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.

Civil Monetary Penalty Authorities Administered by HHS Agencies and Penalty Amounts[Effective September 6, 2016]Citation HHS agency Description 2 Date of last penalty figure or adjustment 3 Pre-inflation penalty ($) Maximum adjusted penalty ($) U.S.C. CFR 1 21 U.S.C.: 333(b)(2)(A)FDAPenalty for violations related to drug samples resulting in a conviction of any representative of manufacturer or distributor in any 10-year period198850,00098,935 333(b)(2)(B)FDAPenalty 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 period19881,000,0001,978,690 333(b)(3)FDAPenalty for failure to make a report required by 21 U.S.C. 353(d)(3)(E) relating to drug samples1988100,000197,869 333(f)(1)(A)FDAPenalty for any person who violates a requirement related to devices for each such violation199015,00026,723 Penalty for aggregate of all violations related to devices in a single proceeding19901,000,0001,781,560 333(f)(2)(A)FDAPenalty 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. 350l199650,00075,123 Penalty in the case of any other person other than an individual) for such introduction or delivery of adulterated food1996250,000375,613 Penalty for aggregate of all such violations related to adulterated food adjudicated in a single proceeding1996500,000751,225 333(f)(3)(A)FDAPenalty for all violations adjudicated in a single proceeding for any person who fails to submit certification required by 42 U.S.C. 282(j)(5)(B) or knowingly submitting a false certification200710,00011,383 333(f)(3)(B)FDAPenalty for each day the above violation is not corrected after a 30-day period following notification until the violation is corrected200710,00011,383 333(f)(4)(A)(i)FDAPenalty 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)2007250,000284,583 Penalty for aggregate of all such above violations in a single proceeding20071,000,0001,138,330 333(f)(4)(A)(ii)FDAPenalty 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 violation2007250,000284,583 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 period20071,000,0001,138,330 Penalty for aggregate of all such above violations adjudicated in a single proceeding200710,000,00011,383,300 333(f)(9)(A)FDAPenalty for any person who violates a requirement which relates to tobacco products for each such violation200915,00016,503 Penalty for aggregate of all such violations of tobacco product requirement adjudicated in a single proceeding20091,000,0001,100,200 333(f)(9)(B)(i)(I)FDAPenalty per violation related to violations of tobacco requirements2009250,000275,050 Penalty for aggregate of all such violations of tobacco product requirements adjudicated in a single proceeding20091,000,0001,100,200 333(f)(9)(B)(i)(II)FDAPenalty 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 violation2009250,000275,050 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 period20091,000,0001,100,200 Penalty for aggregate of all such violations related to tobacco product requirements adjudicated in a single proceeding200910,000,00011,002,000 333(f)(9)(B)(ii)(I)FDAPenalty 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 products2009250,000275,050 Penalty for aggregate of for all such above violations adjudicated in a single proceeding20091,000,0001,100,200 333(f)(9)(B)(ii)(II)FDAPenalty 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 violation2009250,000275,050 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 period20091,000,0001,100,200 Penalty for aggregate above tobacco product requirement violations adjudicated in a single proceeding200910,000,00011,002,000 333(g)(1)FDAPenalty 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 period2007250,000284,583 Penalty for each subsequent above violation in any 3-year period2007500,000569,165 333 noteFDAPenalty to be applied for 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 period2009250275 Penalty in the case of a third tobacco product regulation violation within a 24-month period2009500550 Penalty in the case of a fourth tobacco product regulation violation within a 24-month period20092,0002,200 Penalty in the case of a fifth tobacco product regulation violation within a 36-month period20095,0005,501 Penalty in the case of a sixth or subsequent tobacco product regulation violation within a 48-month period as determined on a case-by-case basis200910,00011,002 Penalty to be applied for 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 violation2009250275 Penalty in the case of a second tobacco product regulation violation within a 12-month period2009500550 Penalty in the case of a third tobacco product regulation violation within a 24-month period20091,0001,100 Penalty in the case of a fourth tobacco product regulation violation within a 24-month period20092,0002,200 Penalty in the case of a fifth tobacco product regulation violation within a 36-month period20095,0005,501 Penalty in the case of a sixth or subsequent tobacco product regulation violation within a 48-month period as determined on a case-by-case basis200910,00011,002 335b(a)FDAPenalty 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 services1992250,000419,320 Penalty in the case of any other person (other than an individual) per above violation19921,000,0001,677,280 360pp(b)(1)FDAPenalty for any person who violates any such requirements for electronic products, with each unlawful act or omission constituting a separate violation19681,1002,750 Penalty imposed for any related series of violations of requirements relating to electronic products1968375,000937,500 42 U.S.C.: 262(d)FDAPenalty per day for violation of order of recall of biological product presenting imminent or substantial hazard1986100,000215,628 263b(h)(3)FDAPenalty for failure to obtain a mammography certificate as required199210,00016,773 300aa-28(b)(1)FDAPenalty per occurrence for any vaccine manufacturer that intentionally destroys, alters, falsifies, or conceals any record or report required1986100,000215,628 256b(d)(1)(B)(vi)HRSAPenalty for each instance of overcharging a 340B covered entity20105,0005,437 299c-(3)(d)AHRQPenalty for an establishment or person supplying information obtained in the course of activities for any purpose other than the purpose for which it was supplied199910,00014,140 653(l)(2)45 CFR 303.21(f)ACFPenalty for Misuse of Information in the National Directory of New Hires19981,0001,450 262a(i)(1)42 CFR Part 1003OIGPenalty for each individual who violates safety and security procedures related to handling dangerous biological agents and toxins2002250,000327,962 Penalty for any other person who violates safety and security procedures related to handling dangerous biological agents and toxins.2002500,000655,925 1320a-7a(a)42 CFR Part 1003OIGPenalty for knowingly presenting or causing to be presented to an officer, employee, or agent of the United States a false claim199610,00015,024 Penalty for knowingly presenting or causing to be presented a request for payment which violates the terms of an assignment, agreement, or PPS agreement199610,00015,024 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 decision199615,00022,537 Penalty for an excluded party retaining ownership or control interest in a participating entity199610,00015,024 Penalty for remuneration offered to induce program beneficiaries to use particular providers, practitioners, or suppliers199610,00015,024 Penalty for employing or contracting with an excluded individual199710,00014,718 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 program199750,00073,588 Penalty for ordering or prescribing medical or other item or service during a period in which the person was excluded201010,00010,874 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 supplier201050,00054,372 Penalty for knowing of an overpayment and failing to report and return201010,00010,874 Penalty for making or using a false record or statement that is material to a false or fraudulent claim201050,00054,372 Penalty for failure to grant timely access to HHS OIG for audits, investigations, evaluations, and other statutory functions of HHS OIG201015,00016,312 1320a-7a(b)42 CFR Part 1003OIGPenalty 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 benefits19862,0004,313 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 benefits19862,0004,313 Penalty for a physician who executes a document that falsely certifies home health needs for Medicare beneficiaries19965,0007,512 1320a-7e(b)(6)(A)42 CFR Part 1003OIGPenalty for failure to report any final adverse action taken against a health care provider, supplier, or practitioner199725,00036,794 1320b-10(b)(1)42 CFR Part 1003OIGPenalty 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 HHS19885,0009,893 1320b-10(b)(2)42 CFR Part 1003OIGPenalty 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 HHS198825,00049,467 1395i-3(b)(3)(B)(ii)(1)OIGPenalty for certification of a false statement in assessment of functional capacity of a Skilled Nursing Facility resident assessment19871,0002,063 1395i-3(b)(3)(B)(ii)(2)OIGPenalty for causing another to certify or make a false statement in assessment of functional capacity of a Skilled Nursing Facility resident assessment19875,00010,314 1395i-3(g)(2)(A)OIGPenalty 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 conducted19872,0004,126 1395w-27(g)(2)(A)42 CFR 422.752; 42 CFR Part 1003OIGPenalty for a Medicare Advantage organization that substantially fails to provide medically necessary, required items and services199625,00037,561 Penalty for a Medicare Advantage organization that charges excessive premiums199725,00036,794 Penalty for a Medicare Advantage organization that improperly expels or refuses to reenroll a beneficiary199725,00036,794 Penalty for a Medicare Advantage organization that engages in practice that would reasonably be expected to have the effect of denying or discouraging enrollment1997100,000147,177 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 enrollment199715,00022,077 Penalty for a Medicare Advantage organization misrepresenting or falsifying information to Secretary1997100,000147,177 Penalty for a Medicare Advantage organization misrepresenting or falsifying information to individual or other entity199725,00036,794 Penalty for Medicare Advantage organization interfering with provider's advice to enrollee and non-MCO affiliated providers that balance bill enrollees199725,00036,794 Penalty for a Medicare Advantage organization that employs or contracts with excluded individual or entity199725,00036,794 Penalty for a Medicare Advantage organization enrolling an individual in without prior written consent201025,00036,794 Penalty for a Medicare Advantage organization transferring an enrollee to another plan without consent or solely for the purpose of earning a commission201025,00036,794 Penalty for a Medicare Advantage organization failing to comply with marketing restrictions or applicable implementing regulations or guidance201025,00036,794 Penalty for a Medicare Advantage organization employing or contracting with an individual or entity who violates 1395w-27(g)(1)(A)-(J)201025,00036,794 1395w-141(i)(3)42 CFR Part 1003OIGPenalty for a prescription drug card sponsor that falsifies or misrepresents marketing materials, overcharges program enrollees, or misuse transitional assistance funds200310,00012,856 1395cc(g)42 CFR Part 1003OIGPenalty for improper billing by Hospitals, Critical Access Hospitals, or Skilled Nursing Facilities19722,0005,000 1395dd(d)(1)42 CFR Part 1003OIGPenalty for a hospital or responsible physician dumping patients needing emergency medical care, if the hospital has 100 beds or more198750,000103,139 Penalty for a hospital or responsible physician dumping patients needing emergency medical care, if the hospital has less than 100 beds198725,00051,570 1395mm(i)(6)(B)(i)42 CFR Part 1003OIGPenalty for a HMO or competitive plan is such plan substantially fails to provide medically necessary, required items or services198725,00051,570 Penalty for HMOs/competitive medical plans that charge premiums in excess of permitted amounts198725,00051,570 Penalty for a HMO or competitive medical plan that expels or refuses to reenroll an individual per prescribed conditions198725,00051,570 Penalty for a HMO or competitive medical plan that implements practices to discourage enrollment of individuals needing services in future1987100,000206,278 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 future198815,00029,680 Penalty for a HMO or competitive medical plan that misrepresents or falsifies information to the Secretary1987100,000206,278 Penalty for a HMO or competitive medical plan that misrepresents or falsifies information to an individual or any other entity198725,00051,570 Penalty for failure by HMO or competitive medical plan to assure prompt payment of Medicare risk sharing contracts or incentive plan provisions198725,00051,570 Penalty for HMO that employs or contracts with excluded individual or entity198925,00047,340 1395nn(g)(3)42 CFR Part 1003OIGPenalty for submitting or causing to be submitted claims in violation of the Stark Law's restrictions on physician self-referrals199415,00023,863 1395nn(g)(4)42 CFR Part 1003OIGPenalty for circumventing Stark Law's restrictions on physician self-referrals1994100,000159,089 1395ss(d)(1)42 CFR Part 1003OIGPenalty for a material misrepresentation regarding Medigap compliance policies19885,0009,893 1395ss(d)(2)42 CFR Part 1003OIGPenalty for selling Medigap policy under false pretense19885,0009,893 1395ss(d)(3)(A)(ii)42 CFR Part 1003OIGPenalty for an issuer that sells health insurance policy that duplicates benefits199025,00044,539 Penalty for someone other than issuer that sells health insurance that duplicates benefits199015,00026,723 1395ss(d)(4)(A)42 CFR Part 1003OIGPenalty for using mail to sell a non-approved Medigap insurance policy19885,0009,893 1396b(m)(5)(B)(i)42 CFR Part 1003OIGPenalty for a Medicaid MCO that substantially fails to provide medically necessary, required items or services198825,00049,467 Penalty for a Medicaid MCO that charges excessive premiums198825,00049,467 Penalty for a Medicaid MCO that improperly expels or refuses to reenroll a beneficiary1988100,000197,869 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 enrollment198815,00029,680 Penalty for a Medicaid MCO misrepresenting or falsifying information to the Secretary1988100,000197,869 Penalty for a Medicaid MCO misrepresenting or falsifying information to an individual or another entity198825,00049,467 Penalty for a Medicaid MCO that fails to comply with contract requirements with respect to physician incentive plans199025,00044,539 1396r(b)(3)(B)(ii)(I)42 CFR Part 1003OIGPenalty for willfully and knowingly certifying a material and false statement in a Skilled Nursing Facility resident assessment19871,0002,063 1396r(b)(3)(B)(ii)(II)42 CFR Part 1003OIGPenalty for willfully and knowingly causing another individual to certify a material and false statement in a Skilled Nursing Facility resident assessment19875,00010,314 1396r(g)(2)(A)(i)42 CFR Part 1003OIGPenalty for notifying or causing to be notified a Skilled Nursing Facility of the time or date on which a survey is to be conducted19872,0004,126 1396r-8(b)(3)(B)42 CFR Part 1003OIGPenalty for the knowing provision of false information or refusing to provide information about charges or prices of a covered outpatient drug1990100,000178,156 1396r-8(b)(3)(C)(i)42 CFR Part 1003Penalty per day for failure to timely provide information by drug manufacturer with rebate agreement199010,00017,816 1396r-8(b)(3)(C)(ii)42 CFR Part 1003Penalty for knowing provision of false information by drug manufacturer with rebate agreement1990100,000178,156 1396t(i)(3)(A)42 CFR Part 1003OIGPenalty for notifying home and community-based providers or settings of survey19902,0003,563 11131(c)42 CFR Part 1003OIGPenalty for failing to report a medical malpractice claim to National Practitioner Data Bank198610,00021,563 11137(b)(2)42 CFR Part 1003OIGPenalty for breaching confidentiality of information reported to National Practitioner Data Bank198610,00021,563 299b-22(f)(1)42 CFR 3.404OCRPenalty for violation of confidentiality provision of the Patient Safety and Quality Improvement Act200510,00011,940 1320(d)-5(a)45 CFR 160.404(b)(1)(i),(ii)OCRPenalty for each pre-February 18, 2009 violation of the HIPAA administrative simplification provisions1996100150 Calendar Year Cap199625,00037,561 1320(d)-5(a)45 CFR 160.404(b)(2)(i)(A), (B)OCRPenalty 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: Minimum2009100110 Maximum200950,00055,010 Calendar Year Cap20091,500,0001,650,300 45 CFR 160.404(b)(2)(ii)(A), (B)OCRPenalty 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: Minimum20091,0001,100 Maximum200950,00055,010 Calendar Year Cap20091,500,0001,650,300 45 CFR 160.404(b)(2)(iii)(A), (B)OCRPenalty 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: Minimum200910,00011,002 Maximum200950,00055,010 Calendar Year Cap20091,500,0001,650,300 45 CFR 160.404(b)(2)(iv)(A), (B)OCRPenalty 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: Minimum200950,00055,010 Maximum20091,500,0001,650,300 Calendar Year Cap20091,500,0001,650,300 263a(h)(2)(B) & 1395w-2(b)(2)(A)(ii)42 CFR 493.1834(d)(2)(i)CMSPenalty for a clinical laboratory's failure to meet participation and certification requirements and poses immediate jeopardy: Minimum19883,0506,035 Maximum198810,00019,787 42 CFR 493.1834(d)(2)(ii)CMSPenalty for a clinical laboratory's failure to meet participation and certification requirements and the failure does not pose immediate jeopardy: Minimum19885099 Maximum19883,0005,936 300gg-15(f)45 CFR 147.200(e)CMSFailure to provide the Summary of Benefits and Coverage20101,0001,087 300gg-1845 CFR 158.606CMSPenalty for violations of regulations related to the medical loss ratio reporting and rebating2010100109 1320a-7h(b)(1)42 CFR 402.105(d)(5); 42 CFR 403.912(a) & (c)CMSPenalty 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: Minimum20101,0001,087 Maximum201010,00010,874 Calendar Year Cap2010150,000163,117 1320a-7h(b)(2)42 CFR 402.105(h); 42 CFR 403 912(b) & (c)CMSPenalty 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: Minimum201010,00010,874 Maximum2010100,000108,745 Calendar Year Cap20101,000,0001,087,450 1320a-7j(h)(3)(A)CMSPenalty for an administrator of a facility that fails to comply with notice requirements for the closure of a facility2010100,000108,745 42 CFR 488.446(a)(1),(2), & (3)CMSMinimum penalty for the first offense of an administrator who fails to provide notice of facility closure2010500544 Minimum penalty for the second offense of an administrator who fails to provide notice of facility closure20101,5001,631 Minimum penalty for the third and subsequent offenses of an administrator who fails to provide notice of facility closure20103,0003,262 1320a-8(a)(1)CMSPenalty 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 disabled19945,0007,954 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 determination20157,5007,500 1320a-8(a)(3)CMSPenalty 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 beneficiary20045,0006,229 1320b-25(c)(1)(A)CMSPenalty 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 facility2010200,000217,490 1320b-25(c)(2)(A)CMSPenalty 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 individual2010300,000326,235 1320b-25(d)(2)CMSPenalty 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 nurse2010200,000217,490 1395b-7(b)(2)(B)42 CFR 402.105(g)CMSPenalty 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 request1997100147 1395i-3(h)(2)(B)(ii)(I)42 CFR 488.408(d)(1)(iii)CMSPenalty per day for a Skilled Nursing Facility that has a Category 2 violation of certification requirements: Minimum198750103 Maximum19873,0006,188 42 CFR 488.408(d)(1)(iv)CMSPenalty per instance of Category 2 noncompliance by a Skilled Nursing Facility: Minimum19871,0002,063 Maximum198710,00020,628 42 CFR 488.408(e)(1)(iii)CMSPenalty per day for a Skilled Nursing Facility that has a Category 3 violation of certification requirements: Minimum19873,0506,291 Maximum198710,00020,628 42 CFR 488.408(e)(1)(iv)CMSPenalty per instance of Category 3 noncompliance by a Skilled Nursing Facility: Minimum19871,0002,063 Maximum198710,00020,628 42 CFR 488.408(e)(2)(ii)CMSPenalty per day and per instance for a Skilled Nursing Facility that has Category 3 noncompliance with Immediate Jeopardy: Per Day (Minimum)19873,0506,291 Per Day (Maximum)198710,00020,628 Per Instance (Minimum)19871,0002,063 Per Instance (Maximum)198710,00020,628 42 CFR 488.438(a)(1)(i)CMSPenalty per day of a Skilled Nursing Facility that fails to meet certification requirements. These amounts represent the upper range per day: Minimum19873,0506,291 Maximum198710,00020,628 42 CFR 488.438(a)(1)(ii)CMSPenalty per day of a Skilled Nursing Facility that fails to meet certification requirements. These amounts represent the lower range per day: Minimum198750103 Maximum19873,0006,188 42 CFR 488.438(a)(2)CMSPenalty per instance of a Skilled Nursing Facility that fails to meet certification requirements: Minimum19871,0002,063 Maximum198710,00020,628 1395l(h)(5)(D)42 CFR 402.105(d)(2)(i)CMSPenalty 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))199610,00015,024 1395l(i)(6)CMSPenalty 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 involved19882,0003,957 1395l(q)(2)(B)(i)42 CFR 402.105(a)CMSPenalty for knowingly and willfully failing to provide information about a referring physician when seeking payment on an unassigned basis19892,0003,787 1395m(a)(11)(A)42 CFR 402.1(c)(4), 402.105(d)(2)(ii)CMSPenalty 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))199610,00015,024 1395m(a)(18)(B)42 CFR 402.1(c)(5), 402.105(d)(2)(iii)CMSPenalty 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))199610,00015,024 1395m(b)(5)(C)42 CFR 402.1(c)(6), 402.105(d)(2)(iv)CMSPenalty 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))199610,00015,024 1395m(h)(3)42 CFR 402.1(c)(8), 402.105(d)(2)(vi)CMSPenalty 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))199610,00015,024 1395m(j)(2)(A)(iii)CMSPenalty 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 Act19941,0001,591 1395m(j)(4)42 CFR 402.1(c)(10), 402.105(d)(2)(vii)CMSPenalty 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))199610,00015,024 1395m(k)(6)42 CFR 402.1(c)(31), 402.105(d)(3)CMSPenalty 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))199610,00015,024 1395m(l)(6)42 CFR 402.1(c)(32), 402.105(d)(4)CMSPenalty 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))199610,00015,024 1395u(b)(18)(B)42 CFR 402.1(c)(11), 402.105(d)(2)(viii)CMSPenalty 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))199610,00015,024 1395u(j)(2)(B)42 CFR 402.1(c)CMSPenalty 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))199610,00015,024 1395u(k)42 CFR 402.1(c)(12), 402.105(d)(2)(ix)CMSPenalty 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))199610,00015,024 1395u(l)(3)42 CFR 402.1(c)(13), 402.105(d)(2)(x)CMSPenalty 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))199610,00015,024 1395u(m)(3)42 CFR 402.1(c)(14), 402.105(d)(2)(xi)CMSPenalty 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))199610,00015,024 1395u(n)(3)42 CFR 402.1(c)(15), 402.105(d)(2)(xii)CMSPenalty 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))199610,00015,024 1395u(o)(3)(B)42 CFR 414.707(b)CMSPenalty 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))199610,00015,024 1395u(p)(3)(A)CMSPenalty 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 basis19882,0003,957 1395w-3a(d)(4)(A)42 CFR 414.806CMSPenalty for a pharmaceutical manufacturer's misrepresentation of average sales price of a drug, or biologic200310,00012,856 1395w-4(g)(1)(B)42 CFR 402.1(c)(17), 402.105(d)(2)(xiii)CMSPenalty 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))199610,00015,024 1395w-4(g)(3)(B)42 CFR 402.1(c)(18), 402.105(d)(2)(xiv)CMSPenalty 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))199610,00015,024 1395w-27(g)(3)(A); 1857(g)(3)42 CFR 422.760(b); 42 CFR 423.760(b)CMSPenalty for each termination determination the Secretary makes that is the result of actions by a Medicare Advantage organization or Part D sponsor that has adversely affected an individual covered under the organization's contract199725,00036,794 1395w-27(g)(3)(B); 1857(g)(3)CMSPenalty 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 regulations199710,00014,718 1395w-27(g)(3)(D); 1857(g)(3)CMSPenalty for a Medicare Advantage organization's or Part D sponsor's early termination of its contract2000100,000136,689 1395y(b)(3)(C)42 CFR 411.103(b)CMSPenalty 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 plan19905,0008,908 1395y(b)(5)(C)(ii)42 CFR 402.1(c)(20); 42 CFR 402.105(b)(2)CMSPenalty 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 coverage19981,0001,450 1395y(b)(6)(B)42 CFR 402.1(c)(21), 402.105(a)CMSPenalty 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 form19942,0003,182 1395y(b)(7)(B)(i)CMSPenalty 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 Secretary20071,0001,138 1395y(b)(8)(E)CMSPenalty 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 claim20071,0001,138 1395nn(g)(5)42 CFR 411.361CMSPenalty for any person that fails to report information required by HHS under Section 1877(f) concerning ownership, investment, and compensation arrangements198910,00018,936 1395pp(h)42 CFR 402.1(c)(23), 402.105(d)(2)(xv)CMSPenalty 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))199610,00015,024 1395ss(a)(2)42 CFR 402.1(c)(24), 405.105(f)(1)CMSPenalty 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 date198725,00051,569 1395ss(d)(3)(A)(vi)(II)CMSPenalty for someone other than issuer that sells or issues a Medicare supplemental policy to beneficiary without a disclosure statement199015,00026,723 Penalty for an issuer that sells or issues a Medicare supplemental policy without disclosure statement199025,00044,539 1395ss(d)(3)(B)(iv)CMSPenalty for someone other than issuer that sells or issues a Medicare supplemental policy without acknowledgement form199015,00026,723 Penalty for issuer that sells or issues a Medicare supplemental policy without an acknowledgement form199025,00044,539 1395ss(p)(8)42 CFR 402.1(c)(25), 402.105(e)CMSPenalty for any person that sells or issues Medicare supplemental polices after a given date that fail to conform to the NAIC or Federal standards established by statute199015,00026,723 42 CFR 402.1(c)(25), 405.105(f)(2)CMSPenalty for any person that sells or issues Medicare supplemental polices after a given date that fail to conform to the NAIC or Federal standards established by statute199025,00044,539 1395ss(p)(9)(C)42 CFR 402.1(c)(26), 402.105(e)CMSPenalty for any person that sells a Medicare supplemental policy and fails to make available for sale the core group of basic benefits when selling other Medicare supplemental policies with additional benefits or fails to provide the individual, before selling the policy, an outline of coverage describing benefits199015,00026,723 42 CFR 402.1(c)(26), 405.105(f)(3), (4)Penalty for any person that sells a Medicare supplemental policy and fails to make available for sale the core group of basic benefits when selling other Medicare supplemental policies with additional benefits or fails to provide the individual, before selling the policy, an outline of coverage describing benefits199025,00044,539 1395ss(q)(5)(C)42 CFR 402.1(c)(27), 405.105(f)(5)CMSPenalty 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 circumstances199025,00044,539 1395ss(r)(6)(A)42 CFR 402.1(c)(28), 405.105(f)(6)CMSPenalty for any person that fails to provide refunds or credits as required by section 1882(r)(1)(B)199025,00044,539 1395ss(s)(4)42 CFR 402.1(c)(29), 405.105(c)CMSPenalty 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 criteria19905,00018,908 1395ss(t)(2)42 CFR 402.1(c)(30), 405.105(f)(7)CMSPenalty for any issuer of a Medicare supplemental policy that fails to fulfill listed responsibilities199025,00044,539 1395ss(v)(4)(A)CMSPenalty someone other than issuer who sells, issues, or renews a medigap Rx policy to an individual who is a Part D enrollee200315,00019,284 Penalty for an issuer who sells, issues, or renews a Medigap Rx policy who is a Part D enrollee200325,00032,140 1395bbb(c)(1)42 CFR 488.725(c)CMSPenalty 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 conducted19872,0004,126 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)CMSMaximum daily penalty amount for each day a home health agency is not in compliance with statutory requirements198810,00019,787 42 CFR 488.845(b)(3)Penalty per day for home health agency's noncompliance (Upper Range): Minimum19888,50016,819 Maximum198810,00019,787 42 CFR 488.845(b)(3)(i)Penalty for a home health agency's deficiency or deficiencies that cause immediate jeopardy and result in actual harm198810,00019,787 42 CFR 488.845(b)(3)(ii)Penalty for a home health agency's deficiency or deficiencies that cause immediate jeopardy and result in potential for harm19889,00017,808 42 CFR 488.845(b)(3)(iii)Penalty for an isolated incident of noncompliance in violation of established HHA policy19888,50016,819 42 CFR 488.845(b)(4)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): Minimum19881,5002,968 Maximum19888,50016,819 42 CFR 488.845(b)(5)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): Minimum1988500989 Maximum19884,0007,915 42 CFR 488.845(b)(6)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: Minimum19881,0001,979 Maximum198810,00019,787 Penalty for each day of noncompliance (Maximum)198810,00019,787 42 CFR 488.845(d)(1)(ii)Penalty for each day of noncompliance (Maximum)198810,00019,787 1396b(m)(5)(B)42 CFR 460.46CMSPenalty for PACE organization's practice that would reasonably be expected to have the effect of denying or discouraging enrollment: Minimum199715,00022,077 Maximum1997100,000147,177 Penalty for a PACE organization that charges excessive premiums199725,00036,794 Penalty for a PACE organization misrepresenting or falsifying information to CMS, the State, or an individual or other entity1997100,000147,177 Penalty for each determination the CMS makes that the PACE organization has failed to provide medically necessary items and services of the failure has adversely affected (or has the substantial likelihood of adversely affecting) a PACE participant199725,00036,794 Penalty for involuntarily disenrolling a participant199725,00036,794 Penalty for discriminating or discouraging enrollment or disenrollment of participants on the basis of an individual's health status or need for health care services199725,00036,794 1396r(h)(3)(C)(ii)(I)42 CFR 488.408(d)(1)(iii)CMSPenalty per day for a nursing facility's failure to meet a Category 2 Certification: Minimum198750103 Maximum19873,0006,188 42 CFR 488.408(d)(1)(iv)CMSPenalty per instance for a nursing facility's failure to meet Category 2 certification: Minimum19871,0002,063 Maximum198710,00020,628 42 CFR 488.408(e)(1)(iii)CMSPenalty per day for a nursing facility's failure to meet Category 3 certification: Minimum19873,0506,291 Maximum198710,00020,628 42 CFR 488.408(e)(1)(iv)CMSPenalty per instance for a nursing facility's failure to meet Category 3 certification:2,063 Minimum19871,00020,628 Maximum198710,000 42 CFR 488.408(e)(2)(ii)CMSPenalty per instance for a nursing facility's failure to meet Category 3 certification, which results in immediate jeopardy:2,063 Minimum19871,00020,628 Maximum198710,000 42 CFR 488.438(a)(1)(i)CMSPenalty per day for nursing facility's failure to meet certification (Upper Range):6,291 Minimum19873,05020,628 Maximum198710,0002,063 42 CFR 488.438(a)(1)(ii)CMSPenalty per day for nursing facility's failure to meet certification (Lower Range): Minimum198750103 Maximum19873,0006,188 42 CFR 488.438(a)(2)CMSPenalty per instance for nursing facility's failure to meet certification: Minimum19871,0002,063 Maximum198710,00020,628 1396r(f)(2)(B)(iii)(I)(c)42 CFR 483.151(b)(2)(iv) and (b)(3)(iii)CMSGrounds 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]19875,00010,314 1396r(h)(3)(C)(ii)(I)42 CFR 483.151(c)(2)CMSGrounds 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]19875,00010,314 1396t(j)(2)(C)CMSPenalty for each day of noncompliance for a home or community care provider that no longer meets the minimum requirements for home and community care: Minimum199012 Maximum199010,00017,816 1396u-2(e)(2)(A)(i)42 CFR 438.704CMSPenalty for a Medicaid managed care organization that fails substantially to provide medically necessary items and services199725,00036,794 Penalty for Medicaid managed care organization that imposes premiums or charges on enrollees in excess of the premiums or charges permitted199725,00036,794 Penalty for a Medicaid managed care organization that misrepresents or falsifies information to another individual or entity199725,00036,794 Penalty for a Medicaid managed care organization that fails to comply with the applicable statutory requirements for such organizations199725,00036,794 1396u-2(e)(2)(A)(ii)42 CFR 438.704CMSPenalty for a Medicaid managed care organization that misrepresents or falsifies information to the HHS Secretary1997100,000147,177 Penalty for Medicaid managed care organization that acts to discriminate among enrollees on the basis of their health status1997100,000147,177 1396u-2(e)(2)(A)(iv)42 CFR 438.704CMSPenalty 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 status199715,00022,077 1396u(h)(2)42 CFR 441, Subpart ICMSPenalty 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 services199010,00020,628 1396w-2(c)(1)CMSPenalty for disclosing information related to eligibility determinations for medical assistance programs200910,00011,002 18041(c)(2)45 CFR 150.315; 45 CFR 156.805(c)CMSFailure to comply with requirements of the Public Health Services Act; Penalty for violations of rules or standards of behavior associated with issuer participation in the Federally-facilitated Exchange. (42 U.S.C. 300gg-22(b)(2)(C))1996100150 18081(h)(1)(A)(i)(II)42 CFR 155.285CMSPenalty for providing false information on Exchange application201025,00027,186 18081(h)(1)(B)42 CFR 155.285CMSPenalty for knowingly or willfully providing false information on Exchange application2010250,000271,862 18081(h)(2)42 CFR 155.260CMSPenalty for knowingly or willfully disclosing protected information from Exchange201025,00027,186 31 U.S.C.: 135245 CFR 93.400(e)HHSPenalty for the first time an individual makes an expenditure prohibited by regulations regarding lobbying disclosure, absent aggravating circumstances198910,00018,936 Penalty for second and subsequent offenses by individuals who make an expenditure prohibited by regulations regarding lobbying disclosure: Minimum198910,00018,936 Maximum1989100,000189,361 Penalty for the first time an individual fails to file or amend a lobbying disclosure form, absent aggravating circumstances198910,00018,936 Penalty for second and subsequent offenses by individuals who fail to file or amend a lobbying disclosure form, absent aggravating circumstances: Minimum198910,00018,936 Maximum1989100,000189,361 45 CFR 93, Appendix AHHSPenalty for failure to provide certification regarding lobbying in the award documents for all sub-awards of all tiers: Minimum198910,00018,936 Maximum1989100,000189,361 Penalty for failure to provide statement regarding lobbying for loan guarantee and loan insurance transactions: Minimum198910,00018,936 Maximum1989100,000189,361 3801-381245 CFR 79.3(a)(1)(iv)HHSPenalty against any individual who - with knowledge or reason to know - makes, presents or submits a false, fictitious or fraudulent claim to the Department19885,0009,894 45 CFR 79.3(b)(1(ii)Penalty against any individual who - with knowledge or reason to know - makes, presents or submits a false, fictitious or fraudulent claim to the Department19885,0009,894 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 non-Inflation Act Adjustment.