42 U.S.C. § 1395ddd — Medicare Integrity Program

Page 3968 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395ddd Pub. L. 100–360, title IV, § 411(f)(10)(C)(iii), July 1, 1988, 102 Stat. 781, provided that: ‘‘The Amendments made by this subparagraph [amending this section and former section 294f of this title] shall be effective 30 days after the date of the enactment of this Act [July 1, 1988].’’ EFFECTIVE DATE Pub. L. 100–203, title IV, § 4052(c), Dec. 22, 1987, 101 Stat. 1330–97, provided that: ‘‘The amendments made by this section [enacting this section and amending sec- tion 254o of this title] shall be effective on the date of the enactment of this Act [Dec. 22, 1987].’’ § 1395ddd. Medicare Integrity Program (a) Establishment of Program There is hereby established the Medicare In- tegrity Program (in this section referred to as the ‘‘Program’’) under which the Secretary shall promote the integrity of the medicare program by entering into contracts in accordance with this section with eligible entities, or otherwise, to carry out the activities described in sub- section (b). (b) Activities described The activities described in this subsection are as follows: (1) Review of activities of providers of serv- ices or other individuals and entities fur- nishing items and services for which payment may be made under this subchapter (including skilled nursing facilities and home health agencies), including medical and utilization review and fraud review (employing similar standards, processes, and technologies used by private health plans, including equipment and software technologies which surpass the capa- bility of the equipment and technologies used in the review of claims under this subchapter as of August 21, 1996). (2) Audit of cost reports. (3) Determinations as to whether payment should not be, or should not have been, made under this subchapter by reason of section 1395y(b) of this title, and recovery of payments that should not have been made. (4) Education of providers of services, bene- ficiaries, and other persons with respect to payment integrity and benefit quality assur- ance issues. (5) Developing (and periodically updating) a list of items of durable medical equipment in accordance with section 1395m(a)(15) of this title which are subject to prior authorization under such section. (6) The Medicare-Medicaid Data Match Pro- gram in accordance with subsection (g). (c) Eligibility of entities An entity is eligible to enter into a contract under the Program to carry out any of the ac- tivities described in subsection (b) if— (1) the entity has demonstrated capability to carry out such activities; (2) in carrying out such activities, the entity agrees to cooperate with the Inspector General of the Department of Health and Human Serv- ices, the Attorney General, and other law en- forcement agencies, as appropriate, in the in- vestigation and deterrence of fraud and abuse in relation to this subchapter and in other cases arising out of such activities; (3) the entity complies with such conflict of interest standards as are generally applicable to Federal acquisition and procurement; (4) the entity agrees to provide the Sec- retary and the Inspector General of the De- partment of Health and Human Services with such performance statistics (including the number and amount of overpayments recov- ered, the number of fraud referrals, and the re- turn on investment of such activities by the entity) as the Secretary or the Inspector Gen- eral may request; and (5) the entity meets such other requirements as the Secretary may impose. In the case of the activity described in sub- section (b)(5), an entity shall be deemed to be el- igible to enter into a contract under the Pro- gram to carry out the activity if the entity is a carrier with a contract in effect under section 1395u of this title. (d) Process for entering into contracts The Secretary shall enter into contracts under the Program in accordance with such procedures as the Secretary shall by regulation establish, except that such procedures shall include the following: (1) Procedures for identifying, evaluating, and resolving organizational conflicts of inter- est that are generally applicable to Federal acquisition and procurement. (2) Competitive procedures to be used— (A) when entering into new contracts under this section; (B) when entering into contracts that may result in the elimination of responsibilities of an individual fiscal intermediary or car- rier under section 202(b) of the Health Insur- ance Portability and Accountability Act of 1996; and (C) at any other time considered appro- priate by the Secretary, except that the Secretary may continue to contract with entities that are carrying out the activities described in this section pursu- ant to agreements under section 1395h of this title or contracts under section 1395u of this title in effect on August 21, 1996. (3) Procedures under which a contract under this section may be renewed without regard to any provision of law requiring competition if the contractor has met or exceeded the per- formance requirements established in the cur- rent contract. The Secretary may enter into such contracts without regard to final rules having been pro- mulgated. (e) Limitation on contractor liability The Secretary shall by regulation provide for the limitation of a contractor’s liability for ac- tions taken to carry out a contract under the Program, and such regulation shall, to the ex- tent the Secretary finds appropriate, employ the same or comparable standards and other sub- stantive and procedural provisions as are con- tained in section 1320c–6 of this title. Page 3969 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395ddd (f) Recovery of overpayments (1) Use of repayment plans (A) In general If the repayment, within 30 days by a pro- vider of services or supplier, of an overpay- ment under this subchapter would constitute a hardship (as described in subparagraph (B)), subject to subparagraph (C), upon re- quest of the provider of services or supplier the Secretary shall enter into a plan with the provider of services or supplier for the repayment (through offset or otherwise) of such overpayment over a period of at least 6 months but not longer than 3 years (or not longer than 5 years in the case of extreme hardship, as determined by the Secretary). Interest shall accrue on the balance through the period of repayment. Such plan shall meet terms and conditions determined to be appropriate by the Secretary. (B) Hardship (i) In general For purposes of subparagraph (A), the re- payment of an overpayment (or overpay- ments) within 30 days is deemed to con- stitute a hardship if— (I) in the case of a provider of services that files cost reports, the aggregate amount of the overpayments exceeds 10 percent of the amount paid under this subchapter to the provider of services for the cost reporting period covered by the most recently submitted cost report; or (II) in the case of another provider of services or supplier, the aggregate amount of the overpayments exceeds 10 percent of the amount paid under this subchapter to the provider of services or supplier for the previous calendar year. (ii) Rule of application The Secretary shall establish rules for the application of this subparagraph in the case of a provider of services or supplier that was not paid under this subchapter during the previous year or was paid under this subchapter only during a portion of that year. (iii) Treatment of previous overpayments If a provider of services or supplier has entered into a repayment plan under sub- paragraph (A) with respect to a specific overpayment amount, such payment amount under the repayment plan shall not be taken into account under clause (i) with respect to subsequent overpayment amounts. (C) Exceptions Subparagraph (A) shall not apply if— (i) the Secretary has reason to suspect that the provider of services or supplier may file for bankruptcy or otherwise cease to do business or discontinue participation in the program under this subchapter; or (ii) there is an indication of fraud or abuse committed against the program. (D) Immediate collection if violation of re- payment plan If a provider of services or supplier fails to make a payment in accordance with a repay- ment plan under this paragraph, the Sec- retary may immediately seek to offset or otherwise recover the total balance out- standing (including applicable interest) under the repayment plan. (E) Relation to no fault provision Nothing in this paragraph shall be con- strued as affecting the application of section 1395gg(c) of this title (relating to no adjust- ment in the cases of certain overpayments). (2) Limitation on recoupment (A) In general In the case of a provider of services or sup- plier that is determined to have received an overpayment under this subchapter and that seeks a reconsideration by a qualified inde- pendent contractor on such determination under section 1395ff(b)(1) of this title, the Secretary may not take any action (or au- thorize any other person, including any medicare contractor, as defined in subpara- graph (C)) to recoup the overpayment until the date the decision on the reconsideration has been rendered. If the provisions of sec- tion 1395ff(b)(1) of this title (providing for such a reconsideration by a qualified inde- pendent contractor) are not in effect, in ap- plying the previous sentence any reference to such a reconsideration shall be treated as a reference to a redetermination by the fis- cal intermediary or carrier involved. (B) Collection with interest Insofar as the determination on such ap- peal is against the provider of services or supplier, interest on the overpayment shall accrue on and after the date of the original notice of overpayment. Insofar as such de- termination against the provider of services or supplier is later reversed, the Secretary shall provide for repayment of the amount recouped plus interest at the same rate as would apply under the previous sentence for the period in which the amount was re- couped. (C) Medicare contractor defined For purposes of this subsection, the term ‘‘medicare contractor’’ has the meaning given such term in section 1395zz(g) of this title. (3) Limitation on use of extrapolation A medicare contractor may not use extrapo- lation to determine overpayment amounts to be recovered by recoupment, offset, or other- wise unless the Secretary determines that— (A) there is a sustained or high level of payment error; or (B) documented educational intervention has failed to correct the payment error. There shall be no administrative or judicial review under section 1395ff of this title, sec- tion 1395oo of this title, or otherwise, of deter- minations by the Secretary of sustained or high levels of payment errors under this para- graph. (4) Provision of supporting documentation In the case of a provider of services or sup- plier with respect to which amounts were pre- Page 3970 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395ddd viously overpaid, a medicare contractor may request the periodic production of records or supporting documentation for a limited sam- ple of submitted claims to ensure that the pre- vious practice is not continuing. (5) Consent settlement reforms (A) In general The Secretary may use a consent settle- ment (as defined in subparagraph (D)) to set- tle a projected overpayment. (B) Opportunity to submit additional infor- mation before consent settlement offer Before offering a provider of services or supplier a consent settlement, the Secretary shall— (i) communicate to the provider of serv- ices or supplier— (I) that, based on a review of the med- ical records requested by the Secretary, a preliminary evaluation of those records indicates that there would be an overpayment; (II) the nature of the problems identi- fied in such evaluation; and (III) the steps that the provider of serv- ices or supplier should take to address the problems; and (ii) provide for a 45-day period during which the provider of services or supplier may furnish additional information con- cerning the medical records for the claims that had been reviewed. (C) Consent settlement offer The Secretary shall review any additional information furnished by the provider of services or supplier under subparagraph (B)(ii). Taking into consideration such infor- mation, the Secretary shall determine if there still appears to be an overpayment. If so, the Secretary— (i) shall provide notice of such deter- mination to the provider of services or supplier, including an explanation of the reason for such determination; and (ii) in order to resolve the overpayment, may offer the provider of services or sup- plier— (I) the opportunity for a statistically valid random sample; or (II) a consent settlement. The opportunity provided under clause (ii)(I) does not waive any appeal rights with re- spect to the alleged overpayment involved. (D) Consent settlement defined For purposes of this paragraph, the term ‘‘consent settlement’’ means an agreement between the Secretary and a provider of services or supplier whereby both parties agree to settle a projected overpayment based on less than a statistically valid sam- ple of claims and the provider of services or supplier agrees not to appeal the claims in- volved. (6) Notice of over-utilization of codes The Secretary shall establish, in consulta- tion with organizations representing the class- es of providers of services and suppliers, a process under which the Secretary provides for notice to classes of providers of services and suppliers served by the contractor in cases in which the contractor has identified that par- ticular billing codes may be overutilized by that class of providers of services or suppliers under the programs under this subchapter (or provisions of subchapter XI insofar as they re- late to such programs). (7) Payment audits (A) Written notice for post-payment audits Subject to subparagraph (C), if a medicare contractor decides to conduct a post-pay- ment audit of a provider of services or sup- plier under this subchapter, the contractor shall provide the provider of services or sup- plier with written notice (which may be in electronic form) of the intent to conduct such an audit. (B) Explanation of findings for all audits Subject to subparagraph (C), if a medicare contractor audits a provider of services or supplier under this subchapter, the con- tractor shall— (i) give the provider of services or sup- plier a full review and explanation of the findings of the audit in a manner that is understandable to the provider of services or supplier and permits the development of an appropriate corrective action plan; (ii) inform the provider of services or supplier of the appeal rights under this subchapter as well as consent settlement options (which are at the discretion of the Secretary); (iii) give the provider of services or sup- plier an opportunity to provide additional information to the contractor; and (iv) take into account information pro- vided, on a timely basis, by the provider of services or supplier under clause (iii). (C) Exception Subparagraphs (A) and (B) shall not apply if the provision of notice or findings would compromise pending law enforcement activi- ties, whether civil or criminal, or reveal findings of law enforcement-related audits. (8) Standard methodology for probe sampling The Secretary shall establish a standard methodology for medicare contractors to use in selecting a sample of claims for review in the case of an abnormal billing pattern. (g) Medicare-Medicaid Data Match Program (1) Expansion of Program (A) In general The Secretary shall enter into contracts with eligible entities or otherwise for the purpose of ensuring that, beginning with 2006, the Medicare-Medicaid Data Match Program (commonly referred to as the ‘‘Medi-Medi Program’’) is conducted with re- spect to the program established under this subchapter and State Medicaid programs under subchapter XIX for the purpose of— (i) identifying program vulnerabilities in the program established under this sub- Page 3971 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395ddd chapter and the Medicaid program estab- lished under subchapter XIX through the use of computer algorithms to review claims data to look for payment anomalies (including billing or billing patterns iden- tified with respect to provider, service, time, or patient that appear to be suspect or otherwise implausible); (ii) working with States, the Attorney General, and the Inspector General of the Department of Health and Human Services to coordinate appropriate actions to inves- tigate and recover amounts with respect to suspect claims to protect the Federal and State share of expenditures under the Med- icaid program under subchapter XIX, as well as the program established under this subchapter; (iii) increasing the effectiveness and effi- ciency of both such programs through cost avoidance, savings, and recoupments of fraudulent, wasteful, or abusive expendi- tures; and (iv) furthering the Secretary’s design, development, installation, or enhancement of an automated data system architec- ture— (I) to collect, integrate, and assess data for purposes of program integrity, program oversight, and administration, including the Medi-Medi Program; and (II) that improves the coordination of requests for data from States. (B) Reporting requirements The Secretary shall make available in a timely manner any data and statistical in- formation collected by the Medi-Medi Pro- gram to the Attorney General, the Director of the Federal Bureau of Investigation, the Inspector General of the Department of Health and Human Services, and the States (including a Medicaid fraud and abuse con- trol unit described in section 1396b(q) of this title). Such information shall be dissemi- nated no less frequently than quarterly. (2) Limited waiver authority The Secretary shall waive only such require- ments of this section and of subchapters XI and XIX as are necessary to carry out para- graph (1). (3) Incentives for States The Secretary shall study and, as appro- priate, may specify incentives for States to work with the Secretary for the purposes de- scribed in paragraph (1)(A)(ii). The application of the previous sentence may include use of the waiver authority described in paragraph (2). (h) Use of recovery audit contractors (1) In general Under the Program, the Secretary shall enter into contracts with recovery audit con- tractors in accordance with this subsection for the purpose of identifying underpayments and overpayments and recouping overpayments under this subchapter with respect to all serv- ices for which payment is made under this subchapter. Under the contracts— (A) payment shall be made to such a con- tractor only from amounts recovered; (B) from such amounts recovered, pay- ment— (i) shall be made on a contingent basis for collecting overpayments; and (ii) may be made in such amounts as the Secretary may specify for identifying un- derpayments; and (C) the Secretary shall retain a portion of the amounts recovered which shall be avail- able to the program management account of the Centers for Medicare & Medicaid Serv- ices for purposes of activities conducted under the recovery audit program under this subsection. (2) Disposition of remaining recoveries The amounts recovered under such contracts that are not paid to the contractor under para- graph (1) or retained by the Secretary under paragraph (1)(C) or paragraph (10) shall be ap- plied to reduce expenditures under this sub- chapter. (3) Nationwide coverage The Secretary shall enter into contracts under paragraph (1) in a manner so as to pro- vide for activities in all States under such a contract by not later than January 1, 2010 (not later than December 31, 2010, in the case of contracts relating to payments made under part C or D). (4) Audit and recovery periods Each such contract shall provide that audit and recovery activities may be conducted dur- ing a fiscal year with respect to payments made under this subchapter— (A) during such fiscal year; and (B) retrospectively (for a period of not more than 4 fiscal years prior to such fiscal year). (5) Waiver The Secretary shall waive such provisions of this subchapter as may be necessary to pro- vide for payment of recovery audit contractors under this subsection in accordance with para- graph (1). (6) Qualifications of contractors (A) In general The Secretary may not enter into a con- tract under paragraph (1) with a recovery audit contractor unless the contractor has staff that has the appropriate clinical knowledge of, and experience with, the pay- ment rules and regulations under this sub- chapter or the contractor has, or will con- tract with, another entity that has such knowledgeable and experienced staff. (B) Ineligibility of certain contractors The Secretary may not enter into a con- tract under paragraph (1) with a recovery audit contractor to the extent the con- tractor is a fiscal intermediary under sec- tion 1395h of this title, a carrier under sec- tion 1395u of this title, or a medicare admin- istrative contractor under section 1395kk–1 of this title. Page 3972 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395ddd 1 See References in Text note below. (C) Preference for entities with dem- onstrated proficiency In awarding contracts to recovery audit contractors under paragraph (1), the Sec- retary shall give preference to those risk en- tities that the Secretary determines have demonstrated more than 3 years direct man- agement experience and a proficiency for cost control or recovery audits with private insurers, health care providers, health plans, under the Medicaid program under sub- chapter XIX, or under this subchapter. (7) Construction relating to conduct of inves- tigation of fraud A recovery of an overpayment to a indi- vidual or entity by a recovery audit con- tractor under this subsection shall not be con- strued to prohibit the Secretary or the Attor- ney General from investigating and pros- ecuting, if appropriate, allegations of fraud or abuse arising from such overpayment. (8) Annual report The Secretary shall annually submit to Con- gress a report on the use of recovery audit contractors under this subsection. Each such report shall include information on the per- formance of such contractors in identifying underpayments and overpayments and recoup- ing overpayments, including an evaluation of the comparative performance of such contrac- tors and savings to the program under this subchapter. (9) Special rules relating to parts C and D The Secretary shall enter into contracts under paragraph (1) to require recovery audit contractors to— (A) ensure that each MA plan under part C has an anti-fraud plan in effect and to re- view the effectiveness of each such anti- fraud plan; (B) ensure that each prescription drug plan under part D has an anti-fraud plan in effect and to review the effectiveness of each such anti-fraud plan; (C) examine claims for reinsurance pay- ments under section 1395w–115(b) of this title to determine whether prescription drug plans submitting such claims incurred costs in excess of the allowable reinsurance costs permitted under paragraph (2) of that sec- tion; and (D) review estimates submitted by pre- scription drug plans by private plans with respect to the enrollment of high cost bene- ficiaries (as defined by the Secretary) and to compare such estimates with the numbers of such beneficiaries actually enrolled by such plans. (10) Use of certain recovered funds (A) In general After application of paragraph (1)(C), the Secretary shall retain a portion of the amounts recovered by recovery audit con- tractors for each year under this section which shall be available to the program management account of the Centers for Medicare & Medicaid Services for purposes of, subject to subparagraph (B), carrying out sections 1395l(z),1 1395m(l)(16), and 1395kk–1(a)(4)(G) of this title, carrying out section 514(b) of the Medicare Access and CHIP Reauthorization Act of 2015, and im- plementing strategies (such as claims proc- essing edits) to help reduce the error rate of payments under this subchapter. The amounts retained under the preceding sen- tence shall not exceed an amount equal to 15 percent of the amounts recovered under this subsection, and shall remain available until expended. (B) Limitation Except for uses that support claims proc- essing (including edits) or system functionality for detecting fraud, amounts retained under subparagraph (A) may not be used for technological-related infrastruc- ture, capital investments, or information systems. (C) No reduction in payments to recovery audit contractors Nothing in subparagraph (A) shall reduce amounts available for payments to recovery audit contractors under this subsection. (i) Evaluations and annual report (1) Evaluations The Secretary shall conduct evaluations of eligible entities which the Secretary contracts with under the Program not less frequently than every 3 years. (2) Annual report Not later than 180 days after the end of each fiscal year (beginning with fiscal year 2011), the Secretary shall submit a report to Con- gress which identifies— (A) the use of funds, including funds trans- ferred from the Federal Hospital Insurance Trust Fund under section 1395i of this title and the Federal Supplementary Insurance Trust Fund under section 1395t of this title, to carry out this section; and (B) the effectiveness of the use of such funds. (j) Expanding activities of Medicare drug integ- rity contractors (MEDICs) (1) Access to information Under contracts entered into under this sec- tion with Medicare drug integrity contractors (including any successor entity to a Medicare drug integrity contractor), the Secretary shall authorize such contractors to directly accept prescription and necessary medical records from entities such as pharmacies, prescription drug plans, MA–PD plans, and physicians with respect to an individual in order for such con- tractors to provide information relevant to the determination of whether such individual is an at-risk beneficiary for prescription drug abuse, as defined in section 1395w–104(c)(5)(C) of this title. (2) Requirement for acknowledgment of refer- rals If a PDP sponsor or MA organization refers information to a contractor described in para- Page 3973 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395ddd 2 So in original. The word ‘‘shall’’ probably should not appear. graph (1) in order for such contractor to assist in the determination described in such para- graph, the contractor shall— (A) acknowledge to the sponsor or organi- zation receipt of the referral; and (B) in the case that any PDP sponsor or MA organization contacts the contractor re- questing to know the determination by the contractor of whether or not an individual has been determined to be an individual de- scribed in such paragraph, shall 2 inform such sponsor or organization of such deter- mination on a date that is not later than 15 days after the date on which the sponsor or organization contacts the contractor. (3) Making data available to other entities (A) In general For purposes of carrying out this sub- section, subject to subparagraph (B), the Secretary shall authorize MEDICs to re- spond to requests for information from PDP sponsors and MA organizations, State pre- scription drug monitoring programs, and other entities delegated by such sponsors or organizations using available programs and systems in the effort to prevent fraud, waste, and abuse. (B) HIPAA compliant information only Information may only be disclosed by a MEDIC under subparagraph (A) if the disclo- sure of such information is permitted under the Federal regulations (concerning the pri- vacy of individually identifiable health in- formation) promulgated under section 264(c) of the Health Insurance Portability and Ac- countability Act of 1996 (42 U.S.C. 1320d–2 note). (Aug. 14, 1935, ch. 531, title XVIII, § 1893, as added Pub. L. 104–191, title II, § 202(a), Aug. 21, 1996, 110 Stat. 1996; amended Pub. L. 108–173, title VII, § 736(c)(7), title IX, § 935(a), Dec. 8, 2003, 117 Stat. 2356, 2407; Pub. L. 109–171, title VI, § 6034(d)(1), Feb. 8, 2006, 120 Stat. 77; Pub. L. 109–432, div. B, title III, § 302(a), Dec. 20, 2006, 120 Stat. 2991; Pub. L. 111–148, title VI, §§ 6402(j)(1), 6411(b), Mar. 23, 2010, 124 Stat. 762, 775; Pub. L. 114–10, title V, §§ 505(b), 510, Apr. 16, 2015, 129 Stat. 167, 170; Pub. L. 114–115, § 9(b), Dec. 28, 2015, 129 Stat. 3135; Pub. L. 114–198, title VII, § 704(c)(1), July 22, 2016, 130 Stat. 749.) Editorial Notes REFERENCES IN TEXT Section 202(b) of the Health Insurance Portability and Accountability Act of 1996, referred to in subsec. (d)(2)(B), is section 202(b) of Pub. L. 104–191, which amended sections 1395h and 1395u of this title. Section 1395l(z) of this title, referred to in subsec. (h)(10)(A), probably means the subsec. (z) of section 1395l of this title which relates to medical review of spi- nal subluxation services, was added by Pub. L. 114–10, title V, § 514(a), Apr. 16, 2015, 129 Stat. 171, and was re- designated subsec. (aa) by Pub. L. 115–271, title VI, § 6083(b)(1), Oct. 24, 2018, 132 Stat. 3994. Section 514(b) of the Medicare Access and CHIP Reau- thorization Act of 2015, referred to in subsec. (h)(10)(A), is section 514(b) of Pub. L. 114–10, which is set out as a note under section 1395l of this title. Section 264(c) of the Health Insurance Portability and Accountability Act of 1996, referred to in subsec. (j)(3)(B), is section 264(c) of Pub. L. 104–191, title II, Aug. 21, 1996, 110 Stat. 2033, which is set out as a note under section 1320d–2 of this title. AMENDMENTS 2016—Subsec. (j). Pub. L. 114–198 added subsec. (j). 2015—Subsec. (g)(1)(A). Pub. L. 114–115, § 9(b)(1), in- serted ‘‘or otherwise’’ after ‘‘eligible entities’’ in intro- ductory provisions. Subsec. (g)(1)(A)(i). Pub. L. 114–115, § 9(b)(2), inserted ‘‘to review claims data’’ after ‘‘algorithms’’ and sub- stituted ‘‘provider, service, time, or patient’’ for ‘‘serv- ice, time, or patient’’. Subsec. (g)(1)(A)(ii). Pub. L. 114–115, § 9(b)(3)(A), in- serted ‘‘to investigate and recover amounts with re- spect to suspect claims’’ after ‘‘appropriate actions’’. Subsec. (g)(1)(A)(iv). Pub. L. 114–115, § 9(b)(3)(B)–(5), added cl. (iv). Subsec. (g)(3). Pub. L. 114–10, § 510, added par. (3). Subsec. (h)(2). Pub. L. 114–10, § 505(b)(1), inserted ‘‘or paragraph (10)’’ after ‘‘paragraph (1)(C)’’. Subsec. (h)(10). Pub. L. 114–10, § 505(b)(2), added par. (10). 2010—Subsec. (a). Pub. L. 111–148, § 6402(j)(1)(C), in- serted ‘‘, or otherwise,’’ after ‘‘entities’’. Subsec. (c)(4), (5). Pub. L. 111–148, § 6402(j)(1)(A), added par. (4) and redesignated former par. (4) as (5). Subsec. (h)(1). Pub. L. 111–148, § 6411(b)(1), substituted ‘‘this subchapter’’ for ‘‘part A or B’’ in introductory provisions. Subsec. (h)(2). Pub. L. 111–148, § 6411(b)(2), substituted ‘‘this subchapter’’ for ‘‘parts A and B’’. Subsec. (h)(3). Pub. L. 111–148, § 6411(b)(3), inserted ‘‘(not later than December 31, 2010, in the case of con- tracts relating to payments made under part C or D)’’ after ‘‘2010’’. Subsec. (h)(4). Pub. L. 111–148, § 6411(b)(4), substituted ‘‘this subchapter’’ for ‘‘part A or B’’ in introductory provisions. Subsec. (h)(9). Pub. L. 111–148, § 6411(b)(5), added par. (9). Subsec. (i). Pub. L. 111–148, § 6402(j)(1)(B), added sub- sec. (i). 2006—Subsec. (b)(6). Pub. L. 109–171, § 6034(d)(1)(A), added par. (6). Subsec. (g). Pub. L. 109–171, § 6034(d)(1)(B), added sub- sec. (g). Subsec. (h). Pub. L. 109–432 added subsec. (h). 2003—Subsec. (a). Pub. L. 108–173, § 736(c)(7), sub- stituted ‘‘medicare program’’ for ‘‘Medicare program’’. Subsec. (f). Pub. L. 108–173, § 935(a), added subsec. (f). Statutory Notes and Related Subsidiaries EFFECTIVE DATE OF 2016 AMENDMENT Amendment by Pub. L. 114–198 applicable to prescrip- tion drug plans (and MA–PD plans) for plan years be- ginning on or after Jan. 1, 2019, see section 704(g)(1) of Pub. L. 114–198, set out as a note under section 1395w–101 of this title. EFFECTIVE DATE OF 2003 AMENDMENT Pub. L. 108–173, title IX, § 935(b), Dec. 8, 2003, 117 Stat. 2411, provided that: ‘‘(1) USE OF REPAYMENT PLANS.—Section 1893(f)(1) of the Social Security Act [42 U.S.C. 1395ddd(f)(1)], as added by subsection (a), shall apply to requests for re- payment plans made after the date of the enactment of this Act [Dec. 8, 2003]. ‘‘(2) LIMITATION ON RECOUPMENT.—Section 1893(f)(2) of the Social Security Act [42 U.S.C. 1395ddd(f)(2)], as added by subsection (a), shall apply to actions taken after the date of the enactment of this Act. ‘‘(3) USE OF EXTRAPOLATION.—Section 1893(f)(3) of the Social Security Act [42 U.S.C. 1395ddd(f)(3)], as added by subsection (a), shall apply to statistically valid random samples initiated after the date that is 1 year after the date of the enactment of this Act. Page 3974 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395eee ‘‘(4) PROVISION OF SUPPORTING DOCUMENTATION.—Sec- tion 1893(f)(4) of the Social Security Act [42 U.S.C. 1395ddd(f)(4)], as added by subsection (a), shall take ef- fect on the date of the enactment of this Act. ‘‘(5) CONSENT SETTLEMENT.—Section 1893(f)(5) of the Social Security Act [42 U.S.C. 1395ddd(f)(5)], as added by subsection (a), shall apply to consent settlements en- tered into after the date of the enactment of this Act. ‘‘(6) NOTICE OF OVERUTILIZATION.—Not later than 1 year after the date of the enactment of this Act, the Secretary [of Health and Human Services] shall first establish the process for notice of overutilization of billing codes under section 1893A(f)(6) [1893(f)(6)] of the Social Security Act [probably means 42 U.S.C. 1395ddd(f)(6)], as added by subsection (a). ‘‘(7) PAYMENT AUDITS.—Section 1893A(f)(7) [1893(f)(7)] of the Social Security Act [probably means 42 U.S.C. 1395ddd(f)(7)], as added by subsection (a), shall apply to audits initiated after the date of the enactment of this Act. ‘‘(8) STANDARD FOR ABNORMAL BILLING PATTERNS.—Not later than 1 year after the date of the enactment of this Act, the Secretary shall first establish a standard methodology for selection of sample claims for abnor- mal billing patterns under section 1893(f)(8) of the So- cial Security Act [42 U.S.C. 1395ddd(f)(8)], as added by subsection (a).’’ IMPROVING THE SHARING OF DATA BETWEEN THE FED- ERAL GOVERNMENT AND STATE MEDICAID PROGRAMS Pub. L. 114–115, § 9, Dec. 28, 2015, 129 Stat. 3135, pro- vided that: ‘‘(a) IN GENERAL.—The Secretary of Health and Human Services (in this section referred to as the ‘Sec- retary’) shall establish a plan to encourage and facili- tate the participation of States in the Medicare-Med- icaid Data Match Program (commonly referred to as the ‘Medi-Medi Program’) under section 1893(g) of the Social Security Act (42 U.S.C. 1395ddd(g)). ‘‘(b) PROGRAM REVISIONS TO IMPROVE MEDI-MEDI DATA MATCH PROGRAM PARTICIPATION BY STATES.— [Amended this section.] ‘‘(c) PROVIDING STATES WITH DATA ON IMPROPER PAY- MENTS MADE FOR ITEMS OR SERVICES PROVIDED TO DUAL ELIGIBLE INDIVIDUALS.— ‘‘(1) IN GENERAL.—The Secretary shall develop and implement a plan that allows each State agency re- sponsible for administering a State plan for medical assistance under title XIX of the Social Security Act [42 U.S.C. 1396 et seq.] access to relevant data on im- proper or fraudulent payments made under the Medi- care program under title XVIII of the Social Security Act (42 U.S.C. 1395 et seq.) for health care items or services provided to dual eligible individuals. ‘‘(2) DUAL ELIGIBLE INDIVIDUAL DEFINED.—In this section, the term ‘dual eligible individual’ means an individual who is entitled to, or enrolled for, benefits under part A of title XVIII of the Social Security Act (42 U.S.C. 1395c et seq.), or enrolled for benefits under part B of title XVIII of such Act (42 U.S.C. 1395j et seq.), and is eligible for medical assistance under a State plan under title XIX of such Act (42 U.S.C. 1396 et seq.) or under a waiver of such plan.’’ EXTENSION OF TWO-MIDNIGHT RULE Pub. L. 113–93, title I, § 111, Apr. 1, 2014, 128 Stat. 1044, as amended by Pub. L. 114–10, title V, § 521, Apr. 16, 2015, 129 Stat. 176, provided that: ‘‘(a) CONTINUATION OF CERTAIN MEDICAL REVIEW AC- TIVITIES.—The Secretary of Health and Human Services may continue medical review activities described in the notice entitled ‘Selecting Hospital Claims for Pa- tient Status Reviews: Admissions On or After October 1, 2013’, posted on the Internet website of the Centers for Medicare & Medicaid Services, through through [sic] the end of fiscal year 2015 for such additional hos- pital claims as the Secretary determines appropriate. ‘‘(b) LIMITATION.—The Secretary of Health and Human Services shall not conduct patient status re- views (as described in such notice) on a post-payment review basis through recovery audit contractors under section 1893(h) of the Social Security Act (42 U.S.C. 1395ddd(h)) for inpatient claims with dates of admission October 1, 2013, through September 30, 2015, unless there is evidence of systematic gaming, fraud, abuse, or delays in the provision of care by a provider of services (as defined in section 1861(u) of such Act (42 U.S.C. 1395x(u))). ‘‘(c) CONSTRUCTION.—Except as provided in sub- sections (a) and (b), nothing in this section shall be construed as limiting the Secretary’s authority to pur- sue fraud and abuse activities under such section 1893(h) or otherwise.’’ ACCESS TO COORDINATION OF BENEFITS CONTRACTOR DATABASE Pub. L. 109–432, div. B, title III, § 302(b), Dec. 20, 2006, 120 Stat. 2992, provided that: ‘‘The Secretary of Health and Human Services shall provide for access by recov- ery audit contractors conducting audit and recovery activities under section 1893(h) of the Social Security Act [42 U.S.C. 1395ddd(h)], as added by subsection (a), to the database of the Coordination of Benefits Contractor of the Centers for Medicare & Medicaid Services with respect to the audit and recovery periods described in paragraph (4) of such section 1893(h).’’ § 1395eee. Payments to, and coverage of benefits under, programs of all-inclusive care for el- derly (PACE) (a) Receipt of benefits through enrollment in PACE program; definitions for PACE pro- gram related terms (1) Benefits through enrollment in a PACE pro- gram In accordance with this section, in the case of an individual who is entitled to benefits under part A or enrolled under part B and who is a PACE program eligible individual (as de- fined in paragraph (5)) with respect to a PACE program offered by a PACE provider under a PACE program agreement— (A) the individual may enroll in the pro- gram under this section; and (B) so long as the individual is so enrolled and in accordance with regulations— (i) the individual shall receive benefits under this subchapter solely through such program; and (ii) the PACE provider is entitled to pay- ment under and in accordance with this section and such agreement for provision of such benefits. (2) ‘‘PACE program’’ defined For purposes of this section, the term ‘‘PACE program’’ means a program of all-in- clusive care for the elderly that meets the fol- lowing requirements: (A) Operation The entity operating the program is a PACE provider (as defined in paragraph (3)). (B) Comprehensive benefits The program provides comprehensive health care services to PACE program eligi- ble individuals in accordance with the PACE program agreement and regulations under this section. (C) Transition In the case of an individual who is enrolled under the program under this section and