Annual Civil Monetary Penalties Inflation Adjustment, 2869-2887 [2020-00738]

Download as PDF Federal Register / Vol. 85, No. 12 / Friday, January 17, 2020 / Rules and Regulations (e) Unsafe Condition This AD was prompted by reports of inflight failure of the left temperature control valve and control cabin trim air modulating valve. The FAA is issuing this AD to address the possible occurrence of temperatures in excess of 100 degrees Fahrenheit in the flight deck or the passenger cabin during cruise, which could lead to the impairment of the flightcrew and prevent continued safe flight and landing. (f) Compliance Comply with this AD within the compliance times specified, unless already done. (g) Retained Valve Replacement, With Revised Compliance Language This paragraph restates the requirements of paragraph (g) of AD 2017–12–07 with revised compliance language. For airplanes identified in Boeing Alert Service Bulletin 737–21A1203, dated June 8, 2016: Within 60 months after July 20, 2017 (the effective date of AD 2017–12–07), replace the left temperature control valve and control cabin trim air modulating valve, as applicable, in accordance with the Accomplishment Instructions of Boeing Alert Service Bulletin 737–21A1203, dated June 8, 2016. (h) New Valve Identification and Replacement For airplanes not identified in paragraph (g) of this AD with an original certificate of airworthiness or an original export certificate of airworthiness dated on or before the effective date of this AD, do the actions specified in paragraphs (h)(1) and (2) of this AD. (1) Within 60 months after the effective date of this AD, perform a general visual inspection of the left temperature control valve and control cabin trim air modulating valve to determine the valve part numbers. A review of airplane maintenance records is acceptable in lieu of this inspection if the part numbers of the valves can be conclusively determined from that review. (2) If the left temperature control valve or control cabin trim air modulating valve has part number 398908–4: Within 60 months after the effective date of this AD, replace the left temperature control valve or control cabin trim air modulating valve in accordance with the Accomplishment Instructions of Boeing Alert Service Bulletin 737–21A1203, dated June 8, 2016. lotter on DSKBCFDHB2PROD with RULES (i) Parts Installation Prohibition As of the effective date of this AD, no person may install a valve having part number 398908–4, in either the left temperature control valve location or the control cabin trim air modulating valve location on any airplane. (j) Alternative Methods of Compliance (AMOCs) (1) The Manager, Seattle ACO Branch, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards VerDate Sep<11>2014 16:20 Jan 16, 2020 Jkt 250001 District Office, as appropriate. If sending information directly to the manager of the certification office, send it to the attention of the person identified in paragraph (k) of this AD. Information may be emailed to: 9-ANMSeattle-ACO-AMOC-Requests@faa.gov. (2) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/ certificate holding district office. (3) An AMOC that provides an acceptable level of safety may be used for any repair, modification, or alteration required by this AD if it is approved by The Boeing Company Organization Designation Authorization (ODA) that has been authorized by the Manager, Seattle ACO Branch, FAA, to make those findings. To be approved, the repair method, modification deviation, or alteration deviation must meet the certification basis of the airplane, and the approval must specifically refer to this AD. (4) For service information that contains steps that are labeled as Required for Compliance (RC), the provisions of paragraphs (j)(4)(i) and (ii) of this AD apply. (i) The steps labeled as RC, including substeps under an RC step and any figures identified in an RC step, must be done to comply with the AD. If a step or substep is labeled ‘‘RC Exempt,’’ then the RC requirement is removed from that step or substep. An AMOC is required for any deviations to RC steps, including substeps and identified figures. (ii) Steps not labeled as RC may be deviated from using accepted methods in accordance with the operator’s maintenance or inspection program without obtaining approval of an AMOC, provided the RC steps, including substeps and identified figures, can still be done as specified, and the airplane can be put back in an airworthy condition. (k) Related Information For more information about this AD, contact Julie Moon, Aerospace Engineer, Cabin Safety and Environmental Systems Section, FAA, Seattle ACO Branch, 2200 South 216th St., Des Moines, WA 98198; phone and fax: 206–231–3571; email: julie.moon@faa.gov. (l) Material Incorporated by Reference (1) The Director of the Federal Register approved the incorporation by reference (IBR) of the service information listed in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51. (2) You must use this service information as applicable to do the actions required by this AD, unless the AD specifies otherwise. (3) The following service information was approved for IBR on July 20, 2017 (82 FR 27417, June 15, 2017). (i) Boeing Alert Service Bulletin 737– 21A1203, dated June 8, 2016. (ii) [Reserved] (4) For service information identified in this AD, contact Boeing Commercial Airplanes, Attention: Contractual & Data Services (C&DS), 2600 Westminster Blvd., MC 110–SK57, Seal Beach, CA 90740–5600; telephone 562–797–1717; internet https:// www.myboeingfleet.com. PO 00000 Frm 00003 Fmt 4700 Sfmt 4700 2869 (5) You may view this service information at the FAA, Transport Standards Branch, 2200 South 216th St., Des Moines, WA. For information on the availability of this material at the FAA, call 206–231–3195. (6) You may view this service information that is incorporated by reference at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, email fedreg.legal@nara.gov, or go to: https:// www.archives.gov/federal-register/cfr/ibrlocations.html. Issued on January 10, 2020. Dionne Palermo, Acting Director, System Oversight Division, Aircraft Certification Service. [FR Doc. 2020–00700 Filed 1–16–20; 8:45 am] BILLING CODE 4910–13–P DEPARTMENT OF HEALTH AND HUMAN SERVICES 45 CFR Part 102 RIN 0991–AC0 Annual Civil Monetary Penalties Inflation 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, and to make changes to reflect an amendment to the Federal Food, Drug, and Cosmetic Act by the Further Consolidated Appropriations Act, 2020 (effective January 1, 2020). DATES: This rule is effective January 17, 2020. FOR FURTHER INFORMATION CONTACT: David Dasher, Deputy Assistant Secretary, Office of Acquisitions, Office of the Assistant Secretary for Financial Resources, Room 536–H, Hubert Humphrey Building, 200 Independence Avenue SW, Washington DC 20201; 202–205–0706. SUPPLEMENTARY INFORMATION: SUMMARY: I. Background The Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (Sec. 701 of Pub. L. 114–74) (the ‘‘2015 Act’’) amended the Federal Civil Penalties Inflation Adjustment Act of 1990 (Pub. L. 101–410, 104 Stat. 890 (1990)), which is intended to improve the effectiveness of civil monetary E:\FR\FM\17JAR1.SGM 17JAR1 2870 Federal Register / Vol. 85, No. 12 / Friday, January 17, 2020 / Rules and Regulations 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, which was issued in an interim final rule published in the September 6, 2016 Federal Register (81 FR 61538). Annual adjustments were subsequently published on February 3, 2017 (82 FR 9175), October 11, 2018 (83 FR 51369), and on November 5, 2019 (84 FR 59549). The Further Consolidated Appropriations Act, 2020 (hereafter, 2020 Appropriations Act), created a new section 906(d)(5) in the Federal Food, Drug, and Cosmetic Act, codified at 21 U.S.C. 387f(d)(5), which increases the minimum age of sale of tobacco products and makes it unlawful for a retailer to sell a tobacco product to any person younger than 21 years old. H.R. 1865 Sec. 603. The 2020 Appropriations Act also amended the civil money penalty schedule codified in 21 U.S.C. 333 note to apply to violations of new section 906(d)(5). Accordingly, the description of 21 U.S.C. 333 note has been modified in the table to reflect these amendments. In addition, a technical error for an incorrect description of 42 U.S.C. 299c–(3)(d) was identified and is corrected below. II. Calculation of Adjustment lotter on DSKBCFDHB2PROD with RULES 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 16, 2019, Office of Management and Budget (OMB) Memorandum for the Heads of Executive Agencies and Departments, M–20–05, Implementation of the Penalty Inflation Adjustments for 2020, VerDate Sep<11>2014 16:20 Jan 16, 2020 Jkt 250001 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 2020, based on the CPI–U for the month of October 2019, not seasonally adjusted, is 1.01764. The multiplier is applied to each applicable penalty amount that was updated and published for FY 2019 and is rounded to the nearest dollar. Using the 2020 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–20–05, the phrase ‘‘notwithstanding section 553’’ in section 4(b)(2) of the 2015 Act means that ‘‘the public procedure the APA generally requires (i.e., 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. Additionally, HHS finds good cause for issuing technical changes as a final rule without notice and comment because these changes only update the PO 00000 Frm 00004 Fmt 4700 Sfmt 4700 implementing regulation to restate the statute in light of amendments recently enacted into law. Pursuant to OMB Memorandum M– 20–05, 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 January 17, 2020. A delayed effective date for the technical changes to the table made to reflect the 2020 Appropriations Act is unnecessary because the new requirements are already effective as a matter of law (5 U.S.C. 553(d)(3)) and they do not establish additional regulatory obligations or impose additional burden on regulated entities. The adjusted civil monetary penalty amounts apply to penalties assessed on or after January 17, 2020, 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 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 45 CFR part 102 as follows: 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 * E:\FR\FM\17JAR1.SGM * Penalty adjustment and table. * 17JAR1 * * Federal Register / Vol. 85, No. 12 / Friday, January 17, 2020 / Rules and Regulations 2871 TABLE 1 TO § 102.3—CIVIL MONETARY PENALTY AUTHORITIES ADMINISTERED BY HHS AGENCIES AND PENALTY AMOUNTS January 17, 2020 HHS agency CFR 1 21 U.S.C.: 333(b)(2)(A) ...................... .................................................. FDA 333(b)(2)(B) ...................... .................................................. FDA 333(b)(3) ........................... .................................................. FDA 333(f)(1)(A) ....................... .................................................. FDA 333(f)(2)(A) ....................... FDA 333(f)(3)(A) ....................... .................................................. FDA 333(f)(3)(B) ....................... .................................................. FDA 333(f)(4)(A)(i) .................... .................................................. FDA 333(f)(4)(A)(ii) ................... lotter on DSKBCFDHB2PROD with RULES .................................................. 333(f)(9)(A) ....................... 333(f)(9)(B)(i)(I) ................ VerDate Sep<11>2014 .................................................. .................................................. .................................................. 16:20 Jan 16, 2020 Jkt 250001 PO 00000 FDA FDA FDA Frm 00005 Date of last penalty figure or adjustment 3 Description 2 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) 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). 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. Fmt 4700 Sfmt 4700 E:\FR\FM\17JAR1.SGM 17JAR1 2019 Maximum adjusted penalty ($) 2020 Maximum adjusted penalty ($) 4 2019 105,194 107,050 2019 2,146,800 2,184,670 2019 210,386 214,097 2019 28,413 28,914 2019 1,894,261 1,927,676 2019 79,875 81,284 2019 399,374 406,419 2019 798,747 812,837 2019 12,103 12,316 2019 12,103 12,316 2019 302,585 307,923 2019 1,210,340 1,231,690 2019 302,585 307,923 2019 1,210,340 1,231,690 2019 12,103,404 12,316,908 2019 17,547 17,857 2019 1,169,798 1,190,433 2019 292,450 297,609 2872 Federal Register / Vol. 85, No. 12 / Friday, January 17, 2020 / Rules and Regulations TABLE 1 TO § 102.3—CIVIL MONETARY PENALTY AUTHORITIES ADMINISTERED BY HHS AGENCIES AND PENALTY AMOUNTS—Continued January 17, 2020 HHS agency CFR 1 333(f)(9)(B)(i)(II) ...................... 333(f)(9)(B)(ii)(I) ............... 333(f)(9)(B)(ii)(II) .............. 333(g)(1) ........................... lotter on DSKBCFDHB2PROD with RULES 333 note ........................... VerDate Sep<11>2014 .................................................. .................................................. .................................................. .................................................. .................................................. 17:14 Jan 16, 2020 Jkt 250001 PO 00000 FDA FDA FDA FDA FDA Frm 00006 Date of last penalty figure or adjustment 3 Description 2 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 30-day 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 30-day 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. 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 30day 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-to-consumer 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 21 U.S.C. 387f(d)(5) or of 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 violation of 21 U.S.C. 387f(d)(5) or of the tobacco product regulations within a 24-month period. Penalty in the case of a fourth violation of 21 U.S.C. 387f(d)(5) or of the tobacco product regulations within a 24-month period. Penalty in the case of a fifth violation of 21 U.S.C. 387f(d)(5) or of the tobacco product regulations within a 36-month period. Fmt 4700 Sfmt 4700 E:\FR\FM\17JAR1.SGM 17JAR1 2019 Maximum adjusted penalty ($) 2020 Maximum adjusted penalty ($) 4 2019 1,169,798 1,190,433 2019 292,450 297,609 2019 1,169,798 1,190,433 2019 11,697,983 11,904,335 2019 292,450 297,609 2019 1,169,798 1,190,433 2019 292,450 297,609 2019 1,169,798 1,190,433 2019 11,697,983 11,904,335 2019 302,585 307,923 2019 605,171 615,846 2019 292 297 2019 584 594 2019 2,340 2,381 2019 5,849 5,952 2873 Federal Register / Vol. 85, No. 12 / Friday, January 17, 2020 / Rules and Regulations TABLE 1 TO § 102.3—CIVIL MONETARY PENALTY AUTHORITIES ADMINISTERED BY HHS AGENCIES AND PENALTY AMOUNTS—Continued January 17, 2020 HHS agency CFR 1 335b(a) ............................. lotter on DSKBCFDHB2PROD with RULES 360pp(b)(1) .............................. .................................................. .................................................. FDA FDA 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 VerDate Sep<11>2014 16:20 Jan 16, 2020 Jkt 250001 PO 00000 Frm 00007 Date of last penalty figure or adjustment 3 Description 2 Penalty in the case of a sixth or subsequent violation of 21 U.S.C. 387f(d)(5) or of the tobacco product regulations within a 48month period as determined on a caseby-case basis. Penalty to be applied for violations of 21 U.S.C. 387f(d)(5) or of 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 violation of 21 U.S.C. 387f(d)(5) or of the tobacco product regulations within a 12-month period. Penalty in the case of a third violation of 21 U.S.C. 387f(d)(5) or of the tobacco product regulations within a 24-month period. Penalty in the case of a fourth violation of 21 U.S.C. 387f(d)(5) or of the tobacco product regulations within a 24-month period. Penalty in the case of a fifth violation of 21 U.S.C. 387f(d)(5) or of the tobacco product regulations within a 36-month period. Penalty in the case of a sixth or subsequent violation of 21 U.S.C. 387f(d)(5) or of the tobacco product regulations within a 48month period as determined on a caseby-case basis. 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. ....................................................................... 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. Fmt 4700 Sfmt 4700 E:\FR\FM\17JAR1.SGM 17JAR1 2019 Maximum adjusted penalty ($) 2020 Maximum adjusted penalty ($) 4 2019 11,698 11,904 2019 292 297 2019 584 594 2019 1,170 1,191 2019 2,340 2,381 2019 5,849 5,952 2019 11,698 11,904 2019 445,846 453,711 2019 1,783,384 1,814,843 2019 2,924 2,976 2019 996,806 1,014,390 2019 2019 .................... 229,269 .................... 233,313 2019 17,834 18,149 2019 229,269 233,313 2019 5,781 5,883 2019 15,034 15,299 2019 1,542 1,569 2019 348,708 354,859 2874 Federal Register / Vol. 85, No. 12 / Friday, January 17, 2020 / Rules and Regulations TABLE 1 TO § 102.3—CIVIL MONETARY PENALTY AUTHORITIES ADMINISTERED BY HHS AGENCIES AND PENALTY AMOUNTS—Continued January 17, 2020 HHS agency CFR 1 300jj–51 ............................ .................................................. OIG 1320a–7a(a) ..................... 42 CFR 1003.210(a)(1) ........... OIG 42 CFR 1003.210(a)(2) ........... 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) ..................... .................................................. OIG lotter on DSKBCFDHB2PROD with RULES 42 CFR 1003.210(a)(10) ......... 1320a–7a(o) ..................... VerDate Sep<11>2014 .................................................. 16:20 Jan 16, 2020 Jkt 250001 PO 00000 OIG Frm 00008 Date of last penalty figure or adjustment 3 Description 2 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. 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 knowingly presenting or causing to be presented a false or fraudulent specified claim under a grant, contract, or other agreement for which the Secretary provides funding. Fmt 4700 Sfmt 4700 E:\FR\FM\17JAR1.SGM 17JAR1 2019 Maximum adjusted penalty ($) 2020 Maximum adjusted penalty ($) 4 2019 697,418 709,720 2019 1,063,260 1,082,016 2019 20,504 20,866 2019 20,504 20,866 2019 30,757 31,300 2019 20,504 20,866 2019 20,504 20,866 2019 20,504 20,866 2019 102,522 104,330 2019 20,504 20,866 2019 102,522 104,330 2019 20,504 20,866 2019 57,812 58,832 2019 30,757 31,300 2019 5,126 5,216 2019 5,126 5,216 2019 10,252 10,433 2016 10,000 10,176 2875 Federal Register / Vol. 85, No. 12 / Friday, January 17, 2020 / Rules and Regulations TABLE 1 TO § 102.3—CIVIL MONETARY PENALTY AUTHORITIES ADMINISTERED BY HHS AGENCIES AND PENALTY AMOUNTS—Continued January 17, 2020 HHS agency lotter on DSKBCFDHB2PROD with RULES CFR 1 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 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 16:20 Jan 16, 2020 Jkt 250001 PO 00000 Frm 00009 Date of last penalty figure or adjustment 3 Description 2 Penalty for knowingly making, using, or causing to be made or used any false statement, omission, or misrepresentation of a material fact in any application, proposal, bid, progress report, or other document required to directly or indirectly receive or retain funds provided pursuant to grant, contract, or other agreement. Penalty for Knowingly making, using, or causing to be made or used, a false record or statement material to a false or fraudulent specified claim under grant, contract, or other agreement. Penalty for knowingly making, using, or causing to be made or used, a false record or statement material to an obligation to pay or transmit funds or property with respect to grant, contract, or other agreement, or knowingly conceals or improperly avoids or decreases any such obligation. Penalty for failure to grant timely access, upon reasonable request, to the Inspector General (I.G.) for purposes of audits, investigations, evaluations, or other statutory functions of I.G. in matters involving grants, contracts, or other agreements. 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. 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. Fmt 4700 Sfmt 4700 E:\FR\FM\17JAR1.SGM 17JAR1 2019 Maximum adjusted penalty ($) 2020 Maximum adjusted penalty ($) 4 2016 50,000 50,882 2016 50,000 50,882 2016 50,000 for each false record or statement, 10,000 per day. 53,231 for each false record statement, 10,646 per day. 2016 15,000 15,265 2019 39,121 39,811 2019 10,519 10,705 2019 52,596 53,524 2019 2,194 2,233 2019 10,967 11,160 2019 4,388 4,465 2019 39,936 40,640 2019 39,121 39,811 2019 39,121 39,811 2019 156,488 159,248 2019 23,473 23,887 2019 156,488 159,248 2876 Federal Register / Vol. 85, No. 12 / Friday, January 17, 2020 / Rules and Regulations TABLE 1 TO § 102.3—CIVIL MONETARY PENALTY AUTHORITIES ADMINISTERED BY HHS AGENCIES AND PENALTY AMOUNTS—Continued January 17, 2020 HHS agency CFR 1 1395w–141(i)(3) ............... .................................................. OIG 1395cc(g) ......................... .................................................. OIG 1395dd(d)(1) ..................... 42 CFR 1003.510 .................... OIG lotter on DSKBCFDHB2PROD with RULES 1395mm(i)(6)(B)(i) ............ VerDate Sep<11>2014 42 CFR 1003.410 .................... 16:20 Jan 16, 2020 Jkt 250001 PO 00000 OIG Frm 00010 Date of last penalty figure or adjustment 3 Description 2 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-managed care organization (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). 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 health maintenance organization (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. Fmt 4700 Sfmt 4700 E:\FR\FM\17JAR1.SGM 17JAR1 2019 Maximum adjusted penalty ($) 2020 Maximum adjusted penalty ($) 4 2019 39,121 39,811 2019 39,121 39,811 2019 39,121 39,811 2019 39,121 39,811 2019 39,121 39,811 2019 39,121 39,811 2019 39,121 39,811 2019 13,669 13,910 2019 5,317 5,411 2019 109,663 111,597 2019 54,833 55,800 2019 54,833 55,800 2019 54,833 55,800 2019 54,833 55,800 2019 219,327 223,196 2019 31,558 32,115 2019 219,327 223,196 2019 54,833 55,800 2019 54,833 55,800 2019 50,334 51,222 2877 Federal Register / Vol. 85, No. 12 / Friday, January 17, 2020 / Rules and Regulations TABLE 1 TO § 102.3—CIVIL MONETARY PENALTY AUTHORITIES ADMINISTERED BY HHS AGENCIES AND PENALTY AMOUNTS—Continued January 17, 2020 HHS agency lotter on DSKBCFDHB2PROD with RULES CFR 1 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 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 45 CFR 160.404(b)(1)(i), (ii) .... OCR VerDate Sep<11>2014 16:20 Jan 16, 2020 Jkt 250001 PO 00000 Frm 00011 Date of last penalty figure or adjustment 3 Description 2 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. Penalty for using mail to sell a non-approved 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 communitybased 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 Health Insurance Portability and Accountability Act (HIPAA) administrative simplification provisions. Calendar Year Cap ....................................... Fmt 4700 Sfmt 4700 E:\FR\FM\17JAR1.SGM 17JAR1 2019 Maximum adjusted penalty ($) 2020 Maximum adjusted penalty ($) 4 2019 25,372 25,820 2019 169,153 172,137 2019 10,519 10,705 2019 10,519 10,705 2019 47,357 48,192 2019 28,413 28,914 2019 10,519 10,705 2019 52,596 53,524 2019 52,596 53,524 2019 210,386 214,097 2019 31,558 32,115 2019 210,386 214,097 2019 52,596 53,524 2019 47,357 48,192 2019 2,194 2,233 2019 10,967 11,160 2019 4,388 4,465 2019 189,427 192,768 2019 18,943 19,277 2019 189,427 192,768 2019 3,788 3,855 2019 22,927 23,331 2019 22,927 23,331 2019 12,695 12,919 2019 159 162 2019 39,936 40,640 2878 Federal Register / Vol. 85, No. 12 / Friday, January 17, 2020 / Rules and Regulations TABLE 1 TO § 102.3—CIVIL MONETARY PENALTY AUTHORITIES ADMINISTERED BY HHS AGENCIES AND PENALTY AMOUNTS—Continued January 17, 2020 1320(d)–5(a) ..................... 45 CFR (B). 45 CFR (B). CFR 1 HHS agency 160.404(b)(2)(i)(A), OCR 160.404(b)(2)(ii)(A), 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) ........ lotter on DSKBCFDHB2PROD with RULES 42 CFR 493.1834(d)(2)(ii) ....... OCR OCR OCR CMS CMS 300gg–15(f) ...................... 45 CFR 147.200(e) ................. CMS 300gg–18 ......................... 45 CFR 158.606 ...................... CMS 1320a–7h(b)(1) ................. 42 CFR 402.105(d)(5), CFR 403.912(a) & (c). CMS 1320a–7h(b)(2) ................. VerDate Sep<11>2014 42 42 CFR 402.105(h), 42 CFR 403.912(b) & (c). 16:20 Jan 16, 2020 Jkt 250001 PO 00000 CMS Frm 00012 Date of last penalty figure or adjustment 3 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 30day 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. 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: Fmt 4700 Sfmt 4700 E:\FR\FM\17JAR1.SGM 17JAR1 2019 Maximum adjusted penalty ($) 2020 Maximum adjusted penalty ($) 4 2019 2019 2019 117 58,490 1,754,698 119 59,522 1,785,651 2019 2019 2019 1,170 58,490 1,754,698 1,191 59,522 1,785,651 2019 2019 2019 11,698 58,490 1,754,698 11,904 59,522 1,785,651 2019 2019 2019 58,490 1,754,698 1,754,698 59,522 1,785,651 1,785,651 2019 2019 6,417 21,039 6,530 21,410 2019 2019 2019 106 6,311 1,156 108 6,422 1,176 2019 116 118 2019 2019 2019 1,156 11,562 173,436 1,176 11,766 176,495 2879 Federal Register / Vol. 85, No. 12 / Friday, January 17, 2020 / Rules and Regulations TABLE 1 TO § 102.3—CIVIL MONETARY PENALTY AUTHORITIES ADMINISTERED BY HHS AGENCIES AND PENALTY AMOUNTS—Continued January 17, 2020 HHS agency CFR 1 CMS 1320a–7j(h)(3)(A) ............. lotter on DSKBCFDHB2PROD with RULES 1320a–8(a)(1) ................... 42 CFR 488.446(a)(1), (2), & (3). .................................................. CMS CMS 1320a–8(a)(3) ................... .................................................. CMS 1320b–25(c)(1)(A) ............ .................................................. CMS 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) ........ VerDate Sep<11>2014 16:20 Jan 16, 2020 Jkt 250001 PO 00000 CMS Frm 00013 Date of last penalty figure or adjustment 3 Description 2 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. 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 ................................................... Fmt 4700 Sfmt 4700 E:\FR\FM\17JAR1.SGM 17JAR1 2019 Maximum adjusted penalty ($) 2020 Maximum adjusted penalty ($) 4 2019 2019 2019 2019 11,562 115,624 1,156,242 115,624 11,766 117,664 1,176,638 117,664 2019 578 588 2019 1,735 1,766 2019 3,468 3,529 2019 8,457 8,606 2019 7,975 8,116 2019 6,623 6,740 2019 231,249 235,328 2019 346,872 352,991 2019 231,249 235,328 2019 156 159 2019 2019 110 6,579 112 6,695 2019 2019 2,194 21,933 2,233 22,320 2880 Federal Register / Vol. 85, No. 12 / Friday, January 17, 2020 / Rules and Regulations TABLE 1 TO § 102.3—CIVIL MONETARY PENALTY AUTHORITIES ADMINISTERED BY HHS AGENCIES AND PENALTY AMOUNTS—Continued January 17, 2020 HHS agency CFR 1 42 CFR 488.408(e)(1)(iii) ........ 42 CFR 488.408(e)(1)(iv) ........ 42 CFR 488.408(e)(2)(ii) ......... 42 CFR 488.438(a)(1)(i) .......... 42 CFR 488.438(a)(1)(ii) ......... lotter on DSKBCFDHB2PROD with RULES 42 CFR 488.438(a)(2) ............. CMS CMS CMS CMS CMS CMS 1395l(h)(5)(D) ................... 42 CFR 402.105(d)(2)(i) .......... CMS 1395l(i)(6) ......................... .................................................. CMS 1395l(q)(2)(B)(i) ................ 42 CFR 402.105(a) ................. CMS 1395m(a)(11)(A) ............... 42 CFR 402.1(c)(4), 402.105(d)(2)(ii). CMS 1395m(a)(18)(B) ............... 42 CFR 402.1(c)(5), 402.105(d)(2)(iii). CMS VerDate Sep<11>2014 16:20 Jan 16, 2020 Jkt 250001 PO 00000 Frm 00014 Date of last penalty figure or adjustment 3 Description 2 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 ................................................... 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)). Fmt 4700 Sfmt 4700 E:\FR\FM\17JAR1.SGM 17JAR1 2019 Maximum adjusted penalty ($) 2020 Maximum adjusted penalty ($) 4 2019 2019 6,690 21,933 6,808 22,320 2019 2019 2,194 21,933 2,233 22,320 2019 2019 2019 2019 6,690 21,933 2,194 21,933 6,808 22,320 2,233 22,320 2019 2019 6,690 21,933 6,808 22,320 2019 2019 110 6,579 112 6,695 2019 2019 2019 2,194 21,933 15,975 2,233 22,320 16,257 2019 4,208 4,282 2019 4,027 4,098 2019 15,975 16,257 2019 15,975 16,257 2881 Federal Register / Vol. 85, No. 12 / Friday, January 17, 2020 / Rules and Regulations TABLE 1 TO § 102.3—CIVIL MONETARY PENALTY AUTHORITIES ADMINISTERED BY HHS AGENCIES AND PENALTY AMOUNTS—Continued January 17, 2020 HHS agency lotter on DSKBCFDHB2PROD with RULES CFR 1 1395m(b)(5)(C) ................. 42 CFR 402.1(c)(6), 402.105(d)(2)(iv). CMS 1395m(h)(3) ...................... 42 CFR 402.1(c)(8), 402.105(d)(2)(vi). CMS 1395m(j)(2)(A)(iii) ............. .................................................. CMS 1395m(j)(4) ....................... 42 CFR 402.1(c)(10), 402.105(d)(2)(vii). CMS 1395m(k)(6) ...................... 42 CFR 402.1(c)(31), 402.105(d)(3). CMS 1395m(l)(6) ....................... 42 CFR 402.1(c)(32), 402.105(d)(4). CMS 1395u(b)(18)(B) ................ 42 CFR 402.1(c)(11), 402.105(d)(2)(viii). CMS 1395u(j)(2)(B) ................... 42 CFR 402.1(c) ...................... CMS VerDate Sep<11>2014 16:20 Jan 16, 2020 Jkt 250001 PO 00000 Frm 00015 Date of last penalty figure or adjustment 3 Description 2 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)). 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)). Fmt 4700 Sfmt 4700 E:\FR\FM\17JAR1.SGM 17JAR1 2019 Maximum adjusted penalty ($) 2020 Maximum adjusted penalty ($) 4 2019 15,975 16,257 2019 15,975 16,257 2019 1,692 1,722 2019 15,975 16,257 2019 15,975 16,257 2019 15,975 16,257 2019 15,975 16,257 2019 15,975 16,257 2882 Federal Register / Vol. 85, No. 12 / Friday, January 17, 2020 / Rules and Regulations TABLE 1 TO § 102.3—CIVIL MONETARY PENALTY AUTHORITIES ADMINISTERED BY HHS AGENCIES AND PENALTY AMOUNTS—Continued January 17, 2020 HHS agency lotter on DSKBCFDHB2PROD with RULES CFR 1 1395u(k) ........................... 42 CFR 402.1(c)(12), 402.105(d)(2)(ix). CMS 1395u(l)(3) ........................ 42 CFR 402.1(c)(13), 402.105(d)(2)(x). CMS 1395u(m)(3) ...................... 42 CFR 402.1(c)(14), 402.105(d)(2)(xi). CMS 1395u(n)(3) ....................... 42 CFR 402.1(c)(15), 402.105(d)(2)(xii). CMS 1395u(o)(3)(B) .................. 42 CFR 414.707(b) ................. CMS 1395u(p)(3)(A) .................. .................................................. CMS 1395w–3a(d)(4)(A) ........... 42 CFR 414.806 ...................... CMS 1395w–4(g)(1)(B) ............. 42 CFR 402.1(c)(17), 402.105(d)(2)(xiii). CMS VerDate Sep<11>2014 16:20 Jan 16, 2020 Jkt 250001 PO 00000 Frm 00016 Date of last penalty figure or adjustment 3 Description 2 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)). 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. Penalty for any nonparticipating physician, supplier, or other person that furnishes physician services not on an assignmentrelated 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)). Fmt 4700 Sfmt 4700 E:\FR\FM\17JAR1.SGM 17JAR1 2019 Maximum adjusted penalty ($) 2020 Maximum adjusted penalty ($) 4 2019 15,975 16,257 2019 15,975 16,257 2019 15,975 16,257 2019 15,975 16,257 2019 15,975 16,257 2019 4,208 4,282 2019 13,669 13,910 2019 15,975 16,257 2883 Federal Register / Vol. 85, No. 12 / Friday, January 17, 2020 / Rules and Regulations TABLE 1 TO § 102.3—CIVIL MONETARY PENALTY AUTHORITIES ADMINISTERED BY HHS AGENCIES AND PENALTY AMOUNTS—Continued January 17, 2020 HHS agency lotter on DSKBCFDHB2PROD with RULES CFR 1 1395w–4(g)(3)(B) ............. 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 402.105(a). 402.1(c)(21), CMS 1395y(b)(7)(B)(i) ............... .................................................. CMS 1395y(b)(8)(E) .................. .................................................. 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 405.105(f)(1). CMS VerDate Sep<11>2014 16:20 Jan 16, 2020 Jkt 250001 402.1(c)(24), PO 00000 Frm 00017 Date of last penalty figure or adjustment 3 Description 2 Penalty for any person that knowingly and willfully bills for statutorily defined Stateplan 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. Penalty for any non-group health plan that fails to identify claimants who are Medicare beneficiaries and provide information to the HHS Secretary to coordinate benefits and pursue any applicable recovery claim. 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. Fmt 4700 Sfmt 4700 E:\FR\FM\17JAR1.SGM 17JAR1 2019 Maximum adjusted penalty ($) 2020 Maximum adjusted penalty ($) 4 2019 15,975 16,257 2019 39,121 39,811 2019 15,649 15,925 2019 145,335 147,899 2019 9,472 9,639 2019 1,542 1,569 2019 3,383 3,443 2019 1,211 1,232 2019 1,211 1,232 2019 20,134 20,489 2019 15,975 16,257 2019 54,832 55,799 2884 Federal Register / Vol. 85, No. 12 / Friday, January 17, 2020 / Rules and Regulations TABLE 1 TO § 102.3—CIVIL MONETARY PENALTY AUTHORITIES ADMINISTERED BY HHS AGENCIES AND PENALTY AMOUNTS—Continued January 17, 2020 HHS agency CFR 1 1395ss(d)(3)(A)(vi)(II) ....... 1395ss(d)(3)(B)(iv) ........... 1395ss(p)(8) ..................... 1395ss(p)(9)(C) ................ CMS .................................................. CMS 42 CFR 402.105(e). 402.1(c)(25), CMS 42 CFR 405.105(f)(2). 402.1(c)(25), CMS 42 CFR 402.105(e). 402.1(c)(26), CMS lotter on DSKBCFDHB2PROD with RULES 42 CFR 402.1(c)(26), 405.105(f)(3), (4). 1395ss(q)(5)(C) ................ 42 CFR 405.105(f)(5). 402.1(c)(27), CMS 1395ss(r)(6)(A) ................. 42 CFR 405.105(f)(6). 402.1(c)(28), CMS 1395ss(s)(4) ..................... 42 CFR 405.105(c). 402.1(c)(29), CMS 1395ss(t)(2) ...................... 42 CFR 405.105(f)(7). 402.1(c)(30), 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). CMS VerDate Sep<11>2014 17:14 Jan 16, 2020 Jkt 250001 PO 00000 Frm 00018 Date of last penalty figure or adjustment 3 Description 2 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 National Association of Insurance Commissioners (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. 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. Fmt 4700 Sfmt 4700 E:\FR\FM\17JAR1.SGM 17JAR1 2019 Maximum adjusted penalty ($) 2020 Maximum adjusted penalty ($) 4 2019 28,413 28,914 2019 47,357 48,192 2019 28,413 28,914 2019 47,357 48,192 2019 28,413 28,914 2019 47,357 48,192 2019 28,413 28,914 2019 47,357 48,192 2019 47,357 48,192 2019 47,357 48,192 2019 20,104 20,459 2019 47,357 48,192 2019 20,503 20,865 2019 34,174 34,777 2019 4,388 4,465 2019 21,039 21,410 2885 Federal Register / Vol. 85, No. 12 / Friday, January 17, 2020 / Rules and Regulations TABLE 1 TO § 102.3—CIVIL MONETARY PENALTY AUTHORITIES ADMINISTERED BY HHS AGENCIES AND PENALTY AMOUNTS—Continued January 17, 2020 HHS agency CFR 1 42 CFR 488.845(b)(3) ............. 42 CFR 488.845(b)(3)(i) .......... 42 CFR 488.845(b)(3)(ii) ......... 42 CFR 488.845(b)(3)(iii) ........ 42 CFR 488.845(b)(4) ............. 42 CFR 488.845(b)(5) ............. 42 CFR 488.845(b)(6) ............. 42 CFR 488.845(d)(1)(ii) ......... 1396b(m)(5)(B) ................. lotter on DSKBCFDHB2PROD with RULES 1396r(h)(3)(C)(ii)(I) ........... 42 CFR 460.46 ........................ 42 CFR 488.408(d)(1)(iii) ........ 42 CFR 488.408(d)(1)(iv) ........ 42 CFR 488.408(e)(1)(iii) ........ VerDate Sep<11>2014 16:20 Jan 16, 2020 Jkt 250001 PO 00000 CMS CMS CMS CMS Frm 00019 Date of last penalty figure or adjustment 3 Description 2 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 home health agency (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 .................................................... 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 Programs of All-Inclusive Care for the Elderly (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: Fmt 4700 Sfmt 4700 E:\FR\FM\17JAR1.SGM 17JAR1 2019 Maximum adjusted penalty ($) 2020 Maximum adjusted penalty ($) 4 2019 2019 2019 17,883 21,039 21,039 18,198 21,410 21,410 2019 18,934 19,268 2019 17,883 18,198 2019 2019 3,157 17,883 3,213 18,198 2019 2019 1,052 8,415 1,071 8,563 2019 2019 2019 2,104 21,039 21,039 2,141 21,410 21,410 2019 21,039 21,410 2019 2019 2019 23,473 156,488 39,121 23,887 159,248 39,811 2019 156,488 159,248 2019 39,121 39,811 2019 39,121 39,811 2019 39,121 39,811 2019 2019 110 6,579 112 6,695 2019 2019 2,194 21,933 2,233 22,320 2886 Federal Register / Vol. 85, No. 12 / Friday, January 17, 2020 / Rules and Regulations TABLE 1 TO § 102.3—CIVIL MONETARY PENALTY AUTHORITIES ADMINISTERED BY HHS AGENCIES AND PENALTY AMOUNTS—Continued January 17, 2020 HHS agency CFR 1 42 CFR 488.408(e)(1)(iv) ........ 42 CFR 488.408(e)(2)(ii) ......... 42 CFR 488.438(a)(1)(i) .......... 42 CFR 488.438(a)(1)(ii) ......... 42 CFR 488.438(a)(2) ............. CMS CMS 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) .......... lotter on DSKBCFDHB2PROD with RULES CMS 42 CFR 438.704 ...................... 42 CFR 438.704 ...................... CMS CMS 1396u–2(e)(2)(A)(iv) ......... 42 CFR 438.704 ...................... CMS 1396u(h)(2) ....................... 42 CFR Part 441, Subpart I .... CMS VerDate Sep<11>2014 17:14 Jan 16, 2020 Jkt 250001 PO 00000 Frm 00020 Date of last penalty figure or adjustment 3 Description 2 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: 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 civil monetary penalties (CMPs) 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 $5,000’’ [Not CMP authority but CMP imposition at this level determines eligibility to seek waiver of disapproval of nurse aide training program]. Penalty for each day of noncompliance for a home or community care provider that no longer meets the minimum requirements for home and community care: Minimum .................................................... Maximum ................................................... Penalty for a Medicaid managed care organization that fails substantially to provide medically necessary items and services. Penalty for Medicaid managed care organization that imposes premiums or charges on enrollees in excess of the premiums or charges permitted. Penalty for a Medicaid managed care organization that misrepresents or falsifies information to another individual or entity. Penalty for a Medicaid managed care organization that fails to comply with the applicable statutory requirements for such organizations. Penalty for a Medicaid managed care organization that misrepresents or falsifies information to the HHS Secretary. Penalty for Medicaid managed care organization that acts to discriminate among enrollees on the basis of their health status. Penalty for each individual that does not enroll as a result of a Medicaid managed care organization that acts to discriminate among enrollees on the basis of their health status. Penalty for a provider not meeting one of the requirements relating to the protection of the health, safety, and welfare of individuals receiving community supported living arrangements services. Fmt 4700 Sfmt 4700 E:\FR\FM\17JAR1.SGM 17JAR1 2019 Maximum adjusted penalty ($) 2020 Maximum adjusted penalty ($) 4 2019 2019 6,690 21,933 6,808 22,320 2019 2019 2,194 21,933 2,233 22,320 2019 2019 2,194 21,933 2,233 22,320 2019 2019 6,690 21,933 6,808 22,320 2019 2019 110 6,579 112 6,695 2019 2019 2019 2,194 21,933 10,967 2,233 22,320 11,160 2019 10,967 11,160 2019 2019 2019 2 18,943 39,121 2 19,277 39,811 2019 39,121 39,811 2019 39,121 39,811 2019 39,121 39,811 2019 156,488 159,248 2019 156,488 159,248 2019 23,473 23,887 2019 21,933 22,320 2887 Federal Register / Vol. 85, No. 12 / Friday, January 17, 2020 / Rules and Regulations TABLE 1 TO § 102.3—CIVIL MONETARY PENALTY AUTHORITIES ADMINISTERED BY HHS AGENCIES AND PENALTY AMOUNTS—Continued January 17, 2020 HHS agency CFR 1 1396w–2(c)(1) .................. .................................................. CMS 18041(c)(2) ....................... 45 CFR 150.315; 45 CFR 156.805(c). CMS 18081(h)(1)(A)(i)(II) .......... 42 CFR 155.285 ...................... CMS 18081(h)(1)(B) .................. 42 CFR 155.285 ...................... CMS 18081(h)(2) ....................... 42 CFR 155.260 ...................... CMS 31 U.S.C.: 1352 ................................. 45 CFR 93.400(e) ................... HHS 45 CFR Part 93, Appendix A .. 3801–3812 ....................... 45 CFR 79.3(a)(1)(iv) .............. HHS HHS 45 CFR 79.3(b)(1)(ii) ............... Date of last penalty figure or adjustment 3 Description 2 2019 Maximum adjusted penalty ($) 2020 Maximum adjusted penalty ($) 4 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. 2019 11,698 11,904 2019 159 162 2019 28,906 29,416 2019 289,060 294,159 2019 28,906 29,416 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 sub-awards 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. 2019 20,134 20,489 2019 2019 2019 20,134 201,340 20,134 20,489 204,892 20,489 2019 2019 20,134 201,340 20,489 204,892 2019 2019 20,134 201,340 20,489 204,892 2019 2019 2019 20,134 201,340 10,520 20,489 204,892 10,706 2019 10,520 10,706 1 Some HHS components have not promulgated regulations regarding their civil monetary penalty-specific statutory authorities. 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 2020, based on the Consumer Price Index for all Urban Consumers (CPI–U) for the month of October 2019, not seasonally adjusted, is 1.01764, as indicated in OMB Memorandum M–20–05, ‘‘Implementation of Penalty Inflation Adjustments for 2019, Pursuant to the Federal Civil Penalties Adjustment Act Improvements Act of 2015’’ (December 16, 2019). 2 The lotter on DSKBCFDHB2PROD with RULES Alex M. Azar II, Secretary, Department of Health and Human Services. [FR Doc. 2020–00738 Filed 1–15–20; 4:15 pm] BILLING CODE 4150–24–P VerDate Sep<11>2014 16:20 Jan 16, 2020 Jkt 250001 PO 00000 Frm 00021 Fmt 4700 Sfmt 9990 E:\FR\FM\17JAR1.SGM 17JAR1

Agencies

DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 85, Number 12 (Friday, January 17, 2020)]
[Rules and Regulations]
[Pages 2869-2887]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-00738]


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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, and to make changes to reflect an amendment to the Federal Food, 
Drug, and Cosmetic Act by the Further Consolidated Appropriations Act, 
2020 (effective January 1, 2020).

DATES: This rule is effective January 17, 2020.

FOR FURTHER INFORMATION CONTACT: David Dasher, Deputy Assistant 
Secretary, Office of Acquisitions, Office of the Assistant Secretary 
for Financial Resources, Room 536-H, Hubert Humphrey Building, 200 
Independence Avenue SW, Washington DC 20201; 202-205-0706.

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'') amended the 
Federal Civil Penalties Inflation Adjustment Act of 1990 (Pub. L. 101-
410, 104 Stat. 890 (1990)), which is intended to improve the 
effectiveness of civil monetary

[[Page 2870]]

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, which was issued 
in an interim final rule published in the September 6, 2016 Federal 
Register (81 FR 61538). Annual adjustments were subsequently published 
on February 3, 2017 (82 FR 9175), October 11, 2018 (83 FR 51369), and 
on November 5, 2019 (84 FR 59549).
    The Further Consolidated Appropriations Act, 2020 (hereafter, 2020 
Appropriations Act), created a new section 906(d)(5) in the Federal 
Food, Drug, and Cosmetic Act, codified at 21 U.S.C. 387f(d)(5), which 
increases the minimum age of sale of tobacco products and makes it 
unlawful for a retailer to sell a tobacco product to any person younger 
than 21 years old. H.R. 1865 Sec. 603. The 2020 Appropriations Act also 
amended the civil money penalty schedule codified in 21 U.S.C. 333 note 
to apply to violations of new section 906(d)(5). Accordingly, the 
description of 21 U.S.C. 333 note has been modified in the table to 
reflect these amendments. In addition, a technical error for an 
incorrect description of 42 U.S.C. 299c-(3)(d) was identified and is 
corrected below.

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 16, 2019, Office of Management 
and Budget (OMB) Memorandum for the Heads of Executive Agencies and 
Departments, M-20-05, Implementation of the Penalty Inflation 
Adjustments for 2020, 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 2020, based on the CPI-U for the month of October 2019, 
not seasonally adjusted, is 1.01764. The multiplier is applied to each 
applicable penalty amount that was updated and published for FY 2019 
and is rounded to the nearest dollar.
    Using the 2020 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-20-05, the phrase ``notwithstanding section 553'' in 
section 4(b)(2) of the 2015 Act means that ``the public procedure the 
APA generally requires (i.e., 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. Additionally, HHS finds good cause for issuing technical 
changes as a final rule without notice and comment because these 
changes only update the implementing regulation to restate the statute 
in light of amendments recently enacted into law.
    Pursuant to OMB Memorandum M-20-05, 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 January 17, 2020. A delayed effective date 
for the technical changes to the table made to reflect the 2020 
Appropriations Act is unnecessary because the new requirements are 
already effective as a matter of law (5 U.S.C. 553(d)(3)) and they do 
not establish additional regulatory obligations or impose additional 
burden on regulated entities. The adjusted civil monetary penalty 
amounts apply to penalties assessed on or after January 17, 2020, 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 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 45 CFR part 102 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.

* * * * *

[[Page 2871]]



  Table 1 to Sec.   102.3--Civil Monetary Penalty Authorities Administered by HHS Agencies and Penalty Amounts
                                                January 17, 2020
----------------------------------------------------------------------------------------------------------------
                                                                             Date of
                                                                               last         2019         2020
                                                   HHS                       penalty      Maximum      Maximum
                                   CFR \1\       agency   Description \2\   figure or     adjusted     adjusted
                                                                            adjustment    penalty      penalty
                                                                               \3\          ($)        ($) \4\
----------------------------------------------------------------------------------------------------------------
21 U.S.C.:
    333(b)(2)(A).............  ...............  FDA       Penalty for             2019      105,194      107,050
                                                           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             2019    2,146,800    2,184,670
                                                           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             2019      210,386      214,097
                                                           failure 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         2019       28,413       28,914
                                                           person who
                                                           violates a
                                                           requirement
                                                           related to
                                                           devices for
                                                           each such
                                                           violation.
                                                          Penalty for             2019    1,894,261    1,927,676
                                                           aggregate of
                                                           all violations
                                                           related to
                                                           devices in a
                                                           single
                                                           proceeding.
    333(f)(2)(A).............  ...............  FDA       Penalty for any         2019       79,875       81,284
                                                           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          2019      399,374      406,419
                                                           case of any
                                                           other person
                                                           other than an
                                                           individual)
                                                           for such
                                                           introduction
                                                           or delivery of
                                                           adulterated
                                                           food.
                                                          Penalty for             2019      798,747      812,837
                                                           aggregate of
                                                           all such
                                                           violations
                                                           related to
                                                           adulterated
                                                           food
                                                           adjudicated in
                                                           a single
                                                           proceeding.
    333(f)(3)(A).............  ...............  FDA       Penalty for all         2019       12,103       12,316
                                                           violations
                                                           adjudicated in
                                                           a single
                                                           proceeding for
                                                           any person who
                                                           violates 21
                                                           U.S.C. 331(jj)
                                                           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             2019       12,103       12,316
                                                           each day 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         2019      302,585      307,923
                                                           responsible
                                                           person that
                                                           violates a
                                                           requirement of
                                                           21 U.S.C.
                                                           355(o) (post-
                                                           marketing
                                                           studies,
                                                           clinical
                                                           trials,
                                                           labeling), 21
                                                           U.S.C. 355(p)
                                                           (risk
                                                           evaluation and
                                                           mitigation
                                                           (REMS)), or 21
                                                           U.S.C. 355-1
                                                           (REMS).
                                                          Penalty for             2019    1,210,340    1,231,690
                                                           aggregate of
                                                           all such above
                                                           violations in
                                                           a single
                                                           proceeding.
    333(f)(4)(A)(ii).........  ...............  FDA       Penalty for             2019      302,585      307,923
                                                           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             2019    1,210,340    1,231,690
                                                           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             2019   12,103,404   12,316,908
                                                           aggregate of
                                                           all such above
                                                           violations
                                                           adjudicated in
                                                           a single
                                                           proceeding.
    333(f)(9)(A).............  ...............  FDA       Penalty for any         2019       17,547       17,857
                                                           person who
                                                           violates a
                                                           requirement
                                                           which relates
                                                           to tobacco
                                                           products for
                                                           each such
                                                           violation.
                                                          Penalty for             2019    1,169,798    1,190,433
                                                           aggregate of
                                                           all such
                                                           violations of
                                                           tobacco
                                                           product
                                                           requirement
                                                           adjudicated in
                                                           a single
                                                           proceeding.
    333(f)(9)(B)(i)(I).......  ...............  FDA       Penalty per             2019      292,450      297,609
                                                           violation
                                                           related to
                                                           violations of
                                                           tobacco
                                                           requirements.

[[Page 2872]]

 
                                                          Penalty for             2019    1,169,798    1,190,433
                                                           aggregate of
                                                           all such
                                                           violations of
                                                           tobacco
                                                           product
                                                           requirements
                                                           adjudicated in
                                                           a single
                                                           proceeding.
333(f)(9)(B)(i)(II)..........  ...............  FDA       Penalty in the          2019      292,450      297,609
                                                           case of a
                                                           violation of
                                                           tobacco
                                                           product
                                                           requirements
                                                           that continues
                                                           after written
                                                           notice to such
                                                           person, for
                                                           the first 30-
                                                           day period (or
                                                           any portion
                                                           thereof) the
                                                           person
                                                           continues to
                                                           be in
                                                           violation.
                                                          Penalty for             2019    1,169,798    1,190,433
                                                           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             2019   11,697,983   11,904,335
                                                           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         2019      292,450      297,609
                                                           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             2019    1,169,798    1,190,433
                                                           aggregate of
                                                           for all such
                                                           above
                                                           violations
                                                           adjudicated in
                                                           a single
                                                           proceeding.
    333(f)(9)(B)(ii)(II).....  ...............  FDA       Penalty for             2019      292,450      297,609
                                                           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.
                                                          Penalty for             2019    1,169,798    1,190,433
                                                           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             2019   11,697,983   11,904,335
                                                           aggregate
                                                           above tobacco
                                                           product
                                                           requirement
                                                           violations
                                                           adjudicated in
                                                           a single
                                                           proceeding.
    333(g)(1)................  ...............  FDA       Penalty for any         2019      302,585      307,923
                                                           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             2019      605,171      615,846
                                                           each
                                                           subsequent
                                                           above
                                                           violation in
                                                           any 3-year
                                                           period.
    333 note.................  ...............  FDA       Penalty to be           2019          292          297
                                                           applied for
                                                           violations of
                                                           21 U.S.C.
                                                           387f(d)(5) or
                                                           of 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          2019          584          594
                                                           case of a
                                                           third
                                                           violation of
                                                           21 U.S.C.
                                                           387f(d)(5) or
                                                           of the tobacco
                                                           product
                                                           regulations
                                                           within a 24-
                                                           month period.
                                                          Penalty in the          2019        2,340        2,381
                                                           case of a
                                                           fourth
                                                           violation of
                                                           21 U.S.C.
                                                           387f(d)(5) or
                                                           of the tobacco
                                                           product
                                                           regulations
                                                           within a 24-
                                                           month period.
                                                          Penalty in the          2019        5,849        5,952
                                                           case of a
                                                           fifth
                                                           violation of
                                                           21 U.S.C.
                                                           387f(d)(5) or
                                                           of the tobacco
                                                           product
                                                           regulations
                                                           within a 36-
                                                           month period.

[[Page 2873]]

 
                                                          Penalty in the          2019       11,698       11,904
                                                           case of a
                                                           sixth or
                                                           subsequent
                                                           violation of
                                                           21 U.S.C.
                                                           387f(d)(5) or
                                                           of the tobacco
                                                           product
                                                           regulations
                                                           within a 48-
                                                           month period
                                                           as determined
                                                           on a case-by-
                                                           case basis.
                                                          Penalty to be           2019          292          297
                                                           applied for
                                                           violations of
                                                           21 U.S.C.
                                                           387f(d)(5) or
                                                           of 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          2019          584          594
                                                           case of a
                                                           second
                                                           violation of
                                                           21 U.S.C.
                                                           387f(d)(5) or
                                                           of the tobacco
                                                           product
                                                           regulations
                                                           within a 12-
                                                           month period.
                                                          Penalty in the          2019        1,170        1,191
                                                           case of a
                                                           third
                                                           violation of
                                                           21 U.S.C.
                                                           387f(d)(5) or
                                                           of the tobacco
                                                           product
                                                           regulations
                                                           within a 24-
                                                           month period.
                                                          Penalty in the          2019        2,340        2,381
                                                           case of a
                                                           fourth
                                                           violation of
                                                           21 U.S.C.
                                                           387f(d)(5) or
                                                           of the tobacco
                                                           product
                                                           regulations
                                                           within a 24-
                                                           month period.
                                                          Penalty in the          2019        5,849        5,952
                                                           case of a
                                                           fifth
                                                           violation of
                                                           21 U.S.C.
                                                           387f(d)(5) or
                                                           of the tobacco
                                                           product
                                                           regulations
                                                           within a 36-
                                                           month period.
                                                          Penalty in the          2019       11,698       11,904
                                                           case of a
                                                           sixth or
                                                           subsequent
                                                           violation of
                                                           21 U.S.C.
                                                           387f(d)(5) or
                                                           of the tobacco
                                                           product
                                                           regulations
                                                           within a 48-
                                                           month period
                                                           as determined
                                                           on a case-by-
                                                           case basis.
    335b(a)..................  ...............  FDA       Penalty for             2019      445,846      453,711
                                                           each violation
                                                           for any
                                                           individual who
                                                           made a false
                                                           statement or
                                                           misrepresentat
                                                           ion 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          2019    1,783,384    1,814,843
                                                           case of any
                                                           other person
                                                           (other than an
                                                           individual)
                                                           per above
                                                           violation.
360pp(b)(1)..................  ...............  FDA       Penalty for any         2019        2,924        2,976
                                                           person who
                                                           violates any
                                                           such
                                                           requirements
                                                           for electronic
                                                           products, with
                                                           each unlawful
                                                           act or
                                                           omission
                                                           constituting a
                                                           separate
                                                           violation.
                                                          Penalty imposed         2019      996,806    1,014,390
                                                           for any
                                                           related series
                                                           of violations
                                                           of
                                                           requirements
                                                           relating to
                                                           electronic
                                                           products.
42 U.S.C.....................  ...............  ........  ...............         2019  ...........  ...........
    262(d)...................  ...............  FDA       Penalty per day         2019      229,269      233,313
                                                           for violation
                                                           of order of
                                                           recall of
                                                           biological
                                                           product
                                                           presenting
                                                           imminent or
                                                           substantial
                                                           hazard.
    263b(h)(3)...............  ...............  FDA       Penalty for             2019       17,834       18,149
                                                           failure to
                                                           obtain a
                                                           mammography
                                                           certificate as
                                                           required.
    300aa-28(b)(1)...........  ...............  FDA       Penalty per             2019      229,269      233,313
                                                           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             2019        5,781        5,883
                                                           each instance
                                                           of
                                                           overcharging a
                                                           340B covered
                                                           entity.
    299c-(3)(d)..............  ...............  AHRQ      Penalty for an          2019       15,034       15,299
                                                           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           ACF       Penalty for             2019        1,542        1,569
                                303.21(f).                 Misuse of
                                                           Information in
                                                           the National
                                                           Directory of
                                                           New Hires.
    262a(i)(1)...............  42 CFR 1003.910  OIG       Penalty for             2019      348,708      354,859
                                                           each
                                                           individual who
                                                           violates
                                                           safety and
                                                           security
                                                           procedures
                                                           related to
                                                           handling
                                                           dangerous
                                                           biological
                                                           agents and
                                                           toxins.

[[Page 2874]]

 
                                                          Penalty for any         2019      697,418      709,720
                                                           other person
                                                           who violates
                                                           safety and
                                                           security
                                                           procedures
                                                           related to
                                                           handling
                                                           dangerous
                                                           biological
                                                           agents and
                                                           toxins.
    300jj-51.................  ...............  OIG       Penalty per             2019    1,063,260    1,082,016
                                                           violation for
                                                           committing
                                                           information
                                                           blocking.
    1320a-7a(a)..............  42 CFR           OIG       Penalty for             2019       20,504       20,866
                                1003.210(a)(1).            knowingly
                                                           presenting or
                                                           causing to be
                                                           presented to
                                                           an officer,
                                                           employee, or
                                                           agent of the
                                                           United States
                                                           a false claim.
                                                          Penalty for             2019       20,504       20,866
                                                           knowingly
                                                           presenting or
                                                           causing to be
                                                           presented a
                                                           request for
                                                           payment which
                                                           violates the
                                                           terms of an
                                                           assignment,
                                                           agreement, or
                                                           PPS agreement.
                               42 CFR           ........  Penalty for             2019       30,757       31,300
                                1003.210(a)(2).            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.
                               42 CFR           ........  Penalty for an          2019       20,504       20,866
                                1003.210(a)(3).            excluded party
                                                           retaining
                                                           ownership or
                                                           control
                                                           interest in a
                                                           participating
                                                           entity.
                               42 CFR           ........  Penalty for             2019       20,504       20,866
                                1003.1010.                 remuneration
                                                           offered to
                                                           induce program
                                                           beneficiaries
                                                           to use
                                                           particular
                                                           providers,
                                                           practitioners,
                                                           or suppliers.
                               42 CFR           ........  Penalty for             2019       20,504       20,866
                                1003.210(a)(4).            employing or
                                                           contracting
                                                           with an
                                                           excluded
                                                           individual.
                               42 CFR           ........  Penalty for             2019      102,522      104,330
                                1003.310(a)(3).            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.
                               42 CFR           ........  Penalty for             2019       20,504       20,866
                                1003.210(a)(1).            ordering or
                                                           prescribing
                                                           medical or
                                                           other item or
                                                           service during
                                                           a period in
                                                           which the
                                                           person was
                                                           excluded.
                               42 CFR           ........  Penalty for             2019      102,522      104,330
                                1003.210(a)(6).            knowingly
                                                           making or
                                                           causing to be
                                                           made a false
                                                           statement,
                                                           omission or
                                                           misrepresentat
                                                           ion of a
                                                           material fact
                                                           in any
                                                           application,
                                                           bid, or
                                                           contract to
                                                           participate or
                                                           enroll as a
                                                           provider or
                                                           supplier.
                               42 CFR           ........  Penalty for             2019       20,504       20,866
                                1003.210(a)(8).            knowing of an
                                                           overpayment
                                                           and failing to
                                                           report and
                                                           return.
                               42 CFR           ........  Penalty for             2019       57,812       58,832
                                1003.210(a)(7).            making or
                                                           using a false
                                                           record or
                                                           statement that
                                                           is material to
                                                           a false or
                                                           fraudulent
                                                           claim.
                               42 CFR           ........  Penalty for             2019       30,757       31,300
                                1003.210(a)(9).            failure to
                                                           grant timely
                                                           access to HHS
                                                           OIG for
                                                           audits,
                                                           investigations
                                                           , evaluations,
                                                           and other
                                                           statutory
                                                           functions of
                                                           HHS OIG.
    1320a-7a(b)..............  ...............  OIG       Penalty for             2019        5,126        5,216
                                                           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             2019        5,126        5,216
                                                           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           2019       10,252       10,433
                                1003.210(a)(10             physician who
                                ).                         executes a
                                                           document that
                                                           falsely
                                                           certifies home
                                                           health needs
                                                           for Medicare
                                                           beneficiaries.
    1320a-7a(o)..............  ...............  OIG       Penalty for             2016       10,000       10,176
                                                           knowingly
                                                           presenting or
                                                           causing to be
                                                           presented a
                                                           false or
                                                           fraudulent
                                                           specified
                                                           claim under a
                                                           grant,
                                                           contract, or
                                                           other
                                                           agreement for
                                                           which the
                                                           Secretary
                                                           provides
                                                           funding.

[[Page 2875]]

 
                                                          Penalty for             2016       50,000       50,882
                                                           knowingly
                                                           making, using,
                                                           or causing to
                                                           be made or
                                                           used any false
                                                           statement,
                                                           omission, or
                                                           misrepresentat
                                                           ion of a
                                                           material fact
                                                           in any
                                                           application,
                                                           proposal, bid,
                                                           progress
                                                           report, or
                                                           other document
                                                           required to
                                                           directly or
                                                           indirectly
                                                           receive or
                                                           retain funds
                                                           provided
                                                           pursuant to
                                                           grant,
                                                           contract, or
                                                           other
                                                           agreement.
                                                          Penalty for             2016       50,000       50,882
                                                           Knowingly
                                                           making, using,
                                                           or causing to
                                                           be made or
                                                           used, a false
                                                           record or
                                                           statement
                                                           material to a
                                                           false or
                                                           fraudulent
                                                           specified
                                                           claim under
                                                           grant,
                                                           contract, or
                                                           other
                                                           agreement.
                                                          Penalty for             2016   50,000 for   53,231 for
                                                           knowingly                     each false   each false
                                                           making, using,                record or      record
                                                           or causing to                 statement,   statement,
                                                           be made or                    10,000 per   10,646 per
                                                           used, a false                    day.         day.
                                                           record or
                                                           statement
                                                           material to an
                                                           obligation to
                                                           pay or
                                                           transmit funds
                                                           or property
                                                           with respect
                                                           to grant,
                                                           contract, or
                                                           other
                                                           agreement, or
                                                           knowingly
                                                           conceals or
                                                           improperly
                                                           avoids or
                                                           decreases any
                                                           such
                                                           obligation.
                                                          Penalty for             2016       15,000       15,265
                                                           failure to
                                                           grant timely
                                                           access, upon
                                                           reasonable
                                                           request, to
                                                           the Inspector
                                                           General (I.G.)
                                                           for purposes
                                                           of audits,
                                                           investigations
                                                           , evaluations,
                                                           or other
                                                           statutory
                                                           functions of
                                                           I.G. in
                                                           matters
                                                           involving
                                                           grants,
                                                           contracts, or
                                                           other
                                                           agreements.
    1320a-7e(b)(6)(A)........  42 CFR 1003.810  OIG       Penalty for             2019       39,121       39,811
                                                           failure to
                                                           report any
                                                           final adverse
                                                           action taken
                                                           against a
                                                           health care
                                                           provider,
                                                           supplier, or
                                                           practitioner.
    1320b-10(b)(1)...........  42 CFR           OIG       Penalty for the         2019       10,519       10,705
                                1003.610(a).               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           OIG       Penalty for the         2019       52,596       53,524
                                1003.610(a).               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.
    1395i-3(b)(3)(B)(ii)(1)..  42 CFR           OIG       Penalty for             2019        2,194        2,233
                                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             2019       10,967       11,160
                                1003.210(a)(11             causing
                                ).                         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           OIG       Penalty for any         2019        4,388        4,465
                                1003.1310.                 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           2019       39,936       40,640
                                                           Medicare
                                                           Advantage
                                                           organization
                                                           that
                                                           substantially
                                                           fails to
                                                           provide
                                                           medically
                                                           necessary,
                                                           required items
                                                           and services.
                                                          Penalty for a           2019       39,121       39,811
                                                           Medicare
                                                           Advantage
                                                           organization
                                                           that charges
                                                           excessive
                                                           premiums.
                                                          Penalty for a           2019       39,121       39,811
                                                           Medicare
                                                           Advantage
                                                           organization
                                                           that
                                                           improperly
                                                           expels or
                                                           refuses to
                                                           reenroll a
                                                           beneficiary.
                                                          Penalty for a           2019      156,488      159,248
                                                           Medicare
                                                           Advantage
                                                           organization
                                                           that engages
                                                           in practice
                                                           that would
                                                           reasonably be
                                                           expected to
                                                           have the
                                                           effect of
                                                           denying or
                                                           discouraging
                                                           enrollment.
                                                          Penalty per             2019       23,473       23,887
                                                           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           2019      156,488      159,248
                                                           Medicare
                                                           Advantage
                                                           organization
                                                           misrepresentin
                                                           g or
                                                           falsifying
                                                           information to
                                                           Secretary.

[[Page 2876]]

 
                                                          Penalty for a           2019       39,121       39,811
                                                           Medicare
                                                           Advantage
                                                           organization
                                                           misrepresentin
                                                           g or
                                                           falsifying
                                                           information to
                                                           individual or
                                                           other entity.
                                                          Penalty for             2019       39,121       39,811
                                                           Medicare
                                                           Advantage
                                                           organization
                                                           interfering
                                                           with
                                                           provider's
                                                           advice to
                                                           enrollee and
                                                           non-managed
                                                           care
                                                           organization
                                                           (MCO)
                                                           affiliated
                                                           providers that
                                                           balance bill
                                                           enrollees.
                                                          Penalty for a           2019       39,121       39,811
                                                           Medicare
                                                           Advantage
                                                           organization
                                                           that employs
                                                           or contracts
                                                           with excluded
                                                           individual or
                                                           entity.
                                                          Penalty for a           2019       39,121       39,811
                                                           Medicare
                                                           Advantage
                                                           organization
                                                           enrolling an
                                                           individual in
                                                           without prior
                                                           written
                                                           consent.
                                                          Penalty for a           2019       39,121       39,811
                                                           Medicare
                                                           Advantage
                                                           organization
                                                           transferring
                                                           an enrollee to
                                                           another plan
                                                           without
                                                           consent or
                                                           solely for the
                                                           purpose of
                                                           earning a
                                                           commission.
                                                          Penalty for a           2019       39,121       39,811
                                                           Medicare
                                                           Advantage
                                                           organization
                                                           failing to
                                                           comply with
                                                           marketing
                                                           restrictions
                                                           or applicable
                                                           implementing
                                                           regulations or
                                                           guidance.
                                                          Penalty for a           2019       39,121       39,811
                                                           Medicare
                                                           Advantage
                                                           organization
                                                           employing or
                                                           contracting
                                                           with an
                                                           individual or
                                                           entity who
                                                           violates 1395w-
                                                           27(g)(1)(A)-(J
                                                           ).
    1395w-141(i)(3)..........  ...............  OIG       Penalty for a           2019       13,669       13,910
                                                           prescription
                                                           drug card
                                                           sponsor that
                                                           falsifies or
                                                           misrepresents
                                                           marketing
                                                           materials,
                                                           overcharges
                                                           program
                                                           enrollees, or
                                                           misuse
                                                           transitional
                                                           assistance
                                                           funds.
    1395cc(g)................  ...............  OIG       Penalty for             2019        5,317        5,411
                                                           improper
                                                           billing by
                                                           Hospitals,
                                                           Critical
                                                           Access
                                                           Hospitals, or
                                                           Skilled
                                                           Nursing
                                                           Facilities.
    1395dd(d)(1).............  42 CFR 1003.510  OIG       Penalty for a           2019      109,663      111,597
                                                           hospital or
                                                           responsible
                                                           physician
                                                           dumping
                                                           patients
                                                           needing
                                                           emergency
                                                           medical care,
                                                           if the
                                                           hospital has
                                                           100 beds or
                                                           more.
                                                          Penalty for a           2019       54,833       55,800
                                                           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           2019       54,833       55,800
                                                           health
                                                           maintenance
                                                           organization
                                                           (HMO) or
                                                           competitive
                                                           plan is such
                                                           plan
                                                           substantially
                                                           fails to
                                                           provide
                                                           medically
                                                           necessary,
                                                           required items
                                                           or services.
                                                          Penalty for             2019       54,833       55,800
                                                           HMOs/
                                                           competitive
                                                           medical plans
                                                           that charge
                                                           premiums in
                                                           excess of
                                                           permitted
                                                           amounts.
                                                          Penalty for a           2019       54,833       55,800
                                                           HMO or
                                                           competitive
                                                           medical plan
                                                           that expels or
                                                           refuses to
                                                           reenroll an
                                                           individual per
                                                           prescribed
                                                           conditions.
                                                          Penalty for a           2019      219,327      223,196
                                                           HMO or
                                                           competitive
                                                           medical plan
                                                           that
                                                           implements
                                                           practices to
                                                           discourage
                                                           enrollment of
                                                           individuals
                                                           needing
                                                           services in
                                                           future.
                                                          Penalty per             2019       31,558       32,115
                                                           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           2019      219,327      223,196
                                                           HMO or
                                                           competitive
                                                           medical plan
                                                           that
                                                           misrepresents
                                                           or falsifies
                                                           information to
                                                           the Secretary.
                                                          Penalty for a           2019       54,833       55,800
                                                           HMO or
                                                           competitive
                                                           medical plan
                                                           that
                                                           misrepresents
                                                           or falsifies
                                                           information to
                                                           an individual
                                                           or any other
                                                           entity.
                                                          Penalty for             2019       54,833       55,800
                                                           failure by HMO
                                                           or competitive
                                                           medical plan
                                                           to assure
                                                           prompt payment
                                                           of Medicare
                                                           risk sharing
                                                           contracts or
                                                           incentive plan
                                                           provisions.
                                                          Penalty for HMO         2019       50,334       51,222
                                                           that employs
                                                           or contracts
                                                           with excluded
                                                           individual or
                                                           entity.

[[Page 2877]]

 
    1395nn(g)(3).............  42 CFR 1003.310  OIG       Penalty for             2019       25,372       25,820
                                                           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             2019      169,153      172,137
                                                           circumventing
                                                           Stark Law's
                                                           restrictions
                                                           on physician
                                                           self-referrals.
    1395ss(d)(1).............  42 CFR           OIG       Penalty for a           2019       10,519       10,705
                                1003.1110.                 material
                                                           misrepresentat
                                                           ion regarding
                                                           Medigap
                                                           compliance
                                                           policies.
    1395ss(d)(2).............  42 CFR           OIG       Penalty for             2019       10,519       10,705
                                1003.1110.                 selling
                                                           Medigap policy
                                                           under false
                                                           pretense.
    1395ss(d)(3)(A)(ii)......  42 CFR           OIG       Penalty for an          2019       47,357       48,192
                                1003.1110.                 issuer that
                                                           sells health
                                                           insurance
                                                           policy that
                                                           duplicates
                                                           benefits.
                                                          Penalty for             2019       28,413       28,914
                                                           someone other
                                                           than issuer
                                                           that sells
                                                           health
                                                           insurance that
                                                           duplicates
                                                           benefits.
    1395ss(d)(4)(A)..........  42 CFR           OIG       Penalty for             2019       10,519       10,705
                                1003.1110.                 using mail to
                                                           sell a non-
                                                           approved
                                                           Medigap
                                                           insurance
                                                           policy.
    1396b(m)(5)(B)(i)........  42 CFR 1003.410  OIG       Penalty for a           2019       52,596       53,524
                                                           Medicaid MCO
                                                           that
                                                           substantially
                                                           fails to
                                                           provide
                                                           medically
                                                           necessary,
                                                           required items
                                                           or services.
                                                          Penalty for a           2019       52,596       53,524
                                                           Medicaid MCO
                                                           that charges
                                                           excessive
                                                           premiums.
                                                          Penalty for a           2019      210,386      214,097
                                                           Medicaid MCO
                                                           that
                                                           improperly
                                                           expels or
                                                           refuses to
                                                           reenroll a
                                                           beneficiary.
                                                          Penalty per             2019       31,558       32,115
                                                           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           2019      210,386      214,097
                                                           Medicaid MCO
                                                           misrepresentin
                                                           g or
                                                           falsifying
                                                           information to
                                                           the Secretary.
                                                          Penalty for a           2019       52,596       53,524
                                                           Medicaid MCO
                                                           misrepresentin
                                                           g or
                                                           falsifying
                                                           information to
                                                           an individual
                                                           or another
                                                           entity.
                                                          Penalty for a           2019       47,357       48,192
                                                           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             2019        2,194        2,233
                                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             2019       10,967       11,160
                                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           OIG       Penalty for             2019        4,388        4,465
                                1003.1310.                 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           OIG       Penalty for the         2019      189,427      192,768
                                1003.1210.                 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           OIG       Penalty per day         2019       18,943       19,277
                                1003.1210.                 for failure to
                                                           timely provide
                                                           information by
                                                           drug
                                                           manufacturer
                                                           with rebate
                                                           agreement.
    1396r-8(b)(3)(C)(ii).....  42 CFR           OIG       Penalty for             2019      189,427      192,768
                                1003.1210.                 knowing
                                                           provision of
                                                           false
                                                           information by
                                                           drug
                                                           manufacturer
                                                           with rebate
                                                           agreement.
    1396t(i)(3)(A)...........  42 CFR           OIG       Penalty for             2019        3,788        3,855
                                1003.1310.                 notifying home
                                                           and community-
                                                           based
                                                           providers or
                                                           settings of
                                                           survey.
    11131(c).................  42 CFR 1003.810  OIG       Penalty for             2019       22,927       23,331
                                                           failing to
                                                           report a
                                                           medical
                                                           malpractice
                                                           claim to
                                                           National
                                                           Practitioner
                                                           Data Bank.
    11137(b)(2)..............  42 CFR 1003.810  OIG       Penalty for             2019       22,927       23,331
                                                           breaching
                                                           confidentialit
                                                           y of
                                                           information
                                                           reported to
                                                           National
                                                           Practitioner
                                                           Data Bank.
    299b-22(f)(1)............  42 CFR 3.404...  OCR       Penalty for             2019       12,695       12,919
                                                           violation of
                                                           confidentialit
                                                           y provision of
                                                           the Patient
                                                           Safety and
                                                           Quality
                                                           Improvement
                                                           Act.
                               45 CFR           OCR       Penalty for             2019          159          162
                                160.404(b)(1)(             each pre-
                                i), (ii).                  February 18,
                                                           2009 violation
                                                           of the Health
                                                           Insurance
                                                           Portability
                                                           and
                                                           Accountability
                                                           Act (HIPAA)
                                                           administrative
                                                           simplification
                                                           provisions.
                                                          Calendar Year           2019       39,936       40,640
                                                           Cap.

[[Page 2878]]

 
    1320(d)-5(a).............  45 CFR           OCR       Penalty for
                                160.404(b)(2)(             each February
                                i)(A), (B).                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......         2019          117          119
                                                            Maximum......         2019       58,490       59,522
                                                            Calendar Year         2019    1,754,698    1,785,651
                                                             Cap.
                               45 CFR           OCR       Penalty for
                                160.404(b)(2)(             each February
                                ii)(A), (B).               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......         2019        1,170        1,191
                                                            Maximum......         2019       58,490       59,522
                                                            Calendar Year         2019    1,754,698    1,785,651
                                                             Cap.
                               45 CFR           OCR       Penalty for
                                160.404(b)(2)(             each February
                                iii)(A), (B).              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......         2019       11,698       11,904
                                                            Maximum......         2019       58,490       59,522
                                                            Calendar Year         2019    1,754,698    1,785,651
                                                             Cap.
                               45 CFR           OCR       Penalty for
                                160.404(b)(2)(             each February
                                iv)(A), (B).               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......         2019       58,490       59,522
                                                            Maximum......         2019    1,754,698    1,785,651
                                                            Calendar Year         2019    1,754,698    1,785,651
                                                             Cap.
    263a(h)(2)(B) & 1395w-     42 CFR           CMS       Penalty for a
     2(b)(2)(A)(ii).            493.1834(d)(2)             clinical
                                (i).                       laboratory's
                                                           failure to
                                                           meet
                                                           participation
                                                           and
                                                           certification
                                                           requirements
                                                           and poses
                                                           immediate
                                                           jeopardy:
                                                            Minimum......         2019        6,417        6,530
                                                            Maximum......         2019       21,039       21,410
                               42 CFR           CMS       Penalty for a
                                493.1834(d)(2)             clinical
                                (ii).                      laboratory's
                                                           failure to
                                                           meet
                                                           participation
                                                           and
                                                           certification
                                                           requirements
                                                           and the
                                                           failure does
                                                           not pose
                                                           immediate
                                                           jeopardy:
                                                            Minimum......         2019          106          108
                                                            Maximum......         2019        6,311        6,422
    300gg-15(f)..............  45 CFR           CMS       Failure to              2019        1,156        1,176
                                147.200(e).                provide the
                                                           Summary of
                                                           Benefits and
                                                           Coverage.
    300gg-18.................  45 CFR 158.606.  CMS       Penalty for             2019          116          118
                                                           violations of
                                                           regulations
                                                           related to the
                                                           medical loss
                                                           ratio
                                                           reporting and
                                                           rebating.
    1320a-7h(b)(1)...........  42 CFR           CMS       Penalty for
                                402.105(d)(5),             manufacturer
                                42 CFR                     or group
                                403.912(a) &               purchasing
                                (c).                       organization
                                                           failing to
                                                           report
                                                           information
                                                           required under
                                                           42 U.S.C.
                                                           1320a-7h(a),
                                                           relating to
                                                           physician
                                                           ownership or
                                                           investment
                                                           interests:
                                                            Minimum......         2019        1,156        1,176
                                                            Maximum......         2019       11,562       11,766
                                                            Calendar Year         2019      173,436      176,495
                                                             Cap.
    1320a-7h(b)(2)...........  42 CFR           CMS       Penalty for
                                402.105(h), 42             manufacturer
                                CFR 403.912(b)             or group
                                & (c).                     purchasing
                                                           organization
                                                           knowingly
                                                           failing to
                                                           report
                                                           information
                                                           required under
                                                           42 U.S.C.
                                                           1320a-7h(a),
                                                           relating to
                                                           physician
                                                           ownership or
                                                           investment
                                                           interests:

[[Page 2879]]

 
                                                            Minimum......         2019       11,562       11,766
                                                            Maximum......         2019      115,624      117,664
                                                            Calendar Year         2019    1,156,242    1,176,638
                                                             Cap.
                                                CMS       Penalty for an          2019      115,624      117,664
                                                           administrator
                                                           of a facility
                                                           that fails to
                                                           comply with
                                                           notice
                                                           requirements
                                                           for the
                                                           closure of a
                                                           facility.
    1320a-7j(h)(3)(A)........  42 CFR           CMS       Minimum penalty         2019          578          588
                                488.446(a)(1),             for the first
                                (2), & (3).                offense of an
                                                           administrator
                                                           who fails to
                                                           provide notice
                                                           of facility
                                                           closure.
                                                          Minimum penalty         2019        1,735        1,766
                                                           for the second
                                                           offense of an
                                                           administrator
                                                           who fails to
                                                           provide notice
                                                           of facility
                                                           closure.
                                                          Minimum penalty         2019        3,468        3,529
                                                           for the third
                                                           and subsequent
                                                           offenses of an
                                                           administrator
                                                           who fails to
                                                           provide notice
                                                           of facility
                                                           closure.
    1320a-8(a)(1)............  ...............  CMS       Penalty for an          2019        8,457        8,606
                                                           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             2019        7,975        8,116
                                                           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           2019        6,623        6,740
                                                           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             2019      231,249      235,328
                                                           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.
    1320b-25(c)(2)(A)........  ...............  CMS       Penalty for             2019      346,872      352,991
                                                           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.
    1320b-25(d)(2)...........  ...............  CMS       Penalty for a           2019      231,249      235,328
                                                           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.
    1395b-7(b)(2)(B).........  42 CFR           CMS       Penalty for any         2019          156          159
                                402.105(g).                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
                                488.408(d)(1)(             for a Skilled
                                iii).                      Nursing
                                                           Facility that
                                                           has a Category
                                                           2 violation of
                                                           certification
                                                           requirements:
                                                            Minimum......         2019          110          112
                                                            Maximum......         2019        6,579        6,695
                               42 CFR           CMS       Penalty per
                                488.408(d)(1)(             instance of
                                iv).                       Category 2
                                                           noncompliance
                                                           by a Skilled
                                                           Nursing
                                                           Facility:
                                                            Minimum......         2019        2,194        2,233
                                                            Maximum......         2019       21,933       22,320

[[Page 2880]]

 
                               42 CFR           CMS       Penalty per day
                                488.408(e)(1)(             for a Skilled
                                iii).                      Nursing
                                                           Facility that
                                                           has a Category
                                                           3 violation of
                                                           certification
                                                           requirements:
                                                            Minimum......         2019        6,690        6,808
                                                            Maximum......         2019       21,933       22,320
                               42 CFR           CMS       Penalty per
                                488.408(e)(1)(             instance of
                                iv).                       Category 3
                                                           noncompliance
                                                           by a Skilled
                                                           Nursing
                                                           Facility:
                                                            Minimum......         2019        2,194        2,233
                                                            Maximum......         2019       21,933       22,320
                               42 CFR           CMS       Penalty per day
                                488.408(e)(2)(             and per
                                ii).                       instance for a
                                                           Skilled
                                                           Nursing
                                                           Facility that
                                                           has Category 3
                                                           noncompliance
                                                           with Immediate
                                                           Jeopardy:
                                                          Per Day                 2019        6,690        6,808
                                                           (Minimum).
                                                          Per Day                 2019       21,933       22,320
                                                           (Maximum).
                                                          Per Instance            2019        2,194        2,233
                                                           (Minimum).
                                                          Per Instance            2019       21,933       22,320
                                                           (Maximum).
                               42 CFR           CMS       Penalty per day
                                488.438(a)(1)(             of a Skilled
                                i).                        Nursing
                                                           Facility that
                                                           fails to meet
                                                           certification
                                                           requirements.
                                                           These amounts
                                                           represent the
                                                           upper range
                                                           per day:
                                                            Minimum......         2019        6,690        6,808
                                                            Maximum......         2019       21,933       22,320
                               42 CFR           CMS       Penalty per day
                                488.438(a)(1)(             of a Skilled
                                ii).                       Nursing
                                                           Facility that
                                                           fails to meet
                                                           certification
                                                           requirements.
                                                           These amounts
                                                           represent the
                                                           lower range
                                                           per day:
                                                            Minimum......         2019          110          112
                                                            Maximum......         2019        6,579        6,695
                               42 CFR           CMS       Penalty per
                                488.438(a)(2).             instance of a
                                                           Skilled
                                                           Nursing
                                                           Facility that
                                                           fails to meet
                                                           certification
                                                           requirements:
                                                            Minimum......         2019        2,194        2,233
                                                            Maximum......         2019       21,933       22,320
    1395l(h)(5)(D)...........  42 CFR           CMS       Penalty for             2019       15,975       16,257
                                402.105(d)(2)(             knowingly,
                                i).                        willfully, and
                                                           repeatedly
                                                           billing for a
                                                           clinical
                                                           diagnostic
                                                           laboratory
                                                           test other
                                                           than on an
                                                           assignment-
                                                           related basis.
                                                           (Penalties are
                                                           assessed in
                                                           the same
                                                           manner as 42
                                                           U.S.C.
                                                           1395u(j)(2)(B)
                                                           , which is
                                                           assessed
                                                           according to
                                                           1320a-7a(a)).
    1395l(i)(6)..............  ...............  CMS       Penalty for             2019        4,208        4,282
                                                           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           CMS       Penalty for             2019        4,027        4,098
                                402.105(a).                knowingly and
                                                           willfully
                                                           failing to
                                                           provide
                                                           information
                                                           about a
                                                           referring
                                                           physician when
                                                           seeking
                                                           payment on an
                                                           unassigned
                                                           basis.
    1395m(a)(11)(A)..........  42 CFR           CMS       Penalty for any         2019       15,975       16,257
                                402.1(c)(4),               durable
                                402.105(d)(2)(             medical
                                ii).                       equipment
                                                           supplier that
                                                           knowingly and
                                                           willfully
                                                           charges for a
                                                           covered
                                                           service that
                                                           is furnished
                                                           on a rental
                                                           basis after
                                                           the rental
                                                           payments may
                                                           no longer be
                                                           made.
                                                           (Penalties are
                                                           assessed in
                                                           the same
                                                           manner as 42
                                                           U.S.C.
                                                           1395u(j)(2)(B)
                                                           , which is
                                                           assessed
                                                           according to
                                                           1320a-7a(a)).
    1395m(a)(18)(B)..........  42 CFR           CMS       Penalty for any         2019       15,975       16,257
                                402.1(c)(5),               nonparticipati
                                402.105(d)(2)(             ng durable
                                iii).                      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)).

[[Page 2881]]

 
    1395m(b)(5)(C)...........  42 CFR           CMS       Penalty for any         2019       15,975       16,257
                                402.1(c)(6),               nonparticipati
                                402.105(d)(2)(             ng physician
                                iv).                       or supplier
                                                           that knowingly
                                                           and willfully
                                                           charges a
                                                           Medicare
                                                           beneficiary
                                                           more than the
                                                           limiting
                                                           charge for
                                                           radiologist
                                                           services.
                                                           (Penalties are
                                                           assessed in
                                                           the same
                                                           manner as 42
                                                           U.S.C.
                                                           1395u(j)(2)(B)
                                                           , which is
                                                           assessed
                                                           according to
                                                           1320a-7a(a)).
    1395m(h)(3)..............  42 CFR           CMS       Penalty for any         2019       15,975       16,257
                                402.1(c)(8),               supplier of
                                402.105(d)(2)(             prosthetic
                                vi).                       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)).
    1395m(j)(2)(A)(iii)......  ...............  CMS       Penalty for any         2019        1,692        1,722
                                                           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)..............  42 CFR           CMS       Penalty for any         2019       15,975       16,257
                                402.1(c)(10),              supplier of
                                402.105(d)(2)(             durable
                                vii).                      medical
                                                           equipment,
                                                           including a
                                                           supplier of
                                                           prosthetic
                                                           devices,
                                                           prosthetics,
                                                           orthotics, or
                                                           supplies that
                                                           knowingly and
                                                           willfully
                                                           fails to make
                                                           refunds in a
                                                           timely manner
                                                           to Medicare
                                                           beneficiaries
                                                           for series
                                                           billed other
                                                           than on as
                                                           assignment-
                                                           related basis
                                                           under certain
                                                           conditions.
                                                           (Penalties are
                                                           assessed in
                                                           the same
                                                           manner as 42
                                                           U.S.C.
                                                           1395m(j)(4)
                                                           and
                                                           1395u(j)(2)(B)
                                                           , which is
                                                           assessed
                                                           according to
                                                           1320a-7a(a)).
    1395m(k)(6)..............  42 CFR           CMS       Penalty for any         2019       15,975       16,257
                                402.1(c)(31),              person or
                                402.105(d)(3).             entity who
                                                           knowingly and
                                                           willfully
                                                           bills or
                                                           collects for
                                                           any outpatient
                                                           therapy
                                                           services or
                                                           comprehensive
                                                           outpatient
                                                           rehabilitation
                                                           services on
                                                           other than an
                                                           assignment-
                                                           related basis.
                                                           (Penalties are
                                                           assessed in
                                                           the same
                                                           manner as 42
                                                           U.S.C.
                                                           1395m(k)(6)
                                                           and
                                                           1395u(j)(2)(B)
                                                           , which is
                                                           assessed
                                                           according to
                                                           1320a-7a(a)).
    1395m(l)(6)..............  42 CFR           CMS       Penalty for any         2019       15,975       16,257
                                402.1(c)(32),              supplier of
                                402.105(d)(4).             ambulance
                                                           services who
                                                           knowingly and
                                                           willfully
                                                           fills or
                                                           collects for
                                                           any services
                                                           on other than
                                                           an assignment-
                                                           related basis.
                                                           (Penalties are
                                                           assessed in
                                                           the same
                                                           manner as 42
                                                           U.S.C.
                                                           1395u(b)(18)(B
                                                           ), which is
                                                           assessed
                                                           according to
                                                           1320a-7a(a)).
    1395u(b)(18)(B)..........  42 CFR           CMS       Penalty for any         2019       15,975       16,257
                                402.1(c)(11),              practitioner
                                402.105(d)(2)(             specified in
                                viii).                     Section
                                                           1842(b)(18)(C)
                                                           of the Act or
                                                           other person
                                                           that knowingly
                                                           and willfully
                                                           bills or
                                                           collects for
                                                           any services
                                                           by the
                                                           practitioners
                                                           on other than
                                                           an assignment-
                                                           related basis.
                                                           (Penalties are
                                                           assessed in
                                                           the same
                                                           manner as 42
                                                           U.S.C.
                                                           1395u(j)(2)(B)
                                                           , which is
                                                           assessed
                                                           according to
                                                           1320a-7a(a)).
    1395u(j)(2)(B)...........  42 CFR 402.1(c)  CMS       Penalty for any         2019       15,975       16,257
                                                           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)).

[[Page 2882]]

 
    1395u(k).................  42 CFR           CMS       Penalty for any         2019       15,975       16,257
                                402.1(c)(12),              physician who
                                402.105(d)(2)(             knowingly and
                                ix).                       willfully
                                                           presents or
                                                           causes to be
                                                           presented a
                                                           claim for bill
                                                           for an
                                                           assistant at a
                                                           cataract
                                                           surgery
                                                           performed on
                                                           or after March
                                                           1, 1987, for
                                                           which payment
                                                           may not be
                                                           made because
                                                           of section
                                                           1862(a)(15).
                                                           (Penalties are
                                                           assessed in
                                                           the same
                                                           manner as 42
                                                           U.S.C.
                                                           1395u(j)(2)(B)
                                                           , which is
                                                           assessed
                                                           according to
                                                           1320a-7a(a)).
    1395u(l)(3)..............  42 CFR           CMS       Penalty for any         2019       15,975       16,257
                                402.1(c)(13),              nonparticipati
                                402.105(d)(2)(             ng physician
                                x).                        who does not
                                                           accept payment
                                                           on an
                                                           assignment-
                                                           related basis
                                                           and who
                                                           knowingly and
                                                           willfully
                                                           fails to
                                                           refund on a
                                                           timely basis
                                                           any amounts
                                                           collected for
                                                           services that
                                                           are not
                                                           reasonable or
                                                           medically
                                                           necessary or
                                                           are of poor
                                                           quality under
                                                           1842(l)(1)(A).
                                                           (Penalties are
                                                           assessed in
                                                           the same
                                                           manner as 42
                                                           U.S.C.
                                                           1395u(j)(2)(B)
                                                           , which is
                                                           assessed
                                                           according to
                                                           1320a-7a(a)).
    1395u(m)(3)..............  42 CFR           CMS       Penalty for any         2019       15,975       16,257
                                402.1(c)(14),              nonparticipati
                                402.105(d)(2)(             ng physician
                                xi).                       charging more
                                                           than $500 who
                                                           does not
                                                           accept payment
                                                           for an
                                                           elective
                                                           surgical
                                                           procedure on
                                                           an assignment
                                                           related basis
                                                           and who
                                                           knowingly and
                                                           willfully
                                                           fails to
                                                           disclose the
                                                           required
                                                           information
                                                           regarding
                                                           charges and
                                                           coinsurance
                                                           amounts and
                                                           fails to
                                                           refund on a
                                                           timely basis
                                                           any amount
                                                           collected for
                                                           the procedure
                                                           in excess of
                                                           the charges
                                                           recognized and
                                                           approved by
                                                           the Medicare
                                                           program.
                                                           (Penalties are
                                                           assessed in
                                                           the same
                                                           manner as 42
                                                           U.S.C.
                                                           1395u(j)(2)(B)
                                                           , which is
                                                           assessed
                                                           according to
                                                           1320a-7a(a)).
    1395u(n)(3)..............  42 CFR           CMS       Penalty for any         2019       15,975       16,257
                                402.1(c)(15),              physician who
                                402.105(d)(2)(             knowingly,
                                xii).                      willfully, and
                                                           repeatedly
                                                           bills one or
                                                           more
                                                           beneficiaries
                                                           for purchased
                                                           diagnostic
                                                           tests any
                                                           amount other
                                                           than the
                                                           payment amount
                                                           specified by
                                                           the Act.
                                                           (Penalties are
                                                           assessed in
                                                           the same
                                                           manner as 42
                                                           U.S.C.
                                                           1395u(j)(2)(B)
                                                           , which is
                                                           assessed
                                                           according to
                                                           1320a-7a(a)).
    1395u(o)(3)(B)...........  42 CFR           CMS       Penalty for any         2019       15,975       16,257
                                414.707(b).                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         2019        4,208        4,282
                                                           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           2019       13,669       13,910
                                                           pharmaceutical
                                                           manufacturer's
                                                           misrepresentat
                                                           ion of average
                                                           sales price of
                                                           a drug, or
                                                           biologic.
    1395w-4(g)(1)(B).........  42 CFR           CMS       Penalty for any         2019       15,975       16,257
                                402.1(c)(17),              nonparticipati
                                402.105(d)(2)(             ng physician,
                                xiii).                     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)).

[[Page 2883]]

 
    1395w-4(g)(3)(B).........  42 CFR           CMS       Penalty for any         2019       15,975       16,257
                                402.1(c)(18),              person that
                                402.105(d)(2)(             knowingly and
                                xiv).                      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);         42 CFR           CMS       Penalty for             2019       39,121       39,811
     1857(g)(3).                422.760(b); 42             each
                                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);         ...............  CMS       Penalty for             2019       15,649       15,925
     1857(g)(3).                                           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.
    1395w-27(g)(3)(D);         ...............  CMS       Penalty for a           2019      145,335      147,899
     1857(g)(3).                                           Medicare
                                                           Advantage
                                                           organization's
                                                           or Part D
                                                           sponsor's
                                                           early
                                                           termination of
                                                           its contract.
    1395y(b)(3)(C)...........  42 CFR           CMS       Penalty for an          2019        9,472        9,639
                                411.103(b).                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           CMS       Penalty for any         2019        1,542        1,569
                                402.1(c)(20),              non-
                                42 CFR                     governmental
                                402.105(b)(2).             employer that,
                                                           before October
                                                           1, 1998,
                                                           willfully or
                                                           repeatedly
                                                           failed to
                                                           provide timely
                                                           and accurate
                                                           information
                                                           requested
                                                           relating to an
                                                           employee's
                                                           group health
                                                           insurance
                                                           coverage.
    1395y(b)(6)(B)...........  42 CFR           CMS       Penalty for any         2019        3,383        3,443
                                402.1(c)(21),              entity that
                                402.105(a).                knowingly,
                                                           willfully, and
                                                           repeatedly
                                                           fails to
                                                           complete a
                                                           claim form
                                                           relating to
                                                           the
                                                           availability
                                                           of other
                                                           health
                                                           benefits in
                                                           accordance
                                                           with statute
                                                           or provides
                                                           inaccurate
                                                           information
                                                           relating to
                                                           such on the
                                                           claim form.
    1395y(b)(7)(B)(i)........  ...............  CMS       Penalty for any         2019        1,211        1,232
                                                           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.
    1395y(b)(8)(E)...........  ...............  CMS       Penalty for any         2019        1,211        1,232
                                                           non-group
                                                           health plan
                                                           that fails to
                                                           identify
                                                           claimants who
                                                           are Medicare
                                                           beneficiaries
                                                           and provide
                                                           information to
                                                           the HHS
                                                           Secretary to
                                                           coordinate
                                                           benefits and
                                                           pursue any
                                                           applicable
                                                           recovery claim.
    1395nn(g)(5).............  42 CFR 411.361.  CMS       Penalty for any         2019       20,134       20,489
                                                           person that
                                                           fails to
                                                           report
                                                           information
                                                           required by
                                                           HHS under
                                                           Section
                                                           1877(f)
                                                           concerning
                                                           ownership,
                                                           investment,
                                                           and
                                                           compensation
                                                           arrangements.
    1395pp(h)................  42 CFR           CMS       Penalty for any         2019       15,975       16,257
                                402.1(c)(23),              durable
                                402.105(d)(2)(             medical
                                xv).                       equipment
                                                           supplier,
                                                           including a
                                                           supplier of
                                                           prosthetic
                                                           devices,
                                                           prosthetics,
                                                           orthotics, or
                                                           supplies, that
                                                           knowingly and
                                                           willfully
                                                           fails to make
                                                           refunds in a
                                                           timely manner
                                                           to Medicare
                                                           beneficiaries
                                                           under certain
                                                           conditions.
                                                           (42 U.S.C.
                                                           1395(m)(18)
                                                           sanctions
                                                           apply here in
                                                           the same
                                                           manner, which
                                                           is under
                                                           1395u(j)(2)
                                                           and 1320a-
                                                           7a(a)).
    1395ss(a)(2).............  42 CFR           CMS       Penalty for any         2019       54,832       55,799
                                402.1(c)(24),              person that
                                405.105(f)(1).             issues a
                                                           Medicare
                                                           supplemental
                                                           policy that
                                                           has not been
                                                           approved by
                                                           the State
                                                           regulatory
                                                           program or
                                                           does not meet
                                                           Federal
                                                           standards
                                                           after a
                                                           statutorily
                                                           defined
                                                           effective date.

[[Page 2884]]

 
    1395ss(d)(3)(A)(vi)(II)..                   CMS       Penalty for             2019       28,413       28,914
                                                           someone other
                                                           than issuer
                                                           that sells or
                                                           issues a
                                                           Medicare
                                                           supplemental
                                                           policy to
                                                           beneficiary
                                                           without a
                                                           disclosure
                                                           statement.
                                                          Penalty for an          2019       47,357       48,192
                                                           issuer that
                                                           sells or
                                                           issues a
                                                           Medicare
                                                           supplemental
                                                           policy without
                                                           disclosure
                                                           statement.
    1395ss(d)(3)(B)(iv)......  ...............  CMS       Penalty for             2019       28,413       28,914
                                                           someone other
                                                           than issuer
                                                           that sells or
                                                           issues a
                                                           Medicare
                                                           supplemental
                                                           policy without
                                                           acknowledgemen
                                                           t form.
                                                          Penalty for             2019       47,357       48,192
                                                           issuer that
                                                           sells or
                                                           issues a
                                                           Medicare
                                                           supplemental
                                                           policy without
                                                           an
                                                           acknowledgemen
                                                           t form.
    1395ss(p)(8).............  42 CFR           CMS       Penalty for any         2019       28,413       28,914
                                402.1(c)(25),              person that
                                402.105(e).                sells or
                                                           issues
                                                           Medicare
                                                           supplemental
                                                           polices after
                                                           a given date
                                                           that fail to
                                                           conform to the
                                                           National
                                                           Association of
                                                           Insurance
                                                           Commissioners
                                                           (NAIC) or
                                                           Federal
                                                           standards
                                                           established by
                                                           statute.
                               42 CFR           CMS       Penalty for any         2019       47,357       48,192
                                402.1(c)(25),              person that
                                405.105(f)(2).             sells or
                                                           issues
                                                           Medicare
                                                           supplemental
                                                           polices after
                                                           a given date
                                                           that fail to
                                                           conform to the
                                                           NAIC or
                                                           Federal
                                                           standards
                                                           established by
                                                           statute.
    1395ss(p)(9)(C)..........  42 CFR           CMS       Penalty for any         2019       28,413       28,914
                                402.1(c)(26),              person that
                                402.105(e).                sells a
                                                           Medicare
                                                           supplemental
                                                           policy and
                                                           fails to make
                                                           available for
                                                           sale the core
                                                           group of basic
                                                           benefits when
                                                           selling other
                                                           Medicare
                                                           supplemental
                                                           policies with
                                                           additional
                                                           benefits or
                                                           fails to
                                                           provide the
                                                           individual,
                                                           before selling
                                                           the policy, an
                                                           outline of
                                                           coverage
                                                           describing
                                                           benefits.
                               42 CFR           ........  Penalty for any         2019       47,357       48,192
                                402.1(c)(26),              person that
                                405.105(f)(3),             sells a
                                (4).                       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           CMS       Penalty for any         2019       47,357       48,192
                                402.1(c)(27),              person that
                                405.105(f)(5).             fails to
                                                           suspend the
                                                           policy of a
                                                           policyholder
                                                           made eligible
                                                           for medical
                                                           assistance or
                                                           automatically
                                                           reinstates the
                                                           policy of a
                                                           policyholder
                                                           who has lost
                                                           eligibility
                                                           for medical
                                                           assistance,
                                                           under certain
                                                           circumstances.
    1395ss(r)(6)(A)..........  42 CFR           CMS       Penalty for any         2019       47,357       48,192
                                402.1(c)(28),              person that
                                405.105(f)(6).             fails to
                                                           provide
                                                           refunds or
                                                           credits as
                                                           required by
                                                           section
                                                           1882(r)(1)(B).
    1395ss(s)(4).............  42 CFR           CMS       Penalty for any         2019       20,104       20,459
                                402.1(c)(29),              issuer of a
                                405.105(c).                Medicare
                                                           supplemental
                                                           policy that
                                                           does not waive
                                                           listed time
                                                           periods if
                                                           they were
                                                           already
                                                           satisfied
                                                           under a
                                                           proceeding
                                                           Medicare
                                                           supplemental
                                                           policy, or
                                                           denies a
                                                           policy, or
                                                           conditions the
                                                           issuances or
                                                           effectiveness
                                                           of the policy,
                                                           or
                                                           discriminates
                                                           in the pricing
                                                           of the policy
                                                           base on health
                                                           status or
                                                           other
                                                           specified
                                                           criteria.
    1395ss(t)(2).............  42 CFR           CMS       Penalty for any         2019       47,357       48,192
                                402.1(c)(30),              issuer of a
                                405.105(f)(7).             Medicare
                                                           supplemental
                                                           policy that
                                                           fails to
                                                           fulfill listed
                                                           responsibiliti
                                                           es.
    1395ss(v)(4)(A)..........  ...............  CMS       Penalty someone         2019       20,503       20,865
                                                           other than
                                                           issuer who
                                                           sells, issues,
                                                           or renews a
                                                           Medigap Rx
                                                           policy to an
                                                           individual who
                                                           is a Part D
                                                           enrollee.
                                                          Penalty for an          2019       34,174       34,777
                                                           issuer who
                                                           sells, issues,
                                                           or renews a
                                                           Medigap Rx
                                                           policy who is
                                                           a Part D
                                                           enrollee.
    1395bbb(c)(1)............  42 CFR           CMS       Penalty for any         2019        4,388        4,465
                                488.725(c).                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           2019       21,039       21,410
                                488.845(b)(2)(             penalty amount
                                iii) 42 CFR                for each day a
                                488.845(b)(3)-             home health
                                (6); and 42                agency is not
                                CFR                        in compliance
                                488.845(d)(1)(             with statutory
                                ii).                       requirements.

[[Page 2885]]

 
                               42 CFR           ........  Penalty per day
                                488.845(b)(3).             for home
                                                           health
                                                           agency's
                                                           noncompliance
                                                           (Upper Range):
                                                            Minimum......         2019       17,883       18,198
                                                            Maximum......         2019       21,039       21,410
                               42 CFR           ........  Penalty for a           2019       21,039       21,410
                                488.845(b)(3)(             home health
                                i).                        agency's
                                                           deficiency or
                                                           deficiencies
                                                           that cause
                                                           immediate
                                                           jeopardy and
                                                           result in
                                                           actual harm.
                               42 CFR           ........  Penalty for a           2019       18,934       19,268
                                488.845(b)(3)(             home health
                                ii).                       agency's
                                                           deficiency or
                                                           deficiencies
                                                           that cause
                                                           immediate
                                                           jeopardy and
                                                           result in
                                                           potential for
                                                           harm.
                               42 CFR           ........  Penalty for an          2019       17,883       18,198
                                488.845(b)(3)(             isolated
                                iii).                      incident of
                                                           noncompliance
                                                           in violation
                                                           of established
                                                           home health
                                                           agency (HHA)
                                                           policy.
                               42 CFR           ........  Penalty for a
                                488.845(b)(4).             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......         2019        3,157        3,213
                                                            Maximum......         2019       17,883       18,198
                               42 CFR           ........  Penalty for a
                                488.845(b)(5).             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......         2019        1,052        1,071
                                                            Maximum......         2019        8,415        8,563
                               42 CFR           ........  Penalty imposed
                                488.845(b)(6).             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......         2019        2,104        2,141
                                                            Maximum......         2019       21,039       21,410
                                                          Penalty for             2019       21,039       21,410
                                                           each day of
                                                           noncompliance
                                                           (Maximum).
                               42 CFR                     Penalty for             2019       21,039       21,410
                                488.845(d)(1)(             each day of
                                ii).                       noncompliance
                                                           (Maximum).
    1396b(m)(5)(B)...........  42 CFR 460.46..  CMS       Penalty for
                                                           Programs of
                                                           All-Inclusive
                                                           Care for the
                                                           Elderly (PACE)
                                                           organization's
                                                           practice that
                                                           would
                                                           reasonably be
                                                           expected to
                                                           have the
                                                           effect of
                                                           denying or
                                                           discouraging
                                                           enrollment:
                                                            Minimum......         2019       23,473       23,887
                                                            Maximum......         2019      156,488      159,248
                                                          Penalty for a           2019       39,121       39,811
                                                           PACE
                                                           organization
                                                           that charges
                                                           excessive
                                                           premiums.
                                                          Penalty for a           2019      156,488      159,248
                                                           PACE
                                                           organization
                                                           misrepresentin
                                                           g or
                                                           falsifying
                                                           information to
                                                           CMS, the
                                                           State, or an
                                                           individual or
                                                           other entity.
                                                          Penalty for             2019       39,121       39,811
                                                           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             2019       39,121       39,811
                                                           involuntarily
                                                           disenrolling a
                                                           participant.
                                                          Penalty for             2019       39,121       39,811
                                                           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
                                488.408(d)(1)(             for a nursing
                                iii).                      facility's
                                                           failure to
                                                           meet a
                                                           Category 2
                                                           Certification:
                                                            Minimum......         2019          110          112
                                                            Maximum......         2019        6,579        6,695
                               42 CFR           CMS       Penalty per
                                488.408(d)(1)(             instance for a
                                iv).                       nursing
                                                           facility's
                                                           failure to
                                                           meet Category
                                                           2
                                                           certification:
                                                            Minimum......         2019        2,194        2,233
                                                            Maximum......         2019       21,933       22,320
                               42 CFR           CMS       Penalty per day
                                488.408(e)(1)(             for a nursing
                                iii).                      facility's
                                                           failure to
                                                           meet Category
                                                           3
                                                           certification:

[[Page 2886]]

 
                                                            Minimum......         2019        6,690        6,808
                                                            Maximum......         2019       21,933       22,320
                               42 CFR           CMS       Penalty per
                                488.408(e)(1)(             instance for a
                                iv).                       nursing
                                                           facility's
                                                           failure to
                                                           meet Category
                                                           3
                                                           certification:
                                                            Minimum......         2019        2,194        2,233
                                                            Maximum......         2019       21,933       22,320
                               42 CFR           CMS       Penalty per
                                488.408(e)(2)(             instance for a
                                ii).                       nursing
                                                           facility's
                                                           failure to
                                                           meet Category
                                                           3
                                                           certification,
                                                           which results
                                                           in immediate
                                                           jeopardy:
                                                            Minimum......         2019        2,194        2,233
                                                            Maximum......         2019       21,933       22,320
                               42 CFR           CMS       Penalty per day
                                488.438(a)(1)(             for nursing
                                i).                        facility's
                                                           failure to
                                                           meet
                                                           certification
                                                           (Upper Range):
                                                            Minimum......         2019        6,690        6,808
                                                            Maximum......         2019       21,933       22,320
                               42 CFR           CMS       Penalty per day
                                488.438(a)(1)(             for nursing
                                ii).                       facility's
                                                           failure to
                                                           meet
                                                           certification
                                                           (Lower Range):
                                                            Minimum......         2019          110          112
                                                            Maximum......         2019        6,579        6,695
                               42 CFR           CMS       Penalty per
                                488.438(a)(2).             instance for
                                                           nursing
                                                           facility's
                                                           failure to
                                                           meet
                                                           certification:
                                                            Minimum......         2019        2,194        2,233
                                                            Maximum......         2019       21,933       22,320
    1396r(f)(2)(B)(iii)(I)(c)  42 CFR           CMS       Grounds to              2019       10,967       11,160
                                483.151(b)(2)(             prohibit
                                iv) and                    approval of
                                (b)(3)(iii).               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
                                                           civil monetary
                                                           penalties
                                                           (CMPs)
                                                           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           CMS       Grounds to              2019       10,967       11,160
                                483.151(c)(2).             waive
                                                           disapproval of
                                                           nurse aide
                                                           training
                                                           program--refer
                                                           ence 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......         2019            2            2
                                                            Maximum......         2019       18,943       19,277
    1396u-2(e)(2)(A)(i)......  42 CFR 438.704.  CMS       Penalty for a           2019       39,121       39,811
                                                           Medicaid
                                                           managed care
                                                           organization
                                                           that fails
                                                           substantially
                                                           to provide
                                                           medically
                                                           necessary
                                                           items and
                                                           services.
                                                          Penalty for             2019       39,121       39,811
                                                           Medicaid
                                                           managed care
                                                           organization
                                                           that imposes
                                                           premiums or
                                                           charges on
                                                           enrollees in
                                                           excess of the
                                                           premiums or
                                                           charges
                                                           permitted.
                                                          Penalty for a           2019       39,121       39,811
                                                           Medicaid
                                                           managed care
                                                           organization
                                                           that
                                                           misrepresents
                                                           or falsifies
                                                           information to
                                                           another
                                                           individual or
                                                           entity.
                                                          Penalty for a           2019       39,121       39,811
                                                           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           2019      156,488      159,248
                                                           Medicaid
                                                           managed care
                                                           organization
                                                           that
                                                           misrepresents
                                                           or falsifies
                                                           information to
                                                           the HHS
                                                           Secretary.
                                                          Penalty for             2019      156,488      159,248
                                                           Medicaid
                                                           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             2019       23,473       23,887
                                                           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.
    1396u(h)(2)..............  42 CFR Part      CMS       Penalty for a           2019       21,933       22,320
                                441, 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.

[[Page 2887]]

 
    1396w-2(c)(1)............  ...............  CMS       Penalty for             2019       11,698       11,904
                                                           disclosing
                                                           information
                                                           related to
                                                           eligibility
                                                           determinations
                                                           for medical
                                                           assistance
                                                           programs.
    18041(c)(2)..............  45 CFR 150.315;  CMS       Failure to              2019          159          162
                                45 CFR                     comply with
                                156.805(c).                requirements
                                                           of the Public
                                                           Health
                                                           Services Act;
                                                           Penalty for
                                                           violations of
                                                           rules or
                                                           standards of
                                                           behavior
                                                           associated
                                                           with issuer
                                                           participation
                                                           in the
                                                           federally-
                                                           facilitated
                                                           Exchange. (42
                                                           U.S.C. 300gg-
                                                           22(b)(2)(C)).
    18081(h)(1)(A)(i)(II)....  42 CFR 155.285.  CMS       Penalty for             2019       28,906       29,416
                                                           providing
                                                           false
                                                           information on
                                                           Exchange
                                                           application.
    18081(h)(1)(B)...........  42 CFR 155.285.  CMS       Penalty for             2019      289,060      294,159
                                                           knowingly or
                                                           willfully
                                                           providing
                                                           false
                                                           information on
                                                           Exchange
                                                           application.
    18081(h)(2)..............  42 CFR 155.260.  CMS       Penalty for             2019       28,906       29,416
                                                           knowingly or
                                                           willfully
                                                           disclosing
                                                           protected
                                                           information
                                                           from Exchange.
31 U.S.C.:
    1352.....................  45 CFR           HHS       Penalty for the         2019       20,134       20,489
                                93.400(e).                 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......         2019       20,134       20,489
                                                            Maximum......         2019      201,340      204,892
                                                          Penalty for the         2019       20,134       20,489
                                                           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......         2019       20,134       20,489
                                                            Maximum......         2019      201,340      204,892
                               45 CFR Part 93,  HHS       Penalty for
                                Appendix A.                failure to
                                                           provide
                                                           certification
                                                           regarding
                                                           lobbying in
                                                           the award
                                                           documents for
                                                           all sub-awards
                                                           of all tiers:
                                                            Minimum......         2019       20,134       20,489
                                                            Maximum......         2019      201,340      204,892
                                                          Penalty for
                                                           failure to
                                                           provide
                                                           statement
                                                           regarding
                                                           lobbying for
                                                           loan guarantee
                                                           and loan
                                                           insurance
                                                           transactions:
                                                            Minimum......         2019       20,134       20,489
                                                            Maximum......         2019      201,340      204,892
    3801-3812................  45 CFR           HHS       Penalty against         2019       10,520       10,706
                                79.3(a)(1)(iv).            any individual
                                                           who--with
                                                           knowledge or
                                                           reason to
                                                           know--makes,
                                                           presents or
                                                           submits a
                                                           false,
                                                           fictitious or
                                                           fraudulent
                                                           claim to the
                                                           Department.
                               45 CFR           ........  Penalty against         2019       10,520       10,706
                                79.3(b)(1)(ii).            any 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.
\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 2020, based on the Consumer Price Index for all Urban Consumers (CPI-U)
  for the month of October 2019, not seasonally adjusted, is 1.01764, as indicated in OMB Memorandum M-20-05,
  ``Implementation of Penalty Inflation Adjustments for 2019, Pursuant to the Federal Civil Penalties Adjustment
  Act Improvements Act of 2015'' (December 16, 2019).


Alex M. Azar II,
Secretary, Department of Health and Human Services.
[FR Doc. 2020-00738 Filed 1-15-20; 4:15 pm]
 BILLING CODE 4150-24-P

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