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Rule

Adjustment of Civil Monetary Penalties for Inflation

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Start Preamble Start Printed Page 61538

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.

Start Further Info

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.

End Further Info End Preamble Start Supplemental Information

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 Start Printed Page 61539each 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

CitationDescription 2Pre-inflation penalty ($)Date of last penalty figure or adjustment 3Percentage increase 4Increase ($) 5Maximum 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 period50,000198897.86948,93598,935
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 period1,000,000198897.869978,6901,978,690
333(b)(3)Penalty for failure to make a report required by 21 U.S.C. 353(d)(3)(E) relating to drug samples100,000198897.86997,869197,869
333(f)(1)(A)Penalty for any person who violates a requirement related to devices for each such violation15,000199078.15611,72326,723
Penalty for aggregate of all violations related to devices in a single proceeding1,000,000199078.156781,5601,781,560
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. 350l50,000199650.42525,12375,123
Penalty in the case of any other person other than an individual for such introduction or delivery of adulterated food250,000199650.425125,613375,613
Penalty for aggregate of all such violations related to adulterated food adjudicated in a single proceeding500,000199650.425251,225751,225
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 certification10,000200713.8331,38311,383
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 corrected10,000200713.8331,38311,383
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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)250,000200713.83334,583284,583
Penalty for aggregate of all such above violations in a single proceeding1,000,000200713.833138,3301,138,330
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 violation250,000200713.83334,583284,583
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 period1,000,000200713.833138,3301,138,330
Penalty for aggregate of all such above violations adjudicated in a single proceeding10,000,000200713.8331,383,30011,383,300
333(f)(9)(A)Penalty for any person who violates a requirement which relates to tobacco products for each such violation15,000200910.021,50316,503
Penalty for aggregate of all such violations of tobacco product requirement adjudicated in a single proceeding1,000,000200910.02100,2001,100,200
333(f)(9)(B)(i)(I)Penalty per violation related to violations of tobacco requirements250,000200910.0225,050275,050
Penalty for aggregate of all such violations of tobacco product requirements adjudicated in a single proceeding1,000,000200910.02100,2001,100,200
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 violation250,000200910.0225,050275,050
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 period1,000,000200910.02100,2001,100,200
Penalty for aggregate of all such violations related to tobacco product requirements adjudicated in a single proceeding10,000,000200910.021,002,00011,002,000
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 products250,000200910.0225,050275,050
Penalty for aggregate of for all such above violations adjudicated in a single proceeding1,000,000200910.02100,2001,100,200
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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 violation250,000200910.0225,050275,050
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 period1,000,000200910.02100,2001,100,200
Penalty for aggregate above tobacco product requirement violations adjudicated in a single proceeding10,000,000200910.021,002,00011,002,000
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 period250,000200713.83334,583284,583
Penalty for each subsequent above violation in any 3-year period500,000200713.83369165569,165
333 notePenalty 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 period250200910.0225275
Penalty in the case of a third tobacco product regulation violation within a 24-month period500200910.0250550
Penalty in the case of a fourth tobacco product regulation violation within a 24-month period2,000200910.022002,200
Penalty in the case of a fifth tobacco product regulation violation within a 36-month period5,000200910.025015,501
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 basis10,000200910.021,00211,002
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 violation250200910.0225275
Penalty in the case of a second tobacco product regulation violation within a 12-month period500200910.0250550
Penalty in the case of a third tobacco product regulation violation within a 24-month period1,000200910.021001,100
Penalty in the case of a fourth tobacco product regulation violation within a 24-month period2,000200910.022002,200
Penalty in the case of a fifth tobacco product regulation violation within a 36-month period5,000200910.025015,501
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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 basis10,000200910.02100211,002
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 services250,000199267.728169,320419,320
Penalty in the case of any other person (other than an individual) per above violation1,000,000199267.728677,2801,677,280
360pp(b)(1)Penalty for any person who violates any such requirements for electronic products, with each unlawful act or omission constituting a separate violation1,10019681501,5002,750
Penalty imposed for any related series of violations of requirements relating to electronic products375,0001968150562,500937,500
42 U.S.C. (FDA):
262(d)Penalty per day for violation of order of recall of biological product presenting imminent or substantial hazard100,0001986115.628115,628215,628
263b(h)(3)Penalty for failure to obtain a mammography certificate as required10,000199267.7286,77316,773
300aa-28(b)(1)Penalty per occurrence for any vaccine manufacturer that intentionally destroys, alters, falsifies, or conceals any record or report required100,0001986115.628115,628215,628
42 U.S.C. (HRSA):
256b(d)(1)(B)(vi)Penalty for each instance of overcharging a 340B covered entity5,00020108.7454375,437
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 supplied10,000199941.4024,14014,140
42 U.S.C. ACF:
653(l)(2)45 CFR 303.21(f)Penalty for Misuse of Information in the National Directory of New Hires1,000199845.0234501,450
42 U.S.C. (OIG):
262a(i)(1)42 CFR Part 1003Penalty for each individual who violates safety and security procedures related to handling dangerous biological agents and toxins250,000200231.18577,962327,962
Penalty for any other person who violates safety and security procedures related to handling dangerous biological agents and toxins500,000200231.185155,925655,925
1320a-7a(a)42 CFR Part 1003Penalty for knowingly presenting or causing to be presented to an officer, employee, or agent of the United States a false claim10,000199650.2455,02415,024
Penalty for knowingly presenting or causing to be presented a request for payment which violates the terms of an assignment, agreement, or PPS agreement10,000199650.2455,02415,024
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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 decision15,000199650.2457,53722,537
Penalty for an excluded party retaining ownership or control interest in a participating entity10,000199650.2455,02415,024
Penalty for remuneration offered to induce program beneficiaries to use particular providers, practitioners, or suppliers10,000199650.2455,02415,024
Penalty for employing or contracting with an excluded individual10,000199747.1774,71814,718
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 program50,000199747.17723,58873,588
Penalty for ordering or prescribing medical or other item or service during a period in which the person was excluded10,00020108.74587410,874
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 supplier50,00020108.7454,37254,372
Penalty for knowing of an overpayment and failing to report and return10,00020108.74587410,874
Penalty for making or using a false record or statement that is material to a false or fraudulent claim50,00020108.7454,37254,372
Penalty for failure to grant timely access to HHS OIG for audits, investigations, evaluations, and other statutory functions of HHS OIG15,00020108.7451,31216,312
1320a-7a(b)42 CFR Part 1003Penalty 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 benefits2,0001986115.6282,3134,313
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 benefits2,0001986115.6282,3134,313
Penalty for a physician who executes a document that falsely certifies home health needs for Medicare beneficiaries5,000199650.2452,5127,512
1320a-7e(b)(6)(A)42 CFR Part 1003Penalty for failure to report any final adverse action taken against a health care provider, supplier, or practitioner25,000199747.17711,79436,794
1320b-10(b)(1)42 CFR Part 1003Penalty 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 HHS5,000198897.8694,8939,893
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1320b-10(b)(2)42 CFR Part 1003Penalty 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 HHS25,000198897.86924,46749,467
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 assessment1,0001987106.2781,0632,063
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 assessment5,0001987106.2785,31410,314
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 conducted2,0001987106.2782,1264,126
1395w-27(g)(2)(A)42 CFR 422.752; 42 CFR Part 1003Penalty for a Medicare Advantage organization that substantially fails to provide medically necessary, required items and services25,000199650.24512,56137,561
Penalty for a Medicare Advantage organization that charges excessive premiums25,000199747.17711,79436,794
Penalty for a Medicare Advantage organization that improperly expels or refuses to reenroll a beneficiary25,000199747.17711,79436,794
Penalty for a Medicare Advantage organization that engages in practice that would reasonably be expected to have the effect of denying or discouraging enrollment100,000199747.17747,177147,177
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 enrollment15,000199747.1777,07722,077
Penalty for a Medicare Advantage organization misrepresenting or falsifying information to Secretary100,000199747.17747,177147,177
Penalty for a Medicare Advantage organization misrepresenting or falsifying information to individual or other entity25,000199747.17711,79436,794
Penalty for Medicare Advantage organization interfering with provider's advice to enrollee and non-MCO affiliated providers that balance bill enrollees25,000199747.17711,79436,794
Penalty for a Medicare Advantage organization that employs or contracts with excluded individual or entity25,000199747.17711,79436,794
Penalty for a Medicare Advantage organization enrolling an individual in without prior written consent25,000201047.17711,79436,794
Penalty for a Medicare Advantage organization transferring an enrollee to another plan without consent or solely for the purpose of earning a commission25,000201047.17711,79436,794
Penalty for a Medicare Advantage organization failing to comply with marketing restrictions or applicable implementing regulations or guidance25,000201047.17711,79436,794
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Penalty for a Medicare Advantage organization employing or contracting with an individual or entity who violates 1395w-27(g)(1)(A)-(J)25,000201047.17711,79436,794
1395w-141(i)(3)42 CFR Part 1003Penalty for a prescription drug card sponsor that falsifies or misrepresents marketing materials, overcharges program enrollees, or misuse transitional assistance funds10,000200328.5612,85612,856
1395cc(g)42 CFR Part 1003Penalty for improper billing by Hospitals, Critical Access Hospitals, or Skilled Nursing Facilities2,00019721503,0005,000
1395dd(d)(1)42 CFR Part 1003Penalty for a hospital or responsible physician dumping patients needing emergency medical care, if the hospital has 100 beds or more50,0001987106.27853,139103,139
Penalty for a hospital or responsible physician dumping patients needing emergency care, if the hospital has less than 100 beds25,0001987106.27826,57051,570
1395mm(i)(6)(B)(i)42 CFR Part 1003Penalty for a HMO or competitive plan is such plan substantially fails to provide medically necessary, required items or services25,0001987106.27826,57051,570
Penalty for HMOs/competitive medical plans that charge premiums in excess of permitted amounts25,0001987106.27826,57051,570
Penalty for a HMO or competitive medical plan that expels or refuses to reenroll an individual per prescribed conditions25,0001987106.27826,57051,570
Penalty for a HMO or competitive medical plan that implements practices to discourage enrollment of individuals needing services in future100,0001987106.278106,278206,278
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 future15,000198897.86914,68029,680
Penalty for a HMO or competitive medical plan that misrepresents or falsifies information to the Secretary100,0001987106.278106,278206,278
Penalty for a HMO or competitive medical plan that misrepresents or falsifies information to an individual or any other entity25,0001987106.27826,57051,570
Penalty for failure by HMO or competitive medical plan to assure prompt payment of Medicare risk sharing contracts or incentive plan provisions25,0001987106.27826,57051,570
Penalty for HMO that employs or contracts with excluded individual or entity25,000198989.36122,34047,340
1395nn(g)(3)42 CFR Part 1003Penalty for submitting or causing to be submitted claims in violation of the Stark Law's restrictions on physician self-referrals15,000199459.0898,86323,863
1395nn(g)(4)42 CFR Part 1003Penalty for circumventing Stark Law's restrictions on physician self-referrals100,000199459.08959,089159,089
1395ss(d)(1)42 CFR Part 1003Penalty for a material misrepresentation regarding Medigap compliance policies5,000198897.8694,8939,893
1395ss(d)(2)42 CFR Part 1003Penalty for selling Medigap policy under false pretense5,000198897.8694,8939,893
1395ss(d)(3)(A)(ii)42 CFR Part 1003Penalty for an issuer that sells health insurance policy that duplicates benefits25,000199078.15619,53944,539
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Penalty for someone other than issuer that sells health insurance that duplicates benefits15,000199078.15611,72326,723
1395ss(d)(4)(A)42 CFR Part 1003Penalty for using mail to sell a non-approved Medigap insurance policy5,000198897.8694,8939,893
1396b(m)(5)(B)(i)42 CFR Part 1003Penalty for a Medicaid MCO that substantially fails to provide medically necessary, required items or services25,000198897.86924,46749,467
Penalty for a Medicaid MCO that charges excessive premiums25,000198897.86924,46749,467
Penalty for a Medicaid MCO that improperly expels or refuses to reenroll a beneficiary100,000198897.86997,869197,869
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 enrollment15,000198897.86914,68029,680
Penalty for a Medicaid MCO misrepresenting or falsifying information to the Secretary100,000198897.86997,869197,869
Penalty for a Medicaid MCO misrepresenting or falsifying information to an individual or another entity25,000198897.86924,46749,467
Penalty for a Medicaid MCO that fails to comply with contract requirements with respect to physician incentive plans25,000199078.15619,53944,539
1396r(b)(3)(B)(ii)(I)42 CFR Part 1003Penalty for willfully and knowingly certifying a material and false statement in a Skilled Nursing Facility resident assessment1,0001987106.2781,0632,063
1396r(b)(3)(B)(ii)(II)42 CFR Part 1003Penalty for willfully and knowingly causing another individual to certify a material and false statement in a Skilled Nursing Facility resident assessment5,0001987106.2785,31410,314
1396r(g)(2)(A)(i)42 CFR Part 1003Penalty for notifying or causing to be notified a Skilled Nursing Facility of the time or date on which a survey is to be conducted2,0001987106.2782,1264,126
1396r-8(b)(3)(B)42 CFR Part 1003Penalty for the knowing provision of false information or refusing to provide information about charges or prices of a covered outpatient drug100,000199078.15678,156178,156
1396r-8(b)(3)(C)(i)42 CFR Part 1003Penalty per day for failure to timely provide information by drug manufacturer with rebate agreement10,000199078.1567,81617,816
1396r-8(b)(3)(C)(ii)42 CFR Part 1003Penalty for knowing provision of false information by drug manufacturer with rebate agreement100,000199078.15678,156178,156
1396t(i)(3)(A)42 CFR Part 1003Penalty for notifying home and community-based providers or settings of survey2,000199078.1561,5633,563
11131(c)42 CFR Part 1003Penalty for failing to report a medical malpractice claim to National Practitioner Data Bank10,0001986115.62811,56321,563
11137(b)(2)42 CFR Part 1003Penalty for breaching confidentiality of information reported to National Practitioner Data Bank10,0001986115.62811,56321,563
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 Act10,000200519.401,94011,940
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 provisions100199650.24550150
Calendar Year Cap25,000199650.24512,56137,561
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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:
Minimum100200910.0210110
Maximum50,000200910.025,01055,010
Calendar Year Cap1,500,000200910.02150,3001,650,300
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:
Minimum1,000200910.021001100
Maximum50,000200910.025,01055,010
Calendar Year Cap1,500,000200910.02150,3001,650,300
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:
Minimum10,000200910.0210011,002
Maximum50,000200910.025,01055,010
Calendar Year Cap1,500,000200910.02150,3001,650,300
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:
Minimum50,000200910.025,01055,010
Maximum1,500,000200910.02150,3001,650,300
Calendar Year Cap1,500,000200910.02150,3001,650,300
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:
Minimum3,050198897.8692,9856,035
Maximum10,000198897.8699,78719,787
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:
Minimum50198897.8694999
Maximum3,000198897.8692,9365,936
300gg-15(f)45 CFR 147.200(e)Failure to provide the Summary of Benefits and Coverage (SBC)1,00020108.745871,087
300gg-1845 CFR 158.606Penalty for violations of regulations related to the medical loss ratio reporting and rebating10020108.7459109
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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:
Minimum1,00020108.745871,087
Maximum10,00020108.74587410,874
Calendar Year Cap150,00020108.74513,117163,117
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:
Minimum10,00020108.74587410,874
Maximum100,00020108.7458,745108,745
Calendar Year Cap1,000,00020108.74587,4501,087,450
1320a-7j(h)(3)(A)Penalty for an administrator of a facility that fails to comply with notice requirements for the closure of a facility100,00020108.7458,745108,745
42 CFR 488.446(a)(1),(2), & (3)Minimum penalty for the first offense of an administrator who fails to provide notice of facility closure50020108.74544544
Minimum penalty for the second offense of an administrator who fails to provide notice of facility closure1,50020108.7451311,631
Minimum penalty for the third and subsequent offenses of an administrator who fails to provide notice of facility closure3,00020108.7452623,262
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 disabled5,000199459.0892,9547,954
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 determination7,500201514,4317,500
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 beneficiary5,000200424.5881,2296,229
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 facility200,00020108.74517,490217,490
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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 individual300,00020108.74526,235326,235
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 nurse200,00020108.74517,490217,490
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 request100199747.17747147
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:
Minimum501987106.27853103
Maximum3,0001987106.2783,1886,188
42 CFR 488.408(d)(1)(iv)Penalty per instance of Category 2 noncompliance by a Skilled Nursing Facility:
Minimum1,0001987106.2781,0632,063
Maximum10,0001987106.27810,62820,628
42 CFR 488.408(e)(1)(iii)Penalty per day for a Skilled Nursing Facility that has a Category 3 violation of certification requirements:
Minimum3,0501987106.2783,2416,291
Maximum10,0001987106.27810,62820,628
42 CFR 488.408(e)(1)(iv)Penalty per instance of Category 3 noncompliance by a Skilled Nursing Facility:
Minimum1,0001987106.2781,0632,063
Maximum10,0001987106.27810,62820,628
Penalty per day and per instance for a Skilled Nursing Facility that has Category 3 noncompliance with Immediate Jeopardy
Per Day (Minimum)3,0501987106.2783,2416,291
Per Day (Maximum)10,0001987106.27810,62820,628
Per Instance (Minimum)1,0001987106.2781,0632,063
Per Instance (Maximum)10,0001987106.27810,62820,628
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:
Minimum3,0501987106.2783,2416,291
Maximum10,0001987106.27810,62820,628
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:
Minimum501987106.27853103
Maximum3,0001987106.2783,1886,188
42 CFR 488.438(a)(2)Penalty per instance of a Skilled Nursing Facility that fails to meet certification requirements:
Minimum1,0001987106.2781,0632,063
Maximum10,0001987106.27810,62820,628
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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))10,000199650.2455,02415,024
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 involved2,0001988197.8691,9573,957
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 basis2,000198989.3611,7873,787
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))10,000199650.2455,02415,024
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))10,000199650.2455,02415,024
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))10,000199650.2455,02415,024
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))10,000199650.2455,02415,024
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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 Act1,000199459.0895911,591
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))10,000199650.2455,02415,024
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))10,000199650.2455,02415,024
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))10,000199650.2455,02415,024
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))10,000199650.2455,02415,024
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))10,000199650.2455,02415,024
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))10,000199650.2455,02415,024
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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))10,000199650.2455,02415,024
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))10,000199650.2455,02415,024
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))10,000199650.2455,02415,024
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))10,000199650.2455,02415,024
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 basis2,000198897.8691,9573,957
1395w-3a(d)(4)(A)42 CFR 414.806Penalty for a pharmaceutical manufacturer's misrepresentation of average sales price of a drug, or biologic10,000200328.5612,85612,856
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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))10,000199650.2455,02415,024
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))10,000199650.2455,02415,024
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 contract25,000199747.17711,79436,794
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 regulations10,000199747.1774,71814,718
1395w-27(g)(3)(D); 1857(g)(3)Penalty for a Medicare Advantage organization's or Part D sponsor's early termination of its contract100,000200036.68936,689136,689
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 plan5,000199078.1563,9088,908
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 coverage1,000199889.3614501,450
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 form2,000199459.0891,1823,182
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 Secretary1,000200713.8331381,138
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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 claim1,000200713.8331381,138
1395nn(g)(5)42 CFR 411.361Penalty for any person that fails to report information required by HHS under Section 1877(f) concerning ownership, investment, and compensation arrangements10,000198989.3618,93618,936
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))10,000199650.2455,02415,024
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 date25,0001987106.27826,56951,569
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 statement15,000199078.15611,72326,723
Penalty for an issuer that sells or issues a Medicare supplemental policy without disclosure statement25,000199078.15619,53944,539
1395ss(d)(3)(B)(iv)Penalty for someone other than issuer that sells or issues a Medicare supplemental policy without acknowledgement form15,000199078.15611,72326,723
Penalty for issuer that sells or issues a Medicare supplemental policy without an acknowledgement form25,000199078.15619,53944,539
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 statute15,000199078.15611,72326,723
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 statute25,000199078.15619,53944,539
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 benefits15,000199078.15611,72326,723
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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 benefits25,000199078.15619,53944,539
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 circumstances25,000199078.15619,53944,539
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)25,000199078.15619,53944,539
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 criteria5,000199078.1563,9088,908
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 responsibilities25,000199078.15619,53944,539
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 enrollee15,000200328.5614,28419,284
Penalty for an issuer who sells, issues, or renews a Medigap Rx policy who is a Part D enrollee25,000200328.5617,14032,140
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 conducted2,0001987106.2782,1264,126
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 requirements10,000198897.8699,78719,787
42 CFR 488.845(b)(3)Penalty per day for home health agency's noncompliance (Upper Range):
Minimum8,500198897.8698,31916,819
Maximum10,000198897.8699,78719,787
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 harm10,000198897.8699,78719,787
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 harm9,000198897.8698,80817,808
42 CFR 488.845(b)(3)(iii)Penalty for an isolated incident of noncompliance in violation of established HHA policy8,500198897.8698,31916,819
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):
Minimum1,500198897.8691,4682,968
Maximum8,500198897.8698,31916,819
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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):
Minimum500198897.869489989
Maximum4,000198897.8693,9157,915
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:
Minimum1,000198897.8699791,979
Maximum10,000198897.8699,78719,787
Penalty for each day of noncompliance (Maximum)10,000198897.8699,78719,787
42 CFR 488.845(d)(1)(ii)Penalty for each day of noncompliance (Maximum)10,000198897.8699,78719,787
1396b(m)(5)(B)42 CFR 460.46Penalty for PACE organization's practice that would reasonably be expected to have the effect of denying or discouraging enrollment:
Minimum15,000199747.1777,07722,077
Maximum100,000199747.17747,177147,177
Penalty for a PACE organization that charges excessive premiums25,000199747.17711,79436,794
Penalty for a PACE organization misrepresenting or falsifying information to CMS, the State, or an individual or other entity100,000199747.17747,177147,177
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 participant25,000199747.17711,79436,794
Penalty for involuntarily disenrolling a participant25,000199747.17711,79436,794
Penalty for discriminating or discouraging enrollment or disenrollment of participants on the basis of an individual's health status or need for health care services25,000199747.17711,79436,794
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:
Minimum501987106.27853103
Maximum3,0001987106.2783,1886,188
42 CFR 488.408(d)(1)(iv)Penalty per instance for a nursing facility's failure to meet Category 2 certification:
Minimum1,0001987106.2781,0632,063
Maximum10,0001987106.27810,62820,628
42 CFR 488.408(e)(1)(iii)Penalty per day for a nursing facility's failure to meet Category 3 certification:
Minimum3,0501987106.2783,2416,291
Maximum10,0001987106.27810,62820,628
42 CFR 488.408(e)(1)(iv)Penalty per instance for a nursing facility's failure to meet Category 3 certification:
Minimum1,0001987106.2781,0632,063
Maximum10,0001987106.27810,62820,628
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:
Minimum1,0001987106.2781,0632,063
Maximum10,0001987106.27810,62820,628
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42 CFR 488.438(a)(1)(i)Penalty per day for nursing facility's failure to meet certification (Upper Range):
Minimum3,0501987106.2783,2416,291
Maximum10,0001987106.27810,62820,628
42 CFR 488.438(a)(1)(ii)Penalty per day for nursing facility's failure to meet certification (Lower Range):
Minimum501987106.27853103
Maximum3,0001987106.2783,1886,188
42 CFR 488.438(a)(2)Penalty per instance for nursing facility's failure to meet certification:
Minimum1,0001987106.2781,0632,063
Maximum10,0001987106.27810,62820,628
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]5,0001987106.2785,31410,314
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]5,0001987106.2785,31410,314
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:
Minimum1199078.15612
Maximum10,000199078.1567,81617,816
1396u-2(e)(2)(A)(i)42 CFR 438.704Penalty for a Medicaid managed care organization that fails substantially to provide medically necessary items and services25,000199747.17711,79436,794
Penalty for Medicaid managed care organization that imposes premiums or charges on enrollees in excess of the premiums or charges permitted25,000199747.17711,79436,794
Penalty for a Medicaid managed care organization that misrepresents or falsifies information to another individual or entity25,000199747.17711,79436,794
Penalty for a Medicaid managed care organization that fails to comply with the applicable statutory requirements for such organizations25,000199747.17711,79436,794
1396u-2(e)(2)(A)(ii)42 CFR 438.704Penalty for a Medicaid managed care organization that misrepresents or falsifies information to the HHS Secretary100,000199747.17747,177147,177
Penalty for Medicaid managed care organization that acts to discriminate among enrollees on the basis of their health status100,000199747.17747,177147,177
1396u-2(e)(2)(A)(iv)42 CFR 438.704Penalty 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 status15,000199747.1777,07722,077
1396u(h)(2)42 CFR 441, Subpart IPenalty 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 services10,0001990106.27810,62820,628
Start Printed Page 61558
1396w-2(c)(1)Penalty for disclosing information related to eligibility determinations for medical assistance programs10,000200910.021,00211,002
1903(m)(5)(B)42 CFR 460.46Penalty for PACE organization's practice that would reasonably be expected to have the effect of denying or discouraging enrollment:
Minimum15,000199747.1777,07722,077
Maximum100,000199747.17747,177147,177
Penalty for a PACE organization that charges excessive premiums25,000199747.17711,79436,794
Penalty for a PACE organization misrepresenting or falsifying information to CMS, the State, or an individual or other entity100,000199747.17747,177147,177
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 participant25,000199747.17711,79436,794
Penalty for involuntarily disenrolling a participant25,000199747.17711,79436,794
Penalty for discriminating or discouraging enrollment or disenrollment of participants on the basis of an individual's health status or need for health care services25,000199747.17711,79436,794
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))100199650.24550150
18081(h)(1)(A)(i)(II)42 CFR 155.285Penalty for providing false information on Exchange application25,00020108.7452,18627,186
18081(h)(1)(B)42 CFR 155.285Penalty for knowingly or willfully providing false information on Exchange application250,00020108.74521,862271,862
18081(h)(2)42 CFR 155.260Penalty for knowingly or willfully disclosing protected information from Exchange25,00020108.7452,18627,186
31 U.S.C. (HHS):
135245 CFR 93.400(e)Penalty for the first time an individual makes an expenditure prohibited by regulations regarding lobbying disclosure, absent aggravating circumstances10,000198989.3618,93618,936
Penalty for second and subsequent offenses by individuals who make an expenditure prohibited by regulations regarding lobbying disclosure:
Minimum10,000198989.3618,93618,936
Maximum100,000198989.36189,361189,361
Penalty for the first time an individual fails to file or amend a lobbying disclosure form, absent aggravating circumstances10,000198989.3618,93618,936
Penalty for second and subsequent offenses by individuals who fail to file or amend a lobbying disclosure form, absent aggravating circumstances:
Minimum10,000198989.3618,93618,936
Maximum100,000198989.36189,361189,361
45 CFR 93, Appendix APenalty for failure to provide certification regarding lobbying in the award documents for all sub-awards of all tiers:
Minimum10,000198989.3618,93618,936
Maximum100,000198989.36189,361189,361
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Penalty for failure to provide statement regarding lobbying for loan guarantee and loan insurance transactions:
Minimum10,000198989.3618,93618,936
Maximum100,000198989.36189,361189,361
3801-381245 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 Department5,000198897.8694,8949,894
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 Department5,000198897.8694,8949,894
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 Start Printed Page 61560determined 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.

Start List of Subjects

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
End List of Subjects

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

Start Part

PART 3—PATIENT SAFETY ORGANIZATIONS AND PATIENT SAFETY WORK PRODUCT

End Part Start Amendment Part

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

End Amendment Part Start Authority

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

End Authority Start Amendment Part

2. Section 3.404 is revised to read as follows:

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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 Start Printed Page 61561updated, is published at 45 CFR part 102.

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

Start Part

PART 402—CIVIL MONEY PENALTIES, ASSESSMENTS, AND EXCLUSIONS

End Part Start Amendment Part

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

End Amendment Part Start Authority

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

End Authority
[Amended]
Start Amendment Part

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:

End Amendment Part
ParagraphRemoveAdd
(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”.
Start Part

PART 403—SPECIAL PROGRAMS AND PROJECTS

End Part Start Amendment Part

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

End Amendment Part Start Authority

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

End Authority
[Amended]
Start Amendment Part

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:

End Amendment Part
ParagraphRemoveAdd
(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”.
Start Part

PART 411—EXCLUSIONS FROM MEDICARE AND LIMITATIONS ON MEDICARE PAYMENT

End Part Start Amendment Part

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

End Amendment Part Start Authority

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).

End Authority Start Amendment Part

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 Start Printed Page 61562the phrase indicated in the fourth column:

End Amendment Part
SectionParagraphsRemoveAdd
§ 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”.
Start Part

PART 412—PROSPECTIVE PAYMENT SYSTEMS FOR INPATIENT HOSPITAL SERVICES

End Part Start Amendment Part

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

End Amendment Part Start Authority

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.

End Authority
[Amended]
Start Amendment Part

13. Section 412.612 is amended as follows:

End Amendment Part Start Amendment Part

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

End Amendment Part Start Amendment Part

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”.

End Amendment Part Start Part

PART 422—MEDICARE ADVANTAGE PROGRAM

End Part Start Amendment Part

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

End Amendment Part Start Authority

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

End Authority
[Amended]
Start Amendment Part

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:

End Amendment Part
ParagraphRemoveAdd
(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”.
Start Part

PART 423—VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT

End Part Start Amendment Part

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

End Amendment Part Start Authority

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).

End Authority
[Amended]
Start Amendment Part

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:

End Amendment Part
ParagraphRemoveAdd
(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”.
Start 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”.
Start Part

PART 483—REQUIREMENTS FOR STATES AND LONG TERM CARE FACILITIES

End Part Start Amendment Part

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

End Amendment Part Start Authority

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

End Authority
[Amended]
Start Amendment Part

19. Section 483.20 is amended as follows:

End Amendment Part Start Amendment Part

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

End Amendment Part Start Amendment Part

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”.

End Amendment Part
[Amended]
Start Amendment Part

20. Section 483.151 is amended as follows:

End Amendment Part Start Amendment Part

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”;

End Amendment Part Start Amendment Part

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

End Amendment Part Start Amendment Part

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”.

End Amendment Part Start Part

PART 488—SURVEY, CERTIFICATION, AND ENFORCEMENT PROCEDURES

End Part Start Amendment Part

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

End Amendment Part Start Authority

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.

End Authority Start Amendment Part

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:

End Amendment Part
SectionParagraphRemoveAdd
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”.
Start 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”.
Start Part

PART 493—LABORATORY REQUIREMENTS

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

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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.

End Authority
[Amended]
Start Amendment Part

24. Section 493.1834 is amended as follows:

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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

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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”.

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

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PART 1003—CIVIL MONEY PENALTIES, ASSESSMENTS AND EXCLUSIONS

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

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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).

End Authority
[Amended]
Start Amendment Part

26. Section 1003.103 is amended:

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a. In paragraph (c)—

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

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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

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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:

End Amendment Part
ParagraphTextAdd 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.”
Start 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

Start Part

PART 79—PROGRAM FRAUD CIVIL PENALTIES

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

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

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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:

End Amendment Part
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.

* * * * *
Start Part

PART 93—NEW RESTRICTIONS ON LOBBYING

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

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

End Authority Start Amendment Part

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:

End Amendment Part
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.

* * * * *
Start Amendment Part

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:

End Amendment Part

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.

* * * * *
Start Amendment Part

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

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PART 102—ADJUSTMENT OF CIVIL MONETARY PENALTIES FOR INFLATION

102.1
Applicability.
102.2
Applicability date.
102.3
Penalty adjustment and table.
Start Authority

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

End Authority
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.Start Printed Page 61566

Civil Monetary Penalty Authorities Administered by HHS Agencies and Penalty Amounts

[Effective September 6, 2016]

CitationHHS agencyDescription 2Date of last penalty figure or adjustment 3Pre-inflation penalty ($)Maximum adjusted penalty ($)
U.S.C.CFR 1
21 U.S.C.:
333(b)(2)(A)FDAPenalty for violations related to drug samples resulting in a conviction of any representative of manufacturer or distributor in any 10-year period198850,00098,935
333(b)(2)(B)FDAPenalty 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 period19881,000,0001,978,690
333(b)(3)FDAPenalty for failure to make a report required by 21 U.S.C. 353(d)(3)(E) relating to drug samples1988100,000197,869
333(f)(1)(A)FDAPenalty for any person who violates a requirement related to devices for each such violation199015,00026,723
Penalty for aggregate of all violations related to devices in a single proceeding19901,000,0001,781,560
333(f)(2)(A)FDAPenalty 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. 350l199650,00075,123
Penalty in the case of any other person other than an individual) for such introduction or delivery of adulterated food1996250,000375,613
Penalty for aggregate of all such violations related to adulterated food adjudicated in a single proceeding1996500,000751,225
333(f)(3)(A)FDAPenalty 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 certification200710,00011,383
333(f)(3)(B)FDAPenalty for each day the above violation is not corrected after a 30-day period following notification until the violation is corrected200710,00011,383
333(f)(4)(A)(i)FDAPenalty 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)2007250,000284,583
Penalty for aggregate of all such above violations in a single proceeding20071,000,0001,138,330
333(f)(4)(A)(ii)FDAPenalty 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 violation2007250,000284,583
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 period20071,000,0001,138,330
Penalty for aggregate of all such above violations adjudicated in a single proceeding200710,000,00011,383,300
333(f)(9)(A)FDAPenalty for any person who violates a requirement which relates to tobacco products for each such violation200915,00016,503
Penalty for aggregate of all such violations of tobacco product requirement adjudicated in a single proceeding20091,000,0001,100,200
333(f)(9)(B)(i)(I)FDAPenalty per violation related to violations of tobacco requirements2009250,000275,050
Penalty for aggregate of all such violations of tobacco product requirements adjudicated in a single proceeding20091,000,0001,100,200
333(f)(9)(B)(i)(II)FDAPenalty 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 violation2009250,000275,050
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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 period20091,000,0001,100,200
Penalty for aggregate of all such violations related to tobacco product requirements adjudicated in a single proceeding200910,000,00011,002,000
333(f)(9)(B)(ii)(I)FDAPenalty 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 products2009250,000275,050
Penalty for aggregate of for all such above violations adjudicated in a single proceeding20091,000,0001,100,200
333(f)(9)(B)(ii)(II)FDAPenalty 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 violation2009250,000275,050
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 period20091,000,0001,100,200
Penalty for aggregate above tobacco product requirement violations adjudicated in a single proceeding200910,000,00011,002,000
333(g)(1)FDAPenalty 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 period2007250,000284,583
Penalty for each subsequent above violation in any 3-year period2007500,000569,165
333 noteFDAPenalty 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 period2009250275
Penalty in the case of a third tobacco product regulation violation within a 24-month period2009500550
Penalty in the case of a fourth tobacco product regulation violation within a 24-month period20092,0002,200
Penalty in the case of a fifth tobacco product regulation violation within a 36-month period20095,0005,501
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 basis200910,00011,002
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 violation2009250275
Penalty in the case of a second tobacco product regulation violation within a 12-month period2009500550
Start Printed Page 61568
Penalty in the case of a third tobacco product regulation violation within a 24-month period20091,0001,100
Penalty in the case of a fourth tobacco product regulation violation within a 24-month period20092,0002,200
Penalty in the case of a fifth tobacco product regulation violation within a 36-month period20095,0005,501
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 basis200910,00011,002
335b(a)FDAPenalty 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 services1992250,000419,320
Penalty in the case of any other person (other than an individual) per above violation19921,000,0001,677,280
360pp(b)(1)FDAPenalty for any person who violates any such requirements for electronic products, with each unlawful act or omission constituting a separate violation19681,1002,750
Penalty imposed for any related series of violations of requirements relating to electronic products1968375,000937,500
42 U.S.C.:
262(d)FDAPenalty per day for violation of order of recall of biological product presenting imminent or substantial hazard1986100,000215,628
263b(h)(3)FDAPenalty for failure to obtain a mammography certificate as required199210,00016,773
300aa-28(b)(1)FDAPenalty per occurrence for any vaccine manufacturer that intentionally destroys, alters, falsifies, or conceals any record or report required1986100,000215,628
256b(d)(1)(B)(vi)HRSAPenalty for each instance of overcharging a 340B covered entity20105,0005,437
299c-(3)(d)AHRQPenalty for an establishment or person supplying information obtained in the course of activities for any purpose other than the purpose for which it was supplied199910,00014,140
653(l)(2)45 CFR 303.21(f)ACFPenalty for Misuse of Information in the National Directory of New Hires19981,0001,450
262a(i)(1)42 CFR Part 1003OIGPenalty for each individual who violates safety and security procedures related to handling dangerous biological agents and toxins2002250,000327,962
Penalty for any other person who violates safety and security procedures related to handling dangerous biological agents and toxins.2002500,000655,925
1320a-7a(a)42 CFR Part 1003OIGPenalty for knowingly presenting or causing to be presented to an officer, employee, or agent of the United States a false claim199610,00015,024
Penalty for knowingly presenting or causing to be presented a request for payment which violates the terms of an assignment, agreement, or PPS agreement199610,00015,024
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 decision199615,00022,537
Penalty for an excluded party retaining ownership or control interest in a participating entity199610,00015,024
Penalty for remuneration offered to induce program beneficiaries to use particular providers, practitioners, or suppliers199610,00015,024
Start Printed Page 61569
Penalty for employing or contracting with an excluded individual199710,00014,718
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 program199750,00073,588
Penalty for ordering or prescribing medical or other item or service during a period in which the person was excluded201010,00010,874
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 supplier201050,00054,372
Penalty for knowing of an overpayment and failing to report and return201010,00010,874
Penalty for making or using a false record or statement that is material to a false or fraudulent claim201050,00054,372
Penalty for failure to grant timely access to HHS OIG for audits, investigations, evaluations, and other statutory functions of HHS OIG201015,00016,312
1320a-7a(b)42 CFR Part 1003OIGPenalty 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 benefits19862,0004,313
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 benefits19862,0004,313
Penalty for a physician who executes a document that falsely certifies home health needs for Medicare beneficiaries19965,0007,512
1320a-7e(b)(6)(A)42 CFR Part 1003OIGPenalty for failure to report any final adverse action taken against a health care provider, supplier, or practitioner199725,00036,794
1320b-10(b)(1)42 CFR Part 1003OIGPenalty 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 HHS19885,0009,893
1320b-10(b)(2)42 CFR Part 1003OIGPenalty 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 HHS198825,00049,467
1395i-3(b)(3)(B)(ii)(1)OIGPenalty for certification of a false statement in assessment of functional capacity of a Skilled Nursing Facility resident assessment19871,0002,063
1395i-3(b)(3)(B)(ii)(2)OIGPenalty for causing another to certify or make a false statement in assessment of functional capacity of a Skilled Nursing Facility resident assessment19875,00010,314
1395i-3(g)(2)(A)OIGPenalty 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 conducted19872,0004,126
1395w-27(g)(2)(A)42 CFR 422.752; 42 CFR Part 1003OIGPenalty for a Medicare Advantage organization that substantially fails to provide medically necessary, required items and services199625,00037,561
Penalty for a Medicare Advantage organization that charges excessive premiums199725,00036,794
Penalty for a Medicare Advantage organization that improperly expels or refuses to reenroll a beneficiary199725,00036,794
Penalty for a Medicare Advantage organization that engages in practice that would reasonably be expected to have the effect of denying or discouraging enrollment1997100,000147,177
Start 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 enrollment199715,00022,077
Penalty for a Medicare Advantage organization misrepresenting or falsifying information to Secretary1997100,000147,177
Penalty for a Medicare Advantage organization misrepresenting or falsifying information to individual or other entity199725,00036,794
Penalty for Medicare Advantage organization interfering with provider's advice to enrollee and non-MCO affiliated providers that balance bill enrollees199725,00036,794
Penalty for a Medicare Advantage organization that employs or contracts with excluded individual or entity199725,00036,794
Penalty for a Medicare Advantage organization enrolling an individual in without prior written consent201025,00036,794
Penalty for a Medicare Advantage organization transferring an enrollee to another plan without consent or solely for the purpose of earning a commission201025,00036,794
Penalty for a Medicare Advantage organization failing to comply with marketing restrictions or applicable implementing regulations or guidance201025,00036,794
Penalty for a Medicare Advantage organization employing or contracting with an individual or entity who violates 1395w-27(g)(1)(A)-(J)201025,00036,794
1395w-141(i)(3)42 CFR Part 1003OIGPenalty for a prescription drug card sponsor that falsifies or misrepresents marketing materials, overcharges program enrollees, or misuse transitional assistance funds200310,00012,856
1395cc(g)42 CFR Part 1003OIGPenalty for improper billing by Hospitals, Critical Access Hospitals, or Skilled Nursing Facilities19722,0005,000
1395dd(d)(1)42 CFR Part 1003OIGPenalty for a hospital or responsible physician dumping patients needing emergency medical care, if the hospital has 100 beds or more198750,000103,139
Penalty for a hospital or responsible physician dumping patients needing emergency medical care, if the hospital has less than 100 beds198725,00051,570
1395mm(i)(6)(B)(i)42 CFR Part 1003OIGPenalty for a HMO or competitive plan is such plan substantially fails to provide medically necessary, required items or services198725,00051,570
Penalty for HMOs/competitive medical plans that charge premiums in excess of permitted amounts198725,00051,570
Penalty for a HMO or competitive medical plan that expels or refuses to reenroll an individual per prescribed conditions198725,00051,570
Penalty for a HMO or competitive medical plan that implements practices to discourage enrollment of individuals needing services in future1987100,000206,278
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 future198815,00029,680
Penalty for a HMO or competitive medical plan that misrepresents or falsifies information to the Secretary1987100,000206,278
Penalty for a HMO or competitive medical plan that misrepresents or falsifies information to an individual or any other entity198725,00051,570
Penalty for failure by HMO or competitive medical plan to assure prompt payment of Medicare risk sharing contracts or incentive plan provisions198725,00051,570
Start Printed Page 61571
Penalty for HMO that employs or contracts with excluded individual or entity198925,00047,340
1395nn(g)(3)42 CFR Part 1003OIGPenalty for submitting or causing to be submitted claims in violation of the Stark Law's restrictions on physician self-referrals199415,00023,863
1395nn(g)(4)42 CFR Part 1003OIGPenalty for circumventing Stark Law's restrictions on physician self-referrals1994100,000159,089
1395ss(d)(1)42 CFR Part 1003OIGPenalty for a material misrepresentation regarding Medigap compliance policies19885,0009,893
1395ss(d)(2)42 CFR Part 1003OIGPenalty for selling Medigap policy under false pretense19885,0009,893
1395ss(d)(3)(A)(ii)42 CFR Part 1003OIGPenalty for an issuer that sells health insurance policy that duplicates benefits199025,00044,539
Penalty for someone other than issuer that sells health insurance that duplicates benefits199015,00026,723
1395ss(d)(4)(A)42 CFR Part 1003OIGPenalty for using mail to sell a non-approved Medigap insurance policy19885,0009,893
1396b(m)(5)(B)(i)42 CFR Part 1003OIGPenalty for a Medicaid MCO that substantially fails to provide medically necessary, required items or services198825,00049,467
Penalty for a Medicaid MCO that charges excessive premiums198825,00049,467
Penalty for a Medicaid MCO that improperly expels or refuses to reenroll a beneficiary1988100,000197,869
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 enrollment198815,00029,680
Penalty for a Medicaid MCO misrepresenting or falsifying information to the Secretary1988100,000197,869
Penalty for a Medicaid MCO misrepresenting or falsifying information to an individual or another entity198825,00049,467
Penalty for a Medicaid MCO that fails to comply with contract requirements with respect to physician incentive plans199025,00044,539
1396r(b)(3)(B)(ii)(I)42 CFR Part 1003OIGPenalty for willfully and knowingly certifying a material and false statement in a Skilled Nursing Facility resident assessment19871,0002,063
1396r(b)(3)(B)(ii)(II)42 CFR Part 1003OIGPenalty for willfully and knowingly causing another individual to certify a material and false statement in a Skilled Nursing Facility resident assessment19875,00010,314
1396r(g)(2)(A)(i)42 CFR Part 1003OIGPenalty for notifying or causing to be notified a Skilled Nursing Facility of the time or date on which a survey is to be conducted19872,0004,126
1396r-8(b)(3)(B)42 CFR Part 1003OIGPenalty for the knowing provision of false information or refusing to provide information about charges or prices of a covered outpatient drug1990100,000178,156
1396r-8(b)(3)(C)(i)42 CFR Part 1003Penalty per day for failure to timely provide information by drug manufacturer with rebate agreement199010,00017,816
1396r-8(b)(3)(C)(ii)42 CFR Part 1003Penalty for knowing provision of false information by drug manufacturer with rebate agreement1990100,000178,156
1396t(i)(3)(A)42 CFR Part 1003OIGPenalty for notifying home and community-based providers or settings of survey19902,0003,563
11131(c)42 CFR Part 1003OIGPenalty for failing to report a medical malpractice claim to National Practitioner Data Bank198610,00021,563
11137(b)(2)42 CFR Part 1003OIGPenalty for breaching confidentiality of information reported to National Practitioner Data Bank198610,00021,563
299b-22(f)(1)42 CFR 3.404OCRPenalty for violation of confidentiality provision of the Patient Safety and Quality Improvement Act200510,00011,940
1320(d)-5(a)45 CFR 160.404(b)(1)(i),(ii)OCRPenalty for each pre-February 18, 2009 violation of the HIPAA administrative simplification provisions1996100150
Calendar Year Cap199625,00037,561
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1320(d)-5(a)45 CFR 160.404(b)(2)(i)(A), (B)OCRPenalty 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:
Minimum2009100110
Maximum200950,00055,010
Calendar Year Cap20091,500,0001,650,300
45 CFR 160.404(b)(2)(ii)(A), (B)OCRPenalty 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:
Minimum20091,0001,100
Maximum200950,00055,010
Calendar Year Cap20091,500,0001,650,300
45 CFR 160.404(b)(2)(iii)(A), (B)OCRPenalty 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:
Minimum200910,00011,002
Maximum200950,00055,010
Calendar Year Cap20091,500,0001,650,300
45 CFR 160.404(b)(2)(iv)(A), (B)OCRPenalty 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:
Minimum200950,00055,010
Maximum20091,500,0001,650,300
Calendar Year Cap20091,500,0001,650,300
263a(h)(2)(B) & 1395w-2(b)(2)(A)(ii)42 CFR 493.1834(d)(2)(i)CMSPenalty for a clinical laboratory's failure to meet participation and certification requirements and poses immediate jeopardy:
Minimum19883,0506,035
Maximum198810,00019,787
42 CFR 493.1834(d)(2)(ii)CMSPenalty for a clinical laboratory's failure to meet participation and certification requirements and the failure does not pose immediate jeopardy:
Minimum19885099
Maximum19883,0005,936
300gg-15(f)45 CFR 147.200(e)CMSFailure to provide the Summary of Benefits and Coverage20101,0001,087
300gg-1845 CFR 158.606CMSPenalty for violations of regulations related to the medical loss ratio reporting and rebating2010100109
1320a-7h(b)(1)42 CFR 402.105(d)(5); 42 CFR 403.912(a) & (c)CMSPenalty 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:
Minimum20101,0001,087
Maximum201010,00010,874
Calendar Year Cap2010150,000163,117
1320a-7h(b)(2)42 CFR 402.105(h); 42 CFR 403 912(b) & (c)CMSPenalty 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:
Minimum201010,00010,874
Maximum2010100,000108,745
Calendar Year Cap20101,000,0001,087,450
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1320a-7j(h)(3)(A)CMSPenalty for an administrator of a facility that fails to comply with notice requirements for the closure of a facility2010100,000108,745
42 CFR 488.446(a)(1),(2), & (3)CMSMinimum penalty for the first offense of an administrator who fails to provide notice of facility closure2010500544
Minimum penalty for the second offense of an administrator who fails to provide notice of facility closure20101,5001,631
Minimum penalty for the third and subsequent offenses of an administrator who fails to provide notice of facility closure20103,0003,262
1320a-8(a)(1)CMSPenalty 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 disabled19945,0007,954
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 determination20157,5007,500
1320a-8(a)(3)CMSPenalty 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 beneficiary20045,0006,229
1320b-25(c)(1)(A)CMSPenalty 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 facility2010200,000217,490
1320b-25(c)(2)(A)CMSPenalty 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 individual2010300,000326,235
1320b-25(d)(2)CMSPenalty 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 nurse2010200,000217,490
1395b-7(b)(2)(B)42 CFR 402.105(g)CMSPenalty 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 request1997100147
1395i-3(h)(2)(B)(ii)(I)42 CFR 488.408(d)(1)(iii)CMSPenalty per day for a Skilled Nursing Facility that has a Category 2 violation of certification requirements:
Minimum198750103
Maximum19873,0006,188
42 CFR 488.408(d)(1)(iv)CMSPenalty per instance of Category 2 noncompliance by a Skilled Nursing Facility:
Minimum19871,0002,063
Maximum198710,00020,628
42 CFR 488.408(e)(1)(iii)CMSPenalty per day for a Skilled Nursing Facility that has a Category 3 violation of certification requirements:
Minimum19873,0506,291
Maximum198710,00020,628
42 CFR 488.408(e)(1)(iv)CMSPenalty per instance of Category 3 noncompliance by a Skilled Nursing Facility:
Minimum19871,0002,063
Maximum198710,00020,628
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42 CFR 488.408(e)(2)(ii)CMSPenalty per day and per instance for a Skilled Nursing Facility that has Category 3 noncompliance with Immediate Jeopardy:
Per Day (Minimum)19873,0506,291
Per Day (Maximum)198710,00020,628
Per Instance (Minimum)19871,0002,063
Per Instance (Maximum)198710,00020,628
42 CFR 488.438(a)(1)(i)CMSPenalty per day of a Skilled Nursing Facility that fails to meet certification requirements. These amounts represent the upper range per day:
Minimum19873,0506,291
Maximum198710,00020,628
42 CFR 488.438(a)(1)(ii)CMSPenalty per day of a Skilled Nursing Facility that fails to meet certification requirements. These amounts represent the lower range per day:
Minimum198750103
Maximum19873,0006,188
42 CFR 488.438(a)(2)CMSPenalty per instance of a Skilled Nursing Facility that fails to meet certification requirements:
Minimum19871,0002,063
Maximum198710,00020,628
1395l(h)(5)(D)42 CFR 402.105(d)(2)(i)CMSPenalty 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))199610,00015,024
1395l(i)(6)CMSPenalty 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 involved19882,0003,957
1395l(q)(2)(B)(i)42 CFR 402.105(a)CMSPenalty for knowingly and willfully failing to provide information about a referring physician when seeking payment on an unassigned basis19892,0003,787
1395m(a)(11)(A)42 CFR 402.1(c)(4), 402.105(d)(2)(ii)CMSPenalty 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))199610,00015,024
1395m(a)(18)(B)42 CFR 402.1(c)(5), 402.105(d)(2)(iii)CMSPenalty 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))199610,00015,024
1395m(b)(5)(C)42 CFR 402.1(c)(6), 402.105(d)(2)(iv)CMSPenalty 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))199610,00015,024
1395m(h)(3)42 CFR 402.1(c)(8), 402.105(d)(2)(vi)CMSPenalty 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))199610,00015,024
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1395m(j)(2)(A)(iii)CMSPenalty 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 Act19941,0001,591
1395m(j)(4)42 CFR 402.1(c)(10), 402.105(d)(2)(vii)CMSPenalty 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))199610,00015,024
1395m(k)(6)42 CFR 402.1(c)(31), 402.105(d)(3)CMSPenalty 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))199610,00015,024
1395m(l)(6)42 CFR 402.1(c)(32), 402.105(d)(4)CMSPenalty 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))199610,00015,024
1395u(b)(18)(B)42 CFR 402.1(c)(11), 402.105(d)(2)(viii)CMSPenalty 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))199610,00015,024
1395u(j)(2)(B)42 CFR 402.1(c)CMSPenalty 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))199610,00015,024
1395u(k)42 CFR 402.1(c)(12), 402.105(d)(2)(ix)CMSPenalty 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))199610,00015,024
1395u(l)(3)42 CFR 402.1(c)(13), 402.105(d)(2)(x)CMSPenalty 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))199610,00015,024
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1395u(m)(3)42 CFR 402.1(c)(14), 402.105(d)(2)(xi)CMSPenalty 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))199610,00015,024
1395u(n)(3)42 CFR 402.1(c)(15), 402.105(d)(2)(xii)CMSPenalty 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))199610,00015,024
1395u(o)(3)(B)42 CFR 414.707(b)CMSPenalty 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))199610,00015,024
1395u(p)(3)(A)CMSPenalty 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 basis19882,0003,957
1395w-3a(d)(4)(A)42 CFR 414.806CMSPenalty for a pharmaceutical manufacturer's misrepresentation of average sales price of a drug, or biologic200310,00012,856
1395w-4(g)(1)(B)42 CFR 402.1(c)(17), 402.105(d)(2)(xiii)CMSPenalty 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))199610,00015,024
1395w-4(g)(3)(B)42 CFR 402.1(c)(18), 402.105(d)(2)(xiv)CMSPenalty 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))199610,00015,024
1395w-27(g)(3)(A); 1857(g)(3)42 CFR 422.760(b); 42 CFR 423.760(b)CMSPenalty 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 contract199725,00036,794
1395w-27(g)(3)(B); 1857(g)(3)CMSPenalty 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 regulations199710,00014,718
1395w-27(g)(3)(D); 1857(g)(3)CMSPenalty for a Medicare Advantage organization's or Part D sponsor's early termination of its contract2000100,000136,689
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1395y(b)(3)(C)42 CFR 411.103(b)CMSPenalty 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 plan19905,0008,908
1395y(b)(5)(C)(ii)42 CFR 402.1(c)(20); 42 CFR 402.105(b)(2)CMSPenalty 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 coverage19981,0001,450
1395y(b)(6)(B)42 CFR 402.1(c)(21), 402.105(a)CMSPenalty 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 form19942,0003,182
1395y(b)(7)(B)(i)CMSPenalty 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 Secretary20071,0001,138
1395y(b)(8)(E)CMSPenalty 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 claim20071,0001,138
1395nn(g)(5)42 CFR 411.361CMSPenalty for any person that fails to report information required by HHS under Section 1877(f) concerning ownership, investment, and compensation arrangements198910,00018,936
1395pp(h)42 CFR 402.1(c)(23), 402.105(d)(2)(xv)CMSPenalty 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))199610,00015,024
1395ss(a)(2)42 CFR 402.1(c)(24), 405.105(f)(1)CMSPenalty 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 date198725,00051,569
1395ss(d)(3)(A)(vi)(II)CMSPenalty for someone other than issuer that sells or issues a Medicare supplemental policy to beneficiary without a disclosure statement199015,00026,723
Penalty for an issuer that sells or issues a Medicare supplemental policy without disclosure statement199025,00044,539
1395ss(d)(3)(B)(iv)CMSPenalty for someone other than issuer that sells or issues a Medicare supplemental policy without acknowledgement form199015,00026,723
Penalty for issuer that sells or issues a Medicare supplemental policy without an acknowledgement form199025,00044,539
1395ss(p)(8)42 CFR 402.1(c)(25), 402.105(e)CMSPenalty 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 statute199015,00026,723
42 CFR 402.1(c)(25), 405.105(f)(2)CMSPenalty 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 statute199025,00044,539
1395ss(p)(9)(C)42 CFR 402.1(c)(26), 402.105(e)CMSPenalty 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 benefits199015,00026,723
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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 benefits199025,00044,539
1395ss(q)(5)(C)42 CFR 402.1(c)(27), 405.105(f)(5)CMSPenalty 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 circumstances199025,00044,539
1395ss(r)(6)(A)42 CFR 402.1(c)(28), 405.105(f)(6)CMSPenalty for any person that fails to provide refunds or credits as required by section 1882(r)(1)(B)199025,00044,539
1395ss(s)(4)42 CFR 402.1(c)(29), 405.105(c)CMSPenalty 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 criteria19905,00018,908
1395ss(t)(2)42 CFR 402.1(c)(30), 405.105(f)(7)CMSPenalty for any issuer of a Medicare supplemental policy that fails to fulfill listed responsibilities199025,00044,539
1395ss(v)(4)(A)CMSPenalty someone other than issuer who sells, issues, or renews a medigap Rx policy to an individual who is a Part D enrollee200315,00019,284
Penalty for an issuer who sells, issues, or renews a Medigap Rx policy who is a Part D enrollee200325,00032,140
1395bbb(c)(1)42 CFR 488.725(c)CMSPenalty 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 conducted19872,0004,126
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)CMSMaximum daily penalty amount for each day a home health agency is not in compliance with statutory requirements198810,00019,787
42 CFR 488.845(b)(3)Penalty per day for home health agency's noncompliance (Upper Range):
Minimum19888,50016,819
Maximum198810,00019,787
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 harm198810,00019,787
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 harm19889,00017,808
42 CFR 488.845(b)(3)(iii)Penalty for an isolated incident of noncompliance in violation of established HHA policy19888,50016,819
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):
Minimum19881,5002,968
Maximum19888,50016,819
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):
Minimum1988500989
Maximum19884,0007,915
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:
Start Printed Page 61579
Minimum19881,0001,979
Maximum198810,00019,787
Penalty for each day of noncompliance (Maximum)198810,00019,787
42 CFR 488.845(d)(1)(ii)Penalty for each day of noncompliance (Maximum)198810,00019,787
1396b(m)(5)(B)42 CFR 460.46CMSPenalty for PACE organization's practice that would reasonably be expected to have the effect of denying or discouraging enrollment:
Minimum199715,00022,077
Maximum1997100,000147,177
Penalty for a PACE organization that charges excessive premiums199725,00036,794
Penalty for a PACE organization misrepresenting or falsifying information to CMS, the State, or an individual or other entity1997100,000147,177
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 participant199725,00036,794
Penalty for involuntarily disenrolling a participant199725,00036,794
Penalty for discriminating or discouraging enrollment or disenrollment of participants on the basis of an individual's health status or need for health care services199725,00036,794
1396r(h)(3)(C)(ii)(I)42 CFR 488.408(d)(1)(iii)CMSPenalty per day for a nursing facility's failure to meet a Category 2 Certification:
Minimum198750103
Maximum19873,0006,188
42 CFR 488.408(d)(1)(iv)CMSPenalty per instance for a nursing facility's failure to meet Category 2 certification:
Minimum19871,0002,063
Maximum198710,00020,628
42 CFR 488.408(e)(1)(iii)CMSPenalty per day for a nursing facility's failure to meet Category 3 certification:
Minimum19873,0506,291
Maximum198710,00020,628
42 CFR 488.408(e)(1)(iv)CMSPenalty per instance for a nursing facility's failure to meet Category 3 certification:2,063
Minimum19871,00020,628
Maximum198710,000
42 CFR 488.408(e)(2)(ii)CMSPenalty per instance for a nursing facility's failure to meet Category 3 certification, which results in immediate jeopardy:2,063
Minimum19871,00020,628
Maximum198710,000
42 CFR 488.438(a)(1)(i)CMSPenalty per day for nursing facility's failure to meet certification (Upper Range):6,291
Minimum19873,05020,628
Maximum198710,0002,063
42 CFR 488.438(a)(1)(ii)CMSPenalty per day for nursing facility's failure to meet certification (Lower Range):
Minimum198750103
Maximum19873,0006,188
42 CFR 488.438(a)(2)CMSPenalty per instance for nursing facility's failure to meet certification:
Minimum19871,0002,063
Maximum198710,00020,628
1396r(f)(2)(B)(iii)(I)(c)42 CFR 483.151(b)(2)(iv) and (b)(3)(iii)CMSGrounds 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]19875,00010,314
1396r(h)(3)(C)(ii)(I)42 CFR 483.151(c)(2)CMSGrounds 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]19875,00010,314
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1396t(j)(2)(C)CMSPenalty for each day of noncompliance for a home or community care provider that no longer meets the minimum requirements for home and community care:
Minimum199012
Maximum199010,00017,816
1396u-2(e)(2)(A)(i)42 CFR 438.704CMSPenalty for a Medicaid managed care organization that fails substantially to provide medically necessary items and services199725,00036,794
Penalty for Medicaid managed care organization that imposes premiums or charges on enrollees in excess of the premiums or charges permitted199725,00036,794
Penalty for a Medicaid managed care organization that misrepresents or falsifies information to another individual or entity199725,00036,794
Penalty for a Medicaid managed care organization that fails to comply with the applicable statutory requirements for such organizations199725,00036,794
1396u-2(e)(2)(A)(ii)42 CFR 438.704CMSPenalty for a Medicaid managed care organization that misrepresents or falsifies information to the HHS Secretary1997100,000147,177
Penalty for Medicaid managed care organization that acts to discriminate among enrollees on the basis of their health status1997100,000147,177
1396u-2(e)(2)(A)(iv)42 CFR 438.704CMSPenalty 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 status199715,00022,077
1396u(h)(2)42 CFR 441, Subpart ICMSPenalty 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 services199010,00020,628
1396w-2(c)(1)CMSPenalty for disclosing information related to eligibility determinations for medical assistance programs200910,00011,002
18041(c)(2)45 CFR 150.315; 45 CFR 156.805(c)CMSFailure 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))1996100150
18081(h)(1)(A)(i)(II)42 CFR 155.285CMSPenalty for providing false information on Exchange application201025,00027,186
18081(h)(1)(B)42 CFR 155.285CMSPenalty for knowingly or willfully providing false information on Exchange application2010250,000271,862
18081(h)(2)42 CFR 155.260CMSPenalty for knowingly or willfully disclosing protected information from Exchange201025,00027,186
31 U.S.C.:
135245 CFR 93.400(e)HHSPenalty for the first time an individual makes an expenditure prohibited by regulations regarding lobbying disclosure, absent aggravating circumstances198910,00018,936
Penalty for second and subsequent offenses by individuals who make an expenditure prohibited by regulations regarding lobbying disclosure:
Minimum198910,00018,936
Maximum1989100,000189,361
Penalty for the first time an individual fails to file or amend a lobbying disclosure form, absent aggravating circumstances198910,00018,936
Penalty for second and subsequent offenses by individuals who fail to file or amend a lobbying disclosure form, absent aggravating circumstances:
Minimum198910,00018,936
Maximum1989100,000189,361
45 CFR 93, Appendix AHHSPenalty for failure to provide certification regarding lobbying in the award documents for all sub-awards of all tiers:
Minimum198910,00018,936
Maximum1989100,000189,361
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Penalty for failure to provide statement regarding lobbying for loan guarantee and loan insurance transactions:
Minimum198910,00018,936
Maximum1989100,000189,361
3801-381245 CFR 79.3(a)(1)(iv)HHSPenalty against any individual who—with knowledge or reason to know—makes, presents or submits a false, fictitious or fraudulent claim to the Department19885,0009,894
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 Department19885,0009,894
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.
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PART 147—HEALTH INSURANCE REFORM REQUIREMENTS FOR THE GROUP AND INDIVIDUAL HEALTH INSURANCE MARKETS

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

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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.

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[Amended]
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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”.

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PART 150—CMS ENFORCEMENT IN GROUP AND INDIVIDUAL INSURANCE MARKETS

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

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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).

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[Amended]
Start Amendment Part

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”.

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

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

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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).

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[Amended]
Start Amendment Part

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”.

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[Amended]
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39. Amend § 155.285 as follows:

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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”;

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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

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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”.

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

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

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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).

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[Amended]
Start Amendment Part

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”.

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

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

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

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[Amended]
Start Amendment Part

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”.

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PART 160—GENERAL ADMINISTRATIVE REQUIREMENTS

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

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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.

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

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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 Start Printed Page 61582Act 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

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PART 303—STANDARDS FOR PROGRAM OPERATIONS

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

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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).

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

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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.

Start Signature

Dated: July 21, 2016.

Sylvia M. Burwell,

Secretary, Department of Health and Human Services.

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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