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Rule

Adjustment of Civil Monetary Penalties for Inflation

A Rule by the Centers for Medicare & Medicaid Services and the Children and Families Administration on 09/06/2016

Published Document: 2016-18680 (81 FR 61538)

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

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Department of Health and Human Services
Office of the Secretary
Centers for Medicare & Medicaid Services
Office of the Inspector General
Office of the Secretary
Administration for Children and Families
  1. 42 CFR Part 3
  2. 42 CFR Parts 402, 403, 411, 412, 422, 423, 460, 483, 488, and 493
  3. 42 CFR Part 1003
  4. 45 CFR Parts 79, 93, 102, 147, 150, 155, 156, 158, and 160
  5. 45 CFR Part 303
  6. RIN 0991-AC0

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]

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 ( printed page 61539) each component, HHS has provided a table showing how the penalties are being increased pursuant to the 2015 Act. The first two columns (“Citation”) identify the United States Code (U.S.C.) statutory citation, and the applicable regulatory citation in the Code of Federal Regulations (CFR), if any. The third column (“Description”) provides a short description of the penalty. In the fourth column (“Pre-Inflation Penalty”), HHS has listed the penalty amount as it exists prior to the inflationary adjustments made by the effective date of this rule, and in the fifth column (“Date of Last Penalty Figure or Adjustment”), HHS has provided the amount and year of the penalty as enacted by Congress or changed through a mechanism other than pursuant to the Inflation Adjustment Act. In column six (“Percentage Increase”), HHS has listed the percentage increase based on the multiplier used to adjust from the CPI-U [2] of the year of enactment of the monetary penalty to the CPI-U for the current year, or a percentage equal to 150 percent, whichever is less. Multiplying the current penalty amount in column four by the percentage increase provides the “Increase” listed in column seven. The “Maximum Adjusted Penalty” in column eight is the sum of the current penalty amount and the “increase”. Where applicable, some HHS agencies will make as soon as practicable conforming edits to regulatory text. Additionally, HHS is issuing new regulatory text including the table showing how the penalties are being increased under the 2015 Act, located at 45 CFR part 102, to implement the civil monetary penalty (CMP) amounts adjusted for inflation agency-wide. Additionally, the 2015 Act requires agencies to publish annual adjustments not later than January 15 of every year after publication of the initial adjustment.

Calculation of CMP Adjustments
Citation Description 2 Pre-inflation penalty ($) Date of last penalty figure or adjustment 3 Percentage increase 4 Increase ($) 5 Maximum adjusted penalty ($)
U.S.C. CFR 1
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
( printed page 61540)
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
( printed page 61541)
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
( printed page 61542)
  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
( printed page 61543)
  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
( printed page 61544)
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
( printed page 61545)
  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
( printed page 61546)
  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
( printed page 61547)
  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
( printed page 61548)
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
( printed page 61549)
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
( printed page 61550)
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
( printed page 61551)
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
( printed page 61552)
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
( printed page 61553)
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
( printed page 61554)
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
( printed page 61555)
  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
( printed page 61556)
  42 CFR 488.845(b)(5) Penalty for a repeat and/or condition-level deficiency that does not constitute immediate jeopardy and that is related predominately to structure or process-oriented conditions (Lower Range):
  Minimum 500 1988 97.869 489 989
  Maximum 4,000 1988 97.869 3,915 7,915
 
42 CFR 488.845(b)(6) Penalty imposed for instance of noncompliance that may be assessed for one or more singular events of condition-level noncompliance that are identified and where the noncompliance was corrected during the onsite survey:
  Minimum 1,000 1988 97.869 979 1,979
  Maximum 10,000 1988 97.869 9,787 19,787
  Penalty for each day of 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
( printed page 61557)
  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
( printed page 61558)
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
( printed page 61559)
  Penalty for failure to provide statement regarding lobbying for loan guarantee and loan insurance transactions:
  Minimum 10,000 1989 89.361 8,936 18,936
  Maximum 100,000 1989 89.361 89,361 189,361
3801-3812 45 CFR 79.3(a)(1(iv) Penalty against any 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 ( printed page 61560) determined that this IFR does not result in expenditures by State, local, and tribal governments, or by the private sector, of $100 million or more in any one year. Accordingly, HHS has not prepared a budgetary impact statement or specifically addressed the regulatory alternatives considered.

VIII. Executive Order 13132 Determination

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

List of Subjects

42 CFR Part 3

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

42 CFR Part 402

  • Administrative practice and procedure
  • Medicaid
  • Medicare
  • Penalties

42 CFR Part 403

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

42 CFR Part 411

  • Kidney diseases
  • Medicare
  • Physician referral
  • Reporting and recordkeeping requirements

42 CFR Part 412

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

42 CFR Part 422

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

42 CFR Part 423

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

42 CFR Part 438

  • Grant programs—health
  • Medicaid
  • Reporting and recordkeeping requirements

42 CFR Part 460

  • Aged
  • Health care
  • Health records
  • Medicaid
  • Medicare
  • Reporting and recordkeeping requirements

42 CFR Part 483

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

42 CFR Part 488

  • Administrative practice and procedure
  • Health facilities
  • Medicare
  • Reporting and recordkeeping requirements

42 CFR Part 493

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

42 CFR Part 1003

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

45 CFR Part 79

  • Administrative practice and procedure
  • Claims
  • Fraud
  • Penalties

45 CFR Part 93

  • Government contracts
  • Grants programs
  • Loan programs
  • Lobbying
  • Penalties

45 CFR Part 102

  • Administrative practice and procedure
  • Penalties

45 CFR Part 147

  • Health care
  • Health insurance
  • Reporting and recordkeeping requirements

45 CFR Part 155

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

45 CFR Part 156

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

45 CFR Part 158

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

45 CFR Part 160

  • Administrative practice and procedures
  • Penalties
  • Records and recordkeeping requirements

45 CFR Part 303

  • Child support
  • Standards for program operations
  • Penalties

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

Title 42—Public Health

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

PART 3—PATIENT SAFETY ORGANIZATIONS AND PATIENT SAFETY WORK PRODUCT

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:

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 ( printed page 61561) updated, is published at 45 CFR part 102.

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

PART 402—CIVIL MONEY PENALTIES, ASSESSMENTS, AND EXCLUSIONS

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).

[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).

[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).

[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 ( printed page 61562) 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.

[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).

[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).

[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”.
( printed page 61563)
(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).

[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”.

[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.

[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”.
( printed page 61564)
  (b)(3)(iii) “$8,500 per day” “$8,500 as adjusted annually under 45 CFR part 102 per day”.
  (b)(4) “range of $1,500-$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.

[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).

[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.”
( printed page 61565)
(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:

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:

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

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.

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.

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.

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. ( printed page 61566)

Civil Monetary Penalty Authorities Administered by HHS Agencies and Penalty Amounts

[Effective September 6, 2016]
Citation HHS agency Description 2 Date of last penalty figure or adjustment 3 Pre-inflation penalty ($) Maximum adjusted penalty ($)
U.S.C. CFR 1
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
( printed page 61567)
  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
( printed page 61568)
  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
( printed page 61569)
  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
( printed page 61570)
  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
( printed page 61571)
  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
( printed page 61572)
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
( printed page 61573)
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
( printed page 61574)
  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
( printed page 61575)
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
( printed page 61576)
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
( printed page 61577)
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
( printed page 61578)
  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:
( printed page 61579)
  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 483.151(c)(2) CMS 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] 1987 5,000 10,314
( printed page 61580)
1396t(j)(2)(C) CMS Penalty for each day of noncompliance for a home or community care provider that no longer meets the minimum requirements for home and community care:
  Minimum 1990 1 2
  Maximum 1990 10,000 17,816
1396u-2(e)(2)(A)(i) 42 CFR 438.704 CMS Penalty for a Medicaid managed care organization that fails substantially to provide medically necessary items and services 1997 25,000 36,794
  Penalty for Medicaid managed care organization that imposes premiums or charges on enrollees in excess of the premiums or charges permitted 1997 25,000 36,794
  Penalty for a Medicaid managed care organization that misrepresents or falsifies information to another individual or entity 1997 25,000 36,794
  Penalty for a Medicaid managed care organization that fails to comply with the applicable statutory requirements for such organizations 1997 25,000 36,794
1396u-2(e)(2)(A)(ii) 42 CFR 438.704 CMS Penalty for a Medicaid managed care organization that misrepresents or falsifies information to the HHS Secretary 1997 100,000 147,177
  Penalty for Medicaid managed care organization that acts to discriminate among enrollees on the basis of their health status 1997 100,000 147,177
1396u-2(e)(2)(A)(iv) 42 CFR 438.704 CMS 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 1997 15,000 22,077
1396u(h)(2) 42 CFR 441, Subpart I CMS 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 1990 10,000 20,628
1396w-2(c)(1) CMS Penalty for disclosing information related to eligibility determinations for medical assistance programs 2009 10,000 11,002
18041(c)(2) 45 CFR 150.315; 45 CFR 156.805(c) CMS Failure to comply with requirements of the Public Health Services Act; Penalty for violations of rules or standards of behavior associated with issuer participation in the Federally-facilitated Exchange. (42 U.S.C. 300gg-22(b)(2)(C)) 1996 100 150
18081(h)(1)(A)(i)(II) 42 CFR 155.285 CMS Penalty for providing false information on Exchange application 2010 25,000 27,186
18081(h)(1)(B) 42 CFR 155.285 CMS Penalty for knowingly or willfully providing false information on Exchange application 2010 250,000 271,862
18081(h)(2) 42 CFR 155.260 CMS Penalty for knowingly or willfully disclosing protected information from Exchange 2010 25,000 27,186
31 U.S.C.:
1352 45 CFR 93.400(e) HHS Penalty for the first time an individual makes an expenditure prohibited by regulations regarding lobbying disclosure, absent aggravating circumstances 1989 10,000 18,936
  Penalty for second and subsequent offenses by individuals who make an expenditure prohibited by regulations regarding lobbying disclosure:
  Minimum 1989 10,000 18,936
  Maximum 1989 100,000 189,361
  Penalty for the first time an individual fails to file or amend a lobbying disclosure form, absent aggravating circumstances 1989 10,000 18,936
  Penalty for second and subsequent offenses by individuals who fail to file or amend a lobbying disclosure form, absent aggravating circumstances:
  Minimum 1989 10,000 18,936
  Maximum 1989 100,000 189,361
  45 CFR 93, Appendix A HHS Penalty for failure to provide certification regarding lobbying in the award documents for all sub-awards of all tiers:
  Minimum 1989 10,000 18,936
  Maximum 1989 100,000 189,361
( printed page 61581)
  Penalty for failure to provide statement regarding lobbying for loan guarantee and loan insurance transactions:
  Minimum 1989 10,000 18,936
  Maximum 1989 100,000 189,361
3801-3812 45 CFR 79.3(a)(1)(iv) HHS Penalty against any individual who—with knowledge or reason to know—makes, presents or submits a false, fictitious or fraudulent claim to the Department 1988 5,000 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 1988 5,000 9,894
1  Some HHS components have not promulgated regulations regarding their civil monetary penalty-specific statutory authorities.
2  The description is not intended to be a comprehensive explanation of the underlying violation; the statute and corresponding regulation, if applicable should be consulted.
3  Statutory, or non-Inflation Act Adjustment.

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

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

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

[Amended]

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

PART 150—CMS ENFORCEMENT IN GROUP AND INDIVIDUAL INSURANCE MARKETS

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

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

[Amended]

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

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

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

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

[Amended]

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

[Amended]

39. Amend § 155.285 as follows:

a. In paragraph (c)(1)(i), by removing the phrase “of $25,000 for” and adding in its place the phrase “of $25,000 as adjusted annually under 45 CFR part 102 for”;

b. In paragraph (c)(1)(ii), removing the phrase “of $250,000 for” and adding in its place the phrase “of $250,000 as adjusted annually under 45 CFR part 102 for”; and

c. In paragraph (c)(2)(i), removing the phrase “not more than $25,000 per” and adding in its place the phrase “not more than $25,000 as adjusted annually under 45 CFR part 102 per”.

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

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

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

[Amended]

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

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

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

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

[Amended]

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

PART 160—GENERAL ADMINISTRATIVE REQUIREMENTS

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

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

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

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 §§ 160.406, 160.408, and 160.412. These amounts were adjusted in accordance with the Federal Civil Monetary Penalty Inflation Adjustment ( printed page 61582) Act of 1990, (Pub. L. 101-140), as amended by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015, (section 701 of Pub. L. 114-74), and appear at 45 CFR part 102. These amounts will be updated annually and published at 45 CFR part 102.

* * * * *

Subtitle B—Regulations Related to Public Welfare

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

PART 303—STANDARDS FOR PROGRAM OPERATIONS

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

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

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

Safeguarding and disclosure of confidential information.
* * * * *

(f) Penalties for unauthorized disclosure. Any disclosure or use of confidential information in violation of 42 U.S.C. 653(l)(2) and implementing regulations shall be subject to:

(1) Any State and Federal statutes that impose legal sanctions for such disclosure; and

(2) The maximum civil monetary penalties associated with the statutory provisions authorizing civil monetary penalties under 42 U.S.C. 653(l)(2) as shown in the table at 45 CFR 102.3.

Dated: July 21, 2016.

Sylvia M. Burwell,

Secretary, Department of Health and Human Services.

Footnotes

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.

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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/​.

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[FR Doc. 2016-18680 Filed 9-2-16; 8:45 am]

BILLING CODE 4150-24-P

Published Document: 2016-18680 (81 FR 61538)