Annual Civil Monetary Penalties Inflation Adjustment, 9174-9189 [2017-02300]

Download as PDF 9174 Federal Register / Vol. 82, No. 22 / Friday, February 3, 2017 / Rules and Regulations TABLE 2—HARDNESS DEFAULTS WITH- DEPARTMENT OF HEALTH AND IN EACH LEVEL III ECOREGION IN HUMAN SERVICES OREGON—Continued 45 CFR Part 102 Hardness mg/L) Level III ecoregion 9 Eastern Cascades Slopes and Foothills ................................... 10 Columbia Plateau .................. 11 Blue Mountains ...................... 12 Snake River Plain .................. 78 Klamath Mountains ................ 80 Northern Basin and Range ... 36.08 58.82 43.49 123.5 40.61 98.62 RIN 0991–AC0 Annual Civil Monetary Penalties Inflation Adjustment Department of Health and Human Services, Office of the Assistant Secretary for Financial Resources. ACTION: Final rule. AGENCY: 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: SUMMARY: (d) Applicability. (1) The criterion in paragraph (b) of this section applies to freshwaters in Oregon where fish and aquatic life are a designated use, and applies concurrently with other applicable water quality criteria. (2) The criterion established in this section is subject to Oregon’s general rules of applicability in the same way and to the same extent as are other federally promulgated and state-adopted numeric criteria when applied to freshwaters in Oregon where fish and aquatic life are a designated use. (i) For all waters with mixing zone regulations or implementation procedures, the criterion applies at the appropriate locations within or at the boundary of the mixing zones and outside of the mixing zones; otherwise the criterion applies throughout the water body including at the end of any discharge pipe, conveyance or other discharge point within the water body. (ii) The state shall not use a low flow value that is less stringent than the values listed below for waters suitable for the establishment of low flow return frequencies (i.e., streams and rivers) when calculating the available dilution for the purposes of determining the need for and establishing Water QualityBased Effluent Limitations in National Pollutant Discharge Elimination System permits: asabaliauskas on DSK3SPTVN1PROD with RULES Acute criteria (CMC) 1Q10 or 1B3 Where: 1. 1Q10 is the lowest one-day average flow event expected to occur once every ten years, on average (determined hydrologically). 2. 1B3 is the lowest one-day average flow event expected to occur once every three years, on average (determined biologically). [FR Doc. 2017–02283 Filed 2–2–17; 8:45 am] BILLING CODE 6560–50–P VerDate Sep<11>2014 21:08 Feb 02, 2017 Jkt 241001 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 PO 00000 Frm 00048 Fmt 4700 Sfmt 4700 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 E:\FR\FM\03FER1.SGM 03FER1 Federal Register / Vol. 82, No. 22 / Friday, February 3, 2017 / Rules and Regulations 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. 9175 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: Authority: Public Law 101–410, Sec. 701 of Public Law 114–74, 31 U.S.C. 3801–3812. PART 102—ADJUSTMENT OF CIVIL MONETARY PENALTIES FOR INFLATION § 102.3 2. Amend § 102.3 by revising the table to read as follows: ■ * Penalty adjustment and table. * * * * 1. The authority citation for part 102 continues to read as follows: ■ CIVIL MONETARY PENALTY AUTHORITIES ADMINISTERED BY HHS AGENCIES AND PENALTY AMOUNTS [Effective February 3, 2017] Citation U.S.C. CFR 1 HHS agency 21 U.S.C.: 333(b)(2)(A) ......................... ....................................... FDA .... 333(b)(2)(B) ......................... ....................................... FDA .... 333(b)(3) ............................. ....................................... FDA .... 333(f)(1)(A) .......................... ....................................... FDA .... 333(f)(2)(A) .......................... ....................................... FDA .... 333(f)(3)(A) .......................... ....................................... FDA .... 333(f)(3)(B) .......................... ....................................... FDA .... 333(f)(4)(A)(i) ...................... ....................................... FDA .... asabaliauskas on DSK3SPTVN1PROD with RULES 333(f)(4)(A)(ii) ...................... 333(f)(9)(A) .......................... VerDate Sep<11>2014 21:08 Feb 02, 2017 ....................................... ....................................... Jkt 241001 PO 00000 FDA .... FDA .... Frm 00049 Date of last penalty figure or adjustment 3 Description 2 Penalty for violations related to drug samples resulting in a conviction of any representative of manufacturer or distributor in any 10-year period. Penalty for violation related to drug samples resulting in a conviction of any representative of manufacturer or distributor after the second conviction in any 10-yr period. Penalty for failure to make a report required by 21 U.S.C. 353(d)(3)(E) relating to drug samples. Penalty for any person who violates a requirement related to devices for each such violation. Penalty for aggregate of all violations related to devices in a single proceeding. Penalty for any individual who introduces or delivers for introduction into interstate commerce food that is adulterated per 21 U.S.C. 342(a)(2)(B) or any individual who does not comply with a recall order under 21 U.S.C. 350l. Penalty in the case of any other person other than an individual) for such introduction or delivery of adulterated food. Penalty for aggregate of all such violations related to adulterated food adjudicated in a single proceeding. Penalty for all violations adjudicated in a single proceeding for any person who violates 21 U.S.C. 331(jj)(1) by failing to submit the certification required by 42 U.S.C. 282(j)(5)(B) or knowingly submitting a false certification; by failing to submit clinical trial information under 42 U.S.C. 282(j); or by submitting clinical trial information under 42 U.S.C. 282(j) that is false or misleading in any particular under 42 U.S.C. 282(j)(5)(D). Penalty for each day any above violation is not corrected after a 30-day period following notification until the violation is corrected. Penalty for any responsible person that violates a requirement of 21 U.S.C. 355(o) (post-marketing studies, clinical trials, labeling), 21 U.S.C. 355(p) (risk evaluation and mitigation (REMS)), or 21 U.S.C. 355–1 (REMS). Penalty for aggregate of all such above violations in a single proceeding. Penalty for REMS violation that continues after written notice to the responsible person for the first 30-day period (or any portion thereof) the responsible person continues to be in violation. Penalty for REMS violation that continues after written notice to responsible person doubles for every 30-day period thereafter the violation continues, but may not exceed penalty amount for any 30-day period. Penalty for aggregate of all such above violations adjudicated in a single proceeding. Penalty for any person who violates a requirement which relates to tobacco products for each such violation. Fmt 4700 Sfmt 4700 E:\FR\FM\03FER1.SGM 03FER1 2016 Maximum adjusted penalty ($) 2017 Maximum adjusted penalty ($) 4 2016 98,935 100,554 2016 1,978,690 2,011,061 2016 197,869 201,106 2016 26,723 27,160 2016 1,781,560 1,810,706 2016 75,123 76,352 2016 375,613 381,758 2016 751,225 763,515 2016 11,383 11,569 2016 11,383 11,569 2016 284,583 289,239 2016 1,138,330 1,156,953 2016 284,583 289,239 2016 1,138,330 1,156,953 2016 11,383,300 11,569,531 2016 16,503 16,773 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] Date of last penalty figure or adjustment 3 Citation U.S.C. 333(f)(9)(B)(i)(I) ................... 333(f)(9)(B)(i)(II) .................. 333(f)(9)(B)(ii)(I) .................. 333(f)(9)(B)(ii)(II) ................. 333(g)(1) ............................. asabaliauskas on DSK3SPTVN1PROD with RULES 333 note .............................. VerDate Sep<11>2014 21:08 Feb 02, 2017 CFR 1 ....................................... ....................................... ....................................... ....................................... ....................................... ....................................... Jkt 241001 PO 00000 HHS agency FDA .... FDA .... FDA .... FDA .... FDA .... FDA .... Frm 00050 Description 2 Penalty for aggregate of all such violations of tobacco product requirement adjudicated in a single proceeding. Penalty per violation related to violations of tobacco requirements. Penalty for aggregate of all such violations of tobacco product requirements adjudicated in a single proceeding. Penalty in the case of a violation of tobacco product requirements that continues after written notice to such person, for the first 30-day period (or any portion thereof) the person continues to be in violation. Penalty for violation of tobacco product requirements that continues after written notice to such person shall double for every 30-day period thereafter the violation continues, but may not exceed penalty amount for any 30-day period. Penalty for aggregate of all such violations related to tobacco product requirements adjudicated in a single proceeding. Penalty for any person who either does not conduct post-market surveillance and studies to determine impact of a modified risk tobacco product for which the HHS Secretary has provided them an order to sell, or who does not submit a protocol to the HHS Secretary after being notified of a requirement to conduct post-market surveillance of such tobacco products. Penalty for aggregate of for all such above violations adjudicated in a single proceeding. Penalty for violation of modified risk tobacco product post-market surveillance that continues after written notice to such person for the first 30-day period (or any portion thereof) that the person continues to be in violation. Penalty for post-notice violation of modified risk tobacco product post-market surveillance shall double for every 30-day period thereafter that the tobacco product requirement violation continues for any 30-day period, but may not exceed penalty amount for any 30-day period. Penalty for aggregate above tobacco product requirement violations adjudicated in a single proceeding. Penalty for any person who disseminates or causes another party to disseminate a directto-consumer advertisement that is false or misleading for the first such violation in any 3year period. Penalty for each subsequent above violation in any 3-year period. Penalty to be applied for violations of restrictions on the sale or distribution of tobacco products promulgated under 21 U.S.C. 387f(d) (e.g., violations of regulations in 21 CFR part 1140) with respect to a retailer with an approved training program in the case of a second regulation violation within a 12-month period. Penalty in the case of a third tobacco product regulation violation within a 24-month period. Penalty in the case of a fourth tobacco product regulation violation within a 24-month period. Penalty in the case of a fifth tobacco product regulation violation within a 36-month period. Penalty in the case of a sixth or subsequent tobacco product regulation violation within a 48month period as determined on a case-bycase basis. Fmt 4700 Sfmt 4700 E:\FR\FM\03FER1.SGM 03FER1 2016 Maximum adjusted penalty ($) 2017 Maximum adjusted penalty ($) 4 2016 1,100,200 1,118,199 2016 275,050 279,550 2016 1,100,200 1,118,199 2016 275,050 279,550 2016 1,100,200 1,118,199 2016 11,002,000 11,181,993 2016 275,050 279,550 2016 1,100,200 1,118,199 2016 275,050 279,550 2016 1,100,200 1,118,199 2016 11,002,000 11,181,993 2016 284,583 289,239 2016 569,165 578,477 2016 275 279 2016 550 559 2016 2,200 2,236 2016 5,501 5,591 2016 11,002 11,182 9177 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] Date of last penalty figure or adjustment 3 Citation CFR 1 U.S.C. 335b(a) ................................ ....................................... 360pp(b)(1) ......................... ....................................... HHS agency FDA .... FDA .... 42 U.S.C. 262(d) .................................. ....................................... FDA .... 263b(h)(3) ........................... ....................................... FDA .... 300aa–28(b)(1) ................... ....................................... FDA .... 256b(d)(1)(B)(vi) ................. ....................................... HRSA 299c–(3)(d) ......................... ....................................... AHRQ 653(l)(2) ............................... 45 CFR 303.21(f) .......... ACF .... 262a(i)(1) ............................. 42 CFR 1003.910 ......... OIG .... ....................................... OIG .... 1320a–7a(a) ........................ asabaliauskas on DSK3SPTVN1PROD with RULES 300jj–51 .............................. 42 CFR 1003.210(a)(1) OIG .... 42 CFR 1003.210(a)(2) 42 CFR 1003.210(a)(3) VerDate Sep<11>2014 ............ ............ 21:08 Feb 02, 2017 Jkt 241001 PO 00000 Frm 00051 Description 2 Penalty to be applied for violations of restrictions on the sale or distribution of tobacco products promulgated under 21 U.S.C. 387f(d) (e.g., violations of regulations in 21 CFR part 1140) with respect to a retailer that does not have an approved training program in the case of the first regulation violation. Penalty in the case of a second tobacco product regulation violation within a 12-month period. Penalty in the case of a third tobacco product regulation violation within a 24-month period. Penalty in the case of a fourth tobacco product regulation violation within a 24-month period. Penalty in the case of a fifth tobacco product regulation violation within a 36-month period. Penalty in the case of a sixth or subsequent tobacco product regulation violation within a 48month period as determined on a case-bycase basis. Penalty for each violation for any individual who made a false statement or misrepresentation of a material fact, bribed, destroyed, altered, removed, or secreted, or procured the destruction, alteration, removal, or secretion of, any material document, failed to disclose a material fact, obstructed an investigation, employed a consultant who was debarred, debarred individual provided consultant services. Penalty in the case of any other person (other than an individual) per above violation. Penalty for any person who violates any such requirements for electronic products, with each unlawful act or omission constituting a separate violation. Penalty imposed for any related series of violations of requirements relating to electronic products. Penalty per day for violation of order of recall of biological product presenting imminent or substantial hazard. Penalty for failure to obtain a mammography certificate as required. Penalty per occurrence for any vaccine manufacturer that intentionally destroys, alters, falsifies, or conceals any record or report required. Penalty for each instance of overcharging a 340B covered entity. Penalty for an establishment or person supplying information obtained in the course of activities for any purpose other than the purpose for which it was supplied. Penalty for Misuse of Information in the National Directory of New Hires. Penalty for each individual who violates safety and security procedures related to handling dangerous biological agents and toxins. Penalty for any other person who violates safety and security procedures related to handling dangerous biological agents and toxins. Penalty per violation for committing information blocking. Penalty for knowingly presenting or causing to be presented to an officer, employee, or agent of the United States a false claim. Penalty for knowingly presenting or causing to be presented a request for payment which violates the terms of an assignment, agreement, or PPS agreement. Penalty for knowingly giving or causing to be presented to a participating provider or supplier false or misleading information that could reasonably be expected to influence a discharge decision. Penalty for an excluded party retaining ownership or control interest in a participating entity. Fmt 4700 Sfmt 4700 E:\FR\FM\03FER1.SGM 03FER1 2016 Maximum adjusted penalty ($) 2017 Maximum adjusted penalty ($) 4 2016 275 279 2016 550 559 2016 1,100 1,118 2016 2,200 2,236 2016 5,501 5,591 2016 11,002 11,182 2016 419,320 426,180 2016 1,677,280 1,704,720 2016 2,750 2,795 2016 937,500 952,838 2016 215,628 219,156 2016 16,773 17,047 2016 215,628 219,156 2016 5,437 5,526 2016 14,140 14,371 2016 1,450 1,474 2016 327,962 333,327 2016 655,925 666,656 2016 1,000,000 1,016,360 2016 15,024 15,270 2016 15,024 15,270 2016 22,537 22,906 2016 15,024 15,270 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] Date of last penalty figure or adjustment 3 Citation HHS agency Description 2 42 CFR 1003.1010 ............ 42 CFR 1003.210(a)(4) ............ 42 CFR 1003.310(a)(3) ............ Penalty for remuneration offered to induce program beneficiaries to use particular providers, practitioners, or suppliers. Penalty for employing or contracting with an excluded individual. Penalty for knowing and willful solicitation, receipt, offer, or payment of remuneration for referring an individual for a service or for purchasing, leasing, or ordering an item to be paid for by a Federal health care program. Penalty for ordering or prescribing medical or other item or service during a period in which the person was excluded. Penalty for knowingly making or causing to be made a false statement, omission or misrepresentation of a material fact in any application, bid, or contract to participate or enroll as a provider or supplier. Penalty for knowing of an overpayment and failing to report and return. Penalty for making or using a false record or statement that is material to a false or fraudulent claim. Penalty for failure to grant timely access to HHS OIG for audits, investigations, evaluations, and other statutory functions of HHS OIG. Penalty for payments by a hospital or critical access hospital to induce a physician to reduce or limit services to individuals under direct care of physician or who are entitled to certain medical assistance benefits. Penalty for physicians who knowingly receive payments from a hospital or critical access hospital to induce such physician to reduce or limit services to individuals under direct care of physician or who are entitled to certain medical assistance benefits. Penalty for a physician who executes a document that falsely certifies home health needs for Medicare beneficiaries. Penalty for failure to report any final adverse action taken against a health care provider, supplier, or practitioner. Penalty for the misuse of words, symbols, or emblems in communications in a manner in which a person could falsely construe that such item is approved, endorsed, or authorized by HHS. Penalty for the misuse of words, symbols, or emblems in a broadcast or telecast in a manner in which a person could falsely construe that such item is approved, endorsed, or authorized by HHS. Penalty for certification of a false statement in assessment of functional capacity of a Skilled Nursing Facility resident assessment. Penalty for causing another to certify or make a false statement in assessment of functional capacity of a Skilled Nursing Facility resident assessment. Penalty for any individual who notifies or causes to be notified a Skilled Nursing Facility of the time or date on which a survey is to be conducted. Penalty for a Medicare Advantage organization that substantially fails to provide medically necessary, required items and services. Penalty for a Medicare Advantage organization that charges excessive premiums. Penalty for a Medicare Advantage organization that improperly expels or refuses to reenroll a beneficiary. Penalty for a Medicare Advantage organization that engages in practice that would reasonably be expected to have the effect of denying or discouraging enrollment. CFR 1 U.S.C. ......................................... 42 CFR 1003.210(a)(1) 42 CFR 1003.210(a)(6) 42 CFR 1003.210(a)(8) ............ 42 CFR 1003.210(a)(7) ............ 42 CFR 1003.210(a)(9) ............ ....................................... OIG .... 1320a–7a(b) ........................ 42 CFR 1003.210(a)(10) 42 CFR 1003.810 ......... OIG .... 1320b–10(b)(1) ................... 42 CFR 1003.610(a) ..... OIG .... 1320b–10(b)(2) ................... 42 CFR 1003.610(a) ..... OIG .... 1395i–3(b)(3)(B)(ii)(1) ......... 42 CFR 1003.210(a)(11) OIG .... 1395i–3(b)(3)(B)(ii)(2) ......... 42 CFR 1003.210(a)(11) OIG .... 1395i–3(g)(2)(A) .................. 42 CFR 1003.1310 ....... OIG .... 1395w–27(g)(2)(A) .............. asabaliauskas on DSK3SPTVN1PROD with RULES 1320a–7e(b)(6)(A) .............. 42 CFR 1003.410 ......... OIG .... VerDate Sep<11>2014 21:08 Feb 02, 2017 Jkt 241001 PO 00000 Frm 00052 Fmt 4700 Sfmt 4700 E:\FR\FM\03FER1.SGM 03FER1 2016 Maximum adjusted penalty ($) 2017 Maximum adjusted penalty ($) 4 2016 15,024 15,270 2016 14,718 14,959 2016 73,588 74,792 2016 10,874 11,052 2016 54,372 55,262 2016 10,874 11,052 2016 54,372 55,262 2016 16,312 16,579 2016 4,313 4,384 2016 4,313 4,384 2016 7,512 7,635 2016 36,794 37,396 2016 9,893 10,055 2016 49,467 50,276 2016 2,063 2,097 2016 10,314 10,483 2016 4,126 4,194 2016 37,561 38,175 2016 36,794 37,396 2016 36,794 37,396 2016 147,177 149,585 9179 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] Date of last penalty figure or adjustment 3 Citation CFR 1 U.S.C. HHS agency 1395w–141(i)(3) .................. ....................................... OIG .... 1395cc(g) ............................ ....................................... OIG .... 1395dd(d)(1) ....................... 42 CFR 1003.510 ......... OIG .... asabaliauskas on DSK3SPTVN1PROD with RULES 1395mm(i)(6)(B)(i) ............... 1395nn(g)(3) ....................... VerDate Sep<11>2014 42 CFR 1003.410 ......... 42 CFR 1003.310 ......... 21:08 Feb 02, 2017 Jkt 241001 PO 00000 OIG .... OIG .... Frm 00053 Description 2 Penalty per individual who does not enroll as a result of a Medicare Advantage organization’s practice that would reasonably be expected to have the effect of denying or discouraging enrollment. Penalty for a Medicare Advantage organization misrepresenting or falsifying information to Secretary. Penalty for a Medicare Advantage organization misrepresenting or falsifying information to individual or other entity. Penalty for Medicare Advantage organization interfering with provider’s advice to enrollee and non-MCO affiliated providers that balance bill enrollees. Penalty for a Medicare Advantage organization that employs or contracts with excluded individual or entity. Penalty for a Medicare Advantage organization enrolling an individual in without prior written consent. Penalty for a Medicare Advantage organization transferring an enrollee to another plan without consent or solely for the purpose of earning a commission. Penalty for a Medicare Advantage organization failing to comply with marketing restrictions or applicable implementing regulations or guidance. Penalty for a Medicare Advantage organization employing or contracting with an individual or entity who violates 1395w–27(g)(1)(A)–(J). Penalty for a prescription drug card sponsor that falsifies or misrepresents marketing materials, overcharges program enrollees, or misuse transitional assistance funds. Penalty for improper billing by Hospitals, Critical Access Hospitals, or Skilled Nursing Facilities. Penalty for a hospital or responsible physician dumping patients needing emergency medical care, if the hospital has 100 beds or more. Penalty for a hospital or responsible physician dumping patients needing emergency medical care, if the hospital has less than 100 beds. Penalty for a HMO or competitive plan is such plan substantially fails to provide medically necessary, required items or services. Penalty for HMOs/competitive medical plans that charge premiums in excess of permitted amounts. Penalty for a HMO or competitive medical plan that expels or refuses to reenroll an individual per prescribed conditions. Penalty for a HMO or competitive medical plan that implements practices to discourage enrollment of individuals needing services in future. Penalty per individual not enrolled in a plan as a result of a HMO or competitive medical plan that implements practices to discourage enrollment of individuals needing services in the future. Penalty for a HMO or competitive medical plan that misrepresents or falsifies information to the Secretary. Penalty for a HMO or competitive medical plan that misrepresents or falsifies information to an individual or any other entity. Penalty for failure by HMO or competitive medical plan to assure prompt payment of Medicare risk sharing contracts or incentive plan provisions. Penalty for HMO that employs or contracts with excluded individual or entity. Penalty for submitting or causing to be submitted claims in violation of the Stark Law’s restrictions on physician self-referrals. Fmt 4700 Sfmt 4700 E:\FR\FM\03FER1.SGM 03FER1 2016 Maximum adjusted penalty ($) 2017 Maximum adjusted penalty ($) 4 2016 22,077 22,438 2016 147,177 149,585 2016 36,794 37,396 2016 36,794 37,396 2016 36,794 37,396 2016 36,794 37,396 2016 36,794 37,396 2016 36,794 37,396 2016 36,794 37,396 2016 12,856 13,066 2016 5,000 5,082 2016 103,139 104,826 2016 51,570 52,414 2016 51,570 52,414 2016 51,570 52,414 2016 51,570 52,414 2016 206,278 209,653 2016 29,680 30,166 2016 206,278 209,653 2016 51,570 52,414 2016 51,570 52,414 2016 47,340 48,114 2016 23,863 24,253 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] Date of last penalty figure or adjustment 3 Citation Description 2 CFR 1 HHS agency 1395nn(g)(4) ....................... 42 CFR 1003.310 ......... OIG .... 1395ss(d)(1) ........................ 42 CFR 1003.1110 ....... OIG .... 1395ss(d)(2) ........................ 42 CFR 1003.1110 ....... OIG .... 1395ss(d)(3)(A)(ii) ............... 42 CFR 1003.1110 ....... OIG .... Penalty for circumventing Stark Law’s restrictions on physician self-referrals. Penalty for a material misrepresentation regarding Medigap compliance policies. Penalty for selling Medigap policy under false pretense. Penalty for an issuer that sells health insurance policy that duplicates benefits. Penalty for someone other than issuer that sells health insurance that duplicates benefits. Penalty for using mail to sell a non-approved Medigap insurance policy. Penalty for a Medicaid MCO that substantially fails to provide medically necessary, required items or services. Penalty for a Medicaid MCO that charges excessive premiums. Penalty for a Medicaid MCO that improperly expels or refuses to reenroll a beneficiary. Penalty per individual who does not enroll as a result of a Medicaid MCO’s practice that would reasonably be expected to have the effect of denying or discouraging enrollment. Penalty for a Medicaid MCO misrepresenting or falsifying information to the Secretary. Penalty for a Medicaid MCO misrepresenting or falsifying information to an individual or another entity. Penalty for a Medicaid MCO that fails to comply with contract requirements with respect to physician incentive plans. Penalty for willfully and knowingly certifying a material and false statement in a Skilled Nursing Facility resident assessment. Penalty for willfully and knowingly causing another individual to certify a material and false statement in a Skilled Nursing Facility resident assessment. Penalty for notifying or causing to be notified a Skilled Nursing Facility of the time or date on which a survey is to be conducted. Penalty for the knowing provision of false information or refusing to provide information about charges or prices of a covered outpatient drug. Penalty per day for failure to timely provide information by drug manufacturer with rebate agreement. Penalty for knowing provision of false information by drug manufacturer with rebate agreement. Penalty for notifying home and community-based providers or settings of survey. Penalty for failing to report a medical malpractice claim to National Practitioner Data Bank. Penalty for breaching confidentiality of information reported to National Practitioner Data Bank. Penalty for violation of confidentiality provision of the Patient Safety and Quality Improvement Act. Penalty for each pre-February 18, 2009 violation of the HIPAA administrative simplification provisions. Calendar Year Cap ............................................... Penalty for each February 18, 2009 or later violation of a HIPAA administrative simplification provision in which it is established that the covered entity or business associate did not know and by exercising reasonable diligence, would not have known that the covered entity or business associate violated such a provision: Minimum ............................................................... Maximum .............................................................. Calendar Year Cap ............................................... U.S.C. 1395ss(d)(4)(A) ................... 42 CFR 1003.1110 ....... OIG .... 1396b(m)(5)(B)(i) ................ 42 CFR 1003.410 ......... OIG .... 1396r(b)(3)(B)(ii)(I) .............. 42 CFR 1003.210(a)(11) OIG .... 1396r(b)(3)(B)(ii)(II) ............. 42 CFR 1003.210(a)(11) OIG .... 1396r(g)(2)(A)(i) .................. 42 CFR 1003.1310 ....... OIG .... 1396r–8(b)(3)(B) ................. 42 CFR 1003.1210 ....... OIG .... 1396r–8(b)(3)(C)(i) .............. 42 CFR 1003.1210 ....... OIG .... 1396r–8(b)(3)(C)(ii) ............. 42 CFR 1003.1210 ....... OIG .... 1396t(i)(3)(A) ....................... 42 CFR 1003.1310 ....... OIG .... 11131(c) .............................. 42 CFR 1003.810 ......... OIG .... 11137(b)(2) ......................... 42 CFR 1003.810 ......... OIG .... 299b–22(f)(1) ...................... 42 CFR 3.404 ............... OCR ... 45 CFR 160.404(b)(1)(i), (ii) OCR ... 45 CFR 160.404(b) (2)(i)(A), (B). OCR ... asabaliauskas on DSK3SPTVN1PROD with RULES 1320(d)–5(a) ....................... 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 2016 Maximum adjusted penalty ($) 2017 Maximum adjusted penalty ($) 4 2016 159,089 161,692 2016 9,893 10,055 2016 9,893 10,055 2016 44,539 45,268 2016 26,723 27,160 2016 9,893 10,055 2016 49,467 50,276 2016 49,467 50,276 2016 197,869 201,106 2016 29,680 30,166 2016 197,869 201,106 2016 49,467 50,276 2016 44,539 45,268 2016 2,063 2,097 2016 10,314 10,483 2016 4,126 4,194 2016 178,156 181,071 2016 17,816 18,107 2016 178,156 181,071 2016 3,563 3,621 2016 21,563 21,916 2016 21,563 21,916 2016 11,940 12,135 2016 150 152 2016 37,561 38,175 2016 2016 2016 110 55,010 1,650,300 112 55,910 1,677,299 9181 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] Date of last penalty figure or adjustment 3 Citation CFR 1 U.S.C. 45 CFR 160.404(b)(2)(ii) (A), (B) 45 CFR 160.404(b) (2)(iii)(A), (B) 45 CFR 160.404(b)(2) (iv)(A), (B) 263a(h)(2)(B) & 1395w– 2(b)(2)(A)(ii). 42 CFR 493.1834(d)(2) (i). 42 CFR 493.1834(d)(2) (ii). HHS agency Description 2 OCR ... Penalty for each February 18, 2009 or later violation of a HIPAA administrative simplification provision in which it is established that the violation was due to reasonable cause and not to willful neglect: Minimum ............................................................... Maximum .............................................................. Calendar Year Cap ............................................... Penalty for each February 18, 2009 or later violation of a HIPAA administrative simplification provision in which it is established that the violation was due to willful neglect and was corrected during the 30-day period beginning on the first date the covered entity or business associate knew, or, by exercising reasonable diligence, would have known that the violation occurred: Minimum ............................................................... Maximum .............................................................. Calendar Year Cap ............................................... Penalty for each February 18, 2009 or later violation of a HIPAA administrative simplification provision in which it is established that the violation was due to willful neglect and was not corrected during the 30-day period beginning on the first date the covered entity or business associate knew, or by exercising reasonable diligence, would have known that the violation occurred: Minimum ............................................................... Maximum .............................................................. Calendar Year Cap ............................................... Penalty for a clinical laboratory’s failure to meet participation and certification requirements and poses immediate jeopardy: Minimum ............................................................... Maximum .............................................................. Penalty for a clinical laboratory’s failure to meet participation and certification requirements and the failure does not pose immediate jeopardy: Minimum ............................................................... Maximum .............................................................. Failure to provide the Summary of Benefits and Coverage. Penalty for violations of regulations related to the medical loss ratio reporting and rebating. Penalty for manufacturer or group purchasing organization failing to report information required under 42 U.S.C. 1320a–7h(a), relating to physician ownership or investment interests: Minimum ............................................................... Maximum .............................................................. Calendar Year Cap ............................................... Penalty for manufacturer or group purchasing organization knowingly failing to report information required under 42 U.S.C. 1320a–7h(a), relating to physician ownership or investment interests: Minimum ............................................................... Maximum .............................................................. Calendar Year Cap ............................................... Penalty for an administrator of a facility that fails to comply with notice requirements for the closure of a facility. Minimum penalty for the first offense of an administrator who fails to provide notice of facility closure. Minimum penalty for the second offense of an administrator who fails to provide notice of facility closure. Minimum penalty for the third and subsequent offenses of an administrator who fails to provide notice of facility closure. OCR ... OCR ... CMS ... CMS ... 300gg–15(f) ......................... 45 CFR 147.200(e) ....... CMS ... 300gg–18 ............................ 45 CFR 158.606 ........... CMS ... 1320a–7h(b)(1) ................... 42 CFR 402.105(d)(5), 42 CFR 403.912(a) & (c). CMS ... 1320a–7h(b)(2) ................... 42 CFR 402.105(h), 42 CFR 403.912(b) & (c). CMS ... asabaliauskas on DSK3SPTVN1PROD with RULES CMS 1320a–7j(h)(3)(A) ................ VerDate Sep<11>2014 42 CFR 488.446(a)(1), (2), & (3). 21:08 Feb 02, 2017 Jkt 241001 PO 00000 CMS ... Frm 00055 Fmt 4700 Sfmt 4700 E:\FR\FM\03FER1.SGM 03FER1 2016 Maximum adjusted penalty ($) 2017 Maximum adjusted penalty ($) 4 2016 2016 2016 1,100 55,010 1,650,300 1,118 55,910 1,677,299 2016 2016 2016 11,002 55,010 1,650,300 11,182 55,910 1,677,299 2016 2016 2016 55,010 1,650,300 1,650,300 55,910 1,677,299 1,677,299 2016 2016 6,035 19,787 6,134 20,111 2016 2016 2016 99 5,936 1,087 101 6,033 1,105 2016 109 111 2016 2016 2016 1,087 10,874 163,117 1,105 11,052 165,786 2016 2016 2016 2016 10,874 108,745 1,087,450 108,745 11,052 110,524 1,105,241 110,524 2016 544 553 2016 1,631 1,658 2016 3,262 3,315 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] Date of last penalty figure or adjustment 3 Citation ....................................... 1320a–8(a)(1) ..................... Description 2 CFR 1 U.S.C. HHS agency CMS ... Penalty for an entity knowingly making a false statement or representation of material fact in the determination of the amount of benefits or payments related to old-age, survivors, and disability insurance benefits, special benefits for certain World War II veterans, or supplemental security income for the aged, blind, and disabled. Penalty for violation of 42 U.S.C. 1320a–8(a)(1) if the violator is a person who receives a fee or other income for services performed in connection with determination of the benefit amount or the person is a physician or other health care provider who submits evidence in connection with such a determination. Penalty for a representative payee (under 42 U.S.C. 405(j), 1007, or 1383(a)(2)) converting any part of a received payment from the benefit programs described in the previous civil monetary penalty to a use other than for the benefit of the beneficiary. Penalty for failure of covered individuals to report to the Secretary and 1 or more law enforcement officials any reasonable suspicion of a crime against a resident, or individual receiving care, from a long-term care facility. Penalty for failure of covered individuals to report to the Secretary and 1 or more law enforcement officials any reasonable suspicion of a crime against a resident, or individual receiving care, from a long-term care facility if such failure exacerbates the harm to the victim of the crime or results in the harm to another individual. Penalty for a long-term care facility that retaliates against any employee because of lawful acts done by the employee, or files a complaint or report with the State professional disciplinary agency against an employee or nurse for lawful acts done by the employee or nurse. Penalty for any person who knowingly and willfully fails to furnish a beneficiary with an itemized statement of items or services within 30 days of the beneficiary’s request. Penalty per day for a Skilled Nursing Facility that has a Category 2 violation of certification requirements: Minimum ............................................................... Maximum .............................................................. Penalty per instance of Category 2 noncompliance by a Skilled Nursing Facility: Minimum ............................................................... Maximum .............................................................. Penalty per day for a Skilled Nursing Facility that has a Category 3 violation of certification requirements: Minimum ............................................................... Maximum .............................................................. Penalty per instance of Category 3 noncompliance by a Skilled Nursing Facility: Minimum ............................................................... Maximum .............................................................. Penalty per day and per instance for a Skilled Nursing Facility that has Category 3 noncompliance with Immediate Jeopardy: Per Day (Minimum) .............................................. Per Day (Maximum) ............................................. Per Instance (Minimum) ....................................... Per Instance (Maximum) ...................................... Penalty per day of a Skilled Nursing Facility that fails to meet certification requirements. These amounts represent the upper range per day: Minimum ............................................................... Maximum .............................................................. Penalty per day of a Skilled Nursing Facility that fails to meet certification requirements. These amounts represent the lower range per day: 1320a–8(a)(3) ..................... ....................................... CMS ... 1320b–25(c)(1)(A) ............... ....................................... CMS ... 1320b–25(c)(2)(A) ............... ....................................... CMS ... 1320b–25(d)(2) ................... ....................................... CMS ... 1395b–7(b)(2)(B) ................ 42 CFR 402.105(g) ....... CMS ... 1395i–3(h)(2)(B)(ii)(I) .......... 42 CFR 488.408(d)(1) (iii). CMS ... 42 CFR 488.408(d)(1) (iv) 42 CFR 488.408(e)(1) (iii) 42 CFR 488.408(e)(1) (iv) asabaliauskas on DSK3SPTVN1PROD with RULES 42 CFR 488.408(e)(2)(ii) 42 CFR 488.438(a)(1)(i) 42 CFR 488.438(a)(1)(ii) VerDate Sep<11>2014 21:08 Feb 02, 2017 Jkt 241001 PO 00000 CMS ... CMS ... CMS ... CMS ... CMS ... CMS ... Frm 00056 Fmt 4700 Sfmt 4700 E:\FR\FM\03FER1.SGM 03FER1 2016 Maximum adjusted penalty ($) 2017 Maximum adjusted penalty ($) 4 2016 7,954 8,084 2016 7,500 7,623 2016 6,229 6,331 2016 217,490 221,048 2016 326,235 331,572 2016 217,490 221,048 2016 147 149 2016 2016 103 6,188 105 6,289 2016 2016 2,063 20,628 2,097 20,965 2016 2016 6,291 20,628 6,394 20,965 2016 2016 2,063 20,628 2,097 20,965 2016 2016 2016 2016 6,291 20,628 2,063 20,628 6,394 20,965 2,097 20,965 2016 2016 6,291 20,628 6,394 20,965 9183 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] Date of last penalty figure or adjustment 3 Citation CFR 1 U.S.C. 42 CFR 488.438(a)(2) HHS agency CMS ... 42 CFR 402.105(d)(2)(i) CMS ... 1395l(i)(6) ............................ ....................................... CMS ... 1395l(q)(2)(B)(i) ................... 42 CFR 402.105(a) ....... CMS ... 1395m(a)(11)(A) ................. 42 CFR 402.1(c)(4), 402.105(d)(2)(ii). CMS ... 1395m(a)(18)(B) ................. 42 CFR 402.1(c)(5), 402.105(d)(2)(iii). CMS ... 1395m(b)(5)(C) ................... 42 CFR 402.1(c)(6), 402.105(d)(2)(iv). CMS ... 1395m(h)(3) ........................ 42 CFR 402.1(c)(8), 402.105(d)(2)(vi). CMS ... 1395m(j)(2)(A)(iii) ................ ....................................... CMS ... 1395m(j)(4) .......................... asabaliauskas on DSK3SPTVN1PROD with RULES 1395l(h)(5)(D) ..................... 42 CFR 402.1(c)(10), 402.105(d)(2)(vii). CMS ... VerDate Sep<11>2014 21:08 Feb 02, 2017 Jkt 241001 PO 00000 Frm 00057 Description 2 Minimum ............................................................... Maximum .............................................................. Penalty per instance of a Skilled Nursing Facility that fails to meet certification requirements: Minimum ............................................................... Maximum .............................................................. Penalty for knowingly, willfully, and repeatedly billing for a clinical diagnostic laboratory test other than on an assignment-related basis. (Penalties are assessed in the same manner as 42 U.S.C. 1395u(j)(2)(B), which is assessed according to 1320a–7a(a)). Penalty for knowingly and willfully presenting or causing to be presented a bill or request for payment for an intraocular lens inserted during or after cataract surgery for which the Medicare payment rate includes the cost of acquiring the class of lens involved. Penalty for knowingly and willfully failing to provide information about a referring physician when seeking payment on an unassigned basis. Penalty for any durable medical equipment supplier that knowingly and willfully charges for a covered service that is furnished on a rental basis after the rental payments may no longer be made. (Penalties are assessed in the same manner as 42 U.S.C. 1395u(j)(2)(B), which is assessed according to 1320a–7a(a)). Penalty for any nonparticipating durable medical equipment supplier that knowingly and willfully fails to make a refund to Medicare beneficiaries for a covered service for which payment is precluded due to an unsolicited telephone contact from the supplier. (Penalties are assessed in the same manner as 42 U.S.C. 1395u(j)(2)(B), which is assessed according to 1320a–7a(a)). Penalty for any nonparticipating physician or supplier that knowingly and willfully charges a Medicare beneficiary more than the limiting charge for radiologist services. (Penalties are assessed in the same manner as 42 U.S.C. 1395u(j)(2)(B), which is assessed according to 1320a–7a(a)). Penalty for any supplier of prosthetic devices, orthotics, and prosthetics that knowing and willfully charges for a covered prosthetic device, orthotic, or prosthetic that is furnished on a rental basis after the rental payment may no longer be made. (Penalties are assessed in the same manner as 42 U.S.C. 1395m(a)(11)(A), that is in the same manner as 1395u(j)(2)(B), which is assessed according to 1320a–7a(a)). Penalty for any supplier of durable medical equipment including a supplier of prosthetic devices, prosthetics, orthotics, or supplies that knowingly and willfully distributes a certificate of medical necessity in violation of Section 1834(j)(2)(A)(i) of the Act or fails to provide the information required under Section 1834(j)(2)(A)(ii) of the Act. Penalty for any supplier of durable medical equipment, including a supplier of prosthetic devices, prosthetics, orthotics, or supplies that knowingly and willfully fails to make refunds in a timely manner to Medicare beneficiaries for series billed other than on as assignment-related basis under certain conditions. (Penalties are assessed in the same manner as 42 U.S.C. 1395m(j)(4) and 1395u(j)(2)(B), which is assessed according to 1320a–7a(a)). Fmt 4700 Sfmt 4700 E:\FR\FM\03FER1.SGM 03FER1 2016 Maximum adjusted penalty ($) 2017 Maximum adjusted penalty ($) 4 2016 2016 103 6,188 105 6,289 2016 2016 2016 2,063 20,628 15,024 2,097 20,965 15,270 2016 3,957 4,022 2016 3,787 3,849 2016 15,024 15,270 2016 15,024 15,270 2016 15,024 15,270 2016 15,024 15,270 2016 1,591 1,617 2016 15,024 15,270 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] Date of last penalty figure or adjustment 3 Citation CFR 1 U.S.C. HHS agency Description 2 Penalty for any person or entity who knowingly and willfully bills or collects for any outpatient therapy services or comprehensive outpatient rehabilitation services on other than an assignment-related basis. (Penalties are assessed in the same manner as 42 U.S.C. 1395m(k)(6) and 1395u(j)(2)(B), which is assessed according to 1320a–7a(a)). Penalty for any supplier of ambulance services who knowingly and willfully fills or collects for any services on other than an assignment-related basis. (Penalties are assessed in the same manner as 42 U.S.C. 1395u(b)(18)(B), which is assessed according to 1320a–7a(a)). Penalty for any practitioner specified in Section 1842(b)(18)(C) of the Act or other person that knowingly and willfully bills or collects for any services by the practitioners on other than an assignment-related basis. (Penalties are assessed in the same manner as 42 U.S.C. 1395u(j)(2)(B), which is assessed according to 1320a–7a(a)). Penalty for any physician who charges more than 125% for a non-participating referral. (Penalties are assessed in the same manner as 42 U.S.C. 1320a–7a(a)). Penalty for any physician who knowingly and willfully presents or causes to be presented a claim for bill for an assistant at a cataract surgery performed on or after March 1, 1987, for which payment may not be made because of section 1862(a)(15). (Penalties are assessed in the same manner as 42 U.S.C. 1395u(j)(2)(B), which is assessed according to 1320a–7a(a)). Penalty for any nonparticipating physician who does not accept payment on an assignmentrelated 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)). Penalty for any nonparticipating physician charging more than $500 who does not accept payment for an elective surgical procedure on an assignment related basis and who knowingly and willfully fails to disclose the required information regarding charges and coinsurance amounts and fails to refund on a timely basis any amount collected for the procedure in excess of the charges recognized and approved by the Medicare program. (Penalties are assessed in the same manner as 42 U.S.C. 1395u(j)(2)(B), which is assessed according to 1320a–7a(a)). Penalty for any physician who knowingly, willfully, and repeatedly bills one or more beneficiaries for purchased diagnostic tests any amount other than the payment amount specified by the Act. (Penalties are assessed in the same manner as 42 U.S.C. 1395u(j)(2)(B), which is assessed according to 1320a–7a(a)). Penalty for any practitioner specified in Section 1842(b)(18)(C) of the Act or other person that knowingly and willfully bills or collects for any services pertaining to drugs or biologics by the practitioners on other than an assignment-related basis. (Penalties are assessed in the same manner as 42 U.S.C. 1395u(b)(18)(B) and 1395u(j)(2)(B), which is assessed according to 1320a–7a(a)). 42 CFR 402.1(c)(31), 402.105(d)(3). CMS ... 1395m(l)(6) .......................... 42 CFR 402.1(c)(32), 402.105(d)(4). CMS ... 1395u(b)(18)(B) .................. 42 CFR 402.1(c)(11), 402.105(d)(2)(viii). CMS ... 1395u(j)(2)(B) ...................... 42 CFR 402.1(c) ........... CMS ... 1395u(k) .............................. 42 CFR 402.1(c)(12), 402.105(d)(2)(ix). CMS ... 1395u(l)(3) ........................... 42 CFR 402.1(c)(13), 402.105(d)(2)(x). CMS ... 1395u(m)(3) ........................ 42 CFR 402.1(c)(14), 402.105(d)(2)(xi). CMS ... 1395u(n)(3) ......................... 42 CFR 402.1(c)(15), 402.105(d)(2)(xii). CMS ... 1395u(o)(3)(B) ..................... asabaliauskas on DSK3SPTVN1PROD with RULES 1395m(k)(6) ......................... 42 CFR 414.707(b) ....... CMS ... 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 2016 Maximum adjusted penalty ($) 2017 Maximum adjusted penalty ($) 4 2016 15,024 15,270 2016 15,024 15,270 2016 15,024 15,270 2016 15,024 15,270 2016 15,024 15,270 2016 15,024 15,270 2016 15,024 15,270 2016 15,024 15,270 2016 15,024 15,270 9185 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] Date of last penalty figure or adjustment 3 Citation Description 2 CFR 1 HHS agency 1395u(p)(3)(A) ..................... ....................................... CMS ... 1395w–3a(d)(4)(A) .............. 42 CFR 414.806 ........... CMS ... 1395w–4(g)(1)(B) ................ 42 CFR 402.1(c)(17), 402.105(d)(2)(xiii). CMS ... 1395w–4(g)(3)(B) ................ 42 CFR 402.1(c)(18), 402.105(d)(2)(xiv). CMS ... 1395w–27(g)(3)(A); 1857(g)(3). 42 CFR 422.760(b); 42 CFR 423.760(b). CMS ... 1395w–27(g)(3)(B); 1857(g)(3). ....................................... CMS ... 1395w–27(g)(3)(D); 1857 (g)(3). ....................................... CMS ... 1395y(b)(3)(C) ..................... 42 CFR 411.103(b) ....... CMS ... 1395y(b)(5)(C)(ii) ................. 42 CFR 402.1(c)(20), 42 CFR 402.105(b)(2). CMS ... 1395y(b)(6)(B) ..................... 42 CFR 402.1(c)(21), 402.105(a). CMS ... 1395y(b)(7)(B)(i) ................. ....................................... CMS ... 1395y(b)(8)(E) ..................... ....................................... CMS ... 1395nn(g)(5) ....................... 42 CFR 411.361 ........... CMS ... Penalty for any physician or practitioner who knowingly and willfully fails promptly to provide the appropriate diagnosis codes upon CMS or Medicare administrative contractor request for payment or bill not submitted on an assignment-related basis. Penalty for a pharmaceutical manufacturer’s misrepresentation of average sales price of a drug, or biologic. Penalty for any nonparticipating physician, supplier, or other person that furnishes physician services not on an assignment-related basis who either knowingly and willfully bills or collects in excess of the statutorily-defined limiting charge or fails to make a timely refund or adjustment. (Penalties are assessed in the same manner as 42 U.S.C. 1395u(j)(2)(B), which is assessed according to 1320a–7a(a)). Penalty for any person that knowingly and willfully bills for statutorily defined State-plan approved physicians’ services on any other basis than an assignment-related basis for a Medicare/Medicaid dual eligible beneficiary. (Penalties are assessed in the same manner as 42 U.S.C. 1395u(j)(2)(B), which is assessed according to 1320a–7a(a)). Penalty for each termination determination the Secretary makes that is the result of actions by a Medicare Advantage organization or Part D sponsor that has adversely affected an individual covered under the organization’s contract. Penalty for each week beginning after the initiation of civil money penalty procedures by the Secretary because a Medicare Advantage organization or Part D sponsor has failed to carry out a contract, or has carried out a contract inconsistently with regulations. Penalty for a Medicare Advantage organization’s or Part D sponsor’s early termination of its contract. Penalty for an employer or other entity to offer any financial or other incentive for an individual entitled to benefits not to enroll under a group health plan or large group health plan which would be a primary plan. Penalty for any non-governmental employer that, before October 1, 1998, willfully or repeatedly failed to provide timely and accurate information requested relating to an employee’s group health insurance coverage. Penalty for any entity that knowingly, willfully, and repeatedly fails to complete a claim form relating to the availability of other health benefits in accordance with statute or provides inaccurate information relating to such on the claim form. Penalty for any entity serving as insurer, third party administrator, or fiduciary for a group health plan that fails to provide information that identifies situations where the group health plan is or was a primary plan to Medicare to the HHS Secretary. Penalty for any non-group health plan that fails to identify claimants who are Medicare beneficiaries and provide information to the HHS Secretary to coordinate benefits and pursue any applicable recovery claim. Penalty for any person that fails to report information required by HHS under Section 1877(f) concerning ownership, investment, and compensation arrangements. asabaliauskas on DSK3SPTVN1PROD with RULES U.S.C. 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 2016 Maximum adjusted penalty ($) 2017 Maximum adjusted penalty ($) 4 2016 3,957 4,022 2016 12,856 13,066 2016 15,024 15,270 2016 15,024 15,270 2016 36,794 37,396 2016 14,718 14,959 2016 136,689 138,925 2016 8,908 9,054 2016 1,450 1,474 2016 3,182 3,234 2016 1,138 1,157 2016 1,138 1,157 2016 18,936 19,246 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] Date of last penalty figure or adjustment 3 Citation CFR 1 U.S.C. HHS agency Description 2 Penalty for any durable medical equipment supplier, including a supplier of prosthetic devices, prosthetics, orthotics, or supplies, that knowingly and willfully fails to make refunds in a timely manner to Medicare beneficiaries under certain conditions. (42 U.S.C. 1395(m)(18) sanctions apply here in the same manner, which is under 1395u(j)(2) and 1320a–7a(a)). Penalty for any person that issues a Medicare supplemental policy that has not been approved by the State regulatory program or does not meet Federal standards after a statutorily defined effective date. Penalty for someone other than issuer that sells or issues a Medicare supplemental policy to beneficiary without a disclosure statement. Penalty for an issuer that sells or issues a Medicare supplemental policy without disclosure statement. Penalty for someone other than issuer that sells or issues a Medicare supplemental policy without acknowledgement form. Penalty for issuer that sells or issues a Medicare supplemental policy without an acknowledgement form. Penalty for any person that sells or issues Medicare supplemental polices after a given date that fail to conform to the NAIC or Federal standards established by statute. Penalty for any person that sells or issues Medicare supplemental polices after a given date that fail to conform to the NAIC or Federal standards established by statute. Penalty for any person that sells a Medicare supplemental policy and fails to make available for sale the core group of basic benefits when selling other Medicare supplemental policies with additional benefits or fails to provide the individual, before selling the policy, an outline of coverage describing benefits. Penalty for any person that sells a Medicare supplemental policy and fails to make available for sale the core group of basic benefits when selling other Medicare supplemental policies with additional benefits or fails to provide the individual, before selling the policy, an outline of coverage describing benefits. Penalty for any person that fails to suspend the policy of a policyholder made eligible for medical assistance or automatically reinstates the policy of a policyholder who has lost eligibility for medical assistance, under certain circumstances. Penalty for any person that fails to provide refunds or credits as required by section 1882(r)(1)(B). Penalty for any issuer of a Medicare supplemental policy that does not waive listed time periods if they were already satisfied under a proceeding Medicare supplemental policy, or denies a policy, or conditions the issuances or effectiveness of the policy, or discriminates in the pricing of the policy base on health status or other specified criteria. Penalty for any issuer of a Medicare supplemental policy that fails to fulfill listed responsibilities. Penalty someone other than issuer who sells, issues, or renews a medigap Rx policy to an individual who is a Part D enrollee. Penalty for an issuer who sells, issues, or renews a Medigap Rx policy who is a Part D enrollee. Penalty for any individual who notifies or causes to be notified a home health agency of the time or date on which a survey of such agency is to be conducted. 1395pp(h) ............................ 42 CFR 402.1(c)(23), 402.105(d)(2)(xv). CMS ... 1395ss(a)(2) ........................ 42 CFR 402.1(c)(24), 405.105(f)(1). CMS ... 1395ss(d)(3)(A)(vi) (II) ........ ....................................... CMS ... 1395ss(d)(3)(B)(iv) .............. 1395ss(p)(8) ........................ ....................................... CMS ... 42 CFR 402.1(c)(25), 402.105(e). CMS ... 42 CFR 402.1(c)(25), 405.105(f)(2) CMS ... 42 CFR 402.1(c)(26), 402.105(e). CMS ... 42 CFR 402.1(c)(26), 405.105(f)(3), (4) ............ 1395ss(q)(5)(C) ................... 42 CFR 402.1(c)(27), 405.105(f)(5). CMS ... 1395ss(r)(6)(A) .................... 42 CFR 402.1(c)(28), 405.105(f)(6). CMS ... 1395ss(s)(4) ........................ 42 CFR 402.1(c)(29), 405.105(c). CMS ... 1395ss(t)(2) ......................... 42 CFR 402.1(c)(30), 405.105(f)(7). CMS ... 1395ss(v)(4)(A) ................... ....................................... CMS ... asabaliauskas on DSK3SPTVN1PROD with RULES 1395ss(p)(9)(C) ................... 1395bbb(c)(1) ..................... VerDate Sep<11>2014 42 CFR 488.725(c) ....... 21:08 Feb 02, 2017 Jkt 241001 PO 00000 CMS ... Frm 00060 Fmt 4700 Sfmt 4700 E:\FR\FM\03FER1.SGM 03FER1 2016 Maximum adjusted penalty ($) 2017 Maximum adjusted penalty ($) 4 2016 15,024 15,270 2016 51,569 52,413 2016 26,723 27,160 2016 44,539 45,268 2016 26,723 27,160 2016 44,539 45,268 2016 26,723 27,160 2016 44,539 45,268 2016 26,723 27,160 2016 44,539 45,268 2016 44,539 45,268 2016 44,539 45,268 2016 18,908 19,217 2016 44,539 45,268 2016 19,284 19,599 2016 32,140 32,666 2016 4,126 4,194 9187 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] Date of last penalty figure or adjustment 3 Citation CFR 1 U.S.C. 1395bbb(f)(2)(A)(i) .............. 42 CFR 488.845(b)(2)(iii) 42 CFR 488.845(b)(3)– (6); and 42 CFR 488.845(d)(1)(ii). 42 CFR 488.845(b)(3) HHS agency Description 2 CMS ... Maximum daily penalty amount for each day a home health agency is not in compliance with statutory requirements. ............ Penalty per day for home health agency’s noncompliance (Upper Range): Minimum ............................................................... Maximum .............................................................. Penalty for a home health agency’s deficiency or deficiencies that cause immediate jeopardy and result in actual harm. Penalty for a home health agency’s deficiency or deficiencies that cause immediate jeopardy and result in potential for harm. Penalty for an isolated incident of noncompliance in violation of established HHA policy. 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 ............................................................... Maximum .............................................................. 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 ............................................................... Maximum .............................................................. 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 ............................................................... Maximum .............................................................. Penalty for each day of noncompliance (Maximum). Penalty for each day of noncompliance (Maximum). Penalty for PACE organization’s practice that would reasonably be expected to have the effect of denying or discouraging enrollment: Minimum ............................................................... Maximum .............................................................. Penalty for a PACE organization that charges excessive premiums. Penalty for a PACE organization misrepresenting or falsifying information to CMS, the State, or an individual or other entity. Penalty for each determination the CMS makes that the PACE organization has failed to provide medically necessary items and services of the failure has adversely affected (or has the substantial likelihood of adversely affecting) a PACE participant. Penalty for involuntarily disenrolling a participant. Penalty for discriminating or discouraging enrollment or disenrollment of participants on the basis of an individual’s health status or need for health care services. Penalty per day for a nursing facility’s failure to meet a Category 2 Certification: Minimum ............................................................... Maximum .............................................................. Penalty per instance for a nursing facility’s failure to meet Category 2 certification: Minimum ............................................................... Maximum .............................................................. Penalty per day for a nursing facility’s failure to meet Category 3 certification: Minimum ............................................................... Maximum .............................................................. Penalty per instance for a nursing facility’s failure to meet Category 3 certification: Minimum ............................................................... 42 CFR 488.845(b)(3)(i) ............ 42 CFR 488.845(b)(3)(ii) ............ 42 CFR 488.845(b)(3)(iii) 42 CFR 488.845(b)(4) ............ 42 CFR 488.845(b)(5) 42 CFR 488.845(b)(6) ............ ............ ............ 42 CFR 488.845(d)(1)(ii) 1396b(m)(5)(B) .................... asabaliauskas on DSK3SPTVN1PROD with RULES 1396r(h)(3)(C)(ii)(I) .............. ............ 42 CFR 460.46 ............. CMS ... 42 CFR 488.408(d)(1)(iii). 42 CFR 488.408(d) (1)(iv) 42 CFR 488.408(e) (1)(iii) 42 CFR 488.408(e) (1)(iv) VerDate Sep<11>2014 21:08 Feb 02, 2017 Jkt 241001 PO 00000 CMS ... CMS ... CMS ... CMS ... Frm 00061 Fmt 4700 Sfmt 4700 E:\FR\FM\03FER1.SGM 03FER1 2016 Maximum adjusted penalty ($) 2017 Maximum adjusted penalty ($) 4 2016 19,787 20,111 2016 2016 2016 16,819 19,787 19,787 17,094 20,111 20,111 2016 17,808 18,099 2016 16,819 17,094 2016 2016 2,968 16,819 3,017 17,094 2016 2016 989 7,915 1,005 8,044 2016 2016 2016 1,979 19,787 19,787 2,011 20,111 20,111 2016 19,787 20,111 2016 2016 2016 22,077 147,177 36,794 22,438 149,585 37,396 2016 147,177 149,585 2016 36,794 37,396 2016 2016 36,794 36,794 37,396 37,396 2016 2016 103 6,188 105 6,289 2016 2016 2,063 20,628 2,097 20,965 2016 2016 6,291 20,628 6,394 20,965 2016 2,063 2,097 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] Date of last penalty figure or adjustment 3 Citation CFR 1 HHS agency 42 CFR 488.408(e)(2)(ii) CMS ... U.S.C. 42 CFR 488.438(a)(1)(i) 42 CFR 488.438(a)(1)(ii) 42 CFR 488.438(a)(2) CMS ... CMS ... CMS ... 1396r(f)(2)(B)(iii)(I)(c) .......... 42 CFR 483.151(b)(2) (iv) and (b)(3)(iii). CMS ... 1396r(h)(3)(C)(ii)(I) .............. 42 CFR 483.151(c)(2) ... CMS ... 1396t(j)(2)(C) ....................... ....................................... CMS ... 1396u–2(e)(2)(A)(i) ............. 1396u–2(e)(2)(A)(ii) ............. 42 CFR 438.704 ........... 42 CFR 438.704 ........... CMS ... CMS ... 42 CFR 438.704 ........... CMS ... 1396u(h)(2) ......................... 42 CFR Part 441, Subpart I. CMS ... 1396w–2(c)(1) ..................... asabaliauskas on DSK3SPTVN1PROD with RULES 1396u–2(e)(2)(A)(iv) ............ ....................................... CMS ... 18041(c)(2) .......................... 45 CFR 150.315; 45 CFR 156.805(c). CMS ... 18081(h)(1)(A)(i)(II) ............. 42 CFR 155.285 ........... CMS ... 18081(h)(1)(B) ..................... 42 CFR 155.285 ........... CMS ... VerDate Sep<11>2014 21:08 Feb 02, 2017 Jkt 241001 PO 00000 Frm 00062 Description 2 Maximum .............................................................. Penalty per instance for a nursing facility’s failure to meet Category 3 certification, which results in immediate jeopardy: Minimum ............................................................... Maximum .............................................................. Penalty per day for nursing facility’s failure to meet certification (Upper Range): Minimum ............................................................... Maximum .............................................................. Penalty per day for nursing facility’s failure to meet certification (Lower Range): Minimum ............................................................... Maximum .............................................................. Penalty per instance for nursing facility’s failure to meet certification: Minimum ............................................................... Maximum .............................................................. Grounds to prohibit approval of Nurse Aide Training Program—if assessed a penalty in 1819(h)(2)(B)(i) or 1919(h)(2)(A)(ii) of ‘‘not less than $5,000’’ [Not CMP authority, but a specific CMP amount (CMP at this level) that is the triggering condition for disapproval]. Grounds to waive disapproval of nurse aide training program—reference to disapproval based on imposition of CMP ‘‘not less than $5,000’’ [Not CMP authority but CMP imposition at this level determines eligibility to seek waiver of disapproval of nurse aide training program]. 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 ............................................................... Maximum .............................................................. Penalty for a Medicaid managed care organization that fails substantially to provide medically necessary items and services. Penalty for Medicaid managed care organization that imposes premiums or charges on enrollees in excess of the premiums or charges permitted. Penalty for a Medicaid managed care organization that misrepresents or falsifies information to another individual or entity. Penalty for a Medicaid managed care organization that fails to comply with the applicable statutory requirements for such organizations. Penalty for a Medicaid managed care organization that misrepresents or falsifies information to the HHS Secretary. Penalty for Medicaid managed care organization that acts to discriminate among enrollees on the basis of their health status. Penalty for each individual that does not enroll as a result of a Medicaid managed care organization that acts to discriminate among enrollees on the basis of their health status. Penalty for a provider not meeting one of the requirements relating to the protection of the health, safety, and welfare of individuals receiving community supported living arrangements services. Penalty for disclosing information related to eligibility determinations for medical assistance programs. Failure to comply with requirements of the Public Health Services Act; Penalty for violations of rules or standards of behavior associated with issuer participation in the Federally-facilitated Exchange. (42 U.S.C. 300gg–22(b)(2)(C)). Penalty for providing false information on Exchange application. Penalty for knowingly or willfully providing false information on Exchange application. Fmt 4700 Sfmt 4700 E:\FR\FM\03FER1.SGM 03FER1 2016 Maximum adjusted penalty ($) 2017 Maximum adjusted penalty ($) 4 2016 20,628 20,965 2016 2016 2,063 20,628 2,097 20,965 2016 2016 6,291 20,628 6,394 20,965 2016 2016 103 6,188 105 6,289 2016 2016 2016 2,063 20,628 10,314 2,097 20,965 10,483 2016 10,314 10,483 2016 2016 2016 2 17,816 36,794 2 18,107 37,396 2016 36,794 37,396 2016 36,794 37,396 2016 36,794 37,396 2016 147,177 149,585 2016 147,177 149,585 2016 22,077 22,438 2016 20,628 20,965 2016 11,002 11,182 2016 150 152 2016 27,186 27,631 2016 271,862 276,310 9189 Federal Register / Vol. 82, No. 22 / Friday, February 3, 2017 / Rules and Regulations CIVIL MONETARY PENALTY AUTHORITIES ADMINISTERED BY HHS AGENCIES AND PENALTY AMOUNTS—Continued [Effective February 3, 2017] Citation Date of last penalty figure or adjustment 3 2016 Maximum adjusted penalty ($) 2017 Maximum adjusted penalty ($) 4 Description 2 CFR 1 HHS agency 18081(h)(2) ......................... 42 CFR 155.260 ........... CMS ... Penalty for knowingly or willfully disclosing protected information from Exchange. 2016 27,186 27,631 31 U.S.C. 1352 .................................... 45 CFR 93.400(e) ......... HHS ... Penalty for the first time an individual makes an expenditure prohibited by regulations regarding lobbying disclosure, absent aggravating circumstances. Penalty for second and subsequent offenses by individuals who make an expenditure prohibited by regulations regarding lobbying disclosure: Minimum ............................................................... Maximum .............................................................. Penalty for the first time an individual fails to file or amend a lobbying disclosure form, absent aggravating circumstances. Penalty for second and subsequent offenses by individuals who fail to file or amend a lobbying disclosure form, absent aggravating circumstances: Minimum ............................................................... Maximum .............................................................. Penalty for failure to provide certification regarding lobbying in the award documents for all sub-awards of all tiers: Minimum ............................................................... Maximum .............................................................. Penalty for failure to provide statement regarding lobbying for loan guarantee and loan insurance transactions: Minimum ............................................................... Maximum .............................................................. Penalty against any individual who—with knowledge or reason to know—makes, presents or submits a false, fictitious or fraudulent claim to the Department. Penalty against any individual who—with knowledge or reason to know—makes, presents or submits a false, fictitious or fraudulent claim to the Department. 2016 18,936 19,246 2016 2016 2016 18,936 189,361 18,936 19,246 192,459 19,246 2016 2016 18,936 189,361 19,246 192,459 2016 2016 18,936 189,361 19,246 192,459 2016 2016 2016 18,936 189,361 9,894 19,246 192,459 10,056 2016 9,894 10,056 U.S.C. ......................................... 3801–3812 .......................... 45 CFR Part 93, Appendix A HHS ... 45 CFR 79.3(a)(1)(iv) .... HHS ... 45 CFR 79.3(b)(1)(ii) ............ 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 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 ACTION: National Oceanic and Atmospheric Administration SUMMARY: 50 CFR Part 622 [Docket No. 101206604–1758–02] asabaliauskas on DSK3SPTVN1PROD with RULES RIN 0648–XF179 Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic; Coastal Migratory Pelagic Resources of the Gulf of Mexico and South Atlantic; Commercial Trip Limit Reduction for Spanish Mackerel National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce. AGENCY: VerDate Sep<11>2014 21:08 Feb 02, 2017 Jkt 241001 Temporary rule; trip limit reduction. DEPARTMENT OF COMMERCE PO 00000 Frm 00063 Fmt 4700 Sfmt 4700 NMFS reduces the commercial trip limit of Atlantic migratory group Spanish mackerel in or from the exclusive economic zone (EEZ) in the Atlantic migratory group southern zone to 1,500 lb (680 kg), round weight, per day. This trip limit reduction is necessary to maximize the socioeconomic benefits of the quota. DATES: Effective 6:00 a.m., local time, February 6, 2017, until 12:01 a.m., local time, March 1, 2017. FOR FURTHER INFORMATION CONTACT: Mary Vara, NMFS Southeast Regional Office, telephone: 727–824–5305, or email: mary.vara@noaa.gov. SUPPLEMENTARY INFORMATION: The fishery for coastal migratory pelagic fish E:\FR\FM\03FER1.SGM 03FER1

Agencies

DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 82, Number 22 (Friday, February 3, 2017)]
[Rules and Regulations]
[Pages 9174-9189]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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

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