[Federal Register Volume 83, Number 197 (Thursday, October 11, 2018)]
[Rules and Regulations]
[Pages 51369-51390]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-22005]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

45 CFR Part 102

RIN 0991-AC0


Annual Civil Monetary Penalties Inflation Adjustment

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

ACTION: Final rule.

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

SUMMARY: The Department of Health and Human Services is updating its 
regulations to reflect required annual inflation-related increases to 
the civil monetary penalties in its regulations, pursuant to the 
Federal Civil Penalties Inflation Adjustment Act Improvements Act of 
2015.

DATES: This rule is effective October 11, 2018.

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

SUPPLEMENTARY INFORMATION: 

I. Background

    The Federal Civil Penalties Inflation Adjustment Act Improvements 
Act of 2015 (Sec. 701 of Pub. L. 114-74) (the ``2015 Act''), which is 
intended to improve the effectiveness of civil monetary penalties 
(CMPs) and to maintain the deterrent effect of such penalties, requires 
agencies to adjust the civil monetary penalties for inflation annually.
    The Department of Health and Human Services (HHS) lists the civil 
monetary penalty authorities and the penalty amounts administered by 
all of its agencies in tabular form in 45 CFR 102.3.

II. Calculation of Adjustment

    The annual inflation adjustment for each applicable civil monetary 
penalty is determined using the percent increase in the Consumer Price 
Index for all Urban Consumers (CPI-U) for the month of October of the 
year in which the amount of each civil penalty was most recently 
established or modified. In the December 15, 2017, Office of Management 
and Budget (OMB) Memorandum for the Heads of Executive Agencies and 
Departments, M-18-03, Implementation of the Penalty Inflation 
Adjustments for 2018, Pursuant to the Federal Civil Penalties Inflation 
Adjustment Act Improvements Act of 2015, OMB published the multiplier 
for the required annual adjustment. The cost-of-living adjustment 
multiplier for 2018, based on the CPI-U for the month of October 2017, 
not seasonally adjusted, is 1.02041.
    Using the 2018 multiplier, HHS adjusted all its applicable monetary 
penalties in 45 CFR 102.3.

III. Statutory and Executive Order Reviews

    The 2015 Act requires federal agencies to publish annual penalty 
inflation adjustments notwithstanding section 553 of the Administrative 
Procedure Act (APA).
    Section 4(a) of the 2015 Act directs federal agencies to publish 
annual adjustments no later than January 15th of each year thereafter. 
In accordance with section 553 of the APA, most rules are subject to 
notice and comment and are effective no earlier than 30 days after 
publication in the Federal Register. However, section 4(b)(2) of the 
2015 Act provides that each agency shall make the annual inflation 
adjustments ``notwithstanding section 553'' of the APA.
    According to OMB's Memorandum M-18-03, the phrase ``notwithstanding 
section 553'' means that ``the public procedure the APA generally 
requires--notice, an opportunity for comment, and a delay in effective 
date--is not required for agencies to issue regulations implementing 
the annual adjustment.'' Consistent with the language of the 2015 Act 
and OMB's implementation guidance, this rule is not subject to notice 
and an opportunity for public comment and will be effective immediately 
upon publication.
    Pursuant to OMB Memorandum M-18-03, HHS has determined that the 
annual inflation adjustment to the civil monetary penalties in its 
regulations does not trigger any requirements under procedural statutes 
and Executive Orders that govern rulemaking procedures.

IV. Effective Date

    This rule is effective October 11 2018. The adjusted civil monetary 
penalty amounts apply to penalties assessed on or after October 11, 
2018, if the violation occurred on or after November 2, 2015. If the 
violation occurred prior to November 2, 2015, or a penalty was assessed 
prior to September 6, 2016, the pre-adjustment civil penalty amounts in

[[Page 51370]]

effect prior to September 6, 2016, will apply.

List of Subjects in 45 CFR Part 102

    Administrative practice and procedure, Penalties.

    For reasons discussed in the preamble, the Department of Health and 
Human Services amends subtitle A, title 45 of the Code of Federal 
Regulations as follows:

PART 102--ADJUSTMENT OF CIVIL MONETARY PENALTIES FOR INFLATION

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

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

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


Sec.  102.3   Penalty adjustment and table.

* * * * *

                                   Civil Monetary Penalty Authorities Administered by HHS Agencies and Penalty Amounts
                                                              [Effective October 11, 2018]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                         Citation                                                                       Date of
----------------------------------------------------------                                                last         2016         2017         2018
                                                                                                      statutorily    Maximum      Maximum      Maximum
                                                                HHS agency         Description \2\    established    adjusted     adjusted     adjusted
              U.S.C.                       CFR \1\                                                      penalty    penalty ($)  penalty ($)  penalty ($)
                                                                                                       figure \3\                   \4\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                        21 U.S.C.
--------------------------------------------------------------------------------------------------------------------------------------------------------
333(b)(2)(A)......................  .....................  FDA                  Penalty for                  2016       98,935      100,554      102,606
                                                                                 violations related
                                                                                 to drug samples
                                                                                 resulting in a
                                                                                 conviction of any
                                                                                 representative of
                                                                                 manufacturer or
                                                                                 distributor in any
                                                                                 10-year period.
333(b)(2)(B)......................  .....................  FDA                  Penalty for                  2016    1,978,690    2,011,061    2,052,107
                                                                                 violation related
                                                                                 to drug samples
                                                                                 resulting in a
                                                                                 conviction of any
                                                                                 representative of
                                                                                 manufacturer or
                                                                                 distributor after
                                                                                 the second
                                                                                 conviction in any
                                                                                 10-yr period.
333(b)(3).........................  .....................  FDA                  Penalty for failure          2016      197,869      201,106      205,211
                                                                                 to make a report
                                                                                 required by 21
                                                                                 U.S.C. 353(d)(3)(E)
                                                                                 relating to drug
                                                                                 samples.
333(f)(1)(A)......................  .....................  FDA                  Penalty for any              2016       26,723       27,160       27,714
                                                                                 person who violates
                                                                                 a requirement
                                                                                 related to devices
                                                                                 for each such
                                                                                 violation.
                                                                                Penalty for                  2016    1,781,560    1,810,706    1,847,663
                                                                                 aggregate of all
                                                                                 violations related
                                                                                 to devices in a
                                                                                 single proceeding.
333(f)(2)(A)......................  .....................  FDA                  Penalty for any              2016       75,123       76,352       77,910
                                                                                 individual who
                                                                                 introduces or
                                                                                 delivers for
                                                                                 introduction into
                                                                                 interstate commerce
                                                                                 food that is
                                                                                 adulterated per 21
                                                                                 U.S.C. 342(a)(2)(B)
                                                                                 or any individual
                                                                                 who does not comply
                                                                                 with a recall order
                                                                                 under 21 U.S.C.
                                                                                 350l.
                                                                                Penalty in the case          2016      375,613      381,758      389,550
                                                                                 of any other person
                                                                                 other than an
                                                                                 individual) for
                                                                                 such introduction
                                                                                 or delivery of
                                                                                 adulterated food.
                                                                                Penalty for                  2016      751,225      763,515      779,098
                                                                                 aggregate of all
                                                                                 such violations
                                                                                 related to
                                                                                 adulterated food
                                                                                 adjudicated in a
                                                                                 single proceeding.
333(f)(3)(A)......................  .....................  FDA                  Penalty for all              2016       11,383       11,569       11,805
                                                                                 violations
                                                                                 adjudicated in a
                                                                                 single proceeding
                                                                                 for any person who
                                                                                 violates 21 U.S.C.
                                                                                 331(jj)(1) by
                                                                                 failing to submit
                                                                                 the certification
                                                                                 required by 42
                                                                                 U.S.C. 282(j)(5)(B)
                                                                                 or knowingly
                                                                                 submitting a false
                                                                                 certification; by
                                                                                 failing to submit
                                                                                 clinical trial
                                                                                 information under
                                                                                 42 U.S.C 282(j); or
                                                                                 by submitting
                                                                                 clinical trial
                                                                                 information under
                                                                                 42 U.S.C. 282(j)
                                                                                 that is false or
                                                                                 misleading in any
                                                                                 particular under 42
                                                                                 U.S.C. 282(j)(5)(D).
333(f)(3)(B)......................  .....................  FDA                  Penalty for each day         2016       11,383       11,569       11,805
                                                                                 any above violation
                                                                                 is not corrected
                                                                                 after a 30-day
                                                                                 period following
                                                                                 notification until
                                                                                 the violation is
                                                                                 corrected.
333(f)(4)(A)(i)...................  .....................  FDA                  Penalty for any              2016      284,583      289,239      295,142
                                                                                 responsible person
                                                                                 that violates a
                                                                                 requirement of 21
                                                                                 U.S.C. 355(o) (post-
                                                                                 marketing studies,
                                                                                 clinical trials,
                                                                                 labeling), 21
                                                                                 U.S.C. 355(p) (risk
                                                                                 evaluation and
                                                                                 mitigation (REMS)),
                                                                                 or 21 U.S.C. 355-1
                                                                                 (REMS).

[[Page 51371]]

 
                                                                                Penalty for                  2016    1,138,330    1,156,953    1,180,566
                                                                                 aggregate of all
                                                                                 such above
                                                                                 violations in a
                                                                                 single proceeding.
333(f)(4)(A)(ii)..................                         FDA                  Penalty for REMS             2016      284,583      289,239      295,142
                                                                                 violation that
                                                                                 continues after
                                                                                 written notice to
                                                                                 the responsible
                                                                                 person for the
                                                                                 first 30-day period
                                                                                 (or any portion
                                                                                 thereof) the
                                                                                 responsible person
                                                                                 continues to be in
                                                                                 violation.
                                                                                Penalty for REMS             2016    1,138,330    1,156,953    1,180,566
                                                                                 violation that
                                                                                 continues after
                                                                                 written notice to
                                                                                 responsible person
                                                                                 doubles for every
                                                                                 30-day period
                                                                                 thereafter the
                                                                                 violation
                                                                                 continues, but may
                                                                                 not exceed penalty
                                                                                 amount for any 30-
                                                                                 day period.
                                                                                Penalty for                  2016   11,383,300   11,569,531   11,805,665
                                                                                 aggregate of all
                                                                                 such above
                                                                                 violations
                                                                                 adjudicated in a
                                                                                 single proceeding.
333(f)(9)(A)......................  .....................  FDA                  Penalty for any              2016       16,503       16,773       17,115
                                                                                 person who violates
                                                                                 a requirement which
                                                                                 relates to tobacco
                                                                                 products for each
                                                                                 such violation.
                                                                                Penalty for                  2016    1,100,200    1,118,199    1,141,021
                                                                                 aggregate of all
                                                                                 such violations of
                                                                                 tobacco product
                                                                                 requirement
                                                                                 adjudicated in a
                                                                                 single proceeding.
333(f)(9)(B)(i)(I)................                         FDA                  Penalty per                  2016      275,050      279,550      285,256
                                                                                 violation related
                                                                                 to violations of
                                                                                 tobacco
                                                                                 requirements.
                                                                                Penalty for                  2016    1,100,200    1,118,199    1,141,021
                                                                                 aggregate of all
                                                                                 such violations of
                                                                                 tobacco product
                                                                                 requirements
                                                                                 adjudicated in a
                                                                                 single proceeding.
333(f)(9)(B)(i)(II)...............  .....................  FDA                  Penalty in the case          2016      275,050      279,550      285,256
                                                                                 of a violation of
                                                                                 tobacco product
                                                                                 requirements that
                                                                                 continues after
                                                                                 written notice to
                                                                                 such person, for
                                                                                 the first 30-day
                                                                                 period (or any
                                                                                 portion thereof)
                                                                                 the person
                                                                                 continues to be in
                                                                                 violation.
                                                                                Penalty for                  2016    1,100,200    1,118,199    1,141,021
                                                                                 violation of
                                                                                 tobacco product
                                                                                 requirements that
                                                                                 continues after
                                                                                 written notice to
                                                                                 such person shall
                                                                                 double for every 30-
                                                                                 day period
                                                                                 thereafter the
                                                                                 violation
                                                                                 continues, but may
                                                                                 not exceed penalty
                                                                                 amount for any 30-
                                                                                 day period.
                                                                                Penalty for                  2016   11,002,000   11,181,993   11,410,218
                                                                                 aggregate of all
                                                                                 such violations
                                                                                 related to tobacco
                                                                                 product
                                                                                 requirements
                                                                                 adjudicated in a
                                                                                 single proceeding.
333(f)(9)(B)(ii)(I)...............  .....................  FDA                  Penalty for any              2016      275,050      279,550      285,256
                                                                                 person who either
                                                                                 does not conduct
                                                                                 post-market
                                                                                 surveillance and
                                                                                 studies to
                                                                                 determine impact of
                                                                                 a modified risk
                                                                                 tobacco product for
                                                                                 which the HHS
                                                                                 Secretary has
                                                                                 provided them an
                                                                                 order to sell, or
                                                                                 who does not submit
                                                                                 a protocol to the
                                                                                 HHS Secretary after
                                                                                 being notified of a
                                                                                 requirement to
                                                                                 conduct post-market
                                                                                 surveillance of
                                                                                 such tobacco
                                                                                 products.
                                                                                Penalty for                  2016    1,100,200    1,118,199    1,141,021
                                                                                 aggregate of for
                                                                                 all such above
                                                                                 violations
                                                                                 adjudicated in a
                                                                                 single proceeding.
333(f)(9)(B)(ii)(II)..............  .....................  FDA                  Penalty for                  2016      275,050      279,550      285,256
                                                                                 violation of
                                                                                 modified risk
                                                                                 tobacco product
                                                                                 post-market
                                                                                 surveillance that
                                                                                 continues after
                                                                                 written notice to
                                                                                 such person for the
                                                                                 first 30-day period
                                                                                 (or any portion
                                                                                 thereof) that the
                                                                                 person continues to
                                                                                 be in violation.

[[Page 51372]]

 
                                                                                Penalty for post-            2016    1,100,200    1,118,199    1,141,021
                                                                                 notice violation of
                                                                                 modified risk
                                                                                 tobacco product
                                                                                 post-market
                                                                                 surveillance shall
                                                                                 double for every 30-
                                                                                 day period
                                                                                 thereafter that the
                                                                                 tobacco product
                                                                                 requirement
                                                                                 violation continues
                                                                                 for any 30-day
                                                                                 period, but may not
                                                                                 exceed penalty
                                                                                 amount for any 30-
                                                                                 day period.
                                                                                Penalty for                  2016   11,002,000   11,181,993   11,410,218
                                                                                 aggregate above
                                                                                 tobacco product
                                                                                 requirement
                                                                                 violations
                                                                                 adjudicated in a
                                                                                 single proceeding.
333(g)(1).........................  .....................  FDA                  Penalty for any              2016      284,583      289,239      295,142
                                                                                 person who
                                                                                 disseminates or
                                                                                 causes another
                                                                                 party to
                                                                                 disseminate a
                                                                                 direct-to-consumer
                                                                                 advertisement that
                                                                                 is false or
                                                                                 misleading for the
                                                                                 first such
                                                                                 violation in any 3-
                                                                                 year period.
                                                                                Penalty for each             2016      569,165      578,477      590,284
                                                                                 subsequent above
                                                                                 violation in any 3-
                                                                                 year period.
333 note..........................  .....................  FDA                  Penalty to be                2016          275          279          285
                                                                                 applied for
                                                                                 violations of
                                                                                 restrictions on the
                                                                                 sale or
                                                                                 distribution of
                                                                                 tobacco products
                                                                                 promulgated under
                                                                                 21 U.S.C. 387f(d)
                                                                                 (e.g., violations
                                                                                 of regulations in
                                                                                 21 CFR Part 1140)
                                                                                 with respect to a
                                                                                 retailer with an
                                                                                 approved training
                                                                                 program in the case
                                                                                 of a second
                                                                                 regulation
                                                                                 violation within a
                                                                                 12-month period.
                                                                                Penalty in the case          2016          550          559          570
                                                                                 of a third tobacco
                                                                                 product regulation
                                                                                 violation within a
                                                                                 24-month period.
                                                                                Penalty in the case          2016        2,200        2,236        2,282
                                                                                 of a fourth tobacco
                                                                                 product regulation
                                                                                 violation within a
                                                                                 24-month period.
                                                                                Penalty in the case          2016        5,501        5,591        5,705
                                                                                 of a fifth tobacco
                                                                                 product regulation
                                                                                 violation within a
                                                                                 36-month period.
                                                                                Penalty in the case          2016       11,002       11,182       11,410
                                                                                 of a sixth or
                                                                                 subsequent tobacco
                                                                                 product regulation
                                                                                 violation within a
                                                                                 48-month period as
                                                                                 determined on a
                                                                                 case-by-case basis.
                                                                                Penalty to be                2016          275          279          285
                                                                                 applied for
                                                                                 violations of
                                                                                 restrictions on the
                                                                                 sale or
                                                                                 distribution of
                                                                                 tobacco products
                                                                                 promulgated under
                                                                                 21 U.S.C. 387f(d)
                                                                                 (e.g., violations
                                                                                 of regulations in
                                                                                 21 CFR Part 1140)
                                                                                 with respect to a
                                                                                 retailer that does
                                                                                 not have an
                                                                                 approved training
                                                                                 program in the case
                                                                                 of the first
                                                                                 regulation
                                                                                 violation.
                                                                                Penalty in the case          2016          550          559          570
                                                                                 of a second tobacco
                                                                                 product regulation
                                                                                 violation within a
                                                                                 12-month period.
                                                                                Penalty in the case          2016        1,100        1,118        1,141
                                                                                 of a third tobacco
                                                                                 product regulation
                                                                                 violation within a
                                                                                 24-month period.
                                                                                Penalty in the case          2016        2,200        2,236        2,282
                                                                                 of a fourth tobacco
                                                                                 product regulation
                                                                                 violation within a
                                                                                 24-month period.
                                                                                Penalty in the case          2016        5,501        5,591        5,705
                                                                                 of a fifth tobacco
                                                                                 product regulation
                                                                                 violation within a
                                                                                 36-month period.
                                                                                Penalty in the case          2016       11,002       11,182       11,410
                                                                                 of a sixth or
                                                                                 subsequent tobacco
                                                                                 product regulation
                                                                                 violation within a
                                                                                 48-month period as
                                                                                 determined on a
                                                                                 case-by-case basis.

[[Page 51373]]

 
335b(a)...........................  .....................  FDA                  Penalty for each             2016      419,320      426,180      434,878
                                                                                 violation for any
                                                                                 individual who made
                                                                                 a false statement
                                                                                 or
                                                                                 misrepresentation
                                                                                 of a material fact,
                                                                                 bribed, destroyed,
                                                                                 altered, removed,
                                                                                 or secreted, or
                                                                                 procured the
                                                                                 destruction,
                                                                                 alteration,
                                                                                 removal, or
                                                                                 secretion of, any
                                                                                 material document,
                                                                                 failed to disclose
                                                                                 a material fact,
                                                                                 obstructed an
                                                                                 investigation,
                                                                                 employed a
                                                                                 consultant who was
                                                                                 debarred, debarred
                                                                                 individual provided
                                                                                 consultant services.
                                                                                Penalty in the case          2016    1,677,280    1,704,720    1,739,513
                                                                                 of any other person
                                                                                 (other than an
                                                                                 individual) per
                                                                                 above violation.
360pp(b)(1).......................  .....................  FDA                  Penalty for any              2016        2,750        2,795        2,852
                                                                                 person who violates
                                                                                 any such
                                                                                 requirements for
                                                                                 electronic
                                                                                 products, with each
                                                                                 unlawful act or
                                                                                 omission
                                                                                 constituting a
                                                                                 separate violation.
                                                                                Penalty imposed for          2016      937,500      952,838      972,285
                                                                                 any related series
                                                                                 of violations of
                                                                                 requirements
                                                                                 relating to
                                                                                 electronic products.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                        42 U.S.C.
--------------------------------------------------------------------------------------------------------------------------------------------------------
262(d)............................  .....................  FDA                  Penalty per day for          2016      215,628      219,156      223,629
                                                                                 violation of order
                                                                                 of recall of
                                                                                 biological product
                                                                                 presenting imminent
                                                                                 or substantial
                                                                                 hazard.
263b(h)(3)........................  .....................  FDA                  Penalty for failure          2016       16,773       17,047       17,395
                                                                                 to obtain a
                                                                                 mammography
                                                                                 certificate as
                                                                                 required.
300aa-28(b)(1)....................  .....................  FDA                  Penalty per                  2016      215,628      219,156      223,629
                                                                                 occurrence for any
                                                                                 vaccine
                                                                                 manufacturer that
                                                                                 intentionally
                                                                                 destroys, alters,
                                                                                 falsifies, or
                                                                                 conceals any record
                                                                                 or report required.
256b(d)(1)(B)(vi).................  .....................  HRSA                 Penalty for each             2016        5,437        5,526        5,639
                                                                                 instance of
                                                                                 overcharging a 340B
                                                                                 covered entity.
299c-3(d).........................  .....................  AHRQ                 Penalty for an               2016       14,140       14,371       14,664
                                                                                 establishment or
                                                                                 person supplying
                                                                                 information
                                                                                 obtained in the
                                                                                 course of
                                                                                 activities for any
                                                                                 purpose other than
                                                                                 the purpose for
                                                                                 which it was
                                                                                 supplied.
653(l)(2).........................  45 CFR 303.21(f).....  ACF                  Penalty for Misuse           2016        1,450        1,474        1,504
                                                                                 of Information in
                                                                                 the National
                                                                                 Directory of New
                                                                                 Hires.
262a(i)(1)........................  42 CFR 1003.910......  OIG                  Penalty for each             2016      327,962      333,327      340,130
                                                                                 individual who
                                                                                 violates safety and
                                                                                 security procedures
                                                                                 related to handling
                                                                                 dangerous
                                                                                 biological agents
                                                                                 and toxins.
                                                                                Penalty for any              2016      655,925      666,656      680,262
                                                                                 other person who
                                                                                 violates safety and
                                                                                 security procedures
                                                                                 related to handling
                                                                                 dangerous
                                                                                 biological agents
                                                                                 and toxins.
300jj-51..........................  .....................  OIG                  Penalty per                  2016    1,000,000    1,016,360    1,037,104
                                                                                 violation for
                                                                                 committing
                                                                                 information
                                                                                 blocking.
1320a-7a(a) \5\...................  42 CFR 1003.210(a)(1)  OIG                  Penalty for                  2018       15,024       15,270       20,000
                                                                                 knowingly
                                                                                 presenting or
                                                                                 causing to be
                                                                                 presented to an
                                                                                 officer, employee,
                                                                                 or agent of the
                                                                                 United States a
                                                                                 false claim.
                                                                                Penalty for                  2018       15,024       15,270       20,000
                                                                                 knowingly
                                                                                 presenting or
                                                                                 causing to be
                                                                                 presented a request
                                                                                 for payment which
                                                                                 violates the terms
                                                                                 of an assignment,
                                                                                 agreement, or PPS
                                                                                 agreement.
                                    42 CFR 1003.210(a)(2)  ...................  Penalty for                  2018       22,537       22,906       30,000
                                                                                 knowingly giving or
                                                                                 causing to be
                                                                                 presented to a
                                                                                 participating
                                                                                 provider or
                                                                                 supplier false or
                                                                                 misleading
                                                                                 information that
                                                                                 could reasonably be
                                                                                 expected to
                                                                                 influence a
                                                                                 discharge decision.

[[Page 51374]]

 
                                    42 CFR 1003.210(a)(3)  ...................  Penalty for an               2018       15,024       15,270       20,000
                                                                                 excluded party
                                                                                 retaining ownership
                                                                                 or control interest
                                                                                 in a participating
                                                                                 entity.
                                    42 CFR 1003.1010.....  ...................  Penalty for                  2018       15,024       15,270       20,000
                                                                                 remuneration
                                                                                 offered to induce
                                                                                 program
                                                                                 beneficiaries to
                                                                                 use particular
                                                                                 providers,
                                                                                 practitioners, or
                                                                                 suppliers.
                                    42 CFR 1003.210(a)(4)  ...................  Penalty for                  2018       14,718       14,959       20,000
                                                                                 employing or
                                                                                 contracting with an
                                                                                 excluded individual.
                                    42 CFR 1003.310(a)(3)  ...................  Penalty for knowing          2018       73,588       74,792      100,000
                                                                                 and willful
                                                                                 solicitation,
                                                                                 receipt, offer, or
                                                                                 payment of
                                                                                 remuneration for
                                                                                 referring an
                                                                                 individual for a
                                                                                 service or for
                                                                                 purchasing,
                                                                                 leasing, or
                                                                                 ordering an item to
                                                                                 be paid for by a
                                                                                 Federal health care
                                                                                 program.
                                    42 CFR 1003.210(a)(1)  ...................  Penalty for ordering         2018       10,874       11,052       20,000
                                                                                 or prescribing
                                                                                 medical or other
                                                                                 item or service
                                                                                 during a period in
                                                                                 which the person
                                                                                 was excluded.
                                    42 CFR 1003.210(a)(6)  ...................  Penalty for                  2018       54,372       55,262      100,000
                                                                                 knowingly making or
                                                                                 causing to be made
                                                                                 a false statement,
                                                                                 omission or
                                                                                 misrepresentation
                                                                                 of a material fact
                                                                                 in any application,
                                                                                 bid, or contract to
                                                                                 participate or
                                                                                 enroll as a
                                                                                 provider or
                                                                                 supplier.
                                    42 CFR 1003.210(a)(8)  ...................  Penalty for knowing          2018       10,874       11,052       20,000
                                                                                 of an overpayment
                                                                                 and failing to
                                                                                 report and return.
                                    42 CFR 1003.210(a)(7)  ...................  Penalty for making           2018       54,372       55,262      100,000
                                                                                 or using a false
                                                                                 record or statement
                                                                                 that is material to
                                                                                 a false or
                                                                                 fraudulent claim.
                                    42 CFR 1003.210(a)(9)  ...................  Penalty for failure          2018       16,312       16,579       30,000
                                                                                 to grant timely
                                                                                 access to HHS OIG
                                                                                 for audits,
                                                                                 investigations,
                                                                                 evaluations, and
                                                                                 other statutory
                                                                                 functions of HHS
                                                                                 OIG.
1320a-7a(b) \5\...................  .....................  OIG                  Penalty for payments         2018        4,313        4,384        5,000
                                                                                 by a hospital or
                                                                                 critical access
                                                                                 hospital to induce
                                                                                 a physician to
                                                                                 reduce or limit
                                                                                 services to
                                                                                 individuals under
                                                                                 direct care of
                                                                                 physician or who
                                                                                 are entitled to
                                                                                 certain medical
                                                                                 assistance benefits.
                                    .....................  ...................  Penalty for                  2018        4,313        4,384        5,000
                                                                                 physicians who
                                                                                 knowingly receive
                                                                                 payments from a
                                                                                 hospital or
                                                                                 critical access
                                                                                 hospital to induce
                                                                                 such physician to
                                                                                 reduce or limit
                                                                                 services to
                                                                                 individuals under
                                                                                 direct care of
                                                                                 physician or who
                                                                                 are entitled to
                                                                                 certain medical
                                                                                 assistance benefits.
                                    42 CFR                 ...................  Penalty for a                2018        7,512        7,635       10,000
                                     1003.210(a)(10).                            physician who
                                                                                 executes a document
                                                                                 that falsely
                                                                                 certifies home
                                                                                 health needs for
                                                                                 Medicare
                                                                                 beneficiaries.
1320a-7e(b)(6)(A).................  42 CFR 1003.810......  OIG                  Penalty for failure          2016       36,794       37,396       38,159
                                                                                 to report any final
                                                                                 adverse action
                                                                                 taken against a
                                                                                 health care
                                                                                 provider, supplier,
                                                                                 or practitioner.
1320b-10(b)(1)....................  42 CFR 1003.610(a)...  OIG                  Penalty for the              2016        9,893       10,055       10,260
                                                                                 misuse of words,
                                                                                 symbols, or emblems
                                                                                 in communications
                                                                                 in a manner in
                                                                                 which a person
                                                                                 could falsely
                                                                                 construe that such
                                                                                 item is approved,
                                                                                 endorsed, or
                                                                                 authorized by HHS.
1320b-10(b)(2)....................  42 CFR 1003.610(a)...  OIG                  Penalty for the              2016       49,467       50,276       51,302
                                                                                 misuse of words,
                                                                                 symbols, or emblems
                                                                                 in a broadcast or
                                                                                 telecast in a
                                                                                 manner in which a
                                                                                 person could
                                                                                 falsely construe
                                                                                 that such item is
                                                                                 approved, endorsed,
                                                                                 or authorized by
                                                                                 HHS.

[[Page 51375]]

 
1395i-3(b)(3)(B)(ii)(1)...........  42 CFR                 OIG                  Penalty for                  2016        2,063        2,097        2,140
                                     1003.210(a)(11).                            certification of a
                                                                                 false statement in
                                                                                 assessment of
                                                                                 functional capacity
                                                                                 of a Skilled
                                                                                 Nursing Facility
                                                                                 resident assessment.
1395i-3(b)(3)(B)(ii)(2)...........  42 CFR                 OIG                  Penalty for causing          2016       10,314       10,483       10,697
                                     1003.210(a)(11).                            another to certify
                                                                                 or make a false
                                                                                 statement in
                                                                                 assessment of
                                                                                 functional capacity
                                                                                 of a Skilled
                                                                                 Nursing Facility
                                                                                 resident assessment.
1395i-3(g)(2)(A)..................  42 CFR 1003.1310.....  OIG                  Penalty for any              2016        4,126        4,194        4,280
                                                                                 individual who
                                                                                 notifies or causes
                                                                                 to be notified a
                                                                                 Skilled Nursing
                                                                                 Facility of the
                                                                                 time or date on
                                                                                 which a survey is
                                                                                 to be conducted.
1395w-27(g)(2)(A).................  42 CFR 1003.410......  OIG                  Penalty for a                2016       37,561       38,175       38,954
                                                                                 Medicare Advantage
                                                                                 organization that
                                                                                 substantially fails
                                                                                 to provide
                                                                                 medically
                                                                                 necessary, required
                                                                                 items and services.
                                                           ...................  Penalty for a                2016       36,794       37,396       38,159
                                                                                 Medicare Advantage
                                                                                 organization that
                                                                                 charges excessive
                                                                                 premiums.
                                                                                Penalty for a                2016       36,794       37,396       38,159
                                                                                 Medicare Advantage
                                                                                 organization that
                                                                                 improperly expels
                                                                                 or refuses to
                                                                                 reenroll a
                                                                                 beneficiary.
                                                                                Penalty for a                2016      147,177      149,585      152,638
                                                                                 Medicare Advantage
                                                                                 organization that
                                                                                 engages in practice
                                                                                 that would
                                                                                 reasonably be
                                                                                 expected to have
                                                                                 the effect of
                                                                                 denying or
                                                                                 discouraging
                                                                                 enrollment.
                                                                                Penalty per                  2016       22,077       22,438       22,896
                                                                                 individual who does
                                                                                 not enroll as a
                                                                                 result of a
                                                                                 Medicare Advantage
                                                                                 organization's
                                                                                 practice that would
                                                                                 reasonably be
                                                                                 expected to have
                                                                                 the effect of
                                                                                 denying or
                                                                                 discouraging
                                                                                 enrollment.
                                                                                Penalty for a                2016      147,177      149,585      152,638
                                                                                 Medicare Advantage
                                                                                 organization
                                                                                 misrepresenting or
                                                                                 falsifying
                                                                                 information to
                                                                                 Secretary.
                                                                                Penalty for a                2016       36,794       37,396       38,159
                                                                                 Medicare Advantage
                                                                                 organization
                                                                                 misrepresenting or
                                                                                 falsifying
                                                                                 information to
                                                                                 individual or other
                                                                                 entity.
                                                                                Penalty for Medicare         2016       36,794       37,396       38,159
                                                                                 Advantage
                                                                                 organization
                                                                                 interfering with
                                                                                 provider's advice
                                                                                 to enrollee and non-
                                                                                 MCO affiliated
                                                                                 providers that
                                                                                 balance bill
                                                                                 enrollees.
                                                                                Penalty for a                2016       36,794       37,396       38,159
                                                                                 Medicare Advantage
                                                                                 organization that
                                                                                 employs or
                                                                                 contracts with
                                                                                 excluded individual
                                                                                 or entity.
                                                                                Penalty for a                2016       36,794       37,396       38,159
                                                                                 Medicare Advantage
                                                                                 organization
                                                                                 enrolling an
                                                                                 individual in
                                                                                 without prior
                                                                                 written consent.
                                                                                Penalty for a                2016       36,794       37,396       38,159
                                                                                 Medicare Advantage
                                                                                 organization
                                                                                 transferring an
                                                                                 enrollee to another
                                                                                 plan without
                                                                                 consent or solely
                                                                                 for the purpose of
                                                                                 earning a
                                                                                 commission.
                                                                                Penalty for a                2016       36,794       37,396       38,159
                                                                                 Medicare Advantage
                                                                                 organization
                                                                                 failing to comply
                                                                                 with marketing
                                                                                 restrictions or
                                                                                 applicable
                                                                                 implementing
                                                                                 regulations or
                                                                                 guidance.
                                                                                Penalty for a                2016       36,794       37,396       38,159
                                                                                 Medicare Advantage
                                                                                 organization
                                                                                 employing or
                                                                                 contracting with an
                                                                                 individual or
                                                                                 entity who violates
                                                                                 1395w-27(g)(1)(A)-(
                                                                                 J).

[[Page 51376]]

 
1395w-141(i)(3)...................                         OIG                  Penalty for a                2016       12,856       13,066       13,333
                                                                                 prescription drug
                                                                                 card sponsor that
                                                                                 falsifies or
                                                                                 misrepresents
                                                                                 marketing
                                                                                 materials,
                                                                                 overcharges program
                                                                                 enrollees, or
                                                                                 misuse transitional
                                                                                 assistance funds.
1395cc(g).........................                         OIG                  Penalty for improper         2016        5,000        5,082        5,186
                                                                                 billing by
                                                                                 Hospitals, Critical
                                                                                 Access Hospitals,
                                                                                 or Skilled Nursing
                                                                                 Facilities.
1395dd(d)(1)......................  42 CFR 1003.510......  OIG                  Penalty for a                2016      103,139      104,826      106,965
                                                                                 hospital or
                                                                                 responsible
                                                                                 physician dumping
                                                                                 patients needing
                                                                                 emergency medical
                                                                                 care, if the
                                                                                 hospital has 100
                                                                                 beds or more.
                                                                                Penalty for a                2016       51,570       52,414       53,484
                                                                                 hospital or
                                                                                 responsible
                                                                                 physician dumping
                                                                                 patients needing
                                                                                 emergency medical
                                                                                 care, if the
                                                                                 hospital has less
                                                                                 than 100 beds.
1395mm(i)(6)(B)(i)................  42 CFR 1003.410......  OIG                  Penalty for a HMO or         2016       51,570       52,414       53,484
                                                                                 competitive plan is
                                                                                 such plan
                                                                                 substantially fails
                                                                                 to provide
                                                                                 medically
                                                                                 necessary, required
                                                                                 items or services.
                                                                                Penalty for HMOs/            2016       51,570       52,414       53,484
                                                                                 competitive medical
                                                                                 plans that charge
                                                                                 premiums in excess
                                                                                 of permitted
                                                                                 amounts.
                                                                                Penalty for a HMO or         2016       51,570       52,414       53,484
                                                                                 competitive medical
                                                                                 plan that expels or
                                                                                 refuses to reenroll
                                                                                 an individual per
                                                                                 prescribed
                                                                                 conditions.
                                                                                Penalty for a HMO or         2016      206,278      209,653      213,932
                                                                                 competitive medical
                                                                                 plan that
                                                                                 implements
                                                                                 practices to
                                                                                 discourage
                                                                                 enrollment of
                                                                                 individuals needing
                                                                                 services in future.
                                                                                Penalty per                  2016       29,680       30,166       30,782
                                                                                 individual not
                                                                                 enrolled in a plan
                                                                                 as a result of a
                                                                                 HMO or competitive
                                                                                 medical plan that
                                                                                 implements
                                                                                 practices to
                                                                                 discourage
                                                                                 enrollment of
                                                                                 individuals needing
                                                                                 services in the
                                                                                 future.
                                                                                Penalty for a HMO or         2016      206,278      209,653      213,932
                                                                                 competitive medical
                                                                                 plan that
                                                                                 misrepresents or
                                                                                 falsifies
                                                                                 information to the
                                                                                 Secretary.
                                                                                Penalty for a HMO or         2016       51,570       52,414       53,484
                                                                                 competitive medical
                                                                                 plan that
                                                                                 misrepresents or
                                                                                 falsifies
                                                                                 information to an
                                                                                 individual or any
                                                                                 other entity.
                                                                                Penalty for failure          2016       51,570       52,414       53,484
                                                                                 by HMO or
                                                                                 competitive medical
                                                                                 plan to assure
                                                                                 prompt payment of
                                                                                 Medicare risk
                                                                                 sharing contracts
                                                                                 or incentive plan
                                                                                 provisions.
                                                                                Penalty for HMO that         2016       47,340       48,114       49,096
                                                                                 employs or
                                                                                 contracts with
                                                                                 excluded individual
                                                                                 or entity.
1395nn(g)(3)......................  42 CFR 1003.310......  OIG                  Penalty for                  2016       23,863       24,253       24,748
                                                                                 submitting or
                                                                                 causing to be
                                                                                 submitted claims in
                                                                                 violation of the
                                                                                 Stark Law's
                                                                                 restrictions on
                                                                                 physician self-
                                                                                 referrals.
1395nn(g)(4)......................  42 CFR 1003.310......  OIG                  Penalty for                  2016      159,089      161,692      164,992
                                                                                 circumventing Stark
                                                                                 Law's restrictions
                                                                                 on physician self-
                                                                                 referrals.
1395ss(d)(1)......................  42 CFR 1003.1110.....  OIG                  Penalty for a                2016        9,893       10,055       10,260
                                                                                 material
                                                                                 misrepresentation
                                                                                 regarding Medigap
                                                                                 compliance policies.
1395ss(d)(2)......................  42 CFR 1003.1110.....  OIG                  Penalty for selling          2016        9,893       10,055       10,260
                                                                                 Medigap policy
                                                                                 under false
                                                                                 pretense.
1395ss(d)(3)(A)(ii)...............  42 CFR 1003.1110.....  OIG                  Penalty for an               2016       44,539       45,268       46,192
                                                                                 issuer that sells
                                                                                 health insurance
                                                                                 policy that
                                                                                 duplicates benefits.
                                                                                Penalty for someone          2016       26,723       27,160       27,714
                                                                                 other than issuer
                                                                                 that sells health
                                                                                 insurance that
                                                                                 duplicates benefits.

[[Page 51377]]

 
1395ss(d)(4)(A)...................  42 CFR 1003.1110.....  OIG                  Penalty for using            2016        9,893       10,055       10,260
                                                                                 mail to sell a non-
                                                                                 approved Medigap
                                                                                 insurance policy.
1396b(m)(5)(B)(i).................  42 CFR 1003.410......  OIG                  Penalty for a                2016       49,467       50,276       51,302
                                                                                 Medicaid MCO that
                                                                                 substantially fails
                                                                                 to provide
                                                                                 medically
                                                                                 necessary, required
                                                                                 items or services.
                                                                                Penalty for a                2016       49,467       50,276       51,302
                                                                                 Medicaid MCO that
                                                                                 charges excessive
                                                                                 premiums.
                                                                                Penalty for a                2016      197,869      201,106      205,211
                                                                                 Medicaid MCO that
                                                                                 improperly expels
                                                                                 or refuses to
                                                                                 reenroll a
                                                                                 beneficiary.
                                                                                Penalty per                  2016       29,680       30,166       30,782
                                                                                 individual who does
                                                                                 not enroll as a
                                                                                 result of a
                                                                                 Medicaid MCO's
                                                                                 practice that would
                                                                                 reasonably be
                                                                                 expected to have
                                                                                 the effect of
                                                                                 denying or
                                                                                 discouraging
                                                                                 enrollment.
                                                                                Penalty for a                2016      197,869      201,106      205,211
                                                                                 Medicaid MCO
                                                                                 misrepresenting or
                                                                                 falsifying
                                                                                 information to the
                                                                                 Secretary.
                                                                                Penalty for a                2016       49,467       50,276       51,302
                                                                                 Medicaid MCO
                                                                                 misrepresenting or
                                                                                 falsifying
                                                                                 information to an
                                                                                 individual or
                                                                                 another entity.
                                                                                Penalty for a                2016       44,539       45,268       46,192
                                                                                 Medicaid MCO that
                                                                                 fails to comply
                                                                                 with contract
                                                                                 requirements with
                                                                                 respect to
                                                                                 physician incentive
                                                                                 plans.
1396r(b)(3)(B)(ii)(I).............  42 CFR                 OIG                  Penalty for                  2016        2,063        2,097        2,140
                                     1003.210(a)(11).                            willfully and
                                                                                 knowingly
                                                                                 certifying a
                                                                                 material and false
                                                                                 statement in a
                                                                                 Skilled Nursing
                                                                                 Facility resident
                                                                                 assessment.
1396r(b)(3)(B)(ii)(II)............  42 CFR                 OIG                  Penalty for                  2016       10,314       10,483       10,697
                                     1003.210(a)(11).                            willfully and
                                                                                 knowingly causing
                                                                                 another individual
                                                                                 to certify a
                                                                                 material and false
                                                                                 statement in a
                                                                                 Skilled Nursing
                                                                                 Facility resident
                                                                                 assessment.
1396r(g)(2)(A)(i).................  42 CFR 1003.1310.....  OIG                  Penalty for                  2016        4,126        4,194        4,280
                                                                                 notifying or
                                                                                 causing to be
                                                                                 notified a Skilled
                                                                                 Nursing Facility of
                                                                                 the time or date on
                                                                                 which a survey is
                                                                                 to be conducted.
1396r-8(b)(3)(B)..................  42 CFR 1003.1210.....  OIG                  Penalty for the              2016      178,156      181,071      184,767
                                                                                 knowing provision
                                                                                 of false
                                                                                 information or
                                                                                 refusing to provide
                                                                                 information about
                                                                                 charges or prices
                                                                                 of a covered
                                                                                 outpatient drug.
1396r-8(b)(3)(C)(i)...............  42 CFR 1003.1210.....  OIG                  Penalty per day for          2016       17,816       18,107       18,477
                                                                                 failure to timely
                                                                                 provide information
                                                                                 by drug
                                                                                 manufacturer with
                                                                                 rebate agreement.
1396r-8(b)(3)(C)(ii)..............  42 CFR 1003.1210.....  OIG                  Penalty for knowing          2016      178,156      181,071      184,767
                                                                                 provision of false
                                                                                 information by drug
                                                                                 manufacturer with
                                                                                 rebate agreement.
1396t(i)(3)(A)....................  42 CFR 1003.1310.....  OIG                  Penalty for                  2016        3,563        3,621        3,695
                                                                                 notifying home and
                                                                                 community-based
                                                                                 providers or
                                                                                 settings of survey.
11131(c)..........................  42 CFR 1003.810......  OIG                  Penalty for failing          2016       21,563       21,916       22,363
                                                                                 to report a medical
                                                                                 malpractice claim
                                                                                 to National
                                                                                 Practitioner Data
                                                                                 Bank.
11137(b)(2).......................  42 CFR 1003.810......  OIG                  Penalty for                  2016       21,563       21,916       22,363
                                                                                 breaching
                                                                                 confidentiality of
                                                                                 information
                                                                                 reported to
                                                                                 National
                                                                                 Practitioner Data
                                                                                 Bank.
299b-22(f)(1).....................  42 CFR 3.404.........  OCR                  Penalty for                  2016       11,940       12,135       12,383
                                                                                 violation of
                                                                                 confidentiality
                                                                                 provision of the
                                                                                 Patient Safety and
                                                                                 Quality Improvement
                                                                                 Act.
1320(d)-5(a)......................  45 CFR                 OCR                  Penalty for each pre-        2016          150          152          155
                                     160.404(b)(1)(i),                           February 18, 2009
                                     (ii).                                       violation of the
                                                                                 HIPAA
                                                                                 administrative
                                                                                 simplification
                                                                                 provisions.
                                                                                Calendar Year Cap...         2016       37,561       38,175       38,954

[[Page 51378]]

 
                                    45 CFR                 OCR                  Penalty for each      ...........  ...........  ...........  ...........
                                     160.404(b)(2)(i)(A),                        February 18, 2009
                                     (B).                                        or later violation
                                                                                 of a HIPAA
                                                                                 administrative
                                                                                 simplification
                                                                                 provision in which
                                                                                 it is established
                                                                                 that the covered
                                                                                 entity or business
                                                                                 associate did not
                                                                                 know and by
                                                                                 exercising
                                                                                 reasonable
                                                                                 diligence, would
                                                                                 not have known that
                                                                                 the covered entity
                                                                                 or business
                                                                                 associate violated
                                                                                 such a provision.
                                                                                Minimum.............         2016          110          112          114
                                                                                Maximum.............         2016       55,010       55,910       57,051
                                                                                Calendar Year Cap...         2016    1,650,300    1,677,299    1,711,533
                                    45 CFR                 OCR                  Penalty for each      ...........  ...........  ...........  ...........
                                     160.404(b)(2)(ii)(A)                        February 18, 2009
                                     , (B).                                      or later violation
                                                                                 of a HIPAA
                                                                                 administrative
                                                                                 simplification
                                                                                 provision in which
                                                                                 it is established
                                                                                 that the violation
                                                                                 was due to
                                                                                 reasonable cause
                                                                                 and not to willful
                                                                                 neglect.
                                                                                Minimum.............         2016        1,100        1,118        1,141
                                                                                Maximum.............         2016       55,010       55,910       57,051
                                                                                Calendar Year Cap...         2016    1,650,300    1,677,299    1,711,533
                                    45 CFR                 OCR                  Penalty for each      ...........  ...........  ...........  ...........
                                     160.404(b)(2)(iii)(A                        February 18, 2009
                                     ), (B).                                     or later violation
                                                                                 of a HIPAA
                                                                                 administrative
                                                                                 simplification
                                                                                 provision in which
                                                                                 it is established
                                                                                 that the violation
                                                                                 was due to willful
                                                                                 neglect and was
                                                                                 corrected during
                                                                                 the 30-day period
                                                                                 beginning on the
                                                                                 first date the
                                                                                 covered entity or
                                                                                 business associate
                                                                                 knew, or, by
                                                                                 exercising
                                                                                 reasonable
                                                                                 diligence, would
                                                                                 have known that the
                                                                                 violation occurred.
                                                                                Minimum.............         2016       11,002       11,182       11,410
                                                                                Maximum.............         2016       55,010       55,910       57,051
                                                                                Calendar Year Cap...         2016    1,650,300    1,677,299    1,711,533
                                    45 CFR                 OCR                  Penalty for each      ...........  ...........  ...........  ...........
                                     160.404(b)(2)(iv)(A)                        February 18, 2009
                                     , (B).                                      or later violation
                                                                                 of a HIPAA
                                                                                 administrative
                                                                                 simplification
                                                                                 provision in which
                                                                                 it is established
                                                                                 that the violation
                                                                                 was due to willful
                                                                                 neglect and was not
                                                                                 corrected during
                                                                                 the 30-day period
                                                                                 beginning on the
                                                                                 first date the
                                                                                 covered entity or
                                                                                 business associate
                                                                                 knew, or by
                                                                                 exercising
                                                                                 reasonable
                                                                                 diligence, would
                                                                                 have known that the
                                                                                 violation occurred.
                                                                                Minimum.............         2016       55,010       55,910       57,051
                                                                                Maximum.............         2016    1,650,300    1,677,299    1,711,533
                                                                                Calendar Year Cap...         2016    1,650,300    1,677,299    1,711,533
263a(h)(2)(B) & 1395w-              42 CFR                 CMS                  Penalty for a         ...........  ...........  ...........  ...........
 2(b)(2)(A)(ii).                     493.1834(d)(2)(i).                          clinical
                                                                                 laboratory's
                                                                                 failure to meet
                                                                                 participation and
                                                                                 certification
                                                                                 requirements and
                                                                                 poses immediate
                                                                                 jeopardy.
                                                                                Minimum.............         2016        6,035        6,134        6,259
                                                                                Maximum.............         2016       19,787       20,111       20,521
                                    42 CFR                 CMS                  Penalty for a         ...........  ...........  ...........            -
                                     493.1834(d)(2)(ii).                         clinical
                                                                                 laboratory's
                                                                                 failure to meet
                                                                                 participation and
                                                                                 certification
                                                                                 requirements and
                                                                                 the failure does
                                                                                 not pose immediate
                                                                                 jeopardy.
                                                                                Minimum.............         2016           99          101          103
                                                                                Maximum.............         2016        5,936        6,033        6,156
300gg-15(f).......................  45 CFR 147.200(e)....  CMS                  Failure to provide           2016        1,087        1,105        1,128
                                                                                 the Summary of
                                                                                 Benefits and
                                                                                 Coverage.
300gg-18..........................  45 CFR 158.606.......  CMS                  Penalty for                  2016          109          111          113
                                                                                 violations of
                                                                                 regulations related
                                                                                 to the medical loss
                                                                                 ratio reporting and
                                                                                 rebating.

[[Page 51379]]

 
1320a-7h(b)(1)....................  42 CFR 402.105(d)(5),  CMS                  Penalty for           ...........  ...........  ...........  ...........
                                     42 CFR 403.912(a) &                         manufacturer or
                                     (c).                                        group purchasing
                                                                                 organization
                                                                                 failing to report
                                                                                 information
                                                                                 required under 42
                                                                                 U.S.C. 1320a-7h(a),
                                                                                 relating to
                                                                                 physician ownership
                                                                                 or investment
                                                                                 interests.
                                                                                Minimum.............         2016        1,087        1,105        1,128
                                                                                Maximum.............         2016       10,874       11,052       11,278
                                                                                Calendar Year Cap...         2016      163,117      165,786      169,170
1320a-7h(b)(2)....................  42 CFR 402.105(h), 42  CMS                  Penalty for           ...........  ...........  ...........  ...........
                                     CFR 403 912(b) & (c).                       manufacturer or
                                                                                 group purchasing
                                                                                 organization
                                                                                 knowingly failing
                                                                                 to report
                                                                                 information
                                                                                 required under 42
                                                                                 U.S.C. 1320a-7h(a)
                                                                                 , relating to
                                                                                 physician ownership
                                                                                 or investment
                                                                                 interests.
                                                                                Minimum.............         2016       10,874       11,052       11,278
                                                                                Maximum.............         2016      108,745      110,524      112,780
                                                                                Calendar Year Cap...         2016    1,087,450    1,105,241    1,127,799
1320a-7j(h)(3)(A).................                         CMS                  Penalty for an               2016      108,745      110,524      112,780
                                                                                 administrator of a
                                                                                 facility that fails
                                                                                 to comply with
                                                                                 notice requirements
                                                                                 for the closure of
                                                                                 a facility.
                                    42 CFR                 CMS                  Minimum penalty for          2016          544          553          564
                                     488.446(a)(1),(2), &                        the first offense
                                     (3).                                        of an administrator
                                                                                 who fails to
                                                                                 provide notice of
                                                                                 facility closure.
                                                                                Minimum penalty for          2016        1,631        1,658        1,692
                                                                                 the second offense
                                                                                 of an administrator
                                                                                 who fails to
                                                                                 provide notice of
                                                                                 facility closure.
                                                                                Minimum penalty for          2016        3,262        3,315        3,383
                                                                                 the third and
                                                                                 subsequent offenses
                                                                                 of an administrator
                                                                                 who fails to
                                                                                 provide notice of
                                                                                 facility closure.
1320a-8(a)(1).....................                         CMS                  Penalty for an               2016        7,954        8,084        8,249
                                                                                 entity knowingly
                                                                                 making a false
                                                                                 statement or
                                                                                 representation of
                                                                                 material fact in
                                                                                 the determination
                                                                                 of the amount of
                                                                                 benefits or
                                                                                 payments related to
                                                                                 old-age, survivors,
                                                                                 and disability
                                                                                 insurance benefits,
                                                                                 special benefits
                                                                                 for certain World
                                                                                 War II veterans, or
                                                                                 supplemental
                                                                                 security income for
                                                                                 the aged, blind,
                                                                                 and disabled.
                                                                                Penalty for                  2016        7,500        7,623        7,779
                                                                                 violation of 42
                                                                                 U.S.C. 1320a-
                                                                                 8(a)(1) if the
                                                                                 violator is a
                                                                                 person who receives
                                                                                 a fee or other
                                                                                 income for services
                                                                                 performed in
                                                                                 connection with
                                                                                 determination of
                                                                                 the benefit amount
                                                                                 or the person is a
                                                                                 physician or other
                                                                                 health care
                                                                                 provider who
                                                                                 submits evidence in
                                                                                 connection with
                                                                                 such a
                                                                                 determination.
1320a-8(a)(3).....................                         CMS                  Penalty for a                2016        6,229        6,331        6,460
                                                                                 representative
                                                                                 payee (under 42
                                                                                 U.S.C. 405(j),
                                                                                 1007, or
                                                                                 1383(a)(2))
                                                                                 converting any part
                                                                                 of a received
                                                                                 payment from the
                                                                                 benefit programs
                                                                                 described in the
                                                                                 previous civil
                                                                                 monetary penalty to
                                                                                 a use other than
                                                                                 for the benefit of
                                                                                 the beneficiary.
1320b-25(c)(1)(A).................                         CMS                  Penalty for failure          2016      217,490      221,048      225,560
                                                                                 of covered
                                                                                 individuals to
                                                                                 report to the
                                                                                 Secretary and 1 or
                                                                                 more law
                                                                                 enforcement
                                                                                 officials any
                                                                                 reasonable
                                                                                 suspicion of a
                                                                                 crime against a
                                                                                 resident, or
                                                                                 individual
                                                                                 receiving care,
                                                                                 from a long-term
                                                                                 care facility.

[[Page 51380]]

 
1320b-25(c)(2)(A).................                         CMS                  Penalty for failure          2016      326,235      331,572      338,339
                                                                                 of covered
                                                                                 individuals to
                                                                                 report to the
                                                                                 Secretary and 1 or
                                                                                 more law
                                                                                 enforcement
                                                                                 officials any
                                                                                 reasonable
                                                                                 suspicion of a
                                                                                 crime against a
                                                                                 resident, or
                                                                                 individual
                                                                                 receiving care,
                                                                                 from a long-term
                                                                                 care facility if
                                                                                 such failure
                                                                                 exacerbates the
                                                                                 harm to the victim
                                                                                 of the crime or
                                                                                 results in the harm
                                                                                 to another
                                                                                 individual.
1320b-25(d)(2)....................                         CMS                  Penalty for a long-          2016      217,490      221,048      225,560
                                                                                 term care facility
                                                                                 that retaliates
                                                                                 against any
                                                                                 employee because of
                                                                                 lawful acts done by
                                                                                 the employee, or
                                                                                 files a complaint
                                                                                 or report with the
                                                                                 State professional
                                                                                 disciplinary agency
                                                                                 against an employee
                                                                                 or nurse for lawful
                                                                                 acts done by the
                                                                                 employee or nurse.
1395b-7(b)(2)(B)..................  42 CFR 402.105(g)....  CMS                  Penalty for any              2016          147          149          152
                                                                                 person who
                                                                                 knowingly and
                                                                                 willfully fails to
                                                                                 furnish a
                                                                                 beneficiary with an
                                                                                 itemized statement
                                                                                 of items or
                                                                                 services within 30
                                                                                 days of the
                                                                                 beneficiary's
                                                                                 request.
1395i-3(h)(2)(B)(ii)(I)...........  42 CFR                 CMS                  Penalty per day for   ...........  ...........  ...........  ...........
                                     488.408(d)(1)(iii).                         a Skilled Nursing
                                                                                 Facility that has a
                                                                                 Category 2
                                                                                 violation of
                                                                                 certification
                                                                                 requirements.
                                                                                Minimum.............         2016          103          105          107
                                                                                Maximum.............         2016        6,188        6,289        6,417
                                    42 CFR                 CMS                  Penalty per instance  ...........  ...........  ...........  ...........
                                     488.408(d)(1)(iv).                          of Category 2
                                                                                 noncompliance by a
                                                                                 Skilled Nursing
                                                                                 Facility.
                                                                                Minimum.............         2016        2,063        2,097        2,140
                                                                                Maximum.............         2016       20,628       20,965       21,393
                                    42 CFR                 CMS                  Penalty per day for   ...........  ...........  ...........  ...........
                                     488.408(e)(1)(iii).                         a Skilled Nursing
                                                                                 Facility that has a
                                                                                 Category 3
                                                                                 violation of
                                                                                 certification
                                                                                 requirements.
                                                                                Minimum.............         2016        6,291        6,394        6,525
                                                                                Maximum.............         2016       20,628       20,965       21,393
                                    42 CFR                 CMS                  Penalty per instance  ...........  ...........  ...........  ...........
                                     488.408(e)(1)(iv).                          of Category 3
                                                                                 noncompliance by a
                                                                                 Skilled Nursing
                                                                                 Facility.
                                                                                Minimum.............         2016        2,063        2,097        2,140
                                                                                Maximum.............         2016       20,628       20,965       21,393
                                    42 CFR 488.408         CMS                  Penalty per day and   ...........  ...........  ...........  ...........
                                     (e)(2)(ii).                                 per instance for a
                                                                                 Skilled Nursing
                                                                                 Facility that has
                                                                                 Category 3
                                                                                 noncompliance with
                                                                                 Immediate Jeopardy.
                                                                                Per Day (Minimum)...         2016        6,291        6,394        6,525
                                                                                Per Day (Maximum)...         2016       20,628       20,965       21,393
                                                                                Per Instance                 2016        2,063        2,097        2,140
                                                                                 (Minimum).
                                                                                Per Instance                 2016       20,628       20,965       21,393
                                                                                 (Maximum).
                                    42 CFR                 CMS                  Penalty per day of a  ...........  ...........  ...........  ...........
                                     488.438(a)(1)(i).                           Skilled Nursing
                                                                                 Facility that fails
                                                                                 to meet
                                                                                 certification
                                                                                 requirements. These
                                                                                 amounts represent
                                                                                 the upper range per
                                                                                 day.
                                                                                Minimum.............         2016        6,291        6,394        6,524
                                                                                Maximum.............         2016       20,628       20,965       21,393
                                    42 CFR                 CMS                  Penalty per day of a  ...........  ...........  ...........  ...........
                                     488.438(a)(1)(ii).                          Skilled Nursing
                                                                                 Facility that fails
                                                                                 to meet
                                                                                 certification
                                                                                 requirements. These
                                                                                 amounts represent
                                                                                 the lower range per
                                                                                 day.
                                                                                Minimum.............         2016          103          105          107
                                                                                Maximum.............         2016        6,188        6,289        6,418
                                    42 CFR 488.438(a)(2).  CMS                  Penalty per instance  ...........  ...........  ...........  ...........
                                                                                 of a Skilled
                                                                                 Nursing Facility
                                                                                 that fails to meet
                                                                                 certification
                                                                                 requirements.
                                                                                Minimum.............         2016        2,063        2,097        2,140
                                                                                Maximum.............         2016       20,628       20,965       21,393

[[Page 51381]]

 
1395l(h)(5)(D) \5\................  42 CFR                 CMS                  Penalty for                  2018       15,024       15,270       30,000
                                     402.105(d)(2)(i).                           knowingly,
                                                                                 willfully, and
                                                                                 repeatedly billing
                                                                                 for a clinical
                                                                                 diagnostic
                                                                                 laboratory test
                                                                                 other than on an
                                                                                 assignment-related
                                                                                 basis. (Penalties
                                                                                 are assessed in the
                                                                                 same manner as 42
                                                                                 U.S.C.
                                                                                 1395u(j)(2)(B),
                                                                                 which is assessed
                                                                                 according to 1320a-
                                                                                 7a(a)).
1395l(i)(6).......................                         CMS                  Penalty for                  2016        3,957        4,022        4,104
                                                                                 knowingly and
                                                                                 willfully
                                                                                 presenting or
                                                                                 causing to be
                                                                                 presented a bill or
                                                                                 request for payment
                                                                                 for an intraocular
                                                                                 lens inserted
                                                                                 during or after
                                                                                 cataract surgery
                                                                                 for which the
                                                                                 Medicare payment
                                                                                 rate includes the
                                                                                 cost of acquiring
                                                                                 the class of lens
                                                                                 involved.
1395l(q)(2)(B)(i).................  42 CFR 402.105(a)....  CMS                  Penalty for                  2016        3,787        3,849        3,928
                                                                                 knowingly and
                                                                                 willfully failing
                                                                                 to provide
                                                                                 information about a
                                                                                 referring physician
                                                                                 when seeking
                                                                                 payment on an
                                                                                 unassigned basis.
1395m(a)(11)(A) \5\...............  42 CFR 402.1(c)(4),    CMS                  Penalty for any              2018       15,024       15,270       30,000
                                     402.105(d)(2)(ii).                          durable medical
                                                                                 equipment supplier
                                                                                 that knowingly and
                                                                                 willfully charges
                                                                                 for a covered
                                                                                 service that is
                                                                                 furnished on a
                                                                                 rental basis after
                                                                                 the rental payments
                                                                                 may no longer be
                                                                                 made. (Penalties
                                                                                 are assessed in the
                                                                                 same manner as 42
                                                                                 U.S.C.
                                                                                 1395u(j)(2)(B),
                                                                                 which is assessed
                                                                                 according to 1320a-
                                                                                 7a(a)).
1395m(a)(18)(B) \5\...............  42 CFR 402.1(c)(5),    CMS                  Penalty for any              2018       15,024       15,270       30,000
                                     402.105(d)(2)(iii).                         nonparticipating
                                                                                 durable medical
                                                                                 equipment supplier
                                                                                 that knowingly and
                                                                                 willfully fails to
                                                                                 make a refund to
                                                                                 Medicare
                                                                                 beneficiaries for a
                                                                                 covered service for
                                                                                 which payment is
                                                                                 precluded due to an
                                                                                 unsolicited
                                                                                 telephone contact
                                                                                 from the supplier.
                                                                                 (Penalties are
                                                                                 assessed in the
                                                                                 same manner as 42
                                                                                 U.S.C.
                                                                                 1395u(j)(2)(B),
                                                                                 which is assessed
                                                                                 according to 1320a-
                                                                                 7a(a)).
1395m(b)(5)(C) \5\................  42 CFR 402.1(c)(6),    CMS                  Penalty for any              2018       15,024       15,270       30,000
                                     402.105(d)(2)(iv).                          nonparticipating
                                                                                 physician or
                                                                                 supplier that
                                                                                 knowingly and
                                                                                 willfully charges a
                                                                                 Medicare
                                                                                 beneficiary more
                                                                                 than the limiting
                                                                                 charge for
                                                                                 radiologist
                                                                                 services.
                                                                                 (Penalties are
                                                                                 assessed in the
                                                                                 same manner as 42
                                                                                 U.S.C.
                                                                                 1395u(j)(2)(B),
                                                                                 which is assessed
                                                                                 according to 1320a-
                                                                                 7a(a)).
1395m(h)(3) \5\...................  42 CFR 402.1(c)(8),    CMS                  Penalty for any              2018       15,024       15,270       30,000
                                     402.105(d)(2)(vi).                          supplier of
                                                                                 prosthetic devices,
                                                                                 orthotics, and
                                                                                 prosthetics that
                                                                                 knowing and
                                                                                 willfully charges
                                                                                 for a covered
                                                                                 prosthetic device,
                                                                                 orthotic, or
                                                                                 prosthetic that is
                                                                                 furnished on a
                                                                                 rental basis after
                                                                                 the rental payment
                                                                                 may no longer be
                                                                                 made. (Penalties
                                                                                 are assessed in the
                                                                                 same manner as 42
                                                                                 U.S.C.
                                                                                 1395m(a)(11)(A),
                                                                                 that is in the same
                                                                                 manner as
                                                                                 1395u(j)(2)(B),
                                                                                 which is assessed
                                                                                 according to 1320a-
                                                                                 7a(a)).

[[Page 51382]]

 
1395m(j)(2)(A)(iii)...............                         CMS                  Penalty for any              2016        1,591        1,617        1,650
                                                                                 supplier of durable
                                                                                 medical equipment
                                                                                 including a
                                                                                 supplier of
                                                                                 prosthetic devices,
                                                                                 prosthetics,
                                                                                 orthotics, or
                                                                                 supplies that
                                                                                 knowingly and
                                                                                 willfully
                                                                                 distributes a
                                                                                 certificate of
                                                                                 medical necessity
                                                                                 in violation of
                                                                                 Section
                                                                                 1834(j)(2)(A)(i) of
                                                                                 the Act or fails to
                                                                                 provide the
                                                                                 information
                                                                                 required under
                                                                                 Section
                                                                                 1834(j)(2)(A)(ii)
                                                                                 of the Act.
1395m(j)(4) \5\...................  42 CFR 402.1(c)(10),   CMS                  Penalty for any              2018       15,024       15,270       30,000
                                     402.105(d)(2)(vii).                         supplier of durable
                                                                                 medical equipment,
                                                                                 including a
                                                                                 supplier of
                                                                                 prosthetic devices,
                                                                                 prosthetics,
                                                                                 orthotics, or
                                                                                 supplies that
                                                                                 knowingly and
                                                                                 willfully fails to
                                                                                 make refunds in a
                                                                                 timely manner to
                                                                                 Medicare
                                                                                 beneficiaries for
                                                                                 series billed other
                                                                                 than on as
                                                                                 assignment-related
                                                                                 basis under certain
                                                                                 conditions.
                                                                                 (Penalties are
                                                                                 assessed in the
                                                                                 same manner as 42
                                                                                 U.S.C. 1395m(j)(4)
                                                                                 and 1395u(j)(2)(B),
                                                                                 which is assessed
                                                                                 according to 1320a-
                                                                                 7a(a)).
1395m(k)(6) \5\...................  42 CFR 402.1(c)(31),   CMS                  Penalty for any              2018       15,024       15,270       30,000
                                     402.105(d)(3).                              person or entity
                                                                                 who knowingly and
                                                                                 willfully bills or
                                                                                 collects for any
                                                                                 outpatient therapy
                                                                                 services or
                                                                                 comprehensive
                                                                                 outpatient
                                                                                 rehabilitation
                                                                                 services on other
                                                                                 than an assignment-
                                                                                 related basis.
                                                                                 (Penalties are
                                                                                 assessed in the
                                                                                 same manner as 42
                                                                                 U.S.C. 1395m(k)(6)
                                                                                 and 1395u(j)(2)(B),
                                                                                 which is assessed
                                                                                 according to 1320a-
                                                                                 7a(a)).
1395m(l)(6) \5\...................  42 CFR 402.1(c)(32),   CMS                  Penalty for any              2018       15,024       15,270       30,000
                                     402.105(d)(4).                              supplier of
                                                                                 ambulance services
                                                                                 who knowingly and
                                                                                 willfully fills or
                                                                                 collects for any
                                                                                 services on other
                                                                                 than an assignment-
                                                                                 related basis.
                                                                                 (Penalties are
                                                                                 assessed in the
                                                                                 same manner as 42
                                                                                 U.S.C.
                                                                                 1395u(b)(18)(B),
                                                                                 which is assessed
                                                                                 according to 1320a-
                                                                                 7a(a)).
1395u(b)(18)(B) \5\...............  42 CFR 402.1(c)(11),   CMS                  Penalty for any              2018       15,024       15,270       30,000
                                     402.105(d)(2)(viii).                        practitioner
                                                                                 specified in
                                                                                 Section
                                                                                 1842(b)(18)(C) of
                                                                                 the Act or other
                                                                                 person that
                                                                                 knowingly and
                                                                                 willfully bills or
                                                                                 collects for any
                                                                                 services by the
                                                                                 practitioners on
                                                                                 other than an
                                                                                 assignment-related
                                                                                 basis. (Penalties
                                                                                 are assessed in the
                                                                                 same manner as 42
                                                                                 U.S.C.
                                                                                 1395u(j)(2)(B),
                                                                                 which is assessed
                                                                                 according to 1320a-
                                                                                 7a(a)).
1395u(j)(2)(B) \5\................  42 CFR 402.1(c)......  CMS                  Penalty for any              2018       15,024       15,270       30,000
                                                                                 physician who
                                                                                 charges more than
                                                                                 125% for a non-
                                                                                 participating
                                                                                 referral.
                                                                                 (Penalties are
                                                                                 assessed in the
                                                                                 same manner as 42
                                                                                 U.S.C. 1320a-7a(a)).
1395u(k) \5\......................  42 CFR 402.1(c)(12),   CMS                  Penalty for any              2018       15,024       15,270       30,000
                                     402.105(d)(2)(ix).                          physician who
                                                                                 knowingly and
                                                                                 willfully presents
                                                                                 or causes to be
                                                                                 presented a claim
                                                                                 for bill for an
                                                                                 assistant at a
                                                                                 cataract surgery
                                                                                 performed on or
                                                                                 after March 1,
                                                                                 1987, for which
                                                                                 payment may not be
                                                                                 made because of
                                                                                 section
                                                                                 1862(a)(15).
                                                                                 (Penalties are
                                                                                 assessed in the
                                                                                 same manner as 42
                                                                                 U.S.C.
                                                                                 1395u(j)(2)(B),
                                                                                 which is assessed
                                                                                 according to 1320a-
                                                                                 7a(a)).

[[Page 51383]]

 
1395u(l)(3) \5\...................  42 CFR 402.1(c)(13),   CMS                  Penalty for any              2018       15,024       15,270       30,000
                                     402.105(d)(2)(x).                           nonparticipating
                                                                                 physician who does
                                                                                 not accept payment
                                                                                 on an assignment-
                                                                                 related basis and
                                                                                 who knowingly and
                                                                                 willfully fails to
                                                                                 refund on a timely
                                                                                 basis any amounts
                                                                                 collected for
                                                                                 services that are
                                                                                 not reasonable or
                                                                                 medically necessary
                                                                                 or are of poor
                                                                                 quality under
                                                                                 1842(l)(1)(A).
                                                                                 (Penalties are
                                                                                 assessed in the
                                                                                 same manner as 42
                                                                                 U.S.C.
                                                                                 1395u(j)(2)(B),
                                                                                 which is assessed
                                                                                 according to 1320a-
                                                                                 7a(a)).
1395u(m)(3) \5\...................  42 CFR 402.1(c)(14),   CMS                  Penalty for any              2018       15,024       15,270       30,000
                                     402.105(d)(2)(xi).                          nonparticipating
                                                                                 physician charging
                                                                                 more than $500 who
                                                                                 does not accept
                                                                                 payment for an
                                                                                 elective surgical
                                                                                 procedure on an
                                                                                 assignment related
                                                                                 basis and who
                                                                                 knowingly and
                                                                                 willfully fails to
                                                                                 disclose the
                                                                                 required
                                                                                 information
                                                                                 regarding charges
                                                                                 and coinsurance
                                                                                 amounts and fails
                                                                                 to refund on a
                                                                                 timely basis any
                                                                                 amount collected
                                                                                 for the procedure
                                                                                 in excess of the
                                                                                 charges recognized
                                                                                 and approved by the
                                                                                 Medicare program.
                                                                                 (Penalties are
                                                                                 assessed in the
                                                                                 same manner as 42
                                                                                 U.S.C.
                                                                                 1395u(j)(2)(B),
                                                                                 which is assessed
                                                                                 according to 1320a-
                                                                                 7a(a)).
1395u(n)(3) \5\...................  42 CFR 402.1(c)(15),   CMS                  Penalty for any              2018       15,024       15,270       30,000
                                     402.105(d)(2)(xii).                         physician who
                                                                                 knowingly,
                                                                                 willfully, and
                                                                                 repeatedly bills
                                                                                 one or more
                                                                                 beneficiaries for
                                                                                 purchased
                                                                                 diagnostic tests
                                                                                 any amount other
                                                                                 than the payment
                                                                                 amount specified by
                                                                                 the Act. (Penalties
                                                                                 are assessed in the
                                                                                 same manner as 42
                                                                                 U.S.C.
                                                                                 1395u(j)(2)(B),
                                                                                 which is assessed
                                                                                 according to 1320a-
                                                                                 7a(a)).
1395u(o)(3)(B) \5\................  42 CFR 414.707(b)....  CMS                  Penalty for any              2018       15,024       15,270       30,000
                                                                                 practitioner
                                                                                 specified in
                                                                                 Section
                                                                                 1842(b)(18)(C) of
                                                                                 the Act or other
                                                                                 person that
                                                                                 knowingly and
                                                                                 willfully bills or
                                                                                 collects for any
                                                                                 services pertaining
                                                                                 to drugs or
                                                                                 biologics by the
                                                                                 practitioners on
                                                                                 other than an
                                                                                 assignment-related
                                                                                 basis. (Penalties
                                                                                 are assessed in the
                                                                                 same manner as 42
                                                                                 U.S.C.
                                                                                 1395u(b)(18)(B) and
                                                                                 1395u(j)(2)(B),
                                                                                 which is assessed
                                                                                 according to 1320a-
                                                                                 7a(a)).
1395u(p)(3)(A)....................  .....................  CMS                  Penalty for any              2016        3,957        4,022        4,104
                                                                                 physician or
                                                                                 practitioner who
                                                                                 knowingly and
                                                                                 willfully fails
                                                                                 promptly to provide
                                                                                 the appropriate
                                                                                 diagnosis codes
                                                                                 upon CMS or
                                                                                 Medicare
                                                                                 administrative
                                                                                 contractor request
                                                                                 for payment or bill
                                                                                 not submitted on an
                                                                                 assignment-related
                                                                                 basis.
1395w-3a(d)(4)(A).................  42 CFR 414.806.......  CMS                  Penalty for a                2016       12,856       13,066       13,333
                                                                                 pharmaceutical
                                                                                 manufacturer's
                                                                                 misrepresentation
                                                                                 of average sales
                                                                                 price of a drug, or
                                                                                 biologic.

[[Page 51384]]

 
1395w-4(g)(1)(B) \5\..............  42 CFR 402.1(c)(17),   CMS                  Penalty for any              2018       15,024       15,270       30,000
                                     402.105(d)(2)(xiii).                        nonparticipating
                                                                                 physician,
                                                                                 supplier, or other
                                                                                 person that
                                                                                 furnishes physician
                                                                                 services not on an
                                                                                 assignment-related
                                                                                 basis who either
                                                                                 knowingly and
                                                                                 willfully bills or
                                                                                 collects in excess
                                                                                 of the statutorily-
                                                                                 defined limiting
                                                                                 charge or fails to
                                                                                 make a timely
                                                                                 refund or
                                                                                 adjustment.
                                                                                 (Penalties are
                                                                                 assessed in the
                                                                                 same manner as 42
                                                                                 U.S.C.
                                                                                 1395u(j)(2)(B),
                                                                                 which is assessed
                                                                                 according to 1320a-
                                                                                 7a(a)).
1395w-4(g)(3)(B) \5\..............  42 CFR 402.1(c)(18),   CMS                  Penalty for any              2018       15,024       15,270       30,000
                                     402.105(d)(2)(xiv).                         person that
                                                                                 knowingly and
                                                                                 willfully bills for
                                                                                 statutorily defined
                                                                                 State-plan approved
                                                                                 physicians'
                                                                                 services on any
                                                                                 other basis than an
                                                                                 assignment-related
                                                                                 basis for a
                                                                                 Medicare/Medicaid
                                                                                 dual eligible
                                                                                 beneficiary.
                                                                                 (Penalties are
                                                                                 assessed in the
                                                                                 same manner as 42
                                                                                 U.S.C.
                                                                                 1395u(j)(2)(B),
                                                                                 which is assessed
                                                                                 according to 1320a-
                                                                                 7a(a)).
1395w-27(g)(3)(A); 1857(g)(3).....  42 CFR 422.760(b); 42  CMS                  Penalty for each             2016       36,794       37,396       38,159
                                     CFR 423.760(b).                             termination
                                                                                 determination the
                                                                                 Secretary makes
                                                                                 that is the result
                                                                                 of actions by a
                                                                                 Medicare Advantage
                                                                                 organization or
                                                                                 Part D sponsor that
                                                                                 has adversely
                                                                                 affected an
                                                                                 individual covered
                                                                                 under the
                                                                                 organization's
                                                                                 contract.
1395w-27(g)(3)(B); 1857(g)(3).....  .....................  CMS                  Penalty for each             2016       14,718       14,959       15,264
                                                                                 week beginning
                                                                                 after the
                                                                                 initiation of civil
                                                                                 money penalty
                                                                                 procedures by the
                                                                                 Secretary because a
                                                                                 Medicare Advantage
                                                                                 organization or
                                                                                 Part D sponsor has
                                                                                 failed to carry out
                                                                                 a contract, or has
                                                                                 carried out a
                                                                                 contract
                                                                                 inconsistently with
                                                                                 regulations.
1395w-27(g)(3)(D); 1857(g)(3).....  .....................  CMS                  Penalty for a                2016      136,689      138,925      141,760
                                                                                 Medicare Advantage
                                                                                 organization's or
                                                                                 Part D sponsor's
                                                                                 early termination
                                                                                 of its contract.
1395y(b)(3)(C)....................  42 CFR 411.103(b)....  CMS                  Penalty for an               2016        8,908        9,054        9,239
                                                                                 employer or other
                                                                                 entity to offer any
                                                                                 financial or other
                                                                                 incentive for an
                                                                                 individual entitled
                                                                                 to benefits not to
                                                                                 enroll under a
                                                                                 group health plan
                                                                                 or large group
                                                                                 health plan which
                                                                                 would be a primary
                                                                                 plan.
1395y(b)(5)(C)(ii)................  42 CFR 402.1(c)(20),   CMS                  Penalty for any non-         2016        1,450        1,474        1,504
                                     42 CFR 402.105(b)(2).                       governmental
                                                                                 employer that,
                                                                                 before October 1,
                                                                                 1998, willfully or
                                                                                 repeatedly failed
                                                                                 to provide timely
                                                                                 and accurate
                                                                                 information
                                                                                 requested relating
                                                                                 to an employee's
                                                                                 group health
                                                                                 insurance coverage.
1395y(b)(6)(B)....................  42 CFR 402.1(c)(21),   CMS                  Penalty for any              2016        3,182        3,234        3,300
                                     402.105(a).                                 entity that
                                                                                 knowingly,
                                                                                 willfully, and
                                                                                 repeatedly fails to
                                                                                 complete a claim
                                                                                 form relating to
                                                                                 the availability of
                                                                                 other health
                                                                                 benefits in
                                                                                 accordance with
                                                                                 statute or provides
                                                                                 inaccurate
                                                                                 information
                                                                                 relating to such on
                                                                                 the claim form.
1395y(b)(7)(B)(i).................  .....................  CMS                  Penalty for any              2016        1,138        1,157        1,181
                                                                                 entity serving as
                                                                                 insurer, third
                                                                                 party
                                                                                 administrator, or
                                                                                 fiduciary for a
                                                                                 group health plan
                                                                                 that fails to
                                                                                 provide information
                                                                                 that identifies
                                                                                 situations where
                                                                                 the group health
                                                                                 plan is or was a
                                                                                 primary plan to
                                                                                 Medicare to the HHS
                                                                                 Secretary.

[[Page 51385]]

 
1395pp(h) \5\.....................  42 CFR 402.1(c)(23),   CMS                  Penalty for any              2018       15,024       15,270       30,000
                                     402.105(d)(2)(xv).                          durable medical
                                                                                 equipment supplier,
                                                                                 including a
                                                                                 supplier of
                                                                                 prosthetic devices,
                                                                                 prosthetics,
                                                                                 orthotics, or
                                                                                 supplies, that
                                                                                 knowingly and
                                                                                 willfully fails to
                                                                                 make refunds in a
                                                                                 timely manner to
                                                                                 Medicare
                                                                                 beneficiaries under
                                                                                 certain conditions.
                                                                                 (42 U.S.C.
                                                                                 1395(m)(18)
                                                                                 sanctions apply
                                                                                 here in the same
                                                                                 manner, which is
                                                                                 under 1395u(j)(2)
                                                                                 and 1320a-7a(a)).
1395nn(g)(5)......................  42 CFR 411.361.......  CMS                  Penalty for any              2016       18,936       19,246       19,639
                                                                                 person that fails
                                                                                 to report
                                                                                 information
                                                                                 required by HHS
                                                                                 under Section
                                                                                 1877(f) concerning
                                                                                 ownership,
                                                                                 investment, and
                                                                                 compensation
                                                                                 arrangements.
1395pp(h).........................  42 CFR 402.1(c)(23),   CMS                  Penalty for any              2016       15,024       15,270       15,582
                                     402.105(d)(2)(xv).                          durable medical
                                                                                 equipment supplier,
                                                                                 including a
                                                                                 supplier of
                                                                                 prosthetic devices,
                                                                                 prosthetics,
                                                                                 orthotics, or
                                                                                 supplies, that
                                                                                 knowingly and
                                                                                 willfully fails to
                                                                                 make refunds in a
                                                                                 timely manner to
                                                                                 Medicare
                                                                                 beneficiaries under
                                                                                 certain conditions.
                                                                                 (42 U.S.C.
                                                                                 1395(m)(18)
                                                                                 sanctions apply
                                                                                 here in the same
                                                                                 manner, which is
                                                                                 under 1395u(j)(2)
                                                                                 and 1320a-7a(a)).
1395ss(a)(2)......................  42 CFR 402.1(c)(24),   CMS                  Penalty for any              2016       51,569       52,413       53,483
                                     405.105(f)(1).                              person that issues
                                                                                 a Medicare
                                                                                 supplemental policy
                                                                                 that has not been
                                                                                 approved by the
                                                                                 State regulatory
                                                                                 program or does not
                                                                                 meet Federal
                                                                                 standards after a
                                                                                 statutorily defined
                                                                                 effective date.
1395ss(d)(3)(A)(vi)(II)...........  .....................  CMS                  Penalty for someone          2016       26,723       27,160       27,714
                                                                                 other than issuer
                                                                                 that sells or
                                                                                 issues a Medicare
                                                                                 supplemental policy
                                                                                 to beneficiary
                                                                                 without a
                                                                                 disclosure
                                                                                 statement.
                                                                                Penalty for an               2016       44,539       45,268       46,192
                                                                                 issuer that sells
                                                                                 or issues a
                                                                                 Medicare
                                                                                 supplemental policy
                                                                                 without disclosure
                                                                                 statement.
1395ss(d)(3)(B)(iv)...............  .....................  CMS                  Penalty for someone          2016       26,723       27,160       27,714
                                                                                 other than issuer
                                                                                 that sells or
                                                                                 issues a Medicare
                                                                                 supplemental policy
                                                                                 without
                                                                                 acknowledgement
                                                                                 form..
                                                                                Penalty for issuer           2016       44,539       45,268       46,192
                                                                                 that sells or
                                                                                 issues a Medicare
                                                                                 supplemental policy
                                                                                 without an
                                                                                 acknowledgement
                                                                                 form.
1395ss(p)(8)......................  42 CFR 402.1(c)(25),   CMS                  Penalty for any              2016       26,723       27,160       27,714
                                     402.105(e).                                 person that sells
                                                                                 or issues Medicare
                                                                                 supplemental
                                                                                 polices after a
                                                                                 given date that
                                                                                 fail to conform to
                                                                                 the NAIC or Federal
                                                                                 standards
                                                                                 established by
                                                                                 statute.
                                    42 CFR 402.1(c)(25),   CMS                  Penalty for any              2016       44,539       45,268       46,192
                                     405.105(f)(2).                              person that sells
                                                                                 or issues Medicare
                                                                                 supplemental
                                                                                 polices after a
                                                                                 given date that
                                                                                 fail to conform to
                                                                                 the NAIC or Federal
                                                                                 standards
                                                                                 established by
                                                                                 statute.
1395ss(p)(9)(C)...................  42 CFR 402.1(c)(26),   CMS                  Penalty for any              2016       26,723       27,160       27,714
                                     402.105(e).                                 person that sells a
                                                                                 Medicare
                                                                                 supplemental policy
                                                                                 and fails to make
                                                                                 available for sale
                                                                                 the core group of
                                                                                 basic benefits when
                                                                                 selling other
                                                                                 Medicare
                                                                                 supplemental
                                                                                 policies with
                                                                                 additional benefits
                                                                                 or fails to provide
                                                                                 the individual,
                                                                                 before selling the
                                                                                 policy, an outline
                                                                                 of coverage
                                                                                 describing benefits.

[[Page 51386]]

 
                                    42 CFR 402.1(c)(26),   ...................  Penalty for any              2016       44,539       45,268       46,192
                                     405.105(f)(3), (4).                         person that sells a
                                                                                 Medicare
                                                                                 supplemental policy
                                                                                 and fails to make
                                                                                 available for sale
                                                                                 the core group of
                                                                                 basic benefits when
                                                                                 selling other
                                                                                 Medicare
                                                                                 supplemental
                                                                                 policies with
                                                                                 additional benefits
                                                                                 or fails to provide
                                                                                 the individual,
                                                                                 before selling the
                                                                                 policy, an outline
                                                                                 of coverage
                                                                                 describing benefits.
1395ss(q)(5)(C)...................  42 CFR 402.1(c)(27),   CMS                  Penalty for any              2016       44,539       45,268       46,192
                                     405.105(f)(5).                              person that fails
                                                                                 to suspend the
                                                                                 policy of a
                                                                                 policyholder made
                                                                                 eligible for
                                                                                 medical assistance
                                                                                 or automatically
                                                                                 reinstates the
                                                                                 policy of a
                                                                                 policyholder who
                                                                                 has lost
                                                                                 eligibility for
                                                                                 medical assistance,
                                                                                 under certain
                                                                                 circumstances.
1395ss(r)(6)(A)...................  42 CFR 402.1(c)(28),   CMS                  Penalty for any              2016       44,539       45,268       46,192
                                     405.105(f)(6).                              person that fails
                                                                                 to provide refunds
                                                                                 or credits as
                                                                                 required by section
                                                                                 1882(r)(1)(B).
1395ss(s)(4)......................  42 CFR 402.1(c)(29),   CMS                  Penalty for any              2016       18,908       19,217       19,609
                                     405.105(c).                                 issuer of a
                                                                                 Medicare
                                                                                 supplemental policy
                                                                                 that does not waive
                                                                                 listed time periods
                                                                                 if they were
                                                                                 already satisfied
                                                                                 under a proceeding
                                                                                 Medicare
                                                                                 supplemental
                                                                                 policy, or denies a
                                                                                 policy, or
                                                                                 conditions the
                                                                                 issuances or
                                                                                 effectiveness of
                                                                                 the policy, or
                                                                                 discriminates in
                                                                                 the pricing of the
                                                                                 policy base on
                                                                                 health status or
                                                                                 other specified
                                                                                 criteria.
1395ss(t)(2)......................  42 CFR 402.1(c)(30),   CMS                  Penalty for any              2016       44,539       45,268       46,192
                                     405.105(f)(7).                              issuer of a
                                                                                 Medicare
                                                                                 supplemental policy
                                                                                 that fails to
                                                                                 fulfill listed
                                                                                 responsibilities.
1395ss(v)(4)(A)...................  .....................  CMS                  Penalty someone              2016       19,284       19,599       19,999
                                                                                 other than issuer
                                                                                 who sells, issues,
                                                                                 or renews a Medigap
                                                                                 Rx policy to an
                                                                                 individual who is a
                                                                                 Part D enrollee.
                                                                                Penalty for an               2016       32,140       32,666       33,333
                                                                                 issuer who sells,
                                                                                 issues, or renews a
                                                                                 Medigap Rx policy
                                                                                 who is a Part D
                                                                                 enrollee.
1395bbb(c)(1).....................  42 CFR 488.725(c)....  CMS                  Penalty for any              2016        4,126        4,194        4,280
                                                                                 individual who
                                                                                 notifies or causes
                                                                                 to be notified a
                                                                                 home health agency
                                                                                 of the time or date
                                                                                 on which a survey
                                                                                 of such agency is
                                                                                 to be conducted.
1395bbb(f)(2)(A)(i)...............  42 CFR                 CMS                  Maximum daily                2016       19,787       20,111       20,521
                                     488.845(b)(2)(iii);                         penalty amount for
                                     42 CFR 488.845(b)(3)-                       each day a home
                                     (6); and 42 CFR                             health agency is
                                     488.845(d)(1)(ii).                          not in compliance
                                                                                 with statutory
                                                                                 requirements.
                                    42 CFR 488.845(b)(3).  ...................  Penalty per day for   ...........  ...........  ...........  ...........
                                                                                 home health
                                                                                 agency's
                                                                                 noncompliance
                                                                                 (Upper Range).
                                                                                Minimum.............         2016       16,819       17,094       17,443
                                                                                Maximum.............         2016       19,787       20,111       20,521
                                    42 CFR                 ...................  Penalty for a home           2016       19,787       20,111       20,521
                                     488.845(b)(3)(i).                           health agency's
                                                                                 deficiency or
                                                                                 deficiencies that
                                                                                 cause immediate
                                                                                 jeopardy and result
                                                                                 in actual harm.
                                    42 CFR                 ...................  Penalty for a home           2016       17,808       18,099       18,468
                                     488.845(b)(3)(ii).                          health agency's
                                                                                 deficiency or
                                                                                 deficiencies that
                                                                                 cause immediate
                                                                                 jeopardy and result
                                                                                 in potential for
                                                                                 harm.
                                    42 CFR                 ...................  Penalty for an               2016       16,819       17,094       17,443
                                     488.845(b)(3)(iii).                         isolated incident
                                                                                 of noncompliance in
                                                                                 violation of
                                                                                 established HHA
                                                                                 policy.
                                    42 CFR 488.845(b)(4).  ...................  Penalty for a repeat  ...........  ...........  ...........  ...........
                                                                                 and/or condition-
                                                                                 level deficiency
                                                                                 that does not
                                                                                 constitute
                                                                                 immediate jeopardy,
                                                                                 but is directly
                                                                                 related to poor
                                                                                 quality patient
                                                                                 care outcomes
                                                                                 (Lower Range).
                                                                                Minimum.............         2016        2,968        3,017        3,079

[[Page 51387]]

 
                                                                                Maximum.............         2016       16,819       17,094       17,443
                                    42 CFR 488.845(b)(5).  ...................  Penalty for a repeat  ...........  ...........  ...........  ...........
                                                                                 and/or condition-
                                                                                 level deficiency
                                                                                 that does not
                                                                                 constitute
                                                                                 immediate jeopardy
                                                                                 and that is related
                                                                                 predominately to
                                                                                 structure or
                                                                                 process-oriented
                                                                                 conditions (Lower
                                                                                 Range).
                                                                                Minimum.............         2016          989        1,005        1,026
                                                                                Maximum.............         2016        7,915        8,044        8,208
                                    42 CFR 488.845(b)(6).  ...................  Penalty imposed for   ...........  ...........  ...........  ...........
                                                                                 instance of
                                                                                 noncompliance that
                                                                                 may be assessed for
                                                                                 one or more
                                                                                 singular events of
                                                                                 condition-level
                                                                                 noncompliance that
                                                                                 are identified and
                                                                                 where the
                                                                                 noncompliance was
                                                                                 corrected during
                                                                                 the onsite survey.
                                                                                Minimum.............         2016        1,979        2,011        2,052
                                                                                Maximum.............         2016       19,787       20,111       20,521
                                                                                Penalty for each day         2016       19,787       20,111       20,521
                                                                                 of noncompliance
                                                                                 (Maximum).
                                    42 CFR                 ...................  Penalty for each day         2016       19,787       20,111       20,521
                                     488.845(d)(1)(ii).                          of noncompliance
                                                                                 (Maximum).
1396b(m)(5)(B)....................  42 CFR 460.46........  CMS                  Penalty for PACE      ...........  ...........  ...........  ...........
                                                                                 organization's
                                                                                 practice that would
                                                                                 reasonably be
                                                                                 expected to have
                                                                                 the effect of
                                                                                 denying or
                                                                                 discouraging
                                                                                 enrollment.
                                                                                Minimum.............         2016       22,077       22,438       22,896
                                                                                Maximum.............         2016      147,177      149,585      152,638
                                                                                Penalty for a PACE           2016       36,794       37,396       38,159
                                                                                 organization that
                                                                                 charges excessive
                                                                                 premiums.
                                                                                Penalty for a PACE           2016      147,177      149,585      152,638
                                                                                 organization
                                                                                 misrepresenting or
                                                                                 falsifying
                                                                                 information to CMS,
                                                                                 the State, or an
                                                                                 individual or other
                                                                                 entity.
                                                                                Penalty for each             2016       36,794       37,396       38,159
                                                                                 determination the
                                                                                 CMS makes that the
                                                                                 PACE organization
                                                                                 has failed to
                                                                                 provide medically
                                                                                 necessary items and
                                                                                 services of the
                                                                                 failure has
                                                                                 adversely affected
                                                                                 (or has the
                                                                                 substantial
                                                                                 likelihood of
                                                                                 adversely
                                                                                 affecting) a PACE
                                                                                 participant.
                                                                                Penalty for                  2016       36,794       37,396       38,159
                                                                                 involuntarily
                                                                                 disenrolling a
                                                                                 participant.
                                                                                Penalty for                  2016       36,794       37,396       38,159
                                                                                 discriminating or
                                                                                 discouraging
                                                                                 enrollment or
                                                                                 disenrollment of
                                                                                 participants on the
                                                                                 basis of an
                                                                                 individual's health
                                                                                 status or need for
                                                                                 health care
                                                                                 services.
1396r(h)(3)(C)(ii)(I).............  42 CFR                 CMS                  Penalty per day for   ...........  ...........  ...........  ...........
                                     488.408(d)(1)(iii).                         a nursing
                                                                                 facility's failure
                                                                                 to meet a Category
                                                                                 2 Certification.
                                                                                Minimum.............         2016          103          105          107
                                                                                Maximum.............         2016        6,188        6,289        6,417
                                    42 CFR                 CMS                  Penalty per instance  ...........  ...........  ...........  ...........
                                     488.408(d)(1)(iv).                          for a nursing
                                                                                 facility's failure
                                                                                 to meet Category 2
                                                                                 certification.
                                                                                Minimum.............         2016        2,063        2,097        2,140
                                                                                Maximum.............         2016       20,628       20,965       21,393
                                    42 CFR                 CMS                  Penalty per day for   ...........  ...........  ...........  ...........
                                     488.408(e)(1)(iii).                         a nursing
                                                                                 facility's failure
                                                                                 to meet Category 3
                                                                                 certification.
                                                                                Minimum.............         2016        6,291        6,394        6,525
                                                                                Maximum.............         2016       20,628       20,965       21,393
                                    42 CFR                 CMS                  Penalty per instance  ...........  ...........  ...........  ...........
                                     488.408(e)(1)(iv).                          for a nursing
                                                                                 facility's failure
                                                                                 to meet Category 3
                                                                                 certification.
                                                                                Minimum.............         2016        2,063        2,097        2,140
                                                                                Maximum.............         2016       20,628       20,965       21,393
                                    42 CFR                 CMS                  Penalty per instance  ...........  ...........  ...........  ...........
                                     488.408(e)(2)(ii).                          for a nursing
                                                                                 facility's failure
                                                                                 to meet Category 3
                                                                                 certification,
                                                                                 which results in
                                                                                 immediate jeopardy.

[[Page 51388]]

 
                                                                                Minimum.............         2016        2,063        2,097        2,140
                                                                                Maximum.............         2016       20,628       20,965       21,393
                                    42 CFR                 CMS                  Penalty per day for   ...........  ...........  ...........  ...........
                                     488.438(a)(1)(i).                           nursing facility's
                                                                                 failure to meet
                                                                                 certification
                                                                                 (Upper Range).
                                                                                Minimum.............         2016        6,291        6,394        6,525
                                                                                Maximum.............         2016       20,628       20,965       21,393
                                    42 CFR                 CMS                  Penalty per day for   ...........  ...........  ...........  ...........
                                     488.438(a)(1)(ii).                          nursing facility's
                                                                                 failure to meet
                                                                                 certification
                                                                                 (Lower Range).
                                                                                Minimum.............         2016          103          105          107
                                                                                Maximum.............         2016        6,188        6,289        6,417
                                    42 CFR 488.438(a)(2).  CMS                  Penalty per instance  ...........  ...........  ...........  ...........
                                                                                 for nursing
                                                                                 facility's failure
                                                                                 to meet
                                                                                 certification.
                                                                                Minimum.............         2016        2,063        2,097        2,140
                                                                                Maximum.............         2016       20,628       20,965       21,393
1396r(f)(2)(B)(iii)(I)(c).........  42 CFR                 CMS                  Grounds to prohibit          2016       10,314       10,483       10,697
                                     483.151(b)(2)(iv)                           approval of Nurse
                                     and (b)(3)(iii).                            Aide Training
                                                                                 Program--if
                                                                                 assessed a penalty
                                                                                 in 1819(h)(2)(B)(i)
                                                                                 or
                                                                                 1919(h)(2)(A)(ii)
                                                                                 of ``not less than
                                                                                 $5,000'' [Not CMP
                                                                                 authority, but a
                                                                                 specific CMP amount
                                                                                 (CMP at this level)
                                                                                 that is the
                                                                                 triggering
                                                                                 condition for
                                                                                 disapproval].
1396r(h)(3)(C)(ii)(I).............  42 CFR 483.151(c)(2).  CMS                  Grounds to waive             2016       10,314       10,483       10,697
                                                                                 disapproval of
                                                                                 nurse aide training
                                                                                 program--reference
                                                                                 to disapproval
                                                                                 based on imposition
                                                                                 of CMP ``not less
                                                                                 than $5,000'' [Not
                                                                                 CMP authority but
                                                                                 CMP imposition at
                                                                                 this level
                                                                                 determines
                                                                                 eligibility to seek
                                                                                 waiver of
                                                                                 disapproval of
                                                                                 nurse aide training
                                                                                 program].
1396t(j)(2)(C)....................  .....................  CMS                  Penalty for each day  ...........  ...........  ...........  ...........
                                                                                 of noncompliance
                                                                                 for a home or
                                                                                 community care
                                                                                 provider that no
                                                                                 longer meets the
                                                                                 minimum
                                                                                 requirements for
                                                                                 home and community
                                                                                 care.
                                                                                Minimum.............         2016            2            2            2
                                                                                Maximum.............         2016       17,816       18,107       18,477
1396u-2(e)(2)(A)(i)...............  42 CFR 438.704.......  CMS                  Penalty for a                2016       36,794       37,396       38,159
                                                                                 Medicaid managed
                                                                                 care organization
                                                                                 that fails
                                                                                 substantially to
                                                                                 provide medically
                                                                                 necessary items and
                                                                                 services.
                                                                                Penalty for Medicaid         2016       36,794       37,396       38,159
                                                                                 managed care
                                                                                 organization that
                                                                                 imposes premiums or
                                                                                 charges on
                                                                                 enrollees in excess
                                                                                 of the premiums or
                                                                                 charges permitted.
                                                                                Penalty for a                2016       36,794       37,396       38,159
                                                                                 Medicaid managed
                                                                                 care organization
                                                                                 that misrepresents
                                                                                 or falsifies
                                                                                 information to
                                                                                 another individual
                                                                                 or entity.
                                                                                Penalty for a                2016       36,794       37,396       38,159
                                                                                 Medicaid managed
                                                                                 care organization
                                                                                 that fails to
                                                                                 comply with the
                                                                                 applicable
                                                                                 statutory
                                                                                 requirements for
                                                                                 such organizations.
1396u-2(e)(2)(A)(ii)..............  42 CFR 438.704.......  CMS                  Penalty for a                2016      147,177      149,585      152,638
                                                                                 Medicaid managed
                                                                                 care organization
                                                                                 that misrepresents
                                                                                 or falsifies
                                                                                 information to the
                                                                                 HHS Secretary.
                                                                                Penalty for Medicaid         2016      147,177      149,585      152,638
                                                                                 managed care
                                                                                 organization that
                                                                                 acts to
                                                                                 discriminate among
                                                                                 enrollees on the
                                                                                 basis of their
                                                                                 health status.
1396u-2(e)(2)(A)(iv)..............  42 CFR 438.704.......  CMS                  Penalty for each             2016       22,077       22,438       22,896
                                                                                 individual that
                                                                                 does not enroll as
                                                                                 a result of a
                                                                                 Medicaid managed
                                                                                 care organization
                                                                                 that acts to
                                                                                 discriminate among
                                                                                 enrollees on the
                                                                                 basis of their
                                                                                 health status.

[[Page 51389]]

 
1396u(h)(2).......................  42 CFR Part 441,       CMS                  Penalty for a                2016       20,628       20,965       21,393
                                     Subpart I.                                  provider not
                                                                                 meeting one of the
                                                                                 requirements
                                                                                 relating to the
                                                                                 protection of the
                                                                                 health, safety, and
                                                                                 welfare of
                                                                                 individuals
                                                                                 receiving community
                                                                                 supported living
                                                                                 arrangements
                                                                                 services.
1396w-2(c)(1).....................                         CMS                  Penalty for                  2016       11,002       11,182       11,410
                                                                                 disclosing
                                                                                 information related
                                                                                 to eligibility
                                                                                 determinations for
                                                                                 medical assistance
                                                                                 programs.
18041(c)(2).......................  45 CFR 150.315; 45     CMS                  Failure to comply            2016          150          152          155
                                     CFR 156.805(c).                             with requirements
                                                                                 of the Public
                                                                                 Health Services
                                                                                 Act; Penalty for
                                                                                 violations of rules
                                                                                 or standards of
                                                                                 behavior associated
                                                                                 with issuer
                                                                                 participation in
                                                                                 the Federally-
                                                                                 facilitated
                                                                                 Exchange. (42
                                                                                 U.S.C. 300gg-
                                                                                 22(b)(2)(C)).
18081(h)(1)(A)(i)(II).............  42 CFR 155.285.......  CMS                  Penalty for                  2016       27,186       27,631       28,195
                                                                                 providing false
                                                                                 information on
                                                                                 Exchange
                                                                                 application.
18081(h)(1)(B)....................  42 CFR 155.285.......  CMS                  Penalty for                  2016      271,862      276,310      281,949
                                                                                 knowingly or
                                                                                 willfully providing
                                                                                 false information
                                                                                 on Exchange
                                                                                 application.
18081(h)(2).......................  42 CFR 155.260.......  CMS                  Penalty for                  2016       27,186       27,631       28,195
                                                                                 knowingly or
                                                                                 willfully
                                                                                 disclosing
                                                                                 protected
                                                                                 information from
                                                                                 Exchange.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                        31 U.S.C.
--------------------------------------------------------------------------------------------------------------------------------------------------------
1352..............................  45 CFR 93.400(e).....  HHS                  Penalty for the              2016       18,936       19,246       19,639
                                                                                 first time an
                                                                                 individual makes an
                                                                                 expenditure
                                                                                 prohibited by
                                                                                 regulations
                                                                                 regarding lobbying
                                                                                 disclosure, absent
                                                                                 aggravating
                                                                                 circumstances.
                                                                                Penalty for second    ...........  ...........  ...........  ...........
                                                                                 and subsequent
                                                                                 offenses by
                                                                                 individuals who
                                                                                 make an expenditure
                                                                                 prohibited by
                                                                                 regulations
                                                                                 regarding lobbying
                                                                                 disclosure.
                                                                                Minimum.............         2016       18,936       19,246       19,639
                                                                                Maximum.............         2016      189,361      192,459      196,387
                                                                                Penalty for the              2016       18,936       19,246       19,639
                                                                                 first time an
                                                                                 individual fails to
                                                                                 file or amend a
                                                                                 lobbying disclosure
                                                                                 form, absent
                                                                                 aggravating
                                                                                 circumstances.
                                                                                Penalty for second    ...........  ...........  ...........  ...........
                                                                                 and subsequent
                                                                                 offenses by
                                                                                 individuals who
                                                                                 fail to file or
                                                                                 amend a lobbying
                                                                                 disclosure form,
                                                                                 absent aggravating
                                                                                 circumstances.
                                                                                Minimum.............         2016       18,936       19,246       19,639
                                                                                Maximum.............         2016      189,361      192,459      196,387
                                    45 CFR Part 93,        HHS                  Penalty for failure   ...........  ...........  ...........  ...........
                                     Appendix A.                                 to provide
                                                                                 certification
                                                                                 regarding lobbying
                                                                                 in the award
                                                                                 documents for all
                                                                                 sub-awards of all
                                                                                 tiers.
                                                                                Minimum.............         2016       18,936       19,246       19,639
                                                                                Maximum.............         2016      189,361      192,459      196,387
                                                                                Penalty for failure   ...........  ...........  ...........  ...........
                                                                                 to provide
                                                                                 statement regarding
                                                                                 lobbying for loan
                                                                                 guarantee and loan
                                                                                 insurance
                                                                                 transactions.
                                                                                Minimum.............         2016       18,936       19,246       19,639
                                                                                Maximum.............         2016      189,361      192,459      196,387
3801-3812.........................  45 CFR 79.3(a)(1)(iv)  HHS                  Penalty against any          2016        9,894       10,056       10,261
                                                                                 individual who--
                                                                                 with knowledge or
                                                                                 reason to know--
                                                                                 makes, presents or
                                                                                 submits a false,
                                                                                 fictitious or
                                                                                 fraudulent claim to
                                                                                 the Department.
                                    45 CFR 79.3(b)(1(ii).  HHS                  Penalty against any          2016        9,894       10,056       10,261
                                                                                 individual who--
                                                                                 with knowledge or
                                                                                 reason to know--
                                                                                 makes, presents or
                                                                                 submits a false,
                                                                                 fictitious or
                                                                                 fraudulent claim to
                                                                                 the Department.
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\1\ Some HHS components have not promulgated regulations regarding their civil monetary penalty-specific statutory authorities.

[[Page 51390]]

 
\2\ The description is not intended to be a comprehensive explanation of the underlying violation; the statute and corresponding regulation, if
  applicable, should be consulted.
\3\ Statutory or Inflation Act Adjustment.
\4\ The cost of living multiplier for 2018, based on the CPI-U for the month of October 2017, not seasonally adjusted, is 1.02041, as indicated in OMB
  Memorandum M-18-03, ``Implementation of Penalty Inflation Adjustments for 2018, Pursuant to the Federal Civil Penalties Adjustment Act Improvements
  Act of 2015'' (December 15, 2017).
\5\ 2018 Maximum Adjusted Penalty column adjusted based on changes to the Bipartisan Budget Act of 2018 for 42 U.S.C.1320a-7a(a),1320a-7a(b),
  1395l(h)(5)(D),1395m(a)(11)(A),1395m(a)(18)(B), 1395m(b)(5)(C), 1395m(h)(3), 1395m(j)(4), 1395m(k)(6), 1395m(l)(6), 1395u(b)(18)(B), 1395u(j)(2)(B),
  1395u(k), 1395u(l)(3), 1395u(m)(3), 1395u(n)(3), 1395u(o)(3)(B), 1395w-4(g)(1)(B), 1395w-4(g)(3)(B),1395pp(h).



    Dated: October 3, 2018.
Alex M. Azar II,
Secretary, Department of Health and Human Services.
[FR Doc. 2018-22005 Filed 10-10-18; 8:45 am]
 BILLING CODE 4150-24-P