2019-23955. Annual Civil Monetary Penalties Inflation Adjustment

AGENCY:

Office of the Assistant Secretary for Financial Resources, Department of Health and Human Services.

ACTION:

Final rule.

SUMMARY:

The Department of Health and Human Services is updating its regulations to reflect required annual inflation-related increases to the civil monetary penalties in its regulations, pursuant to the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 and is making a technical change to correct an error in the regulation.

DATES:

This rule is effective November 5, 2019.

FOR FURTHER INFORMATION CONTACT:

David Dasher, Deputy Assistant Secretary, Office of Acquisitions, Office of the Assistant Secretary for Financial Resources, Room 536-H, Hubert Humphrey Building, 200 Independence Avenue SW, Washington DC 20201; 202-205-0706.

SUPPLEMENTARY INFORMATION:

I. Background

The Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (Sec. 701 of Pub. L. 114-74) (the “2015 Act”) amended the Federal Civil Penalties Inflation Adjustment Act of 1990 (Pub. L. 101-410, 104 Stat. 890 (1990)), which is intended to improve the effectiveness of civil monetary penalties (CMPs) and to maintain the deterrent effect of such penalties, requires agencies to adjust the civil monetary penalties for inflation annually.

The Department of Health and Human Services (HHS) lists the civil monetary penalty authorities and the penalty amounts administered by all of its agencies in tabular form in 45 CFR 102.3, which was issued in an interim final rule published in the September 6, 2016 Federal Register (81 FR 61538). Annual adjustments were subsequently published on February 3, 2017 (82 FR 9175) and on October 11, 2018 (83 FR 51369).

II. Calculation of Adjustment

The annual inflation adjustment for each applicable civil monetary penalty is determined using the percent increase in the Consumer Price Index for all Urban Consumers (CPI-U) for the month of October of the year in which the amount of each civil penalty was most recently established or modified. In the December 14, 2018, Office of Management and Budget (OMB) Memorandum for the Heads of Executive Agencies and Departments, M-19-04, Implementation of the Penalty Inflation Adjustments for 2019, Pursuant to the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015, OMB published the multiplier for the required annual adjustment. The cost-of-living adjustment multiplier for 2019, based on the CPI-U for the month of October 2018, not seasonally adjusted, is 1.02522. The multiplier is applied to each applicable penalty amount that was updated and published for FY 2018 and is rounded to the nearest dollar.

Using the 2019 multiplier, HHS adjusted all its applicable monetary penalties in 45 CFR 102.3. In addition to the adjustment, a technical error for an incorrect citation in the description of 21 U.S.C. 333(f)(3)(A) was identified and is corrected below.

III. Statutory and Executive Order Reviews

The 2015 Act requires federal agencies to publish annual penalty inflation adjustments notwithstanding section 553 of the Administrative Procedure Act (APA).

Section 4(a) of the 2015 Act directs federal agencies to publish annual adjustments no later than January 15th of each year thereafter. In accordance with section 553 of the APA, most rules are subject to notice and comment and are effective no earlier than 30 days after publication in the Federal Register. However, section 4(b)(2) of the 2015 Act provides that each agency shall make the annual inflation adjustments “notwithstanding section 553” of the APA. According to OMB's Memorandum M-19-04, the phrase “notwithstanding section 553” in section 4(b)(2) of the 2015 Act means that “the public procedure the APA generally requires (i.e., notice, an opportunity for comment, and a delay in effective date) is not required for agencies to issue regulations implementing the annual adjustment.”

Consistent with the language of the 2015 Act and OMB's implementation guidance, this rule is not subject to notice and an opportunity for public comment and will be effective immediately upon publication.

Pursuant to OMB Memorandum M-19-04, HHS has determined that the annual inflation adjustment to the civil monetary penalties in its regulations does not trigger any requirements under procedural statutes and Executive Orders that govern rulemaking procedures.

IV. Effective Date

This rule is effective November 5, 2019. The adjusted civil monetary penalty amounts apply to penalties assessed on or after November 5, 2019, if the violation occurred on or after November 2, 2015. If the violation occurred prior to November 2, 2015, or a penalty was assessed prior to September 6, 2016, the pre-adjustment civil penalty amounts in effect prior to September 6, 2016, will apply.

List of Subjects in 45 CFR Part 102

• Administrative practice and procedure
• Penalties

For reasons discussed in the preamble, the Department of Health and Human Services amends 45 CFR part 102 as follows:

PART 102—ADJUSTMENT OF CIVIL MONETARY PENALTIES FOR INFLATION

1. The authority citation for part 102 continues to read as follows:

Authority: Public Law 101-410, Sec. 701 of Public Law 114-74, 31 U.S.C. 3801-3812.

2. Amend § 102.3 by revising the table to read as follows:

§ 102.3

Penalty adjustment and table.

* * * * *

Civil Monetary Penalty Authorities Administered by HHS Agencies and Penalty Amounts

[Effective November 5, 2019]

U.S.C.	CFR 1	HHS agency	Description 2	Date of last statutorily established penalty figure 3	2018 Maximum adjusted penalty ($)	2019 Maximum adjusted penalty ($) 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	2018	102,606	105,194
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	2018	2,052,107	2,103,861
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	2018	205,211	210,386
333(f)(1)(A)		FDA	Penalty for any person who violates a requirement related to devices for each such violation	2018	27,714	28,413
			Penalty for aggregate of all violations related to devices in a single proceeding	2018	1,847,663	1,894,261
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	2018	77,910	79,875
			Penalty in the case of any other person other than an individual) for such introduction or delivery of adulterated food	2018	389,550	399,374
			Penalty for aggregate of all such violations related to adulterated food adjudicated in a single proceeding	2018	779,098	798,747
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)	2018	11,805	12,103
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	2018	11,805	12,103
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)	2018	295,142	302,585
			Penalty for aggregate of all such above violations in a single proceeding	2018	1,180,566	1,210,340
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	2018	295,142	302,585
			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	2018	1,180,566	1,210,340
			Penalty for aggregate of all such above violations adjudicated in a single proceeding	2018	11,805,665	12,103,404
333(f)(9)(A)		FDA	Penalty for any person who violates a requirement which relates to tobacco products for each such violation	2018	17,115	17,547
			Penalty for aggregate of all such violations of tobacco product requirement adjudicated in a single proceeding	2018	1,141,021	1,169,798
333(f)(9)(B)(i)(I)		FDA	Penalty per violation related to violations of tobacco requirements	2018	285,256	292,450
			Penalty for aggregate of all such violations of tobacco product requirements adjudicated in a single proceeding	2018	1,141,021	1,169,798
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	2018	285,256	292,450
			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	2018	1,141,021	1,169,798
			Penalty for aggregate of all such violations related to tobacco product requirements adjudicated in a single proceeding	2018	11,410,217	11,697,983
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	2018	285,256	292,450
			Penalty for aggregate of for all such above violations adjudicated in a single proceeding	2018	1,141,021	1,169,798
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	2018	285,256	292,450
			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	2018	1,141,021	1,169,798
			Penalty for aggregate above tobacco product requirement violations adjudicated in a single proceeding	2018	11,410,217	11,697,983
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	2018	295,142	302,585
			Penalty for each subsequent above violation in any 3-year period	2018	590,284	605,171
333 note		FDA	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 with an approved training program in the case of a second regulation violation within a 12-month period	2018	284.69439	292
			Penalty in the case of a third tobacco product regulation violation within a 24-month period	2018	570.40919	584
			Penalty in the case of a fourth tobacco product regulation violation within a 24-month period	2018	2,282	2,340
			Penalty in the case of a fifth tobacco product regulation violation within a 36-month period	2018	5,705	5,849
			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 basis	2018	11,410	11,698
			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 violation	2018	284.69439	292
			Penalty in the case of a second tobacco product regulation violation within a 12-month period	2018	570.40919	584
			Penalty in the case of a third tobacco product regulation violation within a 24-month period	2018	1,141	1,170
			Penalty in the case of a fourth tobacco product regulation violation within a 24-month period	2018	2,282	2,340
			Penalty in the case of a fifth tobacco product regulation violation within a 36-month period	2018	5,705	5,849
			Penalty in the case of a fifth tobacco product regulation violation within a 36-month period	2018	5,705	5,849
			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 basis	2018	11,410	11,698
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	2018	434,878	445,846
			Penalty in the case of any other person (other than an individual) per above violation.	2018	1,739,513	1,783,384
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	2018	2,852	2,924
			Penalty imposed for any related series of violations of requirements relating to electronic products.	2018	972,285	996,806
42 U.S.C:
262(d)		FDA	Penalty per day for violation of order of recall of biological product presenting imminent or substantial hazard	2018	223,629	229,269
263b(h)(3)		FDA	Penalty for failure to obtain a mammography certificate as required	2018	17,395	17,834
300aa-28(b)(1)		FDA	Penalty per occurrence for any vaccine manufacturer that intentionally destroys, alters, falsifies, or conceals any record or report required	2018	223,629	229,269
256b(d)(1)(B)(vi)		HRSA	Penalty for each instance of overcharging a 340B covered entity	2018	5,639	5,781
299c-(3)(d)		AHRQ	Penalty for an establishment or person supplying information obtained in the course of activities for any purpose other than the purpose for which it was supplied	2018	14,664	15,034
653(l)(2)	45 CFR 303.21(f)	ACF	Penalty for Misuse of Information in the National Directory of New Hires	2018	1,504	1,542
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	2018	340,130	348,708
			Penalty for any other person who violates safety and security procedures related to handling dangerous biological agents and toxins	2018	680,262	697,418
300jj-51		OIG	Penalty per violation for committing information blocking	2018	1,037,104	1,063,260
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	2018	20,000	20,504
			Penalty for knowingly presenting or causing to be presented a request for payment which violates the terms of an assignment, agreement, or PPS agreement	2018	20,000	20,504
	42 CFR 1003.210(a)(2)		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	2018	30,000	30,757
	42 CFR 1003.210(a)(3)		Penalty for an excluded party retaining ownership or control interest in a participating entity	2018	20,000	20,504
	42 CFR 1003.1010		Penalty for remuneration offered to induce program beneficiaries to use particular providers, practitioners, or suppliers	2018	20,000	20,504
	42 CFR 1003.210(a)(4)		Penalty for employing or contracting with an excluded individual	2018	20,000	20,504
	42 CFR 1003.310(a)(3)		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	2018	100,000	102,522
	42 CFR 1003.210(a)(1)		Penalty for ordering or prescribing medical or other item or service during a period in which the person was excluded	2018	20,000	20,504
	42 CFR 1003.210(a)(6)		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	2018	100,000	102,522
	42 CFR 1003.210(a)(8)		Penalty for knowing of an overpayment and failing to report and return	2018	20,000	20,504
	42 CFR 1003.210(a)(7)		Penalty for making or using a false record or statement that is material to a false or fraudulent claim	2018	100,000	102,522
	42 CFR 1003.210(a)(9)		Penalty for failure to grant timely access to HHS OIG for audits, investigations, evaluations, and other statutory functions of HHS OIG	2018	30,000	30,757
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	2018	5,000	5,126
			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	2018	5,000	5,126
	42 CFR 1003.210(a)(10)		Penalty for a physician who executes a document that falsely certifies home health needs for Medicare beneficiaries	2018	10,000	10,252
1320a-7a(o)		OIG	Penalty for knowingly presenting or causing to be presented a false or fraudulent specified claim under a grant, contract, or other agreement for which the Secretary provides funding	2016	10,000	10,461
			Knowingly makes, uses, or causes to be made or used any false statement, omission, or misrepresentation of a material fact in any application, proposal, bid, progress report, or other document required to directly or indirectly receive or retain funds provided pursuant to grant, contract, or other agreement	2016	50,000	52,308
			Knowingly makes, uses, or causes to be made or used, a false record or statement material to a false or fraudulent specified claim under grant, contract, or other agreement	2016	50,000	52,308
			Knowingly makes, uses, or causes to be made or used, a false record or statement material to an obligation to pay or transmit funds or property with respect to grant, contract, or other agreement, or knowingly conceals or improperly avoids or decreases any such obligation.	2016	* 50,000	** 52,308
			Fails 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.	2016	15,000	15,692
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	2018	38,159	39,121
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	2018	10,260	10,519
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	2018	51,302	52,596
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	2018	2,140	2,194
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	2018	10,697	10,967
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	2018	4,280	4,388
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	2018	38,954	39,936
			Penalty for a Medicare Advantage organization that charges excessive premiums	2018	38,159	39,121
			Penalty for a Medicare Advantage organization that improperly expels or refuses to reenroll a beneficiary	2018	38,159	39,121
			Penalty for a Medicare Advantage organization that engages in practice that would reasonably be expected to have the effect of denying or discouraging enrollment	2018	152,638	156,488
			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	2018	22,896	23,473
			Penalty for a Medicare Advantage organization misrepresenting or falsifying information to Secretary	2018	152,638	156,488
			Penalty for a Medicare Advantage organization misrepresenting or falsifying information to individual or other entity	2018	38,159	39,121
			Penalty for Medicare Advantage organization interfering with provider's advice to enrollee and non-MCO affiliated providers that balance bill enrollees	2018	38,159	39,121
			Penalty for a Medicare Advantage organization that employs or contracts with excluded individual or entity	2018	38,159	39,121
			Penalty for a Medicare Advantage organization enrolling an individual in without prior written consent	2018	38,159	39,121
			Penalty for a Medicare Advantage organization transferring an enrollee to another plan without consent or solely for the purpose of earning a commission	2018	38,159	39,121
			Penalty for a Medicare Advantage organization failing to comply with marketing restrictions or applicable implementing regulations or guidance	2018	38,159	39,121
			Penalty for a Medicare Advantage organization employing or contracting with an individual or entity who violates 1395w-27(g)(1)(A)-(J)	2018	38,159	39,121
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	2018	13,333	13,669
1395cc(g)	42 CFR 1003.210(a)(5)	OIG	Penalty for improper billing by Hospitals, Critical Access Hospitals, or Skilled Nursing Facilities	2018	5,186	5,317
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	2018	106,965	109,663
			Penalty for a hospital with less than 100 beds dumping patients needing emergency medical care	2018	53,484	54,833
1395mm(i)(6)(B)(i)	42 CFR 1003.410	OIG	Penalty for a HMO or competitive plan if such plan substantially fails to provide medically necessary, required items or services	2018	53,484	54,833
			Penalty for HMOs/competitive medical plans that charge premiums in excess of permitted amounts	2018	53,484	54,833
			Penalty for a HMO or competitive medical plan that expels or refuses to reenroll an individual per prescribed conditions	2018	53,484	54,833
			Penalty for a HMO or competitive medical plan that implements practices to discourage enrollment of individuals needing services in future	2018	213,932	219,327
			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	2018	30,782	31,558
			Penalty for a HMO or competitive medical plan that misrepresents or falsifies information to the Secretary	2018	213,932	219,327
			Penalty for a HMO or competitive medical plan that misrepresents or falsifies information to an individual or any other entity	2018	53,484	54,833
			Penalty for failure by HMO or competitive medical plan to assure prompt payment of Medicare risk sharing contracts or incentive plan provisions	2018	53,484	54,833
			Penalty for HMO that employs or contracts with excluded individual or entity	2018	49,096	50,334
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	2018	24,748	25,372
1395nn(g)(4)	42 CFR 1003.310	OIG	Penalty for circumventing Stark Law's restrictions on physician self-referrals	2018	164,992	169,153
1395ss(d)(1)	42 CFR 1003.1110	OIG	Penalty for a material misrepresentation regarding Medigap compliance policies	2018	10,260	10,519
1395ss(d)(2)	42 CFR 1003.1110	OIG	Penalty for selling Medigap policy under false pretense	2018	10,260	10,519
1395ss(d)(3)(A)(ii)	42 CFR 1003.1110	OIG	Penalty for an issuer that sells health insurance policy that duplicates benefits	2018	46,192	47,357
			Penalty for someone other than issuer that sells health insurance that duplicates benefits	2018	27,714	28,413
1395ss(d)(4)(A)	42 CFR 1003.1110	OIG	Penalty for using mail to sell a non-approved Medigap insurance policy	2018	10,260	10,519
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	2018	51,302	52,596
			Penalty for a Medicaid MCO that charges excessive premiums	2018	51,302	52,596
			Penalty for a Medicaid MCO that improperly expels or refuses to reenroll a beneficiary	2018	205,211	210,386
			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	2018	30,782	31,558
			Penalty for a Medicaid MCO misrepresenting or falsifying information to the Secretary	2018	205,211	210,386
			Penalty for a Medicaid MCO misrepresenting or falsifying information to an individual or another entity	2018	51,302	52,596
			Penalty for a Medicaid MCO that fails to comply with contract requirements with respect to physician incentive plans	2018	46,192	47,357
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	2018	2,140	2,194
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	2018	10,697	10,967
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	2018	4,280	4,388
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	2018	184,767	189,427
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	2018	18,477	18,943
1396r-8(b)(3)(C)(ii)	42 CFR 1003.1210	OIG	Penalty for knowing provision of false information by drug manufacturer with rebate agreement	2018	184,767	189,427
1396t(i)(3)(A)	42 CFR 1003.1310	OIG	Penalty for notifying home and community-based providers or settings of survey	2018	3,695	3,788
11131(c)	42 CFR 1003.810	OIG	Penalty for failing to report a medical malpractice claim to National Practitioner Data Bank	2018	22,363	22,927
11137(b)(2)	42 CFR 1003.810	OIG	Penalty for breaching confidentiality of information reported to National Practitioner Data Bank	2018	22,363	22,927
299b-22(f)(1)	42 CFR 3.404	OCR	Penalty for violation of confidentiality provision of the Patient Safety and Quality Improvement Act	2018	12,383	12,695
	45 CFR 160.404(b)(1)(i), (ii)	OCR	Penalty for each pre-February 18, 2009 violation of the HIPAA administrative simplification provisions	2018	155.10232	159
			Calendar Year Cap	2018	38,954	39,936
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:	2018
			Minimum	2018	114.28592	117
			Maximum	2018	57,051	58,490
			Calendar Year Cap	2018	1,711,533	1,754,698
	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:	2018
			Minimum	2018	1,141	1,170
			Maximum	2018	57,051	58,490
			Calendar Year Cap	2018	1,711,533	1,754,698
	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:	2018
			Minimum	2018	11,410	11,698
			Maximum	2018	57,051	58,490
			Calendar Year Cap	2018	1,711,533	1,754,698
	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:	2018
			Minimum	2018	57,051	58,490
			Maximum	2018	1,711,533	1,754,698
			Calendar Year Cap	2018	1,711,533	1,754,698
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:	2018
			Minimum	2018	6,259	6,417
			Maximum	2018	20,521	21,039
	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:	2018
			Minimum	2018	103	106
			Maximum	2018	6,156	6,311
300gg-15(f)	45 CFR 147.200(e)	CMS	Failure to provide the Summary of Benefits and Coverage	2018	1,128	1,156
300gg-18	45 CFR 158.606	CMS	Penalty for violations of regulations related to the medical loss ratio reporting and rebating	2018	113	116
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:	2018
			Minimum	2018	1,128	1,156
			Maximum	2018	11,278	11,562
			Calendar Year Cap	2018	169,170	173,436
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:	2018
			Minimum	2018	11,278	11,562
			Maximum	2018	112,780	115,624
			Calendar Year Cap	2018	1,127,799	1,156,242
		CMS	Penalty for an administrator of a facility that fails to comply with notice requirements for the closure of a facility	2018	112,780	115,624
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	2018	564.28673	578
			Minimum penalty for the second offense of an administrator who fails to provide notice of facility closure	2018	1,692	1,735
			Minimum penalty for the third and subsequent offenses of an administrator who fails to provide notice of facility closure	2018	3,383	3,468
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	2018	8,249	8,457
			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	2018	7,779	7,975
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	2018	6,460	6,623
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	2018	225,560	231,249
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	2018	338,339	346,872
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	2018	225,560	231,249
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	2018	152	156
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:	2018
			Minimum	2018	107	110
			Maximum	2018	6,417	6,579
	42 CFR 488.408(d)(1)(iv)	CMS	Penalty per instance of Category 2 noncompliance by a Skilled Nursing Facility:	2018
			Minimum	2018	2,140	2,194
			Maximum	2018	21,393	21,933
	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:	2018
			Minimum	2018	6,525	6,690
			Maximum	2018	21,393	21,933
	42 CFR 488.408(e)(1)(iv)	CMS	Penalty per instance of Category 3 noncompliance by a Skilled Nursing Facility:	2018
			Minimum	2018	2,140	2,194
			Maximum	2018	21,393	21,933
	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:	2018
			Per Day (Minimum)	2018	6,525	6,690
			Per Day (Maximum)	2018	21,393	21,933
			Per Instance (Minimum)	2018	2,140	2,194
			Per Instance (Maximum)	2018	21,393	21,933
	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:	2018
			Minimum	2018	6,525	6,690
			Maximum	2018	21,393	21,933
	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:	2018
			Minimum	2018	107	110
			Maximum	2018	6,417	6,579
	42 CFR 488.438(a)(2)	CMS	Penalty per instance of a Skilled Nursing Facility that fails to meet certification requirements:	2018
			Minimum	2018	2,140	2,194
			Maximum	2018	21,393	21,933
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))	2018	15,582	15,975
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	2018	4,104	4,208
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	2018	3,928	4,027
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))	2018	15,582	15,975
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))	2018	15,582	15,975
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))	2018	15,582	15,975
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))	2018	15,582	15,975
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	2018	1,650	1,692
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))	2018	15,582	15,975
1395m(k)(6)	42 CFR 402.1(c)(31), 402.105(d)(3)	CMS	Penalty for any person or entity who knowingly and willfully bills or collects for any outpatient therapy services or comprehensive outpatient rehabilitation services on other than an assignment-related basis. (Penalties are assessed in the same manner as 42 U.S.C. 1395m(k)(6) and 1395u(j)(2)(B), which is assessed according to 1320a-7a(a))	2018	15,582	15,975
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))	2018	15,582	15,975
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))	2018	15,582	15,975
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))	2018	15,582	15,975
1395u(k)	42 CFR 402.1(c)(12), 402.105(d)(2)(ix)	CMS	Penalty for any physician who knowingly and willfully presents or causes to be presented a claim for bill for an assistant at a cataract surgery performed on or after March 1, 1987, for which payment may not be made because of section 1862(a)(15). (Penalties are assessed in the same manner as 42 U.S.C. 1395u(j)(2)(B), which is assessed according to 1320a-7a(a))	2018	15,582	15,975
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))	2018	15,582	15,975
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))	2018	15,582	15,975
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))	2018	15,582	15,975
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))	2018	15,582	15,975
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	2018	4,104	4,208
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	2018	13,333	13,669
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))	2018	15,582	15,975
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))	2018	15,582	15,975
1395w-27(g)(3)(A); 1857(g)(3) (A)	42 CFR 422.760(b)(1)-(2); 42 CFR 423.760(b)(1)-(2)	CMS	Penalty for each termination determination the Secretary makes that is the result of actions by a Medicare Advantage organization or Part D sponsor that has adversely affected an individual covered under the organization's contract	2018	38,159	39,121
1395w-27(g)(3)(B); 1857(g)(3)(B)	42 CFR 422.760(b)(3); 42 CFR 423.760(b)(3)	CMS	Penalty for each week beginning after the initiation of civil money penalty procedures by the Secretary because a Medicare Advantage organization or Part D sponsor has failed to carry out a contract, or has carried out a contract inconsistently with regulations	2018	15,264	15,649
1395w-27(g)(3)(D); 1857(g)(3)(D)		CMS	Penalty for a Medicare Advantage organization's or Part D sponsor's early termination of its contract	2018	141,760	145,335
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	2018	9,239	9,472
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	2018	1,504	1,542
1395y(b)(6)(B)	42 CFR 402.1(c)(21), 402.105(a)	CMS	Penalty for any entity that knowingly, willfully, and repeatedly fails to complete a claim form relating to the availability of other health benefits in accordance with statute or provides inaccurate information relating to such on the claim form	2018	3,300	3,383
1395y(b)(7)(B)(i)		CMS	Penalty for any entity serving as insurer, third party administrator, or fiduciary for a group health plan that fails to provide information that identifies situations where the group health plan is or was a primary plan to Medicare to the HHS Secretary	2018	1,181	1,211
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	2018	1,181	1,211
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	2018	19,639	20,134
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))	2018	15,582	15,975
1395ss(a)(2)	42 CFR 402.1(c)(24), 405.105(f)(1)	CMS	Penalty for any person that issues a Medicare supplemental policy that has not been approved by the State regulatory program or does not meet Federal standards after a statutorily defined effective date	2018	53,483	54,832
1395ss(d)(3)(A)(vi) (II)		CMS	Penalty for someone other than issuer that sells or issues a Medicare supplemental policy to beneficiary without a disclosure statement	2018	27,714	28,413
			Penalty for an issuer that sells or issues a Medicare supplemental policy without disclosure statement	2018	46,192	47,357
1395ss(d)(3)(B)(iv)		CMS	Penalty for someone other than issuer that sells or issues a Medicare supplemental policy without acknowledgement form	2018	27,714	28,413
			Penalty for issuer that sells or issues a Medicare supplemental policy without an acknowledgement form	2018	46,192	47,357
1395ss(p)(8)	42 CFR 402.1(c)(25), 402.105(e)	CMS	Penalty for any person that sells or issues Medicare supplemental polices after a given date that fail to conform to the NAIC or Federal standards established by statute	2018	27,714	28,413
	42 CFR 402.1(c)(25), 405.105(f)(2)	CMS	Penalty for any person that sells or issues Medicare supplemental polices after a given date that fail to conform to the NAIC or Federal standards established by statute	2018	46,192	47,357
1395ss(p)(9)(C)	42 CFR 402.1(c)(26), 402.105(e)	CMS	Penalty for any person that sells a Medicare supplemental policy and fails to make available for sale the core group of basic benefits when selling other Medicare supplemental policies with additional benefits or fails to provide the individual, before selling the policy, an outline of coverage describing benefits	2018	27,714	28,413
	42 CFR 402.1(c)(26), 405.105(f)(3), (4)		Penalty for any person that sells a Medicare supplemental policy and fails to make available for sale the core group of basic benefits when selling other Medicare supplemental policies with additional benefits or fails to provide the individual, before selling the policy, an outline of coverage describing benefits	2018	46,192	47,357
1395ss(q)(5)(C)	42 CFR 402.1(c)(27), 405.105(f)(5)	CMS	Penalty for any person that fails to suspend the policy of a policyholder made eligible for medical assistance or automatically reinstates the policy of a policyholder who has lost eligibility for medical assistance, under certain circumstances	2018	46,192	47,357
1395ss(r)(6)(A)	42 CFR 402.1(c)(28), 405.105(f)(6)	CMS	Penalty for any person that fails to provide refunds or credits as required by section 1882(r)(1)(B)	2018	46,192	47,357
1395ss(s)(4)	42 CFR 402.1(c)(29), 405.105(c)	CMS	Penalty for any issuer of a Medicare supplemental policy that does not waive listed time periods if they were already satisfied under a proceeding Medicare supplemental policy, or denies a policy, or conditions the issuances or effectiveness of the policy, or discriminates in the pricing of the policy base on health status or other specified criteria	2018	19,609	20,104
1395ss(t)(2)	42 CFR 402.1(c)(30), 405.105(f)(7)	CMS	Penalty for any issuer of a Medicare supplemental policy that fails to fulfill listed responsibilities	2018	46,192	47,357
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	2018	19,999	20,503
			Penalty for an issuer who sells, issues, or renews a Medigap Rx policy who is a Part D enrollee	2018	33,333	34,174
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	2018	4,280	4,388
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	2018	20,521	21,039
	42 CFR 488.845(b)(3)		Penalty per day for home health agency's noncompliance (Upper Range):	2018
			Minimum	2018	17,443	17,883
			Maximum	2018	20,521	21,039
	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 harm	2018	20,521	21,039
	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 harm	2018	18,468	18,934
	42 CFR 488.845(b)(3)(iii)		Penalty for an isolated incident of noncompliance in violation of established HHA policy	2018	17,443	17,883
	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):	2018
			Minimum	2018	3,079	3,157
			Maximum	2018	17,443	17,883
	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):	2018
			Minimum	2018	1,026	1,052
			Maximum	2018	8,208	8,415
	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:	2018
			Minimum	2018	2,052	2,104
			Maximum	2018	20,521	21,039
			Penalty for each day of noncompliance (Maximum)	2018	20,521	21,039
	42 CFR 488.845(d)(1)(ii)		Penalty for each day of noncompliance (Maximum)	2018	20,521	21,039
1396b(m)(5)(B)	42 CFR 460.46 (a)(1)	CMS	Penalty for discriminating or discouraging enrollment or disenrollment of participants on the basis of an individual's health status or need for health care services.	2018
	42 CFR 460.46 (a)(1)		Minimum	2018	22,896	23,473
	42 CFR 460.46 (a)(1)		Maximum	2018	152,638	156,488
	42 CFR 460.46 (a)(2)		Penalty for a PACE organization that charges excessive premiums.	2018	38,159	39,121
	42 CFR 460.46 (a)(3)		Penalty for a PACE organization misrepresenting or falsifying information to CMS, the State, or an individual or other entity.	2018	152,638	156,488
	42 CFR 460.46 (a)(4)		Penalty for each determination the CMS makes that the PACE organization has failed to provide medically necessary items and services of the failure has adversely affected (or has the substantial likelihood of adversely affecting) a PACE participant	2018	38,159	39,121
	42 CFR 460.46 (a)(4)		Penalty for involuntarily disenrolling a participant.	2018	38,159	39,121
	42 CFR 460.46 (a)(4)		Penalty for PACE organization's practice that would reasonably be expected to have the effect of denying or discouraging enrollment	2018	38,159	39,121
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:	2018
			Minimum	2018	107.14305	110
			Maximum	2018	6,417	6,579
	42 CFR 488.408(d)(1)(iv)	CMS	Penalty per instance for a nursing facility's failure to meet Category 2 certification:	2018
			Minimum	2018	2,140	2,194
			Maximum	2018	21,393	21,933
	42 CFR 488.408(e)(1)(iii)	CMS	Penalty per day for a nursing facility's failure to meet Category 3 certification:	2018
			Minimum	2018	6,525	6,690
			Maximum	2018	21,393	21,933
	42 CFR 488.408(e)(1)(iv)	CMS	Penalty per instance for a nursing facility's failure to meet Category 3 certification:	2018
			Minimum	2018	2,140	2,194
			Maximum	2018	21,393	21,933
	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:	2018
			Minimum	2018	2,140	2,194
			Maximum	2018	21,393	21,933
	42 CFR 488.438(a)(1)(i)	CMS	Penalty per day for nursing facility's failure to meet certification (Upper Range):	2018
			Minimum	2018	6,525	6,690
			Maximum	2018	21,393	21,933
	42 CFR 488.438(a)(1)(ii)	CMS	Penalty per day for nursing facility's failure to meet certification (Lower Range):	2018
			Minimum	2018	107.14305	110
			Maximum	2018	6,417	6,579
	42 CFR 488.438(a)(2)	CMS	Penalty per instance for nursing facility's failure to meet certification:	2018
			Minimum	2018	2,140	2,194
			Maximum	2018	21,393	21,933
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]	2018	10,697	10,967
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]	2018	10,697	10,967
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:	2018
			Minimum	2018	2	2
			Maximum	2018	18,477	18,943
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	2018	38,159	39,121
			Penalty for Medicaid managed care organization that imposes premiums or charges on enrollees in excess of the premiums or charges permitted	2018	38,159	39,121
			Penalty for a Medicaid managed care organization that misrepresents or falsifies information to another individual or entity	2018	38,159	39,121
			Penalty for a Medicaid managed care organization that fails to comply with the applicable statutory requirements for such organizations	2018	38,159	39,121
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	2018	152,638	156,488
			Penalty for Medicaid managed care organization that acts to discriminate among enrollees on the basis of their health status	2018	152,638	156,488
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	2018	22,896	23,473
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	2018	21,393	21,933
1396w-2(c)(1)		CMS	Penalty for disclosing information related to eligibility determinations for medical assistance programs	2018	11,410	11,698
18041(c)(2)	45 CFR 150.315; 45 CFR 156.805(c)	CMS	Failure to comply with requirements of the Public Health Services Act; Penalty for violations of rules or standards of behavior associated with issuer participation in the Federally-facilitated Exchange. (42 U.S.C. 300gg-22(b)(2)(C))	2018	155.10232	159
18081(h)(1)(A)(i)(II)	42 CFR 155.285	CMS	Penalty for providing false information on Exchange application	2018	28,195	28,906
18081(h)(1)(B)	42 CFR 155.285	CMS	Penalty for knowingly or willfully providing false information on Exchange application	2018	281,949	289,060
18081(h)(2)	42 CFR 155.260	CMS	Penalty for knowingly or willfully disclosing protected information from Exchange	2018	28,195	28,906
31 U.S.C.:
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	2018	19,639	20,134
			Penalty for second and subsequent offenses by individuals who make an expenditure prohibited by regulations regarding lobbying disclosure:	2018
			Minimum	2018	19,639	20,134
			Maximum	2018	196,387	201,340
			Penalty for the first time an individual fails to file or amend a lobbying disclosure form, absent aggravating circumstances	2018	19,639	20,134
			Penalty for second and subsequent offenses by individuals who fail to file or amend a lobbying disclosure form, absent aggravating circumstances:	2018
			Minimum	2018	19,639	20,134
			Maximum	2018	196,387	201,340
	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:	2018
			Minimum	2018	19,639	20,134
			Maximum	2018	196,387	201,340
			Penalty for failure to provide statement regarding lobbying for loan guarantee and loan insurance transactions:	2018
			Minimum	2018	19,639	20,134
			Maximum	2018	196,387	201,340
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	2018	10,261	10,520
	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 Department	2018	10,261	10,520
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 The cost of living multiplier for 2019, based on the CPI-U for the month of October 2018, not seasonally adjusted, is 1.02522, as indicated in OMB Memorandum M-19-04, “Implementation of Penalty Inflation Adjustments for 2018, Pursuant to the Federal Civil Penalties Adjustment Act Improvements Act of 2015” (December 14, 2018).
* For each false record or statement, 10,000 per day.
** For each false record statement, 10,461 per day.

Dated: October 28, 2019.

Alex M. Azar II,

Secretary, Department of Health and Human Services.