AGENCY:
Office of the Assistant Secretary for Financial Resources, Department of Health and Human Services.
ACTION:
Final rule.
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 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
1. The authority citation for part 102 continues to read as follows:
Authority: Public Law 101-410, Sec. 701 of Public Law 114-74, 31 U.S.C. 3801-3812.
2. Amend § 102.3 by revising the table to read as follows:
§ 102.3
Penalty adjustment and table.
Table 1 to § 102.3—Civil Monetary Penalty Authorities Administered by HHS Agencies and Penalty Amounts
January 17, 2020
21 U.S.C.:42 U.S.C45 CFR 303.21(f)42 CFR 1003.91042 CFR 1003.210(a)(1)42 CFR 1003.210(a)(2)42 CFR 1003.210(a)(3)42 CFR 1003.101042 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)42 CFR 1003.210(a)(10)42 CFR 1003.81042 CFR 1003.610(a)42 CFR 1003.610(a)42 CFR 1003.210(a)(11)42 CFR 1003.210(a)(11)42 CFR 1003.131042 CFR 1003.41042 CFR 1003.51042 CFR 1003.41042 CFR 1003.31042 CFR 1003.31042 CFR 1003.111042 CFR 1003.111042 CFR 1003.111042 CFR 1003.111042 CFR 1003.41042 CFR 1003.210(a)(11)42 CFR 1003.210(a)(11)42 CFR 1003.131042 CFR 1003.121042 CFR 1003.121042 CFR 1003.121042 CFR 1003.131042 CFR 1003.81042 CFR 1003.81042 CFR 3.40442 CFR 493.1834(d)(2)(i)42 CFR 493.1834(d)(2)(ii)45 CFR 147.200(e)45 CFR 158.60642 CFR 402.105(g)42 CFR 488.408(d)(1)(iii)42 CFR 488.408(d)(1)(iv)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)42 CFR 488.438(a)(2)42 CFR 402.105(d)(2)(i)42 CFR 402.105(a)42 CFR 402.1(c)42 CFR 414.707(b)42 CFR 414.80642 CFR 411.103(b)42 CFR 411.36142 CFR 488.725(c)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)42 CFR 460.4642 CFR 488.408(d)(1)(iii)42 CFR 488.408(d)(1)(iv)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)42 CFR 488.438(a)(2)42 CFR 483.151(c)(2)42 CFR 438.70442 CFR 438.70442 CFR 438.70431 U.S.C.:45 CFR 93.400(e)45 CFR 79.3(a)(1)(iv)45 CFR 79.3(b)(1)(ii)| CFR | HHS agency | Description | Date of last penalty figure or adjustment | 2019 Maximum adjusted penalty ($) | 2020 Maximum adjusted penalty ($) | |
|---|---|---|---|---|---|---|
| 333(b)(2)(A) | FDA | Penalty for violations related to drug samples resulting in a conviction of any representative of manufacturer or distributor in any 10-year period | 2019 | 105,194 | 107,050 | |
| 333(b)(2)(B) | FDA | Penalty for violation related to drug samples resulting in a conviction of any representative of manufacturer or distributor after the second conviction in any 10-yr period | 2019 | 2,146,800 | 2,184,670 | |
| 333(b)(3) | FDA | Penalty for failure to make a report required by 21 U.S.C. 353(d)(3)(E) relating to drug samples | 2019 | 210,386 | 214,097 | |
| 333(f)(1)(A) | FDA | Penalty for any person who violates a requirement related to devices for each such violation | 2019 | 28,413 | 28,914 | |
| Penalty for aggregate of all violations related to devices in a single proceeding | 2019 | 1,894,261 | 1,927,676 | |||
| 333(f)(2)(A) | FDA | Penalty for any individual who introduces or delivers for introduction into interstate commerce food that is adulterated per 21 U.S.C. 342(a)(2)(B) or any individual who does not comply with a recall order under 21 U.S.C. 350l | 2019 | 79,875 | 81,284 | |
| Penalty in the case of any other person other than an individual) for such introduction or delivery of adulterated food | 2019 | 399,374 | 406,419 | |||
| Penalty for aggregate of all such violations related to adulterated food adjudicated in a single proceeding | 2019 | 798,747 | 812,837 | |||
| 333(f)(3)(A) | FDA | 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) | 2019 | 12,103 | 12,316 | |
| 333(f)(3)(B) | FDA | Penalty for each day any above violation is not corrected after a 30-day period following notification until the violation is corrected | 2019 | 12,103 | 12,316 | |
| 333(f)(4)(A)(i) | FDA | Penalty for any responsible person that violates a requirement of 21 U.S.C. 355(o) (post-marketing studies, clinical trials, labeling), 21 U.S.C. 355(p) (risk evaluation and mitigation (REMS)), or 21 U.S.C. 355-1 (REMS) | 2019 | 302,585 | 307,923 | |
| Penalty for aggregate of all such above violations in a single proceeding | 2019 | 1,210,340 | 1,231,690 | |||
| 333(f)(4)(A)(ii) | FDA | Penalty for REMS violation that continues after written notice to the responsible person for the first 30-day period (or any portion thereof) the responsible person continues to be in violation | 2019 | 302,585 | 307,923 | |
| 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 | 2019 | 1,210,340 | 1,231,690 | |||
| Penalty for aggregate of all such above violations adjudicated in a single proceeding | 2019 | 12,103,404 | 12,316,908 | |||
| 333(f)(9)(A) | FDA | Penalty for any person who violates a requirement which relates to tobacco products for each such violation | 2019 | 17,547 | 17,857 | |
| Penalty for aggregate of all such violations of tobacco product requirement adjudicated in a single proceeding | 2019 | 1,169,798 | 1,190,433 | |||
| 333(f)(9)(B)(i)(I) | FDA | Penalty per violation related to violations of tobacco requirements | 2019 | 292,450 | 297,609 | |
| Penalty for aggregate of all such violations of tobacco product requirements adjudicated in a single proceeding | 2019 | 1,169,798 | 1,190,433 | |||
| 333(f)(9)(B)(i)(II) | FDA | Penalty in the case of a violation of tobacco product requirements that continues after written notice to such person, for the first 30-day period (or any portion thereof) the person continues to be in violation | 2019 | 292,450 | 297,609 | |
| 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 | 2019 | 1,169,798 | 1,190,433 | |||
| Penalty for aggregate of all such violations related to tobacco product requirements adjudicated in a single proceeding | 2019 | 11,697,983 | 11,904,335 | |||
| 333(f)(9)(B)(ii)(I) | FDA | Penalty for any person who either does not conduct post-market surveillance and studies to determine impact of a modified risk tobacco product for which the HHS Secretary has provided them an order to sell, or who does not submit a protocol to the HHS Secretary after being notified of a requirement to conduct post-market surveillance of such tobacco products | 2019 | 292,450 | 297,609 | |
| Penalty for aggregate of for all such above violations adjudicated in a single proceeding | 2019 | 1,169,798 | 1,190,433 | |||
| 333(f)(9)(B)(ii)(II) | FDA | Penalty for violation of modified risk tobacco product post-market surveillance that continues after written notice to such person for the first 30-day period (or any portion thereof) that the person continues to be in violation | 2019 | 292,450 | 297,609 | |
| Penalty for post-notice violation of modified risk tobacco product post-market surveillance shall double for every 30-day period thereafter that the tobacco product requirement violation continues for any 30-day period, but may not exceed penalty amount for any 30-day period | 2019 | 1,169,798 | 1,190,433 | |||
| Penalty for aggregate above tobacco product requirement violations adjudicated in a single proceeding | 2019 | 11,697,983 | 11,904,335 | |||
| 333(g)(1) | FDA | Penalty for any person who disseminates or causes another party to disseminate a direct-to-consumer advertisement that is false or misleading for the first such violation in any 3-year period | 2019 | 302,585 | 307,923 | |
| Penalty for each subsequent above violation in any 3-year period | 2019 | 605,171 | 615,846 | |||
| 333 note | FDA | 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 | 2019 | 292 | 297 | |
| 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 | 2019 | 584 | 594 | |||
| 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 | 2019 | 2,340 | 2,381 | |||
| 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 | 2019 | 5,849 | 5,952 | |||
| 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 48-month period as determined on a case-by-case basis | 2019 | 11,698 | 11,904 | |||
| 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 | 2019 | 292 | 297 | |||
| 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 | 2019 | 584 | 594 | |||
| 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 | 2019 | 1,170 | 1,191 | |||
| 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 | 2019 | 2,340 | 2,381 | |||
| 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 | 2019 | 5,849 | 5,952 | |||
| 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 48-month period as determined on a case-by-case basis | 2019 | 11,698 | 11,904 | |||
| 335b(a) | FDA | Penalty for each violation for any individual who made a false statement or misrepresentation of a material fact, bribed, destroyed, altered, removed, or secreted, or procured the destruction, alteration, removal, or secretion of, any material document, failed to disclose a material fact, obstructed an investigation, employed a consultant who was debarred, debarred individual provided consultant services | 2019 | 445,846 | 453,711 | |
| Penalty in the case of any other person (other than an individual) per above violation | 2019 | 1,783,384 | 1,814,843 | |||
| 360pp(b)(1) | FDA | Penalty for any person who violates any such requirements for electronic products, with each unlawful act or omission constituting a separate violation | 2019 | 2,924 | 2,976 | |
| Penalty imposed for any related series of violations of requirements relating to electronic products | 2019 | 996,806 | 1,014,390 | |||
| 2019 | ||||||
| 262(d) | FDA | Penalty per day for violation of order of recall of biological product presenting imminent or substantial hazard | 2019 | 229,269 | 233,313 | |
| 263b(h)(3) | FDA | Penalty for failure to obtain a mammography certificate as required | 2019 | 17,834 | 18,149 | |
| 300aa-28(b)(1) | FDA | Penalty per occurrence for any vaccine manufacturer that intentionally destroys, alters, falsifies, or conceals any record or report required | 2019 | 229,269 | 233,313 | |
| 256b(d)(1)(B)(vi) | HRSA | Penalty for each instance of overcharging a 340B covered entity | 2019 | 5,781 | 5,883 | |
| 299c-(3)(d) | AHRQ | Penalty for an establishment or person supplying information obtained in the course of activities for any purpose other than the purpose for which it was supplied | 2019 | 15,034 | 15,299 | |
| 653(l)(2) | ACF | Penalty for Misuse of Information in the National Directory of New Hires | 2019 | 1,542 | 1,569 | |
| 262a(i)(1) | OIG | Penalty for each individual who violates safety and security procedures related to handling dangerous biological agents and toxins | 2019 | 348,708 | 354,859 | |
| Penalty for any other person who violates safety and security procedures related to handling dangerous biological agents and toxins | 2019 | 697,418 | 709,720 | |||
| 300jj-51 | OIG | Penalty per violation for committing information blocking | 2019 | 1,063,260 | 1,082,016 | |
| 1320a-7a(a) | OIG | Penalty for knowingly presenting or causing to be presented to an officer, employee, or agent of the United States a false claim | 2019 | 20,504 | 20,866 | |
| Penalty for knowingly presenting or causing to be presented a request for payment which violates the terms of an assignment, agreement, or PPS agreement | 2019 | 20,504 | 20,866 | |||
| 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 | 2019 | 30,757 | 31,300 | |||
| Penalty for an excluded party retaining ownership or control interest in a participating entity | 2019 | 20,504 | 20,866 | |||
| Penalty for remuneration offered to induce program beneficiaries to use particular providers, practitioners, or suppliers | 2019 | 20,504 | 20,866 | |||
| Penalty for employing or contracting with an excluded individual | 2019 | 20,504 | 20,866 | |||
| 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 | 2019 | 102,522 | 104,330 | |||
| Penalty for ordering or prescribing medical or other item or service during a period in which the person was excluded | 2019 | 20,504 | 20,866 | |||
| 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 | 2019 | 102,522 | 104,330 | |||
| Penalty for knowing of an overpayment and failing to report and return | 2019 | 20,504 | 20,866 | |||
| Penalty for making or using a false record or statement that is material to a false or fraudulent claim | 2019 | 57,812 | 58,832 | |||
| Penalty for failure to grant timely access to HHS OIG for audits, investigations, evaluations, and other statutory functions of HHS OIG | 2019 | 30,757 | 31,300 | |||
| 1320a-7a(b) | 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 | 2019 | 5,126 | 5,216 | |
| 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 | 2019 | 5,126 | 5,216 | |||
| Penalty for a physician who executes a document that falsely certifies home health needs for Medicare beneficiaries | 2019 | 10,252 | 10,433 | |||
| 1320a-7a(o) | OIG | 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 | 2016 | 10,000 | 10,176 | |
| 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 | 2016 | 50,000 | 50,882 | |||
| 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 | 2016 | 50,000 | 50,882 | |||
| 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 | 2016 | 50,000 for each false record or statement, 10,000 per day. | 53,231 for each false record statement, 10,646 per day. | |||
| 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 | 2016 | 15,000 | 15,265 | |||
| 1320a-7e(b)(6)(A) | OIG | Penalty for failure to report any final adverse action taken against a health care provider, supplier, or practitioner | 2019 | 39,121 | 39,811 | |
| 1320b-10(b)(1) | OIG | Penalty for the misuse of words, symbols, or emblems in communications in a manner in which a person could falsely construe that such item is approved, endorsed, or authorized by HHS | 2019 | 10,519 | 10,705 | |
| 1320b-10(b)(2) | OIG | Penalty for the misuse of words, symbols, or emblems in a broadcast or telecast in a manner in which a person could falsely construe that such item is approved, endorsed, or authorized by HHS | 2019 | 52,596 | 53,524 | |
| 1395i-3(b)(3)(B)(ii)(1) | OIG | Penalty for certification of a false statement in assessment of functional capacity of a Skilled Nursing Facility resident assessment | 2019 | 2,194 | 2,233 | |
| 1395i-3(b)(3)(B)(ii)(2) | OIG | Penalty for causing another to certify or make a false statement in assessment of functional capacity of a Skilled Nursing Facility resident assessment | 2019 | 10,967 | 11,160 | |
| 1395i-3(g)(2)(A) | OIG | Penalty for any individual who notifies or causes to be notified a Skilled Nursing Facility of the time or date on which a survey is to be conducted | 2019 | 4,388 | 4,465 | |
| 1395w-27(g)(2)(A) | OIG | Penalty for a Medicare Advantage organization that substantially fails to provide medically necessary, required items and services | 2019 | 39,936 | 40,640 | |
| Penalty for a Medicare Advantage organization that charges excessive premiums | 2019 | 39,121 | 39,811 | |||
| Penalty for a Medicare Advantage organization that improperly expels or refuses to reenroll a beneficiary | 2019 | 39,121 | 39,811 | |||
| Penalty for a Medicare Advantage organization that engages in practice that would reasonably be expected to have the effect of denying or discouraging enrollment | 2019 | 156,488 | 159,248 | |||
| 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 | 2019 | 23,473 | 23,887 | |||
| Penalty for a Medicare Advantage organization misrepresenting or falsifying information to Secretary | 2019 | 156,488 | 159,248 | |||
| Penalty for a Medicare Advantage organization misrepresenting or falsifying information to individual or other entity | 2019 | 39,121 | 39,811 | |||
| Penalty for Medicare Advantage organization interfering with provider's advice to enrollee and non-managed care organization (MCO) affiliated providers that balance bill enrollees | 2019 | 39,121 | 39,811 | |||
| Penalty for a Medicare Advantage organization that employs or contracts with excluded individual or entity | 2019 | 39,121 | 39,811 | |||
| Penalty for a Medicare Advantage organization enrolling an individual in without prior written consent | 2019 | 39,121 | 39,811 | |||
| Penalty for a Medicare Advantage organization transferring an enrollee to another plan without consent or solely for the purpose of earning a commission | 2019 | 39,121 | 39,811 | |||
| Penalty for a Medicare Advantage organization failing to comply with marketing restrictions or applicable implementing regulations or guidance | 2019 | 39,121 | 39,811 | |||
| Penalty for a Medicare Advantage organization employing or contracting with an individual or entity who violates 1395w-27(g)(1)(A)-(J) | 2019 | 39,121 | 39,811 | |||
| 1395w-141(i)(3) | OIG | Penalty for a prescription drug card sponsor that falsifies or misrepresents marketing materials, overcharges program enrollees, or misuse transitional assistance funds | 2019 | 13,669 | 13,910 | |
| 1395cc(g) | OIG | Penalty for improper billing by Hospitals, Critical Access Hospitals, or Skilled Nursing Facilities | 2019 | 5,317 | 5,411 | |
| 1395dd(d)(1) | OIG | Penalty for a hospital or responsible physician dumping patients needing emergency medical care, if the hospital has 100 beds or more | 2019 | 109,663 | 111,597 | |
| Penalty for a hospital or responsible physician dumping patients needing emergency medical care, if the hospital has less than 100 beds | 2019 | 54,833 | 55,800 | |||
| 1395mm(i)(6)(B)(i) | OIG | Penalty for a health maintenance organization (HMO) or competitive plan is such plan substantially fails to provide medically necessary, required items or services | 2019 | 54,833 | 55,800 | |
| Penalty for HMOs/competitive medical plans that charge premiums in excess of permitted amounts | 2019 | 54,833 | 55,800 | |||
| Penalty for a HMO or competitive medical plan that expels or refuses to reenroll an individual per prescribed conditions | 2019 | 54,833 | 55,800 | |||
| Penalty for a HMO or competitive medical plan that implements practices to discourage enrollment of individuals needing services in future | 2019 | 219,327 | 223,196 | |||
| 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 | 2019 | 31,558 | 32,115 | |||
| Penalty for a HMO or competitive medical plan that misrepresents or falsifies information to the Secretary | 2019 | 219,327 | 223,196 | |||
| Penalty for a HMO or competitive medical plan that misrepresents or falsifies information to an individual or any other entity | 2019 | 54,833 | 55,800 | |||
| Penalty for failure by HMO or competitive medical plan to assure prompt payment of Medicare risk sharing contracts or incentive plan provisions | 2019 | 54,833 | 55,800 | |||
| Penalty for HMO that employs or contracts with excluded individual or entity | 2019 | 50,334 | 51,222 | |||
| 1395nn(g)(3) | OIG | Penalty for submitting or causing to be submitted claims in violation of the Stark Law's restrictions on physician self-referrals | 2019 | 25,372 | 25,820 | |
| 1395nn(g)(4) | OIG | Penalty for circumventing Stark Law's restrictions on physician self-referrals | 2019 | 169,153 | 172,137 | |
| 1395ss(d)(1) | OIG | Penalty for a material misrepresentation regarding Medigap compliance policies | 2019 | 10,519 | 10,705 | |
| 1395ss(d)(2) | OIG | Penalty for selling Medigap policy under false pretense | 2019 | 10,519 | 10,705 | |
| 1395ss(d)(3)(A)(ii) | OIG | Penalty for an issuer that sells health insurance policy that duplicates benefits | 2019 | 47,357 | 48,192 | |
| Penalty for someone other than issuer that sells health insurance that duplicates benefits | 2019 | 28,413 | 28,914 | |||
| 1395ss(d)(4)(A) | OIG | Penalty for using mail to sell a non-approved Medigap insurance policy | 2019 | 10,519 | 10,705 | |
| 1396b(m)(5)(B)(i) | OIG | Penalty for a Medicaid MCO that substantially fails to provide medically necessary, required items or services | 2019 | 52,596 | 53,524 | |
| Penalty for a Medicaid MCO that charges excessive premiums | 2019 | 52,596 | 53,524 | |||
| Penalty for a Medicaid MCO that improperly expels or refuses to reenroll a beneficiary | 2019 | 210,386 | 214,097 | |||
| 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 | 2019 | 31,558 | 32,115 | |||
| Penalty for a Medicaid MCO misrepresenting or falsifying information to the Secretary | 2019 | 210,386 | 214,097 | |||
| Penalty for a Medicaid MCO misrepresenting or falsifying information to an individual or another entity | 2019 | 52,596 | 53,524 | |||
| Penalty for a Medicaid MCO that fails to comply with contract requirements with respect to physician incentive plans | 2019 | 47,357 | 48,192 | |||
| 1396r(b)(3)(B)(ii)(I) | OIG | Penalty for willfully and knowingly certifying a material and false statement in a Skilled Nursing Facility resident assessment | 2019 | 2,194 | 2,233 | |
| 1396r(b)(3)(B)(ii)(II) | OIG | Penalty for willfully and knowingly causing another individual to certify a material and false statement in a Skilled Nursing Facility resident assessment | 2019 | 10,967 | 11,160 | |
| 1396r(g)(2)(A)(i) | OIG | Penalty for notifying or causing to be notified a Skilled Nursing Facility of the time or date on which a survey is to be conducted | 2019 | 4,388 | 4,465 | |
| 1396r-8(b)(3)(B) | OIG | Penalty for the knowing provision of false information or refusing to provide information about charges or prices of a covered outpatient drug | 2019 | 189,427 | 192,768 | |
| 1396r-8(b)(3)(C)(i) | OIG | Penalty per day for failure to timely provide information by drug manufacturer with rebate agreement | 2019 | 18,943 | 19,277 | |
| 1396r-8(b)(3)(C)(ii) | OIG | Penalty for knowing provision of false information by drug manufacturer with rebate agreement | 2019 | 189,427 | 192,768 | |
| 1396t(i)(3)(A) | OIG | Penalty for notifying home and community-based providers or settings of survey | 2019 | 3,788 | 3,855 | |
| 11131(c) | OIG | Penalty for failing to report a medical malpractice claim to National Practitioner Data Bank | 2019 | 22,927 | 23,331 | |
| 11137(b)(2) | OIG | Penalty for breaching confidentiality of information reported to National Practitioner Data Bank | 2019 | 22,927 | 23,331 | |
| 299b-22(f)(1) | OCR | Penalty for violation of confidentiality provision of the Patient Safety and Quality Improvement Act | 2019 | 12,695 | 12,919 | |
| 45 CFR 160.404(b)(1)(i), (ii) | OCR | Penalty for each pre-February 18, 2009 violation of the Health Insurance Portability and Accountability Act (HIPAA) administrative simplification provisions | 2019 | 159 | 162 | |
| Calendar Year Cap | 2019 | 39,936 | 40,640 | |||
| 1320(d)-5(a) | 45 CFR 160.404(b)(2)(i)(A), (B) | OCR | Penalty for each February 18, 2009 or later violation of a HIPAA administrative simplification provision in which it is established that the covered entity or business associate did not know and by exercising reasonable diligence, would not have known that the covered entity or business associate violated such a provision: | |||
| Minimum | 2019 | 117 | 119 | |||
| Maximum | 2019 | 58,490 | 59,522 | |||
| Calendar Year Cap | 2019 | 1,754,698 | 1,785,651 | |||
| 45 CFR 160.404(b)(2)(ii)(A), (B) | OCR | Penalty for each February 18, 2009 or later violation of a HIPAA administrative simplification provision in which it is established that the violation was due to reasonable cause and not to willful neglect: | ||||
| Minimum | 2019 | 1,170 | 1,191 | |||
| Maximum | 2019 | 58,490 | 59,522 | |||
| Calendar Year Cap | 2019 | 1,754,698 | 1,785,651 | |||
| 45 CFR 160.404(b)(2)(iii)(A), (B) | OCR | Penalty for each February 18, 2009 or later violation of a HIPAA administrative simplification provision in which it is established that the violation was due to willful neglect and was corrected during the 30-day period beginning on the first date the covered entity or business associate knew, or, by exercising reasonable diligence, would have known that the violation occurred: | ||||
| Minimum | 2019 | 11,698 | 11,904 | |||
| Maximum | 2019 | 58,490 | 59,522 | |||
| Calendar Year Cap | 2019 | 1,754,698 | 1,785,651 | |||
| 45 CFR 160.404(b)(2)(iv)(A), (B) | OCR | Penalty for each February 18, 2009 or later violation of a HIPAA administrative simplification provision in which it is established that the violation was due to willful neglect and was not corrected during the 30-day period beginning on the first date the covered entity or business associate knew, or by exercising reasonable diligence, would have known that the violation occurred: | ||||
| Minimum | 2019 | 58,490 | 59,522 | |||
| Maximum | 2019 | 1,754,698 | 1,785,651 | |||
| Calendar Year Cap | 2019 | 1,754,698 | 1,785,651 | |||
| 263a(h)(2)(B) & 1395w-2(b)(2)(A)(ii) | CMS | Penalty for a clinical 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 | |||
| CMS | Penalty for a clinical 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) | CMS | Failure to provide the Summary of Benefits and Coverage | 2019 | 1,156 | 1,176 | |
| 300gg-18 | CMS | Penalty for violations of regulations related to the medical loss ratio reporting and rebating | 2019 | 116 | 118 | |
| 1320a-7h(b)(1) | 42 CFR 402.105(d)(5), 42 CFR 403.912(a) & (c) | CMS | Penalty for manufacturer or group purchasing organization failing to report information required under 42 U.S.C. 1320a-7h(a), relating to physician ownership or investment interests: | |||
| Minimum | 2019 | 1,156 | 1,176 | |||
| Maximum | 2019 | 11,562 | 11,766 | |||
| Calendar Year Cap | 2019 | 173,436 | 176,495 | |||
| 1320a-7h(b)(2) | 42 CFR 402.105(h), 42 CFR 403.912(b) & (c) | CMS | Penalty for manufacturer or group purchasing organization knowingly failing to report information required under 42 U.S.C. 1320a-7h(a), relating to physician ownership or investment interests: | |||
| Minimum | 2019 | 11,562 | 11,766 | |||
| Maximum | 2019 | 115,624 | 117,664 | |||
| Calendar Year Cap | 2019 | 1,156,242 | 1,176,638 | |||
| CMS | Penalty for an administrator of a facility that fails to comply with notice requirements for the closure of a facility | 2019 | 115,624 | 117,664 | ||
| 1320a-7j(h)(3)(A) | 42 CFR 488.446(a)(1), (2), & (3) | CMS | Minimum penalty for the first offense of an administrator who fails to provide notice of facility closure | 2019 | 578 | 588 |
| Minimum penalty for the second offense of an administrator who fails to provide notice of facility closure | 2019 | 1,735 | 1,766 | |||
| Minimum penalty for the third and subsequent offenses of an administrator who fails to provide notice of facility closure | 2019 | 3,468 | 3,529 | |||
| 1320a-8(a)(1) | CMS | Penalty for an entity knowingly making a false statement or representation of material fact in the determination of the amount of benefits or payments related to old-age, survivors, and disability insurance benefits, special benefits for certain World War II veterans, or supplemental security income for the aged, blind, and disabled | 2019 | 8,457 | 8,606 | |
| 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 | 2019 | 7,975 | 8,116 | |||
| 1320a-8(a)(3) | CMS | Penalty for a representative payee (under 42 U.S.C. 405(j), 1007, or 1383(a)(2)) converting any part of a received payment from the benefit programs described in the previous civil monetary penalty to a use other than for the benefit of the beneficiary | 2019 | 6,623 | 6,740 | |
| 1320b-25(c)(1)(A) | CMS | Penalty for failure of covered individuals to report to the Secretary and 1 or more law enforcement officials any reasonable suspicion of a crime against a resident, or individual receiving care, from a long-term care facility | 2019 | 231,249 | 235,328 | |
| 1320b-25(c)(2)(A) | CMS | Penalty for failure of covered individuals to report to the Secretary and 1 or more law enforcement officials any reasonable suspicion of a crime against a resident, or individual receiving care, from a long-term care facility if such failure exacerbates the harm to the victim of the crime or results in the harm to another individual | 2019 | 346,872 | 352,991 | |
| 1320b-25(d)(2) | CMS | Penalty for a long-term care facility that retaliates against any employee because of lawful acts done by the employee, or files a complaint or report with the State professional disciplinary agency against an employee or nurse for lawful acts done by the employee or nurse | 2019 | 231,249 | 235,328 | |
| 1395b-7(b)(2)(B) | CMS | Penalty for any person who knowingly and willfully fails to furnish a beneficiary with an itemized statement of items or services within 30 days of the beneficiary's request | 2019 | 156 | 159 | |
| 1395i-3(h)(2)(B)(ii)(I) | CMS | Penalty per day for a Skilled Nursing Facility that has a Category 2 violation of certification requirements: | ||||
| Minimum | 2019 | 110 | 112 | |||
| Maximum | 2019 | 6,579 | 6,695 | |||
| CMS | Penalty per instance of Category 2 noncompliance by a Skilled Nursing Facility: | |||||
| Minimum | 2019 | 2,194 | 2,233 | |||
| Maximum | 2019 | 21,933 | 22,320 | |||
| CMS | Penalty per day for a Skilled Nursing Facility that has a Category 3 violation of certification requirements: | |||||
| Minimum | 2019 | 6,690 | 6,808 | |||
| Maximum | 2019 | 21,933 | 22,320 | |||
| CMS | Penalty per instance of Category 3 noncompliance by a Skilled Nursing Facility: | |||||
| Minimum | 2019 | 2,194 | 2,233 | |||
| Maximum | 2019 | 21,933 | 22,320 | |||
| CMS | Penalty per day and per instance for a Skilled Nursing Facility that has Category 3 noncompliance with Immediate Jeopardy: | |||||
| Per Day (Minimum) | 2019 | 6,690 | 6,808 | |||
| Per Day (Maximum) | 2019 | 21,933 | 22,320 | |||
| Per Instance (Minimum) | 2019 | 2,194 | 2,233 | |||
| Per Instance (Maximum) | 2019 | 21,933 | 22,320 | |||
| CMS | Penalty per day of a Skilled 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 | |||
| CMS | Penalty per day of a Skilled 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 | |||
| CMS | Penalty per 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) | CMS | Penalty for knowingly, willfully, and repeatedly billing for a clinical diagnostic laboratory test other than on an assignment-related basis. (Penalties are assessed in the same manner as 42 U.S.C. 1395u(j)(2)(B), which is assessed according to 1320a-7a(a)) | 2019 | 15,975 | 16,257 | |
| 1395l(i)(6) | CMS | Penalty for knowingly and willfully presenting or causing to be presented a bill or request for payment for an intraocular lens inserted during or after cataract surgery for which the Medicare payment rate includes the cost of acquiring the class of lens involved | 2019 | 4,208 | 4,282 | |
| 1395l(q)(2)(B)(i) | CMS | Penalty for knowingly and willfully failing to provide information about a referring physician when seeking payment on an unassigned basis | 2019 | 4,027 | 4,098 | |
| 1395m(a)(11)(A) | 42 CFR 402.1(c)(4), 402.105(d)(2)(ii) | CMS | Penalty for any durable medical equipment supplier that knowingly and willfully charges for a covered service that is furnished on a rental basis after the rental payments may no longer be made. (Penalties are assessed in the same manner as 42 U.S.C. 1395u(j)(2)(B), which is assessed according to 1320a-7a(a)) | 2019 | 15,975 | 16,257 |
| 1395m(a)(18)(B) | 42 CFR 402.1(c)(5), 402.105(d)(2)(iii) | CMS | Penalty for any nonparticipating durable medical equipment supplier that knowingly and willfully fails to make a refund to Medicare beneficiaries for a covered service for which payment is precluded due to an unsolicited telephone contact from the supplier. (Penalties are assessed in the same manner as 42 U.S.C. 1395u(j)(2)(B), which is assessed according to 1320a-7a(a)) | 2019 | 15,975 | 16,257 |
| 1395m(b)(5)(C) | 42 CFR 402.1(c)(6), 402.105(d)(2)(iv) | CMS | Penalty for any nonparticipating physician or supplier that knowingly and willfully charges a Medicare beneficiary more than the limiting charge for radiologist services. (Penalties are assessed in the same manner as 42 U.S.C. 1395u(j)(2)(B), which is assessed according to 1320a-7a(a)) | 2019 | 15,975 | 16,257 |
| 1395m(h)(3) | 42 CFR 402.1(c)(8), 402.105(d)(2)(vi) | CMS | Penalty for any supplier of prosthetic devices, orthotics, and prosthetics that knowing and willfully charges for a covered prosthetic device, orthotic, or prosthetic that is furnished on a rental basis after the rental payment may no longer be made. (Penalties are assessed in the same manner as 42 U.S.C. 1395m(a)(11)(A), that is in the same manner as 1395u(j)(2)(B), which is assessed according to 1320a-7a(a)) | 2019 | 15,975 | 16,257 |
| 1395m(j)(2)(A)(iii) | CMS | Penalty for any supplier of durable medical equipment including a supplier of prosthetic devices, prosthetics, orthotics, or supplies that knowingly and willfully distributes a certificate of medical necessity in violation of Section 1834(j)(2)(A)(i) of the Act or fails to provide the information required under Section 1834(j)(2)(A)(ii) of the Act | 2019 | 1,692 | 1,722 | |
| 1395m(j)(4) | 42 CFR 402.1(c)(10), 402.105(d)(2)(vii) | CMS | Penalty for any supplier of durable medical equipment, including a supplier of prosthetic devices, prosthetics, orthotics, or supplies that knowingly and willfully fails to make refunds in a timely manner to Medicare beneficiaries for series billed other than on as assignment-related basis under certain conditions. (Penalties are assessed in the same manner as 42 U.S.C. 1395m(j)(4) and 1395u(j)(2)(B), which is assessed according to 1320a-7a(a)) | 2019 | 15,975 | 16,257 |
| 1395m(k)(6) | 42 CFR 402.1(c)(31), 402.105(d)(3) | CMS | Penalty for any person or entity who knowingly and willfully bills or collects for any outpatient therapy services or comprehensive outpatient rehabilitation services on other than an assignment-related basis. (Penalties are assessed in the same manner as 42 U.S.C. 1395m(k)(6) and 1395u(j)(2)(B), which is assessed according to 1320a-7a(a)) | 2019 | 15,975 | 16,257 |
| 1395m(l)(6) | 42 CFR 402.1(c)(32), 402.105(d)(4) | CMS | Penalty for any supplier of ambulance services who knowingly and willfully fills or collects for any services on other than an assignment-related basis. (Penalties are assessed in the same manner as 42 U.S.C. 1395u(b)(18)(B), which is assessed according to 1320a-7a(a)) | 2019 | 15,975 | 16,257 |
| 1395u(b)(18)(B) | 42 CFR 402.1(c)(11), 402.105(d)(2)(viii) | CMS | Penalty for any practitioner specified in Section 1842(b)(18)(C) of the Act or other person that knowingly and willfully bills or collects for any services by the practitioners on other than an assignment-related basis. (Penalties are assessed in the same manner as 42 U.S.C. 1395u(j)(2)(B), which is assessed according to 1320a-7a(a)) | 2019 | 15,975 | 16,257 |
| 1395u(j)(2)(B) | CMS | Penalty for any physician who charges more than 125% for a non-participating referral. (Penalties are assessed in the same manner as 42 U.S.C. 1320a-7a(a)) | 2019 | 15,975 | 16,257 | |
| 1395u(k) | 42 CFR 402.1(c)(12), 402.105(d)(2)(ix) | CMS | Penalty for any physician who knowingly and willfully presents or causes to be presented a claim for bill for an assistant at a cataract surgery performed on or after March 1, 1987, for which payment may not be made because of section 1862(a)(15). (Penalties are assessed in the same manner as 42 U.S.C. 1395u(j)(2)(B), which is assessed according to 1320a-7a(a)) | 2019 | 15,975 | 16,257 |
| 1395u(l)(3) | 42 CFR 402.1(c)(13), 402.105(d)(2)(x) | CMS | Penalty for any nonparticipating physician who does not accept payment on an assignment-related basis and who knowingly and willfully fails to refund on a timely basis any amounts collected for services that are not reasonable or medically necessary or are of poor quality under 1842(l)(1)(A). (Penalties are assessed in the same manner as 42 U.S.C. 1395u(j)(2)(B), which is assessed according to 1320a-7a(a)) | 2019 | 15,975 | 16,257 |
| 1395u(m)(3) | 42 CFR 402.1(c)(14), 402.105(d)(2)(xi) | CMS | Penalty for any nonparticipating physician charging more than $500 who does not accept payment for an elective surgical procedure on an assignment related basis and who knowingly and willfully fails to disclose the required information regarding charges and coinsurance amounts and fails to refund on a timely basis any amount collected for the procedure in excess of the charges recognized and approved by the Medicare program. (Penalties are assessed in the same manner as 42 U.S.C. 1395u(j)(2)(B), which is assessed according to 1320a-7a(a)) | 2019 | 15,975 | 16,257 |
| 1395u(n)(3) | 42 CFR 402.1(c)(15), 402.105(d)(2)(xii) | CMS | Penalty for any physician who knowingly, willfully, and repeatedly bills one or more beneficiaries for purchased diagnostic tests any amount other than the payment amount specified by the Act. (Penalties are assessed in the same manner as 42 U.S.C. 1395u(j)(2)(B), which is assessed according to 1320a-7a(a)) | 2019 | 15,975 | 16,257 |
| 1395u(o)(3)(B) | CMS | Penalty for any practitioner specified in Section 1842(b)(18)(C) of the Act or other person that knowingly and willfully bills or collects for any services pertaining to drugs or biologics by the practitioners on other than an assignment-related basis. (Penalties are assessed in the same manner as 42 U.S.C. 1395u(b)(18)(B) and 1395u(j)(2)(B), which is assessed according to 1320a-7a(a)) | 2019 | 15,975 | 16,257 | |
| 1395u(p)(3)(A) | CMS | Penalty for any physician or practitioner who knowingly and willfully fails promptly to provide the appropriate diagnosis codes upon CMS or Medicare administrative contractor request for payment or bill not submitted on an assignment-related basis | 2019 | 4,208 | 4,282 | |
| 1395w-3a(d)(4)(A) | CMS | Penalty for a pharmaceutical manufacturer's misrepresentation of average sales price of a drug, or biologic | 2019 | 13,669 | 13,910 | |
| 1395w-4(g)(1)(B) | 42 CFR 402.1(c)(17), 402.105(d)(2)(xiii) | CMS | Penalty for any nonparticipating physician, supplier, or other person that furnishes physician services not on an assignment-related basis who either knowingly and willfully bills or collects in excess of the statutorily-defined limiting charge or fails to make a timely refund or adjustment. (Penalties are assessed in the same manner as 42 U.S.C. 1395u(j)(2)(B), which is assessed according to 1320a-7a(a)) | 2019 | 15,975 | 16,257 |
| 1395w-4(g)(3)(B) | 42 CFR 402.1(c)(18), 402.105(d)(2)(xiv) | CMS | Penalty for any person that knowingly and willfully bills for statutorily defined State-plan approved physicians' services on any other basis than an assignment-related basis for a Medicare/Medicaid dual eligible beneficiary. (Penalties are assessed in the same manner as 42 U.S.C. 1395u(j)(2)(B), which is assessed according to 1320a-7a(a)) | 2019 | 15,975 | 16,257 |
| 1395w-27(g)(3)(A); 1857(g)(3) | 42 CFR 422.760(b); 42 CFR 423.760(b) | CMS | Penalty for each termination determination the Secretary makes that is the result of actions by a Medicare Advantage organization or Part D sponsor that has adversely affected an individual covered under the organization's contract | 2019 | 39,121 | 39,811 |
| 1395w-27(g)(3)(B); 1857(g)(3) | CMS | Penalty for each week beginning after the initiation of civil money penalty procedures by the Secretary because a Medicare Advantage organization or Part D sponsor has failed to carry out a contract, or has carried out a contract inconsistently with regulations | 2019 | 15,649 | 15,925 | |
| 1395w-27(g)(3)(D); 1857(g)(3) | CMS | Penalty for a Medicare Advantage organization's or Part D sponsor's early termination of its contract | 2019 | 145,335 | 147,899 | |
| 1395y(b)(3)(C) | CMS | Penalty for an employer or other entity to offer any financial or other incentive for an individual entitled to benefits not to enroll under a group health plan or large group health plan which would be a primary plan | 2019 | 9,472 | 9,639 | |
| 1395y(b)(5)(C)(ii) | 42 CFR 402.1(c)(20), 42 CFR 402.105(b)(2) | CMS | Penalty for any non-governmental employer that, before October 1, 1998, willfully or repeatedly failed to provide timely and accurate information requested relating to an employee's group health insurance coverage | 2019 | 1,542 | 1,569 |
| 1395y(b)(6)(B) | 42 CFR 402.1(c)(21), 402.105(a) | CMS | Penalty for any entity that knowingly, willfully, and repeatedly fails to complete a claim form relating to the availability of other health benefits in accordance with statute or provides inaccurate information relating to such on the claim form | 2019 | 3,383 | 3,443 |
| 1395y(b)(7)(B)(i) | CMS | Penalty for any entity serving as insurer, third party administrator, or fiduciary for a group health plan that fails to provide information that identifies situations where the group health plan is or was a primary plan to Medicare to the HHS Secretary | 2019 | 1,211 | 1,232 | |
| 1395y(b)(8)(E) | CMS | Penalty for any non-group health plan that fails to identify claimants who are Medicare beneficiaries and provide information to the HHS Secretary to coordinate benefits and pursue any applicable recovery claim | 2019 | 1,211 | 1,232 | |
| 1395nn(g)(5) | CMS | Penalty for any person that fails to report information required by HHS under Section 1877(f) concerning ownership, investment, and compensation arrangements | 2019 | 20,134 | 20,489 | |
| 1395pp(h) | 42 CFR 402.1(c)(23), 402.105(d)(2)(xv) | CMS | Penalty for any durable medical equipment supplier, including a supplier of prosthetic devices, prosthetics, orthotics, or supplies, that knowingly and willfully fails to make refunds in a timely manner to Medicare beneficiaries under certain conditions. (42 U.S.C. 1395(m)(18) sanctions apply here in the same manner, which is under 1395u(j)(2) and 1320a-7a(a)) | 2019 | 15,975 | 16,257 |
| 1395ss(a)(2) | 42 CFR 402.1(c)(24), 405.105(f)(1) | CMS | Penalty for any person that issues a Medicare supplemental policy that has not been approved by the State regulatory program or does not meet Federal standards after a statutorily defined effective date | 2019 | 54,832 | 55,799 |
| 1395ss(d)(3)(A)(vi)(II) | CMS | Penalty for someone other than issuer that sells or issues a Medicare supplemental policy to beneficiary without a disclosure statement | 2019 | 28,413 | 28,914 | |
| Penalty for an issuer that sells or issues a Medicare supplemental policy without disclosure statement | 2019 | 47,357 | 48,192 | |||
| 1395ss(d)(3)(B)(iv) | CMS | Penalty for someone other than issuer that sells or issues a Medicare supplemental policy without acknowledgement form | 2019 | 28,413 | 28,914 | |
| Penalty for issuer that sells or issues a Medicare supplemental policy without an acknowledgement form | 2019 | 47,357 | 48,192 | |||
| 1395ss(p)(8) | 42 CFR 402.1(c)(25), 402.105(e) | CMS | Penalty for any person that sells or issues Medicare supplemental polices after a given date that fail to conform to the National Association of Insurance Commissioners (NAIC) or Federal standards established by statute | 2019 | 28,413 | 28,914 |
| 42 CFR 402.1(c)(25), 405.105(f)(2) | CMS | Penalty for any person that sells or issues Medicare supplemental polices after a given date that fail to conform to the NAIC or Federal standards established by statute | 2019 | 47,357 | 48,192 | |
| 1395ss(p)(9)(C) | 42 CFR 402.1(c)(26), 402.105(e) | CMS | Penalty for any person that sells a Medicare supplemental policy and fails to make available for sale the core group of basic benefits when selling other Medicare supplemental policies with additional benefits or fails to provide the individual, before selling the policy, an outline of coverage describing benefits | 2019 | 28,413 | 28,914 |
| 42 CFR 402.1(c)(26), 405.105(f)(3), (4) | Penalty for any person that sells a Medicare supplemental policy and fails to make available for sale the core group of basic benefits when selling other Medicare supplemental policies with additional benefits or fails to provide the individual, before selling the policy, an outline of coverage describing benefits | 2019 | 47,357 | 48,192 | ||
| 1395ss(q)(5)(C) | 42 CFR 402.1(c)(27), 405.105(f)(5) | CMS | Penalty for any person that fails to suspend the policy of a policyholder made eligible for medical assistance or automatically reinstates the policy of a policyholder who has lost eligibility for medical assistance, under certain circumstances | 2019 | 47,357 | 48,192 |
| 1395ss(r)(6)(A) | 42 CFR 402.1(c)(28), 405.105(f)(6) | CMS | Penalty for any person that fails to provide refunds or credits as required by section 1882(r)(1)(B) | 2019 | 47,357 | 48,192 |
| 1395ss(s)(4) | 42 CFR 402.1(c)(29), 405.105(c) | CMS | Penalty for any issuer of a Medicare supplemental policy that does not waive listed time periods if they were already satisfied under a proceeding Medicare supplemental policy, or denies a policy, or conditions the issuances or effectiveness of the policy, or discriminates in the pricing of the policy base on health status or other specified criteria | 2019 | 20,104 | 20,459 |
| 1395ss(t)(2) | 42 CFR 402.1(c)(30), 405.105(f)(7) | CMS | Penalty for any issuer of a Medicare supplemental policy that fails to fulfill listed responsibilities | 2019 | 47,357 | 48,192 |
| 1395ss(v)(4)(A) | CMS | Penalty someone other than issuer who sells, issues, or renews a Medigap Rx policy to an individual who is a Part D enrollee | 2019 | 20,503 | 20,865 | |
| Penalty for an issuer who sells, issues, or renews a Medigap Rx policy who is a Part D enrollee | 2019 | 34,174 | 34,777 | |||
| 1395bbb(c)(1) | CMS | Penalty for any individual who notifies or causes to be notified a home health agency of the time or date on which a survey of such agency is to be conducted | 2019 | 4,388 | 4,465 | |
| 1395bbb(f)(2)(A)(i) | 42 CFR 488.845(b)(2)(iii) 42 CFR 488.845(b)(3)-(6); and 42 CFR 488.845(d)(1)(ii) | CMS | Maximum daily penalty amount for each day a home health agency is not in compliance with statutory requirements | 2019 | 21,039 | 21,410 |
| Penalty per day for home health agency's noncompliance (Upper Range): | ||||||
| Minimum | 2019 | 17,883 | 18,198 | |||
| Maximum | 2019 | 21,039 | 21,410 | |||
| Penalty for a home health agency's deficiency or deficiencies that cause immediate jeopardy and result in actual harm | 2019 | 21,039 | 21,410 | |||
| Penalty for a home health agency's deficiency or deficiencies that cause immediate jeopardy and result in potential for harm | 2019 | 18,934 | 19,268 | |||
| Penalty for an isolated incident of noncompliance in violation of established home health agency (HHA) policy | 2019 | 17,883 | 18,198 | |||
| 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 | 2019 | 3,157 | 3,213 | |||
| Maximum | 2019 | 17,883 | 18,198 | |||
| 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 | 2019 | 1,052 | 1,071 | |||
| Maximum | 2019 | 8,415 | 8,563 | |||
| 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 | 2019 | 2,104 | 2,141 | |||
| Maximum | 2019 | 21,039 | 21,410 | |||
| Penalty for each day of noncompliance (Maximum) | 2019 | 21,039 | 21,410 | |||
| Penalty for each day of noncompliance (Maximum) | 2019 | 21,039 | 21,410 | |||
| 1396b(m)(5)(B) | 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 PACE organization that charges excessive premiums | 2019 | 39,121 | 39,811 | |||
| Penalty for a PACE organization misrepresenting or falsifying information to CMS, the State, or an individual or other entity | 2019 | 156,488 | 159,248 | |||
| 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 | 2019 | 39,121 | 39,811 | |||
| Penalty for involuntarily disenrolling a participant | 2019 | 39,121 | 39,811 | |||
| 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 | 2019 | 39,121 | 39,811 | |||
| 1396r(h)(3)(C)(ii)(I) | CMS | Penalty per day for a nursing facility's failure to meet a Category 2 Certification: | ||||
| Minimum | 2019 | 110 | 112 | |||
| Maximum | 2019 | 6,579 | 6,695 | |||
| CMS | Penalty per instance for a nursing facility's failure to meet Category 2 certification: | |||||
| Minimum | 2019 | 2,194 | 2,233 | |||
| Maximum | 2019 | 21,933 | 22,320 | |||
| CMS | Penalty per day for a nursing facility's failure to meet Category 3 certification: | |||||
| Minimum | 2019 | 6,690 | 6,808 | |||
| Maximum | 2019 | 21,933 | 22,320 | |||
| CMS | Penalty per instance for a nursing facility's failure to meet Category 3 certification: | |||||
| Minimum | 2019 | 2,194 | 2,233 | |||
| Maximum | 2019 | 21,933 | 22,320 | |||
| CMS | Penalty per instance for a 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 | |||
| CMS | Penalty per day for nursing facility's failure to meet certification (Upper Range): | |||||
| Minimum | 2019 | 6,690 | 6,808 | |||
| Maximum | 2019 | 21,933 | 22,320 | |||
| CMS | Penalty per day for nursing facility's failure to meet certification (Lower Range): | |||||
| Minimum | 2019 | 110 | 112 | |||
| Maximum | 2019 | 6,579 | 6,695 | |||
| CMS | Penalty per 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 483.151(b)(2)(iv) and (b)(3)(iii) | CMS | Grounds to prohibit approval of Nurse Aide Training Program—if assessed a penalty in 1819(h)(2)(B)(i) or 1919(h)(2)(A)(ii) of “not less than $5,000” [Not civil monetary penalties (CMPs) authority, but a specific CMP amount (CMP at this level) that is the triggering condition for disapproval] | 2019 | 10,967 | 11,160 |
| 1396r(h)(3)(C)(ii)(I) | CMS | Grounds to waive disapproval of nurse aide training program—reference to disapproval based on imposition of CMP “not less than $5,000” [Not CMP authority but CMP imposition at this level determines eligibility to seek waiver of disapproval of nurse aide training program] | 2019 | 10,967 | 11,160 | |
| 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) | CMS | Penalty for a Medicaid managed care organization that fails substantially to provide medically necessary items and services | 2019 | 39,121 | 39,811 | |
| Penalty for Medicaid managed care organization that imposes premiums or charges on enrollees in excess of the premiums or charges permitted | 2019 | 39,121 | 39,811 | |||
| Penalty for a Medicaid managed care organization that misrepresents or falsifies information to another individual or entity | 2019 | 39,121 | 39,811 | |||
| Penalty for a Medicaid managed care organization that fails to comply with the applicable statutory requirements for such organizations | 2019 | 39,121 | 39,811 | |||
| 1396u-2(e)(2)(A)(ii) | CMS | Penalty for a Medicaid managed care organization that misrepresents or falsifies information to the HHS Secretary | 2019 | 156,488 | 159,248 | |
| Penalty for Medicaid managed care organization that acts to discriminate among enrollees on the basis of their health status | 2019 | 156,488 | 159,248 | |||
| 1396u-2(e)(2)(A)(iv) | CMS | Penalty for each individual that does not enroll as a result of a Medicaid managed care organization that acts to discriminate among enrollees on the basis of their health status | 2019 | 23,473 | 23,887 | |
| 1396u(h)(2) | 42 CFR Part 441, Subpart I | CMS | Penalty for a provider not meeting one of the requirements relating to the protection of the health, safety, and welfare of individuals receiving community supported living arrangements services | 2019 | 21,933 | 22,320 |
| 1396w-2(c)(1) | CMS | Penalty for disclosing information related to eligibility determinations for medical assistance programs | 2019 | 11,698 | 11,904 | |
| 18041(c)(2) | 45 CFR 150.315; 45 CFR 156.805(c) | CMS | Failure to comply with requirements of the Public Health Services Act; Penalty for violations of rules or standards of behavior associated with issuer participation in the federally-facilitated Exchange. (42 U.S.C. 300gg-22(b)(2)(C)) | 2019 | 159 | 162 |
| 18081(h)(1)(A)(i)(II) | 42 CFR 155.285 | CMS | Penalty for providing false information on Exchange application | 2019 | 28,906 | 29,416 |
| 18081(h)(1)(B) | 42 CFR 155.285 | CMS | Penalty for knowingly or willfully providing false information on Exchange application | 2019 | 289,060 | 294,159 |
| 18081(h)(2) | 42 CFR 155.260 | CMS | Penalty for knowingly or willfully disclosing protected information from Exchange | 2019 | 28,906 | 29,416 |
| 1352 | HHS | Penalty for the first time an individual makes an expenditure prohibited by regulations regarding lobbying disclosure, absent aggravating circumstances | 2019 | 20,134 | 20,489 | |
| 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 first time an individual fails to file or amend a lobbying disclosure form, absent aggravating circumstances | 2019 | 20,134 | 20,489 | |||
| 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, Appendix A | HHS | Penalty for 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 | HHS | Penalty against any individual who—with knowledge or reason to know—makes, presents or submits a false, fictitious or fraudulent claim to the Department | 2019 | 10,520 | 10,706 | |
| 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 | 10,520 | 10,706 | |||
| Some HHS components have not promulgated regulations regarding their civil monetary penalty-specific statutory authorities. | ||||||
| The description is not intended to be a comprehensive explanation of the underlying violation; the statute and corresponding regulation, if applicable, should be consulted. | ||||||
| Statutory or Inflation Act Adjustment. | ||||||
| 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