Notices. Final rule

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BILLING CODE 3411-15-P DEPARTMENT OF HEALTH AND HUMAN SERVICES 45 CFR Part 102 RIN 0991-AC38 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 upon publication to the **Federal Register** . *Applicability date:* The adjusted civil monetary penalty amounts apply to penalties assessed on or after the date of publication to the **Federal Register** , if the violation occurred on or after November 2, 2015. FOR FURTHER INFORMATION CONTACT: Jennifer Johnson, Acting, 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;

(771)215-0133. 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, **Federal Register** (81 FR 61538). Annual adjustments were subsequently published 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), October 6, 2023 (88 FR 69531), and August 8, 2024 (89 FR 64815) *.* 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 17, 2024, Office of Management and Budget

(OMB)Memorandum for the Heads of Executive Departments and Agencies, M-25-02, “Implementation of Penalty Inflation Adjustments for 2025, 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 2025, based on the CPI-U for the month of October 2024, not seasonally adjusted, is 1.02598. The multiplier is applied to each applicable penalty amount that was updated and published for fiscal year

(FY)2024 and is rounded to the nearest dollar. In addition to the inflation adjustments for 2025, this final rule corrects several technical errors and updates descriptions for clarification and accuracy. The following non-substantive technical errors were identified and are corrected and following descriptions are updated in the table in 45 CFR 102.3: • The description of 42 U.S.C. 1320a-7j(h)(3)(A) is revised to add the word “Maximum” to accurately reflect the statutory maximum penalty amount. • The regulatory cite associated with “Penalty against hospital identified by CMS as noncompliant according to § 182.50 with respect to price transparency requirements regarding diagnostic tests for COVID-19” was corrected from 45 CFR 180.90 to 45 CFR 182.70. • The 2024 maximum penalty associated with 45 CFR 180.90(c)(2)(ii)(C) was revised as it was cited incorrectly as $3,021 but should have been $6,118 in the last adjustment. In the 2024 adjustment, the amount reflected in the 2023 Maximum Adjusted Penalty column should have been $5,926, which was the actual adjusted amount in 2023 (see 88 FR at 69541). However, this amount was inadvertently mistyped as $2,926 in the last adjustment (see 89 FR at 64823). Applying the 2024 multiplier to the correct amount would have resulted in $6,118 ($5,926 × 1.03241). Therefore, the 2024 Maximum Adjusted Penalty was revised in this rule to $6,118. 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-25-02, the phrase “notwithstanding section 553” in section 4(b)(2) of the 2015 Act means that “the notice and comment process 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, 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. Also, HHS finds that notice and comment procedures would be impracticable and unnecessary under the APA for the ministerial and technical changes in this rule. In addition, HHS is waiving notice and comment for the non-substantive technical corrections set out in this final rule. HHS finds good cause for issuing these changes as a final rule without prior notice and comment because these changes make technical clarifying edits to descriptions and corrections to inadvertent typographical errors from the last update. For these same reasons, HHS also finds good cause to make the final rule effective upon publication. Pursuant to OMB Memorandum M-25-02, 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 2024 Maximum adjusted penalty ($) 2025 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 2024 127,983 131,308 333(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 2024 2,559,636 2,626,135 333(b)(3) FDA Penalty for failure to make a report required by 21 U.S.C. 353(d)(3)(E) relating to drug samples 2024 255,964 262,614 333(f)(1)(A) FDA Penalty for any person who violates a requirement related to devices for each such violation 2024 34,568 35,466 FDA Penalty for aggregate of all violations related to devices in a single proceeding 2024 2,304,629 2,364,503 333(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 2024 97,179 99,704 FDA Penalty in the case of any other person (other than an individual) for such introduction or delivery of adulterated food 2024 485,893 498,517 FDA Penalty for aggregate of all such violations related to adulterated food adjudicated in a single proceeding 2024 971,787 997,034 333(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) 2024 14,724 15,107 333(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 2024 14,724 15,107 333(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)2024 368,137 377,701 FDA Penalty for aggregate of all such above violations in a single proceeding 2024 1,472,546 1,510,803 333(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 2024 368,137 377,701 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 2024 1,472,546 1,510,803 FDA Penalty for aggregate of all such above violations adjudicated in a single proceeding 2024 14,725,456 15,108,023 333(f)(9)(A) FDA Penalty for any person who violates a requirement which relates to tobacco products for each such violation 2024 21,348 21,903 FDA Penalty for aggregate of all such violations of tobacco product requirement adjudicated in a single proceeding 2024 1,423,220 1,460,195 333(f)(9)(B)(i)(I) FDA Penalty per violation related to violations of tobacco requirements 2024 355,806 365,050 FDA Penalty for aggregate of all such violations of tobacco product requirements adjudicated in a single proceeding 2024 1,423,220 1,460,195 333(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 2024 355,806 365,050 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 2024 1,423,220 1,460,195 FDA Penalty for aggregate of all such violations related to tobacco product requirements adjudicated in a single proceeding 2024 14,232,205 14,601,958 333(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 2024 355,806 365,050 FDA Penalty for aggregate of for all such above violations adjudicated in a single proceeding 2024 1,423,220 1,460,195 333(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 2024 355,806 365,050 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 2024 1,423,220 1,460,195 Penalty for aggregate above tobacco product requirement violations adjudicated in a single proceeding 2024 14,232,205 14,601,958 333(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 2024 368,137 377,701 Penalty for each subsequent above violation in any 3-year period 2024 736,274 755,402 333 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. 2024 356 365 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 2024 709 727 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 2024 2,846 2,920 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 2024 7,115 7,300 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 2024 14,232 14,602 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 2024 356 365 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 2024 709 727 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 2024 1,424 1,461 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 2024 2,846 2,920 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 2024 7,115 7,300 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 2024 14,232 14,602 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 2024 542,434 556,526 FDA Penalty in the case of any other person (other than an individual) per above violation 2024 2,169,731 2,226,101 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 2024 3,558 3,650 FDA Penalty imposed for any related series of violations of requirements relating to electronic products 2024 1,212,751 1,244,258 42 U.S.C 2024 262(d) FDA Penalty per day for violation of order of recall of biological product presenting imminent or substantial hazard 2024 278,937 286,184 263b(h)(3) FDA Penalty for failure to obtain a mammography certificate as required 2024 21,699 22,263 300aa-28(b)(1) FDA Penalty per occurrence for any vaccine manufacturer that intentionally destroys, alters, falsifies, or conceals any record or report required 2024 278,937 286,184 56b(d)(1)(B)(vi) HRSA Penalty for each instance of overcharging a 340B covered entity 2024 7,034 7,217 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 2024 18,291 18,766 653(l)(2) 45 CFR 303.21(f) ACF Penalty for Misuse of Information in the National Directory of New Hires 2024 1,877 1,926 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 2024 424,250 435,272 42 CFR 1003.1410 OIG Penalty for any other person who violates safety and security procedures related to handling dangerous biological agents and toxins 2024 848,505 870,549 300jj-51 OIG Penalty per violation for committing information blocking 2024 1,293,601 1,327,209 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 2024 24,947 25,595 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 2024 24,947 25,595 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 2024 37,421 38,393 42 CFR 1003.210(a)(3) OIG Penalty for an excluded party retaining ownership or control interest in a participating entity 2024 24,947 25,595 42 CFR 1003.1010 OIG Penalty for remuneration offered to induce program beneficiaries to use particular providers, practitioners, or suppliers 2024 24,947 25,595 42 CFR 1003.210(a)(4) OIG Penalty for employing or contracting with an excluded individual 2024 24,947 25,595 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 2024 124,732 127,973 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 2024 24,947 25,595 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 2024 124,732 127,973 42 CFR 1003.210(a)(8) OIG Penalty for knowing of an overpayment and failing to report and return 2024 24,947 25,595 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 2024 70,336 72,163 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 2024 37,421 38,393 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 2024 6,236 6,398 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 2024 6,236 6,398 42 CFR 1003.210(a)(10) OIG Penalty for a physician who executes a document that falsely certifies home health needs for Medicare beneficiaries 2024 12,473 12,797 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 2024 12,166 12,482 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 2024 60,831 62,411 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 2024 60,831 62,411 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 2024 63,450 65,098 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 2024 12,707 13,037 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 2024 18,250 18,724 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 2024 47,596 48,833 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 2024 12,799 13,132 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 2024 63,991 65,653 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 2024 2,670 2,739 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 2024 13,343 13,690 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 2024 5,339 5,478 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 2024 48,586 49,848 OIG Penalty for a Medicare Advantage organization that charges excessive premiums 2024 47,596 48,833 OIG Penalty for a Medicare Advantage organization that improperly expels or refuses to reenroll a beneficiary 2024 47,596 48,833 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 2024 190,389 195,335 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 2024 28,557 29,299 OIG Penalty for a Medicare Advantage organization misrepresenting or falsifying information to Secretary 2024 190,389 195,335 OIG Penalty for a Medicare Advantage organization misrepresenting or falsifying information to individual or other entity 2024 47,596 48,833 OIG Penalty for Medicare Advantage organization interfering with provider's advice to enrollee and non-MCO affiliated providers that balance bill enrollees 2024 47,596 48,833 OIG Penalty for a Medicare Advantage organization that employs or contracts with excluded individual or entity 2024 47,596 48,833 OIG Penalty for a Medicare Advantage organization enrolling an individual in without prior written consent 2024 47,596 48,833 OIG Penalty for a Medicare Advantage organization transferring an enrollee to another plan without consent or solely for the purpose of earning a commission 2024 47,596 48,833 OIG Penalty for a Medicare Advantage organization failing to comply with marketing restrictions or applicable implementing regulations or guidance 2024 47,596 48,833 OIG Penalty for a Medicare Advantage organization employing or contracting with an individual or entity who violates 1395w-27(g)(1)(A)-(J) 2024 47,596 48,833 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 2024 16,630 17,062 1395cc(g) 42 CFR 1003.210(a)(5) OIG Penalty for improper billing by Hospitals, Critical Access Hospitals, or Skilled Nursing Facilities 2024 6,469 6,637 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 2024 133,420 136,886 OIG Penalty for a hospital with less than 100 beds dumping patients needing emergency medical care 2024 66,712 68,445 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 2024 66,712 68,445 OIG Penalty for HMOs/competitive medical plans that charge premiums in excess of permitted amounts 2024 66,712 68,445 OIG Penalty for a HMO or competitive medical plan that expels or refuses to reenroll an individual per prescribed conditions 2024 66,712 68,445 OIG Penalty for a HMO or competitive medical plan that implements practices to discourage enrollment of individuals needing services in future 2024 266,841 273,774 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 2024 38,395 39,393 OIG Penalty for a HMO or competitive medical plan that misrepresents or falsifies information to the Secretary 2024 266,841 273,774 OIG Penalty for a HMO or competitive medical plan that misrepresents or falsifies information to an individual or any other entity 2024 66,712 68,445 OIG Penalty for failure by HMO or competitive medical plan to assure prompt payment of Medicare risk sharing contracts or incentive plan provisions 2024 66,712 68,445 OIG Penalty for HMO that employs or contracts with excluded individual or entity 2024 61,238 62,829 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 2024 30,868 31,670 1395nn(g)(4) 42 CFR 1003.310 OIG Penalty for circumvention schemes in violation of the Stark Law's restrictions on physician self-referrals 2024 205,799 211,146 1395ss(d)(1) 42 CFR 1003.1110 OIG Penalty for a material misrepresentation regarding Medigap compliance policies 2024 12,799 13,132 1395ss(d)(2) 42 CFR 1003.1110 OIG Penalty for selling Medigap policy under false pretense 2024 12,799 13,132 1395ss(d)(3)(A)(ii) 42 CFR 1003.1110 OIG Penalty for an issuer that sells health insurance policy that duplicates benefits 2024 57,617 59,114 OIG Penalty for someone other than issuer that sells health insurance that duplicates benefits 2024 34,568 35,466 1395ss(d)(4)(A) 42 CFR 1003.1110 OIG Penalty for using mail to sell a non-approved Medigap insurance policy 2024 12,799 13,132 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 2024 63,991 65,653 OIG Penalty for a Medicaid MCO that charges excessive premiums 2024 63,991 65,653 OIG Penalty for a Medicaid MCO that improperly expels or refuses to reenroll a beneficiary 2024 255,964 262,614 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 2024 38,395 39,393 OIG Penalty for a Medicaid MCO misrepresenting or falsifying information to the Secretary 2024 255,964 262,614 OIG Penalty for a Medicaid MCO misrepresenting or falsifying information to an individual or another entity 2024 63,991 65,653 OIG Penalty for a Medicaid MCO that fails to comply with contract requirements with respect to physician incentive plans 2024 57,617 59,114 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 2024 2,670 2,739 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 2024 13,343 13,690 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 2024 5,339 5,478 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 2024 230,464 236,451 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 2024 23,048 23,647 1396r-8(b)(3)(C)(ii) 42 CFR 1003.1210 OIG Penalty for knowing provision of false information by drug manufacturer with rebate agreement 2024 230,464 236,451 1396t(i)(3)(A) 42 CFR 1003.1310 OIG Penalty for notifying home and community-based providers or settings of survey 2024 4,610 4,730 11131(c) 42 CFR 1003.810 OIG Penalty for failing to report a medical malpractice claim to National Practitioner Data Bank 2024 27,894 28,619 11137(b)(2) 42 CFR 1003.810 OIG Penalty for breaching confidentiality of information reported to National Practitioner Data Bank 2024 27,894 28,619 299b-22(f)(1) 42 CFR 3.404 OCR Penalty for violation of confidentiality provision of the Patient Safety and Quality Improvement Act 2024 15,445 15,846 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 2024 193 198 OIG Calendar Year Cap 2024 48,586 49,848 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 2024 Minimum 2024 141 145 Maximum 2024 71,162 73,011 Calendar Year Cap 2024 2,134,831 2,190,294 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 2024 Minimum 2024 1,424 1,461 Maximum 2024 71,162 73,011 Calendar Year Cap 2024 2,134,831 2,190,294 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 2024 Minimum 2024 14,232 14,602 Maximum 2024 71,162 73,011 Calendar Year Cap 2024 2,134,831 2,190,294 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 2024 Minimum 2024 71,162 73,011 Maximum 2024 2,134,831 2,190,294 Calendar Year Cap 2024 2,134,831 2,190,294 290dd-2(f) 42 CFR 2.3(a) and

(c)OCR Penalty for each violation of a 42 CFR part 2 provision in which it is established that the person did not know and by exercising reasonable diligence, would not have known that the person violated such a provision 2024 Minimum 2024 100 103 Maximum 2024 50,000 51,299 Calendar Year Cap 2024 1,500,000 1,538,970 42 CFR 2.3(a) and

(c)OCR Penalty for each violation of a 42 CFR part 2 provision in which it is established that the violation was due to reasonable cause and not to willful neglect 2024 Minimum 2024 1,000 1,026 Maximum 2024 50,000 51,299 Calendar Year Cap 2024 1,500,000 1,538,970 42 CFR 2.3(a) and

(c)OCR Penalty for each violation of a 42 CFR part 2 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 person knew, or, by exercising reasonable diligence, would have known that the violation occurred 2024 Minimum 2024 10,000 10,260 Maximum 2024 50,000 51,299 Calendar Year Cap 2024 1,500,000 1,538,970 42 CFR 2.3(a) and

(c)OCR Penalty for each violation of a 42 CFR part 2 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 person knew, or, by exercising reasonable diligence, would have known that the violation occurred 2024 Minimum 2024 50,000 51,299 Maximum 2024 1,500,000 1,538,970 Calendar Year Cap 2024 1,500,000 1,538,970 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 2024 333 342 Per Day (Maximum) 2024 6,118 6,277 45 CFR 180.90(c)(2)(i) CMS Applicable solely to CY 2021 penalties, per day penalty for a hospital's noncompliance with making public standard charges for hospital items and services 2024 339 348 45 CFR 180.90(c)(2)(ii)(A) CMS Per day penalty for hospitals with equal to or less than 30 beds 2024 333 342 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 2024 11 11 45 CFR 180.90(c)(2)(ii)(C) CMS Per day penalty for hospitals having greater than 550 beds 2024 6,118 6,277 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 2024 Per Day (Maximum) 2024 N/A N/A 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 2024 Minimum 2024 7,807 8,010 Maximum 2024 25,597 26,262 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 2024 Minimum 2024 129 132 Maximum 2024 7,678 7,877 42 CFR 493.1834(d)(2)(iii) CMS Penalty for a clinical laboratory's failure to meet SARS-CoV-2 test reporting requirements 2024 First day of noncompliance 2024 Each additional day of noncompliance 2024 300gg-15(f) 45 CFR 147.200(e) CMS Failure to provide the Summary of Benefits and Coverage 2024 1,406 1,443 300gg-18 45 CFR 158.606 CMS Penalty for violations of regulations related to the medical loss ratio reporting and rebating 2024 140 144 45 CFR 180.70 CMS Penalty against hospital identified by CMS as noncompliant according to § 182.50 with respect to price transparency requirements regarding diagnostic tests for COVID-19 2024 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 2024 11,816 12,123 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 2024 Minimum 2024 1,406 1,443 Maximum 2024 14,067 14,432 Calendar Year Cap 2024 211,008 216,490 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 2024 Minimum 2024 14,067 14,432 Maximum 2024 140,674 144,329 Calendar Year Cap 2024 1,406,728 1,443,275 1320a-7j(h)(3)(A) CMS Maximum penalty for an administrator of a facility that fails to comply with notice requirements for the closure of a facility 2024 140,674 144,329 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 2024 703 721 Minimum penalty for the second offense of an administrator who fails to provide notice of facility closure 2024 2,111 2,166 Minimum penalty for the third and subsequent offenses of an administrator who fails to provide notice of facility closure 2024 4,219 4,329 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 2024 10,289 10,556 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 2024 9,704 9,956 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 2024 8,058 8,267 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 2024 281,346 288,655 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 2024 422,017 432,981 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 2024 281,346 288,655 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 2024 190 195 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 2024 Minimum 2024 133 136 Maximum 2024 8,003 8,211 42 CFR 488.408(d)(1)(iv) CMS Penalty per instance of Category 2 noncompliance by a Skilled Nursing Facility 2024 Minimum 2024 2,670 2,739 Maximum 2024 26,685 27,378 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 2024 Minimum 2024 8,140 8,351 Maximum 2024 26,685 27,378 42 CFR 488.408(e)(1)(iv) CMS Penalty per instance of Category 3 noncompliance by a Skilled Nursing Facility 2024 Minimum 2024 2,670 2,739 Maximum 2024 26,685 27,378 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 2024 0 Per Day (Minimum) 2024 8,140 8,351 Per Day (Maximum) 2024 26,685 27,378 Per Instance (Minimum) 2024 2,670 2,739 Per Instance (Maximum) 2024 26,685 27,378 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 2024 0 Minimum 2024 8,140 8,351 Maximum 2024 26,685 27,378 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 2024 0 Minimum 2024 133 136 Maximum 2024 8,003 8,211 42 CFR 488.438(a)(2) CMS Penalty per instance of a Skilled Nursing Facility that fails to meet certification requirements 2024 0 Minimum 2024 2,670 2,739 Maximum 2024 26,685 27,378 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)2024 First occurrence 2024 1,196 1,227 Incremental increases for each subsequent occurrence 2024 598 614 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. 2024 11,124 11,413 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 2024 11,124 11,413 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 2024 Minimum 2024 9,455 9,701 Maximum 2024 11,124 11,413 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 2024 11,124 11,413 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 2024 10,011 10,271 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 2024 9,455 9,701 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 2024 Minimum 2024 1,668 1,711 Maximum 2024 9,455 9,701 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 2024 Minimum 2024 556 570 Maximum 2024 4,450 4,566 42 CFR 488.1245(b)(6) CMS Penalty range imposed for per instance of hospice noncompliance 2024 Minimum 2024 1,112 1,141 Maximum 2024 11,124 11,413 42 CFR 488.1245(d)(1)(ii) CMS Penalty for each per instance of hospice noncompliance, maximum per day per hospice program 2024 11,124 11,413 2024 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)) 2024 19,435 19,940 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 2024 5,121 5,254 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 2024 4,899 5,026 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)) 2024 19,435 19,940 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)) 2024 19,435 19,940 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)) 2024 19,435 19,940 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)) 2024 19,435 19,940 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 2024 2,058 2,111 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)) 2024 19,435 19,940 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 2024 12,958 13,295 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)) 2024 19,435 19,940 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)) 2024 19,435 19,940 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)) 2024 19,435 19,940 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)) 2024 19,435 19,940 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)) 2024 19,435 19,940 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)) 2024 19,435 19,940 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)) 2024 19,435 19,940 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)) 2024 19,435 19,940 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)) 2024 19,435 19,940 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 2024 5,121 5,254 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 2024 16,630 17,062 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)) 2024 19,435 19,940 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)) 2024 19,435 19,940 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 2024 47,596 48,833 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 2024 19,040 19,535 1395w-27(g)(3)(D); 1857(g)(3): 1860D-12(b)(3)(E) CMS Penalty for a Medicare Advantage organization's or Part D sponsor's early termination of its contract 2024 176,807 181,400 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 2024 11,524 11,823 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 2024 1,877 1,926 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 2024 4,117 4,224 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 2024 1,474 1,512 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 2024 1,474 1,512 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 2024 24,496 25,132 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)) 2024 19,435 19,940 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 2024 66,711 68,444 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 2024 34,568 35,466 CMS Penalty for an issuer that sells or issues a Medicare supplemental policy without disclosure statement 2024 57,617 59,114 1395ss(d)(3)(B)(iv) CMS Penalty for someone other than issuer that sells or issues a Medicare supplemental policy without acknowledgement form 2024 34,568 35,466 CMS Penalty for issuer that sells or issues a Medicare supplemental policy without an acknowledgement form 2024 57,617 59,114 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 2024 34,568 35,466 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 2024 57,617 59,114 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 2024 34,568 35,466 42 CFR 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 2024 57,617 59,114 1395ss(q)(5)(C) 42 CFR 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 2024 57,617 59,114 1395ss(r)(6)(A) 42 CFR 402.105(f)(6) CMS Penalty for any person that fails to provide refunds or credits as required by section 1882(r)(1)(B) 2024 57,617 59,114 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 C2024 24,460 25,095 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 2024 57,617 59,114 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 2024 24,946 25,594 CMS Penalty for an issuer who sells, issues, or renews a Medigap Rx policy who is a Part D enrollee 2024 41,577 42,657 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 2024 5,339 5,478 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 2024 25,597 26,262 42 CFR 488.845(b)(3) CMS Penalty per day for home health agency's noncompliance (Upper Range) 2024 0 Minimum 2024 21,757 22,322 Maximum 2024 25,597 26,262 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 2024 25,597 26,262 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 2024 23,036 23,634 42 CFR 488.845(b)(3)(iii) CMS Penalty for an isolated incident of noncompliance in violation of established HHA policy 2024 21,757 22,322 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) 2024 0 Minimum 2024 3,841 3,941 Maximum 2024 21,757 22,322 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) 2024 0 Minimum 2024 1,280 1,313 Maximum 2024 2,559 2,625 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 2024 0 Penalty for each day of noncompliance (Minimum) 2024 2,559 2,625 Penalty for each day of noncompliance (Maximum) 2024 25,597 26,262 42 CFR 488.845(d)(1)(ii) CMS Penalty for each day of noncompliance (Maximum) 2024 25,597 26,262 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 2024 47,596 48,833 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 2024 Minimum 2024 17,933 18,399 Maximum 2024 119,555 122,661 CMS Penalty for a PACE organization that charges excessive premiums 2024 47,596 48,833 CMS Penalty for a PACE organization misrepresenting or falsifying information to CMS or the State 2024 190,389 195,335 CMS Penalty for any other violation specified in 42 CFR 460.40 2024 47,596 48,833 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 2024 0 Minimum 2024 133 136 Maximum 2024 8,003 8,211 42 CFR 488.408(d)(1)(iv) CMS Penalty per instance for a nursing facility's failure to meet Category 2 certification 2024 Minimum 2024 2,670 2,739 Maximum 2024 26,685 27,378 42 CFR 488.408(e)(1)(iii) CMS Penalty per day for a nursing facility's failure to meet Category 3 certification 2024 Minimum 2024 8,140 8,351 Maximum 2024 26,685 27,378 42 CFR 488.408(e)(1)(iv) CMS Penalty per instance for a nursing facility's failure to meet Category 3 certification 2024 0 Minimum 2024 2,670 2,739 Maximum 2024 26,685 27,378 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 2024 0 Minimum 2024 2,670 2,739 Maximum 2024 26,685 27,378 42 CFR 488.438(a)(1)(i) CMS Penalty per day for nursing facility's failure to meet certification (Upper Range) 2024 0 Minimum 2024 8,140 8,351 Maximum 2024 26,685 27,378 42 CFR 488.438(a)(1)(ii) CMS Penalty per day for nursing facility's failure to meet certification (Lower Range) 2024 0 Minimum 2024 133 136 Maximum 2024 8,003 8,211 42 CFR 488.438(a)(2) CMS Penalty per instance for nursing facility's failure to meet certification 2024 0 Minimum 2024 2,670 2,739 Maximum 2024 26,685 27,378 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)2024 First occurrence (Minimum) 2024 1,196 1,227 Incremental increases for each subsequent occurrence 2024 598 614 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] 2024 13,343 13,690 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] 2024 13,343 13,690 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 2024 0 Minimum 2024 2 2 Maximum 2024 23,048 23,647 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 2024 47,596 48,833 CMS Penalty for Medicaid managed care organization that imposes premiums or charges on enrollees in excess of the premiums or charges permitted 2024 47,596 48,833 CMS Penalty for a Medicaid managed care organization that misrepresents or falsifies information to another individual or entity 2024 47,596 48,833 CMS Penalty for a Medicaid managed care organization that fails to comply with the applicable statutory requirements for such organizations. 2024 47,596 48,833 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 2024 190,389 195,335 CMS Penalty for Medicaid managed care organization that acts to discriminate among enrollees on the basis of their health status 2024 190,389 195,335 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 2024 28,557 29,299 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 2024 26,685 27,378 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 2024 14,232 14,602 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 2024 193 198 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 2024 183 188 18081(h)(1)(A)(i)(II) 45 CFR 155.285 CMS Penalty for providing false information on Exchange application 2024 35,169 36,083 18081(h)(1)(B) 45 CFR 155.285 CMS Penalty for knowingly or willfully providing false information on Exchange application 2024 351,681 360,818 18081(h)(2) 45 CFR 155.260 CMS Penalty for knowingly or willfully disclosing protected information from Exchange 2024 0 CMS Maximum 2024 35,169 36,083 CMS Minimum 2024 359 368 18041(c)(2) 45 CFR 155.206(i) CMS Penalties for violation of applicable Exchange standards by consumer assistance entities in Federally-facilitated Exchanges 2024 43,128 44,248 Maximum (Per Day) 2024 119 122 31 U.S.C 45 CFR 93.400(e) HHS 2024 359 368 Penalty for the first time an individual makes an expenditure prohibited by regulations regarding lobbying disclosure, absent aggravating circumstances 2024 24,496 25,132 Penalty for second and subsequent offenses by individuals who make an expenditure prohibited by regulations regarding lobbying disclosure 2024 0 Minimum 2024 24,496 25,132 Maximum 2024 244,958 251,322 1352 HHS Penalty for the first time an individual fails to file or amend a lobbying disclosure form, absent aggravating circumstances 2024 24,496 25,132 Penalty for second and subsequent offenses by individuals who fail to file or amend a lobbying disclosure form, absent aggravating circumstances 2024 0 Minimum 2024 24,496 25,132 Maximum 2024 244,958 251,322 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 2024 0 Minimum 2024 24,496 25,132 Maximum 2024 244,958 251,322 HHS Penalty for failure to provide statement regarding lobbying for loan guarantee and loan insurance transactions 2024 0 Minimum 2024 24,496 25,132 Maximum 2024 244,958 251,322 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 2024 12,800 13,133 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 2024 12,800 13,133 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,* *M-24-07, and M-25-02* 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 2024 CPI-U (315.664) */* October 2023 CPI-U (307.671) = 1.02598. Robert F. Kennedy, Jr., Secretary, Department of Health and Human Services. [FR Doc. 2026-01688 Filed 1-27-26; 8:45 am]

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