Annual Civil Monetary Penalties Inflation Adjustment

Federal Register, Volume 82 Issue 22 (Friday, February 3, 2017)

Federal Register Volume 82, Number 22 (Friday, February 3, 2017)

Rules and Regulations

Pages 9174-9189

From the Federal Register Online via the Government Publishing Office www.gpo.gov

FR Doc No: 2017-02300

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

45 CFR Part 102

RIN 0991-AC0

Annual Civil Monetary Penalties Inflation Adjustment

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

ACTION: Final rule.

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SUMMARY: The Department of Health and Human Services (HHS) 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 Improvement Act of 2015.

DATES: This rule is effective February 3, 2017.

FOR FURTHER INFORMATION CONTACT: Andrea Brandon, Deputy Assistant Secretary for Grants and Acquisitions, 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:

  1. Background

    The Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (Sec. 701 of Pub. L. 114-74) (the ``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 penalties and the penalty amounts administered by all of its agencies in tabular form in 45 CFR 102.3.

  2. Calculation of Adjustment

    The annual inflation adjustment for each applicable civil monetary penalty is determined using the percent increase in the Consumer Price Index for all Urban Consumers (CPI-U) for the month of October of the year in which the amount of each civil penalty was most recently established or modified. In the December 16, 2016, OMB Memorandum for the Heads of Executive Agencies and Departments, M-17-11, Implementation of the 2017 annual adjustment 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 2017, based on the CPI-U for the month of October 2016, not seasonally adjusted, is 1.01636.

    Using the 2017 multiplier, HHS adjusted all its applicable monetary penalties in 45 CFR 102.3.

  3. 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

    1. Executive Order 12866: Regulatory Planning and Review and Executive Order 13563: Improving Regulation and Regulatory Review

      Section 4 of the 2015 Act directs federal agencies to publish annual adjustments no later than January 15, 2017. In accordance with section 553 of the Administrative Procedure Act (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-17-11, Memorandum of the Heads of Executive Departments and Agencies (December 16, 2016) the phrase ``notwithstanding section 553'' means that ``the public procedure the APA generally provides--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.

    2. Review Under Procedural Statutes and Executive Orders

      Pursuant to OMB Memorandum for the Heads of Executive Departments and Agencies, M-17-11, HHS has determined that making technical changes to the amount of civil monetary penalties in its regulations does not trigger any requirements under procedural statutes and Executive Orders that govern rulemaking procedures.

  4. Effective Date

    This rule is effective February 3, 2017. The adjusted civil penalty amounts apply to civil penalties assessed on or after February 3, 2017, when the

    Page 9175

    violation occurred after November 2, 2015. If the violation occurred prior to November 2, 2015, or a penalty was assessed prior to September 6, 2016, the pre-adjustment civil penalty amounts in effect prior to September 6, 2016 will apply.

    List of Subjects in 45 CFR Part 102

    Administrative practice and procedure, Penalties.

    For reasons discussed in the preamble, the Department of Health and Human Services amends 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 February 3, 2017

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

    Citation Date of

    ------------------------------------------------------------------- last 2016 2017

    penalty Maximum Maximum

    HHS agency Description \2\ figure or adjusted adjusted

    U.S.C. CFR \1\ adjustment penalty ($) penalty ($)

    \3\ \4\

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

    21 U.S.C.:

    333(b)(2)(A)......................... ....................... FDA............. Penalty for violations 2016 98,935 100,554

    related to drug samples

    resulting in a conviction

    of any representative of

    manufacturer or

    distributor in any 10-year

    period.

    333(b)(2)(B)......................... ....................... FDA............. Penalty for violation 2016 1,978,690 2,011,061

    related to drug samples

    resulting in a conviction

    of any representative of

    manufacturer or

    distributor after the

    second conviction in any

    10-yr period.

    333(b)(3)............................ ....................... FDA............. Penalty for failure to make 2016 197,869 201,106

    a report required by 21

    U.S.C. 353(d)(3)(E)

    relating to drug samples.

    333(f)(1)(A)......................... ....................... FDA............. Penalty for any person who 2016 26,723 27,160

    violates a requirement

    related to devices for

    each such violation.

    Penalty for aggregate of 2016 1,781,560 1,810,706

    all violations related to

    devices in a single

    proceeding.

    333(f)(2)(A)......................... ....................... FDA............. Penalty for any individual 2016 75,123 76,352

    who introduces or delivers

    for introduction into

    interstate commerce food

    that is adulterated per 21

    U.S.C. 342(a)(2)(B) or any

    individual who does not

    comply with a recall order

    under 21 U.S.C. 350l.

    Penalty in the case of any 2016 375,613 381,758

    other person other than an

    individual) for such

    introduction or delivery

    of adulterated food.

    Penalty for aggregate of 2016 751,225 763,515

    all such violations

    related to adulterated

    food adjudicated in a

    single proceeding.

    333(f)(3)(A)......................... ....................... FDA............. Penalty for all violations 2016 11,383 11,569

    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 any 2016 11,383 11,569

    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 responsible 2016 284,583 289,239

    person that violates a

    requirement of 21 U.S.C.

    355(o) (post-marketing

    studies, clinical trials,

    labeling), 21 U.S.C.

    355(p) (risk evaluation

    and mitigation (REMS)), or

    21 U.S.C. 355-1 (REMS).

    Penalty for aggregate of 2016 1,138,330 1,156,953

    all such above violations

    in a single proceeding.

    333(f)(4)(A)(ii)..................... ....................... FDA............. Penalty for REMS violation 2016 284,583 289,239

    that continues after

    written notice to the

    responsible person for the

    first 30-day period (or

    any portion thereof) the

    responsible person

    continues to be in

    violation.

    Penalty for REMS violation 2016 1,138,330 1,156,953

    that continues after

    written notice to

    responsible person doubles

    for every 30-day period

    thereafter the violation

    continues, but may not

    exceed penalty amount for

    any 30-day period.

    Penalty for aggregate of 2016 11,383,300 11,569,531

    all such above violations

    adjudicated in a single

    proceeding.

    333(f)(9)(A)......................... ....................... FDA............. Penalty for any person who 2016 16,503 16,773

    violates a requirement

    which relates to tobacco

    products for each such

    violation.

    Page 9176

    Penalty for aggregate of 2016 1,100,200 1,118,199

    all such violations of

    tobacco product

    requirement adjudicated in

    a single proceeding.

    333(f)(9)(B)(i)(I)................... ....................... FDA............. Penalty per violation 2016 275,050 279,550

    related to violations of

    tobacco requirements.

    Penalty for aggregate of 2016 1,100,200 1,118,199

    all such violations of

    tobacco product

    requirements adjudicated

    in a single proceeding.

    333(f)(9)(B)(i)(II).................. ....................... FDA............. Penalty in the case of a 2016 275,050 279,550

    violation of tobacco

    product requirements that

    continues after written

    notice to such person, for

    the first 30-day period

    (or any portion thereof)

    the person continues to be

    in violation.

    Penalty for violation of 2016 1,100,200 1,118,199

    tobacco product

    requirements that

    continues after written

    notice to such person

    shall double for every 30-

    day period thereafter the

    violation continues, but

    may not exceed penalty

    amount for any 30-day

    period.

    Penalty for aggregate of 2016 11,002,000 11,181,993

    all such violations

    related to tobacco product

    requirements adjudicated

    in a single proceeding.

    333(f)(9)(B)(ii)(I).................. ....................... FDA............. Penalty for any person who 2016 275,050 279,550

    either does not conduct

    post-market surveillance

    and studies to determine

    impact of a modified risk

    tobacco product for which

    the HHS Secretary has

    provided them an order to

    sell, or who does not

    submit a protocol to the

    HHS Secretary after being

    notified of a requirement

    to conduct post-market

    surveillance of such

    tobacco products.

    Penalty for aggregate of 2016 1,100,200 1,118,199

    for all such above

    violations adjudicated in

    a single proceeding.

    333(f)(9)(B)(ii)(II)................. ....................... FDA............. Penalty for violation of 2016 275,050 279,550

    modified risk tobacco

    product post-market

    surveillance that

    continues after written

    notice to such person for

    the first 30-day period

    (or any portion thereof)

    that the person continues

    to be in violation.

    Penalty for post-notice 2016 1,100,200 1,118,199

    violation of modified risk

    tobacco product post-

    market surveillance shall

    double for every 30-day

    period thereafter that the

    tobacco product

    requirement violation

    continues for any 30-day

    period, but may not exceed

    penalty amount for any 30-

    day period.

    Penalty for aggregate above 2016 11,002,000 11,181,993

    tobacco product

    requirement violations

    adjudicated in a single

    proceeding.

    333(g)(1)............................ ....................... FDA............. Penalty for any person who 2016 284,583 289,239

    disseminates or causes

    another party to

    disseminate a direct-to-

    consumer advertisement

    that is false or

    misleading for the first

    such violation in any 3-

    year period.

    Penalty for each subsequent 2016 569,165 578,477

    above violation in any 3-

    year period.

    333 note............................. ....................... FDA............. Penalty to be applied for 2016 275 279

    violations of restrictions

    on the sale or

    distribution of tobacco

    products promulgated under

    21 U.S.C. 387f(d) (e.g.,

    violations of regulations

    in 21 CFR part 1140) with

    respect to a retailer with

    an approved training

    program in the case of a

    second regulation

    violation within a 12-

    month period.

    Penalty in the case of a 2016 550 559

    third tobacco product

    regulation violation

    within a 24-month period.

    Penalty in the case of a 2016 2,200 2,236

    fourth tobacco product

    regulation violation

    within a 24-month period.

    Penalty in the case of a 2016 5,501 5,591

    fifth tobacco product

    regulation violation

    within a 36-month period.

    Penalty in the case of a 2016 11,002 11,182

    sixth or subsequent

    tobacco product regulation

    violation within a 48-

    month period as determined

    on a case-by-case basis.

    Page 9177

    Penalty to be applied for 2016 275 279

    violations of restrictions

    on the sale or

    distribution of tobacco

    products promulgated under

    21 U.S.C. 387f(d) (e.g.,

    violations of regulations

    in 21 CFR part 1140) with

    respect to a retailer that

    does not have an approved

    training program in the

    case of the first

    regulation violation.

    Penalty in the case of a 2016 550 559

    second tobacco product

    regulation violation

    within a 12-month period.

    Penalty in the case of a 2016 1,100 1,118

    third tobacco product

    regulation violation

    within a 24-month period.

    Penalty in the case of a 2016 2,200 2,236

    fourth tobacco product

    regulation violation

    within a 24-month period.

    Penalty in the case of a 2016 5,501 5,591

    fifth tobacco product

    regulation violation

    within a 36-month period.

    Penalty in the case of a 2016 11,002 11,182

    sixth or subsequent

    tobacco product regulation

    violation within a 48-

    month period as determined

    on a case-by-case basis.

    335b(a).............................. ....................... FDA............. Penalty for each violation 2016 419,320 426,180

    for any individual who

    made a false statement or

    misrepresentation of a

    material fact, bribed,

    destroyed, altered,

    removed, or secreted, or

    procured the destruction,

    alteration, removal, or

    secretion of, any material

    document, failed to

    disclose a material fact,

    obstructed an

    investigation, employed a

    consultant who was

    debarred, debarred

    individual provided

    consultant services.

    Penalty in the case of any 2016 1,677,280 1,704,720

    other person (other than

    an individual) per above

    violation.

    360pp(b)(1).......................... ....................... FDA............. Penalty for any person who 2016 2,750 2,795

    violates any such

    requirements for

    electronic products, with

    each unlawful act or

    omission constituting a

    separate violation.

    Penalty imposed for any 2016 937,500 952,838

    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

    violation of order of

    recall of biological

    product presenting

    imminent or substantial

    hazard.

    263b(h)(3)........................... ....................... FDA............. Penalty for failure to 2016 16,773 17,047

    obtain a mammography

    certificate as required.

    300aa-28(b)(1)....................... ....................... FDA............. Penalty per occurrence for 2016 215,628 219,156

    any vaccine manufacturer

    that intentionally

    destroys, alters,

    falsifies, or conceals any

    record or report required.

    256b(d)(1)(B)(vi).................... ....................... HRSA............ Penalty for each instance 2016 5,437 5,526

    of overcharging a 340B

    covered entity.

    299c-(3)(d).......................... ....................... AHRQ............ Penalty for an 2016 14,140 14,371

    establishment or person

    supplying information

    obtained in the course of

    activities for any purpose

    other than the purpose for

    which it was supplied.

    653(l)(2)............................ 45 CFR 303.21(f)....... ACF............. Penalty for Misuse of 2016 1,450 1,474

    Information in the

    National Directory of New

    Hires.

    262a(i)(1)........................... 42 CFR 1003.910........ OIG............. Penalty for each individual 2016 327,962 333,327

    who violates safety and

    security procedures

    related to handling

    dangerous biological

    agents and toxins.

    Penalty for any other 2016 655,925 666,656

    person who violates safety

    and security procedures

    related to handling

    dangerous biological

    agents and toxins.

    300jj-51............................. ....................... OIG............. Penalty per violation for 2016 1,000,000 1,016,360

    committing information

    blocking.

    1320a-7a(a).......................... 42 CFR 1003.210(a)(1).. OIG............. Penalty for knowingly 2016 15,024 15,270

    presenting or causing to

    be presented to an

    officer, employee, or

    agent of the United States

    a false claim.

    Penalty for knowingly 2016 15,024 15,270

    presenting or causing to

    be presented a request for

    payment which violates the

    terms of an assignment,

    agreement, or PPS

    agreement.

    42 CFR 1003.210(a)(2) ................ Penalty for knowingly 2016 22,537 22,906

    giving or causing to be

    presented to a

    participating provider or

    supplier false or

    misleading information

    that could reasonably be

    expected to influence a

    discharge decision.

    42 CFR 1003.210(a)(3) ................ Penalty for an excluded 2016 15,024 15,270

    party retaining ownership

    or control interest in a

    participating entity.

    Page 9178

    42 CFR 1003.1010 ................ Penalty for remuneration 2016 15,024 15,270

    offered to induce program

    beneficiaries to use

    particular providers,

    practitioners, or

    suppliers.

    42 CFR 1003.210(a)(4) ................ Penalty for employing or 2016 14,718 14,959

    contracting with an

    excluded individual.

    42 CFR 1003.310(a)(3) ................ Penalty for knowing and 2016 73,588 74,792

    willful solicitation,

    receipt, offer, or payment

    of remuneration for

    referring an individual

    for a service or for

    purchasing, leasing, or

    ordering an item to be

    paid for by a Federal

    health care program.

    42 CFR 1003.210(a)(1) Penalty for ordering or 2016 10,874 11,052

    prescribing medical or

    other item or service

    during a period in which

    the person was excluded.

    42 CFR 1003.210(a)(6) Penalty for knowingly 2016 54,372 55,262

    making or causing to be

    made a false statement,

    omission or

    misrepresentation of a

    material fact in any

    application, bid, or

    contract to participate or

    enroll as a provider or

    supplier.

    42 CFR 1003.210(a)(8) ................ Penalty for knowing of an 2016 10,874 11,052

    overpayment and failing to

    report and return.

    42 CFR 1003.210(a)(7) ................ Penalty for making or using 2016 54,372 55,262

    a false record or

    statement that is material

    to a false or fraudulent

    claim.

    42 CFR 1003.210(a)(9) ................ Penalty for failure to 2016 16,312 16,579

    grant timely access to HHS

    OIG for audits,

    investigations,

    evaluations, and other

    statutory functions of HHS

    OIG.

    1320a-7a(b).......................... ....................... OIG............. Penalty for payments by a 2016 4,313 4,384

    hospital or critical

    access hospital to induce

    a physician to reduce or

    limit services to

    individuals under direct

    care of physician or who

    are entitled to certain

    medical assistance

    benefits.

    Penalty for physicians who 2016 4,313 4,384

    knowingly receive payments

    from a hospital or

    critical access hospital

    to induce such physician

    to reduce or limit

    services to individuals

    under direct care of

    physician or who are

    entitled to certain

    medical assistance

    benefits.

    42 CFR 1003.210(a)(10) Penalty for a physician who 2016 7,512 7,635

    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 to 2016 36,794 37,396

    report any final adverse

    action taken against a

    health care provider,

    supplier, or practitioner.

    1320b-10(b)(1)....................... 42 CFR 1003.610(a)..... OIG............. Penalty for the misuse of 2016 9,893 10,055

    words, symbols, or emblems

    in communications in a

    manner in which a person

    could falsely construe

    that such item is

    approved, endorsed, or

    authorized by HHS.

    1320b-10(b)(2)....................... 42 CFR 1003.610(a)..... OIG............. Penalty for the misuse of 2016 49,467 50,276

    words, symbols, or emblems

    in a broadcast or telecast

    in a manner in which a

    person could falsely

    construe that such item is

    approved, endorsed, or

    authorized by HHS.

    1395i-3(b)(3)(B)(ii)(1).............. 42 CFR 1003.210(a)(11). OIG............. Penalty for certification 2016 2,063 2,097

    of a false statement in

    assessment of functional

    capacity of a Skilled

    Nursing Facility resident

    assessment.

    1395i-3(b)(3)(B)(ii)(2).............. 42 CFR 1003.210(a)(11). OIG............. Penalty for causing another 2016 10,314 10,483

    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 individual 2016 4,126 4,194

    who notifies or causes to

    be notified a Skilled

    Nursing Facility of the

    time or date on which a

    survey is to be conducted.

    1395w-27(g)(2)(A).................... 42 CFR 1003.410........ OIG............. Penalty for a Medicare 2016 37,561 38,175

    Advantage organization

    that substantially fails

    to provide medically

    necessary, required items

    and services.

    Penalty for a Medicare 2016 36,794 37,396

    Advantage organization

    that charges excessive

    premiums.

    Penalty for a Medicare 2016 36,794 37,396

    Advantage organization

    that improperly expels or

    refuses to reenroll a

    beneficiary.

    Penalty for a Medicare 2016 147,177 149,585

    Advantage organization

    that engages in practice

    that would reasonably be

    expected to have the

    effect of denying or

    discouraging enrollment.

    Page 9179

    Penalty per individual who 2016 22,077 22,438

    does not enroll as a

    result of a Medicare

    Advantage organization's

    practice that would

    reasonably be expected to

    have the effect of denying

    or discouraging

    enrollment.

    Penalty for a Medicare 2016 147,177 149,585

    Advantage organization

    misrepresenting or

    falsifying information to

    Secretary.

    Penalty for a Medicare 2016 36,794 37,396

    Advantage organization

    misrepresenting or

    falsifying information to

    individual or other

    entity.

    Penalty for Medicare 2016 36,794 37,396

    Advantage organization

    interfering with

    provider's advice to

    enrollee and non-MCO

    affiliated providers that

    balance bill enrollees.

    Penalty for a Medicare 2016 36,794 37,396

    Advantage organization

    that employs or contracts

    with excluded individual

    or entity.

    Penalty for a Medicare 2016 36,794 37,396

    Advantage organization

    enrolling an individual in

    without prior written

    consent.

    Penalty for a Medicare 2016 36,794 37,396

    Advantage organization

    transferring an enrollee

    to another plan without

    consent or solely for the

    purpose of earning a

    commission.

    Penalty for a Medicare 2016 36,794 37,396

    Advantage organization

    failing to comply with

    marketing restrictions or

    applicable implementing

    regulations or guidance.

    Penalty for a Medicare 2016 36,794 37,396

    Advantage organization

    employing or contracting

    with an individual or

    entity who violates 1395w-

    27(g)(1)(A)-(J).

    1395w-141(i)(3)...................... ....................... OIG............. Penalty for a prescription 2016 12,856 13,066

    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

    billing by Hospitals,

    Critical Access Hospitals,

    or Skilled Nursing

    Facilities.

    1395dd(d)(1)......................... 42 CFR 1003.510........ OIG............. Penalty for a hospital or 2016 103,139 104,826

    responsible physician

    dumping patients needing

    emergency medical care, if

    the hospital has 100 beds

    or more.

    Penalty for a hospital or 2016 51,570 52,414

    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

    competitive plan is such

    plan substantially fails

    to provide medically

    necessary, required items

    or services.

    Penalty for HMOs/ 2016 51,570 52,414

    competitive medical plans

    that charge premiums in

    excess of permitted

    amounts.

    Penalty for a HMO or 2016 51,570 52,414

    competitive medical plan

    that expels or refuses to

    reenroll an individual per

    prescribed conditions.

    Penalty for a HMO or 2016 206,278 209,653

    competitive medical plan

    that implements practices

    to discourage enrollment

    of individuals needing

    services in future.

    Penalty per individual not 2016 29,680 30,166

    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

    competitive medical plan

    that misrepresents or

    falsifies information to

    the Secretary.

    Penalty for a HMO or 2016 51,570 52,414

    competitive medical plan

    that misrepresents or

    falsifies information to

    an individual or any other

    entity.

    Penalty for failure by HMO 2016 51,570 52,414

    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

    employs or contracts with

    excluded individual or

    entity.

    1395nn(g)(3)......................... 42 CFR 1003.310........ OIG............. Penalty for submitting or 2016 23,863 24,253

    causing to be submitted

    claims in violation of the

    Stark Law's restrictions

    on physician self-

    referrals.

    Page 9180

    1395nn(g)(4)......................... 42 CFR 1003.310........ OIG............. Penalty for circumventing 2016 159,089 161,692

    Stark Law's restrictions

    on physician self-

    referrals.

    1395ss(d)(1)......................... 42 CFR 1003.1110....... OIG............. Penalty for a material 2016 9,893 10,055

    misrepresentation

    regarding Medigap

    compliance policies.

    1395ss(d)(2)......................... 42 CFR 1003.1110....... OIG............. Penalty for selling Medigap 2016 9,893 10,055

    policy under false

    pretense.

    1395ss(d)(3)(A)(ii).................. 42 CFR 1003.1110....... OIG............. Penalty for an issuer that 2016 44,539 45,268

    sells health insurance

    policy that duplicates

    benefits.

    Penalty for someone other 2016 26,723 27,160

    than issuer that sells

    health insurance that

    duplicates benefits.

    1395ss(d)(4)(A)...................... 42 CFR 1003.1110....... OIG............. Penalty for using mail to 2016 9,893 10,055

    sell a non-approved

    Medigap insurance policy.

    1396b(m)(5)(B)(i).................... 42 CFR 1003.410........ OIG............. Penalty for a Medicaid MCO 2016 49,467 50,276

    that substantially fails

    to provide medically

    necessary, required items

    or services.

    Penalty for a Medicaid MCO 2016 49,467 50,276

    that charges excessive

    premiums.

    Penalty for a Medicaid MCO 2016 197,869 201,106

    that improperly expels or

    refuses to reenroll a

    beneficiary.

    Penalty per individual who 2016 29,680 30,166

    does not enroll as a

    result of a Medicaid MCO's

    practice that would

    reasonably be expected to

    have the effect of denying

    or discouraging

    enrollment.

    Penalty for a Medicaid MCO 2016 197,869 201,106

    misrepresenting or

    falsifying information to

    the Secretary.

    Penalty for a Medicaid MCO 2016 49,467 50,276

    misrepresenting or

    falsifying information to

    an individual or another

    entity.

    Penalty for a Medicaid MCO 2016 44,539 45,268

    that fails to comply with

    contract requirements with

    respect to physician

    incentive plans.

    1396r(b)(3)(B)(ii)(I)................ 42 CFR 1003.210(a)(11). OIG............. Penalty for willfully and 2016 2,063 2,097

    knowingly certifying a

    material and false

    statement in a Skilled

    Nursing Facility resident

    assessment.

    1396r(b)(3)(B)(ii)(II)............... 42 CFR 1003.210(a)(11). OIG............. Penalty for willfully and 2016 10,314 10,483

    knowingly causing another

    individual to certify a

    material and false

    statement in a Skilled

    Nursing Facility resident

    assessment.

    1396r(g)(2)(A)(i).................... 42 CFR 1003.1310....... OIG............. Penalty for notifying or 2016 4,126 4,194

    causing to be notified a

    Skilled Nursing Facility

    of the time or date on

    which a survey is to be

    conducted.

    1396r-8(b)(3)(B)..................... 42 CFR 1003.1210....... OIG............. Penalty for the knowing 2016 178,156 181,071

    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 failure 2016 17,816 18,107

    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

    provision of false

    information by drug

    manufacturer with rebate

    agreement.

    1396t(i)(3)(A)....................... 42 CFR 1003.1310....... OIG............. Penalty for notifying home 2016 3,563 3,621

    and community-based

    providers or settings of

    survey.

    11131(c)............................. 42 CFR 1003.810........ OIG............. Penalty for failing to 2016 21,563 21,916

    report a medical

    malpractice claim to

    National Practitioner Data

    Bank.

    11137(b)(2).......................... 42 CFR 1003.810........ OIG............. Penalty for breaching 2016 21,563 21,916

    confidentiality of

    information reported to

    National Practitioner Data

    Bank.

    299b-22(f)(1)........................ 42 CFR 3.404........... OCR............. Penalty for violation of 2016 11,940 12,135

    confidentiality provision

    of the Patient Safety and

    Quality Improvement Act.

    45 CFR OCR............. Penalty for each pre- 2016 150 152

    160.404(b)(1)(i), (ii) February 18, 2009

    violation of the HIPAA

    administrative

    simplification provisions.

    Calendar Year Cap.......... 2016 37,561 38,175

    1320(d)-5(a)......................... 45 CFR OCR............. Penalty for each February

    160.404(b)(2)(i)(A), 18, 2009 or later

    (B). violation of a HIPAA

    administrative

    simplification provision

    in which it is established

    that the covered entity or

    business associate did not

    know and by exercising

    reasonable diligence,

    would not have known that

    the covered entity or

    business associate

    violated such a provision:

    Minimum.................... 2016 110 112

    Maximum.................... 2016 55,010 55,910

    Calendar Year Cap.......... 2016 1,650,300 1,677,299

    Page 9181

    45 CFR OCR............. Penalty for each February

    160.404(b)(2)(ii)(A), 18, 2009 or later

    (B) violation of a HIPAA

    administrative

    simplification provision

    in which it is established

    that the violation was due

    to reasonable cause and

    not to willful neglect:

    Minimum.................... 2016 1,100 1,118

    Maximum.................... 2016 55,010 55,910

    Calendar Year Cap.......... 2016 1,650,300 1,677,299

    45 CFR OCR............. Penalty for each February

    160.404(b)(2)(iii)(A), 18, 2009 or later

    (B) violation of a HIPAA

    administrative

    simplification provision

    in which it is established

    that the violation was due

    to willful neglect and was

    corrected during the 30-

    day period beginning on

    the first date the covered

    entity or business

    associate knew, or, by

    exercising reasonable

    diligence, would have

    known that the violation

    occurred:

    Minimum.................... 2016 11,002 11,182

    Maximum.................... 2016 55,010 55,910

    Calendar Year Cap.......... 2016 1,650,300 1,677,299

    45 CFR OCR............. Penalty for each February

    160.404(b)(2)(iv)(A), 18, 2009 or later

    (B) violation of a HIPAA

    administrative

    simplification provision

    in which it is established

    that the violation was due

    to willful neglect and was

    not corrected during the

    30-day period beginning on

    the first date the covered

    entity or business

    associate knew, or by

    exercising reasonable

    diligence, would have

    known that the violation

    occurred:

    Minimum.................... 2016 55,010 55,910

    Maximum.................... 2016 1,650,300 1,677,299

    Calendar Year Cap.......... 2016 1,650,300 1,677,299

    263a(h)(2)(B) & 1395w-2(b)(2)(A)(ii). 42 CFR CMS............. Penalty for a clinical

    493.1834(d)(2)(i). laboratory's failure to

    meet participation and

    certification requirements

    and poses immediate

    jeopardy:

    Minimum.................... 2016 6,035 6,134

    Maximum.................... 2016 19,787 20,111

    42 CFR CMS............. Penalty for a clinical

    493.1834(d)(2)(ii). laboratory's failure to

    meet participation and

    certification requirements

    and the failure does not

    pose immediate jeopardy:

    Minimum.................... 2016 99 101

    Maximum.................... 2016 5,936 6,033

    300gg-15(f).......................... 45 CFR 147.200(e)...... CMS............. Failure to provide the 2016 1,087 1,105

    Summary of Benefits and

    Coverage.

    300gg-18............................. 45 CFR 158.606......... CMS............. Penalty for violations of 2016 109 111

    regulations related to the

    medical loss ratio

    reporting and rebating.

    1320a-7h(b)(1)....................... 42 CFR 402.105(d)(5), CMS............. Penalty for manufacturer or

    42 CFR 403.912(a) & group purchasing

    (c). 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

    Maximum.................... 2016 10,874 11,052

    Calendar Year Cap.......... 2016 163,117 165,786

    1320a-7h(b)(2)....................... 42 CFR 402.105(h), 42 CMS............. Penalty for manufacturer or

    CFR 403.912(b) & (c). group purchasing

    organization knowingly

    failing to report

    information required under

    42 U.S.C. 1320a-7h(a),

    relating to physician

    ownership or investment

    interests:

    Minimum.................... 2016 10,874 11,052

    Maximum.................... 2016 108,745 110,524

    Calendar Year Cap.......... 2016 1,087,450 1,105,241

    CMS Penalty for an 2016 108,745 110,524

    administrator of a

    facility that fails to

    comply with notice

    requirements for the

    closure of a facility.

    1320a-7j(h)(3)(A).................... 42 CFR 488.446(a)(1), CMS............. Minimum penalty for the 2016 544 553

    (2), & (3). first offense of an

    administrator who fails to

    provide notice of facility

    closure.

    Minimum penalty for the 2016 1,631 1,658

    second offense of an

    administrator who fails to

    provide notice of facility

    closure.

    Minimum penalty for the 2016 3,262 3,315

    third and subsequent

    offenses of an

    administrator who fails to

    provide notice of facility

    closure.

    Page 9182

    1320a-8(a)(1)........................ ....................... CMS............. Penalty for an entity 2016 7,954 8,084

    knowingly making a false

    statement or

    representation of material

    fact in the determination

    of the amount of benefits

    or payments related to old-

    age, survivors, and

    disability insurance

    benefits, special benefits

    for certain World War II

    veterans, or supplemental

    security income for the

    aged, blind, and disabled.

    Penalty for violation of 42 2016 7,500 7,623

    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

    representative payee

    (under 42 U.S.C. 405(j),

    1007, or 1383(a)(2))

    converting any part of a

    received payment from the

    benefit programs described

    in the previous civil

    monetary penalty to a use

    other than for the benefit

    of the beneficiary.

    1320b-25(c)(1)(A).................... ....................... CMS............. Penalty for failure of 2016 217,490 221,048

    covered individuals to

    report to the Secretary

    and 1 or more law

    enforcement officials any

    reasonable suspicion of a

    crime against a resident,

    or individual receiving

    care, from a long-term

    care facility.

    1320b-25(c)(2)(A).................... ....................... CMS............. Penalty for failure of 2016 326,235 331,572

    covered individuals to

    report to the Secretary

    and 1 or more law

    enforcement officials any

    reasonable suspicion of a

    crime against a resident,

    or individual receiving

    care, from a long-term

    care facility if such

    failure exacerbates the

    harm to the victim of the

    crime or results in the

    harm to another individual.

    1320b-25(d)(2)....................... ....................... CMS............. Penalty for a long-term 2016 217,490 221,048

    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 person who 2016 147 149

    knowingly and willfully

    fails to furnish a

    beneficiary with an

    itemized statement of

    items or services within

    30 days of the

    beneficiary's request.

    1395i-3(h)(2)(B)(ii)(I).............. 42 CFR CMS............. Penalty per day for a

    488.408(d)(1)(iii). Skilled Nursing Facility

    that has a Category 2

    violation of certification

    requirements:

    Minimum.................... 2016 103 105

    Maximum.................... 2016 6,188 6,289

    42 CFR CMS............. Penalty per instance of

    488.408(d)(1)(iv) Category 2 noncompliance

    by a Skilled Nursing

    Facility:

    Minimum.................... 2016 2,063 2,097

    Maximum.................... 2016 20,628 20,965

    42 CFR CMS............. Penalty per day for a

    488.408(e)(1)(iii) Skilled Nursing Facility

    that has a Category 3

    violation of certification

    requirements:

    Minimum.................... 2016 6,291 6,394

    Maximum.................... 2016 20,628 20,965

    42 CFR CMS............. Penalty per instance of

    488.408(e)(1)(iv) Category 3 noncompliance

    by a Skilled Nursing

    Facility:

    Minimum.................... 2016 2,063 2,097

    Maximum.................... 2016 20,628 20,965

    42 CFR CMS............. Penalty per day and per

    488.408(e)(2)(ii) instance for a Skilled

    Nursing Facility that has

    Category 3 noncompliance

    with Immediate Jeopardy:

    Per Day (Minimum).......... 2016 6,291 6,394

    Per Day (Maximum).......... 2016 20,628 20,965

    Per Instance (Minimum)..... 2016 2,063 2,097

    Per Instance (Maximum)..... 2016 20,628 20,965

    42 CFR 488.438(a)(1)(i) CMS............. Penalty per day of a

    Skilled Nursing Facility

    that fails to meet

    certification

    requirements. These

    amounts represent the

    upper range per day:

    Minimum.................... 2016 6,291 6,394

    Maximum.................... 2016 20,628 20,965

    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:

    Page 9183

    Minimum.................... 2016 103 105

    Maximum.................... 2016 6,188 6,289

    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

    Maximum.................... 2016 20,628 20,965

    1395l(h)(5)(D)....................... 42 CFR 402.105(d)(2)(i) CMS............. Penalty for knowingly, 2016 15,024 15,270

    willfully, and repeatedly

    billing for a clinical

    diagnostic laboratory test

    other than on an

    assignment-related basis.

    (Penalties are assessed in

    the same manner as 42

    U.S.C. 1395u(j)(2)(B),

    which is assessed

    according to 1320a-7a(a)).

    1395l(i)(6).......................... ....................... CMS............. Penalty for knowingly and 2016 3,957 4,022

    willfully presenting or

    causing to be presented a

    bill or request for

    payment for an intraocular

    lens inserted during or

    after cataract surgery for

    which the Medicare payment

    rate includes the cost of

    acquiring the class of

    lens involved.

    1395l(q)(2)(B)(i).................... 42 CFR 402.105(a)...... CMS............. Penalty for knowingly and 2016 3,787 3,849

    willfully failing to

    provide information about

    a referring physician when

    seeking payment on an

    unassigned basis.

    1395m(a)(11)(A)...................... 42 CFR 402.1(c)(4), CMS............. Penalty for any durable 2016 15,024 15,270

    402.105(d)(2)(ii). medical equipment supplier

    that knowingly and

    willfully charges for a

    covered service that is

    furnished on a rental

    basis after the rental

    payments may no longer be

    made. (Penalties are

    assessed in the same

    manner as 42 U.S.C.

    1395u(j)(2)(B), which is

    assessed according to

    1320a-7a(a)).

    1395m(a)(18)(B)...................... 42 CFR 402.1(c)(5), CMS............. Penalty for any 2016 15,024 15,270

    402.105(d)(2)(iii). nonparticipating durable

    medical equipment supplier

    that knowingly and

    willfully fails to make a

    refund to Medicare

    beneficiaries for a

    covered service for which

    payment is precluded due

    to an unsolicited

    telephone contact from the

    supplier. (Penalties are

    assessed in the same

    manner as 42 U.S.C.

    1395u(j)(2)(B), which is

    assessed according to

    1320a-7a(a)).

    1395m(b)(5)(C)....................... 42 CFR 402.1(c)(6), CMS............. Penalty for any 2016 15,024 15,270

    402.105(d)(2)(iv). nonparticipating physician

    or supplier that knowingly

    and willfully charges a

    Medicare beneficiary more

    than the limiting charge

    for radiologist services.

    (Penalties are assessed in

    the same manner as 42

    U.S.C. 1395u(j)(2)(B),

    which is assessed

    according to 1320a-7a(a)).

    1395m(h)(3).......................... 42 CFR 402.1(c)(8), CMS............. Penalty for any supplier of 2016 15,024 15,270

    402.105(d)(2)(vi). prosthetic devices,

    orthotics, and prosthetics

    that knowing and willfully

    charges for a covered

    prosthetic device,

    orthotic, or prosthetic

    that is furnished on a

    rental basis after the

    rental payment may no

    longer be made. (Penalties

    are assessed in the same

    manner as 42 U.S.C.

    1395m(a)(11)(A), that is

    in the same manner as

    1395u(j)(2)(B), which is

    assessed according to

    1320a-7a(a)).

    1395m(j)(2)(A)(iii).................. ....................... CMS............. Penalty for any supplier of 2016 1,591 1,617

    durable medical equipment

    including a supplier of

    prosthetic devices,

    prosthetics, orthotics, or

    supplies that knowingly

    and willfully distributes

    a certificate of medical

    necessity in violation of

    Section 1834(j)(2)(A)(i)

    of the Act or fails to

    provide the information

    required under Section

    1834(j)(2)(A)(ii) of the

    Act.

    1395m(j)(4).......................... 42 CFR 402.1(c)(10), CMS............. Penalty for any supplier of 2016 15,024 15,270

    402.105(d)(2)(vii). durable medical equipment,

    including a supplier of

    prosthetic devices,

    prosthetics, orthotics, or

    supplies that knowingly

    and willfully fails to

    make refunds in a timely

    manner to Medicare

    beneficiaries for series

    billed other than on as

    assignment-related basis

    under certain conditions.

    (Penalties are assessed in

    the same manner as 42

    U.S.C. 1395m(j)(4) and

    1395u(j)(2)(B), which is

    assessed according to

    1320a-7a(a)).

    Page 9184

    1395m(k)(6).......................... 42 CFR 402.1(c)(31), CMS............. Penalty for any person or 2016 15,024 15,270

    402.105(d)(3). entity who knowingly and

    willfully bills or

    collects for any

    outpatient therapy

    services or comprehensive

    outpatient rehabilitation

    services on other than an

    assignment-related basis.

    (Penalties are assessed in

    the same manner as 42

    U.S.C. 1395m(k)(6) and

    1395u(j)(2)(B), which is

    assessed according to

    1320a-7a(a)).

    1395m(l)(6).......................... 42 CFR 402.1(c)(32), CMS............. Penalty for any supplier of 2016 15,024 15,270

    402.105(d)(4). ambulance services who

    knowingly and willfully

    fills or collects for any

    services on other than an

    assignment-related basis.

    (Penalties are assessed in

    the same manner as 42

    U.S.C. 1395u(b)(18)(B),

    which is assessed

    according to 1320a-7a(a)).

    1395u(b)(18)(B)...................... 42 CFR 402.1(c)(11), CMS............. Penalty for any 2016 15,024 15,270

    402.105(d)(2)(viii). practitioner specified in

    Section 1842(b)(18)(C) of

    the Act or other person

    that knowingly and

    willfully bills or

    collects for any services

    by the practitioners on

    other than an assignment-

    related basis. (Penalties

    are assessed in the same

    manner as 42 U.S.C.

    1395u(j)(2)(B), which is

    assessed according to

    1320a-7a(a)).

    1395u(j)(2)(B)....................... 42 CFR 402.1(c)........ CMS............. Penalty for any physician 2016 15,024 15,270

    who charges more than 125%

    for a non-participating

    referral. (Penalties are

    assessed in the same

    manner as 42 U.S.C. 1320a-

    7a(a)).

    1395u(k)............................. 42 CFR 402.1(c)(12), CMS............. Penalty for any physician 2016 15,024 15,270

    402.105(d)(2)(ix). who knowingly and

    willfully presents or

    causes to be presented a

    claim for bill for an

    assistant at a cataract

    surgery performed on or

    after March 1, 1987, for

    which payment may not be

    made because of section

    1862(a)(15). (Penalties

    are assessed in the same

    manner as 42 U.S.C.

    1395u(j)(2)(B), which is

    assessed according to

    1320a-7a(a)).

    1395u(l)(3).......................... 42 CFR 402.1(c)(13), CMS............. Penalty for any 2016 15,024 15,270

    402.105(d)(2)(x). nonparticipating physician

    who does not accept

    payment on an assignment-

    related basis and who

    knowingly and willfully

    fails to refund on a

    timely basis any amounts

    collected for services

    that are not reasonable or

    medically necessary or are

    of poor quality under

    1842(l)(1)(A). (Penalties

    are assessed in the same

    manner as 42 U.S.C.

    1395u(j)(2)(B), which is

    assessed according to

    1320a-7a(a)).

    1395u(m)(3).......................... 42 CFR 402.1(c)(14), CMS............. Penalty for any 2016 15,024 15,270

    402.105(d)(2)(xi). nonparticipating physician

    charging more than $500

    who does not accept

    payment for an elective

    surgical procedure on an

    assignment related basis

    and who knowingly and

    willfully fails to

    disclose the required

    information regarding

    charges and coinsurance

    amounts and fails to

    refund on a timely basis

    any amount collected for

    the procedure in excess of

    the charges recognized and

    approved by the Medicare

    program. (Penalties are

    assessed in the same

    manner as 42 U.S.C.

    1395u(j)(2)(B), which is

    assessed according to

    1320a-7a(a)).

    1395u(n)(3).......................... 42 CFR 402.1(c)(15), CMS............. Penalty for any physician 2016 15,024 15,270

    402.105(d)(2)(xii). who knowingly, willfully,

    and repeatedly bills one

    or more beneficiaries for

    purchased diagnostic tests

    any amount other than the

    payment amount specified

    by the Act. (Penalties are

    assessed in the same

    manner as 42 U.S.C.

    1395u(j)(2)(B), which is

    assessed according to

    1320a-7a(a)).

    1395u(o)(3)(B)....................... 42 CFR 414.707(b)...... CMS............. Penalty for any 2016 15,024 15,270

    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)).

    Page 9185

    1395u(p)(3)(A)....................... ....................... CMS............. Penalty for any physician 2016 3,957 4,022

    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

    pharmaceutical

    manufacturer's

    misrepresentation of

    average sales price of a

    drug, or biologic.

    1395w-4(g)(1)(B)..................... 42 CFR 402.1(c)(17), CMS............. Penalty for any 2016 15,024 15,270

    402.105(d)(2)(xiii). nonparticipating

    physician, supplier, or

    other person that

    furnishes physician

    services not on an

    assignment-related basis

    who either knowingly and

    willfully bills or

    collects in excess of the

    statutorily-defined

    limiting charge or fails

    to make a timely refund or

    adjustment. (Penalties are

    assessed in the same

    manner as 42 U.S.C.

    1395u(j)(2)(B), which is

    assessed according to

    1320a-7a(a)).

    1395w-4(g)(3)(B)..................... 42 CFR 402.1(c)(18), CMS............. Penalty for any person that 2016 15,024 15,270

    402.105(d)(2)(xiv). knowingly and willfully

    bills for statutorily

    defined State-plan

    approved physicians'

    services on any other

    basis than an assignment-

    related basis for a

    Medicare/Medicaid dual

    eligible beneficiary.

    (Penalties are assessed in

    the same manner as 42

    U.S.C. 1395u(j)(2)(B),

    which is assessed

    according to 1320a-7a(a)).

    1395w-27(g)(3)(A); 1857(g)(3)........ 42 CFR 422.760(b); 42 CMS............. Penalty for each 2016 36,794 37,396

    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 week 2016 14,718 14,959

    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 Medicare 2016 136,689 138,925

    Advantage organization's

    or Part D sponsor's early

    termination of its

    contract.

    1395y(b)(3)(C)....................... 42 CFR 411.103(b)...... CMS............. Penalty for an employer or 2016 8,908 9,054

    other entity to offer any

    financial or other

    incentive for an

    individual entitled to

    benefits not to enroll

    under a group health plan

    or large group health plan

    which would be a primary

    plan.

    1395y(b)(5)(C)(ii)................... 42 CFR 402.1(c)(20), 42 CMS............. Penalty for any non- 2016 1,450 1,474

    CFR 402.105(b)(2). governmental employer

    that, before October 1,

    1998, willfully or

    repeatedly failed to

    provide timely and

    accurate information

    requested relating to an

    employee's group health

    insurance coverage.

    1395y(b)(6)(B)....................... 42 CFR 402.1(c)(21), CMS............. Penalty for any entity that 2016 3,182 3,234

    402.105(a). knowingly, willfully, and

    repeatedly fails to

    complete a claim form

    relating to the

    availability of other

    health benefits in

    accordance with statute or

    provides inaccurate

    information relating to

    such on the claim form.

    1395y(b)(7)(B)(i).................... ....................... CMS............. Penalty for any entity 2016 1,138 1,157

    serving as insurer, third

    party administrator, or

    fiduciary for a group

    health plan that fails to

    provide information that

    identifies situations

    where the group health

    plan is or was a primary

    plan to Medicare to the

    HHS Secretary.

    1395y(b)(8)(E)....................... ....................... CMS............. Penalty for any non-group 2016 1,138 1,157

    health plan that fails to

    identify claimants who are

    Medicare beneficiaries and

    provide information to the

    HHS Secretary to

    coordinate benefits and

    pursue any applicable

    recovery claim.

    1395nn(g)(5)......................... 42 CFR 411.361......... CMS............. Penalty for any person that 2016 18,936 19,246

    fails to report

    information required by

    HHS under Section 1877(f)

    concerning ownership,

    investment, and

    compensation arrangements.

    Page 9186

    1395pp(h)............................ 42 CFR 402.1(c)(23), CMS............. Penalty for any durable 2016 15,024 15,270

    402.105(d)(2)(xv). medical equipment

    supplier, including a

    supplier of prosthetic

    devices, prosthetics,

    orthotics, or supplies,

    that knowingly and

    willfully fails to make

    refunds in a timely manner

    to Medicare beneficiaries

    under certain conditions.

    (42 U.S.C. 1395(m)(18)

    sanctions apply here in

    the same manner, which is

    under 1395u(j)(2) and

    1320a-7a(a)).

    1395ss(a)(2)......................... 42 CFR 402.1(c)(24), CMS............. Penalty for any person that 2016 51,569 52,413

    405.105(f)(1). issues a Medicare

    supplemental policy that

    has not been approved by

    the State regulatory

    program or does not meet

    Federal standards after a

    statutorily defined

    effective date.

    1395ss(d)(3)(A)(vi) (II)............. ....................... CMS............. Penalty for someone other 2016 26,723 27,160

    than issuer that sells or

    issues a Medicare

    supplemental policy to

    beneficiary without a

    disclosure statement.

    Penalty for an issuer that 2016 44,539 45,268

    sells or issues a Medicare

    supplemental policy

    without disclosure

    statement.

    1395ss(d)(3)(B)(iv).................. ....................... CMS............. Penalty for someone other 2016 26,723 27,160

    than issuer that sells or

    issues a Medicare

    supplemental policy

    without acknowledgement

    form.

    Penalty for issuer that 2016 44,539 45,268

    sells or issues a Medicare

    supplemental policy

    without an acknowledgement

    form.

    1395ss(p)(8)......................... 42 CFR 402.1(c)(25), CMS............. Penalty for any person that 2016 26,723 27,160

    402.105(e). sells or issues Medicare

    supplemental polices after

    a given date that fail to

    conform to the NAIC or

    Federal standards

    established by statute.

    42 CFR 402.1(c)(25), CMS............. Penalty for any person that 2016 44,539 45,268

    405.105(f)(2) sells or issues Medicare

    supplemental polices after

    a given date that fail to

    conform to the NAIC or

    Federal standards

    established by statute.

    1395ss(p)(9)(C)...................... 42 CFR 402.1(c)(26), CMS............. Penalty for any person that 2016 26,723 27,160

    402.105(e). sells a Medicare

    supplemental policy and

    fails to make available

    for sale the core group of

    basic benefits when

    selling other Medicare

    supplemental policies with

    additional benefits or

    fails to provide the

    individual, before selling

    the policy, an outline of

    coverage describing

    benefits.

    42 CFR 402.1(c)(26), ................ Penalty for any person that 2016 44,539 45,268

    405.105(f)(3), (4) sells a Medicare

    supplemental policy and

    fails to make available

    for sale the core group of

    basic benefits when

    selling other Medicare

    supplemental policies with

    additional benefits or

    fails to provide the

    individual, before selling

    the policy, an outline of

    coverage describing

    benefits.

    1395ss(q)(5)(C)...................... 42 CFR 402.1(c)(27), CMS............. Penalty for any person that 2016 44,539 45,268

    405.105(f)(5). fails to suspend the

    policy of a policyholder

    made eligible for medical

    assistance or

    automatically reinstates

    the policy of a

    policyholder who has lost

    eligibility for medical

    assistance, under certain

    circumstances.

    1395ss(r)(6)(A)...................... 42 CFR 402.1(c)(28), CMS............. Penalty for any person that 2016 44,539 45,268

    405.105(f)(6). fails to provide refunds

    or credits as required by

    section 1882(r)(1)(B).

    1395ss(s)(4)......................... 42 CFR 402.1(c)(29), CMS............. Penalty for any issuer of a 2016 18,908 19,217

    405.105(c). Medicare supplemental

    policy that does not waive

    listed time periods if

    they were already

    satisfied under a

    proceeding Medicare

    supplemental policy, or

    denies a policy, or

    conditions the issuances

    or effectiveness of the

    policy, or discriminates

    in the pricing of the

    policy base on health

    status or other specified

    criteria.

    1395ss(t)(2)......................... 42 CFR 402.1(c)(30), CMS............. Penalty for any issuer of a 2016 44,539 45,268

    405.105(f)(7). Medicare supplemental

    policy that fails to

    fulfill listed

    responsibilities.

    1395ss(v)(4)(A)...................... ....................... CMS............. Penalty someone other than 2016 19,284 19,599

    issuer who sells, issues,

    or renews a medigap Rx

    policy to an individual

    who is a Part D enrollee.

    Penalty for an issuer who 2016 32,140 32,666

    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 individual 2016 4,126 4,194

    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.

    Page 9187

    1395bbb(f)(2)(A)(i).................. 42 CFR CMS............. Maximum daily penalty 2016 19,787 20,111

    488.845(b)(2)(iii) 42 amount for each day a home

    CFR 488.845(b)(3)-(6); health agency is not in

    and 42 CFR compliance with statutory

    488.845(d)(1)(ii). requirements.

    42 CFR 488.845(b)(3) ................ Penalty per day for home

    health agency's

    noncompliance (Upper

    Range):

    Minimum.................... 2016 16,819 17,094

    Maximum.................... 2016 19,787 20,111

    42 CFR 488.845(b)(3)(i) ................ Penalty for a home health 2016 19,787 20,111

    agency's deficiency or

    deficiencies that cause

    immediate jeopardy and

    result in actual harm.

    42 CFR ................ Penalty for a home health 2016 17,808 18,099

    488.845(b)(3)(ii) agency's deficiency or

    deficiencies that cause

    immediate jeopardy and

    result in potential for

    harm.

    42 CFR ................ Penalty for an isolated 2016 16,819 17,094

    488.845(b)(3)(iii) incident of noncompliance

    in violation of

    established HHA policy.

    42 CFR 488.845(b)(4) ................ Penalty for a repeat and/or

    condition-level deficiency

    that does not constitute

    immediate jeopardy, but is

    directly related to poor

    quality patient care

    outcomes (Lower Range):

    Minimum.................... 2016 2,968 3,017

    Maximum.................... 2016 16,819 17,094

    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

    Maximum.................... 2016 7,915 8,044

    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

    Maximum.................... 2016 19,787 20,111

    Penalty for each day of 2016 19,787 20,111

    noncompliance (Maximum).

    42 CFR ................ Penalty for each day of 2016 19,787 20,111

    488.845(d)(1)(ii) noncompliance (Maximum).

    1396b(m)(5)(B)....................... 42 CFR 460.46.......... CMS............. Penalty for PACE

    organization's practice

    that would reasonably be

    expected to have the

    effect of denying or

    discouraging enrollment:

    Minimum.................... 2016 22,077 22,438

    Maximum.................... 2016 147,177 149,585

    Penalty for a PACE 2016 36,794 37,396

    organization that charges

    excessive premiums.

    Penalty for a PACE 2016 147,177 149,585

    organization

    misrepresenting or

    falsifying information to

    CMS, the State, or an

    individual or other

    entity.

    Penalty for each 2016 36,794 37,396

    determination the CMS

    makes that the PACE

    organization has failed to

    provide medically

    necessary items and

    services of the failure

    has adversely affected (or

    has the substantial

    likelihood of adversely

    affecting) a PACE

    participant.

    Penalty for involuntarily 2016 36,794 37,396

    disenrolling a

    participant.

    Penalty for discriminating 2016 36,794 37,396

    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 a

    488.408(d)(1)(iii). nursing facility's failure

    to meet a Category 2

    Certification:

    Minimum.................... 2016 103 105

    Maximum.................... 2016 6,188 6,289

    42 CFR CMS............. Penalty per instance for a

    488.408(d)(1)(iv) nursing facility's failure

    to meet Category 2

    certification:

    Minimum.................... 2016 2,063 2,097

    Maximum.................... 2016 20,628 20,965

    42 CFR CMS............. Penalty per day for a

    488.408(e)(1)(iii) nursing facility's failure

    to meet Category 3

    certification:

    Minimum.................... 2016 6,291 6,394

    Maximum.................... 2016 20,628 20,965

    42 CFR CMS............. Penalty per instance for a

    488.408(e)(1)(iv) nursing facility's failure

    to meet Category 3

    certification:

    Minimum.................... 2016 2,063 2,097

    Page 9188

    Maximum.................... 2016 20,628 20,965

    42 CFR CMS............. Penalty per instance for a

    488.408(e)(2)(ii) nursing facility's failure

    to meet Category 3

    certification, which

    results in immediate

    jeopardy:

    Minimum.................... 2016 2,063 2,097

    Maximum.................... 2016 20,628 20,965

    42 CFR 488.438(a)(1)(i) CMS............. Penalty per day for nursing

    facility's failure to meet

    certification (Upper

    Range):

    Minimum.................... 2016 6,291 6,394

    Maximum.................... 2016 20,628 20,965

    42 CFR CMS............. Penalty per day for nursing

    488.438(a)(1)(ii) facility's failure to meet

    certification (Lower

    Range):

    Minimum.................... 2016 103 105

    Maximum.................... 2016 6,188 6,289

    42 CFR 488.438(a)(2) CMS............. Penalty per instance for

    nursing facility's failure

    to meet certification:

    Minimum.................... 2016 2,063 2,097

    Maximum.................... 2016 20,628 20,965

    1396r(f)(2)(B)(iii)(I)(c)............ 42 CFR CMS............. Grounds to prohibit 2016 10,314 10,483

    483.151(b)(2)(iv) and approval of Nurse Aide

    (b)(3)(iii). Training Program--if

    assessed a penalty in

    1819(h)(2)(B)(i) or

    1919(h)(2)(A)(ii) of ``not

    less than $5,000'' Not

    CMP authority, but a

    specific CMP amount (CMP

    at this level) that is the

    triggering condition for

    disapproval.

    1396r(h)(3)(C)(ii)(I)................ 42 CFR 483.151(c)(2)... CMS............. Grounds to waive 2016 10,314 10,483

    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

    Maximum.................... 2016 17,816 18,107

    1396u-2(e)(2)(A)(i).................. 42 CFR 438.704......... CMS............. Penalty for a Medicaid 2016 36,794 37,396

    managed care organization

    that fails substantially

    to provide medically

    necessary items and

    services.

    Penalty for Medicaid 2016 36,794 37,396

    managed care organization

    that imposes premiums or

    charges on enrollees in

    excess of the premiums or

    charges permitted.

    Penalty for a Medicaid 2016 36,794 37,396

    managed care organization

    that misrepresents or

    falsifies information to

    another individual or

    entity.

    Penalty for a Medicaid 2016 36,794 37,396

    managed care organization

    that fails to comply with

    the applicable statutory

    requirements for such

    organizations.

    1396u-2(e)(2)(A)(ii)................. 42 CFR 438.704......... CMS............. Penalty for a Medicaid 2016 147,177 149,585

    managed care organization

    that misrepresents or

    falsifies information to

    the HHS Secretary.

    Penalty for Medicaid 2016 147,177 149,585

    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 individual 2016 22,077 22,438

    that does not enroll as a

    result of a Medicaid

    managed care organization

    that acts to discriminate

    among enrollees on the

    basis of their health

    status.

    1396u(h)(2).......................... 42 CFR Part 441, CMS............. Penalty for a provider not 2016 20,628 20,965

    Subpart I. meeting one of the

    requirements relating to

    the protection of the

    health, safety, and

    welfare of individuals

    receiving community

    supported living

    arrangements services.

    1396w-2(c)(1)........................ ....................... CMS............. Penalty for disclosing 2016 11,002 11,182

    information related to

    eligibility determinations

    for medical assistance

    programs.

    18041(c)(2).......................... 45 CFR 150.315; 45 CFR CMS............. Failure to comply with 2016 150 152

    156.805(c). requirements of the Public

    Health Services Act;

    Penalty for violations of

    rules or standards of

    behavior associated with

    issuer participation in

    the Federally-facilitated

    Exchange. (42 U.S.C. 300gg-

    22(b)(2)(C)).

    18081(h)(1)(A)(i)(II)................ 42 CFR 155.285......... CMS............. Penalty for providing false 2016 27,186 27,631

    information on Exchange

    application.

    18081(h)(1)(B)....................... 42 CFR 155.285......... CMS............. Penalty for knowingly or 2016 271,862 276,310

    willfully providing false

    information on Exchange

    application.

    Page 9189

    18081(h)(2).......................... 42 CFR 155.260......... CMS............. Penalty for knowingly or 2016 27,186 27,631

    willfully disclosing

    protected information from

    Exchange.

    31 U.S.C.

    1352................................. 45 CFR 93.400(e)....... HHS............. Penalty for the first time 2016 18,936 19,246

    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

    Maximum.................... 2016 189,361 192,459

    Penalty for the first time 2016 18,936 19,246

    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

    Maximum.................... 2016 189,361 192,459

    45 CFR Part 93, HHS............. Penalty for failure to

    Appendix A provide certification

    regarding lobbying in the

    award documents for all

    sub-awards of all tiers:

    Minimum.................... 2016 18,936 19,246

    Maximum.................... 2016 189,361 192,459

    Penalty for failure to

    provide statement

    regarding lobbying for

    loan guarantee and loan

    insurance transactions:

    Minimum.................... 2016 18,936 19,246

    Maximum.................... 2016 189,361 192,459

    3801-3812............................ 45 CFR 79.3(a)(1)(iv).. HHS............. Penalty against any 2016 9,894 10,056

    individual who--with

    knowledge or reason to

    know--makes, presents or

    submits a false,

    fictitious or fraudulent

    claim to the Department.

    45 CFR 79.3(b)(1)(ii) ................ Penalty against any 2016 9,894 10,056

    individual who--with

    knowledge or reason to

    know--makes, presents or

    submits a false,

    fictitious or fraudulent

    claim to the Department.

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

    \1\ Some HHS components have not promulgated regulations regarding their civil monetary penalty-specific statutory authorities.

    \2\ The description is not intended to be a comprehensive explanation of the underlying violation; the statute and corresponding regulation, if

    applicable should be consulted.

    \3\ Statutory or Inflation Act Adjustment.

    \4\ The cost of living multiplier for 2017, based on the Consumer Price Index (CPI-U) for the month of October 2016, not seasonally adjusted, is

    1.01636, as indicated in OMB Memorandum M-17-11, ``Implementation of the 2017 annual adjustment pursuant to the Federal Civil Penalties Adjustment Act

    Improvements Act of 2015'' (December 16, 2016).

    Dated: January 30, 2017.

    Norris Cochran,

    Acting Secretary, Department of Health and Human Services.

    FR Doc. 2017-02300 Filed 2-2-17; 8:45 am

    BILLING CODE 4150-24-P

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