Adjustment of Civil Monetary Penalties for Inflation

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary

42 CFR Part 3

Centers for Medicare & Medicaid Services

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

Office of the Inspector General

42 CFR Part 1003

Office of the Secretary

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

Administration for Children and Families

45 CFR Part 303

RIN 0991-AC0

Adjustment of Civil Monetary Penalties for Inflation

AGENCY:

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

ACTION:

Interim final rule.

SUMMARY:

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

DATES:

This rule is effective on September 6, 2016.

FOR FURTHER INFORMATION CONTACT:

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

SUPPLEMENTARY INFORMATION:

I. Regulatory Information

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

1

1

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

II. Background and Requirements of the Law

On November 2, 2015, the President signed into law the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (the 2015 Act) (Sec. 701 of the Bipartisan Budget Act of 2015, Public Law 114-74, November 2, 2015), which amended the Federal Civil Penalties Inflation Adjustment Act of 1990 (the Inflation Adjustment Act) (Pub. L. 101-410, 104 Stat. 890 (1990) (codified as amended at 28 U.S.C. 2461 note 2(a)), to improve the effectiveness of civil monetary penalties and to maintain their deterrent effect. The 2015 Act, which removed an inflation update exclusion that previously applied to the Social Security Act as well as the Occupational Safety and Health Act, requires agencies to: (1) Adjust the level of civil monetary penalties with an initial “catch-up” adjustment through an interim final rulemaking (IFR); and (2) make subsequent annual adjustments for inflation.

The method of calculating inflation adjustments in the 2015 Act differs substantially from the methods used in past inflation adjustment rulemakings conducted pursuant to the Inflation Adjustment Act. Previously, adjustments to civil monetary penalties were conducted under rules that required significant rounding of figures. While this allowed penalties to be kept at round numbers, it meant that penalties would often not be increased at all if the inflation factor was not large enough. Furthermore, increases to penalties were capped at 10 percent. Over time, this formula caused penalties to lose value relative to total inflation.

The 2015 Act has removed these rounding rules; now, penalties are simply rounded to the nearest dollar. While this creates penalty values that are no longer round numbers, it does ensure that penalties will be increased each year to a figure commensurate with the actual calculated inflation. Furthermore, the 2015 Act “resets” the inflation calculations by excluding prior inflationary adjustments under the Inflation Adjustment Act, which contributed to a decline in the real value of penalty levels. To do this, the 2015 Act requires agencies to identify, for each penalty, the year and corresponding amount(s) for which the maximum penalty level or range of minimum and maximum penalties was established (

i.e.,

originally enacted by Congress) or last adjusted other than pursuant to the Inflation Adjustment Act.

In this rule, the adjusted civil penalty amounts are applicable only to civil penalties assessed after August 1, 2016, whose associated violations occurred after November 2, 2015, the date of enactment of the 2015 Amendments. Therefore, violations occurring on or before November 2, 2015, and assessments made prior to August 1, 2016, whose associated violations occurred after November 2, 2015, will continue to be subject to the civil monetary penalty amounts set forth in the Department's existing regulations or as set forth by statute if the amount has not yet been adjusted by regulation.

Pursuant to the 2015 Act, the Department of Health and Human Services (HHS) has undertaken a thorough review of civil monetary penalties administered by its various components. This IFR sets forth the initial “catch-up” adjustment for civil monetary penalties as well as any necessary technical conforming changes to the language of the various regulations affected by this IFR. For

each component, HHS has provided a table showing how the penalties are being increased pursuant to the 2015 Act. The first two columns (“Citation”) identify the United States Code (U.S.C.) statutory citation, and the applicable regulatory citation in the Code of Federal Regulations (CFR), if any. The third column (“Description”) provides a short description of the penalty. In the fourth column (“Pre-Inflation Penalty”), HHS has listed the penalty amount as it exists prior to the inflationary adjustments made by the effective date of this rule, and in the fifth column (“Date of Last Penalty Figure or Adjustment”), HHS has provided the amount and year of the penalty as enacted by Congress or changed through a mechanism other than pursuant to the Inflation Adjustment Act. In column six (“Percentage Increase”), HHS has listed the percentage increase based on the multiplier used to adjust from the CPI-U

2

of the year of enactment of the monetary penalty to the CPI-U for the current year, or a percentage equal to 150 percent, whichever is less. Multiplying the current penalty amount in column four by the percentage increase provides the “Increase” listed in column seven. The “Maximum Adjusted Penalty” in column eight is the sum of the current penalty amount and the “increase”. Where applicable, some HHS agencies will make as soon as practicable conforming edits to regulatory text. Additionally, HHS is issuing new regulatory text including the table showing how the penalties are being increased under the 2015 Act, located at 45 CFR part 102, to implement the civil monetary penalty (CMP) amounts adjusted for inflation agency-wide. Additionally, the 2015 Act requires agencies to publish annual adjustments not later than January 15 of every year after publication of the initial adjustment.

2

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

http://www.bls.gov/cpi/.

Calculation of CMP Adjustments

Citation

U.S.C.

CFR

1

Description

2

Pre-inflation penalty

($)

Date of last penalty

figure or

adjustment

3

Percentage

increase

4

Increase

($)

5

Maximum

adjusted

penalty

($)

21 U.S.C. (FDA):

333(b)(2)(A)

Penalty for violations related to drug samples resulting in a conviction of any representative of manufacturer or distributor in any 10-year period

50,000

1988

97.869

48,935

98,935

333(b)(2)(B)

Penalty for 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

1,000,000

1988

97.869

978,690

1,978,690

333(b)(3)

Penalty for failure to make a report required by 21 U.S.C. 353(d)(3)(E) relating to drug samples

100,000

1988

97.869

97,869

197,869

333(f)(1)(A)

Penalty for any person who violates a requirement related to devices for each such violation

15,000

1990

78.156

11,723

26,723

Penalty for aggregate of all violations related to devices in a single proceeding

1,000,000

1990

78.156

781,560

1,781,560

333(f)(2)(A)

Penalty for any 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

50,000

1996

50.425

25,123

75,123

Penalty in the case of any other person other than an individual for such introduction or delivery of adulterated food

250,000

1996

50.425

125,613

375,613

Penalty for aggregate of all such violations related to adulterated food adjudicated in a single proceeding

500,000

1996

50.425

251,225

751,225

333(f)(3)(A)

Penalty for all violations adjudicated in a single proceeding for any person who fails to submit certification required by 42 U.S.C. 282(j)(5)(B) or knowingly submitting a false certification

10,000

2007

13.833

1,383

11,383

333(f)(3)(B)

Penalty for each day the above violation is not corrected after a 30-day period following notification until the violation is corrected

10,000

2007

13.833

1,383

11,383

333(f)(4)(A)(i)

Penalty for any 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)

250,000

2007

13.833

34,583

284,583

Penalty for aggregate of all such above violations in a single proceeding

1,000,000

2007

13.833

138,330

1,138,330

333(f)(4)(A)(ii)

Penalty for REMS violation that continues after written notice to the responsible person for the first 30-day period (or any portion thereof) the responsible person continues to be in violation

250,000

2007

13.833

34,583

284,583

Penalty for REMS violation that continues after written notice to responsible person doubles for every 30-day period thereafter the violation continues, but may not exceed penalty amount for any 30-day period

1,000,000

2007

13.833

138,330

1,138,330

Penalty for aggregate of all such above violations adjudicated in a single proceeding

10,000,000

2007

13.833

1,383,300

11,383,300

333(f)(9)(A)

Penalty for any person who violates a requirement which relates to tobacco products for each such violation

15,000

2009

10.02

1,503

16,503

Penalty for aggregate of all such violations of tobacco product requirement adjudicated in a single proceeding

1,000,000

2009

10.02

100,200

1,100,200

333(f)(9)(B)(i)(I)

Penalty per violation related to violations of tobacco requirements

250,000

2009

10.02

25,050

275,050

Penalty for aggregate of all such violations of tobacco product requirements adjudicated in a single proceeding

1,000,000

2009

10.02

100,200

1,100,200

333(f)(9)(B)(i)(II)

Penalty in the case of a violation of tobacco product requirements that continues after written notice to such person, for the first 30-day period (or any portion thereof) the person continues to be in violation

250,000

2009

10.02

25,050

275,050

Penalty for 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

1,000,000

2009

10.02

100,200

1,100,200

Penalty for aggregate of all such violations related to tobacco product requirements adjudicated in a single proceeding

10,000,000

2009

10.02

1,002,000

11,002,000

333(f)(9)(B)(ii)(I)

Penalty for any 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

250,000

2009

10.02

25,050

275,050

Penalty for aggregate of for all such above violations adjudicated in a single proceeding

1,000,000

2009

10.02

100,200

1,100,200

333(f)(9)(B)(ii)(II)

Penalty for 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

250,000

2009

10.02

25,050

275,050

Penalty for post-notice violation of modified risk tobacco product post-market surveillance shall double for every 30-day period thereafter that the tobacco product requirement violation continues for any 30-day period, but may not exceed penalty amount for any 30-day period

1,000,000

2009

10.02

100,200

1,100,200

Penalty for aggregate above tobacco product requirement violations adjudicated in a single proceeding

10,000,000

2009

10.02

1,002,000

11,002,000

333(g)(1)

Penalty for any 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

250,000

2007

13.833

34,583

284,583

Penalty for each subsequent above violation in any 3-year period

500,000

2007

13.833

69165

569,165

333 note

Penalty to be 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

250

2009

10.02

25

275

Penalty in the case of a third tobacco product regulation violation within a 24-month period

500

2009

10.02

50

550

Penalty in the case of a fourth tobacco product regulation violation within a 24-month period

2,000

2009

10.02

200

2,200

Penalty in the case of a fifth tobacco product regulation violation within a 36-month period

5,000

2009

10.02

501

5,501

Penalty in the case of a sixth or subsequent tobacco product regulation violation within a 48-month period as determined on a case-by-case basis

10,000

2009

10.02

1,002

11,002

Penalty to be 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

250

2009

10.02

25

275

Penalty in the case of a second tobacco product regulation violation within a 12-month period

500

2009

10.02

50

550

Penalty in the case of a third tobacco product regulation violation within a 24-month period

1,000

2009

10.02

100

1,100

Penalty in the case of a fourth tobacco product regulation violation within a 24-month period

2,000

2009

10.02

200

2,200

Penalty in the case of a fifth tobacco product regulation violation within a 36-month period

5,000

2009

10.02

501

5,501

Penalty in the case of a sixth or subsequent tobacco product regulation violation within a 48-month period as determined on a case-by-case basis

10,000

2009

10.02

1002

11,002

335b(a)

Penalty for each 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

250,000

1992

67.728

169,320

419,320

Penalty in the case of any other person (other than an individual) per above violation

1,000,000

1992

67.728

677,280

1,677,280

360pp(b)(1)

Penalty for any person who violates any such requirements for electronic products, with each unlawful act or omission constituting a separate violation

1,100

1968

150

1,500

2,750

Penalty imposed for any related series of violations of requirements relating to electronic products

375,000

1968

150

562,500

937,500

42 U.S.C. (FDA):

262(d)

Penalty per day for violation of order of recall of biological product presenting imminent or substantial hazard

100,000

1986

115.628

115,628

215,628

263b(h)(3)

Penalty for failure to obtain a mammography certificate as required

10,000

1992

67.728

6,773

16,773

300aa-28(b)(1)

Penalty per occurrence for any vaccine manufacturer that intentionally destroys, alters, falsifies, or conceals any record or report required

100,000

1986

115.628

115,628

215,628

42 U.S.C. (HRSA):

256b(d)(1)(B)(vi)

Penalty for each instance of overcharging a 340B covered entity

5,000

2010

8.745

437

5,437

42 U.S.C. (AHRQ):

299c-(3)(d)

Penalty for an establishment or person supplying information obtained in the course of activities for any purpose other than the purpose for which it was supplied

10,000

1999

41.402

4,140

14,140

42 U.S.C. ACF:

653(l)(2)

45 CFR 303.21(f)

Penalty for Misuse of Information in the National Directory of New Hires

1,000

1998

45.023

450

1,450

42 U.S.C. (OIG):

262a(i)(1)

42 CFR Part 1003

Penalty for each individual who violates safety and security procedures related to handling dangerous biological agents and toxins

250,000

2002

31.185

77,962

327,962

Penalty for any other person who violates safety and security procedures related to handling dangerous biological agents and toxins

500,000

2002

31.185

155,925

655,925

1320a-7a(a)

42 CFR Part 1003

Penalty for knowingly presenting or causing to be presented to an officer, employee, or agent of the United States a false claim

10,000

1996

50.245

5,024

15,024

Penalty for knowingly presenting or causing to be presented a request for payment which violates the terms of an assignment, agreement, or PPS agreement

10,000

1996

50.245

5,024

15,024

Penalty for 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

15,000

1996

50.245

7,537

22,537

Penalty for an excluded party retaining ownership or control interest in a participating entity

10,000

1996

50.245

5,024

15,024

Penalty for remuneration offered to induce program beneficiaries to use particular providers, practitioners, or suppliers

10,000

1996

50.245

5,024

15,024

Penalty for employing or contracting with an excluded individual

10,000

1997

47.177

4,718

14,718

Penalty for knowing and willful solicitation, receipt, offer, or payment of remuneration for referring an individual for a service or for purchasing, leasing, or ordering an item to be paid for by a Federal health care program

50,000

1997

47.177

23,588

73,588

Penalty for ordering or prescribing medical or other item or service during a period in which the person was excluded

10,000

2010

8.745

874

10,874

Penalty for 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

50,000

2010

8.745

4,372

54,372

Penalty for knowing of an overpayment and failing to report and return

10,000

2010

8.745

874

10,874

Penalty for making or using a false record or statement that is material to a false or fraudulent claim

50,000

2010

8.745

4,372

54,372

Penalty for failure to grant timely access to HHS OIG for audits, investigations, evaluations, and other statutory functions of HHS OIG

15,000

2010

8.745

1,312

16,312

1320a-7a(b)

42 CFR Part 1003

Penalty for payments by a hospital or critical access hospital to induce a physician to reduce or limit services to individuals under direct care of physician or who are entitled to certain medical assistance benefits

2,000

1986

115.628

2,313

4,313

Penalty for 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

2,000

1986

115.628

2,313

4,313

Penalty for a physician who executes a document that falsely certifies home health needs for Medicare beneficiaries

5,000

1996

50.245

2,512

7,512

1320a-7e(b)(6)(A)

42 CFR Part 1003

Penalty for failure to report any final adverse action taken against a health care provider, supplier, or practitioner

25,000

1997

47.177

11,794

36,794

1320b-10(b)(1)

42 CFR Part 1003

Penalty for the 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

5,000

1988

97.869

4,893

9,893

1320b-10(b)(2)

42 CFR Part 1003

Penalty for the 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

25,000

1988

97.869

24,467

49,467

1395i-3(b)(3)(B)(ii)(1)

Penalty for certification of a false statement in assessment of functional capacity of a Skilled Nursing Facility resident assessment

1,000

1987

106.278

1,063

2,063

1395i-3(b)(3)(B)(ii)(2)

Penalty for causing another to certify or make a false statement in assessment of functional capacity of a Skilled Nursing Facility resident assessment

5,000

1987

106.278

5,314

10,314

1395i-3(g)(2)(A)

Penalty for any 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

2,000

1987

106.278

2,126

4,126

1395w-27(g)(2)(A)

42 CFR 422.752; 42 CFR Part 1003

Penalty for a Medicare Advantage organization that substantially fails to provide medically necessary, required items and services

25,000

1996

50.245

12,561

37,561

Penalty for a Medicare Advantage organization that charges excessive premiums

25,000

1997

47.177

11,794

36,794

Penalty for a Medicare Advantage organization that improperly expels or refuses to reenroll a beneficiary

25,000

1997

47.177

11,794

36,794

Penalty for a Medicare Advantage organization that engages in practice that would reasonably be expected to have the effect of denying or discouraging enrollment

100,000

1997

47.177

47,177

147,177

Penalty per 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

15,000

1997

47.177

7,077

22,077

Penalty for a Medicare Advantage organization misrepresenting or falsifying information to Secretary

100,000

1997

47.177

47,177

147,177

Penalty for a Medicare Advantage organization misrepresenting or falsifying information to individual or other entity

25,000

1997

47.177

11,794

36,794

Penalty for Medicare Advantage organization interfering with provider's advice to enrollee and non-MCO affiliated providers that balance bill enrollees

25,000

1997

47.177

11,794

36,794

Penalty for a Medicare Advantage organization that employs or contracts with excluded individual or entity

25,000

1997

47.177

11,794

36,794

Penalty for a Medicare Advantage organization enrolling an individual in without prior written consent

25,000

2010

47.177

11,794

36,794

Penalty for a Medicare Advantage organization transferring an enrollee to another plan without consent or solely for the purpose of earning a commission

25,000

2010

47.177

11,794

36,794

Penalty for a Medicare Advantage organization failing to comply with marketing restrictions or applicable implementing regulations or guidance

25,000

2010

47.177

11,794

36,794

Penalty for a Medicare Advantage organization employing or contracting with an individual or entity who violates 1395w-27(g)(1)(A)-(J)

25,000

2010

47.177

11,794

36,794

1395w-141(i)(3)

42 CFR Part 1003

Penalty for a prescription drug card sponsor that falsifies or misrepresents marketing materials, overcharges program enrollees, or misuse transitional assistance funds

10,000

2003

28.561

2,856

12,856

1395cc(g)

42 CFR Part 1003

Penalty for improper billing by Hospitals, Critical Access Hospitals, or Skilled Nursing Facilities

2,000

1972

150

3,000

5,000

1395dd(d)(1)

42 CFR Part 1003

Penalty for a hospital or responsible physician dumping patients needing emergency medical care, if the hospital has 100 beds or more

50,000

1987

106.278

53,139

103,139

Penalty for a hospital or responsible physician dumping patients needing emergency care, if the hospital has less than 100 beds

25,000

1987

106.278

26,570

51,570

1395mm(i)(6)(B)(i)

42 CFR Part 1003

Penalty for a HMO or competitive plan is such plan substantially fails to provide medically necessary, required items or services

25,000

1987

106.278

26,570

51,570

Penalty for HMOs/competitive medical plans that charge premiums in excess of permitted amounts

25,000

1987

106.278

26,570

51,570

Penalty for a HMO or competitive medical plan that expels or refuses to reenroll an individual per prescribed conditions

25,000

1987

106.278

26,570

51,570

Penalty for a HMO or competitive medical plan that implements practices to discourage enrollment of individuals needing services in future

100,000

1987

106.278

106,278

206,278

Penalty per 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

15,000

1988

97.869

14,680

29,680

Penalty for a HMO or competitive medical plan that misrepresents or falsifies information to the Secretary

100,000

1987

106.278

106,278

206,278

Penalty for a HMO or competitive medical plan that misrepresents or falsifies information to an individual or any other entity

25,000

1987

106.278

26,570

51,570

Penalty for failure by HMO or competitive medical plan to assure prompt payment of Medicare risk sharing contracts or incentive plan provisions

25,000

1987

106.278

26,570

51,570

Penalty for HMO that employs or contracts with excluded individual or entity

25,000

1989

89.361

22,340

47,340

1395nn(g)(3)

42 CFR Part 1003

Penalty for submitting or causing to be submitted claims in violation of the Stark Law's restrictions on physician self-referrals

15,000

1994

59.089

8,863

23,863

1395nn(g)(4)

42 CFR Part 1003

Penalty for circumventing Stark Law's restrictions on physician self-referrals

100,000

1994

59.089

59,089

159,089

1395ss(d)(1)

42 CFR Part 1003

Penalty for a material misrepresentation regarding Medigap compliance policies

5,000

1988

97.869

4,893

9,893

1395ss(d)(2)

42 CFR Part 1003

Penalty for selling Medigap policy under false pretense

5,000

1988

97.869

4,893

9,893

1395ss(d)(3)(A)(ii)

42 CFR Part 1003

Penalty for an issuer that sells health insurance policy that duplicates benefits

25,000

1990

78.156

19,539

44,539

Penalty for someone other than issuer that sells health insurance that duplicates benefits

15,000

1990

78.156

11,723

26,723

1395ss(d)(4)(A)

42 CFR Part 1003

Penalty for using mail to sell a non-approved Medigap insurance policy

5,000

1988

97.869

4,893

9,893

1396b(m)(5)(B)(i)

42 CFR Part 1003

Penalty for a Medicaid MCO that substantially fails to provide medically necessary, required items or services

25,000

1988

97.869

24,467

49,467

Penalty for a Medicaid MCO that charges excessive premiums

25,000

1988

97.869

24,467

49,467

Penalty for a Medicaid MCO that improperly expels or refuses to reenroll a beneficiary

100,000

1988

97.869

97,869

197,869

Penalty per 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

15,000

1988

97.869

14,680

29,680

Penalty for a Medicaid MCO misrepresenting or falsifying information to the Secretary

100,000

1988

97.869

97,869

197,869

Penalty for a Medicaid MCO misrepresenting or falsifying information to an individual or another entity

25,000

1988

97.869

24,467

49,467

Penalty for a Medicaid MCO that fails to comply with contract requirements with respect to physician incentive plans

25,000

1990

78.156

19,539

44,539

1396r(b)(3)(B)(ii)(I)

42 CFR Part 1003

Penalty for willfully and knowingly certifying a material and false statement in a Skilled Nursing Facility resident assessment

1,000

1987

106.278

1,063

2,063

1396r(b)(3)(B)(ii)(II)

42 CFR Part 1003

Penalty for willfully and knowingly causing another individual to certify a material and false statement in a Skilled Nursing Facility resident assessment

5,000

1987

106.278

5,314

10,314

1396r(g)(2)(A)(i)

42 CFR Part 1003

Penalty for notifying or causing to be notified a Skilled Nursing Facility of the time or date on which a survey is to be conducted

2,000

1987

106.278

2,126

4,126

1396r-8(b)(3)(B)

42 CFR Part 1003

Penalty for the knowing provision of false information or refusing to provide information about charges or prices of a covered outpatient drug

100,000

1990

78.156

78,156

178,156

1396r-8(b)(3)(C)(i)

42 CFR Part 1003

Penalty per day for failure to timely provide information by drug manufacturer with rebate agreement

10,000

1990

78.156

7,816

17,816

1396r-8(b)(3)(C)(ii)

42 CFR Part 1003

Penalty for knowing provision of false information by drug manufacturer with rebate agreement

100,000

1990

78.156

78,156

178,156

1396t(i)(3)(A)

42 CFR Part 1003

Penalty for notifying home and community-based providers or settings of survey

2,000

1990

78.156

1,563

3,563

11131(c)

42 CFR Part 1003

Penalty for failing to report a medical malpractice claim to National Practitioner Data Bank

10,000

1986

115.628

11,563

21,563

11137(b)(2)

42 CFR Part 1003

Penalty for breaching confidentiality of information reported to National Practitioner Data Bank

10,000

1986

115.628

11,563

21,563

42 U.S.C. (OCR):

299b-22(f)(1)

42 CFR 3.404(b)

Penalty for violation of confidentiality provision of the Patient Safety and Quality Improvement Act

10,000

2005

19.40

1,940

11,940

1320(d)-5(a)

45 CFR 160.404(b)(1)(i),(ii)

Penalty for each pre-February 18, 2009 violation of the HIPAA administrative simplification provisions

100

1996

50.245

50

150

Calendar Year Cap

25,000

1996

50.245

12,561

37,561

45 CFR 160.404(b)(2)(i)(A),(B)

Penalty for each February 18, 2009 or later violation of a HIPAA administrative simplification provision in which it is established that the covered entity or business associate did not know and by exercising reasonable diligence, would not have known that the covered entity or business associate violated such a provision:

Minimum

100

2009

10.02

10

110

Maximum

50,000

2009

10.02

5,010

55,010

Calendar Year Cap

1,500,000

2009

10.02

150,300

1,650,300

45 CFR 160.404(b)(2)(ii)(A), (B)

Penalty for each February 18, 2009 or later violation of a HIPAA administrative simplification provision in which it is established that the violation was due to reasonable cause and not to willful neglect:

Minimum

1,000

2009

10.02

100

1100

Maximum

50,000

2009

10.02

5,010

55,010

Calendar Year Cap

1,500,000

2009

10.02

150,300

1,650,300

45 CFR 160.404(b)(2)(iii)(A), (B)

Penalty for each February 18, 2009 or later violation of a HIPAA administrative simplification provision in which it is established that the violation was due to willful neglect and was corrected during the 30-day period beginning on the first date the covered entity or business associate knew, or, by exercising reasonable diligence, would have known that the violation occurred:

Minimum

10,000

2009

10.02

100

11,002

Maximum

50,000

2009

10.02

5,010

55,010

Calendar Year Cap

1,500,000

2009

10.02

150,300

1,650,300

45 CFR 160.404(b)(2)(iv)(A), (B)

Penalty for each February 18, 2009 or later violation of a HIPAA administrative simplification provision in which it is established that the violation was due to willful neglect and was not corrected during the 30-day period beginning on the first date the covered entity or business associate knew, or by exercising reasonable diligence, would have known that the violation occurred:

Minimum

50,000

2009

10.02

5,010

55,010

Maximum

1,500,000

2009

10.02

150,300

1,650,300

Calendar Year Cap

1,500,000

2009

10.02

150,300

1,650,300

42 U.S.C. (CMS):

263a(h)(2)(B) & 1395w-2(b)(2)(A)(ii)

42 CFR 493.1834(d)(2)(i)

Penalty for a clinical laboratory's failure to meet participation and certification requirements and poses immediate jeopardy:

Minimum

3,050

1988

97.869

2,985

6,035

Maximum

10,000

1988

97.869

9,787

19,787

42 CFR 493.1834(d)(2)(ii)

Penalty for a clinical laboratory's failure to meet participation and certification requirements and the failure does not pose immediate jeopardy:

Minimum

50

1988

97.869

49

99

Maximum

3,000

1988

97.869

2,936

5,936

300gg-15(f)

45 CFR 147.200(e)

Failure to provide the Summary of Benefits and Coverage (SBC)

1,000

2010

8.745

87

1,087

300gg-18

45 CFR 158.606

Penalty for violations of regulations related to the medical loss ratio reporting and rebating

100

2010

8.745

9

109

1320a-7h(b)(1)

42 CFR 402.105(d)(5), 42 CFR 403.912(a) & (c)

Penalty for manufacturer or group purchasing organization failing to report information required under 42 U.S.C. 1320a-7h(a), relating to physician ownership or investment interests:

Minimum

1,000

2010

8.745

87

1,087

Maximum

10,000

2010

8.745

874

10,874

Calendar Year Cap

150,000

2010

8.745

13,117

163,117

1320a-7h(b)(2)

42 CFR 402.105(h), 42 CFR 403 912(b) & (c)

Penalty for 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

10,000

2010

8.745

874

10,874

Maximum

100,000

2010

8.745

8,745

108,745

Calendar Year Cap

1,000,000

2010

8.745

87,450

1,087,450

1320a-7j(h)(3)(A)

Penalty for an administrator of a facility that fails to comply with notice requirements for the closure of a facility

100,000

2010

8.745

8,745

108,745

42 CFR 488.446(a)(1),(2), & (3)

Minimum penalty for the first offense of an administrator who fails to provide notice of facility closure

500

2010

8.745

44

544

Minimum penalty for the second offense of an administrator who fails to provide notice of facility closure

1,500

2010

8.745

131

1,631

Minimum penalty for the third and subsequent offenses of an administrator who fails to provide notice of facility closure

3,000

2010

8.745

262

3,262

1320a-8(a)(1)

Penalty for an 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

5,000

1994

59.089

2,954

7,954

Penalty for the violation of 42 U.S.C. 1320a-8a(1) if the violator is a person who receives a fee or other income for services performed in connection with determination of the benefit amount or the person is a physician or other health care provider who submits evidence in connection with such a determination

7,500

2015

1

4,431

7,500

1320a-8(a)(3)

Penalty for a 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

5,000

2004

24.588

1,229

6,229

1320b-25(c)(1)(A)

Penalty for failure of covered individuals to report to the Secretary and 1 or more law enforcement officials any reasonable suspicion of a crime against a resident, or individual receiving care, from a long-term care facility

200,000

2010

8.745

17,490

217,490

1320b-25(c)(2)(A)

Penalty for failure of covered individuals to report to the Secretary and 1 or more law enforcement officials any reasonable suspicion of a crime against a resident, or individual receiving care, from a long-term care facility if such failure exacerbates the harm to the victim of the crime or results in the harm to another individual

300,000

2010

8.745

26,235

326,235

1320b-25(d)(2)

Penalty for a long-term care facility that retaliates against any employee because of lawful acts done by the employee, or files a complaint or report with the State professional disciplinary agency against an employee or nurse for lawful acts done by the employee or nurse

200,000

2010

8.745

17,490

217,490

1395b-7(b)(2)(B)

42 CFR 402.105(g)

Penalty for any 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

100

1997

47.177

47

147

1395i-3(h)(2)(B)(ii)(I)

42 CFR 488.408(d)(1)(iii)

Penalty per day for a Skilled Nursing Facility that has a Category 2 violation of certification requirements:

Minimum

50

1987

106.278

53

103

Maximum

3,000

1987

106.278

3,188

6,188

42 CFR 488.408(d)(1)(iv)

Penalty per instance of Category 2 noncompliance by a Skilled Nursing Facility:

Minimum

1,000

1987

106.278

1,063

2,063

Maximum

10,000

1987

106.278

10,628

20,628

42 CFR 488.408(e)(1)(iii)

Penalty per day for a Skilled Nursing Facility that has a Category 3 violation of certification requirements:

Minimum

3,050

1987

106.278

3,241

6,291

Maximum

10,000

1987

106.278

10,628

20,628

42 CFR 488.408(e)(1)(iv)

Penalty per instance of Category 3 noncompliance by a Skilled Nursing Facility:

Minimum

1,000

1987

106.278

1,063

2,063

Maximum

10,000

1987

106.278

10,628

20,628

Penalty per day and per instance for a Skilled Nursing Facility that has Category 3 noncompliance with Immediate Jeopardy

Per Day (Minimum)

3,050

1987

106.278

3,241

6,291

Per Day (Maximum)

10,000

1987

106.278

10,628

20,628

Per Instance (Minimum)

1,000

1987

106.278

1,063

2,063

Per Instance (Maximum)

10,000

1987

106.278

10,628

20,628

42 CFR 488.438(a)(1)(i)

Penalty per day of a Skilled Nursing Facility that fails to meet certification requirements. These amounts represent the upper range per day:

Minimum

3,050

1987

106.278

3,241

6,291

Maximum

10,000

1987

106.278

10,628

20,628

42 CFR 488.438(a)(1)(ii)

Penalty per day of a Skilled Nursing Facility that fails to meet certification requirements. These amounts represent the lower range per day:

Minimum

50

1987

106.278

53

103

Maximum

3,000

1987

106.278

3,188

6,188

42 CFR 488.438(a)(2)

Penalty per instance of a Skilled Nursing Facility that fails to meet certification requirements:

Minimum

1,000

1987

106.278

1,063

2,063

Maximum

10,000

1987

106.278

10,628

20,628

1395l(h)(5)(D)

42 CFR 402.105(d)(2)(i)

Penalty for 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))

10,000

1996

50.245

5,024

15,024

1395l(i)(6)

Penalty for 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

2,000

1988

197.869

1,957

3,957

1395l(q)(2)(B)(i)

42 CFR 402.105(a)

Penalty for knowingly and willfully failing to provide information about a referring physician when seeking payment on an unassigned basis

2,000

1989

89.361

1,787

3,787

1395m(a)(11)(A)

42 CFR 402.1(c)(4), 402.105(d)(2)(ii)

Penalty for any 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))

10,000

1996

50.245

5,024

15,024

1395m(a)(18)(B)

42 CFR 402.1(c)(5), 402.105(d)(2)(iii)

Penalty for any 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))

10,000

1996

50.245

5,024

15,024

1395m(b)(5)(C)

42 CFR 402.1(c)(6), 402.105(d)(2)(iv)

Penalty for any 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))

10,000

1996

50.245

5,024

15,024

1395m(h)(3)

42 CFR 402.1(c)(8), 402.105(d)(2)(vi)

Penalty for any 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))

10,000

1996

50.245

5,024

15,024

1395m(j)(2)(A)(iii)

Penalty for any 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

1,000

1994

59.089

591

1,591

1395m(j)(4)

42 CFR 402.1(c)(10), 402.105(d)(2)(vii)

Penalty for any 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))

10,000

1996

50.245

5,024

15,024

1395m(k)(6)

42 CFR 402.1(c)(31), 402.105(d)(3)

Penalty for any 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))

10,000

1996

50.245

5,024

15,024

1395m(l)(6)

42 CFR 402.1(c)(32), 402.105(d)(4)

Penalty for any 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))

10,000

1996

50.245

5,024

15,024

1395u(b)(18)(B)

42 CFR 402.1(c)(11), 402.105(d)(2)(viii)

Penalty for any 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))

10,000

1996

50.245

5,024

15,024

1395u(j)(2)(B)

42 CFR 402.1(c)

Penalty for any 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))

10,000

1996

50.245

5,024

15,024

1395u(k)

42 CFR 402.1(c)(12), 402.105(d)(2)(ix)

Penalty for any 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))

10,000

1996

50.245

5,024

15,024

1395u(l)(3)

42 CFR 402.1(c)(13), 402.105(d)(2)(x)

Penalty for any 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))

10,000

1996

50.245

5,024

15,024

1395u(m)(3)

42 CFR 402.1(c)(14), 402.105(d)(2)(xi)

Penalty for any 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))

10,000

1996

50.245

5,024

15,024

1395u(n)(3)

42 CFR 402.1(c)(15), 402.105(d)(2)(xii)

Penalty for any 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))

10,000

1996

50.245

5,024

15,024

1395u(o)(3)(B)

42 CFR 414.707(b)

Penalty for any 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))

10,000

1996

50.245

5,024

15,024

1395u(p)(3)(A)

Penalty for any 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

2,000

1988

97.869

1,957

3,957

1395w-3a(d)(4)(A)

42 CFR 414.806

Penalty for a pharmaceutical manufacturer's misrepresentation of average sales price of a drug, or biologic

10,000

2003

28.561

2,856

12,856

1395w-4(g)(1)(B)

42 CFR 402.1(c)(17), 402.105(d)(2)(xiii)

Penalty for any 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))

10,000

1996

50.245

5,024

15,024

1395w-4(g)(3)(B)

42 CFR 402.1(c)(18), 402.105(d)(2)(xiv)

Penalty for any 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))

10,000

1996

50.245

5,024

15,024

1395w-27(g)(3)(A); 1857(g)(3)

42 CFR 422.760(b); 42 CFR 423.760(b)

Penalty for each 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

25,000

1997

47.177

11,794

36,794

1395w-27(g)(3)(B); 1857(g)(3)

Penalty for each week beginning after the initiation of civil money penalty procedures by the Secretary because a Medicare Advantage organization or Part D sponsor has failed to carry out a contract, or has carried out a contract inconsistently with regulations

10,000

1997

47.177

4,718

14,718

1395w-27(g)(3)(D); 1857(g)(3)

Penalty for a Medicare Advantage organization's or Part D sponsor's early termination of its contract

100,000

2000

36.689

36,689

136,689

1395y(b)(3)(C)

42 CFR 411.103(b)

Penalty for an 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

5,000

1990

78.156

3,908

8,908

1395y(b)(5)(C)(ii)

42 CFR 402.1(c)(20), 402.105(b)(2)

Penalty for any non-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

1,000

1998

89.361

450

1,450

1395y(b)(6)(B)

42 CFR 402.1(c)(21), 402.105(a)

Penalty for any 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

2,000

1994

59.089

1,182

3,182

1395y(b)(7)(B)(i)

Penalty for any 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

1,000

2007

13.833

138

1,138

1395y(b)(8)(E)

Penalty for any non-group health plan that fails to identify claimants who are Medicare beneficiaries and provide information to the HHS Secretary to coordinate benefits and pursue any applicable recovery claim

1,000

2007

13.833

138

1,138

1395nn(g)(5)

42 CFR 411.361

Penalty for any person that fails to report information required by HHS under Section 1877(f) concerning ownership, investment, and compensation arrangements

10,000

1989

89.361

8,936

18,936

1395pp(h)

42 CFR 402.1(c)(23), 402.105(d)(2)(xv)

Penalty for any 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))

10,000

1996

50.245

5,024

15,024

1395ss(a)(2)

42 CFR 402.1(c)(24), 405.105(f)(1)

Penalty for any 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

25,000

1987

106.278

26,569

51,569

1395ss(d)(3)(A)(vi) (II)

Penalty for someone other than issuer that sells or issues a Medicare supplemental policy to beneficiary without a disclosure statement

15,000

1990

78.156

11,723

26,723

Penalty for an issuer that sells or issues a Medicare supplemental policy without disclosure statement

25,000

1990

78.156

19,539

44,539

1395ss(d)(3)(B)(iv)

Penalty for someone other than issuer that sells or issues a Medicare supplemental policy without acknowledgement form

15,000

1990

78.156

11,723

26,723

Penalty for issuer that sells or issues a Medicare supplemental policy without an acknowledgement form

25,000

1990

78.156

19,539

44,539

1395ss(p)(8)

42 CFR 402.1(c)(25), 402.105(e)

Penalty for any 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

15,000

1990

78.156

11,723

26,723

42 CFR 402.1(c)(25), 405.105(f)(2)

Penalty for any 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

25,000

1990

78.156

19,539

44,539

1395ss(p)(9)(C)

42 CFR 402.1(c)(26), 402.105(e)

Penalty for any 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

15,000

1990

78.156

11,723

26,723

42 CFR 402.1(c)(26), 405.105(f)(3), (4)

Penalty for any 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

25,000

1990

78.156

19,539

44,539

1395ss(q)(5)(C)

42 CFR 402.1(c)(27), 405.105(f)(5)

Penalty for any 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

25,000

1990

78.156

19,539

44,539

1395ss(r)(6)(A)

42 CFR 402.1(c)(28), 405.105(f)(6)

Penalty for any person that fails to provide refunds or credits as required by section 1882(r)(1)(B)

25,000

1990

78.156

19,539

44,539

1395ss(s)(4)

42 CFR 402.1(c)(29), 405.105(c)

Penalty for any 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

5,000

1990

78.156

3,908

8,908

1395ss(t)(2)

42 CFR 402.1(c)(30), 405.105(f)(7)

Penalty for any issuer of a Medicare supplemental policy that fails to fulfill listed responsibilities

25,000

1990

78.156

19,539

44,539

1395ss(v)(4)(A)

Penalty someone other than issuer who sells, issues, or renews a medigap Rx policy to an individual who is a Part D enrollee

15,000

2003

28.561

4,284

19,284

Penalty for an issuer who sells, issues, or renews a Medigap Rx policy who is a Part D enrollee

25,000

2003

28.561

7,140

32,140

1395bbb(c)(1)

42 CFR 488.725(c)

Penalty for any 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

2,000

1987

106.278

2,126

4,126

1395bbb(f)(2)(A)(i)

42 CFR 488.845(b)(2)(iii)

Maximum daily penalty amount for each day a home health agency is not in compliance with statutory requirements

10,000

1988

97.869

9,787

19,787

42 CFR 488.845(b)(3)

Penalty per day for home health agency's noncompliance (Upper Range):

Minimum

8,500

1988

97.869

8,319

16,819

Maximum

10,000

1988

97.869

9,787

19,787

42 CFR 488.845(b)(3)(i)

Penalty for a home health agency's deficiency or deficiencies that cause immediate jeopardy and result in actual harm

10,000

1988

97.869

9,787

19,787

42 CFR 488.845(b)(3)(ii)

Penalty for a home health agency's deficiency or deficiencies that cause immediate jeopardy and result in potential for harm

9,000

1988

97.869

8,808

17,808

42 CFR 488.845(b)(3)(iii)

Penalty for an isolated incident of noncompliance in violation of established HHA policy

8,500

1988

97.869

8,319

16,819

42 CFR 488.845(b)(4)

Penalty for a repeat and/or condition-level deficiency that does not constitute immediate jeopardy, but is directly related to poor quality patient care outcomes (Lower Range):

Minimum

1,500

1988

97.869

1,468

2,968

Maximum

8,500

1988

97.869

8,319

16,819

42 CFR 488.845(b)(5)

Penalty for a repeat and/or condition-level deficiency that does not constitute immediate jeopardy and that is related predominately to structure or process-oriented conditions (Lower Range):

Minimum

500

1988

97.869

489

989

Maximum

4,000

1988

97.869

3,915

7,915

42 CFR 488.845(b)(6)

Penalty imposed for instance of noncompliance that may be assessed for one or more singular events of condition-level noncompliance that are identified and where the noncompliance was corrected during the onsite survey:

Minimum

1,000

1988

97.869

979

1,979

Maximum

10,000

1988

97.869

9,787

19,787

Penalty for each day of noncompliance (Maximum)

10,000

1988

97.869

9,787

19,787

42 CFR 488.845(d)(1)(ii)

Penalty for each day of noncompliance (Maximum)

10,000

1988

97.869

9,787

19,787

1396b(m)(5)(B)

42 CFR 460.46

Penalty for PACE organization's practice that would reasonably be expected to have the effect of denying or discouraging enrollment:

Minimum

15,000

1997

47.177

7,077

22,077

Maximum

100,000

1997

47.177

47,177

147,177

Penalty for a PACE organization that charges excessive premiums

25,000

1997

47.177

11,794

36,794

Penalty for a PACE organization misrepresenting or falsifying information to CMS, the State, or an individual or other entity

100,000

1997

47.177

47,177

147,177

Penalty for each determination the CMS makes that the PACE organization has failed to provide medically necessary items and services of the failure has adversely affected (or has the substantial likelihood of adversely affecting) a PACE participant

25,000

1997

47.177

11,794

36,794

Penalty for involuntarily disenrolling a participant

25,000

1997

47.177

11,794

36,794

Penalty for discriminating or discouraging enrollment or disenrollment of participants on the basis of an individual's health status or need for health care services

25,000

1997

47.177

11,794

36,794

1396r(h)(3)(C)(ii)(I)

42 CFR 488.408(d)(1)(iii)

Penalty per day for a nursing facility's failure to meet a Category 2 Certification:

Minimum

50

1987

106.278

53

103

Maximum

3,000

1987

106.278

3,188

6,188

42 CFR 488.408(d)(1)(iv)

Penalty per instance for a nursing facility's failure to meet Category 2 certification:

Minimum

1,000

1987

106.278

1,063

2,063

Maximum

10,000

1987

106.278

10,628

20,628

42 CFR 488.408(e)(1)(iii)

Penalty per day for a nursing facility's failure to meet Category 3 certification:

Minimum

3,050

1987

106.278

3,241

6,291

Maximum

10,000

1987

106.278

10,628

20,628

42 CFR 488.408(e)(1)(iv)

Penalty per instance for a nursing facility's failure to meet Category 3 certification:

Minimum

1,000

1987

106.278

1,063

2,063

Maximum

10,000

1987

106.278

10,628

20,628

42 CFR 488.408(e)(2)(ii)

Penalty per instance for a nursing facility's failure to meet Category 3 certification, which results in immediate jeopardy:

Minimum

1,000

1987

106.278

1,063

2,063

Maximum

10,000

1987

106.278

10,628

20,628

42 CFR 488.438(a)(1)(i)

Penalty per day for nursing facility's failure to meet certification (Upper Range):

Minimum

3,050

1987

106.278

3,241

6,291

Maximum

10,000

1987

106.278

10,628

20,628

42 CFR 488.438(a)(1)(ii)

Penalty per day for nursing facility's failure to meet certification (Lower Range):

Minimum

50

1987

106.278

53

103

Maximum

3,000

1987

106.278

3,188

6,188

42 CFR 488.438(a)(2)

Penalty per instance for nursing facility's failure to meet certification:

Minimum

1,000

1987

106.278

1,063

2,063

Maximum

10,000

1987

106.278

10,628

20,628

1396r(f)(2)(B)(iii)(I)(c)

42 CFR 483.151(b)(2)(iv) and (b)(3)(iii)

Grounds to prohibit approval of Nurse Aide Training Program—if assessed a penalty in 1819(h)(2)(B)(i) or 1919(h)(2)(A)(ii) of “not less than $5,000” [Not CMP authority, but a specific CMP amount (CMP at this level) that is the triggering condition for disapproval]

5,000

1987

106.278

5,314

10,314

1396r(h)(3)(C)(ii)(I)

42 CFR 483.151(c)(2)

Grounds to waive 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]

5,000

1987

106.278

5,314

10,314

1396t(j)(2)(C)

Penalty for each day of noncompliance for a home or community care provider that no longer meets the minimum requirements for home and community care:

Minimum

1

1990

78.156

1

2

Maximum

10,000

1990

78.156

7,816

17,816

1396u-2(e)(2)(A)(i)

42 CFR 438.704

Penalty for a Medicaid managed care organization that fails substantially to provide medically necessary items and services

25,000

1997

47.177

11,794

36,794

Penalty for Medicaid managed care organization that imposes premiums or charges on enrollees in excess of the premiums or charges permitted

25,000

1997

47.177

11,794

36,794

Penalty for a Medicaid managed care organization that misrepresents or falsifies information to another individual or entity

25,000

1997

47.177

11,794

36,794

Penalty for a Medicaid managed care organization that fails to comply with the applicable statutory requirements for such organizations

25,000

1997

47.177

11,794

36,794

1396u-2(e)(2)(A)(ii)

42 CFR 438.704

Penalty for a Medicaid managed care organization that misrepresents or falsifies information to the HHS Secretary

100,000

1997

47.177

47,177

147,177

Penalty for Medicaid managed care organization that acts to discriminate among enrollees on the basis of their health status

100,000

1997

47.177

47,177

147,177

1396u-2(e)(2)(A)(iv)

42 CFR 438.704

Penalty for each individual that does not enroll as a result of a Medicaid managed care organization that acts to discriminate among enrollees on the basis of their health status

15,000

1997

47.177

7,077

22,077

1396u(h)(2)

42 CFR 441, Subpart I

Penalty for a 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

10,000

1990

106.278

10,628

20,628

1396w-2(c)(1)

Penalty for disclosing information related to eligibility determinations for medical assistance programs

10,000

2009

10.02

1,002

11,002

1903(m)(5)(B)

42 CFR 460.46

Penalty for PACE organization's practice that would reasonably be expected to have the effect of denying or discouraging enrollment:

Minimum

15,000

1997

47.177

7,077

22,077

Maximum

100,000

1997

47.177

47,177

147,177

Penalty for a PACE organization that charges excessive premiums

25,000

1997

47.177

11,794

36,794

Penalty for a PACE organization misrepresenting or falsifying information to CMS, the State, or an individual or other entity

100,000

1997

47.177

47,177

147,177

Penalty for each determination the CMS makes that the PACE organization has failed to provide medically necessary items and services of the failure has adversely affected (or has the substantial likelihood of adversely affecting) a PACE participant

25,000

1997

47.177

11,794

36,794

Penalty for involuntarily disenrolling a participant

25,000

1997

47.177

11,794

36,794

Penalty for discriminating or discouraging enrollment or disenrollment of participants on the basis of an individual's health status or need for health care services

25,000

1997

47.177

11,794

36,794

18041(c)(2)

45 CFR 150.315 and 45 CFR 156.805(c)

Failure to comply with requirements of Public Health Services Act; Penalty for violations of rules or standards of behavior associated with issuer participation in the Federally-facilitated Exchange. (42 U.S.C. 300gg-22(b)(C))

100

1996

50.245

50

150

18081(h)(1)(A)(i)(II)

42 CFR 155.285

Penalty for providing false information on Exchange application

25,000

2010

8.745

2,186

27,186

18081(h)(1)(B)

42 CFR 155.285

Penalty for knowingly or willfully providing false information on Exchange application

250,000

2010

8.745

21,862

271,862

18081(h)(2)

42 CFR 155.260

Penalty for knowingly or willfully disclosing protected information from Exchange

25,000

2010

8.745

2,186

27,186

31 U.S.C. (HHS):

1352

45 CFR 93.400(e)

Penalty for the first time an individual makes an expenditure prohibited by regulations regarding lobbying disclosure, absent aggravating circumstances

10,000

1989

89.361

8,936

18,936

Penalty for second and subsequent offenses by individuals who make an expenditure prohibited by regulations regarding lobbying disclosure:

Minimum

10,000

1989

89.361

8,936

18,936

Maximum

100,000

1989

89.361

89,361

189,361

Penalty for the first time an individual fails to file or amend a lobbying disclosure form, absent aggravating circumstances

10,000

1989

89.361

8,936

18,936

Penalty for second and subsequent offenses by individuals who fail to file or amend a lobbying disclosure form, absent aggravating circumstances:

Minimum

10,000

1989

89.361

8,936

18,936

Maximum

100,000

1989

89.361

89,361

189,361

45 CFR 93, Appendix A

Penalty for failure to provide certification regarding lobbying in the award documents for all sub-awards of all tiers:

Minimum

10,000

1989

89.361

8,936

18,936

Maximum

100,000

1989

89.361

89,361

189,361

Penalty for failure to provide statement regarding lobbying for loan guarantee and loan insurance transactions:

Minimum

10,000

1989

89.361

8,936

18,936

Maximum

100,000

1989

89.361

89,361

189,361

3801-3812

45 CFR 79.3(a)(1(iv)

Penalty against any individual who—with knowledge or reason to know—makes, presents or submits a false, fictitious or fraudulent claim to the Department

5,000

1988

97.869

4,894

9,894

45 CFR 79.3(b)(1)(ii)

Penalty against any individual who—with knowledge or reason to know—makes, presents or submits a false, fictitious or fraudulent claim to the Department

5,000

1988

97.869

4,894

9,894

1

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

2

The description is not intended to be a comprehensive explanation of the underlying violation; the statute and corresponding regulation, if applicable, should be consulted.

3

Statutory, or non-Inflation Act Adjustment.

4

Based on the lesser of the CPI-U multiplier for October 2015, or 150%.

5

Rounded to the nearest dollar.

III. Environmental Impact

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

IV. Paperwork Reduction Act

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

V. Regulatory Flexibility Act

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

VI. Executive Orders 12866 and 13563

Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. Agencies must prepare a regulatory impact analysis for major rules with economically significant effects ($100 million or more in any 1 year). HHS has determined that this IFR is not economically significant.

HHS analyzed the economic significance of this IFR, by collecting data for fiscal years 2010 through 2014 on the total value of civil monetary penalties collected by Operating/Staff Divisions, except in the case of CMS, for which HHS used collections data through FY 2015. Such data included the statutory authority for the civil monetary penalty, which HHS used to apply the appropriate multiplier for each of the penalties collected. With respect to CMS, HHS determined the multiplier for the CMS collections by pro rating all of the multipliers for the civil monetary penalty authorities attributed to CMS.

HHS then applied the multiplier to collections for each Fiscal Year (2010 through 2014) to calculate the collections for each Fiscal Year with the inflation adjustment. HHS also performed an additional calculation for FY 2014/2015 using the inflated collections amount for FY 2015 for CMS and using the inflated collections amount for all other Operating/Staff Divisions for FY 2014. When collections were adjusted for inflation, the Department's lowest collection amount was $58,332,000 for FY 2012 and the highest total was $168,000,000 for FY 2014/2015.

Finally, HHS subtracted the collections value for a Fiscal Year (for example, FY 2010) from the collections value for the same Fiscal Year with the inflation adjustment (for example, FY 2010 with inflation adjustment) to assess the economic significance of this IFR for that Fiscal Year (for example, FY 2010 Economic Significance). When the calculations were completed, the Fiscal Year Economic Significance values ranged from a low of $23,698,917 for FY 2013, to a high of $70,913,713 for FY 2014/2015. Based on these calculations, HHS does not believe this IFR will be economically significant as defined in Executive Order 12866.

VII. Unfunded Mandates Reform Act of 1995 Determination

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

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

VIII. Executive Order 13132 Determination

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

List of Subjects

42 CFR Part 3

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

42 CFR Part 402

Administrative practice and procedure, Medicaid, Medicare, Penalties.

42 CFR Part 403

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

42 CFR Part 411

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

42 CFR Part 412

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

42 CFR Part 422

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

42 CFR Part 423

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

42 CFR Part 438

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

42 CFR Part 460

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

42 CFR Part 483

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

42 CFR Part 488

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

42 CFR Part 493

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

42 CFR Part 1003

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

45 CFR Part 79

Administrative practice and procedure, Claims, Fraud, Penalties.

45 CFR Part 93

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

45 CFR Part 102

Administrative practice and procedure, Penalties.

45 CFR Part 147

Health care, Health insurance, Reporting and recordkeeping requirements.

45 CFR Part 155

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

45 CFR Part 156

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

45 CFR Part 158

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

45 CFR Part 160

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

45 CFR Part 303

Child support, Standards for program operations, Penalties.

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

Title 42—Public Health

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

PART 3—PATIENT SAFETY ORGANIZATIONS AND PATIENT SAFETY WORK PRODUCT

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

Authority:

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

2. Section 3.404 is revised to read as follows:

§ 3.404

Amount of a civil money penalty.

(a) The amount of a civil money penalty will be determined in accordance with paragraph (b) of this section and § 3.408.

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

updated, is published at 45 CFR part 102.

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

PART 402—CIVIL MONEY PENALTIES, ASSESSMENTS, AND EXCLUSIONS

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

Authority:

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

§ 402.105

[Amended]

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

Paragraph

Remove

Add

(a)

“$2,000 for each service”

“$2,000 as adjusted annually under 45 CFR part 102 for each service”.

(b) introductory text

“not more than $1,000 for”

“not more than $1,000 as adjusted annually under 45 CFR part 102 for”.

(c) introductory text

“not more than $5,000 for”

“not more than $5,000 as adjusted annually under 45 CFR part 102 for”.

(d)(1)

“not more than $10,000 for”

“not more than $10,000 as adjusted annually under 45 CFR part 102 for”.

(d)(2) introductory text

“not more than $10,000 for”

“not more than $10,000 as adjusted annually under 45 CFR part 102 for”.

(d)(3)

“not more than $10,000 for”

“not more than $10,000 as adjusted annually under 45 CFR part 102 for”.

(d)(4)

“not more than $10,000 for”

“not more than $10,000 as adjusted annually under 45 CFR part 102 for”.

(d)(5)

“not more than $10,000 for”

“not more than $10,000 as adjusted annually under 45 CFR part 102 for”.

(d)(5)

“will not exceed $150,000”

“will not exceed $150,000 as annually adjusted under 45 CFR part 102”.

(e)

“not more than $15,000 for”

“not more than $15,000 as adjusted annually under 45 CFR part 102 for”.

(f) introductory text

“not more than $25,000 for”

“not more than $25,000 as adjusted annually under 45 CFR part 102 for”.

(g)

“not more than $100 for”

“not more than $100 as adjusted annually under 45 CFR part 102 for”.

(h)

“not more than $100,000 for”

“not more than $10,000 as adjusted annually under 45 CFR part 102 for”.

(h)

“will not exceed $1,000,000”

“will not exceed $1,000,000 as annually adjusted under 45 CFR part 102”.

PART 403—SPECIAL PROGRAMS AND PROJECTS

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

Authority:

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

§ 403.912

[Amended]

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

Paragraph

Remove

Add

(a)(1)

“not less than $1,000, but not more than $10,000 for”

“not less than $10,000, but not more than $100,000, as adjusted annually under 45 CFR part 102 for”.

(a)(2)

“will not exceed $150,000”

“will not exceed $150,000 as adjusted annually under 45 CFR part 102”.

(b)(1)

“not less than $10,000, but not more than $100,000 for”

“not less than $10,000, but not more than $100,000, as adjusted annually under 45 CFR part 102 for”.

(b)(2)

“will not exceed $1,000,000”

“will not exceed $1,000,000 as adjusted annually under 45 CFR part 102”.

(c)(2)

“with a maximum combined annual total of $1,150,000”

“with a maximum combined annual total of $1,150,000 as adjusted annually under 45 CFR part 102”.

PART 411—EXCLUSIONS FROM MEDICARE AND LIMITATIONS ON MEDICARE PAYMENT

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

Authority:

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

§§ 411.103 and 411.361

[Amended]

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

the phrase indicated in the fourth column:

Section

Paragraphs

Remove

Add

§ 411.103

(b)(1)

“up to $5,000 for”

“up to $5,000 as adjusted annually under 45 CFR part 102 for”.

(b)(2)

“up to $5,000”

“up to $5,000 as adjusted annually under 45 CFR part 102”.

§ 411.361

(f)

“up to $10,000 for”

“up to $10,000 as adjusted annually under 45 CFR part 102 for”.

PART 412—PROSPECTIVE PAYMENT SYSTEMS FOR INPATIENT HOSPITAL SERVICES

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

Authority:

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

§ 412.612

[Amended]

13. Section 412.612 is amended as follows:

a. In paragraph (b)(1)(i), by removing the phrase “not more than $1,000 for” and adding in its place the phrase “not more than $1,000 as adjusted annually under 45 CFR part 102 for”; and

b. In paragraph (b)(1)(ii), by removing the phrase “not more than $5,000 for” and adding in its place the phrase “not more than $5,000 as adjusted annually under 45 CFR part 102 for”.

PART 422—MEDICARE ADVANTAGE PROGRAM

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

Authority:

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

§ 422.760

[Amended]

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

Paragraph

Remove

Add

(b)(1)

“up to $25,000 for each”

“up to $25,000 as adjusted annually under 45 CFR part 102 for each”.

(b)(2)

“up to $25,000 for each”

“up to $25,000 as adjusted annually under 45 CFR part 102 for each”.

(b)(3)

“determination—up to $10,000”

“determination—up to $10,000 as adjusted annually under 45 CFR part 102”.

(b)(4)

“$250 per Medicare enrollee”

“$250 as adjusted annually under 45 CFR part 102 per Medicare enrollee”.

(b)(4)

“or $100,000, whichever is greater”

“or $100,000 as adjusted annually under 45 CFR part 102, whichever is greater”.

(c)(1)

“not more than $25,000 for”

“not more than $25,000 as adjusted annually under 45 CFR part 102 for”.

(c)(2)

“not more than $100,000 for”

“not more than $100,000 as adjusted annually under 45 CFR part 102 for”.

(c)(4)

“$15,000 for each individual”

“$15,000 as adjusted annually under 45 CFR part 102 for each individual”.

PART 423—VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT

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

Authority:

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

§ 423.760

[Amended]

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

Paragraph

Remove

Add

(b)(1)

“enrollees—up to $25,000 for each determination”

“enrollees—up to $25,000 as adjusted annually under 45 CFR part 102 for each determination”.

(b)(2)

“of up to $25,000 for each Part D enrollee”

“of up to $25,000 as adjusted annually under 45 CFR part 102 for each Part D enrollee”.

(b)(3)

“up to $10,000”

“up to $10,000 as adjusted annually under 45 CFR part 102”.

(b)(4)

“$250 per Medicare enrollee”

“$250 as adjusted annually under 45 CFR part 102 per Medicare enrollee”.

(b)(4)

“or $100,000, whichever is greater”

“or $100,000 as adjusted annually under 45 CFR part 102, whichever is greater”.

(c)(1)

“of not more than $25,000 for each”

“of not more than $25,000 as adjusted annually under 45 CFR part 102 for each”.

(c)(2)

“not more than $100,000 for each”

“not more than $100,000 as adjusted annually under 45 CFR part 102 for each”.

(c)(4)

“$15,000 for each individual”

“$15,000 as adjusted annually under 45 CFR part 102 for each individual”.

PART 483—REQUIREMENTS FOR STATES AND LONG TERM CARE FACILITIES

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

Authority:

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

§ 483.20

[Amended]

19. Section 483.20 is amended as follows:

a. In paragraph (j)(1)(i), by removing the phrase “not more than $1,000 for” and adding in its place the phrase “not more than $1,000 as adjusted annually under 45 CFR part 102 for”; and

b. In paragraph (j)(1)(ii), by removing the phrase “not more than $5,000 for” and adding it its place the phrase “not more than $5,000 as adjusted annually under 45 CFR part 102 for”.

§ 483.151

[Amended]

20. Section 483.151 is amended as follows:

a. In paragraph (b)(2)(iv), by removing the phrase “not less than $5,000; or” and adding in its place the phrase “not less than $5,000 as adjusted annually under 45 CFR part 102; or”;

b. In paragraph (b)(3)(iii), by removing the phrase “not less than $5,000 for” and adding in its place the phrase “not less than $5,000 as adjusted annually under 45 CFR part 102 for”; and

c. In paragraph (c)(1), by removing the phrase “not less than $5,000” and adding in its place the phrase “not less than $5,000 as adjusted annually under 45 CFR part 102”.

PART 488—SURVEY, CERTIFICATION, AND ENFORCEMENT PROCEDURES

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

Authority:

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

§§ 488.307, 488.408, 488.438, 488.446, 488.725, and 488.845

[Amended]

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

Section

Paragraph

Remove

Add

488.307

(c)

“not to exceed $2,000”

“not to exceed $2,000 as adjusted annually under 45 CFR part 102”.

488.408

(d)(1)(iii)

“$50-$3,000 per day”

“$50-$3,000 as adjusted annually under 45 CFR part 102 per day”.

(d)(1)(iv)

“$1,000-$10,000 per instance”

“$1,000-$10,000 as adjusted annually under 45 CFR part 102 per instance”.

(e)(1)(iii)

“$3,050-$10,000 per day”

“$3,050-$10,000 as adjusted annually under 45 CFR part 102 per day”.

(e)(1)(iv)

“$1,000-$10,000 per instance”

“$1,000-$10,000 as adjusted annually under 45 CFR part 102 per instance”.

(e)(2)(ii)

“3,050-$10,000 per day or $1,000-$10,000 per instance”

“3,050-$10,000 as adjusted annually under 45 CFR part 102 per day or $1,000-$10,000 as adjusted annually under 45 CFR part 102 per instance”.

488.438

(a)(1)(i)

“Upper range—$3,050-$10,000”

“Upper range”.

(a)(1)(i)

“$3,050-$10,000 per day”

“$3,050-$10,000 as adjusted annually under 45 CFR part 102 per day”.

(a)(1)(ii)

“Lower range—$50-$3,000”

“Upper range”.

(a)(1)(ii)

“$50-$3,000 per day”

“$50-$3,000 as adjusted annually under 45 CFR part 102 per day”.

(a)(2)

“$1,000-$10,000 per instance”

“$1,000-$10,000 as adjusted annually under 45 CFR part 102 per instance”.

488.446

(a)(1)

“A minimum of $500 for”

“A minimum of $500 as adjusted annually under 45 CFR part 102 for”.

(a)(2)

“A minimum of $1,500 for”

“A minimum of $1,500 as adjusted annually under 45 CFR part 102 for”.

(a)(3)

“A minimum of $3,000 for”

“A minimum of $3,000 as adjusted annually under 45 CFR part 102 for”.

488.725

(c)

“not to exceed $2,000”

“not to exceed $2,000 as adjusted annually under 45 CFR part 102”.

488.845

(b)(2)(iii)

“shall exceed $10,000 for”

“will exceed $10,000 as adjusted under 45 CFR part 102 for”.

(b)(3) introductory text

“upper range of $8,500 to $10,000 per day”

“upper range of $8,500 to $10,000 as adjusted annually under 45 CFR part 102 per day”.

(b)(3)(i)

“$10,000 per day”

“$10,000 as adjusted annually under 45 CFR part 102 per day”.

(b)(3))(ii)

“$9,000 per day”

“$9,000 as adjusted annually under 45 CFR part 102 per day”.

(b)(3)(iii)

“$8,500 per day”

“$8,500 as adjusted annually under 45 CFR part 102 per day”.

(b)(4)

“range of $1,500-$8,500 per day”

“range of $1,500-$8,500 as adjusted annually under 45 CFR part 102 per day”.

(b)(5)

“range of $500-$4,000 are imposed”

“range of $500-$4,000 as adjusted annually under 45 CFR part 102 are imposed”.

(b)(6)

“range of $1,000 to $10,000 per instance, not to exceed $10,000 each day”

“range of $1,000 to $10,000 as adjusted annually under 45 CFR part 102 per instance, not to exceed $10,000 as adjusted annually under 45 CFR part 102 each day”.

(d)(1)(ii)

“maximum of $10,000 per day”

“maximum of $10,000 as adjusted annually under 45 CFR part 102 per day”.

PART 493—LABORATORY REQUIREMENTS

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

Authority:

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

§ 493.1834

[Amended]

24. Section 493.1834 is amended as follows:

a. In paragraph (d)(2)(i), by removing the phrase “$3,050-$10,000 per day” and adding in its place the phrase “$3,050-$10,000 as adjusted annually under 45 CFR part 102 per day”; and

b. In paragraph (d)(2)(ii), by removing the phrase “$50-$3,000 per day” and adding in its place the phrase “$50-$3,000 as adjusted annually under 45 CFR part 102 per day”.

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

PART 1003—CIVIL MONEY PENALTIES, ASSESSMENTS AND EXCLUSIONS

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

Authority:

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

§ 1003.103

[Amended]

26. Section 1003.103 is amended:

a. In paragraph (c)—

i. By removing the footnote in paragraph (c); and

ii. In paragraph (c) by removing the phrase “not more than $11,000 for each payment” and adding in its place the phrase “not more than $10,000 for each payment”; and

b. In the table below, § 1003.103 is further amended in each paragraph indicated by the first column by adding the footnote in the third column after the phrase in the second column:

Paragraph

Text

Add footnote

(a)(1)

“$2,000”

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

(a)(2)

“$10,000”

“2. This penalty amount is adjusted annually for inflation, and is published at 45 CFR part 102.”

(b)

“not more than $15,000”

“3. This penalty amount is adjusted annually for inflation, and is published at 45 CFR part 102.”

“not more than $100,000”

“4. This penalty amount is adjusted annually for inflation, and is published at 45 CFR part 102.”

(c)

“not more than $10,000”

“5. This penalty amount is adjusted annually for inflation, and is published at 45 CFR part 102.”

(d)(1)

“not more than $5,000”

“6. This penalty amount is adjusted annually for inflation, and is published at 45 CFR part 102.”

“not more than $25,000”

“7. This penalty amount is adjusted annually for inflation, and is published at 45 CFR part 102.”

(e)(1)

“not more than $50,000”

“8. This penalty amount is adjusted annually for inflation, and is published at 45 CFR part 102.”

“will not exceed $25,000;”

“9. This penalty amount is adjusted annually for inflation, and is published at 45 CFR part 102.”

(e)(2)

“not more than $50,000”

“10. This penalty amount is adjusted annually for inflation, and is published at 45 CFR part 102.”

(f)(1) introductory text

“up to $25,000”

“11. This penalty amount is adjusted annually for inflation, and is published at 45 CFR part 102.”

(f)(2) introductory text

“up to $25,000”

“12. This penalty amount is adjusted annually for inflation, and is published at 45 CFR part 102.”

(f)(3) introductory text

“up to $100,000”

“13. This penalty amount is adjusted annually for inflation, and is published at 45 CFR part 102.”

(f)(5)

“an additional $15,000”

“14. This penalty amount is adjusted annually for inflation, and is published at 45 CFR part 102.”

(g)

“not more than $25,000”

“15. This penalty amount is adjusted annually for inflation, and is published at 45 CFR part 102.”

(h)(1)

“not more than $50,000”

“16. This penalty amount is adjusted annually for inflation, and is published at 45 CFR part 102.”

(h)(2)(i)(1)

“$5,000”

“17. This penalty amount is adjusted annually for inflation, and is published at 45 CFR part 102.”

(j)

“not more than $10,000”

“18. This penalty amount is adjusted annually for inflation, and is published at 45 CFR part 102.”

(k)

“not more than $2,000”

“19. This penalty amount is adjusted annually for inflation, and is published at 45 CFR part 102.”

(l)

“not more than $250,000”

“20. This penalty amount is adjusted annually for inflation, and is published at 45 CFR part 102.”

(l)

“and not more than $500,000”

“21. This penalty amount is adjusted annually for inflation, and is published at 45 CFR part 102.”

(m)

“not more than $10,000”

“22. This penalty amount is adjusted annually for inflation, and is published at 45 CFR part 102.”

Title 45—Public Welfare

Subtitle A—Department of Health and Human Services

PART 79—PROGRAM FRAUD CIVIL PENALTIES

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

Authority:

31 U.S.C. 3801-3812.

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

§ 79.3

Basis for civil penalties and assessments.

(a) * * *

(1) * * *

(iv) * * *

1

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

(b) * * *

(1) * * *

(ii) * * *

2

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

PART 93—NEW RESTRICTIONS ON LOBBYING

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

Authority:

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

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

§ 93.400

Penalties.

(a) * * *

1

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

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

Appendix A—Certification Regarding Lobbying

Certification for Contracts, Grants, Loans, and Cooperative Agreements

(3) * * *

1

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

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

PART 102—ADJUSTMENT OF CIVIL MONETARY PENALTIES FOR INFLATION

Sec.

102.1

Applicability.

102.2

Applicability date.

102.3

Penalty adjustment and table.

Authority:

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

§ 102.1

Applicability.

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

§ 102.2

Applicability date.

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

§ 102.3

Penalty adjustment and table.

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

Civil Monetary Penalty Authorities Administered by HHS Agencies and Penalty Amounts

[Effective September 6, 2016]

Citation

U.S.C.

CFR

1

HHS

agency

Description

2

Date of last penalty

figure or

adjustment

3

Pre-inflation penalty

($)

Maximum

adjusted

penalty

($)

21 U.S.C.:

333(b)(2)(A)

FDA

Penalty for violations related to drug samples resulting in a conviction of any representative of manufacturer or distributor in any 10-year period

1988

50,000

98,935

333(b)(2)(B)

FDA

Penalty for 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

1988

1,000,000

1,978,690

333(b)(3)

FDA

Penalty for failure to make a report required by 21 U.S.C. 353(d)(3)(E) relating to drug samples

1988

100,000

197,869

333(f)(1)(A)

FDA

Penalty for any person who violates a requirement related to devices for each such violation

1990

15,000

26,723

Penalty for aggregate of all violations related to devices in a single proceeding

1990

1,000,000

1,781,560

333(f)(2)(A)

FDA

Penalty for any 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

1996

50,000

75,123

Penalty in the case of any other person other than an individual) for such introduction or delivery of adulterated food

1996

250,000

375,613

Penalty for aggregate of all such violations related to adulterated food adjudicated in a single proceeding

1996

500,000

751,225

333(f)(3)(A)

FDA

Penalty for all violations adjudicated in a single proceeding for any person who fails to submit certification required by 42 U.S.C. 282(j)(5)(B) or knowingly submitting a false certification

2007

10,000

11,383

333(f)(3)(B)

FDA

Penalty for each day the above violation is not corrected after a 30-day period following notification until the violation is corrected

2007

10,000

11,383

333(f)(4)(A)(i)

FDA

Penalty for any 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)

2007

250,000

284,583

Penalty for aggregate of all such above violations in a single proceeding

2007

1,000,000

1,138,330

333(f)(4)(A)(ii)

FDA

Penalty for REMS violation that continues after written notice to the responsible person for the first 30-day period (or any portion thereof) the responsible person continues to be in violation

2007

250,000

284,583

Penalty for REMS violation that continues after written notice to responsible person doubles for every 30-day period thereafter the violation continues, but may not exceed penalty amount for any 30-day period

2007

1,000,000

1,138,330

Penalty for aggregate of all such above violations adjudicated in a single proceeding

2007

10,000,000

11,383,300

333(f)(9)(A)

FDA

Penalty for any person who violates a requirement which relates to tobacco products for each such violation

2009

15,000

16,503

Penalty for aggregate of all such violations of tobacco product requirement adjudicated in a single proceeding

2009

1,000,000

1,100,200

333(f)(9)(B)(i)(I)

FDA

Penalty per violation related to violations of tobacco requirements

2009

250,000

275,050

Penalty for aggregate of all such violations of tobacco product requirements adjudicated in a single proceeding

2009

1,000,000

1,100,200

333(f)(9)(B)(i)(II)

FDA

Penalty in the case of a violation of tobacco product requirements that continues after written notice to such person, for the first 30-day period (or any portion thereof) the person continues to be in violation

2009

250,000

275,050

Penalty for 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

2009

1,000,000

1,100,200

Penalty for aggregate of all such violations related to tobacco product requirements adjudicated in a single proceeding

2009

10,000,000

11,002,000

333(f)(9)(B)(ii)(I)

FDA

Penalty for any 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

2009

250,000

275,050

Penalty for aggregate of for all such above violations adjudicated in a single proceeding

2009

1,000,000

1,100,200

333(f)(9)(B)(ii)(II)

FDA

Penalty for 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

2009

250,000

275,050

Penalty for post-notice violation of modified risk tobacco product post-market surveillance shall double for every 30-day period thereafter that the tobacco product requirement violation continues for any 30-day period, but may not exceed penalty amount for any 30-day period

2009

1,000,000

1,100,200

Penalty for aggregate above tobacco product requirement violations adjudicated in a single proceeding

2009

10,000,000

11,002,000

333(g)(1)

FDA

Penalty for any 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

2007

250,000

284,583

Penalty for each subsequent above violation in any 3-year period

2007

500,000

569,165

333 note

FDA

Penalty to be 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

2009

250

275

Penalty in the case of a third tobacco product regulation violation within a 24-month period

2009

500

550

Penalty in the case of a fourth tobacco product regulation violation within a 24-month period

2009

2,000

2,200

Penalty in the case of a fifth tobacco product regulation violation within a 36-month period

2009

5,000

5,501

Penalty in the case of a sixth or subsequent tobacco product regulation violation within a 48-month period as determined on a case-by-case basis

2009

10,000

11,002

Penalty to be 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

2009

250

275

Penalty in the case of a second tobacco product regulation violation within a 12-month period

2009

500

550

Penalty in the case of a third tobacco product regulation violation within a 24-month period

2009

1,000

1,100

Penalty in the case of a fourth tobacco product regulation violation within a 24-month period

2009

2,000

2,200

Penalty in the case of a fifth tobacco product regulation violation within a 36-month period

2009

5,000

5,501

Penalty in the case of a sixth or subsequent tobacco product regulation violation within a 48-month period as determined on a case-by-case basis

2009

10,000

11,002

335b(a)

FDA

Penalty for each 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

1992

250,000

419,320

Penalty in the case of any other person (other than an individual) per above violation

1992

1,000,000

1,677,280

360pp(b)(1)

FDA

Penalty for any person who violates any such requirements for electronic products, with each unlawful act or omission constituting a separate violation

1968

1,100

2,750

Penalty imposed for any related series of violations of requirements relating to electronic products

1968

375,000

937,500

42 U.S.C.:

262(d)

FDA

Penalty per day for violation of order of recall of biological product presenting imminent or substantial hazard

1986

100,000

215,628

263b(h)(3)

FDA

Penalty for failure to obtain a mammography certificate as required

1992

10,000

16,773

300aa-28(b)(1)

FDA

Penalty per occurrence for any vaccine manufacturer that intentionally destroys, alters, falsifies, or conceals any record or report required

1986

100,000

215,628

256b(d)(1)(B)(vi)

HRSA

Penalty for each instance of overcharging a 340B covered entity

2010

5,000

5,437

299c-(3)(d)

AHRQ

Penalty for an establishment or person supplying information obtained in the course of activities for any purpose other than the purpose for which it was supplied

1999

10,000

14,140

653(l)(2)

45 CFR 303.21(f)

ACF

Penalty for Misuse of Information in the National Directory of New Hires

1998

1,000

1,450

262a(i)(1)

42 CFR Part 1003

OIG

Penalty for each individual who violates safety and security procedures related to handling dangerous biological agents and toxins

2002

250,000

327,962

Penalty for any other person who violates safety and security procedures related to handling dangerous biological agents and toxins.

2002

500,000

655,925

1320a-7a(a)

42 CFR Part 1003

OIG

Penalty for knowingly presenting or causing to be presented to an officer, employee, or agent of the United States a false claim

1996

10,000

15,024

Penalty for knowingly presenting or causing to be presented a request for payment which violates the terms of an assignment, agreement, or PPS agreement

1996

10,000

15,024

Penalty for 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

1996

15,000

22,537

Penalty for an excluded party retaining ownership or control interest in a participating entity

1996

10,000

15,024

Penalty for remuneration offered to induce program beneficiaries to use particular providers, practitioners, or suppliers

1996

10,000

15,024

Penalty for employing or contracting with an excluded individual

1997

10,000

14,718

Penalty for knowing and willful solicitation, receipt, offer, or payment of remuneration for referring an individual for a service or for purchasing, leasing, or ordering an item to be paid for by a Federal health care program

1997

50,000

73,588

Penalty for ordering or prescribing medical or other item or service during a period in which the person was excluded

2010

10,000

10,874

Penalty for 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

2010

50,000

54,372

Penalty for knowing of an overpayment and failing to report and return

2010

10,000

10,874

Penalty for making or using a false record or statement that is material to a false or fraudulent claim

2010

50,000

54,372

Penalty for failure to grant timely access to HHS OIG for audits, investigations, evaluations, and other statutory functions of HHS OIG

2010

15,000

16,312

1320a-7a(b)

42 CFR Part 1003

OIG

Penalty for payments by a hospital or critical access hospital to induce a physician to reduce or limit services to individuals under direct care of physician or who are entitled to certain medical assistance benefits

1986

2,000

4,313

Penalty for 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

1986

2,000

4,313

Penalty for a physician who executes a document that falsely certifies home health needs for Medicare beneficiaries

1996

5,000

7,512

1320a-7e(b)(6)(A)

42 CFR Part 1003

OIG

Penalty for failure to report any final adverse action taken against a health care provider, supplier, or practitioner

1997

25,000

36,794

1320b-10(b)(1)

42 CFR Part 1003

OIG

Penalty for the 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

1988

5,000

9,893

1320b-10(b)(2)

42 CFR Part 1003

OIG

Penalty for the 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

1988

25,000

49,467

1395i-3(b)(3)(B)(ii)(1)

OIG

Penalty for certification of a false statement in assessment of functional capacity of a Skilled Nursing Facility resident assessment

1987

1,000

2,063

1395i-3(b)(3)(B)(ii)(2)

OIG

Penalty for causing another to certify or make a false statement in assessment of functional capacity of a Skilled Nursing Facility resident assessment

1987

5,000

10,314

1395i-3(g)(2)(A)

OIG

Penalty for any 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

1987

2,000

4,126

1395w-27(g)(2)(A)

42 CFR 422.752; 42 CFR Part 1003

OIG

Penalty for a Medicare Advantage organization that substantially fails to provide medically necessary, required items and services

1996

25,000

37,561

Penalty for a Medicare Advantage organization that charges excessive premiums

1997

25,000

36,794

Penalty for a Medicare Advantage organization that improperly expels or refuses to reenroll a beneficiary

1997

25,000

36,794

Penalty for a Medicare Advantage organization that engages in practice that would reasonably be expected to have the effect of denying or discouraging enrollment

1997

100,000

147,177

Penalty per 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

1997

15,000

22,077

Penalty for a Medicare Advantage organization misrepresenting or falsifying information to Secretary

1997

100,000

147,177

Penalty for a Medicare Advantage organization misrepresenting or falsifying information to individual or other entity

1997

25,000

36,794

Penalty for Medicare Advantage organization interfering with provider's advice to enrollee and non-MCO affiliated providers that balance bill enrollees

1997

25,000

36,794

Penalty for a Medicare Advantage organization that employs or contracts with excluded individual or entity

1997

25,000

36,794

Penalty for a Medicare Advantage organization enrolling an individual in without prior written consent

2010

25,000

36,794

Penalty for a Medicare Advantage organization transferring an enrollee to another plan without consent or solely for the purpose of earning a commission

2010

25,000

36,794

Penalty for a Medicare Advantage organization failing to comply with marketing restrictions or applicable implementing regulations or guidance

2010

25,000

36,794

Penalty for a Medicare Advantage organization employing or contracting with an individual or entity who violates 1395w-27(g)(1)(A)-(J)

2010

25,000

36,794

1395w-141(i)(3)

42 CFR Part 1003

OIG

Penalty for a prescription drug card sponsor that falsifies or misrepresents marketing materials, overcharges program enrollees, or misuse transitional assistance funds

2003

10,000

12,856

1395cc(g)

42 CFR Part 1003

OIG

Penalty for improper billing by Hospitals, Critical Access Hospitals, or Skilled Nursing Facilities

1972

2,000

5,000

1395dd(d)(1)

42 CFR Part 1003

OIG

Penalty for a hospital or responsible physician dumping patients needing emergency medical care, if the hospital has 100 beds or more

1987

50,000

103,139

Penalty for a hospital or responsible physician dumping patients needing emergency medical care, if the hospital has less than 100 beds

1987

25,000

51,570

1395mm(i)(6)(B)(i)

42 CFR Part 1003

OIG

Penalty for a HMO or competitive plan is such plan substantially fails to provide medically necessary, required items or services

1987

25,000

51,570

Penalty for HMOs/competitive medical plans that charge premiums in excess of permitted amounts

1987

25,000

51,570

Penalty for a HMO or competitive medical plan that expels or refuses to reenroll an individual per prescribed conditions

1987

25,000

51,570

Penalty for a HMO or competitive medical plan that implements practices to discourage enrollment of individuals needing services in future

1987

100,000

206,278

Penalty per 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

1988

15,000

29,680

Penalty for a HMO or competitive medical plan that misrepresents or falsifies information to the Secretary

1987

100,000

206,278

Penalty for a HMO or competitive medical plan that misrepresents or falsifies information to an individual or any other entity

1987

25,000

51,570

Penalty for failure by HMO or competitive medical plan to assure prompt payment of Medicare risk sharing contracts or incentive plan provisions

1987

25,000

51,570

Penalty for HMO that employs or contracts with excluded individual or entity

1989

25,000

47,340

1395nn(g)(3)

42 CFR Part 1003

OIG

Penalty for submitting or causing to be submitted claims in violation of the Stark Law's restrictions on physician self-referrals

1994

15,000

23,863

1395nn(g)(4)

42 CFR Part 1003

OIG

Penalty for circumventing Stark Law's restrictions on physician self-referrals

1994

100,000

159,089

1395ss(d)(1)

42 CFR Part 1003

OIG

Penalty for a material misrepresentation regarding Medigap compliance policies

1988

5,000

9,893

1395ss(d)(2)

42 CFR Part 1003

OIG

Penalty for selling Medigap policy under false pretense

1988

5,000

9,893

1395ss(d)(3)(A)(ii)

42 CFR Part 1003

OIG

Penalty for an issuer that sells health insurance policy that duplicates benefits

1990

25,000

44,539

Penalty for someone other than issuer that sells health insurance that duplicates benefits

1990

15,000

26,723

1395ss(d)(4)(A)

42 CFR Part 1003

OIG

Penalty for using mail to sell a non-approved Medigap insurance policy

1988

5,000

9,893

1396b(m)(5)(B)(i)

42 CFR Part 1003

OIG

Penalty for a Medicaid MCO that substantially fails to provide medically necessary, required items or services

1988

25,000

49,467

Penalty for a Medicaid MCO that charges excessive premiums

1988

25,000

49,467

Penalty for a Medicaid MCO that improperly expels or refuses to reenroll a beneficiary

1988

100,000

197,869

Penalty per 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

1988

15,000

29,680

Penalty for a Medicaid MCO misrepresenting or falsifying information to the Secretary

1988

100,000

197,869

Penalty for a Medicaid MCO misrepresenting or falsifying information to an individual or another entity

1988

25,000

49,467

Penalty for a Medicaid MCO that fails to comply with contract requirements with respect to physician incentive plans

1990

25,000

44,539

1396r(b)(3)(B)(ii)(I)

42 CFR Part 1003

OIG

Penalty for willfully and knowingly certifying a material and false statement in a Skilled Nursing Facility resident assessment

1987

1,000

2,063

1396r(b)(3)(B)(ii)(II)

42 CFR Part 1003

OIG

Penalty for willfully and knowingly causing another individual to certify a material and false statement in a Skilled Nursing Facility resident assessment

1987

5,000

10,314

1396r(g)(2)(A)(i)

42 CFR Part 1003

OIG

Penalty for notifying or causing to be notified a Skilled Nursing Facility of the time or date on which a survey is to be conducted

1987

2,000

4,126

1396r-8(b)(3)(B)

42 CFR Part 1003

OIG

Penalty for the knowing provision of false information or refusing to provide information about charges or prices of a covered outpatient drug

1990

100,000

178,156

1396r-8(b)(3)(C)(i)

42 CFR Part 1003

Penalty per day for failure to timely provide information by drug manufacturer with rebate agreement

1990

10,000

17,816

1396r-8(b)(3)(C)(ii)

42 CFR Part 1003

Penalty for knowing provision of false information by drug manufacturer with rebate agreement

1990

100,000

178,156

1396t(i)(3)(A)

42 CFR Part 1003

OIG

Penalty for notifying home and community-based providers or settings of survey

1990

2,000

3,563

11131(c)

42 CFR Part 1003

OIG

Penalty for failing to report a medical malpractice claim to National Practitioner Data Bank

1986

10,000

21,563

11137(b)(2)

42 CFR Part 1003

OIG

Penalty for breaching confidentiality of information reported to National Practitioner Data Bank

1986

10,000

21,563

299b-22(f)(1)

42 CFR 3.404

OCR

Penalty for violation of confidentiality provision of the Patient Safety and Quality Improvement Act

2005

10,000

11,940

1320(d)-5(a)

45 CFR 160.404(b)(1)(i),(ii)

OCR

Penalty for each pre-February 18, 2009 violation of the HIPAA administrative simplification provisions

1996

100

150

Calendar Year Cap

1996

25,000

37,561

1320(d)-5(a)

45 CFR 160.404(b)(2)(i)(A), (B)

OCR

Penalty for each February 18, 2009 or later violation of a HIPAA administrative simplification provision in which it is established that the covered entity or business associate did not know and by exercising reasonable diligence, would not have known that the covered entity or business associate violated such a provision:

Minimum

2009

100

110

Maximum

2009

50,000

55,010

Calendar Year Cap

2009

1,500,000

1,650,300

45 CFR 160.404(b)(2)(ii)(A), (B)

OCR

Penalty for each February 18, 2009 or later violation of a HIPAA administrative simplification provision in which it is established that the violation was due to reasonable cause and not to willful neglect:

Minimum

2009

1,000

1,100

Maximum

2009

50,000

55,010

Calendar Year Cap

2009

1,500,000

1,650,300

45 CFR 160.404(b)(2)(iii)(A), (B)

OCR

Penalty for each February 18, 2009 or later violation of a HIPAA administrative simplification provision in which it is established that the violation was due to willful neglect and was corrected during the 30-day period beginning on the first date the covered entity or business associate knew, or, by exercising reasonable diligence, would have known that the violation occurred:

Minimum

2009

10,000

11,002

Maximum

2009

50,000

55,010

Calendar Year Cap

2009

1,500,000

1,650,300

45 CFR 160.404(b)(2)(iv)(A), (B)

OCR

Penalty for each February 18, 2009 or later violation of a HIPAA administrative simplification provision in which it is established that the violation was due to willful neglect and was not corrected during the 30-day period beginning on the first date the covered entity or business associate knew, or by exercising reasonable diligence, would have known that the violation occurred:

Minimum

2009

50,000

55,010

Maximum

2009

1,500,000

1,650,300

Calendar Year Cap

2009

1,500,000

1,650,300

263a(h)(2)(B) & 1395w-2(b)(2)(A)(ii)

42 CFR 493.1834(d)(2)(i)

CMS

Penalty for a clinical laboratory's failure to meet participation and certification requirements and poses immediate jeopardy:

Minimum

1988

3,050

6,035

Maximum

1988

10,000

19,787

42 CFR 493.1834(d)(2)(ii)

CMS

Penalty for a clinical laboratory's failure to meet participation and certification requirements and the failure does not pose immediate jeopardy:

Minimum

1988

50

99

Maximum

1988

3,000

5,936

300gg-15(f)

45 CFR 147.200(e)

CMS

Failure to provide the Summary of Benefits and Coverage

2010

1,000

1,087

300gg-18

45 CFR 158.606

CMS

Penalty for violations of regulations related to the medical loss ratio reporting and rebating

2010

100

109

1320a-7h(b)(1)

42 CFR 402.105(d)(5); 42 CFR 403.912(a) & (c)

CMS

Penalty for manufacturer or group purchasing organization failing to report information required under 42 U.S.C. 1320a-7h(a), relating to physician ownership or investment interests:

Minimum

2010

1,000

1,087

Maximum

2010

10,000

10,874

Calendar Year Cap

2010

150,000

163,117

1320a-7h(b)(2)

42 CFR 402.105(h); 42 CFR 403 912(b) & (c)

CMS

Penalty for 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

2010

10,000

10,874

Maximum

2010

100,000

108,745

Calendar Year Cap

2010

1,000,000

1,087,450

1320a-7j(h)(3)(A)

CMS

Penalty for an administrator of a facility that fails to comply with notice requirements for the closure of a facility

2010

100,000

108,745

42 CFR 488.446(a)(1),(2), & (3)

CMS

Minimum penalty for the first offense of an administrator who fails to provide notice of facility closure

2010

500

544

Minimum penalty for the second offense of an administrator who fails to provide notice of facility closure

2010

1,500

1,631

Minimum penalty for the third and subsequent offenses of an administrator who fails to provide notice of facility closure

2010

3,000

3,262

1320a-8(a)(1)

CMS

Penalty for an 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

1994

5,000

7,954

Penalty for 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

2015

7,500

7,500

1320a-8(a)(3)

CMS

Penalty for a 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

2004

5,000

6,229

1320b-25(c)(1)(A)

CMS

Penalty for failure of covered individuals to report to the Secretary and 1 or more law enforcement officials any reasonable suspicion of a crime against a resident, or individual receiving care, from a long-term care facility

2010

200,000

217,490

1320b-25(c)(2)(A)

CMS

Penalty for failure of covered individuals to report to the Secretary and 1 or more law enforcement officials any reasonable suspicion of a crime against a resident, or individual receiving care, from a long-term care facility if such failure exacerbates the harm to the victim of the crime or results in the harm to another individual

2010

300,000

326,235

1320b-25(d)(2)

CMS

Penalty for a long-term care facility that retaliates against any employee because of lawful acts done by the employee, or files a complaint or report with the State professional disciplinary agency against an employee or nurse for lawful acts done by the employee or nurse

2010

200,000

217,490

1395b-7(b)(2)(B)

42 CFR 402.105(g)

CMS

Penalty for any 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

1997

100

147

1395i-3(h)(2)(B)(ii)(I)

42 CFR 488.408(d)(1)(iii)

CMS

Penalty per day for a Skilled Nursing Facility that has a Category 2 violation of certification requirements:

Minimum

1987

50

103

Maximum

1987

3,000

6,188

42 CFR 488.408(d)(1)(iv)

CMS

Penalty per instance of Category 2 noncompliance by a Skilled Nursing Facility:

Minimum

1987

1,000

2,063

Maximum

1987

10,000

20,628

42 CFR 488.408(e)(1)(iii)

CMS

Penalty per day for a Skilled Nursing Facility that has a Category 3 violation of certification requirements:

Minimum

1987

3,050

6,291

Maximum

1987

10,000

20,628

42 CFR 488.408(e)(1)(iv)

CMS

Penalty per instance of Category 3 noncompliance by a Skilled Nursing Facility:

Minimum

1987

1,000

2,063

Maximum

1987

10,000

20,628

42 CFR 488.408(e)(2)(ii)

CMS

Penalty per day and per instance for a Skilled Nursing Facility that has Category 3 noncompliance with Immediate Jeopardy:

Per Day (Minimum)

1987

3,050

6,291

Per Day (Maximum)

1987

10,000

20,628

Per Instance (Minimum)

1987

1,000

2,063

Per Instance (Maximum)

1987

10,000

20,628

42 CFR 488.438(a)(1)(i)

CMS

Penalty per day of a Skilled Nursing Facility that fails to meet certification requirements. These amounts represent the upper range per day:

Minimum

1987

3,050

6,291

Maximum

1987

10,000

20,628

42 CFR 488.438(a)(1)(ii)

CMS

Penalty per day of a Skilled Nursing Facility that fails to meet certification requirements. These amounts represent the lower range per day:

Minimum

1987

50

103

Maximum

1987

3,000

6,188

42 CFR 488.438(a)(2)

CMS

Penalty per instance of a Skilled Nursing Facility that fails to meet certification requirements:

Minimum

1987

1,000

2,063

Maximum

1987

10,000

20,628

1395l(h)(5)(D)

42 CFR 402.105(d)(2)(i)

CMS

Penalty for knowingly, 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))

1996

10,000

15,024

1395l(i)(6)

CMS

Penalty for 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

1988

2,000

3,957

1395l(q)(2)(B)(i)

42 CFR 402.105(a)

CMS

Penalty for knowingly and willfully failing to provide information about a referring physician when seeking payment on an unassigned basis

1989

2,000

3,787

1395m(a)(11)(A)

42 CFR 402.1(c)(4), 402.105(d)(2)(ii)

CMS

Penalty for any 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))

1996

10,000

15,024

1395m(a)(18)(B)

42 CFR 402.1(c)(5), 402.105(d)(2)(iii)

CMS

Penalty for any 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))

1996

10,000

15,024

1395m(b)(5)(C)

42 CFR 402.1(c)(6), 402.105(d)(2)(iv)

CMS

Penalty for any 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))

1996

10,000

15,024

1395m(h)(3)

42 CFR 402.1(c)(8), 402.105(d)(2)(vi)

CMS

Penalty for any 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))

1996

10,000

15,024

1395m(j)(2)(A)(iii)

CMS

Penalty for any 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

1994

1,000

1,591

1395m(j)(4)

42 CFR 402.1(c)(10), 402.105(d)(2)(vii)

CMS

Penalty for any 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))

1996

10,000

15,024

1395m(k)(6)

42 CFR 402.1(c)(31), 402.105(d)(3)

CMS

Penalty for any 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))

1996

10,000

15,024

1395m(l)(6)

42 CFR 402.1(c)(32), 402.105(d)(4)

CMS

Penalty for any 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))

1996

10,000

15,024

1395u(b)(18)(B)

42 CFR 402.1(c)(11), 402.105(d)(2)(viii)

CMS

Penalty for any 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))

1996

10,000

15,024

1395u(j)(2)(B)

42 CFR 402.1(c)

CMS

Penalty for any 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))

1996

10,000

15,024

1395u(k)

42 CFR 402.1(c)(12), 402.105(d)(2)(ix)

CMS

Penalty for any 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))

1996

10,000

15,024

1395u(l)(3)

42 CFR 402.1(c)(13), 402.105(d)(2)(x)

CMS

Penalty for any 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))

1996

10,000

15,024

1395u(m)(3)

42 CFR 402.1(c)(14), 402.105(d)(2)(xi)

CMS

Penalty for any 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))

1996

10,000

15,024

1395u(n)(3)

42 CFR 402.1(c)(15), 402.105(d)(2)(xii)

CMS

Penalty for any 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))

1996

10,000

15,024

1395u(o)(3)(B)

42 CFR 414.707(b)

CMS

Penalty for any 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))

1996

10,000

15,024

1395u(p)(3)(A)

CMS

Penalty for any 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

1988

2,000

3,957

1395w-3a(d)(4)(A)

42 CFR 414.806

CMS

Penalty for a pharmaceutical manufacturer's misrepresentation of average sales price of a drug, or biologic

2003

10,000

12,856

1395w-4(g)(1)(B)

42 CFR 402.1(c)(17), 402.105(d)(2)(xiii)

CMS

Penalty for any 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))

1996

10,000

15,024

1395w-4(g)(3)(B)

42 CFR 402.1(c)(18), 402.105(d)(2)(xiv)

CMS

Penalty for any 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))

1996

10,000

15,024

1395w-27(g)(3)(A); 1857(g)(3)

42 CFR 422.760(b); 42 CFR 423.760(b)

CMS

Penalty for each 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

1997

25,000

36,794

1395w-27(g)(3)(B); 1857(g)(3)

CMS

Penalty for each week beginning after the initiation of civil money penalty procedures by the Secretary because a Medicare Advantage organization or Part D sponsor has failed to carry out a contract, or has carried out a contract inconsistently with regulations

1997

10,000

14,718

1395w-27(g)(3)(D); 1857(g)(3)

CMS

Penalty for a Medicare Advantage organization's or Part D sponsor's early termination of its contract

2000

100,000

136,689

1395y(b)(3)(C)

42 CFR 411.103(b)

CMS

Penalty for an 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

1990

5,000

8,908

1395y(b)(5)(C)(ii)

42 CFR 402.1(c)(20); 42 CFR 402.105(b)(2)

CMS

Penalty for any non-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

1998

1,000

1,450

1395y(b)(6)(B)

42 CFR 402.1(c)(21), 402.105(a)

CMS

Penalty for any 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

1994

2,000

3,182

1395y(b)(7)(B)(i)

CMS

Penalty for any 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

2007

1,000

1,138

1395y(b)(8)(E)

CMS

Penalty for any non-group health plan that fails to identify claimants who are Medicare beneficiaries and provide information to the HHS Secretary to coordinate benefits and pursue any applicable recovery claim

2007

1,000

1,138

1395nn(g)(5)

42 CFR 411.361

CMS

Penalty for any person that fails to report information required by HHS under Section 1877(f) concerning ownership, investment, and compensation arrangements

1989

10,000

18,936

1395pp(h)

42 CFR 402.1(c)(23), 402.105(d)(2)(xv)

CMS

Penalty for any 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))

1996

10,000

15,024

1395ss(a)(2)

42 CFR 402.1(c)(24), 405.105(f)(1)

CMS

Penalty for any 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

1987

25,000

51,569

1395ss(d)(3)(A)(vi)(II)

CMS

Penalty for someone other than issuer that sells or issues a Medicare supplemental policy to beneficiary without a disclosure statement

1990

15,000

26,723

Penalty for an issuer that sells or issues a Medicare supplemental policy without disclosure statement

1990

25,000

44,539

1395ss(d)(3)(B)(iv)

CMS

Penalty for someone other than issuer that sells or issues a Medicare supplemental policy without acknowledgement form

1990

15,000

26,723

Penalty for issuer that sells or issues a Medicare supplemental policy without an acknowledgement form

1990

25,000

44,539

1395ss(p)(8)

42 CFR 402.1(c)(25), 402.105(e)

CMS

Penalty for any 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

1990

15,000

26,723

42 CFR 402.1(c)(25), 405.105(f)(2)

CMS

Penalty for any 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

1990

25,000

44,539

1395ss(p)(9)(C)

42 CFR 402.1(c)(26), 402.105(e)

CMS

Penalty for any 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

1990

15,000

26,723

42 CFR 402.1(c)(26), 405.105(f)(3), (4)

Penalty for any 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

1990

25,000

44,539

1395ss(q)(5)(C)

42 CFR 402.1(c)(27), 405.105(f)(5)

CMS

Penalty for any 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

1990

25,000

44,539

1395ss(r)(6)(A)

42 CFR 402.1(c)(28), 405.105(f)(6)

CMS

Penalty for any person that fails to provide refunds or credits as required by section 1882(r)(1)(B)

1990

25,000

44,539

1395ss(s)(4)

42 CFR 402.1(c)(29), 405.105(c)

CMS

Penalty for any 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

1990

5,000

18,908

1395ss(t)(2)

42 CFR 402.1(c)(30), 405.105(f)(7)

CMS

Penalty for any issuer of a Medicare supplemental policy that fails to fulfill listed responsibilities

1990

25,000

44,539

1395ss(v)(4)(A)

CMS

Penalty someone other than issuer who sells, issues, or renews a medigap Rx policy to an individual who is a Part D enrollee

2003

15,000

19,284

Penalty for an issuer who sells, issues, or renews a Medigap Rx policy who is a Part D enrollee

2003

25,000

32,140

1395bbb(c)(1)

42 CFR 488.725(c)

CMS

Penalty for any 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

1987

2,000

4,126

1395bbb(f)(2)(A)(i)

42 CFR 488.845(b)(2)(iii); 42 CFR 488.845(b)(3)-(6); and 42 CFR 488.845(d)(1)(ii)

CMS

Maximum daily penalty amount for each day a home health agency is not in compliance with statutory requirements

1988

10,000

19,787

42 CFR 488.845(b)(3)

Penalty per day for home health agency's noncompliance (Upper Range):

Minimum

1988

8,500

16,819

Maximum

1988

10,000

19,787

42 CFR 488.845(b)(3)(i)

Penalty for a home health agency's deficiency or deficiencies that cause immediate jeopardy and result in actual harm

1988

10,000

19,787

42 CFR 488.845(b)(3)(ii)

Penalty for a home health agency's deficiency or deficiencies that cause immediate jeopardy and result in potential for harm

1988

9,000

17,808

42 CFR 488.845(b)(3)(iii)

Penalty for an isolated incident of noncompliance in violation of established HHA policy

1988

8,500

16,819

42 CFR 488.845(b)(4)

Penalty for a repeat and/or condition-level deficiency that does not constitute immediate jeopardy, but is directly related to poor quality patient care outcomes (Lower Range):

Minimum

1988

1,500

2,968

Maximum

1988

8,500

16,819

42 CFR 488.845(b)(5)

Penalty for a repeat and/or condition-level deficiency that does not constitute immediate jeopardy and that is related predominately to structure or process-oriented conditions (Lower Range):

Minimum

1988

500

989

Maximum

1988

4,000

7,915

42 CFR 488.845(b)(6)

Penalty imposed for instance of noncompliance that may be assessed for one or more singular events of condition-level noncompliance that are identified and where the noncompliance was corrected during the onsite survey:

Minimum

1988

1,000

1,979

Maximum

1988

10,000

19,787

Penalty for each day of noncompliance (Maximum)

1988

10,000

19,787

42 CFR 488.845(d)(1)(ii)

Penalty for each day of noncompliance (Maximum)

1988

10,000

19,787

1396b(m)(5)(B)

42 CFR 460.46

CMS

Penalty for PACE organization's practice that would reasonably be expected to have the effect of denying or discouraging enrollment:

Minimum

1997

15,000

22,077

Maximum

1997

100,000

147,177

Penalty for a PACE organization that charges excessive premiums

1997

25,000

36,794

Penalty for a PACE organization misrepresenting or falsifying information to CMS, the State, or an individual or other entity

1997

100,000

147,177

Penalty for each determination the CMS makes that the PACE organization has failed to provide medically necessary items and services of the failure has adversely affected (or has the substantial likelihood of adversely affecting) a PACE participant

1997

25,000

36,794

Penalty for involuntarily disenrolling a participant

1997

25,000

36,794

Penalty for discriminating or discouraging enrollment or disenrollment of participants on the basis of an individual's health status or need for health care services

1997

25,000

36,794

1396r(h)(3)(C)(ii)(I)

42 CFR 488.408(d)(1)(iii)

CMS

Penalty per day for a nursing facility's failure to meet a Category 2 Certification:

Minimum

1987

50

103

Maximum

1987

3,000

6,188

42 CFR 488.408(d)(1)(iv)

CMS

Penalty per instance for a nursing facility's failure to meet Category 2 certification:

Minimum

1987

1,000

2,063

Maximum

1987

10,000

20,628

42 CFR 488.408(e)(1)(iii)

CMS

Penalty per day for a nursing facility's failure to meet Category 3 certification:

Minimum

1987

3,050

6,291

Maximum

1987

10,000

20,628

42 CFR 488.408(e)(1)(iv)

CMS

Penalty per instance for a nursing facility's failure to meet Category 3 certification:

2,063

Minimum

1987

1,000

20,628

Maximum

1987

10,000

42 CFR 488.408(e)(2)(ii)

CMS

Penalty per instance for a nursing facility's failure to meet Category 3 certification, which results in immediate jeopardy:

2,063

Minimum

1987

1,000

20,628

Maximum

1987

10,000

42 CFR 488.438(a)(1)(i)

CMS

Penalty per day for nursing facility's failure to meet certification (Upper Range):

6,291

Minimum

1987

3,050

20,628

Maximum

1987

10,000

2,063

42 CFR 488.438(a)(1)(ii)

CMS

Penalty per day for nursing facility's failure to meet certification (Lower Range):

Minimum

1987

50

103

Maximum

1987

3,000

6,188

42 CFR 488.438(a)(2)

CMS

Penalty per instance for nursing facility's failure to meet certification:

Minimum

1987

1,000

2,063

Maximum

1987

10,000

20,628

1396r(f)(2)(B)(iii)(I)(c)

42 CFR 483.151(b)(2)(iv) and (b)(3)(iii)

CMS

Grounds to prohibit approval of Nurse Aide Training Program—if assessed a penalty in 1819(h)(2)(B)(i) or 1919(h)(2)(A)(ii) of “not less than $5,000” [Not CMP authority, but a specific CMP amount (CMP at this level) that is the triggering condition for disapproval]

1987

5,000

10,314

1396r(h)(3)(C)(ii)(I)

42 CFR

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