45 C.F.R. § 102.3
Current through October 31, 2024
The adjusted statutory penalty provisions and their applicable amounts are set out in the following table. The right-most column in the table, "Maximum Adjusted Penalty ($)", provides the maximum adjusted civil penalty amounts. The civil monetary penalty amounts are adjusted annually.
Table 1 to § 102.3 -Civil Monetary Penalty Authorities Administered by HHS
| U.S.C. section(s) | CFR1 | HHS agency | Description2 | Date of last penalty figure or adjustment3 | 2023 Maximum adjusted penalty ($) | 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 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 | 13,785 | 14,232 | |||
| Maximum | 2023 | 68,928 | 71,162 | |||
| Calendar Year Cap | 2023 | 2,067,813 | 2,134,831 | |||
| 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 | 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.
45 C.F.R. §102.3