| Page Range | 61538-61582 | |
| FR Document | 2016-18680 |
[Federal Register Volume 81, Number 172 (Tuesday, September 6, 2016)] [Rules and Regulations] [Pages 61538-61582] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-18680] [[Page 61537]] Vol. 81 Tuesday, No. 172 September 6, 2016 Part IV Department of Health and Human Services ----------------------------------------------------------------------- Centers for Medicare & Medicaid Services Office of the Inspector General Administration for Children and Families ----------------------------------------------------------------------- 42 CFR Parts 3, 402, 403, et al. 45 CFR Parts 79, 93, 102, et al. Adjustment of Civil Monetary Penalties for Inflation; Interim Final Rule Federal Register / Vol. 81 , No. 172 / Tuesday, September 6, 2016 / Rules and Regulations [[Page 61538]] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary 42 CFR Part 3 Centers for Medicare & Medicaid Services 42 CFR Parts 402, 403, 411, 412, 422, 423, 460, 483, 488, and 493 Office of the Inspector General 42 CFR Part 1003 Office of the Secretary 45 CFR Parts 79, 93, 102, 147, 150, 155, 156, 158, and 160 Administration for Children and Families 45 CFR Part 303 RIN 0991-AC0 Adjustment of Civil Monetary Penalties for Inflation AGENCY: Department of Health and Human Services, Office of the Assistant Secretary for Financial Resources, Centers for Medicare & and Medicaid Services, Office of the Inspector General, Administration for Children and Families. ACTION: Interim final rule. ----------------------------------------------------------------------- SUMMARY: The Department of Health and Human Services (HHS) is issuing a new regulation to adjust for inflation the maximum civil monetary penalty amounts for the various civil monetary penalty authorities for all agencies within HHS. We are taking this action to comply with the Federal Civil Penalties Inflation Adjustment Act of 1990 (the Inflation Adjustment Act), as amended by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015. In addition, this interim final rule includes updates to certain agency-specific regulations to identify their updated information, and note the location of HHS-wide regulations. DATES: This rule is effective on September 6, 2016. FOR FURTHER INFORMATION CONTACT: Office of the Assistant Secretary for Financial Resources, Room 514-G, Hubert Humphrey Building, 200 Independence Avenue SW., Washington, DC 20201; 202-690-6396; FAX 202- 690-5405. SUPPLEMENTARY INFORMATION: I. Regulatory Information The Department of Health and Human Services (HHS) is promulgating this interim final rule to ensure that the amount of civil monetary penalties authorized to be assessed or enforced by HHS reflect the statutorily mandated amounts and ranges as adjusted for inflation. Pursuant to Section 4(b) of the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (the 2015 Act), HHS is required to promulgate a ``catch-up adjustment'' through an interim final rule. Pursuant to the 2015 Act and 5 U.S.C. 553(b)(3)(B), HHS finds that good cause exists for immediate implementation of this interim final rule without prior notice and comment because it would be impracticable to delay publication of this rule for notice and comment. The 2015 Act specifies that the adjustments shall take effect not later than August 1, 2016. Additionally, the 2015 Act provides a clear formula for adjustment of the civil monetary penalties, leaving agencies little room for discretion. For these reasons, HHS finds that notice and comment would be impracticable in this situation. Additionally, if applicable, HHS agencies will update their civil monetary penalty- specific regulations to include a cross-reference to the revised regulations located at 45 CFR part 102 reflecting the new adjusted penalty amounts set out by HHS.\1\ --------------------------------------------------------------------------- \1\ All applicable civil monetary penalty authorities within the jurisdiction of HHS must be adjusted in accordance with the 2015 Act. Where existing HHS agency regulations setting forth civil monetary penalty amounts are not updated by this interim final rule, they will be amended in a separate action as soon as practicable. --------------------------------------------------------------------------- II. Background and Requirements of the Law On November 2, 2015, the President signed into law the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (the 2015 Act) (Sec. 701 of the Bipartisan Budget Act of 2015, Public Law 114-74, November 2, 2015), which amended the Federal Civil Penalties Inflation Adjustment Act of 1990 (the Inflation Adjustment Act) (Pub. L. 101-410, 104 Stat. 890 (1990) (codified as amended at 28 U.S.C. 2461 note 2(a)), to improve the effectiveness of civil monetary penalties and to maintain their deterrent effect. The 2015 Act, which removed an inflation update exclusion that previously applied to the Social Security Act as well as the Occupational Safety and Health Act, requires agencies to: (1) Adjust the level of civil monetary penalties with an initial ``catch-up'' adjustment through an interim final rulemaking (IFR); and (2) make subsequent annual adjustments for inflation. The method of calculating inflation adjustments in the 2015 Act differs substantially from the methods used in past inflation adjustment rulemakings conducted pursuant to the Inflation Adjustment Act. Previously, adjustments to civil monetary penalties were conducted under rules that required significant rounding of figures. While this allowed penalties to be kept at round numbers, it meant that penalties would often not be increased at all if the inflation factor was not large enough. Furthermore, increases to penalties were capped at 10 percent. Over time, this formula caused penalties to lose value relative to total inflation. The 2015 Act has removed these rounding rules; now, penalties are simply rounded to the nearest dollar. While this creates penalty values that are no longer round numbers, it does ensure that penalties will be increased each year to a figure commensurate with the actual calculated inflation. Furthermore, the 2015 Act ``resets'' the inflation calculations by excluding prior inflationary adjustments under the Inflation Adjustment Act, which contributed to a decline in the real value of penalty levels. To do this, the 2015 Act requires agencies to identify, for each penalty, the year and corresponding amount(s) for which the maximum penalty level or range of minimum and maximum penalties was established (i.e., originally enacted by Congress) or last adjusted other than pursuant to the Inflation Adjustment Act. In this rule, the adjusted civil penalty amounts are applicable only to civil penalties assessed after August 1, 2016, whose associated violations occurred after November 2, 2015, the date of enactment of the 2015 Amendments. Therefore, violations occurring on or before November 2, 2015, and assessments made prior to August 1, 2016, whose associated violations occurred after November 2, 2015, will continue to be subject to the civil monetary penalty amounts set forth in the Department's existing regulations or as set forth by statute if the amount has not yet been adjusted by regulation. Pursuant to the 2015 Act, the Department of Health and Human Services (HHS) has undertaken a thorough review of civil monetary penalties administered by its various components. This IFR sets forth the initial ``catch-up'' adjustment for civil monetary penalties as well as any necessary technical conforming changes to the language of the various regulations affected by this IFR. For [[Page 61539]] each component, HHS has provided a table showing how the penalties are being increased pursuant to the 2015 Act. The first two columns (``Citation'') identify the United States Code (U.S.C.) statutory citation, and the applicable regulatory citation in the Code of Federal Regulations (CFR), if any. The third column (``Description'') provides a short description of the penalty. In the fourth column (``Pre- Inflation Penalty''), HHS has listed the penalty amount as it exists prior to the inflationary adjustments made by the effective date of this rule, and in the fifth column (``Date of Last Penalty Figure or Adjustment''), HHS has provided the amount and year of the penalty as enacted by Congress or changed through a mechanism other than pursuant to the Inflation Adjustment Act. In column six (``Percentage Increase''), HHS has listed the percentage increase based on the multiplier used to adjust from the CPI-U \2\ of the year of enactment of the monetary penalty to the CPI-U for the current year, or a percentage equal to 150 percent, whichever is less. Multiplying the current penalty amount in column four by the percentage increase provides the ``Increase'' listed in column seven. The ``Maximum Adjusted Penalty'' in column eight is the sum of the current penalty amount and the ``increase''. Where applicable, some HHS agencies will make as soon as practicable conforming edits to regulatory text. Additionally, HHS is issuing new regulatory text including the table showing how the penalties are being increased under the 2015 Act, located at 45 CFR part 102, to implement the civil monetary penalty (CMP) amounts adjusted for inflation agency-wide. Additionally, the 2015 Act requires agencies to publish annual adjustments not later than January 15 of every year after publication of the initial adjustment. --------------------------------------------------------------------------- \2\ Based upon the Consumer Price Index (CPI-U) for the month of October 2015. The CPI-U is published by the Department of Labor, Bureau of Labor Statistics, and is available at its Web site: http://www.bls.gov/cpi/. Calculation of CMP Adjustments -------------------------------------------------------------------------------------------------------------------------------------------------------- Citation Date of ------------------------------------------------------------ last Pre- penalty Percentage Increase Maximum Description \2\ inflation figure or increase ($) \5\ adjusted U.S.C. CFR \1\ penalty ($) adjustment \4\ penalty ($) \3\ -------------------------------------------------------------------------------------------------------------------------------------------------------- 21 U.S.C. (FDA): 333(b)(2)(A)................... ...................... Penalty for violations 50,000 1988 97.869 48,935 98,935 related to drug samples resulting in a conviction of any representative of manufacturer or distributor in any 10- year period. 333(b)(2)(B)................... ...................... Penalty for violation 1,000,000 1988 97.869 978,690 1,978,690 related to drug samples resulting in a conviction of any representative of manufacturer or distributor after the second conviction in any 10-yr period. 333(b)(3)...................... ...................... Penalty for failure to 100,000 1988 97.869 97,869 197,869 make a report required by 21 U.S.C. 353(d)(3)(E) relating to drug samples. 333(f)(1)(A)................... ...................... Penalty for any person who 15,000 1990 78.156 11,723 26,723 violates a requirement related to devices for each such violation. Penalty for aggregate of 1,000,000 1990 78.156 781,560 1,781,560 all violations related to devices in a single proceeding. 333(f)(2)(A)................... ...................... Penalty for any individual 50,000 1996 50.425 25,123 75,123 who introduces or delivers for introduction into interstate commerce food that is adulterated per 21 U.S.C. 342(a)(2)(B) or any individual who does not comply with a recall order under 21 U.S.C. 350l. Penalty in the case of any 250,000 1996 50.425 125,613 375,613 other person other than an individual for such introduction or delivery of adulterated food. Penalty for aggregate of 500,000 1996 50.425 251,225 751,225 all such violations related to adulterated food adjudicated in a single proceeding. 333(f)(3)(A)................... ...................... Penalty for all violations 10,000 2007 13.833 1,383 11,383 adjudicated in a single proceeding for any person who fails to submit certification required by 42 U.S.C. 282(j)(5)(B) or knowingly submitting a false certification. 333(f)(3)(B)................... ...................... Penalty for each day the 10,000 2007 13.833 1,383 11,383 above violation is not corrected after a 30-day period following notification until the violation is corrected. [[Page 61540]] 333(f)(4)(A)(i)................ ...................... Penalty for any 250,000 2007 13.833 34,583 284,583 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). Penalty for aggregate of 1,000,000 2007 13.833 138,330 1,138,330 all such above violations in a single proceeding. 333(f)(4)(A)(ii)............... ...................... Penalty for REMS violation 250,000 2007 13.833 34,583 284,583 that continues after written notice to the responsible person for the first 30-day period (or any portion thereof) the responsible person continues to be in violation. Penalty for REMS violation 1,000,000 2007 13.833 138,330 1,138,330 that continues after written notice to responsible person doubles for every 30-day period thereafter the violation continues, but may not exceed penalty amount for any 30-day period. Penalty for aggregate of 10,000,000 2007 13.833 1,383,300 11,383,300 all such above violations adjudicated in a single proceeding. 333(f)(9)(A)................... ...................... Penalty for any person who 15,000 2009 10.02 1,503 16,503 violates a requirement which relates to tobacco products for each such violation. Penalty for aggregate of 1,000,000 2009 10.02 100,200 1,100,200 all such violations of tobacco product requirement adjudicated in a single proceeding. 333(f)(9)(B)(i)(I)............. ...................... Penalty per violation 250,000 2009 10.02 25,050 275,050 related to violations of tobacco requirements. Penalty for aggregate of 1,000,000 2009 10.02 100,200 1,100,200 all such violations of tobacco product requirements adjudicated in a single proceeding. 333(f)(9)(B)(i)(II)............ ...................... Penalty in the case of a 250,000 2009 10.02 25,050 275,050 violation of tobacco product requirements that continues after written notice to such person, for the first 30-day period (or any portion thereof) the person continues to be in violation. Penalty for violation of 1,000,000 2009 10.02 100,200 1,100,200 tobacco product requirements that continues after written notice to such person shall double for every 30- day period thereafter the violation continues, but may not exceed penalty amount for any 30-day period. Penalty for aggregate of 10,000,000 2009 10.02 1,002,000 11,002,000 all such violations related to tobacco product requirements adjudicated in a single proceeding. 333(f)(9)(B)(ii)(I)............ ...................... Penalty for any person who 250,000 2009 10.02 25,050 275,050 either does not conduct post-market surveillance and studies to determine impact of a modified risk tobacco product for which the HHS Secretary has provided them an order to sell, or who does not submit a protocol to the HHS Secretary after being notified of a requirement to conduct post-market surveillance of such tobacco products. Penalty for aggregate of 1,000,000 2009 10.02 100,200 1,100,200 for all such above violations adjudicated in a single proceeding. [[Page 61541]] 333(f)(9)(B)(ii)(II)........... ...................... Penalty for violation of 250,000 2009 10.02 25,050 275,050 modified risk tobacco product post-market surveillance that continues after written notice to such person for the first 30-day period (or any portion thereof) that the person continues to be in violation. Penalty for post-notice 1,000,000 2009 10.02 100,200 1,100,200 violation of modified risk tobacco product post- market surveillance shall double for every 30-day period thereafter that the tobacco product requirement violation continues for any 30-day period, but may not exceed penalty amount for any 30-day period. Penalty for aggregate 10,000,000 2009 10.02 1,002,000 11,002,000 above tobacco product requirement violations adjudicated in a single proceeding. 333(g)(1)...................... ...................... Penalty for any person who 250,000 2007 13.833 34,583 284,583 disseminates or causes another party to disseminate a direct-to- consumer advertisement that is false or misleading for the first such violation in any 3- year period. Penalty for each 500,000 2007 13.833 69165 569,165 subsequent above violation in any 3-year period. 333 note....................... ...................... Penalty to be applied for 250 2009 10.02 25 275 violations of restrictions on the sale or distribution of tobacco products promulgated under 21 U.S.C. 387f(d) (e.g., violations of regulations in 21 CFR Part 1140) with respect to a retailer with an approved training program in the case of a second regulation violation within a 12- month period. Penalty in the case of a 500 2009 10.02 50 550 third tobacco product regulation violation within a 24-month period. Penalty in the case of a 2,000 2009 10.02 200 2,200 fourth tobacco product regulation violation within a 24-month period. Penalty in the case of a 5,000 2009 10.02 501 5,501 fifth tobacco product regulation violation within a 36-month period. Penalty in the case of a 10,000 2009 10.02 1,002 11,002 sixth or subsequent tobacco product regulation violation within a 48-month period as determined on a case- by-case basis. Penalty to be applied for 250 2009 10.02 25 275 violations of restrictions on the sale or distribution of tobacco products promulgated under 21 U.S.C. 387f(d) (e.g., violations of regulations in 21 CFR Part 1140) with respect to a retailer that does not have an approved training program in the case of the first regulation violation. Penalty in the case of a 500 2009 10.02 50 550 second tobacco product regulation violation within a 12-month period. Penalty in the case of a 1,000 2009 10.02 100 1,100 third tobacco product regulation violation within a 24-month period. Penalty in the case of a 2,000 2009 10.02 200 2,200 fourth tobacco product regulation violation within a 24-month period. Penalty in the case of a 5,000 2009 10.02 501 5,501 fifth tobacco product regulation violation within a 36-month period. [[Page 61542]] Penalty in the case of a 10,000 2009 10.02 1002 11,002 sixth or subsequent tobacco product regulation violation within a 48-month period as determined on a case- by-case basis. 335b(a)........................ ...................... Penalty for each violation 250,000 1992 67.728 169,320 419,320 for any individual who made a false statement or misrepresentation of a material fact, bribed, destroyed, altered, removed, or secreted, or procured the destruction, alteration, removal, or secretion of, any material document, failed to disclose a material fact, obstructed an investigation, employed a consultant who was debarred, debarred individual provided consultant services. Penalty in the case of any 1,000,000 1992 67.728 677,280 1,677,280 other person (other than an individual) per above violation. 360pp(b)(1).................... ...................... Penalty for any person who 1,100 1968 150 1,500 2,750 violates any such requirements for electronic products, with each unlawful act or omission constituting a separate violation. Penalty imposed for any 375,000 1968 150 562,500 937,500 related series of violations of requirements relating to electronic products. 42 U.S.C. (FDA): 262(d)......................... ...................... Penalty per day for 100,000 1986 115.628 115,628 215,628 violation of order of recall of biological product presenting imminent or substantial hazard. 263b(h)(3)..................... ...................... Penalty for failure to 10,000 1992 67.728 6,773 16,773 obtain a mammography certificate as required. 300aa-28(b)(1)................. ...................... Penalty per occurrence for 100,000 1986 115.628 115,628 215,628 any vaccine manufacturer that intentionally destroys, alters, falsifies, or conceals any record or report required. 42 U.S.C. (HRSA): 256b(d)(1)(B)(vi).............. ...................... Penalty for each instance 5,000 2010 8.745 437 5,437 of overcharging a 340B covered entity. 42 U.S.C. (AHRQ): 299c-(3)(d).................... ...................... Penalty for an 10,000 1999 41.402 4,140 14,140 establishment or person supplying information obtained in the course of activities for any purpose other than the purpose for which it was supplied. 42 U.S.C. ACF: 653(l)(2)...................... 45 CFR 303.21(f)...... Penalty for Misuse of 1,000 1998 45.023 450 1,450 Information in the National Directory of New Hires. 42 U.S.C. (OIG): 262a(i)(1)..................... 42 CFR Part 1003...... Penalty for each 250,000 2002 31.185 77,962 327,962 individual who violates safety and security procedures related to handling dangerous biological agents and toxins. Penalty for any other 500,000 2002 31.185 155,925 655,925 person who violates safety and security procedures related to handling dangerous biological agents and toxins. 1320a-7a(a).................... 42 CFR Part 1003...... Penalty for knowingly 10,000 1996 50.245 5,024 15,024 presenting or causing to be presented to an officer, employee, or agent of the United States a false claim. Penalty for knowingly 10,000 1996 50.245 5,024 15,024 presenting or causing to be presented a request for payment which violates the terms of an assignment, agreement, or PPS agreement. [[Page 61543]] Penalty for knowingly 15,000 1996 50.245 7,537 22,537 giving or causing to be presented to a participating provider or supplier false or misleading information that could reasonably be expected to influence a discharge decision. Penalty for an excluded 10,000 1996 50.245 5,024 15,024 party retaining ownership or control interest in a participating entity. Penalty for remuneration 10,000 1996 50.245 5,024 15,024 offered to induce program beneficiaries to use particular providers, practitioners, or suppliers. Penalty for employing or 10,000 1997 47.177 4,718 14,718 contracting with an excluded individual. Penalty for knowing and 50,000 1997 47.177 23,588 73,588 willful solicitation, receipt, offer, or payment of remuneration for referring an individual for a service or for purchasing, leasing, or ordering an item to be paid for by a Federal health care program. Penalty for ordering or 10,000 2010 8.745 874 10,874 prescribing medical or other item or service during a period in which the person was excluded. Penalty for knowingly 50,000 2010 8.745 4,372 54,372 making or causing to be made a false statement, omission or misrepresentation of a material fact in any application, bid, or contract to participate or enroll as a provider or supplier. Penalty for knowing of an 10,000 2010 8.745 874 10,874 overpayment and failing to report and return. Penalty for making or 50,000 2010 8.745 4,372 54,372 using a false record or statement that is material to a false or fraudulent claim. Penalty for failure to 15,000 2010 8.745 1,312 16,312 grant timely access to HHS OIG for audits, investigations, evaluations, and other statutory functions of HHS OIG. 1320a-7a(b).................... 42 CFR Part 1003...... Penalty for payments by a 2,000 1986 115.628 2,313 4,313 hospital or critical access hospital to induce a physician to reduce or limit services to individuals under direct care of physician or who are entitled to certain medical assistance benefits. Penalty for physicians who 2,000 1986 115.628 2,313 4,313 knowingly receive payments from a hospital or critical access hospital to induce such physician to reduce or limit services to individuals under direct care of physician or who are entitled to certain medical assistance benefits. Penalty for a physician 5,000 1996 50.245 2,512 7,512 who executes a document that falsely certifies home health needs for Medicare beneficiaries. 1320a-7e(b)(6)(A).............. 42 CFR Part 1003...... Penalty for failure to 25,000 1997 47.177 11,794 36,794 report any final adverse action taken against a health care provider, supplier, or practitioner. 1320b-10(b)(1)................. 42 CFR Part 1003...... Penalty for the misuse of 5,000 1988 97.869 4,893 9,893 words, symbols, or emblems in communications in a manner in which a person could falsely construe that such item is approved, endorsed, or authorized by HHS. [[Page 61544]] 1320b-10(b)(2)................. 42 CFR Part 1003...... Penalty for the misuse of 25,000 1988 97.869 24,467 49,467 words, symbols, or emblems in a broadcast or telecast in a manner in which a person could falsely construe that such item is approved, endorsed, or authorized by HHS. 1395i-3(b)(3)(B)(ii)(1)........ ...................... Penalty for certification 1,000 1987 106.278 1,063 2,063 of a false statement in assessment of functional capacity of a Skilled Nursing Facility resident assessment. 1395i-3(b)(3)(B)(ii)(2)........ ...................... Penalty for causing 5,000 1987 106.278 5,314 10,314 another to certify or make a false statement in assessment of functional capacity of a Skilled Nursing Facility resident assessment. 1395i-3(g)(2)(A)............... ...................... Penalty for any individual 2,000 1987 106.278 2,126 4,126 who notifies or causes to be notified a Skilled Nursing Facility of the time or date on which a survey is to be conducted. 1395w-27(g)(2)(A).............. 42 CFR 422.752; 42 CFR Penalty for a Medicare 25,000 1996 50.245 12,561 37,561 Part 1003. Advantage organization that substantially fails to provide medically necessary, required items and services. Penalty for a Medicare 25,000 1997 47.177 11,794 36,794 Advantage organization that charges excessive premiums. Penalty for a Medicare 25,000 1997 47.177 11,794 36,794 Advantage organization that improperly expels or refuses to reenroll a beneficiary. Penalty for a Medicare 100,000 1997 47.177 47,177 147,177 Advantage organization that engages in practice that would reasonably be expected to have the effect of denying or discouraging enrollment. Penalty per individual who 15,000 1997 47.177 7,077 22,077 does not enroll as a result of a Medicare Advantage organization's practice that would reasonably be expected to have the effect of denying or discouraging enrollment. Penalty for a Medicare 100,000 1997 47.177 47,177 147,177 Advantage organization misrepresenting or falsifying information to Secretary. Penalty for a Medicare 25,000 1997 47.177 11,794 36,794 Advantage organization misrepresenting or falsifying information to individual or other entity. Penalty for Medicare 25,000 1997 47.177 11,794 36,794 Advantage organization interfering with provider's advice to enrollee and non-MCO affiliated providers that balance bill enrollees. Penalty for a Medicare 25,000 1997 47.177 11,794 36,794 Advantage organization that employs or contracts with excluded individual or entity. Penalty for a Medicare 25,000 2010 47.177 11,794 36,794 Advantage organization enrolling an individual in without prior written consent. Penalty for a Medicare 25,000 2010 47.177 11,794 36,794 Advantage organization transferring an enrollee to another plan without consent or solely for the purpose of earning a commission. Penalty for a Medicare 25,000 2010 47.177 11,794 36,794 Advantage organization failing to comply with marketing restrictions or applicable implementing regulations or guidance. [[Page 61545]] Penalty for a Medicare 25,000 2010 47.177 11,794 36,794 Advantage organization employing or contracting with an individual or entity who violates 1395w- 27(g)(1)(A)-(J). 1395w-141(i)(3)................ 42 CFR Part 1003...... Penalty for a prescription 10,000 2003 28.561 2,856 12,856 drug card sponsor that falsifies or misrepresents marketing materials, overcharges program enrollees, or misuse transitional assistance funds. 1395cc(g)...................... 42 CFR Part 1003...... Penalty for improper 2,000 1972 150 3,000 5,000 billing by Hospitals, Critical Access Hospitals, or Skilled Nursing Facilities. 1395dd(d)(1)................... 42 CFR Part 1003...... Penalty for a hospital or 50,000 1987 106.278 53,139 103,139 responsible physician dumping patients needing emergency medical care, if the hospital has 100 beds or more. Penalty for a hospital or 25,000 1987 106.278 26,570 51,570 responsible physician dumping patients needing emergency care, if the hospital has less than 100 beds. 1395mm(i)(6)(B)(i)............. 42 CFR Part 1003...... Penalty for a HMO or 25,000 1987 106.278 26,570 51,570 competitive plan is such plan substantially fails to provide medically necessary, required items or services. Penalty for HMOs/ 25,000 1987 106.278 26,570 51,570 competitive medical plans that charge premiums in excess of permitted amounts. Penalty for a HMO or 25,000 1987 106.278 26,570 51,570 competitive medical plan that expels or refuses to reenroll an individual per prescribed conditions. Penalty for a HMO or 100,000 1987 106.278 106,278 206,278 competitive medical plan that implements practices to discourage enrollment of individuals needing services in future. Penalty per individual not 15,000 1988 97.869 14,680 29,680 enrolled in a plan as a result of a HMO or competitive medical plan that implements practices to discourage enrollment of individuals needing services in the future. Penalty for a HMO or 100,000 1987 106.278 106,278 206,278 competitive medical plan that misrepresents or falsifies information to the Secretary. Penalty for a HMO or 25,000 1987 106.278 26,570 51,570 competitive medical plan that misrepresents or falsifies information to an individual or any other entity. Penalty for failure by HMO 25,000 1987 106.278 26,570 51,570 or competitive medical plan to assure prompt payment of Medicare risk sharing contracts or incentive plan provisions. Penalty for HMO that 25,000 1989 89.361 22,340 47,340 employs or contracts with excluded individual or entity. 1395nn(g)(3)................... 42 CFR Part 1003...... Penalty for submitting or 15,000 1994 59.089 8,863 23,863 causing to be submitted claims in violation of the Stark Law's restrictions on physician self-referrals. 1395nn(g)(4)................... 42 CFR Part 1003...... Penalty for circumventing 100,000 1994 59.089 59,089 159,089 Stark Law's restrictions on physician self- referrals. 1395ss(d)(1)................... 42 CFR Part 1003...... Penalty for a material 5,000 1988 97.869 4,893 9,893 misrepresentation regarding Medigap compliance policies. 1395ss(d)(2)................... 42 CFR Part 1003...... Penalty for selling 5,000 1988 97.869 4,893 9,893 Medigap policy under false pretense. 1395ss(d)(3)(A)(ii)............ 42 CFR Part 1003...... Penalty for an issuer that 25,000 1990 78.156 19,539 44,539 sells health insurance policy that duplicates benefits. [[Page 61546]] Penalty for someone other 15,000 1990 78.156 11,723 26,723 than issuer that sells health insurance that duplicates benefits. 1395ss(d)(4)(A)................ 42 CFR Part 1003...... Penalty for using mail to 5,000 1988 97.869 4,893 9,893 sell a non-approved Medigap insurance policy. 1396b(m)(5)(B)(i).............. 42 CFR Part 1003...... Penalty for a Medicaid MCO 25,000 1988 97.869 24,467 49,467 that substantially fails to provide medically necessary, required items or services. Penalty for a Medicaid MCO 25,000 1988 97.869 24,467 49,467 that charges excessive premiums. Penalty for a Medicaid MCO 100,000 1988 97.869 97,869 197,869 that improperly expels or refuses to reenroll a beneficiary. Penalty per individual who 15,000 1988 97.869 14,680 29,680 does not enroll as a result of a Medicaid MCO's practice that would reasonably be expected to have the effect of denying or discouraging enrollment. Penalty for a Medicaid MCO 100,000 1988 97.869 97,869 197,869 misrepresenting or falsifying information to the Secretary. Penalty for a Medicaid MCO 25,000 1988 97.869 24,467 49,467 misrepresenting or falsifying information to an individual or another entity. Penalty for a Medicaid MCO 25,000 1990 78.156 19,539 44,539 that fails to comply with contract requirements with respect to physician incentive plans. 1396r(b)(3)(B)(ii)(I).......... 42 CFR Part 1003...... Penalty for willfully and 1,000 1987 106.278 1,063 2,063 knowingly certifying a material and false statement in a Skilled Nursing Facility resident assessment. 1396r(b)(3)(B)(ii)(II)......... 42 CFR Part 1003...... Penalty for willfully and 5,000 1987 106.278 5,314 10,314 knowingly causing another individual to certify a material and false statement in a Skilled Nursing Facility resident assessment. 1396r(g)(2)(A)(i).............. 42 CFR Part 1003...... Penalty for notifying or 2,000 1987 106.278 2,126 4,126 causing to be notified a Skilled Nursing Facility of the time or date on which a survey is to be conducted. 1396r-8(b)(3)(B)............... 42 CFR Part 1003...... Penalty for the knowing 100,000 1990 78.156 78,156 178,156 provision of false information or refusing to provide information about charges or prices of a covered outpatient drug. 1396r-8(b)(3)(C)(i)............ 42 CFR Part 1003...... Penalty per day for 10,000 1990 78.156 7,816 17,816 failure to timely provide information by drug manufacturer with rebate agreement. 1396r-8(b)(3)(C)(ii)........... 42 CFR Part 1003...... Penalty for knowing 100,000 1990 78.156 78,156 178,156 provision of false information by drug manufacturer with rebate agreement. 1396t(i)(3)(A)................. 42 CFR Part 1003...... Penalty for notifying home 2,000 1990 78.156 1,563 3,563 and community-based providers or settings of survey. 11131(c)....................... 42 CFR Part 1003...... Penalty for failing to 10,000 1986 115.628 11,563 21,563 report a medical malpractice claim to National Practitioner Data Bank. 11137(b)(2).................... 42 CFR Part 1003...... Penalty for breaching 10,000 1986 115.628 11,563 21,563 confidentiality of information reported to National Practitioner Data Bank. 42 U.S.C. (OCR): 299b-22(f)(1).................. 42 CFR 3.404(b)....... Penalty for violation of 10,000 2005 19.40 1,940 11,940 confidentiality provision of the Patient Safety and Quality Improvement Act. 1320(d)-5(a)................... 45 CFR Penalty for each pre- 100 1996 50.245 50 150 160.404(b)(1)(i),(ii). February 18, 2009 violation of the HIPAA administrative simplification provisions. Calendar Year Cap......... 25,000 1996 50.245 12,561 37,561 [[Page 61547]] 45 CFR Penalty for each February 160.404(b)(2)(i)(A),( 18, 2009 or later B). violation of a HIPAA administrative simplification provision in which it is established that the covered entity or business associate did not know and by exercising reasonable diligence, would not have known that the covered entity or business associate violated such a provision: Minimum................ 100 2009 10.02 10 110 Maximum................ 50,000 2009 10.02 5,010 55,010 Calendar Year Cap...... 1,500,000 2009 10.02 150,300 1,650,300 45 CFR Penalty for each February 160.404(b)(2)(ii)(A), 18, 2009 or later (B). violation of a HIPAA administrative simplification provision in which it is established that the violation was due to reasonable cause and not to willful neglect: Minimum................ 1,000 2009 10.02 100 1100 Maximum................ 50,000 2009 10.02 5,010 55,010 Calendar Year Cap...... 1,500,000 2009 10.02 150,300 1,650,300 45 CFR Penalty for each February 160.404(b)(2)(iii)(A) 18, 2009 or later , (B). violation of a HIPAA administrative simplification provision in which it is established that the violation was due to willful neglect and was corrected during the 30- day period beginning on the first date the covered entity or business associate knew, or, by exercising reasonable diligence, would have known that the violation occurred: Minimum................ 10,000 2009 10.02 100 11,002 Maximum................ 50,000 2009 10.02 5,010 55,010 Calendar Year Cap...... 1,500,000 2009 10.02 150,300 1,650,300 45 CFR Penalty for each February 160.404(b)(2)(iv)(A), 18, 2009 or later (B). violation of a HIPAA administrative simplification provision in which it is established that the violation was due to willful neglect and was not corrected during the 30-day period beginning on the first date the covered entity or business associate knew, or by exercising reasonable diligence, would have known that the violation occurred: Minimum................ 50,000 2009 10.02 5,010 55,010 Maximum................ 1,500,000 2009 10.02 150,300 1,650,300 Calendar Year Cap...... 1,500,000 2009 10.02 150,300 1,650,300 42 U.S.C. (CMS): 263a(h)(2)(B) & 1395w- 42 CFR Penalty for a clinical 2(b)(2)(A)(ii). 493.1834(d)(2)(i). laboratory's failure to meet participation and certification requirements and poses immediate jeopardy: Minimum................ 3,050 1988 97.869 2,985 6,035 Maximum................ 10,000 1988 97.869 9,787 19,787 42 CFR Penalty for a clinical 493.1834(d)(2)(ii). laboratory's failure to meet participation and certification requirements and the failure does not pose immediate jeopardy: Minimum................ 50 1988 97.869 49 99 Maximum................ 3,000 1988 97.869 2,936 5,936 300gg-15(f).................... 45 CFR 147.200(e)..... Failure to provide the 1,000 2010 8.745 87 1,087 Summary of Benefits and Coverage (SBC). 300gg-18....................... 45 CFR 158.606........ Penalty for violations of 100 2010 8.745 9 109 regulations related to the medical loss ratio reporting and rebating. [[Page 61548]] 1320a-7h(b)(1)................. 42 CFR 402.105(d)(5), Penalty for manufacturer 42 CFR 403.912(a) & or group purchasing (c). organization failing to report information required under 42 U.S.C. 1320a-7h(a), relating to physician ownership or investment interests: Minimum................ 1,000 2010 8.745 87 1,087 Maximum................ 10,000 2010 8.745 874 10,874 Calendar Year Cap...... 150,000 2010 8.745 13,117 163,117 1320a-7h(b)(2)................. 42 CFR 402.105(h), 42 Penalty for manufacturer CFR 403 912(b) & (c). or group purchasing organization knowingly failing to report information required under 42 U.S.C. 1320a- 7h(a) , relating to physician ownership or investment interests: Minimum................ 10,000 2010 8.745 874 10,874 Maximum................ 100,000 2010 8.745 8,745 108,745 Calendar Year Cap...... 1,000,000 2010 8.745 87,450 1,087,450 1320a-7j(h)(3)(A).............. ...................... Penalty for an 100,000 2010 8.745 8,745 108,745 administrator of a facility that fails to comply with notice requirements for the closure of a facility. 42 CFR Minimum penalty for the 500 2010 8.745 44 544 488.446(a)(1),(2), & first offense of an (3). administrator who fails to provide notice of facility closure. Minimum penalty for the 1,500 2010 8.745 131 1,631 second offense of an administrator who fails to provide notice of facility closure. Minimum penalty for the 3,000 2010 8.745 262 3,262 third and subsequent offenses of an administrator who fails to provide notice of facility closure. 1320a-8(a)(1).................. ...................... Penalty for an entity 5,000 1994 59.089 2,954 7,954 knowingly making a false statement or representation of material fact in the determination of the amount of benefits or payments related to old- age, survivors, and disability insurance benefits, special benefits for certain World War II veterans, or supplemental security income for the aged, blind, and disabled. Penalty for the violation 7,500 2015 1 4,431 7,500 of 42 U.S.C. 1320a-8a(1) if the violator is a person who receives a fee or other income for services performed in connection with determination of the benefit amount or the person is a physician or other health care provider who submits evidence in connection with such a determination. 1320a-8(a)(3).................. ...................... Penalty for a 5,000 2004 24.588 1,229 6,229 representative payee (under 42 U.S.C. 405(j), 1007, or 1383(a)(2)) converting any part of a received payment from the benefit programs described in the previous civil monetary penalty to a use other than for the benefit of the beneficiary. 1320b-25(c)(1)(A).............. ...................... Penalty for failure of 200,000 2010 8.745 17,490 217,490 covered individuals to report to the Secretary and 1 or more law enforcement officials any reasonable suspicion of a crime against a resident, or individual receiving care, from a long-term care facility. [[Page 61549]] 1320b-25(c)(2)(A).............. ...................... Penalty for failure of 300,000 2010 8.745 26,235 326,235 covered individuals to report to the Secretary and 1 or more law enforcement officials any reasonable suspicion of a crime against a resident, or individual receiving care, from a long-term care facility if such failure exacerbates the harm to the victim of the crime or results in the harm to another individual. 1320b-25(d)(2)................. ...................... Penalty for a long-term 200,000 2010 8.745 17,490 217,490 care facility that retaliates against any employee because of lawful acts done by the employee, or files a complaint or report with the State professional disciplinary agency against an employee or nurse for lawful acts done by the employee or nurse. 1395b-7(b)(2)(B)............... 42 CFR 402.105(g)..... Penalty for any person who 100 1997 47.177 47 147 knowingly and willfully fails to furnish a beneficiary with an itemized statement of items or services within 30 days of the beneficiary's request. 1395i-3(h)(2)(B)(ii)(I)........ 42 CFR Penalty per day for a 488.408(d)(1)(iii). Skilled Nursing Facility that has a Category 2 violation of certification requirements: Minimum................ 50 1987 106.278 53 103 Maximum................ 3,000 1987 106.278 3,188 6,188 42 CFR Penalty per instance of 488.408(d)(1)(iv). Category 2 noncompliance by a Skilled Nursing Facility: Minimum................ 1,000 1987 106.278 1,063 2,063 Maximum................ 10,000 1987 106.278 10,628 20,628 42 CFR Penalty per day for a 488.408(e)(1)(iii). Skilled Nursing Facility that has a Category 3 violation of certification requirements: Minimum................ 3,050 1987 106.278 3,241 6,291 Maximum................ 10,000 1987 106.278 10,628 20,628 42 CFR Penalty per instance of 488.408(e)(1)(iv). Category 3 noncompliance by a Skilled Nursing Facility: Minimum................ 1,000 1987 106.278 1,063 2,063 Maximum................ 10,000 1987 106.278 10,628 20,628 Penalty per day and per instance for a Skilled Nursing Facility that has Category 3 noncompliance with Immediate Jeopardy. Per Day (Minimum)...... 3,050 1987 106.278 3,241 6,291 Per Day (Maximum)...... 10,000 1987 106.278 10,628 20,628 Per Instance (Minimum). 1,000 1987 106.278 1,063 2,063 Per Instance (Maximum). 10,000 1987 106.278 10,628 20,628 42 CFR Penalty per day of a 488.438(a)(1)(i). Skilled Nursing Facility that fails to meet certification requirements. These amounts represent the upper range per day: Minimum................ 3,050 1987 106.278 3,241 6,291 Maximum................ 10,000 1987 106.278 10,628 20,628 42 CFR Penalty per day of a 488.438(a)(1)(ii). Skilled Nursing Facility that fails to meet certification requirements. These amounts represent the lower range per day: Minimum................ 50 1987 106.278 53 103 Maximum................ 3,000 1987 106.278 3,188 6,188 42 CFR 488.438(a)(2).. Penalty per instance of a Skilled Nursing Facility that fails to meet certification requirements: Minimum................ 1,000 1987 106.278 1,063 2,063 Maximum................ 10,000 1987 106.278 10,628 20,628 [[Page 61550]] 1395l(h)(5)(D)................. 42 CFR Penalty for knowingly, 10,000 1996 50.245 5,024 15,024 402.105(d)(2)(i). willfully, and repeatedly billing for a clinical diagnostic laboratory test other than on an assignment-related basis. (Penalties are assessed in the same manner as 42 U.S.C. 1395u(j)(2)(B), which is assessed according to 1320a-7a(a)). 1395l(i)(6).................... ...................... Penalty for knowingly and 2,000 1988 197.869 1,957 3,957 willfully presenting or causing to be presented a bill or request for payment for an intraocular lens inserted during or after cataract surgery for which the Medicare payment rate includes the cost of acquiring the class of lens involved. 1395l(q)(2)(B)(i).............. 42 CFR 402.105(a)..... Penalty for knowingly and 2,000 1989 89.361 1,787 3,787 willfully failing to provide information about a referring physician when seeking payment on an unassigned basis. 1395m(a)(11)(A)................ 42 CFR 402.1(c)(4), Penalty for any durable 10,000 1996 50.245 5,024 15,024 402.105(d)(2)(ii). medical equipment supplier that knowingly and willfully charges for a covered service that is furnished on a rental basis after the rental payments may no longer be made. (Penalties are assessed in the same manner as 42 U.S.C. 1395u(j)(2)(B), which is assessed according to 1320a-7a(a)). 1395m(a)(18)(B)................ 42 CFR 402.1(c)(5), Penalty for any 10,000 1996 50.245 5,024 15,024 402.105(d)(2)(iii). nonparticipating durable medical equipment supplier that knowingly and willfully fails to make a refund to Medicare beneficiaries for a covered service for which payment is precluded due to an unsolicited telephone contact from the supplier. (Penalties are assessed in the same manner as 42 U.S.C. 1395u(j)(2)(B), which is assessed according to 1320a-7a(a)). 1395m(b)(5)(C)................. 42 CFR 402.1(c)(6), Penalty for any 10,000 1996 50.245 5,024 15,024 402.105(d)(2)(iv). nonparticipating physician or supplier that knowingly and willfully charges a Medicare beneficiary more than the limiting charge for radiologist services. (Penalties are assessed in the same manner as 42 U.S.C. 1395u(j)(2)(B), which is assessed according to 1320a-7a(a)). 1395m(h)(3).................... 42 CFR 402.1(c)(8), Penalty for any supplier 10,000 1996 50.245 5,024 15,024 402.105(d)(2)(vi). of prosthetic devices, orthotics, and prosthetics that knowing and willfully charges for a covered prosthetic device, orthotic, or prosthetic that is furnished on a rental basis after the rental payment may no longer be made. (Penalties are assessed in the same manner as 42 U.S.C. 1395m(a)(11)(A), that is in the same manner as 1395u(j)(2)(B), which is assessed according to 1320a-7a(a)). [[Page 61551]] 1395m(j)(2)(A)(iii)............ ...................... Penalty for any supplier 1,000 1994 59.089 591 1,591 of durable medical equipment including a supplier of prosthetic devices, prosthetics, orthotics, or supplies that knowingly and willfully distributes a certificate of medical necessity in violation of Section 1834(j)(2)(A)(i) of the Act or fails to provide the information required under Section 1834(j)(2)(A)(ii) of the Act. 1395m(j)(4).................... 42 CFR 402.1(c)(10), Penalty for any supplier 10,000 1996 50.245 5,024 15,024 402.105(d)(2)(vii). of durable medical equipment, including a supplier of prosthetic devices, prosthetics, orthotics, or supplies that knowingly and willfully fails to make refunds in a timely manner to Medicare beneficiaries for series billed other than on as assignment-related basis under certain conditions. (Penalties are assessed in the same manner as 42 U.S.C. 1395m(j)(4) and 1395u(j)(2)(B), which is assessed according to 1320a-7a(a)). 1395m(k)(6).................... 42 CFR 402.1(c)(31), Penalty for any person or 10,000 1996 50.245 5,024 15,024 402.105(d)(3). entity who knowingly and willfully bills or collects for any outpatient therapy services or comprehensive outpatient rehabilitation services on other than an assignment-related basis. (Penalties are assessed in the same manner as 42 U.S.C. 1395m(k)(6) and 1395u(j)(2)(B), which is assessed according to 1320a-7a(a)). 1395m(l)(6).................... 42 CFR 402.1(c)(32), Penalty for any supplier 10,000 1996 50.245 5,024 15,024 402.105(d)(4). of ambulance services who knowingly and willfully fills or collects for any services on other than an assignment-related basis. (Penalties are assessed in the same manner as 42 U.S.C. 1395u(b)(18)(B), which is assessed according to 1320a-7a(a)). 1395u(b)(18)(B)................ 42 CFR 402.1(c)(11), Penalty for any 10,000 1996 50.245 5,024 15,024 402.105(d)(2)(viii). practitioner specified in Section 1842(b)(18)(C) of the Act or other person that knowingly and willfully bills or collects for any services by the practitioners on other than an assignment- related basis. (Penalties are assessed in the same manner as 42 U.S.C. 1395u(j)(2)(B), which is assessed according to 1320a-7a(a)). 1395u(j)(2)(B)................. 42 CFR 402.1(c)....... Penalty for any physician 10,000 1996 50.245 5,024 15,024 who charges more than 125% for a non- participating referral. (Penalties are assessed in the same manner as 42 U.S.C. 1320a-7a(a)). 1395u(k)....................... 42 CFR 402.1(c)(12), Penalty for any physician 10,000 1996 50.245 5,024 15,024 402.105(d)(2)(ix). who knowingly and willfully presents or causes to be presented a claim for bill for an assistant at a cataract surgery performed on or after March 1, 1987, for which payment may not be made because of section 1862(a)(15). (Penalties are assessed in the same manner as 42 U.S.C. 1395u(j)(2)(B), which is assessed according to 1320a-7a(a)). [[Page 61552]] 1395u(l)(3).................... 42 CFR 402.1(c)(13), Penalty for any 10,000 1996 50.245 5,024 15,024 402.105(d)(2)(x). nonparticipating physician who does not accept payment on an assignment-related basis and who knowingly and willfully fails to refund on a timely basis any amounts collected for services that are not reasonable or medically necessary or are of poor quality under 1842(l)(1)(A). (Penalties are assessed in the same manner as 42 U.S.C. 1395u(j)(2)(B), which is assessed according to 1320a-7a(a)). 1395u(m)(3).................... 42 CFR 402.1(c)(14), Penalty for any 10,000 1996 50.245 5,024 15,024 402.105(d)(2)(xi). nonparticipating physician charging more than $500 who does not accept payment for an elective surgical procedure on an assignment related basis and who knowingly and willfully fails to disclose the required information regarding charges and coinsurance amounts and fails to refund on a timely basis any amount collected for the procedure in excess of the charges recognized and approved by the Medicare program. (Penalties are assessed in the same manner as 42 U.S.C. 1395u(j)(2)(B), which is assessed according to 1320a-7a(a)). 1395u(n)(3).................... 42 CFR 402.1(c)(15), Penalty for any physician 10,000 1996 50.245 5,024 15,024 402.105(d)(2)(xii). who knowingly, willfully, and repeatedly bills one or more beneficiaries for purchased diagnostic tests any amount other than the payment amount specified by the Act. (Penalties are assessed in the same manner as 42 U.S.C. 1395u(j)(2)(B), which is assessed according to 1320a-7a(a)). 1395u(o)(3)(B)................. 42 CFR 414.707(b)..... Penalty for any 10,000 1996 50.245 5,024 15,024 practitioner specified in Section 1842(b)(18)(C) of the Act or other person that knowingly and willfully bills or collects for any services pertaining to drugs or biologics by the practitioners on other than an assignment- related basis. (Penalties are assessed in the same manner as 42 U.S.C. 1395u(b)(18)(B) and 1395u(j)(2)(B), which is assessed according to 1320a-7a(a)). 1395u(p)(3)(A)................. ...................... Penalty for any physician 2,000 1988 97.869 1,957 3,957 or practitioner who knowingly and willfully fails promptly to provide the appropriate diagnosis codes upon CMS or Medicare administrative contractor request for payment or bill not submitted on an assignment-related basis. 1395w-3a(d)(4)(A).............. 42 CFR 414.806........ Penalty for a 10,000 2003 28.561 2,856 12,856 pharmaceutical manufacturer's misrepresentation of average sales price of a drug, or biologic. [[Page 61553]] 1395w-4(g)(1)(B)............... 42 CFR 402.1(c)(17), Penalty for any 10,000 1996 50.245 5,024 15,024 402.105(d)(2)(xiii). nonparticipating physician, supplier, or other person that furnishes physician services not on an assignment-related basis who either knowingly and willfully bills or collects in excess of the statutorily-defined limiting charge or fails to make a timely refund or adjustment. (Penalties are assessed in the same manner as 42 U.S.C. 1395u(j)(2)(B), which is assessed according to 1320a-7a(a)). 1395w-4(g)(3)(B)............... 42 CFR 402.1(c)(18), Penalty for any person 10,000 1996 50.245 5,024 15,024 402.105(d)(2)(xiv). that knowingly and willfully bills for statutorily defined State- plan approved physicians' services on any other basis than an assignment- related basis for a Medicare/Medicaid dual eligible beneficiary. (Penalties are assessed in the same manner as 42 U.S.C. 1395u(j)(2)(B), which is assessed according to 1320a-7a(a)). 1395w-27(g)(3)(A); 1857(g)(3).. 42 CFR 422.760(b); 42 Penalty for each 25,000 1997 47.177 11,794 36,794 CFR 423.760(b). termination determination the Secretary makes that is the result of actions by a Medicare Advantage organization or Part D sponsor that has adversely affected an individual covered under the organization's contract. 1395w-27(g)(3)(B); 1857(g)(3).. ...................... Penalty for each week 10,000 1997 47.177 4,718 14,718 beginning after the initiation of civil money penalty procedures by the Secretary because a Medicare Advantage organization or Part D sponsor has failed to carry out a contract, or has carried out a contract inconsistently with regulations. 1395w-27(g)(3)(D); 1857(g)(3).. ...................... Penalty for a Medicare 100,000 2000 36.689 36,689 136,689 Advantage organization's or Part D sponsor's early termination of its contract. 1395y(b)(3)(C)................. 42 CFR 411.103(b)..... Penalty for an employer or 5,000 1990 78.156 3,908 8,908 other entity to offer any financial or other incentive for an individual entitled to benefits not to enroll under a group health plan or large group health plan which would be a primary plan. 1395y(b)(5)(C)(ii)............. 42 CFR 402.1(c)(20), Penalty for any non- 1,000 1998 89.361 450 1,450 402.105(b)(2). governmental employer that, before October 1, 1998, willfully or repeatedly failed to provide timely and accurate information requested relating to an employee's group health insurance coverage. 1395y(b)(6)(B)................. 42 CFR 402.1(c)(21), Penalty for any entity 2,000 1994 59.089 1,182 3,182 402.105(a). that knowingly, willfully, and repeatedly fails to complete a claim form relating to the availability of other health benefits in accordance with statute or provides inaccurate information relating to such on the claim form. 1395y(b)(7)(B)(i).............. ...................... Penalty for any entity 1,000 2007 13.833 138 1,138 serving as insurer, third party administrator, or fiduciary for a group health plan that fails to provide information that identifies situations where the group health plan is or was a primary plan to Medicare to the HHS Secretary. [[Page 61554]] 1395y(b)(8)(E)................. ...................... Penalty for any non-group 1,000 2007 13.833 138 1,138 health plan that fails to identify claimants who are Medicare beneficiaries and provide information to the HHS Secretary to coordinate benefits and pursue any applicable recovery claim. 1395nn(g)(5)................... 42 CFR 411.361........ Penalty for any person 10,000 1989 89.361 8,936 18,936 that fails to report information required by HHS under Section 1877(f) concerning ownership, investment, and compensation arrangements. 1395pp(h)...................... 42 CFR 402.1(c)(23), Penalty for any durable 10,000 1996 50.245 5,024 15,024 402.105(d)(2)(xv). medical equipment supplier, including a supplier of prosthetic devices, prosthetics, orthotics, or supplies, that knowingly and willfully fails to make refunds in a timely manner to Medicare beneficiaries under certain conditions. (42 U.S.C. 1395(m)(18) sanctions apply here in the same manner, which is under 1395u(j)(2) and 1320a-7a(a)). 1395ss(a)(2)................... 42 CFR 402.1(c)(24), Penalty for any person 25,000 1987 106.278 26,569 51,569 405.105(f)(1). that issues a Medicare supplemental policy that has not been approved by the State regulatory program or does not meet Federal standards after a statutorily defined effective date. 1395ss(d)(3)(A)(vi) (II)....... ...................... Penalty for someone other 15,000 1990 78.156 11,723 26,723 than issuer that sells or issues a Medicare supplemental policy to beneficiary without a disclosure statement. Penalty for an issuer that 25,000 1990 78.156 19,539 44,539 sells or issues a Medicare supplemental policy without disclosure statement. 1395ss(d)(3)(B)(iv)................ ...................... Penalty for someone other 15,000 1990 78.156 11,723 26,723 than issuer that sells or issues a Medicare supplemental policy without acknowledgement form. Penalty for issuer that 25,000 1990 78.156 19,539 44,539 sells or issues a Medicare supplemental policy without an acknowledgement form. 1395ss(p)(8)................... 42 CFR 402.1(c)(25), Penalty for any person 15,000 1990 78.156 11,723 26,723 402.105(e). that sells or issues Medicare supplemental polices after a given date that fail to conform to the NAIC or Federal standards established by statute. 42 CFR 402.1(c)(25), Penalty for any person 25,000 1990 78.156 19,539 44,539 405.105(f)(2). that sells or issues Medicare supplemental polices after a given date that fail to conform to the NAIC or Federal standards established by statute. 1395ss(p)(9)(C)................ 42 CFR 402.1(c)(26), Penalty for any person 15,000 1990 78.156 11,723 26,723 402.105(e). that sells a Medicare supplemental policy and fails to make available for sale the core group of basic benefits when selling other Medicare supplemental policies with additional benefits or fails to provide the individual, before selling the policy, an outline of coverage describing benefits. [[Page 61555]] 42 CFR 402.1(c)(26), Penalty for any person 25,000 1990 78.156 19,539 44,539 405.105(f)(3), (4). that sells a Medicare supplemental policy and fails to make available for sale the core group of basic benefits when selling other Medicare supplemental policies with additional benefits or fails to provide the individual, before selling the policy, an outline of coverage describing benefits. 1395ss(q)(5)(C)................ 42 CFR 402.1(c)(27), Penalty for any person 25,000 1990 78.156 19,539 44,539 405.105(f)(5). that fails to suspend the policy of a policyholder made eligible for medical assistance or automatically reinstates the policy of a policyholder who has lost eligibility for medical assistance, under certain circumstances. 1395ss(r)(6)(A)................ 42 CFR 402.1(c)(28), Penalty for any person 25,000 1990 78.156 19,539 44,539 405.105(f)(6). that fails to provide refunds or credits as required by section 1882(r)(1)(B). 1395ss(s)(4)................... 42 CFR 402.1(c)(29), Penalty for any issuer of 5,000 1990 78.156 3,908 8,908 405.105(c). a Medicare supplemental policy that does not waive listed time periods if they were already satisfied under a proceeding Medicare supplemental policy, or denies a policy, or conditions the issuances or effectiveness of the policy, or discriminates in the pricing of the policy base on health status or other specified criteria. 1395ss(t)(2)................... 42 CFR 402.1(c)(30), Penalty for any issuer of 25,000 1990 78.156 19,539 44,539 405.105(f)(7). a Medicare supplemental policy that fails to fulfill listed responsibilities. 1395ss(v)(4)(A).................... ...................... Penalty someone other than 15,000 2003 28.561 4,284 19,284 issuer who sells, issues, or renews a medigap Rx policy to an individual who is a Part D enrollee. Penalty for an issuer who 25,000 2003 28.561 7,140 32,140 sells, issues, or renews a Medigap Rx policy who is a Part D enrollee. 1395bbb(c)(1).................. 42 CFR 488.725(c)..... Penalty for any individual 2,000 1987 106.278 2,126 4,126 who notifies or causes to be notified a home health agency of the time or date on which a survey of such agency is to be conducted. 1395bbb(f)(2)(A)(i)............ 42 CFR Maximum daily penalty 10,000 1988 97.869 9,787 19,787 488.845(b)(2)(iii). amount for each day a home health agency is not in compliance with statutory requirements. 42 CFR 488.845(b)(3).. Penalty per day for home health agency's noncompliance (Upper Range): Minimum................ 8,500 1988 97.869 8,319 16,819 Maximum................ 10,000 1988 97.869 9,787 19,787 42 CFR Penalty for a home health 10,000 1988 97.869 9,787 19,787 488.845(b)(3)(i). agency's deficiency or deficiencies that cause immediate jeopardy and result in actual harm. 42 CFR Penalty for a home health 9,000 1988 97.869 8,808 17,808 488.845(b)(3)(ii). agency's deficiency or deficiencies that cause immediate jeopardy and result in potential for harm. 42 CFR Penalty for an isolated 8,500 1988 97.869 8,319 16,819 488.845(b)(3)(iii). incident of noncompliance in violation of established HHA policy. 42 CFR 488.845(b)(4).. Penalty for a repeat and/ or condition-level deficiency that does not constitute immediate jeopardy, but is directly related to poor quality patient care outcomes (Lower Range): Minimum................ 1,500 1988 97.869 1,468 2,968 Maximum................ 8,500 1988 97.869 8,319 16,819 [[Page 61556]] 42 CFR 488.845(b)(5).. Penalty for a repeat and/ or condition-level deficiency that does not constitute immediate jeopardy and that is related predominately to structure or process- oriented conditions (Lower Range): Minimum................ 500 1988 97.869 489 989 Maximum................ 4,000 1988 97.869 3,915 7,915 ...................... 42 CFR 488.845(b)(6)............... ...................... Penalty imposed for instance of noncompliance that may be assessed for one or more singular events of condition-level noncompliance that are identified and where the noncompliance was corrected during the onsite survey: Minimum................ 1,000 1988 97.869 979 1,979 Maximum................ 10,000 1988 97.869 9,787 19,787 Penalty for each day of 10,000 1988 97.869 9,787 19,787 noncompliance (Maximum). 42 CFR Penalty for each day of 10,000 1988 97.869 9,787 19,787 488.845(d)(1)(ii). noncompliance (Maximum). 1396b(m)(5)(B)................. 42 CFR 460.46......... Penalty for PACE organization's practice that would reasonably be expected to have the effect of denying or discouraging enrollment: Minimum................ 15,000 1997 47.177 7,077 22,077 Maximum................ 100,000 1997 47.177 47,177 147,177 Penalty for a PACE 25,000 1997 47.177 11,794 36,794 organization that charges excessive premiums. Penalty for a PACE 100,000 1997 47.177 47,177 147,177 organization misrepresenting or falsifying information to CMS, the State, or an individual or other entity. Penalty for each 25,000 1997 47.177 11,794 36,794 determination the CMS makes that the PACE organization has failed to provide medically necessary items and services of the failure has adversely affected (or has the substantial likelihood of adversely affecting) a PACE participant. Penalty for involuntarily 25,000 1997 47.177 11,794 36,794 disenrolling a participant. Penalty for discriminating 25,000 1997 47.177 11,794 36,794 or discouraging enrollment or disenrollment of participants on the basis of an individual's health status or need for health care services. 1396r(h)(3)(C)(ii)(I).......... 42 CFR Penalty per day for a 488.408(d)(1)(iii). nursing facility's failure to meet a Category 2 Certification: Minimum................ 50 1987 106.278 53 103 Maximum................ 3,000 1987 106.278 3,188 6,188 42 CFR Penalty per instance for a 488.408(d)(1)(iv). nursing facility's failure to meet Category 2 certification: Minimum................ 1,000 1987 106.278 1,063 2,063 Maximum................ 10,000 1987 106.278 10,628 20,628 42 CFR Penalty per day for a 488.408(e)(1)(iii). nursing facility's failure to meet Category 3 certification: Minimum................ 3,050 1987 106.278 3,241 6,291 Maximum................ 10,000 1987 106.278 10,628 20,628 42 CFR Penalty per instance for a 488.408(e)(1)(iv). nursing facility's failure to meet Category 3 certification: Minimum................ 1,000 1987 106.278 1,063 2,063 Maximum................ 10,000 1987 106.278 10,628 20,628 42 CFR Penalty per instance for a 488.408(e)(2)(ii). nursing facility's failure to meet Category 3 certification, which results in immediate jeopardy: Minimum................ 1,000 1987 106.278 1,063 2,063 Maximum................ 10,000 1987 106.278 10,628 20,628 [[Page 61557]] 42 CFR Penalty per day for 488.438(a)(1)(i). nursing facility's failure to meet certification (Upper Range): Minimum................ 3,050 1987 106.278 3,241 6,291 Maximum................ 10,000 1987 106.278 10,628 20,628 42 CFR Penalty per day for 488.438(a)(1)(ii). nursing facility's failure to meet certification (Lower Range): Minimum................ 50 1987 106.278 53 103 Maximum................ 3,000 1987 106.278 3,188 6,188 42 CFR 488.438(a)(2).. Penalty per instance for nursing facility's failure to meet certification: Minimum................ 1,000 1987 106.278 1,063 2,063 Maximum................ 10,000 1987 106.278 10,628 20,628 1396r(f)(2)(B)(iii)(I)(c)...... 42 CFR Grounds to prohibit 5,000 1987 106.278 5,314 10,314 483.151(b)(2)(iv) and approval of Nurse Aide (b)(3)(iii). Training Program--if assessed a penalty in 1819(h)(2)(B)(i) or 1919(h)(2)(A)(ii) of ``not less than $5,000'' [Not CMP authority, but a specific CMP amount (CMP at this level) that is the triggering condition for disapproval]. 1396r(h)(3)(C)(ii)(I).......... 42 CFR 483.151(c)(2).. Grounds to waive 5,000 1987 106.278 5,314 10,314 disapproval of nurse aide training program-- reference to disapproval based on imposition of CMP ``not less than $5,000'' [Not CMP authority but CMP imposition at this level determines eligibility to seek waiver of disapproval of nurse aide training program]. 1396t(j)(2)(C)................. ...................... Penalty for each day of noncompliance for a home or community care provider that no longer meets the minimum requirements for home and community care: Minimum................ 1 1990 78.156 1 2 Maximum................ 10,000 1990 78.156 7,816 17,816 1396u-2(e)(2)(A)(i)............ 42 CFR 438.704........ Penalty for a Medicaid 25,000 1997 47.177 11,794 36,794 managed care organization that fails substantially to provide medically necessary items and services. Penalty for Medicaid 25,000 1997 47.177 11,794 36,794 managed care organization that imposes premiums or charges on enrollees in excess of the premiums or charges permitted. Penalty for a Medicaid 25,000 1997 47.177 11,794 36,794 managed care organization that misrepresents or falsifies information to another individual or entity. Penalty for a Medicaid 25,000 1997 47.177 11,794 36,794 managed care organization that fails to comply with the applicable statutory requirements for such organizations. 1396u-2(e)(2)(A)(ii)........... 42 CFR 438.704........ Penalty for a Medicaid 100,000 1997 47.177 47,177 147,177 managed care organization that misrepresents or falsifies information to the HHS Secretary. Penalty for Medicaid 100,000 1997 47.177 47,177 147,177 managed care organization that acts to discriminate among enrollees on the basis of their health status. 1396u-2(e)(2)(A)(iv)........... 42 CFR 438.704........ Penalty for each 15,000 1997 47.177 7,077 22,077 individual that does not enroll as a result of a Medicaid managed care organization that acts to discriminate among enrollees on the basis of their health status. 1396u(h)(2).................... 42 CFR 441, Subpart I. Penalty for a provider not 10,000 1990 106.278 10,628 20,628 meeting one of the requirements relating to the protection of the health, safety, and welfare of individuals receiving community supported living arrangements services. [[Page 61558]] 1396w-2(c)(1).................. ...................... Penalty for disclosing 10,000 2009 10.02 1,002 11,002 information related to eligibility determinations for medical assistance programs. 1903(m)(5)(B).................. 42 CFR 460.46......... Penalty for PACE organization's practice that would reasonably be expected to have the effect of denying or discouraging enrollment: Minimum................ 15,000 1997 47.177 7,077 22,077 Maximum................ 100,000 1997 47.177 47,177 147,177 Penalty for a PACE 25,000 1997 47.177 11,794 36,794 organization that charges excessive premiums. Penalty for a PACE 100,000 1997 47.177 47,177 147,177 organization misrepresenting or falsifying information to CMS, the State, or an individual or other entity. Penalty for each 25,000 1997 47.177 11,794 36,794 determination the CMS makes that the PACE organization has failed to provide medically necessary items and services of the failure has adversely affected (or has the substantial likelihood of adversely affecting) a PACE participant. Penalty for involuntarily 25,000 1997 47.177 11,794 36,794 disenrolling a participant. Penalty for discriminating 25,000 1997 47.177 11,794 36,794 or discouraging enrollment or disenrollment of participants on the basis of an individual's health status or need for health care services. 18041(c)(2).................... 45 CFR 150.315 and 45 Failure to comply with 100 1996 50.245 50 150 CFR 156.805(c). 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)). 18081(h)(1)(A)(i)(II).......... 42 CFR 155.285........ Penalty for providing 25,000 2010 8.745 2,186 27,186 false information on Exchange application. 18081(h)(1)(B)................. 42 CFR 155.285........ Penalty for knowingly or 250,000 2010 8.745 21,862 271,862 willfully providing false information on Exchange application. 18081(h)(2).................... 42 CFR 155.260........ Penalty for knowingly or 25,000 2010 8.745 2,186 27,186 willfully disclosing protected information from Exchange. 31 U.S.C. (HHS): 1352........................... 45 CFR 93.400(e)...... Penalty for the first time 10,000 1989 89.361 8,936 18,936 an individual makes an expenditure prohibited by regulations regarding lobbying disclosure, absent aggravating circumstances. Penalty for second and subsequent offenses by individuals who make an expenditure prohibited by regulations regarding lobbying disclosure: Minimum................ 10,000 1989 89.361 8,936 18,936 Maximum................ 100,000 1989 89.361 89,361 189,361 Penalty for the first time 10,000 1989 89.361 8,936 18,936 an individual fails to file or amend a lobbying disclosure form, absent aggravating circumstances. Penalty for second and subsequent offenses by individuals who fail to file or amend a lobbying disclosure form, absent aggravating circumstances: Minimum................ 10,000 1989 89.361 8,936 18,936 Maximum................ 100,000 1989 89.361 89,361 189,361 45 CFR 93, Appendix A. Penalty for failure to provide certification regarding lobbying in the award documents for all sub-awards of all tiers: Minimum................ 10,000 1989 89.361 8,936 18,936 Maximum................ 100,000 1989 89.361 89,361 189,361 [[Page 61559]] Penalty for failure to provide statement regarding lobbying for loan guarantee and loan insurance transactions: Minimum................ 10,000 1989 89.361 8,936 18,936 Maximum................ 100,000 1989 89.361 89,361 189,361 3801-3812...................... 45 CFR 79.3(a)(1(iv).. Penalty against any 5,000 1988 97.869 4,894 9,894 individual who--with knowledge or reason to know--makes, presents or submits a false, fictitious or fraudulent claim to the Department. 45 CFR 79.3(b)(1)(ii). Penalty against any 5,000 1988 97.869 4,894 9,894 individual who--with knowledge or reason to know--makes, presents or submits a false, fictitious or fraudulent claim to the Department. -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ Some HHS components have not promulgated regulations regarding their civil monetary 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 [[Page 61560]] determined that this IFR does not result in expenditures by State, local, and tribal governments, or by the private sector, of $100 million or more in any one year. Accordingly, HHS has not prepared a budgetary impact statement or specifically addressed the regulatory alternatives considered. VIII. Executive Order 13132 Determination HHS has determined that this IFR does not have any Federalism implications, as required by Executive Order 13132. List of Subjects 42 CFR Part 3 Administrative practice and procedure, Conflicts of interests, Health records, Privacy, Reporting and recordkeeping requirements. 42 CFR Part 402 Administrative practice and procedure, Medicaid, Medicare, Penalties. 42 CFR Part 403 Grant programs--health, Health insurance, Hospitals, Intergovernmental relations, Medicare, Reporting and recordkeeping requirements. 42 CFR Part 411 Kidney diseases, Medicare, Physician referral, Reporting and recordkeeping requirements. 42 CFR Part 412 Administrative practice and procedure, Health facilities, Medicare, Puerto Rico, Reporting and recordkeeping requirements. 42 CFR Part 422 Administrative practice and procedure, Health facilities, Health maintenance organizations (HMO), Medicare, Penalties, Privacy, Reporting and recordkeeping requirements. 42 CFR Part 423 Administrative practice and procedure, Emergency medical services, Health facilities, Health maintenance organizations (HMO), Health professionals, Medicare, Penalties, Privacy, Reporting and recordkeeping requirements. 42 CFR Part 438 Grant programs--health, Medicaid, Reporting and recordkeeping requirements. 42 CFR Part 460 Aged, Health care, Health records, Medicaid, Medicare, Reporting and recordkeeping requirements. 42 CFR Part 483 Grant programs--health, Health facilities, Health professions, Health records, Medicaid, Medicare, Nursing homes, Nutrition, Reporting and recordkeeping requirements, Safety. 42 CFR Part 488 Administrative practice and procedure, Health facilities, Medicare, Reporting and recordkeeping requirements. 42 CFR Part 493 Administrative practice and procedure, Grant programs--health, Health facilities, Laboratories, Medicaid, Medicare, Penalties, Reporting and recordkeeping requirements. 42 CFR Part 1003 Fraud, Grant programs--health, Health facilities, Health professions, Medicaid, Reporting and recordkeeping. 45 CFR Part 79 Administrative practice and procedure, Claims, Fraud, Penalties. 45 CFR Part 93 Government contracts, Grants programs, Loan programs, Lobbying, Penalties. 45 CFR Part 102 Administrative practice and procedure, Penalties. 45 CFR Part 147 Health care, Health insurance, Reporting and recordkeeping requirements. 45 CFR Part 155 Administrative practice and procedure, Advertising, Brokers, Conflict of interest, Consumer protection, Grant programs--health, Grants administration, Health care, Health insurance, Health maintenance organization (HMO), Health records, Hospitals, Indians, Individuals with disabilities, Loan programs--health, Organization and functions (Government agencies), Medicaid, Public assistance programs, Reporting and recordkeeping requirements, Safety, State and local governments, Technical assistance, Women, and Youth. 45 CFR Part 156 Administrative practice and procedure, Advertising, Advisory committees, Brokers, Conflict of interest, Consumer protection, Grant programs--health, Grants administration, Health care, Health insurance, Health maintenance organization (HMO), Health records, Hospitals, Indians, Individuals with disabilities, Loan programs--health, Organization and functions (Government agencies), Medicaid, Public assistance programs, Reporting and recordkeeping requirements, Safety, State and local governments, Sunshine Act, Technical assistance, Women, and Youth. 45 CFR Part 158 Administrative practice and procedure, Claims, Health care, Health insurance, Health plans, penalties, Reporting and recordkeeping requirements, Premium revenues, Medical loss ratio, Rebating. 45 CFR Part 160 Administrative practice and procedures, Penalties, Records and recordkeeping requirements. 45 CFR Part 303 Child support, Standards for program operations, Penalties. For the reasons set forth in the preamble, the Department of Health and Human Services amends 42 CFR chapter I and 45 CFR subtitle A, the Centers for Medicare & Medicaid Services amends 42 CFR chapter IV, the Office of the Inspector General amends 42 CFR chapter 42 CFR chapter V, and the Administration for Children and Families amends 45 CFR chapter III as follows: Title 42--Public Health Chapter I--Public Health Service, Department of Health and Human Services PART 3--PATIENT SAFETY ORGANIZATIONS AND PATIENT SAFETY WORK PRODUCT 0 1. The authority citation for part 3 continues to read as follows: Authority: 42 U.S.C. 216, 299b-21 through 299b-26; 42 U.S.C. 299c-6. 0 2. Section 3.404 is revised to read as follows: Sec. 3.404 Amount of a civil money penalty. (a) The amount of a civil money penalty will be determined in accordance with paragraph (b) of this section and Sec. 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 [[Page 61561]] updated, is published at 45 CFR part 102. CHAPTER IV--CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES PART 402--CIVIL MONEY PENALTIES, ASSESSMENTS, AND EXCLUSIONS 0 3. The authority citation for part 402 continues to read as follows: Authority: Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh). Sec. 402.105 [Amended] 0 4. In the table below, Sec. 402.105 is amended in each paragraph indicated in the first column, by removing the phrase indicated in the second column and adding in its place the phrase in the third column: ------------------------------------------------------------------------ Paragraph Remove Add ------------------------------------------------------------------------ (a)........................... ``$2,000 for each ``$2,000 as adjusted service''. annually under 45 CFR part 102 for each service''. (b) introductory text......... ``not more than ``not more than $1,000 for''. $1,000 as adjusted annually under 45 CFR part 102 for''. (c) introductory text......... ``not more than ``not more than $5,000 for''. $5,000 as adjusted annually under 45 CFR part 102 for''. (d)(1)........................ ``not more than ``not more than $10,000 for''. $10,000 as adjusted annually under 45 CFR part 102 for''. (d)(2) introductory text...... ``not more than ``not more than $10,000 for''. $10,000 as adjusted annually under 45 CFR part 102 for''. (d)(3)........................ ``not more than ``not more than $10,000 for''. $10,000 as adjusted annually under 45 CFR part 102 for''. (d)(4)........................ ``not more than ``not more than $10,000 for''. $10,000 as adjusted annually under 45 CFR part 102 for''. (d)(5)........................ ``not more than ``not more than $10,000 for''. $10,000 as adjusted annually under 45 CFR part 102 for''. (d)(5)........................ ``will not exceed ``will not exceed $150,000''. $150,000 as annually adjusted under 45 CFR part 102''. (e)........................... ``not more than ``not more than $15,000 for''. $15,000 as adjusted annually under 45 CFR part 102 for''. (f) introductory text......... ``not more than ``not more than $25,000 for''. $25,000 as adjusted annually under 45 CFR part 102 for''. (g)........................... ``not more than ``not more than $100 $100 for''. as adjusted annually under 45 CFR part 102 for''. (h)........................... ``not more than ``not more than $100,000 for''. $10,000 as adjusted annually under 45 CFR part 102 for''. (h)........................... ``will not exceed ``will not exceed $1,000,000''. $1,000,000 as annually adjusted under 45 CFR part 102''. ------------------------------------------------------------------------ PART 403--SPECIAL PROGRAMS AND PROJECTS 0 5. The authority citation for part 403 continues to read as follows: Authority: 42 U.S.C. 1395b-3 and Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh). Sec. 403.912 [Amended] 0 6. In the table below, Sec. 403.912 is amended in each paragraph indicated in the first column, by removing the phrase indicated in the third column and adding in its place the phrase indicated in the fourth column: ------------------------------------------------------------------------ Paragraph Remove Add ------------------------------------------------------------------------ (a)(1)........................ ``not less than ``not less than $1,000, but not $10,000, but not more than more than $100,000, $10,000 for''. as adjusted annually under 45 CFR part 102 for''. (a)(2)........................ ``will not exceed ``will not exceed $150,000''. $150,000 as adjusted annually under 45 CFR part 102''. (b)(1)........................ ``not less than ``not less than $10,000, but not $10,000, but not more than more than $100,000, $100,000 for''. as adjusted annually under 45 CFR part 102 for''. (b)(2)........................ ``will not exceed ``will not exceed $1,000,000''. $1,000,000 as adjusted annually under 45 CFR part 102''. (c)(2)........................ ``with a maximum ``with a maximum combined annual combined annual total of total of $1,150,000 $1,150,000''. as adjusted annually under 45 CFR part 102''. ------------------------------------------------------------------------ PART 411--EXCLUSIONS FROM MEDICARE AND LIMITATIONS ON MEDICARE PAYMENT 0 7. The authority citation for part 411 continues to read as follows: Authority: Secs. 1102, 1860D-1 through 1860D-42, 1871, and 1877 of the Social Security Act (42 U.S.C. 1302, 1395w-101 through 1395w- 152, 1395hh, and 1395nn). Sec. Sec. 411.103 and 411.361 [Amended] 0 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 [[Page 61562]] the phrase indicated in the fourth column: ---------------------------------------------------------------------------------------------------------------- Section Paragraphs Remove Add ---------------------------------------------------------------------------------------------------------------- Sec. 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''. Sec. 411.361..................... (f)................... ``up to $10,000 for''. ``up to $10,000 as adjusted annually under 45 CFR part 102 for''. ---------------------------------------------------------------------------------------------------------------- PART 412--PROSPECTIVE PAYMENT SYSTEMS FOR INPATIENT HOSPITAL SERVICES 0 12. The authority citation for part 412 continues to read as follows: Authority: Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh), sec. 124 of Pub. L. 106-113 (113 Stat. 1501A-332), sec. 1206 of Pub. L. 113-67, and sec. 112 of Pub. L. 113-93. Sec. 412.612 [Amended] 0 13. Section 412.612 is amended as follows: 0 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 0 b. In paragraph (b)(1)(ii), by removing the phrase ``not more than $5,000 for'' and adding in its place the phrase ``not more than $5,000 as adjusted annually under 45 CFR part 102 for''. PART 422--MEDICARE ADVANTAGE PROGRAM 0 14. The authority citation for part 422 continues to read as follows: Authority: Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh). Sec. 422.760 [Amended] 0 15. In the table below, Sec. 422.760 is amended in each paragraph indicated in the first column, by removing the phrase indicated in the second column and add in its place the phrase indicated in the third column: ------------------------------------------------------------------------ Paragraph Remove Add ------------------------------------------------------------------------ (b)(1)........................ ``up to $25,000 ``up to $25,000 as for each''. adjusted annually under 45 CFR part 102 for each''. (b)(2)........................ ``up to $25,000 ``up to $25,000 as for each''. adjusted annually under 45 CFR part 102 for each''. (b)(3)........................ ``determination-- ``determination--up up to $10,000''. to $10,000 as adjusted annually under 45 CFR part 102''. (b)(4)........................ ``$250 per ``$250 as adjusted Medicare annually under 45 enrollee''. CFR part 102 per Medicare enrollee''. (b)(4)........................ ``or $100,000, ``or $100,000 as whichever is adjusted annually greater''. under 45 CFR part 102, whichever is greater''. (c)(1)........................ ``not more than ``not more than $25,000 for''. $25,000 as adjusted annually under 45 CFR part 102 for''. (c)(2)........................ ``not more than ``not more than $100,000 for''. $100,000 as adjusted annually under 45 CFR part 102 for''. (c)(4)........................ ``$15,000 for ``$15,000 as adjusted each annually under 45 individual''. CFR part 102 for each individual''. ------------------------------------------------------------------------ PART 423--VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT 0 16. The authority citation for part 423 continues to read as follows: Authority: Sections 1102, 1106, 1860D-1 through 1860D-42, and 1871 of the Social Security Act (42 U.S.C. 1302, 1306, 1395w-101 through 1395w-152, and 1395hh). Sec. 423.760 [Amended] 0 17. In the table below, Sec. 423.760 is amended in each paragraph indicated by the first column, by removing the phrase indicated in the second column and add in its place the phrase indicated in the third column: ------------------------------------------------------------------------ Paragraph Remove Add ------------------------------------------------------------------------ (b)(1)........................ ``enrollees--up ``enrollees--up to to $25,000 for $25,000 as adjusted each annually under 45 determination''. CFR part 102 for each determination''. (b)(2)........................ ``of up to ``of up to $25,000 as $25,000 for each adjusted annually Part D under 45 CFR part enrollee''. 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 ``$250 as adjusted Medicare annually under 45 enrollee''. CFR part 102 per Medicare enrollee''. (b)(4)........................ ``or $100,000, ``or $100,000 as whichever is adjusted annually greater''. under 45 CFR part 102, whichever is greater''. (c)(1)........................ ``of not more ``of not more than than $25,000 for $25,000 as adjusted each''. annually under 45 CFR part 102 for each''. [[Page 61563]] (c)(2)........................ ``not more than ``not more than $100,000 for $100,000 as adjusted each''. annually under 45 CFR part 102 for each''. (c)(4)........................ ``$15,000 for ``$15,000 as adjusted each annually under 45 individual''. CFR part 102 for each individual''. ------------------------------------------------------------------------ PART 483--REQUIREMENTS FOR STATES AND LONG TERM CARE FACILITIES 0 18. The authority citation for part 483 continues to read as follows: Authority: Secs. 1102, 1128I, 1819, 1871 and 1919 of the Social Security Act (42 U.S.C. 1302, 1320a-7, 1395i, 1395hh and 1396r). Sec. 483.20 [Amended] 0 19. Section 483.20 is amended as follows: 0 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 0 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''. Sec. 483.151 [Amended] 0 20. Section 483.151 is amended as follows: 0 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''; 0 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 0 c. In paragraph (c)(1), by removing the phrase ``not less than $5,000'' and adding in its place the phrase ``not less than $5,000 as adjusted annually under 45 CFR part 102''. PART 488--SURVEY, CERTIFICATION, AND ENFORCEMENT PROCEDURES 0 21. The authority citation for part 488 continues to read as follows: Authority: Secs. 1102, 1128l, 1864, 1865, 1871 and 1875 of the Social Security Act, unless otherwise noted (42 U.S.C. 1302, 1320a- 7j, 1395aa, 1395bb, 1395hh) and 1395ll. Sec. Sec. 488.307, 488.408, 488.438, 488.446, 488.725, and 488.845 [Amended] 0 22. In the table below, for each section and paragraph indicated in the first two columns, remove the phrase indicated in the third column and add in its place the phrase indicated in the fourth column: ---------------------------------------------------------------------------------------------------------------- Section Paragraph Remove Add ---------------------------------------------------------------------------------------------------------------- 488.307............................ (c)................... ``not to exceed ``not to exceed $2,000 as $2,000''. 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 ``$1,000-$10,000 as instance''. adjusted annually under 45 CFR part 102 per instance''. (e)(1)(iii)........... ``$3,050-$10,000 per ``$3,050-$10,000 as day''. adjusted annually under 45 CFR part 102 per day''. (e)(1)(iv)............ ``$1,000-$10,000 per ``$1,000-$10,000 as instance''. adjusted annually under 45 CFR part 102 per instance''. (e)(2)(ii)............ ``3,050-$10,000 per ``3,050-$10,000 as adjusted day or $1,000-$10,000 annually under 45 CFR part per instance''. 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- ``Upper range''. $10,000''. (a)(1)(i)............. ``$3,050-$10,000 per ``$3,050-$10,000 as day''. adjusted annually under 45 CFR part 102 per day''. (a)(1)(ii)............ ``Lower range--$50- ``Upper range''. $3,000''. (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 ``$1,000-$10,000 as instance''. adjusted annually under 45 CFR part 102 per instance''. 488.446............................ (a)(1)................ ``A minimum of $500 ``A minimum of $500 as for''. adjusted annually under 45 CFR part 102 for''. (a)(2)................ ``A minimum of $1,500 ``A minimum of $1,500 as for''. adjusted annually under 45 CFR part 102 for''. (a)(3)................ ``A minimum of $3,000 ``A minimum of $3,000 as for''. adjusted annually under 45 CFR part 102 for''. 488.725............................ (c)................... ``not to exceed ``not to exceed $2,000 as $2,000''. adjusted annually under 45 CFR part 102''. 488.845............................ (b)(2)(iii)........... ``shall exceed $10,000 ``will exceed $10,000 as for''. adjusted under 45 CFR part 102 for''. (b)(3) introductory ``upper range of ``upper range of $8,500 to text. $8,500 to $10,000 per $10,000 as adjusted day''. 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''. [[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- ``range of $1,500-$8,500 as $8,500 per day''. adjusted annually under 45 CFR part 102 per day''. (b)(5)................ ``range of $500-$4,000 ``range of $500-$4,000 as are imposed''. adjusted annually under 45 CFR part 102 are imposed''. (b)(6)................ ``range of $1,000 to ``range of $1,000 to $10,000 per instance, $10,000 as adjusted not to exceed $10,000 annually under 45 CFR part each day''. 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 ``maximum of $10,000 as per day''. adjusted annually under 45 CFR part 102 per day''. ---------------------------------------------------------------------------------------------------------------- PART 493--LABORATORY REQUIREMENTS 0 23. The authority citation for part 493 continues to read as follows: Authority: Sec. 353 of the Public Health Service Act, secs. 1102, 1861(e), the sentence following sections 1861(s)(11) through 1861(s)(16) of the Social Security Act (42 U.S.C. 263a, 1302, 1395x(e), the sentence following 1395x(s)(11) through 1395x(s)(16)), and the Pub. L. 112-202 amendments to 42 U.S.C. 263a. Sec. 493.1834 [Amended] 0 24. Section 493.1834 is amended as follows: 0 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 0 b. In paragraph (d)(2)(ii), by removing the phrase ``$50-$3,000 per day'' and adding in its place the phrase ``$50-$3,000 as adjusted annually under 45 CFR part 102 per day''. CHAPTER V--OFFICE OF INSPECTOR GENERAL--HEALTH CARE, DEPARTMENT OF HEALTH AND HUMAN SERVICES PART 1003--CIVIL MONEY PENALTIES, ASSESSMENTS AND EXCLUSIONS 0 25. The authority citation for part 1003 continues to read as follows: Authority: 42 U.S.C. 262a, 1302, 1320-7, 1320a-7a, 1320b-10, 1395u(j), 1395u(k), 1395cc(j), 1395w-141(i)(3), 1395dd(d)(1), 1395mm, 1395nn(g), 1395ss(d), 1396b(m), 11131(c), and 11137(b)(2). Sec. 1003.103 [Amended] 0 26. Section 1003.103 is amended: 0 a. In paragraph (c)-- 0 i. By removing the footnote in paragraph (c); and 0 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 0 b. In the table below, Sec. 1003.103 is further amended in each paragraph indicated by the first column by adding the footnote in the third column after the phrase in the second column: ------------------------------------------------------------------------ Paragraph Text Add footnote ------------------------------------------------------------------------ (a)(1)........................ ``$2,000''....... ``1. This penalty amount is updated annually, as adjusted in accordance with the Federal Civil Monetary Penalty Inflation Adjustment Act of 1990 (Pub. L. 101-140), as amended by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (section 701 of Pub. L. 114-74). Annually adjusted amounts are published at 45 CFR part 102.'' (a)(2)........................ ``$10,000''...... ``2. This penalty amount is adjusted annually for inflation, and is published at 45 CFR part 102.'' (b)........................... ``not more than ``3. This penalty $15,000''. amount is adjusted annually for inflation, and is published at 45 CFR part 102.'' ``not more than ``4. This penalty $100,000''. amount is adjusted annually for inflation, and is published at 45 CFR part 102.'' (c)........................... ``not more than ``5. This penalty $10,000''. amount is adjusted annually for inflation, and is published at 45 CFR part 102.'' (d)(1)........................ ``not more than ``6. This penalty $5,000''. amount is adjusted annually for inflation, and is published at 45 CFR part 102.'' ``not more than ``7. This penalty $25,000''. amount is adjusted annually for inflation, and is published at 45 CFR part 102.'' (e)(1)........................ ``not more than ``8. This penalty $50,000''. amount is adjusted annually for inflation, and is published at 45 CFR part 102.'' ``will not exceed ``9. This penalty $25,000;''. amount is adjusted annually for inflation, and is published at 45 CFR part 102.'' (e)(2)........................ ``not more than ``10. This penalty $50,000''. 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 ``13. This penalty $100,000''. amount is adjusted annually for inflation, and is published at 45 CFR part 102.'' (f)(5)........................ ``an additional ``14. This penalty $15,000''. amount is adjusted annually for inflation, and is published at 45 CFR part 102.'' (g)........................... ``not more than ``15. This penalty $25,000''. amount is adjusted annually for inflation, and is published at 45 CFR part 102.'' [[Page 61565]] (h)(1)........................ ``not more than ``16. This penalty $50,000''. 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 ``18. This penalty $10,000''. amount is adjusted annually for inflation, and is published at 45 CFR part 102.'' (k)........................... ``not more than ``19. This penalty $2,000''. amount is adjusted annually for inflation, and is published at 45 CFR part 102.'' (l)........................... ``not more than ``20. This penalty $250,000''. amount is adjusted annually for inflation, and is published at 45 CFR part 102.'' (l)........................... ``and not more ``21. This penalty than $500,000''. amount is adjusted annually for inflation, and is published at 45 CFR part 102.'' (m)........................... ``not more than ``22. This penalty $10,000''. amount is adjusted annually for inflation, and is published at 45 CFR part 102.'' ------------------------------------------------------------------------ Title 45--Public Welfare Subtitle A--Department of Health and Human Services PART 79--PROGRAM FRAUD CIVIL PENALTIES 0 27. The authority for part 79 continues to read as follows: Authority: 31 U.S.C. 3801-3812. 0 28. In Sec. 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: Sec. 79.3 Basis for civil penalties and assessments. (a) * * * (1) * * * (iv) * * * \1\ The amounts specified in this section are updated annually, as adjusted in accordance with the Federal Civil Monetary Penalty Inflation Adjustment Act of 1990 (Pub. L. 101-140), as amended by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (section 701 of Pub. L. 114-74). Annually adjusted amounts are published at 45 CFR part 102. * * * * * (b) * * * (1) * * * (ii) * * * \2\ The amounts specified in this section are updated annually, as adjusted in accordance with the Federal Civil Monetary Penalty Inflation Adjustment Act of 1990 (Pub. L. 101-140), as amended by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (section 701 of Pub. L. 114-74). Annually adjusted amounts are published at 45 CFR part 102. * * * * * PART 93--NEW RESTRICTIONS ON LOBBYING 0 29. The authority for part 93 continues to read as follows: Authority: Section 319, Public Law 101-121 (31 U.S.C. 1352); (5 U.S.C. 301). 0 30. Section Sec. 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: Sec. 93.400 Penalties. (a) * * * \1\ The amounts specified in this section are updated annually, as adjusted in accordance with the Federal Civil Monetary Penalty Inflation Adjustment Act of 1990 (Pub. L. 101-140), as amended by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (section 701 of Pub. L. 114-74). Annually adjusted amounts are published at 45 CFR part 102. * * * * * 0 31. Appendix A to part 93 is amended in the undesignated paragraph following paragraph (3), under ``Certification for Contracts, Grants, Loans, and Cooperative Agreements,'' by adding a footnote at the end of the phrase ``of not less than $10,000 and not more than 100,000'' to read as follows: Appendix A--Certification Regarding Lobbying Certification for Contracts, Grants, Loans, and Cooperative Agreements * * * * * (3) * * * \1\ The amounts specified in Appendix A to Part 93 are updated annually, as adjusted in accordance with the Federal Civil Monetary Penalty Inflation Adjustment Act of 1990 (Pub. L. 101-140), as amended by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (section 701 of Pub. L. 114-74). Annually adjusted amounts are published at 45 CFR part 102. * * * * * 0 32. Part 102 is added to subchapter A to read as follows: PART 102--ADJUSTMENT OF CIVIL MONETARY PENALTIES FOR INFLATION Sec. 102.1 Applicability. 102.2 Applicability date. 102.3 Penalty adjustment and table. Authority: Public Law 101-410, Sec. 701 of Public Law 114-74, 31 U.S.C. 3801-3812. Sec. 102.1 Applicability. This part applies to each statutory provision under the laws administered by the Department of Health and Human Services concerning the civil monetary penalties which may be assessed or enforced by an agency pursuant to Federal law or is assessed or enforced pursuant to civil judicial actions in the Federal courts or administrative proceedings. The regulations cited in this part supersede existing HHS regulations setting forth civil monetary penalty amounts. If applicable, the HHS agencies responsible for specific civil monetary penalties will amend their regulations to reflect the adjusted amounts and/or a cross-reference to 45 CFR part 102 in separate actions as soon as practicable. Sec. 102.2 Applicability date. The increased penalty amounts set forth in the right-most column of the table in Section 102.3, ``Maximum Adjusted Penalty ($)'', apply to all civil monetary penalties which are assessed after August 1, 2016, including those penalties whose associated violations occurred after November 2, 2015. Sec. 102.3 Penalty adjustment and table. The adjusted statutory penalty provisions and their applicable amounts are set out in the following table. The right-most column in the table, ``Maximum Adjusted Penalty ($)'', provides the maximum adjusted civil penalty amounts. The civil monetary penalty amounts are adjusted annually. [[Page 61566]] Civil Monetary Penalty Authorities Administered by HHS Agencies and Penalty Amounts [Effective September 6, 2016] -------------------------------------------------------------------------------------------------------------------------------------------------------- Citation Date of -------------------------------------------------------------- last Pre- Maximum penalty inflation adjusted HHS agency Description \2\ figure or penalty penalty U.S.C. CFR \1\ adjustment ($) ($) \3\ -------------------------------------------------------------------------------------------------------------------------------------------------------- 21 U.S.C.: 333(b)(2)(A).................... ....................... FDA Penalty for violations related 1988 50,000 98,935 to drug samples resulting in a conviction of any representative of manufacturer or distributor in any 10-year period. 333(b)(2)(B).................... ....................... FDA Penalty for violation related to 1988 1,000,000 1,978,690 drug samples resulting in a conviction of any representative of manufacturer or distributor after the second conviction in any 10-yr period. 333(b)(3)....................... ....................... FDA Penalty for failure to make a 1988 100,000 197,869 report required by 21 U.S.C. 353(d)(3)(E) relating to drug samples. 333(f)(1)(A).................... ....................... FDA Penalty for any person who 1990 15,000 26,723 violates a requirement related to devices for each such violation. Penalty for aggregate of all 1990 1,000,000 1,781,560 violations related to devices in a single proceeding. 333(f)(2)(A).................... ....................... FDA Penalty for any individual who 1996 50,000 75,123 introduces or delivers for introduction into interstate commerce food that is adulterated per 21 U.S.C. 342(a)(2)(B) or any individual who does not comply with a recall order under 21 U.S.C. 350l. Penalty in the case of any other 1996 250,000 375,613 person other than an individual) for such introduction or delivery of adulterated food. Penalty for aggregate of all 1996 500,000 751,225 such violations related to adulterated food adjudicated in a single proceeding. 333(f)(3)(A).................... ....................... FDA Penalty for all violations 2007 10,000 11,383 adjudicated in a single proceeding for any person who fails to submit certification required by 42 U.S.C. 282(j)(5)(B) or knowingly submitting a false certification. 333(f)(3)(B).................... ....................... FDA Penalty for each day the above 2007 10,000 11,383 violation is not corrected after a 30-day period following notification until the violation is corrected. 333(f)(4)(A)(i)................. ....................... FDA Penalty for any responsible 2007 250,000 284,583 person that violates a requirement of 21 U.S.C. 355(o) (post-marketing studies, clinical trials, labeling), 21 U.S.C. 355(p) (risk evaluation and mitigation (REMS)), or 21 U.S.C. 355-1 (REMS). Penalty for aggregate of all 2007 1,000,000 1,138,330 such above violations in a single proceeding. 333(f)(4)(A)(ii)................ ....................... FDA Penalty for REMS violation that 2007 250,000 284,583 continues after written notice to the responsible person for the first 30-day period (or any portion thereof) the responsible person continues to be in violation. Penalty for REMS violation that 2007 1,000,000 1,138,330 continues after written notice to responsible person doubles for every 30-day period thereafter the violation continues, but may not exceed penalty amount for any 30-day period. Penalty for aggregate of all 2007 10,000,000 11,383,300 such above violations adjudicated in a single proceeding. 333(f)(9)(A).................... ....................... FDA Penalty for any person who 2009 15,000 16,503 violates a requirement which relates to tobacco products for each such violation. Penalty for aggregate of all 2009 1,000,000 1,100,200 such violations of tobacco product requirement adjudicated in a single proceeding. 333(f)(9)(B)(i)(I).............. ....................... FDA Penalty per violation related to 2009 250,000 275,050 violations of tobacco requirements. Penalty for aggregate of all 2009 1,000,000 1,100,200 such violations of tobacco product requirements adjudicated in a single proceeding. 333(f)(9)(B)(i)(II)............. ....................... FDA Penalty in the case of a 2009 250,000 275,050 violation of tobacco product requirements that continues after written notice to such person, for the first 30-day period (or any portion thereof) the person continues to be in violation. [[Page 61567]] Penalty for violation of tobacco 2009 1,000,000 1,100,200 product requirements that continues after written notice to such person shall double for every 30-day period thereafter the violation continues, but may not exceed penalty amount for any 30-day period. Penalty for aggregate of all 2009 10,000,000 11,002,000 such violations related to tobacco product requirements adjudicated in a single proceeding. 333(f)(9)(B)(ii)(I)............. ....................... FDA Penalty for any person who 2009 250,000 275,050 either does not conduct post- market surveillance and studies to determine impact of a modified risk tobacco product for which the HHS Secretary has provided them an order to sell, or who does not submit a protocol to the HHS Secretary after being notified of a requirement to conduct post- market surveillance of such tobacco products. Penalty for aggregate of for all 2009 1,000,000 1,100,200 such above violations adjudicated in a single proceeding. 333(f)(9)(B)(ii)(II)............ ....................... FDA Penalty for violation of 2009 250,000 275,050 modified risk tobacco product post-market surveillance that continues after written notice to such person for the first 30- day period (or any portion thereof) that the person continues to be in violation. Penalty for post-notice 2009 1,000,000 1,100,200 violation of modified risk tobacco product post-market surveillance shall double for every 30-day period thereafter that the tobacco product requirement violation continues for any 30-day period, but may not exceed penalty amount for any 30-day period. Penalty for aggregate above 2009 10,000,000 11,002,000 tobacco product requirement violations adjudicated in a single proceeding. 333(g)(1)....................... ....................... FDA Penalty for any person who 2007 250,000 284,583 disseminates or causes another party to disseminate a direct- to-consumer advertisement that is false or misleading for the first such violation in any 3- year period. Penalty for each subsequent 2007 500,000 569,165 above violation in any 3-year period. 333 note........................ ....................... FDA Penalty to be applied for 2009 250 275 violations of restrictions on the sale or distribution of tobacco products promulgated under 21 U.S.C. 387f(d) (e.g., violations of regulations in 21 CFR Part 1140) with respect to a retailer with an approved training program in the case of a second regulation violation within a 12-month period. Penalty in the case of a third 2009 500 550 tobacco product regulation violation within a 24-month period. Penalty in the case of a fourth 2009 2,000 2,200 tobacco product regulation violation within a 24-month period. Penalty in the case of a fifth 2009 5,000 5,501 tobacco product regulation violation within a 36-month period. Penalty in the case of a sixth 2009 10,000 11,002 or subsequent tobacco product regulation violation within a 48-month period as determined on a case-by-case basis. Penalty to be applied for 2009 250 275 violations of restrictions on the sale or distribution of tobacco products promulgated under 21 U.S.C. 387f(d) (e.g., violations of regulations in 21 CFR Part 1140) with respect to a retailer that does not have an approved training program in the case of the first regulation violation. Penalty in the case of a second 2009 500 550 tobacco product regulation violation within a 12-month period. [[Page 61568]] Penalty in the case of a third 2009 1,000 1,100 tobacco product regulation violation within a 24-month period. Penalty in the case of a fourth 2009 2,000 2,200 tobacco product regulation violation within a 24-month period. Penalty in the case of a fifth 2009 5,000 5,501 tobacco product regulation violation within a 36-month period. Penalty in the case of a sixth 2009 10,000 11,002 or subsequent tobacco product regulation violation within a 48-month period as determined on a case-by-case basis. 335b(a)......................... ....................... FDA Penalty for each violation for 1992 250,000 419,320 any individual who made a false statement or misrepresentation of a material fact, bribed, destroyed, altered, removed, or secreted, or procured the destruction, alteration, removal, or secretion of, any material document, failed to disclose a material fact, obstructed an investigation, employed a consultant who was debarred, debarred individual provided consultant services. Penalty in the case of any other 1992 1,000,000 1,677,280 person (other than an individual) per above violation. 360pp(b)(1)..................... ....................... FDA Penalty for any person who 1968 1,100 2,750 violates any such requirements for electronic products, with each unlawful act or omission constituting a separate violation. Penalty imposed for any related 1968 375,000 937,500 series of violations of requirements relating to electronic products. 42 U.S.C.: 262(d).......................... ....................... FDA Penalty per day for violation of 1986 100,000 215,628 order of recall of biological product presenting imminent or substantial hazard. 263b(h)(3)...................... ....................... FDA Penalty for failure to obtain a 1992 10,000 16,773 mammography certificate as required. 300aa-28(b)(1).................. ....................... FDA Penalty per occurrence for any 1986 100,000 215,628 vaccine manufacturer that intentionally destroys, alters, falsifies, or conceals any record or report required. 256b(d)(1)(B)(vi)............... ....................... HRSA Penalty for each instance of 2010 5,000 5,437 overcharging a 340B covered entity. 299c-(3)(d)..................... ....................... AHRQ Penalty for an establishment or 1999 10,000 14,140 person supplying information obtained in the course of activities for any purpose other than the purpose for which it was supplied. 653(l)(2)....................... 45 CFR 303.21(f)....... ACF Penalty for Misuse of 1998 1,000 1,450 Information in the National Directory of New Hires. 262a(i)(1)...................... 42 CFR Part 1003....... OIG Penalty for each individual who 2002 250,000 327,962 violates safety and security procedures related to handling dangerous biological agents and toxins. Penalty for any other person who 2002 500,000 655,925 violates safety and security procedures related to handling dangerous biological agents and toxins.. 1320a-7a(a)..................... 42 CFR Part 1003....... OIG Penalty for knowingly presenting 1996 10,000 15,024 or causing to be presented to an officer, employee, or agent of the United States a false claim. Penalty for knowingly presenting 1996 10,000 15,024 or causing to be presented a request for payment which violates the terms of an assignment, agreement, or PPS agreement. Penalty for knowingly giving or 1996 15,000 22,537 causing to be presented to a participating provider or supplier false or misleading information that could reasonably be expected to influence a discharge decision. Penalty for an excluded party 1996 10,000 15,024 retaining ownership or control interest in a participating entity. Penalty for remuneration offered 1996 10,000 15,024 to induce program beneficiaries to use particular providers, practitioners, or suppliers. [[Page 61569]] Penalty for employing or 1997 10,000 14,718 contracting with an excluded individual. Penalty for knowing and willful 1997 50,000 73,588 solicitation, receipt, offer, or payment of remuneration for referring an individual for a service or for purchasing, leasing, or ordering an item to be paid for by a Federal health care program. Penalty for ordering or 2010 10,000 10,874 prescribing medical or other item or service during a period in which the person was excluded. Penalty for knowingly making or 2010 50,000 54,372 causing to be made a false statement, omission or misrepresentation of a material fact in any application, bid, or contract to participate or enroll as a provider or supplier. Penalty for knowing of an 2010 10,000 10,874 overpayment and failing to report and return. Penalty for making or using a 2010 50,000 54,372 false record or statement that is material to a false or fraudulent claim. Penalty for failure to grant 2010 15,000 16,312 timely access to HHS OIG for audits, investigations, evaluations, and other statutory functions of HHS OIG. 1320a-7a(b)..................... 42 CFR Part 1003....... OIG Penalty for payments by a 1986 2,000 4,313 hospital or critical access hospital to induce a physician to reduce or limit services to individuals under direct care of physician or who are entitled to certain medical assistance benefits. Penalty for physicians who 1986 2,000 4,313 knowingly receive payments from a hospital or critical access hospital to induce such physician to reduce or limit services to individuals under direct care of physician or who are entitled to certain medical assistance benefits. Penalty for a physician who 1996 5,000 7,512 executes a document that falsely certifies home health needs for Medicare beneficiaries. 1320a-7e(b)(6)(A)............... 42 CFR Part 1003....... OIG Penalty for failure to report 1997 25,000 36,794 any final adverse action taken against a health care provider, supplier, or practitioner. 1320b-10(b)(1).................. 42 CFR Part 1003....... OIG Penalty for the misuse of words, 1988 5,000 9,893 symbols, or emblems in communications in a manner in which a person could falsely construe that such item is approved, endorsed, or authorized by HHS. 1320b-10(b)(2).................. 42 CFR Part 1003....... OIG Penalty for the misuse of words, 1988 25,000 49,467 symbols, or emblems in a broadcast or telecast in a manner in which a person could falsely construe that such item is approved, endorsed, or authorized by HHS. 1395i-3(b)(3)(B)(ii)(1)......... ....................... OIG Penalty for certification of a 1987 1,000 2,063 false statement in assessment of functional capacity of a Skilled Nursing Facility resident assessment. 1395i-3(b)(3)(B)(ii)(2)......... ....................... OIG Penalty for causing another to 1987 5,000 10,314 certify or make a false statement in assessment of functional capacity of a Skilled Nursing Facility resident assessment. 1395i-3(g)(2)(A)................ ....................... OIG Penalty for any individual who 1987 2,000 4,126 notifies or causes to be notified a Skilled Nursing Facility of the time or date on which a survey is to be conducted. 1395w-27(g)(2)(A)............... 42 CFR 422.752; 42 CFR OIG Penalty for a Medicare Advantage 1996 25,000 37,561 Part 1003. organization that substantially fails to provide medically necessary, required items and services. Penalty for a Medicare Advantage 1997 25,000 36,794 organization that charges excessive premiums. Penalty for a Medicare Advantage 1997 25,000 36,794 organization that improperly expels or refuses to reenroll a beneficiary. Penalty for a Medicare Advantage 1997 100,000 147,177 organization that engages in practice that would reasonably be expected to have the effect of denying or discouraging enrollment. [[Page 61570]] Penalty per individual who does 1997 15,000 22,077 not enroll as a result of a Medicare Advantage organization's practice that would reasonably be expected to have the effect of denying or discouraging enrollment. Penalty for a Medicare Advantage 1997 100,000 147,177 organization misrepresenting or falsifying information to Secretary. Penalty for a Medicare Advantage 1997 25,000 36,794 organization misrepresenting or falsifying information to individual or other entity. Penalty for Medicare Advantage 1997 25,000 36,794 organization interfering with provider's advice to enrollee and non-MCO affiliated providers that balance bill enrollees. Penalty for a Medicare Advantage 1997 25,000 36,794 organization that employs or contracts with excluded individual or entity. Penalty for a Medicare Advantage 2010 25,000 36,794 organization enrolling an individual in without prior written consent. Penalty for a Medicare Advantage 2010 25,000 36,794 organization transferring an enrollee to another plan without consent or solely for the purpose of earning a commission. Penalty for a Medicare Advantage 2010 25,000 36,794 organization failing to comply with marketing restrictions or applicable implementing regulations or guidance. Penalty for a Medicare Advantage 2010 25,000 36,794 organization employing or contracting with an individual or entity who violates 1395w- 27(g)(1)(A)-(J). 1395w-141(i)(3)................. 42 CFR Part 1003....... OIG Penalty for a prescription drug 2003 10,000 12,856 card sponsor that falsifies or misrepresents marketing materials, overcharges program enrollees, or misuse transitional assistance funds. 1395cc(g)....................... 42 CFR Part 1003....... OIG Penalty for improper billing by 1972 2,000 5,000 Hospitals, Critical Access Hospitals, or Skilled Nursing Facilities. 1395dd(d)(1).................... 42 CFR Part 1003....... OIG Penalty for a hospital or 1987 50,000 103,139 responsible physician dumping patients needing emergency medical care, if the hospital has 100 beds or more. Penalty for a hospital or 1987 25,000 51,570 responsible physician dumping patients needing emergency medical care, if the hospital has less than 100 beds. 1395mm(i)(6)(B)(i).............. 42 CFR Part 1003....... OIG Penalty for a HMO or competitive 1987 25,000 51,570 plan is such plan substantially fails to provide medically necessary, required items or services. Penalty for HMOs/competitive 1987 25,000 51,570 medical plans that charge premiums in excess of permitted amounts. Penalty for a HMO or competitive 1987 25,000 51,570 medical plan that expels or refuses to reenroll an individual per prescribed conditions. Penalty for a HMO or competitive 1987 100,000 206,278 medical plan that implements practices to discourage enrollment of individuals needing services in future. Penalty per individual not 1988 15,000 29,680 enrolled in a plan as a result of a HMO or competitive medical plan that implements practices to discourage enrollment of individuals needing services in the future. Penalty for a HMO or competitive 1987 100,000 206,278 medical plan that misrepresents or falsifies information to the Secretary. Penalty for a HMO or competitive 1987 25,000 51,570 medical plan that misrepresents or falsifies information to an individual or any other entity. Penalty for failure by HMO or 1987 25,000 51,570 competitive medical plan to assure prompt payment of Medicare risk sharing contracts or incentive plan provisions. [[Page 61571]] Penalty for HMO that employs or 1989 25,000 47,340 contracts with excluded individual or entity. 1395nn(g)(3).................... 42 CFR Part 1003....... OIG Penalty for submitting or 1994 15,000 23,863 causing to be submitted claims in violation of the Stark Law's restrictions on physician self- referrals. 1395nn(g)(4).................... 42 CFR Part 1003....... OIG Penalty for circumventing Stark 1994 100,000 159,089 Law's restrictions on physician self-referrals. 1395ss(d)(1).................... 42 CFR Part 1003....... OIG Penalty for a material 1988 5,000 9,893 misrepresentation regarding Medigap compliance policies. 1395ss(d)(2).................... 42 CFR Part 1003....... OIG Penalty for selling Medigap 1988 5,000 9,893 policy under false pretense. 1395ss(d)(3)(A)(ii)............. 42 CFR Part 1003....... OIG Penalty for an issuer that sells 1990 25,000 44,539 health insurance policy that duplicates benefits. Penalty for someone other than 1990 15,000 26,723 issuer that sells health insurance that duplicates benefits. 1395ss(d)(4)(A)................. 42 CFR Part 1003....... OIG Penalty for using mail to sell a 1988 5,000 9,893 non-approved Medigap insurance policy. 1396b(m)(5)(B)(i)............... 42 CFR Part 1003....... OIG Penalty for a Medicaid MCO that 1988 25,000 49,467 substantially fails to provide medically necessary, required items or services. Penalty for a Medicaid MCO that 1988 25,000 49,467 charges excessive premiums. Penalty for a Medicaid MCO that 1988 100,000 197,869 improperly expels or refuses to reenroll a beneficiary. Penalty per individual who does 1988 15,000 29,680 not enroll as a result of a Medicaid MCO's practice that would reasonably be expected to have the effect of denying or discouraging enrollment. Penalty for a Medicaid MCO 1988 100,000 197,869 misrepresenting or falsifying information to the Secretary. Penalty for a Medicaid MCO 1988 25,000 49,467 misrepresenting or falsifying information to an individual or another entity. Penalty for a Medicaid MCO that 1990 25,000 44,539 fails to comply with contract requirements with respect to physician incentive plans. 1396r(b)(3)(B)(ii)(I)........... 42 CFR Part 1003....... OIG Penalty for willfully and 1987 1,000 2,063 knowingly certifying a material and false statement in a Skilled Nursing Facility resident assessment. 1396r(b)(3)(B)(ii)(II).......... 42 CFR Part 1003....... OIG Penalty for willfully and 1987 5,000 10,314 knowingly causing another individual to certify a material and false statement in a Skilled Nursing Facility resident assessment. 1396r(g)(2)(A)(i)............... 42 CFR Part 1003....... OIG Penalty for notifying or causing 1987 2,000 4,126 to be notified a Skilled Nursing Facility of the time or date on which a survey is to be conducted. 1396r-8(b)(3)(B)................ 42 CFR Part 1003....... OIG Penalty for the knowing 1990 100,000 178,156 provision of false information or refusing to provide information about charges or prices of a covered outpatient drug. 1396r-8(b)(3)(C)(i)............. 42 CFR Part 1003....... Penalty per day for failure to 1990 10,000 17,816 timely provide information by drug manufacturer with rebate agreement. 1396r-8(b)(3)(C)(ii)............ 42 CFR Part 1003....... Penalty for knowing provision of 1990 100,000 178,156 false information by drug manufacturer with rebate agreement. 1396t(i)(3)(A).................. 42 CFR Part 1003....... OIG Penalty for notifying home and 1990 2,000 3,563 community-based providers or settings of survey. 11131(c)........................ 42 CFR Part 1003....... OIG Penalty for failing to report a 1986 10,000 21,563 medical malpractice claim to National Practitioner Data Bank. 11137(b)(2)..................... 42 CFR Part 1003....... OIG Penalty for breaching 1986 10,000 21,563 confidentiality of information reported to National Practitioner Data Bank. 299b-22(f)(1)................... 42 CFR 3.404........... OCR Penalty for violation of 2005 10,000 11,940 confidentiality provision of the Patient Safety and Quality Improvement Act. 1320(d)-5(a).................... 45 CFR OCR Penalty for each pre-February 1996 100 150 160.404(b)(1)(i),(ii). 18, 2009 violation of the HIPAA administrative simplification provisions. Calendar Year Cap............ 1996 25,000 37,561 [[Page 61572]] 1320(d)-5(a).................... 45 CFR OCR Penalty for each February 18, 160.404(b)(2)(i)(A), 2009 or later violation of a (B). HIPAA administrative simplification provision in which it is established that the covered entity or business associate did not know and by exercising reasonable diligence, would not have known that the covered entity or business associate violated such a provision: Minimum...................... 2009 100 110 Maximum...................... 2009 50,000 55,010 Calendar Year Cap............ 2009 1,500,000 1,650,300 45 CFR OCR Penalty for each February 18, 160.404(b)(2)(ii)(A), 2009 or later violation of a (B). HIPAA administrative simplification provision in which it is established that the violation was due to reasonable cause and not to willful neglect: Minimum...................... 2009 1,000 1,100 Maximum...................... 2009 50,000 55,010 Calendar Year Cap............ 2009 1,500,000 1,650,300 45 CFR OCR Penalty for each February 18, 160.404(b)(2)(iii)(A), 2009 or later violation of a (B). HIPAA administrative simplification provision in which it is established that the violation was due to willful neglect and was corrected during the 30-day period beginning on the first date the covered entity or business associate knew, or, by exercising reasonable diligence, would have known that the violation occurred: Minimum...................... 2009 10,000 11,002 Maximum...................... 2009 50,000 55,010 Calendar Year Cap............ 2009 1,500,000 1,650,300 45 CFR OCR Penalty for each February 18, 160.404(b)(2)(iv)(A), 2009 or later violation of a (B). HIPAA administrative simplification provision in which it is established that the violation was due to willful neglect and was not corrected during the 30-day period beginning on the first date the covered entity or business associate knew, or by exercising reasonable diligence, would have known that the violation occurred: Minimum...................... 2009 50,000 55,010 Maximum...................... 2009 1,500,000 1,650,300 Calendar Year Cap............ 2009 1,500,000 1,650,300 263a(h)(2)(B) & 1395w- 42 CFR CMS Penalty for a clinical 2(b)(2)(A)(ii). 493.1834(d)(2)(i). laboratory's failure to meet participation and certification requirements and poses immediate jeopardy: Minimum...................... 1988 3,050 6,035 Maximum...................... 1988 10,000 19,787 42 CFR CMS Penalty for a clinical 493.1834(d)(2)(ii). laboratory's failure to meet participation and certification requirements and the failure does not pose immediate jeopardy: Minimum...................... 1988 50 99 Maximum...................... 1988 3,000 5,936 300gg-15(f)..................... 45 CFR 147.200(e)...... CMS Failure to provide the Summary 2010 1,000 1,087 of Benefits and Coverage. 300gg-18........................ 45 CFR 158.606......... CMS Penalty for violations of 2010 100 109 regulations related to the medical loss ratio reporting and rebating. 1320a-7h(b)(1).................. 42 CFR 402.105(d)(5); CMS Penalty for manufacturer or 42 CFR 403.912(a) & group purchasing organization (c). failing to report information required under 42 U.S.C. 1320a- 7h(a), relating to physician ownership or investment interests: Minimum...................... 2010 1,000 1,087 Maximum...................... 2010 10,000 10,874 Calendar Year Cap............ 2010 150,000 163,117 1320a-7h(b)(2).................. 42 CFR 402.105(h); 42 CMS Penalty for manufacturer or CFR 403 912(b) & (c). group purchasing organization knowingly failing to report information required under 42 U.S.C. 1320a-7h(a), relating to physician ownership or investment interests: Minimum...................... 2010 10,000 10,874 Maximum...................... 2010 100,000 108,745 Calendar Year Cap............ 2010 1,000,000 1,087,450 [[Page 61573]] 1320a-7j(h)(3)(A)............... ....................... CMS Penalty for an administrator of 2010 100,000 108,745 a facility that fails to comply with notice requirements for the closure of a facility. 42 CFR CMS Minimum penalty for the first 2010 500 544 488.446(a)(1),(2), & offense of an administrator who (3). fails to provide notice of facility closure. Minimum penalty for the second 2010 1,500 1,631 offense of an administrator who fails to provide notice of facility closure. Minimum penalty for the third 2010 3,000 3,262 and subsequent offenses of an administrator who fails to provide notice of facility closure. 1320a-8(a)(1)................... ....................... CMS Penalty for an entity knowingly 1994 5,000 7,954 making a false statement or representation of material fact in the determination of the amount of benefits or payments related to old-age, survivors, and disability insurance benefits, special benefits for certain World War II veterans, or supplemental security income for the aged, blind, and disabled. Penalty for violation of 42 2015 7,500 7,500 U.S.C. 1320a-8(a)(1) if the violator is a person who receives a fee or other income for services performed in connection with determination of the benefit amount or the person is a physician or other health care provider who submits evidence in connection with such a determination. 1320a-8(a)(3)................... ....................... CMS Penalty for a representative 2004 5,000 6,229 payee (under 42 U.S.C. 405(j), 1007, or 1383(a)(2)) converting any part of a received payment from the benefit programs described in the previous civil monetary penalty to a use other than for the benefit of the beneficiary. 1320b-25(c)(1)(A)............... ....................... CMS Penalty for failure of covered 2010 200,000 217,490 individuals to report to the Secretary and 1 or more law enforcement officials any reasonable suspicion of a crime against a resident, or individual receiving care, from a long-term care facility. 1320b-25(c)(2)(A)............... ....................... CMS Penalty for failure of covered 2010 300,000 326,235 individuals to report to the Secretary and 1 or more law enforcement officials any reasonable suspicion of a crime against a resident, or individual receiving care, from a long-term care facility if such failure exacerbates the harm to the victim of the crime or results in the harm to another individual. 1320b-25(d)(2).................. ....................... CMS Penalty for a long-term care 2010 200,000 217,490 facility that retaliates against any employee because of lawful acts done by the employee, or files a complaint or report with the State professional disciplinary agency against an employee or nurse for lawful acts done by the employee or nurse. 1395b-7(b)(2)(B)................ 42 CFR 402.105(g)...... CMS Penalty for any person who 1997 100 147 knowingly and willfully fails to furnish a beneficiary with an itemized statement of items or services within 30 days of the beneficiary's request. 1395i-3(h)(2)(B)(ii)(I)......... 42 CFR CMS Penalty per day for a Skilled 488.408(d)(1)(iii). Nursing Facility that has a Category 2 violation of certification requirements: Minimum...................... 1987 50 103 Maximum...................... 1987 3,000 6,188 42 CFR CMS Penalty per instance of Category 488.408(d)(1)(iv). 2 noncompliance by a Skilled Nursing Facility: Minimum...................... 1987 1,000 2,063 Maximum...................... 1987 10,000 20,628 42 CFR CMS Penalty per day for a Skilled 488.408(e)(1)(iii). Nursing Facility that has a Category 3 violation of certification requirements: Minimum...................... 1987 3,050 6,291 Maximum...................... 1987 10,000 20,628 42 CFR CMS Penalty per instance of Category 488.408(e)(1)(iv). 3 noncompliance by a Skilled Nursing Facility: Minimum...................... 1987 1,000 2,063 Maximum...................... 1987 10,000 20,628 [[Page 61574]] 42 CFR CMS Penalty per day and per instance 488.408(e)(2)(ii). for a Skilled Nursing Facility that has Category 3 noncompliance with Immediate Jeopardy: Per Day (Minimum)............ 1987 3,050 6,291 Per Day (Maximum)............ 1987 10,000 20,628 Per Instance (Minimum)....... 1987 1,000 2,063 Per Instance (Maximum)....... 1987 10,000 20,628 42 CFR 488.438(a)(1)(i) CMS Penalty per day of a Skilled Nursing Facility that fails to meet certification requirements. These amounts represent the upper range per day: Minimum...................... 1987 3,050 6,291 Maximum...................... 1987 10,000 20,628 42 CFR CMS Penalty per day of a Skilled 488.438(a)(1)(ii). Nursing Facility that fails to meet certification requirements. These amounts represent the lower range per day: Minimum...................... 1987 50 103 Maximum...................... 1987 3,000 6,188 42 CFR 488.438(a)(2)... CMS Penalty per instance of a Skilled Nursing Facility that fails to meet certification requirements: Minimum...................... 1987 1,000 2,063 Maximum...................... 1987 10,000 20,628 1395l(h)(5)(D).................. 42 CFR 402.105(d)(2)(i) CMS Penalty for knowingly, 1996 10,000 15,024 willfully, and repeatedly billing for a clinical diagnostic laboratory test other than on an assignment- related basis. (Penalties are assessed in the same manner as 42 U.S.C. 1395u(j)(2)(B), which is assessed according to 1320a- 7a(a)). 1395l(i)(6)..................... ....................... CMS Penalty for knowingly and 1988 2,000 3,957 willfully presenting or causing to be presented a bill or request for payment for an intraocular lens inserted during or after cataract surgery for which the Medicare payment rate includes the cost of acquiring the class of lens involved. 1395l(q)(2)(B)(i)............... 42 CFR 402.105(a)...... CMS Penalty for knowingly and 1989 2,000 3,787 willfully failing to provide information about a referring physician when seeking payment on an unassigned basis. 1395m(a)(11)(A)................. 42 CFR 402.1(c)(4), CMS Penalty for any durable medical 1996 10,000 15,024 402.105(d)(2)(ii). equipment supplier that knowingly and willfully charges for a covered service that is furnished on a rental basis after the rental payments may no longer be made. (Penalties are assessed in the same manner as 42 U.S.C. 1395u(j)(2)(B), which is assessed according to 1320a-7a(a)). 1395m(a)(18)(B)................. 42 CFR 402.1(c)(5), CMS Penalty for any nonparticipating 1996 10,000 15,024 402.105(d)(2)(iii). durable medical equipment supplier that knowingly and willfully fails to make a refund to Medicare beneficiaries for a covered service for which payment is precluded due to an unsolicited telephone contact from the supplier. (Penalties are assessed in the same manner as 42 U.S.C. 1395u(j)(2)(B), which is assessed according to 1320a- 7a(a)). 1395m(b)(5)(C).................. 42 CFR 402.1(c)(6), CMS Penalty for any nonparticipating 1996 10,000 15,024 402.105(d)(2)(iv). physician or supplier that knowingly and willfully charges a Medicare beneficiary more than the limiting charge for radiologist services. (Penalties are assessed in the same manner as 42 U.S.C. 1395u(j)(2)(B), which is assessed according to 1320a- 7a(a)). 1395m(h)(3)..................... 42 CFR 402.1(c)(8), CMS Penalty for any supplier of 1996 10,000 15,024 402.105(d)(2)(vi). prosthetic devices, orthotics, and prosthetics that knowing and willfully charges for a covered prosthetic device, orthotic, or prosthetic that is furnished on a rental basis after the rental payment may no longer be made. (Penalties are assessed in the same manner as 42 U.S.C. 1395m(a)(11)(A), that is in the same manner as 1395u(j)(2)(B), which is assessed according to 1320a- 7a(a)). [[Page 61575]] 1395m(j)(2)(A)(iii)............. ....................... CMS Penalty for any supplier of 1994 1,000 1,591 durable medical equipment including a supplier of prosthetic devices, prosthetics, orthotics, or supplies that knowingly and willfully distributes a certificate of medical necessity in violation of Section 1834(j)(2)(A)(i) of the Act or fails to provide the information required under Section 1834(j)(2)(A)(ii) of the Act. 1395m(j)(4)..................... 42 CFR 402.1(c)(10), CMS Penalty for any supplier of 1996 10,000 15,024 402.105(d)(2)(vii). durable medical equipment, including a supplier of prosthetic devices, prosthetics, orthotics, or supplies that knowingly and willfully fails to make refunds in a timely manner to Medicare beneficiaries for series billed other than on as assignment- related basis under certain conditions. (Penalties are assessed in the same manner as 42 U.S.C. 1395m(j)(4) and 1395u(j)(2)(B), which is assessed according to 1320a- 7a(a)). 1395m(k)(6)..................... 42 CFR 402.1(c)(31), CMS Penalty for any person or entity 1996 10,000 15,024 402.105(d)(3). who knowingly and willfully bills or collects for any outpatient therapy services or comprehensive outpatient rehabilitation services on other than an assignment- related basis. (Penalties are assessed in the same manner as 42 U.S.C. 1395m(k)(6) and 1395u(j)(2)(B), which is assessed according to 1320a- 7a(a)). 1395m(l)(6)..................... 42 CFR 402.1(c)(32), CMS Penalty for any supplier of 1996 10,000 15,024 402.105(d)(4). ambulance services who knowingly and willfully fills or collects for any services on other than an assignment- related basis. (Penalties are assessed in the same manner as 42 U.S.C. 1395u(b)(18)(B), which is assessed according to 1320a-7a(a)). 1395u(b)(18)(B)................. 42 CFR 402.1(c)(11), CMS Penalty for any practitioner 1996 10,000 15,024 402.105(d)(2)(viii). specified in Section 1842(b)(18)(C) of the Act or other person that knowingly and willfully bills or collects for any services by the practitioners on other than an assignment-related basis. (Penalties are assessed in the same manner as 42 U.S.C. 1395u(j)(2)(B), which is assessed according to 1320a- 7a(a)). 1395u(j)(2)(B).................. 42 CFR 402.1(c)........ CMS Penalty for any physician who 1996 10,000 15,024 charges more than 125% for a non-participating referral. (Penalties are assessed in the same manner as 42 U.S.C. 1320a- 7a(a)). 1395u(k)........................ 42 CFR 402.1(c)(12), CMS Penalty for any physician who 1996 10,000 15,024 402.105(d)(2)(ix). knowingly and willfully presents or causes to be presented a claim for bill for an assistant at a cataract surgery performed on or after March 1, 1987, for which payment may not be made because of section 1862(a)(15). (Penalties are assessed in the same manner as 42 U.S.C. 1395u(j)(2)(B), which is assessed according to 1320a- 7a(a)). 1395u(l)(3)..................... 42 CFR 402.1(c)(13), CMS Penalty for any nonparticipating 1996 10,000 15,024 402.105(d)(2)(x). 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)). [[Page 61576]] 1395u(m)(3)..................... 42 CFR 402.1(c)(14), CMS Penalty for any nonparticipating 1996 10,000 15,024 402.105(d)(2)(xi). physician charging more than $500 who does not accept payment for an elective surgical procedure on an assignment related basis and who knowingly and willfully fails to disclose the required information regarding charges and coinsurance amounts and fails to refund on a timely basis any amount collected for the procedure in excess of the charges recognized and approved by the Medicare program. (Penalties are assessed in the same manner as 42 U.S.C. 1395u(j)(2)(B), which is assessed according to 1320a- 7a(a)). 1395u(n)(3)..................... 42 CFR 402.1(c)(15), CMS Penalty for any physician who 1996 10,000 15,024 402.105(d)(2)(xii). knowingly, willfully, and repeatedly bills one or more beneficiaries for purchased diagnostic tests any amount other than the payment amount specified by the Act. (Penalties are assessed in the same manner as 42 U.S.C. 1395u(j)(2)(B), which is assessed according to 1320a- 7a(a)). 1395u(o)(3)(B).................. 42 CFR 414.707(b)...... CMS Penalty for any practitioner 1996 10,000 15,024 specified in Section 1842(b)(18)(C) of the Act or other person that knowingly and willfully bills or collects for any services pertaining to drugs or biologics by the practitioners on other than an assignment-related basis. (Penalties are assessed in the same manner as 42 U.S.C. 1395u(b)(18)(B) and 1395u(j)(2)(B), which is assessed according to 1320a- 7a(a)). 1395u(p)(3)(A).................. ....................... CMS Penalty for any physician or 1988 2,000 3,957 practitioner who knowingly and willfully fails promptly to provide the appropriate diagnosis codes upon CMS or Medicare administrative contractor request for payment or bill not submitted on an assignment-related basis. 1395w-3a(d)(4)(A)............... 42 CFR 414.806......... CMS Penalty for a pharmaceutical 2003 10,000 12,856 manufacturer's misrepresentation of average sales price of a drug, or biologic. 1395w-4(g)(1)(B)................ 42 CFR 402.1(c)(17), CMS Penalty for any nonparticipating 1996 10,000 15,024 402.105(d)(2)(xiii). physician, supplier, or other person that furnishes physician services not on an assignment- related basis who either knowingly and willfully bills or collects in excess of the statutorily-defined limiting charge or fails to make a timely refund or adjustment. (Penalties are assessed in the same manner as 42 U.S.C. 1395u(j)(2)(B), which is assessed according to 1320a- 7a(a)). 1395w-4(g)(3)(B)................ 42 CFR 402.1(c)(18), CMS Penalty for any person that 1996 10,000 15,024 402.105(d)(2)(xiv). knowingly and willfully bills for statutorily defined State- plan approved physicians' services on any other basis than an assignment-related basis for a Medicare/Medicaid dual eligible beneficiary. (Penalties are assessed in the same manner as 42 U.S.C. 1395u(j)(2)(B), which is assessed according to 1320a- 7a(a)). 1395w-27(g)(3)(A); 1857(g)(3)... 42 CFR 422.760(b); 42 CMS Penalty for each termination 1997 25,000 36,794 CFR 423.760(b). determination the Secretary makes that is the result of actions by a Medicare Advantage organization or Part D sponsor that has adversely affected an individual covered under the organization's contract. 1395w-27(g)(3)(B); 1857(g)(3)... ....................... CMS Penalty for each week beginning 1997 10,000 14,718 after the initiation of civil money penalty procedures by the Secretary because a Medicare Advantage organization or Part D sponsor has failed to carry out a contract, or has carried out a contract inconsistently with regulations. 1395w-27(g)(3)(D); 1857(g)(3)... ....................... CMS Penalty for a Medicare Advantage 2000 100,000 136,689 organization's or Part D sponsor's early termination of its contract. [[Page 61577]] 1395y(b)(3)(C).................. 42 CFR 411.103(b)...... CMS Penalty for an employer or other 1990 5,000 8,908 entity to offer any financial or other incentive for an individual entitled to benefits not to enroll under a group health plan or large group health plan which would be a primary plan. 1395y(b)(5)(C)(ii).............. 42 CFR 402.1(c)(20); 42 CMS Penalty for any non-governmental 1998 1,000 1,450 CFR 402.105(b)(2). employer that, before October 1, 1998, willfully or repeatedly failed to provide timely and accurate information requested relating to an employee's group health insurance coverage. 1395y(b)(6)(B).................. 42 CFR 402.1(c)(21), CMS Penalty for any entity that 1994 2,000 3,182 402.105(a). knowingly, willfully, and repeatedly fails to complete a claim form relating to the availability of other health benefits in accordance with statute or provides inaccurate information relating to such on the claim form. 1395y(b)(7)(B)(i)............... ....................... CMS Penalty for any entity serving 2007 1,000 1,138 as insurer, third party administrator, or fiduciary for a group health plan that fails to provide information that identifies situations where the group health plan is or was a primary plan to Medicare to the HHS Secretary. 1395y(b)(8)(E).................. ....................... CMS Penalty for any non-group health 2007 1,000 1,138 plan that fails to identify claimants who are Medicare beneficiaries and provide information to the HHS Secretary to coordinate benefits and pursue any applicable recovery claim. 1395nn(g)(5).................... 42 CFR 411.361......... CMS Penalty for any person that 1989 10,000 18,936 fails to report information required by HHS under Section 1877(f) concerning ownership, investment, and compensation arrangements. 1395pp(h)....................... 42 CFR 402.1(c)(23), CMS Penalty for any durable medical 1996 10,000 15,024 402.105(d)(2)(xv). equipment supplier, including a supplier of prosthetic devices, prosthetics, orthotics, or supplies, that knowingly and willfully fails to make refunds in a timely manner to Medicare beneficiaries under certain conditions. (42 U.S.C. 1395(m)(18) sanctions apply here in the same manner, which is under 1395u(j)(2) and 1320a- 7a(a)). 1395ss(a)(2).................... 42 CFR 402.1(c)(24), CMS Penalty for any person that 1987 25,000 51,569 405.105(f)(1). issues a Medicare supplemental policy that has not been approved by the State regulatory program or does not meet Federal standards after a statutorily defined effective date. 1395ss(d)(3)(A)(vi)(II)......... ....................... CMS Penalty for someone other than 1990 15,000 26,723 issuer that sells or issues a Medicare supplemental policy to beneficiary without a disclosure statement. Penalty for an issuer that sells 1990 25,000 44,539 or issues a Medicare supplemental policy without disclosure statement. 1395ss(d)(3)(B)(iv)............. ....................... CMS Penalty for someone other than 1990 15,000 26,723 issuer that sells or issues a Medicare supplemental policy without acknowledgement form. Penalty for issuer that sells or 1990 25,000 44,539 issues a Medicare supplemental policy without an acknowledgement form. 1395ss(p)(8).................... 42 CFR 402.1(c)(25), CMS Penalty for any person that 1990 15,000 26,723 402.105(e). sells or issues Medicare supplemental polices after a given date that fail to conform to the NAIC or Federal standards established by statute. 42 CFR 402.1(c)(25), CMS Penalty for any person that 1990 25,000 44,539 405.105(f)(2). sells or issues Medicare supplemental polices after a given date that fail to conform to the NAIC or Federal standards established by statute. 1395ss(p)(9)(C)................. 42 CFR 402.1(c)(26), CMS Penalty for any person that 1990 15,000 26,723 402.105(e). sells a Medicare supplemental policy and fails to make available for sale the core group of basic benefits when selling other Medicare supplemental policies with additional benefits or fails to provide the individual, before selling the policy, an outline of coverage describing benefits. [[Page 61578]] 42 CFR 402.1(c)(26), Penalty for any person that 1990 25,000 44,539 405.105(f)(3), (4). sells a Medicare supplemental policy and fails to make available for sale the core group of basic benefits when selling other Medicare supplemental policies with additional benefits or fails to provide the individual, before selling the policy, an outline of coverage describing benefits. 1395ss(q)(5)(C)................. 42 CFR 402.1(c)(27), CMS Penalty for any person that 1990 25,000 44,539 405.105(f)(5). fails to suspend the policy of a policyholder made eligible for medical assistance or automatically reinstates the policy of a policyholder who has lost eligibility for medical assistance, under certain circumstances. 1395ss(r)(6)(A)................. 42 CFR 402.1(c)(28), CMS Penalty for any person that 1990 25,000 44,539 405.105(f)(6). fails to provide refunds or credits as required by section 1882(r)(1)(B). 1395ss(s)(4).................... 42 CFR 402.1(c)(29), CMS Penalty for any issuer of a 1990 5,000 18,908 405.105(c). Medicare supplemental policy that does not waive listed time periods if they were already satisfied under a proceeding Medicare supplemental policy, or denies a policy, or conditions the issuances or effectiveness of the policy, or discriminates in the pricing of the policy base on health status or other specified criteria. 1395ss(t)(2).................... 42 CFR 402.1(c)(30), CMS Penalty for any issuer of a 1990 25,000 44,539 405.105(f)(7). Medicare supplemental policy that fails to fulfill listed responsibilities. 1395ss(v)(4)(A)................. ....................... CMS Penalty someone other than 2003 15,000 19,284 issuer who sells, issues, or renews a medigap Rx policy to an individual who is a Part D enrollee. Penalty for an issuer who sells, 2003 25,000 32,140 issues, or renews a Medigap Rx policy who is a Part D enrollee. 1395bbb(c)(1)................... 42 CFR 488.725(c)...... CMS Penalty for any individual who 1987 2,000 4,126 notifies or causes to be notified a home health agency of the time or date on which a survey of such agency is to be conducted. 1395bbb(f)(2)(A)(i)............. 42 CFR CMS Maximum daily penalty amount for 1988 10,000 19,787 488.845(b)(2)(iii); 42 each day a home health agency CFR 488.845(b)(3)-(6); is not in compliance with and 42 CFR statutory requirements. 488.845(d)(1)(ii). 42 CFR 488.845(b)(3)... ................ Penalty per day for home health agency's noncompliance (Upper Range): Minimum...................... 1988 8,500 16,819 Maximum...................... 1988 10,000 19,787 42 CFR 488.845(b)(3)(i) Penalty for a home health 1988 10,000 19,787 agency's deficiency or deficiencies that cause immediate jeopardy and result in actual harm. 42 CFR Penalty for a home health 1988 9,000 17,808 488.845(b)(3)(ii). agency's deficiency or deficiencies that cause immediate jeopardy and result in potential for harm. 42 CFR Penalty for an isolated incident 1988 8,500 16,819 488.845(b)(3)(iii). of noncompliance in violation of established HHA policy. 42 CFR 488.845(b)(4)... Penalty for a repeat and/or condition-level deficiency that does not constitute immediate jeopardy, but is directly related to poor quality patient care outcomes (Lower Range): Minimum...................... 1988 1,500 2,968 Maximum...................... 1988 8,500 16,819 42 CFR 488.845(b)(5)... Penalty for a repeat and/or condition-level deficiency that does not constitute immediate jeopardy and that is related predominately to structure or process-oriented conditions (Lower Range): Minimum...................... 1988 500 989 Maximum...................... 1988 4,000 7,915 42 CFR 488.845(b)(6)... Penalty imposed for instance of noncompliance that may be assessed for one or more singular events of condition- level noncompliance that are identified and where the noncompliance was corrected during the onsite survey: [[Page 61579]] Minimum...................... 1988 1,000 1,979 Maximum...................... 1988 10,000 19,787 Penalty for each day of 1988 10,000 19,787 noncompliance (Maximum). 42 CFR Penalty for each day of 1988 10,000 19,787 488.845(d)(1)(ii). noncompliance (Maximum). 1396b(m)(5)(B).................. 42 CFR 460.46.......... CMS Penalty for PACE organization's practice that would reasonably be expected to have the effect of denying or discouraging enrollment: Minimum...................... 1997 15,000 22,077 Maximum...................... 1997 100,000 147,177 Penalty for a PACE organization 1997 25,000 36,794 that charges excessive premiums. Penalty for a PACE organization 1997 100,000 147,177 misrepresenting or falsifying information to CMS, the State, or an individual or other entity. Penalty for each determination 1997 25,000 36,794 the CMS makes that the PACE organization has failed to provide medically necessary items and services of the failure has adversely affected (or has the substantial likelihood of adversely affecting) a PACE participant. Penalty for involuntarily 1997 25,000 36,794 disenrolling a participant. Penalty for discriminating or 1997 25,000 36,794 discouraging enrollment or disenrollment of participants on the basis of an individual's health status or need for health care services. 1396r(h)(3)(C)(ii)(I)........... 42 CFR CMS Penalty per day for a nursing 488.408(d)(1)(iii). facility's failure to meet a Category 2 Certification: Minimum...................... 1987 50 103 Maximum...................... 1987 3,000 6,188 42 CFR CMS Penalty per instance for a 488.408(d)(1)(iv). nursing facility's failure to meet Category 2 certification: Minimum...................... 1987 1,000 2,063 Maximum...................... 1987 10,000 20,628 42 CFR CMS Penalty per day for a nursing 488.408(e)(1)(iii). facility's failure to meet Category 3 certification: Minimum...................... 1987 3,050 6,291 Maximum...................... 1987 10,000 20,628 42 CFR CMS Penalty per instance for a ........... ........... 2,063 488.408(e)(1)(iv). nursing facility's failure to meet Category 3 certification: Minimum...................... 1987 1,000 20,628 Maximum...................... 1987 10,000 42 CFR CMS Penalty per instance for a ........... ........... 2,063 488.408(e)(2)(ii). nursing facility's failure to meet Category 3 certification, which results in immediate jeopardy: Minimum...................... 1987 1,000 20,628 Maximum...................... 1987 10,000 42 CFR 488.438(a)(1)(i) CMS Penalty per day for nursing ........... ........... 6,291 facility's failure to meet certification (Upper Range): Minimum...................... 1987 3,050 20,628 Maximum...................... 1987 10,000 2,063 42 CFR CMS Penalty per day for nursing 488.438(a)(1)(ii). facility's failure to meet certification (Lower Range): Minimum...................... 1987 50 103 Maximum...................... 1987 3,000 6,188 42 CFR 488.438(a)(2)... CMS Penalty per instance for nursing facility's failure to meet certification: Minimum...................... 1987 1,000 2,063 Maximum...................... 1987 10,000 20,628 1396r(f)(2)(B)(iii)(I)(c)....... 42 CFR CMS Grounds to prohibit approval of 1987 5,000 10,314 483.151(b)(2)(iv) and Nurse Aide Training Program--if (b)(3)(iii). assessed a penalty in 1819(h)(2)(B)(i) or 1919(h)(2)(A)(ii) of ``not less than $5,000'' [Not CMP authority, but a specific CMP amount (CMP at this level) that is the triggering condition for disapproval]. 1396r(h)(3)(C)(ii)(I)........... 42 CFR 483.151(c)(2)... CMS Grounds to waive disapproval of 1987 5,000 10,314 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]. [[Page 61580]] 1396t(j)(2)(C).................. ....................... CMS Penalty for each day of noncompliance for a home or community care provider that no longer meets the minimum requirements for home and community care: Minimum...................... 1990 1 2 Maximum...................... 1990 10,000 17,816 1396u-2(e)(2)(A)(i)............. 42 CFR 438.704......... CMS Penalty for a Medicaid managed 1997 25,000 36,794 care organization that fails substantially to provide medically necessary items and services. Penalty for Medicaid managed 1997 25,000 36,794 care organization that imposes premiums or charges on enrollees in excess of the premiums or charges permitted. Penalty for a Medicaid managed 1997 25,000 36,794 care organization that misrepresents or falsifies information to another individual or entity. Penalty for a Medicaid managed 1997 25,000 36,794 care organization that fails to comply with the applicable statutory requirements for such organizations. 1396u-2(e)(2)(A)(ii)............ 42 CFR 438.704......... CMS Penalty for a Medicaid managed 1997 100,000 147,177 care organization that misrepresents or falsifies information to the HHS Secretary. Penalty for Medicaid managed 1997 100,000 147,177 care organization that acts to discriminate among enrollees on the basis of their health status. 1396u-2(e)(2)(A)(iv)............ 42 CFR 438.704......... CMS Penalty for each individual that 1997 15,000 22,077 does not enroll as a result of a Medicaid managed care organization that acts to discriminate among enrollees on the basis of their health status. 1396u(h)(2)..................... 42 CFR 441, Subpart I.. CMS Penalty for a provider not 1990 10,000 20,628 meeting one of the requirements relating to the protection of the health, safety, and welfare of individuals receiving community supported living arrangements services. 1396w-2(c)(1)................... ....................... CMS Penalty for disclosing 2009 10,000 11,002 information related to eligibility determinations for medical assistance programs. 18041(c)(2)..................... 45 CFR 150.315; 45 CFR CMS Failure to comply with 1996 100 150 156.805(c). requirements of the Public Health Services Act; Penalty for violations of rules or standards of behavior associated with issuer participation in the Federally- facilitated Exchange. (42 U.S.C. 300gg-22(b)(2)(C)). 18081(h)(1)(A)(i)(II)........... 42 CFR 155.285......... CMS Penalty for providing false 2010 25,000 27,186 information on Exchange application. 18081(h)(1)(B).................. 42 CFR 155.285......... CMS Penalty for knowingly or 2010 250,000 271,862 willfully providing false information on Exchange application. 18081(h)(2)..................... 42 CFR 155.260......... CMS Penalty for knowingly or 2010 25,000 27,186 willfully disclosing protected information from Exchange. 31 U.S.C.: 1352............................ 45 CFR 93.400(e)....... HHS Penalty for the first time an 1989 10,000 18,936 individual makes an expenditure prohibited by regulations regarding lobbying disclosure, absent aggravating circumstances. Penalty for second and subsequent offenses by individuals who make an expenditure prohibited by regulations regarding lobbying disclosure: Minimum...................... 1989 10,000 18,936 Maximum...................... 1989 100,000 189,361 Penalty for the first time an 1989 10,000 18,936 individual fails to file or amend a lobbying disclosure form, absent aggravating circumstances. Penalty for second and subsequent offenses by individuals who fail to file or amend a lobbying disclosure form, absent aggravating circumstances: Minimum...................... 1989 10,000 18,936 Maximum...................... 1989 100,000 189,361 45 CFR 93, Appendix A.. HHS Penalty for failure to provide certification regarding lobbying in the award documents for all sub-awards of all tiers: Minimum...................... 1989 10,000 18,936 Maximum...................... 1989 100,000 189,361 [[Page 61581]] Penalty for failure to provide statement regarding lobbying for loan guarantee and loan insurance transactions: Minimum...................... 1989 10,000 18,936 Maximum...................... 1989 100,000 189,361 3801-3812....................... 45 CFR 79.3(a)(1)(iv).. HHS Penalty against any individual 1988 5,000 9,894 who--with knowledge or reason to know--makes, presents or submits a false, fictitious or fraudulent claim to the Department. 45 CFR 79.3(b)(1(ii)... Penalty against any individual 1988 5,000 9,894 who--with knowledge or reason to know--makes, presents or submits a false, fictitious or fraudulent claim to the Department. -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ Some HHS components have not promulgated regulations regarding their civil monetary penalty-specific statutory authorities. \2\ The description is not intended to be a comprehensive explanation of the underlying violation; the statute and corresponding regulation, if applicable should be consulted. \3\ Statutory, or non-Inflation Act Adjustment. PART 147--HEALTH INSURANCE REFORM REQUIREMENTS FOR THE GROUP AND INDIVIDUAL HEALTH INSURANCE MARKETS 0 33. The authority citation for part 147 continues to read as follows: Authority: Secs. 2701 through 2763, 2791, and 2792 of the Public Health Service Act (42 U.S.C. 300gg through 300gg-63, 300gg-91, and 300gg-92), as amended. Sec. 147.200 [Amended] 0 34. Section 147.200(e) is amended by removing the phrase ``not more than $1,000 for'' and adding in its place the phrase ``not more than $1,000 as adjusted annually under 45 CFR part 102 for''. PART 150--CMS ENFORCEMENT IN GROUP AND INDIVIDUAL INSURANCE MARKETS 0 35. The authority citation for part 150 continues to read as follows: Authority: Secs. 2701 through 2763, 2791, and 2792 of the PHS Act (42 U.S.C. 300gg through 300gg-63, 300gg-91, and 300gg-92). Sec. 150.315 [Amended] 0 36. Section 150.315 is amended by removing the phrase ``may not exceed $100 for'' and adding in its place the phrase ``may not exceed $100 as adjusted annually under 45 CFR part 102 for''. PART 155--EXCHANGE ESTABLISHMENT STANDARDS AND OTHER RELATED STANDARDS UNDER THE AFFORDABLE CARE ACT 0 37. The authority citation for part 155 continues to read as follows: Authority: Title I of the Affordable Care Act, sections 1301, 1302, 1303, 1304, 1311, 1312, 1313, 1321, 1322, 1331, 1332, 1334, 1402, 1411, 1412, 1413, Pub. L. 111-148, 124 Stat. 119 (42 U.S.C. 18021-18024, 18031-18033, 18041-18042, 18051, 18054, 18071, and 18081-18083). Sec. 155.260 [Amended] 0 38. In Sec. 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''. Sec. 155.285 [Amended] 0 39. Amend Sec. 155.285 as follows: 0 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''; 0 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 0 c. In paragraph (c)(2)(i), removing the phrase ``not more than $25,000 per'' and adding in its place the phrase ``not more than $25,000 as adjusted annually under 45 CFR part 102 per''. PART 156--HEALTH INSURANCE ISSUER STANDARDS UNDER THE AFFORDABLE CARE ACT, INCLUDING STANDARDS RELATED TO EXCHANGES 0 40. The authority citation for part 156 continues to read as follows: Authority: Title I of the Affordable Care Act, sections 1301- 1304, 1311-1313, 1321-1322, 1324, 1334, 1342-1343, 1401-1402, Pub. L. 111-148, 124 Stat. 119 (42 U.S.C. 18021-18024, 18031-18032, 18041-18042, 18044, 18054, 18061, 18063, 18071, 18082, 26 U.S.C. 36B, and 31 U.S.C. 9701). Sec. 156.805 [Amended] 0 41. In Sec. 156.805, paragraph (c) is amended by removing the phrase ``$100 for'' and adding in its place the phrase ``$100 as adjusted annually under 45 CFR part 102 for''. PART 158--ISSUER USE OF PREMIUM REVENUE: REPORTING AND REBATE REQUIREMENTS 0 42. The authority citation for part 158 continues to read as follows: Authority: Section 2718 of the Public Health Service Act (42 U.S.C. 300gg-18), as amended. Sec. 158.606 [Amended] 0 43. Section 158.606 is amended by removing the phrase ``may not exceed $100 for'' and adding in its place the phrase ``may not exceed $100 as adjusted annually under 45 CFR part 102 for''. PART 160--GENERAL ADMINISTRATIVE REQUIREMENTS 0 44. The authority for part 160 continues to read as follows: Authority: 42 U.S.C. 1302(a); 42 U.S.C. 1320d-1320d-9; sec. 264, Pub. L. 104-191, 110 Stat. 2033-2034 (42 U.S.C. 1320d-2 (note)); 5 U.S.C. 552; secs. 13400-13424, Pub. L. 111-5, 123 Stat. 258-279; and sec. 1104 of Pub. L. 111-148, 124 Stat. 146-154. 0 45. Section 160.404 is amended by revising paragraph (a) to read as follows: Sec. 160.404 Amount of a civil money penalty. (a) The amount of a civil money penalty will be determined in accordance with paragraph (b) of this section, and Sec. Sec. 160.406, 160.408, and 160.412. These amounts were adjusted in accordance with the Federal Civil Monetary Penalty Inflation Adjustment [[Page 61582]] Act of 1990, (Pub. L. 101-140), as amended by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015, (section 701 of Pub. L. 114-74), and appear at 45 CFR part 102. These amounts will be updated annually and published at 45 CFR part 102. * * * * * Subtitle B--Regulations Related to Public Welfare Chapter II--Office of Family Assistance (Assistance Programs), Administration for Children and Families, Department of Health and Human Services PART 303--STANDARDS FOR PROGRAM OPERATIONS 0 46. The authority citation for part 303 continues to read as follows: Authority: 42 U.S.C. 651 through 658, 659a, 660, 663, 664, 666, 667, 1302, 1396a(a)(25), 1396b(d)(2), 1396b(o), 1396b(p), and 1396(k). 0 47. Section 303.21 is amended by revising paragraph (f) to read as follows: Sec. 303.21 Safeguarding and disclosure of confidential information. * * * * * (f) Penalties for unauthorized disclosure. Any disclosure or use of confidential information in violation of 42 U.S.C. 653(l)(2) and implementing regulations shall be subject to: (1) Any State and Federal statutes that impose legal sanctions for such disclosure; and (2) The maximum civil monetary penalties associated with the statutory provisions authorizing civil monetary penalties under 42 U.S.C. 653(l)(2) as shown in the table at 45 CFR 102.3. Dated: July 21, 2016. Sylvia M. Burwell, Secretary, Department of Health and Human Services. [FR Doc. 2016-18680 Filed 9-2-16; 8:45 am] BILLING CODE 4150-24-P
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| Action | Interim final rule. | |
| Dates | This rule is effective on September 6, 2016. | |
| 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. | |
| FR Citation | 81 FR 61538 | |
| CFR Citation | 42
CFR
1003 42 CFR 3 42 CFR 402 42 CFR 403 42 CFR 411 42 CFR 412 42 CFR 422 42 CFR 423 42 CFR 460 42 CFR 483 42 CFR 488 42 CFR 493 45 CFR 102 45 CFR 147 45 CFR 150 45 CFR 155 45 CFR 156 45 CFR 158 45 CFR 160 45 CFR 303 45 CFR 79 45 CFR 93 | |
| CFR Associated | Administrative Practice and Procedure; Conflicts of Interests; Health Records; Privacy; Reporting and Recordkeeping Requirements; Grant Programs-Health; Health Insurance; Hospitals; Intergovernmental Relations; Emergency Medical Services; Health Professionals; Health Professions; Nursing Homes; Nutrition; Safety; Laboratories; Fraud; Reporting and Recordkeeping; Government Contracts; Grants Programs; Loan Programs; Lobbying; Child Support; Standards for Program Operations; Medicaid; Medicare; Penalties; Kidney Diseases; Physician Referral; Health Facilities; Puerto Rico; Health Maintenance Organizations (hmo); Aged; Health Care; Advertising; Brokers; Conflict of Interest; Consumer Protection; Grants Administration; Health Maintenance Organization (hmo); Indians; Individuals with Disabilities; Loan Programs-Health; Organization and Functions (government Agencies); Public Assistance Programs; State and Local Governments; Technical Assistance; Women; Youth; Advisory Committees; Sunshine Act; Health Plans; Penalties; Premium Revenues; Medical Loss Ratio; Rebating; Administrative Practice and Procedures; Records and Recordkeeping Requirements and Claims |