82 FR 9174 - Annual Civil Monetary Penalties Inflation Adjustment
DEPARTMENT OF HEALTH AND HUMAN SERVICES Federal Register Volume 82, Issue 22 (February 3, 2017)
Federal Register Volume 82, Issue 22 (February 3, 2017)
| Page Range | 9174-9189 | |
| FR Document | 2017-02300 |
[Federal Register Volume 82, Number 22 (Friday, February 3, 2017)] [Rules and Regulations] [Pages 9174-9189] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-02300] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES 45 CFR Part 102 RIN 0991-AC0 Annual Civil Monetary Penalties Inflation Adjustment AGENCY: Department of Health and Human Services, Office of the Assistant Secretary for Financial Resources. ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: The Department of Health and Human Services (HHS) is updating its regulations to reflect required annual inflation-related increases to the civil monetary penalties in its regulations, pursuant to the Federal Civil Penalties Inflation Adjustment Act Improvement Act of 2015. DATES: This rule is effective February 3, 2017. FOR FURTHER INFORMATION CONTACT: Andrea Brandon, Deputy Assistant Secretary for Grants and Acquisitions, 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 ``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 penalties 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 16, 2016, OMB Memorandum for the Heads of Executive Agencies and Departments, M-17-11, Implementation of the 2017 annual adjustment 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 2017, based on the CPI-U for the month of October 2016, not seasonally adjusted, is 1.01636. Using the 2017 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 A. Executive Order 12866: Regulatory Planning and Review and Executive Order 13563: Improving Regulation and Regulatory Review Section 4 of the 2015 Act directs federal agencies to publish annual adjustments no later than January 15, 2017. In accordance with section 553 of the Administrative Procedure Act (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-17-11, Memorandum of the Heads of Executive Departments and Agencies (December 16, 2016) the phrase ``notwithstanding section 553'' means that ``the public procedure the APA generally provides--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. B. Review Under Procedural Statutes and Executive Orders Pursuant to OMB Memorandum for the Heads of Executive Departments and Agencies, M-17-11, HHS has determined that making technical changes to the amount of 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 February 3, 2017. The adjusted civil penalty amounts apply to civil penalties assessed on or after February 3, 2017, when the [[Page 9175]] violation occurred after November 2, 2015. If the violation occurred prior to November 2, 2015, or a penalty was assessed prior to September 6, 2016, the pre-adjustment civil penalty amounts in effect prior to September 6, 2016 will apply. List of Subjects in 45 CFR Part 102 Administrative practice and procedure, Penalties. For reasons discussed in the preamble, the Department of Health and Human Services amends 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 February 3, 2017] -------------------------------------------------------------------------------------------------------------------------------------------------------- Citation Date of ------------------------------------------------------------------- last 2016 2017 penalty Maximum Maximum HHS agency Description \2\ figure or adjusted adjusted U.S.C. CFR \1\ adjustment penalty ($) penalty ($) \3\ \4\ -------------------------------------------------------------------------------------------------------------------------------------------------------- 21 U.S.C.: 333(b)(2)(A)......................... ....................... FDA............. Penalty for violations 2016 98,935 100,554 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 violation 2016 1,978,690 2,011,061 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 to make 2016 197,869 201,106 a report required by 21 U.S.C. 353(d)(3)(E) relating to drug samples. 333(f)(1)(A)......................... ....................... FDA............. Penalty for any person who 2016 26,723 27,160 violates a requirement related to devices for each such violation. Penalty for aggregate of 2016 1,781,560 1,810,706 all violations related to devices in a single proceeding. 333(f)(2)(A)......................... ....................... FDA............. Penalty for any individual 2016 75,123 76,352 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 of any 2016 375,613 381,758 other person other than an individual) for such introduction or delivery of adulterated food. Penalty for aggregate of 2016 751,225 763,515 all such violations related to adulterated food adjudicated in a single proceeding. 333(f)(3)(A)......................... ....................... FDA............. Penalty for all violations 2016 11,383 11,569 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 any 2016 11,383 11,569 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 responsible 2016 284,583 289,239 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). Penalty for aggregate of 2016 1,138,330 1,156,953 all such above violations in a single proceeding. 333(f)(4)(A)(ii)..................... ....................... FDA............. Penalty for REMS violation 2016 284,583 289,239 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 violation 2016 1,138,330 1,156,953 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 aggregate of 2016 11,383,300 11,569,531 all such above violations adjudicated in a single proceeding. 333(f)(9)(A)......................... ....................... FDA............. Penalty for any person who 2016 16,503 16,773 violates a requirement which relates to tobacco products for each such violation. [[Page 9176]] Penalty for aggregate of 2016 1,100,200 1,118,199 all such violations of tobacco product requirement adjudicated in a single proceeding. 333(f)(9)(B)(i)(I)................... ....................... FDA............. Penalty per violation 2016 275,050 279,550 related to violations of tobacco requirements. Penalty for aggregate of 2016 1,100,200 1,118,199 all such violations of tobacco product requirements adjudicated in a single proceeding. 333(f)(9)(B)(i)(II).................. ....................... FDA............. Penalty in the case of a 2016 275,050 279,550 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 violation of 2016 1,100,200 1,118,199 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 aggregate of 2016 11,002,000 11,181,993 all such violations related to tobacco product requirements adjudicated in a single proceeding. 333(f)(9)(B)(ii)(I).................. ....................... FDA............. Penalty for any person who 2016 275,050 279,550 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 aggregate of 2016 1,100,200 1,118,199 for all such above violations adjudicated in a single proceeding. 333(f)(9)(B)(ii)(II)................. ....................... FDA............. Penalty for violation of 2016 275,050 279,550 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. Penalty for post-notice 2016 1,100,200 1,118,199 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 aggregate above 2016 11,002,000 11,181,993 tobacco product requirement violations adjudicated in a single proceeding. 333(g)(1)............................ ....................... FDA............. Penalty for any person who 2016 284,583 289,239 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 subsequent 2016 569,165 578,477 above violation in any 3- year period. 333 note............................. ....................... FDA............. Penalty to be applied for 2016 275 279 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 of a 2016 550 559 third tobacco product regulation violation within a 24-month period. Penalty in the case of a 2016 2,200 2,236 fourth tobacco product regulation violation within a 24-month period. Penalty in the case of a 2016 5,501 5,591 fifth tobacco product regulation violation within a 36-month period. Penalty in the case of a 2016 11,002 11,182 sixth or subsequent tobacco product regulation violation within a 48- month period as determined on a case-by-case basis. [[Page 9177]] Penalty to be applied for 2016 275 279 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 of a 2016 550 559 second tobacco product regulation violation within a 12-month period. Penalty in the case of a 2016 1,100 1,118 third tobacco product regulation violation within a 24-month period. Penalty in the case of a 2016 2,200 2,236 fourth tobacco product regulation violation within a 24-month period. Penalty in the case of a 2016 5,501 5,591 fifth tobacco product regulation violation within a 36-month period. Penalty in the case of a 2016 11,002 11,182 sixth or subsequent tobacco product regulation violation within a 48- month period as determined on a case-by-case basis. 335b(a).............................. ....................... FDA............. Penalty for each violation 2016 419,320 426,180 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 of any 2016 1,677,280 1,704,720 other person (other than an individual) per above violation. 360pp(b)(1).......................... ....................... FDA............. Penalty for any person who 2016 2,750 2,795 violates any such requirements for electronic products, with each unlawful act or omission constituting a separate violation. Penalty imposed for any 2016 937,500 952,838 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 violation of order of recall of biological product presenting imminent or substantial hazard. 263b(h)(3)........................... ....................... FDA............. Penalty for failure to 2016 16,773 17,047 obtain a mammography certificate as required. 300aa-28(b)(1)....................... ....................... FDA............. Penalty per occurrence for 2016 215,628 219,156 any vaccine manufacturer that intentionally destroys, alters, falsifies, or conceals any record or report required. 256b(d)(1)(B)(vi).................... ....................... HRSA............ Penalty for each instance 2016 5,437 5,526 of overcharging a 340B covered entity. 299c-(3)(d).......................... ....................... AHRQ............ Penalty for an 2016 14,140 14,371 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 of 2016 1,450 1,474 Information in the National Directory of New Hires. 262a(i)(1)........................... 42 CFR 1003.910........ OIG............. Penalty for each individual 2016 327,962 333,327 who violates safety and security procedures related to handling dangerous biological agents and toxins. Penalty for any other 2016 655,925 666,656 person who violates safety and security procedures related to handling dangerous biological agents and toxins. 300jj-51............................. ....................... OIG............. Penalty per violation for 2016 1,000,000 1,016,360 committing information blocking. 1320a-7a(a).......................... 42 CFR 1003.210(a)(1).. OIG............. Penalty for knowingly 2016 15,024 15,270 presenting or causing to be presented to an officer, employee, or agent of the United States a false claim. Penalty for knowingly 2016 15,024 15,270 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 knowingly 2016 22,537 22,906 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. 42 CFR 1003.210(a)(3) ................ Penalty for an excluded 2016 15,024 15,270 party retaining ownership or control interest in a participating entity. [[Page 9178]] 42 CFR 1003.1010 ................ Penalty for remuneration 2016 15,024 15,270 offered to induce program beneficiaries to use particular providers, practitioners, or suppliers. 42 CFR 1003.210(a)(4) ................ Penalty for employing or 2016 14,718 14,959 contracting with an excluded individual. 42 CFR 1003.310(a)(3) ................ Penalty for knowing and 2016 73,588 74,792 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 or 2016 10,874 11,052 prescribing medical or other item or service during a period in which the person was excluded. 42 CFR 1003.210(a)(6) Penalty for knowingly 2016 54,372 55,262 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 of an 2016 10,874 11,052 overpayment and failing to report and return. 42 CFR 1003.210(a)(7) ................ Penalty for making or using 2016 54,372 55,262 a false record or statement that is material to a false or fraudulent claim. 42 CFR 1003.210(a)(9) ................ Penalty for failure to 2016 16,312 16,579 grant timely access to HHS OIG for audits, investigations, evaluations, and other statutory functions of HHS OIG. 1320a-7a(b).......................... ....................... OIG............. Penalty for payments by a 2016 4,313 4,384 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 physicians who 2016 4,313 4,384 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 1003.210(a)(10) Penalty for a physician who 2016 7,512 7,635 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 to 2016 36,794 37,396 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 misuse of 2016 9,893 10,055 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 misuse of 2016 49,467 50,276 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. 1395i-3(b)(3)(B)(ii)(1).............. 42 CFR 1003.210(a)(11). OIG............. Penalty for certification 2016 2,063 2,097 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 1003.210(a)(11). OIG............. Penalty for causing another 2016 10,314 10,483 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 individual 2016 4,126 4,194 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 Medicare 2016 37,561 38,175 Advantage organization that substantially fails to provide medically necessary, required items and services. Penalty for a Medicare 2016 36,794 37,396 Advantage organization that charges excessive premiums. Penalty for a Medicare 2016 36,794 37,396 Advantage organization that improperly expels or refuses to reenroll a beneficiary. Penalty for a Medicare 2016 147,177 149,585 Advantage organization that engages in practice that would reasonably be expected to have the effect of denying or discouraging enrollment. [[Page 9179]] Penalty per individual who 2016 22,077 22,438 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 Medicare 2016 147,177 149,585 Advantage organization misrepresenting or falsifying information to Secretary. Penalty for a Medicare 2016 36,794 37,396 Advantage organization misrepresenting or falsifying information to individual or other entity. Penalty for Medicare 2016 36,794 37,396 Advantage organization interfering with provider's advice to enrollee and non-MCO affiliated providers that balance bill enrollees. Penalty for a Medicare 2016 36,794 37,396 Advantage organization that employs or contracts with excluded individual or entity. Penalty for a Medicare 2016 36,794 37,396 Advantage organization enrolling an individual in without prior written consent. Penalty for a Medicare 2016 36,794 37,396 Advantage organization transferring an enrollee to another plan without consent or solely for the purpose of earning a commission. Penalty for a Medicare 2016 36,794 37,396 Advantage organization failing to comply with marketing restrictions or applicable implementing regulations or guidance. Penalty for a Medicare 2016 36,794 37,396 Advantage organization employing or contracting with an individual or entity who violates 1395w- 27(g)(1)(A)-(J). 1395w-141(i)(3)...................... ....................... OIG............. Penalty for a prescription 2016 12,856 13,066 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 billing by Hospitals, Critical Access Hospitals, or Skilled Nursing Facilities. 1395dd(d)(1)......................... 42 CFR 1003.510........ OIG............. Penalty for a hospital or 2016 103,139 104,826 responsible physician dumping patients needing emergency medical care, if the hospital has 100 beds or more. Penalty for a hospital or 2016 51,570 52,414 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 competitive plan is such plan substantially fails to provide medically necessary, required items or services. Penalty for HMOs/ 2016 51,570 52,414 competitive medical plans that charge premiums in excess of permitted amounts. Penalty for a HMO or 2016 51,570 52,414 competitive medical plan that expels or refuses to reenroll an individual per prescribed conditions. Penalty for a HMO or 2016 206,278 209,653 competitive medical plan that implements practices to discourage enrollment of individuals needing services in future. Penalty per individual not 2016 29,680 30,166 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 competitive medical plan that misrepresents or falsifies information to the Secretary. Penalty for a HMO or 2016 51,570 52,414 competitive medical plan that misrepresents or falsifies information to an individual or any other entity. Penalty for failure by HMO 2016 51,570 52,414 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 employs or contracts with excluded individual or entity. 1395nn(g)(3)......................... 42 CFR 1003.310........ OIG............. Penalty for submitting or 2016 23,863 24,253 causing to be submitted claims in violation of the Stark Law's restrictions on physician self- referrals. [[Page 9180]] 1395nn(g)(4)......................... 42 CFR 1003.310........ OIG............. Penalty for circumventing 2016 159,089 161,692 Stark Law's restrictions on physician self- referrals. 1395ss(d)(1)......................... 42 CFR 1003.1110....... OIG............. Penalty for a material 2016 9,893 10,055 misrepresentation regarding Medigap compliance policies. 1395ss(d)(2)......................... 42 CFR 1003.1110....... OIG............. Penalty for selling Medigap 2016 9,893 10,055 policy under false pretense. 1395ss(d)(3)(A)(ii).................. 42 CFR 1003.1110....... OIG............. Penalty for an issuer that 2016 44,539 45,268 sells health insurance policy that duplicates benefits. Penalty for someone other 2016 26,723 27,160 than issuer that sells health insurance that duplicates benefits. 1395ss(d)(4)(A)...................... 42 CFR 1003.1110....... OIG............. Penalty for using mail to 2016 9,893 10,055 sell a non-approved Medigap insurance policy. 1396b(m)(5)(B)(i).................... 42 CFR 1003.410........ OIG............. Penalty for a Medicaid MCO 2016 49,467 50,276 that substantially fails to provide medically necessary, required items or services. Penalty for a Medicaid MCO 2016 49,467 50,276 that charges excessive premiums. Penalty for a Medicaid MCO 2016 197,869 201,106 that improperly expels or refuses to reenroll a beneficiary. Penalty per individual who 2016 29,680 30,166 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 Medicaid MCO 2016 197,869 201,106 misrepresenting or falsifying information to the Secretary. Penalty for a Medicaid MCO 2016 49,467 50,276 misrepresenting or falsifying information to an individual or another entity. Penalty for a Medicaid MCO 2016 44,539 45,268 that fails to comply with contract requirements with respect to physician incentive plans. 1396r(b)(3)(B)(ii)(I)................ 42 CFR 1003.210(a)(11). OIG............. Penalty for willfully and 2016 2,063 2,097 knowingly 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 2016 10,314 10,483 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 notifying or 2016 4,126 4,194 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 knowing 2016 178,156 181,071 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 failure 2016 17,816 18,107 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 provision of false information by drug manufacturer with rebate agreement. 1396t(i)(3)(A)....................... 42 CFR 1003.1310....... OIG............. Penalty for notifying home 2016 3,563 3,621 and community-based providers or settings of survey. 11131(c)............................. 42 CFR 1003.810........ OIG............. Penalty for failing to 2016 21,563 21,916 report a medical malpractice claim to National Practitioner Data Bank. 11137(b)(2).......................... 42 CFR 1003.810........ OIG............. Penalty for breaching 2016 21,563 21,916 confidentiality of information reported to National Practitioner Data Bank. 299b-22(f)(1)........................ 42 CFR 3.404........... OCR............. Penalty for violation of 2016 11,940 12,135 confidentiality provision of the Patient Safety and Quality Improvement Act. 45 CFR OCR............. Penalty for each pre- 2016 150 152 160.404(b)(1)(i), (ii) February 18, 2009 violation of the HIPAA administrative simplification provisions. Calendar Year Cap.......... 2016 37,561 38,175 1320(d)-5(a)......................... 45 CFR OCR............. Penalty for each February 160.404(b)(2)(i)(A), 18, 2009 or later (B). 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 Maximum.................... 2016 55,010 55,910 Calendar Year Cap.......... 2016 1,650,300 1,677,299 [[Page 9181]] 45 CFR OCR............. Penalty for each February 160.404(b)(2)(ii)(A), 18, 2009 or later (B) 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 Maximum.................... 2016 55,010 55,910 Calendar Year Cap.......... 2016 1,650,300 1,677,299 45 CFR OCR............. Penalty for each February 160.404(b)(2)(iii)(A), 18, 2009 or later (B) 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 Maximum.................... 2016 55,010 55,910 Calendar Year Cap.......... 2016 1,650,300 1,677,299 45 CFR OCR............. Penalty for each February 160.404(b)(2)(iv)(A), 18, 2009 or later (B) 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 Maximum.................... 2016 1,650,300 1,677,299 Calendar Year Cap.......... 2016 1,650,300 1,677,299 263a(h)(2)(B) & 1395w-2(b)(2)(A)(ii). 42 CFR CMS............. Penalty for a clinical 493.1834(d)(2)(i). laboratory's failure to meet participation and certification requirements and poses immediate jeopardy: Minimum.................... 2016 6,035 6,134 Maximum.................... 2016 19,787 20,111 42 CFR CMS............. Penalty for a clinical 493.1834(d)(2)(ii). laboratory's failure to meet participation and certification requirements and the failure does not pose immediate jeopardy: Minimum.................... 2016 99 101 Maximum.................... 2016 5,936 6,033 300gg-15(f).......................... 45 CFR 147.200(e)...... CMS............. Failure to provide the 2016 1,087 1,105 Summary of Benefits and Coverage. 300gg-18............................. 45 CFR 158.606......... CMS............. Penalty for violations of 2016 109 111 regulations related to the medical loss ratio reporting and rebating. 1320a-7h(b)(1)....................... 42 CFR 402.105(d)(5), CMS............. Penalty for manufacturer or 42 CFR 403.912(a) & group purchasing (c). 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 Maximum.................... 2016 10,874 11,052 Calendar Year Cap.......... 2016 163,117 165,786 1320a-7h(b)(2)....................... 42 CFR 402.105(h), 42 CMS............. Penalty for manufacturer or CFR 403.912(b) & (c). 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 Maximum.................... 2016 108,745 110,524 Calendar Year Cap.......... 2016 1,087,450 1,105,241 CMS Penalty for an 2016 108,745 110,524 administrator of a facility that fails to comply with notice requirements for the closure of a facility. 1320a-7j(h)(3)(A).................... 42 CFR 488.446(a)(1), CMS............. Minimum penalty for the 2016 544 553 (2), & (3). first offense of an administrator who fails to provide notice of facility closure. Minimum penalty for the 2016 1,631 1,658 second offense of an administrator who fails to provide notice of facility closure. Minimum penalty for the 2016 3,262 3,315 third and subsequent offenses of an administrator who fails to provide notice of facility closure. [[Page 9182]] 1320a-8(a)(1)........................ ....................... CMS............. Penalty for an entity 2016 7,954 8,084 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 violation of 42 2016 7,500 7,623 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 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 of 2016 217,490 221,048 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. 1320b-25(c)(2)(A).................... ....................... CMS............. Penalty for failure of 2016 326,235 331,572 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-term 2016 217,490 221,048 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 person who 2016 147 149 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 a 488.408(d)(1)(iii). Skilled Nursing Facility that has a Category 2 violation of certification requirements: Minimum.................... 2016 103 105 Maximum.................... 2016 6,188 6,289 42 CFR CMS............. Penalty per instance of 488.408(d)(1)(iv) Category 2 noncompliance by a Skilled Nursing Facility: Minimum.................... 2016 2,063 2,097 Maximum.................... 2016 20,628 20,965 42 CFR CMS............. Penalty per day for a 488.408(e)(1)(iii) Skilled Nursing Facility that has a Category 3 violation of certification requirements: Minimum.................... 2016 6,291 6,394 Maximum.................... 2016 20,628 20,965 42 CFR CMS............. Penalty per instance of 488.408(e)(1)(iv) Category 3 noncompliance by a Skilled Nursing Facility: Minimum.................... 2016 2,063 2,097 Maximum.................... 2016 20,628 20,965 42 CFR CMS............. Penalty per day and per 488.408(e)(2)(ii) instance for a Skilled Nursing Facility that has Category 3 noncompliance with Immediate Jeopardy: Per Day (Minimum).......... 2016 6,291 6,394 Per Day (Maximum).......... 2016 20,628 20,965 Per Instance (Minimum)..... 2016 2,063 2,097 Per Instance (Maximum)..... 2016 20,628 20,965 42 CFR 488.438(a)(1)(i) CMS............. Penalty per day of a Skilled Nursing Facility that fails to meet certification requirements. These amounts represent the upper range per day: Minimum.................... 2016 6,291 6,394 Maximum.................... 2016 20,628 20,965 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: [[Page 9183]] Minimum.................... 2016 103 105 Maximum.................... 2016 6,188 6,289 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 Maximum.................... 2016 20,628 20,965 1395l(h)(5)(D)....................... 42 CFR 402.105(d)(2)(i) CMS............. Penalty for knowingly, 2016 15,024 15,270 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 knowingly and 2016 3,957 4,022 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 knowingly and 2016 3,787 3,849 willfully failing to provide information about a referring physician when seeking payment on an unassigned basis. 1395m(a)(11)(A)...................... 42 CFR 402.1(c)(4), CMS............. Penalty for any durable 2016 15,024 15,270 402.105(d)(2)(ii). 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)...................... 42 CFR 402.1(c)(5), CMS............. Penalty for any 2016 15,024 15,270 402.105(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)....................... 42 CFR 402.1(c)(6), CMS............. Penalty for any 2016 15,024 15,270 402.105(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).......................... 42 CFR 402.1(c)(8), CMS............. Penalty for any supplier of 2016 15,024 15,270 402.105(d)(2)(vi). 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)). 1395m(j)(2)(A)(iii).................. ....................... CMS............. Penalty for any supplier of 2016 1,591 1,617 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).......................... 42 CFR 402.1(c)(10), CMS............. Penalty for any supplier of 2016 15,024 15,270 402.105(d)(2)(vii). 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)). [[Page 9184]] 1395m(k)(6).......................... 42 CFR 402.1(c)(31), CMS............. Penalty for any person or 2016 15,024 15,270 402.105(d)(3). 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).......................... 42 CFR 402.1(c)(32), CMS............. Penalty for any supplier of 2016 15,024 15,270 402.105(d)(4). 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)...................... 42 CFR 402.1(c)(11), CMS............. Penalty for any 2016 15,024 15,270 402.105(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)....................... 42 CFR 402.1(c)........ CMS............. Penalty for any physician 2016 15,024 15,270 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)............................. 42 CFR 402.1(c)(12), CMS............. Penalty for any physician 2016 15,024 15,270 402.105(d)(2)(ix). 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)). 1395u(l)(3).......................... 42 CFR 402.1(c)(13), CMS............. Penalty for any 2016 15,024 15,270 402.105(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).......................... 42 CFR 402.1(c)(14), CMS............. Penalty for any 2016 15,024 15,270 402.105(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).......................... 42 CFR 402.1(c)(15), CMS............. Penalty for any physician 2016 15,024 15,270 402.105(d)(2)(xii). 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)....................... 42 CFR 414.707(b)...... CMS............. Penalty for any 2016 15,024 15,270 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)). [[Page 9185]] 1395u(p)(3)(A)....................... ....................... CMS............. Penalty for any physician 2016 3,957 4,022 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 pharmaceutical manufacturer's misrepresentation of average sales price of a drug, or biologic. 1395w-4(g)(1)(B)..................... 42 CFR 402.1(c)(17), CMS............. Penalty for any 2016 15,024 15,270 402.105(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)..................... 42 CFR 402.1(c)(18), CMS............. Penalty for any person that 2016 15,024 15,270 402.105(d)(2)(xiv). 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 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 week 2016 14,718 14,959 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 Medicare 2016 136,689 138,925 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 employer or 2016 8,908 9,054 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), 42 CMS............. Penalty for any non- 2016 1,450 1,474 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 entity that 2016 3,182 3,234 402.105(a). 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 entity 2016 1,138 1,157 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. 1395y(b)(8)(E)....................... ....................... CMS............. Penalty for any non-group 2016 1,138 1,157 health plan that fails to identify claimants who are Medicare beneficiaries and provide information to the HHS Secretary to coordinate benefits and pursue any applicable recovery claim. 1395nn(g)(5)......................... 42 CFR 411.361......... CMS............. Penalty for any person that 2016 18,936 19,246 fails to report information required by HHS under Section 1877(f) concerning ownership, investment, and compensation arrangements. [[Page 9186]] 1395pp(h)............................ 42 CFR 402.1(c)(23), CMS............. Penalty for any durable 2016 15,024 15,270 402.105(d)(2)(xv). 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 person that 2016 51,569 52,413 405.105(f)(1). 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 other 2016 26,723 27,160 than issuer that sells or issues a Medicare supplemental policy to beneficiary without a disclosure statement. Penalty for an issuer that 2016 44,539 45,268 sells or issues a Medicare supplemental policy without disclosure statement. 1395ss(d)(3)(B)(iv).................. ....................... CMS............. Penalty for someone other 2016 26,723 27,160 than issuer that sells or issues a Medicare supplemental policy without acknowledgement form. Penalty for issuer that 2016 44,539 45,268 sells or issues a Medicare supplemental policy without an acknowledgement form. 1395ss(p)(8)......................... 42 CFR 402.1(c)(25), CMS............. Penalty for any person that 2016 26,723 27,160 402.105(e). 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 person that 2016 44,539 45,268 405.105(f)(2) 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 person that 2016 26,723 27,160 402.105(e). 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. 42 CFR 402.1(c)(26), ................ Penalty for any person that 2016 44,539 45,268 405.105(f)(3), (4) 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 person that 2016 44,539 45,268 405.105(f)(5). 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 person that 2016 44,539 45,268 405.105(f)(6). 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 issuer of a 2016 18,908 19,217 405.105(c). 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 issuer of a 2016 44,539 45,268 405.105(f)(7). Medicare supplemental policy that fails to fulfill listed responsibilities. 1395ss(v)(4)(A)...................... ....................... CMS............. Penalty someone other than 2016 19,284 19,599 issuer who sells, issues, or renews a medigap Rx policy to an individual who is a Part D enrollee. Penalty for an issuer who 2016 32,140 32,666 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 individual 2016 4,126 4,194 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. [[Page 9187]] 1395bbb(f)(2)(A)(i).................. 42 CFR CMS............. Maximum daily penalty 2016 19,787 20,111 488.845(b)(2)(iii) 42 amount for each day a home CFR 488.845(b)(3)-(6); health agency is not in and 42 CFR compliance with statutory 488.845(d)(1)(ii). requirements. 42 CFR 488.845(b)(3) ................ Penalty per day for home health agency's noncompliance (Upper Range): Minimum.................... 2016 16,819 17,094 Maximum.................... 2016 19,787 20,111 42 CFR 488.845(b)(3)(i) ................ Penalty for a home health 2016 19,787 20,111 agency's deficiency or deficiencies that cause immediate jeopardy and result in actual harm. 42 CFR ................ Penalty for a home health 2016 17,808 18,099 488.845(b)(3)(ii) agency's deficiency or deficiencies that cause immediate jeopardy and result in potential for harm. 42 CFR ................ Penalty for an isolated 2016 16,819 17,094 488.845(b)(3)(iii) 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 Maximum.................... 2016 16,819 17,094 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 Maximum.................... 2016 7,915 8,044 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 Maximum.................... 2016 19,787 20,111 Penalty for each day of 2016 19,787 20,111 noncompliance (Maximum). 42 CFR ................ Penalty for each day of 2016 19,787 20,111 488.845(d)(1)(ii) 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 Maximum.................... 2016 147,177 149,585 Penalty for a PACE 2016 36,794 37,396 organization that charges excessive premiums. Penalty for a PACE 2016 147,177 149,585 organization misrepresenting or falsifying information to CMS, the State, or an individual or other entity. Penalty for each 2016 36,794 37,396 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 involuntarily 2016 36,794 37,396 disenrolling a participant. Penalty for discriminating 2016 36,794 37,396 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 a 488.408(d)(1)(iii). nursing facility's failure to meet a Category 2 Certification: Minimum.................... 2016 103 105 Maximum.................... 2016 6,188 6,289 42 CFR CMS............. Penalty per instance for a 488.408(d)(1)(iv) nursing facility's failure to meet Category 2 certification: Minimum.................... 2016 2,063 2,097 Maximum.................... 2016 20,628 20,965 42 CFR CMS............. Penalty per day for a 488.408(e)(1)(iii) nursing facility's failure to meet Category 3 certification: Minimum.................... 2016 6,291 6,394 Maximum.................... 2016 20,628 20,965 42 CFR CMS............. Penalty per instance for a 488.408(e)(1)(iv) nursing facility's failure to meet Category 3 certification: Minimum.................... 2016 2,063 2,097 [[Page 9188]] Maximum.................... 2016 20,628 20,965 42 CFR CMS............. Penalty per instance for a 488.408(e)(2)(ii) nursing facility's failure to meet Category 3 certification, which results in immediate jeopardy: Minimum.................... 2016 2,063 2,097 Maximum.................... 2016 20,628 20,965 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 Maximum.................... 2016 20,628 20,965 42 CFR CMS............. Penalty per day for nursing 488.438(a)(1)(ii) facility's failure to meet certification (Lower Range): Minimum.................... 2016 103 105 Maximum.................... 2016 6,188 6,289 42 CFR 488.438(a)(2) CMS............. Penalty per instance for nursing facility's failure to meet certification: Minimum.................... 2016 2,063 2,097 Maximum.................... 2016 20,628 20,965 1396r(f)(2)(B)(iii)(I)(c)............ 42 CFR CMS............. Grounds to prohibit 2016 10,314 10,483 483.151(b)(2)(iv) and approval of Nurse Aide (b)(3)(iii). 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 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 Maximum.................... 2016 17,816 18,107 1396u-2(e)(2)(A)(i).................. 42 CFR 438.704......... CMS............. Penalty for a Medicaid 2016 36,794 37,396 managed care organization that fails substantially to provide medically necessary items and services. Penalty for Medicaid 2016 36,794 37,396 managed care organization that imposes premiums or charges on enrollees in excess of the premiums or charges permitted. Penalty for a Medicaid 2016 36,794 37,396 managed care organization that misrepresents or falsifies information to another individual or entity. Penalty for a Medicaid 2016 36,794 37,396 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 Medicaid 2016 147,177 149,585 managed care organization that misrepresents or falsifies information to the HHS Secretary. Penalty for Medicaid 2016 147,177 149,585 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 individual 2016 22,077 22,438 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. 1396u(h)(2).......................... 42 CFR Part 441, CMS............. Penalty for a provider not 2016 20,628 20,965 Subpart I. 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 disclosing 2016 11,002 11,182 information related to eligibility determinations for medical assistance programs. 18041(c)(2).......................... 45 CFR 150.315; 45 CFR CMS............. Failure to comply with 2016 150 152 156.805(c). 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 providing false 2016 27,186 27,631 information on Exchange application. 18081(h)(1)(B)....................... 42 CFR 155.285......... CMS............. Penalty for knowingly or 2016 271,862 276,310 willfully providing false information on Exchange application. [[Page 9189]] 18081(h)(2).......................... 42 CFR 155.260......... CMS............. Penalty for knowingly or 2016 27,186 27,631 willfully disclosing protected information from Exchange. 31 U.S.C. 1352................................. 45 CFR 93.400(e)....... HHS............. Penalty for the first time 2016 18,936 19,246 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 Maximum.................... 2016 189,361 192,459 Penalty for the first time 2016 18,936 19,246 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 Maximum.................... 2016 189,361 192,459 45 CFR Part 93, HHS............. Penalty for failure to Appendix A provide certification regarding lobbying in the award documents for all sub-awards of all tiers: Minimum.................... 2016 18,936 19,246 Maximum.................... 2016 189,361 192,459 Penalty for failure to provide statement regarding lobbying for loan guarantee and loan insurance transactions: Minimum.................... 2016 18,936 19,246 Maximum.................... 2016 189,361 192,459 3801-3812............................ 45 CFR 79.3(a)(1)(iv).. HHS............. Penalty against any 2016 9,894 10,056 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) ................ Penalty against any 2016 9,894 10,056 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. \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 2017, based on the Consumer Price Index (CPI-U) for the month of October 2016, not seasonally adjusted, is 1.01636, as indicated in OMB Memorandum M-17-11, ``Implementation of the 2017 annual adjustment pursuant to the Federal Civil Penalties Adjustment Act Improvements Act of 2015'' (December 16, 2016). Dated: January 30, 2017. Norris Cochran, Acting Secretary, Department of Health and Human Services. [FR Doc. 2017-02300 Filed 2-2-17; 8:45 am] BILLING CODE 4150-24-P
![9174 Federal Register / Vol. 82, No. 22 / Friday, February 3, 2017 / Rules and Regulations
TABLE 2—HARDNESS DEFAULTS WITH- DEPARTMENT OF HEALTH AND the required annual adjustment. The
IN EACH LEVEL III ECOREGION IN HUMAN SERVICES cost-of-living adjustment multiplier for
OREGON—Continued 2017, based on the CPI–U for the month
45 CFR Part 102 of October 2016, not seasonally
Hardness adjusted, is 1.01636.
Level III ecoregion RIN 0991–AC0
mg/L) Using the 2017 multiplier, HHS
Annual Civil Monetary Penalties adjusted all its applicable monetary
9 Eastern Cascades Slopes and penalties in 45 CFR 102.3.
Foothills ................................... 36.08
Inflation Adjustment
10 Columbia Plateau .................. 58.82 III. Statutory and Executive Order
AGENCY: Department of Health and
11 Blue Mountains ...................... 43.49 Reviews
Human Services, Office of the Assistant
12 Snake River Plain .................. 123.5 Secretary for Financial Resources. The 2015 Act Requires Federal Agencies
78 Klamath Mountains ................ 40.61 To Publish Annual Penalty Inflation
ACTION: Final rule.
80 Northern Basin and Range ... 98.62 Adjustments Notwithstanding Section
SUMMARY: The Department of Health and 553 of the Administrative Procedure
(d) Applicability. (1) The criterion in Human Services (HHS) is updating its Act
paragraph (b) of this section applies to regulations to reflect required annual A. Executive Order 12866: Regulatory
freshwaters in Oregon where fish and inflation-related increases to the civil Planning and Review and Executive
aquatic life are a designated use, and monetary penalties in its regulations, Order 13563: Improving Regulation and
applies concurrently with other pursuant to the Federal Civil Penalties Regulatory Review
applicable water quality criteria. Inflation Adjustment Act Improvement
Act of 2015. Section 4 of the 2015 Act directs
(2) The criterion established in this federal agencies to publish annual
DATES: This rule is effective February 3,
section is subject to Oregon’s general adjustments no later than January 15,
2017.
rules of applicability in the same way 2017. In accordance with section 553 of
and to the same extent as are other FOR FURTHER INFORMATION CONTACT: the Administrative Procedure Act
federally promulgated and state-adopted Andrea Brandon, Deputy Assistant (APA), most rules are subject to notice
numeric criteria when applied to Secretary for Grants and Acquisitions, and comment and are effective no
freshwaters in Oregon where fish and Office of the Assistant Secretary for earlier than 30 days after publication in
Financial Resources, Room 514–G, the Federal Register. However, Section
aquatic life are a designated use.
Hubert Humphrey Building, 200 4(b)(2) of the 2015 Act provides that
(i) For all waters with mixing zone Independence Avenue SW., Washington each agency shall make the annual
regulations or implementation DC 20201; 202–690–6396; FAX 202– inflation adjustments ‘‘notwithstanding
procedures, the criterion applies at the 690–5405. section 553’’ of the APA. According to
appropriate locations within or at the SUPPLEMENTARY INFORMATION: OMB’s Memorandum M–17–11,
boundary of the mixing zones and Memorandum of the Heads of Executive
outside of the mixing zones; otherwise I. Background
Departments and Agencies (December
the criterion applies throughout the The Federal Civil Penalties Inflation 16, 2016) the phrase ‘‘notwithstanding
water body including at the end of any Adjustment Act Improvements Act of section 553’’ means that ‘‘the public
discharge pipe, conveyance or other 2015 (Sec. 701 of Pub. L. 114–74) (the procedure the APA generally provides—
discharge point within the water body. ‘‘Act’’), which is intended to improve notice, an opportunity for comment, and
(ii) The state shall not use a low flow the effectiveness of civil monetary a delay in effective date—is not required
value that is less stringent than the penalties (‘‘CMPs’’) and to maintain the for agencies to issue regulations
deterrent effect of such penalties, implementing the annual adjustment.’’
values listed below for waters suitable
requires agencies to adjust the civil Consistent with the language of the 2015
for the establishment of low flow return
monetary penalties for inflation Act and OMB’s implementation
frequencies (i.e., streams and rivers) annually.
when calculating the available dilution guidance, this rule is not subject to
The Department of Health and Human notice and an opportunity for public
for the purposes of determining the Services (HHS) lists the civil monetary
need for and establishing Water Quality- comment and will be effective
penalties and the penalty amounts immediately upon publication.
Based Effluent Limitations in National administered by all of its agencies in
Pollutant Discharge Elimination System tabular form in 45 CFR 102.3. B. Review Under Procedural Statutes
permits: and Executive Orders
II. Calculation of Adjustment
Pursuant to OMB Memorandum for
Acute The annual inflation adjustment for the Heads of Executive Departments and
criteria 1Q10 or 1B3 each applicable civil monetary penalty
(CMC) Agencies, M–17–11, HHS has
is determined using the percent increase determined that making technical
Where: in the Consumer Price Index for all changes to the amount of civil monetary
1. 1Q10 is the lowest one-day average Urban Consumers (CPI–U) for the month penalties in its regulations does not
flow event expected to occur once every of October of the year in which the trigger any requirements under
ten years, on average (determined amount of each civil penalty was most procedural statutes and Executive
asabaliauskas on DSK3SPTVN1PROD with RULES
hydrologically). recently established or modified. In the Orders that govern rulemaking
2. 1B3 is the lowest one-day average flow December 16, 2016, OMB Memorandum procedures.
event expected to occur once every for the Heads of Executive Agencies and
three years, on average (determined bio- Departments, M–17–11, Implementation IV. Effective Date
logically). of the 2017 annual adjustment pursuant This rule is effective February 3, 2017.
[FR Doc. 2017–02283 Filed 2–2–17; 8:45 am]
to the Federal Civil Penalties Inflation The adjusted civil penalty amounts
Adjustment Act Improvements Act of apply to civil penalties assessed on or
BILLING CODE 6560–50–P
2015, OMB published the multiplier for after February 3, 2017, when the
VerDate Sep<11>2014 21:08 Feb 02, 2017 Jkt 241001 PO 00000 Frm 00048 Fmt 4700 Sfmt 4700 E:\FR\FM\03FER1.SGM 03FER1](https://thefederalregister.org/doc/82_FR_9196/page/1.svg)
![Federal Register / Vol. 82, No. 22 / Friday, February 3, 2017 / Rules and Regulations 9175
violation occurred after November 2, For reasons discussed in the Authority: Public Law 101–410, Sec. 701
2015. If the violation occurred prior to preamble, the Department of Health and of Public Law 114–74, 31 U.S.C. 3801–3812.
November 2, 2015, or a penalty was Human Services amends subtitle A, title
45 of the Code of Federal Regulations as ■ 2. Amend § 102.3 by revising the table
assessed prior to September 6, 2016, the
follows: to read as follows:
pre-adjustment civil penalty amounts in
effect prior to September 6, 2016 will § 102.3 Penalty adjustment and table.
apply. PART 102—ADJUSTMENT OF CIVIL
MONETARY PENALTIES FOR * * * * *
List of Subjects in 45 CFR Part 102 INFLATION
Administrative practice and ■ 1. The authority citation for part 102
procedure, Penalties. continues to read as follows:
CIVIL MONETARY PENALTY AUTHORITIES ADMINISTERED BY HHS AGENCIES AND PENALTY AMOUNTS
[Effective February 3, 2017]
Citation Date of last 2016 2017
HHS penalty fig- Maximum Maximum
Description 2
agency ure or ad- adjusted adjusted
U.S.C. CFR 1 justment 3 penalty ($) penalty ($) 4
21 U.S.C.:
333(b)(2)(A) ......................... ....................................... FDA .... Penalty for violations related to drug samples re- 2016 98,935 100,554
sulting in a conviction of any representative of
manufacturer or distributor in any 10-year pe-
riod.
333(b)(2)(B) ......................... ....................................... FDA .... Penalty for violation related to drug samples re- 2016 1,978,690 2,011,061
sulting 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 to make a report required by 2016 197,869 201,106
21 U.S.C. 353(d)(3)(E) relating to drug sam-
ples.
333(f)(1)(A) .......................... ....................................... FDA .... Penalty for any person who violates a require- 2016 26,723 27,160
ment related to devices for each such violation.
Penalty for aggregate of all violations related to 2016 1,781,560 1,810,706
devices in a single proceeding.
333(f)(2)(A) .......................... ....................................... FDA .... Penalty for any individual who introduces or de- 2016 75,123 76,352
livers 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 of any other person other 2016 375,613 381,758
than an individual) for such introduction or de-
livery of adulterated food.
Penalty for aggregate of all such violations re- 2016 751,225 763,515
lated to adulterated food adjudicated in a sin-
gle proceeding.
333(f)(3)(A) .......................... ....................................... FDA .... Penalty for all violations adjudicated in a single 2016 11,383 11,569
proceeding for any person who violates 21
U.S.C. 331(jj)(1) by failing to submit the certifi-
cation 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 any above violation is not 2016 11,383 11,569
corrected after a 30-day period following notifi-
cation until the violation is corrected.
333(f)(4)(A)(i) ...................... ....................................... FDA .... Penalty for any responsible person that violates 2016 284,583 289,239
a requirement of 21 U.S.C. 355(o) (post-mar-
keting studies, clinical trials, labeling), 21
U.S.C. 355(p) (risk evaluation and mitigation
(REMS)), or 21 U.S.C. 355–1 (REMS).
Penalty for aggregate of all such above viola- 2016 1,138,330 1,156,953
tions in a single proceeding.
333(f)(4)(A)(ii) ...................... ....................................... FDA .... Penalty for REMS violation that continues after 2016 284,583 289,239
written notice to the responsible person for the
first 30-day period (or any portion thereof) the
responsible person continues to be in violation.
asabaliauskas on DSK3SPTVN1PROD with RULES
Penalty for REMS violation that continues after 2016 1,138,330 1,156,953
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 above viola- 2016 11,383,300 11,569,531
tions adjudicated in a single proceeding.
333(f)(9)(A) .......................... ....................................... FDA .... Penalty for any person who violates a require- 2016 16,503 16,773
ment which relates to tobacco products for
each such violation.
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![9176 Federal Register / Vol. 82, No. 22 / Friday, February 3, 2017 / Rules and Regulations
CIVIL MONETARY PENALTY AUTHORITIES ADMINISTERED BY HHS AGENCIES AND PENALTY AMOUNTS—Continued
[Effective February 3, 2017]
Citation Date of last 2016 2017
HHS penalty fig- Maximum Maximum
Description 2
U.S.C. CFR 1 agency ure or ad- adjusted adjusted
justment 3 penalty ($) penalty ($) 4
Penalty for aggregate of all such violations of to- 2016 1,100,200 1,118,199
bacco product requirement adjudicated in a
single proceeding.
333(f)(9)(B)(i)(I) ................... ....................................... FDA .... Penalty per violation related to violations of to- 2016 275,050 279,550
bacco requirements.
Penalty for aggregate of all such violations of to- 2016 1,100,200 1,118,199
bacco product requirements adjudicated in a
single proceeding.
333(f)(9)(B)(i)(II) .................. ....................................... FDA .... Penalty in the case of a violation of tobacco 2016 275,050 279,550
product requirements that continues after writ-
ten notice to such person, for the first 30-day
period (or any portion thereof) the person con-
tinues to be in violation.
Penalty for violation of tobacco product require- 2016 1,100,200 1,118,199
ments that continues after written notice to
such person shall double for every 30-day pe-
riod thereafter the violation continues, but may
not exceed penalty amount for any 30-day pe-
riod.
Penalty for aggregate of all such violations re- 2016 11,002,000 11,181,993
lated to tobacco product requirements adju-
dicated in a single proceeding.
333(f)(9)(B)(ii)(I) .................. ....................................... FDA .... Penalty for any person who either does not con- 2016 275,050 279,550
duct post-market surveillance and studies to
determine impact of a modified risk tobacco
product for which the HHS Secretary has pro-
vided 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 prod-
ucts.
Penalty for aggregate of for all such above viola- 2016 1,100,200 1,118,199
tions adjudicated in a single proceeding.
333(f)(9)(B)(ii)(II) ................. ....................................... FDA .... Penalty for violation of modified risk tobacco 2016 275,050 279,550
product post-market surveillance that con-
tinues after written notice to such person for
the first 30-day period (or any portion thereof)
that the person continues to be in violation.
Penalty for post-notice violation of modified risk 2016 1,100,200 1,118,199
tobacco product post-market surveillance shall
double for every 30-day period thereafter that
the tobacco product requirement violation con-
tinues for any 30-day period, but may not ex-
ceed penalty amount for any 30-day period.
Penalty for aggregate above tobacco product re- 2016 11,002,000 11,181,993
quirement violations adjudicated in a single
proceeding.
333(g)(1) ............................. ....................................... FDA .... Penalty for any person who disseminates or 2016 284,583 289,239
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 subsequent above violation in 2016 569,165 578,477
any 3-year period.
333 note .............................. ....................................... FDA .... Penalty to be applied for violations of restrictions 2016 275 279
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 regu-
lation violation within a 12-month period.
Penalty in the case of a third tobacco product 2016 550 559
regulation violation within a 24-month period.
Penalty in the case of a fourth tobacco product 2016 2,200 2,236
regulation violation within a 24-month period.
asabaliauskas on DSK3SPTVN1PROD with RULES
Penalty in the case of a fifth tobacco product 2016 5,501 5,591
regulation violation within a 36-month period.
Penalty in the case of a sixth or subsequent to- 2016 11,002 11,182
bacco product regulation violation within a 48-
month period as determined on a case-by-
case basis.
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![Federal Register / Vol. 82, No. 22 / Friday, February 3, 2017 / Rules and Regulations 9177
CIVIL MONETARY PENALTY AUTHORITIES ADMINISTERED BY HHS AGENCIES AND PENALTY AMOUNTS—Continued
[Effective February 3, 2017]
Citation Date of last 2016 2017
HHS penalty fig- Maximum Maximum
Description 2
U.S.C. CFR 1 agency ure or ad- adjusted adjusted
justment 3 penalty ($) penalty ($) 4
Penalty to be applied for violations of restrictions 2016 275 279
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 of a second tobacco product 2016 550 559
regulation violation within a 12-month period.
Penalty in the case of a third tobacco product 2016 1,100 1,118
regulation violation within a 24-month period.
Penalty in the case of a fourth tobacco product 2016 2,200 2,236
regulation violation within a 24-month period.
Penalty in the case of a fifth tobacco product 2016 5,501 5,591
regulation violation within a 36-month period.
Penalty in the case of a sixth or subsequent to- 2016 11,002 11,182
bacco product regulation violation within a 48-
month period as determined on a case-by-
case basis.
335b(a) ................................ ....................................... FDA .... Penalty for each violation for any individual who 2016 419,320 426,180
made a false statement or misrepresentation
of a material fact, bribed, destroyed, altered,
removed, or secreted, or procured the destruc-
tion, alteration, removal, or secretion of, any
material document, failed to disclose a mate-
rial fact, obstructed an investigation, employed
a consultant who was debarred, debarred indi-
vidual provided consultant services.
Penalty in the case of any other person (other 2016 1,677,280 1,704,720
than an individual) per above violation.
360pp(b)(1) ......................... ....................................... FDA .... Penalty for any person who violates any such re- 2016 2,750 2,795
quirements for electronic products, with each
unlawful act or omission constituting a sepa-
rate violation.
Penalty imposed for any related series of viola- 2016 937,500 952,838
tions of requirements relating to electronic
products.
42 U.S.C.
262(d) .................................. ....................................... FDA .... Penalty per day for violation of order of recall of 2016 215,628 219,156
biological product presenting imminent or sub-
stantial hazard.
263b(h)(3) ........................... ....................................... FDA .... Penalty for failure to obtain a mammography cer- 2016 16,773 17,047
tificate as required.
300aa–28(b)(1) ................... ....................................... FDA .... Penalty per occurrence for any vaccine manufac- 2016 215,628 219,156
turer that intentionally destroys, alters, falsifies,
or conceals any record or report required.
256b(d)(1)(B)(vi) ................. ....................................... HRSA Penalty for each instance of overcharging a 2016 5,437 5,526
340B covered entity.
299c–(3)(d) ......................... ....................................... AHRQ Penalty for an establishment or person supplying 2016 14,140 14,371
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 of Information in the National 2016 1,450 1,474
Directory of New Hires.
262a(i)(1) ............................. 42 CFR 1003.910 ......... OIG .... Penalty for each individual who violates safety 2016 327,962 333,327
and security procedures related to handling
dangerous biological agents and toxins.
Penalty for any other person who violates safety 2016 655,925 666,656
and security procedures related to handling
dangerous biological agents and toxins.
300jj–51 .............................. ....................................... OIG .... Penalty per violation for committing information 2016 1,000,000 1,016,360
blocking.
1320a–7a(a) ........................ 42 CFR 1003.210(a)(1) OIG .... Penalty for knowingly presenting or causing to 2016 15,024 15,270
be presented to an officer, employee, or agent
of the United States a false claim.
Penalty for knowingly presenting or causing to 2016 15,024 15,270
asabaliauskas on DSK3SPTVN1PROD with RULES
be presented a request for payment which vio-
lates the terms of an assignment, agreement,
or PPS agreement.
42 CFR 1003.210(a)(2) ............ Penalty for knowingly giving or causing to be 2016 22,537 22,906
presented to a participating provider or sup-
plier false or misleading information that could
reasonably be expected to influence a dis-
charge decision.
42 CFR 1003.210(a)(3) ............ Penalty for an excluded party retaining owner- 2016 15,024 15,270
ship or control interest in a participating entity.
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![9178 Federal Register / Vol. 82, No. 22 / Friday, February 3, 2017 / Rules and Regulations
CIVIL MONETARY PENALTY AUTHORITIES ADMINISTERED BY HHS AGENCIES AND PENALTY AMOUNTS—Continued
[Effective February 3, 2017]
Citation Date of last 2016 2017
HHS penalty fig- Maximum Maximum
Description 2
U.S.C. CFR 1 agency ure or ad- adjusted adjusted
justment 3 penalty ($) penalty ($) 4
42 CFR 1003.1010 ............ Penalty for remuneration offered to induce pro- 2016 15,024 15,270
gram beneficiaries to use particular providers,
practitioners, or suppliers.
42 CFR 1003.210(a)(4) ............ Penalty for employing or contracting with an ex- 2016 14,718 14,959
cluded individual.
......................................... 42 CFR 1003.310(a)(3) ............ Penalty for knowing and willful solicitation, re- 2016 73,588 74,792
ceipt, offer, or payment of remuneration for re-
ferring an individual for a service or for pur-
chasing, leasing, or ordering an item to be
paid for by a Federal health care program.
42 CFR 1003.210(a)(1) Penalty for ordering or prescribing medical or 2016 10,874 11,052
other item or service during a period in which
the person was excluded.
42 CFR 1003.210(a)(6) Penalty for knowingly making or causing to be 2016 54,372 55,262
made a false statement, omission or misrepre-
sentation 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 of an overpayment and fail- 2016 10,874 11,052
ing to report and return.
42 CFR 1003.210(a)(7) ............ Penalty for making or using a false record or 2016 54,372 55,262
statement that is material to a false or fraudu-
lent claim.
42 CFR 1003.210(a)(9) ............ Penalty for failure to grant timely access to HHS 2016 16,312 16,579
OIG for audits, investigations, evaluations, and
other statutory functions of HHS OIG.
1320a–7a(b) ........................ ....................................... OIG .... Penalty for payments by a hospital or critical ac- 2016 4,313 4,384
cess 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 physicians who knowingly receive 2016 4,313 4,384
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 med-
ical assistance benefits.
42 CFR 1003.210(a)(10) Penalty for a physician who executes a docu- 2016 7,512 7,635
ment 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 final adverse ac- 2016 36,794 37,396
tion taken against a health care provider, sup-
plier, or practitioner.
1320b–10(b)(1) ................... 42 CFR 1003.610(a) ..... OIG .... Penalty for the misuse of words, symbols, or em- 2016 9,893 10,055
blems 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 misuse of words, symbols, or em- 2016 49,467 50,276
blems in a broadcast or telecast in a manner
in which a person could falsely construe that
such item is approved, endorsed, or author-
ized by HHS.
1395i–3(b)(3)(B)(ii)(1) ......... 42 CFR 1003.210(a)(11) OIG .... Penalty for certification of a false statement in 2016 2,063 2,097
assessment of functional capacity of a Skilled
Nursing Facility resident assessment.
1395i–3(b)(3)(B)(ii)(2) ......... 42 CFR 1003.210(a)(11) OIG .... Penalty for causing another to certify or make a 2016 10,314 10,483
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 individual who notifies or causes 2016 4,126 4,194
to be notified a Skilled Nursing Facility of the
time or date on which a survey is to be con-
ducted.
1395w–27(g)(2)(A) .............. 42 CFR 1003.410 ......... OIG .... Penalty for a Medicare Advantage organization 2016 37,561 38,175
that substantially fails to provide medically
asabaliauskas on DSK3SPTVN1PROD with RULES
necessary, required items and services.
Penalty for a Medicare Advantage organization 2016 36,794 37,396
that charges excessive premiums.
Penalty for a Medicare Advantage organization 2016 36,794 37,396
that improperly expels or refuses to reenroll a
beneficiary.
Penalty for a Medicare Advantage organization 2016 147,177 149,585
that engages in practice that would reasonably
be expected to have the effect of denying or
discouraging enrollment.
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![Federal Register / Vol. 82, No. 22 / Friday, February 3, 2017 / Rules and Regulations 9179
CIVIL MONETARY PENALTY AUTHORITIES ADMINISTERED BY HHS AGENCIES AND PENALTY AMOUNTS—Continued
[Effective February 3, 2017]
Citation Date of last 2016 2017
HHS penalty fig- Maximum Maximum
Description 2
U.S.C. CFR 1 agency ure or ad- adjusted adjusted
justment 3 penalty ($) penalty ($) 4
Penalty per individual who does not enroll as a 2016 22,077 22,438
result of a Medicare Advantage organization’s
practice that would reasonably be expected to
have the effect of denying or discouraging en-
rollment.
Penalty for a Medicare Advantage organization 2016 147,177 149,585
misrepresenting or falsifying information to
Secretary.
Penalty for a Medicare Advantage organization 2016 36,794 37,396
misrepresenting or falsifying information to in-
dividual or other entity.
Penalty for Medicare Advantage organization 2016 36,794 37,396
interfering with provider’s advice to enrollee
and non-MCO affiliated providers that balance
bill enrollees.
Penalty for a Medicare Advantage organization 2016 36,794 37,396
that employs or contracts with excluded indi-
vidual or entity.
Penalty for a Medicare Advantage organization 2016 36,794 37,396
enrolling an individual in without prior written
consent.
Penalty for a Medicare Advantage organization 2016 36,794 37,396
transferring an enrollee to another plan without
consent or solely for the purpose of earning a
commission.
Penalty for a Medicare Advantage organization 2016 36,794 37,396
failing to comply with marketing restrictions or
applicable implementing regulations or guid-
ance.
Penalty for a Medicare Advantage organization 2016 36,794 37,396
employing or contracting with an individual or
entity who violates 1395w–27(g)(1)(A)–(J).
1395w–141(i)(3) .................. ....................................... OIG .... Penalty for a prescription drug card sponsor that 2016 12,856 13,066
falsifies or misrepresents marketing materials,
overcharges program enrollees, or misuse
transitional assistance funds.
1395cc(g) ............................ ....................................... OIG .... Penalty for improper billing by Hospitals, Critical 2016 5,000 5,082
Access Hospitals, or Skilled Nursing Facilities.
1395dd(d)(1) ....................... 42 CFR 1003.510 ......... OIG .... Penalty for a hospital or responsible physician 2016 103,139 104,826
dumping patients needing emergency medical
care, if the hospital has 100 beds or more.
Penalty for a hospital or responsible physician 2016 51,570 52,414
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 plan is such 2016 51,570 52,414
plan substantially fails to provide medically
necessary, required items or services.
Penalty for HMOs/competitive medical plans that 2016 51,570 52,414
charge premiums in excess of permitted
amounts.
Penalty for a HMO or competitive medical plan 2016 51,570 52,414
that expels or refuses to reenroll an individual
per prescribed conditions.
Penalty for a HMO or competitive medical plan 2016 206,278 209,653
that implements practices to discourage enroll-
ment of individuals needing services in future.
Penalty per individual not enrolled in a plan as a 2016 29,680 30,166
result of a HMO or competitive medical plan
that implements practices to discourage enroll-
ment of individuals needing services in the fu-
ture.
Penalty for a HMO or competitive medical plan 2016 206,278 209,653
that misrepresents or falsifies information to
the Secretary.
Penalty for a HMO or competitive medical plan 2016 51,570 52,414
that misrepresents or falsifies information to an
asabaliauskas on DSK3SPTVN1PROD with RULES
individual or any other entity.
Penalty for failure by HMO or competitive med- 2016 51,570 52,414
ical plan to assure prompt payment of Medi-
care risk sharing contracts or incentive plan
provisions.
Penalty for HMO that employs or contracts with 2016 47,340 48,114
excluded individual or entity.
1395nn(g)(3) ....................... 42 CFR 1003.310 ......... OIG .... Penalty for submitting or causing to be submitted 2016 23,863 24,253
claims in violation of the Stark Law’s restric-
tions on physician self-referrals.
VerDate Sep<11>2014 21:08 Feb 02, 2017 Jkt 241001 PO 00000 Frm 00053 Fmt 4700 Sfmt 4700 E:\FR\FM\03FER1.SGM 03FER1](https://thefederalregister.org/doc/82_FR_9196/page/6.svg)
![9180 Federal Register / Vol. 82, No. 22 / Friday, February 3, 2017 / Rules and Regulations
CIVIL MONETARY PENALTY AUTHORITIES ADMINISTERED BY HHS AGENCIES AND PENALTY AMOUNTS—Continued
[Effective February 3, 2017]
Citation Date of last 2016 2017
HHS penalty fig- Maximum Maximum
Description 2
U.S.C. CFR 1 agency ure or ad- adjusted adjusted
justment 3 penalty ($) penalty ($) 4
1395nn(g)(4) ....................... 42 CFR 1003.310 ......... OIG .... Penalty for circumventing Stark Law’s restrictions 2016 159,089 161,692
on physician self-referrals.
1395ss(d)(1) ........................ 42 CFR 1003.1110 ....... OIG .... Penalty for a material misrepresentation regard- 2016 9,893 10,055
ing Medigap compliance policies.
1395ss(d)(2) ........................ 42 CFR 1003.1110 ....... OIG .... Penalty for selling Medigap policy under false 2016 9,893 10,055
pretense.
1395ss(d)(3)(A)(ii) ............... 42 CFR 1003.1110 ....... OIG .... Penalty for an issuer that sells health insurance 2016 44,539 45,268
policy that duplicates benefits.
Penalty for someone other than issuer that sells 2016 26,723 27,160
health insurance that duplicates benefits.
1395ss(d)(4)(A) ................... 42 CFR 1003.1110 ....... OIG .... Penalty for using mail to sell a non-approved 2016 9,893 10,055
Medigap insurance policy.
1396b(m)(5)(B)(i) ................ 42 CFR 1003.410 ......... OIG .... Penalty for a Medicaid MCO that substantially 2016 49,467 50,276
fails to provide medically necessary, required
items or services.
Penalty for a Medicaid MCO that charges exces- 2016 49,467 50,276
sive premiums.
Penalty for a Medicaid MCO that improperly ex- 2016 197,869 201,106
pels or refuses to reenroll a beneficiary.
Penalty per individual who does not enroll as a 2016 29,680 30,166
result of a Medicaid MCO’s practice that would
reasonably be expected to have the effect of
denying or discouraging enrollment.
Penalty for a Medicaid MCO misrepresenting or 2016 197,869 201,106
falsifying information to the Secretary.
Penalty for a Medicaid MCO misrepresenting or 2016 49,467 50,276
falsifying information to an individual or an-
other entity.
Penalty for a Medicaid MCO that fails to comply 2016 44,539 45,268
with contract requirements with respect to phy-
sician incentive plans.
1396r(b)(3)(B)(ii)(I) .............. 42 CFR 1003.210(a)(11) OIG .... Penalty for willfully and knowingly certifying a 2016 2,063 2,097
material and false statement in a Skilled Nurs-
ing Facility resident assessment.
1396r(b)(3)(B)(ii)(II) ............. 42 CFR 1003.210(a)(11) OIG .... Penalty for willfully and knowingly causing an- 2016 10,314 10,483
other 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 notifying or causing to be notified a 2016 4,126 4,194
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 knowing provision of false infor- 2016 178,156 181,071
mation 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 provide infor- 2016 17,816 18,107
mation by drug manufacturer with rebate
agreement.
1396r–8(b)(3)(C)(ii) ............. 42 CFR 1003.1210 ....... OIG .... Penalty for knowing provision of false information 2016 178,156 181,071
by drug manufacturer with rebate agreement.
1396t(i)(3)(A) ....................... 42 CFR 1003.1310 ....... OIG .... Penalty for notifying home and community-based 2016 3,563 3,621
providers or settings of survey.
11131(c) .............................. 42 CFR 1003.810 ......... OIG .... Penalty for failing to report a medical malpractice 2016 21,563 21,916
claim to National Practitioner Data Bank.
11137(b)(2) ......................... 42 CFR 1003.810 ......... OIG .... Penalty for breaching confidentiality of informa- 2016 21,563 21,916
tion reported to National Practitioner Data
Bank.
299b–22(f)(1) ...................... 42 CFR 3.404 ............... OCR ... Penalty for violation of confidentiality provision of 2016 11,940 12,135
the Patient Safety and Quality Improvement
Act.
45 CFR 160.404(b)(1)(i), OCR ... Penalty for each pre-February 18, 2009 violation 2016 150 152
(ii) of the HIPAA administrative simplification pro-
visions.
Calendar Year Cap ............................................... 2016 37,561 38,175
1320(d)–5(a) ....................... 45 CFR 160.404(b) OCR ... Penalty for each February 18, 2009 or later vio-
asabaliauskas on DSK3SPTVN1PROD with RULES
(2)(i)(A), (B). lation 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 provi-
sion:
Minimum ............................................................... 2016 110 112
Maximum .............................................................. 2016 55,010 55,910
Calendar Year Cap ............................................... 2016 1,650,300 1,677,299
VerDate Sep<11>2014 21:08 Feb 02, 2017 Jkt 241001 PO 00000 Frm 00054 Fmt 4700 Sfmt 4700 E:\FR\FM\03FER1.SGM 03FER1](https://thefederalregister.org/doc/82_FR_9196/page/7.svg)
![Federal Register / Vol. 82, No. 22 / Friday, February 3, 2017 / Rules and Regulations 9181
CIVIL MONETARY PENALTY AUTHORITIES ADMINISTERED BY HHS AGENCIES AND PENALTY AMOUNTS—Continued
[Effective February 3, 2017]
Citation Date of last 2016 2017
HHS penalty fig- Maximum Maximum
Description 2
U.S.C. CFR 1 agency ure or ad- adjusted adjusted
justment 3 penalty ($) penalty ($) 4
45 CFR 160.404(b)(2)(ii) OCR ... Penalty for each February 18, 2009 or later vio-
(A), (B) lation of a HIPAA administrative simplification
provision in which it is established that the vio-
lation was due to reasonable cause and not to
willful neglect:
Minimum ............................................................... 2016 1,100 1,118
Maximum .............................................................. 2016 55,010 55,910
Calendar Year Cap ............................................... 2016 1,650,300 1,677,299
45 CFR 160.404(b) OCR ... Penalty for each February 18, 2009 or later vio-
(2)(iii)(A), (B) lation of a HIPAA administrative simplification
provision in which it is established that the vio-
lation was due to willful neglect and was cor-
rected 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
Maximum .............................................................. 2016 55,010 55,910
Calendar Year Cap ............................................... 2016 1,650,300 1,677,299
45 CFR 160.404(b)(2) OCR ... Penalty for each February 18, 2009 or later vio-
(iv)(A), (B) lation of a HIPAA administrative simplification
provision in which it is established that the vio-
lation 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
Maximum .............................................................. 2016 1,650,300 1,677,299
Calendar Year Cap ............................................... 2016 1,650,300 1,677,299
263a(h)(2)(B) & 1395w– 42 CFR 493.1834(d)(2) CMS ... Penalty for a clinical laboratory’s failure to meet
2(b)(2)(A)(ii). (i). participation and certification requirements and
poses immediate jeopardy:
Minimum ............................................................... 2016 6,035 6,134
Maximum .............................................................. 2016 19,787 20,111
42 CFR 493.1834(d)(2) CMS ... Penalty for a clinical laboratory’s failure to meet
(ii). participation and certification requirements and
the failure does not pose immediate jeopardy:
Minimum ............................................................... 2016 99 101
Maximum .............................................................. 2016 5,936 6,033
300gg–15(f) ......................... 45 CFR 147.200(e) ....... CMS ... Failure to provide the Summary of Benefits and 2016 1,087 1,105
Coverage.
300gg–18 ............................ 45 CFR 158.606 ........... CMS ... Penalty for violations of regulations related to the 2016 109 111
medical loss ratio reporting and rebating.
1320a–7h(b)(1) ................... 42 CFR 402.105(d)(5), CMS ... Penalty for manufacturer or group purchasing or-
42 CFR 403.912(a) & ganization failing to report information required
(c). under 42 U.S.C. 1320a–7h(a), relating to phy-
sician ownership or investment interests:
Minimum ............................................................... 2016 1,087 1,105
Maximum .............................................................. 2016 10,874 11,052
Calendar Year Cap ............................................... 2016 163,117 165,786
1320a–7h(b)(2) ................... 42 CFR 402.105(h), 42 CMS ... Penalty for manufacturer or group purchasing or-
CFR 403.912(b) & (c). ganization knowingly failing to report informa-
tion required under 42 U.S.C. 1320a–7h(a), re-
lating to physician ownership or investment in-
terests:
Minimum ............................................................... 2016 10,874 11,052
Maximum .............................................................. 2016 108,745 110,524
Calendar Year Cap ............................................... 2016 1,087,450 1,105,241
CMS Penalty for an administrator of a facility that fails 2016 108,745 110,524
to comply with notice requirements for the clo-
sure of a facility.
asabaliauskas on DSK3SPTVN1PROD with RULES
1320a–7j(h)(3)(A) ................ 42 CFR 488.446(a)(1), CMS ... Minimum penalty for the first offense of an ad- 2016 544 553
(2), & (3). ministrator who fails to provide notice of facility
closure.
Minimum penalty for the second offense of an 2016 1,631 1,658
administrator who fails to provide notice of fa-
cility closure.
Minimum penalty for the third and subsequent 2016 3,262 3,315
offenses of an administrator who fails to pro-
vide notice of facility closure.
VerDate Sep<11>2014 21:08 Feb 02, 2017 Jkt 241001 PO 00000 Frm 00055 Fmt 4700 Sfmt 4700 E:\FR\FM\03FER1.SGM 03FER1](https://thefederalregister.org/doc/82_FR_9196/page/8.svg)
![9182 Federal Register / Vol. 82, No. 22 / Friday, February 3, 2017 / Rules and Regulations
CIVIL MONETARY PENALTY AUTHORITIES ADMINISTERED BY HHS AGENCIES AND PENALTY AMOUNTS—Continued
[Effective February 3, 2017]
Citation Date of last 2016 2017
HHS penalty fig- Maximum Maximum
Description 2
U.S.C. CFR 1 agency ure or ad- adjusted adjusted
justment 3 penalty ($) penalty ($) 4
1320a–8(a)(1) ..................... ....................................... CMS ... Penalty for an entity knowingly making a false 2016 7,954 8,084
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 supple-
mental security income for the aged, blind,
and disabled.
Penalty for violation of 42 U.S.C. 1320a–8(a)(1) 2016 7,500 7,623
if the violator is a person who receives a fee
or other income for services performed in con-
nection 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 representative payee (under 42 2016 6,229 6,331
U.S.C. 405(j), 1007, or 1383(a)(2)) converting
any part of a received payment from the ben-
efit 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 individuals to report 2016 217,490 221,048
to the Secretary and 1 or more law enforce-
ment officials any reasonable suspicion of a
crime against a resident, or individual receiv-
ing care, from a long-term care facility.
1320b–25(c)(2)(A) ............... ....................................... CMS ... Penalty for failure of covered individuals to report 2016 326,235 331,572
to the Secretary and 1 or more law enforce-
ment officials any reasonable suspicion of a
crime against a resident, or individual receiv-
ing 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 in-
dividual.
1320b–25(d)(2) ................... ....................................... CMS ... Penalty for a long-term care facility that retaliates 2016 217,490 221,048
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 law-
ful acts done by the employee or nurse.
1395b–7(b)(2)(B) ................ 42 CFR 402.105(g) ....... CMS ... Penalty for any person who knowingly and will- 2016 147 149
fully 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 488.408(d)(1) CMS ... Penalty per day for a Skilled Nursing Facility that
(iii). has a Category 2 violation of certification re-
quirements:
Minimum ............................................................... 2016 103 105
Maximum .............................................................. 2016 6,188 6,289
42 CFR 488.408(d)(1) CMS ... Penalty per instance of Category 2 noncompli-
(iv) ance by a Skilled Nursing Facility:
Minimum ............................................................... 2016 2,063 2,097
Maximum .............................................................. 2016 20,628 20,965
42 CFR 488.408(e)(1) CMS ... Penalty per day for a Skilled Nursing Facility that
(iii) has a Category 3 violation of certification re-
quirements:
Minimum ............................................................... 2016 6,291 6,394
Maximum .............................................................. 2016 20,628 20,965
42 CFR 488.408(e)(1) CMS ... Penalty per instance of Category 3 noncompli-
(iv) ance by a Skilled Nursing Facility:
Minimum ............................................................... 2016 2,063 2,097
Maximum .............................................................. 2016 20,628 20,965
42 CFR 488.408(e)(2)(ii) CMS ... Penalty per day and per instance for a Skilled
Nursing Facility that has Category 3 non-
compliance with Immediate Jeopardy:
Per Day (Minimum) .............................................. 2016 6,291 6,394
Per Day (Maximum) ............................................. 2016 20,628 20,965
asabaliauskas on DSK3SPTVN1PROD with RULES
Per Instance (Minimum) ....................................... 2016 2,063 2,097
Per Instance (Maximum) ...................................... 2016 20,628 20,965
42 CFR 488.438(a)(1)(i) CMS ... Penalty per day of a Skilled Nursing Facility that
fails to meet certification requirements. These
amounts represent the upper range per day:
Minimum ............................................................... 2016 6,291 6,394
Maximum .............................................................. 2016 20,628 20,965
42 CFR 488.438(a)(1)(ii) CMS ... Penalty per day of a Skilled Nursing Facility that
fails to meet certification requirements. These
amounts represent the lower range per day:
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![Federal Register / Vol. 82, No. 22 / Friday, February 3, 2017 / Rules and Regulations 9183
CIVIL MONETARY PENALTY AUTHORITIES ADMINISTERED BY HHS AGENCIES AND PENALTY AMOUNTS—Continued
[Effective February 3, 2017]
Citation Date of last 2016 2017
HHS penalty fig- Maximum Maximum
Description 2
U.S.C. CFR 1 agency ure or ad- adjusted adjusted
justment 3 penalty ($) penalty ($) 4
Minimum ............................................................... 2016 103 105
Maximum .............................................................. 2016 6,188 6,289
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
Maximum .............................................................. 2016 20,628 20,965
1395l(h)(5)(D) ..................... 42 CFR 402.105(d)(2)(i) CMS ... Penalty for knowingly, willfully, and repeatedly 2016 15,024 15,270
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 as-
sessed according to 1320a–7a(a)).
1395l(i)(6) ............................ ....................................... CMS ... Penalty for knowingly and willfully presenting or 2016 3,957 4,022
causing to be presented a bill or request for
payment for an intraocular lens inserted during
or after cataract surgery for which the Medi-
care payment rate includes the cost of acquir-
ing the class of lens involved.
1395l(q)(2)(B)(i) ................... 42 CFR 402.105(a) ....... CMS ... Penalty for knowingly and willfully failing to pro- 2016 3,787 3,849
vide information about a referring physician
when seeking payment on an unassigned
basis.
1395m(a)(11)(A) ................. 42 CFR 402.1(c)(4), CMS ... Penalty for any durable medical equipment sup- 2016 15,024 15,270
402.105(d)(2)(ii). plier 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) ................. 42 CFR 402.1(c)(5), CMS ... Penalty for any nonparticipating durable medical 2016 15,024 15,270
402.105(d)(2)(iii). equipment supplier that knowingly and willfully
fails to make a refund to Medicare bene-
ficiaries for a covered service for which pay-
ment is precluded 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) ................... 42 CFR 402.1(c)(6), CMS ... Penalty for any nonparticipating physician or 2016 15,024 15,270
402.105(d)(2)(iv). 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) ........................ 42 CFR 402.1(c)(8), CMS ... Penalty for any supplier of prosthetic devices, 2016 15,024 15,270
402.105(d)(2)(vi). orthotics, and prosthetics that knowing and
willfully charges for a covered prosthetic de-
vice, 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)).
1395m(j)(2)(A)(iii) ................ ....................................... CMS ... Penalty for any supplier of durable medical 2016 1,591 1,617
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) .......................... 42 CFR 402.1(c)(10), CMS ... Penalty for any supplier of durable medical 2016 15,024 15,270
402.105(d)(2)(vii). equipment, including a supplier of prosthetic
devices, prosthetics, orthotics, or supplies that
asabaliauskas on DSK3SPTVN1PROD with RULES
knowingly and willfully fails to make refunds in
a timely manner to Medicare beneficiaries for
series billed other than on as assignment-re-
lated 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)).
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![9184 Federal Register / Vol. 82, No. 22 / Friday, February 3, 2017 / Rules and Regulations
CIVIL MONETARY PENALTY AUTHORITIES ADMINISTERED BY HHS AGENCIES AND PENALTY AMOUNTS—Continued
[Effective February 3, 2017]
Citation Date of last 2016 2017
HHS penalty fig- Maximum Maximum
Description 2
U.S.C. CFR 1 agency ure or ad- adjusted adjusted
justment 3 penalty ($) penalty ($) 4
1395m(k)(6) ......................... 42 CFR 402.1(c)(31), CMS ... Penalty for any person or entity who knowingly 2016 15,024 15,270
402.105(d)(3). and willfully bills or collects for any outpatient
therapy services or comprehensive outpatient
rehabilitation services on other than an assign-
ment-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 accord-
ing to 1320a–7a(a)).
1395m(l)(6) .......................... 42 CFR 402.1(c)(32), CMS ... Penalty for any supplier of ambulance services 2016 15,024 15,270
402.105(d)(4). who knowingly and willfully fills or collects for
any services on other than an assignment-re-
lated 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) .................. 42 CFR 402.1(c)(11), CMS ... Penalty for any practitioner specified in Section 2016 15,024 15,270
402.105(d)(2)(viii). 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 as-
sessed 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) ...................... 42 CFR 402.1(c) ........... CMS ... Penalty for any physician who charges more 2016 15,024 15,270
than 125% for a non-participating referral.
(Penalties are assessed in the same manner
as 42 U.S.C. 1320a–7a(a)).
1395u(k) .............................. 42 CFR 402.1(c)(12), CMS ... Penalty for any physician who knowingly and 2016 15,024 15,270
402.105(d)(2)(ix). willfully presents or causes to be presented a
claim for bill for an assistant at a cataract sur-
gery 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)).
1395u(l)(3) ........................... 42 CFR 402.1(c)(13), CMS ... Penalty for any nonparticipating physician who 2016 15,024 15,270
402.105(d)(2)(x). 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) ........................ 42 CFR 402.1(c)(14), CMS ... Penalty for any nonparticipating physician charg- 2016 15,024 15,270
402.105(d)(2)(xi). ing more than $500 who does not accept pay-
ment for an elective surgical procedure on an
assignment related basis and who knowingly
and willfully fails to disclose the required infor-
mation regarding charges and coinsurance
amounts and fails to refund on a timely basis
any amount collected for the procedure in ex-
cess of the charges recognized and approved
by the Medicare program. (Penalties are as-
sessed in the same manner as 42 U.S.C.
1395u(j)(2)(B), which is assessed according to
1320a–7a(a)).
1395u(n)(3) ......................... 42 CFR 402.1(c)(15), CMS ... Penalty for any physician who knowingly, will- 2016 15,024 15,270
402.105(d)(2)(xii). fully, and repeatedly bills one or more bene-
ficiaries for purchased diagnostic tests any
amount other than the payment amount speci-
fied by the Act. (Penalties are assessed in the
same manner as 42 U.S.C. 1395u(j)(2)(B),
which is assessed according to 1320a–7a(a)).
1395u(o)(3)(B) ..................... 42 CFR 414.707(b) ....... CMS ... Penalty for any practitioner specified in Section 2016 15,024 15,270
1842(b)(18)(C) of the Act or other person that
asabaliauskas on DSK3SPTVN1PROD with RULES
knowingly and willfully bills or collects for any
services pertaining to drugs or biologics by the
practitioners on other than an assignment-re-
lated basis. (Penalties are assessed in the
same manner as 42 U.S.C. 1395u(b)(18)(B)
and 1395u(j)(2)(B), which is assessed accord-
ing to 1320a–7a(a)).
VerDate Sep<11>2014 21:08 Feb 02, 2017 Jkt 241001 PO 00000 Frm 00058 Fmt 4700 Sfmt 4700 E:\FR\FM\03FER1.SGM 03FER1](https://thefederalregister.org/doc/82_FR_9196/page/11.svg)
![Federal Register / Vol. 82, No. 22 / Friday, February 3, 2017 / Rules and Regulations 9185
CIVIL MONETARY PENALTY AUTHORITIES ADMINISTERED BY HHS AGENCIES AND PENALTY AMOUNTS—Continued
[Effective February 3, 2017]
Citation Date of last 2016 2017
HHS penalty fig- Maximum Maximum
Description 2
U.S.C. CFR 1 agency ure or ad- adjusted adjusted
justment 3 penalty ($) penalty ($) 4
1395u(p)(3)(A) ..................... ....................................... CMS ... Penalty for any physician or practitioner who 2016 3,957 4,022
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 assign-
ment-related basis.
1395w–3a(d)(4)(A) .............. 42 CFR 414.806 ........... CMS ... Penalty for a pharmaceutical manufacturer’s mis- 2016 12,856 13,066
representation of average sales price of a
drug, or biologic.
1395w–4(g)(1)(B) ................ 42 CFR 402.1(c)(17), CMS ... Penalty for any nonparticipating physician, sup- 2016 15,024 15,270
402.105(d)(2)(xiii). plier, or other person that furnishes physician
services not on an assignment-related basis
who either knowingly and willfully bills or col-
lects in excess of the statutorily-defined lim-
iting 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) ................ 42 CFR 402.1(c)(18), CMS ... Penalty for any person that knowingly and will- 2016 15,024 15,270
402.105(d)(2)(xiv). fully bills for statutorily defined State-plan ap-
proved physicians’ services on any other basis
than an assignment-related basis for a Medi-
care/Medicaid dual eligible beneficiary. (Pen-
alties are assessed in the same manner as 42
U.S.C. 1395u(j)(2)(B), which is assessed ac-
cording to 1320a–7a(a)).
1395w–27(g)(3)(A); 42 CFR 422.760(b); 42 CMS ... Penalty for each termination determination the 2016 36,794 37,396
1857(g)(3). CFR 423.760(b). Secretary makes that is the result of actions
by a Medicare Advantage organization or Part
D sponsor that has adversely affected an indi-
vidual covered under the organization’s con-
tract.
1395w–27(g)(3)(B); ....................................... CMS ... Penalty for each week beginning after the initi- 2016 14,718 14,959
1857(g)(3). ation of civil money penalty procedures by the
Secretary because a Medicare Advantage or-
ganization or Part D sponsor has failed to
carry out a contract, or has carried out a con-
tract inconsistently with regulations.
1395w–27(g)(3)(D); 1857 ....................................... CMS ... Penalty for a Medicare Advantage organization’s 2016 136,689 138,925
(g)(3). or Part D sponsor’s early termination of its
contract.
1395y(b)(3)(C) ..................... 42 CFR 411.103(b) ....... CMS ... Penalty for an employer or other entity to offer 2016 8,908 9,054
any financial or other incentive for an indi-
vidual 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 employer that, 2016 1,450 1,474
CFR 402.105(b)(2). before October 1, 1998, willfully or repeatedly
failed to provide timely and accurate informa-
tion requested relating to an employee’s group
health insurance coverage.
1395y(b)(6)(B) ..................... 42 CFR 402.1(c)(21), CMS ... Penalty for any entity that knowingly, willfully, 2016 3,182 3,234
402.105(a). and repeatedly fails to complete a claim form
relating to the availability of other health bene-
fits in accordance with statute or provides in-
accurate information relating to such on the
claim form.
1395y(b)(7)(B)(i) ................. ....................................... CMS ... Penalty for any entity serving as insurer, third 2016 1,138 1,157
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 Medi-
care to the HHS Secretary.
1395y(b)(8)(E) ..................... ....................................... CMS ... Penalty for any non-group health plan that fails 2016 1,138 1,157
to identify claimants who are Medicare bene-
ficiaries and provide information to the HHS
asabaliauskas on DSK3SPTVN1PROD with RULES
Secretary to coordinate benefits and pursue
any applicable recovery claim.
1395nn(g)(5) ....................... 42 CFR 411.361 ........... CMS ... Penalty for any person that fails to report infor- 2016 18,936 19,246
mation required by HHS under Section 1877(f)
concerning ownership, investment, and com-
pensation arrangements.
VerDate Sep<11>2014 21:08 Feb 02, 2017 Jkt 241001 PO 00000 Frm 00059 Fmt 4700 Sfmt 4700 E:\FR\FM\03FER1.SGM 03FER1](https://thefederalregister.org/doc/82_FR_9196/page/12.svg)
![9186 Federal Register / Vol. 82, No. 22 / Friday, February 3, 2017 / Rules and Regulations
CIVIL MONETARY PENALTY AUTHORITIES ADMINISTERED BY HHS AGENCIES AND PENALTY AMOUNTS—Continued
[Effective February 3, 2017]
Citation Date of last 2016 2017
HHS penalty fig- Maximum Maximum
Description 2
U.S.C. CFR 1 agency ure or ad- adjusted adjusted
justment 3 penalty ($) penalty ($) 4
1395pp(h) ............................ 42 CFR 402.1(c)(23), CMS ... Penalty for any durable medical equipment sup- 2016 15,024 15,270
402.105(d)(2)(xv). plier, including a supplier of prosthetic devices,
prosthetics, orthotics, or supplies, that know-
ingly 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 person that issues a Medicare 2016 51,569 52,413
405.105(f)(1). supplemental policy that has not been ap-
proved by the State regulatory program or
does not meet Federal standards after a statu-
torily defined effective date.
1395ss(d)(3)(A)(vi) (II) ........ ....................................... CMS ... Penalty for someone other than issuer that sells 2016 26,723 27,160
or issues a Medicare supplemental policy to
beneficiary without a disclosure statement.
Penalty for an issuer that sells or issues a Medi- 2016 44,539 45,268
care supplemental policy without disclosure
statement.
1395ss(d)(3)(B)(iv) .............. ....................................... CMS ... Penalty for someone other than issuer that sells 2016 26,723 27,160
or issues a Medicare supplemental policy with-
out acknowledgement form.
Penalty for issuer that sells or issues a Medicare 2016 44,539 45,268
supplemental policy without an acknowledge-
ment form.
1395ss(p)(8) ........................ 42 CFR 402.1(c)(25), CMS ... Penalty for any person that sells or issues Medi- 2016 26,723 27,160
402.105(e). care 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 person that sells or issues Medi- 2016 44,539 45,268
405.105(f)(2) care 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 person that sells a Medicare 2016 26,723 27,160
402.105(e). supplemental policy and fails to make avail-
able for sale the core group of basic benefits
when selling other Medicare supplemental
policies with additional benefits or fails to pro-
vide the individual, before selling the policy, an
outline of coverage describing benefits.
42 CFR 402.1(c)(26), ............ Penalty for any person that sells a Medicare 2016 44,539 45,268
405.105(f)(3), (4) supplemental policy and fails to make avail-
able for sale the core group of basic benefits
when selling other Medicare supplemental
policies with additional benefits or fails to pro-
vide 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 person that fails to suspend the 2016 44,539 45,268
405.105(f)(5). policy of a policyholder made eligible for med-
ical assistance or automatically reinstates 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 provide re- 2016 44,539 45,268
405.105(f)(6). funds or credits as required by section
1882(r)(1)(B).
1395ss(s)(4) ........................ 42 CFR 402.1(c)(29), CMS ... Penalty for any issuer of a Medicare supple- 2016 18,908 19,217
405.105(c). mental 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 issuer of a Medicare supple- 2016 44,539 45,268
405.105(f)(7). mental policy that fails to fulfill listed respon-
sibilities.
asabaliauskas on DSK3SPTVN1PROD with RULES
1395ss(v)(4)(A) ................... ....................................... CMS ... Penalty someone other than issuer who sells, 2016 19,284 19,599
issues, or renews a medigap Rx policy to an
individual who is a Part D enrollee.
Penalty for an issuer who sells, issues, or re- 2016 32,140 32,666
news a Medigap Rx policy who is a Part D en-
rollee.
1395bbb(c)(1) ..................... 42 CFR 488.725(c) ....... CMS ... Penalty for any individual who notifies or causes 2016 4,126 4,194
to be notified a home health agency of the
time or date on which a survey of such agency
is to be conducted.
VerDate Sep<11>2014 21:08 Feb 02, 2017 Jkt 241001 PO 00000 Frm 00060 Fmt 4700 Sfmt 4700 E:\FR\FM\03FER1.SGM 03FER1](https://thefederalregister.org/doc/82_FR_9196/page/13.svg)
![Federal Register / Vol. 82, No. 22 / Friday, February 3, 2017 / Rules and Regulations 9187
CIVIL MONETARY PENALTY AUTHORITIES ADMINISTERED BY HHS AGENCIES AND PENALTY AMOUNTS—Continued
[Effective February 3, 2017]
Citation Date of last 2016 2017
HHS penalty fig- Maximum Maximum
Description 2
U.S.C. CFR 1 agency ure or ad- adjusted adjusted
justment 3 penalty ($) penalty ($) 4
1395bbb(f)(2)(A)(i) .............. 42 CFR CMS ... Maximum daily penalty amount for each day a 2016 19,787 20,111
488.845(b)(2)(iii) 42 home health agency is not in compliance with
CFR 488.845(b)(3)– statutory requirements.
(6); and 42 CFR
488.845(d)(1)(ii).
42 CFR 488.845(b)(3) ............ Penalty per day for home health agency’s non-
compliance (Upper Range):
Minimum ............................................................... 2016 16,819 17,094
Maximum .............................................................. 2016 19,787 20,111
42 CFR 488.845(b)(3)(i) ............ Penalty for a home health agency’s deficiency or 2016 19,787 20,111
deficiencies that cause immediate jeopardy
and result in actual harm.
42 CFR 488.845(b)(3)(ii) ............ Penalty for a home health agency’s deficiency or 2016 17,808 18,099
deficiencies that cause immediate jeopardy
and result in potential for harm.
42 CFR ............ Penalty for an isolated incident of noncompliance 2016 16,819 17,094
488.845(b)(3)(iii) in violation of established HHA policy.
42 CFR 488.845(b)(4) ............ Penalty for a repeat and/or condition-level defi-
ciency that does not constitute immediate
jeopardy, but is directly related to poor quality
patient care outcomes (Lower Range):
Minimum ............................................................... 2016 2,968 3,017
Maximum .............................................................. 2016 16,819 17,094
42 CFR 488.845(b)(5) ............ Penalty for a repeat and/or condition-level defi-
ciency that does not constitute immediate
jeopardy and that is related predominately to
structure or process-oriented conditions
(Lower Range):
Minimum ............................................................... 2016 989 1,005
Maximum .............................................................. 2016 7,915 8,044
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
Maximum .............................................................. 2016 19,787 20,111
Penalty for each day of noncompliance (Max- 2016 19,787 20,111
imum).
42 CFR 488.845(d)(1)(ii) ............ Penalty for each day of noncompliance (Max- 2016 19,787 20,111
imum).
1396b(m)(5)(B) .................... 42 CFR 460.46 ............. CMS ... Penalty for PACE organization’s practice that
would reasonably be expected to have the ef-
fect of denying or discouraging enrollment:
Minimum ............................................................... 2016 22,077 22,438
Maximum .............................................................. 2016 147,177 149,585
Penalty for a PACE organization that charges 2016 36,794 37,396
excessive premiums.
Penalty for a PACE organization misrepresenting 2016 147,177 149,585
or falsifying information to CMS, the State, or
an individual or other entity.
Penalty for each determination the CMS makes 2016 36,794 37,396
that the PACE organization has failed to pro-
vide medically necessary items and services
of the failure has adversely affected (or has
the substantial likelihood of adversely affect-
ing) a PACE participant.
Penalty for involuntarily disenrolling a participant. 2016 36,794 37,396
Penalty for discriminating or discouraging enroll- 2016 36,794 37,396
ment 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 a nursing facility’s failure to
488.408(d)(1)(iii). meet a Category 2 Certification:
Minimum ............................................................... 2016 103 105
Maximum .............................................................. 2016 6,188 6,289
42 CFR 488.408(d) CMS ... Penalty per instance for a nursing facility’s failure
asabaliauskas on DSK3SPTVN1PROD with RULES
(1)(iv) to meet Category 2 certification:
Minimum ............................................................... 2016 2,063 2,097
Maximum .............................................................. 2016 20,628 20,965
42 CFR 488.408(e) CMS ... Penalty per day for a nursing facility’s failure to
(1)(iii) meet Category 3 certification:
Minimum ............................................................... 2016 6,291 6,394
Maximum .............................................................. 2016 20,628 20,965
42 CFR 488.408(e) CMS ... Penalty per instance for a nursing facility’s failure
(1)(iv) to meet Category 3 certification:
Minimum ............................................................... 2016 2,063 2,097
VerDate Sep<11>2014 21:08 Feb 02, 2017 Jkt 241001 PO 00000 Frm 00061 Fmt 4700 Sfmt 4700 E:\FR\FM\03FER1.SGM 03FER1](https://thefederalregister.org/doc/82_FR_9196/page/14.svg)
![9188 Federal Register / Vol. 82, No. 22 / Friday, February 3, 2017 / Rules and Regulations
CIVIL MONETARY PENALTY AUTHORITIES ADMINISTERED BY HHS AGENCIES AND PENALTY AMOUNTS—Continued
[Effective February 3, 2017]
Citation Date of last 2016 2017
HHS penalty fig- Maximum Maximum
Description 2
U.S.C. CFR 1 agency ure or ad- adjusted adjusted
justment 3 penalty ($) penalty ($) 4
Maximum .............................................................. 2016 20,628 20,965
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:
Minimum ............................................................... 2016 2,063 2,097
Maximum .............................................................. 2016 20,628 20,965
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
Maximum .............................................................. 2016 20,628 20,965
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
Maximum .............................................................. 2016 6,188 6,289
42 CFR 488.438(a)(2) CMS ... Penalty per instance for nursing facility’s failure
to meet certification:
Minimum ............................................................... 2016 2,063 2,097
Maximum .............................................................. 2016 20,628 20,965
1396r(f)(2)(B)(iii)(I)(c) .......... 42 CFR 483.151(b)(2) CMS ... Grounds to prohibit approval of Nurse Aide 2016 10,314 10,483
(iv) and (b)(3)(iii). 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 spe-
cific 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 nurse aide 2016 10,314 10,483
training program—reference to disapproval
based on imposition of CMP ‘‘not less than
$5,000’’ [Not CMP authority but CMP imposi-
tion 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
Maximum .............................................................. 2016 17,816 18,107
1396u–2(e)(2)(A)(i) ............. 42 CFR 438.704 ........... CMS ... Penalty for a Medicaid managed care organiza- 2016 36,794 37,396
tion that fails substantially to provide medically
necessary items and services.
Penalty for Medicaid managed care organization 2016 36,794 37,396
that imposes premiums or charges on enroll-
ees in excess of the premiums or charges per-
mitted.
Penalty for a Medicaid managed care organiza- 2016 36,794 37,396
tion that misrepresents or falsifies information
to another individual or entity.
Penalty for a Medicaid managed care organiza- 2016 36,794 37,396
tion 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 Medicaid managed care organiza- 2016 147,177 149,585
tion that misrepresents or falsifies information
to the HHS Secretary.
Penalty for Medicaid managed care organization 2016 147,177 149,585
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 individual that does not enroll 2016 22,077 22,438
as a result of a Medicaid managed care orga-
nization that acts to discriminate among enroll-
ees on the basis of their health status.
1396u(h)(2) ......................... 42 CFR Part 441, Sub- CMS ... Penalty for a provider not meeting one of the re- 2016 20,628 20,965
part I. quirements relating to the protection of the
health, safety, and welfare of individuals re-
ceiving community supported living arrange-
ments services.
1396w–2(c)(1) ..................... ....................................... CMS ... Penalty for disclosing information related to eligi- 2016 11,002 11,182
bility determinations for medical assistance
asabaliauskas on DSK3SPTVN1PROD with RULES
programs.
18041(c)(2) .......................... 45 CFR 150.315; 45 CMS ... Failure to comply with requirements of the Public 2016 150 152
CFR 156.805(c). 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 information on Ex- 2016 27,186 27,631
change application.
18081(h)(1)(B) ..................... 42 CFR 155.285 ........... CMS ... Penalty for knowingly or willfully providing false 2016 271,862 276,310
information on Exchange application.
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![Federal Register / Vol. 82, No. 22 / Friday, February 3, 2017 / Rules and Regulations 9189
CIVIL MONETARY PENALTY AUTHORITIES ADMINISTERED BY HHS AGENCIES AND PENALTY AMOUNTS—Continued
[Effective February 3, 2017]
Citation Date of last 2016 2017
HHS penalty fig- Maximum Maximum
Description 2
U.S.C. CFR 1 agency ure or ad- adjusted adjusted
justment 3 penalty ($) penalty ($) 4
18081(h)(2) ......................... 42 CFR 155.260 ........... CMS ... Penalty for knowingly or willfully disclosing pro- 2016 27,186 27,631
tected information from Exchange.
31 U.S.C.
1352 .................................... 45 CFR 93.400(e) ......... HHS ... Penalty for the first time an individual makes an 2016 18,936 19,246
expenditure prohibited by regulations regard-
ing lobbying disclosure, absent aggravating
circumstances.
Penalty for second and subsequent offenses by
individuals who make an expenditure prohib-
ited by regulations regarding lobbying disclo-
sure:
Minimum ............................................................... 2016 18,936 19,246
Maximum .............................................................. 2016 189,361 192,459
Penalty for the first time an individual fails to file 2016 18,936 19,246
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 cir-
cumstances:
Minimum ............................................................... 2016 18,936 19,246
Maximum .............................................................. 2016 189,361 192,459
......................................... 45 CFR Part 93, Appen- HHS ... Penalty for failure to provide certification regard-
dix A ing lobbying in the award documents for all
sub-awards of all tiers:
Minimum ............................................................... 2016 18,936 19,246
Maximum .............................................................. 2016 189,361 192,459
Penalty for failure to provide statement regarding
lobbying for loan guarantee and loan insur-
ance transactions:
Minimum ............................................................... 2016 18,936 19,246
Maximum .............................................................. 2016 189,361 192,459
3801–3812 .......................... 45 CFR 79.3(a)(1)(iv) .... HHS ... Penalty against any individual who—with knowl- 2016 9,894 10,056
edge or reason to know—makes, presents or
submits a false, fictitious or fraudulent claim to
the Department.
45 CFR 79.3(b)(1)(ii) ............ Penalty against any individual who—with knowl- 2016 9,894 10,056
edge 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.
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.
3 Statutory or Inflation Act Adjustment.
4 The cost of living multiplier for 2017, based on the Consumer Price Index (CPI–U) for the month of October 2016, not seasonally adjusted, is 1.01636, as indi-
cated in OMB Memorandum M–17–11, ‘‘Implementation of the 2017 annual adjustment pursuant to the Federal Civil Penalties Adjustment Act Improvements Act of
2015’’ (December 16, 2016).
Dated: January 30, 2017. DEPARTMENT OF COMMERCE ACTION: Temporary rule; trip limit
Norris Cochran, reduction.
Acting Secretary, Department of Health and National Oceanic and Atmospheric
Human Services. Administration SUMMARY: NMFS reduces the
commercial trip limit of Atlantic
[FR Doc. 2017–02300 Filed 2–2–17; 8:45 am]
50 CFR Part 622 migratory group Spanish mackerel in or
BILLING CODE 4150–24–P
from the exclusive economic zone (EEZ)
[Docket No. 101206604–1758–02] in the Atlantic migratory group southern
zone to 1,500 lb (680 kg), round weight,
RIN 0648–XF179
per day. This trip limit reduction is
necessary to maximize the
Fisheries of the Caribbean, Gulf of socioeconomic benefits of the quota.
Mexico, and South Atlantic; Coastal DATES: Effective 6:00 a.m., local time,
Migratory Pelagic Resources of the February 6, 2017, until 12:01 a.m., local
asabaliauskas on DSK3SPTVN1PROD with RULES
Gulf of Mexico and South Atlantic; time, March 1, 2017.
Commercial Trip Limit Reduction for FOR FURTHER INFORMATION CONTACT:
Spanish Mackerel Mary Vara, NMFS Southeast Regional
AGENCY: National Marine Fisheries Office, telephone: 727–824–5305, or
Service (NMFS), National Oceanic and email: mary.vara@noaa.gov.
Atmospheric Administration (NOAA), SUPPLEMENTARY INFORMATION: The
Commerce. fishery for coastal migratory pelagic fish
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Document Created: 2018-02-01 14:35:00
Document Modified: 2018-02-01 14:35:00
| 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 February 3, 2017. | |
| Contact | Andrea Brandon, Deputy Assistant Secretary for Grants and Acquisitions, 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 | 82 FR 9174 | |
| CFR Associated | Administrative Practice and Procedure and Penalties |
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