                           violations
                                                           adjudicated in
                                                           a single
                                                           proceeding.
    333(f)(9)(A).............  ...............  FDA       Penalty for any         2019       17,547       17,857
                                                           person who
                                                           violates a
                                                           requirement
                                                           which relates
                                                           to tobacco
                                                           products for
                                                           each such
                                                           violation.
                                                          Penalty for             2019    1,169,798    1,190,433
                                                           aggregate of
                                                           all such
                                                           violations of
                                                           tobacco
                                                           product
                                                           requirement
                                                           adjudicated in
                                                           a single
                                                           proceeding.
    333(f)(9)(B)(i)(I).......  ...............  FDA       Penalty per             2019      292,450      297,609
                                                           violation
                                                           related to
                                                           violations of
                                                           tobacco
                                                           requirements.

[[Page 2872]]

 
                                                          Penalty for             2019    1,169,798    1,190,433
                                                           aggregate of
                                                           all such
                                                           violations of
                                                           tobacco
                                                           product
                                                           requirements
                                                           adjudicated in
                                                           a single
                                                           proceeding.
333(f)(9)(B)(i)(II)..........  ...............  FDA       Penalty in the          2019      292,450      297,609
                                                           case of a
                                                           violation of
                                                           tobacco
                                                           product
                                                           requirements
                                                           that continues
                                                           after written
                                                           notice to such
                                                           person, for
                                                           the first 30-
                                                           day period (or
                                                           any portion
                                                           thereof) the
                                                           person
                                                           continues to
                                                           be in
                                                           violation.
                                                          Penalty for             2019    1,169,798    1,190,433
                                                           violation of
                                                           tobacco
                                                           product
                                                           requirements
                                                           that continues
                                                           after written
                                                           notice to such
                                                           person shall
                                                           double for
                                                           every 30-day
                                                           period
                                                           thereafter the
                                                           violation
                                                           continues, but
                                                           may not exceed
                                                           penalty amount
                                                           for any 30-day
                                                           period.
                                                          Penalty for             2019   11,697,983   11,904,335
                                                           aggregate of
                                                           all such
                                                           violations
                                                           related to
                                                           tobacco
                                                           product
                                                           requirements
                                                           adjudicated in
                                                           a single
                                                           proceeding.
    333(f)(9)(B)(ii)(I)......  ...............  FDA       Penalty for any         2019      292,450      297,609
                                                           person who
                                                           either does
                                                           not conduct
                                                           post-market
                                                           surveillance
                                                           and studies to
                                                           determine
                                                           impact of a
                                                           modified risk
                                                           tobacco
                                                           product for
                                                           which the HHS
                                                           Secretary has
                                                           provided them
                                                           an order to
                                                           sell, or who
                                                           does not
                                                           submit a
                                                           protocol to
                                                           the HHS
                                                           Secretary
                                                           after being
                                                           notified of a
                                                           requirement to
                                                           conduct post-
                                                           market
                                                           surveillance
                                                           of such
                                                           tobacco
                                                           products.
                                                          Penalty for             2019    1,169,798    1,190,433
                                                           aggregate of
                                                           for all such
                                                           above
                                                           violations
                                                           adjudicated in
                                                           a single
                                                           proceeding.
    333(f)(9)(B)(ii)(II).....  ...............  FDA       Penalty for             2019      292,450      297,609
                                                           violation of
                                                           modified risk
                                                           tobacco
                                                           product post-
                                                           market
                                                           surveillance
                                                           that continues
                                                           after written
                                                           notice to such
                                                           person for the
                                                           first 30-day
                                                           period (or any
                                                           portion
                                                           thereof) that
                                                           the person
                                                           continues to
                                                           be in
                                                           violation.
                                                          Penalty for             2019    1,169,798    1,190,433
                                                           post-notice
                                                           violation of
                                                           modified risk
                                                           tobacco
                                                           product post-
                                                           market
                                                           surveillance
                                                           shall double
                                                           for every 30-
                                                           day period
                                                           thereafter
                                                           that the
                                                           tobacco
                                                           product
                                                           requirement
                                                           violation
                                                           continues for
                                                           any 30-day
                                                           period, but
                                                           may not exceed
                                                           penalty amount
                                                           for any 30-day
                                                           period.
                                                          Penalty for             2019   11,697,983   11,904,335
                                                           aggregate
                                                           above tobacco
                                                           product
                                                           requirement
                                                           violations
                                                           adjudicated in
                                                           a single
                                                           proceeding.
    333(g)(1)................  ...............  FDA       Penalty for any         2019      302,585      307,923
                                                           person who
                                                           disseminates
                                                           or causes
                                                           another party
                                                           to disseminate
                                                           a direct-to-
                                                           consumer
                                                           advertisement
                                                           that is false
                                                           or misleading
                                                           for the first
                                                           such violation
                                                           in any 3-year
                                                           period.
                                                          Penalty for             2019      605,171      615,846
                                                           each
                                                           subsequent
                                                           above
                                                           violation in
                                                           any 3-year
                                                           period.
    333 note.................  ...............  FDA       Penalty to be           2019          292          297
                                                           applied for
                                                           violations of
                                                           21 U.S.C.
                                                           387f(d)(5) or
                                                           of violations
                                                           of
                                                           restrictions
                                                           on the sale or
                                                           distribution
                                                           of tobacco
                                                           products
                                                           promulgated
                                                           under 21
                                                           U.S.C. 387f(d)
                                                           (e.g.,
                                                           violations of
                                                           regulations in
                                                           21 CFR part
                                                           1140) with
                                                           respect to a
                                                           retailer with
                                                           an approved
                                                           training
                                                           program in the
                                                           case of a
                                                           second
                                                           regulation
                                                           violation
                                                           within a 12-
                                                           month period.
                                                          Penalty in the          2019          584          594
                                                           case of a
                                                           third
                                                           violation of
                                                           21 U.S.C.
                                                           387f(d)(5) or
                                                           of the tobacco
                                                           product
                                                           regulations
                                                           within a 24-
                                                           month period.
                                                          Penalty in the          2019        2,340        2,381
                                                           case of a
                                                           fourth
                                                           violation of
                                                           21 U.S.C.
                                                           387f(d)(5) or
                                                           of the tobacco
                                                           product
                                                           regulations
                                                           within a 24-
                                                           month period.
                                                          Penalty in the          2019        5,849        5,952
                                                           case of a
                                                           fifth
                                                           violation of
                                                           21 U.S.C.
                                                           387f(d)(5) or
                                                           of the tobacco
                                                           product
                                                           regulations
                                                           within a 36-
                                                           month period.

[[Page 2873]]

 
                                                          Penalty in the          2019       11,698       11,904
                                                           case of a
                                                           sixth or
                                                           subsequent
                                                           violation of
                                                           21 U.S.C.
                                                           387f(d)(5) or
                                                           of the tobacco
                                                           product
                                                           regulations
                                                           within a 48-
                                                           month period
                                                           as determined
                                                           on a case-by-
                                                           case basis.
                                                          Penalty to be           2019          292          297
                                                           applied for
                                                           violations of
                                                           21 U.S.C.
                                                           387f(d)(5) or
                                                           of violations
                                                           of
                                                           restrictions
                                                           on the sale or
                                                           distribution
                                                           of tobacco
                                                           products
                                                           promulgated
                                                           under 21
                                                           U.S.C. 387f(d)
                                                           (e.g.,
                                                           violations of
                                                           regulations in
                                                           21 CFR part
                                                           1140) with
                                                           respect to a
                                                           retailer that
                                                           does not have
                                                           an approved
                                                           training
                                                           program in the
                                                           case of the
                                                           first
                                                           regulation
                                                           violation.
                                                          Penalty in the          2019          584          594
                                                           case of a
                                                           second
                                                           violation of
                                                           21 U.S.C.
                                                           387f(d)(5) or
                                                           of the tobacco
                                                           product
                                                           regulations
                                                           within a 12-
                                                           month period.
                                                          Penalty in the          2019        1,170        1,191
                                                           case of a
                                                           third
                                                           violation of
                                                           21 U.S.C.
                                                           387f(d)(5) or
                                                           of the tobacco
                                                           product
                                                           regulations
                                                           within a 24-
                                                           month period.
                                                          Penalty in the          2019        2,340        2,381
                                                           case of a
                                                           fourth
                                                           violation of
                                                           21 U.S.C.
                                                           387f(d)(5) or
                                                           of the tobacco
                                                           product
                                                           regulations
                                                           within a 24-
                                                           month period.
                                                          Penalty in the          2019        5,849        5,952
                                                           case of a
                                                           fifth
                                                           violation of
                                                           21 U.S.C.
                                                           387f(d)(5) or
                                                           of the tobacco
                                                           product
                                                           regulations
                                                           within a 36-
                                                           month period.
                                                          Penalty in the          2019       11,698       11,904
                                                           case of a
                                                           sixth or
                                                           subsequent
                                                           violation of
                                                           21 U.S.C.
                                                           387f(d)(5) or
                                                           of the tobacco
                                                           product
                                                           regulations
                                                           within a 48-
                                                           month period
                                                           as determined
                                                           on a case-by-
                                                           case basis.
    335b(a)..................  ...............  FDA       Penalty for             2019      445,846      453,711
                                                           each violation
                                                           for any
                                                           individual who
                                                           made a false
                                                           statement or
                                                           misrepresentat
                                                           ion of a
                                                           material fact,
                                                           bribed,
                                                           destroyed,
                                                           altered,
                                                           removed, or
                                                           secreted, or
                                                           procured the
                                                           destruction,
                                                           alteration,
                                                           removal, or
                                                           secretion of,
                                                           any material
                                                           document,
                                                           failed to
                                                           disclose a
                                                           material fact,
                                                           obstructed an
                                                           investigation,
                                                           employed a
                                                           consultant who
                                                           was debarred,
                                                           debarred
                                                           individual
                                                           provided
                                                           consultant
                                                           services.
                                                          Penalty in the          2019    1,783,384    1,814,843
                                                           case of any
                                                           other person
                                                           (other than an
                                                           individual)
                                                           per above
                                                           violation.
360pp(b)(1)..................  ...............  FDA       Penalty for any         2019        2,924        2,976
                                                           person who
                                                           violates any
                                                           such
                                                           requirements
                                                           for electronic
                                                           products, with
                                                           each unlawful
                                                           act or
                                                           omission
                                                           constituting a
                                                           separate
                                                           violation.
                                                          Penalty imposed         2019      996,806    1,014,390
                                                           for any
                                                           related series
                                                           of violations
                                                           of
                                                           requirements
                                                           relating to
                                                           electronic
                                                           products.
42 U.S.C.....................  ...............  ........  ...............         2019  ...........  ...........
    262(d)...................  ...............  FDA       Penalty per day         2019      229,269      233,313
                                                           for violation
                                                           of order of
                                                           recall of
                                                           biological
                                                           product
                                                           presenting
                                                           imminent or
                                                           substantial
                                                           hazard.
    263b(h)(3)...............  ...............  FDA       Penalty for             2019       17,834       18,149
                                                           failure to
                                                           obtain a
                                                           mammography
                                                           certificate as
                                                           required.
    300aa-28(b)(1)...........  ...............  FDA       Penalty per             2019      229,269      233,313
                                                           occurrence for
                                                           any vaccine
                                                           manufacturer
                                                           that
                                                           intentionally
                                                           destroys,
                                                           alters,
                                                           falsifies, or
                                                           conceals any
                                                           record or
                                                           report
                                                           required.
    256b(d)(1)(B)(vi)........  ...............  HRSA      Penalty for             2019        5,781        5,883
                                                           each instance
                                                           of
                                                           overcharging a
                                                           340B covered
                                                           entity.
    299c-(3)(d)..............  ...............  AHRQ      Penalty for an          2019       15,034       15,299
                                                           establishment
                                                           or person
                                                           supplying
                                                           information
                                                           obtained in
                                                           the course of
                                                           activities for
                                                           any purpose
                                                           other than the
                                                           purpose for
                                                           which it was
                                                           supplied.
    653(l)(2)................  45 CFR           ACF       Penalty for             2019        1,542        1,569
                                303.21(f).                 Misuse of
                                                           Information in
                                                           the National
                                                           Directory of
                                                           New Hires.
    262a(i)(1)...............  42 CFR 1003.910  OIG       Penalty for             2019      348,708      354,859
                                                           each
                                                           individual who
                                                           violates
                                                           safety and
                                                           security
                                                           procedures
                                                           related to
                                                           handling
                                                           dangerous
                                                           biological
                                                           agents and
                                                           toxins.

[[Page 2874]]

 
                                                          Penalty for any         2019      697,418      709,720
                                                           other person
                                                           who violates
                                                           safety and
                                                           security
                                                           procedures
                                                           related to
                                                           handling
                                                           dangerous
                                                           biological
                                                           agents and
                                                           toxins.
    300jj-51.................  ...............  OIG       Penalty per             2019    1,063,260    1,082,016
                                                           violation for
                                                           committing
                                                           information
                                                           blocking.
    1320a-7a(a)..............  42 CFR           OIG       Penalty for             2019       20,504       20,866
                                1003.210(a)(1).            knowingly
                                                           presenting or
                                                           causing to be
                                                           presented to
                                                           an officer,
                                                           employee, or
                                                           agent of the
                                                           United States
                                                           a false claim.
                                                          Penalty for             2019       20,504       20,866
                                                           knowingly
                                                           presenting or
                                                           causing to be
                                                           presented a
                                                           request for
                                                           payment which
                                                           violates the
                                                           terms of an
                                                           assignment,
                                                           agreement, or
                                                           PPS agreement.
                               42 CFR           ........  Penalty for             2019       30,757       31,300
                                1003.210(a)(2).            knowingly
                                                           giving or
                                                           causing to be
                                                           presented to a
                                                           participating
                                                           provider or
                                                           supplier false
                                                           or misleading
                                                           information
                                                           that could
                                                           reasonably be
                                                           expected to
                                                           influence a
                                                           discharge
                                                           decision.
                               42 CFR           ........  Penalty for an          2019       20,504       20,866
                                1003.210(a)(3).            excluded party
                                                           retaining
                                                           ownership or
                                                           control
                                                           interest in a
                                                           participating
                                                           entity.
                               42 CFR           ........  Penalty for             2019       20,504       20,866
                                1003.1010.                 remuneration
                                                           offered to
                                                           induce program
                                                           beneficiaries
                                                           to use
                                                           particular
                                                           providers,
                                                           practitioners,
                                                           or suppliers.
                               42 CFR           ........  Penalty for             2019       20,504       20,866
                                1003.210(a)(4).            employing or
                                                           contracting
                                                           with an
                                                           excluded
                                                           individual.
                               42 CFR           ........  Penalty for             2019      102,522      104,330
                                1003.310(a)(3).            knowing and
                                                           willful
                                                           solicitation,
                                                           receipt,
                                                           offer, or
                                                           payment of
                                                           remuneration
                                                           for referring
                                                           an individual
                                                           for a service
                                                           or for
                                                           purchasing,
                                                           leasing, or
                                                           ordering an
                                                           item to be
                                                           paid for by a
                                                           Federal health
                                                           care program.
                               42 CFR           ........  Penalty for             2019       20,504       20,866
                                1003.210(a)(1).            ordering or
                                                           prescribing
                                                           medical or
                                                           other item or
                                                           service during
                                                           a period in
                                                           which the
                                                           person was
                                                           excluded.
                               42 CFR           ........  Penalty for             2019      102,522      104,330
                                1003.210(a)(6).            knowingly
                                                           making or
                                                           causing to be
                                                           made a false
                                                           statement,
                                                           omission or
                                                           misrepresentat
                                                           ion of a
                                                           material fact
                                                           in any
                                                           application,
                                                           bid, or
                                                           contract to
                                                           participate or
                                                           enroll as a
                                                           provider or
                                                           supplier.
                               42 CFR           ........  Penalty for             2019       20,504       20,866
                                1003.210(a)(8).            knowing of an
                                                           overpayment
                                                           and failing to
                                                           report and
                                                           return.
                               42 CFR           ........  Penalty for             2019       57,812       58,832
                                1003.210(a)(7).            making or
                                                           using a false
                                                           record or
                                                           statement that
                                                           is material to
                                                           a false or
                                                           fraudulent
                                                           claim.
                               42 CFR           ........  Penalty for             2019       30,757       31,300
                                1003.210(a)(9).            failure to
                                                           grant timely
                                                           access to HHS
                                                           OIG for
                                                           audits,
                                                           investigations
                                                           , evaluations,
                                                           and other
                                                           statutory
                                                           functions of
                                                           HHS OIG.
    1320a-7a(b)..............  ...............  OIG       Penalty for             2019        5,126        5,216
                                                           payments by a
                                                           hospital or
                                                           critical
                                                           access
                                                           hospital to
                                                           induce a
                                                           physician to
                                                           reduce or
                                                           limit services
                                                           to individuals
                                                           under direct
                                                           care of
                                                           physician or
                                                           who are
                                                           entitled to
                                                           certain
                                                           medical
                                                           assistance
                                                           benefits.
                                                          Penalty for             2019        5,126        5,216
                                                           physicians who
                                                           knowingly
                                                           receive
                                                           payments from
                                                           a hospital or
                                                           critical
                                                           access
                                                           hospital to
                                                           induce such
                                                           physician to
                                                           reduce or
                                                           limit services
                                                           to individuals
                                                           under direct
                                                           care of
                                                           physician or
                                                           who are
                                                           entitled to
                                                           certain
                                                           medical
                                                           assistance
                                                           benefits.
                               42 CFR           ........  Penalty for a           2019       10,252       10,433
                                1003.210(a)(10             physician who
                                ).                         executes a
                                                           document that
                                                           falsely
                                                           certifies home
                                                           health needs
                                                           for Medicare
                                                           beneficiaries.
    1320a-7a(o)..............  ...............  OIG       Penalty for             2016       10,000       10,176
                                                           knowingly
                                                           presenting or
                                                           causing to be
                                                           presented a
                                                           false or
                                                           fraudulent
                                                           specified
                                                           claim under a
                                                           grant,
                                                           contract, or
                                                           other
                                                           agreement for
                                                           which the
                                                           Secretary
                                                           provides
                                                           funding.

[[Page 2875]]

 
                                                          Penalty for             2016       50,000       50,882
                                                           knowingly
                                                           making, using,
                                                           or causing to
                                                           be made or
                                                           used any false
                                                           statement,
                                                           omission, or
                                                           misrepresentat
                                                           ion of a
                                                           material fact
                                                           in any
                                                           application,
                                                           proposal, bid,
                                                           progress
                                                           report, or
                                                           other document
                                                           required to
                                                           directly or
                                                           indirectly
                                                           receive or
                                                           retain funds
                                                           provided
                                                           pursuant to
                                                           grant,
                                                           contract, or
                                                           other
                                                           agreement.
                                                          Penalty for             2016       50,000       50,882
                                                           Knowingly
                                                           making, using,
                                                           or causing to
                                                           be made or
                                                           used, a false
                                                           record or
                                                           statement
                                                           material to a
                                                           false or
                                                           fraudulent
                                                           specified
                                                           claim under
                                                           grant,
                                                           contract, or
                                                           other
                                                           agreement.
                                                          Penalty for             2016   50,000 for   53,231 for
                                                           knowingly                     each false   each false
                                                           making, using,                record or      record
                                                           or causing to                 statement,   statement,
                                                           be made or                    10,000 per   10,646 per
                                                           used, a false                    day.         day.
                                                           record or
                                                           statement
                                                           material to an
                                                           obligation to
                                                           pay or
                                                           transmit funds
                                                           or property
                                                           with respect
                                                           to grant,
                                                           contract, or
                                                           other
                                                           agreement, or
                                                           knowingly
                                                           conceals or
                                                           improperly
                                                           avoids or
                                                           decreases any
                                                           such
                                                           obligation.
                                                          Penalty for             2016       15,000       15,265
                                                           failure to
                                                           grant timely
                                                           access, upon
                                                           reasonable
                                                           request, to
                                                           the Inspector
                                                           General (I.G.)
                                                           for purposes
                                                           of audits,
                                                           investigations
                                                           , evaluations,
                                                           or other
                                                           statutory
                                                           functions of
                                                           I.G. in
                                                           matters
                                                           involving
                                                           grants,
                                                           contracts, or
                                                           other
                                                           agreements.
    1320a-7e(b)(6)(A)........  42 CFR 1003.810  OIG       Penalty for             2019       39,121       39,811
                                                           failure to
                                                           report any
                                                           final adverse
                                                           action taken
                                                           against a
                                                           health care
                                                           provider,
                                                           supplier, or
                                                           practitioner.
    1320b-10(b)(1)...........  42 CFR           OIG       Penalty for the         2019       10,519       10,705
                                1003.610(a).               misuse of
                                                           words,
                                                           symbols, or
                                                           emblems in
                                                           communications
                                                           in a manner in
                                                           which a person
                                                           could falsely
                                                           construe that
                                                           such item is
                                                           approved,
                                                           endorsed, or
                                                           authorized by
                                                           HHS.
    1320b-10(b)(2)...........  42 CFR           OIG       Penalty for the         2019       52,596       53,524
                                1003.610(a).               misuse of
                                                           words,
                                                           symbols, or
                                                           emblems in a
                                                           broadcast or
                                                           telecast in a
                                                           manner in
                                                           which a person
                                                           could falsely
                                                           construe that
                                                           such item is
                                                           approved,
                                                           endorsed, or
                                                           authorized by
                                                           HHS.
    1395i-3(b)(3)(B)(ii)(1)..  42 CFR           OIG       Penalty for             2019        2,194        2,233
                                1003.210(a)(11             certification
                                ).                         of a false
                                                           statement in
                                                           assessment of
                                                           functional
                                                           capacity of a
                                                           Skilled
                                                           Nursing
                                                           Facility
                                                           resident
                                                           assessment.
    1395i-3(b)(3)(B)(ii)(2)..  42 CFR           OIG       Penalty for             2019       10,967       11,160
                                1003.210(a)(11             causing
                                ).                         another to
                                                           certify or
                                                           make a false
                                                           statement in
                                                           assessment of
                                                           functional
                                                           capacity of a
                                                           Skilled
                                                           Nursing
                                                           Facility
                                                           resident
                                                           assessment.
    1395i-3(g)(2)(A).........  42 CFR           OIG       Penalty for any         2019        4,388        4,465
                                1003.1310.                 individual who
                                                           notifies or
                                                           causes to be
                                                           notified a
                                                           Skilled
                                                           Nursing
                                                           Facility of
                                                           the time or
                                                           date on which
                                                           a survey is to
                                                           be conducted.
    1395w-27(g)(2)(A)........  42 CFR 1003.410  OIG       Penalty for a           2019       39,936       40,640
                                                           Medicare
                                                           Advantage
                                                           organization
                                                           that
                                                           substantially
                                                           fails to
                                                           provide
                                                           medically
                                                           necessary,
                                                           required items
                                                           and services.
                                                          Penalty for a           2019       39,121       39,811
                                                           Medicare
                                                           Advantage
                                                           organization
                                                           that charges
                                                           excessive
                                                           premiums.
                                                          Penalty for a           2019       39,121       39,811
                                                           Medicare
                                                           Advantage
                                                           organization
                                                           that
                                                           improperly
                                                           expels or
                                                           refuses to
                                                           reenroll a
                                                           beneficiary.
                                                          Penalty for a           2019      156,488      159,248
                                                           Medicare
                                                           Advantage
                                                           organization
                                                           that engages
                                                           in practice
                                                           that would
                                                           reasonably be
                                                           expected to
                                                           have the
                                                           effect of
                                                           denying or
                                                           discouraging
                                                           enrollment.
                                                          Penalty per             2019       23,473       23,887
                                                           individual who
                                                           does not
                                                           enroll as a
                                                           result of a
                                                           Medicare
                                                           Advantage
                                                           organization's
                                                           practice that
                                                           would
                                                           reasonably be
                                                           expected to
                                                           have the
                                                           effect of
                                                           denying or
                                                           discouraging
                                                           enrollment.
                                                          Penalty for a           2019      156,488      159,248
                                                           Medicare
                                                           Advantage
                                                           organization
                                                           misrepresentin
                                                           g or
                                                           falsifying
                                                           information to
                                                           Secretary.

[[Page 2876]]

 
                                                          Penalty for a           2019       39,121       39,811
                                                           Medicare
                                                           Advantage
                                                           organization
                                                           misrepresentin
                                                           g or
                                                           falsifying
                                                           information to
                                                           individual or
                                                           other entity.
                                                          Penalty for             2019       39,121       39,811
                                                           Medicare
                                                           Advantage
                                                           organization
                                                           interfering
                                                           with
                                                           provider's
                                                           advice to
                                                           enrollee and
                                                           non-managed
                                                           care
                                                           organization
                                                           (MCO)
                                                           affiliated
                                                           providers that
                                                           balance bill
                                                           enrollees.
                                                          Penalty for a           2019       39,121       39,811
                                                           Medicare
                                                           Advantage
                                                           organization
                                                           that employs
                                                           or contracts
                                                           with excluded
                                                           individual or
                                                           entity.
                                                          Penalty for a           2019       39,121       39,811
                                                           Medicare
                                                           Advantage
                                                           organization
                                                           enrolling an
                                                           individual in
                                                           without prior
                                                           written
                                                           consent.
                                                          Penalty for a           2019       39,121       39,811
                                                           Medicare
                                                           Advantage
                                                           organization
                                                           transferring
                                                           an enrollee to
                                                           another plan
                                                           without
                                                           consent or
                                                           solely for the
                                                           purpose of
                                                           earning a
                                                           commission.
                                                          Penalty for a           2019       39,121       39,811
                                                           Medicare
                                                           Advantage
                                                           organization
                                                           failing to
                                                           comply with
                                                           marketing
                                                           restrictions
                                                           or applicable
                                                           implementing
                                                           regulations or
                                                           guidance.
                                                          Penalty for a           2019       39,121       39,811
                                                           Medicare
                                                           Advantage
                                                           organization
                                                           employing or
                                                           contracting
                                                           with an
                                                           individual or
                                                           entity who
                                                           violates 1395w-
                                                           27(g)(1)(A)-(J
                                                           ).
    1395w-141(i)(3)..........  ...............  OIG       Penalty for a           2019       13,669       13,910
                                                           prescription
                                                           drug card
                                                           sponsor that
                                                           falsifies or
                                                           misrepresents
                                                           marketing
                                                           materials,
                                                           overcharges
                                                           program
                                                           enrollees, or
                                                           misuse
                                                           transitional
                                                           assistance
                                                           funds.
    1395cc(g)................  ...............  OIG       Penalty for             2019        5,317        5,411
                                                           improper
                                                           billing by
                                                           Hospitals,
                                                           Critical
                                                           Access
                                                           Hospitals, or
                                                           Skilled
                                                           Nursing
                                                           Facilities.
    1395dd(d)(1).............  42 CFR 1003.510  OIG       Penalty for a           2019      109,663      111,597
                                                           hospital or
                                                           responsible
                                                           physician
                                                           dumping
                                                           patients
                                                           needing
                                                           emergency
                                                           medical care,
                                                           if the
                                                           hospital has
                                                           100 beds or
                                                           more.
                                                          Penalty for a           2019       54,833       55,800
                                                           hospital or
                                                           responsible
                                                           physician
                                                           dumping
                                                           patients
                                                           needing
                                                           emergency
                                                           medical care,
                                                           if the
                                                           hospital has
                                                           less than 100
                                                           beds.
    1395mm(i)(6)(B)(i).......  42 CFR 1003.410  OIG       Penalty for a           2019       54,833       55,800
                                                           health
                                                           maintenance
                                                           organization
                                                           (HMO) or
                                                           competitive
                                                           plan is such
                                                           plan
                                                           substantially
                                                           fails to
                                                           provide
                                                           medically
                                                           necessary,
                                                           required items
                                                           or services.
                                                          Penalty for             2019       54,833       55,800
                                                           HMOs/
                                                           competitive
                                                           medical plans
                                                           that charge
                                                           premiums in
                                                           excess of
                                                           permitted
                                                           amounts.
                                                          Penalty for a           2019       54,833       55,800
                                                           HMO or
                                                           competitive
                                                           medical plan
                                                           that expels or
                                                           refuses to
                                                           reenroll an
                                                           individual per
                                                           prescribed
                                                           conditions.
                                                          Penalty for a           2019      219,327      223,196
                                                           HMO or
                                                           competitive
                                                           medical plan
                                                           that
                                                           implements
                                                           practices to
                                                           discourage
                                                           enrollment of
                                                           individuals
                                                           needing
                                                           services in
                                                           future.
                                                          Penalty per             2019       31,558       32,115
                                                           individual not
                                                           enrolled in a
                                                           plan as a
                                                           result of a
                                                           HMO or
                                                           competitive
                                                           medical plan
                                                           that
                                                           implements
                                                           practices to
                                                           discourage
                                                           enrollment of
                                                           individuals
                                                           needing
                                                           services in
                                                           the future.
                                                          Penalty for a           2019      219,327      223,196
                                                           HMO or
                                                           competitive
                                                           medical plan
                                                           that
                                                           misrepresents
                                                           or falsifies
                                                           information to
                                                           the Secretary.
                                                          Penalty for a           2019       54,833       55,800
                                                           HMO or
                                                           competitive
                                                           medical plan
                                                           that
                                                           misrepresents
                                                           or falsifies
                                                           information to
                                                           an individual
                                                           or any other
                                                           entity.
                                                          Penalty for             2019       54,833       55,800
                                                           failure by HMO
                                                           or competitive
                                                           medical plan
                                                           to assure
                                                           prompt payment
                                                           of Medicare
                                                           risk sharing
                                                           contracts or
                                                           incentive plan
                                                           provisions.
                                                          Penalty for HMO         2019       50,334       51,222
                                                           that employs
                                                           or contracts
                                                           with excluded
                                                           individual or
                                                           entity.

[[Page 2877]]

 
    1395nn(g)(3).............  42 CFR 1003.310  OIG       Penalty for             2019       25,372       25,820
                                                           submitting or
                                                           causing to be
                                                           submitted
                                                           claims in
                                                           violation of
                                                           the Stark
                                                           Law's
                                                           restrictions
                                                           on physician
                                                           self-referrals.
    1395nn(g)(4).............  42 CFR 1003.310  OIG       Penalty for             2019      169,153      172,137
                                                           circumventing
                                                           Stark Law's
                                                           restrictions
                                                           on physician
                                                           self-referrals.
    1395ss(d)(1).............  42 CFR           OIG       Penalty for a           2019       10,519       10,705
                                1003.1110.                 material
                                                           misrepresentat
                                                           ion regarding
                                                           Medigap
                                                           compliance
                                                           policies.
    1395ss(d)(2).............  42 CFR           OIG       Penalty for             2019       10,519       10,705
                                1003.1110.                 selling
                                                           Medigap policy
                                                           under false
                                                           pretense.
    1395ss(d)(3)(A)(ii)......  42 CFR           OIG       Penalty for an          2019       47,357       48,192
                                1003.1110.                 issuer that
                                                           sells health
                                                           insurance
                                                           policy that
                                                           duplicates
                                                           benefits.
                                                          Penalty for             2019       28,413       28,914
                                                           someone other
                                                           than issuer
                                                           that sells
                                                           health
                                                           insurance that
                                                           duplicates
                                                           benefits.
    1395ss(d)(4)(A)..........  42 CFR           OIG       Penalty for             2019       10,519       10,705
                                1003.1110.                 using mail to
                                                           sell a non-
                                                           approved
                                                           Medigap
                                                           insurance
                                                           policy.
    1396b(m)(5)(B)(i)........  42 CFR 1003.410  OIG       Penalty for a           2019       52,596       53,524
                                                           Medicaid MCO
                                                           that
                                                           substantially
                                                           fails to
                                                           provide
                                                           medically
                                                           necessary,
                                                           required items
                                                           or services.
                                                          Penalty for a           2019       52,596       53,524
                                                           Medicaid MCO
                                                           that charges
                                                           excessive
                                                           premiums.
                                                          Penalty for a           2019      210,386      214,097
                                                           Medicaid MCO
                                                           that
                                                           improperly
                                                           expels or
                                                           refuses to
                                                           reenroll a
                                                           beneficiary.
                                                          Penalty per             2019       31,558       32,115
                                                           individual who
                                                           does not
                                                           enroll as a
                                                           result of a
                                                           Medicaid MCO's
                                                           practice that
                                                           would
                                                           reasonably be
                                                           expected to
                                                           have the
                                                           effect of
                                                           denying or
                                                           discouraging
                                                           enrollment.
                                                          Penalty for a           2019      210,386      214,097
                                                           Medicaid MCO
                                                           misrepresentin
                                                           g or
                                                           falsifying
                                                           information to
                                                           the Secretary.
                                                          Penalty for a           2019       52,596       53,524
                                                           Medicaid MCO
                                                           misrepresentin
                                                           g or
                                                           falsifying
                                                           information to
                                                           an individual
                                                           or another
                                                           entity.
                                                          Penalty for a           2019       47,357       48,192
                                                           Medicaid MCO
                                                           that fails to
                                                           comply with
                                                           contract
                                                           requirements
                                                           with respect
                                                           to physician
                                                           incentive
                                                           plans.
    1396r(b)(3)(B)(ii)(I)....  42 CFR           OIG       Penalty for             2019        2,194        2,233
                                1003.210(a)(11             willfully and
                                ).                         knowingly
                                                           certifying a
                                                           material and
                                                           false
                                                           statement in a
                                                           Skilled
                                                           Nursing
                                                           Facility
                                                           resident
                                                           assessment.
    1396r(b)(3)(B)(ii)(II)...  42 CFR           OIG       Penalty for             2019       10,967       11,160
                                1003.210(a)(11             willfully and
                                ).                         knowingly
                                                           causing
                                                           another
                                                           individual to
                                                           certify a
                                                           material and
                                                           false
                                                           statement in a
                                                           Skilled
                                                           Nursing
                                                           Facility
                                                           resident
                                                           assessment.
    1396r(g)(2)(A)(i)........  42 CFR           OIG       Penalty for             2019        4,388        4,465
                                1003.1310.                 notifying or
                                                           causing to be
                                                           notified a
                                                           Skilled
                                                           Nursing
                                                           Facility of
                                                           the time or
                                                           date on which
                                                           a survey is to
                                                           be conducted.
    1396r-8(b)(3)(B).........  42 CFR           OIG       Penalty for the         2019      189,427      192,768
                                1003.1210.                 knowing
                                                           provision of
                                                           false
                                                           information or
                                                           refusing to
                                                           provide
                                                           information
                                                           about charges
                                                           or prices of a
                                                           covered
                                                           outpatient
                                                           drug.
    1396r-8(b)(3)(C)(i)......  42 CFR           OIG       Penalty per day         2019       18,943       19,277
                                1003.1210.                 for failure to
                                                           timely provide
                                                           information by
                                                           drug
                                                           manufacturer
                                                           with rebate
                                                           agreement.
    1396r-8(b)(3)(C)(ii).....  42 CFR           OIG       Penalty for             2019      189,427      192,768
                                1003.1210.                 knowing
                                                           provision of
                                                           false
                                                           information by
                                                           drug
                                                           manufacturer
                                                           with rebate
                                                           agreement.
    1396t(i)(3)(A)...........  42 CFR           OIG       Penalty for             2019        3,788        3,855
                                1003.1310.                 notifying home
                                                           and community-
                                                           based
                                                           providers or
                                                           settings of
                                                           survey.
    11131(c).................  42 CFR 1003.810  OIG       Penalty for             2019       22,927       23,331
                                                           failing to
                                                           report a
                                                           medical
                                                           malpractice
                                                           claim to
                                                           National
                                                           Practitioner
                                                           Data Bank.
    11137(b)(2)..............  42 CFR 1003.810  OIG       Penalty for             2019       22,927       23,331
                                                           breaching
                                                           confidentialit
                                                           y of
                                                           information
                                                           reported to
                                                           National
                                                           Practitioner
                                                           Data Bank.
    299b-22(f)(1)............  42 CFR 3.404...  OCR       Penalty for             2019       12,695       12,919
                                                           violation of
                                                           confidentialit
                                                           y provision of
                                                           the Patient
                                                           Safety and
                                                           Quality
                                                           Improvement
                                                           Act.
                               45 CFR           OCR       Penalty for             2019          159          162
                                160.404(b)(1)(             each pre-
                                i), (ii).                  February 18,
                                                           2009 violation
                                                           of the Health
                                                           Insurance
                                                           Portability
                                                           and
                                                           Accountability
                                                           Act (HIPAA)
                                                           administrative
                                                           simplification
                                                           provisions.
                                                          Calendar Year           2019       39,936       40,640
                                                           Cap.

[[Page 2878]]

 
    1320(d)-5(a).............  45 CFR           OCR       Penalty for
                                160.404(b)(2)(             each February
                                i)(A), (B).                18, 2009 or
                                                           later
                                                           violation of a
                                                           HIPAA
                                                           administrative
                                                           simplification
                                                           provision in
                                                           which it is
                                                           established
                                                           that the
                                                           covered entity
                                                           or business
                                                           associate did
                                                           not know and
                                                           by exercising
                                                           reasonable
                                                           diligence,
                                                           would not have
                                                           known that the
                                                           covered entity
                                                           or business
                                                           associate
                                                           violated such
                                                           a provision:
                                                            Minimum......         2019          117          119
                                                            Maximum......         2019       58,490       59,522
                                                            Calendar Year         2019    1,754,698    1,785,651
                                                             Cap.
                               45 CFR           OCR       Penalty for
                                160.404(b)(2)(             each February
                                ii)(A), (B).               18, 2009 or
                                                           later
                                                           violation of a
                                                           HIPAA
                                                           administrative
                                                           simplification
                                                           provision in
                                                           which it is
                                                           established
                                                           that the
                                                           violation was
                                                           due to
                                                           reasonable
                                                           cause and not
                                                           to willful
                                                           neglect:
                                                            Minimum......         2019        1,170        1,191
                                                            Maximum......         2019       58,490       59,522
                                                            Calendar Year         2019    1,754,698    1,785,651
                                                             Cap.
                               45 CFR           OCR       Penalty for
                                160.404(b)(2)(             each February
                                iii)(A), (B).              18, 2009 or
                                                           later
                                                           violation of a
                                                           HIPAA
                                                           administrative
                                                           simplification
                                                           provision in
                                                           which it is
                                                           established
                                                           that the
                                                           violation was
                                                           due to willful
                                                           neglect and
                                                           was corrected
                                                           during the 30-
                                                           day period
                                                           beginning on
                                                           the first date
                                                           the covered
                                                           entity or
                                                           business
                                                           associate
                                                           knew, or, by
                                                           exercising
                                                           reasonable
                                                           diligence,
                                                           would have
                                                           known that the
                                                           violation
                                                           occurred:
                                                            Minimum......         2019       11,698       11,904
                                                            Maximum......         2019       58,490       59,522
                                                            Calendar Year         2019    1,754,698    1,785,651
                                                             Cap.
                               45 CFR           OCR       Penalty for
                                160.404(b)(2)(             each February
                                iv)(A), (B).               18, 2009 or
                                                           later
                                                           violation of a
                                                           HIPAA
                                                           administrative
                                                           simplification
                                                           provision in
                                                           which it is
                                                           established
                                                           that the
                                                           violation was
                                                           due to willful
                                                           neglect and
                                                           was not
                                                           corrected
                                                           during the 30-
                                                           day period
                                                           beginning on
                                                           the first date
                                                           the covered
                                                           entity or
                                                           business
                                                           associate
                                                           knew, or by
                                                           exercising
                                                           reasonable
                                                           diligence,
                                                           would have
                                                           known that the
                                                           violation
                                                           occurred:
                                                            Minimum......         2019       58,490       59,522
                                                            Maximum......         2019    1,754,698    1,785,651
                                                            Calendar Year         2019    1,754,698    1,785,651
                                                             Cap.
    263a(h)(2)(B) & 1395w-     42 CFR           CMS       Penalty for a
     2(b)(2)(A)(ii).            493.1834(d)(2)             clinical
                                (i).                       laboratory's
                                                           failure to
                                                           meet
                                                           participation
                                                           and
                                                           certification
                                                           requirements
                                                           and poses
                                                           immediate
                                                           jeopardy:
                                                            Minimum......         2019        6,417        6,530
                                                            Maximum......         2019       21,039       21,410
                               42 CFR           CMS       Penalty for a
                                493.1834(d)(2)             clinical
                                (ii).                      laboratory's
                                                           failure to
                                                           meet
                                                           participation
                                                           and
                                                           certification
                                                           requirements
                                                           and the
                                                           failure does
                                                           not pose
                                                           immediate
                                                           jeopardy:
                                                            Minimum......         2019          106          108
                                                            Maximum......         2019        6,311        6,422
    300gg-15(f)..............  45 CFR           CMS       Failure to              2019        1,156        1,176
                                147.200(e).                provide the
                                                           Summary of
                                                           Benefits and
                                                           Coverage.
    300gg-18.................  45 CFR 158.606.  CMS       Penalty for             2019          116          118
                                                           violations of
                                                           regulations
                                                           related to the
                                                           medical loss
                                                           ratio
                                                           reporting and
                                                           rebating.
    1320a-7h(b)(1)...........  42 CFR           CMS       Penalty for
                                402.105(d)(5),             manufacturer
                                42 CFR                     or group
                                403.912(a) &               purchasing
                                (c).                       organization
                                                           failing to
                                                           report
                                                           information
                                                           required under
                                                           42 U.S.C.
                                                           1320a-7h(a),
                                                           relating to
                                                           physician
                                                           ownership or
                                                           investment
                                                           interests:
                                                            Minimum......         2019        1,156        1,176
                                                            Maximum......         2019       11,562       11,766
                                                            Calendar Year         2019      173,436      176,495
                                                             Cap.
    1320a-7h(b)(2)...........  42 CFR           CMS       Penalty for
                                402.105(h), 42             manufacturer
                                CFR 403.912(b)             or group
                                & (c).                     purchasing
                                                           organization
                                                           knowingly
                                                           failing to
                                                           report
                                                           information
                                                           required under
                                                           42 U.S.C.
                                                           1320a-7h(a),
                                                           relating to
                                                           physician
                                                           ownership or
                                                           investment
                                                           interests:

[[Page 2879]]

 
                                                            Minimum......         2019       11,562       11,766
                                                            Maximum......         2019      115,624      117,664
                                                            Calendar Year         2019    1,156,242    1,176,638
                                                             Cap.
                                                CMS       Penalty for an          2019      115,624      117,664
                                                           administrator
                                                           of a facility
                                                           that fails to
                                                           comply with
                                                           notice
                                                           requirements
                                                           for the
                                                           closure of a
                                                           facility.
    1320a-7j(h)(3)(A)........  42 CFR           CMS       Minimum penalty         2019          578          588
                                488.446(a)(1),             for the first
                                (2), & (3).                offense of an
                                                           administrator
                                                           who fails to
                                                           provide notice
                                                           of facility
                                                           closure.
                                                          Minimum penalty         2019        1,735        1,766
                                                           for the second
                                                           offense of an
                                                           administrator
                                                           who fails to
                                                           provide notice
                                                           of facility
                                                           closure.
                                                          Minimum penalty         2019        3,468        3,529
                                                           for the third
                                                           and subsequent
                                                           offenses of an
                                                           administrator
                                                           who fails to
                                                           provide notice
                                                           of facility
                                                           closure.
    1320a-8(a)(1)............  ...............  CMS       Penalty for an          2019        8,457        8,606
                                                           entity
                                                           knowingly
                                                           making a false
                                                           statement or
                                                           representation
                                                           of material
                                                           fact in the
                                                           determination
                                                           of the amount
                                                           of benefits or
                                                           payments
                                                           related to old-
                                                           age,
                                                           survivors, and
                                                           disability
                                                           insurance
                                                           benefits,
                                                           special
                                                           benefits for
                                                           certain World
                                                           War II
                                                           veterans, or
                                                           supplemental
                                                           security
                                                           income for the
                                                           aged, blind,
                                                           and disabled.
                                                          Penalty for             2019        7,975        8,116
                                                           violation of
                                                           42 U.S.C.
                                                           1320a-8(a)(1)
                                                           if the
                                                           violator is a
                                                           person who
                                                           receives a fee
                                                           or other
                                                           income for
                                                           services
                                                           performed in
                                                           connection
                                                           with
                                                           determination
                                                           of the benefit
                                                           amount or the
                                                           person is a
                                                           physician or
                                                           other health
                                                           care provider
                                                           who submits
                                                           evidence in
                                                           connection
                                                           with such a
                                                           determination.
    1320a-8(a)(3)............  ...............  CMS       Penalty for a           2019        6,623        6,740
                                                           representative
                                                           payee (under
                                                           42 U.S.C.
                                                           405(j), 1007,
                                                           or 1383(a)(2))
                                                           converting any
                                                           part of a
                                                           received
                                                           payment from
                                                           the benefit
                                                           programs
                                                           described in
                                                           the previous
                                                           civil monetary
                                                           penalty to a
                                                           use other than
                                                           for the
                                                           benefit of the
                                                           beneficiary.
    1320b-25(c)(1)(A)........  ...............  CMS       Penalty for             2019      231,249      235,328
                                                           failure of
                                                           covered
                                                           individuals to
                                                           report to the
                                                           Secretary and
                                                           1 or more law
                                                           enforcement
                                                           officials any
                                                           reasonable
                                                           suspicion of a
                                                           crime against
                                                           a resident, or
                                                           individual
                                                           receiving
                                                           care, from a
                                                           long-term care
                                                           facility.
    1320b-25(c)(2)(A)........  ...............  CMS       Penalty for             2019      346,872      352,991
                                                           failure of
                                                           covered
                                                           individuals to
                                                           report to the
                                                           Secretary and
                                                           1 or more law
                                                           enforcement
                                                           officials any
                                                           reasonable
                                                           suspicion of a
                                                           crime against
                                                           a resident, or
                                                           individual
                                                           receiving
                                                           care, from a
                                                           long-term care
                                                           facility if
                                                           such failure
                                                           exacerbates
                                                           the harm to
                                                           the victim of
                                                           the crime or
                                                           results in the
                                                           harm to
                                                           another
                                                           individual.
    1320b-25(d)(2)...........  ...............  CMS       Penalty for a           2019      231,249      235,328
                                                           long-term care
                                                           facility that
                                                           retaliates
                                                           against any
                                                           employee
                                                           because of
                                                           lawful acts
                                                           done by the
                                                           employee, or
                                                           files a
                                                           complaint or
                                                           report with
                                                           the State
                                                           professional
                                                           disciplinary
                                                           agency against
                                                           an employee or
                                                           nurse for
                                                           lawful acts
                                                           done by the
                                                           employee or
                                                           nurse.
    1395b-7(b)(2)(B).........  42 CFR           CMS       Penalty for any         2019          156          159
                                402.105(g).                person who
                                                           knowingly and
                                                           willfully
                                                           fails to
                                                           furnish a
                                                           beneficiary
                                                           with an
                                                           itemized
                                                           statement of
                                                           items or
                                                           services
                                                           within 30 days
                                                           of the
                                                           beneficiary's
                                                           request.
    1395i-3(h)(2)(B)(ii)(I)..  42 CFR           CMS       Penalty per day
                                488.408(d)(1)(             for a Skilled
                                iii).                      Nursing
                                                           Facility that
                                                           has a Category
                                                           2 violation of
                                                           certification
                                                           requirements:
                                                            Minimum......         2019          110          112
                                                            Maximum......         2019        6,579        6,695
                               42 CFR           CMS       Penalty per
                                488.408(d)(1)(             instance of
                                iv).                       Category 2
                                                           noncompliance
                                                           by a Skilled
                                                           Nursing
                                                           Facility:
                                                            Minimum......         2019        2,194        2,233
                                                            Maximum......         2019       21,933       22,320

[[Page 2880]]

 
                               42 CFR           CMS       Penalty per day
                                488.408(e)(1)(             for a Skilled
                                iii).                      Nursing
                                                           Facility that
                                                           has a Category
                                                           3 violation of
                                                           certification
                                                           requirements:
                                                            Minimum......         2019        6,690        6,808
                                                            Maximum......         2019       21,933       22,320
                               42 CFR           CMS       Penalty per
                                488.408(e)(1)(             instance of
                                iv).                       Category 3
                                                           noncompliance
                                                           by a Skilled
                                                           Nursing
                                                           Facility:
                                                            Minimum......         2019        2,194        2,233
                                                            Maximum......         2019       21,933       22,320
                               42 CFR           CMS       Penalty per day
                                488.408(e)(2)(             and per
                                ii).                       instance for a
                                                           Skilled
                                                           Nursing
                                                           Facility that
                                                           has Category 3
                                                           noncompliance
                                                           with Immediate
                                                           Jeopardy:
                                                          Per Day                 2019        6,690        6,808
                                                           (Minimum).
                                                          Per Day                 2019       21,933       22,320
                                                           (Maximum).
                                                          Per Instance            2019        2,194        2,233
                                                           (Minimum).
                                                          Per Instance            2019       21,933       22,320
                                                           (Maximum).
                               42 CFR           CMS       Penalty per day
                                488.438(a)(1)(             of a Skilled
                                i).                        Nursing
                                                           Facility that
                                                           fails to meet
                                                           certification
                                                           requirements.
                                                           These amounts
                                                           represent the
                                                           upper range
                                                           per day:
                                                            Minimum......         2019        6,690        6,808
                                                            Maximum......         2019       21,933       22,320
                               42 CFR           CMS       Penalty per day
                                488.438(a)(1)(             of a Skilled
                                ii).                       Nursing
                                                           Facility that
                                                           fails to meet
                                                           certification
                                                           requirements.
                                                           These amounts
                                                           represent the
                                                           lower range
                                                           per day:
                                                            Minimum......         2019          110          112
                                                            Maximum......         2019        6,579        6,695
                               42 CFR           CMS       Penalty per
                                488.438(a)(2).             instance of a
                                                           Skilled
                                                           Nursing
                                                           Facility that
                                                           fails to meet
                                                           certification
                                                           requirements:
                                                            Minimum......         2019        2,194        2,233
                                                            Maximum......         2019       21,933       22,320
    1395l(h)(5)(D)...........  42 CFR           CMS       Penalty for             2019       15,975       16,257
                                402.105(d)(2)(             knowingly,
                                i).                        willfully, and
                                                           repeatedly
                                                           billing for a
                                                           clinical
                                                           diagnostic
                                                           laboratory
                                                           test other
                                                           than on an
                                                           assignment-
                                                           related basis.
                                                           (Penalties are
                                                           assessed in
                                                           the same
                                                           manner as 42
                                                           U.S.C.
                                                           1395u(j)(2)(B)
                                                           , which is
                                                           assessed
                                                           according to
                                                           1320a-7a(a)).
    1395l(i)(6)..............  ...............  CMS       Penalty for             2019        4,208        4,282
                                                           knowingly and
                                                           willfully
                                                           presenting or
                                                           causing to be
                                                           presented a
                                                           bill or
                                                           request for
                                                           payment for an
                                                           intraocular
                                                           lens inserted
                                                           during or
                                                           after cataract
                                                           surgery for
                                                           which the
                                                           Medicare
                                                           payment rate
                                                           includes the
                                                           cost of
                                                           acquiring the
                                                           class of lens
                                                           involved.
    1395l(q)(2)(B)(i)........  42 CFR           CMS       Penalty for             2019        4,027        4,098
                                402.105(a).                knowingly and
                                                           willfully
                                                           failing to
                                                           provide
                                                           information
                                                           about a
                                                           referring
                                                           physician when
                                                           seeking
                                                           payment on an
                                                           unassigned
                                                           basis.
    1395m(a)(11)(A)..........  42 CFR           CMS       Penalty for any         2019       15,975       16,257
                                402.1(c)(4),               durable
                                402.105(d)(2)(             medical
                                ii).                       equipment
                                                           supplier that
                                                           knowingly and
                                                           willfully
                                                           charges for a
                                                           covered
                                                           service that
                                                           is furnished
                                                           on a rental
                                                           basis after
                                                           the rental
                                                           payments may
                                                           no longer be
                                                           made.
                                                           (Penalties are
                                                           assessed in
                                                           the same
                                                           manner as 42
                                                           U.S.C.
                                                           1395u(j)(2)(B)
                                                           , which is
                                                           assessed
                                                           according to
                                                           1320a-7a(a)).
    1395m(a)(18)(B)..........  42 CFR           CMS       Penalty for any         2019       15,975       16,257
                                402.1(c)(5),               nonparticipati
                                402.105(d)(2)(             ng durable
                                iii).                      medical
                                                           equipment
                                                           supplier that
                                                           knowingly and
                                                           willfully
                                                           fails to make
                                                           a refund to
                                                           Medicare
                                                           beneficiaries
                                                           for a covered
                                                           service for
                                                           which payment
                                                           is precluded
                                                           due to an
                                                           unsolicited
                                                           telephone
                                                           contact from
                                                           the supplier.
                                                           (Penalties are
                                                           assessed in
                                                           the same
                                                           manner as 42
                                                           U.S.C.
                                                           1395u(j)(2)(B)
                                                           , which is
                                                           assessed
                                                           according to
                                                           1320a-7a(a)).

[[Page 2881]]

 
    1395m(b)(5)(C)...........  42 CFR           CMS       Penalty for any         2019       15,975       16,257
                                402.1(c)(6),               nonparticipati
                                402.105(d)(2)(             ng physician
                                iv).                       or supplier
                                                           that knowingly
                                                           and willfully
                                                           charges a
                                                           Medicare
                                                           beneficiary
                                                           more than the
                                                           limiting
                                                           charge for
                                                           radiologist
                                                           services.
                                                           (Penalties are
                                                           assessed in
                                                           the same
                                                           manner as 42
                                                           U.S.C.
                                                           1395u(j)(2)(B)
                                                           , which is
                                                           assessed
                                                           according to
                                                           1320a-7a(a)).
    1395m(h)(3)..............  42 CFR           CMS       Penalty for any         2019       15,975       16,257
                                402.1(c)(8),               supplier of
                                402.105(d)(2)(             prosthetic
                                vi).                       devices,
                                                           orthotics, and
                                                           prosthetics
                                                           that knowing
                                                           and willfully
                                                           charges for a
                                                           covered
                                                           prosthetic
                                                           device,
                                                           orthotic, or
                                                           prosthetic
                                                           that is
                                                           furnished on a
                                                           rental basis
                                                           after the
                                                           rental payment
                                                           may no longer
                                                           be made.
                                                           (Penalties are
                                                           assessed in
                                                           the same
                                                           manner as 42
                                                           U.S.C.
                                                           1395m(a)(11)(A
                                                           ), that is in
                                                           the same
                                                           manner as
                                                           1395u(j)(2)(B)
                                                           , which is
                                                           assessed
                                                           according to
                                                           1320a-7a(a)).
    1395m(j)(2)(A)(iii)......  ...............  CMS       Penalty for any         2019        1,692        1,722
                                                           supplier of
                                                           durable
                                                           medical
                                                           equipment
                                                           including a
                                                           supplier of
                                                           prosthetic
                                                           devices,
                                                           prosthetics,
                                                           orthotics, or
                                                           supplies that
                                                           knowingly and
                                                           willfully
                                                           distributes a
                                                           certificate of
                                                           medical
                                                           necessity in
                                                           violation of
                                                           Section
                                                           1834(j)(2)(A)(
                                                           i) of the Act
                                                           or fails to
                                                           provide the
                                                           information
                                                           required under
                                                           Section
                                                           1834(j)(2)(A)(
                                                           ii) of the Act.
    1395m(j)(4)..............  42 CFR           CMS       Penalty for any         2019       15,975       16,257
                                402.1(c)(10),              supplier of
                                402.105(d)(2)(             durable
                                vii).                      medical
                                                           equipment,
                                                           including a
                                                           supplier of
                                                           prosthetic
                                                           devices,
                                                           prosthetics,
                                                           orthotics, or
                                                           supplies that
                                                           knowingly and
                                                           willfully
                                                           fails to make
                                                           refunds in a
                                                           timely manner
                                                           to Medicare
                                                           beneficiaries
                                                           for series
                                                           billed other
                                                           than on as
                                                           assignment-
                                                           related basis
                                                           under certain
                                                           conditions.
                                                           (Penalties are
                                                           assessed in
                                                           the same
                                                           manner as 42
                                                           U.S.C.
                                                           1395m(j)(4)
                                                           and
                                                           1395u(j)(2)(B)
                                                           , which is
                                                           assessed
                                                           according to
                                                           1320a-7a(a)).
    1395m(k)(6)..............  42 CFR           CMS       Penalty for any         2019       15,975       16,257
                                402.1(c)(31),              person or
                                402.105(d)(3).             entity who
                                                           knowingly and
                                                           willfully
                                                           bills or
                                                           collects for
                                                           any outpatient
                                                           therapy
                                                           services or
                                                           comprehensive
                                                           outpatient
                                                           rehabilitation
                                                           services on
                                                           other than an
                                                           assignment-
                                                           related basis.
                                                           (Penalties are
                                                           assessed in
                                                           the same
                                                           manner as 42
                                                           U.S.C.
                                                           1395m(k)(6)
                                                           and
                                                           1395u(j)(2)(B)
                                                           , which is
                                                           assessed
                                                           according to
                                                           1320a-7a(a)).
    1395m(l)(6)..............  42 CFR           CMS       Penalty for any         2019       15,975       16,257
                                402.1(c)(32),              supplier of
                                402.105(d)(4).             ambulance
                                                           services who
                                                           knowingly and
                                                           willfully
                                                           fills or
                                                           collects for
                                                           any services
                                                           on other than
                                                           an assignment-
                                                           related basis.
                                                           (Penalties are
                                                           assessed in
                                                           the same
                                                           manner as 42
                                                           U.S.C.
                                                           1395u(b)(18)(B
                                                           ), which is
                                                           assessed
                                                           according to
                                                           1320a-7a(a)).
    1395u(b)(18)(B)..........  42 CFR           CMS       Penalty for any         2019       15,975       16,257
                                402.1(c)(11),              practitioner
                                402.105(d)(2)(             specified in
                                viii).                     Section
                                                           1842(b)(18)(C)
                                                           of the Act or
                                                           other person
                                                           that knowingly
                                                           and willfully
                                                           bills or
                                                           collects for
                                                           any services
                                                           by the
                                                           practitioners
                                                           on other than
                                                           an assignment-
                                                           related basis.
                                                           (Penalties are
                                                           assessed in
                                                           the same
                                                           manner as 42
                                                           U.S.C.
                                                           1395u(j)(2)(B)
                                                           , which is
                                                           assessed
                                                           according to
                                                           1320a-7a(a)).
    1395u(j)(2)(B)...........  42 CFR 402.1(c)  CMS       Penalty for any         2019       15,975       16,257
                                                           physician who
                                                           charges more
                                                           than 125% for
                                                           a non-
                                                           participating
                                                           referral.
                                                           (Penalties are
                                                           assessed in
                                                           the same
                                                           manner as 42
                                                           U.S.C. 1320a-
                                                           7a(a)).

[[Page 2882]]

 
    1395u(k).................  42 CFR           CMS       Penalty for any         2019       15,975       16,257
                                402.1(c)(12),              physician who
                                402.105(d)(2)(             knowingly and
                                ix).                       willfully
                                                           presents or
                                                           causes to be
                                                           presented a
                                                           claim for bill
                                                           for an
                                                           assistant at a
                                                           cataract
                                                           surgery
                                                           performed on
                                                           or after March
                                                           1, 1987, for
                                                           which payment
                                                           may not be
                                                           made because
                                                           of section
                                                           1862(a)(15).
                                                           (Penalties are
                                                           assessed in
                                                           the same
                                                           manner as 42
                                                           U.S.C.
                                                           1395u(j)(2)(B)
                                                           , which is
                                                           assessed
                                                           according to
                                                           1320a-7a(a)).
    1395u(l)(3)..............  42 CFR           CMS       Penalty for any         2019       15,975       16,257
                                402.1(c)(13),              nonparticipati
                                402.105(d)(2)(             ng physician
                                x).                        who does not
                                                           accept payment
                                                           on an
                                                           assignment-
                                                           related basis
                                                           and who
                                                           knowingly and
                                                           willfully
                                                           fails to
                                                           refund on a
                                                           timely basis
                                                           any amounts
                                                           collected for
                                                           services that
                                                           are not
                                                           reasonable or
                                                           medically
                                                           necessary or
                                                           are of poor
                                                           quality under
                                                           1842(l)(1)(A).
                                                           (Penalties are
                                                           assessed in
                                                           the same
                                                           manner as 42
                                                           U.S.C.
                                                           1395u(j)(2)(B)
                                                           , which is
                                                           assessed
                                                           according to
                                                           1320a-7a(a)).
    1395u(m)(3)..............  42 CFR           CMS       Penalty for any         2019       15,975       16,257
                                402.1(c)(14),              nonparticipati
                                402.105(d)(2)(             ng physician
                                xi).                       charging more
                                                           than $500 who
                                                           does not
                                                           accept payment
                                                           for an
                                                           elective
                                                           surgical
                                                           procedure on
                                                           an assignment
                                                           related basis
                                                           and who
                                                           knowingly and
                                                           willfully
                                                           fails to
                                                           disclose the
                                                           required
                                                           information
                                                           regarding
                                                           charges and
                                                           coinsurance
                                                           amounts and
                                                           fails to
                                                           refund on a
                                                           timely basis
                                                           any amount
                                                           collected for
                                                           the procedure
                                                           in excess of
                                                           the charges
                                                           recognized and
                                                           approved by
                                                           the Medicare
                                                           program.
                                                           (Penalties are
                                                           assessed in
                                                           the same
                                                           manner as 42
                                                           U.S.C.
                                                           1395u(j)(2)(B)
                                                           , which is
                                                           assessed
                                                           according to
                                                           1320a-7a(a)).
    1395u(n)(3)..............  42 CFR           CMS       Penalty for any         2019       15,975       16,257
                                402.1(c)(15),              physician who
                                402.105(d)(2)(             knowingly,
                                xii).                      willfully, and
                                                           repeatedly
                                                           bills one or
                                                           more
                                                           beneficiaries
                                                           for purchased
                                                           diagnostic
                                                           tests any
                                                           amount other
                                                           than the
                                                           payment amount
                                                           specified by
                                                           the Act.
                                                           (Penalties are
                                                           assessed in
                                                           the same
                                                           manner as 42
                                                           U.S.C.
                                                           1395u(j)(2)(B)
                                                           , which is
                                                           assessed
                                                           according to
                                                           1320a-7a(a)).
    1395u(o)(3)(B)...........  42 CFR           CMS       Penalty for any         2019       15,975       16,257
                                414.707(b).                practitioner
                                                           specified in
                                                           Section
                                                           1842(b)(18)(C)
                                                           of the Act or
                                                           other person
                                                           that knowingly
                                                           and willfully
                                                           bills or
                                                           collects for
                                                           any services
                                                           pertaining to
                                                           drugs or
                                                           biologics by
                                                           the
                                                           practitioners
                                                           on other than
                                                           an assignment-
                                                           related basis.
                                                           (Penalties are
                                                           assessed in
                                                           the same
                                                           manner as 42
                                                           U.S.C.
                                                           1395u(b)(18)(B
                                                           ) and
                                                           1395u(j)(2)(B)
                                                           , which is
                                                           assessed
                                                           according to
                                                           1320a-7a(a)).
    1395u(p)(3)(A)...........  ...............  CMS       Penalty for any         2019        4,208        4,282
                                                           physician or
                                                           practitioner
                                                           who knowingly
                                                           and willfully
                                                           fails promptly
                                                           to provide the
                                                           appropriate
                                                           diagnosis
                                                           codes upon CMS
                                                           or Medicare
                                                           administrative
                                                           contractor
                                                           request for
                                                           payment or
                                                           bill not
                                                           submitted on
                                                           an assignment-
                                                           related basis.
    1395w-3a(d)(4)(A)........  42 CFR 414.806.  CMS       Penalty for a           2019       13,669       13,910
                                                           pharmaceutical
                                                           manufacturer's
                                                           misrepresentat
                                                           ion of average
                                                           sales price of
                                                           a drug, or
                                                           biologic.
    1395w-4(g)(1)(B).........  42 CFR           CMS       Penalty for any         2019       15,975       16,257
                                402.1(c)(17),              nonparticipati
                                402.105(d)(2)(             ng physician,
                                xiii).                     supplier, or
                                                           other person
                                                           that furnishes
                                                           physician
                                                           services not
                                                           on an
                                                           assignment-
                                                           related basis
                                                           who either
                                                           knowingly and
                                                           willfully
                                                           bills or
                                                           collects in
                                                           excess of the
                                                           statutorily-
                                                           defined
                                                           limiting
                                                           charge or
                                                           fails to make
                                                           a timely
                                                           refund or
                                                           adjustment.
                                                           (Penalties are
                                                           assessed in
                                                           the same
                                                           manner as 42
                                                           U.S.C.
                                                           1395u(j)(2)(B)
                                                           , which is
                                                           assessed
                                                           according to
                                                           1320a-7a(a)).

[[Page 2883]]

 
    1395w-4(g)(3)(B).........  42 CFR           CMS       Penalty for any         2019       15,975       16,257
                                402.1(c)(18),              person that
                                402.105(d)(2)(             knowingly and
                                xiv).                      willfully
                                                           bills for
                                                           statutorily
                                                           defined State-
                                                           plan approved
                                                           physicians'
                                                           services on
                                                           any other
                                                           basis than an
                                                           assignment-
                                                           related basis
                                                           for a Medicare/
                                                           Medicaid dual
                                                           eligible
                                                           beneficiary.
                                                           (Penalties are
                                                           assessed in
                                                           the same
                                                           manner as 42
                                                           U.S.C.
                                                           1395u(j)(2)(B)
                                                           , which is
                                                           assessed
                                                           according to
                                                           1320a-7a(a)).
    1395w-27(g)(3)(A);         42 CFR           CMS       Penalty for             2019       39,121       39,811
     1857(g)(3).                422.760(b); 42             each
                                CFR 423.760(b).            termination
                                                           determination
                                                           the Secretary
                                                           makes that is
                                                           the result of
                                                           actions by a
                                                           Medicare
                                                           Advantage
                                                           organization
                                                           or Part D
                                                           sponsor that
                                                           has adversely
                                                           affected an
                                                           individual
                                                           covered under
                                                           the
                                                           organization's
                                                           contract.
    1395w-27(g)(3)(B);         ...............  CMS       Penalty for             2019       15,649       15,925
     1857(g)(3).                                           each week
                                                           beginning
                                                           after the
                                                           initiation of
                                                           civil money
                                                           penalty
                                                           procedures by
                                                           the Secretary
                                                           because a
                                                           Medicare
                                                           Advantage
                                                           organization
                                                           or Part D
                                                           sponsor has
                                                           failed to
                                                           carry out a
                                                           contract, or
                                                           has carried
                                                           out a contract
                                                           inconsistently
                                                           with
                                                           regulations.
    1395w-27(g)(3)(D);         ...............  CMS       Penalty for a           2019      145,335      147,899
     1857(g)(3).                                           Medicare
                                                           Advantage
                                                           organization's
                                                           or Part D
                                                           sponsor's
                                                           early
                                                           termination of
                                                           its contract.
    1395y(b)(3)(C)...........  42 CFR           CMS       Penalty for an          2019        9,472        9,639
                                411.103(b).                employer or
                                                           other entity
                                                           to offer any
                                                           financial or
                                                           other
                                                           incentive for
                                                           an individual
                                                           entitled to
                                                           benefits not
                                                           to enroll
                                                           under a group
                                                           health plan or
                                                           large group
                                                           health plan
                                                           which would be
                                                           a primary plan.
    1395y(b)(5)(C)(ii).......  42 CFR           CMS       Penalty for any         2019        1,542        1,569
                                402.1(c)(20),              non-
                                42 CFR                     governmental
                                402.105(b)(2).             employer that,
                                                           before October
                                                           1, 1998,
                                                           willfully or
                                                           repeatedly
                                                           failed to
                                                           provide timely
                                                           and accurate
                                                           information
                                                           requested
                                                           relating to an
                                                           employee's
                                                           group health
                                                           insurance
                                                           coverage.
    1395y(b)(6)(B)...........  42 CFR           CMS       Penalty for any         2019        3,383        3,443
                                402.1(c)(21),              entity that
                                402.105(a).                knowingly,
                                                           willfully, and
                                                           repeatedly
                                                           fails to
                                                           complete a
                                                           claim form
                                                           relating to
                                                           the
                                                           availability
                                                           of other
                                                           health
                                                           benefits in
                                                           accordance
                                                           with statute
                                                           or provides
                                                           inaccurate
                                                           information
                                                           relating to
                                                           such on the
                                                           claim form.
    1395y(b)(7)(B)(i)........  ...............  CMS       Penalty for any         2019        1,211        1,232
                                                           entity serving
                                                           as insurer,
                                                           third party
                                                           administrator,
                                                           or fiduciary
                                                           for a group
                                                           health plan
                                                           that fails to
                                                           provide
                                                           information
                                                           that
                                                           identifies
                                                           situations
                                                           where the
                                                           group health
                                                           plan is or was
                                                           a primary plan
                                                           to Medicare to
                                                           the HHS
                                                           Secretary.
    1395y(b)(8)(E)...........  ...............  CMS       Penalty for any         2019        1,211        1,232
                                                           non-group
                                                           health plan
                                                           that fails to
                                                           identify
                                                           claimants who
                                                           are Medicare
                                                           beneficiaries
                                                           and provide
                                                           information to
                                                           the HHS
                                                           Secretary to
                                                           coordinate
                                                           benefits and
                                                           pursue any
                                                           applicable
                                                           recovery claim.
    1395nn(g)(5).............  42 CFR 411.361.  CMS       Penalty for any         2019       20,134       20,489
                                                           person that
                                                           fails to
                                                           report
                                                           information
                                                           required by
                                                           HHS under
                                                           Section
                                                           1877(f)
                                                           concerning
                                                           ownership,
                                                           investment,
                                                           and
                                                           compensation
                                                           arrangements.
    1395pp(h)................  42 CFR           CMS       Penalty for any         2019       15,975       16,257
                                402.1(c)(23),              durable
                                402.105(d)(2)(             medical
                                xv).                       equipment
                                                           supplier,
                                                           including a
                                                           supplier of
                                                           prosthetic
                                                           devices,
                                                           prosthetics,
                                                           orthotics, or
                                                           supplies, that
                                                           knowingly and
                                                           willfully
                                                           fails to make
                                                           refunds in a
                                                           timely manner
                                                           to Medicare
                                                           beneficiaries
                                                           under certain
                                                           conditions.
                                                           (42 U.S.C.
                                                           1395(m)(18)
                                                           sanctions
                                                           apply here in
                                                           the same
                                                           manner, which
                                                           is under
                                                           1395u(j)(2)
                                                           and 1320a-
                                                           7a(a)).
    1395ss(a)(2).............  42 CFR           CMS       Penalty for any         2019       54,832       55,799
                                402.1(c)(24),              person that
                                405.105(f)(1).             issues a
                                                           Medicare
                                                           supplemental
                                                           policy that
                                                           has not been
                                                           approved by
                                                           the State
                                                           regulatory
                                                           program or
                                                           does not meet
                                                           Federal
                                                           standards
                                                           after a
                                                           statutorily
                                                           defined
                                                           effective date.

[[Page 2884]]

 
    1395ss(d)(3)(A)(vi)(II)..                   CMS       Penalty for             2019       28,413       28,914
                                                           someone other
                                                           than issuer
                                                           that sells or
                                                           issues a
                                                           Medicare
                                                           supplemental
                                                           policy to
                                                           beneficiary
                                                           without a
                                                           disclosure
                                                           statement.
                                                          Penalty for an          2019       47,357       48,192
                                                           issuer that
                                                           sells or
                                                           issues a
                                                           Medicare
                                                           supplemental
                                                           policy without
                                                           disclosure
                                                           statement.
    1395ss(d)(3)(B)(iv)......  ...............  CMS       Penalty for             2019       28,413       28,914
                                                           someone other
                                                           than issuer
                                                           that sells or
                                                           issues a
                                                           Medicare
                                                           supplemental
                                                           policy without
                                                           acknowledgemen
                                                           t form.
                                                          Penalty for             2019       47,357       48,192
                                                           issuer that
                                                           sells or
                                                           issues a
                                                           Medicare
                                                           supplemental
                                                           policy without
                                                           an
                                                           acknowledgemen
                                                           t form.
    1395ss(p)(8).............  42 CFR           CMS       Penalty for any         2019       28,413       28,914
                                402.1(c)(25),              person that
                                402.105(e).                sells or
                                                           issues
                                                           Medicare
                                                           supplemental
                                                           polices after
                                                           a given date
                                                           that fail to
                                                           conform to the
                                                           National
                                                           Association of
                                                           Insurance
                                                           Commissioners
                                                           (NAIC) or
                                                           Federal
                                                           standards
                                                           established by
                                                           statute.
                               42 CFR           CMS       Penalty for any         2019       47,357       48,192
                                402.1(c)(25),              person that
                                405.105(f)(2).             sells or
                                                           issues
                                                           Medicare
                                                           supplemental
                                                           polices after
                                                           a given date
                                                           that fail to
                                                           conform to the
                                                           NAIC or
                                                           Federal
                                                           standards
                                                           established by
                                                           statute.
    1395ss(p)(9)(C)..........  42 CFR           CMS       Penalty for any         2019       28,413       28,914
                                402.1(c)(26),              person that
                                402.105(e).                sells a
                                                           Medicare
                                                           supplemental
                                                           policy and
                                                           fails to make
                                                           available for
                                                           sale the core
                                                           group of basic
                                                           benefits when
                                                           selling other
                                                           Medicare
                                                           supplemental
                                                           policies with
                                                           additional
                                                           benefits or
                                                           fails to
                                                           provide the
                                                           individual,
                                                           before selling
                                                           the policy, an
                                                           outline of
                                                           coverage
                                                           describing
                                                           benefits.
                               42 CFR           ........  Penalty for any         2019       47,357       48,192
                                402.1(c)(26),              person that
                                405.105(f)(3),             sells a
                                (4).                       Medicare
                                                           supplemental
                                                           policy and
                                                           fails to make
                                                           available for
                                                           sale the core
                                                           group of basic
                                                           benefits when
                                                           selling other
                                                           Medicare
                                                           supplemental
                                                           policies with
                                                           additional
                                                           benefits or
                                                           fails to
                                                           provide the
                                                           individual,
                                                           before selling
                                                           the policy, an
                                                           outline of
                                                           coverage
                                                           describing
                                                           benefits.
    1395ss(q)(5)(C)..........  42 CFR           CMS       Penalty for any         2019       47,357       48,192
                                402.1(c)(27),              person that
                                405.105(f)(5).             fails to
                                                           suspend the
                                                           policy of a
                                                           policyholder
                                                           made eligible
                                                           for medical
                                                           assistance or
                                                           automatically
                                                           reinstates the
                                                           policy of a
                                                           policyholder
                                                           who has lost
                                                           eligibility
                                                           for medical
                                                           assistance,
                                                           under certain
                                                           circumstances.
    1395ss(r)(6)(A)..........  42 CFR           CMS       Penalty for any         2019       47,357       48,192
                                402.1(c)(28),              person that
                                405.105(f)(6).             fails to
                                                           provide
                                                           refunds or
                                                           credits as
                                                           required by
                                                           section
                                                           1882(r)(1)(B).
    1395ss(s)(4).............  42 CFR           CMS       Penalty for any         2019       20,104       20,459
                                402.1(c)(29),              issuer of a
                                405.105(c).                Medicare
                                                           supplemental
                                                           policy that
                                                           does not waive
                                                           listed time
                                                           periods if
                                                           they were
                                                           already
                                                           satisfied
                                                           under a
                                                           proceeding
                                                           Medicare
                                                           supplemental
                                                           policy, or
                                                           denies a
                                                           policy, or
                                                           conditions the
                                                           issuances or
                                                           effectiveness
                                                           of the policy,
                                                           or
                                                           discriminates
                                                           in the pricing
                                                           of the policy
                                                           base on health
                                                           status or
                                                           other
                                                           specified
                                                           criteria.
    1395ss(t)(2).............  42 CFR           CMS       Penalty for any         2019       47,357       48,192
                                402.1(c)(30),              issuer of a
                                405.105(f)(7).             Medicare
                                                           supplemental
                                                           policy that
                                                           fails to
                                                           fulfill listed
                                                           responsibiliti
                                                           es.
    1395ss(v)(4)(A)..........  ...............  CMS       Penalty someone         2019       20,503       20,865
                                                           other than
                                                           issuer who
                                                           sells, issues,
                                                           or renews a
                                                           Medigap Rx
                                                           policy to an
                                                           individual who
                                                           is a Part D
                                                           enrollee.
                                                          Penalty for an          2019       34,174       34,777
                                                           issuer who
                                                           sells, issues,
                                                           or renews a
                                                           Medigap Rx
                                                           policy who is
                                                           a Part D
                                                           enrollee.
    1395bbb(c)(1)............  42 CFR           CMS       Penalty for any         2019        4,388        4,465
                                488.725(c).                individual who
                                                           notifies or
                                                           causes to be
                                                           notified a
                                                           home health
                                                           agency of the
                                                           time or date
                                                           on which a
                                                           survey of such
                                                           agency is to
                                                           be conducted.
    1395bbb(f)(2)(A)(i)......  42 CFR           CMS       Maximum daily           2019       21,039       21,410
                                488.845(b)(2)(             penalty amount
                                iii) 42 CFR                for each day a
                                488.845(b)(3)-             home health
                                (6); and 42                agency is not
                                CFR                        in compliance
                                488.845(d)(1)(             with statutory
                                ii).                       requirements.

[[Page 2885]]

 
                               42 CFR           ........  Penalty per day
                                488.845(b)(3).             for home
                                                           health
                                                           agency's
                                                           noncompliance
                                                           (Upper Range):
                                                            Minimum......         2019       17,883       18,198
                                                            Maximum......         2019       21,039       21,410
                               42 CFR           ........  Penalty for a           2019       21,039       21,410
                                488.845(b)(3)(             home health
                                i).                        agency's
                                                           deficiency or
                                                           deficiencies
                                                           that cause
                                                           immediate
                                                           jeopardy and
                                                           result in
                                                           actual harm.
                               42 CFR           ........  Penalty for a           2019       18,934       19,268
                                488.845(b)(3)(             home health
                                ii).                       agency's
                                                           deficiency or
                                                           deficiencies
                                                           that cause
                                                           immediate
                                                           jeopardy and
                                                           result in
                                                           potential for
                                                           harm.
                               42 CFR           ........  Penalty for an          2019       17,883       18,198
                                488.845(b)(3)(             isolated
                                iii).                      incident of
                                                           noncompliance
                                                           in violation
                                                           of established
                                                           home health
                                                           agency (HHA)
                                                           policy.
                               42 CFR           ........  Penalty for a
                                488.845(b)(4).             repeat and/or
                                                           condition-
                                                           level
                                                           deficiency
                                                           that does not
                                                           constitute
                                                           immediate
                                                           jeopardy, but
                                                           is directly
                                                           related to
                                                           poor quality
                                                           patient care
                                                           outcomes
                                                           (Lower Range):
                                                            Minimum......         2019        3,157        3,213
                                                            Maximum......         2019       17,883       18,198
                               42 CFR           ........  Penalty for a
                                488.845(b)(5).             repeat and/or
                                                           condition-
                                                           level
                                                           deficiency
                                                           that does not
                                                           constitute
                                                           immediate
                                                           jeopardy and
                                                           that is
                                                           related
                                                           predominately
                                                           to structure
                                                           or process-
                                                           oriented
                                                           conditions
                                                           (Lower Range):
                                                            Minimum......         2019        1,052        1,071
                                                            Maximum......         2019        8,415        8,563
                               42 CFR           ........  Penalty imposed
                                488.845(b)(6).             for instance
                                                           of
                                                           noncompliance
                                                           that may be
                                                           assessed for
                                                           one or more
                                                           singular
                                                           events of
                                                           condition-
                                                           level
                                                           noncompliance
                                                           that are
                                                           identified and
                                                           where the
                                                           noncompliance
                                                           was corrected
                                                           during the
                                                           onsite survey:
                                                            Minimum......         2019        2,104        2,141
                                                            Maximum......         2019       21,039       21,410
                                                          Penalty for             2019       21,039       21,410
                                                           each day of
                                                           noncompliance
                                                           (Maximum).
                               42 CFR                     Penalty for             2019       21,039       21,410
                                488.845(d)(1)(             each day of
                                ii).                       noncompliance
                                                           (Maximum).
    1396b(m)(5)(B)...........  42 CFR 460.46..  CMS       Penalty for
                                                           Programs of
                                                           All-Inclusive
                                                           Care for the
                                                           Elderly (PACE)
                                                           organization's
                                                           practice that
                                                           would
                                                           reasonably be
                                                           expected to
                                                           have the
                                                           effect of
                                                           denying or
                                                           discouraging
                                                           enrollment:
                                                            Minimum......         2019       23,473       23,887
                                                            Maximum......         2019      156,488      159,248
                                                          Penalty for a           2019       39,121       39,811
                                                           PACE
                                                           organization
                                                           that charges
                                                           excessive
                                                           premiums.
                                                          Penalty for a           2019      156,488      159,248
                                                           PACE
                                                           organization
                                                           misrepresentin
                                                           g or
                                                           falsifying
                                                           information to
                                                           CMS, the
                                                           State, or an
                                                           individual or
                                                           other entity.
                                                          Penalty for             2019       39,121       39,811
                                                           each
                                                           determination
                                                           the CMS makes
                                                           that the PACE
                                                           organization
                                                           has failed to
                                                           provide
                                                           medically
                                                           necessary
                                                           items and
                                                           services of
                                                           the failure
                                                           has adversely
                                                           affected (or
                                                           has the
                                                           substantial
                                                           likelihood of
                                                           adversely
                                                           affecting) a
                                                           PACE
                                                           participant.
                                                          Penalty for             2019       39,121       39,811
                                                           involuntarily
                                                           disenrolling a
                                                           participant.
                                                          Penalty for             2019       39,121       39,811
                                                           discriminating
                                                           or
                                                           discouraging
                                                           enrollment or
                                                           disenrollment
                                                           of
                                                           participants
                                                           on the basis
                                                           of an
                                                           individual's
                                                           health status
                                                           or need for
                                                           health care
                                                           services.
    1396r(h)(3)(C)(ii)(I)....  42 CFR           CMS       Penalty per day
                                488.408(d)(1)(             for a nursing
                                iii).                      facility's
                                                           failure to
                                                           meet a
                                                           Category 2
                                                           Certification:
                                                            Minimum......         2019          110          112
                                                            Maximum......         2019        6,579        6,695
                               42 CFR           CMS       Penalty per
                                488.408(d)(1)(             instance for a
                                iv).                       nursing
                                                           facility's
                                                           failure to
                                                           meet Category
                                                           2
                                                           certification:
                                                            Minimum......         2019        2,194        2,233
                                                            Maximum......         2019       21,933       22,320
                               42 CFR           CMS       Penalty per day
                                488.408(e)(1)(             for a nursing
                                iii).                      facility's
                                                           failure to
                                                           meet Category
                                                           3
                                                           certification:

[[Page 2886]]

 
                                                            Minimum......         2019        6,690        6,808
                                                            Maximum......         2019       21,933       22,320
                               42 CFR           CMS       Penalty per
                                488.408(e)(1)(             instance for a
                                iv).                       nursing
                                                           facility's
                                                           failure to
                                                           meet Category
                                                           3
                                                           certification:
                                                            Minimum......         2019        2,194        2,233
                                                            Maximum......         2019       21,933       22,320
                               42 CFR           CMS       Penalty per
                                488.408(e)(2)(             instance for a
                                ii).                       nursing
                                                           facility's
                                                           failure to
                                                           meet Category
                                                           3
                                                           certification,
                                                           which results
                                                           in immediate
                                                           jeopardy:
                                                            Minimum......         2019        2,194        2,233
                                                            Maximum......         2019       21,933       22,320
                               42 CFR           CMS       Penalty per day
                                488.438(a)(1)(             for nursing
                                i).                        facility's
                                                           failure to
                                                           meet
                                                           certification
                                                           (Upper Range):
                                                            Minimum......         2019        6,690        6,808
                                                            Maximum......         2019       21,933       22,320
                               42 CFR           CMS       Penalty per day
                                488.438(a)(1)(             for nursing
                                ii).                       facility's
                                                           failure to
                                                           meet
                                                           certification
                                                           (Lower Range):
                                                            Minimum......         2019          110          112
                                                            Maximum......         2019        6,579        6,695
                               42 CFR           CMS       Penalty per
                                488.438(a)(2).             instance for
                                                           nursing
                                                           facility's
                                                           failure to
                                                           meet
                                                           certification:
                                                            Minimum......         2019        2,194        2,233
                                                            Maximum......         2019       21,933       22,320
    1396r(f)(2)(B)(iii)(I)(c)  42 CFR           CMS       Grounds to              2019       10,967       11,160
                                483.151(b)(2)(             prohibit
                                iv) and                    approval of
                                (b)(3)(iii).               Nurse Aide
                                                           Training
                                                           Program--if
                                                           assessed a
                                                           penalty in
                                                           1819(h)(2)(B)(
                                                           i) or
                                                           1919(h)(2)(A)(
                                                           ii) of ``not
                                                           less than
                                                           $5,000'' [Not
                                                           civil monetary
                                                           penalties
                                                           (CMPs)
                                                           authority, but
                                                           a specific CMP
                                                           amount (CMP at
                                                           this level)
                                                           that is the
                                                           triggering
                                                           condition for
                                                           disapproval].
    1396r(h)(3)(C)(ii)(I)....  42 CFR           CMS       Grounds to              2019       10,967       11,160
                                483.151(c)(2).             waive
                                                           disapproval of
                                                           nurse aide
                                                           training
                                                           program--refer
                                                           ence to
                                                           disapproval
                                                           based on
                                                           imposition of
                                                           CMP ``not less
                                                           than $5,000''
                                                           [Not CMP
                                                           authority but
                                                           CMP imposition
                                                           at this level
                                                           determines
                                                           eligibility to
                                                           seek waiver of
                                                           disapproval of
                                                           nurse aide
                                                           training
                                                           program].
    1396t(j)(2)(C)...........  ...............  CMS       Penalty for
                                                           each day of
                                                           noncompliance
                                                           for a home or
                                                           community care
                                                           provider that
                                                           no longer
                                                           meets the
                                                           minimum
                                                           requirements
                                                           for home and
                                                           community
                                                           care:
                                                            Minimum......         2019            2            2
                                                            Maximum......         2019       18,943       19,277
    1396u-2(e)(2)(A)(i)......  42 CFR 438.704.  CMS       Penalty for a           2019       39,121       39,811
                                                           Medicaid
                                                           managed care
                                                           organization
                                                           that fails
                                                           substantially
                                                           to provide
                                                           medically
                                                           necessary
                                                           items and
                                                           services.
                                                          Penalty for             2019       39,121       39,811
                                                           Medicaid
                                                           managed care
                                                           organization
                                                           that imposes
                                                           premiums or
                                                           charges on
                                                           enrollees in
                                                           excess of the
                                                           premiums or
                                                           charges
                                                           permitted.
                                                          Penalty for a           2019       39,121       39,811
                                                           Medicaid
                                                           managed care
                                                           organization
                                                           that
                                                           misrepresents
                                                           or falsifies
                                                           information to
                                                           another
                                                           individual or
                                                           entity.
                                                          Penalty for a           2019       39,121       39,811
                                                           Medicaid
                                                           managed care
                                                           organization
                                                           that fails to
                                                           comply with
                                                           the applicable
                                                           statutory
                                                           requirements
                                                           for such
                                                           organizations.
    1396u-2(e)(2)(A)(ii).....  42 CFR 438.704.  CMS       Penalty for a           2019      156,488      159,248
                                                           Medicaid
                                                           managed care
                                                           organization
                                                           that
                                                           misrepresents
                                                           or falsifies
                                                           information to
                                                           the HHS
                                                           Secretary.
                                                          Penalty for             2019      156,488      159,248
                                                           Medicaid
                                                           managed care
                                                           organization
                                                           that acts to
                                                           discriminate
                                                           among
                                                           enrollees on
                                                           the basis of
                                                           their health
                                                           status.
    1396u-2(e)(2)(A)(iv).....  42 CFR 438.704.  CMS       Penalty for             2019       23,473       23,887
                                                           each
                                                           individual
                                                           that does not
                                                           enroll as a
                                                           result of a
                                                           Medicaid
                                                           managed care
                                                           organization
                                                           that acts to
                                                           discriminate
                                                           among
                                                           enrollees on
                                                           the basis of
                                                           their health
                                                           status.
    1396u(h)(2)..............  42 CFR Part      CMS       Penalty for a           2019       21,933       22,320
                                441, Subpart I.            provider not
                                                           meeting one of
                                                           the
                                                           requirements
                                                           relating to
                                                           the protection
                                                           of the health,
                                                           safety, and
                                                           welfare of
                                                           individuals
                                                           receiving
                                                           community
                                                           supported
                                                           living
                                                           arrangements
                                                           services.

[[Page 2887]]

 
    1396w-2(c)(1)............  ...............  CMS       Penalty for             2019       11,698       11,904
                                                           disclosing
                                                           information
                                                           related to
                                                           eligibility
                                                           determinations
                                                           for medical
                                                           assistance
                                                           programs.
    18041(c)(2)..............  45 CFR 150.315;  CMS       Failure to              2019          159          162
                                45 CFR                     comply with
                                156.805(c).                requirements
                                                           of the Public
                                                           Health
                                                           Services Act;
                                                           Penalty for
                                                           violations of
                                                           rules or
                                                           standards of
                                                           behavior
                                                           associated
                                                           with issuer
                                                           participation
                                                           in the
                                                           federally-
                                                           facilitated
                                                           Exchange. (42
                                                           U.S.C. 300gg-
                                                           22(b)(2)(C)).
    18081(h)(1)(A)(i)(II)....  42 CFR 155.285.  CMS       Penalty for             2019       28,906       29,416
                                                           providing
                                                           false
                                                           information on
                                                           Exchange
                                                           application.
    18081(h)(1)(B)...........  42 CFR 155.285.  CMS       Penalty for             2019      289,060      294,159
                                                           knowingly or
                                                           willfully
                                                           providing
                                                           false
                                                           information on
                                                           Exchange
                                                           application.
    18081(h)(2)..............  42 CFR 155.260.  CMS       Penalty for             2019       28,906       29,416
                                                           knowingly or
                                                           willfully
                                                           disclosing
                                                           protected
                                                           information
                                                           from Exchange.
31 U.S.C.:
    1352.....................  45 CFR           HHS       Penalty for the         2019       20,134       20,489
                                93.400(e).                 first time an
                                                           individual
                                                           makes an
                                                           expenditure
                                                           prohibited by
                                                           regulations
                                                           regarding
                                                           lobbying
                                                           disclosure,
                                                           absent
                                                           aggravating
                                                           circumstances.
                                                          Penalty for
                                                           second and
                                                           subsequent
                                                           offenses by
                                                           individuals
                                                           who make an
                                                           expenditure
                                                           prohibited by
                                                           regulations
                                                           regarding
                                                           lobbying
                                                           disclosure:
                                                            Minimum......         2019       20,134       20,489
                                                            Maximum......         2019      201,340      204,892
                                                          Penalty for the         2019       20,134       20,489
                                                           first time an
                                                           individual
                                                           fails to file
                                                           or amend a
                                                           lobbying
                                                           disclosure
                                                           form, absent
                                                           aggravating
                                                           circumstances
                                                          Penalty for
                                                           second and
                                                           subsequent
                                                           offenses by
                                                           individuals
                                                           who fail to
                                                           file or amend
                                                           a lobbying
                                                           disclosure
                                                           form, absent
                                                           aggravating
                                                           circumstances:
                                                            Minimum......         2019       20,134       20,489
                                                            Maximum......         2019      201,340      204,892
                               45 CFR Part 93,  HHS       Penalty for
                                Appendix A.                failure to
                                                           provide
                                                           certification
                                                           regarding
                                                           lobbying in
                                                           the award
                                                           documents for
                                                           all sub-awards
                                                           of all tiers:
                                                            Minimum......         2019       20,134       20,489
                                                            Maximum......         2019      201,340      204,892
                                                          Penalty for
                                                           failure to
                                                           provide
                                                           statement
                                                           regarding
                                                           lobbying for
                                                           loan guarantee
                                                           and loan
                                                           insurance
                                                           transactions:
                                                            Minimum......         2019       20,134       20,489
                                                            Maximum......         2019      201,340      204,892
    3801-3812................  45 CFR           HHS       Penalty against         2019       10,520       10,706
                                79.3(a)(1)(iv).            any individual
                                                           who--with
                                                           knowledge or
                                                           reason to
                                                           know--makes,
                                                           presents or
                                                           submits a
                                                           false,
                                                           fictitious or
                                                           fraudulent
                                                           claim to the
                                                           Department.
                               45 CFR           ........  Penalty against         2019       10,520       10,706
                                79.3(b)(1)(ii).            any individual
                                                           who--with
                                                           knowledge or
                                                           reason to
                                                           know--makes,
                                                           presents or
                                                           submits a
                                                           false,
                                                           fictitious or
                                                           fraudulent
                                                           claim to the
                                                           Department.
----------------------------------------------------------------------------------------------------------------
\1\ Some HHS components have not promulgated regulations regarding their civil monetary penalty-specific
  statutory authorities.
\2\ The description is not intended to be a comprehensive explanation of the underlying violation; the statute
  and corresponding regulation, if applicable, should be consulted.
\3\ Statutory or Inflation Act Adjustment.
\4\ The cost of living multiplier for 2020, based on the Consumer Price Index for all Urban Consumers (CPI-U)
  for the month of October 2019, not seasonally adjusted, is 1.01764, as indicated in OMB Memorandum M-20-05,
  ``Implementation of Penalty Inflation Adjustments for 2019, Pursuant to the Federal Civil Penalties Adjustment
  Act Improvements Act of 2015'' (December 16, 2019).


Alex M. Azar II,
Secretary, Department of Health and Human Services.
[FR Doc. 2020-00738 Filed 1-15-20; 4:15 pm]
 BILLING CODE 4150-24-P