83 FR 51369 - Annual Civil Monetary Penalties Inflation Adjustment
DEPARTMENT OF HEALTH AND HUMAN SERVICES Federal Register Volume 83, Issue 197 (October 11, 2018)
Federal Register Volume 83, Issue 197 (October 11, 2018)
| Page Range | 51369-51390 | |
| FR Document | 2018-22005 |
[Federal Register Volume 83, Number 197 (Thursday, October 11, 2018)] [Rules and Regulations] [Pages 51369-51390] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-22005] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES 45 CFR Part 102 RIN 0991-AC0 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. DATES: This rule is effective October 11, 2018. FOR FURTHER INFORMATION CONTACT: Shaunta Johnson, Office of Grants and Acquisition Policy and Accountability, Office of the Assistant Secretary for Financial Resources, Room 514-G, Hubert Humphrey Building, 200 Independence Avenue SW, Washington, DC 20201; 202-690- 6396; FAX 202-690-5405. 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''), 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. 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 15, 2017, Office of Management and Budget (OMB) Memorandum for the Heads of Executive Agencies and Departments, M-18-03, Implementation of the Penalty Inflation Adjustments for 2018, 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 2018, based on the CPI-U for the month of October 2017, not seasonally adjusted, is 1.02041. Using the 2018 multiplier, HHS adjusted all its applicable monetary penalties in 45 CFR 102.3. 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-18-03, the phrase ``notwithstanding section 553'' means that ``the public procedure the APA generally requires--notice, an opportunity for comment, and a delay in effective date--is not required for agencies to issue regulations implementing the annual adjustment.'' Consistent with the language of the 2015 Act and OMB's implementation guidance, 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-18-03, 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 October 11 2018. The adjusted civil monetary penalty amounts apply to penalties assessed on or after October 11, 2018, 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 [[Page 51370]] 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 subtitle A, title 45 of the Code of Federal Regulations as follows: PART 102--ADJUSTMENT OF CIVIL MONETARY PENALTIES FOR INFLATION 0 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. 0 2. Amend Sec. 102.3 by revising the table to read as follows: Sec. 102.3 Penalty adjustment and table. * * * * * Civil Monetary Penalty Authorities Administered by HHS Agencies and Penalty Amounts [Effective October 11, 2018] -------------------------------------------------------------------------------------------------------------------------------------------------------- Citation Date of ---------------------------------------------------------- last 2016 2017 2018 statutorily Maximum Maximum Maximum HHS agency Description \2\ established adjusted adjusted adjusted U.S.C. CFR \1\ penalty penalty ($) penalty ($) penalty ($) figure \3\ \4\ -------------------------------------------------------------------------------------------------------------------------------------------------------- 21 U.S.C. -------------------------------------------------------------------------------------------------------------------------------------------------------- 333(b)(2)(A)...................... ..................... FDA Penalty for 2016 98,935 100,554 102,606 violations related to drug samples resulting in a conviction of any representative of manufacturer or distributor in any 10-year period. 333(b)(2)(B)...................... ..................... FDA Penalty for 2016 1,978,690 2,011,061 2,052,107 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. 333(b)(3)......................... ..................... FDA Penalty for failure 2016 197,869 201,106 205,211 to make a report required by 21 U.S.C. 353(d)(3)(E) relating to drug samples. 333(f)(1)(A)...................... ..................... FDA Penalty for any 2016 26,723 27,160 27,714 person who violates a requirement related to devices for each such violation. Penalty for 2016 1,781,560 1,810,706 1,847,663 aggregate of all violations related to devices in a single proceeding. 333(f)(2)(A)...................... ..................... FDA Penalty for any 2016 75,123 76,352 77,910 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. Penalty in the case 2016 375,613 381,758 389,550 of any other person other than an individual) for such introduction or delivery of adulterated food. Penalty for 2016 751,225 763,515 779,098 aggregate of all such violations related to adulterated food adjudicated in a single proceeding. 333(f)(3)(A)...................... ..................... FDA Penalty for all 2016 11,383 11,569 11,805 violations adjudicated in a single proceeding for any person who violates 21 U.S.C. 331(jj)(1) 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). 333(f)(3)(B)...................... ..................... FDA Penalty for each day 2016 11,383 11,569 11,805 any above violation is not corrected after a 30-day period following notification until the violation is corrected. 333(f)(4)(A)(i)................... ..................... FDA Penalty for any 2016 284,583 289,239 295,142 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). [[Page 51371]] Penalty for 2016 1,138,330 1,156,953 1,180,566 aggregate of all such above violations in a single proceeding. 333(f)(4)(A)(ii).................. FDA Penalty for REMS 2016 284,583 289,239 295,142 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. Penalty for REMS 2016 1,138,330 1,156,953 1,180,566 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. Penalty for 2016 11,383,300 11,569,531 11,805,665 aggregate of all such above violations adjudicated in a single proceeding. 333(f)(9)(A)...................... ..................... FDA Penalty for any 2016 16,503 16,773 17,115 person who violates a requirement which relates to tobacco products for each such violation. Penalty for 2016 1,100,200 1,118,199 1,141,021 aggregate of all such violations of tobacco product requirement adjudicated in a single proceeding. 333(f)(9)(B)(i)(I)................ FDA Penalty per 2016 275,050 279,550 285,256 violation related to violations of tobacco requirements. Penalty for 2016 1,100,200 1,118,199 1,141,021 aggregate of all such violations of tobacco product requirements adjudicated in a single proceeding. 333(f)(9)(B)(i)(II)............... ..................... FDA Penalty in the case 2016 275,050 279,550 285,256 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. Penalty for 2016 1,100,200 1,118,199 1,141,021 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. Penalty for 2016 11,002,000 11,181,993 11,410,218 aggregate of all such violations related to tobacco product requirements adjudicated in a single proceeding. 333(f)(9)(B)(ii)(I)............... ..................... FDA Penalty for any 2016 275,050 279,550 285,256 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. Penalty for 2016 1,100,200 1,118,199 1,141,021 aggregate of for all such above violations adjudicated in a single proceeding. 333(f)(9)(B)(ii)(II).............. ..................... FDA Penalty for 2016 275,050 279,550 285,256 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. [[Page 51372]] Penalty for post- 2016 1,100,200 1,118,199 1,141,021 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. Penalty for 2016 11,002,000 11,181,993 11,410,218 aggregate above tobacco product requirement violations adjudicated in a single proceeding. 333(g)(1)......................... ..................... FDA Penalty for any 2016 284,583 289,239 295,142 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. Penalty for each 2016 569,165 578,477 590,284 subsequent above violation in any 3- year period. 333 note.......................... ..................... FDA Penalty to be 2016 275 279 285 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. Penalty in the case 2016 550 559 570 of a third tobacco product regulation violation within a 24-month period. Penalty in the case 2016 2,200 2,236 2,282 of a fourth tobacco product regulation violation within a 24-month period. Penalty in the case 2016 5,501 5,591 5,705 of a fifth tobacco product regulation violation within a 36-month period. Penalty in the case 2016 11,002 11,182 11,410 of a sixth or subsequent tobacco product regulation violation within a 48-month period as determined on a case-by-case basis. Penalty to be 2016 275 279 285 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. Penalty in the case 2016 550 559 570 of a second tobacco product regulation violation within a 12-month period. Penalty in the case 2016 1,100 1,118 1,141 of a third tobacco product regulation violation within a 24-month period. Penalty in the case 2016 2,200 2,236 2,282 of a fourth tobacco product regulation violation within a 24-month period. Penalty in the case 2016 5,501 5,591 5,705 of a fifth tobacco product regulation violation within a 36-month period. Penalty in the case 2016 11,002 11,182 11,410 of a sixth or subsequent tobacco product regulation violation within a 48-month period as determined on a case-by-case basis. [[Page 51373]] 335b(a)........................... ..................... FDA Penalty for each 2016 419,320 426,180 434,878 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. Penalty in the case 2016 1,677,280 1,704,720 1,739,513 of any other person (other than an individual) per above violation. 360pp(b)(1)....................... ..................... FDA Penalty for any 2016 2,750 2,795 2,852 person who violates any such requirements for electronic products, with each unlawful act or omission constituting a separate violation. Penalty imposed for 2016 937,500 952,838 972,285 any related series of violations of requirements relating to electronic products. -------------------------------------------------------------------------------------------------------------------------------------------------------- 42 U.S.C. -------------------------------------------------------------------------------------------------------------------------------------------------------- 262(d)............................ ..................... FDA Penalty per day for 2016 215,628 219,156 223,629 violation of order of recall of biological product presenting imminent or substantial hazard. 263b(h)(3)........................ ..................... FDA Penalty for failure 2016 16,773 17,047 17,395 to obtain a mammography certificate as required. 300aa-28(b)(1).................... ..................... FDA Penalty per 2016 215,628 219,156 223,629 occurrence for any vaccine manufacturer that intentionally destroys, alters, falsifies, or conceals any record or report required. 256b(d)(1)(B)(vi)................. ..................... HRSA Penalty for each 2016 5,437 5,526 5,639 instance of overcharging a 340B covered entity. 299c-3(d)......................... ..................... AHRQ Penalty for an 2016 14,140 14,371 14,664 establishment or person supplying information obtained in the course of activities for any purpose other than the purpose for which it was supplied. 653(l)(2)......................... 45 CFR 303.21(f)..... ACF Penalty for Misuse 2016 1,450 1,474 1,504 of Information in the National Directory of New Hires. 262a(i)(1)........................ 42 CFR 1003.910...... OIG Penalty for each 2016 327,962 333,327 340,130 individual who violates safety and security procedures related to handling dangerous biological agents and toxins. Penalty for any 2016 655,925 666,656 680,262 other person who violates safety and security procedures related to handling dangerous biological agents and toxins. 300jj-51.......................... ..................... OIG Penalty per 2016 1,000,000 1,016,360 1,037,104 violation for committing information blocking. 1320a-7a(a) \5\................... 42 CFR 1003.210(a)(1) OIG Penalty for 2018 15,024 15,270 20,000 knowingly presenting or causing to be presented to an officer, employee, or agent of the United States a false claim. Penalty for 2018 15,024 15,270 20,000 knowingly presenting or causing to be presented a request for payment which violates the terms of an assignment, agreement, or PPS agreement. 42 CFR 1003.210(a)(2) ................... Penalty for 2018 22,537 22,906 30,000 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. [[Page 51374]] 42 CFR 1003.210(a)(3) ................... Penalty for an 2018 15,024 15,270 20,000 excluded party retaining ownership or control interest in a participating entity. 42 CFR 1003.1010..... ................... Penalty for 2018 15,024 15,270 20,000 remuneration offered to induce program beneficiaries to use particular providers, practitioners, or suppliers. 42 CFR 1003.210(a)(4) ................... Penalty for 2018 14,718 14,959 20,000 employing or contracting with an excluded individual. 42 CFR 1003.310(a)(3) ................... Penalty for knowing 2018 73,588 74,792 100,000 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. 42 CFR 1003.210(a)(1) ................... Penalty for ordering 2018 10,874 11,052 20,000 or prescribing medical or other item or service during a period in which the person was excluded. 42 CFR 1003.210(a)(6) ................... Penalty for 2018 54,372 55,262 100,000 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. 42 CFR 1003.210(a)(8) ................... Penalty for knowing 2018 10,874 11,052 20,000 of an overpayment and failing to report and return. 42 CFR 1003.210(a)(7) ................... Penalty for making 2018 54,372 55,262 100,000 or using a false record or statement that is material to a false or fraudulent claim. 42 CFR 1003.210(a)(9) ................... Penalty for failure 2018 16,312 16,579 30,000 to grant timely access to HHS OIG for audits, investigations, evaluations, and other statutory functions of HHS OIG. 1320a-7a(b) \5\................... ..................... OIG Penalty for payments 2018 4,313 4,384 5,000 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. ..................... ................... Penalty for 2018 4,313 4,384 5,000 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. 42 CFR ................... Penalty for a 2018 7,512 7,635 10,000 1003.210(a)(10). physician who executes a document that falsely certifies home health needs for Medicare beneficiaries. 1320a-7e(b)(6)(A)................. 42 CFR 1003.810...... OIG Penalty for failure 2016 36,794 37,396 38,159 to report any final adverse action taken against a health care provider, supplier, or practitioner. 1320b-10(b)(1).................... 42 CFR 1003.610(a)... OIG Penalty for the 2016 9,893 10,055 10,260 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. 1320b-10(b)(2).................... 42 CFR 1003.610(a)... OIG Penalty for the 2016 49,467 50,276 51,302 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. [[Page 51375]] 1395i-3(b)(3)(B)(ii)(1)........... 42 CFR OIG Penalty for 2016 2,063 2,097 2,140 1003.210(a)(11). certification of a false statement in assessment of functional capacity of a Skilled Nursing Facility resident assessment. 1395i-3(b)(3)(B)(ii)(2)........... 42 CFR OIG Penalty for causing 2016 10,314 10,483 10,697 1003.210(a)(11). another to certify or make a false statement in assessment of functional capacity of a Skilled Nursing Facility resident assessment. 1395i-3(g)(2)(A).................. 42 CFR 1003.1310..... OIG Penalty for any 2016 4,126 4,194 4,280 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. 1395w-27(g)(2)(A)................. 42 CFR 1003.410...... OIG Penalty for a 2016 37,561 38,175 38,954 Medicare Advantage organization that substantially fails to provide medically necessary, required items and services. ................... Penalty for a 2016 36,794 37,396 38,159 Medicare Advantage organization that charges excessive premiums. Penalty for a 2016 36,794 37,396 38,159 Medicare Advantage organization that improperly expels or refuses to reenroll a beneficiary. Penalty for a 2016 147,177 149,585 152,638 Medicare Advantage organization that engages in practice that would reasonably be expected to have the effect of denying or discouraging enrollment. Penalty per 2016 22,077 22,438 22,896 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. Penalty for a 2016 147,177 149,585 152,638 Medicare Advantage organization misrepresenting or falsifying information to Secretary. Penalty for a 2016 36,794 37,396 38,159 Medicare Advantage organization misrepresenting or falsifying information to individual or other entity. Penalty for Medicare 2016 36,794 37,396 38,159 Advantage organization interfering with provider's advice to enrollee and non- MCO affiliated providers that balance bill enrollees. Penalty for a 2016 36,794 37,396 38,159 Medicare Advantage organization that employs or contracts with excluded individual or entity. Penalty for a 2016 36,794 37,396 38,159 Medicare Advantage organization enrolling an individual in without prior written consent. Penalty for a 2016 36,794 37,396 38,159 Medicare Advantage organization transferring an enrollee to another plan without consent or solely for the purpose of earning a commission. Penalty for a 2016 36,794 37,396 38,159 Medicare Advantage organization failing to comply with marketing restrictions or applicable implementing regulations or guidance. Penalty for a 2016 36,794 37,396 38,159 Medicare Advantage organization employing or contracting with an individual or entity who violates 1395w-27(g)(1)(A)-( J). [[Page 51376]] 1395w-141(i)(3)................... OIG Penalty for a 2016 12,856 13,066 13,333 prescription drug card sponsor that falsifies or misrepresents marketing materials, overcharges program enrollees, or misuse transitional assistance funds. 1395cc(g)......................... OIG Penalty for improper 2016 5,000 5,082 5,186 billing by Hospitals, Critical Access Hospitals, or Skilled Nursing Facilities. 1395dd(d)(1)...................... 42 CFR 1003.510...... OIG Penalty for a 2016 103,139 104,826 106,965 hospital or responsible physician dumping patients needing emergency medical care, if the hospital has 100 beds or more. Penalty for a 2016 51,570 52,414 53,484 hospital or responsible physician dumping patients needing emergency medical care, if the hospital has less than 100 beds. 1395mm(i)(6)(B)(i)................ 42 CFR 1003.410...... OIG Penalty for a HMO or 2016 51,570 52,414 53,484 competitive plan is such plan substantially fails to provide medically necessary, required items or services. Penalty for HMOs/ 2016 51,570 52,414 53,484 competitive medical plans that charge premiums in excess of permitted amounts. Penalty for a HMO or 2016 51,570 52,414 53,484 competitive medical plan that expels or refuses to reenroll an individual per prescribed conditions. Penalty for a HMO or 2016 206,278 209,653 213,932 competitive medical plan that implements practices to discourage enrollment of individuals needing services in future. Penalty per 2016 29,680 30,166 30,782 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. Penalty for a HMO or 2016 206,278 209,653 213,932 competitive medical plan that misrepresents or falsifies information to the Secretary. Penalty for a HMO or 2016 51,570 52,414 53,484 competitive medical plan that misrepresents or falsifies information to an individual or any other entity. Penalty for failure 2016 51,570 52,414 53,484 by HMO or competitive medical plan to assure prompt payment of Medicare risk sharing contracts or incentive plan provisions. Penalty for HMO that 2016 47,340 48,114 49,096 employs or contracts with excluded individual or entity. 1395nn(g)(3)...................... 42 CFR 1003.310...... OIG Penalty for 2016 23,863 24,253 24,748 submitting or causing to be submitted claims in violation of the Stark Law's restrictions on physician self- referrals. 1395nn(g)(4)...................... 42 CFR 1003.310...... OIG Penalty for 2016 159,089 161,692 164,992 circumventing Stark Law's restrictions on physician self- referrals. 1395ss(d)(1)...................... 42 CFR 1003.1110..... OIG Penalty for a 2016 9,893 10,055 10,260 material misrepresentation regarding Medigap compliance policies. 1395ss(d)(2)...................... 42 CFR 1003.1110..... OIG Penalty for selling 2016 9,893 10,055 10,260 Medigap policy under false pretense. 1395ss(d)(3)(A)(ii)............... 42 CFR 1003.1110..... OIG Penalty for an 2016 44,539 45,268 46,192 issuer that sells health insurance policy that duplicates benefits. Penalty for someone 2016 26,723 27,160 27,714 other than issuer that sells health insurance that duplicates benefits. [[Page 51377]] 1395ss(d)(4)(A)................... 42 CFR 1003.1110..... OIG Penalty for using 2016 9,893 10,055 10,260 mail to sell a non- approved Medigap insurance policy. 1396b(m)(5)(B)(i)................. 42 CFR 1003.410...... OIG Penalty for a 2016 49,467 50,276 51,302 Medicaid MCO that substantially fails to provide medically necessary, required items or services. Penalty for a 2016 49,467 50,276 51,302 Medicaid MCO that charges excessive premiums. Penalty for a 2016 197,869 201,106 205,211 Medicaid MCO that improperly expels or refuses to reenroll a beneficiary. Penalty per 2016 29,680 30,166 30,782 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. Penalty for a 2016 197,869 201,106 205,211 Medicaid MCO misrepresenting or falsifying information to the Secretary. Penalty for a 2016 49,467 50,276 51,302 Medicaid MCO misrepresenting or falsifying information to an individual or another entity. Penalty for a 2016 44,539 45,268 46,192 Medicaid MCO that fails to comply with contract requirements with respect to physician incentive plans. 1396r(b)(3)(B)(ii)(I)............. 42 CFR OIG Penalty for 2016 2,063 2,097 2,140 1003.210(a)(11). willfully and knowingly certifying a material and false statement in a Skilled Nursing Facility resident assessment. 1396r(b)(3)(B)(ii)(II)............ 42 CFR OIG Penalty for 2016 10,314 10,483 10,697 1003.210(a)(11). willfully and knowingly causing another individual to certify a material and false statement in a Skilled Nursing Facility resident assessment. 1396r(g)(2)(A)(i)................. 42 CFR 1003.1310..... OIG Penalty for 2016 4,126 4,194 4,280 notifying or causing to be notified a Skilled Nursing Facility of the time or date on which a survey is to be conducted. 1396r-8(b)(3)(B).................. 42 CFR 1003.1210..... OIG Penalty for the 2016 178,156 181,071 184,767 knowing provision of false information or refusing to provide information about charges or prices of a covered outpatient drug. 1396r-8(b)(3)(C)(i)............... 42 CFR 1003.1210..... OIG Penalty per day for 2016 17,816 18,107 18,477 failure to timely provide information by drug manufacturer with rebate agreement. 1396r-8(b)(3)(C)(ii).............. 42 CFR 1003.1210..... OIG Penalty for knowing 2016 178,156 181,071 184,767 provision of false information by drug manufacturer with rebate agreement. 1396t(i)(3)(A).................... 42 CFR 1003.1310..... OIG Penalty for 2016 3,563 3,621 3,695 notifying home and community-based providers or settings of survey. 11131(c).......................... 42 CFR 1003.810...... OIG Penalty for failing 2016 21,563 21,916 22,363 to report a medical malpractice claim to National Practitioner Data Bank. 11137(b)(2)....................... 42 CFR 1003.810...... OIG Penalty for 2016 21,563 21,916 22,363 breaching confidentiality of information reported to National Practitioner Data Bank. 299b-22(f)(1)..................... 42 CFR 3.404......... OCR Penalty for 2016 11,940 12,135 12,383 violation of confidentiality provision of the Patient Safety and Quality Improvement Act. 1320(d)-5(a)...................... 45 CFR OCR Penalty for each pre- 2016 150 152 155 160.404(b)(1)(i), February 18, 2009 (ii). violation of the HIPAA administrative simplification provisions. Calendar Year Cap... 2016 37,561 38,175 38,954 [[Page 51378]] 45 CFR OCR Penalty for each ........... ........... ........... ........... 160.404(b)(2)(i)(A), February 18, 2009 (B). 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. Minimum............. 2016 110 112 114 Maximum............. 2016 55,010 55,910 57,051 Calendar Year Cap... 2016 1,650,300 1,677,299 1,711,533 45 CFR OCR Penalty for each ........... ........... ........... ........... 160.404(b)(2)(ii)(A) February 18, 2009 , (B). 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. Minimum............. 2016 1,100 1,118 1,141 Maximum............. 2016 55,010 55,910 57,051 Calendar Year Cap... 2016 1,650,300 1,677,299 1,711,533 45 CFR OCR Penalty for each ........... ........... ........... ........... 160.404(b)(2)(iii)(A February 18, 2009 ), (B). 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. Minimum............. 2016 11,002 11,182 11,410 Maximum............. 2016 55,010 55,910 57,051 Calendar Year Cap... 2016 1,650,300 1,677,299 1,711,533 45 CFR OCR Penalty for each ........... ........... ........... ........... 160.404(b)(2)(iv)(A) February 18, 2009 , (B). 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. Minimum............. 2016 55,010 55,910 57,051 Maximum............. 2016 1,650,300 1,677,299 1,711,533 Calendar Year Cap... 2016 1,650,300 1,677,299 1,711,533 263a(h)(2)(B) & 1395w- 42 CFR CMS Penalty for a ........... ........... ........... ........... 2(b)(2)(A)(ii). 493.1834(d)(2)(i). clinical laboratory's failure to meet participation and certification requirements and poses immediate jeopardy. Minimum............. 2016 6,035 6,134 6,259 Maximum............. 2016 19,787 20,111 20,521 42 CFR CMS Penalty for a ........... ........... ........... - 493.1834(d)(2)(ii). clinical laboratory's failure to meet participation and certification requirements and the failure does not pose immediate jeopardy. Minimum............. 2016 99 101 103 Maximum............. 2016 5,936 6,033 6,156 300gg-15(f)....................... 45 CFR 147.200(e).... CMS Failure to provide 2016 1,087 1,105 1,128 the Summary of Benefits and Coverage. 300gg-18.......................... 45 CFR 158.606....... CMS Penalty for 2016 109 111 113 violations of regulations related to the medical loss ratio reporting and rebating. [[Page 51379]] 1320a-7h(b)(1).................... 42 CFR 402.105(d)(5), CMS Penalty for ........... ........... ........... ........... 42 CFR 403.912(a) & manufacturer or (c). group purchasing organization failing to report information required under 42 U.S.C. 1320a-7h(a), relating to physician ownership or investment interests. Minimum............. 2016 1,087 1,105 1,128 Maximum............. 2016 10,874 11,052 11,278 Calendar Year Cap... 2016 163,117 165,786 169,170 1320a-7h(b)(2).................... 42 CFR 402.105(h), 42 CMS Penalty for ........... ........... ........... ........... CFR 403 912(b) & (c). 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. Minimum............. 2016 10,874 11,052 11,278 Maximum............. 2016 108,745 110,524 112,780 Calendar Year Cap... 2016 1,087,450 1,105,241 1,127,799 1320a-7j(h)(3)(A)................. CMS Penalty for an 2016 108,745 110,524 112,780 administrator of a facility that fails to comply with notice requirements for the closure of a facility. 42 CFR CMS Minimum penalty for 2016 544 553 564 488.446(a)(1),(2), & the first offense (3). of an administrator who fails to provide notice of facility closure. Minimum penalty for 2016 1,631 1,658 1,692 the second offense of an administrator who fails to provide notice of facility closure. Minimum penalty for 2016 3,262 3,315 3,383 the third and subsequent offenses of an administrator who fails to provide notice of facility closure. 1320a-8(a)(1)..................... CMS Penalty for an 2016 7,954 8,084 8,249 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. Penalty for 2016 7,500 7,623 7,779 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. 1320a-8(a)(3)..................... CMS Penalty for a 2016 6,229 6,331 6,460 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. 1320b-25(c)(1)(A)................. CMS Penalty for failure 2016 217,490 221,048 225,560 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. [[Page 51380]] 1320b-25(c)(2)(A)................. CMS Penalty for failure 2016 326,235 331,572 338,339 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. 1320b-25(d)(2).................... CMS Penalty for a long- 2016 217,490 221,048 225,560 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. 1395b-7(b)(2)(B).................. 42 CFR 402.105(g).... CMS Penalty for any 2016 147 149 152 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. 1395i-3(h)(2)(B)(ii)(I)........... 42 CFR CMS Penalty per day for ........... ........... ........... ........... 488.408(d)(1)(iii). a Skilled Nursing Facility that has a Category 2 violation of certification requirements. Minimum............. 2016 103 105 107 Maximum............. 2016 6,188 6,289 6,417 42 CFR CMS Penalty per instance ........... ........... ........... ........... 488.408(d)(1)(iv). of Category 2 noncompliance by a Skilled Nursing Facility. Minimum............. 2016 2,063 2,097 2,140 Maximum............. 2016 20,628 20,965 21,393 42 CFR CMS Penalty per day for ........... ........... ........... ........... 488.408(e)(1)(iii). a Skilled Nursing Facility that has a Category 3 violation of certification requirements. Minimum............. 2016 6,291 6,394 6,525 Maximum............. 2016 20,628 20,965 21,393 42 CFR CMS Penalty per instance ........... ........... ........... ........... 488.408(e)(1)(iv). of Category 3 noncompliance by a Skilled Nursing Facility. Minimum............. 2016 2,063 2,097 2,140 Maximum............. 2016 20,628 20,965 21,393 42 CFR 488.408 CMS Penalty per day and ........... ........... ........... ........... (e)(2)(ii). per instance for a Skilled Nursing Facility that has Category 3 noncompliance with Immediate Jeopardy. Per Day (Minimum)... 2016 6,291 6,394 6,525 Per Day (Maximum)... 2016 20,628 20,965 21,393 Per Instance 2016 2,063 2,097 2,140 (Minimum). Per Instance 2016 20,628 20,965 21,393 (Maximum). 42 CFR CMS Penalty per day of a ........... ........... ........... ........... 488.438(a)(1)(i). Skilled Nursing Facility that fails to meet certification requirements. These amounts represent the upper range per day. Minimum............. 2016 6,291 6,394 6,524 Maximum............. 2016 20,628 20,965 21,393 42 CFR CMS Penalty per day of a ........... ........... ........... ........... 488.438(a)(1)(ii). Skilled Nursing Facility that fails to meet certification requirements. These amounts represent the lower range per day. Minimum............. 2016 103 105 107 Maximum............. 2016 6,188 6,289 6,418 42 CFR 488.438(a)(2). CMS Penalty per instance ........... ........... ........... ........... of a Skilled Nursing Facility that fails to meet certification requirements. Minimum............. 2016 2,063 2,097 2,140 Maximum............. 2016 20,628 20,965 21,393 [[Page 51381]] 1395l(h)(5)(D) \5\................ 42 CFR CMS Penalty for 2018 15,024 15,270 30,000 402.105(d)(2)(i). 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)). 1395l(i)(6)....................... CMS Penalty for 2016 3,957 4,022 4,104 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. 1395l(q)(2)(B)(i)................. 42 CFR 402.105(a).... CMS Penalty for 2016 3,787 3,849 3,928 knowingly and willfully failing to provide information about a referring physician when seeking payment on an unassigned basis. 1395m(a)(11)(A) \5\............... 42 CFR 402.1(c)(4), CMS Penalty for any 2018 15,024 15,270 30,000 402.105(d)(2)(ii). 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)). 1395m(a)(18)(B) \5\............... 42 CFR 402.1(c)(5), CMS Penalty for any 2018 15,024 15,270 30,000 402.105(d)(2)(iii). 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)). 1395m(b)(5)(C) \5\................ 42 CFR 402.1(c)(6), CMS Penalty for any 2018 15,024 15,270 30,000 402.105(d)(2)(iv). 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)). 1395m(h)(3) \5\................... 42 CFR 402.1(c)(8), CMS Penalty for any 2018 15,024 15,270 30,000 402.105(d)(2)(vi). 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)). [[Page 51382]] 1395m(j)(2)(A)(iii)............... CMS Penalty for any 2016 1,591 1,617 1,650 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. 1395m(j)(4) \5\................... 42 CFR 402.1(c)(10), CMS Penalty for any 2018 15,024 15,270 30,000 402.105(d)(2)(vii). 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)). 1395m(k)(6) \5\................... 42 CFR 402.1(c)(31), CMS Penalty for any 2018 15,024 15,270 30,000 402.105(d)(3). 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)). 1395m(l)(6) \5\................... 42 CFR 402.1(c)(32), CMS Penalty for any 2018 15,024 15,270 30,000 402.105(d)(4). 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)). 1395u(b)(18)(B) \5\............... 42 CFR 402.1(c)(11), CMS Penalty for any 2018 15,024 15,270 30,000 402.105(d)(2)(viii). 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)). 1395u(j)(2)(B) \5\................ 42 CFR 402.1(c)...... CMS Penalty for any 2018 15,024 15,270 30,000 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)). 1395u(k) \5\...................... 42 CFR 402.1(c)(12), CMS Penalty for any 2018 15,024 15,270 30,000 402.105(d)(2)(ix). 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)). [[Page 51383]] 1395u(l)(3) \5\................... 42 CFR 402.1(c)(13), CMS Penalty for any 2018 15,024 15,270 30,000 402.105(d)(2)(x). 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)). 1395u(m)(3) \5\................... 42 CFR 402.1(c)(14), CMS Penalty for any 2018 15,024 15,270 30,000 402.105(d)(2)(xi). 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)). 1395u(n)(3) \5\................... 42 CFR 402.1(c)(15), CMS Penalty for any 2018 15,024 15,270 30,000 402.105(d)(2)(xii). 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)). 1395u(o)(3)(B) \5\................ 42 CFR 414.707(b).... CMS Penalty for any 2018 15,024 15,270 30,000 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)). 1395u(p)(3)(A).................... ..................... CMS Penalty for any 2016 3,957 4,022 4,104 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. 1395w-3a(d)(4)(A)................. 42 CFR 414.806....... CMS Penalty for a 2016 12,856 13,066 13,333 pharmaceutical manufacturer's misrepresentation of average sales price of a drug, or biologic. [[Page 51384]] 1395w-4(g)(1)(B) \5\.............. 42 CFR 402.1(c)(17), CMS Penalty for any 2018 15,024 15,270 30,000 402.105(d)(2)(xiii). 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)). 1395w-4(g)(3)(B) \5\.............. 42 CFR 402.1(c)(18), CMS Penalty for any 2018 15,024 15,270 30,000 402.105(d)(2)(xiv). 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)). 1395w-27(g)(3)(A); 1857(g)(3)..... 42 CFR 422.760(b); 42 CMS Penalty for each 2016 36,794 37,396 38,159 CFR 423.760(b). 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. 1395w-27(g)(3)(B); 1857(g)(3)..... ..................... CMS Penalty for each 2016 14,718 14,959 15,264 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. 1395w-27(g)(3)(D); 1857(g)(3)..... ..................... CMS Penalty for a 2016 136,689 138,925 141,760 Medicare Advantage organization's or Part D sponsor's early termination of its contract. 1395y(b)(3)(C).................... 42 CFR 411.103(b).... CMS Penalty for an 2016 8,908 9,054 9,239 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. 1395y(b)(5)(C)(ii)................ 42 CFR 402.1(c)(20), CMS Penalty for any non- 2016 1,450 1,474 1,504 42 CFR 402.105(b)(2). 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. 1395y(b)(6)(B).................... 42 CFR 402.1(c)(21), CMS Penalty for any 2016 3,182 3,234 3,300 402.105(a). 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. 1395y(b)(7)(B)(i)................. ..................... CMS Penalty for any 2016 1,138 1,157 1,181 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. [[Page 51385]] 1395pp(h) \5\..................... 42 CFR 402.1(c)(23), CMS Penalty for any 2018 15,024 15,270 30,000 402.105(d)(2)(xv). 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)). 1395nn(g)(5)...................... 42 CFR 411.361....... CMS Penalty for any 2016 18,936 19,246 19,639 person that fails to report information required by HHS under Section 1877(f) concerning ownership, investment, and compensation arrangements. 1395pp(h)......................... 42 CFR 402.1(c)(23), CMS Penalty for any 2016 15,024 15,270 15,582 402.105(d)(2)(xv). 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)). 1395ss(a)(2)...................... 42 CFR 402.1(c)(24), CMS Penalty for any 2016 51,569 52,413 53,483 405.105(f)(1). 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. 1395ss(d)(3)(A)(vi)(II)........... ..................... CMS Penalty for someone 2016 26,723 27,160 27,714 other than issuer that sells or issues a Medicare supplemental policy to beneficiary without a disclosure statement. Penalty for an 2016 44,539 45,268 46,192 issuer that sells or issues a Medicare supplemental policy without disclosure statement. 1395ss(d)(3)(B)(iv)............... ..................... CMS Penalty for someone 2016 26,723 27,160 27,714 other than issuer that sells or issues a Medicare supplemental policy without acknowledgement form.. Penalty for issuer 2016 44,539 45,268 46,192 that sells or issues a Medicare supplemental policy without an acknowledgement form. 1395ss(p)(8)...................... 42 CFR 402.1(c)(25), CMS Penalty for any 2016 26,723 27,160 27,714 402.105(e). 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. 42 CFR 402.1(c)(25), CMS Penalty for any 2016 44,539 45,268 46,192 405.105(f)(2). 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. 1395ss(p)(9)(C)................... 42 CFR 402.1(c)(26), CMS Penalty for any 2016 26,723 27,160 27,714 402.105(e). 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. [[Page 51386]] 42 CFR 402.1(c)(26), ................... Penalty for any 2016 44,539 45,268 46,192 405.105(f)(3), (4). 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. 1395ss(q)(5)(C)................... 42 CFR 402.1(c)(27), CMS Penalty for any 2016 44,539 45,268 46,192 405.105(f)(5). 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. 1395ss(r)(6)(A)................... 42 CFR 402.1(c)(28), CMS Penalty for any 2016 44,539 45,268 46,192 405.105(f)(6). person that fails to provide refunds or credits as required by section 1882(r)(1)(B). 1395ss(s)(4)...................... 42 CFR 402.1(c)(29), CMS Penalty for any 2016 18,908 19,217 19,609 405.105(c). 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. 1395ss(t)(2)...................... 42 CFR 402.1(c)(30), CMS Penalty for any 2016 44,539 45,268 46,192 405.105(f)(7). issuer of a Medicare supplemental policy that fails to fulfill listed responsibilities. 1395ss(v)(4)(A)................... ..................... CMS Penalty someone 2016 19,284 19,599 19,999 other than issuer who sells, issues, or renews a Medigap Rx policy to an individual who is a Part D enrollee. Penalty for an 2016 32,140 32,666 33,333 issuer who sells, issues, or renews a Medigap Rx policy who is a Part D enrollee. 1395bbb(c)(1)..................... 42 CFR 488.725(c).... CMS Penalty for any 2016 4,126 4,194 4,280 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. 1395bbb(f)(2)(A)(i)............... 42 CFR CMS Maximum daily 2016 19,787 20,111 20,521 488.845(b)(2)(iii); penalty amount for 42 CFR 488.845(b)(3)- each day a home (6); and 42 CFR health agency is 488.845(d)(1)(ii). not in compliance with statutory requirements. 42 CFR 488.845(b)(3). ................... Penalty per day for ........... ........... ........... ........... home health agency's noncompliance (Upper Range). Minimum............. 2016 16,819 17,094 17,443 Maximum............. 2016 19,787 20,111 20,521 42 CFR ................... Penalty for a home 2016 19,787 20,111 20,521 488.845(b)(3)(i). health agency's deficiency or deficiencies that cause immediate jeopardy and result in actual harm. 42 CFR ................... Penalty for a home 2016 17,808 18,099 18,468 488.845(b)(3)(ii). health agency's deficiency or deficiencies that cause immediate jeopardy and result in potential for harm. 42 CFR ................... Penalty for an 2016 16,819 17,094 17,443 488.845(b)(3)(iii). isolated incident of noncompliance in violation of established HHA policy. 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). Minimum............. 2016 2,968 3,017 3,079 [[Page 51387]] Maximum............. 2016 16,819 17,094 17,443 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). Minimum............. 2016 989 1,005 1,026 Maximum............. 2016 7,915 8,044 8,208 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. Minimum............. 2016 1,979 2,011 2,052 Maximum............. 2016 19,787 20,111 20,521 Penalty for each day 2016 19,787 20,111 20,521 of noncompliance (Maximum). 42 CFR ................... Penalty for each day 2016 19,787 20,111 20,521 488.845(d)(1)(ii). of noncompliance (Maximum). 1396b(m)(5)(B).................... 42 CFR 460.46........ CMS Penalty for PACE ........... ........... ........... ........... organization's practice that would reasonably be expected to have the effect of denying or discouraging enrollment. Minimum............. 2016 22,077 22,438 22,896 Maximum............. 2016 147,177 149,585 152,638 Penalty for a PACE 2016 36,794 37,396 38,159 organization that charges excessive premiums. Penalty for a PACE 2016 147,177 149,585 152,638 organization misrepresenting or falsifying information to CMS, the State, or an individual or other entity. Penalty for each 2016 36,794 37,396 38,159 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. Penalty for 2016 36,794 37,396 38,159 involuntarily disenrolling a participant. Penalty for 2016 36,794 37,396 38,159 discriminating or discouraging enrollment or disenrollment of participants on the basis of an individual's health status or need for health care services. 1396r(h)(3)(C)(ii)(I)............. 42 CFR CMS Penalty per day for ........... ........... ........... ........... 488.408(d)(1)(iii). a nursing facility's failure to meet a Category 2 Certification. Minimum............. 2016 103 105 107 Maximum............. 2016 6,188 6,289 6,417 42 CFR CMS Penalty per instance ........... ........... ........... ........... 488.408(d)(1)(iv). for a nursing facility's failure to meet Category 2 certification. Minimum............. 2016 2,063 2,097 2,140 Maximum............. 2016 20,628 20,965 21,393 42 CFR CMS Penalty per day for ........... ........... ........... ........... 488.408(e)(1)(iii). a nursing facility's failure to meet Category 3 certification. Minimum............. 2016 6,291 6,394 6,525 Maximum............. 2016 20,628 20,965 21,393 42 CFR CMS Penalty per instance ........... ........... ........... ........... 488.408(e)(1)(iv). for a nursing facility's failure to meet Category 3 certification. Minimum............. 2016 2,063 2,097 2,140 Maximum............. 2016 20,628 20,965 21,393 42 CFR CMS Penalty per instance ........... ........... ........... ........... 488.408(e)(2)(ii). for a nursing facility's failure to meet Category 3 certification, which results in immediate jeopardy. [[Page 51388]] Minimum............. 2016 2,063 2,097 2,140 Maximum............. 2016 20,628 20,965 21,393 42 CFR CMS Penalty per day for ........... ........... ........... ........... 488.438(a)(1)(i). nursing facility's failure to meet certification (Upper Range). Minimum............. 2016 6,291 6,394 6,525 Maximum............. 2016 20,628 20,965 21,393 42 CFR CMS Penalty per day for ........... ........... ........... ........... 488.438(a)(1)(ii). nursing facility's failure to meet certification (Lower Range). Minimum............. 2016 103 105 107 Maximum............. 2016 6,188 6,289 6,417 42 CFR 488.438(a)(2). CMS Penalty per instance ........... ........... ........... ........... for nursing facility's failure to meet certification. Minimum............. 2016 2,063 2,097 2,140 Maximum............. 2016 20,628 20,965 21,393 1396r(f)(2)(B)(iii)(I)(c)......... 42 CFR CMS Grounds to prohibit 2016 10,314 10,483 10,697 483.151(b)(2)(iv) approval of Nurse and (b)(3)(iii). 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]. 1396r(h)(3)(C)(ii)(I)............. 42 CFR 483.151(c)(2). CMS Grounds to waive 2016 10,314 10,483 10,697 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]. 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. Minimum............. 2016 2 2 2 Maximum............. 2016 17,816 18,107 18,477 1396u-2(e)(2)(A)(i)............... 42 CFR 438.704....... CMS Penalty for a 2016 36,794 37,396 38,159 Medicaid managed care organization that fails substantially to provide medically necessary items and services. Penalty for Medicaid 2016 36,794 37,396 38,159 managed care organization that imposes premiums or charges on enrollees in excess of the premiums or charges permitted. Penalty for a 2016 36,794 37,396 38,159 Medicaid managed care organization that misrepresents or falsifies information to another individual or entity. Penalty for a 2016 36,794 37,396 38,159 Medicaid managed care organization that fails to comply with the applicable statutory requirements for such organizations. 1396u-2(e)(2)(A)(ii).............. 42 CFR 438.704....... CMS Penalty for a 2016 147,177 149,585 152,638 Medicaid managed care organization that misrepresents or falsifies information to the HHS Secretary. Penalty for Medicaid 2016 147,177 149,585 152,638 managed care organization that acts to discriminate among enrollees on the basis of their health status. 1396u-2(e)(2)(A)(iv).............. 42 CFR 438.704....... CMS Penalty for each 2016 22,077 22,438 22,896 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. [[Page 51389]] 1396u(h)(2)....................... 42 CFR Part 441, CMS Penalty for a 2016 20,628 20,965 21,393 Subpart I. 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. 1396w-2(c)(1)..................... CMS Penalty for 2016 11,002 11,182 11,410 disclosing information related to eligibility determinations for medical assistance programs. 18041(c)(2)....................... 45 CFR 150.315; 45 CMS Failure to comply 2016 150 152 155 CFR 156.805(c). 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)). 18081(h)(1)(A)(i)(II)............. 42 CFR 155.285....... CMS Penalty for 2016 27,186 27,631 28,195 providing false information on Exchange application. 18081(h)(1)(B).................... 42 CFR 155.285....... CMS Penalty for 2016 271,862 276,310 281,949 knowingly or willfully providing false information on Exchange application. 18081(h)(2)....................... 42 CFR 155.260....... CMS Penalty for 2016 27,186 27,631 28,195 knowingly or willfully disclosing protected information from Exchange. -------------------------------------------------------------------------------------------------------------------------------------------------------- 31 U.S.C. -------------------------------------------------------------------------------------------------------------------------------------------------------- 1352.............................. 45 CFR 93.400(e)..... HHS Penalty for the 2016 18,936 19,246 19,639 first time an individual makes an expenditure prohibited by regulations regarding lobbying disclosure, absent aggravating circumstances. Penalty for second ........... ........... ........... ........... and subsequent offenses by individuals who make an expenditure prohibited by regulations regarding lobbying disclosure. Minimum............. 2016 18,936 19,246 19,639 Maximum............. 2016 189,361 192,459 196,387 Penalty for the 2016 18,936 19,246 19,639 first time an individual fails to file or amend a lobbying disclosure form, absent aggravating circumstances. Penalty for second ........... ........... ........... ........... and subsequent offenses by individuals who fail to file or amend a lobbying disclosure form, absent aggravating circumstances. Minimum............. 2016 18,936 19,246 19,639 Maximum............. 2016 189,361 192,459 196,387 45 CFR Part 93, HHS Penalty for failure ........... ........... ........... ........... Appendix A. to provide certification regarding lobbying in the award documents for all sub-awards of all tiers. Minimum............. 2016 18,936 19,246 19,639 Maximum............. 2016 189,361 192,459 196,387 Penalty for failure ........... ........... ........... ........... to provide statement regarding lobbying for loan guarantee and loan insurance transactions. Minimum............. 2016 18,936 19,246 19,639 Maximum............. 2016 189,361 192,459 196,387 3801-3812......................... 45 CFR 79.3(a)(1)(iv) HHS Penalty against any 2016 9,894 10,056 10,261 individual who-- with knowledge or reason to know-- makes, presents or submits a false, fictitious or fraudulent claim to the Department. 45 CFR 79.3(b)(1(ii). HHS Penalty against any 2016 9,894 10,056 10,261 individual who-- with knowledge or reason to know-- makes, presents or submits a false, fictitious or fraudulent claim to the Department. -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ Some HHS components have not promulgated regulations regarding their civil monetary penalty-specific statutory authorities. [[Page 51390]] \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 2018, based on the CPI-U for the month of October 2017, not seasonally adjusted, is 1.02041, as indicated in OMB Memorandum M-18-03, ``Implementation of Penalty Inflation Adjustments for 2018, Pursuant to the Federal Civil Penalties Adjustment Act Improvements Act of 2015'' (December 15, 2017). \5\ 2018 Maximum Adjusted Penalty column adjusted based on changes to the Bipartisan Budget Act of 2018 for 42 U.S.C.1320a-7a(a),1320a-7a(b), 1395l(h)(5)(D),1395m(a)(11)(A),1395m(a)(18)(B), 1395m(b)(5)(C), 1395m(h)(3), 1395m(j)(4), 1395m(k)(6), 1395m(l)(6), 1395u(b)(18)(B), 1395u(j)(2)(B), 1395u(k), 1395u(l)(3), 1395u(m)(3), 1395u(n)(3), 1395u(o)(3)(B), 1395w-4(g)(1)(B), 1395w-4(g)(3)(B),1395pp(h). Dated: October 3, 2018. Alex M. Azar II, Secretary, Department of Health and Human Services. [FR Doc. 2018-22005 Filed 10-10-18; 8:45 am] BILLING CODE 4150-24-P
![Federal Register / Vol. 83, No. 197 / Thursday, October 11, 2018 / Rules and Regulations 51369
EPA-APPROVED REGULATIONS, TECHNICAL MEMORANDA, AND STATUTES IN THE MARYLAND SIP—Continued
Code of Maryland State
Administrative Additional explanation/citation
Title/subject effective EPA approval date
Regulations at 40 CFR 52.1100
date
(COMAR) citation
* * * * * * *
26.11.40 NOX Ozone Season Emission Caps for Non-trading Large NOX Units
26.11.40.01 ............. Definitions ....................... 04/23/18 10/11/18, [Insert Federal
Register citation].
26.11.40.02 ............. Applicability ..................... 04/23/18 10/11/18, [Insert Federal
Register citation].
26.11.40.03 ............. NOX Ozone Season 04/23/18 10/11/18, [Insert Federal
Emission Caps. Register citation].
26.11.40.04 ............. Monitoring and Reporting 04/23/18 10/11/18, [Insert Federal
Requirements. Register citation].
* * * * * * *
* * * * * monetary penalties (CMPs) and to Section 4(a) of the 2015 Act directs
[FR Doc. 2018–21653 Filed 10–10–18; 8:45 am] maintain the deterrent effect of such federal agencies to publish annual
BILLING CODE 6560–50–P penalties, requires agencies to adjust the adjustments no later than January 15th
civil monetary penalties for inflation of each year thereafter. In accordance
annually. with section 553 of the APA, most rules
DEPARTMENT OF HEALTH AND The Department of Health and Human are subject to notice and comment and
HUMAN SERVICES Services (HHS) lists the civil monetary are effective no earlier than 30 days after
penalty authorities and the penalty publication in the Federal Register.
45 CFR Part 102 amounts administered by all of its However, section 4(b)(2) of the 2015 Act
RIN 0991–AC0 agencies in tabular form in 45 CFR provides that each agency shall make
102.3. the annual inflation adjustments
Annual Civil Monetary Penalties ‘‘notwithstanding section 553’’ of the
II. Calculation of Adjustment
Inflation Adjustment APA.
The annual inflation adjustment for According to OMB’s Memorandum
AGENCY: Office of the Assistant each applicable civil monetary penalty
Secretary for Financial Resources, M–18–03, the phrase ‘‘notwithstanding
is determined using the percent increase section 553’’ means that ‘‘the public
Department of Health and Human in the Consumer Price Index for all
Services. procedure the APA generally requires—
Urban Consumers (CPI–U) for the month notice, an opportunity for comment, and
ACTION: Final rule. of October of the year in which the a delay in effective date—is not required
amount of each civil penalty was most for agencies to issue regulations
SUMMARY: The Department of Health and recently established or modified. In the
Human Services is updating its implementing the annual adjustment.’’
December 15, 2017, Office of Consistent with the language of the 2015
regulations to reflect required annual Management and Budget (OMB)
inflation-related increases to the civil Act and OMB’s implementation
Memorandum for the Heads of guidance, this rule is not subject to
monetary penalties in its regulations, Executive Agencies and Departments,
pursuant to the Federal Civil Penalties notice and an opportunity for public
M–18–03, Implementation of the
Inflation Adjustment Act Improvements comment and will be effective
Penalty Inflation Adjustments for 2018,
Act of 2015. immediately upon publication.
Pursuant to the Federal Civil Penalties
DATES: This rule is effective October 11, Inflation Adjustment Act Improvements Pursuant to OMB Memorandum M–
2018. Act of 2015, OMB published the 18–03, HHS has determined that the
FOR FURTHER INFORMATION CONTACT: multiplier for the required annual annual inflation adjustment to the civil
Shaunta Johnson, Office of Grants and adjustment. The cost-of-living monetary penalties in its regulations
Acquisition Policy and Accountability, adjustment multiplier for 2018, based does not trigger any requirements under
Office of the Assistant Secretary for on the CPI–U for the month of October procedural statutes and Executive
Financial Resources, Room 514–G, 2017, not seasonally adjusted, is Orders that govern rulemaking
Hubert Humphrey Building, 200 1.02041. procedures.
Independence Avenue SW, Washington, Using the 2018 multiplier, HHS IV. Effective Date
DC 20201; 202–690–6396; FAX 202– adjusted all its applicable monetary
690–5405. penalties in 45 CFR 102.3. This rule is effective October 11 2018.
SUPPLEMENTARY INFORMATION: The adjusted civil monetary penalty
III. Statutory and Executive Order
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amounts apply to penalties assessed on
I. Background Reviews
or after October 11, 2018, if the violation
The Federal Civil Penalties Inflation The 2015 Act requires federal occurred on or after November 2, 2015.
Adjustment Act Improvements Act of agencies to publish annual penalty If the violation occurred prior to
2015 (Sec. 701 of Pub. L. 114–74) (the inflation adjustments notwithstanding November 2, 2015, or a penalty was
‘‘2015 Act’’), which is intended to section 553 of the Administrative assessed prior to September 6, 2016, the
improve the effectiveness of civil Procedure Act (APA). pre-adjustment civil penalty amounts in
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![51370 Federal Register / Vol. 83, No. 197 / Thursday, October 11, 2018 / Rules and Regulations
effect prior to September 6, 2016, will 45 of the Code of Federal Regulations as Authority: Public Law 101–410, Sec. 701
apply. follows: of Public Law 114–74, 31 U.S.C. 3801–3812.
List of Subjects in 45 CFR Part 102 PART 102—ADJUSTMENT OF CIVIL ■ 2. Amend § 102.3 by revising the table
Administrative practice and MONETARY PENALTIES FOR to read as follows:
procedure, Penalties. INFLATION § 102.3 Penalty adjustment and table.
For reasons discussed in the * * * * *
preamble, the Department of Health and ■ 1. The authority citation for part 102
Human Services amends subtitle A, title continues to read as follows:
CIVIL MONETARY PENALTY AUTHORITIES ADMINISTERED BY HHS AGENCIES AND PENALTY AMOUNTS
[Effective October 11, 2018]
Citation Date of last 2016 2017 2018
statutorily Maximum Maximum Maximum
HHS Description 2 established adjusted adjusted adjusted
U.S.C. CFR 1 agency penalty penalty penalty penalty
figure 3 ($) ($) 4 ($)
21 U.S.C.
333(b)(2)(A) .................... ........................................ FDA Penalty for violations related to 2016 98,935 100,554 102,606
drug samples resulting in a con-
viction of any representative of
manufacturer or distributor in any
10-year period.
333(b)(2)(B) .................... ........................................ FDA Penalty for violation related to drug 2016 1,978,690 2,011,061 2,052,107
samples resulting in a conviction
of any representative of manu-
facturer or distributor after the
second conviction in any 10-yr
period.
333(b)(3) ......................... ........................................ FDA Penalty for failure to make a report 2016 197,869 201,106 205,211
required by 21 U.S.C.
353(d)(3)(E) relating to drug
samples.
333(f)(1)(A) ..................... ........................................ FDA Penalty for any person who violates 2016 26,723 27,160 27,714
a requirement related to devices
for each such violation.
Penalty for aggregate of all viola- 2016 1,781,560 1,810,706 1,847,663
tions related to devices in a sin-
gle proceeding.
333(f)(2)(A) ..................... ........................................ FDA Penalty for any individual who intro- 2016 75,123 76,352 77,910
duces 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 re-
call order under 21 U.S.C. 350l.
Penalty in the case of any other 2016 375,613 381,758 389,550
person other than an individual)
for such introduction or delivery
of adulterated food.
Penalty for aggregate of all such 2016 751,225 763,515 779,098
violations related to adulterated
food adjudicated in a single pro-
ceeding.
333(f)(3)(A) ..................... ........................................ FDA Penalty for all violations adju- 2016 11,383 11,569 11,805
dicated in a single proceeding for
any person who violates 21
U.S.C. 331(jj)(1) by failing to sub-
mit the certification required by
42 U.S.C. 282(j)(5)(B) or know-
ingly submitting a false certifi-
cation; 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).
333(f)(3)(B) ..................... ........................................ FDA Penalty for each day any above 2016 11,383 11,569 11,805
violation is not corrected after a
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30-day period following notifica-
tion until the violation is corrected.
333(f)(4)(A)(i) .................. ........................................ FDA Penalty for any responsible person 2016 284,583 289,239 295,142
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).
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![Federal Register / Vol. 83, No. 197 / Thursday, October 11, 2018 / Rules and Regulations 51371
CIVIL MONETARY PENALTY AUTHORITIES ADMINISTERED BY HHS AGENCIES AND PENALTY AMOUNTS—Continued
[Effective October 11, 2018]
Citation Date of last 2016 2017 2018
statutorily Maximum Maximum Maximum
HHS Description 2 established adjusted adjusted adjusted
U.S.C. CFR 1 agency penalty penalty penalty penalty
figure 3 ($) ($) 4 ($)
Penalty for aggregate of all such 2016 1,138,330 1,156,953 1,180,566
above violations in a single pro-
ceeding.
333(f)(4)(A)(ii) ................. FDA Penalty for REMS violation that 2016 284,583 289,239 295,142
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.
Penalty for REMS violation that 2016 1,138,330 1,156,953 1,180,566
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.
Penalty for aggregate of all such 2016 11,383,300 11,569,531 11,805,665
above violations adjudicated in a
single proceeding.
333(f)(9)(A) ..................... ........................................ FDA Penalty for any person who violates 2016 16,503 16,773 17,115
a requirement which relates to
tobacco products for each such
violation.
Penalty for aggregate of all such 2016 1,100,200 1,118,199 1,141,021
violations of tobacco product re-
quirement adjudicated in a single
proceeding.
333(f)(9)(B)(i)(I) ............... FDA Penalty per violation related to vio- 2016 275,050 279,550 285,256
lations of tobacco requirements.
Penalty for aggregate of all such 2016 1,100,200 1,118,199 1,141,021
violations of tobacco product re-
quirements adjudicated in a sin-
gle proceeding.
333(f)(9)(B)(i)(II) .............. ........................................ FDA Penalty in the case of a violation of 2016 275,050 279,550 285,256
tobacco product requirements
that continues after written notice
to such person, for the first 30-
day period (or any portion there-
of) the person continues to be in
violation.
Penalty for violation of tobacco 2016 1,100,200 1,118,199 1,141,021
product requirements that con-
tinues 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.
Penalty for aggregate of all such 2016 11,002,000 11,181,993 11,410,218
violations related to tobacco
product requirements adjudicated
in a single proceeding.
333(f)(9)(B)(ii)(I) .............. ........................................ FDA Penalty for any person who either 2016 275,050 279,550 285,256
does not conduct post-market
surveillance and studies to deter-
mine impact of a modified risk to-
bacco 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-mar-
ket surveillance of such tobacco
products.
Penalty for aggregate of for all 2016 1,100,200 1,118,199 1,141,021
such above violations adju-
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dicated in a single proceeding.
333(f)(9)(B)(ii)(II) ............. ........................................ FDA Penalty for violation of modified risk 2016 275,050 279,550 285,256
tobacco product post-market sur-
veillance that continues after writ-
ten notice to such person for the
first 30-day period (or any portion
thereof) that the person con-
tinues to be in violation.
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![51372 Federal Register / Vol. 83, No. 197 / Thursday, October 11, 2018 / Rules and Regulations
CIVIL MONETARY PENALTY AUTHORITIES ADMINISTERED BY HHS AGENCIES AND PENALTY AMOUNTS—Continued
[Effective October 11, 2018]
Citation Date of last 2016 2017 2018
statutorily Maximum Maximum Maximum
HHS Description 2 established adjusted adjusted adjusted
U.S.C. CFR 1 agency penalty penalty penalty penalty
figure 3 ($) ($) 4 ($)
Penalty for post-notice violation of 2016 1,100,200 1,118,199 1,141,021
modified risk tobacco product
post-market surveillance shall
double for every 30-day period
thereafter that the tobacco prod-
uct requirement violation con-
tinues for any 30-day period, but
may not exceed penalty amount
for any 30-day period.
Penalty for aggregate above to- 2016 11,002,000 11,181,993 11,410,218
bacco product requirement viola-
tions adjudicated in a single pro-
ceeding.
333(g)(1) ......................... ........................................ FDA Penalty for any person who dis- 2016 284,583 289,239 295,142
seminates 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 pe-
riod.
Penalty for each subsequent above 2016 569,165 578,477 590,284
violation in any 3-year period.
333 note .......................... ........................................ FDA Penalty to be applied for violations 2016 275 279 285
of restrictions on the sale or dis-
tribution of tobacco products pro-
mulgated under 21 U.S.C.
387f(d) (e.g., violations of regula-
tions in 21 CFR Part 1140) with
respect to a retailer with an ap-
proved training program in the
case of a second regulation vio-
lation within a 12-month period.
Penalty in the case of a third to- 2016 550 559 570
bacco product regulation violation
within a 24-month period.
Penalty in the case of a fourth to- 2016 2,200 2,236 2,282
bacco product regulation violation
within a 24-month period.
Penalty in the case of a fifth to- 2016 5,501 5,591 5,705
bacco product regulation violation
within a 36-month period.
Penalty in the case of a sixth or 2016 11,002 11,182 11,410
subsequent tobacco product reg-
ulation violation within a 48-
month period as determined on a
case-by-case basis.
Penalty to be applied for violations 2016 275 279 285
of restrictions on the sale or dis-
tribution of tobacco products pro-
mulgated under 21 U.S.C.
387f(d) (e.g., violations of regula-
tions in 21 CFR Part 1140) with
respect to a retailer that does not
have an approved training pro-
gram in the case of the first regu-
lation violation.
Penalty in the case of a second to- 2016 550 559 570
bacco product regulation violation
within a 12-month period.
Penalty in the case of a third to- 2016 1,100 1,118 1,141
bacco product regulation violation
within a 24-month period.
Penalty in the case of a fourth to- 2016 2,200 2,236 2,282
bacco product regulation violation
within a 24-month period.
Penalty in the case of a fifth to- 2016 5,501 5,591 5,705
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bacco product regulation violation
within a 36-month period.
Penalty in the case of a sixth or 2016 11,002 11,182 11,410
subsequent tobacco product reg-
ulation violation within a 48-
month period as determined on a
case-by-case basis.
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![Federal Register / Vol. 83, No. 197 / Thursday, October 11, 2018 / Rules and Regulations 51373
CIVIL MONETARY PENALTY AUTHORITIES ADMINISTERED BY HHS AGENCIES AND PENALTY AMOUNTS—Continued
[Effective October 11, 2018]
Citation Date of last 2016 2017 2018
statutorily Maximum Maximum Maximum
HHS Description 2 established adjusted adjusted adjusted
U.S.C. CFR 1 agency penalty penalty penalty penalty
figure 3 ($) ($) 4 ($)
335b(a) ............................ ........................................ FDA Penalty for each violation for any 2016 419,320 426,180 434,878
individual who made a false
statement or misrepresentation of
a material fact, bribed, destroyed,
altered, removed, or secreted, or
procured the destruction, alter-
ation, removal, or secretion of,
any material document, failed to
disclose a material fact, ob-
structed an investigation, em-
ployed a consultant who was
debarred, debarred individual
provided consultant services.
Penalty in the case of any other 2016 1,677,280 1,704,720 1,739,513
person (other than an individual)
per above violation.
360pp(b)(1) ..................... ........................................ FDA Penalty for any person who violates 2016 2,750 2,795 2,852
any such requirements for elec-
tronic products, with each unlaw-
ful act or omission constituting a
separate violation.
Penalty imposed for any related se- 2016 937,500 952,838 972,285
ries of violations of requirements
relating to electronic products.
42 U.S.C.
262(d) .............................. ........................................ FDA Penalty per day for violation of 2016 215,628 219,156 223,629
order of recall of biological prod-
uct presenting imminent or sub-
stantial hazard.
263b(h)(3) ....................... ........................................ FDA Penalty for failure to obtain a mam- 2016 16,773 17,047 17,395
mography certificate as required.
300aa–28(b)(1) ............... ........................................ FDA Penalty per occurrence for any vac- 2016 215,628 219,156 223,629
cine manufacturer that inten-
tionally destroys, alters, falsifies,
or conceals any record or report
required.
256b(d)(1)(B)(vi) ............. ........................................ HRSA Penalty for each instance of over- 2016 5,437 5,526 5,639
charging a 340B covered entity.
299c–3(d) ........................ ........................................ AHRQ Penalty for an establishment or 2016 14,140 14,371 14,664
person supplying information ob-
tained in the course of activities
for any purpose other than the
purpose for which it was supplied.
653(l)(2) .......................... 45 CFR 303.21(f) ........... ACF Penalty for Misuse of Information in 2016 1,450 1,474 1,504
the National Directory of New
Hires.
262a(i)(1) ........................ 42 CFR 1003.910 .......... OIG Penalty for each individual who vio- 2016 327,962 333,327 340,130
lates safety and security proce-
dures related to handling dan-
gerous biological agents and tox-
ins.
Penalty for any other person who 2016 655,925 666,656 680,262
violates safety and security pro-
cedures related to handling dan-
gerous biological agents and tox-
ins.
300jj–51 .......................... ........................................ OIG Penalty per violation for committing 2016 1,000,000 1,016,360 1,037,104
information blocking.
1320a–7a(a) 5 ................. 42 CFR 1003.210(a)(1) OIG Penalty for knowingly presenting or 2018 15,024 15,270 20,000
causing to be presented to an of-
ficer, employee, or agent of the
United States a false claim.
Penalty for knowingly presenting or 2018 15,024 15,270 20,000
causing to be presented a re-
quest for payment which violates
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the terms of an assignment,
agreement, or PPS agreement.
42 CFR 1003.210(a)(2) Penalty for knowingly giving or 2018 22,537 22,906 30,000
causing to be presented to a par-
ticipating provider or supplier
false or misleading information
that could reasonably be ex-
pected to influence a discharge
decision.
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![51374 Federal Register / Vol. 83, No. 197 / Thursday, October 11, 2018 / Rules and Regulations
CIVIL MONETARY PENALTY AUTHORITIES ADMINISTERED BY HHS AGENCIES AND PENALTY AMOUNTS—Continued
[Effective October 11, 2018]
Citation Date of last 2016 2017 2018
statutorily Maximum Maximum Maximum
HHS Description 2 established adjusted adjusted adjusted
U.S.C. CFR 1 agency penalty penalty penalty penalty
figure 3 ($) ($) 4 ($)
42 CFR 1003.210(a)(3) Penalty for an excluded party re- 2018 15,024 15,270 20,000
taining ownership or control inter-
est in a participating entity.
42 CFR 1003.1010 ........ Penalty for remuneration offered to 2018 15,024 15,270 20,000
induce program beneficiaries to
use particular providers, practi-
tioners, or suppliers.
42 CFR 1003.210(a)(4) Penalty for employing or con- 2018 14,718 14,959 20,000
tracting with an excluded indi-
vidual.
42 CFR 1003.310(a)(3) Penalty for knowing and willful so- 2018 73,588 74,792 100,000
licitation, receipt, offer, or pay-
ment of remuneration for refer-
ring an individual for a service or
for purchasing, leasing, or order-
ing an item to be paid for by a
Federal health care program.
42 CFR 1003.210(a)(1) Penalty for ordering or prescribing 2018 10,874 11,052 20,000
medical or other item or service
during a period in which the per-
son was excluded.
42 CFR 1003.210(a)(6) Penalty for knowingly making or 2018 54,372 55,262 100,000
causing to be made a false state-
ment, omission or misrepresenta-
tion of a material fact in any ap-
plication, bid, or contract to par-
ticipate or enroll as a provider or
supplier.
42 CFR 1003.210(a)(8) Penalty for knowing of an overpay- 2018 10,874 11,052 20,000
ment and failing to report and re-
turn.
42 CFR 1003.210(a)(7) Penalty for making or using a false 2018 54,372 55,262 100,000
record or statement that is mate-
rial to a false or fraudulent claim.
42 CFR 1003.210(a)(9) Penalty for failure to grant timely 2018 16,312 16,579 30,000
access to HHS OIG for audits,
investigations, evaluations, and
other statutory functions of HHS
OIG.
1320a–7a(b) 5 ................. ........................................ OIG Penalty for payments by a hospital 2018 4,313 4,384 5,000
or critical access hospital to in-
duce a physician to reduce or
limit services to individuals under
direct care of physician or who
are entitled to certain medical as-
sistance benefits.
........................................ Penalty for physicians who know- 2018 4,313 4,384 5,000
ingly receive payments from a
hospital or critical access hospital
to induce such physician to re-
duce or limit services to individ-
uals under direct care of physi-
cian or who are entitled to certain
medical assistance benefits.
42 CFR 1003.210(a)(10) Penalty for a physician who exe- 2018 7,512 7,635 10,000
cutes a document that falsely
certifies home health needs for
Medicare beneficiaries.
1320a–7e(b)(6)(A) .......... 42 CFR 1003.810 .......... OIG Penalty for failure to report any 2016 36,794 37,396 38,159
final adverse action taken against
a health care provider, supplier,
or practitioner.
1320b–10(b)(1) ............... 42 CFR 1003.610(a) ...... OIG Penalty for the misuse of words, 2016 9,893 10,055 10,260
symbols, or emblems in commu-
nications in a manner in which a
person could falsely construe
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that such item is approved, en-
dorsed, or authorized by HHS.
1320b–10(b)(2) ............... 42 CFR 1003.610(a) ...... OIG Penalty for the misuse of words, 2016 49,467 50,276 51,302
symbols, or emblems in a broad-
cast or telecast in a manner in
which a person could falsely con-
strue that such item is approved,
endorsed, or authorized by HHS.
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![Federal Register / Vol. 83, No. 197 / Thursday, October 11, 2018 / Rules and Regulations 51375
CIVIL MONETARY PENALTY AUTHORITIES ADMINISTERED BY HHS AGENCIES AND PENALTY AMOUNTS—Continued
[Effective October 11, 2018]
Citation Date of last 2016 2017 2018
statutorily Maximum Maximum Maximum
HHS Description 2 established adjusted adjusted adjusted
U.S.C. CFR 1 agency penalty penalty penalty penalty
figure 3 ($) ($) 4 ($)
1395i–3(b)(3)(B)(ii)(1) ..... 42 CFR 1003.210(a)(11) OIG Penalty for certification of a false 2016 2,063 2,097 2,140
statement in assessment of func-
tional capacity of a Skilled Nurs-
ing Facility resident assessment.
1395i–3(b)(3)(B)(ii)(2) ..... 42 CFR 1003.210(a)(11) OIG Penalty for causing another to cer- 2016 10,314 10,483 10,697
tify or make a false statement in
assessment of functional capac-
ity of a Skilled Nursing Facility
resident assessment.
1395i–3(g)(2)(A) .............. 42 CFR 1003.1310 ........ OIG Penalty for any individual who noti- 2016 4,126 4,194 4,280
fies or causes to be notified a
Skilled Nursing Facility of the
time or date on which a survey is
to be conducted.
1395w–27(g)(2)(A) .......... 42 CFR 1003.410 .......... OIG Penalty for a Medicare Advantage 2016 37,561 38,175 38,954
organization that substantially
fails to provide medically nec-
essary, required items and serv-
ices.
Penalty for a Medicare Advantage 2016 36,794 37,396 38,159
organization that charges exces-
sive premiums.
Penalty for a Medicare Advantage 2016 36,794 37,396 38,159
organization that improperly ex-
pels or refuses to reenroll a ben-
eficiary.
Penalty for a Medicare Advantage 2016 147,177 149,585 152,638
organization that engages in
practice that would reasonably
be expected to have the effect of
denying or discouraging enroll-
ment.
Penalty per individual who does not 2016 22,077 22,438 22,896
enroll as a result of a Medicare
Advantage organization’s prac-
tice that would reasonably be ex-
pected to have the effect of de-
nying or discouraging enrollment.
Penalty for a Medicare Advantage 2016 147,177 149,585 152,638
organization misrepresenting or
falsifying information to Secretary.
Penalty for a Medicare Advantage 2016 36,794 37,396 38,159
organization misrepresenting or
falsifying information to individual
or other entity.
Penalty for Medicare Advantage or- 2016 36,794 37,396 38,159
ganization interfering with pro-
vider’s advice to enrollee and
non-MCO affiliated providers that
balance bill enrollees.
Penalty for a Medicare Advantage 2016 36,794 37,396 38,159
organization that employs or con-
tracts with excluded individual or
entity.
Penalty for a Medicare Advantage 2016 36,794 37,396 38,159
organization enrolling an indi-
vidual in without prior written
consent.
Penalty for a Medicare Advantage 2016 36,794 37,396 38,159
organization transferring an en-
rollee to another plan without
consent or solely for the purpose
of earning a commission.
Penalty for a Medicare Advantage 2016 36,794 37,396 38,159
organization failing to comply
with marketing restrictions or ap-
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plicable implementing regulations
or guidance.
Penalty for a Medicare Advantage 2016 36,794 37,396 38,159
organization employing or con-
tracting with an individual or enti-
ty who violates 1395w–
27(g)(1)(A)–(J).
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![51376 Federal Register / Vol. 83, No. 197 / Thursday, October 11, 2018 / Rules and Regulations
CIVIL MONETARY PENALTY AUTHORITIES ADMINISTERED BY HHS AGENCIES AND PENALTY AMOUNTS—Continued
[Effective October 11, 2018]
Citation Date of last 2016 2017 2018
statutorily Maximum Maximum Maximum
HHS Description 2 established adjusted adjusted adjusted
U.S.C. CFR 1 agency penalty penalty penalty penalty
figure 3 ($) ($) 4 ($)
1395w–141(i)(3) .............. OIG Penalty for a prescription drug card 2016 12,856 13,066 13,333
sponsor that falsifies or misrepre-
sents marketing materials, over-
charges program enrollees, or
misuse transitional assistance
funds.
1395cc(g) ........................ OIG Penalty for improper billing by Hos- 2016 5,000 5,082 5,186
pitals, Critical Access Hospitals,
or Skilled Nursing Facilities.
1395dd(d)(1) ................... 42 CFR 1003.510 .......... OIG Penalty for a hospital or respon- 2016 103,139 104,826 106,965
sible physician dumping patients
needing emergency medical
care, if the hospital has 100 beds
or more.
Penalty for a hospital or respon- 2016 51,570 52,414 53,484
sible physician dumping patients
needing emergency medical
care, if the hospital has less than
100 beds.
1395mm(i)(6)(B)(i) .......... 42 CFR 1003.410 .......... OIG Penalty for a HMO or competitive 2016 51,570 52,414 53,484
plan is such plan substantially
fails to provide medically nec-
essary, required items or serv-
ices.
Penalty for HMOs/competitive med- 2016 51,570 52,414 53,484
ical plans that charge premiums
in excess of permitted amounts.
Penalty for a HMO or competitive 2016 51,570 52,414 53,484
medical plan that expels or re-
fuses to reenroll an individual per
prescribed conditions.
Penalty for a HMO or competitive 2016 206,278 209,653 213,932
medical plan that implements
practices to discourage enroll-
ment of individuals needing serv-
ices in future.
Penalty per individual not enrolled 2016 29,680 30,166 30,782
in a plan as a result of a HMO or
competitive medical plan that im-
plements practices to discourage
enrollment of individuals needing
services in the future.
Penalty for a HMO or competitive 2016 206,278 209,653 213,932
medical plan that misrepresents
or falsifies information to the
Secretary.
Penalty for a HMO or competitive 2016 51,570 52,414 53,484
medical plan that misrepresents
or falsifies information to an indi-
vidual or any other entity.
Penalty for failure by HMO or com- 2016 51,570 52,414 53,484
petitive medical plan to assure
prompt payment of Medicare risk
sharing contracts or incentive
plan provisions.
Penalty for HMO that employs or 2016 47,340 48,114 49,096
contracts with excluded individual
or entity.
1395nn(g)(3) ................... 42 CFR 1003.310 .......... OIG Penalty for submitting or causing to 2016 23,863 24,253 24,748
be submitted claims in violation
of the Stark Law’s restrictions on
physician self-referrals.
1395nn(g)(4) ................... 42 CFR 1003.310 .......... OIG Penalty for circumventing Stark 2016 159,089 161,692 164,992
Law’s restrictions on physician
self-referrals.
1395ss(d)(1) .................... 42 CFR 1003.1110 ........ OIG Penalty for a material misrepresen- 2016 9,893 10,055 10,260
tation regarding Medigap compli-
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ance policies.
1395ss(d)(2) .................... 42 CFR 1003.1110 ........ OIG Penalty for selling Medigap policy 2016 9,893 10,055 10,260
under false pretense.
1395ss(d)(3)(A)(ii) ........... 42 CFR 1003.1110 ........ OIG Penalty for an issuer that sells 2016 44,539 45,268 46,192
health insurance policy that dupli-
cates benefits.
Penalty for someone other than 2016 26,723 27,160 27,714
issuer that sells health insurance
that duplicates benefits.
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![Federal Register / Vol. 83, No. 197 / Thursday, October 11, 2018 / Rules and Regulations 51377
CIVIL MONETARY PENALTY AUTHORITIES ADMINISTERED BY HHS AGENCIES AND PENALTY AMOUNTS—Continued
[Effective October 11, 2018]
Citation Date of last 2016 2017 2018
statutorily Maximum Maximum Maximum
HHS Description 2 established adjusted adjusted adjusted
U.S.C. CFR 1 agency penalty penalty penalty penalty
figure 3 ($) ($) 4 ($)
1395ss(d)(4)(A) ............... 42 CFR 1003.1110 ........ OIG Penalty for using mail to sell a non- 2016 9,893 10,055 10,260
approved Medigap insurance pol-
icy.
1396b(m)(5)(B)(i) ............ 42 CFR 1003.410 .......... OIG Penalty for a Medicaid MCO that 2016 49,467 50,276 51,302
substantially fails to provide
medically necessary, required
items or services.
Penalty for a Medicaid MCO that 2016 49,467 50,276 51,302
charges excessive premiums.
Penalty for a Medicaid MCO that 2016 197,869 201,106 205,211
improperly expels or refuses to
reenroll a beneficiary.
Penalty per individual who does not 2016 29,680 30,166 30,782
enroll as a result of a Medicaid
MCO’s practice that would rea-
sonably be expected to have the
effect of denying or discouraging
enrollment.
Penalty for a Medicaid MCO mis- 2016 197,869 201,106 205,211
representing or falsifying informa-
tion to the Secretary.
Penalty for a Medicaid MCO mis- 2016 49,467 50,276 51,302
representing or falsifying informa-
tion to an individual or another
entity.
Penalty for a Medicaid MCO that 2016 44,539 45,268 46,192
fails to comply with contract re-
quirements with respect to physi-
cian incentive plans.
1396r(b)(3)(B)(ii)(I) .......... 42 CFR 1003.210(a)(11) OIG Penalty for willfully and knowingly 2016 2,063 2,097 2,140
certifying a material and false
statement in a Skilled Nursing
Facility resident assessment.
1396r(b)(3)(B)(ii)(II) ......... 42 CFR 1003.210(a)(11) OIG Penalty for willfully and knowingly 2016 10,314 10,483 10,697
causing another individual to cer-
tify a material and false state-
ment in a Skilled Nursing Facility
resident assessment.
1396r(g)(2)(A)(i) .............. 42 CFR 1003.1310 ........ OIG Penalty for notifying or causing to 2016 4,126 4,194 4,280
be notified a Skilled Nursing Fa-
cility of the time or date on which
a survey is to be conducted.
1396r–8(b)(3)(B) ............. 42 CFR 1003.1210 ........ OIG Penalty for the knowing provision of 2016 178,156 181,071 184,767
false information or refusing to
provide information about
charges or prices of a covered
outpatient drug.
1396r–8(b)(3)(C)(i) .......... 42 CFR 1003.1210 ........ OIG Penalty per day for failure to timely 2016 17,816 18,107 18,477
provide information by drug man-
ufacturer with rebate agreement.
1396r–8(b)(3)(C)(ii) ......... 42 CFR 1003.1210 ........ OIG Penalty for knowing provision of 2016 178,156 181,071 184,767
false information by drug manu-
facturer with rebate agreement.
1396t(i)(3)(A) ................... 42 CFR 1003.1310 ........ OIG Penalty for notifying home and 2016 3,563 3,621 3,695
community-based providers or
settings of survey.
11131(c) .......................... 42 CFR 1003.810 .......... OIG Penalty for failing to report a med- 2016 21,563 21,916 22,363
ical malpractice claim to National
Practitioner Data Bank.
11137(b)(2) ..................... 42 CFR 1003.810 .......... OIG Penalty for breaching confidentiality 2016 21,563 21,916 22,363
of information reported to Na-
tional Practitioner Data Bank.
299b–22(f)(1) .................. 42 CFR 3.404 ................ OCR Penalty for violation of confiden- 2016 11,940 12,135 12,383
tiality provision of the Patient
Safety and Quality Improvement
Act.
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1320(d)–5(a) ................... 45 CFR 160.404(b)(1)(i), OCR Penalty for each pre-February 18, 2016 150 152 155
(ii). 2009 violation of the HIPAA ad-
ministrative simplification provi-
sions.
Calendar Year Cap ......................... 2016 37,561 38,175 38,954
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![51378 Federal Register / Vol. 83, No. 197 / Thursday, October 11, 2018 / Rules and Regulations
CIVIL MONETARY PENALTY AUTHORITIES ADMINISTERED BY HHS AGENCIES AND PENALTY AMOUNTS—Continued
[Effective October 11, 2018]
Citation Date of last 2016 2017 2018
statutorily Maximum Maximum Maximum
HHS Description 2 established adjusted adjusted adjusted
U.S.C. CFR 1 agency penalty penalty penalty penalty
figure 3 ($) ($) 4 ($)
45 CFR OCR Penalty for each February 18, 2009 .................... .................... .................... ....................
160.404(b)(2)(i)(A), (B). or later violation of a HIPAA ad-
ministrative simplification provi-
sion in which it is established
that the covered entity or busi-
ness associate did not know and
by exercising reasonable dili-
gence, would not have known
that the covered entity or busi-
ness associate violated such a
provision.
Minimum .......................................... 2016 110 112 114
Maximum ......................................... 2016 55,010 55,910 57,051
Calendar Year Cap ......................... 2016 1,650,300 1,677,299 1,711,533
45 CFR OCR Penalty for each February 18, 2009 .................... .................... .................... ....................
160.404(b)(2)(ii)(A), or later violation of a HIPAA ad-
(B). ministrative simplification provi-
sion in which it is established
that the violation was due to rea-
sonable cause and not to willful
neglect.
Minimum .......................................... 2016 1,100 1,118 1,141
Maximum ......................................... 2016 55,010 55,910 57,051
Calendar Year Cap ......................... 2016 1,650,300 1,677,299 1,711,533
45 CFR 160.404(b)(2) OCR Penalty for each February 18, 2009 .................... .................... .................... ....................
(iii)(A), (B). or later violation of a HIPAA ad-
ministrative simplification provi-
sion in which it is established
that the violation was due to will-
ful neglect and was corrected
during the 30-day period begin-
ning on the first date the covered
entity or business associate
knew, or, by exercising reason-
able diligence, would have
known that the violation occurred.
Minimum .......................................... 2016 11,002 11,182 11,410
Maximum ......................................... 2016 55,010 55,910 57,051
Calendar Year Cap ......................... 2016 1,650,300 1,677,299 1,711,533
45 CFR OCR Penalty for each February 18, 2009 .................... .................... .................... ....................
160.404(b)(2)(iv)(A), or later violation of a HIPAA ad-
(B). ministrative simplification provi-
sion in which it is established
that the violation was due to will-
ful neglect and was not corrected
during the 30-day period begin-
ning on the first date the covered
entity or business associate
knew, or by exercising reason-
able diligence, would have
known that the violation occurred.
Minimum .......................................... 2016 55,010 55,910 57,051
Maximum ......................................... 2016 1,650,300 1,677,299 1,711,533
Calendar Year Cap ......................... 2016 1,650,300 1,677,299 1,711,533
263a(h)(2)(B) & 1395w– 42 CFR CMS Penalty for a clinical laboratory’s .................... .................... .................... ....................
2(b)(2)(A)(ii). 493.1834(d)(2)(i). failure to meet participation and
certification requirements and
poses immediate jeopardy.
Minimum .......................................... 2016 6,035 6,134 6,259
Maximum ......................................... 2016 19,787 20,111 20,521
42 CFR CMS Penalty for a clinical laboratory’s .................... .................... .................... -
493.1834(d)(2)(ii). failure to meet participation and
certification requirements and the
failure does not pose immediate
jeopardy.
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Minimum .......................................... 2016 99 101 103
Maximum ......................................... 2016 5,936 6,033 6,156
300gg–15(f) ..................... 45 CFR 147.200(e) ........ CMS Failure to provide the Summary of 2016 1,087 1,105 1,128
Benefits and Coverage.
300gg–18 ........................ 45 CFR 158.606 ............ CMS Penalty for violations of regulations 2016 109 111 113
related to the medical loss ratio
reporting and rebating.
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![Federal Register / Vol. 83, No. 197 / Thursday, October 11, 2018 / Rules and Regulations 51379
CIVIL MONETARY PENALTY AUTHORITIES ADMINISTERED BY HHS AGENCIES AND PENALTY AMOUNTS—Continued
[Effective October 11, 2018]
Citation Date of last 2016 2017 2018
statutorily Maximum Maximum Maximum
HHS Description 2 established adjusted adjusted adjusted
U.S.C. CFR 1 agency penalty penalty penalty penalty
figure 3 ($) ($) 4 ($)
1320a–7h(b)(1) ............... 42 CFR 402.105(d)(5), CMS Penalty for manufacturer or group .................... .................... .................... ....................
42 CFR 403.912(a) & purchasing organization failing to
(c). report information required under
42 U.S.C. 1320a–7h(a), relating
to physician ownership or invest-
ment interests.
Minimum .......................................... 2016 1,087 1,105 1,128
Maximum ......................................... 2016 10,874 11,052 11,278
Calendar Year Cap ......................... 2016 163,117 165,786 169,170
1320a–7h(b)(2) ............... 42 CFR 402.105(h), 42 CMS Penalty for manufacturer or group .................... .................... .................... ....................
CFR 403 912(b) & (c). purchasing organization know-
ingly failing to report information
required under 42 U.S.C. 1320a–
7h(a) , relating to physician own-
ership or investment interests.
Minimum .......................................... 2016 10,874 11,052 11,278
Maximum ......................................... 2016 108,745 110,524 112,780
Calendar Year Cap ......................... 2016 1,087,450 1,105,241 1,127,799
1320a–7j(h)(3)(A) ............ CMS Penalty for an administrator of a fa- 2016 108,745 110,524 112,780
cility that fails to comply with no-
tice requirements for the closure
of a facility.
42 CFR CMS Minimum penalty for the first of- 2016 544 553 564
488.446(a)(1),(2), & fense of an administrator who
(3). fails to provide notice of facility
closure.
Minimum penalty for the second of- 2016 1,631 1,658 1,692
fense of an administrator who
fails to provide notice of facility
closure.
Minimum penalty for the third and 2016 3,262 3,315 3,383
subsequent offenses of an ad-
ministrator who fails to provide
notice of facility closure.
1320a–8(a)(1) ................. CMS Penalty for an entity knowingly 2016 7,954 8,084 8,249
making a false statement or rep-
resentation of material fact in the
determination of the amount of
benefits or payments related to
old-age, survivors, and disability
insurance benefits, special bene-
fits for certain World War II vet-
erans, or supplemental security
income for the aged, blind, and
disabled.
Penalty for violation of 42 U.S.C. 2016 7,500 7,623 7,779
1320a–8(a)(1) if the violator is a
person who receives a fee or
other income for services per-
formed in connection with deter-
mination of the benefit amount or
the person is a physician or other
health care provider who submits
evidence in connection with such
a determination.
1320a–8(a)(3) ................. CMS Penalty for a representative payee 2016 6,229 6,331 6,460
(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.
1320b–25(c)(1)(A) ........... CMS Penalty for failure of covered indi- 2016 217,490 221,048 225,560
viduals to report to the Secretary
and 1 or more law enforcement
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officials any reasonable suspicion
of a crime against a resident, or
individual receiving care, from a
long-term care facility.
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![51380 Federal Register / Vol. 83, No. 197 / Thursday, October 11, 2018 / Rules and Regulations
CIVIL MONETARY PENALTY AUTHORITIES ADMINISTERED BY HHS AGENCIES AND PENALTY AMOUNTS—Continued
[Effective October 11, 2018]
Citation Date of last 2016 2017 2018
statutorily Maximum Maximum Maximum
HHS Description 2 established adjusted adjusted adjusted
U.S.C. CFR 1 agency penalty penalty penalty penalty
figure 3 ($) ($) 4 ($)
1320b–25(c)(2)(A) ........... CMS Penalty for failure of covered indi- 2016 326,235 331,572 338,339
viduals 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 fail-
ure exacerbates the harm to the
victim of the crime or results in
the harm to another individual.
1320b–25(d)(2) ............... CMS Penalty for a long-term care facility 2016 217,490 221,048 225,560
that retaliates against any em-
ployee 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.
1395b–7(b)(2)(B) ............ 42 CFR 402.105(g) ........ CMS Penalty for any person who know- 2016 147 149 152
ingly and willfully fails to furnish a
beneficiary with an itemized
statement of items or services
within 30 days of the bene-
ficiary’s request.
1395i–3(h)(2)(B)(ii)(I) ...... 42 CFR 488.408(d)(1)(iii) CMS Penalty per day for a Skilled Nurs- .................... .................... .................... ....................
ing Facility that has a Category 2
violation of certification require-
ments.
Minimum .......................................... 2016 103 105 107
Maximum ......................................... 2016 6,188 6,289 6,417
42 CFR CMS Penalty per instance of Category 2 .................... .................... .................... ....................
488.408(d)(1)(iv). noncompliance by a Skilled Nurs-
ing Facility.
Minimum .......................................... 2016 2,063 2,097 2,140
Maximum ......................................... 2016 20,628 20,965 21,393
42 CFR 488.408(e)(1)(iii) CMS Penalty per day for a Skilled Nurs- .................... .................... .................... ....................
ing Facility that has a Category 3
violation of certification require-
ments.
Minimum .......................................... 2016 6,291 6,394 6,525
Maximum ......................................... 2016 20,628 20,965 21,393
42 CFR CMS Penalty per instance of Category 3 .................... .................... .................... ....................
488.408(e)(1)(iv). noncompliance by a Skilled Nurs-
ing Facility.
Minimum .......................................... 2016 2,063 2,097 2,140
Maximum ......................................... 2016 20,628 20,965 21,393
42 CFR 488.408 CMS Penalty per day and per instance .................... .................... .................... ....................
(e)(2)(ii). for a Skilled Nursing Facility that
has Category 3 noncompliance
with Immediate Jeopardy.
Per Day (Minimum) ......................... 2016 6,291 6,394 6,525
Per Day (Maximum) ........................ 2016 20,628 20,965 21,393
Per Instance (Minimum) .................. 2016 2,063 2,097 2,140
Per Instance (Maximum) ................. 2016 20,628 20,965 21,393
42 CFR 488.438(a)(1)(i) CMS Penalty per day of a Skilled Nurs- .................... .................... .................... ....................
ing Facility that fails to meet cer-
tification requirements. These
amounts represent the upper
range per day.
Minimum .......................................... 2016 6,291 6,394 6,524
Maximum ......................................... 2016 20,628 20,965 21,393
42 CFR 488.438(a)(1)(ii) CMS Penalty per day of a Skilled Nurs- .................... .................... .................... ....................
ing Facility that fails to meet cer-
tification requirements. These
amounts represent the lower
khammond on DSK30JT082PROD with RULES
range per day.
Minimum .......................................... 2016 103 105 107
Maximum ......................................... 2016 6,188 6,289 6,418
42 CFR 488.438(a)(2) ... CMS Penalty per instance of a Skilled .................... .................... .................... ....................
Nursing Facility that fails to meet
certification requirements.
Minimum .......................................... 2016 2,063 2,097 2,140
Maximum ......................................... 2016 20,628 20,965 21,393
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![Federal Register / Vol. 83, No. 197 / Thursday, October 11, 2018 / Rules and Regulations 51381
CIVIL MONETARY PENALTY AUTHORITIES ADMINISTERED BY HHS AGENCIES AND PENALTY AMOUNTS—Continued
[Effective October 11, 2018]
Citation Date of last 2016 2017 2018
statutorily Maximum Maximum Maximum
HHS Description 2 established adjusted adjusted adjusted
U.S.C. CFR 1 agency penalty penalty penalty penalty
figure 3 ($) ($) 4 ($)
1395l(h)(5)(D) 5 ............... 42 CFR 402.105(d)(2)(i) CMS Penalty for knowingly, willfully, and 2018 15,024 15,270 30,000
repeatedly billing for a clinical di-
agnostic 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)).
1395l(i)(6) ........................ CMS Penalty for knowingly and willfully 2016 3,957 4,022 4,104
presenting or causing to be pre-
sented a bill or request for pay-
ment for an intraocular lens in-
serted during or after cataract
surgery for which the Medicare
payment rate includes the cost of
acquiring the class of lens in-
volved.
1395l(q)(2)(B)(i) .............. 42 CFR 402.105(a) ........ CMS Penalty for knowingly and willfully 2016 3,787 3,849 3,928
failing to provide information
about a referring physician when
seeking payment on an unas-
signed basis.
1395m(a)(11)(A) 5 ........... 42 CFR 402.1(c)(4), CMS Penalty for any durable medical 2018 15,024 15,270 30,000
402.105(d)(2)(ii). equipment supplier that know-
ingly 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)).
1395m(a)(18)(B) 5 ........... 42 CFR 402.1(c)(5), CMS Penalty for any nonparticipating du- 2018 15,024 15,270 30,000
402.105(d)(2)(iii). rable medical equipment supplier
that knowingly and willfully fails
to make a refund to Medicare
beneficiaries for a covered serv-
ice for which payment is pre-
cluded due to an unsolicited tele-
phone 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)).
1395m(b)(5)(C) 5 ............. 42 CFR 402.1(c)(6), CMS Penalty for any nonparticipating 2018 15,024 15,270 30,000
402.105(d)(2)(iv). physician or supplier that know-
ingly 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)).
1395m(h)(3) 5 .................. 42 CFR 402.1(c)(8), CMS Penalty for any supplier of pros- 2018 15,024 15,270 30,000
402.105(d)(2)(vi). thetic devices, orthotics, and
prosthetics that knowing and will-
fully charges for a covered pros-
thetic device, orthotic, or pros-
thetic that is furnished on a rental
basis after the rental payment
may no longer be made. (Pen-
alties 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
khammond on DSK30JT082PROD with RULES
1320a–7a(a)).
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![51382 Federal Register / Vol. 83, No. 197 / Thursday, October 11, 2018 / Rules and Regulations
CIVIL MONETARY PENALTY AUTHORITIES ADMINISTERED BY HHS AGENCIES AND PENALTY AMOUNTS—Continued
[Effective October 11, 2018]
Citation Date of last 2016 2017 2018
statutorily Maximum Maximum Maximum
HHS Description 2 established adjusted adjusted adjusted
U.S.C. CFR 1 agency penalty penalty penalty penalty
figure 3 ($) ($) 4 ($)
1395m(j)(2)(A)(iii) ............ CMS Penalty for any supplier of durable 2016 1,591 1,617 1,650
medical equipment including a
supplier of prosthetic devices,
prosthetics, orthotics, or supplies
that knowingly and willfully dis-
tributes a certificate of medical
necessity in violation of Section
1834(j)(2)(A)(i) of the Act or fails
to provide the information re-
quired under Section
1834(j)(2)(A)(ii) of the Act.
1395m(j)(4) 5 ................... 42 CFR 402.1(c)(10), CMS Penalty for any supplier of durable 2018 15,024 15,270 30,000
402.105(d)(2)(vii). medical equipment, including a
supplier of prosthetic devices,
prosthetics, orthotics, or supplies
that knowingly and willfully fails
to make refunds in a timely man-
ner to Medicare beneficiaries for
series billed other than on as as-
signment-related basis under cer-
tain conditions. (Penalties are as-
sessed 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)).
1395m(k)(6) 5 .................. 42 CFR 402.1(c)(31), CMS Penalty for any person or entity 2018 15,024 15,270 30,000
402.105(d)(3). who knowingly and willfully bills
or collects for any outpatient
therapy services or comprehen-
sive outpatient rehabilitation serv-
ices on other than an assign-
ment-related basis. (Penalties
are assessed in the same man-
ner as 42 U.S.C. 1395m(k)(6)
and 1395u(j)(2)(B), which is as-
sessed according to 1320a–
7a(a)).
1395m(l)(6) 5 ................... 42 CFR 402.1(c)(32), CMS Penalty for any supplier of ambu- 2018 15,024 15,270 30,000
402.105(d)(4). lance services who knowingly
and willfully fills or collects for
any services on other than an
assignment-related basis. (Pen-
alties are assessed in the same
manner as 42 U.S.C.
1395u(b)(18)(B), which is as-
sessed according to 1320a–
7a(a)).
1395u(b)(18)(B) 5 ............ 42 CFR 402.1(c)(11), CMS Penalty for any practitioner speci- 2018 15,024 15,270 30,000
402.105(d)(2)(viii). fied 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 as-
signment-related basis. (Pen-
alties are assessed in the same
manner as 42 U.S.C.
1395u(j)(2)(B), which is assessed
according to 1320a–7a(a)).
1395u(j)(2)(B) 5 ............... 42 CFR 402.1(c) ............ CMS Penalty for any physician who 2018 15,024 15,270 30,000
charges more than 125% for a
non-participating referral. (Pen-
alties are assessed in the same
manner as 42 U.S.C. 1320a–
7a(a)).
1395u(k) 5 ........................ 42 CFR 402.1(c)(12), CMS Penalty for any physician who 2018 15,024 15,270 30,000
402.105(d)(2)(ix). knowingly and willfully presents
or causes to be presented a
khammond on DSK30JT082PROD with RULES
claim for bill for an assistant at a
cataract surgery performed on or
after March 1, 1987, for which
payment may not be made be-
cause 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)).
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![Federal Register / Vol. 83, No. 197 / Thursday, October 11, 2018 / Rules and Regulations 51383
CIVIL MONETARY PENALTY AUTHORITIES ADMINISTERED BY HHS AGENCIES AND PENALTY AMOUNTS—Continued
[Effective October 11, 2018]
Citation Date of last 2016 2017 2018
statutorily Maximum Maximum Maximum
HHS Description 2 established adjusted adjusted adjusted
U.S.C. CFR 1 agency penalty penalty penalty penalty
figure 3 ($) ($) 4 ($)
1395u(l)(3) 5 .................... 42 CFR 402.1(c)(13), CMS Penalty for any nonparticipating 2018 15,024 15,270 30,000
402.105(d)(2)(x). physician who does not accept
payment on an assignment-re-
lated basis and who knowingly
and willfully fails to refund on a
timely basis any amounts col-
lected for services that are not
reasonable or medically nec-
essary or are of poor quality
under 1842(l)(1)(A). (Penalties
are assessed in the same man-
ner as 42 U.S.C. 1395u(j)(2)(B),
which is assessed according to
1320a–7a(a)).
1395u(m)(3) 5 .................. 42 CFR 402.1(c)(14), CMS Penalty for any nonparticipating 2018 15,024 15,270 30,000
402.105(d)(2)(xi). physician charging more than
$500 who does not accept pay-
ment for an elective surgical pro-
cedure on an assignment related
basis and who knowingly and
willfully fails to disclose the re-
quired information regarding
charges and coinsurance
amounts and fails to refund on a
timely basis any amount col-
lected for the procedure in ex-
cess of the charges recognized
and approved by the Medicare
program. (Penalties are as-
sessed in the same manner as
42 U.S.C. 1395u(j)(2)(B), which
is assessed according to 1320a–
7a(a)).
1395u(n)(3) 5 ................... 42 CFR 402.1(c)(15), CMS Penalty for any physician who 2018 15,024 15,270 30,000
402.105(d)(2)(xii). knowingly, willfully, and repeat-
edly bills one or more bene-
ficiaries 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)).
1395u(o)(3)(B) 5 .............. 42 CFR 414.707(b) ........ CMS Penalty for any practitioner speci- 2018 15,024 15,270 30,000
fied in Section 1842(b)(18)(C) of
the Act or other person that
knowingly and willfully bills or
collects for any services per-
taining to drugs or biologics by
the practitioners on other than an
assignment-related basis. (Pen-
alties 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)).
1395u(p)(3)(A) ................ ........................................ CMS Penalty for any physician or practi- 2016 3,957 4,022 4,104
tioner who knowingly and willfully
fails promptly to provide the ap-
propriate diagnosis codes upon
CMS or Medicare administrative
contractor request for payment or
bill not submitted on an assign-
ment-related basis.
1395w–3a(d)(4)(A) .......... 42 CFR 414.806 ............ CMS Penalty for a pharmaceutical manu- 2016 12,856 13,066 13,333
facturer’s misrepresentation of
average sales price of a drug, or
khammond on DSK30JT082PROD with RULES
biologic.
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![51384 Federal Register / Vol. 83, No. 197 / Thursday, October 11, 2018 / Rules and Regulations
CIVIL MONETARY PENALTY AUTHORITIES ADMINISTERED BY HHS AGENCIES AND PENALTY AMOUNTS—Continued
[Effective October 11, 2018]
Citation Date of last 2016 2017 2018
statutorily Maximum Maximum Maximum
HHS Description 2 established adjusted adjusted adjusted
U.S.C. CFR 1 agency penalty penalty penalty penalty
figure 3 ($) ($) 4 ($)
1395w–4(g)(1)(B) 5 .......... 42 CFR 402.1(c)(17), CMS Penalty for any nonparticipating 2018 15,024 15,270 30,000
402.105(d)(2)(xiii). physician, supplier, or other per-
son that furnishes physician serv-
ices not on an assignment-re-
lated basis who either knowingly
and willfully bills or collects in ex-
cess 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)).
1395w–4(g)(3)(B) 5 .......... 42 CFR 402.1(c)(18), CMS Penalty for any person that know- 2018 15,024 15,270 30,000
402.105(d)(2)(xiv). ingly and willfully bills for statu-
torily defined State-plan ap-
proved physicians’ services on
any other basis than an assign-
ment-related basis for a Medi-
care/Medicaid dual eligible bene-
ficiary. (Penalties are assessed
in the same manner as 42
U.S.C. 1395u(j)(2)(B), which is
assessed according to 1320a–
7a(a)).
1395w–27(g)(3)(A); 42 CFR 422.760(b); 42 CMS Penalty for each termination deter- 2016 36,794 37,396 38,159
1857(g)(3). CFR 423.760(b). mination the Secretary makes
that is the result of actions by a
Medicare Advantage organization
or Part D sponsor that has ad-
versely affected an individual
covered under the organization’s
contract.
1395w–27(g)(3)(B); ........................................ CMS Penalty for each week beginning 2016 14,718 14,959 15,264
1857(g)(3). after the initiation of civil money
penalty procedures by the Sec-
retary because a Medicare Ad-
vantage organization or Part D
sponsor has failed to carry out a
contract, or has carried out a
contract inconsistently with regu-
lations.
1395w–27(g)(3)(D); ........................................ CMS Penalty for a Medicare Advantage 2016 136,689 138,925 141,760
1857(g)(3). organization’s or Part D spon-
sor’s early termination of its con-
tract.
1395y(b)(3)(C) ................ 42 CFR 411.103(b) ........ CMS Penalty for an employer or other 2016 8,908 9,054 9,239
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.
1395y(b)(5)(C)(ii) ............ 42 CFR 402.1(c)(20), 42 CMS Penalty for any non-governmental 2016 1,450 1,474 1,504
CFR 402.105(b)(2). employer that, before October 1,
1998, willfully or repeatedly failed
to provide timely and accurate in-
formation requested relating to
an employee’s group health in-
surance coverage.
1395y(b)(6)(B) ................. 42 CFR 402.1(c)(21), CMS Penalty for any entity that know- 2016 3,182 3,234 3,300
402.105(a). ingly, willfully, and repeatedly
fails to complete a claim form re-
lating to the availability of other
health benefits in accordance
with statute or provides inac-
curate information relating to
khammond on DSK30JT082PROD with RULES
such on the claim form.
1395y(b)(7)(B)(i) ............. ........................................ CMS Penalty for any entity serving as in- 2016 1,138 1,157 1,181
surer, 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.
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![Federal Register / Vol. 83, No. 197 / Thursday, October 11, 2018 / Rules and Regulations 51385
CIVIL MONETARY PENALTY AUTHORITIES ADMINISTERED BY HHS AGENCIES AND PENALTY AMOUNTS—Continued
[Effective October 11, 2018]
Citation Date of last 2016 2017 2018
statutorily Maximum Maximum Maximum
HHS Description 2 established adjusted adjusted adjusted
U.S.C. CFR 1 agency penalty penalty penalty penalty
figure 3 ($) ($) 4 ($)
1395pp(h) 5 ..................... 42 CFR 402.1(c)(23), CMS Penalty for any durable medical 2018 15,024 15,270 30,000
402.105(d)(2)(xv). equipment supplier, including a
supplier of prosthetic devices,
prosthetics, orthotics, or supplies,
that knowingly and willfully fails
to make refunds in a timely man-
ner 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)).
1395nn(g)(5) ................... 42 CFR 411.361 ............ CMS Penalty for any person that fails to 2016 18,936 19,246 19,639
report information required by
HHS under Section 1877(f) con-
cerning ownership, investment,
and compensation arrangements.
1395pp(h) ........................ 42 CFR 402.1(c)(23), CMS Penalty for any durable medical 2016 15,024 15,270 15,582
402.105(d)(2)(xv). equipment supplier, including a
supplier of prosthetic devices,
prosthetics, orthotics, or supplies,
that knowingly and willfully fails
to make refunds in a timely man-
ner 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)).
1395ss(a)(2) .................... 42 CFR 402.1(c)(24), CMS Penalty for any person that issues 2016 51,569 52,413 53,483
405.105(f)(1). a Medicare supplemental policy
that has not been approved by
the State regulatory program or
does not meet Federal standards
after a statutorily defined effec-
tive date.
1395ss(d)(3)(A)(vi)(II) ..... ........................................ CMS Penalty for someone other than 2016 26,723 27,160 27,714
issuer that sells or issues a
Medicare supplemental policy to
beneficiary without a disclosure
statement.
Penalty for an issuer that sells or 2016 44,539 45,268 46,192
issues a Medicare supplemental
policy without disclosure state-
ment.
1395ss(d)(3)(B)(iv) .......... ........................................ CMS Penalty for someone other than 2016 26,723 27,160 27,714
issuer that sells or issues a
Medicare supplemental policy
without acknowledgement form..
Penalty for issuer that sells or 2016 44,539 45,268 46,192
issues a Medicare supplemental
policy without an acknowledge-
ment form.
1395ss(p)(8) .................... 42 CFR 402.1(c)(25), CMS Penalty for any person that sells or 2016 26,723 27,160 27,714
402.105(e). issues Medicare supplemental
polices after a given date that fail
to conform to the NAIC or Fed-
eral standards established by
statute.
42 CFR 402.1(c)(25), CMS Penalty for any person that sells or 2016 44,539 45,268 46,192
405.105(f)(2). issues Medicare supplemental
polices after a given date that fail
to conform to the NAIC or Fed-
eral standards established by
statute.
1395ss(p)(9)(C) ............... 42 CFR 402.1(c)(26), CMS Penalty for any person that sells a 2016 26,723 27,160 27,714
khammond on DSK30JT082PROD with RULES
402.105(e). Medicare supplemental policy
and fails to make available for
sale the core group of basic ben-
efits when selling other Medicare
supplemental policies with addi-
tional benefits or fails to provide
the individual, before selling the
policy, an outline of coverage de-
scribing benefits.
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![51386 Federal Register / Vol. 83, No. 197 / Thursday, October 11, 2018 / Rules and Regulations
CIVIL MONETARY PENALTY AUTHORITIES ADMINISTERED BY HHS AGENCIES AND PENALTY AMOUNTS—Continued
[Effective October 11, 2018]
Citation Date of last 2016 2017 2018
statutorily Maximum Maximum Maximum
HHS Description 2 established adjusted adjusted adjusted
U.S.C. CFR 1 agency penalty penalty penalty penalty
figure 3 ($) ($) 4 ($)
42 CFR 402.1(c)(26), Penalty for any person that sells a 2016 44,539 45,268 46,192
405.105(f)(3), (4). Medicare supplemental policy
and fails to make available for
sale the core group of basic ben-
efits when selling other Medicare
supplemental policies with addi-
tional benefits or fails to provide
the individual, before selling the
policy, an outline of coverage de-
scribing benefits.
1395ss(q)(5)(C) ............... 42 CFR 402.1(c)(27), CMS Penalty for any person that fails to 2016 44,539 45,268 46,192
405.105(f)(5). suspend the policy of a policy-
holder made eligible for medical
assistance or automatically rein-
states the policy of a policyholder
who has lost eligibility for medical
assistance, under certain cir-
cumstances.
1395ss(r)(6)(A) ................ 42 CFR 402.1(c)(28), CMS Penalty for any person that fails to 2016 44,539 45,268 46,192
405.105(f)(6). provide refunds or credits as re-
quired by section 1882(r)(1)(B).
1395ss(s)(4) .................... 42 CFR 402.1(c)(29), CMS Penalty for any issuer of a Medi- 2016 18,908 19,217 19,609
405.105(c). care supplemental policy that
does not waive listed time peri-
ods 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.
1395ss(t)(2) ..................... 42 CFR 402.1(c)(30), CMS Penalty for any issuer of a Medi- 2016 44,539 45,268 46,192
405.105(f)(7). care supplemental policy that
fails to fulfill listed responsibilities.
1395ss(v)(4)(A) ............... ........................................ CMS Penalty someone other than issuer 2016 19,284 19,599 19,999
who sells, issues, or renews a
Medigap Rx policy to an indi-
vidual who is a Part D enrollee.
Penalty for an issuer who sells, 2016 32,140 32,666 33,333
issues, or renews a Medigap Rx
policy who is a Part D enrollee.
1395bbb(c)(1) ................. 42 CFR 488.725(c) ........ CMS Penalty for any individual who noti- 2016 4,126 4,194 4,280
fies 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.
1395bbb(f)(2)(A)(i) .......... 42 CFR CMS Maximum daily penalty amount for 2016 19,787 20,111 20,521
488.845(b)(2)(iii); 42 each day a home health agency
CFR 488.845(b)(3)– is not in compliance with statu-
(6); and 42 CFR tory requirements.
488.845(d)(1)(ii).
42 CFR 488.845(b)(3) ... Penalty per day for home health .................... .................... .................... ....................
agency’s noncompliance (Upper
Range).
Minimum .......................................... 2016 16,819 17,094 17,443
Maximum ......................................... 2016 19,787 20,111 20,521
42 CFR 488.845(b)(3)(i) Penalty for a home health agency’s 2016 19,787 20,111 20,521
deficiency or deficiencies that
cause immediate jeopardy and
result in actual harm.
42 CFR 488.845(b)(3)(ii) Penalty for a home health agency’s 2016 17,808 18,099 18,468
deficiency or deficiencies that
cause immediate jeopardy and
result in potential for harm.
42 CFR 488.845(b)(3)(iii) Penalty for an isolated incident of 2016 16,819 17,094 17,443
khammond on DSK30JT082PROD with RULES
noncompliance in violation of es-
tablished HHA policy.
42 CFR 488.845(b)(4) ... Penalty for a repeat and/or condi- .................... .................... .................... ....................
tion-level deficiency that does not
constitute immediate jeopardy,
but is directly related to poor
quality patient care outcomes
(Lower Range).
Minimum .......................................... 2016 2,968 3,017 3,079
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![Federal Register / Vol. 83, No. 197 / Thursday, October 11, 2018 / Rules and Regulations 51387
CIVIL MONETARY PENALTY AUTHORITIES ADMINISTERED BY HHS AGENCIES AND PENALTY AMOUNTS—Continued
[Effective October 11, 2018]
Citation Date of last 2016 2017 2018
statutorily Maximum Maximum Maximum
HHS Description 2 established adjusted adjusted adjusted
U.S.C. CFR 1 agency penalty penalty penalty penalty
figure 3 ($) ($) 4 ($)
Maximum ......................................... 2016 16,819 17,094 17,443
42 CFR 488.845(b)(5) ... Penalty for a repeat and/or condi- .................... .................... .................... ....................
tion-level deficiency that does not
constitute immediate jeopardy
and that is related predominately
to structure or process-oriented
conditions (Lower Range).
Minimum .......................................... 2016 989 1,005 1,026
Maximum ......................................... 2016 7,915 8,044 8,208
42 CFR 488.845(b)(6) ... Penalty imposed for instance of .................... .................... .................... ....................
noncompliance that may be as-
sessed for one or more singular
events of condition-level non-
compliance that are identified
and where the noncompliance
was corrected during the onsite
survey.
Minimum .......................................... 2016 1,979 2,011 2,052
Maximum ......................................... 2016 19,787 20,111 20,521
Penalty for each day of noncompli- 2016 19,787 20,111 20,521
ance (Maximum).
42 CFR 488.845(d)(1)(ii) Penalty for each day of noncompli- 2016 19,787 20,111 20,521
ance (Maximum).
1396b(m)(5)(B) ............... 42 CFR 460.46 .............. CMS Penalty for PACE organization’s .................... .................... .................... ....................
practice that would reasonably
be expected to have the effect of
denying or discouraging enroll-
ment.
Minimum .......................................... 2016 22,077 22,438 22,896
Maximum ......................................... 2016 147,177 149,585 152,638
Penalty for a PACE organization 2016 36,794 37,396 38,159
that charges excessive premiums.
Penalty for a PACE organization 2016 147,177 149,585 152,638
misrepresenting or falsifying in-
formation to CMS, the State, or
an individual or other entity.
Penalty for each determination the 2016 36,794 37,396 38,159
CMS makes that the PACE orga-
nization has failed to provide
medically necessary items and
services of the failure has ad-
versely affected (or has the sub-
stantial likelihood of adversely af-
fecting) a PACE participant.
Penalty for involuntarily disenrolling 2016 36,794 37,396 38,159
a participant.
Penalty for discriminating or dis- 2016 36,794 37,396 38,159
couraging enrollment or
disenrollment of participants on
the basis of an individual’s health
status or need for health care
services.
1396r(h)(3)(C)(ii)(I) .......... 42 CFR 488.408(d)(1)(iii) CMS Penalty per day for a nursing facili- .................... .................... .................... ....................
ty’s failure to meet a Category 2
Certification.
Minimum .......................................... 2016 103 105 107
Maximum ......................................... 2016 6,188 6,289 6,417
42 CFR CMS Penalty per instance for a nursing .................... .................... .................... ....................
488.408(d)(1)(iv). facility’s failure to meet Category
2 certification.
Minimum .......................................... 2016 2,063 2,097 2,140
Maximum ......................................... 2016 20,628 20,965 21,393
42 CFR 488.408(e)(1)(iii) CMS Penalty per day for a nursing facili- .................... .................... .................... ....................
ty’s failure to meet Category 3
certification.
Minimum .......................................... 2016 6,291 6,394 6,525
Maximum ......................................... 2016 20,628 20,965 21,393
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42 CFR CMS Penalty per instance for a nursing .................... .................... .................... ....................
488.408(e)(1)(iv). facility’s failure to meet Category
3 certification.
Minimum .......................................... 2016 2,063 2,097 2,140
Maximum ......................................... 2016 20,628 20,965 21,393
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.
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![51388 Federal Register / Vol. 83, No. 197 / Thursday, October 11, 2018 / Rules and Regulations
CIVIL MONETARY PENALTY AUTHORITIES ADMINISTERED BY HHS AGENCIES AND PENALTY AMOUNTS—Continued
[Effective October 11, 2018]
Citation Date of last 2016 2017 2018
statutorily Maximum Maximum Maximum
HHS Description 2 established adjusted adjusted adjusted
U.S.C. CFR 1 agency penalty penalty penalty penalty
figure 3 ($) ($) 4 ($)
Minimum .......................................... 2016 2,063 2,097 2,140
Maximum ......................................... 2016 20,628 20,965 21,393
42 CFR 488.438(a)(1)(i) CMS Penalty per day for nursing facility’s .................... .................... .................... ....................
failure to meet certification
(Upper Range).
Minimum .......................................... 2016 6,291 6,394 6,525
Maximum ......................................... 2016 20,628 20,965 21,393
42 CFR 488.438(a)(1)(ii) CMS Penalty per day for nursing facility’s .................... .................... .................... ....................
failure to meet certification
(Lower Range).
Minimum .......................................... 2016 103 105 107
Maximum ......................................... 2016 6,188 6,289 6,417
42 CFR 488.438(a)(2) ... CMS Penalty per instance for nursing fa- .................... .................... .................... ....................
cility’s failure to meet certification.
Minimum .......................................... 2016 2,063 2,097 2,140
Maximum ......................................... 2016 20,628 20,965 21,393
1396r(f)(2)(B)(iii)(I)(c) ...... 42 CFR CMS Grounds to prohibit approval of 2016 10,314 10,483 10,697
483.151(b)(2)(iv) and Nurse Aide Training Program—if
(b)(3)(iii). 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].
1396r(h)(3)(C)(ii)(I) .......... 42 CFR 483.151(c)(2) ... CMS Grounds to waive disapproval of 2016 10,314 10,483 10,697
nurse aide training program—ref-
erence to disapproval based on
imposition of CMP ‘‘not less than
$5,000’’ [Not CMP authority but
CMP imposition at this level de-
termines eligibility to seek waiver
of disapproval of nurse aide
training program].
1396t(j)(2)(C) .................. ........................................ CMS Penalty for each day of noncompli- .................... .................... .................... ....................
ance for a home or community
care provider that no longer
meets the minimum requirements
for home and community care.
Minimum .......................................... 2016 2 2 2
Maximum ......................................... 2016 17,816 18,107 18,477
1396u–2(e)(2)(A)(i) ......... 42 CFR 438.704 ............ CMS Penalty for a Medicaid managed 2016 36,794 37,396 38,159
care organization that fails sub-
stantially to provide medically
necessary items and services.
Penalty for Medicaid managed care 2016 36,794 37,396 38,159
organization that imposes pre-
miums or charges on enrollees in
excess of the premiums or
charges permitted.
Penalty for a Medicaid managed 2016 36,794 37,396 38,159
care organization that misrepre-
sents or falsifies information to
another individual or entity.
Penalty for a Medicaid managed 2016 36,794 37,396 38,159
care organization that fails to
comply with the applicable statu-
tory requirements for such orga-
nizations.
1396u–2(e)(2)(A)(ii) ........ 42 CFR 438.704 ............ CMS Penalty for a Medicaid managed 2016 147,177 149,585 152,638
care organization that misrepre-
sents or falsifies information to
the HHS Secretary.
Penalty for Medicaid managed care 2016 147,177 149,585 152,638
organization that acts to discrimi-
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nate among enrollees on the
basis of their health status.
1396u–2(e)(2)(A)(iv) ....... 42 CFR 438.704 ............ CMS Penalty for each individual that 2016 22,077 22,438 22,896
does not enroll as a result of a
Medicaid managed care organi-
zation that acts to discriminate
among enrollees on the basis of
their health status.
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![Federal Register / Vol. 83, No. 197 / Thursday, October 11, 2018 / Rules and Regulations 51389
CIVIL MONETARY PENALTY AUTHORITIES ADMINISTERED BY HHS AGENCIES AND PENALTY AMOUNTS—Continued
[Effective October 11, 2018]
Citation Date of last 2016 2017 2018
statutorily Maximum Maximum Maximum
HHS Description 2 established adjusted adjusted adjusted
U.S.C. CFR 1 agency penalty penalty penalty penalty
figure 3 ($) ($) 4 ($)
1396u(h)(2) ..................... 42 CFR Part 441, Sub- CMS Penalty for a provider not meeting 2016 20,628 20,965 21,393
part I. one of the requirements relating
to the protection of the health,
safety, and welfare of individuals
receiving community supported
living arrangements services.
1396w–2(c)(1) ................. CMS Penalty for disclosing information 2016 11,002 11,182 11,410
related to eligibility determina-
tions for medical assistance pro-
grams.
18041(c)(2) ..................... 45 CFR 150.315; 45 CMS Failure to comply with requirements 2016 150 152 155
CFR 156.805(c). 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)).
18081(h)(1)(A)(i)(II) ......... 42 CFR 155.285 ............ CMS Penalty for providing false informa- 2016 27,186 27,631 28,195
tion on Exchange application.
18081(h)(1)(B) ................ 42 CFR 155.285 ............ CMS Penalty for knowingly or willfully 2016 271,862 276,310 281,949
providing false information on Ex-
change application.
18081(h)(2) ..................... 42 CFR 155.260 ............ CMS Penalty for knowingly or willfully 2016 27,186 27,631 28,195
disclosing protected information
from Exchange.
31 U.S.C.
1352 ................................ 45 CFR 93.400(e) .......... HHS Penalty for the first time an indi- 2016 18,936 19,246 19,639
vidual makes an expenditure pro-
hibited by regulations regarding
lobbying disclosure, absent ag-
gravating circumstances.
Penalty for second and subsequent .................... .................... .................... ....................
offenses by individuals who
make an expenditure prohibited
by regulations regarding lobbying
disclosure.
Minimum .......................................... 2016 18,936 19,246 19,639
Maximum ......................................... 2016 189,361 192,459 196,387
Penalty for the first time an indi- 2016 18,936 19,246 19,639
vidual fails to file or amend a lob-
bying disclosure form, absent ag-
gravating circumstances.
Penalty for second and subsequent .................... .................... .................... ....................
offenses by individuals who fail
to file or amend a lobbying dis-
closure form, absent aggravating
circumstances.
Minimum .......................................... 2016 18,936 19,246 19,639
Maximum ......................................... 2016 189,361 192,459 196,387
45 CFR Part 93, Appen- HHS Penalty for failure to provide certifi- .................... .................... .................... ....................
dix A. cation regarding lobbying in the
award documents for all sub-
awards of all tiers.
Minimum .......................................... 2016 18,936 19,246 19,639
Maximum ......................................... 2016 189,361 192,459 196,387
Penalty for failure to provide state- .................... .................... .................... ....................
ment regarding lobbying for loan
guarantee and loan insurance
transactions.
Minimum .......................................... 2016 18,936 19,246 19,639
Maximum ......................................... 2016 189,361 192,459 196,387
3801–3812 ...................... 45 CFR 79.3(a)(1)(iv) .... HHS Penalty against any individual 2016 9,894 10,056 10,261
who—with knowledge or reason
to know—makes, presents or
submits a false, fictitious or
fraudulent claim to the Depart-
khammond on DSK30JT082PROD with RULES
ment.
45 CFR 79.3(b)(1(ii) ...... HHS Penalty against any individual 2016 9,894 10,056 10,261
who—with knowledge or reason
to know—makes, presents or
submits a false, fictitious or
fraudulent claim to the Depart-
ment.
1 Some HHS components have not promulgated regulations regarding their civil monetary penalty-specific statutory authorities.
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![51390 Federal Register / Vol. 83, No. 197 / Thursday, October 11, 2018 / Rules and Regulations
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 2018, based on the CPI–U for the month of October 2017, not seasonally adjusted, is 1.02041, as indicated in OMB Memorandum
M–18–03, ‘‘Implementation of Penalty Inflation Adjustments for 2018, Pursuant to the Federal Civil Penalties Adjustment Act Improvements Act of 2015’’ (December
15, 2017).
5 2018 Maximum Adjusted Penalty column adjusted based on changes to the Bipartisan Budget Act of 2018 for 42 U.S.C.1320a–7a(a),1320a–7a(b),
1395l(h)(5)(D),1395m(a)(11)(A),1395m(a)(18)(B), 1395m(b)(5)(C), 1395m(h)(3), 1395m(j)(4), 1395m(k)(6), 1395m(l)(6), 1395u(b)(18)(B), 1395u(j)(2)(B), 1395u(k),
1395u(l)(3), 1395u(m)(3), 1395u(n)(3), 1395u(o)(3)(B), 1395w–4(g)(1)(B), 1395w–4(g)(3)(B),1395pp(h).
Mexico (FMP). The Gulf of Mexico gray triggerfish and is consistent with
Dated: October 3, 2018. Fishery Management Council (Council) the Magnuson-Stevens Act and other
Alex M. Azar II, prepared the FMP and NMFS applicable laws.
Secretary, Department of Health and Human implements the FMP under the This action is taken under 50 CFR
Services. authority of the Magnuson-Stevens
622.41(b)(1) and is exempt from review
[FR Doc. 2018–22005 Filed 10–10–18; 8:45 am] Fishery Conservation and Management
under Executive Order 12866.
BILLING CODE 4150–24–P Act (Magnuson-Stevens Act) by
regulations at 50 CFR part 622. All gray These measures are exempt from the
triggerfish weights discussed in this procedures of the Regulatory Flexibility
DEPARTMENT OF COMMERCE temporary rule are in round weight. Act because the temporary rule is issued
On August 4, 2008, NMFS established without opportunity for prior notice and
National Oceanic and Atmospheric gray triggerfish AMs as well as comment.
Administration commercial quotas for gray triggerfish
This action responds to the best
through Amendment 30A to the FMP
scientific information available. The
50 CFR Part 622 (73 FR 38139). On May 9, 2013, NMFS
issued a final rule to implement Assistant Administrator for NOAA
[Docket No. 121004518–3398–01] Amendment 37 to the FMP (78 FR Fisheries (AA) finds that the need to
27084). In part, Amendment 37 revised immediately implement this action to
RIN 0648–XG524
gray triggerfish commercial ACLs and close the commercial sector for gray
Reef Fish Fishery of the Gulf of ACTs. The 2018 commercial quota (i.e., triggerfish constitutes good cause to
Mexico; 2018 Commercial the commercial ACT) for Gulf gray waive the requirements to provide prior
Accountability Measure and Closure triggerfish specified in 50 CFR notice and opportunity for public
for Gulf of Mexico Gray Triggerfish 622.39(a)(1)(vi) is 60,900 lb (27,624 kg). comment on this temporary rule
As specified by 50 CFR 622.41(b)(1), pursuant to the authority set forth in 5
AGENCY: National Marine Fisheries NMFS is required to close the U.S.C. 553(b)(B), because such
Service (NMFS), National Oceanic and commercial sector for gray triggerfish procedures are unnecessary and
Atmospheric Administration (NOAA), when the commercial quota is reached, contrary to the public interest. Such
Commerce. or is projected to be reached, by filing procedures are unnecessary because
ACTION: Temporary rule; closure. a notification to that effect with the Amendment 37 to the FMP (78 FR
Office of the Federal Register. NMFS has 27084; May 9, 2013), which established
SUMMARY: NMFS implements determined the 2018 commercial quota
accountability measures (AMs) for the the closure provisions, was subject to
for Gulf gray triggerfish will be reached
gray triggerfish commercial sector in the notice and comment, and all that
by October 7, 2018. Accordingly, this
exclusive economic zone (EEZ) of the remains is to notify the public of the
temporary rule closes the commercial
Gulf of Mexico (Gulf) through this sector for Gulf gray triggerfish effective closure. Such procedures are contrary to
temporary rule. NMFS projects that at 12:01 a.m., local time, October 7, the public interest because of the need
2018 commercial landings for gray 2018, and it will remain closed until the to immediately implement this action to
triggerfish will reach the commercial start of the next commercial fishing protect gray triggerfish since the
annual catch target (ACT) (commercial season on January 1, 2019. capacity of the fishing fleet allows for
quota) by October 7, 2018. Therefore, During the commercial closure, the rapid harvest of the commercial quota.
NMFS is closing the commercial sector operator of a vessel with a valid Prior notice and opportunity for public
for Gulf gray triggerfish on October 7, commercial vessel permit for Gulf reef comment would require time and could
2018, and it will remain closed through fish having gray triggerfish onboard potentially result in a harvest well in
the end of the fishing year on December must have landed and bartered, traded, excess of the established commercial
31, 2018. This closure is necessary to or sold such gray triggerfish prior to quota.
protect the Gulf gray triggerfish 12:01 a.m., local time, October 7, 2018.
For the aforementioned reasons, the
resource. During the closure, the sale or purchase
AA also finds good cause to waive the
DATES: This temporary rule is effective of gray triggerfish taken from the Gulf
EEZ is prohibited. The prohibition on 30-day delay in the effectiveness of this
at 12:01 a.m., local time, on October 7, action under 5 U.S.C. 553(d)(3).
2018, until 12:01 a.m., local time, on the sale or purchase does not apply to
January 1, 2019. gray triggerfish that were harvested, Authority: 16 U.S.C. 1801 et seq.
landed ashore, and sold prior to 12:01
FOR FURTHER INFORMATION CONTACT: Margo B. Schulze-Haugen,
a.m., local time, October 7, 2018, and
Lauren Waters, NMFS Southeast were held in cold storage by a dealer or Acting Director, Office of Sustainable
khammond on DSK30JT082PROD with RULES
Regional Office, telephone: 727–824– processor. Fisheries, National Marine Fisheries Service.
5305, email: lauren.waters@noaa.gov. [FR Doc. 2018–22142 Filed 10–5–18; 4:15 pm]
SUPPLEMENTARY INFORMATION: NMFS Classification
BILLING CODE 3510–22–P
manages the Gulf reef fish fishery, The Regional Administrator for the
which includes gray triggerfish, under NMFS Southeast Region has determined
the Fishery Management Plan for the this temporary rule is necessary for the
Reef Fish Resources of the Gulf of conservation and management of Gulf
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Document Created: 2018-10-11 15:37:03
Document Modified: 2018-10-11 15:37:03
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| Action | Final rule. | |
| Dates | This rule is effective October 11, 2018. | |
| Contact | Shaunta Johnson, Office of Grants and Acquisition Policy and Accountability, Office of the Assistant Secretary for Financial Resources, Room 514-G, Hubert Humphrey Building, 200 Independence Avenue SW, Washington, DC 20201; 202-690- 6396; FAX 202-690-5405. | |
| FR Citation | 83 FR 51369 | |
| CFR Associated | Administrative Practice and Procedure and Penalties |
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