Annual Civil Monetary Penalties Inflation Adjustment, 51369-51390 [2018-22005]

Download as PDF 51369 Federal Register / Vol. 83, No. 197 / Thursday, October 11, 2018 / Rules and Regulations EPA-APPROVED REGULATIONS, TECHNICAL MEMORANDA, AND STATUTES IN THE MARYLAND SIP—Continued Code of Maryland Administrative Regulations (COMAR) citation State effective date Title/subject * * * 26.11.40 04/23/18 26.11.40.02 ............. Applicability ..................... 04/23/18 26.11.40.03 ............. NOX Ozone Season Emission Caps. Monitoring and Reporting Requirements. 04/23/18 * * * * * * * 04/23/18 * * monetary penalties (CMPs) and to maintain the deterrent effect of such penalties, requires agencies to adjust the civil monetary penalties for inflation annually. The Department of Health and Human Services (HHS) lists the civil monetary penalty authorities and the penalty amounts administered by all of its agencies in tabular form in 45 CFR 102.3. BILLING CODE 6560–50–P DEPARTMENT OF HEALTH AND HUMAN SERVICES 45 CFR Part 102 RIN 0991–AC0 Annual Civil Monetary Penalties Inflation Adjustment II. Calculation of Adjustment Office of the Assistant Secretary for Financial Resources, Department of Health and Human Services. ACTION: Final rule. AGENCY: The Department of Health and Human Services is updating its regulations to reflect required annual inflation-related increases to the civil monetary penalties in its regulations, pursuant to the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015. DATES: This rule is effective October 11, 2018. FOR FURTHER INFORMATION CONTACT: Shaunta Johnson, Office of Grants and Acquisition Policy and Accountability, 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: SUMMARY: The annual inflation adjustment for each applicable civil monetary penalty is determined using the percent increase in the Consumer Price Index for all Urban Consumers (CPI–U) for the month of October of the year in which the amount of each civil penalty was most recently established or modified. In the December 15, 2017, Office of Management and Budget (OMB) Memorandum for the Heads of Executive Agencies and Departments, M–18–03, Implementation of the Penalty Inflation Adjustments for 2018, Pursuant to the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015, OMB published the multiplier for the required annual adjustment. The cost-of-living adjustment multiplier for 2018, based on the CPI–U for the month of October 2017, not seasonally adjusted, is 1.02041. Using the 2018 multiplier, HHS adjusted all its applicable monetary penalties in 45 CFR 102.3. I. Background III. Statutory and Executive Order Reviews The Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (Sec. 701 of Pub. L. 114–74) (the ‘‘2015 Act’’), which is intended to improve the effectiveness of civil The 2015 Act requires federal agencies to publish annual penalty inflation adjustments notwithstanding section 553 of the Administrative Procedure Act (APA). 19:54 Oct 10, 2018 Jkt 247001 * 10/11/18, [Insert Federal Register citation]. 10/11/18, [Insert Federal Register citation]. 10/11/18, [Insert Federal Register citation]. 10/11/18, [Insert Federal Register citation]. * [FR Doc. 2018–21653 Filed 10–10–18; 8:45 am] VerDate Sep<11>2014 * NOX Ozone Season Emission Caps for Non-trading Large NOX Units Definitions ....................... * khammond on DSK30JT082PROD with RULES * 26.11.40.01 ............. 26.11.40.04 ............. Additional explanation/citation at 40 CFR 52.1100 EPA approval date PO 00000 Frm 00069 Fmt 4700 Sfmt 4700 * * Section 4(a) of the 2015 Act directs federal agencies to publish annual adjustments no later than January 15th of each year thereafter. In accordance with section 553 of the APA, most rules are subject to notice and comment and are effective no earlier than 30 days after publication in the Federal Register. However, section 4(b)(2) of the 2015 Act provides that each agency shall make the annual inflation adjustments ‘‘notwithstanding section 553’’ of the APA. According to OMB’s Memorandum M–18–03, the phrase ‘‘notwithstanding section 553’’ means that ‘‘the public procedure the APA generally requires— notice, an opportunity for comment, and a delay in effective date—is not required for agencies to issue regulations implementing the annual adjustment.’’ Consistent with the language of the 2015 Act and OMB’s implementation guidance, this rule is not subject to notice and an opportunity for public comment and will be effective immediately upon publication. Pursuant to OMB Memorandum M– 18–03, HHS has determined that the annual inflation adjustment to the civil monetary penalties in its regulations does not trigger any requirements under procedural statutes and Executive Orders that govern rulemaking procedures. IV. Effective Date This rule is effective October 11 2018. The adjusted civil monetary penalty amounts apply to penalties assessed on or after October 11, 2018, if the violation occurred on or after November 2, 2015. If the violation occurred prior to November 2, 2015, or a penalty was assessed prior to September 6, 2016, the pre-adjustment civil penalty amounts in E:\FR\FM\11OCR1.SGM 11OCR1 51370 Federal Register / Vol. 83, No. 197 / Thursday, October 11, 2018 / Rules and Regulations effect prior to September 6, 2016, will apply. 45 of the Code of Federal Regulations as follows: List of Subjects in 45 CFR Part 102 Administrative practice and procedure, Penalties. For reasons discussed in the preamble, the Department of Health and Human Services amends subtitle A, title PART 102—ADJUSTMENT OF CIVIL MONETARY PENALTIES FOR INFLATION 1. The authority citation for part 102 continues to read as follows: ■ Authority: Public Law 101–410, Sec. 701 of Public Law 114–74, 31 U.S.C. 3801–3812. 2. Amend § 102.3 by revising the table to read as follows: ■ § 102.3 * Penalty adjustment and table. * * * * CIVIL MONETARY PENALTY AUTHORITIES ADMINISTERED BY HHS AGENCIES AND PENALTY AMOUNTS [Effective October 11, 2018] Citation HHS agency CFR 1 U.S.C. 2016 Maximum adjusted penalty ($) Date of last statutorily established penalty figure 3 Description 2 2017 Maximum adjusted penalty ($) 4 2018 Maximum adjusted penalty ($) 21 U.S.C. 333(b)(2)(A) .................... ........................................ FDA 333(b)(2)(B) .................... ........................................ FDA 333(b)(3) ......................... ........................................ FDA 333(f)(1)(A) ..................... ........................................ FDA khammond on DSK30JT082PROD with RULES 333(f)(2)(A) ..................... ........................................ FDA 333(f)(3)(A) ..................... ........................................ FDA 333(f)(3)(B) ..................... ........................................ FDA 333(f)(4)(A)(i) .................. ........................................ FDA VerDate Sep<11>2014 19:54 Oct 10, 2018 Jkt 247001 PO 00000 Penalty for violations related to drug samples resulting in a conviction of any representative of manufacturer or distributor in any 10-year period. Penalty for violation related to drug samples resulting in a conviction of any representative of manufacturer or distributor after the second conviction in any 10-yr period. Penalty for failure to make a report required by 21 U.S.C. 353(d)(3)(E) relating to drug samples. Penalty for any person who violates a requirement related to devices for each such violation. Penalty for aggregate of all violations related to devices in a single proceeding. Penalty for any individual who introduces or delivers for introduction into interstate commerce food that is adulterated per 21 U.S.C. 342(a)(2)(B) or any individual who does not comply with a recall order under 21 U.S.C. 350l. Penalty in the case of any other person other than an individual) for such introduction or delivery of adulterated food. Penalty for aggregate of all such violations related to adulterated food adjudicated in a single proceeding. Penalty for all violations adjudicated in a single proceeding for any person who violates 21 U.S.C. 331(jj)(1) by failing to submit the certification required by 42 U.S.C. 282(j)(5)(B) or knowingly submitting a false certification; by failing to submit clinical trial information under 42 U.S.C 282(j); or by submitting clinical trial information under 42 U.S.C. 282(j) that is false or misleading in any particular under 42 U.S.C. 282(j)(5)(D). Penalty for each day any above violation is not corrected after a 30-day period following notification until the violation is corrected. Penalty for any responsible person that violates a requirement of 21 U.S.C. 355(o) (post-marketing studies, clinical trials, labeling), 21 U.S.C. 355(p) (risk evaluation and mitigation (REMS)), or 21 U.S.C. 355–1 (REMS). Frm 00070 Fmt 4700 Sfmt 4700 2016 98,935 100,554 102,606 2016 1,978,690 2,011,061 2,052,107 2016 197,869 201,106 205,211 2016 26,723 27,160 27,714 2016 1,781,560 1,810,706 1,847,663 2016 75,123 76,352 77,910 2016 375,613 381,758 389,550 2016 751,225 763,515 779,098 2016 11,383 11,569 11,805 2016 11,383 11,569 11,805 2016 284,583 289,239 295,142 E:\FR\FM\11OCR1.SGM 11OCR1 Federal Register / Vol. 83, No. 197 / Thursday, October 11, 2018 / Rules and Regulations 51371 CIVIL MONETARY PENALTY AUTHORITIES ADMINISTERED BY HHS AGENCIES AND PENALTY AMOUNTS—Continued [Effective October 11, 2018] Citation HHS agency CFR 1 U.S.C. 333(f)(4)(A)(ii) ................. 333(f)(9)(A) ..................... FDA ........................................ 333(f)(9)(B)(i)(I) ............... 333(f)(9)(B)(i)(II) .............. khammond on DSK30JT082PROD with RULES 333(f)(9)(B)(ii)(I) .............. 333(f)(9)(B)(ii)(II) ............. VerDate Sep<11>2014 FDA FDA ........................................ ........................................ ........................................ 19:54 Oct 10, 2018 Jkt 247001 FDA FDA FDA PO 00000 Penalty for aggregate of all such above violations in a single proceeding. Penalty for REMS violation that continues after written notice to the responsible person for the first 30-day period (or any portion thereof) the responsible person continues to be in violation. Penalty for REMS violation that continues after written notice to responsible person doubles for every 30-day period thereafter the violation continues, but may not exceed penalty amount for any 30-day period. Penalty for aggregate of all such above violations adjudicated in a single proceeding. Penalty for any person who violates a requirement which relates to tobacco products for each such violation. Penalty for aggregate of all such violations of tobacco product requirement adjudicated in a single proceeding. Penalty per violation related to violations of tobacco requirements. Penalty for aggregate of all such violations of tobacco product requirements adjudicated in a single proceeding. Penalty in the case of a violation of tobacco product requirements that continues after written notice to such person, for the first 30day period (or any portion thereof) the person continues to be in violation. Penalty for violation of tobacco product requirements that continues after written notice to such person shall double for every 30day period thereafter the violation continues, but may not exceed penalty amount for any 30-day period. Penalty for aggregate of all such violations related to tobacco product requirements adjudicated in a single proceeding. Penalty for any person who either does not conduct post-market surveillance and studies to determine impact of a modified risk tobacco product for which the HHS Secretary has provided them an order to sell, or who does not submit a protocol to the HHS Secretary after being notified of a requirement to conduct post-market surveillance of such tobacco products. Penalty for aggregate of for all such above violations adjudicated in a single proceeding. Penalty for violation of modified risk tobacco product post-market surveillance that continues after written notice to such person for the first 30-day period (or any portion thereof) that the person continues to be in violation. Frm 00071 Fmt 4700 Sfmt 4700 2016 Maximum adjusted penalty ($) Date of last statutorily established penalty figure 3 Description 2 2017 Maximum adjusted penalty ($) 4 2018 Maximum adjusted penalty ($) 2016 1,138,330 1,156,953 1,180,566 2016 284,583 289,239 295,142 2016 1,138,330 1,156,953 1,180,566 2016 11,383,300 11,569,531 11,805,665 2016 16,503 16,773 17,115 2016 1,100,200 1,118,199 1,141,021 2016 275,050 279,550 285,256 2016 1,100,200 1,118,199 1,141,021 2016 275,050 279,550 285,256 2016 1,100,200 1,118,199 1,141,021 2016 11,002,000 11,181,993 11,410,218 2016 275,050 279,550 285,256 2016 1,100,200 1,118,199 1,141,021 2016 275,050 279,550 285,256 E:\FR\FM\11OCR1.SGM 11OCR1 51372 Federal Register / Vol. 83, No. 197 / Thursday, October 11, 2018 / Rules and Regulations CIVIL MONETARY PENALTY AUTHORITIES ADMINISTERED BY HHS AGENCIES AND PENALTY AMOUNTS—Continued [Effective October 11, 2018] Citation CFR 1 U.S.C. 333(g)(1) ......................... khammond on DSK30JT082PROD with RULES 333 note .......................... VerDate Sep<11>2014 HHS agency ........................................ ........................................ 19:54 Oct 10, 2018 Jkt 247001 FDA FDA PO 00000 Penalty for post-notice violation of modified risk tobacco product post-market surveillance shall double for every 30-day period thereafter that the tobacco product requirement violation continues for any 30-day period, but may not exceed penalty amount for any 30-day period. Penalty for aggregate above tobacco product requirement violations adjudicated in a single proceeding. Penalty for any person who disseminates or causes another party to disseminate a direct-toconsumer advertisement that is false or misleading for the first such violation in any 3-year period. Penalty for each subsequent above violation in any 3-year period. Penalty to be applied for violations of restrictions on the sale or distribution of tobacco products promulgated under 21 U.S.C. 387f(d) (e.g., violations of regulations in 21 CFR Part 1140) with respect to a retailer with an approved training program in the case of a second regulation violation within a 12-month period. Penalty in the case of a third tobacco product regulation violation within a 24-month period. Penalty in the case of a fourth tobacco product regulation violation within a 24-month period. Penalty in the case of a fifth tobacco product regulation violation within a 36-month period. Penalty in the case of a sixth or subsequent tobacco product regulation violation within a 48month period as determined on a case-by-case basis. Penalty to be applied for violations of restrictions on the sale or distribution of tobacco products promulgated under 21 U.S.C. 387f(d) (e.g., violations of regulations in 21 CFR Part 1140) with respect to a retailer that does not have an approved training program in the case of the first regulation violation. Penalty in the case of a second tobacco product regulation violation within a 12-month period. Penalty in the case of a third tobacco product regulation violation within a 24-month period. Penalty in the case of a fourth tobacco product regulation violation within a 24-month period. Penalty in the case of a fifth tobacco product regulation violation within a 36-month period. Penalty in the case of a sixth or subsequent tobacco product regulation violation within a 48month period as determined on a case-by-case basis. Frm 00072 Fmt 4700 Sfmt 4700 2016 Maximum adjusted penalty ($) Date of last statutorily established penalty figure 3 Description 2 2017 Maximum adjusted penalty ($) 4 2018 Maximum adjusted penalty ($) 2016 1,100,200 1,118,199 1,141,021 2016 11,002,000 11,181,993 11,410,218 2016 284,583 289,239 295,142 2016 569,165 578,477 590,284 2016 275 279 285 2016 550 559 570 2016 2,200 2,236 2,282 2016 5,501 5,591 5,705 2016 11,002 11,182 11,410 2016 275 279 285 2016 550 559 570 2016 1,100 1,118 1,141 2016 2,200 2,236 2,282 2016 5,501 5,591 5,705 2016 11,002 11,182 11,410 E:\FR\FM\11OCR1.SGM 11OCR1 Federal Register / Vol. 83, No. 197 / Thursday, October 11, 2018 / Rules and Regulations 51373 CIVIL MONETARY PENALTY AUTHORITIES ADMINISTERED BY HHS AGENCIES AND PENALTY AMOUNTS—Continued [Effective October 11, 2018] Citation HHS agency U.S.C. CFR 1 335b(a) ............................ ........................................ 360pp(b)(1) ..................... ........................................ FDA Penalty for each violation for any individual who made a false statement or misrepresentation of a material fact, bribed, destroyed, altered, removed, or secreted, or procured the destruction, alteration, removal, or secretion of, any material document, failed to disclose a material fact, obstructed an investigation, employed a consultant who was debarred, debarred individual provided consultant services. Penalty in the case of any other person (other than an individual) per above violation. Penalty for any person who violates any such requirements for electronic products, with each unlawful act or omission constituting a separate violation. Penalty imposed for any related series of violations of requirements relating to electronic products. FDA 2016 Maximum adjusted penalty ($) Date of last statutorily established penalty figure 3 Description 2 2017 Maximum adjusted penalty ($) 4 2018 Maximum adjusted penalty ($) 2016 419,320 426,180 434,878 2016 1,677,280 1,704,720 1,739,513 2016 2,750 2,795 2,852 2016 937,500 952,838 972,285 2016 215,628 219,156 223,629 2016 16,773 17,047 17,395 2016 215,628 219,156 223,629 2016 5,437 5,526 5,639 2016 14,140 14,371 14,664 2016 1,450 1,474 1,504 2016 327,962 333,327 340,130 2016 655,925 666,656 680,262 2016 1,000,000 1,016,360 1,037,104 2018 15,024 15,270 20,000 2018 15,024 15,270 20,000 2018 22,537 22,906 30,000 khammond on DSK30JT082PROD with RULES 42 U.S.C. 262(d) .............................. ........................................ FDA 263b(h)(3) ....................... ........................................ FDA 300aa–28(b)(1) ............... ........................................ FDA 256b(d)(1)(B)(vi) ............. ........................................ HRSA 299c–3(d) ........................ ........................................ AHRQ 653(l)(2) .......................... 45 CFR 303.21(f) ........... ACF 262a(i)(1) ........................ 42 CFR 1003.910 .......... OIG 300jj–51 .......................... ........................................ OIG 1320a–7a(a) 5 ................. 42 CFR 1003.210(a)(1) OIG 42 CFR 1003.210(a)(2) VerDate Sep<11>2014 19:54 Oct 10, 2018 Jkt 247001 PO 00000 Penalty per day for violation of order of recall of biological product presenting imminent or substantial hazard. Penalty for failure to obtain a mammography certificate as required. Penalty per occurrence for any vaccine manufacturer that intentionally destroys, alters, falsifies, or conceals any record or report required. Penalty for each instance of overcharging a 340B covered entity. Penalty for an establishment or person supplying information obtained in the course of activities for any purpose other than the purpose for which it was supplied. Penalty for Misuse of Information in the National Directory of New Hires. Penalty for each individual who violates safety and security procedures related to handling dangerous biological agents and toxins. Penalty for any other person who violates safety and security procedures related to handling dangerous biological agents and toxins. Penalty per violation for committing information blocking. Penalty for knowingly presenting or causing to be presented to an officer, employee, or agent of the United States a false claim. Penalty for knowingly presenting 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 causing to be presented to a participating provider or supplier false or misleading information that could reasonably be expected to influence a discharge decision. Frm 00073 Fmt 4700 Sfmt 4700 E:\FR\FM\11OCR1.SGM 11OCR1 51374 Federal Register / Vol. 83, No. 197 / Thursday, October 11, 2018 / Rules and Regulations CIVIL MONETARY PENALTY AUTHORITIES ADMINISTERED BY HHS AGENCIES AND PENALTY AMOUNTS—Continued [Effective October 11, 2018] Citation HHS agency CFR 1 U.S.C. 42 CFR 1003.210(a)(3) 42 CFR 1003.1010 ........ 42 CFR 1003.210(a)(4) 42 CFR 1003.310(a)(3) 42 CFR 1003.210(a)(1) 42 CFR 1003.210(a)(6) 42 CFR 1003.210(a)(8) 42 CFR 1003.210(a)(7) 42 CFR 1003.210(a)(9) 1320a–7a(b) 5 ................. ........................................ OIG ........................................ khammond on DSK30JT082PROD with RULES 42 CFR 1003.210(a)(10) 1320a–7e(b)(6)(A) .......... 42 CFR 1003.810 .......... OIG 1320b–10(b)(1) ............... 42 CFR 1003.610(a) ...... OIG 1320b–10(b)(2) ............... 42 CFR 1003.610(a) ...... OIG VerDate Sep<11>2014 19:54 Oct 10, 2018 Jkt 247001 PO 00000 Penalty for an excluded party retaining ownership or control interest in a participating entity. Penalty for remuneration offered to induce program beneficiaries to use particular providers, practitioners, or suppliers. Penalty for employing or contracting with an excluded individual. Penalty for knowing and willful solicitation, receipt, offer, or payment of remuneration for referring an individual for a service or for purchasing, leasing, or ordering an item to be paid for by a Federal health care program. Penalty for ordering or prescribing medical or other item or service during a period in which the person was excluded. Penalty for knowingly making or causing to be made a false statement, omission or misrepresentation of a material fact in any application, bid, or contract to participate or enroll as a provider or supplier. Penalty for knowing of an overpayment and failing to report and return. Penalty for making or using a false record or statement that is material to a false or fraudulent claim. Penalty for failure to grant timely access to HHS OIG for audits, investigations, evaluations, and other statutory functions of HHS OIG. Penalty for payments by a hospital or critical access hospital to induce a physician to reduce or limit services to individuals under direct care of physician or who are entitled to certain medical assistance benefits. Penalty for physicians who knowingly receive payments from a hospital or critical access hospital to induce such physician to reduce or limit services to individuals under direct care of physician or who are entitled to certain medical assistance benefits. Penalty for a physician who executes a document that falsely certifies home health needs for Medicare beneficiaries. Penalty for failure to report any final adverse action taken against a health care provider, supplier, or practitioner. Penalty for the misuse of words, symbols, or emblems in communications in a manner in which a person could falsely construe that such item is approved, endorsed, or authorized by HHS. Penalty for the misuse of words, symbols, or emblems in a broadcast or telecast in a manner in which a person could falsely construe that such item is approved, endorsed, or authorized by HHS. Frm 00074 Fmt 4700 Sfmt 4700 2016 Maximum adjusted penalty ($) Date of last statutorily established penalty figure 3 Description 2 2017 Maximum adjusted penalty ($) 4 2018 Maximum adjusted penalty ($) 2018 15,024 15,270 20,000 2018 15,024 15,270 20,000 2018 14,718 14,959 20,000 2018 73,588 74,792 100,000 2018 10,874 11,052 20,000 2018 54,372 55,262 100,000 2018 10,874 11,052 20,000 2018 54,372 55,262 100,000 2018 16,312 16,579 30,000 2018 4,313 4,384 5,000 2018 4,313 4,384 5,000 2018 7,512 7,635 10,000 2016 36,794 37,396 38,159 2016 9,893 10,055 10,260 2016 49,467 50,276 51,302 E:\FR\FM\11OCR1.SGM 11OCR1 Federal Register / Vol. 83, No. 197 / Thursday, October 11, 2018 / Rules and Regulations 51375 CIVIL MONETARY PENALTY AUTHORITIES ADMINISTERED BY HHS AGENCIES AND PENALTY AMOUNTS—Continued [Effective October 11, 2018] khammond on DSK30JT082PROD with RULES Citation HHS agency U.S.C. CFR 1 1395i–3(b)(3)(B)(ii)(1) ..... 42 CFR 1003.210(a)(11) OIG 1395i–3(b)(3)(B)(ii)(2) ..... 42 CFR 1003.210(a)(11) OIG 1395i–3(g)(2)(A) .............. 42 CFR 1003.1310 ........ OIG 1395w–27(g)(2)(A) .......... 42 CFR 1003.410 .......... OIG VerDate Sep<11>2014 19:54 Oct 10, 2018 Jkt 247001 PO 00000 Penalty for certification of a false statement in assessment of functional capacity of a Skilled Nursing Facility resident assessment. Penalty for causing another to certify or make a false statement in assessment of functional capacity of a Skilled Nursing Facility resident assessment. Penalty for any individual who notifies or causes to be notified a Skilled Nursing Facility of the time or date on which a survey is to be conducted. Penalty for a Medicare Advantage organization that substantially fails to provide medically necessary, required items and services. Penalty for a Medicare Advantage organization that charges excessive premiums. Penalty for a Medicare Advantage organization that improperly expels or refuses to reenroll a beneficiary. Penalty for a Medicare Advantage organization that engages in practice that would reasonably be expected to have the effect of denying or discouraging enrollment. Penalty per individual who does not enroll as a result of a Medicare Advantage organization’s practice that would reasonably be expected to have the effect of denying or discouraging enrollment. Penalty for a Medicare Advantage organization misrepresenting or falsifying information to Secretary. Penalty for a Medicare Advantage organization misrepresenting or falsifying information to individual or other entity. Penalty for Medicare Advantage organization interfering with provider’s advice to enrollee and non-MCO affiliated providers that balance bill enrollees. Penalty for a Medicare Advantage organization that employs or contracts with excluded individual or entity. Penalty for a Medicare Advantage organization enrolling an individual in without prior written consent. Penalty for a Medicare Advantage organization transferring an enrollee to another plan without consent or solely for the purpose of earning a commission. Penalty for a Medicare Advantage organization failing to comply with marketing restrictions or applicable implementing regulations or guidance. Penalty for a Medicare Advantage organization employing or contracting with an individual or entity who violates 1395w– 27(g)(1)(A)–(J). Frm 00075 Fmt 4700 Sfmt 4700 2016 Maximum adjusted penalty ($) Date of last statutorily established penalty figure 3 Description 2 2017 Maximum adjusted penalty ($) 4 2018 Maximum adjusted penalty ($) 2016 2,063 2,097 2,140 2016 10,314 10,483 10,697 2016 4,126 4,194 4,280 2016 37,561 38,175 38,954 2016 36,794 37,396 38,159 2016 36,794 37,396 38,159 2016 147,177 149,585 152,638 2016 22,077 22,438 22,896 2016 147,177 149,585 152,638 2016 36,794 37,396 38,159 2016 36,794 37,396 38,159 2016 36,794 37,396 38,159 2016 36,794 37,396 38,159 2016 36,794 37,396 38,159 2016 36,794 37,396 38,159 2016 36,794 37,396 38,159 E:\FR\FM\11OCR1.SGM 11OCR1 51376 Federal Register / Vol. 83, No. 197 / Thursday, October 11, 2018 / Rules and Regulations CIVIL MONETARY PENALTY AUTHORITIES ADMINISTERED BY HHS AGENCIES AND PENALTY AMOUNTS—Continued [Effective October 11, 2018] Citation CFR 1 U.S.C. 1395w–141(i)(3) .............. OIG 1395cc(g) ........................ OIG 1395dd(d)(1) ................... 1395mm(i)(6)(B)(i) .......... khammond on DSK30JT082PROD with RULES HHS agency 42 CFR 1003.510 .......... 42 CFR 1003.410 .......... OIG OIG 1395nn(g)(3) ................... 42 CFR 1003.310 .......... OIG 1395nn(g)(4) ................... 42 CFR 1003.310 .......... OIG 1395ss(d)(1) .................... 42 CFR 1003.1110 ........ OIG 1395ss(d)(2) .................... 42 CFR 1003.1110 ........ OIG 1395ss(d)(3)(A)(ii) ........... 42 CFR 1003.1110 ........ OIG VerDate Sep<11>2014 19:54 Oct 10, 2018 Jkt 247001 PO 00000 Penalty for a prescription drug card sponsor that falsifies or misrepresents marketing materials, overcharges program enrollees, or misuse transitional assistance funds. Penalty for improper billing by Hospitals, Critical Access Hospitals, or Skilled Nursing Facilities. Penalty for a hospital or responsible physician dumping patients needing emergency medical care, if the hospital has 100 beds or more. Penalty for a hospital or responsible physician dumping patients needing emergency medical care, if the hospital has less than 100 beds. Penalty for a HMO or competitive plan is such plan substantially fails to provide medically necessary, required items or services. Penalty for HMOs/competitive medical plans that charge premiums in excess of permitted amounts. Penalty for a HMO or competitive medical plan that expels or refuses to reenroll an individual per prescribed conditions. Penalty for a HMO or competitive medical plan that implements practices to discourage enrollment of individuals needing services in future. Penalty per individual not enrolled in a plan as a result of a HMO or competitive medical plan that implements practices to discourage enrollment of individuals needing services in the future. Penalty for a HMO or competitive medical plan that misrepresents or falsifies information to the Secretary. Penalty for a HMO or competitive medical plan that misrepresents or falsifies information to an individual or any other entity. Penalty for failure by HMO or competitive medical plan to assure prompt payment of Medicare risk sharing contracts or incentive plan provisions. Penalty for HMO that employs or contracts with excluded individual or entity. Penalty for submitting or causing to be submitted claims in violation of the Stark Law’s restrictions on physician self-referrals. Penalty for circumventing Stark Law’s restrictions on physician self-referrals. Penalty for a material misrepresentation regarding Medigap compliance policies. Penalty for selling Medigap policy under false pretense. Penalty for an issuer that sells health insurance policy that duplicates benefits. Penalty for someone other than issuer that sells health insurance that duplicates benefits. Frm 00076 Fmt 4700 Sfmt 4700 2016 Maximum adjusted penalty ($) Date of last statutorily established penalty figure 3 Description 2 2017 Maximum adjusted penalty ($) 4 2018 Maximum adjusted penalty ($) 2016 12,856 13,066 13,333 2016 5,000 5,082 5,186 2016 103,139 104,826 106,965 2016 51,570 52,414 53,484 2016 51,570 52,414 53,484 2016 51,570 52,414 53,484 2016 51,570 52,414 53,484 2016 206,278 209,653 213,932 2016 29,680 30,166 30,782 2016 206,278 209,653 213,932 2016 51,570 52,414 53,484 2016 51,570 52,414 53,484 2016 47,340 48,114 49,096 2016 23,863 24,253 24,748 2016 159,089 161,692 164,992 2016 9,893 10,055 10,260 2016 9,893 10,055 10,260 2016 44,539 45,268 46,192 2016 26,723 27,160 27,714 E:\FR\FM\11OCR1.SGM 11OCR1 Federal Register / Vol. 83, No. 197 / Thursday, October 11, 2018 / Rules and Regulations 51377 CIVIL MONETARY PENALTY AUTHORITIES ADMINISTERED BY HHS AGENCIES AND PENALTY AMOUNTS—Continued [Effective October 11, 2018] khammond on DSK30JT082PROD with RULES Citation HHS agency U.S.C. CFR 1 1395ss(d)(4)(A) ............... 42 CFR 1003.1110 ........ OIG 1396b(m)(5)(B)(i) ............ 42 CFR 1003.410 .......... OIG 1396r(b)(3)(B)(ii)(I) .......... 42 CFR 1003.210(a)(11) OIG 1396r(b)(3)(B)(ii)(II) ......... 42 CFR 1003.210(a)(11) OIG 1396r(g)(2)(A)(i) .............. 42 CFR 1003.1310 ........ OIG 1396r–8(b)(3)(B) ............. 42 CFR 1003.1210 ........ OIG 1396r–8(b)(3)(C)(i) .......... 42 CFR 1003.1210 ........ OIG 1396r–8(b)(3)(C)(ii) ......... 42 CFR 1003.1210 ........ OIG 1396t(i)(3)(A) ................... 42 CFR 1003.1310 ........ OIG 11131(c) .......................... 42 CFR 1003.810 .......... OIG 11137(b)(2) ..................... 42 CFR 1003.810 .......... OIG 299b–22(f)(1) .................. 42 CFR 3.404 ................ OCR 1320(d)–5(a) ................... 45 CFR 160.404(b)(1)(i), (ii). OCR VerDate Sep<11>2014 19:54 Oct 10, 2018 Jkt 247001 PO 00000 Penalty for using mail to sell a nonapproved Medigap insurance policy. Penalty for a Medicaid MCO that substantially fails to provide medically necessary, required items or services. Penalty for a Medicaid MCO that charges excessive premiums. Penalty for a Medicaid MCO that improperly expels or refuses to reenroll a beneficiary. Penalty per individual who does not enroll as a result of a Medicaid MCO’s practice that would reasonably be expected to have the effect of denying or discouraging enrollment. Penalty for a Medicaid MCO misrepresenting or falsifying information to the Secretary. Penalty for a Medicaid MCO misrepresenting or falsifying information to an individual or another entity. Penalty for a Medicaid MCO that fails to comply with contract requirements with respect to physician incentive plans. Penalty for willfully and knowingly certifying a material and false statement in a Skilled Nursing Facility resident assessment. Penalty for willfully and knowingly causing another individual to certify a material and false statement in a Skilled Nursing Facility resident assessment. Penalty for notifying or causing to be notified a Skilled Nursing Facility of the time or date on which a survey is to be conducted. Penalty for the knowing provision of false information or refusing to provide information about charges or prices of a covered outpatient drug. Penalty per day for failure to timely provide information by drug manufacturer with rebate agreement. Penalty for knowing provision of false information by drug manufacturer with rebate agreement. Penalty for notifying home and community-based providers or settings of survey. Penalty for failing to report a medical malpractice claim to National Practitioner Data Bank. Penalty for breaching confidentiality of information reported to National Practitioner Data Bank. Penalty for violation of confidentiality provision of the Patient Safety and Quality Improvement Act. Penalty for each pre-February 18, 2009 violation of the HIPAA administrative simplification provisions. Calendar Year Cap ......................... Frm 00077 Fmt 4700 Sfmt 4700 2016 Maximum adjusted penalty ($) Date of last statutorily established penalty figure 3 Description 2 2017 Maximum adjusted penalty ($) 4 2018 Maximum adjusted penalty ($) 2016 9,893 10,055 10,260 2016 49,467 50,276 51,302 2016 49,467 50,276 51,302 2016 197,869 201,106 205,211 2016 29,680 30,166 30,782 2016 197,869 201,106 205,211 2016 49,467 50,276 51,302 2016 44,539 45,268 46,192 2016 2,063 2,097 2,140 2016 10,314 10,483 10,697 2016 4,126 4,194 4,280 2016 178,156 181,071 184,767 2016 17,816 18,107 18,477 2016 178,156 181,071 184,767 2016 3,563 3,621 3,695 2016 21,563 21,916 22,363 2016 21,563 21,916 22,363 2016 11,940 12,135 12,383 2016 150 152 155 2016 37,561 38,175 38,954 E:\FR\FM\11OCR1.SGM 11OCR1 51378 Federal Register / Vol. 83, No. 197 / Thursday, October 11, 2018 / Rules and Regulations CIVIL MONETARY PENALTY AUTHORITIES ADMINISTERED BY HHS AGENCIES AND PENALTY AMOUNTS—Continued [Effective October 11, 2018] Citation HHS agency CFR 1 U.S.C. 45 CFR OCR 160.404(b)(2)(i)(A), (B). 45 CFR 160.404(b)(2)(ii)(A), (B). 45 CFR 160.404(b)(2) (iii)(A), (B). 45 CFR 160.404(b)(2)(iv)(A), (B). 263a(h)(2)(B) & 1395w– 2(b)(2)(A)(ii). 42 CFR 493.1834(d)(2)(i). OCR OCR CMS 42 CFR 493.1834(d)(2)(ii). khammond on DSK30JT082PROD with RULES OCR CMS 300gg–15(f) ..................... 45 CFR 147.200(e) ........ CMS 300gg–18 ........................ 45 CFR 158.606 ............ CMS VerDate Sep<11>2014 19:54 Oct 10, 2018 Jkt 247001 PO 00000 Description 2 Penalty for each February 18, 2009 or later violation of a HIPAA administrative simplification provision in which it is established that the covered entity or business associate did not know and by exercising reasonable diligence, would not have known that the covered entity or business associate violated such a provision. Minimum .......................................... Maximum ......................................... Calendar Year Cap ......................... Penalty for each February 18, 2009 or later violation of a HIPAA administrative simplification provision in which it is established that the violation was due to reasonable cause and not to willful neglect. Minimum .......................................... Maximum ......................................... Calendar Year Cap ......................... Penalty for each February 18, 2009 or later violation of a HIPAA administrative simplification provision in which it is established that the violation was due to willful neglect and was corrected during the 30-day period beginning on the first date the covered entity or business associate knew, or, by exercising reasonable diligence, would have known that the violation occurred. Minimum .......................................... Maximum ......................................... Calendar Year Cap ......................... Penalty for each February 18, 2009 or later violation of a HIPAA administrative simplification provision in which it is established that the violation was due to willful neglect and was not corrected during the 30-day period beginning on the first date the covered entity or business associate knew, or by exercising reasonable diligence, would have known that the violation occurred. Minimum .......................................... Maximum ......................................... Calendar Year Cap ......................... Penalty for a clinical laboratory’s failure to meet participation and certification requirements and poses immediate jeopardy. Minimum .......................................... Maximum ......................................... Penalty for a clinical laboratory’s failure to meet participation and certification requirements and the failure does not pose immediate jeopardy. Minimum .......................................... Maximum ......................................... Failure to provide the Summary of Benefits and Coverage. Penalty for violations of regulations related to the medical loss ratio reporting and rebating. Frm 00078 Fmt 4700 Sfmt 4700 Date of last statutorily established penalty figure 3 2016 Maximum adjusted penalty ($) 2017 Maximum adjusted penalty ($) 4 2018 Maximum adjusted penalty ($) .................... .................... .................... .................... 2016 2016 2016 .................... 110 55,010 1,650,300 .................... 112 55,910 1,677,299 .................... 114 57,051 1,711,533 .................... 2016 2016 2016 .................... 1,100 55,010 1,650,300 .................... 1,118 55,910 1,677,299 .................... 1,141 57,051 1,711,533 .................... 2016 2016 2016 .................... 11,002 55,010 1,650,300 .................... 11,182 55,910 1,677,299 .................... 11,410 57,051 1,711,533 .................... 2016 2016 2016 .................... 55,010 1,650,300 1,650,300 .................... 55,910 1,677,299 1,677,299 .................... 57,051 1,711,533 1,711,533 .................... 2016 2016 .................... 6,035 19,787 .................... 6,134 20,111 .................... 6,259 20,521 - 2016 2016 2016 99 5,936 1,087 101 6,033 1,105 103 6,156 1,128 2016 109 111 113 E:\FR\FM\11OCR1.SGM 11OCR1 Federal Register / Vol. 83, No. 197 / Thursday, October 11, 2018 / Rules and Regulations 51379 CIVIL MONETARY PENALTY AUTHORITIES ADMINISTERED BY HHS AGENCIES AND PENALTY AMOUNTS—Continued [Effective October 11, 2018] Citation HHS agency CFR 1 U.S.C. 1320a–7h(b)(1) ............... 1320a–7h(b)(2) ............... 42 CFR 402.105(d)(5), 42 CFR 403.912(a) & (c). 42 CFR 402.105(h), 42 CFR 403 912(b) & (c). 1320a–7j(h)(3)(A) ............ CMS CMS 42 CFR 488.446(a)(1),(2), & (3). 1320a–8(a)(1) ................. khammond on DSK30JT082PROD with RULES CMS CMS CMS 1320a–8(a)(3) ................. CMS 1320b–25(c)(1)(A) ........... CMS VerDate Sep<11>2014 19:54 Oct 10, 2018 Jkt 247001 PO 00000 Description 2 Penalty for manufacturer or group purchasing organization failing to report information required under 42 U.S.C. 1320a–7h(a), relating to physician ownership or investment interests. Minimum .......................................... Maximum ......................................... Calendar Year Cap ......................... Penalty for manufacturer or group purchasing organization knowingly failing to report information required under 42 U.S.C. 1320a– 7h(a) , relating to physician ownership or investment interests. Minimum .......................................... Maximum ......................................... Calendar Year Cap ......................... Penalty for an administrator of a facility that fails to comply with notice requirements for the closure of a facility. Minimum penalty for the first offense of an administrator who fails to provide notice of facility closure. Minimum penalty for the second offense of an administrator who fails to provide notice of facility closure. Minimum penalty for the third and subsequent offenses of an administrator who fails to provide notice of facility closure. Penalty for an entity knowingly making a false statement or representation of material fact in the determination of the amount of benefits or payments related to old-age, survivors, and disability insurance benefits, special benefits for certain World War II veterans, or supplemental security income for the aged, blind, and disabled. Penalty for violation of 42 U.S.C. 1320a–8(a)(1) if the violator is a person who receives a fee or other income for services performed in connection with determination of the benefit amount or the person is a physician or other health care provider who submits evidence in connection with such a determination. Penalty for a representative payee (under 42 U.S.C. 405(j), 1007, or 1383(a)(2)) converting any part of a received payment from the benefit programs described in the previous civil monetary penalty to a use other than for the benefit of the beneficiary. Penalty for failure of covered individuals to report to the Secretary and 1 or more law enforcement officials any reasonable suspicion of a crime against a resident, or individual receiving care, from a long-term care facility. Frm 00079 Fmt 4700 Sfmt 4700 Date of last statutorily established penalty figure 3 2016 Maximum adjusted penalty ($) 2017 Maximum adjusted penalty ($) 4 2018 Maximum adjusted penalty ($) .................... .................... .................... .................... 2016 2016 2016 .................... 1,087 10,874 163,117 .................... 1,105 11,052 165,786 .................... 1,128 11,278 169,170 .................... 2016 2016 2016 2016 10,874 108,745 1,087,450 108,745 11,052 110,524 1,105,241 110,524 11,278 112,780 1,127,799 112,780 2016 544 553 564 2016 1,631 1,658 1,692 2016 3,262 3,315 3,383 2016 7,954 8,084 8,249 2016 7,500 7,623 7,779 2016 6,229 6,331 6,460 2016 217,490 221,048 225,560 E:\FR\FM\11OCR1.SGM 11OCR1 51380 Federal Register / Vol. 83, No. 197 / Thursday, October 11, 2018 / Rules and Regulations CIVIL MONETARY PENALTY AUTHORITIES ADMINISTERED BY HHS AGENCIES AND PENALTY AMOUNTS—Continued [Effective October 11, 2018] HHS agency CFR 1 U.S.C. 1320b–25(c)(2)(A) ........... CMS 1320b–25(d)(2) ............... CMS 1395b–7(b)(2)(B) ............ 42 CFR 402.105(g) ........ CMS 1395i–3(h)(2)(B)(ii)(I) ...... 42 CFR 488.408(d)(1)(iii) CMS 42 CFR 488.408(d)(1)(iv). CMS 42 CFR 488.408(e)(1)(iii) 42 CFR 488.408(e)(1)(iv). CMS 42 CFR 488.408 (e)(2)(ii). CMS 42 CFR 488.438(a)(1)(i) khammond on DSK30JT082PROD with RULES 42 CFR 488.438(a)(1)(ii) 42 CFR 488.438(a)(2) ... VerDate Sep<11>2014 19:54 Oct 10, 2018 Jkt 247001 CMS CMS CMS CMS PO 00000 Description 2 Penalty for failure of covered individuals to report to the Secretary and 1 or more law enforcement officials any reasonable suspicion of a crime against a resident, or individual receiving care, from a long-term care facility if such failure exacerbates the harm to the victim of the crime or results in the harm to another individual. Penalty for a long-term care facility that retaliates against any employee because of lawful acts done by the employee, or files a complaint or report with the State professional disciplinary agency against an employee or nurse for lawful acts done by the employee or nurse. Penalty for any person who knowingly and willfully fails to furnish a beneficiary with an itemized statement of items or services within 30 days of the beneficiary’s request. Penalty per day for a Skilled Nursing Facility that has a Category 2 violation of certification requirements. Minimum .......................................... Maximum ......................................... Penalty per instance of Category 2 noncompliance by a Skilled Nursing Facility. Minimum .......................................... Maximum ......................................... Penalty per day for a Skilled Nursing Facility that has a Category 3 violation of certification requirements. Minimum .......................................... Maximum ......................................... Penalty per instance of Category 3 noncompliance by a Skilled Nursing Facility. Minimum .......................................... Maximum ......................................... Penalty per day and per instance for a Skilled Nursing Facility that has Category 3 noncompliance with Immediate Jeopardy. Per Day (Minimum) ......................... Per Day (Maximum) ........................ Per Instance (Minimum) .................. Per Instance (Maximum) ................. Penalty per day of a Skilled Nursing Facility that fails to meet certification requirements. These amounts represent the upper range per day. Minimum .......................................... Maximum ......................................... Penalty per day of a Skilled Nursing Facility that fails to meet certification requirements. These amounts represent the lower range per day. Minimum .......................................... Maximum ......................................... Penalty per instance of a Skilled Nursing Facility that fails to meet certification requirements. Minimum .......................................... Maximum ......................................... Frm 00080 Fmt 4700 Sfmt 4700 2016 Maximum adjusted penalty ($) Date of last statutorily established penalty figure 3 Citation 2017 Maximum adjusted penalty ($) 4 2018 Maximum adjusted penalty ($) 2016 326,235 331,572 338,339 2016 217,490 221,048 225,560 2016 147 149 152 .................... .................... .................... .................... 2016 2016 .................... 103 6,188 .................... 105 6,289 .................... 107 6,417 .................... 2016 2016 .................... 2,063 20,628 .................... 2,097 20,965 .................... 2,140 21,393 .................... 2016 2016 .................... 6,291 20,628 .................... 6,394 20,965 .................... 6,525 21,393 .................... 2016 2016 .................... 2,063 20,628 .................... 2,097 20,965 .................... 2,140 21,393 .................... 2016 2016 2016 2016 .................... 6,291 20,628 2,063 20,628 .................... 6,394 20,965 2,097 20,965 .................... 6,525 21,393 2,140 21,393 .................... 2016 2016 .................... 6,291 20,628 .................... 6,394 20,965 .................... 6,524 21,393 .................... 2016 2016 .................... 103 6,188 .................... 105 6,289 .................... 107 6,418 .................... 2016 2016 2,063 20,628 2,097 20,965 2,140 21,393 E:\FR\FM\11OCR1.SGM 11OCR1 Federal Register / Vol. 83, No. 197 / Thursday, October 11, 2018 / Rules and Regulations 51381 CIVIL MONETARY PENALTY AUTHORITIES ADMINISTERED BY HHS AGENCIES AND PENALTY AMOUNTS—Continued [Effective October 11, 2018] Citation HHS agency U.S.C. CFR 1 1395l(h)(5)(D) 5 ............... 42 CFR 402.105(d)(2)(i) 1395l(i)(6) ........................ 1395l(q)(2)(B)(i) .............. CMS 42 CFR 402.105(a) ........ CMS ........... 42 CFR 402.1(c)(4), 402.105(d)(2)(ii). CMS 1395m(a)(18)(B) 5 ........... 42 CFR 402.1(c)(5), 402.105(d)(2)(iii). CMS 1395m(b)(5)(C) 5 ............. 42 CFR 402.1(c)(6), 402.105(d)(2)(iv). CMS 1395m(h)(3) 5 .................. 42 CFR 402.1(c)(8), 402.105(d)(2)(vi). CMS 1395m(a)(11)(A) khammond on DSK30JT082PROD with RULES CMS VerDate Sep<11>2014 5 19:54 Oct 10, 2018 Jkt 247001 PO 00000 Penalty for knowingly, willfully, and repeatedly billing for a clinical diagnostic laboratory test other than on an assignment-related basis. (Penalties are assessed in the same manner as 42 U.S.C. 1395u(j)(2)(B), which is assessed according to 1320a–7a(a)). Penalty for knowingly and willfully presenting or causing to be presented a bill or request for payment for an intraocular lens inserted during or after cataract surgery for which the Medicare payment rate includes the cost of acquiring the class of lens involved. Penalty for knowingly and willfully failing to provide information about a referring physician when seeking payment on an unassigned basis. Penalty for any durable medical equipment supplier that knowingly and willfully charges for a covered service that is furnished on a rental basis after the rental payments may no longer be made. (Penalties are assessed in the same manner as 42 U.S.C. 1395u(j)(2)(B), which is assessed according to 1320a–7a(a)). Penalty for any nonparticipating durable medical equipment supplier that knowingly and willfully fails to make a refund to Medicare beneficiaries for a covered service for which payment is precluded due to an unsolicited telephone contact from the supplier. (Penalties are assessed in the same manner as 42 U.S.C. 1395u(j)(2)(B), which is assessed according to 1320a–7a(a)). Penalty for any nonparticipating physician or supplier that knowingly and willfully charges a Medicare beneficiary more than the limiting charge for radiologist services. (Penalties are assessed in the same manner as 42 U.S.C. 1395u(j)(2)(B), which is assessed according to 1320a– 7a(a)). Penalty for any supplier of prosthetic devices, orthotics, and prosthetics that knowing and willfully charges for a covered prosthetic device, orthotic, or prosthetic that is furnished on a rental basis after the rental payment may no longer be made. (Penalties are assessed in the same manner as 42 U.S.C. 1395m(a)(11)(A), that is in the same manner as 1395u(j)(2)(B), which is assessed according to 1320a–7a(a)). Frm 00081 Fmt 4700 Sfmt 4700 2016 Maximum adjusted penalty ($) Date of last statutorily established penalty figure 3 Description 2 2017 Maximum adjusted penalty ($) 4 2018 Maximum adjusted penalty ($) 2018 15,024 15,270 30,000 2016 3,957 4,022 4,104 2016 3,787 3,849 3,928 2018 15,024 15,270 30,000 2018 15,024 15,270 30,000 2018 15,024 15,270 30,000 2018 15,024 15,270 30,000 E:\FR\FM\11OCR1.SGM 11OCR1 51382 Federal Register / Vol. 83, No. 197 / Thursday, October 11, 2018 / Rules and Regulations CIVIL MONETARY PENALTY AUTHORITIES ADMINISTERED BY HHS AGENCIES AND PENALTY AMOUNTS—Continued [Effective October 11, 2018] Citation HHS agency CFR 1 U.S.C. 1395m(j)(2)(A)(iii) ............ 1395m(j)(4) 5 ................... 42 CFR 402.1(c)(10), 402.105(d)(2)(vii). CMS 1395m(k)(6) 5 .................. 42 CFR 402.1(c)(31), 402.105(d)(3). CMS 5 ................... 42 CFR 402.1(c)(32), 402.105(d)(4). CMS 1395u(b)(18)(B) 5 ............ 42 CFR 402.1(c)(11), 402.105(d)(2)(viii). CMS 1395u(j)(2)(B) 5 ............... 42 CFR 402.1(c) ............ CMS 1395u(k) 5 ........................ 42 CFR 402.1(c)(12), 402.105(d)(2)(ix). CMS 1395m(l)(6) khammond on DSK30JT082PROD with RULES CMS VerDate Sep<11>2014 19:54 Oct 10, 2018 Jkt 247001 PO 00000 Penalty for any supplier of durable medical equipment including a supplier of prosthetic devices, prosthetics, orthotics, or supplies that knowingly and willfully distributes a certificate of medical necessity in violation of Section 1834(j)(2)(A)(i) of the Act or fails to provide the information required under Section 1834(j)(2)(A)(ii) of the Act. Penalty for any supplier of durable medical equipment, including a supplier of prosthetic devices, prosthetics, orthotics, or supplies that knowingly and willfully fails to make refunds in a timely manner to Medicare beneficiaries for series billed other than on as assignment-related basis under certain conditions. (Penalties are assessed in the same manner as 42 U.S.C. 1395m(j)(4) and 1395u(j)(2)(B), which is assessed according to 1320a–7a(a)). Penalty for any person or entity who knowingly and willfully bills or collects for any outpatient therapy services or comprehensive outpatient rehabilitation services on other than an assignment-related basis. (Penalties are assessed in the same manner as 42 U.S.C. 1395m(k)(6) and 1395u(j)(2)(B), which is assessed according to 1320a– 7a(a)). Penalty for any supplier of ambulance services who knowingly and willfully fills or collects for any services on other than an assignment-related basis. (Penalties are assessed in the same manner as 42 U.S.C. 1395u(b)(18)(B), which is assessed according to 1320a– 7a(a)). Penalty for any practitioner specified in Section 1842(b)(18)(C) of the Act or other person that knowingly and willfully bills or collects for any services by the practitioners on other than an assignment-related basis. (Penalties are assessed in the same manner as 42 U.S.C. 1395u(j)(2)(B), which is assessed according to 1320a–7a(a)). Penalty for any physician who charges more than 125% for a non-participating referral. (Penalties are assessed in the same manner as 42 U.S.C. 1320a– 7a(a)). Penalty for any physician who knowingly and willfully presents or causes to be presented a claim for bill for an assistant at a cataract surgery performed on or after March 1, 1987, for which payment may not be made because of section 1862(a)(15). (Penalties are assessed in the same manner as 42 U.S.C. 1395u(j)(2)(B), which is assessed according to 1320a–7a(a)). Frm 00082 Fmt 4700 Sfmt 4700 2016 Maximum adjusted penalty ($) Date of last statutorily established penalty figure 3 Description 2 2017 Maximum adjusted penalty ($) 4 2018 Maximum adjusted penalty ($) 2016 1,591 1,617 1,650 2018 15,024 15,270 30,000 2018 15,024 15,270 30,000 2018 15,024 15,270 30,000 2018 15,024 15,270 30,000 2018 15,024 15,270 30,000 2018 15,024 15,270 30,000 E:\FR\FM\11OCR1.SGM 11OCR1 Federal Register / Vol. 83, No. 197 / Thursday, October 11, 2018 / Rules and Regulations 51383 CIVIL MONETARY PENALTY AUTHORITIES ADMINISTERED BY HHS AGENCIES AND PENALTY AMOUNTS—Continued [Effective October 11, 2018] Citation CFR 1 U.S.C. khammond on DSK30JT082PROD with RULES HHS agency 1395u(l)(3) 5 .................... 42 CFR 402.1(c)(13), 402.105(d)(2)(x). CMS 1395u(m)(3) 5 .................. 42 CFR 402.1(c)(14), 402.105(d)(2)(xi). CMS 1395u(n)(3) 5 ................... 42 CFR 402.1(c)(15), 402.105(d)(2)(xii). CMS 1395u(o)(3)(B) 5 .............. 42 CFR 414.707(b) ........ CMS 1395u(p)(3)(A) ................ ........................................ CMS 1395w–3a(d)(4)(A) .......... 42 CFR 414.806 ............ CMS VerDate Sep<11>2014 19:54 Oct 10, 2018 Jkt 247001 PO 00000 Penalty for any nonparticipating physician who does not accept payment on an assignment-related basis and who knowingly and willfully fails to refund on a timely basis any amounts collected for services that are not reasonable or medically necessary or are of poor quality under 1842(l)(1)(A). (Penalties are assessed in the same manner as 42 U.S.C. 1395u(j)(2)(B), which is assessed according to 1320a–7a(a)). Penalty for any nonparticipating physician charging more than $500 who does not accept payment for an elective surgical procedure on an assignment related basis and who knowingly and willfully fails to disclose the required information regarding charges and coinsurance amounts and fails to refund on a timely basis any amount collected for the procedure in excess of the charges recognized and approved by the Medicare program. (Penalties are assessed in the same manner as 42 U.S.C. 1395u(j)(2)(B), which is assessed according to 1320a– 7a(a)). Penalty for any physician who knowingly, willfully, and repeatedly bills one or more beneficiaries for purchased diagnostic tests any amount other than the payment amount specified by the Act. (Penalties are assessed in the same manner as 42 U.S.C. 1395u(j)(2)(B), which is assessed according to 1320a–7a(a)). Penalty for any practitioner specified in Section 1842(b)(18)(C) of the Act or other person that knowingly and willfully bills or collects for any services pertaining to drugs or biologics by the practitioners on other than an assignment-related basis. (Penalties are assessed in the same manner as 42 U.S.C. 1395u(b)(18)(B) and 1395u(j)(2)(B), which is assessed according to 1320a–7a(a)). Penalty for any physician or practitioner who knowingly and willfully fails promptly to provide the appropriate diagnosis codes upon CMS or Medicare administrative contractor request for payment or bill not submitted on an assignment-related basis. Penalty for a pharmaceutical manufacturer’s misrepresentation of average sales price of a drug, or biologic. Frm 00083 Fmt 4700 Sfmt 4700 2016 Maximum adjusted penalty ($) Date of last statutorily established penalty figure 3 Description 2 2017 Maximum adjusted penalty ($) 4 2018 Maximum adjusted penalty ($) 2018 15,024 15,270 30,000 2018 15,024 15,270 30,000 2018 15,024 15,270 30,000 2018 15,024 15,270 30,000 2016 3,957 4,022 4,104 2016 12,856 13,066 13,333 E:\FR\FM\11OCR1.SGM 11OCR1 51384 Federal Register / Vol. 83, No. 197 / Thursday, October 11, 2018 / Rules and Regulations CIVIL MONETARY PENALTY AUTHORITIES ADMINISTERED BY HHS AGENCIES AND PENALTY AMOUNTS—Continued [Effective October 11, 2018] Citation CFR 1 U.S.C. khammond on DSK30JT082PROD with RULES HHS agency 1395w–4(g)(1)(B) 5 .......... 42 CFR 402.1(c)(17), 402.105(d)(2)(xiii). CMS 1395w–4(g)(3)(B) 5 .......... 42 CFR 402.1(c)(18), 402.105(d)(2)(xiv). CMS 1395w–27(g)(3)(A); 1857(g)(3). 42 CFR 422.760(b); 42 CFR 423.760(b). CMS 1395w–27(g)(3)(B); 1857(g)(3). ........................................ CMS 1395w–27(g)(3)(D); 1857(g)(3). ........................................ CMS 1395y(b)(3)(C) ................ 42 CFR 411.103(b) ........ CMS 1395y(b)(5)(C)(ii) ............ 42 CFR 402.1(c)(20), 42 CFR 402.105(b)(2). CMS 1395y(b)(6)(B) ................. 42 CFR 402.1(c)(21), 402.105(a). CMS 1395y(b)(7)(B)(i) ............. ........................................ CMS VerDate Sep<11>2014 19:54 Oct 10, 2018 Jkt 247001 PO 00000 Penalty for any nonparticipating physician, supplier, or other person that furnishes physician services not on an assignment-related basis who either knowingly and willfully bills or collects in excess of the statutorily-defined limiting charge or fails to make a timely refund or adjustment. (Penalties are assessed in the same manner as 42 U.S.C. 1395u(j)(2)(B), which is assessed according to 1320a–7a(a)). Penalty for any person that knowingly and willfully bills for statutorily defined State-plan approved physicians’ services on any other basis than an assignment-related basis for a Medicare/Medicaid dual eligible beneficiary. (Penalties are assessed in the same manner as 42 U.S.C. 1395u(j)(2)(B), which is assessed according to 1320a– 7a(a)). Penalty for each termination determination the Secretary makes that is the result of actions by a Medicare Advantage organization or Part D sponsor that has adversely affected an individual covered under the organization’s contract. Penalty for each week beginning after the initiation of civil money penalty procedures by the Secretary because a Medicare Advantage organization or Part D sponsor has failed to carry out a contract, or has carried out a contract inconsistently with regulations. Penalty for a Medicare Advantage organization’s or Part D sponsor’s early termination of its contract. Penalty for an employer or other entity to offer any financial or other incentive for an individual entitled to benefits not to enroll under a group health plan or large group health plan which would be a primary plan. Penalty for any non-governmental employer that, before October 1, 1998, willfully or repeatedly failed to provide timely and accurate information requested relating to an employee’s group health insurance coverage. Penalty for any entity that knowingly, willfully, and repeatedly fails to complete a claim form relating to the availability of other health benefits in accordance with statute or provides inaccurate information relating to such on the claim form. Penalty for any entity serving as insurer, third party administrator, or fiduciary for a group health plan that fails to provide information that identifies situations where the group health plan is or was a primary plan to Medicare to the HHS Secretary. Frm 00084 Fmt 4700 Sfmt 4700 2016 Maximum adjusted penalty ($) Date of last statutorily established penalty figure 3 Description 2 2017 Maximum adjusted penalty ($) 4 2018 Maximum adjusted penalty ($) 2018 15,024 15,270 30,000 2018 15,024 15,270 30,000 2016 36,794 37,396 38,159 2016 14,718 14,959 15,264 2016 136,689 138,925 141,760 2016 8,908 9,054 9,239 2016 1,450 1,474 1,504 2016 3,182 3,234 3,300 2016 1,138 1,157 1,181 E:\FR\FM\11OCR1.SGM 11OCR1 Federal Register / Vol. 83, No. 197 / Thursday, October 11, 2018 / Rules and Regulations 51385 CIVIL MONETARY PENALTY AUTHORITIES ADMINISTERED BY HHS AGENCIES AND PENALTY AMOUNTS—Continued [Effective October 11, 2018] Citation CFR 1 U.S.C. 1395pp(h) 5 ..................... 42 CFR 402.1(c)(23), 402.105(d)(2)(xv). CMS 1395nn(g)(5) ................... 42 CFR 411.361 ............ CMS 1395pp(h) ........................ 42 CFR 402.1(c)(23), 402.105(d)(2)(xv). CMS 1395ss(a)(2) .................... 42 CFR 402.1(c)(24), 405.105(f)(1). CMS 1395ss(d)(3)(A)(vi)(II) ..... ........................................ CMS 1395ss(d)(3)(B)(iv) .......... 1395ss(p)(8) .................... 1395ss(p)(9)(C) ............... khammond on DSK30JT082PROD with RULES HHS agency VerDate Sep<11>2014 ........................................ CMS 42 CFR 402.1(c)(25), 402.105(e). CMS 42 CFR 402.1(c)(25), 405.105(f)(2). CMS 42 CFR 402.1(c)(26), 402.105(e). CMS 19:54 Oct 10, 2018 Jkt 247001 PO 00000 Penalty for any durable medical equipment supplier, including a supplier of prosthetic devices, prosthetics, orthotics, or supplies, that knowingly and willfully fails to make refunds in a timely manner to Medicare beneficiaries under certain conditions. (42 U.S.C. 1395(m)(18) sanctions apply here in the same manner, which is under 1395u(j)(2) and 1320a–7a(a)). Penalty for any person that fails to report information required by HHS under Section 1877(f) concerning ownership, investment, and compensation arrangements. Penalty for any durable medical equipment supplier, including a supplier of prosthetic devices, prosthetics, orthotics, or supplies, that knowingly and willfully fails to make refunds in a timely manner to Medicare beneficiaries under certain conditions. (42 U.S.C. 1395(m)(18) sanctions apply here in the same manner, which is under 1395u(j)(2) and 1320a–7a(a)). Penalty for any person that issues a Medicare supplemental policy that has not been approved by the State regulatory program or does not meet Federal standards after a statutorily defined effective date. Penalty for someone other than issuer that sells or issues a Medicare supplemental policy to beneficiary without a disclosure statement. Penalty for an issuer that sells or issues a Medicare supplemental policy without disclosure statement. Penalty for someone other than issuer that sells or issues a Medicare supplemental policy without acknowledgement form.. Penalty for issuer that sells or issues a Medicare supplemental policy without an acknowledgement form. Penalty for any person that sells or issues Medicare supplemental polices after a given date that fail to conform to the NAIC or Federal standards established by statute. Penalty for any person that sells or issues Medicare supplemental polices after a given date that fail to conform to the NAIC or Federal standards established by statute. Penalty for any person that sells a Medicare supplemental policy and fails to make available for sale the core group of basic benefits when selling other Medicare supplemental policies with additional benefits or fails to provide the individual, before selling the policy, an outline of coverage describing benefits. Frm 00085 Fmt 4700 Sfmt 4700 2016 Maximum adjusted penalty ($) Date of last statutorily established penalty figure 3 Description 2 2017 Maximum adjusted penalty ($) 4 2018 Maximum adjusted penalty ($) 2018 15,024 15,270 30,000 2016 18,936 19,246 19,639 2016 15,024 15,270 15,582 2016 51,569 52,413 53,483 2016 26,723 27,160 27,714 2016 44,539 45,268 46,192 2016 26,723 27,160 27,714 2016 44,539 45,268 46,192 2016 26,723 27,160 27,714 2016 44,539 45,268 46,192 2016 26,723 27,160 27,714 E:\FR\FM\11OCR1.SGM 11OCR1 51386 Federal Register / Vol. 83, No. 197 / Thursday, October 11, 2018 / Rules and Regulations CIVIL MONETARY PENALTY AUTHORITIES ADMINISTERED BY HHS AGENCIES AND PENALTY AMOUNTS—Continued [Effective October 11, 2018] Citation HHS agency CFR 1 U.S.C. 42 CFR 402.1(c)(26), 405.105(f)(3), (4). 1395ss(q)(5)(C) ............... 42 CFR 402.1(c)(27), 405.105(f)(5). CMS 1395ss(r)(6)(A) ................ 42 CFR 402.1(c)(28), 405.105(f)(6). CMS 1395ss(s)(4) .................... 42 CFR 402.1(c)(29), 405.105(c). CMS 1395ss(t)(2) ..................... 42 CFR 402.1(c)(30), 405.105(f)(7). CMS 1395ss(v)(4)(A) ............... ........................................ CMS 1395bbb(c)(1) ................. 42 CFR 488.725(c) ........ CMS 1395bbb(f)(2)(A)(i) .......... 42 CFR 488.845(b)(2)(iii); 42 CFR 488.845(b)(3)– (6); and 42 CFR 488.845(d)(1)(ii). 42 CFR 488.845(b)(3) ... CMS 42 CFR 488.845(b)(3)(i) 42 CFR 488.845(b)(3)(ii) khammond on DSK30JT082PROD with RULES 42 CFR 488.845(b)(3)(iii) 42 CFR 488.845(b)(4) ... VerDate Sep<11>2014 19:54 Oct 10, 2018 Jkt 247001 PO 00000 Penalty for any person that sells a Medicare supplemental policy and fails to make available for sale the core group of basic benefits when selling other Medicare supplemental policies with additional benefits or fails to provide the individual, before selling the policy, an outline of coverage describing benefits. Penalty for any person that fails to suspend the policy of a policyholder made eligible for medical assistance or automatically reinstates the policy of a policyholder who has lost eligibility for medical assistance, under certain circumstances. Penalty for any person that fails to provide refunds or credits as required by section 1882(r)(1)(B). Penalty for any issuer of a Medicare supplemental policy that does not waive listed time periods if they were already satisfied under a proceeding Medicare supplemental policy, or denies a policy, or conditions the issuances or effectiveness of the policy, or discriminates in the pricing of the policy base on health status or other specified criteria. Penalty for any issuer of a Medicare supplemental policy that fails to fulfill listed responsibilities. Penalty someone other than 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, issues, or renews a Medigap Rx policy who is a Part D enrollee. Penalty for any individual who notifies or causes to be notified a home health agency of the time or date on which a survey of such agency is to be conducted. Maximum daily penalty amount for each day a home health agency is not in compliance with statutory requirements. Penalty per day for home health agency’s noncompliance (Upper Range). Minimum .......................................... Maximum ......................................... Penalty for a home health agency’s deficiency or deficiencies that cause immediate jeopardy and result in actual harm. Penalty for a home health agency’s deficiency or deficiencies that cause immediate jeopardy and result in potential for harm. Penalty for an isolated incident of noncompliance in violation of established HHA policy. 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 .......................................... Frm 00086 Fmt 4700 Sfmt 4700 2016 Maximum adjusted penalty ($) Date of last statutorily established penalty figure 3 Description 2 2017 Maximum adjusted penalty ($) 4 2018 Maximum adjusted penalty ($) 2016 44,539 45,268 46,192 2016 44,539 45,268 46,192 2016 44,539 45,268 46,192 2016 18,908 19,217 19,609 2016 44,539 45,268 46,192 2016 19,284 19,599 19,999 2016 32,140 32,666 33,333 2016 4,126 4,194 4,280 2016 19,787 20,111 20,521 .................... .................... .................... .................... 2016 2016 2016 16,819 19,787 19,787 17,094 20,111 20,111 17,443 20,521 20,521 2016 17,808 18,099 18,468 2016 16,819 17,094 17,443 .................... .................... .................... .................... 2016 2,968 3,017 3,079 E:\FR\FM\11OCR1.SGM 11OCR1 Federal Register / Vol. 83, No. 197 / Thursday, October 11, 2018 / Rules and Regulations 51387 CIVIL MONETARY PENALTY AUTHORITIES ADMINISTERED BY HHS AGENCIES AND PENALTY AMOUNTS—Continued [Effective October 11, 2018] Citation HHS agency CFR 1 U.S.C. 42 CFR 488.845(b)(5) ... 42 CFR 488.845(b)(6) ... 42 CFR 488.845(d)(1)(ii) 1396b(m)(5)(B) ............... 1396r(h)(3)(C)(ii)(I) .......... 42 CFR 460.46 .............. 42 CFR 488.408(d)(1)(iii) 42 CFR 488.408(d)(1)(iv). khammond on DSK30JT082PROD with RULES 42 CFR 488.408(e)(1)(iv). Jkt 247001 CMS CMS 42 CFR 488.408(e)(2)(ii) 19:54 Oct 10, 2018 CMS CMS 42 CFR 488.408(e)(1)(iii) VerDate Sep<11>2014 CMS CMS PO 00000 Description 2 Maximum ......................................... 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 .......................................... Maximum ......................................... 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 .......................................... Maximum ......................................... Penalty for each day of noncompliance (Maximum). Penalty for each day of noncompliance (Maximum). Penalty for PACE organization’s practice that would reasonably be expected to have the effect of denying or discouraging enrollment. Minimum .......................................... Maximum ......................................... Penalty for a PACE organization that charges excessive premiums. Penalty for a PACE organization misrepresenting or falsifying information to CMS, the State, or an individual or other entity. Penalty for each determination the CMS makes that the PACE organization has failed to provide medically necessary items and services of the failure has adversely affected (or has the substantial likelihood of adversely affecting) a PACE participant. Penalty for involuntarily disenrolling a participant. Penalty for discriminating or discouraging enrollment or disenrollment of participants on the basis of an individual’s health status or need for health care services. Penalty per day for a nursing facility’s failure to meet a Category 2 Certification. Minimum .......................................... Maximum ......................................... Penalty per instance for a nursing facility’s failure to meet Category 2 certification. Minimum .......................................... Maximum ......................................... Penalty per day for a nursing facility’s failure to meet Category 3 certification. Minimum .......................................... Maximum ......................................... Penalty per instance for a nursing facility’s failure to meet Category 3 certification. Minimum .......................................... Maximum ......................................... Penalty per instance for a nursing facility’s failure to meet Category 3 certification, which results in immediate jeopardy. Frm 00087 Fmt 4700 Sfmt 4700 Date of last statutorily established penalty figure 3 2016 Maximum adjusted penalty ($) 2017 Maximum adjusted penalty ($) 4 2018 Maximum adjusted penalty ($) 2016 .................... 16,819 .................... 17,094 .................... 17,443 .................... 2016 2016 .................... 989 7,915 .................... 1,005 8,044 .................... 1,026 8,208 .................... 2016 2016 2016 1,979 19,787 19,787 2,011 20,111 20,111 2,052 20,521 20,521 2016 19,787 20,111 20,521 .................... .................... .................... .................... 2016 2016 2016 22,077 147,177 36,794 22,438 149,585 37,396 22,896 152,638 38,159 2016 147,177 149,585 152,638 2016 36,794 37,396 38,159 2016 36,794 37,396 38,159 2016 36,794 37,396 38,159 .................... .................... .................... .................... 2016 2016 .................... 103 6,188 .................... 105 6,289 .................... 107 6,417 .................... 2016 2016 .................... 2,063 20,628 .................... 2,097 20,965 .................... 2,140 21,393 .................... 2016 2016 .................... 6,291 20,628 .................... 6,394 20,965 .................... 6,525 21,393 .................... 2016 2016 .................... 2,063 20,628 .................... 2,097 20,965 .................... 2,140 21,393 .................... E:\FR\FM\11OCR1.SGM 11OCR1 51388 Federal Register / Vol. 83, No. 197 / Thursday, October 11, 2018 / Rules and Regulations CIVIL MONETARY PENALTY AUTHORITIES ADMINISTERED BY HHS AGENCIES AND PENALTY AMOUNTS—Continued [Effective October 11, 2018] Citation HHS agency CFR 1 U.S.C. 42 CFR 488.438(a)(1)(i) 42 CFR 488.438(a)(1)(ii) 42 CFR 488.438(a)(2) ... CMS CMS 1396r(f)(2)(B)(iii)(I)(c) ...... 42 CFR 483.151(b)(2)(iv) and (b)(3)(iii). CMS 1396r(h)(3)(C)(ii)(I) .......... 42 CFR 483.151(c)(2) ... CMS 1396t(j)(2)(C) .................. ........................................ CMS 1396u–2(e)(2)(A)(i) ......... 1396u–2(e)(2)(A)(ii) ........ khammond on DSK30JT082PROD with RULES CMS 1396u–2(e)(2)(A)(iv) ....... VerDate Sep<11>2014 42 CFR 438.704 ............ 42 CFR 438.704 ............ 42 CFR 438.704 ............ 19:54 Oct 10, 2018 Jkt 247001 CMS CMS CMS PO 00000 Description 2 Minimum .......................................... Maximum ......................................... Penalty per day for nursing facility’s failure to meet certification (Upper Range). Minimum .......................................... Maximum ......................................... Penalty per day for nursing facility’s failure to meet certification (Lower Range). Minimum .......................................... Maximum ......................................... Penalty per instance for nursing facility’s failure to meet certification. Minimum .......................................... Maximum ......................................... Grounds to prohibit approval of Nurse Aide Training Program—if assessed a penalty in 1819(h)(2)(B)(i) or 1919(h)(2)(A)(ii) of ‘‘not less than $5,000’’ [Not CMP authority, but a specific CMP amount (CMP at this level) that is the triggering condition for disapproval]. Grounds to waive disapproval of nurse aide training program—reference to disapproval based on imposition of CMP ‘‘not less than $5,000’’ [Not CMP authority but CMP imposition at this level determines eligibility to seek waiver of disapproval of nurse aide training program]. Penalty for each day of noncompliance for a home or community care provider that no longer meets the minimum requirements for home and community care. Minimum .......................................... Maximum ......................................... Penalty for a Medicaid managed care organization that fails substantially to provide medically necessary items and services. Penalty for Medicaid managed care organization that imposes premiums or charges on enrollees in excess of the premiums or charges permitted. Penalty for a Medicaid managed care organization that misrepresents or falsifies information to another individual or entity. Penalty for a Medicaid managed care organization that fails to comply with the applicable statutory requirements for such organizations. Penalty for a Medicaid managed care organization that misrepresents or falsifies information to the HHS Secretary. Penalty for Medicaid managed care organization that acts to discriminate among enrollees on the basis of their health status. Penalty for each individual that does not enroll as a result of a Medicaid managed care organization that acts to discriminate among enrollees on the basis of their health status. Frm 00088 Fmt 4700 Sfmt 4700 Date of last statutorily established penalty figure 3 2016 Maximum adjusted penalty ($) 2017 Maximum adjusted penalty ($) 4 2018 Maximum adjusted penalty ($) 2016 2016 .................... 2,063 20,628 .................... 2,097 20,965 .................... 2,140 21,393 .................... 2016 2016 .................... 6,291 20,628 .................... 6,394 20,965 .................... 6,525 21,393 .................... 2016 2016 .................... 103 6,188 .................... 105 6,289 .................... 107 6,417 .................... 2016 2016 2016 2,063 20,628 10,314 2,097 20,965 10,483 2,140 21,393 10,697 2016 10,314 10,483 10,697 .................... .................... .................... .................... 2016 2016 2016 2 17,816 36,794 2 18,107 37,396 2 18,477 38,159 2016 36,794 37,396 38,159 2016 36,794 37,396 38,159 2016 36,794 37,396 38,159 2016 147,177 149,585 152,638 2016 147,177 149,585 152,638 2016 22,077 22,438 22,896 E:\FR\FM\11OCR1.SGM 11OCR1 Federal Register / Vol. 83, No. 197 / Thursday, October 11, 2018 / Rules and Regulations 51389 CIVIL MONETARY PENALTY AUTHORITIES ADMINISTERED BY HHS AGENCIES AND PENALTY AMOUNTS—Continued [Effective October 11, 2018] HHS agency CFR 1 U.S.C. 1396u(h)(2) ..................... 42 CFR Part 441, Subpart I. 1396w–2(c)(1) ................. CMS CMS 18041(c)(2) ..................... 45 CFR 150.315; 45 CFR 156.805(c). CMS 18081(h)(1)(A)(i)(II) ......... 42 CFR 155.285 ............ CMS 18081(h)(1)(B) ................ 42 CFR 155.285 ............ CMS 18081(h)(2) ..................... 42 CFR 155.260 ............ CMS 1352 ................................ 45 CFR 93.400(e) .......... HHS 2016 Maximum adjusted penalty ($) Date of last statutorily established penalty figure 3 Citation Description 2 Penalty for a provider not meeting one of the requirements relating to the protection of the health, safety, and welfare of individuals receiving community supported living arrangements services. Penalty for disclosing information related to eligibility determinations for medical assistance programs. Failure to comply with requirements of the Public Health Services Act; Penalty for violations of rules or standards of behavior associated with issuer participation in the Federally-facilitated Exchange. (42 U.S.C. 300gg–22(b)(2)(C)). Penalty for providing false information on Exchange application. Penalty for knowingly or willfully providing false information on Exchange application. Penalty for knowingly or willfully disclosing protected information from Exchange. 2017 Maximum adjusted penalty ($) 4 2018 Maximum adjusted penalty ($) 2016 20,628 20,965 21,393 2016 11,002 11,182 11,410 2016 150 152 155 2016 27,186 27,631 28,195 2016 271,862 276,310 281,949 2016 27,186 27,631 28,195 2016 18,936 19,246 19,639 .................... .................... .................... .................... 2016 2016 2016 18,936 189,361 18,936 19,246 192,459 19,246 19,639 196,387 19,639 .................... .................... .................... .................... 2016 2016 .................... 18,936 189,361 .................... 19,246 192,459 .................... 19,639 196,387 .................... 2016 2016 .................... 18,936 189,361 .................... 19,246 192,459 .................... 19,639 196,387 .................... 2016 2016 2016 18,936 189,361 9,894 19,246 192,459 10,056 19,639 196,387 10,261 2016 9,894 10,056 10,261 31 U.S.C. 45 CFR Part 93, Appendix A. khammond on DSK30JT082PROD with RULES 3801–3812 ...................... 1 Some HHS 45 CFR 79.3(a)(1)(iv) .... HHS 45 CFR 79.3(b)(1(ii) ...... HHS Penalty for the first time 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 .......................................... Maximum ......................................... Penalty for the first time 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 .......................................... Maximum ......................................... Penalty for failure to provide certification regarding lobbying in the award documents for all subawards of all tiers. Minimum .......................................... Maximum ......................................... Penalty for failure to provide statement regarding lobbying for loan guarantee and loan insurance transactions. Minimum .......................................... Maximum ......................................... Penalty against any individual who—with knowledge or reason to know—makes, presents or submits a false, fictitious or fraudulent claim to the Department. Penalty against any individual who—with knowledge or reason to know—makes, presents or submits a false, fictitious or fraudulent claim to the Department. HHS components have not promulgated regulations regarding their civil monetary penalty-specific statutory authorities. VerDate Sep<11>2014 19:54 Oct 10, 2018 Jkt 247001 PO 00000 Frm 00089 Fmt 4700 Sfmt 4700 E:\FR\FM\11OCR1.SGM 11OCR1 51390 Federal Register / Vol. 83, No. 197 / Thursday, October 11, 2018 / Rules and Regulations 2 The description is not intended to be a comprehensive explanation of the underlying violation; the statute and corresponding regulation, if applicable, should be consulted. 3 Statutory or Inflation Act Adjustment. 4 The cost of living multiplier for 2018, based on the CPI–U for the month of October 2017, not seasonally adjusted, is 1.02041, as indicated in OMB Memorandum M–18–03, ‘‘Implementation of Penalty Inflation Adjustments for 2018, Pursuant to the Federal Civil Penalties Adjustment Act Improvements Act of 2015’’ (December 15, 2017). 5 2018 Maximum Adjusted Penalty column adjusted based on changes to the Bipartisan Budget Act of 2018 for 42 U.S.C.1320a–7a(a),1320a–7a(b), 1395l(h)(5)(D),1395m(a)(11)(A),1395m(a)(18)(B), 1395m(b)(5)(C), 1395m(h)(3), 1395m(j)(4), 1395m(k)(6), 1395m(l)(6), 1395u(b)(18)(B), 1395u(j)(2)(B), 1395u(k), 1395u(l)(3), 1395u(m)(3), 1395u(n)(3), 1395u(o)(3)(B), 1395w–4(g)(1)(B), 1395w–4(g)(3)(B),1395pp(h). Dated: October 3, 2018. Alex M. Azar II, Secretary, Department of Health and Human Services. [FR Doc. 2018–22005 Filed 10–10–18; 8:45 am] BILLING CODE 4150–24–P DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 622 [Docket No. 121004518–3398–01] RIN 0648–XG524 Reef Fish Fishery of the Gulf of Mexico; 2018 Commercial Accountability Measure and Closure for Gulf of Mexico Gray Triggerfish National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce. ACTION: Temporary rule; closure. AGENCY: NMFS implements accountability measures (AMs) for the gray triggerfish commercial sector in the exclusive economic zone (EEZ) of the Gulf of Mexico (Gulf) through this temporary rule. NMFS projects that 2018 commercial landings for gray triggerfish will reach the commercial annual catch target (ACT) (commercial quota) by October 7, 2018. Therefore, NMFS is closing the commercial sector for Gulf gray triggerfish on October 7, 2018, and it will remain closed through the end of the fishing year on December 31, 2018. This closure is necessary to protect the Gulf gray triggerfish resource. SUMMARY: This temporary rule is effective at 12:01 a.m., local time, on October 7, 2018, until 12:01 a.m., local time, on January 1, 2019. FOR FURTHER INFORMATION CONTACT: Lauren Waters, NMFS Southeast Regional Office, telephone: 727–824– 5305, email: lauren.waters@noaa.gov. SUPPLEMENTARY INFORMATION: NMFS manages the Gulf reef fish fishery, which includes gray triggerfish, under the Fishery Management Plan for the Reef Fish Resources of the Gulf of khammond on DSK30JT082PROD with RULES DATES: VerDate Sep<11>2014 19:54 Oct 10, 2018 Jkt 247001 Mexico (FMP). The Gulf of Mexico Fishery Management Council (Council) prepared the FMP and NMFS implements the FMP under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) by regulations at 50 CFR part 622. All gray triggerfish weights discussed in this temporary rule are in round weight. On August 4, 2008, NMFS established gray triggerfish AMs as well as commercial quotas for gray triggerfish through Amendment 30A to the FMP (73 FR 38139). On May 9, 2013, NMFS issued a final rule to implement Amendment 37 to the FMP (78 FR 27084). In part, Amendment 37 revised gray triggerfish commercial ACLs and ACTs. The 2018 commercial quota (i.e., the commercial ACT) for Gulf gray triggerfish specified in 50 CFR 622.39(a)(1)(vi) is 60,900 lb (27,624 kg). As specified by 50 CFR 622.41(b)(1), NMFS is required to close the commercial sector for gray triggerfish when the commercial quota is reached, or is projected to be reached, by filing a notification to that effect with the Office of the Federal Register. NMFS has determined the 2018 commercial quota for Gulf gray triggerfish will be reached by October 7, 2018. Accordingly, this temporary rule closes the commercial sector for Gulf gray triggerfish effective at 12:01 a.m., local time, October 7, 2018, and it will remain closed until the start of the next commercial fishing season on January 1, 2019. During the commercial closure, the operator of a vessel with a valid commercial vessel permit for Gulf reef fish having gray triggerfish onboard must have landed and bartered, traded, or sold such gray triggerfish prior to 12:01 a.m., local time, October 7, 2018. During the closure, the sale or purchase of gray triggerfish taken from the Gulf EEZ is prohibited. The prohibition on the sale or purchase does not apply to gray triggerfish that were harvested, landed ashore, and sold prior to 12:01 a.m., local time, October 7, 2018, and were held in cold storage by a dealer or processor. Classification The Regional Administrator for the NMFS Southeast Region has determined this temporary rule is necessary for the conservation and management of Gulf PO 00000 Frm 00090 Fmt 4700 Sfmt 9990 gray triggerfish and is consistent with the Magnuson-Stevens Act and other applicable laws. This action is taken under 50 CFR 622.41(b)(1) and is exempt from review under Executive Order 12866. These measures are exempt from the procedures of the Regulatory Flexibility Act because the temporary rule is issued without opportunity for prior notice and comment. This action responds to the best scientific information available. The Assistant Administrator for NOAA Fisheries (AA) finds that the need to immediately implement this action to close the commercial sector for gray triggerfish constitutes good cause to waive the requirements to provide prior notice and opportunity for public comment on this temporary rule pursuant to the authority set forth in 5 U.S.C. 553(b)(B), because such procedures are unnecessary and contrary to the public interest. Such procedures are unnecessary because Amendment 37 to the FMP (78 FR 27084; May 9, 2013), which established the closure provisions, was subject to notice and comment, and all that remains is to notify the public of the closure. Such procedures are contrary to the public interest because of the need to immediately implement this action to protect gray triggerfish since the capacity of the fishing fleet allows for rapid harvest of the commercial quota. Prior notice and opportunity for public comment would require time and could potentially result in a harvest well in excess of the established commercial quota. For the aforementioned reasons, the AA also finds good cause to waive the 30-day delay in the effectiveness of this action under 5 U.S.C. 553(d)(3). Authority: 16 U.S.C. 1801 et seq. Margo B. Schulze-Haugen, Acting Director, Office of Sustainable Fisheries, National Marine Fisheries Service. [FR Doc. 2018–22142 Filed 10–5–18; 4:15 pm] BILLING CODE 3510–22–P E:\FR\FM\11OCR1.SGM 11OCR1

Agencies

DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 83, Number 197 (Thursday, October 11, 2018)]
[Rules and Regulations]
[Pages 51369-51390]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-22005]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

45 CFR Part 102

RIN 0991-AC0


Annual Civil Monetary Penalties Inflation Adjustment

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

ACTION: Final rule.

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SUMMARY: The Department of Health and Human Services is updating its 
regulations to reflect required annual inflation-related increases to 
the civil monetary penalties in its regulations, pursuant to the 
Federal Civil Penalties Inflation Adjustment Act Improvements Act of 
2015.

DATES: This rule is effective October 11, 2018.

FOR FURTHER INFORMATION CONTACT: Shaunta Johnson, Office of Grants and 
Acquisition Policy and Accountability, 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. Background

    The Federal Civil Penalties Inflation Adjustment Act Improvements 
Act of 2015 (Sec. 701 of Pub. L. 114-74) (the ``2015 Act''), which is 
intended to improve the effectiveness of civil monetary penalties 
(CMPs) and to maintain the deterrent effect of such penalties, requires 
agencies to adjust the civil monetary penalties for inflation annually.
    The Department of Health and Human Services (HHS) lists the civil 
monetary penalty authorities and the penalty amounts administered by 
all of its agencies in tabular form in 45 CFR 102.3.

II. Calculation of Adjustment

    The annual inflation adjustment for each applicable civil monetary 
penalty is determined using the percent increase in the Consumer Price 
Index for all Urban Consumers (CPI-U) for the month of October of the 
year in which the amount of each civil penalty was most recently 
established or modified. In the December 15, 2017, Office of Management 
and Budget (OMB) Memorandum for the Heads of Executive Agencies and 
Departments, M-18-03, Implementation of the Penalty Inflation 
Adjustments for 2018, Pursuant to the Federal Civil Penalties Inflation 
Adjustment Act Improvements Act of 2015, OMB published the multiplier 
for the required annual adjustment. The cost-of-living adjustment 
multiplier for 2018, based on the CPI-U for the month of October 2017, 
not seasonally adjusted, is 1.02041.
    Using the 2018 multiplier, HHS adjusted all its applicable monetary 
penalties in 45 CFR 102.3.

III. Statutory and Executive Order Reviews

    The 2015 Act requires federal agencies to publish annual penalty 
inflation adjustments notwithstanding section 553 of the Administrative 
Procedure Act (APA).
    Section 4(a) of the 2015 Act directs federal agencies to publish 
annual adjustments no later than January 15th of each year thereafter. 
In accordance with section 553 of the APA, most rules are subject to 
notice and comment and are effective no earlier than 30 days after 
publication in the Federal Register. However, section 4(b)(2) of the 
2015 Act provides that each agency shall make the annual inflation 
adjustments ``notwithstanding section 553'' of the APA.
    According to OMB's Memorandum M-18-03, the phrase ``notwithstanding 
section 553'' means that ``the public procedure the APA generally 
requires--notice, an opportunity for comment, and a delay in effective 
date--is not required for agencies to issue regulations implementing 
the annual adjustment.'' Consistent with the language of the 2015 Act 
and OMB's implementation guidance, this rule is not subject to notice 
and an opportunity for public comment and will be effective immediately 
upon publication.
    Pursuant to OMB Memorandum M-18-03, HHS has determined that the 
annual inflation adjustment to the civil monetary penalties in its 
regulations does not trigger any requirements under procedural statutes 
and Executive Orders that govern rulemaking procedures.

IV. Effective Date

    This rule is effective October 11 2018. The adjusted civil monetary 
penalty amounts apply to penalties assessed on or after October 11, 
2018, if the violation occurred on or after November 2, 2015. If the 
violation occurred prior to November 2, 2015, or a penalty was assessed 
prior to September 6, 2016, the pre-adjustment civil penalty amounts in

[[Page 51370]]

effect prior to September 6, 2016, will apply.

List of Subjects in 45 CFR Part 102

    Administrative practice and procedure, Penalties.

    For reasons discussed in the preamble, the Department of Health and 
Human Services amends subtitle A, title 45 of the Code of Federal 
Regulations as follows:

PART 102--ADJUSTMENT OF CIVIL MONETARY PENALTIES FOR INFLATION

0
1. The authority citation for part 102 continues to read as follows:

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

0
2. Amend Sec.  102.3 by revising the table to read as follows:


Sec.  102.3   Penalty adjustment and table.

* * * * *

                                   Civil Monetary Penalty Authorities Administered by HHS Agencies and Penalty Amounts
                                                              [Effective October 11, 2018]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                         Citation                                                                       Date of
----------------------------------------------------------                                                last         2016         2017         2018
                                                                                                      statutorily    Maximum      Maximum      Maximum
                                                                HHS agency         Description \2\    established    adjusted     adjusted     adjusted
              U.S.C.                       CFR \1\                                                      penalty    penalty ($)  penalty ($)  penalty ($)
                                                                                                       figure \3\                   \4\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                        21 U.S.C.
--------------------------------------------------------------------------------------------------------------------------------------------------------
333(b)(2)(A)......................  .....................  FDA                  Penalty for                  2016       98,935      100,554      102,606
                                                                                 violations related
                                                                                 to drug samples
                                                                                 resulting in a
                                                                                 conviction of any
                                                                                 representative of
                                                                                 manufacturer or
                                                                                 distributor in any
                                                                                 10-year period.
333(b)(2)(B)......................  .....................  FDA                  Penalty for                  2016    1,978,690    2,011,061    2,052,107
                                                                                 violation related
                                                                                 to drug samples
                                                                                 resulting in a
                                                                                 conviction of any
                                                                                 representative of
                                                                                 manufacturer or
                                                                                 distributor after
                                                                                 the second
                                                                                 conviction in any
                                                                                 10-yr period.
333(b)(3).........................  .....................  FDA                  Penalty for failure          2016      197,869      201,106      205,211
                                                                                 to make a report
                                                                                 required by 21
                                                                                 U.S.C. 353(d)(3)(E)
                                                                                 relating to drug
                                                                                 samples.
333(f)(1)(A)......................  .....................  FDA                  Penalty for any              2016       26,723       27,160       27,714
                                                                                 person who violates
                                                                                 a requirement
                                                                                 related to devices
                                                                                 for each such
                                                                                 violation.
                                                                                Penalty for                  2016    1,781,560    1,810,706    1,847,663
                                                                                 aggregate of all
                                                                                 violations related
                                                                                 to devices in a
                                                                                 single proceeding.
333(f)(2)(A)......................  .....................  FDA                  Penalty for any              2016       75,123       76,352       77,910
                                                                                 individual who
                                                                                 introduces or
                                                                                 delivers for
                                                                                 introduction into
                                                                                 interstate commerce
                                                                                 food that is
                                                                                 adulterated per 21
                                                                                 U.S.C. 342(a)(2)(B)
                                                                                 or any individual
                                                                                 who does not comply
                                                                                 with a recall order
                                                                                 under 21 U.S.C.
                                                                                 350l.
                                                                                Penalty in the case          2016      375,613      381,758      389,550
                                                                                 of any other person
                                                                                 other than an
                                                                                 individual) for
                                                                                 such introduction
                                                                                 or delivery of
                                                                                 adulterated food.
                                                                                Penalty for                  2016      751,225      763,515      779,098
                                                                                 aggregate of all
                                                                                 such violations
                                                                                 related to
                                                                                 adulterated food
                                                                                 adjudicated in a
                                                                                 single proceeding.
333(f)(3)(A)......................  .....................  FDA                  Penalty for all              2016       11,383       11,569       11,805
                                                                                 violations
                                                                                 adjudicated in a
                                                                                 single proceeding
                                                                                 for any person who
                                                                                 violates 21 U.S.C.
                                                                                 331(jj)(1) by
                                                                                 failing to submit
                                                                                 the certification
                                                                                 required by 42
                                                                                 U.S.C. 282(j)(5)(B)
                                                                                 or knowingly
                                                                                 submitting a false
                                                                                 certification; by
                                                                                 failing to submit
                                                                                 clinical trial
                                                                                 information under
                                                                                 42 U.S.C 282(j); or
                                                                                 by submitting
                                                                                 clinical trial
                                                                                 information under
                                                                                 42 U.S.C. 282(j)
                                                                                 that is false or
                                                                                 misleading in any
                                                                                 particular under 42
                                                                                 U.S.C. 282(j)(5)(D).
333(f)(3)(B)......................  .....................  FDA                  Penalty for each day         2016       11,383       11,569       11,805
                                                                                 any above violation
                                                                                 is not corrected
                                                                                 after a 30-day
                                                                                 period following
                                                                                 notification until
                                                                                 the violation is
                                                                                 corrected.
333(f)(4)(A)(i)...................  .....................  FDA                  Penalty for any              2016      284,583      289,239      295,142
                                                                                 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).

[[Page 51371]]

 
                                                                                Penalty for                  2016    1,138,330    1,156,953    1,180,566
                                                                                 aggregate of all
                                                                                 such above
                                                                                 violations in a
                                                                                 single proceeding.
333(f)(4)(A)(ii)..................                         FDA                  Penalty for REMS             2016      284,583      289,239      295,142
                                                                                 violation that
                                                                                 continues after
                                                                                 written notice to
                                                                                 the responsible
                                                                                 person for the
                                                                                 first 30-day period
                                                                                 (or any portion
                                                                                 thereof) the
                                                                                 responsible person
                                                                                 continues to be in
                                                                                 violation.
                                                                                Penalty for REMS             2016    1,138,330    1,156,953    1,180,566
                                                                                 violation that
                                                                                 continues after
                                                                                 written notice to
                                                                                 responsible person
                                                                                 doubles for every
                                                                                 30-day period
                                                                                 thereafter the
                                                                                 violation
                                                                                 continues, but may
                                                                                 not exceed penalty
                                                                                 amount for any 30-
                                                                                 day period.
                                                                                Penalty for                  2016   11,383,300   11,569,531   11,805,665
                                                                                 aggregate of all
                                                                                 such above
                                                                                 violations
                                                                                 adjudicated in a
                                                                                 single proceeding.
333(f)(9)(A)......................  .....................  FDA                  Penalty for any              2016       16,503       16,773       17,115
                                                                                 person who violates
                                                                                 a requirement which
                                                                                 relates to tobacco
                                                                                 products for each
                                                                                 such violation.
                                                                                Penalty for                  2016    1,100,200    1,118,199    1,141,021
                                                                                 aggregate of all
                                                                                 such violations of
                                                                                 tobacco product
                                                                                 requirement
                                                                                 adjudicated in a
                                                                                 single proceeding.
333(f)(9)(B)(i)(I)................                         FDA                  Penalty per                  2016      275,050      279,550      285,256
                                                                                 violation related
                                                                                 to violations of
                                                                                 tobacco
                                                                                 requirements.
                                                                                Penalty for                  2016    1,100,200    1,118,199    1,141,021
                                                                                 aggregate of all
                                                                                 such violations of
                                                                                 tobacco product
                                                                                 requirements
                                                                                 adjudicated in a
                                                                                 single proceeding.
333(f)(9)(B)(i)(II)...............  .....................  FDA                  Penalty in the case          2016      275,050      279,550      285,256
                                                                                 of a violation of
                                                                                 tobacco product
                                                                                 requirements that
                                                                                 continues after
                                                                                 written notice to
                                                                                 such person, for
                                                                                 the first 30-day
                                                                                 period (or any
                                                                                 portion thereof)
                                                                                 the person
                                                                                 continues to be in
                                                                                 violation.
                                                                                Penalty for                  2016    1,100,200    1,118,199    1,141,021
                                                                                 violation of
                                                                                 tobacco product
                                                                                 requirements that
                                                                                 continues after
                                                                                 written notice to
                                                                                 such person shall
                                                                                 double for every 30-
                                                                                 day period
                                                                                 thereafter the
                                                                                 violation
                                                                                 continues, but may
                                                                                 not exceed penalty
                                                                                 amount for any 30-
                                                                                 day period.
                                                                                Penalty for                  2016   11,002,000   11,181,993   11,410,218
                                                                                 aggregate of all
                                                                                 such violations
                                                                                 related to tobacco
                                                                                 product
                                                                                 requirements
                                                                                 adjudicated in a
                                                                                 single proceeding.
333(f)(9)(B)(ii)(I)...............  .....................  FDA                  Penalty for any              2016      275,050      279,550      285,256
                                                                                 person who either
                                                                                 does not conduct
                                                                                 post-market
                                                                                 surveillance and
                                                                                 studies to
                                                                                 determine impact of
                                                                                 a modified risk
                                                                                 tobacco product for
                                                                                 which the HHS
                                                                                 Secretary has
                                                                                 provided them an
                                                                                 order to sell, or
                                                                                 who does not submit
                                                                                 a protocol to the
                                                                                 HHS Secretary after
                                                                                 being notified of a
                                                                                 requirement to
                                                                                 conduct post-market
                                                                                 surveillance of
                                                                                 such tobacco
                                                                                 products.
                                                                                Penalty for                  2016    1,100,200    1,118,199    1,141,021
                                                                                 aggregate of for
                                                                                 all such above
                                                                                 violations
                                                                                 adjudicated in a
                                                                                 single proceeding.
333(f)(9)(B)(ii)(II)..............  .....................  FDA                  Penalty for                  2016      275,050      279,550      285,256
                                                                                 violation of
                                                                                 modified risk
                                                                                 tobacco product
                                                                                 post-market
                                                                                 surveillance that
                                                                                 continues after
                                                                                 written notice to
                                                                                 such person for the
                                                                                 first 30-day period
                                                                                 (or any portion
                                                                                 thereof) that the
                                                                                 person continues to
                                                                                 be in violation.

[[Page 51372]]

 
                                                                                Penalty for post-            2016    1,100,200    1,118,199    1,141,021
                                                                                 notice violation of
                                                                                 modified risk
                                                                                 tobacco product
                                                                                 post-market
                                                                                 surveillance shall
                                                                                 double for every 30-
                                                                                 day period
                                                                                 thereafter that the
                                                                                 tobacco product
                                                                                 requirement
                                                                                 violation continues
                                                                                 for any 30-day
                                                                                 period, but may not
                                                                                 exceed penalty
                                                                                 amount for any 30-
                                                                                 day period.
                                                                                Penalty for                  2016   11,002,000   11,181,993   11,410,218
                                                                                 aggregate above
                                                                                 tobacco product
                                                                                 requirement
                                                                                 violations
                                                                                 adjudicated in a
                                                                                 single proceeding.
333(g)(1).........................  .....................  FDA                  Penalty for any              2016      284,583      289,239      295,142
                                                                                 person who
                                                                                 disseminates or
                                                                                 causes another
                                                                                 party to
                                                                                 disseminate a
                                                                                 direct-to-consumer
                                                                                 advertisement that
                                                                                 is false or
                                                                                 misleading for the
                                                                                 first such
                                                                                 violation in any 3-
                                                                                 year period.
                                                                                Penalty for each             2016      569,165      578,477      590,284
                                                                                 subsequent above
                                                                                 violation in any 3-
                                                                                 year period.
333 note..........................  .....................  FDA                  Penalty to be                2016          275          279          285
                                                                                 applied for
                                                                                 violations of
                                                                                 restrictions on the
                                                                                 sale or
                                                                                 distribution of
                                                                                 tobacco products
                                                                                 promulgated under
                                                                                 21 U.S.C. 387f(d)
                                                                                 (e.g., violations
                                                                                 of regulations in
                                                                                 21 CFR Part 1140)
                                                                                 with respect to a
                                                                                 retailer with an
                                                                                 approved training
                                                                                 program in the case
                                                                                 of a second
                                                                                 regulation
                                                                                 violation within a
                                                                                 12-month period.
                                                                                Penalty in the case          2016          550          559          570
                                                                                 of a third tobacco
                                                                                 product regulation
                                                                                 violation within a
                                                                                 24-month period.
                                                                                Penalty in the case          2016        2,200        2,236        2,282
                                                                                 of a fourth tobacco
                                                                                 product regulation
                                                                                 violation within a
                                                                                 24-month period.
                                                                                Penalty in the case          2016        5,501        5,591        5,705
                                                                                 of a fifth tobacco
                                                                                 product regulation
                                                                                 violation within a
                                                                                 36-month period.
                                                                                Penalty in the case          2016       11,002       11,182       11,410
                                                                                 of a sixth or
                                                                                 subsequent tobacco
                                                                                 product regulation
                                                                                 violation within a
                                                                                 48-month period as
                                                                                 determined on a
                                                                                 case-by-case basis.
                                                                                Penalty to be                2016          275          279          285
                                                                                 applied for
                                                                                 violations of
                                                                                 restrictions on the
                                                                                 sale or
                                                                                 distribution of
                                                                                 tobacco products
                                                                                 promulgated under
                                                                                 21 U.S.C. 387f(d)
                                                                                 (e.g., violations
                                                                                 of regulations in
                                                                                 21 CFR Part 1140)
                                                                                 with respect to a
                                                                                 retailer that does
                                                                                 not have an
                                                                                 approved training
                                                                                 program in the case
                                                                                 of the first
                                                                                 regulation
                                                                                 violation.
                                                                                Penalty in the case          2016          550          559          570
                                                                                 of a second tobacco
                                                                                 product regulation
                                                                                 violation within a
                                                                                 12-month period.
                                                                                Penalty in the case          2016        1,100        1,118        1,141
                                                                                 of a third tobacco
                                                                                 product regulation
                                                                                 violation within a
                                                                                 24-month period.
                                                                                Penalty in the case          2016        2,200        2,236        2,282
                                                                                 of a fourth tobacco
                                                                                 product regulation
                                                                                 violation within a
                                                                                 24-month period.
                                                                                Penalty in the case          2016        5,501        5,591        5,705
                                                                                 of a fifth tobacco
                                                                                 product regulation
                                                                                 violation within a
                                                                                 36-month period.
                                                                                Penalty in the case          2016       11,002       11,182       11,410
                                                                                 of a sixth or
                                                                                 subsequent tobacco
                                                                                 product regulation
                                                                                 violation within a
                                                                                 48-month period as
                                                                                 determined on a
                                                                                 case-by-case basis.

[[Page 51373]]

 
335b(a)...........................  .....................  FDA                  Penalty for each             2016      419,320      426,180      434,878
                                                                                 violation for any
                                                                                 individual who made
                                                                                 a false statement
                                                                                 or
                                                                                 misrepresentation
                                                                                 of a material fact,
                                                                                 bribed, destroyed,
                                                                                 altered, removed,
                                                                                 or secreted, or
                                                                                 procured the
                                                                                 destruction,
                                                                                 alteration,
                                                                                 removal, or
                                                                                 secretion of, any
                                                                                 material document,
                                                                                 failed to disclose
                                                                                 a material fact,
                                                                                 obstructed an
                                                                                 investigation,
                                                                                 employed a
                                                                                 consultant who was
                                                                                 debarred, debarred
                                                                                 individual provided
                                                                                 consultant services.
                                                                                Penalty in the case          2016    1,677,280    1,704,720    1,739,513
                                                                                 of any other person
                                                                                 (other than an
                                                                                 individual) per
                                                                                 above violation.
360pp(b)(1).......................  .....................  FDA                  Penalty for any              2016        2,750        2,795        2,852
                                                                                 person who violates
                                                                                 any such
                                                                                 requirements for
                                                                                 electronic
                                                                                 products, with each
                                                                                 unlawful act or
                                                                                 omission
                                                                                 constituting a
                                                                                 separate violation.
                                                                                Penalty imposed for          2016      937,500      952,838      972,285
                                                                                 any related series
                                                                                 of violations of
                                                                                 requirements
                                                                                 relating to
                                                                                 electronic products.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                        42 U.S.C.
--------------------------------------------------------------------------------------------------------------------------------------------------------
262(d)............................  .....................  FDA                  Penalty per day for          2016      215,628      219,156      223,629
                                                                                 violation of order
                                                                                 of recall of
                                                                                 biological product
                                                                                 presenting imminent
                                                                                 or substantial
                                                                                 hazard.
263b(h)(3)........................  .....................  FDA                  Penalty for failure          2016       16,773       17,047       17,395
                                                                                 to obtain a
                                                                                 mammography
                                                                                 certificate as
                                                                                 required.
300aa-28(b)(1)....................  .....................  FDA                  Penalty per                  2016      215,628      219,156      223,629
                                                                                 occurrence for any
                                                                                 vaccine
                                                                                 manufacturer that
                                                                                 intentionally
                                                                                 destroys, alters,
                                                                                 falsifies, or
                                                                                 conceals any record
                                                                                 or report required.
256b(d)(1)(B)(vi).................  .....................  HRSA                 Penalty for each             2016        5,437        5,526        5,639
                                                                                 instance of
                                                                                 overcharging a 340B
                                                                                 covered entity.
299c-3(d).........................  .....................  AHRQ                 Penalty for an               2016       14,140       14,371       14,664
                                                                                 establishment or
                                                                                 person supplying
                                                                                 information
                                                                                 obtained in the
                                                                                 course of
                                                                                 activities for any
                                                                                 purpose other than
                                                                                 the purpose for
                                                                                 which it was
                                                                                 supplied.
653(l)(2).........................  45 CFR 303.21(f).....  ACF                  Penalty for Misuse           2016        1,450        1,474        1,504
                                                                                 of Information in
                                                                                 the National
                                                                                 Directory of New
                                                                                 Hires.
262a(i)(1)........................  42 CFR 1003.910......  OIG                  Penalty for each             2016      327,962      333,327      340,130
                                                                                 individual who
                                                                                 violates safety and
                                                                                 security procedures
                                                                                 related to handling
                                                                                 dangerous
                                                                                 biological agents
                                                                                 and toxins.
                                                                                Penalty for any              2016      655,925      666,656      680,262
                                                                                 other person who
                                                                                 violates safety and
                                                                                 security procedures
                                                                                 related to handling
                                                                                 dangerous
                                                                                 biological agents
                                                                                 and toxins.
300jj-51..........................  .....................  OIG                  Penalty per                  2016    1,000,000    1,016,360    1,037,104
                                                                                 violation for
                                                                                 committing
                                                                                 information
                                                                                 blocking.
1320a-7a(a) \5\...................  42 CFR 1003.210(a)(1)  OIG                  Penalty for                  2018       15,024       15,270       20,000
                                                                                 knowingly
                                                                                 presenting or
                                                                                 causing to be
                                                                                 presented to an
                                                                                 officer, employee,
                                                                                 or agent of the
                                                                                 United States a
                                                                                 false claim.
                                                                                Penalty for                  2018       15,024       15,270       20,000
                                                                                 knowingly
                                                                                 presenting or
                                                                                 causing to be
                                                                                 presented a request
                                                                                 for payment which
                                                                                 violates the terms
                                                                                 of an assignment,
                                                                                 agreement, or PPS
                                                                                 agreement.
                                    42 CFR 1003.210(a)(2)  ...................  Penalty for                  2018       22,537       22,906       30,000
                                                                                 knowingly giving or
                                                                                 causing to be
                                                                                 presented to a
                                                                                 participating
                                                                                 provider or
                                                                                 supplier false or
                                                                                 misleading
                                                                                 information that
                                                                                 could reasonably be
                                                                                 expected to
                                                                                 influence a
                                                                                 discharge decision.

[[Page 51374]]

 
                                    42 CFR 1003.210(a)(3)  ...................  Penalty for an               2018       15,024       15,270       20,000
                                                                                 excluded party
                                                                                 retaining ownership
                                                                                 or control interest
                                                                                 in a participating
                                                                                 entity.
                                    42 CFR 1003.1010.....  ...................  Penalty for                  2018       15,024       15,270       20,000
                                                                                 remuneration
                                                                                 offered to induce
                                                                                 program
                                                                                 beneficiaries to
                                                                                 use particular
                                                                                 providers,
                                                                                 practitioners, or
                                                                                 suppliers.
                                    42 CFR 1003.210(a)(4)  ...................  Penalty for                  2018       14,718       14,959       20,000
                                                                                 employing or
                                                                                 contracting with an
                                                                                 excluded individual.
                                    42 CFR 1003.310(a)(3)  ...................  Penalty for knowing          2018       73,588       74,792      100,000
                                                                                 and willful
                                                                                 solicitation,
                                                                                 receipt, offer, or
                                                                                 payment of
                                                                                 remuneration for
                                                                                 referring an
                                                                                 individual for a
                                                                                 service or for
                                                                                 purchasing,
                                                                                 leasing, or
                                                                                 ordering an item to
                                                                                 be paid for by a
                                                                                 Federal health care
                                                                                 program.
                                    42 CFR 1003.210(a)(1)  ...................  Penalty for ordering         2018       10,874       11,052       20,000
                                                                                 or prescribing
                                                                                 medical or other
                                                                                 item or service
                                                                                 during a period in
                                                                                 which the person
                                                                                 was excluded.
                                    42 CFR 1003.210(a)(6)  ...................  Penalty for                  2018       54,372       55,262      100,000
                                                                                 knowingly making or
                                                                                 causing to be made
                                                                                 a false statement,
                                                                                 omission or
                                                                                 misrepresentation
                                                                                 of a material fact
                                                                                 in any application,
                                                                                 bid, or contract to
                                                                                 participate or
                                                                                 enroll as a
                                                                                 provider or
                                                                                 supplier.
                                    42 CFR 1003.210(a)(8)  ...................  Penalty for knowing          2018       10,874       11,052       20,000
                                                                                 of an overpayment
                                                                                 and failing to
                                                                                 report and return.
                                    42 CFR 1003.210(a)(7)  ...................  Penalty for making           2018       54,372       55,262      100,000
                                                                                 or using a false
                                                                                 record or statement
                                                                                 that is material to
                                                                                 a false or
                                                                                 fraudulent claim.
                                    42 CFR 1003.210(a)(9)  ...................  Penalty for failure          2018       16,312       16,579       30,000
                                                                                 to grant timely
                                                                                 access to HHS OIG
                                                                                 for audits,
                                                                                 investigations,
                                                                                 evaluations, and
                                                                                 other statutory
                                                                                 functions of HHS
                                                                                 OIG.
1320a-7a(b) \5\...................  .....................  OIG                  Penalty for payments         2018        4,313        4,384        5,000
                                                                                 by a hospital or
                                                                                 critical access
                                                                                 hospital to induce
                                                                                 a physician to
                                                                                 reduce or limit
                                                                                 services to
                                                                                 individuals under
                                                                                 direct care of
                                                                                 physician or who
                                                                                 are entitled to
                                                                                 certain medical
                                                                                 assistance benefits.
                                    .....................  ...................  Penalty for                  2018        4,313        4,384        5,000
                                                                                 physicians who
                                                                                 knowingly receive
                                                                                 payments from a
                                                                                 hospital or
                                                                                 critical access
                                                                                 hospital to induce
                                                                                 such physician to
                                                                                 reduce or limit
                                                                                 services to
                                                                                 individuals under
                                                                                 direct care of
                                                                                 physician or who
                                                                                 are entitled to
                                                                                 certain medical
                                                                                 assistance benefits.
                                    42 CFR                 ...................  Penalty for a                2018        7,512        7,635       10,000
                                     1003.210(a)(10).                            physician who
                                                                                 executes a document
                                                                                 that falsely
                                                                                 certifies home
                                                                                 health needs for
                                                                                 Medicare
                                                                                 beneficiaries.
1320a-7e(b)(6)(A).................  42 CFR 1003.810......  OIG                  Penalty for failure          2016       36,794       37,396       38,159
                                                                                 to report any final
                                                                                 adverse action
                                                                                 taken against a
                                                                                 health care
                                                                                 provider, supplier,
                                                                                 or practitioner.
1320b-10(b)(1)....................  42 CFR 1003.610(a)...  OIG                  Penalty for the              2016        9,893       10,055       10,260
                                                                                 misuse of words,
                                                                                 symbols, or emblems
                                                                                 in communications
                                                                                 in a manner in
                                                                                 which a person
                                                                                 could falsely
                                                                                 construe that such
                                                                                 item is approved,
                                                                                 endorsed, or
                                                                                 authorized by HHS.
1320b-10(b)(2)....................  42 CFR 1003.610(a)...  OIG                  Penalty for the              2016       49,467       50,276       51,302
                                                                                 misuse of words,
                                                                                 symbols, or emblems
                                                                                 in a broadcast or
                                                                                 telecast in a
                                                                                 manner in which a
                                                                                 person could
                                                                                 falsely construe
                                                                                 that such item is
                                                                                 approved, endorsed,
                                                                                 or authorized by
                                                                                 HHS.

[[Page 51375]]

 
1395i-3(b)(3)(B)(ii)(1)...........  42 CFR                 OIG                  Penalty for                  2016        2,063        2,097        2,140
                                     1003.210(a)(11).                            certification of a
                                                                                 false statement in
                                                                                 assessment of
                                                                                 functional capacity
                                                                                 of a Skilled
                                                                                 Nursing Facility
                                                                                 resident assessment.
1395i-3(b)(3)(B)(ii)(2)...........  42 CFR                 OIG                  Penalty for causing          2016       10,314       10,483       10,697
                                     1003.210(a)(11).                            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)..................  42 CFR 1003.1310.....  OIG                  Penalty for any              2016        4,126        4,194        4,280
                                                                                 individual who
                                                                                 notifies or causes
                                                                                 to be notified a
                                                                                 Skilled Nursing
                                                                                 Facility of the
                                                                                 time or date on
                                                                                 which a survey is
                                                                                 to be conducted.
1395w-27(g)(2)(A).................  42 CFR 1003.410......  OIG                  Penalty for a                2016       37,561       38,175       38,954
                                                                                 Medicare Advantage
                                                                                 organization that
                                                                                 substantially fails
                                                                                 to provide
                                                                                 medically
                                                                                 necessary, required
                                                                                 items and services.
                                                           ...................  Penalty for a                2016       36,794       37,396       38,159
                                                                                 Medicare Advantage
                                                                                 organization that
                                                                                 charges excessive
                                                                                 premiums.
                                                                                Penalty for a                2016       36,794       37,396       38,159
                                                                                 Medicare Advantage
                                                                                 organization that
                                                                                 improperly expels
                                                                                 or refuses to
                                                                                 reenroll a
                                                                                 beneficiary.
                                                                                Penalty for a                2016      147,177      149,585      152,638
                                                                                 Medicare Advantage
                                                                                 organization that
                                                                                 engages in practice
                                                                                 that would
                                                                                 reasonably be
                                                                                 expected to have
                                                                                 the effect of
                                                                                 denying or
                                                                                 discouraging
                                                                                 enrollment.
                                                                                Penalty per                  2016       22,077       22,438       22,896
                                                                                 individual who does
                                                                                 not enroll as a
                                                                                 result of a
                                                                                 Medicare Advantage
                                                                                 organization's
                                                                                 practice that would
                                                                                 reasonably be
                                                                                 expected to have
                                                                                 the effect of
                                                                                 denying or
                                                                                 discouraging
                                                                                 enrollment.
                                                                                Penalty for a                2016      147,177      149,585      152,638
                                                                                 Medicare Advantage
                                                                                 organization
                                                                                 misrepresenting or
                                                                                 falsifying
                                                                                 information to
                                                                                 Secretary.
                                                                                Penalty for a                2016       36,794       37,396       38,159
                                                                                 Medicare Advantage
                                                                                 organization
                                                                                 misrepresenting or
                                                                                 falsifying
                                                                                 information to
                                                                                 individual or other
                                                                                 entity.
                                                                                Penalty for Medicare         2016       36,794       37,396       38,159
                                                                                 Advantage
                                                                                 organization
                                                                                 interfering with
                                                                                 provider's advice
                                                                                 to enrollee and non-
                                                                                 MCO affiliated
                                                                                 providers that
                                                                                 balance bill
                                                                                 enrollees.
                                                                                Penalty for a                2016       36,794       37,396       38,159
                                                                                 Medicare Advantage
                                                                                 organization that
                                                                                 employs or
                                                                                 contracts with
                                                                                 excluded individual
                                                                                 or entity.
                                                                                Penalty for a                2016       36,794       37,396       38,159
                                                                                 Medicare Advantage
                                                                                 organization
                                                                                 enrolling an
                                                                                 individual in
                                                                                 without prior
                                                                                 written consent.
                                                                                Penalty for a                2016       36,794       37,396       38,159
                                                                                 Medicare Advantage
                                                                                 organization
                                                                                 transferring an
                                                                                 enrollee to another
                                                                                 plan without
                                                                                 consent or solely
                                                                                 for the purpose of
                                                                                 earning a
                                                                                 commission.
                                                                                Penalty for a                2016       36,794       37,396       38,159
                                                                                 Medicare Advantage
                                                                                 organization
                                                                                 failing to comply
                                                                                 with marketing
                                                                                 restrictions or
                                                                                 applicable
                                                                                 implementing
                                                                                 regulations or
                                                                                 guidance.
                                                                                Penalty for a                2016       36,794       37,396       38,159
                                                                                 Medicare Advantage
                                                                                 organization
                                                                                 employing or
                                                                                 contracting with an
                                                                                 individual or
                                                                                 entity who violates
                                                                                 1395w-27(g)(1)(A)-(
                                                                                 J).

[[Page 51376]]

 
1395w-141(i)(3)...................                         OIG                  Penalty for a                2016       12,856       13,066       13,333
                                                                                 prescription drug
                                                                                 card sponsor that
                                                                                 falsifies or
                                                                                 misrepresents
                                                                                 marketing
                                                                                 materials,
                                                                                 overcharges program
                                                                                 enrollees, or
                                                                                 misuse transitional
                                                                                 assistance funds.
1395cc(g).........................                         OIG                  Penalty for improper         2016        5,000        5,082        5,186
                                                                                 billing by
                                                                                 Hospitals, Critical
                                                                                 Access Hospitals,
                                                                                 or Skilled Nursing
                                                                                 Facilities.
1395dd(d)(1)......................  42 CFR 1003.510......  OIG                  Penalty for a                2016      103,139      104,826      106,965
                                                                                 hospital or
                                                                                 responsible
                                                                                 physician dumping
                                                                                 patients needing
                                                                                 emergency medical
                                                                                 care, if the
                                                                                 hospital has 100
                                                                                 beds or more.
                                                                                Penalty for a                2016       51,570       52,414       53,484
                                                                                 hospital or
                                                                                 responsible
                                                                                 physician dumping
                                                                                 patients needing
                                                                                 emergency medical
                                                                                 care, if the
                                                                                 hospital has less
                                                                                 than 100 beds.
1395mm(i)(6)(B)(i)................  42 CFR 1003.410......  OIG                  Penalty for a HMO or         2016       51,570       52,414       53,484
                                                                                 competitive plan is
                                                                                 such plan
                                                                                 substantially fails
                                                                                 to provide
                                                                                 medically
                                                                                 necessary, required
                                                                                 items or services.
                                                                                Penalty for HMOs/            2016       51,570       52,414       53,484
                                                                                 competitive medical
                                                                                 plans that charge
                                                                                 premiums in excess
                                                                                 of permitted
                                                                                 amounts.
                                                                                Penalty for a HMO or         2016       51,570       52,414       53,484
                                                                                 competitive medical
                                                                                 plan that expels or
                                                                                 refuses to reenroll
                                                                                 an individual per
                                                                                 prescribed
                                                                                 conditions.
                                                                                Penalty for a HMO or         2016      206,278      209,653      213,932
                                                                                 competitive medical
                                                                                 plan that
                                                                                 implements
                                                                                 practices to
                                                                                 discourage
                                                                                 enrollment of
                                                                                 individuals needing
                                                                                 services in future.
                                                                                Penalty per                  2016       29,680       30,166       30,782
                                                                                 individual not
                                                                                 enrolled in a plan
                                                                                 as a result of a
                                                                                 HMO or competitive
                                                                                 medical plan that
                                                                                 implements
                                                                                 practices to
                                                                                 discourage
                                                                                 enrollment of
                                                                                 individuals needing
                                                                                 services in the
                                                                                 future.
                                                                                Penalty for a HMO or         2016      206,278      209,653      213,932
                                                                                 competitive medical
                                                                                 plan that
                                                                                 misrepresents or
                                                                                 falsifies
                                                                                 information to the
                                                                                 Secretary.
                                                                                Penalty for a HMO or         2016       51,570       52,414       53,484
                                                                                 competitive medical
                                                                                 plan that
                                                                                 misrepresents or
                                                                                 falsifies
                                                                                 information to an
                                                                                 individual or any
                                                                                 other entity.
                                                                                Penalty for failure          2016       51,570       52,414       53,484
                                                                                 by HMO or
                                                                                 competitive medical
                                                                                 plan to assure
                                                                                 prompt payment of
                                                                                 Medicare risk
                                                                                 sharing contracts
                                                                                 or incentive plan
                                                                                 provisions.
                                                                                Penalty for HMO that         2016       47,340       48,114       49,096
                                                                                 employs or
                                                                                 contracts with
                                                                                 excluded individual
                                                                                 or entity.
1395nn(g)(3)......................  42 CFR 1003.310......  OIG                  Penalty for                  2016       23,863       24,253       24,748
                                                                                 submitting or
                                                                                 causing to be
                                                                                 submitted claims in
                                                                                 violation of the
                                                                                 Stark Law's
                                                                                 restrictions on
                                                                                 physician self-
                                                                                 referrals.
1395nn(g)(4)......................  42 CFR 1003.310......  OIG                  Penalty for                  2016      159,089      161,692      164,992
                                                                                 circumventing Stark
                                                                                 Law's restrictions
                                                                                 on physician self-
                                                                                 referrals.
1395ss(d)(1)......................  42 CFR 1003.1110.....  OIG                  Penalty for a                2016        9,893       10,055       10,260
                                                                                 material
                                                                                 misrepresentation
                                                                                 regarding Medigap
                                                                                 compliance policies.
1395ss(d)(2)......................  42 CFR 1003.1110.....  OIG                  Penalty for selling          2016        9,893       10,055       10,260
                                                                                 Medigap policy
                                                                                 under false
                                                                                 pretense.
1395ss(d)(3)(A)(ii)...............  42 CFR 1003.1110.....  OIG                  Penalty for an               2016       44,539       45,268       46,192
                                                                                 issuer that sells
                                                                                 health insurance
                                                                                 policy that
                                                                                 duplicates benefits.
                                                                                Penalty for someone          2016       26,723       27,160       27,714
                                                                                 other than issuer
                                                                                 that sells health
                                                                                 insurance that
                                                                                 duplicates benefits.

[[Page 51377]]

 
1395ss(d)(4)(A)...................  42 CFR 1003.1110.....  OIG                  Penalty for using            2016        9,893       10,055       10,260
                                                                                 mail to sell a non-
                                                                                 approved Medigap
                                                                                 insurance policy.
1396b(m)(5)(B)(i).................  42 CFR 1003.410......  OIG                  Penalty for a                2016       49,467       50,276       51,302
                                                                                 Medicaid MCO that
                                                                                 substantially fails
                                                                                 to provide
                                                                                 medically
                                                                                 necessary, required
                                                                                 items or services.
                                                                                Penalty for a                2016       49,467       50,276       51,302
                                                                                 Medicaid MCO that
                                                                                 charges excessive
                                                                                 premiums.
                                                                                Penalty for a                2016      197,869      201,106      205,211
                                                                                 Medicaid MCO that
                                                                                 improperly expels
                                                                                 or refuses to
                                                                                 reenroll a
                                                                                 beneficiary.
                                                                                Penalty per                  2016       29,680       30,166       30,782
                                                                                 individual who does
                                                                                 not enroll as a
                                                                                 result of a
                                                                                 Medicaid MCO's
                                                                                 practice that would
                                                                                 reasonably be
                                                                                 expected to have
                                                                                 the effect of
                                                                                 denying or
                                                                                 discouraging
                                                                                 enrollment.
                                                                                Penalty for a                2016      197,869      201,106      205,211
                                                                                 Medicaid MCO
                                                                                 misrepresenting or
                                                                                 falsifying
                                                                                 information to the
                                                                                 Secretary.
                                                                                Penalty for a                2016       49,467       50,276       51,302
                                                                                 Medicaid MCO
                                                                                 misrepresenting or
                                                                                 falsifying
                                                                                 information to an
                                                                                 individual or
                                                                                 another entity.
                                                                                Penalty for a                2016       44,539       45,268       46,192
                                                                                 Medicaid MCO that
                                                                                 fails to comply
                                                                                 with contract
                                                                                 requirements with
                                                                                 respect to
                                                                                 physician incentive
                                                                                 plans.
1396r(b)(3)(B)(ii)(I).............  42 CFR                 OIG                  Penalty for                  2016        2,063        2,097        2,140
                                     1003.210(a)(11).                            willfully and
                                                                                 knowingly
                                                                                 certifying a
                                                                                 material and false
                                                                                 statement in a
                                                                                 Skilled Nursing
                                                                                 Facility resident
                                                                                 assessment.
1396r(b)(3)(B)(ii)(II)............  42 CFR                 OIG                  Penalty for                  2016       10,314       10,483       10,697
                                     1003.210(a)(11).                            willfully and
                                                                                 knowingly causing
                                                                                 another individual
                                                                                 to certify a
                                                                                 material and false
                                                                                 statement in a
                                                                                 Skilled Nursing
                                                                                 Facility resident
                                                                                 assessment.
1396r(g)(2)(A)(i).................  42 CFR 1003.1310.....  OIG                  Penalty for                  2016        4,126        4,194        4,280
                                                                                 notifying or
                                                                                 causing to be
                                                                                 notified a Skilled
                                                                                 Nursing Facility of
                                                                                 the time or date on
                                                                                 which a survey is
                                                                                 to be conducted.
1396r-8(b)(3)(B)..................  42 CFR 1003.1210.....  OIG                  Penalty for the              2016      178,156      181,071      184,767
                                                                                 knowing provision
                                                                                 of false
                                                                                 information or
                                                                                 refusing to provide
                                                                                 information about
                                                                                 charges or prices
                                                                                 of a covered
                                                                                 outpatient drug.
1396r-8(b)(3)(C)(i)...............  42 CFR 1003.1210.....  OIG                  Penalty per day for          2016       17,816       18,107       18,477
                                                                                 failure to timely
                                                                                 provide information
                                                                                 by drug
                                                                                 manufacturer with
                                                                                 rebate agreement.
1396r-8(b)(3)(C)(ii)..............  42 CFR 1003.1210.....  OIG                  Penalty for knowing          2016      178,156      181,071      184,767
                                                                                 provision of false
                                                                                 information by drug
                                                                                 manufacturer with
                                                                                 rebate agreement.
1396t(i)(3)(A)....................  42 CFR 1003.1310.....  OIG                  Penalty for                  2016        3,563        3,621        3,695
                                                                                 notifying home and
                                                                                 community-based
                                                                                 providers or
                                                                                 settings of survey.
11131(c)..........................  42 CFR 1003.810......  OIG                  Penalty for failing          2016       21,563       21,916       22,363
                                                                                 to report a medical
                                                                                 malpractice claim
                                                                                 to National
                                                                                 Practitioner Data
                                                                                 Bank.
11137(b)(2).......................  42 CFR 1003.810......  OIG                  Penalty for                  2016       21,563       21,916       22,363
                                                                                 breaching
                                                                                 confidentiality of
                                                                                 information
                                                                                 reported to
                                                                                 National
                                                                                 Practitioner Data
                                                                                 Bank.
299b-22(f)(1).....................  42 CFR 3.404.........  OCR                  Penalty for                  2016       11,940       12,135       12,383
                                                                                 violation of
                                                                                 confidentiality
                                                                                 provision of the
                                                                                 Patient Safety and
                                                                                 Quality Improvement
                                                                                 Act.
1320(d)-5(a)......................  45 CFR                 OCR                  Penalty for each pre-        2016          150          152          155
                                     160.404(b)(1)(i),                           February 18, 2009
                                     (ii).                                       violation of the
                                                                                 HIPAA
                                                                                 administrative
                                                                                 simplification
                                                                                 provisions.
                                                                                Calendar Year Cap...         2016       37,561       38,175       38,954

[[Page 51378]]

 
                                    45 CFR                 OCR                  Penalty for each      ...........  ...........  ...........  ...........
                                     160.404(b)(2)(i)(A),                        February 18, 2009
                                     (B).                                        or later violation
                                                                                 of a HIPAA
                                                                                 administrative
                                                                                 simplification
                                                                                 provision in which
                                                                                 it is established
                                                                                 that the covered
                                                                                 entity or business
                                                                                 associate did not
                                                                                 know and by
                                                                                 exercising
                                                                                 reasonable
                                                                                 diligence, would
                                                                                 not have known that
                                                                                 the covered entity
                                                                                 or business
                                                                                 associate violated
                                                                                 such a provision.
                                                                                Minimum.............         2016          110          112          114
                                                                                Maximum.............         2016       55,010       55,910       57,051
                                                                                Calendar Year Cap...         2016    1,650,300    1,677,299    1,711,533
                                    45 CFR                 OCR                  Penalty for each      ...........  ...........  ...........  ...........
                                     160.404(b)(2)(ii)(A)                        February 18, 2009
                                     , (B).                                      or later violation
                                                                                 of a HIPAA
                                                                                 administrative
                                                                                 simplification
                                                                                 provision in which
                                                                                 it is established
                                                                                 that the violation
                                                                                 was due to
                                                                                 reasonable cause
                                                                                 and not to willful
                                                                                 neglect.
                                                                                Minimum.............         2016        1,100        1,118        1,141
                                                                                Maximum.............         2016       55,010       55,910       57,051
                                                                                Calendar Year Cap...         2016    1,650,300    1,677,299    1,711,533
                                    45 CFR                 OCR                  Penalty for each      ...........  ...........  ...........  ...........
                                     160.404(b)(2)(iii)(A                        February 18, 2009
                                     ), (B).                                     or later violation
                                                                                 of a HIPAA
                                                                                 administrative
                                                                                 simplification
                                                                                 provision in which
                                                                                 it is established
                                                                                 that the violation
                                                                                 was due to willful
                                                                                 neglect and was
                                                                                 corrected during
                                                                                 the 30-day period
                                                                                 beginning on the
                                                                                 first date the
                                                                                 covered entity or
                                                                                 business associate
                                                                                 knew, or, by
                                                                                 exercising
                                                                                 reasonable
                                                                                 diligence, would
                                                                                 have known that the
                                                                                 violation occurred.
                                                                                Minimum.............         2016       11,002       11,182       11,410
                                                                                Maximum.............         2016       55,010       55,910       57,051
                                                                                Calendar Year Cap...         2016    1,650,300    1,677,299    1,711,533
                                    45 CFR                 OCR                  Penalty for each      ...........  ...........  ...........  ...........
                                     160.404(b)(2)(iv)(A)                        February 18, 2009
                                     , (B).                                      or later violation
                                                                                 of a HIPAA
                                                                                 administrative
                                                                                 simplification
                                                                                 provision in which
                                                                                 it is established
                                                                                 that the violation
                                                                                 was due to willful
                                                                                 neglect and was not
                                                                                 corrected during
                                                                                 the 30-day period
                                                                                 beginning on the
                                                                                 first date the
                                                                                 covered entity or
                                                                                 business associate
                                                                                 knew, or by
                                                                                 exercising
                                                                                 reasonable
                                                                                 diligence, would
                                                                                 have known that the
                                                                                 violation occurred.
                                                                                Minimum.............         2016       55,010       55,910       57,051
                                                                                Maximum.............         2016    1,650,300    1,677,299    1,711,533
                                                                                Calendar Year Cap...         2016    1,650,300    1,677,299    1,711,533
263a(h)(2)(B) & 1395w-              42 CFR                 CMS                  Penalty for a         ...........  ...........  ...........  ...........
 2(b)(2)(A)(ii).                     493.1834(d)(2)(i).                          clinical
                                                                                 laboratory's
                                                                                 failure to meet
                                                                                 participation and
                                                                                 certification
                                                                                 requirements and
                                                                                 poses immediate
                                                                                 jeopardy.
                                                                                Minimum.............         2016        6,035        6,134        6,259
                                                                                Maximum.............         2016       19,787       20,111       20,521
                                    42 CFR                 CMS                  Penalty for a         ...........  ...........  ...........            -
                                     493.1834(d)(2)(ii).                         clinical
                                                                                 laboratory's
                                                                                 failure to meet
                                                                                 participation and
                                                                                 certification
                                                                                 requirements and
                                                                                 the failure does
                                                                                 not pose immediate
                                                                                 jeopardy.
                                                                                Minimum.............         2016           99          101          103
                                                                                Maximum.............         2016        5,936        6,033        6,156
300gg-15(f).......................  45 CFR 147.200(e)....  CMS                  Failure to provide           2016        1,087        1,105        1,128
                                                                                 the Summary of
                                                                                 Benefits and
                                                                                 Coverage.
300gg-18..........................  45 CFR 158.606.......  CMS                  Penalty for                  2016          109          111          113
                                                                                 violations of
                                                                                 regulations related
                                                                                 to the medical loss
                                                                                 ratio reporting and
                                                                                 rebating.

[[Page 51379]]

 
1320a-7h(b)(1)....................  42 CFR 402.105(d)(5),  CMS                  Penalty for           ...........  ...........  ...........  ...........
                                     42 CFR 403.912(a) &                         manufacturer or
                                     (c).                                        group purchasing
                                                                                 organization
                                                                                 failing to report
                                                                                 information
                                                                                 required under 42
                                                                                 U.S.C. 1320a-7h(a),
                                                                                 relating to
                                                                                 physician ownership
                                                                                 or investment
                                                                                 interests.
                                                                                Minimum.............         2016        1,087        1,105        1,128
                                                                                Maximum.............         2016       10,874       11,052       11,278
                                                                                Calendar Year Cap...         2016      163,117      165,786      169,170
1320a-7h(b)(2)....................  42 CFR 402.105(h), 42  CMS                  Penalty for           ...........  ...........  ...........  ...........
                                     CFR 403 912(b) & (c).                       manufacturer or
                                                                                 group purchasing
                                                                                 organization
                                                                                 knowingly failing
                                                                                 to report
                                                                                 information
                                                                                 required under 42
                                                                                 U.S.C. 1320a-7h(a)
                                                                                 , relating to
                                                                                 physician ownership
                                                                                 or investment
                                                                                 interests.
                                                                                Minimum.............         2016       10,874       11,052       11,278
                                                                                Maximum.............         2016      108,745      110,524      112,780
                                                                                Calendar Year Cap...         2016    1,087,450    1,105,241    1,127,799
1320a-7j(h)(3)(A).................                         CMS                  Penalty for an               2016      108,745      110,524      112,780
                                                                                 administrator of a
                                                                                 facility that fails
                                                                                 to comply with
                                                                                 notice requirements
                                                                                 for the closure of
                                                                                 a facility.
                                    42 CFR                 CMS                  Minimum penalty for          2016          544          553          564
                                     488.446(a)(1),(2), &                        the first offense
                                     (3).                                        of an administrator
                                                                                 who fails to
                                                                                 provide notice of
                                                                                 facility closure.
                                                                                Minimum penalty for          2016        1,631        1,658        1,692
                                                                                 the second offense
                                                                                 of an administrator
                                                                                 who fails to
                                                                                 provide notice of
                                                                                 facility closure.
                                                                                Minimum penalty for          2016        3,262        3,315        3,383
                                                                                 the third and
                                                                                 subsequent offenses
                                                                                 of an administrator
                                                                                 who fails to
                                                                                 provide notice of
                                                                                 facility closure.
1320a-8(a)(1).....................                         CMS                  Penalty for an               2016        7,954        8,084        8,249
                                                                                 entity knowingly
                                                                                 making a false
                                                                                 statement or
                                                                                 representation of
                                                                                 material fact in
                                                                                 the determination
                                                                                 of the amount of
                                                                                 benefits or
                                                                                 payments related to
                                                                                 old-age, survivors,
                                                                                 and disability
                                                                                 insurance benefits,
                                                                                 special benefits
                                                                                 for certain World
                                                                                 War II veterans, or
                                                                                 supplemental
                                                                                 security income for
                                                                                 the aged, blind,
                                                                                 and disabled.
                                                                                Penalty for                  2016        7,500        7,623        7,779
                                                                                 violation of 42
                                                                                 U.S.C. 1320a-
                                                                                 8(a)(1) if the
                                                                                 violator is a
                                                                                 person who receives
                                                                                 a fee or other
                                                                                 income for services
                                                                                 performed in
                                                                                 connection with
                                                                                 determination of
                                                                                 the benefit amount
                                                                                 or the person is a
                                                                                 physician or other
                                                                                 health care
                                                                                 provider who
                                                                                 submits evidence in
                                                                                 connection with
                                                                                 such a
                                                                                 determination.
1320a-8(a)(3).....................                         CMS                  Penalty for a                2016        6,229        6,331        6,460
                                                                                 representative
                                                                                 payee (under 42
                                                                                 U.S.C. 405(j),
                                                                                 1007, or
                                                                                 1383(a)(2))
                                                                                 converting any part
                                                                                 of a received
                                                                                 payment from the
                                                                                 benefit programs
                                                                                 described in the
                                                                                 previous civil
                                                                                 monetary penalty to
                                                                                 a use other than
                                                                                 for the benefit of
                                                                                 the beneficiary.
1320b-25(c)(1)(A).................                         CMS                  Penalty for failure          2016      217,490      221,048      225,560
                                                                                 of covered
                                                                                 individuals to
                                                                                 report to the
                                                                                 Secretary and 1 or
                                                                                 more law
                                                                                 enforcement
                                                                                 officials any
                                                                                 reasonable
                                                                                 suspicion of a
                                                                                 crime against a
                                                                                 resident, or
                                                                                 individual
                                                                                 receiving care,
                                                                                 from a long-term
                                                                                 care facility.

[[Page 51380]]

 
1320b-25(c)(2)(A).................                         CMS                  Penalty for failure          2016      326,235      331,572      338,339
                                                                                 of covered
                                                                                 individuals to
                                                                                 report to the
                                                                                 Secretary and 1 or
                                                                                 more law
                                                                                 enforcement
                                                                                 officials any
                                                                                 reasonable
                                                                                 suspicion of a
                                                                                 crime against a
                                                                                 resident, or
                                                                                 individual
                                                                                 receiving care,
                                                                                 from a long-term
                                                                                 care facility if
                                                                                 such failure
                                                                                 exacerbates the
                                                                                 harm to the victim
                                                                                 of the crime or
                                                                                 results in the harm
                                                                                 to another
                                                                                 individual.
1320b-25(d)(2)....................                         CMS                  Penalty for a long-          2016      217,490      221,048      225,560
                                                                                 term care facility
                                                                                 that retaliates
                                                                                 against any
                                                                                 employee because of
                                                                                 lawful acts done by
                                                                                 the employee, or
                                                                                 files a complaint
                                                                                 or report with the
                                                                                 State professional
                                                                                 disciplinary agency
                                                                                 against an employee
                                                                                 or nurse for lawful
                                                                                 acts done by the
                                                                                 employee or nurse.
1395b-7(b)(2)(B)..................  42 CFR 402.105(g)....  CMS                  Penalty for any              2016          147          149          152
                                                                                 person who
                                                                                 knowingly and
                                                                                 willfully fails to
                                                                                 furnish a
                                                                                 beneficiary with an
                                                                                 itemized statement
                                                                                 of items or
                                                                                 services within 30
                                                                                 days of the
                                                                                 beneficiary's
                                                                                 request.
1395i-3(h)(2)(B)(ii)(I)...........  42 CFR                 CMS                  Penalty per day for   ...........  ...........  ...........  ...........
                                     488.408(d)(1)(iii).                         a Skilled Nursing
                                                                                 Facility that has a
                                                                                 Category 2
                                                                                 violation of
                                                                                 certification
                                                                                 requirements.
                                                                                Minimum.............         2016          103          105          107
                                                                                Maximum.............         2016        6,188        6,289        6,417
                                    42 CFR                 CMS                  Penalty per instance  ...........  ...........  ...........  ...........
                                     488.408(d)(1)(iv).                          of Category 2
                                                                                 noncompliance by a
                                                                                 Skilled Nursing
                                                                                 Facility.
                                                                                Minimum.............         2016        2,063        2,097        2,140
                                                                                Maximum.............         2016       20,628       20,965       21,393
                                    42 CFR                 CMS                  Penalty per day for   ...........  ...........  ...........  ...........
                                     488.408(e)(1)(iii).                         a Skilled Nursing
                                                                                 Facility that has a
                                                                                 Category 3
                                                                                 violation of
                                                                                 certification
                                                                                 requirements.
                                                                                Minimum.............         2016        6,291        6,394        6,525
                                                                                Maximum.............         2016       20,628       20,965       21,393
                                    42 CFR                 CMS                  Penalty per instance  ...........  ...........  ...........  ...........
                                     488.408(e)(1)(iv).                          of Category 3
                                                                                 noncompliance by a
                                                                                 Skilled Nursing
                                                                                 Facility.
                                                                                Minimum.............         2016        2,063        2,097        2,140
                                                                                Maximum.............         2016       20,628       20,965       21,393
                                    42 CFR 488.408         CMS                  Penalty per day and   ...........  ...........  ...........  ...........
                                     (e)(2)(ii).                                 per instance for a
                                                                                 Skilled Nursing
                                                                                 Facility that has
                                                                                 Category 3
                                                                                 noncompliance with
                                                                                 Immediate Jeopardy.
                                                                                Per Day (Minimum)...         2016        6,291        6,394        6,525
                                                                                Per Day (Maximum)...         2016       20,628       20,965       21,393
                                                                                Per Instance                 2016        2,063        2,097        2,140
                                                                                 (Minimum).
                                                                                Per Instance                 2016       20,628       20,965       21,393
                                                                                 (Maximum).
                                    42 CFR                 CMS                  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.............         2016        6,291        6,394        6,524
                                                                                Maximum.............         2016       20,628       20,965       21,393
                                    42 CFR                 CMS                  Penalty per day of a  ...........  ...........  ...........  ...........
                                     488.438(a)(1)(ii).                          Skilled Nursing
                                                                                 Facility that fails
                                                                                 to meet
                                                                                 certification
                                                                                 requirements. These
                                                                                 amounts represent
                                                                                 the lower range per
                                                                                 day.
                                                                                Minimum.............         2016          103          105          107
                                                                                Maximum.............         2016        6,188        6,289        6,418
                                    42 CFR 488.438(a)(2).  CMS                  Penalty per instance  ...........  ...........  ...........  ...........
                                                                                 of a Skilled
                                                                                 Nursing Facility
                                                                                 that fails to meet
                                                                                 certification
                                                                                 requirements.
                                                                                Minimum.............         2016        2,063        2,097        2,140
                                                                                Maximum.............         2016       20,628       20,965       21,393

[[Page 51381]]

 
1395l(h)(5)(D) \5\................  42 CFR                 CMS                  Penalty for                  2018       15,024       15,270       30,000
                                     402.105(d)(2)(i).                           knowingly,
                                                                                 willfully, and
                                                                                 repeatedly billing
                                                                                 for a clinical
                                                                                 diagnostic
                                                                                 laboratory test
                                                                                 other than on an
                                                                                 assignment-related
                                                                                 basis. (Penalties
                                                                                 are assessed in the
                                                                                 same manner as 42
                                                                                 U.S.C.
                                                                                 1395u(j)(2)(B),
                                                                                 which is assessed
                                                                                 according to 1320a-
                                                                                 7a(a)).
1395l(i)(6).......................                         CMS                  Penalty for                  2016        3,957        4,022        4,104
                                                                                 knowingly and
                                                                                 willfully
                                                                                 presenting or
                                                                                 causing to be
                                                                                 presented a bill or
                                                                                 request for payment
                                                                                 for an intraocular
                                                                                 lens inserted
                                                                                 during or after
                                                                                 cataract surgery
                                                                                 for which the
                                                                                 Medicare payment
                                                                                 rate includes the
                                                                                 cost of acquiring
                                                                                 the class of lens
                                                                                 involved.
1395l(q)(2)(B)(i).................  42 CFR 402.105(a)....  CMS                  Penalty for                  2016        3,787        3,849        3,928
                                                                                 knowingly and
                                                                                 willfully failing
                                                                                 to provide
                                                                                 information about a
                                                                                 referring physician
                                                                                 when seeking
                                                                                 payment on an
                                                                                 unassigned basis.
1395m(a)(11)(A) \5\...............  42 CFR 402.1(c)(4),    CMS                  Penalty for any              2018       15,024       15,270       30,000
                                     402.105(d)(2)(ii).                          durable medical
                                                                                 equipment supplier
                                                                                 that knowingly and
                                                                                 willfully charges
                                                                                 for a covered
                                                                                 service that is
                                                                                 furnished on a
                                                                                 rental basis after
                                                                                 the rental payments
                                                                                 may no longer be
                                                                                 made. (Penalties
                                                                                 are assessed in the
                                                                                 same manner as 42
                                                                                 U.S.C.
                                                                                 1395u(j)(2)(B),
                                                                                 which is assessed
                                                                                 according to 1320a-
                                                                                 7a(a)).
1395m(a)(18)(B) \5\...............  42 CFR 402.1(c)(5),    CMS                  Penalty for any              2018       15,024       15,270       30,000
                                     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) \5\................  42 CFR 402.1(c)(6),    CMS                  Penalty for any              2018       15,024       15,270       30,000
                                     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) \5\...................  42 CFR 402.1(c)(8),    CMS                  Penalty for any              2018       15,024       15,270       30,000
                                     402.105(d)(2)(vi).                          supplier of
                                                                                 prosthetic devices,
                                                                                 orthotics, and
                                                                                 prosthetics that
                                                                                 knowing and
                                                                                 willfully charges
                                                                                 for a covered
                                                                                 prosthetic device,
                                                                                 orthotic, or
                                                                                 prosthetic that is
                                                                                 furnished on a
                                                                                 rental basis after
                                                                                 the rental payment
                                                                                 may no longer be
                                                                                 made. (Penalties
                                                                                 are assessed in the
                                                                                 same manner as 42
                                                                                 U.S.C.
                                                                                 1395m(a)(11)(A),
                                                                                 that is in the same
                                                                                 manner as
                                                                                 1395u(j)(2)(B),
                                                                                 which is assessed
                                                                                 according to 1320a-
                                                                                 7a(a)).

[[Page 51382]]

 
1395m(j)(2)(A)(iii)...............                         CMS                  Penalty for any              2016        1,591        1,617        1,650
                                                                                 supplier of durable
                                                                                 medical equipment
                                                                                 including a
                                                                                 supplier of
                                                                                 prosthetic devices,
                                                                                 prosthetics,
                                                                                 orthotics, or
                                                                                 supplies that
                                                                                 knowingly and
                                                                                 willfully
                                                                                 distributes a
                                                                                 certificate of
                                                                                 medical necessity
                                                                                 in violation of
                                                                                 Section
                                                                                 1834(j)(2)(A)(i) of
                                                                                 the Act or fails to
                                                                                 provide the
                                                                                 information
                                                                                 required under
                                                                                 Section
                                                                                 1834(j)(2)(A)(ii)
                                                                                 of the Act.
1395m(j)(4) \5\...................  42 CFR 402.1(c)(10),   CMS                  Penalty for any              2018       15,024       15,270       30,000
                                     402.105(d)(2)(vii).                         supplier of durable
                                                                                 medical equipment,
                                                                                 including a
                                                                                 supplier of
                                                                                 prosthetic devices,
                                                                                 prosthetics,
                                                                                 orthotics, or
                                                                                 supplies that
                                                                                 knowingly and
                                                                                 willfully fails to
                                                                                 make refunds in a
                                                                                 timely manner to
                                                                                 Medicare
                                                                                 beneficiaries for
                                                                                 series billed other
                                                                                 than on as
                                                                                 assignment-related
                                                                                 basis under certain
                                                                                 conditions.
                                                                                 (Penalties are
                                                                                 assessed in the
                                                                                 same manner as 42
                                                                                 U.S.C. 1395m(j)(4)
                                                                                 and 1395u(j)(2)(B),
                                                                                 which is assessed
                                                                                 according to 1320a-
                                                                                 7a(a)).
1395m(k)(6) \5\...................  42 CFR 402.1(c)(31),   CMS                  Penalty for any              2018       15,024       15,270       30,000
                                     402.105(d)(3).                              person or entity
                                                                                 who knowingly and
                                                                                 willfully bills or
                                                                                 collects for any
                                                                                 outpatient therapy
                                                                                 services or
                                                                                 comprehensive
                                                                                 outpatient
                                                                                 rehabilitation
                                                                                 services on other
                                                                                 than an assignment-
                                                                                 related basis.
                                                                                 (Penalties are
                                                                                 assessed in the
                                                                                 same manner as 42
                                                                                 U.S.C. 1395m(k)(6)
                                                                                 and 1395u(j)(2)(B),
                                                                                 which is assessed
                                                                                 according to 1320a-
                                                                                 7a(a)).
1395m(l)(6) \5\...................  42 CFR 402.1(c)(32),   CMS                  Penalty for any              2018       15,024       15,270       30,000
                                     402.105(d)(4).                              supplier of
                                                                                 ambulance services
                                                                                 who knowingly and
                                                                                 willfully fills or
                                                                                 collects for any
                                                                                 services on other
                                                                                 than an assignment-
                                                                                 related basis.
                                                                                 (Penalties are
                                                                                 assessed in the
                                                                                 same manner as 42
                                                                                 U.S.C.
                                                                                 1395u(b)(18)(B),
                                                                                 which is assessed
                                                                                 according to 1320a-
                                                                                 7a(a)).
1395u(b)(18)(B) \5\...............  42 CFR 402.1(c)(11),   CMS                  Penalty for any              2018       15,024       15,270       30,000
                                     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) \5\................  42 CFR 402.1(c)......  CMS                  Penalty for any              2018       15,024       15,270       30,000
                                                                                 physician who
                                                                                 charges more than
                                                                                 125% for a non-
                                                                                 participating
                                                                                 referral.
                                                                                 (Penalties are
                                                                                 assessed in the
                                                                                 same manner as 42
                                                                                 U.S.C. 1320a-7a(a)).
1395u(k) \5\......................  42 CFR 402.1(c)(12),   CMS                  Penalty for any              2018       15,024       15,270       30,000
                                     402.105(d)(2)(ix).                          physician who
                                                                                 knowingly and
                                                                                 willfully presents
                                                                                 or causes to be
                                                                                 presented a claim
                                                                                 for bill for an
                                                                                 assistant at a
                                                                                 cataract surgery
                                                                                 performed on or
                                                                                 after March 1,
                                                                                 1987, for which
                                                                                 payment may not be
                                                                                 made because of
                                                                                 section
                                                                                 1862(a)(15).
                                                                                 (Penalties are
                                                                                 assessed in the
                                                                                 same manner as 42
                                                                                 U.S.C.
                                                                                 1395u(j)(2)(B),
                                                                                 which is assessed
                                                                                 according to 1320a-
                                                                                 7a(a)).

[[Page 51383]]

 
1395u(l)(3) \5\...................  42 CFR 402.1(c)(13),   CMS                  Penalty for any              2018       15,024       15,270       30,000
                                     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) \5\...................  42 CFR 402.1(c)(14),   CMS                  Penalty for any              2018       15,024       15,270       30,000
                                     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) \5\...................  42 CFR 402.1(c)(15),   CMS                  Penalty for any              2018       15,024       15,270       30,000
                                     402.105(d)(2)(xii).                         physician who
                                                                                 knowingly,
                                                                                 willfully, and
                                                                                 repeatedly bills
                                                                                 one or more
                                                                                 beneficiaries for
                                                                                 purchased
                                                                                 diagnostic tests
                                                                                 any amount other
                                                                                 than the payment
                                                                                 amount specified by
                                                                                 the Act. (Penalties
                                                                                 are assessed in the
                                                                                 same manner as 42
                                                                                 U.S.C.
                                                                                 1395u(j)(2)(B),
                                                                                 which is assessed
                                                                                 according to 1320a-
                                                                                 7a(a)).
1395u(o)(3)(B) \5\................  42 CFR 414.707(b)....  CMS                  Penalty for any              2018       15,024       15,270       30,000
                                                                                 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)....................  .....................  CMS                  Penalty for any              2016        3,957        4,022        4,104
                                                                                 physician or
                                                                                 practitioner who
                                                                                 knowingly and
                                                                                 willfully fails
                                                                                 promptly to provide
                                                                                 the appropriate
                                                                                 diagnosis codes
                                                                                 upon CMS or
                                                                                 Medicare
                                                                                 administrative
                                                                                 contractor request
                                                                                 for payment or bill
                                                                                 not submitted on an
                                                                                 assignment-related
                                                                                 basis.
1395w-3a(d)(4)(A).................  42 CFR 414.806.......  CMS                  Penalty for a                2016       12,856       13,066       13,333
                                                                                 pharmaceutical
                                                                                 manufacturer's
                                                                                 misrepresentation
                                                                                 of average sales
                                                                                 price of a drug, or
                                                                                 biologic.

[[Page 51384]]

 
1395w-4(g)(1)(B) \5\..............  42 CFR 402.1(c)(17),   CMS                  Penalty for any              2018       15,024       15,270       30,000
                                     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) \5\..............  42 CFR 402.1(c)(18),   CMS                  Penalty for any              2018       15,024       15,270       30,000
                                     402.105(d)(2)(xiv).                         person that
                                                                                 knowingly and
                                                                                 willfully bills for
                                                                                 statutorily defined
                                                                                 State-plan approved
                                                                                 physicians'
                                                                                 services on any
                                                                                 other basis than an
                                                                                 assignment-related
                                                                                 basis for a
                                                                                 Medicare/Medicaid
                                                                                 dual eligible
                                                                                 beneficiary.
                                                                                 (Penalties are
                                                                                 assessed in the
                                                                                 same manner as 42
                                                                                 U.S.C.
                                                                                 1395u(j)(2)(B),
                                                                                 which is assessed
                                                                                 according to 1320a-
                                                                                 7a(a)).
1395w-27(g)(3)(A); 1857(g)(3).....  42 CFR 422.760(b); 42  CMS                  Penalty for each             2016       36,794       37,396       38,159
                                     CFR 423.760(b).                             termination
                                                                                 determination the
                                                                                 Secretary makes
                                                                                 that is the result
                                                                                 of actions by a
                                                                                 Medicare Advantage
                                                                                 organization or
                                                                                 Part D sponsor that
                                                                                 has adversely
                                                                                 affected an
                                                                                 individual covered
                                                                                 under the
                                                                                 organization's
                                                                                 contract.
1395w-27(g)(3)(B); 1857(g)(3).....  .....................  CMS                  Penalty for each             2016       14,718       14,959       15,264
                                                                                 week beginning
                                                                                 after the
                                                                                 initiation of civil
                                                                                 money penalty
                                                                                 procedures by the
                                                                                 Secretary because a
                                                                                 Medicare Advantage
                                                                                 organization or
                                                                                 Part D sponsor has
                                                                                 failed to carry out
                                                                                 a contract, or has
                                                                                 carried out a
                                                                                 contract
                                                                                 inconsistently with
                                                                                 regulations.
1395w-27(g)(3)(D); 1857(g)(3).....  .....................  CMS                  Penalty for a                2016      136,689      138,925      141,760
                                                                                 Medicare Advantage
                                                                                 organization's or
                                                                                 Part D sponsor's
                                                                                 early termination
                                                                                 of its contract.
1395y(b)(3)(C)....................  42 CFR 411.103(b)....  CMS                  Penalty for an               2016        8,908        9,054        9,239
                                                                                 employer or other
                                                                                 entity to offer any
                                                                                 financial or other
                                                                                 incentive for an
                                                                                 individual entitled
                                                                                 to benefits not to
                                                                                 enroll under a
                                                                                 group health plan
                                                                                 or large group
                                                                                 health plan which
                                                                                 would be a primary
                                                                                 plan.
1395y(b)(5)(C)(ii)................  42 CFR 402.1(c)(20),   CMS                  Penalty for any non-         2016        1,450        1,474        1,504
                                     42 CFR 402.105(b)(2).                       governmental
                                                                                 employer that,
                                                                                 before October 1,
                                                                                 1998, willfully or
                                                                                 repeatedly failed
                                                                                 to provide timely
                                                                                 and accurate
                                                                                 information
                                                                                 requested relating
                                                                                 to an employee's
                                                                                 group health
                                                                                 insurance coverage.
1395y(b)(6)(B)....................  42 CFR 402.1(c)(21),   CMS                  Penalty for any              2016        3,182        3,234        3,300
                                     402.105(a).                                 entity that
                                                                                 knowingly,
                                                                                 willfully, and
                                                                                 repeatedly fails to
                                                                                 complete a claim
                                                                                 form relating to
                                                                                 the availability of
                                                                                 other health
                                                                                 benefits in
                                                                                 accordance with
                                                                                 statute or provides
                                                                                 inaccurate
                                                                                 information
                                                                                 relating to such on
                                                                                 the claim form.
1395y(b)(7)(B)(i).................  .....................  CMS                  Penalty for any              2016        1,138        1,157        1,181
                                                                                 entity serving as
                                                                                 insurer, third
                                                                                 party
                                                                                 administrator, or
                                                                                 fiduciary for a
                                                                                 group health plan
                                                                                 that fails to
                                                                                 provide information
                                                                                 that identifies
                                                                                 situations where
                                                                                 the group health
                                                                                 plan is or was a
                                                                                 primary plan to
                                                                                 Medicare to the HHS
                                                                                 Secretary.

[[Page 51385]]

 
1395pp(h) \5\.....................  42 CFR 402.1(c)(23),   CMS                  Penalty for any              2018       15,024       15,270       30,000
                                     402.105(d)(2)(xv).                          durable medical
                                                                                 equipment supplier,
                                                                                 including a
                                                                                 supplier of
                                                                                 prosthetic devices,
                                                                                 prosthetics,
                                                                                 orthotics, or
                                                                                 supplies, that
                                                                                 knowingly and
                                                                                 willfully fails to
                                                                                 make refunds in a
                                                                                 timely manner to
                                                                                 Medicare
                                                                                 beneficiaries under
                                                                                 certain conditions.
                                                                                 (42 U.S.C.
                                                                                 1395(m)(18)
                                                                                 sanctions apply
                                                                                 here in the same
                                                                                 manner, which is
                                                                                 under 1395u(j)(2)
                                                                                 and 1320a-7a(a)).
1395nn(g)(5)......................  42 CFR 411.361.......  CMS                  Penalty for any              2016       18,936       19,246       19,639
                                                                                 person 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),   CMS                  Penalty for any              2016       15,024       15,270       15,582
                                     402.105(d)(2)(xv).                          durable medical
                                                                                 equipment supplier,
                                                                                 including a
                                                                                 supplier of
                                                                                 prosthetic devices,
                                                                                 prosthetics,
                                                                                 orthotics, or
                                                                                 supplies, that
                                                                                 knowingly and
                                                                                 willfully fails to
                                                                                 make refunds in a
                                                                                 timely manner to
                                                                                 Medicare
                                                                                 beneficiaries under
                                                                                 certain conditions.
                                                                                 (42 U.S.C.
                                                                                 1395(m)(18)
                                                                                 sanctions apply
                                                                                 here in the same
                                                                                 manner, which is
                                                                                 under 1395u(j)(2)
                                                                                 and 1320a-7a(a)).
1395ss(a)(2)......................  42 CFR 402.1(c)(24),   CMS                  Penalty for any              2016       51,569       52,413       53,483
                                     405.105(f)(1).                              person that issues
                                                                                 a Medicare
                                                                                 supplemental policy
                                                                                 that has not been
                                                                                 approved by the
                                                                                 State regulatory
                                                                                 program or does not
                                                                                 meet Federal
                                                                                 standards after a
                                                                                 statutorily defined
                                                                                 effective date.
1395ss(d)(3)(A)(vi)(II)...........  .....................  CMS                  Penalty for someone          2016       26,723       27,160       27,714
                                                                                 other than issuer
                                                                                 that sells or
                                                                                 issues a Medicare
                                                                                 supplemental policy
                                                                                 to beneficiary
                                                                                 without a
                                                                                 disclosure
                                                                                 statement.
                                                                                Penalty for an               2016       44,539       45,268       46,192
                                                                                 issuer that sells
                                                                                 or issues a
                                                                                 Medicare
                                                                                 supplemental policy
                                                                                 without disclosure
                                                                                 statement.
1395ss(d)(3)(B)(iv)...............  .....................  CMS                  Penalty for someone          2016       26,723       27,160       27,714
                                                                                 other than issuer
                                                                                 that sells or
                                                                                 issues a Medicare
                                                                                 supplemental policy
                                                                                 without
                                                                                 acknowledgement
                                                                                 form..
                                                                                Penalty for issuer           2016       44,539       45,268       46,192
                                                                                 that sells or
                                                                                 issues a Medicare
                                                                                 supplemental policy
                                                                                 without an
                                                                                 acknowledgement
                                                                                 form.
1395ss(p)(8)......................  42 CFR 402.1(c)(25),   CMS                  Penalty for any              2016       26,723       27,160       27,714
                                     402.105(e).                                 person that sells
                                                                                 or issues Medicare
                                                                                 supplemental
                                                                                 polices after a
                                                                                 given date that
                                                                                 fail to conform to
                                                                                 the NAIC or Federal
                                                                                 standards
                                                                                 established by
                                                                                 statute.
                                    42 CFR 402.1(c)(25),   CMS                  Penalty for any              2016       44,539       45,268       46,192
                                     405.105(f)(2).                              person that sells
                                                                                 or issues Medicare
                                                                                 supplemental
                                                                                 polices after a
                                                                                 given date that
                                                                                 fail to conform to
                                                                                 the NAIC or Federal
                                                                                 standards
                                                                                 established by
                                                                                 statute.
1395ss(p)(9)(C)...................  42 CFR 402.1(c)(26),   CMS                  Penalty for any              2016       26,723       27,160       27,714
                                     402.105(e).                                 person that sells a
                                                                                 Medicare
                                                                                 supplemental policy
                                                                                 and fails to make
                                                                                 available for sale
                                                                                 the core group of
                                                                                 basic benefits when
                                                                                 selling other
                                                                                 Medicare
                                                                                 supplemental
                                                                                 policies with
                                                                                 additional benefits
                                                                                 or fails to provide
                                                                                 the individual,
                                                                                 before selling the
                                                                                 policy, an outline
                                                                                 of coverage
                                                                                 describing benefits.

[[Page 51386]]

 
                                    42 CFR 402.1(c)(26),   ...................  Penalty for any              2016       44,539       45,268       46,192
                                     405.105(f)(3), (4).                         person that sells a
                                                                                 Medicare
                                                                                 supplemental policy
                                                                                 and fails to make
                                                                                 available for sale
                                                                                 the core group of
                                                                                 basic benefits when
                                                                                 selling other
                                                                                 Medicare
                                                                                 supplemental
                                                                                 policies with
                                                                                 additional benefits
                                                                                 or fails to provide
                                                                                 the individual,
                                                                                 before selling the
                                                                                 policy, an outline
                                                                                 of coverage
                                                                                 describing benefits.
1395ss(q)(5)(C)...................  42 CFR 402.1(c)(27),   CMS                  Penalty for any              2016       44,539       45,268       46,192
                                     405.105(f)(5).                              person that fails
                                                                                 to suspend the
                                                                                 policy of a
                                                                                 policyholder made
                                                                                 eligible for
                                                                                 medical assistance
                                                                                 or automatically
                                                                                 reinstates the
                                                                                 policy of a
                                                                                 policyholder who
                                                                                 has lost
                                                                                 eligibility for
                                                                                 medical assistance,
                                                                                 under certain
                                                                                 circumstances.
1395ss(r)(6)(A)...................  42 CFR 402.1(c)(28),   CMS                  Penalty for any              2016       44,539       45,268       46,192
                                     405.105(f)(6).                              person that 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              2016       18,908       19,217       19,609
                                     405.105(c).                                 issuer of a
                                                                                 Medicare
                                                                                 supplemental policy
                                                                                 that does not waive
                                                                                 listed time periods
                                                                                 if they were
                                                                                 already satisfied
                                                                                 under a proceeding
                                                                                 Medicare
                                                                                 supplemental
                                                                                 policy, or denies a
                                                                                 policy, or
                                                                                 conditions the
                                                                                 issuances or
                                                                                 effectiveness of
                                                                                 the policy, or
                                                                                 discriminates in
                                                                                 the pricing of the
                                                                                 policy base on
                                                                                 health status or
                                                                                 other specified
                                                                                 criteria.
1395ss(t)(2)......................  42 CFR 402.1(c)(30),   CMS                  Penalty for any              2016       44,539       45,268       46,192
                                     405.105(f)(7).                              issuer of a
                                                                                 Medicare
                                                                                 supplemental policy
                                                                                 that fails to
                                                                                 fulfill listed
                                                                                 responsibilities.
1395ss(v)(4)(A)...................  .....................  CMS                  Penalty someone              2016       19,284       19,599       19,999
                                                                                 other than issuer
                                                                                 who sells, issues,
                                                                                 or renews a Medigap
                                                                                 Rx policy to an
                                                                                 individual who is a
                                                                                 Part D enrollee.
                                                                                Penalty for an               2016       32,140       32,666       33,333
                                                                                 issuer who sells,
                                                                                 issues, or renews a
                                                                                 Medigap Rx policy
                                                                                 who is a Part D
                                                                                 enrollee.
1395bbb(c)(1).....................  42 CFR 488.725(c)....  CMS                  Penalty for any              2016        4,126        4,194        4,280
                                                                                 individual who
                                                                                 notifies or causes
                                                                                 to be notified a
                                                                                 home health agency
                                                                                 of the time or date
                                                                                 on which a survey
                                                                                 of such agency is
                                                                                 to be conducted.
1395bbb(f)(2)(A)(i)...............  42 CFR                 CMS                  Maximum daily                2016       19,787       20,111       20,521
                                     488.845(b)(2)(iii);                         penalty amount for
                                     42 CFR 488.845(b)(3)-                       each day a home
                                     (6); and 42 CFR                             health agency is
                                     488.845(d)(1)(ii).                          not in compliance
                                                                                 with statutory
                                                                                 requirements.
                                    42 CFR 488.845(b)(3).  ...................  Penalty per day for   ...........  ...........  ...........  ...........
                                                                                 home health
                                                                                 agency's
                                                                                 noncompliance
                                                                                 (Upper Range).
                                                                                Minimum.............         2016       16,819       17,094       17,443
                                                                                Maximum.............         2016       19,787       20,111       20,521
                                    42 CFR                 ...................  Penalty for a home           2016       19,787       20,111       20,521
                                     488.845(b)(3)(i).                           health agency's
                                                                                 deficiency or
                                                                                 deficiencies that
                                                                                 cause immediate
                                                                                 jeopardy and result
                                                                                 in actual harm.
                                    42 CFR                 ...................  Penalty for a home           2016       17,808       18,099       18,468
                                     488.845(b)(3)(ii).                          health agency's
                                                                                 deficiency or
                                                                                 deficiencies that
                                                                                 cause immediate
                                                                                 jeopardy and result
                                                                                 in potential for
                                                                                 harm.
                                    42 CFR                 ...................  Penalty for an               2016       16,819       17,094       17,443
                                     488.845(b)(3)(iii).                         isolated incident
                                                                                 of noncompliance in
                                                                                 violation of
                                                                                 established HHA
                                                                                 policy.
                                    42 CFR 488.845(b)(4).  ...................  Penalty for a repeat  ...........  ...........  ...........  ...........
                                                                                 and/or condition-
                                                                                 level deficiency
                                                                                 that does not
                                                                                 constitute
                                                                                 immediate jeopardy,
                                                                                 but is directly
                                                                                 related to poor
                                                                                 quality patient
                                                                                 care outcomes
                                                                                 (Lower Range).
                                                                                Minimum.............         2016        2,968        3,017        3,079

[[Page 51387]]

 
                                                                                Maximum.............         2016       16,819       17,094       17,443
                                    42 CFR 488.845(b)(5).  ...................  Penalty for a repeat  ...........  ...........  ...........  ...........
                                                                                 and/or condition-
                                                                                 level deficiency
                                                                                 that does not
                                                                                 constitute
                                                                                 immediate jeopardy
                                                                                 and that is related
                                                                                 predominately to
                                                                                 structure or
                                                                                 process-oriented
                                                                                 conditions (Lower
                                                                                 Range).
                                                                                Minimum.............         2016          989        1,005        1,026
                                                                                Maximum.............         2016        7,915        8,044        8,208
                                    42 CFR 488.845(b)(6).  ...................  Penalty imposed for   ...........  ...........  ...........  ...........
                                                                                 instance of
                                                                                 noncompliance that
                                                                                 may be assessed for
                                                                                 one or more
                                                                                 singular events of
                                                                                 condition-level
                                                                                 noncompliance that
                                                                                 are identified and
                                                                                 where the
                                                                                 noncompliance was
                                                                                 corrected during
                                                                                 the onsite survey.
                                                                                Minimum.............         2016        1,979        2,011        2,052
                                                                                Maximum.............         2016       19,787       20,111       20,521
                                                                                Penalty for each day         2016       19,787       20,111       20,521
                                                                                 of noncompliance
                                                                                 (Maximum).
                                    42 CFR                 ...................  Penalty for each day         2016       19,787       20,111       20,521
                                     488.845(d)(1)(ii).                          of noncompliance
                                                                                 (Maximum).
1396b(m)(5)(B)....................  42 CFR 460.46........  CMS                  Penalty for PACE      ...........  ...........  ...........  ...........
                                                                                 organization's
                                                                                 practice that would
                                                                                 reasonably be
                                                                                 expected to have
                                                                                 the effect of
                                                                                 denying or
                                                                                 discouraging
                                                                                 enrollment.
                                                                                Minimum.............         2016       22,077       22,438       22,896
                                                                                Maximum.............         2016      147,177      149,585      152,638
                                                                                Penalty for a PACE           2016       36,794       37,396       38,159
                                                                                 organization that
                                                                                 charges excessive
                                                                                 premiums.
                                                                                Penalty for a PACE           2016      147,177      149,585      152,638
                                                                                 organization
                                                                                 misrepresenting or
                                                                                 falsifying
                                                                                 information to CMS,
                                                                                 the State, or an
                                                                                 individual or other
                                                                                 entity.
                                                                                Penalty for each             2016       36,794       37,396       38,159
                                                                                 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                  2016       36,794       37,396       38,159
                                                                                 involuntarily
                                                                                 disenrolling a
                                                                                 participant.
                                                                                Penalty for                  2016       36,794       37,396       38,159
                                                                                 discriminating or
                                                                                 discouraging
                                                                                 enrollment or
                                                                                 disenrollment of
                                                                                 participants on the
                                                                                 basis of an
                                                                                 individual's health
                                                                                 status or need for
                                                                                 health care
                                                                                 services.
1396r(h)(3)(C)(ii)(I).............  42 CFR                 CMS                  Penalty per day for   ...........  ...........  ...........  ...........
                                     488.408(d)(1)(iii).                         a nursing
                                                                                 facility's failure
                                                                                 to meet a Category
                                                                                 2 Certification.
                                                                                Minimum.............         2016          103          105          107
                                                                                Maximum.............         2016        6,188        6,289        6,417
                                    42 CFR                 CMS                  Penalty per instance  ...........  ...........  ...........  ...........
                                     488.408(d)(1)(iv).                          for a nursing
                                                                                 facility's failure
                                                                                 to meet Category 2
                                                                                 certification.
                                                                                Minimum.............         2016        2,063        2,097        2,140
                                                                                Maximum.............         2016       20,628       20,965       21,393
                                    42 CFR                 CMS                  Penalty per day for   ...........  ...........  ...........  ...........
                                     488.408(e)(1)(iii).                         a nursing
                                                                                 facility's failure
                                                                                 to meet Category 3
                                                                                 certification.
                                                                                Minimum.............         2016        6,291        6,394        6,525
                                                                                Maximum.............         2016       20,628       20,965       21,393
                                    42 CFR                 CMS                  Penalty per instance  ...........  ...........  ...........  ...........
                                     488.408(e)(1)(iv).                          for a nursing
                                                                                 facility's failure
                                                                                 to meet Category 3
                                                                                 certification.
                                                                                Minimum.............         2016        2,063        2,097        2,140
                                                                                Maximum.............         2016       20,628       20,965       21,393
                                    42 CFR                 CMS                  Penalty per instance  ...........  ...........  ...........  ...........
                                     488.408(e)(2)(ii).                          for a nursing
                                                                                 facility's failure
                                                                                 to meet Category 3
                                                                                 certification,
                                                                                 which results in
                                                                                 immediate jeopardy.

[[Page 51388]]

 
                                                                                Minimum.............         2016        2,063        2,097        2,140
                                                                                Maximum.............         2016       20,628       20,965       21,393
                                    42 CFR                 CMS                  Penalty per day for   ...........  ...........  ...........  ...........
                                     488.438(a)(1)(i).                           nursing facility's
                                                                                 failure to meet
                                                                                 certification
                                                                                 (Upper Range).
                                                                                Minimum.............         2016        6,291        6,394        6,525
                                                                                Maximum.............         2016       20,628       20,965       21,393
                                    42 CFR                 CMS                  Penalty per day for   ...........  ...........  ...........  ...........
                                     488.438(a)(1)(ii).                          nursing facility's
                                                                                 failure to meet
                                                                                 certification
                                                                                 (Lower Range).
                                                                                Minimum.............         2016          103          105          107
                                                                                Maximum.............         2016        6,188        6,289        6,417
                                    42 CFR 488.438(a)(2).  CMS                  Penalty per instance  ...........  ...........  ...........  ...........
                                                                                 for nursing
                                                                                 facility's failure
                                                                                 to meet
                                                                                 certification.
                                                                                Minimum.............         2016        2,063        2,097        2,140
                                                                                Maximum.............         2016       20,628       20,965       21,393
1396r(f)(2)(B)(iii)(I)(c).........  42 CFR                 CMS                  Grounds to prohibit          2016       10,314       10,483       10,697
                                     483.151(b)(2)(iv)                           approval of Nurse
                                     and (b)(3)(iii).                            Aide Training
                                                                                 Program--if
                                                                                 assessed a penalty
                                                                                 in 1819(h)(2)(B)(i)
                                                                                 or
                                                                                 1919(h)(2)(A)(ii)
                                                                                 of ``not less than
                                                                                 $5,000'' [Not CMP
                                                                                 authority, but a
                                                                                 specific CMP amount
                                                                                 (CMP at this level)
                                                                                 that is the
                                                                                 triggering
                                                                                 condition for
                                                                                 disapproval].
1396r(h)(3)(C)(ii)(I).............  42 CFR 483.151(c)(2).  CMS                  Grounds to waive             2016       10,314       10,483       10,697
                                                                                 disapproval of
                                                                                 nurse aide training
                                                                                 program--reference
                                                                                 to disapproval
                                                                                 based on imposition
                                                                                 of CMP ``not less
                                                                                 than $5,000'' [Not
                                                                                 CMP authority but
                                                                                 CMP imposition at
                                                                                 this level
                                                                                 determines
                                                                                 eligibility to seek
                                                                                 waiver of
                                                                                 disapproval of
                                                                                 nurse aide training
                                                                                 program].
1396t(j)(2)(C)....................  .....................  CMS                  Penalty for each day  ...........  ...........  ...........  ...........
                                                                                 of noncompliance
                                                                                 for a home or
                                                                                 community care
                                                                                 provider that no
                                                                                 longer meets the
                                                                                 minimum
                                                                                 requirements for
                                                                                 home and community
                                                                                 care.
                                                                                Minimum.............         2016            2            2            2
                                                                                Maximum.............         2016       17,816       18,107       18,477
1396u-2(e)(2)(A)(i)...............  42 CFR 438.704.......  CMS                  Penalty for a                2016       36,794       37,396       38,159
                                                                                 Medicaid managed
                                                                                 care organization
                                                                                 that fails
                                                                                 substantially to
                                                                                 provide medically
                                                                                 necessary items and
                                                                                 services.
                                                                                Penalty for Medicaid         2016       36,794       37,396       38,159
                                                                                 managed care
                                                                                 organization that
                                                                                 imposes premiums or
                                                                                 charges on
                                                                                 enrollees in excess
                                                                                 of the premiums or
                                                                                 charges permitted.
                                                                                Penalty for a                2016       36,794       37,396       38,159
                                                                                 Medicaid managed
                                                                                 care organization
                                                                                 that misrepresents
                                                                                 or falsifies
                                                                                 information to
                                                                                 another individual
                                                                                 or entity.
                                                                                Penalty for a                2016       36,794       37,396       38,159
                                                                                 Medicaid managed
                                                                                 care organization
                                                                                 that fails to
                                                                                 comply with the
                                                                                 applicable
                                                                                 statutory
                                                                                 requirements for
                                                                                 such organizations.
1396u-2(e)(2)(A)(ii)..............  42 CFR 438.704.......  CMS                  Penalty for a                2016      147,177      149,585      152,638
                                                                                 Medicaid managed
                                                                                 care organization
                                                                                 that misrepresents
                                                                                 or falsifies
                                                                                 information to the
                                                                                 HHS Secretary.
                                                                                Penalty for Medicaid         2016      147,177      149,585      152,638
                                                                                 managed care
                                                                                 organization that
                                                                                 acts to
                                                                                 discriminate among
                                                                                 enrollees on the
                                                                                 basis of their
                                                                                 health status.
1396u-2(e)(2)(A)(iv)..............  42 CFR 438.704.......  CMS                  Penalty for each             2016       22,077       22,438       22,896
                                                                                 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.

[[Page 51389]]

 
1396u(h)(2).......................  42 CFR Part 441,       CMS                  Penalty for a                2016       20,628       20,965       21,393
                                     Subpart I.                                  provider not
                                                                                 meeting one of the
                                                                                 requirements
                                                                                 relating to the
                                                                                 protection of the
                                                                                 health, safety, and
                                                                                 welfare of
                                                                                 individuals
                                                                                 receiving community
                                                                                 supported living
                                                                                 arrangements
                                                                                 services.
1396w-2(c)(1).....................                         CMS                  Penalty for                  2016       11,002       11,182       11,410
                                                                                 disclosing
                                                                                 information related
                                                                                 to eligibility
                                                                                 determinations for
                                                                                 medical assistance
                                                                                 programs.
18041(c)(2).......................  45 CFR 150.315; 45     CMS                  Failure to comply            2016          150          152          155
                                     CFR 156.805(c).                             with requirements
                                                                                 of the Public
                                                                                 Health Services
                                                                                 Act; Penalty for
                                                                                 violations of rules
                                                                                 or standards of
                                                                                 behavior associated
                                                                                 with issuer
                                                                                 participation in
                                                                                 the Federally-
                                                                                 facilitated
                                                                                 Exchange. (42
                                                                                 U.S.C. 300gg-
                                                                                 22(b)(2)(C)).
18081(h)(1)(A)(i)(II).............  42 CFR 155.285.......  CMS                  Penalty for                  2016       27,186       27,631       28,195
                                                                                 providing false
                                                                                 information on
                                                                                 Exchange
                                                                                 application.
18081(h)(1)(B)....................  42 CFR 155.285.......  CMS                  Penalty for                  2016      271,862      276,310      281,949
                                                                                 knowingly or
                                                                                 willfully providing
                                                                                 false information
                                                                                 on Exchange
                                                                                 application.
18081(h)(2).......................  42 CFR 155.260.......  CMS                  Penalty for                  2016       27,186       27,631       28,195
                                                                                 knowingly or
                                                                                 willfully
                                                                                 disclosing
                                                                                 protected
                                                                                 information from
                                                                                 Exchange.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                        31 U.S.C.
--------------------------------------------------------------------------------------------------------------------------------------------------------
1352..............................  45 CFR 93.400(e).....  HHS                  Penalty for the              2016       18,936       19,246       19,639
                                                                                 first time an
                                                                                 individual makes an
                                                                                 expenditure
                                                                                 prohibited by
                                                                                 regulations
                                                                                 regarding lobbying
                                                                                 disclosure, absent
                                                                                 aggravating
                                                                                 circumstances.
                                                                                Penalty for second    ...........  ...........  ...........  ...........
                                                                                 and subsequent
                                                                                 offenses by
                                                                                 individuals who
                                                                                 make an expenditure
                                                                                 prohibited by
                                                                                 regulations
                                                                                 regarding lobbying
                                                                                 disclosure.
                                                                                Minimum.............         2016       18,936       19,246       19,639
                                                                                Maximum.............         2016      189,361      192,459      196,387
                                                                                Penalty for the              2016       18,936       19,246       19,639
                                                                                 first time an
                                                                                 individual fails to
                                                                                 file or amend a
                                                                                 lobbying disclosure
                                                                                 form, absent
                                                                                 aggravating
                                                                                 circumstances.
                                                                                Penalty for second    ...........  ...........  ...........  ...........
                                                                                 and subsequent
                                                                                 offenses by
                                                                                 individuals who
                                                                                 fail to file or
                                                                                 amend a lobbying
                                                                                 disclosure form,
                                                                                 absent aggravating
                                                                                 circumstances.
                                                                                Minimum.............         2016       18,936       19,246       19,639
                                                                                Maximum.............         2016      189,361      192,459      196,387
                                    45 CFR Part 93,        HHS                  Penalty for failure   ...........  ...........  ...........  ...........
                                     Appendix A.                                 to provide
                                                                                 certification
                                                                                 regarding lobbying
                                                                                 in the award
                                                                                 documents for all
                                                                                 sub-awards of all
                                                                                 tiers.
                                                                                Minimum.............         2016       18,936       19,246       19,639
                                                                                Maximum.............         2016      189,361      192,459      196,387
                                                                                Penalty for failure   ...........  ...........  ...........  ...........
                                                                                 to provide
                                                                                 statement regarding
                                                                                 lobbying for loan
                                                                                 guarantee and loan
                                                                                 insurance
                                                                                 transactions.
                                                                                Minimum.............         2016       18,936       19,246       19,639
                                                                                Maximum.............         2016      189,361      192,459      196,387
3801-3812.........................  45 CFR 79.3(a)(1)(iv)  HHS                  Penalty against any          2016        9,894       10,056       10,261
                                                                                 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).  HHS                  Penalty against any          2016        9,894       10,056       10,261
                                                                                 individual who--
                                                                                 with knowledge or
                                                                                 reason to know--
                                                                                 makes, presents or
                                                                                 submits a false,
                                                                                 fictitious or
                                                                                 fraudulent claim to
                                                                                 the Department.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Some HHS components have not promulgated regulations regarding their civil monetary penalty-specific statutory authorities.

[[Page 51390]]

 
\2\ The description is not intended to be a comprehensive explanation of the underlying violation; the statute and corresponding regulation, if
  applicable, should be consulted.
\3\ Statutory or Inflation Act Adjustment.
\4\ The cost of living multiplier for 2018, based on the CPI-U for the month of October 2017, not seasonally adjusted, is 1.02041, as indicated in OMB
  Memorandum M-18-03, ``Implementation of Penalty Inflation Adjustments for 2018, Pursuant to the Federal Civil Penalties Adjustment Act Improvements
  Act of 2015'' (December 15, 2017).
\5\ 2018 Maximum Adjusted Penalty column adjusted based on changes to the Bipartisan Budget Act of 2018 for 42 U.S.C.1320a-7a(a),1320a-7a(b),
  1395l(h)(5)(D),1395m(a)(11)(A),1395m(a)(18)(B), 1395m(b)(5)(C), 1395m(h)(3), 1395m(j)(4), 1395m(k)(6), 1395m(l)(6), 1395u(b)(18)(B), 1395u(j)(2)(B),
  1395u(k), 1395u(l)(3), 1395u(m)(3), 1395u(n)(3), 1395u(o)(3)(B), 1395w-4(g)(1)(B), 1395w-4(g)(3)(B),1395pp(h).



    Dated: October 3, 2018.
Alex M. Azar II,
Secretary, Department of Health and Human Services.
[FR Doc. 2018-22005 Filed 10-10-18; 8:45 am]
 BILLING CODE 4150-24-P

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