Notices. Final rule

10,290 words·~47 min read·/register/2024/08/08/2024-17466

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BILLING CODE 6560-50-P DEPARTMENT OF HEALTH AND HUMAN SERVICES 45 CFR Part 102 RIN 0991-AC34 Annual Civil Monetary Penalties Inflation Adjustment 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

(HHS)is updating its regulations to reflect required annual inflation-related increases to the civil monetary penalty

(CMP)amounts in its statutes and regulations, under the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015. DATES: *Effective date:* This final rule is effective August 8, 2024. *Applicability date:* The adjusted civil monetary penalty amounts apply to penalties assessed on or after August 8, 2024, if the violation occurred on or after November 2, 2015. FOR FURTHER INFORMATION CONTACT: Katrina Brisbon, 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)260-6677. SUPPLEMENTARY INFORMATION: I. Background The Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (section 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 CMPs and to maintain the deterrent effect of such penalties, requires agencies to adjust the CMPs for inflation annually. HHS lists the CMP authorities and the 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, issue of the **Federal Register** (81 FR 61538). Annual adjustments were subsequently published in the **Federal Register** on February 3, 2017 (82 FR 9175), October 11, 2018 (83 FR 51369), November 5, 2019 (84 FR 59549), January 17, 2020 (85 FR 2869), November 15, 2021 (86 FR 62928), March 17, 2022 (87 FR 15100), and October 6, 2023 (88 FR 69531). II. Calculation of Annual Inflation Adjustment and Other Updates The annual inflation adjustment for each applicable CMP 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 CMP was most recently established or modified. In the December 19, 2023, Office of Management and Budget

(OMB)Memorandum for the Heads of Executive Agencies and Departments, M-24-07, “Implementation of Penalty Inflation Adjustments for 2024, 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 2024, based on the CPI-U for the month of October 2023, not seasonally adjusted, is 1.03241. The multiplier is applied to each applicable penalty amount that was updated and published for fiscal year

(FY)2023 and is rounded to the nearest dollar. In addition to the inflation adjustments for 2023, this final rule makes a few non-substantive changes to punctuation in the table in 45 CFR 102.3. III. Statutory and Executive Order Reviews and Waiver of Proposed Rulemaking 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-24-07, the phrase “notwithstanding section 553” in section 4(b)(2) of the 2015 Act means that “the public procedure the APA generally requires—notice, an opportunity for comment, and a delay in effective date—is not required for agencies to issue regulations implementing the annual adjustment.” Consistent with the language of the 2015 Act and OMB's implementation guidance, the inflation adjustments set out in this rule are not subject to notice and an opportunity for public comment and will be effective immediately upon publication. Pursuant to OMB Memorandum M-24-07, 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 and Applicability Dates This rule is effective on the date specified in the DATES section of this final rule. The adjusted civil monetary penalty amounts apply to penalties assessed on or after the date specified in the DATES section of this final rule, if the violation occurred on or after November 2, 2015 ( *i.e.,* the date of enactment of the 2015 Act). If the violation occurred before November 2, 2015, or a penalty was assessed before September 6, 2016, the pre-adjustment civil penalty amounts in effect before September 6, 2016, will apply. List of Subjects in 45 CFR Part 102 Administrative practice and procedure, Penalties. For reasons discussed in the preamble, the Department of Health and Human Services amends subtitle A, title 45 of the Code of Federal Regulations as follows: PART 102—ADJUSTMENT OF CIVIL MONETARY PENALTIES FOR INFLATION 1. The authority citation for part 102 continues to read as follows: Authority: Pub. L. 101-410, Sec. 701 of Pub. L. 114-74, 31 U.S.C. 3801-3812. 2. Amend § 102.3 by revising table 1 to read as follows: § 102.3 Penalty adjustment and table. Table 1 to § 102.3—Civil Monetary Penalty Authorities Administered by HHS U.S.C. section(s) CFR 1 HHS agency Description 2 Date of last penalty figure or adjustment 3 2023 Maximum adjusted penalty ($) 2024 Maximum adjusted penalty ($) 4 21 U.S.C.: 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 2023 123,965 127,983 333(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 2023 2,479,282 2,559,636 333(b)(3) FDA Penalty for failure to make a report required by 21 U.S.C. 353(d)(3)(E) relating to drug samples 2023 247,929 255,964 333(f)(1)(A) FDA Penalty for any person who violates a requirement related to devices for each such violation 2023 33,483 34,568 FDA Penalty for aggregate of all violations related to devices in a single proceeding 2023 2,232,281 2,304,629 333(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 2023 94,128 97,179 FDA Penalty in the case of any other person (other than an individual) for such introduction or delivery of adulterated food 2023 470,640 485,893 FDA Penalty for aggregate of all such violations related to adulterated food adjudicated in a single proceeding 2023 941,280 971,787 333(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) 2023 14,262 14,724 333(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 2023 14,262 14,724 333(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)2023 356,580 368,137 FDA Penalty for aggregate of all such above violations in a single proceeding 2023 1,426,319 1,472,546 333(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 2023 356,580 368,137 FDA 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 2023 1,426,319 1,472,546 FDA Penalty for aggregate of all such above violations adjudicated in a single proceeding 2023 14,263,186 14,725,456 333(f)(9)(A) FDA Penalty for any person who violates a requirement which relates to tobacco products for each such violation 2023 20,678 21,348 FDA Penalty for aggregate of all such violations of tobacco product requirement adjudicated in a single proceeding 2023 1,378,541 1,423,220 333(f)(9)(B)(i)(I) FDA Penalty per violation related to violations of tobacco requirements 2023 344,636 355,806 FDA Penalty for aggregate of all such violations of tobacco product requirements adjudicated in a single proceeding 2023 1,378,541 1,423,220 333(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 2023 344,636 355,806 FDA 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 2023 1,378,541 1,423,220 FDA Penalty for aggregate of all such violations related to tobacco product requirements adjudicated in a single proceeding 2023 13,785,420 14,232,205 333(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 2023 344,636 355,806 FDA Penalty for aggregate of for all such above violations adjudicated in a single proceeding 2023 1,378,541 1,423,220 333(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 2023 344,636 355,806 FDA 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 2023 1,378,541 1,423,220 Penalty for aggregate above tobacco product requirement violations adjudicated in a single proceeding 2023 13,785,420 14,232,205 333(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 2023 356,580 368,137 Penalty for each subsequent above violation in any 3-year period 2023 713,160 736,274 333 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 2023 345 356 FDA 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 2023 687 709 FDA 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 2023 2,757 2,846 FDA 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 2023 6,892 7,115 FDA 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 2023 13,785 14,232 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 that does not have an approved training program in the case of the first regulation violation 2023 345 356 FDA 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 2023 687 709 FDA 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 2023 1,379 1,424 FDA 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 2023 2,757 2,846 FDA 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 2023 6,892 7,115 FDA 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 2023 13,785 14,232 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 2023 525,406 542,434 FDA Penalty in the case of any other person (other than an individual) per above violation 2023 2,101,618 2,169,731 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 2023 3,446 3,558 FDA Penalty imposed for any related series of violations of requirements relating to electronic products 2023 1,174,680 1,212,751 42 U.S.C 2023 262(d) FDA Penalty per day for violation of order of recall of biological product presenting imminent or substantial hazard 2023 270,180 278,937 263b(h)(3) FDA Penalty for failure to obtain a mammography certificate as required 2023 21,018 21,699 300aa-28(b)(1) FDA Penalty per occurrence for any vaccine manufacturer that intentionally destroys, alters, falsifies, or conceals any record or report required 2023 270,180 278,937 256b(d)(1)(B)(vi) HRSA Penalty for each instance of overcharging a 340B covered entity 2023 6,813 7,034 299c-3(d) AHRQ Penalty for using or disclosing identifiable information obtained in the course of activities undertaken pursuant to Title IX of the Public Health Service Act, for a purpose other than that for which the information was supplied, without consent to do so 2023 17,717 18,291 653(l)(2) 45 CFR 303.21(f) ACF Penalty for Misuse of Information in the National Directory of New Hires 2023 1,818 1,877 262a(i)(1) 42 CFR 1003.910 OIG Penalty for each individual who violates safety and security procedures related to handling dangerous biological agents and toxins 2023 410,932 424,250 42 CFR 1003.1410 OIG Penalty for any other person who violates safety and security procedures related to handling dangerous biological agents and toxins 2023 821,868 848,505 300jj-51 OIG Penalty per violation for committing information blocking 2023 1,252,992 1,293,601 1320a-7a(a) 42 CFR 1003.210(a)(1) OIG Penalty for knowingly presenting or causing to be presented to an officer, employee, or agent of the United States a false claim 2023 24,164 24,947 OIG Penalty for knowingly presenting or causing to be presented a request for payment which violates the terms of an assignment, agreement, or PPS agreement 2023 24,164 24,947 42 CFR 1003.210(a)(2) OIG 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 2023 36,246 37,421 42 CFR 1003.210(a)(3) OIG Penalty for an excluded party retaining ownership or control interest in a participating entity 2023 24,164 24,947 42 CFR 1003.1010 OIG Penalty for remuneration offered to induce program beneficiaries to use particular providers, practitioners, or suppliers 2023 24,164 24,947 42 CFR 1003.210(a)(4) OIG Penalty for employing or contracting with an excluded individual 2023 24,164 24,947 42 CFR 1003.310(a)(3) OIG 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 2023 120,816 124,732 42 CFR 1003.210(a)(1) OIG Penalty for ordering or prescribing medical or other item or service during a period in which the person was excluded 2023 24,164 24,947 42 CFR 1003.210(a)(6) OIG 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 2023 120,816 124,732 42 CFR 1003.210(a)(8) OIG Penalty for knowing of an overpayment and failing to report and return 2023 24,164 24,947 42 CFR 1003.210(a)(7) OIG Penalty for making or using a false record or statement that is material to a false or fraudulent claim 2023 68,128 70,336 42 CFR 1003.210(a)(9) OIG Penalty for failure to grant timely access to HHS OIG for audits, investigations, evaluations, and other statutory functions of HHS OIG 2023 36,246 37,421 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 2023 6,040 6,236 OIG 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 2023 6,040 6,236 42 CFR 1003.210(a)(10) OIG Penalty for a physician who executes a document that falsely certifies home health needs for Medicare beneficiaries 2023 12,081 12,473 1320a-7a(o) 42 CFR 1003.710(a)(1) 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 2023 11,784 12,166 42 CFR 1003.710(a)(2) OIG 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 2023 58,921 60,831 42 CFR 1003.710(a)(3) OIG 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 2023 58,921 60,831 42 CFR 1003.710(a)(4) OIG 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, per each false record or statement 2023 61,458 63,450 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, per day 2023 12,308 12,707 42 CFR 1003.710(a)(5) OIG Penalty for failure to grant timely access, upon reasonable request, to the I.G. for purposes of audits, investigations, evaluations, or other statutory functions of I.G. in matters involving grants, contracts, or other agreements 2023 17,677 18,250 1320a-7e(b)(6)(A) 42 CFR 1003.810 OIG Penalty for failure to report any final adverse action taken against a health care provider, supplier, or practitioner 2023 46,102 47,596 1320b-10(b)(1) 42 CFR 1003.610(a) 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 2023 12,397 12,799 1320b-10(b)(2) 42 CFR 1003.610(a) 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 2023 61,982 63,991 1395i-3(b)(3)(B)(ii)(1) 42 CFR 1003.210(a)(11) OIG Penalty for certification of a false statement in assessment of functional capacity of a Skilled Nursing Facility resident assessment 2023 2,586 2,670 1395i-3(b)(3)(B)(ii)(2) 42 CFR 1003.210(a)(11) OIG Penalty for causing another to certify or make a false statement in assessment of functional capacity of a Skilled Nursing Facility resident assessment 2023 12,924 13,343 1395i-3(g)(2)(A) 42 CFR 1003.1310 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 2023 5,171 5,339 1395w-27(g)(2)(A) 42 CFR 1003.410 OIG Penalty for a Medicare Advantage organization that substantially fails to provide medically necessary, required items and services 2023 47,061 48,586 OIG Penalty for a Medicare Advantage organization that charges excessive premiums 2023 46,102 47,596 OIG Penalty for a Medicare Advantage organization that improperly expels or refuses to reenroll a beneficiary 2023 46,102 47,596 OIG Penalty for a Medicare Advantage organization that engages in practice that would reasonably be expected to have the effect of denying or discouraging enrollment 2023 184,412 190,389 OIG 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 2023 27,661 28,557 OIG Penalty for a Medicare Advantage organization misrepresenting or falsifying information to Secretary 2023 184,412 190,389 OIG Penalty for a Medicare Advantage organization misrepresenting or falsifying information to individual or other entity 2023 46,102 47,596 OIG Penalty for Medicare Advantage organization interfering with provider's advice to enrollee and non-MCO affiliated providers that balance bill enrollees 2023 46,102 47,596 OIG Penalty for a Medicare Advantage organization that employs or contracts with excluded individual or entity 2023 46,102 47,596 OIG Penalty for a Medicare Advantage organization enrolling an individual in without prior written consent 2023 46,102 47,596 OIG Penalty for a Medicare Advantage organization transferring an enrollee to another plan without consent or solely for the purpose of earning a commission 2023 46,102 47,596 OIG Penalty for a Medicare Advantage organization failing to comply with marketing restrictions or applicable implementing regulations or guidance 2023 46,102 47,596 OIG Penalty for a Medicare Advantage organization employing or contracting with an individual or entity who violates 1395w-27(g)(1)(A)-(J) 2023 46,102 47,596 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 2023 16,108 16,630 1395cc(g) 42 CFR 1003.210(a)(5) OIG Penalty for improper billing by Hospitals, Critical Access Hospitals, or Skilled Nursing Facilities 2023 6,266 6,469 1395dd(d)(1) 42 CFR 1003.510 OIG Penalty for a hospital with 100 beds or more or responsible physician dumping patients needing emergency medical care 2023 129,232 133,420 OIG Penalty for a hospital with less than 100 beds dumping patients needing emergency medical care 2023 64,618 66,712 1395mm(i)(6)(B)(i) 42 CFR 1003.410 OIG Penalty for a HMO or competitive medical plan if such plan substantially fails to provide medically necessary, required items or services 2023 64,618 66,712 OIG Penalty for HMOs/competitive medical plans that charge premiums in excess of permitted amounts 2023 64,618 66,712 OIG Penalty for a HMO or competitive medical plan that expels or refuses to reenroll an individual per prescribed conditions 2023 64,618 66,712 OIG Penalty for a HMO or competitive medical plan that implements practices to discourage enrollment of individuals needing services in future 2023 258,464 266,841 OIG 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 2023 37,190 38,395 OIG Penalty for a HMO or competitive medical plan that misrepresents or falsifies information to the Secretary 2023 258,464 266,841 OIG Penalty for a HMO or competitive medical plan that misrepresents or falsifies information to an individual or any other entity 2023 64,618 66,712 OIG Penalty for failure by HMO or competitive medical plan to assure prompt payment of Medicare risk sharing contracts or incentive plan provisions 2023 64,618 66,712 OIG Penalty for HMO that employs or contracts with excluded individual or entity 2023 59,316 61,238 1395nn(g)(3) 42 CFR 1003.310 OIG Penalty for submitting or causing to be submitted claims in violation of the Stark Law's restrictions on physician self-referrals 2023 29,899 30,868 1395nn(g)(4) 42 CFR 1003.310 OIG Penalty for circumvention schemes in violation of the Stark Law's restrictions on physician self-referrals 2023 199,338 205,799 1395ss(d)(1) 42 CFR 1003.1110 OIG Penalty for a material misrepresentation regarding Medigap compliance policies 2023 12,397 12,799 1395ss(d)(2) 42 CFR 1003.1110 OIG Penalty for selling Medigap policy under false pretense 2023 12,397 12,799 1395ss(d)(3)(A)(ii) 42 CFR 1003.1110 OIG Penalty for an issuer that sells health insurance policy that duplicates benefits 2023 55,808 57,617 OIG Penalty for someone other than issuer that sells health insurance that duplicates benefits 2023 33,483 34,568 1395ss(d)(4)(A) 42 CFR 1003.1110 OIG Penalty for using mail to sell a non-approved Medigap insurance policy 2023 12,397 12,799 1396b(m)(5)(B)(i) 42 CFR 1003.410 OIG Penalty for a Medicaid MCO that substantially fails to provide medically necessary, required items or services 2023 61,982 63,991 OIG Penalty for a Medicaid MCO that charges excessive premiums 2023 61,982 63,991 OIG Penalty for a Medicaid MCO that improperly expels or refuses to reenroll a beneficiary 2023 247,929 255,964 OIG 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 2023 37,190 38,395 OIG Penalty for a Medicaid MCO misrepresenting or falsifying information to the Secretary 2023 247,929 255,964 OIG Penalty for a Medicaid MCO misrepresenting or falsifying information to an individual or another entity 2023 61,982 63,991 OIG Penalty for a Medicaid MCO that fails to comply with contract requirements with respect to physician incentive plans 2023 55,808 57,617 1396r(b)(3)(B)(ii)(I) 42 CFR 1003.210(a)(11) OIG Penalty for willfully and knowingly certifying a material and false statement in a Skilled Nursing Facility resident assessment 2023 2,586 2,670 1396r(b)(3)(B)(ii)(II) 42 CFR 1003.210(a)(11) OIG Penalty for willfully and knowingly causing another individual to certify a material and false statement in a Skilled Nursing Facility resident assessment 2023 12,924 13,343 1396r(g)(2)(A)(i) 42 CFR 1003.1310 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 2023 5,171 5,339 1396r-8(b)(3)(B) 42 CFR 1003.1210 OIG Penalty for the knowing provision of false information or refusing to provide information about charges or prices of a covered outpatient drug 2023 223,229 230,464 1396r-8(b)(3)(C)(i) 42 CFR 1003.1210 OIG Penalty per day for failure to timely provide information by drug manufacturer with rebate agreement 2023 22,324 23,048 1396r-8(b)(3)(C)(ii) 42 CFR 1003.1210 OIG Penalty for knowing provision of false information by drug manufacturer with rebate agreement 2023 223,229 230,464 1396t(i)(3)(A) 42 CFR 1003.1310 OIG Penalty for notifying home and community-based providers or settings of survey 2023 4,465 4,610 11131(c) 42 CFR 1003.810 OIG Penalty for failing to report a medical malpractice claim to National Practitioner Data Bank 2023 27,018 27,894 11137(b)(2) 42 CFR 1003.810 OIG Penalty for breaching confidentiality of information reported to National Practitioner Data Bank 2023 27,018 27,894 299b-22(f)(1) 42 CFR 3.404 OCR Penalty for violation of confidentiality provision of the Patient Safety and Quality Improvement Act 2023 14,960 15,445 1320(d)-5(a) 45 CFR 160.404(b)(1)(i),

(ii)OCR Penalty for each pre-February 18, 2009 violation of the HIPAA administrative simplification provisions 2023 187 193 OCR Calendar Year Cap 2023 47,061 48,586 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 2023 Minimum 2023 137 141 Maximum 2023 68,928 71,162 Calendar Year Cap 2023 2,067,813 2,134,831 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 2023 Minimum 2023 1,379 1,424 Maximum 2023 68,928 71,162 Calendar Year Cap 2023 2,067,813 2,134,831 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 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 2023 Minimum 2023 68,928 71,162 Maximum 2023 2,067,813 2,134,831 Calendar Year Cap 2023 2,067,813 2,134,831 42 U.S.C. 300gg-18, 42 U.S.C. 1302 45 CFR 180.90 CMS Penalty for a hospital's non-compliance with making public standard charges for hospital items and services 2023 323 333 Per Day (Maximum) 2023 5,926 6,118 45 CFR 180.90(c)(2)(i) CMS Per day penalty for a hospital's noncompliance with making public standard charges for hospital items and services 328 339 45 CFR 180.90(c)(2)(ii)(A) CMS Per day penalty for hospitals with equal to or less than 30 beds 323 333 45 CFR 180.90(c)(2)(ii)(B) CMS Per day, per bed penalty for hospitals having at least 31 and up to and including 550 beds 11 11 45 CFR 180.90(c)(2)(ii)(C) CMS Per day penalty for hospitals having greater than 550 beds 2,926 3,021 CARES Act, Public Law 116-136, section 3202(b)(2) 45 CFR 182.70 CMS Penalty for a provider's non-compliance with price transparency requirements regarding diagnostic tests for COVID-19 2023 Per Day (Maximum) 2023 323 333 263a(h)(2)(B) & 1395w-2(b)(2)(A)(ii) 42 CFR 493.1834(d)(2)(i) CMS Penalty for a clinical laboratory's failure to meet participation and certification requirements and poses immediate jeopardy 2023 Minimum 2023 7,562 7,807 Maximum 2023 24,793 25,597 42 CFR 493.1834(d)(2)(ii) CMS Penalty for a clinical laboratory's failure to meet participation and certification requirements and the failure does not pose immediate jeopardy 2023 Minimum 2023 125 129 Maximum 2023 7,437 7,678 42 CFR 493.1834(d)(2)(iii) CMS Penalty for a clinical laboratory's failure to meet SARS-CoV-2 test reporting requirements 2023 First day of noncompliance 2023 Each additional day of noncompliance 2023 300gg-15(f) 45 CFR 147.200(e) CMS Failure to provide the Summary of Benefits and Coverage 2023 1,362 1,406 300gg-18 45 CFR 158.606 CMS Penalty for violations of regulations related to the medical loss ratio reporting and rebating 2023 136 140 45 CFR 180.90 CMS Price against hospital identified by CMS as noncompliant according to § 182.50 with respect to price transparency requirements regarding diagnostic tests for COVID-19 2023 42 U.S.C. 300gg-118 note, 300gg-134 CMS Penalties for failure to comply with No Surprises Act requirements on providers, facilities, providers of air ambulance services 2023 11,445 11,816 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 2023 Minimum 2023 1,362 1,406 Maximum 2023 13,625 14,067 Calendar Year Cap 2023 204,384 211,008 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 2023 Minimum 2023 13,625 14,067 Maximum 2023 136,258 140,674 Calendar Year Cap 2023 1,362,567 1,406,728 CMS Penalty for an administrator of a facility that fails to comply with notice requirements for the closure of a facility 2023 136,258 140,674 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 2023 681 703 Minimum penalty for the second offense of an administrator who fails to provide notice of facility closure 2023 2,045 2,111 Minimum penalty for the third and subsequent offenses of an administrator who fails to provide notice of facility closure 2023 4,087 4,219 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 2023 9,966 10,289 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 2023 9,399 9,704 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 2023 7,805 8,058 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 2023 272,514 281,346 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 2023 408,769 422,017 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 2023 272,514 281,346 1395b-7(b)(2)(B) 42 CFR 402.105(g) 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 2023 184 190 1395i-3(h)(2)(B)(ii)(I) 42 CFR 488.408(d)(1)(iii) CMS Penalty per day for a Skilled Nursing Facility that has a Category 2 violation of certification requirements 2023 Minimum 2023 129 133 Maximum 2023 7,752 8,003 42 CFR 488.408(d)(1)(iv) CMS Penalty per instance of Category 2 noncompliance by a Skilled Nursing Facility 2023 Minimum 2023 2,586 2,670 Maximum 2023 25,847 26,685 42 CFR 488.408(e)(1)(iii) CMS Penalty per day for a Skilled Nursing Facility that has a Category 3 violation of certification requirements 2023 Minimum 2023 7,884 8,140 Maximum 2023 25,847 26,685 42 CFR 488.408(e)(1)(iv) CMS Penalty per instance of Category 3 noncompliance by a Skilled Nursing Facility 2023 Minimum 2023 2,586 2,670 Maximum 2023 25,847 26,685 42 CFR 488.408(e)(2)(ii) CMS Penalty per day and per instance for a Skilled Nursing Facility that has Category 3 noncompliance with Immediate Jeopardy 2023 Per Day (Minimum) 2023 7,884 8,140 Per Day (Maximum) 2023 25,847 26,685 Per Instance (Minimum) 2023 2,586 2,670 Per Instance (Maximum) 2023 25,847 26,685 42 CFR 488.438(a)(1)(i) CMS Penalty per day of a Skilled Nursing Facility that fails to meet certification requirements. These amounts represent the upper range per day 2023 Minimum 2023 7,884 8,140 Maximum 2023 25,847 26,685 42 CFR 488.438(a)(1)(ii) CMS Penalty per day of a Skilled Nursing Facility that fails to meet certification requirements. These amounts represent the lower range per day 2023 Minimum 2023 129 133 Maximum 2023 7,752 8,003 42 CFR 488.438(a)(2) CMS Penalty per instance of a Skilled Nursing Facility that fails to meet certification requirements 2023 Minimum 2023 2,586 2,670 Maximum 2023 25,847 26,685 42 CFR 488.447 CMS Penalty imposed for failure to comply with infection control weekly reporting requirements at 42 CFR 483.80(g)(1) and

(2)2023 First occurrence 2023 1,158 1,196 Incremental increases for each subsequent occurrences 2023 579 598 1395i-6(c)(5)(B)(i) 42 CFR 488.1245 CMS Penalty for noncompliance by hospice program with requirements specified in section 1395x(dd) of 42 U.S.C 2023 10,775 11,124 42 CFR 488.1245(b)(2)(iii) CMS Adjustment to penalties. Maximum penalty assessment for each day a hospice is not in substantial compliance with one or more conditions of participation 2023 10,775 11,124 42 CFR 488.1245(b)(3) CMS Penalty imposed for hospice condition-level deficiency that is immediate jeopardy. These amounts represent the upper range of penalty Minimum 2023 9,158 9,455 Maximum 2023 10,775 11,124 42 CFR 488.1245(b)(3)(i) CMS Penalty imposed for hospice condition-level deficiency that is immediate jeopardy. These amounts represent the upper range of penalty 2023 10,775 11,124 42 CFR 488.1245(b)(3)(ii) CMS Penalty imposed for hospice condition-level deficiency that is immediate jeopardy. These amounts represent the upper range of penalty 2023 9,697 10,011 42 CFR 488.1245(b)(3)(iii) CMS Penalty imposed for hospice condition-level deficiency that is immediate jeopardy. These amounts represent the upper range of penalty 2023 9,158 9,455 42 CFR 488.1245(b)(4) CMS Penalty imposed for hospice repeat or condition-level deficiency or both that does not constitute immediate jeopardy but is directly related to poor quality patient care outcomes. These amounts represent the middle range of penalty Minimum 2023 1,616 1,668 Maximum 2023 9,158 9,455 42 CFR 488.1245(b)(5) CMS Penalty imposed for hospice repeat or condition-level deficiency or both that does not constitute immediate jeopardy and are related predominantly to structure or process-oriented conditions rather than directly related to patient outcomes. These amounts represent the lower range of penalty Minimum 2023 539 556 Maximum 2023 4,310 4,450 42 CFR 488.1245(b)(6) CMS Penalty range imposed for per instance of hospice noncompliance Minimum 2023 1,077 1,112 Maximum 2023 10,775 11,124 42 CFR 488.1245(d)(1)(ii) CMS Penalty for each per instance of hospice noncompliance, maximum per day per hospice program 2023 10,775 11,124 1395l(h)(5)(D) 42 CFR 402.105(d)(2)(i) 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)) 2023 18,825 19,435 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 2023 4,960 5,121 1395l(q)(2)(B)(i) 42 CFR 402.105(a) CMS Penalty for knowingly and willfully failing to provide information about a referring physician when seeking payment on an unassigned basis 2023 4,745 4,899 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)) 2023 18,825 19,435 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)) 2023 18,825 19,435 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)) 2023 18,825 19,435 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)) 2023 18,825 19,435 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 2023 1,993 2,058 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)) 2023 18,825 19,435 1395m-1(a) 42 CFR 414.504(e) CMS Penalty for an applicable entity that has failed to report or made a misrepresentation or omission in reporting applicable information with respect to a clinical diagnostic laboratory test 2023 12,551 12,958 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)) 2023 18,825 19,435 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)) 2023 18,825 19,435 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)) 2023 18,825 19,435 1395u(j)(2)(B) 42 CFR 402.1(c) 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)) 2023 18,825 19,435 1395u(k) 42 CFR 402.1(c)(12), 402.105(d)(2)(ix) 1834A(a)(9) and 42 CFR 414.504(e) 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)) 2023 18,825 19,435 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)) 2023 18,825 19,435 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)) 2023 18,825 19,435 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)) 2023 18,825 19,435 1395u(o)(3)(B) 42 CFR 414.707(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)) 2023 18,825 19,435 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 2023 4,960 5,121 1395w-3a(d)(4)(A) 42 CFR 414.806 CMS Penalty for a pharmaceutical manufacturer's misrepresentation of average sales price of a drug, or biologic 2023 16,108 16,630 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)) 2023 18,825 19,435 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)) 2023 18,825 19,435 1395w-27(g)(3)(A); 1857(g)(3); 1860D-12(b)(3)(E) 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 (or has the substantial likelihood of adversely affecting) an individual covered under the organization's contract 2023 46,102 47,596 1395w-27(g)(3)(B); 1857(g)(3); 1860D-12(b)(3)(E) 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 2023 18,442 19,040 1395w-27(g)(3)(D); 1857(g)(3): 1860D-12(b)(3)(E) CMS Penalty for a Medicare Advantage organizations or Part D sponsor's early termination of its contract 2023 171,257 176,807 1395y(b)(3)(C) 42 CFR 411.103(b) 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 2023 11,162 11,524 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 2023 1,818 1,877 1395y(b)(6)(B) 42 CFR 402.1(c)(20), 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 2023 3,988 4,117 1395y(b)(7)(B)(i) 42 CFR 402.1(c)(21), 402.105(a) 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 2023 1,428 1,474 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 2023 1,428 1,474 1395nn(g)(5) 42 CFR 411.361 CMS Penalty for any person that fails to report information required by HHS under Section 1877(f) concerning ownership, investment, and compensation arrangements 2023 23,727 24,496 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)) 2023 18,825 19,435 1395ss(a)(2) 402.102(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 2023 64,617 66,711 1395ss(d)(3)(A)(vi)

(II)42 CFR 402.1(c)(25), 402.105(e), 402.105(f)(2) CMS Penalty for someone other than issuer that sells or issues a Medicare supplemental policy to beneficiary without a disclosure statement 2023 33,483 34,568 CMS Penalty for an issuer that sells or issues a Medicare supplemental policy without disclosure statement 2023 55,808 57,617 1395ss(d)(3)(B)(iv) CMS Penalty for someone other than issuer that sells or issues a Medicare supplemental policy without acknowledgement form 2023 33,483 34,568 CMS Penalty for issuer that sells or issues a Medicare supplemental policy without an acknowledgement form 2023 55,808 57,617 1395ss(p)(8) 42 CFR 402.1(c)(25), 402.105(e) CMS Penalty for someone other than issuer that sells or issues Medicare supplemental polices after a given date that fail to conform to the NAIC or Federal standards established by statute 2023 33,483 34,568 42 CFR 402.1(c)(25), 405402.105(f)(2) CMS Penalty for an issuer that sells or issues Medicare supplemental polices after a given date that fail to conform to the NAIC or Federal standards established by statute 2023 55,808 57,617 1395ss(p)(9)(C) 42 CFR 402.1(c)(26), 402.105(e), 402.105(f)(3),

(4)CMS Penalty for someone other than issuer 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 2023 33,483 34,568 402.105(f)(3),(4) CMS Penalty for an issuer 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 2023 55,808 57,617 1395ss(q)(5)(C) 402.105(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 2023 55,808 57,617 1395ss(r)(6)(A) 402.105(f)(6) CMS Penalty for any person that fails to provide refunds or credits as required by section 1882(r)(1)(B) 2023 55,808 57,617 1395ss(s)(4) 42 CFR 402.1(c)(29), 402.105(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 2023 23,692 24,460 1395ss(t)(2) 42 CFR 402.1(c)(30), 402.105(f)(7) CMS Penalty for any issuer of a Medicare supplemental policy that fails to fulfill listed responsibilities 2023 55,808 57,617 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 2023 24,163 24,946 CMS Penalty for an issuer who sells, issues, or renews a Medigap Rx policy who is a Part D enrollee 2023 40,272 41,577 1395bbb(c)(1) 42 CFR 488.725(c) 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 2023 5,171 5,339 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 2023 24,793 25,597 42 CFR 488.845(b)(3) CMS Penalty per day for home health agency's noncompliance (Upper Range) 2023 Minimum 2023 21,074 21,757 Maximum 2023 24,793 25,597 42 CFR 488.845(b)(3)(i) CMS Penalty for a home health agency's deficiency or deficiencies that cause immediate jeopardy and result in actual harm 2023 24,793 25,597 42 CFR 488.845(b)(3)(ii) CMS Penalty for a home health agency's deficiency or deficiencies that cause immediate jeopardy and result in potential for harm 2023 22,313 23,036 42 CFR 488.845(b)(3)(iii) CMS Penalty for an isolated incident of noncompliance in violation of established HHA policy 2023 21,074 21,757 42 CFR 488.845(b)(4) CMS 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) 2023 Minimum 2023 3,720 3,841 Maximum 2023 21,074 21,757 42 CFR 488.845(b)(5) CMS 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) 2023 Minimum 2023 1,240 1,280 Maximum 2023 2,479 2,559 42 CFR 488.845(b)(6) CMS 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 2023 Penalty for each day of noncompliance (Minimum) 2023 2,479 2,559 Penalty for each day of noncompliance (Maximum) 2023 24,793 25,597 42 CFR 488.845(d)(1)(ii) CMS Penalty for each day of noncompliance (Maximum) 2023 24,793 25,597 1395eee(e)(6)(B); 1396u-4(e)(6)(B) 42 CFR 460.46 CMS Penalty for PACE organization that discriminates in enrollment or disenrollment, or engages in any practice that would reasonably be expected to have the effect of denying or discouraging enrollment, on the basis of health status or the need for services 2023 46,102 47,596 CMS For each individual not enrolled as a result of the PACE organization's discrimination in enrollment or disenrollment or practice that would deny or discourage enrollment 2023 Minimum 2023 17,370 17,933 Maximum 2023 115,802 119,555 CMS Penalty for a PACE organization that charges excessive premiums 2023 46,102 47,596 CMS Penalty for a PACE organization misrepresenting or falsifying information to CMS or the State 2023 184,412 190,389 CMS Penalty for any other violation specified in 42 CFR 460.40 2023 46,102 47,596 1396r(h)(3)(C)(ii)(I) 42 CFR 488.408(d)(1)(iii) CMS Penalty per day for a nursing facility's failure to meet a Category 2 Certification 2023 Minimum 2023 129 133 Maximum 2023 7,752 8,003 42 CFR 488.408(d)(1)(iv) CMS Penalty per instance for a nursing facility's failure to meet Category 2 certification 2023 Minimum 2023 2,586 2,670 Maximum 2023 25,847 26,685 42 CFR 488.408(e)(1)(iii) CMS Penalty per day for a nursing facility's failure to meet Category 3 certification 2023 Minimum 2023 7,884 8,140 Maximum 2023 25,847 26,685 42 CFR 488.408(e)(1)(iv) CMS Penalty per instance for a nursing facility's failure to meet Category 3 certification 2023 Minimum 2023 2,586 2,670 Maximum 2023 25,847 26,685 42 CFR 488.408(e)(2)(ii) CMS Penalty per instance for a nursing facility's failure to meet Category 3 certification, which results in immediate jeopardy 2023 Minimum 2023 2,586 2,670 Maximum 2023 25,847 26,685 42 CFR 488.438(a)(1)(i) CMS Penalty per day for nursing facility's failure to meet certification (Upper Range) 2023 Minimum 2023 7,884 8,140 Maximum 2023 25,847 26,685 42 CFR 488.438(a)(1)(ii) CMS Penalty per day for nursing facility's failure to meet certification (Lower Range) 2023 Minimum 2023 129 133 Maximum 2023 7,752 8,003 42 CFR 488.438(a)(2) CMS Penalty per instance for nursing facility's failure to meet certification 2023 Minimum 2023 2,586 2,670 Maximum 2023 25,847 26,685 42 CFR 488.447 CMS Penalty imposed for failure to comply with infection control weekly reporting requirements at 42 CFR 483.80(g)(1) and

(2)2023 First occurrence (Minimum) 2023 1,158 1,196 Incremental increases for each subsequent occurrence 2023 579 598 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 CMP authority, but a specific CMP amount (CMP at this level) that is the triggering condition for disapproval] 2023 12,924 13,343 1396r(h)(3)(C)(ii)(I) 42 CFR 483.151(c)(2) 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] 2023 12,924 13,343 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 2023 Minimum 2023 2 2 Maximum 2023 22,324 23,048 1396u-2(e)(2)(A)(i) 42 CFR 438.704 CMS Penalty for a Medicaid managed care organization that fails substantially to provide medically necessary items and services 2023 46,102 47,596 CMS Penalty for Medicaid managed care organization that imposes premiums or charges on enrollees in excess of the premiums or charges permitted 2023 46,102 47,596 CMS Penalty for a Medicaid managed care organization that misrepresents or falsifies information to another individual or entity 2023 46,102 47,596 CMS Penalty for a Medicaid managed care organization that fails to comply with the applicable statutory requirements for such organizations 2023 46,102 47,596 1396u-2(e)(2)(A)(ii) 42 CFR 438.704 CMS Penalty for a Medicaid managed care organization that misrepresents or falsifies information to the HHS Secretary 2023 184,412 190,389 CMS Penalty for Medicaid managed care organization that acts to discriminate among enrollees on the basis of their health status 2023 184,412 190,389 1396u-2(e)(2)(A)(iv) 42 CFR 438.704 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 2023 27,661 28,557 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 2023 25,847 26,685 1396w-2(c)(1) 42 U.S.C. 300gg-22(b)(2)(C)(i), 45 CFR 150.315 CMS Penalty for each day, for each individual affected by the failure of a health insurance issuer or non-Federal governmental group health plan to comply with federal market reform provisions in part A or D of title XXVII of the PHS Act| 2022|174| 177 2023 13,785 14,232 18041(c)(2) 45 CFR 156.805(c) CMS Failure to comply with ACA requirements related to risk adjustment, reinsurance, risk corridors, Exchanges (including QHP standards) and other ACA Subtitle D standards; Penalty for violations of rules or standards of behavior associated with issuer compliance with risk adjustment, reinsurance, risk corridors, Exchanges (including QHP standards) and other ACA Subtitle D standards 2023 187 193 42 U.S.C. 300gg-22(b)(2)(C)(i) 45 CFR 150.315 CMS Penalty for each day, for each individual affected by the failure of a health insurance issuer or non-Federal governmental group health plan to comply with federal market reform provisions in part A or D of title XXVII of the PHS Act 2023 177 183 18081(h)(1)(A)(i)(II) 45 CFR 155.285 CMS Penalty for providing false information on Exchange application 2023 34,065 35,169 18081(h)(1)(B) 45 CFR 155.285 CMS Penalty for knowingly or willfully providing false information on Exchange application 2023 340,641 351,681 18081(h)(2) 45 CFR 155.260 CMS Penalty for knowingly or willfully disclosing protected information from Exchange 2023 CMS Maximum 2023 34,065 35,169 CMS Minimum 2023 348 359 18041(c)(2) 45 CFR 155.206(i) CMS Penalties for violation of applicable Exchange standards by consumer assistance entities in Federally-facilitated Exchanges 2023 41,774 43,128 Maximum (Per Day) 2023 115 119 31 U.S.C 2023 348 359 1352 45 CFR 93.400(e) HHS Penalty for the first time an individual makes an expenditure prohibited by regulations regarding lobbying disclosure, absent aggravating circumstances 2023 23,727 24,496 Penalty for second and subsequent offenses by individuals who make an expenditure prohibited by regulations regarding lobbying disclosure 2023 Minimum 2023 23,727 24,496 Maximum 2023 237,268 244,958 HHS Penalty for the first time an individual fails to file or amend a lobbying disclosure form, absent aggravating circumstances 2023 23,727 24,496 Penalty for second and subsequent offenses by individuals who fail to file or amend a lobbying disclosure form, absent aggravating circumstances 2023 Minimum 2023 23,727 24,496 Maximum 2023 237,268 244,958 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 2023 Minimum 2023 23,727 24,496 Maximum 2023 237,268 244,958 HHS Penalty for failure to provide statement regarding lobbying for loan guarantee and loan insurance transactions 2023 Minimum 2023 23,727 24,496 Maximum 2023 237,268 244,958 3801-3812 45 CFR 79.3(a)(1)(iv) 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 2023 12,398 12,800 45 CFR 79.3(b)(1)(ii) 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 2023 12,398 12,800 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 OMB Memorandum *M-16-06,* Implementation of the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015, published February 24, 2016, guided agencies on initial “catch-up” adjustment requirements, and *M-17-11,* Implementation of the 2017 annual adjustment pursuant to the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015, published December 16, 2016; followed by *M-18-03, M-19-04,* *M-20-05, M-21-10,* *M-22-07, M-23-05,* and *M-24-07* guided agencies on annual adjustment requirements. 5 *OMB Circular A-136,* Financial Reporting Requirements, Section II.4.9, directs that agencies must make annual inflation adjustments to civil monetary penalties and report on the adjustments in the Agency Financial Report

(AFR)or Performance and Accountability Report (PAR). 6 Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015, § 701(b)(1)(A) (codified as amended at 28 U.S.C. 2461 note). 7 Annual inflation adjustments are based on the percent change between each published October's CPI-U. In this case, October 2023 CPI-U (307.671)/October 2022 CPI-U (298.012) = 1.03241. Xavier Becerra, Secretary, Department of Health and Human Services. [FR Doc. 2024-17466 Filed 8-7-24; 8:45 am]

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