[Federal Register Volume 81, Number 172 (Tuesday, September 6, 2016)]
[Rules and Regulations]
[Pages 61537-61582]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-18680]



[[Page 61537]]

Vol. 81

Tuesday,

No. 172

September 6, 2016

Part IV





 Department of Health and Human Services





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





 Centers for Medicare & Medicaid Services





Office of the Inspector General





Administration for Children and Families





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





42 CFR Parts 3, 402, 403, et al.

45 CFR Parts 79, 93, 102, et al.





 Adjustment of Civil Monetary Penalties for Inflation; Interim Final 
Rule

Federal Register / Vol. 81 , No. 172 / Tuesday, September 6, 2016 / 
Rules and Regulations

[[Page 61538]]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary

42 CFR Part 3

Centers for Medicare & Medicaid Services

42 CFR Parts 402, 403, 411, 412, 422, 423, 460, 483, 488, and 493

Office of the Inspector General

42 CFR Part 1003

Office of the Secretary

45 CFR Parts 79, 93, 102, 147, 150, 155, 156, 158, and 160

Administration for Children and Families

45 CFR Part 303

RIN 0991-AC0


Adjustment of Civil Monetary Penalties for Inflation

AGENCY: Department of Health and Human Services, Office of the 
Assistant Secretary for Financial Resources, Centers for Medicare & and 
Medicaid Services, Office of the Inspector General, Administration for 
Children and Families.

ACTION: Interim final rule.

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

SUMMARY: The Department of Health and Human Services (HHS) is issuing a 
new regulation to adjust for inflation the maximum civil monetary 
penalty amounts for the various civil monetary penalty authorities for 
all agencies within HHS. We are taking this action to comply with the 
Federal Civil Penalties Inflation Adjustment Act of 1990 (the Inflation 
Adjustment Act), as amended by the Federal Civil Penalties Inflation 
Adjustment Act Improvements Act of 2015. In addition, this interim 
final rule includes updates to certain agency-specific regulations to 
identify their updated information, and note the location of HHS-wide 
regulations.

DATES: This rule is effective on September 6, 2016.

FOR FURTHER INFORMATION CONTACT: Office of the Assistant Secretary for 
Financial Resources, Room 514-G, Hubert Humphrey Building, 200 
Independence Avenue SW., Washington, DC 20201; 202-690-6396; FAX 202-
690-5405.

SUPPLEMENTARY INFORMATION: 

I. Regulatory Information

    The Department of Health and Human Services (HHS) is promulgating 
this interim final rule to ensure that the amount of civil monetary 
penalties authorized to be assessed or enforced by HHS reflect the 
statutorily mandated amounts and ranges as adjusted for inflation. 
Pursuant to Section 4(b) of the Federal Civil Penalties Inflation 
Adjustment Act Improvements Act of 2015 (the 2015 Act), HHS is required 
to promulgate a ``catch-up adjustment'' through an interim final rule. 
Pursuant to the 2015 Act and 5 U.S.C. 553(b)(3)(B), HHS finds that good 
cause exists for immediate implementation of this interim final rule 
without prior notice and comment because it would be impracticable to 
delay publication of this rule for notice and comment. The 2015 Act 
specifies that the adjustments shall take effect not later than August 
1, 2016. Additionally, the 2015 Act provides a clear formula for 
adjustment of the civil monetary penalties, leaving agencies little 
room for discretion. For these reasons, HHS finds that notice and 
comment would be impracticable in this situation. Additionally, if 
applicable, HHS agencies will update their civil monetary penalty-
specific regulations to include a cross-reference to the revised 
regulations located at 45 CFR part 102 reflecting the new adjusted 
penalty amounts set out by HHS.\1\
---------------------------------------------------------------------------

    \1\ All applicable civil monetary penalty authorities within the 
jurisdiction of HHS must be adjusted in accordance with the 2015 
Act. Where existing HHS agency regulations setting forth civil 
monetary penalty amounts are not updated by this interim final rule, 
they will be amended in a separate action as soon as practicable.
---------------------------------------------------------------------------

II. Background and Requirements of the Law

    On November 2, 2015, the President signed into law the Federal 
Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (the 
2015 Act) (Sec. 701 of the Bipartisan Budget Act of 2015, Public Law 
114-74, November 2, 2015), which amended the Federal Civil Penalties 
Inflation Adjustment Act of 1990 (the Inflation Adjustment Act) (Pub. 
L. 101-410, 104 Stat. 890 (1990) (codified as amended at 28 U.S.C. 2461 
note 2(a)), to improve the effectiveness of civil monetary penalties 
and to maintain their deterrent effect. The 2015 Act, which removed an 
inflation update exclusion that previously applied to the Social 
Security Act as well as the Occupational Safety and Health Act, 
requires agencies to: (1) Adjust the level of civil monetary penalties 
with an initial ``catch-up'' adjustment through an interim final 
rulemaking (IFR); and (2) make subsequent annual adjustments for 
inflation.
    The method of calculating inflation adjustments in the 2015 Act 
differs substantially from the methods used in past inflation 
adjustment rulemakings conducted pursuant to the Inflation Adjustment 
Act. Previously, adjustments to civil monetary penalties were conducted 
under rules that required significant rounding of figures. While this 
allowed penalties to be kept at round numbers, it meant that penalties 
would often not be increased at all if the inflation factor was not 
large enough. Furthermore, increases to penalties were capped at 10 
percent. Over time, this formula caused penalties to lose value 
relative to total inflation.
    The 2015 Act has removed these rounding rules; now, penalties are 
simply rounded to the nearest dollar. While this creates penalty values 
that are no longer round numbers, it does ensure that penalties will be 
increased each year to a figure commensurate with the actual calculated 
inflation. Furthermore, the 2015 Act ``resets'' the inflation 
calculations by excluding prior inflationary adjustments under the 
Inflation Adjustment Act, which contributed to a decline in the real 
value of penalty levels. To do this, the 2015 Act requires agencies to 
identify, for each penalty, the year and corresponding amount(s) for 
which the maximum penalty level or range of minimum and maximum 
penalties was established (i.e., originally enacted by Congress) or 
last adjusted other than pursuant to the Inflation Adjustment Act.
    In this rule, the adjusted civil penalty amounts are applicable 
only to civil penalties assessed after August 1, 2016, whose associated 
violations occurred after November 2, 2015, the date of enactment of 
the 2015 Amendments. Therefore, violations occurring on or before 
November 2, 2015, and assessments made prior to August 1, 2016, whose 
associated violations occurred after November 2, 2015, will continue to 
be subject to the civil monetary penalty amounts set forth in the 
Department's existing regulations or as set forth by statute if the 
amount has not yet been adjusted by regulation.
    Pursuant to the 2015 Act, the Department of Health and Human 
Services (HHS) has undertaken a thorough review of civil monetary 
penalties administered by its various components. This IFR sets forth 
the initial ``catch-up'' adjustment for civil monetary penalties as 
well as any necessary technical conforming changes to the language of 
the various regulations affected by this IFR. For

[[Page 61539]]

each component, HHS has provided a table showing how the penalties are 
being increased pursuant to the 2015 Act. The first two columns 
(``Citation'') identify the United States Code (U.S.C.) statutory 
citation, and the applicable regulatory citation in the Code of Federal 
Regulations (CFR), if any. The third column (``Description'') provides 
a short description of the penalty. In the fourth column (``Pre-
Inflation Penalty''), HHS has listed the penalty amount as it exists 
prior to the inflationary adjustments made by the effective date of 
this rule, and in the fifth column (``Date of Last Penalty Figure or 
Adjustment''), HHS has provided the amount and year of the penalty as 
enacted by Congress or changed through a mechanism other than pursuant 
to the Inflation Adjustment Act. In column six (``Percentage 
Increase''), HHS has listed the percentage increase based on the 
multiplier used to adjust from the CPI-U \2\ of the year of enactment 
of the monetary penalty to the CPI-U for the current year, or a 
percentage equal to 150 percent, whichever is less. Multiplying the 
current penalty amount in column four by the percentage increase 
provides the ``Increase'' listed in column seven. The ``Maximum 
Adjusted Penalty'' in column eight is the sum of the current penalty 
amount and the ``increase''. Where applicable, some HHS agencies will 
make as soon as practicable conforming edits to regulatory text. 
Additionally, HHS is issuing new regulatory text including the table 
showing how the penalties are being increased under the 2015 Act, 
located at 45 CFR part 102, to implement the civil monetary penalty 
(CMP) amounts adjusted for inflation agency-wide. Additionally, the 
2015 Act requires agencies to publish annual adjustments not later than 
January 15 of every year after publication of the initial adjustment.
---------------------------------------------------------------------------

    \2\ Based upon the Consumer Price Index (CPI-U) for the month of 
October 2015. The CPI-U is published by the Department of Labor, 
Bureau of Labor Statistics, and is available at its Web site: http://www.bls.gov/cpi/.

                                                             Calculation of CMP Adjustments
--------------------------------------------------------------------------------------------------------------------------------------------------------
                          Citation                                                                      Date of
------------------------------------------------------------                                              last
                                                                                             Pre-       penalty     Percentage    Increase     Maximum
                                                                   Description \2\        inflation    figure or     increase     ($) \5\      adjusted
               U.S.C.                        CFR \1\                                     penalty ($)   adjustment      \4\                   penalty ($)
                                                                                                          \3\
--------------------------------------------------------------------------------------------------------------------------------------------------------
21 U.S.C. (FDA):
    333(b)(2)(A)...................  ......................  Penalty for violations           50,000         1988       97.869       48,935       98,935
                                                              related to drug samples
                                                              resulting in a conviction
                                                              of any representative of
                                                              manufacturer or
                                                              distributor in any 10-
                                                              year period.
    333(b)(2)(B)...................  ......................  Penalty for violation         1,000,000         1988       97.869      978,690    1,978,690
                                                              related to drug samples
                                                              resulting in a conviction
                                                              of any representative of
                                                              manufacturer or
                                                              distributor after the
                                                              second conviction in any
                                                              10-yr period.
    333(b)(3)......................  ......................  Penalty for failure to          100,000         1988       97.869       97,869      197,869
                                                              make a report required by
                                                              21 U.S.C. 353(d)(3)(E)
                                                              relating to drug samples.
    333(f)(1)(A)...................  ......................  Penalty for any person who       15,000         1990       78.156       11,723       26,723
                                                              violates a requirement
                                                              related to devices for
                                                              each such violation.
                                                             Penalty for aggregate of      1,000,000         1990       78.156      781,560    1,781,560
                                                              all violations related to
                                                              devices in a single
                                                              proceeding.
    333(f)(2)(A)...................  ......................  Penalty for any individual       50,000         1996       50.425       25,123       75,123
                                                              who introduces or
                                                              delivers for introduction
                                                              into interstate commerce
                                                              food that is adulterated
                                                              per 21 U.S.C.
                                                              342(a)(2)(B) or any
                                                              individual who does not
                                                              comply with a recall
                                                              order under 21 U.S.C.
                                                              350l.
                                                             Penalty in the case of any      250,000         1996       50.425      125,613      375,613
                                                              other person other than
                                                              an individual for such
                                                              introduction or delivery
                                                              of adulterated food.
                                                             Penalty for aggregate of        500,000         1996       50.425      251,225      751,225
                                                              all such violations
                                                              related to adulterated
                                                              food adjudicated in a
                                                              single proceeding.
    333(f)(3)(A)...................  ......................  Penalty for all violations       10,000         2007       13.833        1,383       11,383
                                                              adjudicated in a single
                                                              proceeding for any person
                                                              who fails to submit
                                                              certification required by
                                                              42 U.S.C. 282(j)(5)(B) or
                                                              knowingly submitting a
                                                              false certification.
    333(f)(3)(B)...................  ......................  Penalty for each day the         10,000         2007       13.833        1,383       11,383
                                                              above violation is not
                                                              corrected after a 30-day
                                                              period following
                                                              notification until the
                                                              violation is corrected.

[[Page 61540]]

 
    333(f)(4)(A)(i)................  ......................  Penalty for any                 250,000         2007       13.833       34,583      284,583
                                                              responsible person that
                                                              violates a requirement of
                                                              21 U.S.C. 355(o) (post-
                                                              marketing studies,
                                                              clinical trials,
                                                              labeling), 21 U.S.C.
                                                              355(p) (risk evaluation
                                                              and mitigation (REMS)),
                                                              or 21 U.S.C. 355-1 (REMS).
                                                             Penalty for aggregate of      1,000,000         2007       13.833      138,330    1,138,330
                                                              all such above violations
                                                              in a single proceeding.
    333(f)(4)(A)(ii)...............  ......................  Penalty for REMS violation      250,000         2007       13.833       34,583      284,583
                                                              that continues after
                                                              written notice to the
                                                              responsible person for
                                                              the first 30-day period
                                                              (or any portion thereof)
                                                              the responsible person
                                                              continues to be in
                                                              violation.
                                                             Penalty for REMS violation    1,000,000         2007       13.833      138,330    1,138,330
                                                              that continues after
                                                              written notice to
                                                              responsible person
                                                              doubles for every 30-day
                                                              period thereafter the
                                                              violation continues, but
                                                              may not exceed penalty
                                                              amount for any 30-day
                                                              period.
                                                             Penalty for aggregate of     10,000,000         2007       13.833    1,383,300   11,383,300
                                                              all such above violations
                                                              adjudicated in a single
                                                              proceeding.
    333(f)(9)(A)...................  ......................  Penalty for any person who       15,000         2009        10.02        1,503       16,503
                                                              violates a requirement
                                                              which relates to tobacco
                                                              products for each such
                                                              violation.
                                                             Penalty for aggregate of      1,000,000         2009        10.02      100,200    1,100,200
                                                              all such violations of
                                                              tobacco product
                                                              requirement adjudicated
                                                              in a single proceeding.
    333(f)(9)(B)(i)(I).............  ......................  Penalty per violation           250,000         2009        10.02       25,050      275,050
                                                              related to violations of
                                                              tobacco requirements.
                                                             Penalty for aggregate of      1,000,000         2009        10.02      100,200    1,100,200
                                                              all such violations of
                                                              tobacco product
                                                              requirements adjudicated
                                                              in a single proceeding.
    333(f)(9)(B)(i)(II)............  ......................  Penalty in the case of a        250,000         2009        10.02       25,050      275,050
                                                              violation of tobacco
                                                              product requirements that
                                                              continues after written
                                                              notice to such person,
                                                              for the first 30-day
                                                              period (or any portion
                                                              thereof) the person
                                                              continues to be in
                                                              violation.
                                                             Penalty for violation of      1,000,000         2009        10.02      100,200    1,100,200
                                                              tobacco product
                                                              requirements that
                                                              continues after written
                                                              notice to such person
                                                              shall double for every 30-
                                                              day period thereafter the
                                                              violation continues, but
                                                              may not exceed penalty
                                                              amount for any 30-day
                                                              period.
                                                             Penalty for aggregate of     10,000,000         2009        10.02    1,002,000   11,002,000
                                                              all such violations
                                                              related to tobacco
                                                              product requirements
                                                              adjudicated in a single
                                                              proceeding.
    333(f)(9)(B)(ii)(I)............  ......................  Penalty for any person who      250,000         2009        10.02       25,050      275,050
                                                              either does not conduct
                                                              post-market surveillance
                                                              and studies to determine
                                                              impact of a modified risk
                                                              tobacco product for which
                                                              the HHS Secretary has
                                                              provided them an order to
                                                              sell, or who does not
                                                              submit a protocol to the
                                                              HHS Secretary after being
                                                              notified of a requirement
                                                              to conduct post-market
                                                              surveillance of such
                                                              tobacco products.
                                                             Penalty for aggregate of      1,000,000         2009        10.02      100,200    1,100,200
                                                              for all such above
                                                              violations adjudicated in
                                                              a single proceeding.

[[Page 61541]]

 
    333(f)(9)(B)(ii)(II)...........  ......................  Penalty for violation of        250,000         2009        10.02       25,050      275,050
                                                              modified risk tobacco
                                                              product post-market
                                                              surveillance that
                                                              continues after written
                                                              notice to such person for
                                                              the first 30-day period
                                                              (or any portion thereof)
                                                              that the person continues
                                                              to be in violation.
                                                             Penalty for post-notice       1,000,000         2009        10.02      100,200    1,100,200
                                                              violation of modified
                                                              risk tobacco product post-
                                                              market surveillance shall
                                                              double for every 30-day
                                                              period thereafter that
                                                              the tobacco product
                                                              requirement violation
                                                              continues for any 30-day
                                                              period, but may not
                                                              exceed penalty amount for
                                                              any 30-day period.
                                                             Penalty for aggregate        10,000,000         2009        10.02    1,002,000   11,002,000
                                                              above tobacco product
                                                              requirement violations
                                                              adjudicated in a single
                                                              proceeding.
    333(g)(1)......................  ......................  Penalty for any person who      250,000         2007       13.833       34,583      284,583
                                                              disseminates or causes
                                                              another party to
                                                              disseminate a direct-to-
                                                              consumer advertisement
                                                              that is false or
                                                              misleading for the first
                                                              such violation in any 3-
                                                              year period.
                                                             Penalty for each                500,000         2007       13.833        69165      569,165
                                                              subsequent above
                                                              violation in any 3-year
                                                              period.
    333 note.......................  ......................  Penalty to be applied for           250         2009        10.02           25          275
                                                              violations of
                                                              restrictions on the sale
                                                              or distribution of
                                                              tobacco products
                                                              promulgated under 21
                                                              U.S.C. 387f(d) (e.g.,
                                                              violations of regulations
                                                              in 21 CFR Part 1140) with
                                                              respect to a retailer
                                                              with an approved training
                                                              program in the case of a
                                                              second regulation
                                                              violation within a 12-
                                                              month period.
                                                             Penalty in the case of a            500         2009        10.02           50          550
                                                              third tobacco product
                                                              regulation violation
                                                              within a 24-month period.
                                                             Penalty in the case of a          2,000         2009        10.02          200        2,200
                                                              fourth tobacco product
                                                              regulation violation
                                                              within a 24-month period.
                                                             Penalty in the case of a          5,000         2009        10.02          501        5,501
                                                              fifth tobacco product
                                                              regulation violation
                                                              within a 36-month period.
                                                             Penalty in the case of a         10,000         2009        10.02        1,002       11,002
                                                              sixth or subsequent
                                                              tobacco product
                                                              regulation violation
                                                              within a 48-month period
                                                              as determined on a case-
                                                              by-case basis.
                                                             Penalty to be applied for           250         2009        10.02           25          275
                                                              violations of
                                                              restrictions on the sale
                                                              or distribution of
                                                              tobacco products
                                                              promulgated under 21
                                                              U.S.C. 387f(d) (e.g.,
                                                              violations of regulations
                                                              in 21 CFR Part 1140) with
                                                              respect to a retailer
                                                              that does not have an
                                                              approved training program
                                                              in the case of the first
                                                              regulation violation.
                                                             Penalty in the case of a            500         2009        10.02           50          550
                                                              second tobacco product
                                                              regulation violation
                                                              within a 12-month period.
                                                             Penalty in the case of a          1,000         2009        10.02          100        1,100
                                                              third tobacco product
                                                              regulation violation
                                                              within a 24-month period.
                                                             Penalty in the case of a          2,000         2009        10.02          200        2,200
                                                              fourth tobacco product
                                                              regulation violation
                                                              within a 24-month period.
                                                             Penalty in the case of a          5,000         2009        10.02          501        5,501
                                                              fifth tobacco product
                                                              regulation violation
                                                              within a 36-month period.

[[Page 61542]]

 
                                                             Penalty in the case of a         10,000         2009        10.02         1002       11,002
                                                              sixth or subsequent
                                                              tobacco product
                                                              regulation violation
                                                              within a 48-month period
                                                              as determined on a case-
                                                              by-case basis.
    335b(a)........................  ......................  Penalty for each violation      250,000         1992       67.728      169,320      419,320
                                                              for any individual who
                                                              made a false statement or
                                                              misrepresentation of a
                                                              material fact, bribed,
                                                              destroyed, altered,
                                                              removed, or secreted, or
                                                              procured the destruction,
                                                              alteration, removal, or
                                                              secretion of, any
                                                              material document, failed
                                                              to disclose a material
                                                              fact, obstructed an
                                                              investigation, employed a
                                                              consultant who was
                                                              debarred, debarred
                                                              individual provided
                                                              consultant services.
                                                             Penalty in the case of any    1,000,000         1992       67.728      677,280    1,677,280
                                                              other person (other than
                                                              an individual) per above
                                                              violation.
    360pp(b)(1)....................  ......................  Penalty for any person who        1,100         1968          150        1,500        2,750
                                                              violates any such
                                                              requirements for
                                                              electronic products, with
                                                              each unlawful act or
                                                              omission constituting a
                                                              separate violation.
                                                             Penalty imposed for any         375,000         1968          150      562,500      937,500
                                                              related series of
                                                              violations of
                                                              requirements relating to
                                                              electronic products.
42 U.S.C. (FDA):
    262(d).........................  ......................  Penalty per day for             100,000         1986      115.628      115,628      215,628
                                                              violation of order of
                                                              recall of biological
                                                              product presenting
                                                              imminent or substantial
                                                              hazard.
    263b(h)(3).....................  ......................  Penalty for failure to           10,000         1992       67.728        6,773       16,773
                                                              obtain a mammography
                                                              certificate as required.
    300aa-28(b)(1).................  ......................  Penalty per occurrence for      100,000         1986      115.628      115,628      215,628
                                                              any vaccine manufacturer
                                                              that intentionally
                                                              destroys, alters,
                                                              falsifies, or conceals
                                                              any record or report
                                                              required.
42 U.S.C. (HRSA):
    256b(d)(1)(B)(vi)..............  ......................  Penalty for each instance         5,000         2010        8.745          437        5,437
                                                              of overcharging a 340B
                                                              covered entity.
42 U.S.C. (AHRQ):
    299c-(3)(d)....................  ......................  Penalty for an                   10,000         1999       41.402        4,140       14,140
                                                              establishment or person
                                                              supplying information
                                                              obtained in the course of
                                                              activities for any
                                                              purpose other than the
                                                              purpose for which it was
                                                              supplied.
42 U.S.C. ACF:
    653(l)(2)......................  45 CFR 303.21(f)......  Penalty for Misuse of             1,000         1998       45.023          450        1,450
                                                              Information in the
                                                              National Directory of New
                                                              Hires.
42 U.S.C. (OIG):
    262a(i)(1).....................  42 CFR Part 1003......  Penalty for each                250,000         2002       31.185       77,962      327,962
                                                              individual who violates
                                                              safety and security
                                                              procedures related to
                                                              handling dangerous
                                                              biological agents and
                                                              toxins.
                                                             Penalty for any other           500,000         2002       31.185      155,925      655,925
                                                              person who violates
                                                              safety and security
                                                              procedures related to
                                                              handling dangerous
                                                              biological agents and
                                                              toxins.
    1320a-7a(a)....................  42 CFR Part 1003......  Penalty for knowingly            10,000         1996       50.245        5,024       15,024
                                                              presenting or causing to
                                                              be presented to an
                                                              officer, employee, or
                                                              agent of the United
                                                              States a false claim.
                                                             Penalty for knowingly            10,000         1996       50.245        5,024       15,024
                                                              presenting or causing to
                                                              be presented a request
                                                              for payment which
                                                              violates the terms of an
                                                              assignment, agreement, or
                                                              PPS agreement.

[[Page 61543]]

 
                                                             Penalty for knowingly            15,000         1996       50.245        7,537       22,537
                                                              giving or causing to be
                                                              presented to a
                                                              participating provider or
                                                              supplier false or
                                                              misleading information
                                                              that could reasonably be
                                                              expected to influence a
                                                              discharge decision.
                                                             Penalty for an excluded          10,000         1996       50.245        5,024       15,024
                                                              party retaining ownership
                                                              or control interest in a
                                                              participating entity.
                                                             Penalty for remuneration         10,000         1996       50.245        5,024       15,024
                                                              offered to induce program
                                                              beneficiaries to use
                                                              particular providers,
                                                              practitioners, or
                                                              suppliers.
                                                             Penalty for employing or         10,000         1997       47.177        4,718       14,718
                                                              contracting with an
                                                              excluded individual.
                                                             Penalty for knowing and          50,000         1997       47.177       23,588       73,588
                                                              willful solicitation,
                                                              receipt, offer, or
                                                              payment of remuneration
                                                              for referring an
                                                              individual for a service
                                                              or for purchasing,
                                                              leasing, or ordering an
                                                              item to be paid for by a
                                                              Federal health care
                                                              program.
                                                             Penalty for ordering or          10,000         2010        8.745          874       10,874
                                                              prescribing medical or
                                                              other item or service
                                                              during a period in which
                                                              the person was excluded.
                                                             Penalty for knowingly            50,000         2010        8.745        4,372       54,372
                                                              making or causing to be
                                                              made a false statement,
                                                              omission or
                                                              misrepresentation of a
                                                              material fact in any
                                                              application, bid, or
                                                              contract to participate
                                                              or enroll as a provider
                                                              or supplier.
                                                             Penalty for knowing of an        10,000         2010        8.745          874       10,874
                                                              overpayment and failing
                                                              to report and return.
                                                             Penalty for making or            50,000         2010        8.745        4,372       54,372
                                                              using a false record or
                                                              statement that is
                                                              material to a false or
                                                              fraudulent claim.
                                                             Penalty for failure to           15,000         2010        8.745        1,312       16,312
                                                              grant timely access to
                                                              HHS OIG for audits,
                                                              investigations,
                                                              evaluations, and other
                                                              statutory functions of
                                                              HHS OIG.
    1320a-7a(b)....................  42 CFR Part 1003......  Penalty for payments by a         2,000         1986      115.628        2,313        4,313
                                                              hospital or critical
                                                              access hospital to induce
                                                              a physician to reduce or
                                                              limit services to
                                                              individuals under direct
                                                              care of physician or who
                                                              are entitled to certain
                                                              medical assistance
                                                              benefits.
                                                             Penalty for physicians who        2,000         1986      115.628        2,313        4,313
                                                              knowingly receive
                                                              payments from a hospital
                                                              or critical access
                                                              hospital to induce such
                                                              physician to reduce or
                                                              limit services to
                                                              individuals under direct
                                                              care of physician or who
                                                              are entitled to certain
                                                              medical assistance
                                                              benefits.
                                                             Penalty for a physician           5,000         1996       50.245        2,512        7,512
                                                              who executes a document
                                                              that falsely certifies
                                                              home health needs for
                                                              Medicare beneficiaries.
    1320a-7e(b)(6)(A)..............  42 CFR Part 1003......  Penalty for failure to           25,000         1997       47.177       11,794       36,794
                                                              report any final adverse
                                                              action taken against a
                                                              health care provider,
                                                              supplier, or practitioner.
    1320b-10(b)(1).................  42 CFR Part 1003......  Penalty for the misuse of         5,000         1988       97.869        4,893        9,893
                                                              words, symbols, or
                                                              emblems in communications
                                                              in a manner in which a
                                                              person could falsely
                                                              construe that such item
                                                              is approved, endorsed, or
                                                              authorized by HHS.

[[Page 61544]]

 
    1320b-10(b)(2).................  42 CFR Part 1003......  Penalty for the misuse of        25,000         1988       97.869       24,467       49,467
                                                              words, symbols, or
                                                              emblems in a broadcast or
                                                              telecast in a manner in
                                                              which a person could
                                                              falsely construe that
                                                              such item is approved,
                                                              endorsed, or authorized
                                                              by HHS.
    1395i-3(b)(3)(B)(ii)(1)........  ......................  Penalty for certification         1,000         1987      106.278        1,063        2,063
                                                              of a false statement in
                                                              assessment of functional
                                                              capacity of a Skilled
                                                              Nursing Facility resident
                                                              assessment.
    1395i-3(b)(3)(B)(ii)(2)........  ......................  Penalty for causing               5,000         1987      106.278        5,314       10,314
                                                              another to certify or
                                                              make a false statement in
                                                              assessment of functional
                                                              capacity of a Skilled
                                                              Nursing Facility resident
                                                              assessment.
    1395i-3(g)(2)(A)...............  ......................  Penalty for any individual        2,000         1987      106.278        2,126        4,126
                                                              who notifies or causes to
                                                              be notified a Skilled
                                                              Nursing Facility of the
                                                              time or date on which a
                                                              survey is to be conducted.
    1395w-27(g)(2)(A)..............  42 CFR 422.752; 42 CFR  Penalty for a Medicare           25,000         1996       50.245       12,561       37,561
                                      Part 1003.              Advantage organization
                                                              that substantially fails
                                                              to provide medically
                                                              necessary, required items
                                                              and services.
                                                             Penalty for a Medicare           25,000         1997       47.177       11,794       36,794
                                                              Advantage organization
                                                              that charges excessive
                                                              premiums.
                                                             Penalty for a Medicare           25,000         1997       47.177       11,794       36,794
                                                              Advantage organization
                                                              that improperly expels or
                                                              refuses to reenroll a
                                                              beneficiary.
                                                             Penalty for a Medicare          100,000         1997       47.177       47,177      147,177
                                                              Advantage organization
                                                              that engages in practice
                                                              that would reasonably be
                                                              expected to have the
                                                              effect of denying or
                                                              discouraging enrollment.
                                                             Penalty per individual who       15,000         1997       47.177        7,077       22,077
                                                              does not enroll as a
                                                              result of a Medicare
                                                              Advantage organization's
                                                              practice that would
                                                              reasonably be expected to
                                                              have the effect of
                                                              denying or discouraging
                                                              enrollment.
                                                             Penalty for a Medicare          100,000         1997       47.177       47,177      147,177
                                                              Advantage organization
                                                              misrepresenting or
                                                              falsifying information to
                                                              Secretary.
                                                             Penalty for a Medicare           25,000         1997       47.177       11,794       36,794
                                                              Advantage organization
                                                              misrepresenting or
                                                              falsifying information to
                                                              individual or other
                                                              entity.
                                                             Penalty for Medicare             25,000         1997       47.177       11,794       36,794
                                                              Advantage organization
                                                              interfering with
                                                              provider's advice to
                                                              enrollee and non-MCO
                                                              affiliated providers that
                                                              balance bill enrollees.
                                                             Penalty for a Medicare           25,000         1997       47.177       11,794       36,794
                                                              Advantage organization
                                                              that employs or contracts
                                                              with excluded individual
                                                              or entity.
                                                             Penalty for a Medicare           25,000         2010       47.177       11,794       36,794
                                                              Advantage organization
                                                              enrolling an individual
                                                              in without prior written
                                                              consent.
                                                             Penalty for a Medicare           25,000         2010       47.177       11,794       36,794
                                                              Advantage organization
                                                              transferring an enrollee
                                                              to another plan without
                                                              consent or solely for the
                                                              purpose of earning a
                                                              commission.
                                                             Penalty for a Medicare           25,000         2010       47.177       11,794       36,794
                                                              Advantage organization
                                                              failing to comply with
                                                              marketing restrictions or
                                                              applicable implementing
                                                              regulations or guidance.

[[Page 61545]]

 
                                                             Penalty for a Medicare           25,000         2010       47.177       11,794       36,794
                                                              Advantage organization
                                                              employing or contracting
                                                              with an individual or
                                                              entity who violates 1395w-
                                                              27(g)(1)(A)-(J).
    1395w-141(i)(3)................  42 CFR Part 1003......  Penalty for a prescription       10,000         2003       28.561        2,856       12,856
                                                              drug card sponsor that
                                                              falsifies or
                                                              misrepresents marketing
                                                              materials, overcharges
                                                              program enrollees, or
                                                              misuse transitional
                                                              assistance funds.
    1395cc(g)......................  42 CFR Part 1003......  Penalty for improper              2,000         1972          150        3,000        5,000
                                                              billing by Hospitals,
                                                              Critical Access
                                                              Hospitals, or Skilled
                                                              Nursing Facilities.
    1395dd(d)(1)...................  42 CFR Part 1003......  Penalty for a hospital or        50,000         1987      106.278       53,139      103,139
                                                              responsible physician
                                                              dumping patients needing
                                                              emergency medical care,
                                                              if the hospital has 100
                                                              beds or more.
                                                             Penalty for a hospital or        25,000         1987      106.278       26,570       51,570
                                                              responsible physician
                                                              dumping patients needing
                                                              emergency care, if the
                                                              hospital has less than
                                                              100 beds.
    1395mm(i)(6)(B)(i).............  42 CFR Part 1003......  Penalty for a HMO or             25,000         1987      106.278       26,570       51,570
                                                              competitive plan is such
                                                              plan substantially fails
                                                              to provide medically
                                                              necessary, required items
                                                              or services.
                                                             Penalty for HMOs/                25,000         1987      106.278       26,570       51,570
                                                              competitive medical plans
                                                              that charge premiums in
                                                              excess of permitted
                                                              amounts.
                                                             Penalty for a HMO or             25,000         1987      106.278       26,570       51,570
                                                              competitive medical plan
                                                              that expels or refuses to
                                                              reenroll an individual
                                                              per prescribed conditions.
                                                             Penalty for a HMO or            100,000         1987      106.278      106,278      206,278
                                                              competitive medical plan
                                                              that implements practices
                                                              to discourage enrollment
                                                              of individuals needing
                                                              services in future.
                                                             Penalty per individual not       15,000         1988       97.869       14,680       29,680
                                                              enrolled in a plan as a
                                                              result of a HMO or
                                                              competitive medical plan
                                                              that implements practices
                                                              to discourage enrollment
                                                              of individuals needing
                                                              services in the future.
                                                             Penalty for a HMO or            100,000         1987      106.278      106,278      206,278
                                                              competitive medical plan
                                                              that misrepresents or
                                                              falsifies information to
                                                              the Secretary.
                                                             Penalty for a HMO or             25,000         1987      106.278       26,570       51,570
                                                              competitive medical plan
                                                              that misrepresents or
                                                              falsifies information to
                                                              an individual or any
                                                              other entity.
                                                             Penalty for failure by HMO       25,000         1987      106.278       26,570       51,570
                                                              or competitive medical
                                                              plan to assure prompt
                                                              payment of Medicare risk
                                                              sharing contracts or
                                                              incentive plan provisions.
                                                             Penalty for HMO that             25,000         1989       89.361       22,340       47,340
                                                              employs or contracts with
                                                              excluded individual or
                                                              entity.
    1395nn(g)(3)...................  42 CFR Part 1003......  Penalty for submitting or        15,000         1994       59.089        8,863       23,863
                                                              causing to be submitted
                                                              claims in violation of
                                                              the Stark Law's
                                                              restrictions on physician
                                                              self-referrals.
    1395nn(g)(4)...................  42 CFR Part 1003......  Penalty for circumventing       100,000         1994       59.089       59,089      159,089
                                                              Stark Law's restrictions
                                                              on physician self-
                                                              referrals.
    1395ss(d)(1)...................  42 CFR Part 1003......  Penalty for a material            5,000         1988       97.869        4,893        9,893
                                                              misrepresentation
                                                              regarding Medigap
                                                              compliance policies.
    1395ss(d)(2)...................  42 CFR Part 1003......  Penalty for selling               5,000         1988       97.869        4,893        9,893
                                                              Medigap policy under
                                                              false pretense.
    1395ss(d)(3)(A)(ii)............  42 CFR Part 1003......  Penalty for an issuer that       25,000         1990       78.156       19,539       44,539
                                                              sells health insurance
                                                              policy that duplicates
                                                              benefits.

[[Page 61546]]

 
                                                             Penalty for someone other        15,000         1990       78.156       11,723       26,723
                                                              than issuer that sells
                                                              health insurance that
                                                              duplicates benefits.
    1395ss(d)(4)(A)................  42 CFR Part 1003......  Penalty for using mail to         5,000         1988       97.869        4,893        9,893
                                                              sell a non-approved
                                                              Medigap insurance policy.
    1396b(m)(5)(B)(i)..............  42 CFR Part 1003......  Penalty for a Medicaid MCO       25,000         1988       97.869       24,467       49,467
                                                              that substantially fails
                                                              to provide medically
                                                              necessary, required items
                                                              or services.
                                                             Penalty for a Medicaid MCO       25,000         1988       97.869       24,467       49,467
                                                              that charges excessive
                                                              premiums.
                                                             Penalty for a Medicaid MCO      100,000         1988       97.869       97,869      197,869
                                                              that improperly expels or
                                                              refuses to reenroll a
                                                              beneficiary.
                                                             Penalty per individual who       15,000         1988       97.869       14,680       29,680
                                                              does not enroll as a
                                                              result of a Medicaid
                                                              MCO's practice that would
                                                              reasonably be expected to
                                                              have the effect of
                                                              denying or discouraging
                                                              enrollment.
                                                             Penalty for a Medicaid MCO      100,000         1988       97.869       97,869      197,869
                                                              misrepresenting or
                                                              falsifying information to
                                                              the Secretary.
                                                             Penalty for a Medicaid MCO       25,000         1988       97.869       24,467       49,467
                                                              misrepresenting or
                                                              falsifying information to
                                                              an individual or another
                                                              entity.
                                                             Penalty for a Medicaid MCO       25,000         1990       78.156       19,539       44,539
                                                              that fails to comply with
                                                              contract requirements
                                                              with respect to physician
                                                              incentive plans.
    1396r(b)(3)(B)(ii)(I)..........  42 CFR Part 1003......  Penalty for willfully and         1,000         1987      106.278        1,063        2,063
                                                              knowingly certifying a
                                                              material and false
                                                              statement in a Skilled
                                                              Nursing Facility resident
                                                              assessment.
    1396r(b)(3)(B)(ii)(II).........  42 CFR Part 1003......  Penalty for willfully and         5,000         1987      106.278        5,314       10,314
                                                              knowingly causing another
                                                              individual to certify a
                                                              material and false
                                                              statement in a Skilled
                                                              Nursing Facility resident
                                                              assessment.
    1396r(g)(2)(A)(i)..............  42 CFR Part 1003......  Penalty for notifying or          2,000         1987      106.278        2,126        4,126
                                                              causing to be notified a
                                                              Skilled Nursing Facility
                                                              of the time or date on
                                                              which a survey is to be
                                                              conducted.
    1396r-8(b)(3)(B)...............  42 CFR Part 1003......  Penalty for the knowing         100,000         1990       78.156       78,156      178,156
                                                              provision of false
                                                              information or refusing
                                                              to provide information
                                                              about charges or prices
                                                              of a covered outpatient
                                                              drug.
    1396r-8(b)(3)(C)(i)............  42 CFR Part 1003......  Penalty per day for              10,000         1990       78.156        7,816       17,816
                                                              failure to timely provide
                                                              information by drug
                                                              manufacturer with rebate
                                                              agreement.
    1396r-8(b)(3)(C)(ii)...........  42 CFR Part 1003......  Penalty for knowing             100,000         1990       78.156       78,156      178,156
                                                              provision of false
                                                              information by drug
                                                              manufacturer with rebate
                                                              agreement.
    1396t(i)(3)(A).................  42 CFR Part 1003......  Penalty for notifying home        2,000         1990       78.156        1,563        3,563
                                                              and community-based
                                                              providers or settings of
                                                              survey.
    11131(c).......................  42 CFR Part 1003......  Penalty for failing to           10,000         1986      115.628       11,563       21,563
                                                              report a medical
                                                              malpractice claim to
                                                              National Practitioner
                                                              Data Bank.
    11137(b)(2)....................  42 CFR Part 1003......  Penalty for breaching            10,000         1986      115.628       11,563       21,563
                                                              confidentiality of
                                                              information reported to
                                                              National Practitioner
                                                              Data Bank.
42 U.S.C. (OCR):
    299b-22(f)(1)..................  42 CFR 3.404(b).......  Penalty for violation of         10,000         2005        19.40        1,940       11,940
                                                              confidentiality provision
                                                              of the Patient Safety and
                                                              Quality Improvement Act.
    1320(d)-5(a)...................  45 CFR                  Penalty for each pre-               100         1996       50.245           50          150
                                      160.404(b)(1)(i),(ii).  February 18, 2009
                                                              violation of the HIPAA
                                                              administrative
                                                              simplification provisions.
                                                             Calendar Year Cap.........       25,000         1996       50.245       12,561       37,561

[[Page 61547]]

 
                                     45 CFR                  Penalty for each February
                                      160.404(b)(2)(i)(A),(   18, 2009 or later
                                      B).                     violation of a HIPAA
                                                              administrative
                                                              simplification provision
                                                              in which it is
                                                              established that the
                                                              covered entity or
                                                              business associate did
                                                              not know and by
                                                              exercising reasonable
                                                              diligence, would not have
                                                              known that the covered
                                                              entity or business
                                                              associate violated such a
                                                              provision:
                                                                Minimum................          100         2009        10.02           10          110
                                                                Maximum................       50,000         2009        10.02        5,010       55,010
                                                                Calendar Year Cap......    1,500,000         2009        10.02      150,300    1,650,300
                                     45 CFR                  Penalty for each February
                                      160.404(b)(2)(ii)(A),   18, 2009 or later
                                      (B).                    violation of a HIPAA
                                                              administrative
                                                              simplification provision
                                                              in which it is
                                                              established that the
                                                              violation was due to
                                                              reasonable cause and not
                                                              to willful neglect:
                                                                Minimum................        1,000         2009        10.02          100         1100
                                                                Maximum................       50,000         2009        10.02        5,010       55,010
                                                                Calendar Year Cap......    1,500,000         2009        10.02      150,300    1,650,300
                                     45 CFR                  Penalty for each February
                                      160.404(b)(2)(iii)(A)   18, 2009 or later
                                      , (B).                  violation of a HIPAA
                                                              administrative
                                                              simplification provision
                                                              in which it is
                                                              established that the
                                                              violation was due to
                                                              willful neglect and was
                                                              corrected during the 30-
                                                              day period beginning on
                                                              the first date the
                                                              covered entity or
                                                              business associate knew,
                                                              or, by exercising
                                                              reasonable diligence,
                                                              would have known that the
                                                              violation occurred:
                                                                Minimum................       10,000         2009        10.02          100       11,002
                                                                Maximum................       50,000         2009        10.02        5,010       55,010
                                                                Calendar Year Cap......    1,500,000         2009        10.02      150,300    1,650,300
                                     45 CFR                  Penalty for each February
                                      160.404(b)(2)(iv)(A),   18, 2009 or later
                                      (B).                    violation of a HIPAA
                                                              administrative
                                                              simplification provision
                                                              in which it is
                                                              established that the
                                                              violation was due to
                                                              willful neglect and was
                                                              not corrected during the
                                                              30-day period beginning
                                                              on the first date the
                                                              covered entity or
                                                              business associate knew,
                                                              or by exercising
                                                              reasonable diligence,
                                                              would have known that the
                                                              violation occurred:
                                                                Minimum................       50,000         2009        10.02        5,010       55,010
                                                                Maximum................    1,500,000         2009        10.02      150,300    1,650,300
                                                                Calendar Year Cap......    1,500,000         2009        10.02      150,300    1,650,300
42 U.S.C. (CMS):
    263a(h)(2)(B) & 1395w-           42 CFR                  Penalty for a clinical
     2(b)(2)(A)(ii).                  493.1834(d)(2)(i).      laboratory's failure to
                                                              meet participation and
                                                              certification
                                                              requirements and poses
                                                              immediate jeopardy:
                                                                Minimum................        3,050         1988       97.869        2,985        6,035
                                                                Maximum................       10,000         1988       97.869        9,787       19,787
                                     42 CFR                  Penalty for a clinical
                                      493.1834(d)(2)(ii).     laboratory's failure to
                                                              meet participation and
                                                              certification
                                                              requirements and the
                                                              failure does not pose
                                                              immediate jeopardy:
                                                                Minimum................           50         1988       97.869           49           99
                                                                Maximum................        3,000         1988       97.869        2,936        5,936
    300gg-15(f)....................  45 CFR 147.200(e).....  Failure to provide the            1,000         2010        8.745           87        1,087
                                                              Summary of Benefits and
                                                              Coverage (SBC).
    300gg-18.......................  45 CFR 158.606........  Penalty for violations of           100         2010        8.745            9          109
                                                              regulations related to
                                                              the medical loss ratio
                                                              reporting and rebating.

[[Page 61548]]

 
    1320a-7h(b)(1).................  42 CFR 402.105(d)(5),   Penalty for manufacturer
                                      42 CFR 403.912(a) &     or group purchasing
                                      (c).                    organization failing to
                                                              report information
                                                              required under 42 U.S.C.
                                                              1320a-7h(a), relating to
                                                              physician ownership or
                                                              investment interests:
                                                                Minimum................        1,000         2010        8.745           87        1,087
                                                                Maximum................       10,000         2010        8.745          874       10,874
                                                                Calendar Year Cap......      150,000         2010        8.745       13,117      163,117
    1320a-7h(b)(2).................  42 CFR 402.105(h), 42   Penalty for manufacturer
                                      CFR 403 912(b) & (c).   or group purchasing
                                                              organization knowingly
                                                              failing to report
                                                              information required
                                                              under 42 U.S.C. 1320a-
                                                              7h(a) , relating to
                                                              physician ownership or
                                                              investment interests:
                                                                Minimum................       10,000         2010        8.745          874       10,874
                                                                Maximum................      100,000         2010        8.745        8,745      108,745
                                                                Calendar Year Cap......    1,000,000         2010        8.745       87,450    1,087,450
    1320a-7j(h)(3)(A)..............  ......................  Penalty for an                  100,000         2010        8.745        8,745      108,745
                                                              administrator of a
                                                              facility that fails to
                                                              comply with notice
                                                              requirements for the
                                                              closure of a facility.
                                     42 CFR                  Minimum penalty for the             500         2010        8.745           44          544
                                      488.446(a)(1),(2), &    first offense of an
                                      (3).                    administrator who fails
                                                              to provide notice of
                                                              facility closure.
                                                             Minimum penalty for the           1,500         2010        8.745          131        1,631
                                                              second offense of an
                                                              administrator who fails
                                                              to provide notice of
                                                              facility closure.
                                                             Minimum penalty for the           3,000         2010        8.745          262        3,262
                                                              third and subsequent
                                                              offenses of an
                                                              administrator who fails
                                                              to provide notice of
                                                              facility closure.
    1320a-8(a)(1)..................  ......................  Penalty for an entity             5,000         1994       59.089        2,954        7,954
                                                              knowingly making a false
                                                              statement or
                                                              representation of
                                                              material fact in the
                                                              determination of the
                                                              amount of benefits or
                                                              payments related to old-
                                                              age, survivors, and
                                                              disability insurance
                                                              benefits, special
                                                              benefits for certain
                                                              World War II veterans, or
                                                              supplemental security
                                                              income for the aged,
                                                              blind, and disabled.
                                                             Penalty for the violation         7,500         2015            1        4,431        7,500
                                                              of 42 U.S.C. 1320a-8a(1)
                                                              if the violator is a
                                                              person who receives a fee
                                                              or other income for
                                                              services performed in
                                                              connection with
                                                              determination of the
                                                              benefit amount or the
                                                              person is a physician or
                                                              other health care
                                                              provider who submits
                                                              evidence in connection
                                                              with such a determination.
    1320a-8(a)(3)..................  ......................  Penalty for a                     5,000         2004       24.588        1,229        6,229
                                                              representative payee
                                                              (under 42 U.S.C. 405(j),
                                                              1007, or 1383(a)(2))
                                                              converting any part of a
                                                              received payment from the
                                                              benefit programs
                                                              described in the previous
                                                              civil monetary penalty to
                                                              a use other than for the
                                                              benefit of the
                                                              beneficiary.
    1320b-25(c)(1)(A)..............  ......................  Penalty for failure of          200,000         2010        8.745       17,490      217,490
                                                              covered individuals to
                                                              report to the Secretary
                                                              and 1 or more law
                                                              enforcement officials any
                                                              reasonable suspicion of a
                                                              crime against a resident,
                                                              or individual receiving
                                                              care, from a long-term
                                                              care facility.

[[Page 61549]]

 
    1320b-25(c)(2)(A)..............  ......................  Penalty for failure of          300,000         2010        8.745       26,235      326,235
                                                              covered individuals to
                                                              report to the Secretary
                                                              and 1 or more law
                                                              enforcement officials any
                                                              reasonable suspicion of a
                                                              crime against a resident,
                                                              or individual receiving
                                                              care, from a long-term
                                                              care facility if such
                                                              failure exacerbates the
                                                              harm to the victim of the
                                                              crime or results in the
                                                              harm to another
                                                              individual.
    1320b-25(d)(2).................  ......................  Penalty for a long-term         200,000         2010        8.745       17,490      217,490
                                                              care facility that
                                                              retaliates against any
                                                              employee because of
                                                              lawful acts done by the
                                                              employee, or files a
                                                              complaint or report with
                                                              the State professional
                                                              disciplinary agency
                                                              against an employee or
                                                              nurse for lawful acts
                                                              done by the employee or
                                                              nurse.
    1395b-7(b)(2)(B)...............  42 CFR 402.105(g).....  Penalty for any person who          100         1997       47.177           47          147
                                                              knowingly and willfully
                                                              fails to furnish a
                                                              beneficiary with an
                                                              itemized statement of
                                                              items or services within
                                                              30 days of the
                                                              beneficiary's request.
    1395i-3(h)(2)(B)(ii)(I)........  42 CFR                  Penalty per day for a
                                      488.408(d)(1)(iii).     Skilled Nursing Facility
                                                              that has a Category 2
                                                              violation of
                                                              certification
                                                              requirements:
                                                                Minimum................           50         1987      106.278           53          103
                                                                Maximum................        3,000         1987      106.278        3,188        6,188
                                     42 CFR                  Penalty per instance of
                                      488.408(d)(1)(iv).      Category 2 noncompliance
                                                              by a Skilled Nursing
                                                              Facility:
                                                                Minimum................        1,000         1987      106.278        1,063        2,063
                                                                Maximum................       10,000         1987      106.278       10,628       20,628
                                     42 CFR                  Penalty per day for a
                                      488.408(e)(1)(iii).     Skilled Nursing Facility
                                                              that has a Category 3
                                                              violation of
                                                              certification
                                                              requirements:
                                                                Minimum................        3,050         1987      106.278        3,241        6,291
                                                                Maximum................       10,000         1987      106.278       10,628       20,628
                                     42 CFR                  Penalty per instance of
                                      488.408(e)(1)(iv).      Category 3 noncompliance
                                                              by a Skilled Nursing
                                                              Facility:
                                                                Minimum................        1,000         1987      106.278        1,063        2,063
                                                                Maximum................       10,000         1987      106.278       10,628       20,628
                                                             Penalty per day and per
                                                              instance for a Skilled
                                                              Nursing Facility that has
                                                              Category 3 noncompliance
                                                              with Immediate Jeopardy.
                                                                Per Day (Minimum)......        3,050         1987      106.278        3,241        6,291
                                                                Per Day (Maximum)......       10,000         1987      106.278       10,628       20,628
                                                                Per Instance (Minimum).        1,000         1987      106.278        1,063        2,063
                                                                Per Instance (Maximum).       10,000         1987      106.278       10,628       20,628
                                     42 CFR                  Penalty per day of a
                                      488.438(a)(1)(i).       Skilled Nursing Facility
                                                              that fails to meet
                                                              certification
                                                              requirements. These
                                                              amounts represent the
                                                              upper range per day:
                                                                Minimum................        3,050         1987      106.278        3,241        6,291
                                                                Maximum................       10,000         1987      106.278       10,628       20,628
                                     42 CFR                  Penalty per day of a
                                      488.438(a)(1)(ii).      Skilled Nursing Facility
                                                              that fails to meet
                                                              certification
                                                              requirements. These
                                                              amounts represent the
                                                              lower range per day:
                                                                Minimum................           50         1987      106.278           53          103
                                                                Maximum................        3,000         1987      106.278        3,188        6,188
                                     42 CFR 488.438(a)(2)..  Penalty per instance of a
                                                              Skilled Nursing Facility
                                                              that fails to meet
                                                              certification
                                                              requirements:
                                                                Minimum................        1,000         1987      106.278        1,063        2,063
                                                                Maximum................       10,000         1987      106.278       10,628       20,628

[[Page 61550]]

 
    1395l(h)(5)(D).................  42 CFR                  Penalty for knowingly,           10,000         1996       50.245        5,024       15,024
                                      402.105(d)(2)(i).       willfully, and repeatedly
                                                              billing for a clinical
                                                              diagnostic laboratory
                                                              test other than on an
                                                              assignment-related basis.
                                                              (Penalties are assessed
                                                              in the same manner as 42
                                                              U.S.C. 1395u(j)(2)(B),
                                                              which is assessed
                                                              according to 1320a-7a(a)).
    1395l(i)(6)....................  ......................  Penalty for knowingly and         2,000         1988      197.869        1,957        3,957
                                                              willfully presenting or
                                                              causing to be presented a
                                                              bill or request for
                                                              payment for an
                                                              intraocular lens inserted
                                                              during or after cataract
                                                              surgery for which the
                                                              Medicare payment rate
                                                              includes the cost of
                                                              acquiring the class of
                                                              lens involved.
    1395l(q)(2)(B)(i)..............  42 CFR 402.105(a).....  Penalty for knowingly and         2,000         1989       89.361        1,787        3,787
                                                              willfully failing to
                                                              provide information about
                                                              a referring physician
                                                              when seeking payment on
                                                              an unassigned basis.
    1395m(a)(11)(A)................  42 CFR 402.1(c)(4),     Penalty for any durable          10,000         1996       50.245        5,024       15,024
                                      402.105(d)(2)(ii).      medical equipment
                                                              supplier that knowingly
                                                              and willfully charges for
                                                              a covered service that is
                                                              furnished on a rental
                                                              basis after the rental
                                                              payments may no longer be
                                                              made. (Penalties are
                                                              assessed in the same
                                                              manner as 42 U.S.C.
                                                              1395u(j)(2)(B), which is
                                                              assessed according to
                                                              1320a-7a(a)).
    1395m(a)(18)(B)................  42 CFR 402.1(c)(5),     Penalty for any                  10,000         1996       50.245        5,024       15,024
                                      402.105(d)(2)(iii).     nonparticipating durable
                                                              medical equipment
                                                              supplier that knowingly
                                                              and willfully fails to
                                                              make a refund to Medicare
                                                              beneficiaries for a
                                                              covered service for which
                                                              payment is precluded due
                                                              to an unsolicited
                                                              telephone contact from
                                                              the supplier. (Penalties
                                                              are assessed in the same
                                                              manner as 42 U.S.C.
                                                              1395u(j)(2)(B), which is
                                                              assessed according to
                                                              1320a-7a(a)).
    1395m(b)(5)(C).................  42 CFR 402.1(c)(6),     Penalty for any                  10,000         1996       50.245        5,024       15,024
                                      402.105(d)(2)(iv).      nonparticipating
                                                              physician or supplier
                                                              that knowingly and
                                                              willfully charges a
                                                              Medicare beneficiary more
                                                              than the limiting charge
                                                              for radiologist services.
                                                              (Penalties are assessed
                                                              in the same manner as 42
                                                              U.S.C. 1395u(j)(2)(B),
                                                              which is assessed
                                                              according to 1320a-7a(a)).
    1395m(h)(3)....................  42 CFR 402.1(c)(8),     Penalty for any supplier         10,000         1996       50.245        5,024       15,024
                                      402.105(d)(2)(vi).      of prosthetic devices,
                                                              orthotics, and
                                                              prosthetics that knowing
                                                              and willfully charges for
                                                              a covered prosthetic
                                                              device, orthotic, or
                                                              prosthetic that is
                                                              furnished on a rental
                                                              basis after the rental
                                                              payment may no longer be
                                                              made. (Penalties are
                                                              assessed in the same
                                                              manner as 42 U.S.C.
                                                              1395m(a)(11)(A), that is
                                                              in the same manner as
                                                              1395u(j)(2)(B), which is
                                                              assessed according to
                                                              1320a-7a(a)).

[[Page 61551]]

 
    1395m(j)(2)(A)(iii)............  ......................  Penalty for any supplier          1,000         1994       59.089          591        1,591
                                                              of durable medical
                                                              equipment including a
                                                              supplier of prosthetic
                                                              devices, prosthetics,
                                                              orthotics, or supplies
                                                              that knowingly and
                                                              willfully distributes a
                                                              certificate of medical
                                                              necessity in violation of
                                                              Section 1834(j)(2)(A)(i)
                                                              of the Act or fails to
                                                              provide the information
                                                              required under Section
                                                              1834(j)(2)(A)(ii) of the
                                                              Act.
    1395m(j)(4)....................  42 CFR 402.1(c)(10),    Penalty for any supplier         10,000         1996       50.245        5,024       15,024
                                      402.105(d)(2)(vii).     of durable medical
                                                              equipment, including a
                                                              supplier of prosthetic
                                                              devices, prosthetics,
                                                              orthotics, or supplies
                                                              that knowingly and
                                                              willfully fails to make
                                                              refunds in a timely
                                                              manner to Medicare
                                                              beneficiaries for series
                                                              billed other than on as
                                                              assignment-related basis
                                                              under certain conditions.
                                                              (Penalties are assessed
                                                              in the same manner as 42
                                                              U.S.C. 1395m(j)(4) and
                                                              1395u(j)(2)(B), which is
                                                              assessed according to
                                                              1320a-7a(a)).
    1395m(k)(6)....................  42 CFR 402.1(c)(31),    Penalty for any person or        10,000         1996       50.245        5,024       15,024
                                      402.105(d)(3).          entity who knowingly and
                                                              willfully bills or
                                                              collects for any
                                                              outpatient therapy
                                                              services or comprehensive
                                                              outpatient rehabilitation
                                                              services on other than an
                                                              assignment-related basis.
                                                              (Penalties are assessed
                                                              in the same manner as 42
                                                              U.S.C. 1395m(k)(6) and
                                                              1395u(j)(2)(B), which is
                                                              assessed according to
                                                              1320a-7a(a)).
    1395m(l)(6)....................  42 CFR 402.1(c)(32),    Penalty for any supplier         10,000         1996       50.245        5,024       15,024
                                      402.105(d)(4).          of ambulance services who
                                                              knowingly and willfully
                                                              fills or collects for any
                                                              services on other than an
                                                              assignment-related basis.
                                                              (Penalties are assessed
                                                              in the same manner as 42
                                                              U.S.C. 1395u(b)(18)(B),
                                                              which is assessed
                                                              according to 1320a-7a(a)).
    1395u(b)(18)(B)................  42 CFR 402.1(c)(11),    Penalty for any                  10,000         1996       50.245        5,024       15,024
                                      402.105(d)(2)(viii).    practitioner specified in
                                                              Section 1842(b)(18)(C) of
                                                              the Act or other person
                                                              that knowingly and
                                                              willfully bills or
                                                              collects for any services
                                                              by the practitioners on
                                                              other than an assignment-
                                                              related basis. (Penalties
                                                              are assessed in the same
                                                              manner as 42 U.S.C.
                                                              1395u(j)(2)(B), which is
                                                              assessed according to
                                                              1320a-7a(a)).
    1395u(j)(2)(B).................  42 CFR 402.1(c).......  Penalty for any physician        10,000         1996       50.245        5,024       15,024
                                                              who charges more than
                                                              125% for a non-
                                                              participating referral.
                                                              (Penalties are assessed
                                                              in the same manner as 42
                                                              U.S.C. 1320a-7a(a)).
    1395u(k).......................  42 CFR 402.1(c)(12),    Penalty for any physician        10,000         1996       50.245        5,024       15,024
                                      402.105(d)(2)(ix).      who knowingly and
                                                              willfully presents or
                                                              causes to be presented a
                                                              claim for bill for an
                                                              assistant at a cataract
                                                              surgery performed on or
                                                              after March 1, 1987, for
                                                              which payment may not be
                                                              made because of section
                                                              1862(a)(15). (Penalties
                                                              are assessed in the same
                                                              manner as 42 U.S.C.
                                                              1395u(j)(2)(B), which is
                                                              assessed according to
                                                              1320a-7a(a)).

[[Page 61552]]

 
    1395u(l)(3)....................  42 CFR 402.1(c)(13),    Penalty for any                  10,000         1996       50.245        5,024       15,024
                                      402.105(d)(2)(x).       nonparticipating
                                                              physician who does not
                                                              accept payment on an
                                                              assignment-related basis
                                                              and who knowingly and
                                                              willfully fails to refund
                                                              on a timely basis any
                                                              amounts collected for
                                                              services that are not
                                                              reasonable or medically
                                                              necessary or are of poor
                                                              quality under
                                                              1842(l)(1)(A). (Penalties
                                                              are assessed in the same
                                                              manner as 42 U.S.C.
                                                              1395u(j)(2)(B), which is
                                                              assessed according to
                                                              1320a-7a(a)).
    1395u(m)(3)....................  42 CFR 402.1(c)(14),    Penalty for any                  10,000         1996       50.245        5,024       15,024
                                      402.105(d)(2)(xi).      nonparticipating
                                                              physician charging more
                                                              than $500 who does not
                                                              accept payment for an
                                                              elective surgical
                                                              procedure on an
                                                              assignment related basis
                                                              and who knowingly and
                                                              willfully fails to
                                                              disclose the required
                                                              information regarding
                                                              charges and coinsurance
                                                              amounts and fails to
                                                              refund on a timely basis
                                                              any amount collected for
                                                              the procedure in excess
                                                              of the charges recognized
                                                              and approved by the
                                                              Medicare program.
                                                              (Penalties are assessed
                                                              in the same manner as 42
                                                              U.S.C. 1395u(j)(2)(B),
                                                              which is assessed
                                                              according to 1320a-7a(a)).
    1395u(n)(3)....................  42 CFR 402.1(c)(15),    Penalty for any physician        10,000         1996       50.245        5,024       15,024
                                      402.105(d)(2)(xii).     who knowingly, willfully,
                                                              and repeatedly bills one
                                                              or more beneficiaries for
                                                              purchased diagnostic
                                                              tests any amount other
                                                              than the payment amount
                                                              specified by the Act.
                                                              (Penalties are assessed
                                                              in the same manner as 42
                                                              U.S.C. 1395u(j)(2)(B),
                                                              which is assessed
                                                              according to 1320a-7a(a)).
    1395u(o)(3)(B).................  42 CFR 414.707(b).....  Penalty for any                  10,000         1996       50.245        5,024       15,024
                                                              practitioner specified in
                                                              Section 1842(b)(18)(C) of
                                                              the Act or other person
                                                              that knowingly and
                                                              willfully bills or
                                                              collects for any services
                                                              pertaining to drugs or
                                                              biologics by the
                                                              practitioners on other
                                                              than an assignment-
                                                              related basis. (Penalties
                                                              are assessed in the same
                                                              manner as 42 U.S.C.
                                                              1395u(b)(18)(B) and
                                                              1395u(j)(2)(B), which is
                                                              assessed according to
                                                              1320a-7a(a)).
    1395u(p)(3)(A).................  ......................  Penalty for any physician         2,000         1988       97.869        1,957        3,957
                                                              or practitioner who
                                                              knowingly and willfully
                                                              fails promptly to provide
                                                              the appropriate diagnosis
                                                              codes upon CMS or
                                                              Medicare administrative
                                                              contractor request for
                                                              payment or bill not
                                                              submitted on an
                                                              assignment-related basis.
    1395w-3a(d)(4)(A)..............  42 CFR 414.806........  Penalty for a                    10,000         2003       28.561        2,856       12,856
                                                              pharmaceutical
                                                              manufacturer's
                                                              misrepresentation of
                                                              average sales price of a
                                                              drug, or biologic.

[[Page 61553]]

 
    1395w-4(g)(1)(B)...............  42 CFR 402.1(c)(17),    Penalty for any                  10,000         1996       50.245        5,024       15,024
                                      402.105(d)(2)(xiii).    nonparticipating
                                                              physician, supplier, or
                                                              other person that
                                                              furnishes physician
                                                              services not on an
                                                              assignment-related basis
                                                              who either knowingly and
                                                              willfully bills or
                                                              collects in excess of the
                                                              statutorily-defined
                                                              limiting charge or fails
                                                              to make a timely refund
                                                              or adjustment. (Penalties
                                                              are assessed in the same
                                                              manner as 42 U.S.C.
                                                              1395u(j)(2)(B), which is
                                                              assessed according to
                                                              1320a-7a(a)).
    1395w-4(g)(3)(B)...............  42 CFR 402.1(c)(18),    Penalty for any person           10,000         1996       50.245        5,024       15,024
                                      402.105(d)(2)(xiv).     that knowingly and
                                                              willfully bills for
                                                              statutorily defined State-
                                                              plan approved physicians'
                                                              services on any other
                                                              basis than an assignment-
                                                              related basis for a
                                                              Medicare/Medicaid dual
                                                              eligible beneficiary.
                                                              (Penalties are assessed
                                                              in the same manner as 42
                                                              U.S.C. 1395u(j)(2)(B),
                                                              which is assessed
                                                              according to 1320a-7a(a)).
    1395w-27(g)(3)(A); 1857(g)(3)..  42 CFR 422.760(b); 42   Penalty for each                 25,000         1997       47.177       11,794       36,794
                                      CFR 423.760(b).         termination determination
                                                              the Secretary makes that
                                                              is the result of actions
                                                              by a Medicare Advantage
                                                              organization or Part D
                                                              sponsor that has
                                                              adversely affected an
                                                              individual covered under
                                                              the organization's
                                                              contract.
    1395w-27(g)(3)(B); 1857(g)(3)..  ......................  Penalty for each week            10,000         1997       47.177        4,718       14,718
                                                              beginning after the
                                                              initiation of civil money
                                                              penalty procedures by the
                                                              Secretary because a
                                                              Medicare Advantage
                                                              organization or Part D
                                                              sponsor has failed to
                                                              carry out a contract, or
                                                              has carried out a
                                                              contract inconsistently
                                                              with regulations.
    1395w-27(g)(3)(D); 1857(g)(3)..  ......................  Penalty for a Medicare          100,000         2000       36.689       36,689      136,689
                                                              Advantage organization's
                                                              or Part D sponsor's early
                                                              termination of its
                                                              contract.
    1395y(b)(3)(C).................  42 CFR 411.103(b).....  Penalty for an employer or        5,000         1990       78.156        3,908        8,908
                                                              other entity to offer any
                                                              financial or other
                                                              incentive for an
                                                              individual entitled to
                                                              benefits not to enroll
                                                              under a group health plan
                                                              or large group health
                                                              plan which would be a
                                                              primary plan.
    1395y(b)(5)(C)(ii).............  42 CFR 402.1(c)(20),    Penalty for any non-              1,000         1998       89.361          450        1,450
                                      402.105(b)(2).          governmental employer
                                                              that, before October 1,
                                                              1998, willfully or
                                                              repeatedly failed to
                                                              provide timely and
                                                              accurate information
                                                              requested relating to an
                                                              employee's group health
                                                              insurance coverage.
    1395y(b)(6)(B).................  42 CFR 402.1(c)(21),    Penalty for any entity            2,000         1994       59.089        1,182        3,182
                                      402.105(a).             that knowingly,
                                                              willfully, and repeatedly
                                                              fails to complete a claim
                                                              form relating to the
                                                              availability of other
                                                              health benefits in
                                                              accordance with statute
                                                              or provides inaccurate
                                                              information relating to
                                                              such on the claim form.
    1395y(b)(7)(B)(i)..............  ......................  Penalty for any entity            1,000         2007       13.833          138        1,138
                                                              serving as insurer, third
                                                              party administrator, or
                                                              fiduciary for a group
                                                              health plan that fails to
                                                              provide information that
                                                              identifies situations
                                                              where the group health
                                                              plan is or was a primary
                                                              plan to Medicare to the
                                                              HHS Secretary.

[[Page 61554]]

 
    1395y(b)(8)(E).................  ......................  Penalty for any non-group         1,000         2007       13.833          138        1,138
                                                              health plan that fails to
                                                              identify claimants who
                                                              are Medicare
                                                              beneficiaries and provide
                                                              information to the HHS
                                                              Secretary to coordinate
                                                              benefits and pursue any
                                                              applicable recovery claim.
    1395nn(g)(5)...................  42 CFR 411.361........  Penalty for any person           10,000         1989       89.361        8,936       18,936
                                                              that fails to report
                                                              information required by
                                                              HHS under Section 1877(f)
                                                              concerning ownership,
                                                              investment, and
                                                              compensation arrangements.
    1395pp(h)......................  42 CFR 402.1(c)(23),    Penalty for any durable          10,000         1996       50.245        5,024       15,024
                                      402.105(d)(2)(xv).      medical equipment
                                                              supplier, including a
                                                              supplier of prosthetic
                                                              devices, prosthetics,
                                                              orthotics, or supplies,
                                                              that knowingly and
                                                              willfully fails to make
                                                              refunds in a timely
                                                              manner to Medicare
                                                              beneficiaries under
                                                              certain conditions. (42
                                                              U.S.C. 1395(m)(18)
                                                              sanctions apply here in
                                                              the same manner, which is
                                                              under 1395u(j)(2) and
                                                              1320a-7a(a)).
    1395ss(a)(2)...................  42 CFR 402.1(c)(24),    Penalty for any person           25,000         1987      106.278       26,569       51,569
                                      405.105(f)(1).          that issues a Medicare
                                                              supplemental policy that
                                                              has not been approved by
                                                              the State regulatory
                                                              program or does not meet
                                                              Federal standards after a
                                                              statutorily defined
                                                              effective date.
    1395ss(d)(3)(A)(vi) (II).......  ......................  Penalty for someone other        15,000         1990       78.156       11,723       26,723
                                                              than issuer that sells or
                                                              issues a Medicare
                                                              supplemental policy to
                                                              beneficiary without a
                                                              disclosure statement.
                                                             Penalty for an issuer that       25,000         1990       78.156       19,539       44,539
                                                              sells or issues a
                                                              Medicare supplemental
                                                              policy without disclosure
                                                              statement.
1395ss(d)(3)(B)(iv)................  ......................  Penalty for someone other        15,000         1990       78.156       11,723       26,723
                                                              than issuer that sells or
                                                              issues a Medicare
                                                              supplemental policy
                                                              without acknowledgement
                                                              form.
                                                             Penalty for issuer that          25,000         1990       78.156       19,539       44,539
                                                              sells or issues a
                                                              Medicare supplemental
                                                              policy without an
                                                              acknowledgement form.
    1395ss(p)(8)...................  42 CFR 402.1(c)(25),    Penalty for any person           15,000         1990       78.156       11,723       26,723
                                      402.105(e).             that sells or issues
                                                              Medicare supplemental
                                                              polices after a given
                                                              date that fail to conform
                                                              to the NAIC or Federal
                                                              standards established by
                                                              statute.
                                     42 CFR 402.1(c)(25),    Penalty for any person           25,000         1990       78.156       19,539       44,539
                                      405.105(f)(2).          that sells or issues
                                                              Medicare supplemental
                                                              polices after a given
                                                              date that fail to conform
                                                              to the NAIC or Federal
                                                              standards established by
                                                              statute.
    1395ss(p)(9)(C)................  42 CFR 402.1(c)(26),    Penalty for any person           15,000         1990       78.156       11,723       26,723
                                      402.105(e).             that sells a Medicare
                                                              supplemental policy and
                                                              fails to make available
                                                              for sale the core group
                                                              of basic benefits when
                                                              selling other Medicare
                                                              supplemental policies
                                                              with additional benefits
                                                              or fails to provide the
                                                              individual, before
                                                              selling the policy, an
                                                              outline of coverage
                                                              describing benefits.

[[Page 61555]]

 
                                     42 CFR 402.1(c)(26),    Penalty for any person           25,000         1990       78.156       19,539       44,539
                                      405.105(f)(3), (4).     that sells a Medicare
                                                              supplemental policy and
                                                              fails to make available
                                                              for sale the core group
                                                              of basic benefits when
                                                              selling other Medicare
                                                              supplemental policies
                                                              with additional benefits
                                                              or fails to provide the
                                                              individual, before
                                                              selling the policy, an
                                                              outline of coverage
                                                              describing benefits.
    1395ss(q)(5)(C)................  42 CFR 402.1(c)(27),    Penalty for any person           25,000         1990       78.156       19,539       44,539
                                      405.105(f)(5).          that fails to suspend the
                                                              policy of a policyholder
                                                              made eligible for medical
                                                              assistance or
                                                              automatically reinstates
                                                              the policy of a
                                                              policyholder who has lost
                                                              eligibility for medical
                                                              assistance, under certain
                                                              circumstances.
    1395ss(r)(6)(A)................  42 CFR 402.1(c)(28),    Penalty for any person           25,000         1990       78.156       19,539       44,539
                                      405.105(f)(6).          that fails to provide
                                                              refunds or credits as
                                                              required by section
                                                              1882(r)(1)(B).
    1395ss(s)(4)...................  42 CFR 402.1(c)(29),    Penalty for any issuer of         5,000         1990       78.156        3,908        8,908
                                      405.105(c).             a Medicare supplemental
                                                              policy that does not
                                                              waive listed time periods
                                                              if they were already
                                                              satisfied under a
                                                              proceeding Medicare
                                                              supplemental policy, or
                                                              denies a policy, or
                                                              conditions the issuances
                                                              or effectiveness of the
                                                              policy, or discriminates
                                                              in the pricing of the
                                                              policy base on health
                                                              status or other specified
                                                              criteria.
    1395ss(t)(2)...................  42 CFR 402.1(c)(30),    Penalty for any issuer of        25,000         1990       78.156       19,539       44,539
                                      405.105(f)(7).          a Medicare supplemental
                                                              policy that fails to
                                                              fulfill listed
                                                              responsibilities.
1395ss(v)(4)(A)....................  ......................  Penalty someone other than       15,000         2003       28.561        4,284       19,284
                                                              issuer who sells, issues,
                                                              or renews a medigap Rx
                                                              policy to an individual
                                                              who is a Part D enrollee.
                                                             Penalty for an issuer who        25,000         2003       28.561        7,140       32,140
                                                              sells, issues, or renews
                                                              a Medigap Rx policy who
                                                              is a Part D enrollee.
    1395bbb(c)(1)..................  42 CFR 488.725(c).....  Penalty for any individual        2,000         1987      106.278        2,126        4,126
                                                              who notifies or causes to
                                                              be notified a home health
                                                              agency of the time or
                                                              date on which a survey of
                                                              such agency is to be
                                                              conducted.
    1395bbb(f)(2)(A)(i)............  42 CFR                  Maximum daily penalty            10,000         1988       97.869        9,787       19,787
                                      488.845(b)(2)(iii).     amount for each day a
                                                              home health agency is not
                                                              in compliance with
                                                              statutory requirements.
                                     42 CFR 488.845(b)(3)..  Penalty per day for home
                                                              health agency's
                                                              noncompliance (Upper
                                                              Range):
                                                                Minimum................        8,500         1988       97.869        8,319       16,819
                                                                Maximum................       10,000         1988       97.869        9,787       19,787
                                     42 CFR                  Penalty for a home health        10,000         1988       97.869        9,787       19,787
                                      488.845(b)(3)(i).       agency's deficiency or
                                                              deficiencies that cause
                                                              immediate jeopardy and
                                                              result in actual harm.
                                     42 CFR                  Penalty for a home health         9,000         1988       97.869        8,808       17,808
                                      488.845(b)(3)(ii).      agency's deficiency or
                                                              deficiencies that cause
                                                              immediate jeopardy and
                                                              result in potential for
                                                              harm.
                                     42 CFR                  Penalty for an isolated           8,500         1988       97.869        8,319       16,819
                                      488.845(b)(3)(iii).     incident of noncompliance
                                                              in violation of
                                                              established HHA policy.
                                     42 CFR 488.845(b)(4)..  Penalty for a repeat and/
                                                              or condition-level
                                                              deficiency that does not
                                                              constitute immediate
                                                              jeopardy, but is directly
                                                              related to poor quality
                                                              patient care outcomes
                                                              (Lower Range):
                                                                Minimum................        1,500         1988       97.869        1,468        2,968
                                                                Maximum................        8,500         1988       97.869        8,319       16,819

[[Page 61556]]

 
                                     42 CFR 488.845(b)(5)..  Penalty for a repeat and/
                                                              or condition-level
                                                              deficiency that does not
                                                              constitute immediate
                                                              jeopardy and that is
                                                              related predominately to
                                                              structure or process-
                                                              oriented conditions
                                                              (Lower Range):
                                                                Minimum................          500         1988       97.869          489          989
                                                                Maximum................        4,000         1988       97.869        3,915        7,915
                                     ......................
42 CFR 488.845(b)(6)...............  ......................  Penalty imposed for
                                                              instance of noncompliance
                                                              that may be assessed for
                                                              one or more singular
                                                              events of condition-level
                                                              noncompliance that are
                                                              identified and where the
                                                              noncompliance was
                                                              corrected during the
                                                              onsite survey:
                                                                Minimum................        1,000         1988       97.869          979        1,979
                                                                Maximum................       10,000         1988       97.869        9,787       19,787
                                                             Penalty for each day of          10,000         1988       97.869        9,787       19,787
                                                              noncompliance (Maximum).
                                     42 CFR                  Penalty for each day of          10,000         1988       97.869        9,787       19,787
                                      488.845(d)(1)(ii).      noncompliance (Maximum).
    1396b(m)(5)(B).................  42 CFR 460.46.........  Penalty for PACE
                                                              organization's practice
                                                              that would reasonably be
                                                              expected to have the
                                                              effect of denying or
                                                              discouraging enrollment:
                                                                Minimum................       15,000         1997       47.177        7,077       22,077
                                                                Maximum................      100,000         1997       47.177       47,177      147,177
                                                             Penalty for a PACE               25,000         1997       47.177       11,794       36,794
                                                              organization that charges
                                                              excessive premiums.
                                                             Penalty for a PACE              100,000         1997       47.177       47,177      147,177
                                                              organization
                                                              misrepresenting or
                                                              falsifying information to
                                                              CMS, the State, or an
                                                              individual or other
                                                              entity.
                                                             Penalty for each                 25,000         1997       47.177       11,794       36,794
                                                              determination the CMS
                                                              makes that the PACE
                                                              organization has failed
                                                              to provide medically
                                                              necessary items and
                                                              services of the failure
                                                              has adversely affected
                                                              (or has the substantial
                                                              likelihood of adversely
                                                              affecting) a PACE
                                                              participant.
                                                             Penalty for involuntarily        25,000         1997       47.177       11,794       36,794
                                                              disenrolling a
                                                              participant.
                                                             Penalty for discriminating       25,000         1997       47.177       11,794       36,794
                                                              or discouraging
                                                              enrollment or
                                                              disenrollment of
                                                              participants on the basis
                                                              of an individual's health
                                                              status or need for health
                                                              care services.
    1396r(h)(3)(C)(ii)(I)..........  42 CFR                  Penalty per day for a
                                      488.408(d)(1)(iii).     nursing facility's
                                                              failure to meet a
                                                              Category 2 Certification:
                                                                Minimum................           50         1987      106.278           53          103
                                                                Maximum................        3,000         1987      106.278        3,188        6,188
                                     42 CFR                  Penalty per instance for a
                                      488.408(d)(1)(iv).      nursing facility's
                                                              failure to meet Category
                                                              2 certification:
                                                                Minimum................        1,000         1987      106.278        1,063        2,063
                                                                Maximum................       10,000         1987      106.278       10,628       20,628
                                     42 CFR                  Penalty per day for a
                                      488.408(e)(1)(iii).     nursing facility's
                                                              failure to meet Category
                                                              3 certification:
                                                                Minimum................        3,050         1987      106.278        3,241        6,291
                                                                Maximum................       10,000         1987      106.278       10,628       20,628
                                     42 CFR                  Penalty per instance for a
                                      488.408(e)(1)(iv).      nursing facility's
                                                              failure to meet Category
                                                              3 certification:
                                                                Minimum................        1,000         1987      106.278        1,063        2,063
                                                                Maximum................       10,000         1987      106.278       10,628       20,628
                                     42 CFR                  Penalty per instance for a
                                      488.408(e)(2)(ii).      nursing facility's
                                                              failure to meet Category
                                                              3 certification, which
                                                              results in immediate
                                                              jeopardy:
                                                                Minimum................        1,000         1987      106.278        1,063        2,063
                                                                Maximum................       10,000         1987      106.278       10,628       20,628

[[Page 61557]]

 
                                     42 CFR                  Penalty per day for
                                      488.438(a)(1)(i).       nursing facility's
                                                              failure to meet
                                                              certification (Upper
                                                              Range):
                                                                Minimum................        3,050         1987      106.278        3,241        6,291
                                                                Maximum................       10,000         1987      106.278       10,628       20,628
                                     42 CFR                  Penalty per day for
                                      488.438(a)(1)(ii).      nursing facility's
                                                              failure to meet
                                                              certification (Lower
                                                              Range):
                                                                Minimum................           50         1987      106.278           53          103
                                                                Maximum................        3,000         1987      106.278        3,188        6,188
                                     42 CFR 488.438(a)(2)..  Penalty per instance for
                                                              nursing facility's
                                                              failure to meet
                                                              certification:
                                                                Minimum................        1,000         1987      106.278        1,063        2,063
                                                                Maximum................       10,000         1987      106.278       10,628       20,628
    1396r(f)(2)(B)(iii)(I)(c)......  42 CFR                  Grounds to prohibit               5,000         1987      106.278        5,314       10,314
                                      483.151(b)(2)(iv) and   approval of Nurse Aide
                                      (b)(3)(iii).            Training Program--if
                                                              assessed a penalty in
                                                              1819(h)(2)(B)(i) or
                                                              1919(h)(2)(A)(ii) of
                                                              ``not less than $5,000''
                                                              [Not CMP authority, but a
                                                              specific CMP amount (CMP
                                                              at this level) that is
                                                              the triggering condition
                                                              for disapproval].
    1396r(h)(3)(C)(ii)(I)..........  42 CFR 483.151(c)(2)..  Grounds to waive                  5,000         1987      106.278        5,314       10,314
                                                              disapproval of nurse aide
                                                              training program--
                                                              reference to disapproval
                                                              based on imposition of
                                                              CMP ``not less than
                                                              $5,000'' [Not CMP
                                                              authority but CMP
                                                              imposition at this level
                                                              determines eligibility to
                                                              seek waiver of
                                                              disapproval of nurse aide
                                                              training program].
    1396t(j)(2)(C).................  ......................  Penalty for each day of
                                                              noncompliance for a home
                                                              or community care
                                                              provider that no longer
                                                              meets the minimum
                                                              requirements for home and
                                                              community care:
                                                                Minimum................            1         1990       78.156            1            2
                                                                Maximum................       10,000         1990       78.156        7,816       17,816
    1396u-2(e)(2)(A)(i)............  42 CFR 438.704........  Penalty for a Medicaid           25,000         1997       47.177       11,794       36,794
                                                              managed care organization
                                                              that fails substantially
                                                              to provide medically
                                                              necessary items and
                                                              services.
                                                             Penalty for Medicaid             25,000         1997       47.177       11,794       36,794
                                                              managed care organization
                                                              that imposes premiums or
                                                              charges on enrollees in
                                                              excess of the premiums or
                                                              charges permitted.
                                                             Penalty for a Medicaid           25,000         1997       47.177       11,794       36,794
                                                              managed care organization
                                                              that misrepresents or
                                                              falsifies information to
                                                              another individual or
                                                              entity.
                                                             Penalty for a Medicaid           25,000         1997       47.177       11,794       36,794
                                                              managed care organization
                                                              that fails to comply with
                                                              the applicable statutory
                                                              requirements for such
                                                              organizations.
    1396u-2(e)(2)(A)(ii)...........  42 CFR 438.704........  Penalty for a Medicaid          100,000         1997       47.177       47,177      147,177
                                                              managed care organization
                                                              that misrepresents or
                                                              falsifies information to
                                                              the HHS Secretary.
                                                             Penalty for Medicaid            100,000         1997       47.177       47,177      147,177
                                                              managed care organization
                                                              that acts to discriminate
                                                              among enrollees on the
                                                              basis of their health
                                                              status.
    1396u-2(e)(2)(A)(iv)...........  42 CFR 438.704........  Penalty for each                 15,000         1997       47.177        7,077       22,077
                                                              individual that does not
                                                              enroll as a result of a
                                                              Medicaid managed care
                                                              organization that acts to
                                                              discriminate among
                                                              enrollees on the basis of
                                                              their health status.
    1396u(h)(2)....................  42 CFR 441, Subpart I.  Penalty for a provider not       10,000         1990      106.278       10,628       20,628
                                                              meeting one of the
                                                              requirements relating to
                                                              the protection of the
                                                              health, safety, and
                                                              welfare of individuals
                                                              receiving community
                                                              supported living
                                                              arrangements services.

[[Page 61558]]

 
    1396w-2(c)(1)..................  ......................  Penalty for disclosing           10,000         2009        10.02        1,002       11,002
                                                              information related to
                                                              eligibility
                                                              determinations for
                                                              medical assistance
                                                              programs.
    1903(m)(5)(B)..................  42 CFR 460.46.........  Penalty for PACE
                                                              organization's practice
                                                              that would reasonably be
                                                              expected to have the
                                                              effect of denying or
                                                              discouraging enrollment:
                                                                Minimum................       15,000         1997       47.177        7,077       22,077
                                                                Maximum................      100,000         1997       47.177       47,177      147,177
                                                             Penalty for a PACE               25,000         1997       47.177       11,794       36,794
                                                              organization that charges
                                                              excessive premiums.
                                                             Penalty for a PACE              100,000         1997       47.177       47,177      147,177
                                                              organization
                                                              misrepresenting or
                                                              falsifying information to
                                                              CMS, the State, or an
                                                              individual or other
                                                              entity.
                                                             Penalty for each                 25,000         1997       47.177       11,794       36,794
                                                              determination the CMS
                                                              makes that the PACE
                                                              organization has failed
                                                              to provide medically
                                                              necessary items and
                                                              services of the failure
                                                              has adversely affected
                                                              (or has the substantial
                                                              likelihood of adversely
                                                              affecting) a PACE
                                                              participant.
                                                             Penalty for involuntarily        25,000         1997       47.177       11,794       36,794
                                                              disenrolling a
                                                              participant.
                                                             Penalty for discriminating       25,000         1997       47.177       11,794       36,794
                                                              or discouraging
                                                              enrollment or
                                                              disenrollment of
                                                              participants on the basis
                                                              of an individual's health
                                                              status or need for health
                                                              care services.
    18041(c)(2)....................  45 CFR 150.315 and 45   Failure to comply with              100         1996       50.245           50          150
                                      CFR 156.805(c).         requirements of Public
                                                              Health Services Act;
                                                              Penalty for violations of
                                                              rules or standards of
                                                              behavior associated with
                                                              issuer participation in
                                                              the Federally-facilitated
                                                              Exchange. (42 U.S.C.
                                                              300gg-22(b)(C)).
    18081(h)(1)(A)(i)(II)..........  42 CFR 155.285........  Penalty for providing            25,000         2010        8.745        2,186       27,186
                                                              false information on
                                                              Exchange application.
    18081(h)(1)(B).................  42 CFR 155.285........  Penalty for knowingly or        250,000         2010        8.745       21,862      271,862
                                                              willfully providing false
                                                              information on Exchange
                                                              application.
    18081(h)(2)....................  42 CFR 155.260........  Penalty for knowingly or         25,000         2010        8.745        2,186       27,186
                                                              willfully disclosing
                                                              protected information
                                                              from Exchange.
31 U.S.C. (HHS):
    1352...........................  45 CFR 93.400(e)......  Penalty for the first time       10,000         1989       89.361        8,936       18,936
                                                              an individual makes an
                                                              expenditure prohibited by
                                                              regulations regarding
                                                              lobbying disclosure,
                                                              absent aggravating
                                                              circumstances.
                                                             Penalty for second and
                                                              subsequent offenses by
                                                              individuals who make an
                                                              expenditure prohibited by
                                                              regulations regarding
                                                              lobbying disclosure:
                                                                Minimum................       10,000         1989       89.361        8,936       18,936
                                                                Maximum................      100,000         1989       89.361       89,361      189,361
                                                             Penalty for the first time       10,000         1989       89.361        8,936       18,936
                                                              an individual fails to
                                                              file or amend a lobbying
                                                              disclosure form, absent
                                                              aggravating circumstances.
                                                             Penalty for second and
                                                              subsequent offenses by
                                                              individuals who fail to
                                                              file or amend a lobbying
                                                              disclosure form, absent
                                                              aggravating
                                                              circumstances:
                                                                Minimum................       10,000         1989       89.361        8,936       18,936
                                                                Maximum................      100,000         1989       89.361       89,361      189,361
                                     45 CFR 93, Appendix A.  Penalty for failure to
                                                              provide certification
                                                              regarding lobbying in the
                                                              award documents for all
                                                              sub-awards of all tiers:
                                                                Minimum................       10,000         1989       89.361        8,936       18,936
                                                                Maximum................      100,000         1989       89.361       89,361      189,361

[[Page 61559]]

 
                                                             Penalty for failure to
                                                              provide statement
                                                              regarding lobbying for
                                                              loan guarantee and loan
                                                              insurance transactions:
                                                                Minimum................       10,000         1989       89.361        8,936       18,936
                                                                Maximum................      100,000         1989       89.361       89,361      189,361
    3801-3812......................  45 CFR 79.3(a)(1(iv)..  Penalty against any               5,000         1988       97.869        4,894        9,894
                                                              individual who--with
                                                              knowledge or reason to
                                                              know--makes, presents or
                                                              submits a false,
                                                              fictitious or fraudulent
                                                              claim to the Department.
                                     45 CFR 79.3(b)(1)(ii).  Penalty against any               5,000         1988       97.869        4,894        9,894
                                                              individual who--with
                                                              knowledge or reason to
                                                              know--makes, presents or
                                                              submits a false,
                                                              fictitious or fraudulent
                                                              claim to the Department.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Some HHS components have not promulgated regulations regarding their civil monetary penalties-specific statutory authorities.
\2\ The description is not intended to be a comprehensive explanation of the underlying violation; the statute and corresponding regulation, if
  applicable, should be consulted.
\3\ Statutory, or non-Inflation Act Adjustment.
\4\ Based on the lesser of the CPI-U multiplier for October 2015, or 150%.
\5\ Rounded to the nearest dollar.

III. Environmental Impact

    HHS has determined that this interim final rule (IFR) does not 
individually or cumulatively have a significant effect on the human 
environment. Therefore, neither an environmental impact assessment nor 
an environmental impact statement is required.

IV. Paperwork Reduction Act

    In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 
chapter 35) and its implementing regulations (5 CFR part 1320), HHS 
reviewed this IFR and determined that there are no new collections of 
information contained therein.

V. Regulatory Flexibility Act

    When an agency promulgates a final rule under 5 U.S.C. 553, after 
being required by that section or any other law to publish a general 
notice of proposed rulemaking, the Regulatory Flexibility Act (RFA) 
mandates that the agency prepare an RFA analysis. 5 U.S.C. 604(a). An 
RFA analysis is not required when a rule is exempt from notice and 
comment rulemaking under 5 U.S.C. 553(b). This interim final rule is 
exempt from notice and comment rulemaking. Therefore, no RFA analysis 
is required under 5 U.S.C. 604 and none was prepared.

VI. Executive Orders 12866 and 13563

    Executive Orders 12866 and 13563 direct agencies to assess all 
costs and benefits of available regulatory alternatives and, if 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety effects, distributive impacts, and equity). Executive 
Order 13563 emphasizes the importance of quantifying both costs and 
benefits, of reducing costs, of harmonizing rules, and of promoting 
flexibility. Agencies must prepare a regulatory impact analysis for 
major rules with economically significant effects ($100 million or more 
in any 1 year). HHS has determined that this IFR is not economically 
significant.
    HHS analyzed the economic significance of this IFR, by collecting 
data for fiscal years 2010 through 2014 on the total value of civil 
monetary penalties collected by Operating/Staff Divisions, except in 
the case of CMS, for which HHS used collections data through FY 2015. 
Such data included the statutory authority for the civil monetary 
penalty, which HHS used to apply the appropriate multiplier for each of 
the penalties collected. With respect to CMS, HHS determined the 
multiplier for the CMS collections by pro rating all of the multipliers 
for the civil monetary penalty authorities attributed to CMS.
    HHS then applied the multiplier to collections for each Fiscal Year 
(2010 through 2014) to calculate the collections for each Fiscal Year 
with the inflation adjustment. HHS also performed an additional 
calculation for FY 2014/2015 using the inflated collections amount for 
FY 2015 for CMS and using the inflated collections amount for all other 
Operating/Staff Divisions for FY 2014. When collections were adjusted 
for inflation, the Department's lowest collection amount was 
$58,332,000 for FY 2012 and the highest total was $168,000,000 for FY 
2014/2015.
    Finally, HHS subtracted the collections value for a Fiscal Year 
(for example, FY 2010) from the collections value for the same Fiscal 
Year with the inflation adjustment (for example, FY 2010 with inflation 
adjustment) to assess the economic significance of this IFR for that 
Fiscal Year (for example, FY 2010 Economic Significance). When the 
calculations were completed, the Fiscal Year Economic Significance 
values ranged from a low of $23,698,917 for FY 2013, to a high of 
$70,913,713 for FY 2014/2015. Based on these calculations, HHS does not 
believe this IFR will be economically significant as defined in 
Executive Order 12866.

VII. Unfunded Mandates Reform Act of 1995 Determination

    Section 202 of the Unfunded Mandates Reform Act of 1995 (Unfunded 
Mandates Act) (2 U.S.C. 1532) requires that covered agencies prepare a 
budgetary impact statement before promulgating a rule that includes any 
Federal mandate that may result in the expenditure by State, local, and 
tribal governments, in the aggregate, or by the private sector, of $100 
million or more in any one year. If a budgetary impact statement is 
required, section 205 of the Unfunded Mandates Act also requires 
covered agencies to identify and consider a reasonable number of 
regulatory alternatives before promulgating a rule. HHS has

[[Page 61560]]

determined that this IFR does not result in expenditures by State, 
local, and tribal governments, or by the private sector, of $100 
million or more in any one year. Accordingly, HHS has not prepared a 
budgetary impact statement or specifically addressed the regulatory 
alternatives considered.

VIII. Executive Order 13132 Determination

    HHS has determined that this IFR does not have any Federalism 
implications, as required by Executive Order 13132.

List of Subjects

42 CFR Part 3

    Administrative practice and procedure, Conflicts of interests, 
Health records, Privacy, Reporting and recordkeeping requirements.

42 CFR Part 402

    Administrative practice and procedure, Medicaid, Medicare, 
Penalties.

42 CFR Part 403

    Grant programs--health, Health insurance, Hospitals, 
Intergovernmental relations, Medicare, Reporting and recordkeeping 
requirements.

42 CFR Part 411

    Kidney diseases, Medicare, Physician referral, Reporting and 
recordkeeping requirements.

42 CFR Part 412

    Administrative practice and procedure, Health facilities, Medicare, 
Puerto Rico, Reporting and recordkeeping requirements.

42 CFR Part 422

    Administrative practice and procedure, Health facilities, Health 
maintenance organizations (HMO), Medicare, Penalties, Privacy, 
Reporting and recordkeeping requirements.

42 CFR Part 423

    Administrative practice and procedure, Emergency medical services, 
Health facilities, Health maintenance organizations (HMO), Health 
professionals, Medicare, Penalties, Privacy, Reporting and 
recordkeeping requirements.

42 CFR Part 438

    Grant programs--health, Medicaid, Reporting and recordkeeping 
requirements.

42 CFR Part 460

    Aged, Health care, Health records, Medicaid, Medicare, Reporting 
and recordkeeping requirements.

42 CFR Part 483

    Grant programs--health, Health facilities, Health professions, 
Health records, Medicaid, Medicare, Nursing homes, Nutrition, Reporting 
and recordkeeping requirements, Safety.

42 CFR Part 488

    Administrative practice and procedure, Health facilities, Medicare, 
Reporting and recordkeeping requirements.

42 CFR Part 493

    Administrative practice and procedure, Grant programs--health, 
Health facilities, Laboratories, Medicaid, Medicare, Penalties, 
Reporting and recordkeeping requirements.

42 CFR Part 1003

    Fraud, Grant programs--health, Health facilities, Health 
professions, Medicaid, Reporting and recordkeeping.

45 CFR Part 79

    Administrative practice and procedure, Claims, Fraud, Penalties.

45 CFR Part 93

    Government contracts, Grants programs, Loan programs, Lobbying, 
Penalties.

45 CFR Part 102

    Administrative practice and procedure, Penalties.

45 CFR Part 147

    Health care, Health insurance, Reporting and recordkeeping 
requirements.

45 CFR Part 155

    Administrative practice and procedure, Advertising, Brokers, 
Conflict of interest, Consumer protection, Grant programs--health, 
Grants administration, Health care, Health insurance, Health 
maintenance organization (HMO), Health records, Hospitals, Indians, 
Individuals with disabilities, Loan programs--health, Organization and 
functions (Government agencies), Medicaid, Public assistance programs, 
Reporting and recordkeeping requirements, Safety, State and local 
governments, Technical assistance, Women, and Youth.

45 CFR Part 156

    Administrative practice and procedure, Advertising, Advisory 
committees, Brokers, Conflict of interest, Consumer protection, Grant 
programs--health, Grants administration, Health care, Health insurance, 
Health maintenance organization (HMO), Health records, Hospitals, 
Indians, Individuals with disabilities, Loan programs--health, 
Organization and functions (Government agencies), Medicaid, Public 
assistance programs, Reporting and recordkeeping requirements, Safety, 
State and local governments, Sunshine Act, Technical assistance, Women, 
and Youth.

45 CFR Part 158

    Administrative practice and procedure, Claims, Health care, Health 
insurance, Health plans, penalties, Reporting and recordkeeping 
requirements, Premium revenues, Medical loss ratio, Rebating.

45 CFR Part 160

    Administrative practice and procedures, Penalties, Records and 
recordkeeping requirements.

45 CFR Part 303

    Child support, Standards for program operations, Penalties.

    For the reasons set forth in the preamble, the Department of Health 
and Human Services amends 42 CFR chapter I and 45 CFR subtitle A, the 
Centers for Medicare & Medicaid Services amends 42 CFR chapter IV, the 
Office of the Inspector General amends 42 CFR chapter 42 CFR chapter V, 
and the Administration for Children and Families amends 45 CFR chapter 
III as follows:

Title 42--Public Health

Chapter I--Public Health Service, Department of Health and Human 
Services

PART 3--PATIENT SAFETY ORGANIZATIONS AND PATIENT SAFETY WORK 
PRODUCT

0
1. The authority citation for part 3 continues to read as follows:

    Authority:  42 U.S.C. 216, 299b-21 through 299b-26; 42 U.S.C. 
299c-6.


0
2. Section 3.404 is revised to read as follows:


Sec.  3.404  Amount of a civil money penalty.

    (a) The amount of a civil money penalty will be determined in 
accordance with paragraph (b) of this section and Sec.  3.408.
    (b) The Secretary may impose a civil monetary penalty in the amount 
of not more than $11,000. This amount has been updated and will be 
updated annually, in accordance with the Federal Civil Monetary penalty 
Inflation Adjustment Act of 1990 (Pub. L. 101-140), as amended by the 
Federal Civil Penalties Inflation Adjustment Act Improvements Act of 
2015 (section 701 of Pub. L. 114-74). The amount, as

[[Page 61561]]

updated, is published at 45 CFR part 102.

CHAPTER IV--CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF 
HEALTH AND HUMAN SERVICES

PART 402--CIVIL MONEY PENALTIES, ASSESSMENTS, AND EXCLUSIONS

0
3. The authority citation for part 402 continues to read as follows:

    Authority:  Secs. 1102 and 1871 of the Social Security Act (42 
U.S.C. 1302 and 1395hh).


Sec.  402.105  [Amended]

0
4. In the table below, Sec.  402.105 is amended in each paragraph 
indicated in the first column, by removing the phrase indicated in the 
second column and adding in its place the phrase in the third column:

------------------------------------------------------------------------
           Paragraph                  Remove                Add
------------------------------------------------------------------------
(a)...........................  ``$2,000 for each  ``$2,000 as adjusted
                                 service''.         annually under 45
                                                    CFR part 102 for
                                                    each service''.
(b) introductory text.........  ``not more than    ``not more than
                                 $1,000 for''.      $1,000 as adjusted
                                                    annually under 45
                                                    CFR part 102 for''.
(c) introductory text.........  ``not more than    ``not more than
                                 $5,000 for''.      $5,000 as adjusted
                                                    annually under 45
                                                    CFR part 102 for''.
(d)(1)........................  ``not more than    ``not more than
                                 $10,000 for''.     $10,000 as adjusted
                                                    annually under 45
                                                    CFR part 102 for''.
(d)(2) introductory text......  ``not more than    ``not more than
                                 $10,000 for''.     $10,000 as adjusted
                                                    annually under 45
                                                    CFR part 102 for''.
(d)(3)........................  ``not more than    ``not more than
                                 $10,000 for''.     $10,000 as adjusted
                                                    annually under 45
                                                    CFR part 102 for''.
(d)(4)........................  ``not more than    ``not more than
                                 $10,000 for''.     $10,000 as adjusted
                                                    annually under 45
                                                    CFR part 102 for''.
(d)(5)........................  ``not more than    ``not more than
                                 $10,000 for''.     $10,000 as adjusted
                                                    annually under 45
                                                    CFR part 102 for''.
(d)(5)........................  ``will not exceed  ``will not exceed
                                 $150,000''.        $150,000 as annually
                                                    adjusted under 45
                                                    CFR part 102''.
(e)...........................  ``not more than    ``not more than
                                 $15,000 for''.     $15,000 as adjusted
                                                    annually under 45
                                                    CFR part 102 for''.
(f) introductory text.........  ``not more than    ``not more than
                                 $25,000 for''.     $25,000 as adjusted
                                                    annually under 45
                                                    CFR part 102 for''.
(g)...........................  ``not more than    ``not more than $100
                                 $100 for''.        as adjusted annually
                                                    under 45 CFR part
                                                    102 for''.
(h)...........................  ``not more than    ``not more than
                                 $100,000 for''.    $10,000 as adjusted
                                                    annually under 45
                                                    CFR part 102 for''.
(h)...........................  ``will not exceed  ``will not exceed
                                 $1,000,000''.      $1,000,000 as
                                                    annually adjusted
                                                    under 45 CFR part
                                                    102''.
------------------------------------------------------------------------

PART 403--SPECIAL PROGRAMS AND PROJECTS

0
5. The authority citation for part 403 continues to read as follows:

    Authority:  42 U.S.C. 1395b-3 and Secs. 1102 and 1871 of the 
Social Security Act (42 U.S.C. 1302 and 1395hh).


Sec.  403.912  [Amended]

0
6. In the table below, Sec.  403.912 is amended in each paragraph 
indicated in the first column, by removing the phrase indicated in the 
third column and adding in its place the phrase indicated in the fourth 
column:

------------------------------------------------------------------------
           Paragraph                  Remove                Add
------------------------------------------------------------------------
(a)(1)........................  ``not less than    ``not less than
                                 $1,000, but not    $10,000, but not
                                 more than          more than $100,000,
                                 $10,000 for''.     as adjusted annually
                                                    under 45 CFR part
                                                    102 for''.
(a)(2)........................  ``will not exceed  ``will not exceed
                                 $150,000''.        $150,000 as adjusted
                                                    annually under 45
                                                    CFR part 102''.
(b)(1)........................  ``not less than    ``not less than
                                 $10,000, but not   $10,000, but not
                                 more than          more than $100,000,
                                 $100,000 for''.    as adjusted annually
                                                    under 45 CFR part
                                                    102 for''.
(b)(2)........................  ``will not exceed  ``will not exceed
                                 $1,000,000''.      $1,000,000 as
                                                    adjusted annually
                                                    under 45 CFR part
                                                    102''.
(c)(2)........................  ``with a maximum   ``with a maximum
                                 combined annual    combined annual
                                 total of           total of $1,150,000
                                 $1,150,000''.      as adjusted annually
                                                    under 45 CFR part
                                                    102''.
------------------------------------------------------------------------

PART 411--EXCLUSIONS FROM MEDICARE AND LIMITATIONS ON MEDICARE 
PAYMENT

0
7. The authority citation for part 411 continues to read as follows:

    Authority:  Secs. 1102, 1860D-1 through 1860D-42, 1871, and 1877 
of the Social Security Act (42 U.S.C. 1302, 1395w-101 through 1395w-
152, 1395hh, and 1395nn).


Sec. Sec.  411.103 and 411.361   [Amended]

0
8. In the table below, for each section and paragraph indicated in the 
first two columns, remove the phrase indicated in the third column and 
add in its place

[[Page 61562]]

the phrase indicated in the fourth column:

----------------------------------------------------------------------------------------------------------------
              Section                      Paragraphs                Remove                      Add
----------------------------------------------------------------------------------------------------------------
Sec.   411.103.....................  (b)(1)................  ``up to $5,000 for''..  ``up to $5,000 as adjusted
                                                                                      annually under 45 CFR part
                                                                                      102 for''.
                                     (b)(2)................  ``up to $5,000''......  ``up to $5,000 as adjusted
                                                                                      annually under 45 CFR part
                                                                                      102''.
Sec.   411.361.....................  (f)...................  ``up to $10,000 for''.  ``up to $10,000 as adjusted
                                                                                      annually under 45 CFR part
                                                                                      102 for''.
----------------------------------------------------------------------------------------------------------------

PART 412--PROSPECTIVE PAYMENT SYSTEMS FOR INPATIENT HOSPITAL 
SERVICES

0
12. The authority citation for part 412 continues to read as follows:

    Authority:  Secs. 1102 and 1871 of the Social Security Act (42 
U.S.C. 1302 and 1395hh), sec. 124 of Pub. L. 106-113 (113 Stat. 
1501A-332), sec. 1206 of Pub. L. 113-67, and sec. 112 of Pub. L. 
113-93.


Sec.  412.612  [Amended]

0
13. Section 412.612 is amended as follows:
0
 a. In paragraph (b)(1)(i), by removing the phrase ``not more than 
$1,000 for'' and adding in its place the phrase ``not more than $1,000 
as adjusted annually under 45 CFR part 102 for''; and
0
b. In paragraph (b)(1)(ii), by removing the phrase ``not more than 
$5,000 for'' and adding in its place the phrase ``not more than $5,000 
as adjusted annually under 45 CFR part 102 for''.

PART 422--MEDICARE ADVANTAGE PROGRAM

0
14. The authority citation for part 422 continues to read as follows:

    Authority:  Secs. 1102 and 1871 of the Social Security Act (42 
U.S.C. 1302 and 1395hh).


Sec.  422.760  [Amended]

0
15. In the table below, Sec.  422.760 is amended in each paragraph 
indicated in the first column, by removing the phrase indicated in the 
second column and add in its place the phrase indicated in the third 
column:

------------------------------------------------------------------------
           Paragraph                  Remove                Add
------------------------------------------------------------------------
(b)(1)........................  ``up to $25,000    ``up to $25,000 as
                                 for each''.        adjusted annually
                                                    under 45 CFR part
                                                    102 for each''.
(b)(2)........................  ``up to $25,000    ``up to $25,000 as
                                 for each''.        adjusted annually
                                                    under 45 CFR part
                                                    102 for each''.
(b)(3)........................  ``determination--  ``determination--up
                                 up to $10,000''.   to $10,000 as
                                                    adjusted annually
                                                    under 45 CFR part
                                                    102''.
(b)(4)........................  ``$250 per         ``$250 as adjusted
                                 Medicare           annually under 45
                                 enrollee''.        CFR part 102 per
                                                    Medicare enrollee''.
(b)(4)........................  ``or $100,000,     ``or $100,000 as
                                 whichever is       adjusted annually
                                 greater''.         under 45 CFR part
                                                    102, whichever is
                                                    greater''.
(c)(1)........................  ``not more than    ``not more than
                                 $25,000 for''.     $25,000 as adjusted
                                                    annually under 45
                                                    CFR part 102 for''.
(c)(2)........................  ``not more than    ``not more than
                                 $100,000 for''.    $100,000 as adjusted
                                                    annually under 45
                                                    CFR part 102 for''.
(c)(4)........................  ``$15,000 for      ``$15,000 as adjusted
                                 each               annually under 45
                                 individual''.      CFR part 102 for
                                                    each individual''.
------------------------------------------------------------------------

PART 423--VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT

0
16. The authority citation for part 423 continues to read as follows:

    Authority:  Sections 1102, 1106, 1860D-1 through 1860D-42, and 
1871 of the Social Security Act (42 U.S.C. 1302, 1306, 1395w-101 
through 1395w-152, and 1395hh).


Sec.  423.760   [Amended]

0
17. In the table below, Sec.  423.760 is amended in each paragraph 
indicated by the first column, by removing the phrase indicated in the 
second column and add in its place the phrase indicated in the third 
column:

------------------------------------------------------------------------
           Paragraph                  Remove                Add
------------------------------------------------------------------------
(b)(1)........................  ``enrollees--up    ``enrollees--up to
                                 to $25,000 for     $25,000 as adjusted
                                 each               annually under 45
                                 determination''.   CFR part 102 for
                                                    each
                                                    determination''.
(b)(2)........................  ``of up to         ``of up to $25,000 as
                                 $25,000 for each   adjusted annually
                                 Part D             under 45 CFR part
                                 enrollee''.        102 for each Part D
                                                    enrollee''.
(b)(3)........................  ``up to $10,000''  ``up to $10,000 as
                                                    adjusted annually
                                                    under 45 CFR part
                                                    102''.
(b)(4)........................  ``$250 per         ``$250 as adjusted
                                 Medicare           annually under 45
                                 enrollee''.        CFR part 102 per
                                                    Medicare enrollee''.
(b)(4)........................  ``or $100,000,     ``or $100,000 as
                                 whichever is       adjusted annually
                                 greater''.         under 45 CFR part
                                                    102, whichever is
                                                    greater''.
(c)(1)........................  ``of not more      ``of not more than
                                 than $25,000 for   $25,000 as adjusted
                                 each''.            annually under 45
                                                    CFR part 102 for
                                                    each''.

[[Page 61563]]

 
(c)(2)........................  ``not more than    ``not more than
                                 $100,000 for       $100,000 as adjusted
                                 each''.            annually under 45
                                                    CFR part 102 for
                                                    each''.
(c)(4)........................  ``$15,000 for      ``$15,000 as adjusted
                                 each               annually under 45
                                 individual''.      CFR part 102 for
                                                    each individual''.
------------------------------------------------------------------------

PART 483--REQUIREMENTS FOR STATES AND LONG TERM CARE FACILITIES

0
18. The authority citation for part 483 continues to read as follows:

    Authority:  Secs. 1102, 1128I, 1819, 1871 and 1919 of the Social 
Security Act (42 U.S.C. 1302, 1320a-7, 1395i, 1395hh and 1396r).


Sec.  483.20   [Amended]

0
19. Section 483.20 is amended as follows:
0
a. In paragraph (j)(1)(i), by removing the phrase ``not more than 
$1,000 for'' and adding in its place the phrase ``not more than $1,000 
as adjusted annually under 45 CFR part 102 for''; and
0
 b. In paragraph (j)(1)(ii), by removing the phrase ``not more than 
$5,000 for'' and adding it its place the phrase ``not more than $5,000 
as adjusted annually under 45 CFR part 102 for''.


Sec.  483.151   [Amended]

0
20. Section 483.151 is amended as follows:
0
 a. In paragraph (b)(2)(iv), by removing the phrase ``not less than 
$5,000; or'' and adding in its place the phrase ``not less than $5,000 
as adjusted annually under 45 CFR part 102; or'';
0
 b. In paragraph (b)(3)(iii), by removing the phrase ``not less than 
$5,000 for'' and adding in its place the phrase ``not less than $5,000 
as adjusted annually under 45 CFR part 102 for''; and
0
 c. In paragraph (c)(1), by removing the phrase ``not less than 
$5,000'' and adding in its place the phrase ``not less than $5,000 as 
adjusted annually under 45 CFR part 102''.

PART 488--SURVEY, CERTIFICATION, AND ENFORCEMENT PROCEDURES

0
21. The authority citation for part 488 continues to read as follows:

    Authority:  Secs. 1102, 1128l, 1864, 1865, 1871 and 1875 of the 
Social Security Act, unless otherwise noted (42 U.S.C. 1302, 1320a-
7j, 1395aa, 1395bb, 1395hh) and 1395ll.


Sec. Sec.  488.307, 488.408, 488.438, 488.446, 488.725, and 
488.845  [Amended]

0
22. In the table below, for each section and paragraph indicated in the 
first two columns, remove the phrase indicated in the third column and 
add in its place the phrase indicated in the fourth column:

----------------------------------------------------------------------------------------------------------------
              Section                       Paragraph                Remove                      Add
----------------------------------------------------------------------------------------------------------------
488.307............................  (c)...................  ``not to exceed         ``not to exceed $2,000 as
                                                              $2,000''.               adjusted annually under 45
                                                                                      CFR part 102''.
488.408............................  (d)(1)(iii)...........  ``$50-$3,000 per day''  ``$50-$3,000 as adjusted
                                                                                      annually under 45 CFR part
                                                                                      102 per day''.
                                     (d)(1)(iv)............  ``$1,000-$10,000 per    ``$1,000-$10,000 as
                                                              instance''.             adjusted annually under 45
                                                                                      CFR part 102 per
                                                                                      instance''.
                                     (e)(1)(iii)...........  ``$3,050-$10,000 per    ``$3,050-$10,000 as
                                                              day''.                  adjusted annually under 45
                                                                                      CFR part 102 per day''.
                                     (e)(1)(iv)............  ``$1,000-$10,000 per    ``$1,000-$10,000 as
                                                              instance''.             adjusted annually under 45
                                                                                      CFR part 102 per
                                                                                      instance''.
                                     (e)(2)(ii)............  ``3,050-$10,000 per     ``3,050-$10,000 as adjusted
                                                              day or $1,000-$10,000   annually under 45 CFR part
                                                              per instance''.         102 per day or $1,000-
                                                                                      $10,000 as adjusted
                                                                                      annually under 45 CFR part
                                                                                      102 per instance''.
488.438............................  (a)(1)(i).............  ``Upper range--$3,050-  ``Upper range''.
                                                              $10,000''.
                                     (a)(1)(i).............  ``$3,050-$10,000 per    ``$3,050-$10,000 as
                                                              day''.                  adjusted annually under 45
                                                                                      CFR part 102 per day''.
                                     (a)(1)(ii)............  ``Lower range--$50-     ``Upper range''.
                                                              $3,000''.
                                     (a)(1)(ii)............  ``$50-$3,000 per day''  ``$50-$3,000 as adjusted
                                                                                      annually under 45 CFR part
                                                                                      102 per day''.
                                     (a)(2)................  ``$1,000-$10,000 per    ``$1,000-$10,000 as
                                                              instance''.             adjusted annually under 45
                                                                                      CFR part 102 per
                                                                                      instance''.
488.446............................  (a)(1)................  ``A minimum of $500     ``A minimum of $500 as
                                                              for''.                  adjusted annually under 45
                                                                                      CFR part 102 for''.
                                     (a)(2)................  ``A minimum of $1,500   ``A minimum of $1,500 as
                                                              for''.                  adjusted annually under 45
                                                                                      CFR part 102 for''.
                                     (a)(3)................  ``A minimum of $3,000   ``A minimum of $3,000 as
                                                              for''.                  adjusted annually under 45
                                                                                      CFR part 102 for''.
488.725............................  (c)...................  ``not to exceed         ``not to exceed $2,000 as
                                                              $2,000''.               adjusted annually under 45
                                                                                      CFR part 102''.
488.845............................  (b)(2)(iii)...........  ``shall exceed $10,000  ``will exceed $10,000 as
                                                              for''.                  adjusted under 45 CFR part
                                                                                      102 for''.
                                     (b)(3) introductory     ``upper range of        ``upper range of $8,500 to
                                      text.                   $8,500 to $10,000 per   $10,000 as adjusted
                                                              day''.                  annually under 45 CFR part
                                                                                      102 per day''.
                                     (b)(3)(i).............  ``$10,000 per day''...  ``$10,000 as adjusted
                                                                                      annually under 45 CFR part
                                                                                      102 per day''.
                                     (b)(3))(ii)...........  ``$9,000 per day''....  ``$9,000 as adjusted
                                                                                      annually under 45 CFR part
                                                                                      102 per day''.

[[Page 61564]]

 
                                     (b)(3)(iii)...........  ``$8,500 per day''....  ``$8,500 as adjusted
                                                                                      annually under 45 CFR part
                                                                                      102 per day''.
                                     (b)(4)................  ``range of $1,500-      ``range of $1,500-$8,500 as
                                                              $8,500 per day''.       adjusted annually under 45
                                                                                      CFR part 102 per day''.
                                     (b)(5)................  ``range of $500-$4,000  ``range of $500-$4,000 as
                                                              are imposed''.          adjusted annually under 45
                                                                                      CFR part 102 are
                                                                                      imposed''.
                                     (b)(6)................  ``range of $1,000 to    ``range of $1,000 to
                                                              $10,000 per instance,   $10,000 as adjusted
                                                              not to exceed $10,000   annually under 45 CFR part
                                                              each day''.             102 per instance, not to
                                                                                      exceed $10,000 as adjusted
                                                                                      annually under 45 CFR part
                                                                                      102 each day''.
                                     (d)(1)(ii)............  ``maximum of $10,000    ``maximum of $10,000 as
                                                              per day''.              adjusted annually under 45
                                                                                      CFR part 102 per day''.
----------------------------------------------------------------------------------------------------------------

PART 493--LABORATORY REQUIREMENTS

0
23. The authority citation for part 493 continues to read as follows:

    Authority:  Sec. 353 of the Public Health Service Act, secs. 
1102, 1861(e), the sentence following sections 1861(s)(11) through 
1861(s)(16) of the Social Security Act (42 U.S.C. 263a, 1302, 
1395x(e), the sentence following 1395x(s)(11) through 1395x(s)(16)), 
and the Pub. L. 112-202 amendments to 42 U.S.C. 263a.


Sec.  493.1834   [Amended]

0
24. Section 493.1834 is amended as follows:
0
 a. In paragraph (d)(2)(i), by removing the phrase ``$3,050-$10,000 per 
day'' and adding in its place the phrase ``$3,050-$10,000 as adjusted 
annually under 45 CFR part 102 per day''; and
0
b. In paragraph (d)(2)(ii), by removing the phrase ``$50-$3,000 per 
day'' and adding in its place the phrase ``$50-$3,000 as adjusted 
annually under 45 CFR part 102 per day''.

CHAPTER V--OFFICE OF INSPECTOR GENERAL--HEALTH CARE, DEPARTMENT OF 
HEALTH AND HUMAN SERVICES

PART 1003--CIVIL MONEY PENALTIES, ASSESSMENTS AND EXCLUSIONS

0
25. The authority citation for part 1003 continues to read as follows:

    Authority: 42 U.S.C. 262a, 1302, 1320-7, 1320a-7a, 1320b-10, 
1395u(j), 1395u(k), 1395cc(j), 1395w-141(i)(3), 1395dd(d)(1), 
1395mm, 1395nn(g), 1395ss(d), 1396b(m), 11131(c), and 11137(b)(2).


Sec.  1003.103  [Amended]

0
26. Section 1003.103 is amended:
0
a. In paragraph (c)--
0
i. By removing the footnote in paragraph (c); and
0
ii. In paragraph (c) by removing the phrase ``not more than $11,000 for 
each payment'' and adding in its place the phrase ``not more than 
$10,000 for each payment''; and
0
b. In the table below, Sec.  1003.103 is further amended in each 
paragraph indicated by the first column by adding the footnote in the 
third column after the phrase in the second column:

------------------------------------------------------------------------
           Paragraph                   Text             Add footnote
------------------------------------------------------------------------
(a)(1)........................  ``$2,000''.......  ``1. This penalty
                                                    amount is updated
                                                    annually, as
                                                    adjusted in
                                                    accordance with the
                                                    Federal Civil
                                                    Monetary Penalty
                                                    Inflation Adjustment
                                                    Act of 1990 (Pub. L.
                                                    101-140), as amended
                                                    by the Federal Civil
                                                    Penalties Inflation
                                                    Adjustment Act
                                                    Improvements Act of
                                                    2015 (section 701 of
                                                    Pub. L. 114-74).
                                                    Annually adjusted
                                                    amounts are
                                                    published at 45 CFR
                                                    part 102.''
(a)(2)........................  ``$10,000''......  ``2. This penalty
                                                    amount is adjusted
                                                    annually for
                                                    inflation, and is
                                                    published at 45 CFR
                                                    part 102.''
(b)...........................  ``not more than    ``3. This penalty
                                 $15,000''.         amount is adjusted
                                                    annually for
                                                    inflation, and is
                                                    published at 45 CFR
                                                    part 102.''
                                ``not more than    ``4. This penalty
                                 $100,000''.        amount is adjusted
                                                    annually for
                                                    inflation, and is
                                                    published at 45 CFR
                                                    part 102.''
(c)...........................  ``not more than    ``5. This penalty
                                 $10,000''.         amount is adjusted
                                                    annually for
                                                    inflation, and is
                                                    published at 45 CFR
                                                    part 102.''
(d)(1)........................  ``not more than    ``6. This penalty
                                 $5,000''.          amount is adjusted
                                                    annually for
                                                    inflation, and is
                                                    published at 45 CFR
                                                    part 102.''
                                ``not more than    ``7. This penalty
                                 $25,000''.         amount is adjusted
                                                    annually for
                                                    inflation, and is
                                                    published at 45 CFR
                                                    part 102.''
(e)(1)........................  ``not more than    ``8. This penalty
                                 $50,000''.         amount is adjusted
                                                    annually for
                                                    inflation, and is
                                                    published at 45 CFR
                                                    part 102.''
                                ``will not exceed  ``9. This penalty
                                 $25,000;''.        amount is adjusted
                                                    annually for
                                                    inflation, and is
                                                    published at 45 CFR
                                                    part 102.''
(e)(2)........................  ``not more than    ``10. This penalty
                                 $50,000''.         amount is adjusted
                                                    annually for
                                                    inflation, and is
                                                    published at 45 CFR
                                                    part 102.''
(f)(1) introductory text......  ``up to $25,000''  ``11. This penalty
                                                    amount is adjusted
                                                    annually for
                                                    inflation, and is
                                                    published at 45 CFR
                                                    part 102.''
(f)(2) introductory text......  ``up to $25,000''  ``12. This penalty
                                                    amount is adjusted
                                                    annually for
                                                    inflation, and is
                                                    published at 45 CFR
                                                    part 102.''
(f)(3) introductory text......  ``up to            ``13. This penalty
                                 $100,000''.        amount is adjusted
                                                    annually for
                                                    inflation, and is
                                                    published at 45 CFR
                                                    part 102.''
(f)(5)........................  ``an additional    ``14. This penalty
                                 $15,000''.         amount is adjusted
                                                    annually for
                                                    inflation, and is
                                                    published at 45 CFR
                                                    part 102.''
(g)...........................  ``not more than    ``15. This penalty
                                 $25,000''.         amount is adjusted
                                                    annually for
                                                    inflation, and is
                                                    published at 45 CFR
                                                    part 102.''

[[Page 61565]]

 
(h)(1)........................  ``not more than    ``16. This penalty
                                 $50,000''.         amount is adjusted
                                                    annually for
                                                    inflation, and is
                                                    published at 45 CFR
                                                    part 102.''
(h)(2)(i)(1)..................  ``$5,000''.......  ``17. This penalty
                                                    amount is adjusted
                                                    annually for
                                                    inflation, and is
                                                    published at 45 CFR
                                                    part 102.''
(j)...........................  ``not more than    ``18. This penalty
                                 $10,000''.         amount is adjusted
                                                    annually for
                                                    inflation, and is
                                                    published at 45 CFR
                                                    part 102.''
(k)...........................  ``not more than    ``19. This penalty
                                 $2,000''.          amount is adjusted
                                                    annually for
                                                    inflation, and is
                                                    published at 45 CFR
                                                    part 102.''
(l)...........................  ``not more than    ``20. This penalty
                                 $250,000''.        amount is adjusted
                                                    annually for
                                                    inflation, and is
                                                    published at 45 CFR
                                                    part 102.''
(l)...........................  ``and not more     ``21. This penalty
                                 than $500,000''.   amount is adjusted
                                                    annually for
                                                    inflation, and is
                                                    published at 45 CFR
                                                    part 102.''
(m)...........................  ``not more than    ``22. This penalty
                                 $10,000''.         amount is adjusted
                                                    annually for
                                                    inflation, and is
                                                    published at 45 CFR
                                                    part 102.''
------------------------------------------------------------------------

Title 45--Public Welfare

Subtitle A--Department of Health and Human Services

PART 79--PROGRAM FRAUD CIVIL PENALTIES

0
27. The authority for part 79 continues to read as follows:

    Authority: 31 U.S.C. 3801-3812.


0
28. In Sec.  79.3, paragraph (a)(1)(iv) is amended by revising footnote 
1 and paragraph (b)(1)(ii) is amended by revising footnote 2 to read as 
follows:


Sec.  79.3  Basis for civil penalties and assessments.

    (a) * * *
    (1) * * *
    (iv) * * *

    \1\ The amounts specified in this section are updated annually, 
as adjusted in accordance with the Federal Civil Monetary Penalty 
Inflation Adjustment Act of 1990 (Pub. L. 101-140), as amended by 
the Federal Civil Penalties Inflation Adjustment Act Improvements 
Act of 2015 (section 701 of Pub. L. 114-74). Annually adjusted 
amounts are published at 45 CFR part 102.
* * * * *
    (b) * * *
    (1) * * *
    (ii) * * *

    \2\ The amounts specified in this section are updated annually, 
as adjusted in accordance with the Federal Civil Monetary Penalty 
Inflation Adjustment Act of 1990 (Pub. L. 101-140), as amended by 
the Federal Civil Penalties Inflation Adjustment Act Improvements 
Act of 2015 (section 701 of Pub. L. 114-74). Annually adjusted 
amounts are published at 45 CFR part 102.
* * * * *

PART 93--NEW RESTRICTIONS ON LOBBYING

0
29. The authority for part 93 continues to read as follows:

    Authority:  Section 319, Public Law 101-121 (31 U.S.C. 1352); (5 
U.S.C. 301).


0
30. Section Sec.  93.400 is amended in paragraph (a) by adding a 
footnote at the end of the phrase ``not less than $10,000 and not more 
than $100,000'' to read as follows:


Sec.  93.400  Penalties.

    (a) * * *

    \1\ The amounts specified in this section are updated annually, 
as adjusted in accordance with the Federal Civil Monetary Penalty 
Inflation Adjustment Act of 1990 (Pub. L. 101-140), as amended by 
the Federal Civil Penalties Inflation Adjustment Act Improvements 
Act of 2015 (section 701 of Pub. L. 114-74). Annually adjusted 
amounts are published at 45 CFR part 102.
* * * * *

0
31. Appendix A to part 93 is amended in the undesignated paragraph 
following paragraph (3), under ``Certification for Contracts, Grants, 
Loans, and Cooperative Agreements,'' by adding a footnote at the end of 
the phrase ``of not less than $10,000 and not more than 100,000'' to 
read as follows:

Appendix A--Certification Regarding Lobbying

Certification for Contracts, Grants, Loans, and Cooperative Agreements

* * * * *
    (3) * * *
    \1\ The amounts specified in Appendix A to Part 93 are updated 
annually, as adjusted in accordance with the Federal Civil Monetary 
Penalty Inflation Adjustment Act of 1990 (Pub. L. 101-140), as 
amended by the Federal Civil Penalties Inflation Adjustment Act 
Improvements Act of 2015 (section 701 of Pub. L. 114-74). Annually 
adjusted amounts are published at 45 CFR part 102.
* * * * *

0
32. Part 102 is added to subchapter A to read as follows:

PART 102--ADJUSTMENT OF CIVIL MONETARY PENALTIES FOR INFLATION

Sec.
102.1 Applicability.
102.2 Applicability date.
102.3 Penalty adjustment and table.

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


Sec.  102.1  Applicability.

    This part applies to each statutory provision under the laws 
administered by the Department of Health and Human Services concerning 
the civil monetary penalties which may be assessed or enforced by an 
agency pursuant to Federal law or is assessed or enforced pursuant to 
civil judicial actions in the Federal courts or administrative 
proceedings. The regulations cited in this part supersede existing HHS 
regulations setting forth civil monetary penalty amounts. If 
applicable, the HHS agencies responsible for specific civil monetary 
penalties will amend their regulations to reflect the adjusted amounts 
and/or a cross-reference to 45 CFR part 102 in separate actions as soon 
as practicable.


Sec.  102.2  Applicability date.

    The increased penalty amounts set forth in the right-most column of 
the table in Section 102.3, ``Maximum Adjusted Penalty ($)'', apply to 
all civil monetary penalties which are assessed after August 1, 2016, 
including those penalties whose associated violations occurred after 
November 2, 2015.


Sec.  102.3  Penalty adjustment and table.

    The adjusted statutory penalty provisions and their applicable 
amounts are set out in the following table. The right-most column in 
the table, ``Maximum Adjusted Penalty ($)'', provides the maximum 
adjusted civil penalty amounts. The civil monetary penalty amounts are 
adjusted annually.

[[Page 61566]]



                                   Civil Monetary Penalty Authorities Administered by HHS Agencies and Penalty Amounts
                                                              [Effective September 6, 2016]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                           Citation                                                                                  Date of
--------------------------------------------------------------                                                         last         Pre-       Maximum
                                                                                                                     penalty     inflation     adjusted
                                                                  HHS agency              Description \2\           figure or     penalty      penalty
               U.S.C.                         CFR \1\                                                               adjustment      ($)          ($)
                                                                                                                       \3\
--------------------------------------------------------------------------------------------------------------------------------------------------------
21 U.S.C.:
    333(b)(2)(A)....................  .......................  FDA               Penalty for violations related           1988       50,000       98,935
                                                                                  to drug samples resulting in a
                                                                                  conviction of any
                                                                                  representative of manufacturer
                                                                                  or distributor in any 10-year
                                                                                  period.
    333(b)(2)(B)....................  .......................  FDA               Penalty for violation related to         1988    1,000,000    1,978,690
                                                                                  drug samples resulting in a
                                                                                  conviction of any
                                                                                  representative of manufacturer
                                                                                  or distributor after the second
                                                                                  conviction in any 10-yr period.
    333(b)(3).......................  .......................  FDA               Penalty for failure to make a            1988      100,000      197,869
                                                                                  report required by 21 U.S.C.
                                                                                  353(d)(3)(E) relating to drug
                                                                                  samples.
    333(f)(1)(A)....................  .......................  FDA               Penalty for any person who               1990       15,000       26,723
                                                                                  violates a requirement related
                                                                                  to devices for each such
                                                                                  violation.
                                                                                 Penalty for aggregate of all             1990    1,000,000    1,781,560
                                                                                  violations related to devices
                                                                                  in a single proceeding.
    333(f)(2)(A)....................  .......................  FDA               Penalty for any individual who           1996       50,000       75,123
                                                                                  introduces or delivers for
                                                                                  introduction into interstate
                                                                                  commerce food that is
                                                                                  adulterated per 21 U.S.C.
                                                                                  342(a)(2)(B) or any individual
                                                                                  who does not comply with a
                                                                                  recall order under 21 U.S.C.
                                                                                  350l.
                                                                                 Penalty in the case of any other         1996      250,000      375,613
                                                                                  person other than an
                                                                                  individual) for such
                                                                                  introduction or delivery of
                                                                                  adulterated food.
                                                                                 Penalty for aggregate of all             1996      500,000      751,225
                                                                                  such violations related to
                                                                                  adulterated food adjudicated in
                                                                                  a single proceeding.
    333(f)(3)(A)....................  .......................  FDA               Penalty for all violations               2007       10,000       11,383
                                                                                  adjudicated in a single
                                                                                  proceeding for any person who
                                                                                  fails to submit certification
                                                                                  required by 42 U.S.C.
                                                                                  282(j)(5)(B) or knowingly
                                                                                  submitting a false
                                                                                  certification.
    333(f)(3)(B)....................  .......................  FDA               Penalty for each day the above           2007       10,000       11,383
                                                                                  violation is not corrected
                                                                                  after a 30-day period following
                                                                                  notification until the
                                                                                  violation is corrected.
    333(f)(4)(A)(i).................  .......................  FDA               Penalty for any responsible              2007      250,000      284,583
                                                                                  person that violates a
                                                                                  requirement of 21 U.S.C. 355(o)
                                                                                  (post-marketing studies,
                                                                                  clinical trials, labeling), 21
                                                                                  U.S.C. 355(p) (risk evaluation
                                                                                  and mitigation (REMS)), or 21
                                                                                  U.S.C. 355-1 (REMS).
                                                                                 Penalty for aggregate of all             2007    1,000,000    1,138,330
                                                                                  such above violations in a
                                                                                  single proceeding.
    333(f)(4)(A)(ii)................  .......................  FDA               Penalty for REMS violation that          2007      250,000      284,583
                                                                                  continues after written notice
                                                                                  to the responsible person for
                                                                                  the first 30-day period (or any
                                                                                  portion thereof) the
                                                                                  responsible person continues to
                                                                                  be in violation.
                                                                                 Penalty for REMS violation that          2007    1,000,000    1,138,330
                                                                                  continues after written notice
                                                                                  to responsible person doubles
                                                                                  for every 30-day period
                                                                                  thereafter the violation
                                                                                  continues, but may not exceed
                                                                                  penalty amount for any 30-day
                                                                                  period.
                                                                                 Penalty for aggregate of all             2007   10,000,000   11,383,300
                                                                                  such above violations
                                                                                  adjudicated in a single
                                                                                  proceeding.
    333(f)(9)(A)....................  .......................  FDA               Penalty for any person who               2009       15,000       16,503
                                                                                  violates a requirement which
                                                                                  relates to tobacco products for
                                                                                  each such violation.
                                                                                 Penalty for aggregate of all             2009    1,000,000    1,100,200
                                                                                  such violations of tobacco
                                                                                  product requirement adjudicated
                                                                                  in a single proceeding.
    333(f)(9)(B)(i)(I)..............  .......................  FDA               Penalty per violation related to         2009      250,000      275,050
                                                                                  violations of tobacco
                                                                                  requirements.
                                                                                 Penalty for aggregate of all             2009    1,000,000    1,100,200
                                                                                  such violations of tobacco
                                                                                  product requirements
                                                                                  adjudicated in a single
                                                                                  proceeding.
    333(f)(9)(B)(i)(II).............  .......................  FDA               Penalty in the case of a                 2009      250,000      275,050
                                                                                  violation of tobacco product
                                                                                  requirements that continues
                                                                                  after written notice to such
                                                                                  person, for the first 30-day
                                                                                  period (or any portion thereof)
                                                                                  the person continues to be in
                                                                                  violation.

[[Page 61567]]

 
                                                                                 Penalty for violation of tobacco         2009    1,000,000    1,100,200
                                                                                  product requirements that
                                                                                  continues after written notice
                                                                                  to such person shall double for
                                                                                  every 30-day period thereafter
                                                                                  the violation continues, but
                                                                                  may not exceed penalty amount
                                                                                  for any 30-day period.
                                                                                 Penalty for aggregate of all             2009   10,000,000   11,002,000
                                                                                  such violations related to
                                                                                  tobacco product requirements
                                                                                  adjudicated in a single
                                                                                  proceeding.
    333(f)(9)(B)(ii)(I).............  .......................  FDA               Penalty for any person who               2009      250,000      275,050
                                                                                  either does not conduct post-
                                                                                  market surveillance and studies
                                                                                  to determine impact of a
                                                                                  modified risk tobacco product
                                                                                  for which the HHS Secretary has
                                                                                  provided them an order to sell,
                                                                                  or who does not submit a
                                                                                  protocol to the HHS Secretary
                                                                                  after being notified of a
                                                                                  requirement to conduct post-
                                                                                  market surveillance of such
                                                                                  tobacco products.
                                                                                 Penalty for aggregate of for all         2009    1,000,000    1,100,200
                                                                                  such above violations
                                                                                  adjudicated in a single
                                                                                  proceeding.
    333(f)(9)(B)(ii)(II)............  .......................  FDA               Penalty for violation of                 2009      250,000      275,050
                                                                                  modified risk tobacco product
                                                                                  post-market surveillance that
                                                                                  continues after written notice
                                                                                  to such person for the first 30-
                                                                                  day period (or any portion
                                                                                  thereof) that the person
                                                                                  continues to be in violation.
                                                                                 Penalty for post-notice                  2009    1,000,000    1,100,200
                                                                                  violation of modified risk
                                                                                  tobacco product post-market
                                                                                  surveillance shall double for
                                                                                  every 30-day period thereafter
                                                                                  that the tobacco product
                                                                                  requirement violation continues
                                                                                  for any 30-day period, but may
                                                                                  not exceed penalty amount for
                                                                                  any 30-day period.
                                                                                 Penalty for aggregate above              2009   10,000,000   11,002,000
                                                                                  tobacco product requirement
                                                                                  violations adjudicated in a
                                                                                  single proceeding.
    333(g)(1).......................  .......................  FDA               Penalty for any person who               2007      250,000      284,583
                                                                                  disseminates or causes another
                                                                                  party to disseminate a direct-
                                                                                  to-consumer advertisement that
                                                                                  is false or misleading for the
                                                                                  first such violation in any 3-
                                                                                  year period.
                                                                                 Penalty for each subsequent              2007      500,000      569,165
                                                                                  above violation in any 3-year
                                                                                  period.
    333 note........................  .......................  FDA               Penalty to be applied for                2009          250          275
                                                                                  violations of restrictions on
                                                                                  the sale or distribution of
                                                                                  tobacco products promulgated
                                                                                  under 21 U.S.C. 387f(d) (e.g.,
                                                                                  violations of regulations in 21
                                                                                  CFR Part 1140) with respect to
                                                                                  a retailer with an approved
                                                                                  training program in the case of
                                                                                  a second regulation violation
                                                                                  within a 12-month period.
                                                                                 Penalty in the case of a third           2009          500          550
                                                                                  tobacco product regulation
                                                                                  violation within a 24-month
                                                                                  period.
                                                                                 Penalty in the case of a fourth          2009        2,000        2,200
                                                                                  tobacco product regulation
                                                                                  violation within a 24-month
                                                                                  period.
                                                                                 Penalty in the case of a fifth           2009        5,000        5,501
                                                                                  tobacco product regulation
                                                                                  violation within a 36-month
                                                                                  period.
                                                                                 Penalty in the case of a sixth           2009       10,000       11,002
                                                                                  or subsequent tobacco product
                                                                                  regulation violation within a
                                                                                  48-month period as determined
                                                                                  on a case-by-case basis.
                                                                                 Penalty to be applied for                2009          250          275
                                                                                  violations of restrictions on
                                                                                  the sale or distribution of
                                                                                  tobacco products promulgated
                                                                                  under 21 U.S.C. 387f(d) (e.g.,
                                                                                  violations of regulations in 21
                                                                                  CFR Part 1140) with respect to
                                                                                  a retailer that does not have
                                                                                  an approved training program in
                                                                                  the case of the first
                                                                                  regulation violation.
                                                                                 Penalty in the case of a second          2009          500          550
                                                                                  tobacco product regulation
                                                                                  violation within a 12-month
                                                                                  period.

[[Page 61568]]

 
                                                                                 Penalty in the case of a third           2009        1,000        1,100
                                                                                  tobacco product regulation
                                                                                  violation within a 24-month
                                                                                  period.
                                                                                 Penalty in the case of a fourth          2009        2,000        2,200
                                                                                  tobacco product regulation
                                                                                  violation within a 24-month
                                                                                  period.
                                                                                 Penalty in the case of a fifth           2009        5,000        5,501
                                                                                  tobacco product regulation
                                                                                  violation within a 36-month
                                                                                  period.
                                                                                 Penalty in the case of a sixth           2009       10,000       11,002
                                                                                  or subsequent tobacco product
                                                                                  regulation violation within a
                                                                                  48-month period as determined
                                                                                  on a case-by-case basis.
    335b(a).........................  .......................  FDA               Penalty for each violation for           1992      250,000      419,320
                                                                                  any individual who made a false
                                                                                  statement or misrepresentation
                                                                                  of a material fact, bribed,
                                                                                  destroyed, altered, removed, or
                                                                                  secreted, or procured the
                                                                                  destruction, alteration,
                                                                                  removal, or secretion of, any
                                                                                  material document, failed to
                                                                                  disclose a material fact,
                                                                                  obstructed an investigation,
                                                                                  employed a consultant who was
                                                                                  debarred, debarred individual
                                                                                  provided consultant services.
                                                                                 Penalty in the case of any other         1992    1,000,000    1,677,280
                                                                                  person (other than an
                                                                                  individual) per above violation.
    360pp(b)(1).....................  .......................  FDA               Penalty for any person who               1968        1,100        2,750
                                                                                  violates any such requirements
                                                                                  for electronic products, with
                                                                                  each unlawful act or omission
                                                                                  constituting a separate
                                                                                  violation.
                                                                                 Penalty imposed for any related          1968      375,000      937,500
                                                                                  series of violations of
                                                                                  requirements relating to
                                                                                  electronic products.
42 U.S.C.:
    262(d)..........................  .......................  FDA               Penalty per day for violation of         1986      100,000      215,628
                                                                                  order of recall of biological
                                                                                  product presenting imminent or
                                                                                  substantial hazard.
    263b(h)(3)......................  .......................  FDA               Penalty for failure to obtain a          1992       10,000       16,773
                                                                                  mammography certificate as
                                                                                  required.
    300aa-28(b)(1)..................  .......................  FDA               Penalty per occurrence for any           1986      100,000      215,628
                                                                                  vaccine manufacturer that
                                                                                  intentionally destroys, alters,
                                                                                  falsifies, or conceals any
                                                                                  record or report required.
    256b(d)(1)(B)(vi)...............  .......................  HRSA              Penalty for each instance of             2010        5,000        5,437
                                                                                  overcharging a 340B covered
                                                                                  entity.
    299c-(3)(d).....................  .......................  AHRQ              Penalty for an establishment or          1999       10,000       14,140
                                                                                  person supplying information
                                                                                  obtained in the course of
                                                                                  activities for any purpose
                                                                                  other than the purpose for
                                                                                  which it was supplied.
    653(l)(2).......................  45 CFR 303.21(f).......  ACF               Penalty for Misuse of                    1998        1,000        1,450
                                                                                  Information in the National
                                                                                  Directory of New Hires.
    262a(i)(1)......................  42 CFR Part 1003.......  OIG               Penalty for each individual who          2002      250,000      327,962
                                                                                  violates safety and security
                                                                                  procedures related to handling
                                                                                  dangerous biological agents and
                                                                                  toxins.
                                                                                 Penalty for any other person who         2002      500,000      655,925
                                                                                  violates safety and security
                                                                                  procedures related to handling
                                                                                  dangerous biological agents and
                                                                                  toxins..
    1320a-7a(a).....................  42 CFR Part 1003.......  OIG               Penalty for knowingly presenting         1996       10,000       15,024
                                                                                  or causing to be presented to
                                                                                  an officer, employee, or agent
                                                                                  of the United States a false
                                                                                  claim.
                                                                                 Penalty for knowingly presenting         1996       10,000       15,024
                                                                                  or causing to be presented a
                                                                                  request for payment which
                                                                                  violates the terms of an
                                                                                  assignment, agreement, or PPS
                                                                                  agreement.
                                                                                 Penalty for knowingly giving or          1996       15,000       22,537
                                                                                  causing to be presented to a
                                                                                  participating provider or
                                                                                  supplier false or misleading
                                                                                  information that could
                                                                                  reasonably be expected to
                                                                                  influence a discharge decision.
                                                                                 Penalty for an excluded party            1996       10,000       15,024
                                                                                  retaining ownership or control
                                                                                  interest in a participating
                                                                                  entity.
                                                                                 Penalty for remuneration offered         1996       10,000       15,024
                                                                                  to induce program beneficiaries
                                                                                  to use particular providers,
                                                                                  practitioners, or suppliers.

[[Page 61569]]

 
                                                                                 Penalty for employing or                 1997       10,000       14,718
                                                                                  contracting with an excluded
                                                                                  individual.
                                                                                 Penalty for knowing and willful          1997       50,000       73,588
                                                                                  solicitation, receipt, offer,
                                                                                  or payment of remuneration for
                                                                                  referring an individual for a
                                                                                  service or for purchasing,
                                                                                  leasing, or ordering an item to
                                                                                  be paid for by a Federal health
                                                                                  care program.
                                                                                 Penalty for ordering or                  2010       10,000       10,874
                                                                                  prescribing medical or other
                                                                                  item or service during a period
                                                                                  in which the person was
                                                                                  excluded.
                                                                                 Penalty for knowingly making or          2010       50,000       54,372
                                                                                  causing to be made a false
                                                                                  statement, omission or
                                                                                  misrepresentation of a material
                                                                                  fact in any application, bid,
                                                                                  or contract to participate or
                                                                                  enroll as a provider or
                                                                                  supplier.
                                                                                 Penalty for knowing of an                2010       10,000       10,874
                                                                                  overpayment and failing to
                                                                                  report and return.
                                                                                 Penalty for making or using a            2010       50,000       54,372
                                                                                  false record or statement that
                                                                                  is material to a false or
                                                                                  fraudulent claim.
                                                                                 Penalty for failure to grant             2010       15,000       16,312
                                                                                  timely access to HHS OIG for
                                                                                  audits, investigations,
                                                                                  evaluations, and other
                                                                                  statutory functions of HHS OIG.
    1320a-7a(b).....................  42 CFR Part 1003.......  OIG               Penalty for payments by a                1986        2,000        4,313
                                                                                  hospital or critical access
                                                                                  hospital to induce a physician
                                                                                  to reduce or limit services to
                                                                                  individuals under direct care
                                                                                  of physician or who are
                                                                                  entitled to certain medical
                                                                                  assistance benefits.
                                                                                 Penalty for physicians who               1986        2,000        4,313
                                                                                  knowingly receive payments from
                                                                                  a hospital or critical access
                                                                                  hospital to induce such
                                                                                  physician to reduce or limit
                                                                                  services to individuals under
                                                                                  direct care of physician or who
                                                                                  are entitled to certain medical
                                                                                  assistance benefits.
                                                                                 Penalty for a physician who              1996        5,000        7,512
                                                                                  executes a document that
                                                                                  falsely certifies home health
                                                                                  needs for Medicare
                                                                                  beneficiaries.
    1320a-7e(b)(6)(A)...............  42 CFR Part 1003.......  OIG               Penalty for failure to report            1997       25,000       36,794
                                                                                  any final adverse action taken
                                                                                  against a health care provider,
                                                                                  supplier, or practitioner.
    1320b-10(b)(1)..................  42 CFR Part 1003.......  OIG               Penalty for the misuse of words,         1988        5,000        9,893
                                                                                  symbols, or emblems in
                                                                                  communications in a manner in
                                                                                  which a person could falsely
                                                                                  construe that such item is
                                                                                  approved, endorsed, or
                                                                                  authorized by HHS.
    1320b-10(b)(2)..................  42 CFR Part 1003.......  OIG               Penalty for the misuse of words,         1988       25,000       49,467
                                                                                  symbols, or emblems in a
                                                                                  broadcast or telecast in a
                                                                                  manner in which a person could
                                                                                  falsely construe that such item
                                                                                  is approved, endorsed, or
                                                                                  authorized by HHS.
    1395i-3(b)(3)(B)(ii)(1).........  .......................  OIG               Penalty for certification of a           1987        1,000        2,063
                                                                                  false statement in assessment
                                                                                  of functional capacity of a
                                                                                  Skilled Nursing Facility
                                                                                  resident assessment.
    1395i-3(b)(3)(B)(ii)(2).........  .......................  OIG               Penalty for causing another to           1987        5,000       10,314
                                                                                  certify or make a false
                                                                                  statement in assessment of
                                                                                  functional capacity of a
                                                                                  Skilled Nursing Facility
                                                                                  resident assessment.
    1395i-3(g)(2)(A)................  .......................  OIG               Penalty for any individual who           1987        2,000        4,126
                                                                                  notifies or causes to be
                                                                                  notified a Skilled Nursing
                                                                                  Facility of the time or date on
                                                                                  which a survey is to be
                                                                                  conducted.
    1395w-27(g)(2)(A)...............  42 CFR 422.752; 42 CFR   OIG               Penalty for a Medicare Advantage         1996       25,000       37,561
                                       Part 1003.                                 organization that substantially
                                                                                  fails to provide medically
                                                                                  necessary, required items and
                                                                                  services.
                                                                                 Penalty for a Medicare Advantage         1997       25,000       36,794
                                                                                  organization that charges
                                                                                  excessive premiums.
                                                                                 Penalty for a Medicare Advantage         1997       25,000       36,794
                                                                                  organization that improperly
                                                                                  expels or refuses to reenroll a
                                                                                  beneficiary.
                                                                                 Penalty for a Medicare Advantage         1997      100,000      147,177
                                                                                  organization that engages in
                                                                                  practice that would reasonably
                                                                                  be expected to have the effect
                                                                                  of denying or discouraging
                                                                                  enrollment.

[[Page 61570]]

 
                                                                                 Penalty per individual who does          1997       15,000       22,077
                                                                                  not enroll as a result of a
                                                                                  Medicare Advantage
                                                                                  organization's practice that
                                                                                  would reasonably be expected to
                                                                                  have the effect of denying or
                                                                                  discouraging enrollment.
                                                                                 Penalty for a Medicare Advantage         1997      100,000      147,177
                                                                                  organization misrepresenting or
                                                                                  falsifying information to
                                                                                  Secretary.
                                                                                 Penalty for a Medicare Advantage         1997       25,000       36,794
                                                                                  organization misrepresenting or
                                                                                  falsifying information to
                                                                                  individual or other entity.
                                                                                 Penalty for Medicare Advantage           1997       25,000       36,794
                                                                                  organization interfering with
                                                                                  provider's advice to enrollee
                                                                                  and non-MCO affiliated
                                                                                  providers that balance bill
                                                                                  enrollees.
                                                                                 Penalty for a Medicare Advantage         1997       25,000       36,794
                                                                                  organization that employs or
                                                                                  contracts with excluded
                                                                                  individual or entity.
                                                                                 Penalty for a Medicare Advantage         2010       25,000       36,794
                                                                                  organization enrolling an
                                                                                  individual in without prior
                                                                                  written consent.
                                                                                 Penalty for a Medicare Advantage         2010       25,000       36,794
                                                                                  organization transferring an
                                                                                  enrollee to another plan
                                                                                  without consent or solely for
                                                                                  the purpose of earning a
                                                                                  commission.
                                                                                 Penalty for a Medicare Advantage         2010       25,000       36,794
                                                                                  organization failing to comply
                                                                                  with marketing restrictions or
                                                                                  applicable implementing
                                                                                  regulations or guidance.
                                                                                 Penalty for a Medicare Advantage         2010       25,000       36,794
                                                                                  organization employing or
                                                                                  contracting with an individual
                                                                                  or entity who violates 1395w-
                                                                                  27(g)(1)(A)-(J).
    1395w-141(i)(3).................  42 CFR Part 1003.......  OIG               Penalty for a prescription drug          2003       10,000       12,856
                                                                                  card sponsor that falsifies or
                                                                                  misrepresents marketing
                                                                                  materials, overcharges program
                                                                                  enrollees, or misuse
                                                                                  transitional assistance funds.
    1395cc(g).......................  42 CFR Part 1003.......  OIG               Penalty for improper billing by          1972        2,000        5,000
                                                                                  Hospitals, Critical Access
                                                                                  Hospitals, or Skilled Nursing
                                                                                  Facilities.
    1395dd(d)(1)....................  42 CFR Part 1003.......  OIG               Penalty for a hospital or                1987       50,000      103,139
                                                                                  responsible physician dumping
                                                                                  patients needing emergency
                                                                                  medical care, if the hospital
                                                                                  has 100 beds or more.
                                                                                 Penalty for a hospital or                1987       25,000       51,570
                                                                                  responsible physician dumping
                                                                                  patients needing emergency
                                                                                  medical care, if the hospital
                                                                                  has less than 100 beds.
    1395mm(i)(6)(B)(i)..............  42 CFR Part 1003.......  OIG               Penalty for a HMO or competitive         1987       25,000       51,570
                                                                                  plan is such plan substantially
                                                                                  fails to provide medically
                                                                                  necessary, required items or
                                                                                  services.
                                                                                 Penalty for HMOs/competitive             1987       25,000       51,570
                                                                                  medical plans that charge
                                                                                  premiums in excess of permitted
                                                                                  amounts.
                                                                                 Penalty for a HMO or competitive         1987       25,000       51,570
                                                                                  medical plan that expels or
                                                                                  refuses to reenroll an
                                                                                  individual per prescribed
                                                                                  conditions.
                                                                                 Penalty for a HMO or competitive         1987      100,000      206,278
                                                                                  medical plan that implements
                                                                                  practices to discourage
                                                                                  enrollment of individuals
                                                                                  needing services in future.
                                                                                 Penalty per individual not               1988       15,000       29,680
                                                                                  enrolled in a plan as a result
                                                                                  of a HMO or competitive medical
                                                                                  plan that implements practices
                                                                                  to discourage enrollment of
                                                                                  individuals needing services in
                                                                                  the future.
                                                                                 Penalty for a HMO or competitive         1987      100,000      206,278
                                                                                  medical plan that misrepresents
                                                                                  or falsifies information to the
                                                                                  Secretary.
                                                                                 Penalty for a HMO or competitive         1987       25,000       51,570
                                                                                  medical plan that misrepresents
                                                                                  or falsifies information to an
                                                                                  individual or any other entity.
                                                                                 Penalty for failure by HMO or            1987       25,000       51,570
                                                                                  competitive medical plan to
                                                                                  assure prompt payment of
                                                                                  Medicare risk sharing contracts
                                                                                  or incentive plan provisions.

[[Page 61571]]

 
                                                                                 Penalty for HMO that employs or          1989       25,000       47,340
                                                                                  contracts with excluded
                                                                                  individual or entity.
    1395nn(g)(3)....................  42 CFR Part 1003.......  OIG               Penalty for submitting or                1994       15,000       23,863
                                                                                  causing to be submitted claims
                                                                                  in violation of the Stark Law's
                                                                                  restrictions on physician self-
                                                                                  referrals.
    1395nn(g)(4)....................  42 CFR Part 1003.......  OIG               Penalty for circumventing Stark          1994      100,000      159,089
                                                                                  Law's restrictions on physician
                                                                                  self-referrals.
    1395ss(d)(1)....................  42 CFR Part 1003.......  OIG               Penalty for a material                   1988        5,000        9,893
                                                                                  misrepresentation regarding
                                                                                  Medigap compliance policies.
    1395ss(d)(2)....................  42 CFR Part 1003.......  OIG               Penalty for selling Medigap              1988        5,000        9,893
                                                                                  policy under false pretense.
    1395ss(d)(3)(A)(ii).............  42 CFR Part 1003.......  OIG               Penalty for an issuer that sells         1990       25,000       44,539
                                                                                  health insurance policy that
                                                                                  duplicates benefits.
                                                                                 Penalty for someone other than           1990       15,000       26,723
                                                                                  issuer that sells health
                                                                                  insurance that duplicates
                                                                                  benefits.
    1395ss(d)(4)(A).................  42 CFR Part 1003.......  OIG               Penalty for using mail to sell a         1988        5,000        9,893
                                                                                  non-approved Medigap insurance
                                                                                  policy.
    1396b(m)(5)(B)(i)...............  42 CFR Part 1003.......  OIG               Penalty for a Medicaid MCO that          1988       25,000       49,467
                                                                                  substantially fails to provide
                                                                                  medically necessary, required
                                                                                  items or services.
                                                                                 Penalty for a Medicaid MCO that          1988       25,000       49,467
                                                                                  charges excessive premiums.
                                                                                 Penalty for a Medicaid MCO that          1988      100,000      197,869
                                                                                  improperly expels or refuses to
                                                                                  reenroll a beneficiary.
                                                                                 Penalty per individual who does          1988       15,000       29,680
                                                                                  not enroll as a result of a
                                                                                  Medicaid MCO's practice that
                                                                                  would reasonably be expected to
                                                                                  have the effect of denying or
                                                                                  discouraging enrollment.
                                                                                 Penalty for a Medicaid MCO               1988      100,000      197,869
                                                                                  misrepresenting or falsifying
                                                                                  information to the Secretary.
                                                                                 Penalty for a Medicaid MCO               1988       25,000       49,467
                                                                                  misrepresenting or falsifying
                                                                                  information to an individual or
                                                                                  another entity.
                                                                                 Penalty for a Medicaid MCO that          1990       25,000       44,539
                                                                                  fails to comply with contract
                                                                                  requirements with respect to
                                                                                  physician incentive plans.
    1396r(b)(3)(B)(ii)(I)...........  42 CFR Part 1003.......  OIG               Penalty for willfully and                1987        1,000        2,063
                                                                                  knowingly certifying a material
                                                                                  and false statement in a
                                                                                  Skilled Nursing Facility
                                                                                  resident assessment.
    1396r(b)(3)(B)(ii)(II)..........  42 CFR Part 1003.......  OIG               Penalty for willfully and                1987        5,000       10,314
                                                                                  knowingly causing another
                                                                                  individual to certify a
                                                                                  material and false statement in
                                                                                  a Skilled Nursing Facility
                                                                                  resident assessment.
    1396r(g)(2)(A)(i)...............  42 CFR Part 1003.......  OIG               Penalty for notifying or causing         1987        2,000        4,126
                                                                                  to be notified a Skilled
                                                                                  Nursing Facility of the time or
                                                                                  date on which a survey is to be
                                                                                  conducted.
    1396r-8(b)(3)(B)................  42 CFR Part 1003.......  OIG               Penalty for the knowing                  1990      100,000      178,156
                                                                                  provision of false information
                                                                                  or refusing to provide
                                                                                  information about charges or
                                                                                  prices of a covered outpatient
                                                                                  drug.
    1396r-8(b)(3)(C)(i).............  42 CFR Part 1003.......                    Penalty per day for failure to           1990       10,000       17,816
                                                                                  timely provide information by
                                                                                  drug manufacturer with rebate
                                                                                  agreement.
    1396r-8(b)(3)(C)(ii)............  42 CFR Part 1003.......                    Penalty for knowing provision of         1990      100,000      178,156
                                                                                  false information by drug
                                                                                  manufacturer with rebate
                                                                                  agreement.
    1396t(i)(3)(A)..................  42 CFR Part 1003.......  OIG               Penalty for notifying home and           1990        2,000        3,563
                                                                                  community-based providers or
                                                                                  settings of survey.
    11131(c)........................  42 CFR Part 1003.......  OIG               Penalty for failing to report a          1986       10,000       21,563
                                                                                  medical malpractice claim to
                                                                                  National Practitioner Data Bank.
    11137(b)(2).....................  42 CFR Part 1003.......  OIG               Penalty for breaching                    1986       10,000       21,563
                                                                                  confidentiality of information
                                                                                  reported to National
                                                                                  Practitioner Data Bank.
    299b-22(f)(1)...................  42 CFR 3.404...........  OCR               Penalty for violation of                 2005       10,000       11,940
                                                                                  confidentiality provision of
                                                                                  the Patient Safety and Quality
                                                                                  Improvement Act.
    1320(d)-5(a)....................  45 CFR                   OCR               Penalty for each pre-February            1996          100          150
                                       160.404(b)(1)(i),(ii).                     18, 2009 violation of the HIPAA
                                                                                  administrative simplification
                                                                                  provisions.
                                                                                    Calendar Year Cap............         1996       25,000       37,561

[[Page 61572]]

 
    1320(d)-5(a)....................  45 CFR                   OCR               Penalty for each February 18,
                                       160.404(b)(2)(i)(A),                       2009 or later violation of a
                                       (B).                                       HIPAA administrative
                                                                                  simplification provision in
                                                                                  which it is established that
                                                                                  the covered entity or business
                                                                                  associate did not know and by
                                                                                  exercising reasonable
                                                                                  diligence, would not have known
                                                                                  that the covered entity or
                                                                                  business associate violated
                                                                                  such a provision:
                                                                                    Minimum......................         2009          100          110
                                                                                    Maximum......................         2009       50,000       55,010
                                                                                    Calendar Year Cap............         2009    1,500,000    1,650,300
                                      45 CFR                   OCR               Penalty for each February 18,
                                       160.404(b)(2)(ii)(A),                      2009 or later violation of a
                                       (B).                                       HIPAA administrative
                                                                                  simplification provision in
                                                                                  which it is established that
                                                                                  the violation was due to
                                                                                  reasonable cause and not to
                                                                                  willful neglect:
                                                                                    Minimum......................         2009        1,000        1,100
                                                                                    Maximum......................         2009       50,000       55,010
                                                                                    Calendar Year Cap............         2009    1,500,000    1,650,300
                                      45 CFR                   OCR               Penalty for each February 18,
                                       160.404(b)(2)(iii)(A),                     2009 or later violation of a
                                       (B).                                       HIPAA administrative
                                                                                  simplification provision in
                                                                                  which it is established that
                                                                                  the violation was due to
                                                                                  willful neglect and was
                                                                                  corrected during the 30-day
                                                                                  period beginning on the first
                                                                                  date the covered entity or
                                                                                  business associate knew, or, by
                                                                                  exercising reasonable
                                                                                  diligence, would have known
                                                                                  that the violation occurred:
                                                                                    Minimum......................         2009       10,000       11,002
                                                                                    Maximum......................         2009       50,000       55,010
                                                                                    Calendar Year Cap............         2009    1,500,000    1,650,300
                                      45 CFR                   OCR               Penalty for each February 18,
                                       160.404(b)(2)(iv)(A),                      2009 or later violation of a
                                       (B).                                       HIPAA administrative
                                                                                  simplification provision in
                                                                                  which it is established that
                                                                                  the violation was due to
                                                                                  willful neglect and was not
                                                                                  corrected during the 30-day
                                                                                  period beginning on the first
                                                                                  date the covered entity or
                                                                                  business associate knew, or by
                                                                                  exercising reasonable
                                                                                  diligence, would have known
                                                                                  that the violation occurred:
                                                                                    Minimum......................         2009       50,000       55,010
                                                                                    Maximum......................         2009    1,500,000    1,650,300
                                                                                    Calendar Year Cap............         2009    1,500,000    1,650,300
    263a(h)(2)(B) & 1395w-            42 CFR                   CMS               Penalty for a clinical
     2(b)(2)(A)(ii).                   493.1834(d)(2)(i).                         laboratory's failure to meet
                                                                                  participation and certification
                                                                                  requirements and poses
                                                                                  immediate jeopardy:
                                                                                    Minimum......................         1988        3,050        6,035
                                                                                    Maximum......................         1988       10,000       19,787
                                      42 CFR                   CMS               Penalty for a clinical
                                       493.1834(d)(2)(ii).                        laboratory's failure to meet
                                                                                  participation and certification
                                                                                  requirements and the failure
                                                                                  does not pose immediate
                                                                                  jeopardy:
                                                                                    Minimum......................         1988           50           99
                                                                                    Maximum......................         1988        3,000        5,936
    300gg-15(f).....................  45 CFR 147.200(e)......  CMS               Failure to provide the Summary           2010        1,000        1,087
                                                                                  of Benefits and Coverage.
    300gg-18........................  45 CFR 158.606.........  CMS               Penalty for violations of                2010          100          109
                                                                                  regulations related to the
                                                                                  medical loss ratio reporting
                                                                                  and rebating.
    1320a-7h(b)(1)..................  42 CFR 402.105(d)(5);    CMS               Penalty for manufacturer or
                                       42 CFR 403.912(a) &                        group purchasing organization
                                       (c).                                       failing to report information
                                                                                  required under 42 U.S.C. 1320a-
                                                                                  7h(a), relating to physician
                                                                                  ownership or investment
                                                                                  interests:
                                                                                    Minimum......................         2010        1,000        1,087
                                                                                    Maximum......................         2010       10,000       10,874
                                                                                    Calendar Year Cap............         2010      150,000      163,117
    1320a-7h(b)(2)..................  42 CFR 402.105(h); 42    CMS               Penalty for manufacturer or
                                       CFR 403 912(b) & (c).                      group purchasing organization
                                                                                  knowingly failing to report
                                                                                  information required under 42
                                                                                  U.S.C. 1320a-7h(a), relating to
                                                                                  physician ownership or
                                                                                  investment interests:
                                                                                    Minimum......................         2010       10,000       10,874
                                                                                    Maximum......................         2010      100,000      108,745
                                                                                    Calendar Year Cap............         2010    1,000,000    1,087,450

[[Page 61573]]

 
    1320a-7j(h)(3)(A)...............  .......................  CMS               Penalty for an administrator of          2010      100,000      108,745
                                                                                  a facility that fails to comply
                                                                                  with notice requirements for
                                                                                  the closure of a facility.
                                      42 CFR                   CMS               Minimum penalty for the first            2010          500          544
                                       488.446(a)(1),(2), &                       offense of an administrator who
                                       (3).                                       fails to provide notice of
                                                                                  facility closure.
                                                                                 Minimum penalty for the second           2010        1,500        1,631
                                                                                  offense of an administrator who
                                                                                  fails to provide notice of
                                                                                  facility closure.
                                                                                 Minimum penalty for the third            2010        3,000        3,262
                                                                                  and subsequent offenses of an
                                                                                  administrator who fails to
                                                                                  provide notice of facility
                                                                                  closure.
    1320a-8(a)(1)...................  .......................  CMS               Penalty for an entity knowingly          1994        5,000        7,954
                                                                                  making a false statement or
                                                                                  representation of material fact
                                                                                  in the determination of the
                                                                                  amount of benefits or payments
                                                                                  related to old-age, survivors,
                                                                                  and disability insurance
                                                                                  benefits, special benefits for
                                                                                  certain World War II veterans,
                                                                                  or supplemental security income
                                                                                  for the aged, blind, and
                                                                                  disabled.
                                                                                 Penalty for violation of 42              2015        7,500        7,500
                                                                                  U.S.C. 1320a-8(a)(1) if the
                                                                                  violator is a person who
                                                                                  receives a fee or other income
                                                                                  for services performed in
                                                                                  connection with determination
                                                                                  of the benefit amount or the
                                                                                  person is a physician or other
                                                                                  health care provider who
                                                                                  submits evidence in connection
                                                                                  with such a determination.
    1320a-8(a)(3)...................  .......................  CMS               Penalty for a representative             2004        5,000        6,229
                                                                                  payee (under 42 U.S.C. 405(j),
                                                                                  1007, or 1383(a)(2)) converting
                                                                                  any part of a received payment
                                                                                  from the benefit programs
                                                                                  described in the previous civil
                                                                                  monetary penalty to a use other
                                                                                  than for the benefit of the
                                                                                  beneficiary.
    1320b-25(c)(1)(A)...............  .......................  CMS               Penalty for failure of covered           2010      200,000      217,490
                                                                                  individuals to report to the
                                                                                  Secretary and 1 or more law
                                                                                  enforcement officials any
                                                                                  reasonable suspicion of a crime
                                                                                  against a resident, or
                                                                                  individual receiving care, from
                                                                                  a long-term care facility.
    1320b-25(c)(2)(A)...............  .......................  CMS               Penalty for failure of covered           2010      300,000      326,235
                                                                                  individuals to report to the
                                                                                  Secretary and 1 or more law
                                                                                  enforcement officials any
                                                                                  reasonable suspicion of a crime
                                                                                  against a resident, or
                                                                                  individual receiving care, from
                                                                                  a long-term care facility if
                                                                                  such failure exacerbates the
                                                                                  harm to the victim of the crime
                                                                                  or results in the harm to
                                                                                  another individual.
    1320b-25(d)(2)..................  .......................  CMS               Penalty for a long-term care             2010      200,000      217,490
                                                                                  facility that retaliates
                                                                                  against any employee because of
                                                                                  lawful acts done by the
                                                                                  employee, or files a complaint
                                                                                  or report with the State
                                                                                  professional disciplinary
                                                                                  agency against an employee or
                                                                                  nurse for lawful acts done by
                                                                                  the employee or nurse.
    1395b-7(b)(2)(B)................  42 CFR 402.105(g)......  CMS               Penalty for any person who               1997          100          147
                                                                                  knowingly and willfully fails
                                                                                  to furnish a beneficiary with
                                                                                  an itemized statement of items
                                                                                  or services within 30 days of
                                                                                  the beneficiary's request.
    1395i-3(h)(2)(B)(ii)(I).........  42 CFR                   CMS               Penalty per day for a Skilled
                                       488.408(d)(1)(iii).                        Nursing Facility that has a
                                                                                  Category 2 violation of
                                                                                  certification requirements:
                                                                                    Minimum......................         1987           50          103
                                                                                    Maximum......................         1987        3,000        6,188
                                      42 CFR                   CMS               Penalty per instance of Category
                                       488.408(d)(1)(iv).                         2 noncompliance by a Skilled
                                                                                  Nursing Facility:
                                                                                    Minimum......................         1987        1,000        2,063
                                                                                    Maximum......................         1987       10,000       20,628
                                      42 CFR                   CMS               Penalty per day for a Skilled
                                       488.408(e)(1)(iii).                        Nursing Facility that has a
                                                                                  Category 3 violation of
                                                                                  certification requirements:
                                                                                    Minimum......................         1987        3,050        6,291
                                                                                    Maximum......................         1987       10,000       20,628
                                      42 CFR                   CMS               Penalty per instance of Category
                                       488.408(e)(1)(iv).                         3 noncompliance by a Skilled
                                                                                  Nursing Facility:
                                                                                    Minimum......................         1987        1,000        2,063
                                                                                    Maximum......................         1987       10,000       20,628

[[Page 61574]]

 
                                      42 CFR                   CMS               Penalty per day and per instance
                                       488.408(e)(2)(ii).                         for a Skilled Nursing Facility
                                                                                  that has Category 3
                                                                                  noncompliance with Immediate
                                                                                  Jeopardy:
                                                                                    Per Day (Minimum)............         1987        3,050        6,291
                                                                                    Per Day (Maximum)............         1987       10,000       20,628
                                                                                    Per Instance (Minimum).......         1987        1,000        2,063
                                                                                    Per Instance (Maximum).......         1987       10,000       20,628
                                      42 CFR 488.438(a)(1)(i)  CMS               Penalty per day of a Skilled
                                                                                  Nursing Facility that fails to
                                                                                  meet certification
                                                                                  requirements. These amounts
                                                                                  represent the upper range per
                                                                                  day:
                                                                                    Minimum......................         1987        3,050        6,291
                                                                                    Maximum......................         1987       10,000       20,628
                                      42 CFR                   CMS               Penalty per day of a Skilled
                                       488.438(a)(1)(ii).                         Nursing Facility that fails to
                                                                                  meet certification
                                                                                  requirements. These amounts
                                                                                  represent the lower range per
                                                                                  day:
                                                                                    Minimum......................         1987           50          103
                                                                                    Maximum......................         1987        3,000        6,188
                                      42 CFR 488.438(a)(2)...  CMS               Penalty per instance of a
                                                                                  Skilled Nursing Facility that
                                                                                  fails to meet certification
                                                                                  requirements:
                                                                                    Minimum......................         1987        1,000        2,063
                                                                                    Maximum......................         1987       10,000       20,628
    1395l(h)(5)(D)..................  42 CFR 402.105(d)(2)(i)  CMS               Penalty for knowingly,                   1996       10,000       15,024
                                                                                  willfully, and repeatedly
                                                                                  billing for a clinical
                                                                                  diagnostic laboratory test
                                                                                  other than on an assignment-
                                                                                  related basis. (Penalties are
                                                                                  assessed in the same manner as
                                                                                  42 U.S.C. 1395u(j)(2)(B), which
                                                                                  is assessed according to 1320a-
                                                                                  7a(a)).
    1395l(i)(6).....................  .......................  CMS               Penalty for knowingly and                1988        2,000        3,957
                                                                                  willfully presenting or causing
                                                                                  to be presented a bill or
                                                                                  request for payment for an
                                                                                  intraocular lens inserted
                                                                                  during or after cataract
                                                                                  surgery for which the Medicare
                                                                                  payment rate includes the cost
                                                                                  of acquiring the class of lens
                                                                                  involved.
    1395l(q)(2)(B)(i)...............  42 CFR 402.105(a)......  CMS               Penalty for knowingly and                1989        2,000        3,787
                                                                                  willfully failing to provide
                                                                                  information about a referring
                                                                                  physician when seeking payment
                                                                                  on an unassigned basis.
    1395m(a)(11)(A).................  42 CFR 402.1(c)(4),      CMS               Penalty for any durable medical          1996       10,000       15,024
                                       402.105(d)(2)(ii).                         equipment supplier that
                                                                                  knowingly and willfully charges
                                                                                  for a covered service that is
                                                                                  furnished on a rental basis
                                                                                  after the rental payments may
                                                                                  no longer be made. (Penalties
                                                                                  are assessed in the same manner
                                                                                  as 42 U.S.C. 1395u(j)(2)(B),
                                                                                  which is assessed according to
                                                                                  1320a-7a(a)).
    1395m(a)(18)(B).................  42 CFR 402.1(c)(5),      CMS               Penalty for any nonparticipating         1996       10,000       15,024
                                       402.105(d)(2)(iii).                        durable medical equipment
                                                                                  supplier that knowingly and
                                                                                  willfully fails to make a
                                                                                  refund to Medicare
                                                                                  beneficiaries for a covered
                                                                                  service for which payment is
                                                                                  precluded due to an unsolicited
                                                                                  telephone contact from the
                                                                                  supplier. (Penalties are
                                                                                  assessed in the same manner as
                                                                                  42 U.S.C. 1395u(j)(2)(B), which
                                                                                  is assessed according to 1320a-
                                                                                  7a(a)).
    1395m(b)(5)(C)..................  42 CFR 402.1(c)(6),      CMS               Penalty for any nonparticipating         1996       10,000       15,024
                                       402.105(d)(2)(iv).                         physician or supplier that
                                                                                  knowingly and willfully charges
                                                                                  a Medicare beneficiary more
                                                                                  than the limiting charge for
                                                                                  radiologist services.
                                                                                  (Penalties are assessed in the
                                                                                  same manner as 42 U.S.C.
                                                                                  1395u(j)(2)(B), which is
                                                                                  assessed according to 1320a-
                                                                                  7a(a)).
    1395m(h)(3).....................  42 CFR 402.1(c)(8),      CMS               Penalty for any supplier of              1996       10,000       15,024
                                       402.105(d)(2)(vi).                         prosthetic devices, orthotics,
                                                                                  and prosthetics that knowing
                                                                                  and willfully charges for a
                                                                                  covered prosthetic device,
                                                                                  orthotic, or prosthetic that is
                                                                                  furnished on a rental basis
                                                                                  after the rental payment may no
                                                                                  longer be made. (Penalties are
                                                                                  assessed in the same manner as
                                                                                  42 U.S.C. 1395m(a)(11)(A), that
                                                                                  is in the same manner as
                                                                                  1395u(j)(2)(B), which is
                                                                                  assessed according to 1320a-
                                                                                  7a(a)).

[[Page 61575]]

 
    1395m(j)(2)(A)(iii).............  .......................  CMS               Penalty for any supplier of              1994        1,000        1,591
                                                                                  durable medical equipment
                                                                                  including a supplier of
                                                                                  prosthetic devices,
                                                                                  prosthetics, orthotics, or
                                                                                  supplies that knowingly and
                                                                                  willfully distributes a
                                                                                  certificate of medical
                                                                                  necessity in violation of
                                                                                  Section 1834(j)(2)(A)(i) of the
                                                                                  Act or fails to provide the
                                                                                  information required under
                                                                                  Section 1834(j)(2)(A)(ii) of
                                                                                  the Act.
    1395m(j)(4).....................  42 CFR 402.1(c)(10),     CMS               Penalty for any supplier of              1996       10,000       15,024
                                       402.105(d)(2)(vii).                        durable medical equipment,
                                                                                  including a supplier of
                                                                                  prosthetic devices,
                                                                                  prosthetics, orthotics, or
                                                                                  supplies that knowingly and
                                                                                  willfully fails to make refunds
                                                                                  in a timely manner to Medicare
                                                                                  beneficiaries for series billed
                                                                                  other than on as assignment-
                                                                                  related basis under certain
                                                                                  conditions. (Penalties are
                                                                                  assessed in the same manner as
                                                                                  42 U.S.C. 1395m(j)(4) and
                                                                                  1395u(j)(2)(B), which is
                                                                                  assessed according to 1320a-
                                                                                  7a(a)).
    1395m(k)(6).....................  42 CFR 402.1(c)(31),     CMS               Penalty for any person or entity         1996       10,000       15,024
                                       402.105(d)(3).                             who knowingly and willfully
                                                                                  bills or collects for any
                                                                                  outpatient therapy services or
                                                                                  comprehensive outpatient
                                                                                  rehabilitation services on
                                                                                  other than an assignment-
                                                                                  related basis. (Penalties are
                                                                                  assessed in the same manner as
                                                                                  42 U.S.C. 1395m(k)(6) and
                                                                                  1395u(j)(2)(B), which is
                                                                                  assessed according to 1320a-
                                                                                  7a(a)).
    1395m(l)(6).....................  42 CFR 402.1(c)(32),     CMS               Penalty for any supplier of              1996       10,000       15,024
                                       402.105(d)(4).                             ambulance services who
                                                                                  knowingly and willfully fills
                                                                                  or collects for any services on
                                                                                  other than an assignment-
                                                                                  related basis. (Penalties are
                                                                                  assessed in the same manner as
                                                                                  42 U.S.C. 1395u(b)(18)(B),
                                                                                  which is assessed according to
                                                                                  1320a-7a(a)).
    1395u(b)(18)(B).................  42 CFR 402.1(c)(11),     CMS               Penalty for any practitioner             1996       10,000       15,024
                                       402.105(d)(2)(viii).                       specified in Section
                                                                                  1842(b)(18)(C) of the Act or
                                                                                  other person that knowingly and
                                                                                  willfully bills or collects for
                                                                                  any services by the
                                                                                  practitioners on other than an
                                                                                  assignment-related basis.
                                                                                  (Penalties are assessed in the
                                                                                  same manner as 42 U.S.C.
                                                                                  1395u(j)(2)(B), which is
                                                                                  assessed according to 1320a-
                                                                                  7a(a)).
    1395u(j)(2)(B)..................  42 CFR 402.1(c)........  CMS               Penalty for any physician who            1996       10,000       15,024
                                                                                  charges more than 125% for a
                                                                                  non-participating referral.
                                                                                  (Penalties are assessed in the
                                                                                  same manner as 42 U.S.C. 1320a-
                                                                                  7a(a)).
    1395u(k)........................  42 CFR 402.1(c)(12),     CMS               Penalty for any physician who            1996       10,000       15,024
                                       402.105(d)(2)(ix).                         knowingly and willfully
                                                                                  presents or causes to be
                                                                                  presented a claim for bill for
                                                                                  an assistant at a cataract
                                                                                  surgery performed on or after
                                                                                  March 1, 1987, for which
                                                                                  payment may not be made because
                                                                                  of section 1862(a)(15).
                                                                                  (Penalties are assessed in the
                                                                                  same manner as 42 U.S.C.
                                                                                  1395u(j)(2)(B), which is
                                                                                  assessed according to 1320a-
                                                                                  7a(a)).
    1395u(l)(3).....................  42 CFR 402.1(c)(13),     CMS               Penalty for any nonparticipating         1996       10,000       15,024
                                       402.105(d)(2)(x).                          physician who does not accept
                                                                                  payment on an assignment-
                                                                                  related basis and who knowingly
                                                                                  and willfully fails to refund
                                                                                  on a timely basis any amounts
                                                                                  collected for services that are
                                                                                  not reasonable or medically
                                                                                  necessary or are of poor
                                                                                  quality under 1842(l)(1)(A).
                                                                                  (Penalties are assessed in the
                                                                                  same manner as 42 U.S.C.
                                                                                  1395u(j)(2)(B), which is
                                                                                  assessed according to 1320a-
                                                                                  7a(a)).

[[Page 61576]]

 
    1395u(m)(3).....................  42 CFR 402.1(c)(14),     CMS               Penalty for any nonparticipating         1996       10,000       15,024
                                       402.105(d)(2)(xi).                         physician charging more than
                                                                                  $500 who does not accept
                                                                                  payment for an elective
                                                                                  surgical procedure on an
                                                                                  assignment related basis and
                                                                                  who knowingly and willfully
                                                                                  fails to disclose the required
                                                                                  information regarding charges
                                                                                  and coinsurance amounts and
                                                                                  fails to refund on a timely
                                                                                  basis any amount collected for
                                                                                  the procedure in excess of the
                                                                                  charges recognized and approved
                                                                                  by the Medicare program.
                                                                                  (Penalties are assessed in the
                                                                                  same manner as 42 U.S.C.
                                                                                  1395u(j)(2)(B), which is
                                                                                  assessed according to 1320a-
                                                                                  7a(a)).
    1395u(n)(3).....................  42 CFR 402.1(c)(15),     CMS               Penalty for any physician who            1996       10,000       15,024
                                       402.105(d)(2)(xii).                        knowingly, willfully, and
                                                                                  repeatedly bills one or more
                                                                                  beneficiaries for purchased
                                                                                  diagnostic tests any amount
                                                                                  other than the payment amount
                                                                                  specified by the Act.
                                                                                  (Penalties are assessed in the
                                                                                  same manner as 42 U.S.C.
                                                                                  1395u(j)(2)(B), which is
                                                                                  assessed according to 1320a-
                                                                                  7a(a)).
    1395u(o)(3)(B)..................  42 CFR 414.707(b)......  CMS               Penalty for any practitioner             1996       10,000       15,024
                                                                                  specified in Section
                                                                                  1842(b)(18)(C) of the Act or
                                                                                  other person that knowingly and
                                                                                  willfully bills or collects for
                                                                                  any services pertaining to
                                                                                  drugs or biologics by the
                                                                                  practitioners on other than an
                                                                                  assignment-related basis.
                                                                                  (Penalties are assessed in the
                                                                                  same manner as 42 U.S.C.
                                                                                  1395u(b)(18)(B) and
                                                                                  1395u(j)(2)(B), which is
                                                                                  assessed according to 1320a-
                                                                                  7a(a)).
    1395u(p)(3)(A)..................  .......................  CMS               Penalty for any physician or             1988        2,000        3,957
                                                                                  practitioner who knowingly and
                                                                                  willfully fails promptly to
                                                                                  provide the appropriate
                                                                                  diagnosis codes upon CMS or
                                                                                  Medicare administrative
                                                                                  contractor request for payment
                                                                                  or bill not submitted on an
                                                                                  assignment-related basis.
    1395w-3a(d)(4)(A)...............  42 CFR 414.806.........  CMS               Penalty for a pharmaceutical             2003       10,000       12,856
                                                                                  manufacturer's
                                                                                  misrepresentation of average
                                                                                  sales price of a drug, or
                                                                                  biologic.
    1395w-4(g)(1)(B)................  42 CFR 402.1(c)(17),     CMS               Penalty for any nonparticipating         1996       10,000       15,024
                                       402.105(d)(2)(xiii).                       physician, supplier, or other
                                                                                  person that furnishes physician
                                                                                  services not on an assignment-
                                                                                  related basis who either
                                                                                  knowingly and willfully bills
                                                                                  or collects in excess of the
                                                                                  statutorily-defined limiting
                                                                                  charge or fails to make a
                                                                                  timely refund or adjustment.
                                                                                  (Penalties are assessed in the
                                                                                  same manner as 42 U.S.C.
                                                                                  1395u(j)(2)(B), which is
                                                                                  assessed according to 1320a-
                                                                                  7a(a)).
    1395w-4(g)(3)(B)................  42 CFR 402.1(c)(18),     CMS               Penalty for any person that              1996       10,000       15,024
                                       402.105(d)(2)(xiv).                        knowingly and willfully bills
                                                                                  for statutorily defined State-
                                                                                  plan approved physicians'
                                                                                  services on any other basis
                                                                                  than an assignment-related
                                                                                  basis for a Medicare/Medicaid
                                                                                  dual eligible beneficiary.
                                                                                  (Penalties are assessed in the
                                                                                  same manner as 42 U.S.C.
                                                                                  1395u(j)(2)(B), which is
                                                                                  assessed according to 1320a-
                                                                                  7a(a)).
    1395w-27(g)(3)(A); 1857(g)(3)...  42 CFR 422.760(b); 42    CMS               Penalty for each termination             1997       25,000       36,794
                                       CFR 423.760(b).                            determination the Secretary
                                                                                  makes that is the result of
                                                                                  actions by a Medicare Advantage
                                                                                  organization or Part D sponsor
                                                                                  that has adversely affected an
                                                                                  individual covered under the
                                                                                  organization's contract.
    1395w-27(g)(3)(B); 1857(g)(3)...  .......................  CMS               Penalty for each week beginning          1997       10,000       14,718
                                                                                  after the initiation of civil
                                                                                  money penalty procedures by the
                                                                                  Secretary because a Medicare
                                                                                  Advantage organization or Part
                                                                                  D sponsor has failed to carry
                                                                                  out a contract, or has carried
                                                                                  out a contract inconsistently
                                                                                  with regulations.
    1395w-27(g)(3)(D); 1857(g)(3)...  .......................  CMS               Penalty for a Medicare Advantage         2000      100,000      136,689
                                                                                  organization's or Part D
                                                                                  sponsor's early termination of
                                                                                  its contract.

[[Page 61577]]

 
    1395y(b)(3)(C)..................  42 CFR 411.103(b)......  CMS               Penalty for an employer or other         1990        5,000        8,908
                                                                                  entity to offer any financial
                                                                                  or other incentive for an
                                                                                  individual entitled to benefits
                                                                                  not to enroll under a group
                                                                                  health plan or large group
                                                                                  health plan which would be a
                                                                                  primary plan.
    1395y(b)(5)(C)(ii)..............  42 CFR 402.1(c)(20); 42  CMS               Penalty for any non-governmental         1998        1,000        1,450
                                       CFR 402.105(b)(2).                         employer that, before October
                                                                                  1, 1998, willfully or
                                                                                  repeatedly failed to provide
                                                                                  timely and accurate information
                                                                                  requested relating to an
                                                                                  employee's group health
                                                                                  insurance coverage.
    1395y(b)(6)(B)..................  42 CFR 402.1(c)(21),     CMS               Penalty for any entity that              1994        2,000        3,182
                                       402.105(a).                                knowingly, willfully, and
                                                                                  repeatedly fails to complete a
                                                                                  claim form relating to the
                                                                                  availability of other health
                                                                                  benefits in accordance with
                                                                                  statute or provides inaccurate
                                                                                  information relating to such on
                                                                                  the claim form.
    1395y(b)(7)(B)(i)...............  .......................  CMS               Penalty for any entity serving           2007        1,000        1,138
                                                                                  as insurer, third party
                                                                                  administrator, or fiduciary for
                                                                                  a group health plan that fails
                                                                                  to provide information that
                                                                                  identifies situations where the
                                                                                  group health plan is or was a
                                                                                  primary plan to Medicare to the
                                                                                  HHS Secretary.
    1395y(b)(8)(E)..................  .......................  CMS               Penalty for any non-group health         2007        1,000        1,138
                                                                                  plan that fails to identify
                                                                                  claimants who are Medicare
                                                                                  beneficiaries and provide
                                                                                  information to the HHS
                                                                                  Secretary to coordinate
                                                                                  benefits and pursue any
                                                                                  applicable recovery claim.
    1395nn(g)(5)....................  42 CFR 411.361.........  CMS               Penalty for any person that              1989       10,000       18,936
                                                                                  fails to report information
                                                                                  required by HHS under Section
                                                                                  1877(f) concerning ownership,
                                                                                  investment, and compensation
                                                                                  arrangements.
    1395pp(h).......................  42 CFR 402.1(c)(23),     CMS               Penalty for any durable medical          1996       10,000       15,024
                                       402.105(d)(2)(xv).                         equipment supplier, including a
                                                                                  supplier of prosthetic devices,
                                                                                  prosthetics, orthotics, or
                                                                                  supplies, that knowingly and
                                                                                  willfully fails to make refunds
                                                                                  in a timely manner to Medicare
                                                                                  beneficiaries under certain
                                                                                  conditions. (42 U.S.C.
                                                                                  1395(m)(18) sanctions apply
                                                                                  here in the same manner, which
                                                                                  is under 1395u(j)(2) and 1320a-
                                                                                  7a(a)).
    1395ss(a)(2)....................  42 CFR 402.1(c)(24),     CMS               Penalty for any person that              1987       25,000       51,569
                                       405.105(f)(1).                             issues a Medicare supplemental
                                                                                  policy that has not been
                                                                                  approved by the State
                                                                                  regulatory program or does not
                                                                                  meet Federal standards after a
                                                                                  statutorily defined effective
                                                                                  date.
    1395ss(d)(3)(A)(vi)(II).........  .......................  CMS               Penalty for someone other than           1990       15,000       26,723
                                                                                  issuer that sells or issues a
                                                                                  Medicare supplemental policy to
                                                                                  beneficiary without a
                                                                                  disclosure statement.
                                                                                 Penalty for an issuer that sells         1990       25,000       44,539
                                                                                  or issues a Medicare
                                                                                  supplemental policy without
                                                                                  disclosure statement.
    1395ss(d)(3)(B)(iv).............  .......................  CMS               Penalty for someone other than           1990       15,000       26,723
                                                                                  issuer that sells or issues a
                                                                                  Medicare supplemental policy
                                                                                  without acknowledgement form.
                                                                                 Penalty for issuer that sells or         1990       25,000       44,539
                                                                                  issues a Medicare supplemental
                                                                                  policy without an
                                                                                  acknowledgement form.
    1395ss(p)(8)....................  42 CFR 402.1(c)(25),     CMS               Penalty for any person that              1990       15,000       26,723
                                       402.105(e).                                sells or issues Medicare
                                                                                  supplemental polices after a
                                                                                  given date that fail to conform
                                                                                  to the NAIC or Federal
                                                                                  standards established by
                                                                                  statute.
                                      42 CFR 402.1(c)(25),     CMS               Penalty for any person that              1990       25,000       44,539
                                       405.105(f)(2).                             sells or issues Medicare
                                                                                  supplemental polices after a
                                                                                  given date that fail to conform
                                                                                  to the NAIC or Federal
                                                                                  standards established by
                                                                                  statute.
    1395ss(p)(9)(C).................  42 CFR 402.1(c)(26),     CMS               Penalty for any person that              1990       15,000       26,723
                                       402.105(e).                                sells a Medicare supplemental
                                                                                  policy and fails to make
                                                                                  available for sale the core
                                                                                  group of basic benefits when
                                                                                  selling other Medicare
                                                                                  supplemental policies with
                                                                                  additional benefits or fails to
                                                                                  provide the individual, before
                                                                                  selling the policy, an outline
                                                                                  of coverage describing benefits.

[[Page 61578]]

 
                                      42 CFR 402.1(c)(26),                       Penalty for any person that              1990       25,000       44,539
                                       405.105(f)(3), (4).                        sells a Medicare supplemental
                                                                                  policy and fails to make
                                                                                  available for sale the core
                                                                                  group of basic benefits when
                                                                                  selling other Medicare
                                                                                  supplemental policies with
                                                                                  additional benefits or fails to
                                                                                  provide the individual, before
                                                                                  selling the policy, an outline
                                                                                  of coverage describing benefits.
    1395ss(q)(5)(C).................  42 CFR 402.1(c)(27),     CMS               Penalty for any person that              1990       25,000       44,539
                                       405.105(f)(5).                             fails to suspend the policy of
                                                                                  a policyholder made eligible
                                                                                  for medical assistance or
                                                                                  automatically reinstates the
                                                                                  policy of a policyholder who
                                                                                  has lost eligibility for
                                                                                  medical assistance, under
                                                                                  certain circumstances.
    1395ss(r)(6)(A).................  42 CFR 402.1(c)(28),     CMS               Penalty for any person that              1990       25,000       44,539
                                       405.105(f)(6).                             fails to provide refunds or
                                                                                  credits as required by section
                                                                                  1882(r)(1)(B).
    1395ss(s)(4)....................  42 CFR 402.1(c)(29),     CMS               Penalty for any issuer of a              1990        5,000       18,908
                                       405.105(c).                                Medicare supplemental policy
                                                                                  that does not waive listed time
                                                                                  periods if they were already
                                                                                  satisfied under a proceeding
                                                                                  Medicare supplemental policy,
                                                                                  or denies a policy, or
                                                                                  conditions the issuances or
                                                                                  effectiveness of the policy, or
                                                                                  discriminates in the pricing of
                                                                                  the policy base on health
                                                                                  status or other specified
                                                                                  criteria.
    1395ss(t)(2)....................  42 CFR 402.1(c)(30),     CMS               Penalty for any issuer of a              1990       25,000       44,539
                                       405.105(f)(7).                             Medicare supplemental policy
                                                                                  that fails to fulfill listed
                                                                                  responsibilities.
    1395ss(v)(4)(A).................  .......................  CMS               Penalty someone other than               2003       15,000       19,284
                                                                                  issuer who sells, issues, or
                                                                                  renews a medigap Rx policy to
                                                                                  an individual who is a Part D
                                                                                  enrollee.
                                                                                 Penalty for an issuer who sells,         2003       25,000       32,140
                                                                                  issues, or renews a Medigap Rx
                                                                                  policy who is a Part D enrollee.
    1395bbb(c)(1)...................  42 CFR 488.725(c)......  CMS               Penalty for any individual who           1987        2,000        4,126
                                                                                  notifies or causes to be
                                                                                  notified a home health agency
                                                                                  of the time or date on which a
                                                                                  survey of such agency is to be
                                                                                  conducted.
    1395bbb(f)(2)(A)(i).............  42 CFR                   CMS               Maximum daily penalty amount for         1988       10,000       19,787
                                       488.845(b)(2)(iii); 42                     each day a home health agency
                                       CFR 488.845(b)(3)-(6);                     is not in compliance with
                                       and 42 CFR                                 statutory requirements.
                                       488.845(d)(1)(ii).
                                      42 CFR 488.845(b)(3)...  ................  Penalty per day for home health
                                                                                  agency's noncompliance (Upper
                                                                                  Range):
                                                                                    Minimum......................         1988        8,500       16,819
                                                                                    Maximum......................         1988       10,000       19,787
                                      42 CFR 488.845(b)(3)(i)                    Penalty for a home health                1988       10,000       19,787
                                                                                  agency's deficiency or
                                                                                  deficiencies that cause
                                                                                  immediate jeopardy and result
                                                                                  in actual harm.
                                      42 CFR                                     Penalty for a home health                1988        9,000       17,808
                                       488.845(b)(3)(ii).                         agency's deficiency or
                                                                                  deficiencies that cause
                                                                                  immediate jeopardy and result
                                                                                  in potential for harm.
                                      42 CFR                                     Penalty for an isolated incident         1988        8,500       16,819
                                       488.845(b)(3)(iii).                        of noncompliance in violation
                                                                                  of established HHA policy.
                                      42 CFR 488.845(b)(4)...                    Penalty for a repeat and/or
                                                                                  condition-level deficiency that
                                                                                  does not constitute immediate
                                                                                  jeopardy, but is directly
                                                                                  related to poor quality patient
                                                                                  care outcomes (Lower Range):
                                                                                    Minimum......................         1988        1,500        2,968
                                                                                    Maximum......................         1988        8,500       16,819
                                      42 CFR 488.845(b)(5)...                    Penalty for a repeat and/or
                                                                                  condition-level deficiency that
                                                                                  does not constitute immediate
                                                                                  jeopardy and that is related
                                                                                  predominately to structure or
                                                                                  process-oriented conditions
                                                                                  (Lower Range):
                                                                                    Minimum......................         1988          500          989
                                                                                    Maximum......................         1988        4,000        7,915
                                      42 CFR 488.845(b)(6)...                    Penalty imposed for instance of
                                                                                  noncompliance that may be
                                                                                  assessed for one or more
                                                                                  singular events of condition-
                                                                                  level noncompliance that are
                                                                                  identified and where the
                                                                                  noncompliance was corrected
                                                                                  during the onsite survey:

[[Page 61579]]

 
                                                                                    Minimum......................         1988        1,000        1,979
                                                                                    Maximum......................         1988       10,000       19,787
                                                                                 Penalty for each day of                  1988       10,000       19,787
                                                                                  noncompliance (Maximum).
                                      42 CFR                                     Penalty for each day of                  1988       10,000       19,787
                                       488.845(d)(1)(ii).                         noncompliance (Maximum).
    1396b(m)(5)(B)..................  42 CFR 460.46..........  CMS               Penalty for PACE organization's
                                                                                  practice that would reasonably
                                                                                  be expected to have the effect
                                                                                  of denying or discouraging
                                                                                  enrollment:
                                                                                    Minimum......................         1997       15,000       22,077
                                                                                    Maximum......................         1997      100,000      147,177
                                                                                 Penalty for a PACE organization          1997       25,000       36,794
                                                                                  that charges excessive premiums.
                                                                                 Penalty for a PACE organization          1997      100,000      147,177
                                                                                  misrepresenting or falsifying
                                                                                  information to CMS, the State,
                                                                                  or an individual or other
                                                                                  entity.
                                                                                 Penalty for each determination           1997       25,000       36,794
                                                                                  the CMS makes that the PACE
                                                                                  organization has failed to
                                                                                  provide medically necessary
                                                                                  items and services of the
                                                                                  failure has adversely affected
                                                                                  (or has the substantial
                                                                                  likelihood of adversely
                                                                                  affecting) a PACE participant.
                                                                                 Penalty for involuntarily                1997       25,000       36,794
                                                                                  disenrolling a participant.
                                                                                 Penalty for discriminating or            1997       25,000       36,794
                                                                                  discouraging enrollment or
                                                                                  disenrollment of participants
                                                                                  on the basis of an individual's
                                                                                  health status or need for
                                                                                  health care services.
    1396r(h)(3)(C)(ii)(I)...........  42 CFR                   CMS               Penalty per day for a nursing
                                       488.408(d)(1)(iii).                        facility's failure to meet a
                                                                                  Category 2 Certification:
                                                                                    Minimum......................         1987           50          103
                                                                                    Maximum......................         1987        3,000        6,188
                                      42 CFR                   CMS               Penalty per instance for a
                                       488.408(d)(1)(iv).                         nursing facility's failure to
                                                                                  meet Category 2 certification:
                                                                                    Minimum......................         1987        1,000        2,063
                                                                                    Maximum......................         1987       10,000       20,628
                                      42 CFR                   CMS               Penalty per day for a nursing
                                       488.408(e)(1)(iii).                        facility's failure to meet
                                                                                  Category 3 certification:
                                                                                    Minimum......................         1987        3,050        6,291
                                                                                    Maximum......................         1987       10,000       20,628
                                      42 CFR                   CMS               Penalty per instance for a        ...........  ...........        2,063
                                       488.408(e)(1)(iv).                         nursing facility's failure to
                                                                                  meet Category 3 certification:
                                                                                    Minimum......................         1987        1,000       20,628
                                                                                    Maximum......................         1987       10,000
                                      42 CFR                   CMS               Penalty per instance for a        ...........  ...........        2,063
                                       488.408(e)(2)(ii).                         nursing facility's failure to
                                                                                  meet Category 3 certification,
                                                                                  which results in immediate
                                                                                  jeopardy:
                                                                                    Minimum......................         1987        1,000       20,628
                                                                                    Maximum......................         1987       10,000
                                      42 CFR 488.438(a)(1)(i)  CMS               Penalty per day for nursing       ...........  ...........        6,291
                                                                                  facility's failure to meet
                                                                                  certification (Upper Range):
                                                                                    Minimum......................         1987        3,050       20,628
                                                                                    Maximum......................         1987       10,000        2,063
                                      42 CFR                   CMS               Penalty per day for nursing
                                       488.438(a)(1)(ii).                         facility's failure to meet
                                                                                  certification (Lower Range):
                                                                                    Minimum......................         1987           50          103
                                                                                    Maximum......................         1987        3,000        6,188
                                      42 CFR 488.438(a)(2)...  CMS               Penalty per instance for nursing
                                                                                  facility's failure to meet
                                                                                  certification:
                                                                                    Minimum......................         1987        1,000        2,063
                                                                                    Maximum......................         1987       10,000       20,628
    1396r(f)(2)(B)(iii)(I)(c).......  42 CFR                   CMS               Grounds to prohibit approval of          1987        5,000       10,314
                                       483.151(b)(2)(iv) and                      Nurse Aide Training Program--if
                                       (b)(3)(iii).                               assessed a penalty in
                                                                                  1819(h)(2)(B)(i) or
                                                                                  1919(h)(2)(A)(ii) of ``not less
                                                                                  than $5,000'' [Not CMP
                                                                                  authority, but a specific CMP
                                                                                  amount (CMP at this level) that
                                                                                  is the triggering condition for
                                                                                  disapproval].
    1396r(h)(3)(C)(ii)(I)...........  42 CFR 483.151(c)(2)...  CMS               Grounds to waive disapproval of          1987        5,000       10,314
                                                                                  nurse aide training program--
                                                                                  reference to disapproval based
                                                                                  on imposition of CMP ``not less
                                                                                  than $5,000'' [Not CMP
                                                                                  authority but CMP imposition at
                                                                                  this level determines
                                                                                  eligibility to seek waiver of
                                                                                  disapproval of nurse aide
                                                                                  training program].

[[Page 61580]]

 
    1396t(j)(2)(C)..................  .......................  CMS               Penalty for each day of
                                                                                  noncompliance for a home or
                                                                                  community care provider that no
                                                                                  longer meets the minimum
                                                                                  requirements for home and
                                                                                  community care:
                                                                                    Minimum......................         1990            1            2
                                                                                    Maximum......................         1990       10,000       17,816
    1396u-2(e)(2)(A)(i).............  42 CFR 438.704.........  CMS               Penalty for a Medicaid managed           1997       25,000       36,794
                                                                                  care organization that fails
                                                                                  substantially to provide
                                                                                  medically necessary items and
                                                                                  services.
                                                                                 Penalty for Medicaid managed             1997       25,000       36,794
                                                                                  care organization that imposes
                                                                                  premiums or charges on
                                                                                  enrollees in excess of the
                                                                                  premiums or charges permitted.
                                                                                 Penalty for a Medicaid managed           1997       25,000       36,794
                                                                                  care organization that
                                                                                  misrepresents or falsifies
                                                                                  information to another
                                                                                  individual or entity.
                                                                                 Penalty for a Medicaid managed           1997       25,000       36,794
                                                                                  care organization that fails to
                                                                                  comply with the applicable
                                                                                  statutory requirements for such
                                                                                  organizations.
    1396u-2(e)(2)(A)(ii)............  42 CFR 438.704.........  CMS               Penalty for a Medicaid managed           1997      100,000      147,177
                                                                                  care organization that
                                                                                  misrepresents or falsifies
                                                                                  information to the HHS
                                                                                  Secretary.
                                                                                 Penalty for Medicaid managed             1997      100,000      147,177
                                                                                  care organization that acts to
                                                                                  discriminate among enrollees on
                                                                                  the basis of their health
                                                                                  status.
    1396u-2(e)(2)(A)(iv)............  42 CFR 438.704.........  CMS               Penalty for each individual that         1997       15,000       22,077
                                                                                  does not enroll as a result of
                                                                                  a Medicaid managed care
                                                                                  organization that acts to
                                                                                  discriminate among enrollees on
                                                                                  the basis of their health
                                                                                  status.
    1396u(h)(2).....................  42 CFR 441, Subpart I..  CMS               Penalty for a provider not               1990       10,000       20,628
                                                                                  meeting one of the requirements
                                                                                  relating to the protection of
                                                                                  the health, safety, and welfare
                                                                                  of individuals receiving
                                                                                  community supported living
                                                                                  arrangements services.
    1396w-2(c)(1)...................  .......................  CMS               Penalty for disclosing                   2009       10,000       11,002
                                                                                  information related to
                                                                                  eligibility determinations for
                                                                                  medical assistance programs.
    18041(c)(2).....................  45 CFR 150.315; 45 CFR   CMS               Failure to comply with                   1996          100          150
                                       156.805(c).                                requirements of the Public
                                                                                  Health Services Act; Penalty
                                                                                  for violations of rules or
                                                                                  standards of behavior
                                                                                  associated with issuer
                                                                                  participation in the Federally-
                                                                                  facilitated Exchange. (42
                                                                                  U.S.C. 300gg-22(b)(2)(C)).
    18081(h)(1)(A)(i)(II)...........  42 CFR 155.285.........  CMS               Penalty for providing false              2010       25,000       27,186
                                                                                  information on Exchange
                                                                                  application.
    18081(h)(1)(B)..................  42 CFR 155.285.........  CMS               Penalty for knowingly or                 2010      250,000      271,862
                                                                                  willfully providing false
                                                                                  information on Exchange
                                                                                  application.
    18081(h)(2).....................  42 CFR 155.260.........  CMS               Penalty for knowingly or                 2010       25,000       27,186
                                                                                  willfully disclosing protected
                                                                                  information from Exchange.
31 U.S.C.:
    1352............................  45 CFR 93.400(e).......  HHS               Penalty for the first time an            1989       10,000       18,936
                                                                                  individual makes an expenditure
                                                                                  prohibited by regulations
                                                                                  regarding lobbying disclosure,
                                                                                  absent aggravating
                                                                                  circumstances.
                                                                                 Penalty for second and
                                                                                  subsequent offenses by
                                                                                  individuals who make an
                                                                                  expenditure prohibited by
                                                                                  regulations regarding lobbying
                                                                                  disclosure:
                                                                                    Minimum......................         1989       10,000       18,936
                                                                                    Maximum......................         1989      100,000      189,361
                                                                                 Penalty for the first time an            1989       10,000       18,936
                                                                                  individual fails to file or
                                                                                  amend a lobbying disclosure
                                                                                  form, absent aggravating
                                                                                  circumstances.
                                                                                 Penalty for second and
                                                                                  subsequent offenses by
                                                                                  individuals who fail to file or
                                                                                  amend a lobbying disclosure
                                                                                  form, absent aggravating
                                                                                  circumstances:
                                                                                    Minimum......................         1989       10,000       18,936
                                                                                    Maximum......................         1989      100,000      189,361
                                      45 CFR 93, Appendix A..  HHS               Penalty for failure to provide
                                                                                  certification regarding
                                                                                  lobbying in the award documents
                                                                                  for all sub-awards of all
                                                                                  tiers:
                                                                                    Minimum......................         1989       10,000       18,936
                                                                                    Maximum......................         1989      100,000      189,361

[[Page 61581]]

 
                                                                                 Penalty for failure to provide
                                                                                  statement regarding lobbying
                                                                                  for loan guarantee and loan
                                                                                  insurance transactions:
                                                                                    Minimum......................         1989       10,000       18,936
                                                                                    Maximum......................         1989      100,000      189,361
    3801-3812.......................  45 CFR 79.3(a)(1)(iv)..  HHS               Penalty against any individual           1988        5,000        9,894
                                                                                  who--with knowledge or reason
                                                                                  to know--makes, presents or
                                                                                  submits a false, fictitious or
                                                                                  fraudulent claim to the
                                                                                  Department.
                                      45 CFR 79.3(b)(1(ii)...                    Penalty against any individual           1988        5,000        9,894
                                                                                  who--with knowledge or reason
                                                                                  to know--makes, presents or
                                                                                  submits a false, fictitious or
                                                                                  fraudulent claim to the
                                                                                  Department.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Some HHS components have not promulgated regulations regarding their civil monetary penalty-specific statutory authorities.
\2\ The description is not intended to be a comprehensive explanation of the underlying violation; the statute and corresponding regulation, if
  applicable should be consulted.
\3\ Statutory, or non-Inflation Act Adjustment.

PART 147--HEALTH INSURANCE REFORM REQUIREMENTS FOR THE GROUP AND 
INDIVIDUAL HEALTH INSURANCE MARKETS

0
33. The authority citation for part 147 continues to read as follows:

    Authority: Secs. 2701 through 2763, 2791, and 2792 of the Public 
Health Service Act (42 U.S.C. 300gg through 300gg-63, 300gg-91, and 
300gg-92), as amended.


Sec.  147.200  [Amended]

0
34. Section 147.200(e) is amended by removing the phrase ``not more 
than $1,000 for'' and adding in its place the phrase ``not more than 
$1,000 as adjusted annually under 45 CFR part 102 for''.

PART 150--CMS ENFORCEMENT IN GROUP AND INDIVIDUAL INSURANCE MARKETS

0
35. The authority citation for part 150 continues to read as follows:

    Authority:  Secs. 2701 through 2763, 2791, and 2792 of the PHS 
Act (42 U.S.C. 300gg through 300gg-63, 300gg-91, and 300gg-92).


Sec.  150.315  [Amended]

0
36. Section 150.315 is amended by removing the phrase ``may not exceed 
$100 for'' and adding in its place the phrase ``may not exceed $100 as 
adjusted annually under 45 CFR part 102 for''.

PART 155--EXCHANGE ESTABLISHMENT STANDARDS AND OTHER RELATED 
STANDARDS UNDER THE AFFORDABLE CARE ACT

0
37. The authority citation for part 155 continues to read as follows:

    Authority:  Title I of the Affordable Care Act, sections 1301, 
1302, 1303, 1304, 1311, 1312, 1313, 1321, 1322, 1331, 1332, 1334, 
1402, 1411, 1412, 1413, Pub. L. 111-148, 124 Stat. 119 (42 U.S.C. 
18021-18024, 18031-18033, 18041-18042, 18051, 18054, 18071, and 
18081-18083).


Sec.  155.260  [Amended]

0
38. In Sec.  155.260, paragraph (g) is amended by removing the phrase 
``not more than $25,000 per'' and adding in its place the phrase ``not 
more than $25,000 as adjusted annually under 45 CFR part 102 per''.


Sec.  155.285  [Amended]

0
39. Amend Sec.  155.285 as follows:
0
a. In paragraph (c)(1)(i), by removing the phrase ``of $25,000 for'' 
and adding in its place the phrase ``of $25,000 as adjusted annually 
under 45 CFR part 102 for'';
0
b. In paragraph (c)(1)(ii), removing the phrase ``of $250,000 for'' and 
adding in its place the phrase ``of $250,000 as adjusted annually under 
45 CFR part 102 for''; and
0
c. In paragraph (c)(2)(i), removing the phrase ``not more than $25,000 
per'' and adding in its place the phrase ``not more than $25,000 as 
adjusted annually under 45 CFR part 102 per''.

PART 156--HEALTH INSURANCE ISSUER STANDARDS UNDER THE AFFORDABLE 
CARE ACT, INCLUDING STANDARDS RELATED TO EXCHANGES

0
40. The authority citation for part 156 continues to read as follows:

    Authority:  Title I of the Affordable Care Act, sections 1301-
1304, 1311-1313, 1321-1322, 1324, 1334, 1342-1343, 1401-1402, Pub. 
L. 111-148, 124 Stat. 119 (42 U.S.C. 18021-18024, 18031-18032, 
18041-18042, 18044, 18054, 18061, 18063, 18071, 18082, 26 U.S.C. 
36B, and 31 U.S.C. 9701).


Sec.  156.805  [Amended]

0
41. In Sec.  156.805, paragraph (c) is amended by removing the phrase 
``$100 for'' and adding in its place the phrase ``$100 as adjusted 
annually under 45 CFR part 102 for''.

PART 158--ISSUER USE OF PREMIUM REVENUE: REPORTING AND REBATE 
REQUIREMENTS

0
42. The authority citation for part 158 continues to read as follows:

    Authority:  Section 2718 of the Public Health Service Act (42 
U.S.C. 300gg-18), as amended.


Sec.  158.606  [Amended]

0
43. Section 158.606 is amended by removing the phrase ``may not exceed 
$100 for'' and adding in its place the phrase ``may not exceed $100 as 
adjusted annually under 45 CFR part 102 for''.

PART 160--GENERAL ADMINISTRATIVE REQUIREMENTS

0
44. The authority for part 160 continues to read as follows:

    Authority: 42 U.S.C. 1302(a); 42 U.S.C. 1320d-1320d-9; sec. 264, 
Pub. L. 104-191, 110 Stat. 2033-2034 (42 U.S.C. 1320d-2 (note)); 5 
U.S.C. 552; secs. 13400-13424, Pub. L. 111-5, 123 Stat. 258-279; and 
sec. 1104 of Pub. L. 111-148, 124 Stat. 146-154.


0
45. Section 160.404 is amended by revising paragraph (a) to read as 
follows:


Sec.  160.404  Amount of a civil money penalty.

    (a) The amount of a civil money penalty will be determined in 
accordance with paragraph (b) of this section, and Sec. Sec.  160.406, 
160.408, and 160.412. These amounts were adjusted in accordance with 
the Federal Civil Monetary Penalty Inflation Adjustment

[[Page 61582]]

Act of 1990, (Pub. L. 101-140), as amended by the Federal Civil 
Penalties Inflation Adjustment Act Improvements Act of 2015, (section 
701 of Pub. L. 114-74), and appear at 45 CFR part 102. These amounts 
will be updated annually and published at 45 CFR part 102.
* * * * *

Subtitle B--Regulations Related to Public Welfare

Chapter II--Office of Family Assistance (Assistance Programs), 
Administration for Children and Families, Department of Health and 
Human Services

PART 303--STANDARDS FOR PROGRAM OPERATIONS

0
46. The authority citation for part 303 continues to read as follows:

    Authority:  42 U.S.C. 651 through 658, 659a, 660, 663, 664, 666, 
667, 1302, 1396a(a)(25), 1396b(d)(2), 1396b(o), 1396b(p), and 
1396(k).


0
47. Section 303.21 is amended by revising paragraph (f) to read as 
follows:


Sec.  303.21   Safeguarding and disclosure of confidential information.

* * * * *
    (f) Penalties for unauthorized disclosure. Any disclosure or use of 
confidential information in violation of 42 U.S.C. 653(l)(2) and 
implementing regulations shall be subject to:
    (1) Any State and Federal statutes that impose legal sanctions for 
such disclosure; and
    (2) The maximum civil monetary penalties associated with the 
statutory provisions authorizing civil monetary penalties under 42 
U.S.C. 653(l)(2) as shown in the table at 45 CFR 102.3.

    Dated: July 21, 2016.
Sylvia M. Burwell,
Secretary, Department of Health and Human Services.
[FR Doc. 2016-18680 Filed 9-2-16; 8:45 am]
 BILLING CODE 4150-24-P