Adjustment of Civil Monetary Penalties for Inflation
Interim final rule.
CFR Part: "42 CFR Part 3"
RIN Number: "RIN 0991-AC0"
Citation: "81 FR 61538"
Page Number: "61538"
"Rules and Regulations"
SUMMARY: The
DATES: This rule is effective on
FOR FURTHER INFORMATION CONTACT:
SUPPLEMENTARY INFORMATION:
I. Regulatory Information
The Department of
FOOTNOTE 1 All applicable civil monetary penalty authorities within the jurisdiction of HHS must be adjusted in accordance with the 2015 Act. Where existing HHS agency regulations setting forth civil monetary penalty amounts are not updated by this interim final rule, they will be amended in a separate action as soon as practicable. END FOOTNOTE
II. Background and Requirements of the Law
On
The method of calculating inflation adjustments in the 2015 Act differs substantially from the methods used in past inflation adjustment rulemakings conducted pursuant to the Inflation Adjustment Act. Previously, adjustments to civil monetary penalties were conducted under rules that required significant rounding of figures. While this allowed penalties to be kept at round numbers, it meant that penalties would often not be increased at all if the inflation factor was not large enough. Furthermore, increases to penalties were capped at 10 percent. Over time, this formula caused penalties to lose value relative to total inflation.
The 2015 Act has removed these rounding rules; now, penalties are simply rounded to the nearest dollar. While this creates penalty values that are no longer round numbers, it does ensure that penalties will be increased each year to a figure commensurate with the actual calculated inflation. Furthermore, the 2015 Act "resets" the inflation calculations by excluding prior inflationary adjustments under the Inflation Adjustment Act, which contributed to a decline in the real value of penalty levels. To do this, the 2015 Act requires agencies to identify, for each penalty, the year and corresponding amount(s) for which the maximum penalty level or range of minimum and maximum penalties was established (i.e., originally enacted by
In this rule, the adjusted civil penalty amounts are applicable only to civil penalties assessed after
Pursuant to the 2015 Act, the
FOOTNOTE 2 Based upon the Consumer Price Index (CPI-U) for the month of
Calculation of CMP Adjustments Citation Description *2 Pre- Date of inflation last penalty penalty ( ] figure or adjust- ment *3 U.S.C. CFR *1 21 U.S.C. (FDA): 333(b) *2(A) Penalty for 50,000 1988 violations related to drug samples resulting in a conviction of any representative of manufacturer or distributor in any 10-year period 333(b) *2(B) Penalty for violation 1,000,000 1988 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 Penalty for failure 100,000 1988 to make a report required by 21 U.S.C. 353(d) *3(E) relating to drug samples 333(f) *1(A) Penalty for any 15,000 1990 person who violates a requirement related to devices for each such violation Penalty for aggregate 1,000,000 1990 of all violations related to devices in a single proceeding 333(f) *2(A) Penalty for any 50,000 1996 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 250,000 1996 of any other person other than an individual for such introduction or delivery of adulterated food Penalty for aggregate 500,000 1996 of all such violations related to adulterated food adjudicated in a single proceeding 333(f) *3(A) Penalty for all 10,000 2007 violations adjudicated in a single proceeding for any person who fails to submit certification required by 42 U.S.C. 282(j)(5)(B) or knowingly submitting a false certification 333(f) *3(B) Penalty for each day 10,000 2007 the above violation is not corrected after a 30-day period following notification until the violation is corrected 333(f) *4(A)(i) Penalty for any 250,000 2007 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 1,000,000 2007 of all such above violations in a single proceeding 333(f) *4(A)(ii) Penalty for REMS 250,000 2007 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 1,000,000 2007 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 10,000,00 2007 of all such above 0 violations adjudicated in a single proceeding 333(f)(9)(A) Penalty for any 15,000 2009 person who violates a requirement which relates to tobacco products for each such violation Penalty for aggregate 1,000,000 2009 of all such violations of tobacco product requirement adjudicated in a single proceeding 333(f)(9)(B)(i) Penalty per violation 250,000 2009 (I) related to violations of tobacco requirements Penalty for aggregate 1,000,000 2009 of all such violations of tobacco product requirements adjudicated in a single proceeding 333(f)(9)(B)(i) Penalty in the case 250,000 2009 (II) 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 1,000,000 2009 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 10,000,00 2009 of all such 0 violations related to tobacco product requirements adjudicated in a single proceeding 333(f)(9)(B)(ii)( Penalty for any 250,000 2009 I) 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 1,000,000 2009 of for all such above violations adjudicated in a single proceeding 333(f)(9)(B)(ii)( Penalty for violation 250,000 2009 II) 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- 1,000,000 2009 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 10,000,00 2009 above tobacco product 0 requirement violations adjudicated in a single proceeding 333(g) *1 Penalty for any 250,000 2007 person who disseminates or causes another party to disseminate a direct-to-consumer advertisement that is false or misleading for the first such violation in any 3- year period Penalty for each 500,000 2007 subsequent above violation in any 3- year period 333 note Penalty to be applied 250 2009 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 500 2009 of a third tobacco product regulation violation within a 24-month period Penalty in the case 2,000 2009 of a fourth tobacco product regulation violation within a 24-month period Penalty in the case 5,000 2009 of a fifth tobacco product regulation violation within a 36-month period Penalty in the case 10,000 2009 of a sixth or subsequent tobacco product regulation violation within a 48-month period as determined on a case- by-case basis Penalty to be applied 250 2009 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 500 2009 of a second tobacco product regulation violation within a 12-month period Penalty in the case 1,000 2009 of a third tobacco product regulation violation within a 24-month period Penalty in the case 2,000 2009 of a fourth tobacco product regulation violation within a 24-month period Penalty in the case 5,000 2009 of a fifth tobacco product regulation violation within a 36-month period Penalty in the case 10,000 2009 of a sixth or subsequent tobacco product regulation violation within a 48-month period as determined on a case- by-case basis 335b(a) Penalty for each 250,000 1992 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 1,000,000 1992 of any other person (other than an individual) per above violation 360pp(b) *1 Penalty for any 1,100 1968 person who violates any such requirements for electronic products, with each unlawful act or omission constituting a separate violation Penalty imposed for 375,000 1968 any related series of violations of requirements relating to electronic products 42 U.S.C. (FDA): 262(d) Penalty per day for 100,000 1986 violation of order of recall of biological product presenting imminent or substantial hazard 263b(h) *3 Penalty for failure 10,000 1992 to obtain a mammography certificate as required 300aa-28(b) *1 Penalty per 100,000 1986 occurrence for any vaccine manufacturer that intentionally destroys, alters, falsifies, or conceals any record or report required 42 U.S.C. (HRSA): 256b(d) *1(B)(vi) Penalty for each 5,000 2010 instance of overcharging a 340B covered entity 42 U.S.C. (AHRQ): 299c- *3(d) Penalty for an 10,000 1999 establishment or person supplying information obtained in the course of activities for any purpose other than the purpose for which it was supplied 42 U.S.C. ACF: 653(l) *2 45 CFR 303.21(f) Penalty for Misuse of 1,000 1998 Information in the National Directory of New Hires 42 U.S.C. (OIG): 262a(i) *1 42 CFR Part 1003 Penalty for each 250,000 2002 individual who violates safety and security procedures related to handling dangerous biological agents and toxins Penalty for any other 500,000 2002 person who violates safety and security procedures related to handling dangerous biological agents and toxins 1320a-7a(a) 42 CFR Part 1003 Penalty for knowingly 10,000 1996 presenting or causing to be presented to an officer, employee, or agent of the United States a false claim Penalty for knowingly 10,000 1996 presenting or causing to be presented a request for payment which violates the terms of an assignment, agreement, or PPS agreement Penalty for knowingly 15,000 1996 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 10,000 1996 excluded party retaining ownership or control interest in a participating entity Penalty for 10,000 1996 remuneration offered to induce program beneficiaries to use particular providers, practitioners, or suppliers Penalty for employing 10,000 1997 or contracting with an excluded individual Penalty for knowing 50,000 1997 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 10,000 2010 or prescribing medical or other item or service during a period in which the person was excluded Penalty for knowingly 50,000 2010 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 10,000 2010 of an overpayment and failing to report and return Penalty for making or 50,000 2010 using a false record or statement that is material to a false or fraudulent claim Penalty for failure 15,000 2010 to grant timely access to HHS OIG for audits, investigations, evaluations, and other statutory functions of HHS OIG 1320a-7a(b) 42 CFR Part 1003 Penalty for payments 2,000 1986 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 2,000 1986 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 5,000 1996 physician who executes a document that falsely certifies home health needs for Medicare beneficiaries 1320a-7e(b)(6)(A) 42 CFR Part 1003 Penalty for failure 25,000 1997 to report any final adverse action taken against a health care provider, supplier, or practitioner 1320b-10(b) *1 42 CFR Part 1003 Penalty for the 5,000 1988 misuse of words, symbols, or emblems in communications in a manner in which a person could falsely construe that such item is approved, endorsed, or authorized by HHS 1320b-10(b)(2) 42 CFR Part 1003 Penalty for the 25,000 1988 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 1395i- Penalty for 1,000 1987 3(b)(3)(B)(ii)(1) certification of a false statement in assessment of functional capacity of a Skilled Nursing Facility resident assessment 1395i- Penalty for causing 5,000 1987 3(b)(3)(B)(ii)(2) another to certify or make a false statement in assessment of functional capacity of a Skilled Nursing Facility resident assessment 1395i-3(g)(2)(A) Penalty for any 2,000 1987 individual who notifies or causes to be notified a Skilled Nursing Facility of the time or date on which a survey is to be conducted 1395w-27(g)(2)(A) 42 CFR 422.752; Penalty for a 25,000 1996 42 CFR Part 1003 Medicare Advantage organization that substantially fails to provide medically necessary, required items and services Penalty for a 25,000 1997 Medicare Advantage organization that charges excessive premiums Penalty for a 25,000 1997 Medicare Advantage organization that improperly expels or refuses to reenroll a beneficiary Penalty for a 100,000 1997 Medicare Advantage organization that engages in practice that would reasonably be expected to have the effect of denying or discouraging enrollment Penalty per 15,000 1997 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 100,000 1997 Medicare Advantage organization misrepresenting or falsifying information to Secretary Penalty for a 25,000 1997 Medicare Advantage organization misrepresenting or falsifying information to individual or other entity Penalty for Medicare 25,000 1997 Advantage organization interfering with provider's advice to enrollee and non-MCO affiliated providers that balance bill enrollees Penalty for a 25,000 1997 Medicare Advantage organization that employs or contracts with excluded individual or entity Penalty for a 25,000 2010 Medicare Advantage organization enrolling an individual in without prior written consent Penalty for a 25,000 2010 Medicare Advantage organization transferring an enrollee to another plan without consent or solely for the purpose of earning a commission Penalty for a 25,000 2010 Medicare Advantage organization failing to comply with marketing restrictions or applicable implementing regulations or guidance Penalty for a 25,000 2010 Medicare Advantage organization employing or contracting with an individual or entity who violates 1395w- 27(g) *1(A)-(J) 1395w-141(i)(3) 42 CFR Part 1003 Penalty for a 10,000 2003 prescription drug card sponsor that falsifies or misrepresents marketing materials, overcharges program enrollees, or misuse transitional assistance funds 1395cc(g) 42 CFR Part 1003 Penalty for improper 2,000 1972 billing by Hospitals, Critical Access Hospitals, or Skilled Nursing Facilities 1395dd(d)(1) 42 CFR Part 1003 Penalty for a 50,000 1987 hospital or responsible physician dumping patients needing emergency medical care, if the hospital has 100 beds or more Penalty for a 25,000 1987 hospital or responsible physician dumping patients needing emergency care, if the hospital has less than 100 beds 1395mm(i)(6)(B) 42 CFR Part 1003 Penalty for a HMO or 25,000 1987 (i) competitive plan is such plan substantially fails to provide medically necessary, required items or services Penalty for 25,000 1987 HMOs/competitive medical plans that charge premiums in excess of permitted amounts Penalty for a HMO or 25,000 1987 competitive medical plan that expels or refuses to reenroll an individual per prescribed conditions Penalty for a HMO or 100,000 1987 competitive medical plan that implements practices to discourage enrollment of individuals needing services in future Penalty per 15,000 1988 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 100,000 1987 competitive medical plan that misrepresents or falsifies information to the Secretary Penalty for a HMO or 25,000 1987 competitive medical plan that misrepresents or falsifies information to an individual or any other entity Penalty for failure 25,000 1987 by HMO or competitive medical plan to assure prompt payment of Medicare risk sharing contracts or incentive plan provisions Penalty for HMO that 25,000 1989 employs or contracts with excluded individual or entity 1395nn(g)(3) 42 CFR Part 1003 Penalty for 15,000 1994 submitting or causing to be submitted claims in violation of the Stark Law's restrictions on physician self- referrals 1395nn(g)(4) 42 CFR Part 1003 Penalty for 100,000 1994 circumventing Stark Law's restrictions on physician self- referrals 1395ss(d)(1) 42 CFR Part 1003 Penalty for a 5,000 1988 material misrepresentation regarding Medigap compliance policies 1395ss(d)(2) 42 CFR Part 1003 Penalty for selling 5,000 1988 Medigap policy under false pretense 1395ss(d)(3)(A) 42 CFR Part 1003 Penalty for an issuer 25,000 1990 (ii) that sells health insurance policy that duplicates benefits Penalty for someone 15,000 1990 other than issuer that sells health insurance that duplicates benefits 1395ss(d)(4)(A) 42 CFR Part 1003 Penalty for using 5,000 1988 mail to sell a non- approved Medigap insurance policy 1396b(m)(5)(B)(i) 42 CFR Part 1003 Penalty for a 25,000 1988 Medicaid MCO that substantially fails to provide medically necessary, required items or services Penalty for a 25,000 1988 Medicaid MCO that charges excessive premiums Penalty for a 100,000 1988 Medicaid MCO that improperly expels or refuses to reenroll a beneficiary Penalty per 15,000 1988 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 100,000 1988 Medicaid MCO misrepresenting or falsifying information to the Secretary Penalty for a 25,000 1988 Medicaid MCO misrepresenting or falsifying information to an individual or another entity Penalty for a 25,000 1990 Medicaid MCO that fails to comply with contract requirements with respect to physician incentive plans 1396r(b)(3)(B) 42 CFR Part 1003 Penalty for willfully 1,000 1987 (ii)(I) and knowingly certifying a material and false statement in a Skilled Nursing Facility resident assessment 1396r(b)(3)(B) 42 CFR Part 1003 Penalty for willfully 5,000 1987 (ii)(II) and knowingly causing another individual to certify a material and false statement in a Skilled Nursing Facility resident assessment 1396r(g)(2)(A)(i) 42 CFR Part 1003 Penalty for notifying 2,000 1987 or causing to be notified a Skilled Nursing Facility of the time or date on which a survey is to be conducted 1396r-8(b)(3)(B) 42 CFR Part 1003 Penalty for the 100,000 1990 knowing provision of false information or refusing to provide information about charges or prices of a covered outpatient drug 1396r- 42 CFR Part 1003 Penalty per day for 10,000 1990 8(b)(3)(C)(i) failure to timely provide information by drug manufacturer with rebate agreement 1396r- 42 CFR Part 1003 Penalty for knowing 100,000 1990 8(b)(3)(C)(ii) provision of false information by drug manufacturer with rebate agreement 1396t(i)(3)(A) 42 CFR Part 1003 Penalty for notifying 2,000 1990 home and community- based providers or settings of survey 11131(c) 42 CFR Part 1003 Penalty for failing 10,000 1986 to report a medical malpractice claim to National Practitioner Data Bank 11137(b)(2) 42 CFR Part 1003 Penalty for breaching 10,000 1986 confidentiality of information reported to National Practitioner Data Bank 42 U.S.C. (OCR): 299b-22(f)(1) 42 CFR 3.404(b) Penalty for violation 10,000 2005 of confidentiality provision of the Patient Safety and Quality Improvement Act 1320(d)-5(a) 45 CFR Penalty for each pre- 100 1996 160.404(b)(1)(i), February 18, 2009 (ii) violation of the HIPAA administrative simplification provisions Calendar Year Cap 25,000 1996 45 CFR 160.404(b) Penalty for each (2)(i)(A),(B) 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 100 2009 Maximum 50,000 2009 Calendar Year Cap 1,500,000 2009 45 CFR Penalty for each 160.404(b)(2)(ii) February 18, 2009 or (A), (B) 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 1,000 2009 Maximum 50,000 2009 Calendar Year Cap 1,500,000 2009 45 CFR 160.404 Penalty for each (b)(2)(iii)(A), February 18, 2009 or (B) 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 10,000 2009 Maximum 50,000 2009 Calendar Year Cap 1,500,000 2009 45 CFR Penalty for each 160.404(b)(2)(iv) February 18, 2009 or (A), (B) 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 50,000 2009 Maximum 1,500,000 2009 Calendar Year Cap 1,500,000 2009 42 U.S.C. (CMS): 263a(h)(2)(B) & 42 CFR Penalty for a 1395w- 493.1834(d)(2)(i) clinical laboratory's 2(b)(2)(A)(ii) failure to meet participation and certification requirements and poses immediate jeopardy: Minimum 3,050 1988 Maximum 10,000 1988 42 CFR 493.1834 Penalty for a (d)(2)(ii) clinical laboratory's failure to meet participation and certification requirements and the failure does not pose immediate jeopardy: Minimum 50 1988 Maximum 3,000 1988 300gg-15(f) 45 CFR 147.200(e) Failure to provide 1,000 2010 the Summary of Benefits and Coverage (SBC) 300gg-18 45 CFR 158.606 Penalty for 100 2010 violations of regulations related to the medical loss ratio reporting and rebating 1320a-7h(b)(1) 42 CFR Penalty for 402.105(d)(5), 42 manufacturer or group CFR 403.912(a) & purchasing (c) organization failing to report information required under 42 U.S.C. 1320a-7h(a), relating to physician ownership or investment interests: Minimum 1,000 2010 Maximum 10,000 2010 Calendar Year Cap 150,000 2010 1320a-7h(b)(2) 42 CFR Penalty for 402.105(h), 42 manufacturer or group CFR 403 912(b) & purchasing (c) organization knowingly failing to report information required under 42 U.S.C. 1320a-7h(a) , relating to physician ownership or investment interests: Minimum 10,000 2010 Maximum 100,000 2010 Calendar Year Cap 1,000,000 2010 1320a-7j(h)(3)(A) Penalty for an 100,000 2010 administrator of a facility that fails to comply with notice requirements for the closure of a facility 42 CFR Minimum penalty for 500 2010 488.446(a)(1),(2) the first offense of , & (3) an administrator who fails to provide notice of facility closure Minimum penalty for 1,500 2010 the second offense of an administrator who fails to provide notice of facility closure Minimum penalty for 3,000 2010 the third and subsequent offenses of an administrator who fails to provide notice of facility closure 1320a-8(a)(1) Penalty for an entity 5,000 1994 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 the 7,500 2015 violation of 42 U.S.C. 1320a-8a(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) Penalty for a 5,000 2004 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) Penalty for failure 200,000 2010 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 1320b-25(c)(2)(A) Penalty for failure 300,000 2010 of covered individuals to report to the Secretary and 1 or more law enforcement officials any reasonable suspicion of a crime against a resident, or individual receiving care, from a long-term care facility if such failure exacerbates the harm to the victim of the crime or results in the harm to another individual 1320b-25(d)(2) Penalty for a long- 200,000 2010 term care facility that retaliates against any employee because of lawful acts done by the employee, or files a complaint or report with the State professional disciplinary agency against an employee or nurse for lawful acts done by the employee or nurse 1395b-7(b)(2)(B) 42 CFR 402.105(g) Penalty for any 100 1997 person who knowingly and willfully fails to furnish a beneficiary with an itemized statement of items or services within 30 days of the beneficiary's request 1395i- 42 CFR 488.408 Penalty per day for a 3(h)(2)(B)(ii)(I) (d)(1)(iii) Skilled Nursing Facility that has a Category 2 violation of certification requirements: Minimum 50 1987 Maximum 3,000 1987 42 CFR Penalty per instance 488.408(d)(1)(iv) of Category 2 noncompliance by a Skilled Nursing Facility: Minimum 1,000 1987 Maximum 10,000 1987 42 CFR 488.408 Penalty per day for a (e)(1)(iii) Skilled Nursing Facility that has a Category 3 violation of certification requirements: Minimum 3,050 1987 Maximum 10,000 1987 42 CFR Penalty per instance 488.408(e)(1)(iv) of Category 3 noncompliance by a Skilled Nursing Facility: Minimum 1,000 1987 Maximum 10,000 1987 Penalty per day and per instance for a Skilled Nursing Facility that has Category 3 noncompliance with Immediate Jeopardy Per Day (Minimum) 3,050 1987 Per Day (Maximum) 10,000 1987 Per Instance 1,000 1987 (Minimum) Per Instance 10,000 1987 (Maximum) 42 CFR Penalty per day of a 488.438(a)(1)(i) Skilled Nursing Facility that fails to meet certification requirements. These amounts represent the upper range per day: Minimum 3,050 1987 Maximum 10,000 1987 42 CFR Penalty per day of a 488.438(a)(1)(ii) Skilled Nursing Facility that fails to meet certification requirements. These amounts represent the lower range per day: Minimum 50 1987 Maximum 3,000 1987 42 CFR Penalty per instance 488.438(a)(2) of a Skilled Nursing Facility that fails to meet certification requirements: Minimum 1,000 1987 Maximum 10,000 1987 1395l(h)(5)(D) 42 CFR Penalty for 10,000 1996 402.105(d)(2)(i) knowingly, willfully, and repeatedly billing for a clinical diagnostic laboratory test other than on an assignment-related basis. (Penalties are assessed in the same manner as 42 U.S.C. 1395u(j)(2)(B), which is assessed according to 1320a-7a(a)) 1395l(i)(6) Penalty for knowingly 2,000 1988 and willfully presenting or causing to be presented a bill or request for payment for an intraocular lens inserted during or after cataract surgery for which the Medicare payment rate includes the cost of acquiring the class of lens involved 1395l(q)(2)(B)(i) 42 CFR 402.105(a) Penalty for knowingly 2,000 1989 and willfully failing to provide information about a referring physician when seeking payment on an unassigned basis 1395m(a)(11)(A) 42 CFR Penalty for any 10,000 1996 402.1(c)(4), durable medical 402.105(d)(2)(ii) 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 Penalty for any 10,000 1996 402.1(c)(5), nonparticipating 402.105(d)(2) durable medical (iii) 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 Penalty for any 10,000 1996 402.1(c)(6), nonparticipating 402.105(d)(2)(iv) 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 Penalty for any 10,000 1996 402.1(c)(8), supplier of 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) Penalty for any 1,000 1994 (iii) supplier of durable medical equipment including a supplier of prosthetic devices, prosthetics, orthotics, or supplies that knowingly and willfully distributes a certificate of medical necessity in violation of Section 1834(j)(2)(A)(i) of the Act or fails to provide the information required under Section 1834(j)(2)(A)(ii) of the Act 1395m(j)(4) 42 CFR Penalty for any 10,000 1996 402.1(c)(10), supplier of durable 402.105(d)(2) medical equipment, (vii) including a supplier of prosthetic devices, prosthetics, orthotics, or supplies that knowingly and willfully fails to make refunds in a timely manner to Medicare beneficiaries for series billed other than on as assignment-related basis under certain conditions. (Penalties are assessed in the same manner as 42 U.S.C. 1395m(j)(4) and 1395u(j)(2)(B), which is assessed according to 1320a-7a(a)) 1395m(k)(6) 42 CFR Penalty for any 10,000 1996 402.1(c)(31), person or entity who 402.105(d)(3) 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 Penalty for any 10,000 1996 402.1(c)(32), supplier of ambulance 402.105(d)(4) 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 Penalty for any 10,000 1996 402.1(c)(11), practitioner 402.105(d)(2) specified in Section (viii) 1842(b)(18)(C) of the Act or other person that knowingly and willfully bills or collects for any services by the practitioners on other than an assignment-related basis. (Penalties are 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) Penalty for any 10,000 1996 physician who charges more than 125% for a non-participating referral. (Penalties are assessed in the same manner as 42 U.S.C. 1320a-7a(a)) 1395u(k) 42 CFR Penalty for any 10,000 1996 402.1(c)(12), physician who 402.105(d)(2)(ix) 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 Penalty for any 10,000 1996 402.1(c)(13), nonparticipating 402.105(d)(2)(x) 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 Penalty for any 10,000 1996 402.1(c)(14), nonparticipating 402.105(d)(2)(xi) 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 Penalty for any 10,000 1996 402.1(c)(15), physician who 402.105(d)(2) knowingly, willfully, (xii) 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) Penalty for any 10,000 1996 practitioner specified in Section 1842(b)(18)(C) of the Act or other person that knowingly and willfully bills or collects for any services pertaining to drugs or biologics by the practitioners on other than an assignment-related basis. (Penalties are assessed in the same manner as 42 U.S.C. 1395u(b)(18)(B) and 1395u(j)(2)(B), which is assessed according to 1320a-7a(a)) 1395u(p)(3)(A) Penalty for any 2,000 1988 physician or practitioner who knowingly and willfully fails promptly to provide the appropriate diagnosis codes upon CMS or Medicare administrative contractor request for payment or bill not submitted on an assignment-related basis 1395w-3a(d)(4)(A) 42 CFR 414.806 Penalty for a 10,000 2003 pharmaceutical manufacturer's misrepresentation of average sales price of a drug, or biologic 1395w-4(g)(1)(B) 42 CFR Penalty for any 10,000 1996 402.1(c)(17), nonparticipating 402.105(d)(2) physician, supplier, (xiii) 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 Penalty for any 10,000 1996 402.1(c)(18), person that knowingly 402.105(d)(2) and willfully bills (xiv) 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- 42 CFR Penalty for each 25,000 1997 27(g)(3)(A); 422.760(b); 42 termination 1857(g)(3) CFR 423.760(b) 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- Penalty for each week 10,000 1997 27(g)(3)(B); beginning after the 1857(g)(3) 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- Penalty for a 100,000 2000 27(g)(3)(D); Medicare Advantage 1857(g)(3) organization's or Part D sponsor's early termination of its contract 1395y(b)(3)(C) 42 CFR 411.103(b) Penalty for an 5,000 1990 employer or other entity to offer any financial or other incentive for an individual entitled to benefits not to enroll under a group health plan or large group health plan which would be a primary plan 1395y(b)(5)(C) 42 CFR Penalty for any non- 1,000 1998 (ii) 402.1(c)(20), governmental employer 402.105(b)(2) 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 Penalty for any 2,000 1994 402.1(c)(21), entity that 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) Penalty for any 1,000 2007 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 1395y(b)(8)(E) Penalty for any non- 1,000 2007 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 1395nn(g)(5) 42 CFR 411.361 Penalty for any 10,000 1989 person that fails to report information required by HHS under Section 1877(f) concerning ownership, investment, and compensation arrangements 1395pp(h) 42 CFR Penalty for any 10,000 1996 402.1(c)(23), durable medical 402.105(d)(2)(xv) equipment supplier, including a supplier of prosthetic devices, prosthetics, orthotics, or supplies, that knowingly and willfully fails to make refunds in a timely 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 Penalty for any 25,000 1987 402.1(c)(24), person that issues a 405.105(f)(1) 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) Penalty for someone 15,000 1990 (vi) (II) other than issuer that sells or issues a Medicare supplemental policy to beneficiary without a disclosure statement Penalty for an issuer 25,000 1990 that sells or issues a Medicare supplemental policy without disclosure statement 1395ss(d)(3)(B) Penalty for someone 15,000 1990 (iv) other than issuer that sells or issues a Medicare supplemental policy without acknowledgement form Penalty for issuer 25,000 1990 that sells or issues a Medicare supplemental policy without an acknowledgement form 1395ss(p)(8) 42 CFR Penalty for any 15,000 1990 402.1(c)(25), person that sells or 402.105(e) issues Medicare supplemental polices after a given date that fail to conform to the NAIC or Federal standards established by statute 42 CFR Penalty for any 25,000 1990 402.1(c)(25), person that sells or 405.105(f)(2) 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 Penalty for any 15,000 1990 402.1(c)(26), person that sells a 402.105(e) 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 Penalty for any 25,000 1990 402.1(c)(26), person that sells a 405.105(f)(3), Medicare supplemental (4) 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 Penalty for any 25,000 1990 402.1(c)(27), person that fails to 405.105(f)(5) 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 Penalty for any 25,000 1990 402.1(c)(28), person that fails to 405.105(f)(6) provide refunds or credits as required by section 1882(r)(1)(B) 1395ss(s)(4) 42 CFR Penalty for any 5,000 1990 402.1(c)(29), issuer of a Medicare 405.105(c) 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 Penalty for any 25,000 1990 402.1(c)(30), issuer of a Medicare 405.105(f)(7) supplemental policy that fails to fulfill listed responsibilities 1395ss(v)(4)(A) Penalty someone other 15,000 2003 than issuer who sells, issues, or renews a medigap Rx policy to an individual who is a Part D enrollee Penalty for an issuer 25,000 2003 who sells, issues, or renews a Medigap Rx policy who is a Part D enrollee 1395bbb(c)(1) 42 CFR 488.725(c) Penalty for any 2,000 1987 individual who notifies or causes to be notified a home health agency of the time or date on which a survey of such agency is to be conducted 1395bbb(f)(2)(A) 42 CFR 488.845 Maximum daily penalty 10,000 1988 (i) (b)(2)(iii) amount for each day a home health agency is not in compliance with statutory requirements 42 CFR Penalty per day for 488.845(b)(3) home health agency's noncompliance (Upper Range): Minimum 8,500 1988 Maximum 10,000 1988 42 CFR Penalty for a home 10,000 1988 488.845(b)(3)(i) health agency's deficiency or deficiencies that cause immediate jeopardy and result in actual harm 42 CFR Penalty for a home 9,000 1988 488.845(b)(3)(ii) health agency's deficiency or deficiencies that cause immediate jeopardy and result in potential for harm 42 CFR Penalty for an 8,500 1988 488.845(b)(3)(iii isolated incident of ) noncompliance in violation of established HHA policy 42 CFR Penalty for a repeat 488.845(b)(4) and/or condition- level deficiency that does not constitute immediate jeopardy, but is directly related to poor quality patient care outcomes (Lower Range): Minimum 1,500 1988 Maximum 8,500 1988 42 CFR Penalty for a repeat 488.845(b)(5) 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 500 1988 Maximum 4,000 1988 42 CFR Penalty imposed for 488.845(b)(6) 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 1,000 1988 Maximum 10,000 1988 Penalty for each day 10,000 1988 of noncompliance (Maximum) 42 CFR Penalty for each day 10,000 1988 488.845(d)(1)(ii) of noncompliance (Maximum) 1396b(m)(5)(B) 42 CFR 460.46 Penalty for PACE organization's practice that would reasonably be expected to have the effect of denying or discouraging enrollment: Minimum 15,000 1997 Maximum 100,000 1997 Penalty for a PACE 25,000 1997 organization that charges excessive premiums Penalty for a PACE 100,000 1997 organization misrepresenting or falsifying information to CMS, the State, or an individual or other entity Penalty for each 25,000 1997 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 25,000 1997 involuntarily disenrolling a participant Penalty for 25,000 1997 discriminating or discouraging enrollment or disenrollment of participants on the basis of an individual's health status or need for health care services 1396r(h)(3)(C) 42 CFR 488.408 Penalty per day for a (ii)(I) (d)(1)(iii) nursing facility's failure to meet a Category 2 Certification: Minimum 50 1987 Maximum 3,000 1987 42 CFR Penalty per instance 488.408(d)(1)(iv) for a nursing facility's failure to meet Category 2 certification: Minimum 1,000 1987 Maximum 10,000 1987 42 CFR 488.408 Penalty per day for a (e)(1)(iii) nursing facility's failure to meet Category 3 certification: Minimum 3,050 1987 Maximum 10,000 1987 42 CFR Penalty per instance 488.408(e)(1)(iv) for a nursing facility's failure to meet Category 3 certification: Minimum 1,000 1987 Maximum 10,000 1987 42 CFR Penalty per instance 488.408(e)(2)(ii) for a nursing facility's failure to meet Category 3 certification, which results in immediate jeopardy: Minimum 1,000 1987 Maximum 10,000 1987 42 CFR Penalty per day for 488.438(a)(1)(i) nursing facility's failure to meet certification (Upper Range): Minimum 3,050 1987 Maximum 10,000 1987 42 CFR Penalty per day for 488.438(a)(1)(ii) nursing facility's failure to meet certification (Lower Range): Minimum 50 1987 Maximum 3,000 1987 42 CFR Penalty per instance 488.438(a)(2) for nursing facility's failure to meet certification: Minimum 1,000 1987 Maximum 10,000 1987 1396r(f)(2)(B) 42 CFR Grounds to prohibit 5,000 1987 (iii)(I)(c) 483.151(b)(2)(iv) approval of Nurse and (b)(3)(iii) Aide Training Program--if assessed a penalty in 1819(h)(2)(B)(i) or 1919(h)(2)(A)(ii) of "not less than
|% 5,000" [Not CMP
authority, but a specific CMP amount (CMP at this level) that is the triggering condition for disapproval] 1396r(h)(3)(C) 42 CFR Grounds to waive 5,000 1987 (ii)(I) 483.151(c)(2) 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)(
Calculation of CMP Adjustments Citation Percentage Increase Maximum increase (4) ( ] (5) adjusted penalty ( ] U.S.C. CFR (1) 21 U.S.C. (FDA): 333(b)(2)(A) 97.869 48,935 98,935 333(b)(2)(B) 97.869 978,690 1,978,690 333(b)(3) 97.869 97,869 197,869 333(f)(1)(A) 78.156 11,723 26,723 78.156 781,560 1,781,560 333(f)(2)(A) 50.425 25,123 75,123 50.425 125,613 375,613 50.425 251,225 751,225 333(f)(3)(A) 13.833 1,383 11,383 333(f)(3)(B) 13.833 1,383 11,383 333(f)(4)(A)(i) 13.833 34,583 284,583 13.833 138,330 1,138,330 333(f)(4)(A)(ii) 13.833 34,583 284,583 13.833 138,330 1,138,330 13.833 1,383,300 11,383,300 333(f)(9)(A) 10.02 1,503 16,503 10.02 100,200 1,100,200 333(f)(9)(B)(i) 10.02 25,050 275,050 (I) 10.02 100,200 1,100,200 333(f)(9)(B)(i) 10.02 25,050 275,050 (II) 10.02 100,200 1,100,200 10.02 1,002,000 11,002,000 333(f)(9)(B)(ii) 10.02 25,050 275,050 (I) 10.02 100,200 1,100,200 333(f)(9)(B)(ii) 10.02 25,050 275,050 (II) 10.02 100,200 1,100,200 10.02 1,002,000 11,002,000 333(g)(1) 13.833 34,583 284,583 13.833 69165 569,165 333 note 10.02 25 275 10.02 50 550 10.02 200 2,200 10.02 501 5,501 10.02 1,002 11,002 10.02 25 275 10.02 50 550 10.02 100 1,100 10.02 200 2,200 10.02 501 5,501 10.02 1002 11,002 335b(a) 67.728 169,320 419,320 67.728 677,280 1,677,280 360pp(b)(1) 150 1,500 2,750 150 562,500 937,500 42 U.S.C. (FDA): 262(d) 115.628 115,628 215,628 263b(h)(3) 67.728 6,773 16,773 300aa-28(b)(1) 115.628 115,628 215,628 42 U.S.C. (HRSA): 256b(d)(1)(B)(vi) 8.745 437 5,437 42 U.S.C. (AHRQ): 299c-(3)(d) 41.402 4,140 14,140 42 U.S.C. ACF: 653(l)(2) 45 CFR 303.21(f) 45.023 450 1,450 42 U.S.C. (OIG): 262a(i)(1) 42 CFR Part 1003 31.185 77,962 327,962 31.185 155,925 655,925 1320a-7a(a) 42 CFR Part 1003 50.245 5,024 15,024 50.245 5,024 15,024 50.245 7,537 22,537 50.245 5,024 15,024 50.245 5,024 15,024 47.177 4,718 14,718 47.177 23,588 73,588 8.745 874 10,874 8.745 4,372 54,372 8.745 874 10,874 8.745 4,372 54,372 8.745 1,312 16,312 1320a-7a(b) 42 CFR Part 1003 115.628 2,313 4,313 115.628 2,313 4,313 50.245 2,512 7,512 1320a-7e(b)(6)(A) 42 CFR Part 1003 47.177 11,794 36,794 1320b-10(b)(1) 42 CFR Part 1003 97.869 4,893 9,893 1320b-10(b)(2) 42 CFR Part 1003 97.869 24,467 49,467 1395i- 106.278 1,063 2,063 3(b)(3)(B)(ii)(1) 1395i- 106.278 5,314 10,314 3(b)(3)(B)(ii)(2) 1395i-3(g)(2)(A) 106.278 2,126 4,126 1395w-27(g)(2)(A) 42 CFR 422.752; 50.245 12,561 37,561 42 CFR Part 1003 47.177 11,794 36,794 47.177 11,794 36,794 47.177 47,177 147,177 47.177 7,077 22,077 47.177 47,177 147,177 47.177 11,794 36,794 47.177 11,794 36,794 47.177 11,794 36,794 47.177 11,794 36,794 47.177 11,794 36,794 47.177 11,794 36,794 47.177 11,794 36,794 1395w-141(i)(3) 42 CFR Part 1003 28.561 2,856 12,856 1395cc(g) 42 CFR Part 1003 150 3,000 5,000 1395dd(d)(1) 42 CFR Part 1003 106.278 53,139 103,139 106.278 26,570 51,570 1395mm(i)(6)(B) 42 CFR Part 1003 106.278 26,570 51,570 (i) 106.278 26,570 51,570 106.278 26,570 51,570 106.278 106,278 206,278 97.869 14,680 29,680 106.278 106,278 206,278 106.278 26,570 51,570 106.278 26,570 51,570 89.361 22,340 47,340 1395nn(g)(3) 42 CFR Part 1003 59.089 8,863 23,863 1395nn(g)(4) 42 CFR Part 1003 59.089 59,089 159,089 1395ss(d)(1) 42 CFR Part 1003 97.869 4,893 9,893 1395ss(d)(2) 42 CFR Part 1003 97.869 4,893 9,893 1395ss(d)(3)(A) 42 CFR Part 1003 78.156 19,539 44,539 (ii) 78.156 11,723 26,723 1395ss(d)(4)(A) 42 CFR Part 1003 97.869 4,893 9,893 1396b(m)(5)(B)(i) 42 CFR Part 1003 97.869 24,467 49,467 97.869 24,467 49,467 97.869 97,869 197,869 97.869 14,680 29,680 97.869 97,869 197,869 97.869 24,467 49,467 78.156 19,539 44,539 1396r(b)(3)(B) 42 CFR Part 1003 106.278 1,063 2,063 (ii)(I) 1396r(b)(3)(B) 42 CFR Part 1003 106.278 5,314 10,314 (ii)(II) 1396r(g)(2)(A)(i) 42 CFR Part 1003 106.278 2,126 4,126 1396r-8(b)(3)(B) 42 CFR Part 1003 78.156 78,156 178,156 1396r- 42 CFR Part 1003 78.156 7,816 17,816 8(b)(3)(C)(i) 1396r- 42 CFR Part 1003 78.156 78,156 178,156 8(b)(3)(C)(ii) 1396t(i)(3)(A) 42 CFR Part 1003 78.156 1,563 3,563 11131(c) 42 CFR Part 1003 115.628 11,563 21,563 11137(b)(2) 42 CFR Part 1003 115.628 11,563 21,563 42 U.S.C. (OCR): 299b-22(f)(1) 42 CFR 3.404(b) 19.40 1,940 11,940 1320(d)-5(a) 45 CFR 50.245 50 150 160.404(b)(1)(i), (ii) 50.245 12,561 37,561 45 CFR 160.404(b) (2)(i)(A),(B) 10.02 10 110 10.02 5,010 55,010 10.02 150,300 1,650,300 45 CFR 160.404(b) (2)(ii)(A), (B) 10.02 100 1100 10.02 5,010 55,010 10.02 150,300 1,650,300 45 CFR 160.404(b) (2)(iii)(A), (B) 10.02 100 11,002 10.02 5,010 55,010 10.02 150,300 1,650,300 45 CFR 160.404(b)(2)(iv) (A), (B) 10.02 5,010 55,010 10.02 150,300 1,650,300 10.02 150,300 1,650,300 42 U.S.C. (CMS): 263a(h)(2)(B) & 42 CFR 1395w- 493.1834(d)(2)(i) 2(b)(2)(A)(ii) 97.869 2,985 6,035 97.869 9,787 19,787 42 CFR 493.1834 (d)(2)(ii) 97.869 49 99 97.869 2,936 5,936 300gg-15(f) 45 CFR 147.200(e) 8.745 87 1,087 300gg-18 45 CFR 158.606 8.745 9 109 1320a-7h(b)(1) 42 CFR 402.105(d)(5), 42 CFR 403.912(a) & (c) 8.745 87 1,087 8.745 874 10,874 8.745 13,117 163,117 1320a-7h(b)(2) 42 CFR 402.105(h), 42 CFR 403 912(b) & (c) 8.745 874 10,874 8.745 8,745 108,745 8.745 87,450 1,087,450 1320a-7j(h)(3)(A) 8.745 8,745 108,745 42 CFR 8.745 44 544 488.446(a)(1),(2) , & (3) 8.745 131 1,631 8.745 262 3,262 1320a-8(a)(1) 59.089 2,954 7,954 1 4,431 7,500 1320a-8(a)(3) 24.588 1,229 6,229 1320b-25(c)(1)(A) 8.745 17,490 217,490 1320b-25(c)(2)(A) 8.745 26,235 326,235 1320b-25(d)(2) 8.745 17,490 217,490 1395b-7(b)(2)(B) 42 CFR 402.105(g) 47.177 47 147 1395i- 42 CFR 488.408(d) 3(h)(2)(B)(ii)(I) (1)(iii) 106.278 53 103 106.278 3,188 6,188 42 CFR 488.408(d)(1)(iv) 106.278 1,063 2,063 106.278 10,628 20,628 42 CFR 488.408(e)(1)(iii ) 106.278 3,241 6,291 106.278 10,628 20,628 42 CFR 488.408(e)(1)(iv) 106.278 1,063 2,063 106.278 10,628 20,628 106.278 3,241 6,291 106.278 10,628 20,628 106.278 1,063 2,063 106.278 10,628 20,628 42 CFR 488.438(a)(1)(i) 106.278 3,241 6,291 106.278 10,628 20,628 42 CFR 488.438(a)(1)(ii) 106.278 53 103 106.278 3,188 6,188 42 CFR 488.438(a)(2) 106.278 1,063 2,063 106.278 10,628 20,628 1395l(h)(5)(D) 42 CFR 50.245 5,024 15,024 402.105(d)(2)(i) 1395l(i)(6) 197.869 1,957 3,957 1395l(q)(2)(B)(i) 42 CFR 402.105(a) 89.361 1,787 3,787 1395m(a)(11)(A) 42 CFR 50.245 5,024 15,024 402.1(c)(4), 402.105(d)(2)(ii) 1395m(a)(18)(B) 42 CFR 50.245 5,024 15,024 402.1(c)(5), 402.105(d)(2) (iii) 1395m(b)(5)(C) 42 CFR 50.245 5,024 15,024 402.1(c)(6), 402.105(d)(2)(iv) 1395m(h)(3) 42 CFR 50.245 5,024 15,024 402.1(c)(8), 402.105(d)(2)(vi) 1395m(j)(2)(A) 59.089 591 1,591 (iii) 1395m(j)(4) 42 CFR 50.245 5,024 15,024 402.1(c)(10), 402.105(d)(2) (vii) 1395m(k)(6) 42 CFR 50.245 5,024 15,024 402.1(c)(31), 402.105(d)(3) 1395m(l)(6) 42 CFR 50.245 5,024 15,024 402.1(c)(32), 402.105(d)(4) 1395u(b)(18)(B) 42 CFR 50.245 5,024 15,024 402.1(c)(11), 402.105(d)(2) (viii) 1395u(j)(2)(B) 42 CFR 402.1(c) 50.245 5,024 15,024 1395u(k) 42 CFR 50.245 5,024 15,024 402.1(c)(12), 402.105(d)(2)(ix) 1395u(l)(3) 42 CFR 50.245 5,024 15,024 402.1(c)(13), 402.105(d)(2)(x) 1395u(m)(3) 42 CFR 50.245 5,024 15,024 402.1(c)(14), 402.105(d)(2)(xi) 1395u(n)(3) 42 CFR 50.245 5,024 15,024 402.1(c)(15), 402.105(d)(2) (xii) 1395u(o)(3)(B) 42 CFR 414.707(b) 50.245 5,024 15,024 1395u(p)(3)(A) 97.869 1,957 3,957 1395w-3a(d)(4)(A) 42 CFR 414.806 28.561 2,856 12,856 1395w-4(g)(1)(B) 42 CFR 50.245 5,024 15,024 402.1(c)(17), 402.105(d)(2) (xiii) 1395w-4(g)(3)(B) 42 CFR 50.245 5,024 15,024 402.1(c)(18), 402.105(d)(2) (xiv) 1395w- 42 CFR 47.177 11,794 36,794 27(g)(3)(A); 422.760(b); 42 1857(g)(3) CFR 423.760(b) 1395w- 47.177 4,718 14,718 27(g)(3)(B); 1857(g)(3) 1395w- 36.689 36,689 136,689 27(g)(3)(D); 1857(g)(3) 1395y(b)(3)(C) 42 CFR 411.103(b) 78.156 3,908 8,908 1395y(b)(5)(C) 42 CFR 89.361 450 1,450 (ii) 402.1(c)(20), 402.105(b)(2) 1395y(b)(6)(B) 42 CFR 59.089 1,182 3,182 402.1(c)(21), 402.105(a) 1395y(b)(7)(B)(i) 13.833 138 1,138 1395y(b)(8)(E) 13.833 138 1,138 1395nn(g)(5) 42 CFR 411.361 89.361 8,936 18,936 1395pp(h) 42 CFR 50.245 5,024 15,024 402.1(c)(23), 402.105(d)(2)(xv) 1395ss(a)(2) 42 CFR 106.278 26,569 51,569 402.1(c)(24), 405.105(f)(1) 1395ss(d)(3)(A) 78.156 11,723 26,723 (vi) (II) 78.156 19,539 44,539 1395ss(d)(3)(B) 78.156 11,723 26,723 (iv) 78.156 19,539 44,539 1395ss(p)(8) 42 CFR 78.156 11,723 26,723 402.1(c)(25), 402.105(e) 42 CFR 78.156 19,539 44,539 402.1(c)(25), 405.105(f)(2) 1395ss(p)(9)(C) 42 CFR 78.156 11,723 26,723 402.1(c)(26), 402.105(e) 42 CFR 78.156 19,539 44,539 402.1(c)(26), 405.105(f)(3), (4) 1395ss(q)(5)(C) 42 CFR 78.156 19,539 44,539 402.1(c)(27), 405.105(f)(5) 1395ss(r)(6)(A) 42 CFR 78.156 19,539 44,539 402.1(c)(28), 405.105(f)(6) 1395ss(s)(4) 42 CFR 78.156 3,908 8,908 402.1(c)(29), 405.105(c) 1395ss(t)(2) 42 CFR 78.156 19,539 44,539 402.1(c)(30), 405.105(f)(7) 1395ss(v)(4)(A) 28.561 4,284 19,284 28.561 7,140 32,140 1395bbb(c)(1) 42 CFR 488.725(c) 106.278 2,126 4,126 1395bbb(f)(2)(A) 42 CFR 488.845 97.869 9,787 19,787 (i) (b)(2)(iii) 42 CFR 488.845(b)(3) 97.869 8,319 16,819 97.869 9,787 19,787 42 CFR 97.869 9,787 19,787 488.845(b)(3)(i) 42 CFR 97.869 8,808 17,808 488.845(b)(3)(ii) 42 CFR 488.845 97.869 8,319 16,819 (b)(3)(iii) 42 CFR 488.845(b)(4) 97.869 1,468 2,968 97.869 8,319 16,819 42 CFR 488.845(b)(5) 97.869 489 989 97.869 3,915 7,915 42 CFR 488.845(b)(6) 97.869 979 1,979 97.869 9,787 19,787 97.869 9,787 19,787 42 CFR 97.869 9,787 19,787 488.845(d)(1)(ii) 1396b(m)(5)(B) 42 CFR 460.46 47.177 7,077 22,077 47.177 47,177 147,177 47.177 11,794 36,794 47.177 47,177 147,177 47.177 11,794 36,794 47.177 11,794 36,794 47.177 11,794 36,794 1396r(h)(3)(C) 42 CFR 488.408 (ii)(I) (d)(1)(iii) 106.278 53 103 106.278 3,188 6,188 42 CFR 488.408(d)(1)(iv) 106.278 1,063 2,063 106.278 10,628 20,628 42 CFR 488.408 (e)(1)(iii) 106.278 3,241 6,291 106.278 10,628 20,628 42 CFR 488.408(e)(1)(iv) 106.278 1,063 2,063 106.278 10,628 20,628 42 CFR 488.408(e)(2)(ii) 106.278 1,063 2,063 106.278 10,628 20,628 42 CFR 488.438(a)(1)(i) 106.278 3,241 6,291 106.278 10,628 20,628 42 CFR 488.438(a)(1)(ii) 106.278 53 103 106.278 3,188 6,188 42 CFR 488.438(a)(2) 106.278 1,063 2,063 106.278 10,628 20,628 1396r(f)(2)(B) 42 CFR 106.278 5,314 10,314 (iii)(I)(c) 483.151(b)(2)(iv) and (b)(3)(iii) 1396r(h)(3)(C) 42 CFR 106.278 5,314 10,314 (ii)(I) 483.151(c)(2) 1396t(j)(2)(C) 78.156 1 2 78.156 7,816 17,816 1396u- 42 CFR 438.704 47.177 11,794 36,794 2(e)(2)(A)(i) 47.177 11,794 36,794 47.177 11,794 36,794 47.177 11,794 36,794 1396u- 42 CFR 438.704 47.177 47,177 147,177 2(e)(2)(A)(ii) 47.177 47,177 147,177 1396u- 42 CFR 438.704 47.177 7,077 22,077 2(e)(2)(A)(iv) 1396u(h)(2) 42 CFR 441, 106.278 10,628 20,628 Subpart I 1396w-2(c)(1) 10.02 1,002 11,002 1903(m)(5)(B) 42 CFR 460.46 47.177 7,077 22,077 47.177 47,177 147,177 47.177 11,794 36,794 47.177 47,177 147,177 47.177 11,794 36,794 47.177 11,794 36,794 47.177 11,794 36,794 18041(c)(2) 45 CFR 150.315 50.245 50 150 and 45 CFR 156.805(c) 18081(h)(1)(A)(i) 42 CFR 155.285 8.745 2,186 27,186 (II) 18081(h)(1)(B) 42 CFR 155.285 8.745 21,862 271,862 18081(h)(2) 42 CFR 155.260 8.745 2,186 27,186 31 U.S.C. (HHS): 1352 45 CFR 93.400(e) 89.361 8,936 18,936 89.361 8,936 18,936 89.361 89,361 189,361 89.361 8,936 18,936 89.361 8,936 18,936 89.361 89,361 189,361 45 CFR 93, Appendix A 89.361 8,936 18,936 89.361 89,361 189,361 89.361 8,936 18,936 89.361 89,361 189,361 3801-3812 45 CFR 97.869 4,894 9,894 79.3(a)(1(iv) 45 CFR 97.869 4,894 9,894 79.3(b)(1)(ii) *1 Some HHS components have not promulgated regulations regarding their civil monetary penalties-specific statutory authorities. *2 The description is not intended to be a comprehensive explanation of the underlying violation; the statute and corresponding regulation, if applicable, should be consulted. *3 Statutory, or non-Inflation Act Adjustment. *4 Based on the lesser of the CPI-U multiplier forOctober 2015 , or 150%. *5 Rounded to the nearest dollar.
III. Environmental Impact
HHS has determined that this interim final rule (IFR) does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental impact assessment nor an environmental impact statement is required.
IV. Paperwork Reduction Act
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35) and its implementing regulations (5 CFR part 1320), HHS reviewed this IFR and determined that there are no new collections of information contained therein.
V. Regulatory Flexibility Act
When an agency promulgates a final rule under 5 U.S.C. 553, after being required by that section or any other law to publish a general notice of proposed rulemaking, the Regulatory Flexibility Act (RFA) mandates that the agency prepare an RFA analysis. 5 U.S.C. 604(a). An RFA analysis is not required when a rule is exempt from notice and comment rulemaking under 5 U.S.C. 553(b). This interim final rule is exempt from notice and comment rulemaking. Therefore, no RFA analysis is required under 5 U.S.C. 604 and none was prepared.
VI. Executive Orders 12866 and 13563
Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. Agencies must prepare a regulatory impact analysis for major rules with economically significant effects (
HHS analyzed the economic significance of this IFR, by collecting data for fiscal years 2010 through 2014 on the total value of civil monetary penalties collected by Operating/Staff Divisions, except in the case of CMS, for which HHS used collections data through FY 2015. Such data included the statutory authority for the civil monetary penalty, which HHS used to apply the appropriate multiplier for each of the penalties collected. With respect to CMS, HHS determined the multiplier for the CMS collections by pro rating all of the multipliers for the civil monetary penalty authorities attributed to CMS.
HHS then applied the multiplier to collections for each Fiscal Year (2010 through 2014) to calculate the collections for each Fiscal Year with the inflation adjustment. HHS also performed an additional calculation for FY 2014/2015 using the inflated collections amount for FY 2015 for CMS and using the inflated collections amount for all other Operating/Staff Divisions for FY 2014. When collections were adjusted for inflation, the Department's lowest collection amount was
Finally, HHS subtracted the collections value for a Fiscal Year (for example, FY 2010) from the collections value for the same Fiscal Year with the inflation adjustment (for example, FY 2010 with inflation adjustment) to assess the economic significance of this IFR for that Fiscal Year (for example, FY 2010 Economic Significance). When the calculations were completed, the Fiscal Year Economic Significance values ranged from a low of
VII. Unfunded Mandates Reform Act of 1995 Determination
Section 202 of the Unfunded Mandates Reform Act of 1995 (Unfunded Mandates Act) (2 U.S.C. 1532) requires that covered agencies prepare a budgetary impact statement before promulgating a rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of
VIII. Executive Order 13132 Determination
HHS has determined that this IFR does not have any Federalism implications, as required by Executive Order 13132.
List of Subjects
42 CFR Part 3
Administrative practice and procedure, Conflicts of interests, Health records, Privacy, Reporting and recordkeeping requirements.
42 CFR Part 402
Administrative practice and procedure,
42 CFR Part 403
Grant programs--health, Health insurance, Hospitals, Intergovernmental relations,
42 CFR Part 411
Kidney diseases,
42 CFR Part 412
Administrative practice and procedure, Health facilities,
42 CFR Part 422
Administrative practice and procedure, Health facilities, Health maintenance organizations (HMO),
42 CFR Part 423
Administrative practice and procedure, Emergency medical services, Health facilities, Health maintenance organizations (HMO), Health professionals,
42 CFR Part 438
Grant programs--health,
42 CFR Part 460
Aged, Health care, Health records,
42 CFR Part 483
Grant programs--health, Health facilities, Health professions, Health records,
42 CFR Part 488
Administrative practice and procedure, Health facilities,
42 CFR Part 493
Administrative practice and procedure, Grant programs--health, Health facilities, Laboratories,
42 CFR Part 1003
Fraud, Grant programs--health, Health facilities, Health professions,
45 CFR Part 79
Administrative practice and procedure, Claims, Fraud, Penalties.
45 CFR Part 93
Government contracts, Grants programs, Loan programs, Lobbying, Penalties.
45 CFR Part 102
Administrative practice and procedure, Penalties.
45 CFR Part 147
Health care, Health insurance, Reporting and recordkeeping requirements.
45 CFR Part 155
Administrative practice and procedure, Advertising, Brokers, Conflict of interest, Consumer protection, Grant programs--health, Grants administration, Health care, Health insurance, Health maintenance organization (HMO), Health records, Hospitals, Indians, Individuals with disabilities, Loan programs--health, Organization and functions (Government agencies),
45 CFR Part 156
Administrative practice and procedure, Advertising, Advisory committees, Brokers, Conflict of interest, Consumer protection, Grant programs--health, Grants administration, Health care, Health insurance, Health maintenance organization (HMO), Health records, Hospitals, Indians, Individuals with disabilities, Loan programs--health, Organization and functions (Government agencies),
45 CFR Part 158
Administrative practice and procedure, Claims, Health care, Health insurance, Health plans, penalties, Reporting and recordkeeping requirements, Premium revenues, Medical loss ratio, Rebating.
45 CFR Part 160
Administrative practice and procedures, Penalties, Records and recordkeeping requirements.
45 CFR Part 303
Child support, Standards for program operations, Penalties.
For the reasons set forth in the preamble, the
Title 42--Public Health
Chapter I--Public Health Service,
PART 3--PATIENT SAFETY ORGANIZATIONS AND PATIENT SAFETY WORK PRODUCT
1. The authority citation for part 3 continues to read as follows:
Authority: 42 U.S.C. 216, 299b-21 through 299b-26; 42 U.S.C. 299c-6.
2. Section 3.404 is revised to read as follows:
(a) The amount of a civil money penalty will be determined in accordance with paragraph (b) of this section and
(b) The Secretary may impose a civil monetary penalty in the amount of not more than
CHAPTER IV--CENTERS FOR MEDICARE & MEDICAID SERVICES,
PART 402--CIVIL MONEY PENALTIES, ASSESSMENTS, AND EXCLUSIONS
3. The authority citation for part 402 continues to read as follows:
Authority: Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh).
4. In the table below,
Paragraph Remove Add (a) "$2,000 for each "$2,000 as adjusted annually under 45 service" CFR part 102 for each service". (b) introductory "not more than "not more than$1,000 as adjusted text$1,000 for" annually under 45 CFR part 102 for". (c) introductory "not more than "not more than$5,000 as adjusted text$5,000 for" annually under 45 CFR part 102 for". (d)(1) "not more than "not more than$10,000 as adjusted$10,000 for" annually under 45 CFR part 102 for". (d)(2) "not more than "not more than$10,000 as adjusted introductory text$10,000 for" annually under 45 CFR part 102 for". (d)(3) "not more than "not more than$10,000 as adjusted$10,000 for" annually under 45 CFR part 102 for". (d)(4) "not more than "not more than$10,000 as adjusted$10,000 for" annually under 45 CFR part 102 for". (d)(5) "not more than "not more than$10,000 as adjusted$10,000 for" annually under 45 CFR part 102 for". (d)(5) "will not exceed "will not exceed$150,000 as annually$150,000 " adjusted under 45 CFR part 102". (e) "not more than "not more than$15,000 as adjusted$15,000 for" annually under 45 CFR part 102 for". (f) introductory "not more than "not more than$25,000 as adjusted text$25,000 for" annually under 45 CFR part 102 for". (g) "not more than "not more than$100 as adjusted$100 for" annually under 45 CFR part 102 for". (h) "not more than "not more than$10,000 as adjusted$100,000 for" annually under 45 CFR part 102 for". (h) "will not exceed "will not exceed$1,000,000 as$1,000,000 " annually adjusted under 45 CFR part 102".
PART 403--SPECIAL PROGRAMS AND PROJECTS
5. The authority citation for part 403 continues to read as follows:
Authority: 42 U.S.C. 1395b-3 and Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh).
6. In the table below,
Paragraph Remove Add (a)(1) "not less than "not less than$10,000 , but not more$1,000 , but not than$100,000 , as adjusted annually more than$10,000 under 45 CFR part 102 for". for" (a)(2) "will not exceed "will not exceed$150,000 as adjusted$150,000 " annually under 45 CFR part 102". (b)(1) "not less than "not less than$10,000 , but not more$10,000 , but not than$100,000 , as adjusted annually more than under 45 CFR part 102 for".$100,000 for" (b)(2) "will not exceed "will not exceed$1,000,000 as$1,000,000 " adjusted annually under 45 CFR part 102". (c)(2) "with a maximum "with a maximum combined annual total combined annual of$1,150,000 as adjusted annually total of under 45 CFR part 102".$1,150,000 "
PART 411--EXCLUSIONS FROM MEDICARE AND LIMITATIONS ON MEDICARE PAYMENT
7. The authority citation for part 411 continues to read as follows:
Authority: Secs. 1102, 1860D-1 through 1860D-42, 1871, and 1877 of the Social Security Act (42 U.S.C. 1302, 1395w-101 through 1395w-152, 1395hh, and 1395nn).
SUBSEC 411.103 and 411.361 [Amended]
8. In the table below, for each section and paragraph indicated in the first two columns, remove the phrase indicated in the third column and add in its place the phrase indicated in the fourth column:
Section Paragraphs Remove Add S. 411.103 (b)(1) "up to$5,000 "up to$5,000 as adjusted for" annually under 45 CFR part 102 for". (b)(2) "up to "up to$5,000 as adjusted$5,000 " annually under 45 CFR part 102". S. 411.361 (f) "up to "up to$10,000 as adjusted$10,000 for" annually under 45 CFR part 102 for".
PART 412--PROSPECTIVE PAYMENT SYSTEMS FOR INPATIENT HOSPITAL SERVICES
12. The authority citation for part 412 continues to read as follows:
Authority: Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh), sec. 124 of Pub. L. 106-113 (113 Stat. 1501A-332), sec. 1206 of Pub. L. 113-67, and sec. 112 of Pub. L. 113-93.
13. Section 412.612 is amended as follows:
a. In paragraph (b)(1)(i), by removing the phrase "not more than
b. In paragraph (b)(1)(ii), by removing the phrase "not more than
PART 422--MEDICARE ADVANTAGE PROGRAM
14. The authority citation for part 422 continues to read as follows:
Authority: Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh).
n the table below,
Paragraph Remove Add (b)(1) "up to$25,000 "up to$25,000 as adjusted annually for each" under 45 CFR part 102 for each". (b)(2) "up to$25,000 "up to$25,000 as adjusted annually for each" under 45 CFR part 102 for each". (b)(3) "determination--up "determination--up to$10,000 as to$10,000 " adjusted annually under 45 CFR part 102". (b)(4) "$250 per "$250 as adjusted annually under 45 Medicare enrollee" CFR part 102 per Medicare enrollee". (b)(4) "or$100,000 , "or$100,000 as adjusted annually whichever is under 45 CFR part 102, whichever is greater" greater". (c)(1) "not more than "not more than$25,000 as adjusted$25,000 for" annually under 45 CFR part 102 for". (c)(2) "not more than "not more than$100,000 as adjusted$100,000 for" annually under 45 CFR part 102 for". (c)(4) "$15,000 for each "$15,000 as adjusted annually under individual" 45 CFR part 102 for each individual".
PART 423--VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT
16. The authority citation for part 423 continues to read as follows:
Authority: Sections 1102, 1106, 1860D-1 through 1860D-42, and 1871 of the Social Security Act (42 U.S.C. 1302, 1306, 1395w-101 through 1395w-152, and 1395hh).
17. In the table below,
Paragraph Remove Add (b)(1) "enrollees--up to "enrollees--up to$25,000 as adjusted$25,000 for each annually under 45 CFR part 102 for determination" each determination". (b)(2) "of up to$25,000 "of up to$25,000 as adjusted for each Part D annually under 45 CFR part 102 for enrollee" each Part D enrollee". (b)(3) "up to$10,000 " "up to$10,000 as adjusted annually under 45 CFR part 102". (b)(4) "$250 per "$250 as adjusted annually under 45 Medicare enrollee" CFR part 102 per Medicare enrollee". (b)(4) "or$100,000 , "or$100,000 as adjusted annually whichever is under 45 CFR part 102, whichever is greater" greater". (c)(1) "of not more than "of not more than$25,000 as adjusted$25,000 for each" annually under 45 CFR part 102 for each". (c)(2) "not more than "not more than$100,000 as adjusted$100,000 for annually under 45 CFR part 102 for each" each". (c)(4) "$15,000 for each "$15,000 as adjusted annually under individual" 45 CFR part 102 for each individual".
PART 483--REQUIREMENTS FOR STATES AND LONG TERM CARE FACILITIES
18. The authority citation for part 483 continues to read as follows:
Authority: Secs. 1102, 1128I, 1819, 1871 and 1919 of the Social Security Act (42 U.S.C. 1302, 1320a-7, 1395i, 1395hh and 1396r).
19. Section 483.20 is amended as follows:
a. In paragraph (j)(1)(i), by removing the phrase "not more than
b. In paragraph (j)(1)(ii), by removing the phrase "not more than
20. Section 483.151 is amended as follows:
a. In paragraph (b)(2)(iv), by removing the phrase "not less than
b. In paragraph (b)(3)(iii), by removing the phrase "not less than
c. In paragraph (c)(1), by removing the phrase "not less than
PART 488--SURVEY, CERTIFICATION, AND ENFORCEMENT PROCEDURES
21. The authority citation for part 488 continues to read as follows:
Authority: Secs. 1102, 1128l, 1864, 1865, 1871 and 1875 of the Social Security Act, unless otherwise noted (42 U.S.C. 1302, 1320a-7j, 1395aa, 1395bb, 1395hh) and 1395ll.
SUBSEC 488.307, 488.408, 488.438, 488.446, 488.725, and 488.845 [Amended]
22. In the table below, for each section and paragraph indicated in the first two columns, remove the phrase indicated in the third column and add in its place the phrase indicated in the fourth column:
Section Paragraph Remove Add 488.307 (c) "not to exceed$2,000 " "not to exceed$2,000 as adjusted annually under 45 CFR part 102". 488.408 (d)(1)(iii) "$50 -$3,000 per day" "$50 -$3,000 as adjusted annually under 45 CFR part 102 per day". (d)(1)(iv) "$1,000 -$10,000 per "$1,000 -$10,000 as instance" adjusted annually under 45 CFR part 102 per instance". (e)(1)(iii) "$3,050 -$10,000 per day" "$3,050 -$10,000 as adjusted annually under 45 CFR part 102 per day". (e)(1)(iv) "$1,000 -$10,000 per "$1,000 -$10,000 as instance" adjusted annually under 45 CFR part 102 per instance". (e)(2)(ii) "3,050-$10,000 per day or "3,050-$10,000 as$1,000 -$10,000 per adjusted annually under 45 instance" CFR part 102 per day or$1,000 -$10,000 as adjusted annually under 45 CFR part 102 per instance". 488.438 (a)(1)(i) "Upper range--$3,050 - "Upper range".$10,000 " (a)(1)(i) "$3,050 -$10,000 per day" "$3,050 -$10,000 as adjusted annually under 45 CFR part 102 per day". (a)(1)(ii) "Lower range--$50 - "Upper range".$3,000 " (a)(1)(ii) "$50 -$3,000 per day" "$50 -$3,000 as adjusted annually under 45 CFR part 102 per day". (a)(2) "$1,000 -$10,000 per "$1,000 -$10,000 as instance" adjusted annually under 45 CFR part 102 per instance". 488.446 (a)(1) "A minimum of$500 for" "A minimum of$500 as adjusted annually under 45 CFR part 102 for". (a)(2) "A minimum of$1,500 for" "A minimum of$1,500 as adjusted annually under 45 CFR part 102 for". (a)(3) "A minimum of$3,000 for" "A minimum of$3,000 as adjusted annually under 45 CFR part 102 for". 488.725 (c) "not to exceed$2,000 " "not to exceed$2,000 as adjusted annually under 45 CFR part 102". 488.845 (b)(2)(iii) "shall exceed$10,000 "will exceed$10,000 as for" adjusted under 45 CFR part 102 for". (b)(3) "upper range of$8,500 to "upper range of$8,500 to introductory$10,000 per day"$10,000 as adjusted text annually under 45 CFR part 102 per day". (b)(3)(i) "$10,000 per day" "$10,000 as adjusted annually under 45 CFR part 102 per day". (b)(3))(ii) "$9,000 per day" "$9,000 as adjusted annually under 45 CFR part 102 per day". (b)(3)(iii) "$8,500 per day" "$8,500 as adjusted annually under 45 CFR part 102 per day". (b)(4) "range of$1,500 -$8,500 "range of$1,500 -$8,500 per day" as adjusted annually under 45 CFR part 102 per day". (b)(5) "range of$500 -$4,000 "range of$500 -$4,000 as are imposed" adjusted annually under 45 CFR part 102 are imposed". (b)(6) "range of$1,000 to "range of$1,000 to$10,000 per instance, not$10,000 as adjusted to exceed$10,000 each annually under 45 CFR part day" 102 per instance, not to exceed$10,000 as adjusted annually under 45 CFR part 102 each day". (d)(1)(ii) "maximum of$10,000 per "maximum of$10,000 as day" adjusted annually under 45 CFR part 102 per day".
PART 493--LABORATORY REQUIREMENTS
23. The authority citation for part 493 continues to read as follows:
Authority: Sec. 353 of the Public Health Service Act, secs. 1102, 1861(e), the sentence following sections 1861(s)(11) through 1861(s)(16) of the Social Security Act (42 U.S.C. 263a, 1302, 1395x(e), the sentence following 1395x(s)(11) through 1395x(s)(16)), and the Pub. L. 112-202 amendments to 42 U.S.C. 263a.
24. Section 493.1834 is amended as follows:
a. In paragraph (d)(2)(i), by removing the phrase "
b. In paragraph (d)(2)(ii), by removing the phrase "
CHAPTER V--OFFICE OF INSPECTOR GENERAL--HEALTH
PART 1003--CIVIL MONEY PENALTIES, ASSESSMENTS AND EXCLUSIONS
25. The authority citation for part 1003 continues to read as follows:
Authority: 42 U.S.C. 262a, 1302, 1320-7, 1320a-7a, 1320b-10, 1395u(j), 1395u(k), 1395cc(j), 1395w-141(i)(3), 1395dd(d)(1), 1395mm, 1395nn(g), 1395ss(d), 1396b(m), 11131(c), and 11137(b)(2).
26. Section 1003.103 is amended:
a. In paragraph (c)--
i. By removing the footnote in paragraph (c); and
ii. In paragraph (c) by removing the phrase "not more than
b. In the table below,
Paragraph Text Add footnote (a)(1) "$2,000 " "1. This penalty amount is updated annually, as adjusted in accordance with the Federal Civil Monetary Penalty Inflation Adjustment Act of 1990 (Pub. L. 101-140), as amended by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (section 701 of Pub. L. 114-74). Annually adjusted amounts are published at 45 CFR part 102." (a)(2) "$10,000 " "2. This penalty amount is adjusted annually for inflation, and is published at 45 CFR part 102." (b) "not more than "3. This penalty amount is adjusted$15,000 " annually for inflation, and is published at 45 CFR part 102." "not more than "4. This penalty amount is adjusted$100,000 " annually for inflation, and is published at 45 CFR part 102." (c) "not more than "5. This penalty amount is adjusted$10,000 " annually for inflation, and is published at 45 CFR part 102." (d)(1) "not more than "6. This penalty amount is adjusted$5,000 " annually for inflation, and is published at 45 CFR part 102." "not more than "7. This penalty amount is adjusted$25,000 " annually for inflation, and is published at 45 CFR part 102." (e)(1) "not more than "8. This penalty amount is adjusted$50,000 " annually for inflation, and is published at 45 CFR part 102." "will not exceed "9. This penalty amount is adjusted$25,000 ;" annually for inflation, and is published at 45 CFR part 102." (e)(2) "not more than "10. This penalty amount is adjusted$50,000 " annually for inflation, and is published at 45 CFR part 102." (f)(1) "up to$25,000 " "11. This penalty amount is adjusted introductory text annually for inflation, and is published at 45 CFR part 102." (f)(2) "up to$25,000 " "12. This penalty amount is adjusted introductory text annually for inflation, and is published at 45 CFR part 102." (f)(3) "up to$100,000 " "13. This penalty amount is adjusted introductory text annually for inflation, and is published at 45 CFR part 102." (f)(5) "an additional "14. This penalty amount is adjusted$15,000 " annually for inflation, and is published at 45 CFR part 102." (g) "not more than "15. This penalty amount is adjusted$25,000 " annually for inflation, and is published at 45 CFR part 102." (h)(1) "not more than "16. This penalty amount is adjusted$50,000 " annually for inflation, and is published at 45 CFR part 102." (h)(2)(i)(1) "$5,000 " "17. This penalty amount is adjusted annually for inflation, and is published at 45 CFR part 102." (j) "not more than "18. This penalty amount is adjusted$10,000 " annually for inflation, and is published at 45 CFR part 102." (k) "not more than "19. This penalty amount is adjusted$2,000 " annually for inflation, and is published at 45 CFR part 102." (l) "not more than "20. This penalty amount is adjusted$250,000 " annually for inflation, and is published at 45 CFR part 102." (l) "and not more than "21. This penalty amount is adjusted$500,000 " annually for inflation, and is published at 45 CFR part 102." (m) "not more than "22. This penalty amount is adjusted$10,000 " annually for inflation, and is published at 45 CFR part 102."
Title 45--Public Welfare
Subtitle A--
PART 79--PROGRAM FRAUD CIVIL PENALTIES
27. The authority for part 79 continues to read as follows:
Authority: 31 U.S.C. 3801-3812.
28. In
(a) * * *
(1) * * *
(iv) * * *
FOOTNOTE 1 The amounts specified in this section are updated annually, as adjusted in accordance with the Federal Civil Monetary Penalty Inflation Adjustment Act of 1990 (Pub. L. 101-140), as amended by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (section 701 of Pub. L. 114-74). Annually adjusted amounts are published at 45 CFR part 102. END FOOTNOTE
* * * * *
(b) * * *
(1) * * *
(ii) * * *
FOOTNOTE 2 The amounts specified in this section are updated annually, as adjusted in accordance with the Federal Civil Monetary Penalty Inflation Adjustment Act of 1990 (Pub. L. 101-140), as amended by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (section 701 of Pub. L. 114-74). Annually adjusted amounts are published at 45 CFR part 102. END FOOTNOTE
* * * * *
PART 93--NEW RESTRICTIONS ON LOBBYING
29. The authority for part 93 continues to read as follows:
Authority: Section 319, Public Law 101-121 (31 U.S.C. 1352); (5 U.S.C. 301).
30. Section
(a) * * *
FOOTNOTE 1 The amounts specified in this section are updated annually, as adjusted in accordance with the Federal Civil Monetary Penalty Inflation Adjustment Act of 1990 (Pub. L. 101-140), as amended by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (section 701 of Pub. L. 114-74). Annually adjusted amounts are published at 45 CFR part 102. END FOOTNOTE
* * * * *
31. Appendix A to part 93 is amended in the undesignated paragraph following paragraph (3), under "Certification for Contracts, Grants, Loans, and Cooperative Agreements," by adding a footnote at the end of the phrase "of not less than
Appendix A--Certification Regarding Lobbying
Certification for Contracts, Grants, Loans, and Cooperative Agreements
* * * * *
(3) * * *
FOOTNOTE 1 The amounts specified in Appendix A to Part 93 are updated annually, as adjusted in accordance with the Federal Civil Monetary Penalty Inflation Adjustment Act of 1990 (Pub. L. 101-140), as amended by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (section 701 of Pub. L. 114-74). Annually adjusted amounts are published at 45 CFR part 102. END FOOTNOTE
* * * * *
32. Part 102 is added to subchapter A to read as follows:
PART 102--ADJUSTMENT OF CIVIL MONETARY PENALTIES FOR INFLATION
Sec.
102.1 Applicability.
102.2 Applicability date.
102.3 Penalty adjustment and table.
Authority: Public Law 101-410, Sec. 701 of Public Law 114-74, 31 U.S.C. 3801-3812.
This part applies to each statutory provision under the laws administered by the
The increased penalty amounts set forth in the right-most column of the table in Section 102.3, "Maximum Adjusted Penalty ($)", apply to all civil monetary penalties which are assessed after
The adjusted statutory penalty provisions and their applicable amounts are set out in the following table. The right-most column in the table, "Maximum Adjusted Penalty ($)", provides the maximum adjusted civil penalty amounts. The civil monetary penalty amounts are adjusted annually.
Civil Monetary Penalty Authorities Administered by HHS Agencies and Penalty Amounts [EffectiveSeptember 6, 2016 ] Citation HHS Description *2 Date of Pre- Maximum agency last inflation adjusted penalty penalty penalty figure or ( ] ( ] adjust- ment *3 U.S.C. CFR *1 21 U.S.C.: 333(b)(2) FDA Penalty for 1988 50,000 98,935 (A) violations related to drug samples resulting in a conviction of any representative of manufacturer or distributor in any 10-year period 333(b)(2) FDA Penalty for 1988 1,000,000 1,978,690 (B) violation related to drug samples resulting in a conviction of any representative of manufacturer or distributor after the second conviction in any 10-yr period 333(b)(3) FDA Penalty for 1988 100,000 197,869 failure to make a report required by 21 U.S.C. 353(d)(3)(E) relating to drug samples 333(f)(1) FDA Penalty for any 1990 15,000 26,723 (A) person who violates a requirement related to devices for each such violation Penalty for 1990 1,000,000 1,781,560 aggregate of all violations related to devices in a single proceeding 333(f)(2) FDA Penalty for any 1996 50,000 75,123 (A) 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 1996 250,000 375,613 case of any other person other than an individual) for such introduction or delivery of adulterated food Penalty for 1996 500,000 751,225 aggregate of all such violations related to adulterated food adjudicated in a single proceeding 333(f)(3) FDA Penalty for all 2007 10,000 11,383 (A) violations adjudicated in a single proceeding for any person who fails to submit certification required by 42 U.S.C. 282(j)(5)(B) or knowingly submitting a false certification 333(f)(3) FDA Penalty for each 2007 10,000 11,383 (B) day the above violation is not corrected after a 30-day period following notification until the violation is corrected 333(f)(4) FDA Penalty for any 2007 250,000 284,583 (A)(i) 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 2007 1,000,000 1,138,330 aggregate of all such above violations in a single proceeding 333(f)(4) FDA Penalty for REMS 2007 250,000 284,583 (A)(ii) 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 2007 1,000,000 1,138,330 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 2007 10,000,00 11,383,30 aggregate of all 0 0 such above violations adjudicated in a single proceeding 333(f)(9) FDA Penalty for any 2009 15,000 16,503 (A) person who violates a requirement which relates to tobacco products for each such violation Penalty for 2009 1,000,000 1,100,200 aggregate of all such violations of tobacco product requirement adjudicated in a single proceeding 333(f)(9) FDA Penalty per 2009 250,000 275,050 (B)(i)(I) violation related to violations of tobacco requirements Penalty for 2009 1,000,000 1,100,200 aggregate of all such violations of tobacco product requirements adjudicated in a single proceeding 333(f)(9) FDA Penalty in the 2009 250,000 275,050 (B)(i) case of a (II) 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 2009 1,000,000 1,100,200 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 2009 10,000,00 11,002,00 aggregate of all 0 0 such violations related to tobacco product requirements adjudicated in a single proceeding 333(f)(9) FDA Penalty for any 2009 250,000 275,050 (B)(ii) person who either (I) 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 2009 1,000,000 1,100,200 aggregate of for all such above violations adjudicated in a single proceeding 333(f)(9) FDA Penalty for 2009 250,000 275,050 (B)(ii) violation of (II) 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- 2009 1,000,000 1,100,200 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 2009 10,000,00 11,002,00 aggregate above 0 0 tobacco product requirement violations adjudicated in a single proceeding 333(g)(1) FDA Penalty for any 2007 250,000 284,583 person who disseminates or causes another party to disseminate a direct-to- consumer advertisement that is false or misleading for the first such violation in any 3-year period Penalty for each 2007 500,000 569,165 subsequent above violation in any 3-year period 333 note FDA Penalty to be 2009 250 275 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 2009 500 550 case of a third tobacco product regulation violation within a 24-month period Penalty in the 2009 2,000 2,200 case of a fourth tobacco product regulation violation within a 24-month period Penalty in the 2009 5,000 5,501 case of a fifth tobacco product regulation violation within a 36-month period Penalty in the 2009 10,000 11,002 case of a sixth or subsequent tobacco product regulation violation within a 48-month period as determined on a case-by-case basis Penalty to be 2009 250 275 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 2009 500 550 case of a second tobacco product regulation violation within a 12-month period Penalty in the 2009 1,000 1,100 case of a third tobacco product regulation violation within a 24-month period Penalty in the 2009 2,000 2,200 case of a fourth tobacco product regulation violation within a 24-month period Penalty in the 2009 5,000 5,501 case of a fifth tobacco product regulation violation within a 36-month period Penalty in the 2009 10,000 11,002 case of a 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 1992 250,000 419,320 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 1992 1,000,000 1,677,280 case of any other person (other than an individual) per above violation 360pp(b) FDA Penalty for any 1968 1,100 2,750 (1) person who violates any such requirements for electronic products, with each unlawful act or omission constituting a separate violation Penalty imposed 1968 375,000 937,500 for any related series of violations of requirements relating to electronic products 42 U.S.C.: 262(d) FDA Penalty per day 1986 100,000 215,628 for violation of order of recall of biological product presenting imminent or substantial hazard 263b(h) FDA Penalty for 1992 10,000 16,773 (3) failure to obtain a mammography certificate as required 300aa- FDA Penalty per 1986 100,000 215,628 28(b)(1) occurrence for any vaccine manufacturer that intentionally destroys, alters, falsifies, or conceals any record or report required 256b(d) HRSA Penalty for each 2010 5,000 5,437 (1)(B) instance of (vi) overcharging a 340B covered entity 299c- AHRQ Penalty for an 1999 10,000 14,140 (3)(d) 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 ACF Penalty for 1998 1,000 1,450 303.21(f) Misuse of Information in the National Directory of New Hires 262a(i) 42 CFR OIG Penalty for each 2002 250,000 327,962 (1) Part 1003 individual who violates safety and security procedures related to handling dangerous biological agents and toxins Penalty for any 2002 500,000 655,925 other person who violates safety and security procedures related to handling dangerous biological agents and toxins. 1320a- 42 CFR OIG Penalty for 1996 10,000 15,024 7a(a) Part 1003 knowingly presenting or causing to be presented to an officer, employee, or agent of the United States a false claim Penalty for 1996 10,000 15,024 knowingly presenting or causing to be presented a request for payment which violates the terms of an assignment, agreement, or PPS agreement Penalty for 1996 15,000 22,537 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 1996 10,000 15,024 excluded party retaining ownership or control interest in a participating entity Penalty for 1996 10,000 15,024 remuneration offered to induce program beneficiaries to use particular providers, practitioners, or suppliers Penalty for 1997 10,000 14,718 employing or contracting with an excluded individual Penalty for 1997 50,000 73,588 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 2010 10,000 10,874 ordering or prescribing medical or other item or service during a period in which the person was excluded Penalty for 2010 50,000 54,372 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 2010 10,000 10,874 knowing of an overpayment and failing to report and return Penalty for 2010 50,000 54,372 making or using a false record or statement that is material to a false or fraudulent claim Penalty for 2010 15,000 16,312 failure to grant timely access to HHS OIG for audits, investigations, evaluations, and other statutory functions of HHS OIG 1320a- 42 CFR OIG Penalty for 1986 2,000 4,313 7a(b) Part 1003 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 1986 2,000 4,313 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 1996 5,000 7,512 physician who executes a document that falsely certifies home health needs for Medicare beneficiaries 1320a- 42 CFR OIG Penalty for 1997 25,000 36,794 7e(b)(6) Part 1003 failure to report (A) any final adverse action taken against a health care provider, supplier, or practitioner 1320b- 42 CFR OIG Penalty for the 1988 5,000 9,893 10(b)(1) Part 1003 misuse of words, symbols, or emblems in communications in a manner in which a person could falsely construe that such item is approved, endorsed, or authorized by HHS 1320b- 42 CFR OIG Penalty for the 1988 25,000 49,467 10(b)(2) Part 1003 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 1395i- OIG Penalty for 1987 1,000 2,063 3(b)(3) certification of (B)(ii) a false statement (1) in assessment of functional capacity of a Skilled Nursing Facility resident assessment 1395i- OIG Penalty for 1987 5,000 10,314 3(b)(3) causing another (B)(ii) to certify or (2) make a false statement in assessment of functional capacity of a Skilled Nursing Facility resident assessment 1395i- OIG Penalty for any 1987 2,000 4,126 3(g)(2) individual who (A) notifies or causes to be notified a Skilled Nursing Facility of the time or date on which a survey is to be conducted 1395w- 42 CFR OIG Penalty for a 1996 25,000 37,561 27(g)(2) 422.752; Medicare (A) 42 CFR Advantage Part 1003 organization that substantially fails to provide medically necessary, required items and services Penalty for a 1997 25,000 36,794 Medicare Advantage organization that charges excessive premiums Penalty for a 1997 25,000 36,794 Medicare Advantage organization that improperly expels or refuses to reenroll a beneficiary Penalty for a 1997 100,000 147,177 Medicare Advantage organization that engages in practice that would reasonably be expected to have the effect of denying or discouraging enrollment Penalty per 1997 15,000 22,077 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 1997 100,000 147,177 Medicare Advantage organization misrepresenting or falsifying information to Secretary Penalty for a 1997 25,000 36,794 Medicare Advantage organization misrepresenting or falsifying information to individual or other entity Penalty for 1997 25,000 36,794 Medicare Advantage organization interfering with provider's advice to enrollee and non-MCO affiliated providers that balance bill enrollees Penalty for a 1997 25,000 36,794 Medicare Advantage organization that employs or contracts with excluded individual or entity Penalty for a 2010 25,000 36,794 Medicare Advantage organization enrolling an individual in without prior written consent Penalty for a 2010 25,000 36,794 Medicare Advantage organization transferring an enrollee to another plan without consent or solely for the purpose of earning a commission Penalty for a 2010 25,000 36,794 Medicare Advantage organization failing to comply with marketing restrictions or applicable implementing regulations or guidance Penalty for a 2010 25,000 36,794 Medicare Advantage organization employing or contracting with an individual or entity who violates 1395w- 27(g)(1)(A)-(J) 1395w- 42 CFR OIG Penalty for a 2003 10,000 12,856 141(i)(3) Part 1003 prescription drug card sponsor that falsifies or misrepresents marketing materials, overcharges program enrollees, or misuse transitional assistance funds 1395cc(g) 42 CFR OIG Penalty for 1972 2,000 5,000 Part 1003 improper billing by Hospitals, Critical Access Hospitals, or Skilled Nursing Facilities 1395dd(d) 42 CFR OIG Penalty for a 1987 50,000 103,139 (1) Part 1003 hospital or responsible physician dumping patients needing emergency medical care, if the hospital has 100 beds or more Penalty for a 1987 25,000 51,570 hospital or responsible physician dumping patients needing emergency medical care, if the hospital has less than 100 beds 1395mm(i) 42 CFR OIG Penalty for a HMO 1987 25,000 51,570 (6)(B)(i) Part 1003 or competitive plan is such plan substantially fails to provide medically necessary, required items or services Penalty for 1987 25,000 51,570 HMOs/competitive medical plans that charge premiums in excess of permitted amounts Penalty for a HMO 1987 25,000 51,570 or competitive medical plan that expels or refuses to reenroll an individual per prescribed conditions Penalty for a HMO 1987 100,000 206,278 or competitive medical plan that implements practices to discourage enrollment of individuals needing services in future Penalty per 1988 15,000 29,680 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 1987 100,000 206,278 or competitive medical plan that misrepresents or falsifies information to the Secretary Penalty for a HMO 1987 25,000 51,570 or competitive medical plan that misrepresents or falsifies information to an individual or any other entity Penalty for 1987 25,000 51,570 failure by HMO or competitive medical plan to assure prompt payment of Medicare risk sharing contracts or incentive plan provisions Penalty for HMO 1989 25,000 47,340 that employs or contracts with excluded individual or entity 1395nn(g) 42 CFR OIG Penalty for 1994 15,000 23,863 (3) Part 1003 submitting or causing to be submitted claims in violation of the Stark Law's restrictions on physician self- referrals 1395nn(g) 42 CFR OIG Penalty for 1994 100,000 159,089 (4) Part 1003 circumventing Stark Law's restrictions on physician self- referrals 1395ss(d) 42 CFR OIG Penalty for a 1988 5,000 9,893 (1) Part 1003 material misrepresentation regarding Medigap compliance policies 1395ss(d) 42 CFR OIG Penalty for 1988 5,000 9,893 (2) Part 1003 selling Medigap policy under false pretense 1395ss(d) 42 CFR OIG Penalty for an 1990 25,000 44,539 (3)(A) Part 1003 issuer that sells (ii) health insurance policy that duplicates benefits Penalty for 1990 15,000 26,723 someone other than issuer that sells health insurance that duplicates benefits 1395ss(d) 42 CFR OIG Penalty for using 1988 5,000 9,893 (4)(A) Part 1003 mail to sell a non-approved Medigap insurance policy 1396b(m) 42 CFR OIG Penalty for a 1988 25,000 49,467 (5)(B)(i) Part 1003 Medicaid MCO that substantially fails to provide medically necessary, required items or services Penalty for a 1988 25,000 49,467 Medicaid MCO that charges excessive premiums Penalty for a 1988 100,000 197,869 Medicaid MCO that improperly expels or refuses to reenroll a beneficiary Penalty per 1988 15,000 29,680 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 1988 100,000 197,869 Medicaid MCO misrepresenting or falsifying information to the Secretary Penalty for a 1988 25,000 49,467 Medicaid MCO misrepresenting or falsifying information to an individual or another entity Penalty for a 1990 25,000 44,539 Medicaid MCO that fails to comply with contract requirements with respect to physician incentive plans 1396r(b) 42 CFR OIG Penalty for 1987 1,000 2,063 (3)(B) Part 1003 willfully and (ii)(I) knowingly certifying a material and false statement in a Skilled Nursing Facility resident assessment 1396r(b) 42 CFR OIG Penalty for 1987 5,000 10,314 (3)(B) Part 1003 willfully and (ii)(II) knowingly causing another individual to certify a material and false statement in a Skilled Nursing Facility resident assessment 1396r(g) 42 CFR OIG Penalty for 1987 2,000 4,126 (2)(A)(i) Part 1003 notifying or causing to be notified a Skilled Nursing Facility of the time or date on which a survey is to be conducted 1396r-8 42 CFR OIG Penalty for the 1990 100,000 178,156 (b)(3)(B) Part 1003 knowing provision of false information or refusing to provide information about charges or prices of a covered outpatient drug 1396r- 42 CFR Penalty per day 1990 10,000 17,816 8(b)(3) Part 1003 for failure to (C)(i) timely provide information by drug manufacturer with rebate agreement 1396r- 42 CFR Penalty for 1990 100,000 178,156 8(b)(3) Part 1003 knowing provision (C)(ii) of false information by drug manufacturer with rebate agreement 1396t(i) 42 CFR OIG Penalty for 1990 2,000 3,563 (3)(A) Part 1003 notifying home and community- based providers or settings of survey 11131(c) 42 CFR OIG Penalty for 1986 10,000 21,563 Part 1003 failing to report a medical malpractice claim to National Practitioner Data Bank 11137(b) 42 CFR OIG Penalty for 1986 10,000 21,563 (2) Part 1003 breaching confidentiality of information reported to National Practitioner Data Bank 299b- 42 CFR OCR Penalty for 2005 10,000 11,940 22(f)(1) 3.404 violation of confidentiality provision of the Patient Safety and Quality Improvement Act 1320(d)- 45 CFR OCR Penalty for each 1996 100 150 5(a) 160.404(b pre-February 18, )(1)(i),( 2009 violation of ii) the HIPAA administrative simplification provisions Calendar Year Cap 1996 25,000 37,561 1320(d)- 45 CFR OCR Penalty for each 5(a) 160.404(b February 18, 2009 )(2)(i)(A 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 2009 100 110 Maximum 2009 50,000 55,010 Calendar Year Cap 2009 1,500,000 1,650,300 45 CFR OCR Penalty for each 160.404 February 18, 2009 (b)(2) or later (ii)(A), violation of a (B) HIPAA administrative simplification provision in which it is established that the violation was due to reasonable cause and not to willful neglect: Minimum 2009 1,000 1,100 Maximum 2009 50,000 55,010 Calendar Year Cap 2009 1,500,000 1,650,300 45 CFR OCR Penalty for each 160.404 February 18, 2009 (b)(2) or later (iii)(A), violation of a (B) 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 2009 10,000 11,002 Maximum 2009 50,000 55,010 Calendar Year Cap 2009 1,500,000 1,650,300 45 CFR OCR Penalty for each 160.404 February 18, 2009 (b)(2) or later (iv)(A), violation of a (B) 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 2009 50,000 55,010 Maximum 2009 1,500,000 1,650,300 Calendar Year Cap 2009 1,500,000 1,650,300 263a(h) 42 CFR CMS Penalty for a (2)(B) & 493.1834 clinical 1395w- (d)(2)(i) laboratory's 2(b)(2) failure to meet (A)(ii) participation and certification requirements and poses immediate jeopardy: Minimum 1988 3,050 6,035 Maximum 1988 10,000 19,787 42 CFR CMS Penalty for a 493.1834 clinical (d)(2) laboratory's (ii) failure to meet participation and certification requirements and the failure does not pose immediate jeopardy: Minimum 1988 50 99 Maximum 1988 3,000 5,936 300gg- 45 CFR CMS Failure to 2010 1,000 1,087 15(f) 147.200 provide the (e) Summary of Benefits and Coverage 300gg-18 45 CFR CMS Penalty for 2010 100 109 158.606 violations of regulations related to the medical loss ratio reporting and rebating 1320a- 42 CFR CMS Penalty for 7h(b)(1) 402.105 manufacturer or (d)(5); group purchasing 42 CFR organization 403.912 failing to report (a) & (c) information required under 42 U.S.C. 1320a- 7h(a), relating to physician ownership or investment interests: Minimum 2010 1,000 1,087 Maximum 2010 10,000 10,874 Calendar Year Cap 2010 150,000 163,117 1320a- 42 CFR CMS Penalty for 7h(b)(2) 402.105 manufacturer or (h); 42 group purchasing CFR 403 organization 912(b) & knowingly failing (c) to report information required under 42 U.S.C. 1320a- 7h(a), relating to physician ownership or investment interests: Minimum 2010 10,000 10,874 Maximum 2010 100,000 108,745 Calendar Year Cap 2010 1,000,000 1,087,450 1320a- CMS Penalty for an 2010 100,000 108,745 7j(h)(3) administrator of (A) a facility that fails to comply with notice requirements for the closure of a facility 42 CFR CMS Minimum penalty 2010 500 544 488.446 for the first (a)(1), offense of an (2), & administrator who (3) fails to provide notice of facility closure Minimum penalty 2010 1,500 1,631 for the second offense of an administrator who fails to provide notice of facility closure Minimum penalty 2010 3,000 3,262 for the third and subsequent offenses of an administrator who fails to provide notice of facility closure 1320a- CMS Penalty for an 1994 5,000 7,954 8(a)(1) 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 2015 7,500 7,500 violation of 42 U.S.C. 1320a- 8(a)(1) if the violator is a person who receives a fee or other income for services performed in connection with determination of the benefit amount or the person is a physician or other health care provider who submits evidence in connection with such a determination 1320a- CMS Penalty for a 2004 5,000 6,229 8(a)(3) 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- CMS Penalty for 2010 200,000 217,490 25(c)(1) failure of (A) 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- CMS Penalty for 2010 300,000 326,235 25(c)(2) failure of (A) 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- CMS Penalty for a 2010 200,000 217,490 25(d)(2) 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 1395b- 42 CFR CMS Penalty for any 1997 100 147 7(b)(2) 402.105 person who (B) (g) 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- 42 CFR CMS Penalty per day 3(h)(2) 488.408 for a Skilled (B)(ii) (d)(1) Nursing Facility (I) (iii) that has a Category 2 violation of certification requirements: Minimum 1987 50 103 Maximum 1987 3,000 6,188 42 CFR CMS Penalty per 488.408 instance of (d)(1) Category 2 (iv) noncompliance by a Skilled Nursing Facility: Minimum 1987 1,000 2,063 Maximum 1987 10,000 20,628 42 CFR CMS Penalty per day 488.408 for a Skilled (e)(1) Nursing Facility (iii) that has a Category 3 violation of certification requirements: Minimum 1987 3,050 6,291 Maximum 1987 10,000 20,628 42 CFR CMS Penalty per 488.408 instance of (e)(1) Category 3 (iv) noncompliance by a Skilled Nursing Facility: Minimum 1987 1,000 2,063 Maximum 1987 10,000 20,628 42 CFR CMS Penalty per day 488.408 and per instance (e)(2) for a Skilled (ii) Nursing Facility that has Category 3 noncompliance with Immediate Jeopardy: Per Day (Minimum) 1987 3,050 6,291 Per Day (Maximum) 1987 10,000 20,628 Per Instance 1987 1,000 2,063 (Minimum) Per Instance 1987 10,000 20,628 (Maximum) 42 CFR CMS Penalty per day 488.438 of a Skilled (a)(1)(i) Nursing Facility that fails to meet certification requirements. These amounts represent the upper range per day: Minimum 1987 3,050 6,291 Maximum 1987 10,000 20,628 42 CFR CMS Penalty per day 488.438 of a Skilled (a)(1) Nursing Facility (ii) that fails to meet certification requirements. These amounts represent the lower range per day: Minimum 1987 50 103 Maximum 1987 3,000 6,188 42 CFR CMS Penalty per 488.438 instance of a (a)(2) Skilled Nursing Facility that fails to meet certification requirements: Minimum 1987 1,000 2,063 Maximum 1987 10,000 20,628 1395l(h) 42 CFR CMS Penalty for 1996 10,000 15,024 (5)(D) 402.105 knowingly, (d)(2)(i) 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) CMS Penalty for 1988 2,000 3,957 (6) knowingly and willfully presenting or causing to be presented a bill or request for payment for an intraocular lens inserted during or after cataract surgery for which the Medicare payment rate includes the cost of acquiring the class of lens involved 1395l(q) 42 CFR CMS Penalty for 1989 2,000 3,787 (2)(B)(i) 402.105 knowingly and (a) willfully failing to provide information about a referring physician when seeking payment on an unassigned basis 1395m(a) 42 CFR CMS Penalty for any 1996 10,000 15,024 (11)(A) 402.1(c) durable medical (4), equipment 402.105 supplier that (d)(2) knowingly and (ii) 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) 42 CFR CMS Penalty for any 1996 10,000 15,024 (18)(B) 402.1(c) nonparticipating (5), durable medical 402.105 equipment (d)(2) supplier that (iii) 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) 42 CFR CMS Penalty for any 1996 10,000 15,024 (5)(C) 402.1(c) nonparticipating (6), physician or 402.105 supplier that (d)(2) knowingly and (iv) 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) 42 CFR CMS Penalty for any 1996 10,000 15,024 (3) 402.1(c) supplier of (8), prosthetic 402.105 devices, (d)(2) orthotics, and (vi) 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) CMS Penalty for any 1994 1,000 1,591 (2)(A) supplier of (iii) 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) 42 CFR CMS Penalty for any 1996 10,000 15,024 (4) 402.1(c) supplier of (10), durable medical 402.105 equipment, (d)(2) including a (vii) supplier of prosthetic devices, prosthetics, orthotics, or supplies that knowingly and willfully fails to make refunds in a timely manner to Medicare beneficiaries for series billed other than on as assignment- related basis under certain conditions. (Penalties are assessed in the same manner as 42 U.S.C. 1395m(j)(4) and 1395u(j)(2)(B), which is assessed according to 1320a-7a(a)) 1395m(k) 42 CFR CMS Penalty for any 1996 10,000 15,024 (6) 402.1(c) person or entity (31), who knowingly and 402.105 willfully bills (d)(3) 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) 42 CFR CMS Penalty for any 1996 10,000 15,024 (6) 402.1(c) supplier of (32), ambulance 402.105 services who (d)(4) 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) 42 CFR CMS Penalty for any 1996 10,000 15,024 (18)(B) 402.1(c) practitioner (11), specified in 402.105 Section (d)(2) 1842(b)(18)(C) of (viii) 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) 42 CFR CMS Penalty for any 1996 10,000 15,024 (2)(B) 402.1(c) physician who charges more than 125% for a non- participating referral. (Penalties are assessed in the same manner as 42 U.S.C. 1320a- 7a(a)) 1395u(k) 42 CFR CMS Penalty for any 1996 10,000 15,024 402.1(c) physician who (12), knowingly and 402.105 willfully (d)(2) presents or (ix) 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) 42 CFR CMS Penalty for any 1996 10,000 15,024 (3) 402.1(c) nonparticipating (13), physician who 402.105 does not accept (d)(2)(x) 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) 42 CFR CMS Penalty for any 1996 10,000 15,024 (3) 402.1(c) nonparticipating (14), physician 402.105 charging more (d)(2) than $500 who (xi) 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)) 42 CFR CMS Penalty for any 1996 10,000 15,024 1395u(n) 402.1(c) physician who (3) (15), knowingly, 402.105 willfully, and (d)(2) repeatedly bills (xii) 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) 42 CFR CMS Penalty for any 1996 10,000 15,024 (3)(B) 414.707 practitioner (b) specified in Section 1842(b)(18)(C) of the Act or other person that knowingly and willfully bills or collects for any services pertaining to drugs or biologics by the practitioners on other than an assignment- related basis. (Penalties are assessed in the same manner as 42 U.S.C. 1395u(b)(18)(B) and 1395u(j)(2)(B), which is assessed according to 1320a-7a(a)) 1395u(p) CMS Penalty for any 1988 2,000 3,957 (3)(A) physician or practitioner who knowingly and willfully fails promptly to provide the appropriate diagnosis codes upon CMS or Medicare administrative contractor request for payment or bill not submitted on an assignment- related basis 1395w- 42 CFR CMS Penalty for a 2003 10,000 12,856 3a(d)(4) 414.806 pharmaceutical (A) manufacturer's misrepresentation of average sales price of a drug, or biologic 1395w- 42 CFR CMS Penalty for any 1996 10,000 15,024 4(g)(1) 402.1(c) nonparticipating (B) (17), physician, 402.105 supplier, or (d)(2) other person that (xiii) 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- 42 CFR CMS Penalty for any 1996 10,000 15,024 4(g)(3) 402.1(c) person that (B) (18), knowingly and 402.105 willfully bills (d)(2) for statutorily (xiv) 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- 42 CFR CMS Penalty for each 1997 25,000 36,794 27(g)(3) 422.760 termination (A); (b); 42 determination the 1857(g) CFR Secretary makes (3) 423.760 that is the (b) 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- CMS Penalty for each 1997 10,000 14,718 27(g)(3) week beginning (B); after the 1857(g) initiation of (3) 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- CMS Penalty for a 2000 100,000 136,689 27(g)(3) Medicare (D); Advantage 1857(g) organization's or (3) Part D sponsor's early termination of its contract 1395y(b) 42 CFR CMS Penalty for an 1990 5,000 8,908 (3)(C) 411.103 employer or other (b) 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) 42 CFR CMS Penalty for any 1998 1,000 1,450 (5)(C) 402.1(c) non-governmental (ii) (20); 42 employer that, CFR before October 1, 402.105 1998, willfully (b)(2) or repeatedly failed to provide timely and accurate information requested relating to an employee's group health insurance coverage 1395y(b) 42 CFR CMS Penalty for any 1994 2,000 3,182 (6)(B) 402.1(c) entity that (21), knowingly, 402.105 willfully, and (a) 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) CMS Penalty for any 2007 1,000 1,138 (7)(B)(i) 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 1395y(b) CMS Penalty for any 2007 1,000 1,138 (8)(E) 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 1395nn(g) 42 CFR CMS Penalty for any 1989 10,000 18,936 (5) 411.361 person that fails to report information required by HHS under Section 1877(f) concerning ownership, investment, and compensation arrangements 1395pp(h) 42 CFR CMS Penalty for any 1996 10,000 15,024 402.1(c) durable medical (23), equipment 402.105 supplier, (d)(2) including a (xv) 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) 42 CFR CMS Penalty for any 1987 25,000 51,569 (2) 402.1(c) person that (24), issues a Medicare 405.105 supplemental (f)(1) 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) CMS Penalty for 1990 15,000 26,723 (3)(A) someone other (vi)(II) than issuer that sells or issues a Medicare supplemental policy to beneficiary without a disclosure statement Penalty for an 1990 25,000 44,539 issuer that sells or issues a Medicare supplemental policy without disclosure statement 1395ss(d) CMS Penalty for 1990 15,000 26,723 (3)(B) someone other (iv) than issuer that sells or issues a Medicare supplemental policy without acknowledgement form Penalty for 1990 25,000 44,539 issuer that sells or issues a Medicare supplemental policy without an acknowledgement form 1395ss(p) 42 CFR CMS Penalty for any 1990 15,000 26,723 (8) 402.1(c) person that sells (25), or issues 402.105 Medicare (e) supplemental polices after a given date that fail to conform to the NAIC or Federal standards established by statute 42 CFR CMS Penalty for any 1990 25,000 44,539 402.1(c) person that sells (25), or issues 405.105 Medicare (f)(2) supplemental polices after a given date that fail to conform to the NAIC or Federal standards established by statute 1395ss(p) 42 CFR CMS Penalty for any 1990 15,000 26,723 (9)(C) 402.1(c) person that sells (26), a Medicare 402.105 supplemental (e) 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 Penalty for any 1990 25,000 44,539 402.1(c) person that sells (26), a Medicare 405.105 supplemental (f)(3), policy and fails (4) 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) 42 CFR CMS Penalty for any 1990 25,000 44,539 (5)(C) 402.1(c) person that fails (27), to suspend the 405.105 policy of a (f)(5) 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) 42 CFR CMS Penalty for any 1990 25,000 44,539 (6)(A) 402.1(c) person that fails (28), to provide 405.105 refunds or (f)(6) credits as required by section 1882(r)(1)(B) 1395ss(s) 42 CFR CMS Penalty for any 1990 5,000 18,908 (4) 402.1(c) issuer of a (29), Medicare 405.105 supplemental (c) 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) 42 CFR CMS Penalty for any 1990 25,000 44,539 (2) 402.1(c) issuer of a (30), Medicare 405.105 supplemental (f)(7) policy that fails to fulfill listed responsibilities 1395ss(v) CMS Penalty someone 2003 15,000 19,284 (4)(A) other than issuer who sells, issues, or renews a medigap Rx policy to an individual who is a Part D enrollee Penalty for an 2003 25,000 32,140 issuer who sells, issues, or renews a Medigap Rx policy who is a Part D enrollee 1395bbb 42 CFR CMS Penalty for any 1987 2,000 4,126 (c)(1) 488.725 individual who (c) notifies or causes to be notified a home health agency of the time or date on which a survey of such agency is to be conducted 1395bbb 42 CFR CMS Maximum daily 1988 10,000 19,787 (f)(2)(A) 488.845 penalty amount (i) (b)(2) for each day a (iii); 42 home health CFR agency is not in 488.845 compliance with (b)(3)- statutory (6); and requirements 42 CFR 488.845 (d)(1) (ii) 42 CFR Penalty per day 488.845 for home health (b)(3) agency's noncompliance (Upper Range): Minimum 1988 8,500 16,819 Maximum 1988 10,000 19,787 42 CFR Penalty for a 1988 10,000 19,787 488.845 home health (b)(3)(i) agency's deficiency or deficiencies that cause immediate jeopardy and result in actual harm 42 CFR Penalty for a 1988 9,000 17,808 488.845 home health (b)(3) agency's (ii) deficiency or deficiencies that cause immediate jeopardy and result in potential for harm 42 CFR Penalty for an 1988 8,500 16,819 488.845 isolated incident (b)(3) of noncompliance (iii) in violation of established HHA policy 42 CFR Penalty for a 488.845 repeat and/or (b)(4) condition-level deficiency that does not constitute immediate jeopardy, but is directly related to poor quality patient care outcomes (Lower Range): Minimum 1988 1,500 2,968 Maximum 1988 8,500 16,819 42 CFR Penalty for a 488.845 repeat and/or (b)(5) condition-level deficiency that does not constitute immediate jeopardy and that is related predominately to structure or process-oriented conditions (Lower Range): Minimum 1988 500 989 Maximum 1988 4,000 7,915 42 CFR Penalty imposed 488.845 for instance of (b)(6) 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 1988 1,000 1,979 Maximum 1988 10,000 19,787 Penalty for each 1988 10,000 19,787 day of noncompliance (Maximum) 42 CFR Penalty for each 1988 10,000 19,787 488.845 day of (d)(1) noncompliance (ii) (Maximum) 1396b(m)( 42 CFR CMS Penalty for PACE 5)(B) 460.46 organization's practice that would reasonably be expected to have the effect of denying or discouraging enrollment: Minimum 1997 15,000 22,077 Maximum 1997 100,000 147,177 Penalty for a 1997 25,000 36,794 PACE organization that charges excessive premiums Penalty for a 1997 100,000 147,177 PACE organization misrepresenting or falsifying information to CMS, the State, or an individual or other entity Penalty for each 1997 25,000 36,794 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 1997 25,000 36,794 involuntarily disenrolling a participant Penalty for 1997 25,000 36,794 discriminating or discouraging enrollment or disenrollment of participants on the basis of an individual's health status or need for health care services 1396r(h) 42 CFR CMS Penalty per day (3)(C) 488.408 for a nursing (ii)(I) (d)(1) facility's (iii) failure to meet a Category 2 Certification: Minimum 1987 50 103 Maximum 1987 3,000 6,188 42 CFR CMS Penalty per 488.408 instance for a (d)(1) nursing (iv) facility's failure to meet Category 2 certification: Minimum 1987 1,000 2,063 Maximum 1987 10,000 20,628 42 CFR CMS Penalty per day 488.408 for a nursing (e)(1) facility's (iii) failure to meet Category 3 certification: Minimum 1987 3,050 6,291 Maximum 1987 10,000 20,628 42 CFR CMS Penalty per 2,063 488.408 instance for a (e)(1) nursing (iv) facility's failure to meet Category 3 certification: Minimum 1987 1,000 20,628 Maximum 1987 10,000 42 CFR CMS Penalty per 2,063 488.408 instance for a (e)(2) nursing (ii) facility's failure to meet Category 3 certification, which results in immediate jeopardy: Minimum 1987 1,000 20,628 Maximum 1987 10,000 42 CFR CMS Penalty per day 6,291 488.438 for nursing (a)(1)(i) facility's failure to meet certification (Upper Range): Minimum 1987 3,050 20,628 Maximum 1987 10,000 2,063 42 CFR CMS Penalty per day 488.438 for nursing (a)(1) facility's (ii) failure to meet certification (Lower Range): Minimum 1987 50 103 Maximum 1987 3,000 6,188 42 CFR CMS Penalty per 488.438 instance for (a)(2) nursing facility's failure to meet certification: Minimum 1987 1,000 2,063 Maximum 1987 10,000 20,628 1396r(f) 42 CFR CMS Grounds to 1987 5,000 10,314 (2)(B) 483.151 prohibit approval (iii)(I) (b)(2) of Nurse Aide (c) (iv) and Training (b)(3) Program--if (iii) assessed a penalty in 1819(h)(2)(B)(i) or 1919(h)(2)(A)(ii) of "not less than $5,000" [Not CMP authority, but a specific CMP amount (CMP at this level) that is the triggering condition for disapproval] 1396r(h) 42 CFR CMS Grounds to waive 1987 5,000 10,314 (3)(C) 483.151 disapproval of (ii)(I) (c)(2) 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) CMS Penalty for each (2)(C) day of noncompliance for a home or community care provider that no longer meets the minimum requirements for home and community care: Minimum 1990 1 2 Maximum 1990 10,000 17,816 1396u- 42 CFR CMS Penalty for a 1997 25,000 36,794 2(e)(2) 438.704 Medicaid managed (A)(i) care organization that fails substantially to provide medically necessary items and services Penalty for 1997 25,000 36,794 Medicaid managed care organization that imposes premiums or charges on enrollees in excess of the premiums or charges permitted Penalty for a 1997 25,000 36,794 Medicaid managed care organization that misrepresents or falsifies information to another individual or entity Penalty for a 1997 25,000 36,794 Medicaid managed care organization that fails to comply with the applicable statutory requirements for such organizations 1396u- 42 CFR CMS Penalty for a 1997 100,000 147,177 2(e)(2) 438.704 Medicaid managed (A)(ii) care organization that misrepresents or falsifies information to the HHS Secretary Penalty for 1997 100,000 147,177 Medicaid managed care organization that acts to discriminate among enrollees on the basis of their health status 1396u- 42 CFR CMS Penalty for each 1997 15,000 22,077 2(e)(2) 438.704 individual that (A)(iv) 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) 42 CFR CMS Penalty for a 1990 10,000 20,628 (2) 441, provider not 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- CMS Penalty for 2009 10,000 11,002 2(c)(1) disclosing information related to eligibility determinations for medical assistance programs 18041(c) 45 CFR CMS Failure to comply 1996 100 150 (2) 150.315; with requirements 45 CFR of the Public 156.805 Health Services (c) 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) 42 CFR CMS Penalty for 2010 25,000 27,186 (1)(A)(i) 155.285 providing false (II) information on Exchange application 18081(h) 42 CFR CMS Penalty for 2010 250,000 271,862 (1)(B) 155.285 knowingly or willfully providing false information on Exchange application 18081(h) 42 CFR CMS Penalty for 2010 25,000 27,186 155.260 knowingly or willfully disclosing protected information from Exchange 31 U.S.C.: 1352 45 CFR HHS Penalty for the 1989 10,000 18,936 93.400(e) 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 1989 10,000 18,936 Maximum 1989 100,000 189,361 Penalty for the 1989 10,000 18,936 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 1989 10,000 18,936 Maximum 1989 100,000 189,361 45 CFR HHS Penalty for 93, failure to Appendix provide A certification regarding lobbying in the award documents for all sub- awards of all tiers: Minimum 1989 10,000 18,936 Maximum 1989 100,000 189,361 Penalty for failure to provide statement regarding lobbying for loan guarantee and loan insurance transactions: Minimum 1989 10,000 18,936 Maximum 1989 100,000 189,361 3801-3812 45 CFR HHS Penalty against 1988 5,000 9,894 79.3(a) any individual (1)(iv) who--with knowledge or reason to know-- makes, presents or submits a false, fictitious or fraudulent claim to the Department 45 CFR Penalty against 1988 5,000 9,894 79.3(b) any individual (1(ii) who--with knowledge or reason to know-- makes, presents or submits a false, fictitious or fraudulent claim to the Department
PART 147--HEALTH INSURANCE REFORM REQUIREMENTS FOR THE GROUP AND INDIVIDUAL HEALTH INSURANCE MARKETS
33. The authority citation for part 147 continues to read as follows:
Authority: Secs. 2701 through 2763, 2791, and 2792 of the Public Health Service Act (42 U.S.C. 300gg through 300gg-63, 300gg-91, and 300gg-92), as amended.
34. Section 147.200(e) is amended by removing the phrase "not more than $1,000 for" and adding in its place the phrase "not more than $1,000 as adjusted annually under 45 CFR part 102 for".
PART 150--CMS ENFORCEMENT IN GROUP AND INDIVIDUAL INSURANCE MARKETS
35. The authority citation for part 150 continues to read as follows:
Authority: Secs. 2701 through 2763, 2791, and 2792 of the PHS Act (42 U.S.C. 300gg through 300gg-63, 300gg-91, and 300gg-92).
36. Section 150.315 is amended by removing the phrase "may not exceed $100 for" and adding in its place the phrase "may not exceed $100 as adjusted annually under 45 CFR part 102 for".
PART 155--EXCHANGE ESTABLISHMENT STANDARDS AND OTHER RELATED STANDARDS UNDER THE AFFORDABLE CARE ACT
37. The authority citation for part 155 continues to read as follows:
Authority: Title I of the Affordable Care Act, sections 1301, 1302, 1303, 1304, 1311, 1312, 1313, 1321, 1322, 1331, 1332, 1334, 1402, 1411, 1412, 1413, Pub. L. 111-148, 124 Stat. 119 (42 U.S.C. 18021-18024, 18031-18033, 18041-18042, 18051, 18054, 18071, and 18081-18083).
38. In
39. Amend
a. In paragraph (c)(1)(i), by removing the phrase "of $25,000 for" and adding in its place the phrase "of $25,000 as adjusted annually under 45 CFR part 102 for";
b. In paragraph (c)(1)(ii), removing the phrase "of $250,000 for" and adding in its place the phrase "of $250,000 as adjusted annually under 45 CFR part 102 for"; and
c. In paragraph (c)(2)(i), removing the phrase "not more than $25,000 per" and adding in its place the phrase "not more than $25,000 as adjusted annually under 45 CFR part 102 per".
PART 156--HEALTH INSURANCE ISSUER STANDARDS UNDER THE AFFORDABLE CARE ACT, INCLUDING STANDARDS RELATED TO EXCHANGES
40. The authority citation for part 156 continues to read as follows:
Authority: Title I of the Affordable Care Act, sections 1301-1304, 1311-1313, 1321-1322, 1324, 1334, 1342-1343, 1401-1402, Pub. L. 111-148, 124 Stat. 119 (42 U.S.C. 18021-18024, 18031-18032, 18041-18042, 18044, 18054, 18061, 18063, 18071, 18082, 26 U.S.C. 36B, and 31 U.S.C. 9701).
41. In
PART 158--ISSUER USE OF PREMIUM REVENUE: REPORTING AND REBATE REQUIREMENTS
42. The authority citation for part 158 continues to read as follows:
Authority: Section 2718 of the Public Health Service Act (42 U.S.C. 300gg-18), as amended.
43. Section 158.606 is amended by removing the phrase "may not exceed $100 for" and adding in its place the phrase "may not exceed $100 as adjusted annually under 45 CFR part 102 for".
PART 160--GENERAL ADMINISTRATIVE REQUIREMENTS
44. The authority for part 160 continues to read as follows:
Authority: 42 U.S.C. 1302(a); 42 U.S.C. 1320d-1320d-9; sec. 264, Pub. L. 104-191, 110 Stat. 2033-2034 (42 U.S.C. 1320d-2 (note)); 5 U.S.C. 552; secs. 13400-13424, Pub. L. 111-5, 123 Stat. 258-279; and sec. 1104 of Pub. L. 111-148, 124 Stat. 146-154.
45. Section 160.404 is amended by revising paragraph (a) to read as follows:
(a) The amount of a civil money penalty will be determined in accordance with paragraph (b) of this section, and SUBSEC 160.406, 160.408, and 160.412. These amounts were adjusted in accordance with the Federal Civil Monetary Penalty Inflation Adjustment Act of 1990, (Pub. L. 101-140), as amended by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015, (section 701 of Pub. L. 114-74), and appear at 45 CFR part 102. These amounts will be updated annually and published at 45 CFR part 102.
* * * * *
Subtitle B--Regulations Related to Public Welfare
Chapter II--Office of Family Assistance (Assistance Programs), Administration for Children and Families,
PART 303--STANDARDS FOR PROGRAM OPERATIONS
46. The authority citation for part 303 continues to read as follows:
Authority: 42 U.S.C. 651 through 658, 659a, 660, 663, 664, 666, 667, 1302, 1396a(a)(25), 1396b(d)(2), 1396b(o), 1396b(p), and 1396(k).
47. Section 303.21 is amended by revising paragraph (f) to read as follows:
* * * * *
(f) Penalties for unauthorized disclosure. Any disclosure or use of confidential information in violation of 42 U.S.C. 653(l)(2) and implementing regulations shall be subject to:
(1) Any State and Federal statutes that impose legal sanctions for such disclosure; and
(2) The maximum civil monetary penalties associated with the statutory provisions authorizing civil monetary penalties under 42 U.S.C. 653(l)(2) as shown in the table at 45 CFR 102.3.
Dated: July 21, 2016.
Secretary,
[FR Doc. 2016-18680 Filed 9-2-16; 8:45 am]
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