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42 U.S.C. § 1315a — Center for Medicare and Medicaid Inno-

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42 U.S.C. § 1315a — Center for Medicare and Medicaid Inno-

Page 2588 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1315a ‘‘(A) one shall be a geographically small State with a population of less than 1,250,000; ‘‘(B) one shall be a State with a population of over 20,000,000; and ‘‘(C) two shall be States with populations of more than 1,000,000 but less than 20,000,000. ‘‘(e) EVALUATION AND REPORT.—(1) Each State con- ducting a demonstration project under this section shall submit to the Secretary for his approval an eval- uation plan that provides for examining the effective- ness of the project in both the home base and periph- eral area of the State. ‘‘(2) Not later than October 1, 1992, the Secretary shall submit to the Congress a report containing a sum- mary of the evaluations conducted by States pursuant to the plans described in paragraph (1). ‘‘(f) FUNDING.—(1) Three-fifths of the total amount appropriated pursuant to this section for any fiscal year for each State conducting a demonstration project shall be expended by such State for the provision of services and facilities within the State’s designated project home base, and 5 percent of such three-fifths shall be set aside for the conduct of the State’s evalua- tion as provided for in subsection (e). ‘‘(2) Two-fifths of the total amounts appropriated pursuant to this section for any fiscal year for each State conducting a demonstration project shall be ex- pended by such State for the provision of services and facilities within the State’s designated peripheral area, and 5 percent of such two-fifths shall be set aside for the conduct of the State’s evaluation as provided for in subsection (e). ‘‘(g) DURATION.—A demonstration project conducted under this section shall be commenced not later than September 30, 1989, and shall be conducted for a 3

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Page 2588 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1315a ‘‘(A) one shall be a geographically small State with a population of less than 1,250,000; ‘‘(B) one shall be a State with a population of over 20,000,000; and ‘‘(C) two shall be States with populations of more than 1,000,000 but less than 20,000,000. ‘‘(e) EVALUATION AND REPORT.—(1) Each State con- ducting a demonstration project under this section shall submit to the Secretary for his approval an eval- uation plan that provides for examining the effective- ness of the project in both the home base and periph- eral area of the State. ‘‘(2) Not later than October 1, 1992, the Secretary shall submit to the Congress a report containing a sum- mary of the evaluations conducted by States pursuant to the plans described in paragraph (1). ‘‘(f) FUNDING.—(1) Three-fifths of the total amount appropriated pursuant to this section for any fiscal year for each State conducting a demonstration project shall be expended by such State for the provision of services and facilities within the State’s designated project home base, and 5 percent of such three-fifths shall be set aside for the conduct of the State’s evalua- tion as provided for in subsection (e). ‘‘(2) Two-fifths of the total amounts appropriated pursuant to this section for any fiscal year for each State conducting a demonstration project shall be ex- pended by such State for the provision of services and facilities within the State’s designated peripheral area, and 5 percent of such two-fifths shall be set aside for the conduct of the State’s evaluation as provided for in subsection (e). ‘‘(g) DURATION.—A demonstration project conducted under this section shall be commenced not later than September 30, 1989, and shall be conducted for a 3-year period; except that the Secretary may terminate a project before the end of such period if he determines that the State conducting the project is not in substan- tial compliance with the terms of the agreement en- tered into with the Secretary under this section. ‘‘(h) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of funding in equal amounts each State dem- onstration project conducted under this section, there is authorized to be appropriated not to exceed $1,500,000 for each of the fiscal years 1990, 1991, and 1992.’’ CONTINUATION OF FEDERAL FINANCIAL PARTICIPATION IN EXPERIMENTAL, PILOT, OR DEMONSTRATION PROJECTS APPROVED BEFORE OCTOBER 1, 1973, FOR PERIOD ON-AND-AFTER DECEMBER 31, 1973, WITHOUT DENIAL OR REDUCTION ON ACCOUNT OF SUBCHAPTER XVI PROVISIONS FOR SUPPLEMENTAL SECURITY IN- COME FOR THE AGED, BLIND AND DISABLED; WAIVER OF SUBCHAPTER XVI RESTRICTIONS FOR INDIVIDUALS; FEDERAL PAYMENTS OF NON-FEDERAL SHARE AS SUP- PLEMENTARY PAYMENTS Pub. L. 93–233, § 11, Dec. 31, 1973, 87 Stat. 958, provided that: ‘‘(a) If any State (other than the Commonwealth of Puerto Rico, the Virgin Islands, or Guam) has any ex- perimental, pilot, or demonstration project (referred to in section 1115 of the Social Security Act [42 U.S.C. 1315])— ‘‘(1) which (prior to October 1, 1973) has been ap- proved by the Secretary of Health, Education, and Welfare [now Health and Human Services] (herein- after in this section referred to as the ‘Secretary’), for a period which ends on or after December 31, 1973, as being a project with respect to which the author- ity conferred upon him by subsection (a) or (b) of such section 1115 [42 U.S.C. 1315(a), (b)] will be exer- cised, and ‘‘(2) with respect to the costs of which Federal fi- nancial participation would (except for the provisions of this section) be denied or reduced on account of the enactment of section 301 of the Social Security Amendments of 1972 [enacting subchapter XVI of this chapter], then, for any period (after December 31, 1973) with re- spect to which such project is approved by the Sec- retary, Federal financial participation in the costs of such project shall be continued in like manner as if— ‘‘(3) such section 301 [enacting subchapter XVI of this chapter] had not been enacted, and ‘‘(4) such State (for the month of January 1974 and any month thereafter) continued to have in effect the State plan (approved under title XVI [42 U.S.C. 1381 et seq.]) which was in effect for the month of October 1973, or the State plans (approved under titles I, X, and XIV of the Social Security Act [42 U.S.C. 301 et seq., 1201 et seq., 1351 et seq.]) which were in effect for such month, as the case may be. ‘‘(b) With respect to individuals— ‘‘(1) who are participants in any project to which the provisions of subsection (a) are applicable, and ‘‘(2) with respect to whom supplemental security income benefits are (or would, except for their par- ticipation in such project, be) payable under title XVI of the Social Security Act, or who meet the require- ments for aid or assistance under a State plan ap- proved under title I, X, XIV, or XVI of the Social Se- curity Act of the State in which such project is con- ducted (as such State plan was in effect for July 1973), the Secretary may waive such requirements of title XVI of such Act (as enacted by section 301 of the Social Security Amendments of 1972) to such extent as he de- termines to be necessary to the successful operation of such project. ‘‘(c) In the case of any State which has entered into an agreement with the Secretary under section 1616 of the Social Security Act [42 U.S.C. 1382e] (or which is deemed, under section 212(d) of Public Law 93–66 [set out as a note under section 1382 of this title], to have entered into such an agreement), then, of the costs of any project of such State with respect to which there is (solely by reason of the provisions of subsection (a)) Federal financial participation, the non-Federal share thereof shall— ‘‘(1) be paid, from time to time, to such State by the Secretary, and ‘‘(2) shall, for purposes of section 1616(d) of the So- cial Security Act [42 U.S.C. 1382e(d)] and section 401 of the Social Security Amendments of 1972 [set out as a note under section 1382e of this title] be treated in like manner as if such non-Federal share were supple- mentary payments made by the Secretary on behalf of such State pursuant to such agreement.’’ § 1315a. Center for Medicare and Medicaid Inno- vation (a) Center for Medicare and Medicaid Innovation established (1) In general There is created within the Centers for Medicare & Medicaid Services a Center for Medicare and Medicaid Innovation (in this sec- tion referred to as the ‘‘CMI’’) to carry out the duties described in this section. The purpose of the CMI is to test innovative payment and service delivery models to reduce program ex- penditures under the applicable subchapters while preserving or enhancing the quality of care furnished to individuals under such sub- chapters. In selecting such models, the Sec- retary shall give preference to models that also improve the coordination, quality, and ef- ficiency of health care services furnished to applicable individuals defined in paragraph (4)(A). (2) Deadline The Secretary shall ensure that the CMI is carrying out the duties described in this sec- tion by not later than January 1, 2011. (3) Consultation In carrying out the duties under this sec- tion, the CMI shall consult representatives of Page 2589 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1315a 1 So in original. Probably should be ‘‘Promoting’’. relevant Federal agencies, and clinical and an- alytical experts with expertise in medicine and health care management. The CMI shall use open door forums or other mechanisms to seek input from interested parties. (4) Definitions In this section: (A) Applicable individual The term ‘‘applicable individual’’ means— (i) an individual who is entitled to, or enrolled for, benefits under part A of sub- chapter XVIII or enrolled for benefits under part B of such subchapter; (ii) an individual who is eligible for med- ical assistance under subchapter XIX, under a State plan or waiver; or (iii) an individual who meets the criteria of both clauses (i) and (ii). (B) Applicable subchapter The term ‘‘applicable subchapter’’ means subchapter XVIII, subchapter XIX, or both. (5) Testing within certain geographic areas For purposes of testing payment and service delivery models under this section, the Sec- retary may elect to limit testing of a model to certain geographic areas. (b) Testing of models (phase I) (1) In general The CMI shall test payment and service de- livery models in accordance with selection cri- teria under paragraph (2) to determine the ef- fect of applying such models under the appli- cable subchapter (as defined in subsection (a)(4)(B)) on program expenditures under such subchapters and the quality of care received by individuals receiving benefits under such subchapter. (2) Selection of models to be tested (A) In general The Secretary shall select models to be tested from models where the Secretary de- termines that there is evidence that the model addresses a defined population for which there are deficits in care leading to poor clinical outcomes or potentially avoid- able expenditures. The Secretary shall focus on models expected to reduce program costs under the applicable subchapter while pre- serving or enhancing the quality of care re- ceived by individuals receiving benefits under such subchapter. The models selected under this subparagraph may include, but are not limited to, the models described in subparagraph (B). (B) Opportunities The models described in this subparagraph are the following models: (i) Promoting broad payment and prac- tice reform in primary care, including pa- tient-centered medical home models for high-need applicable individuals, medical homes that address women’s unique health care needs, and models that transition pri- mary care practices away from fee-for- service based reimbursement and toward comprehensive payment or salary-based payment. (ii) Contracting directly with groups of providers of services and suppliers to pro- mote innovative care delivery models, such as through risk-based comprehensive payment or salary-based payment. (iii) Utilizing geriatric assessments and comprehensive care plans to coordinate the care (including through interdiscipli- nary teams) of applicable individuals with multiple chronic conditions and at least one of the following: (I) An inability to perform 2 or more activities of daily living. (II) Cognitive impairment, including dementia. (iv) Promote 1 care coordination between providers of services and suppliers that transition health care providers away from fee-for-service based reimbursement and toward salary-based payment. (v) Supporting care coordination for chronically-ill applicable individuals at high risk of hospitalization through a health information technology-enabled provider network that includes care coor- dinators, a chronic disease registry, and home tele-health technology. (vi) Varying payment to physicians who order advanced diagnostic imaging serv- ices (as defined in section 1395m(e)(1)(B) of this title) according to the physician’s ad- herence to appropriateness criteria for the ordering of such services, as determined in consultation with physician specialty groups and other relevant stakeholders. (vii) Utilizing medication therapy man- agement services, such as those described in section 299b–35 of this title. (viii) Establishing community-based health teams to support small-practice medical homes by assisting the primary care practitioner in chronic care manage- ment, including patient self-management, activities. (ix) Assisting applicable individuals in making informed health care choices by paying providers of services and suppliers for using patient decision-support tools, including tools that meet the standards developed and identified under section 299b–36(c)(2)(A) of this title, that improve applicable individual and caregiver under- standing of medical treatment options. (x) Allowing States to test and evaluate fully integrating care for dual eligible in- dividuals in the State, including the man- agement and oversight of all funds under the applicable subchapters with respect to such individuals. (xi) Allowing States to test and evaluate systems of all-payer payment reform for the medical care of residents of the State, including dual eligible individuals. (xii) Aligning nationally recognized, evi- dence-based guidelines of cancer care with payment incentives under subchapter XVIII in the areas of treatment planning and follow-up care planning for applicable Page 2590 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1315a individuals described in clause (i) or (iii) of subsection (a)(4)(A) with cancer, including the identification of gaps in applicable quality measures. (xiii) Improving post-acute care through continuing care hospitals that offer inpa- tient rehabilitation, long-term care hos- pitals, and home health or skilled nursing care during an inpatient stay and the 30 days immediately following discharge. (xiv) Funding home health providers who offer chronic care management services to applicable individuals in cooperation with interdisciplinary teams. (xv) Promoting improved quality and re- duced cost by developing a collaborative of high-quality, low-cost health care institu- tions that is responsible for— (I) developing, documenting, and dis- seminating best practices and proven care methods; (II) implementing such best practices and proven care methods within such in- stitutions to demonstrate further im- provements in quality and efficiency; and (III) providing assistance to other health care institutions on how best to employ such best practices and proven care methods to improve health care quality and lower costs. (xvi) Facilitate inpatient care, including intensive care, of hospitalized applicable individuals at their local hospital through the use of electronic monitoring by spe- cialists, including intensivists and critical care specialists, based at integrated health systems. (xvii) Promoting greater efficiencies and timely access to outpatient services (such as outpatient physical therapy services) through models that do not require a phy- sician or other health professional to refer the service or be involved in establishing the plan of care for the service, when such service is furnished by a health profes- sional who has the authority to furnish the service under existing State law. (xviii) Establishing comprehensive pay- ments to Healthcare Innovation Zones, consisting of groups of providers that in- clude a teaching hospital, physicians, and other clinical entities, that, through their structure, operations, and joint-activity deliver a full spectrum of integrated and comprehensive health care services to ap- plicable individuals while also incor- porating innovative methods for the clin- ical training of future health care profes- sionals. (xix) Utilizing, in particular in entities located in medically underserved areas and facilities of the Indian Health Service (whether operated by such Service or by an Indian tribe or tribal organization (as those terms are defined in section 1603 of title 25)), telehealth services— (I) in treating behavioral health issues (such as post-traumatic stress disorder) and stroke; and (II) to improve the capacity of non- medical providers and non-specialized medical providers to provide health serv- ices for patients with chronic complex conditions. (xx) Utilizing a diverse network of pro- viders of services and suppliers to improve care coordination for applicable individ- uals described in subsection (a)(4)(A)(i) with 2 or more chronic conditions and a history of prior-year hospitalization through interventions developed under the Medicare Coordinated Care Demonstration Project under section 4016 of the Balanced Budget Act of 1997 (42 U.S.C. 1395b–1 note). (xxi) Focusing primarily on physicians’ services (as defined in section 1395w–4(j)(3) of this title) furnished by physicians who are not primary care practitioners. (xxii) Focusing on practices of 15 or fewer professionals. (xxiii) Focusing on risk-based models for small physician practices which may in- volve two-sided risk and prospective pa- tient assignment, and which examine risk- adjusted decreases in mortality rates, hos- pital readmissions rates, and other rel- evant and appropriate clinical measures. (xxiv) Focusing primarily on subchapter XIX, working in conjunction with the Cen- ter for Medicaid and CHIP Services. (xxv) Providing, for the adoption and use of certified EHR technology (as defined in section 1395w–4(o)(4) of this title) to im- prove the quality and coordination of care through the electronic documentation and exchange of health information, incentive payments to behavioral health providers (such as psychiatric hospitals (as defined in section 1395x(f) of this title), commu- nity mental health centers (as defined in section 1395x(ff)(3)(B) of this title), hos- pitals that participate in a State plan under subchapter XIX or a waiver of such plan, treatment facilities that participate in such a State plan or such a waiver, men- tal health or substance use disorder pro- viders that participate in such a State plan or such a waiver, clinical psycholo- gists (as defined in section 1395x(ii) of this title), nurse practitioners (as defined in section 1395x(aa)(5) of this title) with re- spect to the provision of psychiatric serv- ices, and clinical social workers (as defined in section 1395x(hh)(1) of this title)). (xxvi) Supporting ways to familiarize in- dividuals with the availability of coverage under part B of subchapter XVIII for quali- fied psychologist services (as defined in section 1395x(ii) of this title). (xxvii) Exploring ways to avoid unneces- sary hospitalizations or emergency depart- ment visits for mental and behavioral health services (such as for treating de- pression) through use of a 24-hour, 7-day a week help line that may inform individ- uals about the availability of treatment options, including the availability of qualified psychologist services (as defined in section 1395x(ii) of this title). Page 2591 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1315a 2 So in original. Probably should be ‘‘in section’’. 3 So in original. Probably should be preceded by ‘‘the’’. (C) Additional factors for consideration In selecting models for testing under sub- paragraph (A), the CMI may consider the fol- lowing additional factors: (i) Whether the model includes a regular process for monitoring and updating pa- tient care plans in a manner that is con- sistent with the needs and preferences of applicable individuals. (ii) Whether the model places the appli- cable individual, including family mem- bers and other informal caregivers of the applicable individual, at the center of the care team of the applicable individual. (iii) Whether the model provides for in- person contact with applicable individuals. (iv) Whether the model utilizes tech- nology, such as electronic health records and patient-based remote monitoring sys- tems, to coordinate care over time and across settings. (v) Whether the model provides for the maintenance of a close relationship be- tween care coordinators, primary care practitioners, specialist physicians, com- munity-based organizations, and other providers of services and suppliers. (vi) Whether the model relies on a team- based approach to interventions, such as comprehensive care assessments, care planning, and self-management coaching. (vii) Whether, under the model, providers of services and suppliers are able to share information with patients, caregivers, and other providers of services and suppliers on a real time basis. (viii) Whether the model demonstrates effective linkage with other public sector payers, private sector payers, or statewide payment models. (3) Budget neutrality (A) Initial period The Secretary shall not require, as a con- dition for testing a model under paragraph (1), that the design of such model ensure that such model is budget neutral initially with respect to expenditures under the appli- cable subchapter. (B) Termination or modification The Secretary shall terminate or modify the design and implementation of a model unless the Secretary determines (and the Chief Actuary of the Centers for Medicare & Medicaid Services, with respect to program spending under the applicable subchapter, certifies), after testing has begun, that the model is expected to— (i) improve the quality of care (as deter- mined by the Administrator of the Centers for Medicare & Medicaid Services) without increasing spending under the applicable subchapter; (ii) reduce spending under the applicable subchapter without reducing the quality of care; or (iii) improve the quality of care and re- duce spending. Such termination may occur at any time after such testing has begun and before com- pletion of the testing. (4) Evaluation (A) In general The Secretary shall conduct an evaluation of each model tested under this subsection. Such evaluation shall include an analysis of— (i) the quality of care furnished under the model, including the measurement of patient-level outcomes and patient- centeredness criteria determined appro- priate by the Secretary; and (ii) the changes in spending under the applicable subchapters by reason of the model. (B) Information The Secretary shall make the results of each evaluation under this paragraph avail- able to the public in a timely fashion and may establish requirements for States and other entities participating in the testing of models under this section to collect and re- port information that the Secretary deter- mines is necessary to monitor and evaluate such models. (C) Measure selection To the extent feasible, the Secretary shall select measures under this paragraph that reflect national priorities for quality im- provement and patient-centered care con- sistent with the measures described in 2 1395aaa(b)(7)(B) of this title. (c) Expansion of models (phase II) Taking into account the evaluation under sub- section (b)(4), the Secretary may, through rule- making, expand (including implementation on a nationwide basis) the duration and the scope of a model that is being tested under subsection (b) or a demonstration project under section 1395cc–3 of this title, to the extent determined appropriate by the Secretary, if— (1) the Secretary determines that such ex- pansion is expected to— (A) reduce spending under applicable 3 sub- chapter without reducing the quality of care; or (B) improve the quality of patient care without increasing spending; (2) the Chief Actuary of the Centers for Medicare & Medicaid Services certifies that such expansion would reduce (or would not re- sult in any increase in) net program spending under applicable subchapters; and (3) the Secretary determines that such ex- pansion would not deny or limit the coverage or provision of benefits under the applicable subchapter for applicable individuals. In determining which models or demonstration projects to expand under the preceding sentence, the Secretary shall focus on models and dem- onstration projects that improve the quality of patient care and reduce spending. (d) Implementation (1) Waiver authority The Secretary may waive such requirements of subchapters XI and XVIII and of sections Page 2592 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1315a 1396a(a)(1), 1396a(a)(13), 1396b(m)(2)(A)(iii), and 1396u–4 (other than subsections (b)(1)(A) and (c)(5) of such section) of this title as may be necessary solely for purposes of carrying out this section with respect to testing models de- scribed in subsection (b). (2) Limitations on review There shall be no administrative or judicial review under section 1395ff of this title, sec- tion 1395oo of this title, or otherwise of— (A) the selection of models for testing or expansion under this section; (B) the selection of organizations, sites, or participants to test those models selected; (C) the elements, parameters, scope, and duration of such models for testing or dis- semination; (D) determinations regarding budget neu- trality under subsection (b)(3); (E) the termination or modification of the design and implementation of a model under subsection (b)(3)(B); and (F) determinations about expansion of the duration and scope of a model under sub- section (c), including the determination that a model is not expected to meet criteria de- scribed in paragraph (1) or (2) of such sub- section. (3) Administration Chapter 35 of title 44 shall not apply to the testing and evaluation of models or expansion of such models under this section. (e) Application to CHIP The Center may carry out activities under this section with respect to subchapter XXI in the same manner as provided under this section with respect to the program under the applica- ble subchapters. (f) Funding (1) In general There are appropriated, from amounts in the Treasury not otherwise appropriated— (A) $5,000,000 for the design, implementa- tion, and evaluation of models under sub- section (b) for fiscal year 2010; (B) $10,000,000,000 for the activities initi- ated under this section for the period of fis- cal years 2011 through 2019; and (C) the amount described in subparagraph (B) for the activities initiated under this section for each subsequent 10-year fiscal pe- riod (beginning with the 10-year fiscal period beginning with fiscal year 2020). Amounts appropriated under the preceding sentence shall remain available until ex- pended. (2) Use of certain funds Out of amounts appropriated under subpara- graphs (B) and (C) of paragraph (1), not less than $25,000,000 shall be made available each such fiscal year to design, implement, and evaluate models under subsection (b). (g) Report to Congress Beginning in 2012, and not less than once every other year thereafter, the Secretary shall sub- mit to Congress a report on activities under this section. Each such report shall describe the models tested under subsection (b), including the number of individuals described in sub- section (a)(4)(A)(i) and of individuals described in subsection (a)(4)(A)(ii) participating in such models and payments made under applicable subchapters for services on behalf of such indi- viduals, any models chosen for expansion under subsection (c), and the results from evaluations under subsection (b)(4). In addition, each such report shall provide such recommendations as the Secretary determines are appropriate for legislative action to facilitate the development and expansion of successful payment models. (Aug. 14, 1935, ch. 531, title XI, § 1115A, as added and amended Pub. L. 111–148, title III, § 3021(a), title X, § 10306, Mar. 23, 2010, 124 Stat. 389, 939; Pub. L. 114–10, title I, § 101(e)(4), Apr. 16, 2015, 129 Stat. 122; Pub. L. 114–85, § 1, Nov. 5, 2015, 129 Stat. 674; Pub. L. 115–271, title VI, §§ 6001, 6085(a), Oct. 24, 2018, 132 Stat. 3976, 3996.) Editorial Notes REFERENCES IN TEXT Section 4016 of the Balanced Budget Act of 1997, re- ferred to in subsec. (b)(2)(B)(xx), is section 4016 of Pub. L. 105–33, which is set out as a note under section 1395b–1 of this title. AMENDMENTS 2018—Subsec. (b)(2)(B)(xxv). Pub. L. 115–271, § 6001, added cl. (xxv). Subsec. (b)(2)(B)(xxvi), (xxvii). Pub. L. 115–271, § 6085(a), added cls. (xxvi) and (xxvii). 2015—Subsec. (b)(2)(B)(xxi) to (xxiv). Pub. L. 114–10, § 101(e)(4)(A), added cls. (xxi) to (xxiv). Subsec. (b)(2)(C)(viii). Pub. L. 114–10, § 101(e)(4)(B), substituted ‘‘other public sector payers, private sector payers, or statewide payment models’’ for ‘‘other public sector or private sector payers’’. Subsec. (d)(1). Pub. L. 114–85 substituted ‘‘1396b(m)(2)(A)(iii), and 1396u–4 (other than subsections (b)(1)(A) and (c)(5) of such section)’’ for ‘‘and 1396b(m)(2)(A)(iii)’’. 2010—Subsec. (a)(5). Pub. L. 111–148, § 10306(1), added par. (5). Subsec. (b)(2)(A). Pub. L. 111–148, § 10306(2)(A), in- serted ‘‘The Secretary shall focus on models expected to reduce program costs under the applicable sub- chapter while preserving or enhancing the quality of care received by individuals receiving benefits under such subchapter.’’ after the first sentence and sub- stituted ‘‘this subparagraph may include, but are not limited to,’’ for ‘‘the preceding sentence may include’’. Subsec. (b)(2)(B)(xix), (xx). Pub. L. 111–148, § 10306(2)(B), added cls. (xix) and (xx). Subsec. (b)(2)(C)(viii). Pub. L. 111–148, § 10306(2)(C), added cl. (viii). Subsec. (b)(4)(C). Pub. L. 111–148, § 10306(3), added sub- par. (C). Subsec. (c). Pub. L. 111–148, § 10306(4)(C), inserted con- cluding provisions. Subsec. (c)(1)(B). Pub. L. 111–148, § 10306(4)(A), sub- stituted ‘‘patient care without increasing spending;’’ for ‘‘care and reduce spending; and’’. Subsec. (c)(2). Pub. L. 111–148, § 10306(4)(B), sub- stituted ‘‘reduce (or would not result in any increase in) net program spending under applicable subchapters; and’’ for ‘‘reduce program spending under applicable subchapters.’’ Subsec. (c)(3). Pub. L. 111–148, § 10306(4)(C), added par. (3). Page 2593 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1315b 1 So in original. Statutory Notes and Related Subsidiaries CONSTRUCTION REGARDING TELEHEALTH SERVICES Pub. L. 114–10, title I, § 101(e)(5), Apr. 16, 2015, 129 Stat. 122, provided that: ‘‘Nothing in the provisions of, or amendments made by, this title [see Tables for classi- fication] shall be construed as precluding an alter- native payment model or a qualifying APM participant (as those terms are defined in section 1833(z) of the So- cial Security Act [42 U.S.C. 1395l(z)], as added by para- graph (1)) from furnishing a telehealth service for which payment is not made under section 1834(m) of the Social Security Act (42 U.S.C. 1395m(m)).’’ MEDICAID GLOBAL PAYMENT SYSTEM DEMONSTRATION PROJECT Pub. L. 111–148, title II, § 2705, Mar. 23, 2010, 124 Stat. 324, provided that: ‘‘(a) IN GENERAL.—The Secretary of Health and Human Services (referred to in this section as the ‘Sec- retary’) shall, in coordination with the Center for Medi- care and Medicaid Innovation (as established under sec- tion 1115A of the Social Security Act [42 U.S.C. 1315a], as added by section 3021 of this Act), establish the Med- icaid Global Payment System Demonstration Project under which a participating State shall adjust the pay- ments made to an eligible safety net hospital system or network from a fee-for-service payment structure to a global capitated payment model. ‘‘(b) DURATION AND SCOPE.—The demonstration project conducted under this section shall operate dur- ing a period of fiscal years 2010 through 2012. The Sec- retary shall select not more than 5 States to partici- pate in the demonstration project. ‘‘(c) ELIGIBLE SAFETY NET HOSPITAL SYSTEM OR NET- WORK.—For purposes of this section, the term ‘eligible safety net hospital system or network’ means a large, safety net hospital system or network (as defined by the Secretary) that operates within a State selected by the Secretary under subsection (b). ‘‘(d) EVALUATION.— ‘‘(1) TESTING.—The Innovation Center shall test and evaluate the demonstration project conducted under this section to examine any changes in health care quality outcomes and spending by the eligible safety net hospital systems or networks. ‘‘(2) BUDGET NEUTRALITY.—During the testing pe- riod under paragraph (1), any budget neutrality re- quirements under section 1115A(b)(3) of the Social Se- curity Act [42 U.S.C. 1315a(b)(3)] (as so added) shall not be applicable. ‘‘(3) MODIFICATION.—During the testing period under paragraph (1), the Secretary may, in the Secretary’s discretion, modify or terminate the demonstration project conducted under this section. ‘‘(e) REPORT.—Not later than 12 months after the date of completion of the demonstration project under this section, the Secretary shall submit to Congress a re- port containing the results of the evaluation and test- ing conducted under subsection (d), together with rec- ommendations for such legislation and administrative action as the Secretary determines appropriate. ‘‘(f) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated such sums as are nec- essary to carry out this section.’’ § 1315b. Providing Federal coverage and pay- ment coordination for dual eligible bene- ficiaries (a) Establishment of Federal Coordinated Health Care Office (1) In general Not later than March 1, 2010, the Secretary of Health and Human Services (in this section referred to as the ‘‘Secretary’’) shall establish a Federal Coordinated Health Care Office. (2) Establishment and reporting to CMS admin- istrator The Federal Coordinated Health Care Of- fice— (A) shall be established within the Centers for Medicare & Medicaid Services; and (B) have as the Office 1 a Director who shall be appointed by, and be in direct line of authority to, the Administrator of the Cen- ters for Medicare & Medicaid Services. (b) Purpose The purpose of the Federal Coordinated Health Care Office is to bring together officers and em- ployees of the Medicare and Medicaid programs at the Centers for Medicare & Medicaid Services in order to— (1) more effectively integrate benefits under the Medicare program under title XVIII of the Social Security Act [42 U.S.C. 1395 et seq.] and the Medicaid program under title XIX of such Act [42 U.S.C. 1396 et seq.]; and (2) improve the coordination between the Federal Government and States for individ- uals eligible for benefits under both such pro- grams in order to ensure that such individuals get full access to the items and services to which they are entitled under titles XVIII and XIX of the Social Security Act. (c) Goals The goals of the Federal Coordinated Health Care Office are as follows: (1) Providing dual eligible individuals full access to the benefits to which such individ- uals are entitled under the Medicare and Med- icaid programs. (2) Simplifying the processes for dual eligi- ble individuals to access the items and serv- ices they are entitled to under the Medicare and Medicaid programs. (3) Improving the quality of health care and long-term services for dual eligible individ- uals. (4) Increasing dual eligible individuals’ un- derstanding of and satisfaction with coverage under the Medicare and Medicaid programs. (5) Eliminating regulatory conflicts between rules under the Medicare and Medicaid pro- grams. (6) Improving care continuity and ensuring safe and effective care transitions for dual eli- gible individuals. (7) Eliminating cost-shifting between the Medicare and Medicaid program and among re- lated health care providers. (8) Improving the quality of performance of providers of services and suppliers under the Medicare and Medicaid programs. (d) Specific responsibilities The specific responsibilities of the Federal Co- ordinated Health Care Office are as follows: (1) Providing States, specialized MA plans for special needs individuals (as defined in sec- tion 1859(b)(6) of the Social Security Act (42 U.S.C. 1395w–28(b)(6))), physicians and other relevant entities or individuals with the edu- cation and tools necessary for developing pro- grams that align benefits under the Medicare

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Federal law — U.S. Code and appendices · legal_authorities

42 U.S.C. § 1315 — Demonstration projects

**(a) Waiver of State plan requirements; costs regarded as State plan expenditures; availability of appropriations** In the case of any experimental, pilot, or demonstration project which, in the judgment of the Secretary, is likely to assist in promoting the objectives of subchapter I, X, XIV, XVI, or XIX, or part A or D of subchapter IV, in a State or States— (1) the Secretary may waive compliance with any of the requirements of section 302, 602, 654, 1202, 1352, 1382, or 1396a of this title, as the case may be, to the extent and for the period he finds necessary to enable such State or States to carry out such project, and (2) (A) costs of such project which would not otherwise be included as expenditures under section 303, 655, 1203, 1353, 1383, or 1396b of this title, as the case may be, and which are not included as part of the costs of projects under [section 1310 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section1310&num=0&edition=prelim), shall, to the extent and for the period prescribed by the Secretary, be regarded as expenditures under the State plan or plans approved under such subchapter, or for administration of such State plan or plans, as may be appropriate, and (B) costs of such project which would not otherwise be a permissible use of funds under part A of subchapter IV and which are not included as part of the costs of projects under [section 1310 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section1310&num=0&edition=prelim), shall to the extent and for the period prescribed by the Secretary, be regarded as a permissible use of funds under such part. In addition, not to exceed $4,000,000 of the aggregate amount appropriated for payments to States under such subch

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Federal law — U.S. Code and appendices · legal_authorities

42 U.S.C. § 1315 — Demonstration projects

Page 2582 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1315 1 See References in Text note below. (iv) Developing the criteria and guide- lines necessary for establishing safe resi- dential placements for foster children who have been sex trafficked as well as victims of trafficking identified through inter- action with law enforcement. (v) Developing training guidelines for caregivers that serve children and youth being cared for outside the home. (D) Informing States of best practices The Committee, in coordination with the National Governors Association, Secretary and Attorney General, shall ensure that State Governors and child welfare agencies are notified and informed on a quarterly basis of the best practices and recommenda- tions for States, and notified 6 months in ad- vance that the Committee will be evaluating the extent to which States adopt the Com- mittee’s recommendations. (E) Report on State implementation Within 3 years after the establishment of the Committee, the Committee shall submit to the Secretary and the Attorney General, as part of its final report as well as for on- line and publicly available publication, a de- scription of what each State has done to im- plement the recommendations of the Com- mittee. (e) Reports (1) In general The Committee shall submit an interim and a final report on the work of the Committee to— (A) the Secretary; (B) the Attorney General; (C) the Committee on Finance of the Sen- ate; and (D) the Committee on Ways and Means of the House of Representatives. (2) Reporting dates The interim report shall be submitted not later than 3 years after the establishment of the Committee. The final report shall be sub- mitted not later than 4 years after the estab- lishment of the Committee. (f) Administr

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Federal law — U.S. Code and appendices · legal_authorities

42 U.S.C. § 1315a — Center for Medicare and Medicaid Innovation

**(a) Center for Medicare and Medicaid Innovation established** (1) **In general** — There is created within the Centers for Medicare & Medicaid Services a Center for Medicare and Medicaid Innovation (in this section referred to as the “CMI”) to carry out the duties described in this section. The purpose of the CMI is to test innovative payment and service delivery models to reduce program expenditures under the applicable subchapters while preserving or enhancing the quality of care furnished to individuals under such subchapters. In selecting such models, the Secretary shall give preference to models that also improve the coordination, quality, and efficiency of health care services furnished to applicable individuals defined in paragraph (4)(A). (2) **Deadline** — The Secretary shall ensure that the CMI is carrying out the duties described in this section by not later than January 1, 2011. (3) **Consultation** — In carrying out the duties under this section, the CMI shall consult representatives of relevant Federal agencies, and clinical and analytical experts with expertise in medicine and health care management. The CMI shall use open door forums or other mechanisms to seek input from interested parties. (4) **Definitions** — In this section: (A) *Applicable individual* — The term “applicable individual” means— (i) an individual who is entitled to, or enrolled for, benefits under part A of subchapter XVIII or enrolled for benefits under part B of such subchapter; (ii) an individual who is eligible for medical assistance under subchapter XIX, under a State plan or waiver; or (iii) an individual who meets the criteria of both clauses (i) and (ii). (B) *Applicable subchapter* — The term “applicable subchapter” means subchapter XVIII, subchapte

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Federal law — U.S. Code and appendices · legal_authorities

42 U.S.C. § 1381 — Omitted

### Statutory Notes #### Codification Section, act Aug. 14, 1935, ch. 531, title XVI, § 1604, as added July 25, 1962, Pub. L. 87–543, title I, § 141(a), 76 Stat. 204, related to operation of State plans, prior to the general revision of this subchapter by Pub. L. 92–603, Oct. 30, 1972, 86 Stat. 1465, eff. Jan. 1, 1974. #### Puerto Rico, Guam, and Virgin Islands Enactment of subchapter XVI of the Social Security Act [this subchapter] by Pub. L. 92–603, eff. Jan. 1, 1974, was not applicable to Puerto Rico, Guam, and the Virgin Islands. See section 303(b) of Pub. L. 92–603, set out as a note under [section 301 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section301&num=0&edition=prelim). Therefore, as to Puerto Rico, Guam, and the Virgin Islands, section 1604 of the Social Security Act [this section] as it existed prior to reenactment of this subchapter by Pub. L. 92–603 continues to apply and reads as follows: § 1384. Operation of State plans If the Commissioner of Social Security, after reasonable notice and opportunity for hearing to the State agency administering or supervising the administration of the State plan approved under this subchapter, finds— (1) that the plan has been so changed that it no longer complies with the provisions of [section 1332 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section1332&num=0&edition=prelim); or (2) that in the administration of the plan there is a failure to comply substantially with any such provision; the Commissioner of Social Security shall notify such State agency that further payments will not be made to the State (or, in the Commissioner’s discretion, that payments will be limited to categories under or parts of the State plan not affected

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Federal law — U.S. Code and appendices · legal_authorities

42 U.S.C. § 1381 — Statement of purpose; authorization of ap-

Page 2801 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1381a Section 1367, act Aug. 14, 1935, ch. 531, title XV, § 1507, as added Sept. 1, 1954, ch. 1212, § 4(a), 68 Stat. 1134; amended Aug. 28, 1958, Pub. L. 85–848, § 4, 72 Stat. 1089; Sept. 13, 1960, Pub. L. 86–778, title V, § 531(f), 74 Stat. 984, provided for dissemination of information by both Fed- eral and State agencies. See section 8506 of Title 5. Section 1368, act Aug. 14, 1935, ch. 531, title XV, § 1508, as added Sept. 1, 1954, ch. 1212, § 4(a), 68 Stat. 1135, re- lated to penalties. See section 8507 of Title 5 and sec- tion 1919 of Title 18, Crimes and Criminal Procedure. Section 1369, act Aug. 14, 1935, ch. 531, title XV, § 1509, as added Sept. 1, 1954, ch. 1212, § 4(a), 68 Stat. 1135, re- lated to rules and regulations. See section 8508 of Title 5. Section 1370, act Aug. 14, 1935, ch. 531, title XV, § 1510, as added Sept. 1, 1954, ch. 1212, § 4(a), 68 Stat. 1135, re- lated to authorization of appropriations. See section 5509 of Title 5. Section 1371, act Aug. 14, 1935, ch. 531, title XV, § 1511, as added Aug. 28, 1958, Pub. L. 85–848, § 3, 72 Stat. 1087; amended Sept. 2, 1958, Pub. L. 85–857, § 13(i)(3), 72 Stat. 1265; Apr. 22, 1960, Pub. L. 86–442, § 2, 74 Stat. 82; Sept. 13, 1960, Pub. L. 86–778, title V, § 542(c), 74 Stat. 986, pro- vided an ex-servicemen’s unemployment compensation program. See sections 8521 to 8525 of Title 5. SUBCHAPTER XVI—SUPPLEMENTAL SECU- RITY INCOME FOR AGED, BLIND, AND DISABLED § 1381. Statement of purpose; authorization of ap- propriations For the purpose of establishing a national pro- gram to provide supplemental security income to individuals who have attained age 65 or are blind or disabled, there are authorized to be ap- propriated sums sufficient to

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Federal law — U.S. Code and appendices · legal_authorities

42 U.S.C. § 1382e — Definitions

**(a)** (1) For purposes of this subchapter, the term “aged, blind, or disabled individual” means an individual who— (A) is 65 years of age or older, is blind (as determined under paragraph (2)), or is disabled (as determined under paragraph (3)), and (B) (i) is a resident of the United States, and is either (I) a citizen or (II) an alien lawfully admitted for permanent residence or otherwise permanently residing in the United States under color of law (including any alien who is lawfully present in the United States as a result of the application of the provisions of [section 1182(d)(5) of title 8](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title8-section1182/d/5&num=0&edition=prelim)), or (ii) is a child who is a citizen of the United States, and who is living with a parent of the child who is a member of the Armed Forces of the United States assigned to permanent duty ashore outside the United States. (2) An individual shall be considered to be blind for purposes of this subchapter if he has central visual acuity of 20/200 or less in the better eye with the use of a correcting lens. An eye which is accompanied by a limitation in the fields of vision such that the widest diameter of the visual field subtends an angle no greater than 20 degrees shall be considered for purposes of the first sentence of this subsection as having a central visual acuity of 20/200 or less. An individual shall also be considered to be blind for purposes of this subchapter if he is blind as defined under a State plan approved under subchapter X or XVI as in effect for October 1972 and received aid under such plan (on the basis of blindness) for December 1973, so long as he is continuously blind as so defined. (3) (A) Except as provided in subparagraph

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Federal law — U.S. Code and appendices · legal_authorities

42 U.S.C. § 1382e — Supplementary assistance by State or

Page 2841 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1382e the date of the enactment of this Act [Nov. 5, 1990] and shall apply to claims for reimbursement pending on or after such date.’’ EFFECTIVE DATE OF 1984 AMENDMENT Amendment by Pub. L. 98–460 applicable with respect to individuals who receive benefits as a result of sec- tion 425(b) or section 1383(a)(6) of this title, or who refuse to continue to accept rehabilitation services or fail to cooperate in an approved vocational rehabilita- tion program, in or after November 1984, see section 11(c) of Pub. L. 98–460, set out as a note under section 422 of this title. Amendment by Pub. L. 98–369 effective July 18, 1984, but not to be construed as changing or affecting any right, liability, status, or interpretation which existed (under the provisions of law involved) before that date, see section 2664(b) of Pub. L. 98–369, set out as a note under section 401 of this title. EFFECTIVE AND TERMINATION DATES OF 1981 AMENDMENT Pub. L. 97–35, title XXI, § 2193(a)(4)(B), Aug. 13, 1981, 95 Stat. 827, provided that the amendment made by that section is effective for fiscal year 1982. For effective date, savings, and transitional provi- sions relating to amendments by section 2193(a)(4)(A) and (c)(8) of Pub. L. 97–35, see section 2194 of Pub. L. 97–35, set out as a note under section 701 of this title. Pub. L. 97–35, title XXIII, § 2344, Aug. 13, 1981, 95 Stat. 867, provided that the amendment made by that section is effective Oct. 1, 1981. EFFECTIVE DATE Pub. L. 92–603, title III, § 301, Oct. 30, 1972, 86 Stat. 1465, provided that this section is effective Jan. 1, 1974. PUBLICATION OF CRITERIA Pub. L. 94–566, title V, § 501(b), Oct. 20, 1976, 90 Stat. 2685, directed Secretary, within 120 days after

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Federal law — U.S. Code and appendices · legal_authorities

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

**(a) Establishment of Program** There is hereby established the Medicare Integrity 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 subsection (b). **(b) Activities described** The activities described in this subsection are as follows: (1) Review of activities of providers of services or other individuals and entities furnishing 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 capability 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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section1395y/b&num=0&edition=prelim), and recovery of payments that should not have been made. (4) Education of providers of services, beneficiaries, and other persons with respect to payment integrity and benefit quality assurance issues. (5) Developing (and periodically updating) a list of items of durable medical equipment in accordance with [section 1395m(a)(15) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section1395m/a/15&num=0&edition=prelim) which are subject to prior aut

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Federal law — U.S. Code and appendices · legal_authorities

42 U.S.C. § 1395b — Option to individuals to obtain other

Page 2895 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395b (C) Practitioner The term ‘‘practitioner’’ has the meaning given such term by section 1395u(b)(18)(C) of this title. (D) Opt-out physician or practitioner The term ‘‘opt-out physician or practi- tioner’’ means a physician or practitioner who has in effect an affidavit under para- graph (3)(B). (Aug. 14, 1935, ch. 531, title XVIII, § 1802, as added Pub. L. 89–97, title I, § 102(a), July 30, 1965, 79 Stat. 291; amended Pub. L. 105–33, title IV, § 4507(a)(1), (2)(A), Aug. 5, 1997, 111 Stat. 439, 441; Pub. L. 108–173, title VI, § 603, Dec. 8, 2003, 117 Stat. 2301; Pub. L. 114–10, title I, § 106(a)(1)(A), (2), Apr. 16, 2015, 129 Stat. 137, 138.) Editorial Notes AMENDMENTS 2015—Subsec. (b)(3)(B)(ii). Pub. L. 114–10, § 106(a)(1)(A)(i), substituted ‘‘during the applicable 2- year period (as defined in subparagraph (D))’’ for ‘‘dur- ing the 2-year period beginning on the date the affi- davit is signed’’. Subsec. (b)(3)(C). Pub. L. 114–10, § 106(a)(1)(A)(ii), sub- stituted ‘‘during the applicable 2-year period’’ for ‘‘dur- ing the 2-year period described in subparagraph (B)(ii)’’ in introductory provisions. Subsec. (b)(3)(D). Pub. L. 114–10, § 106(a)(1)(A)(iii), added subpar. (D). Subsec. (b)(5). Pub. L. 114–10, § 106(a)(2)(C), added par. (5). Former par. (5) redesignated (6). Subsec. (b)(5)(D). Pub. L. 114–10, § 106(a)(2)(A), added subpar. (D). Subsec. (b)(6). Pub. L. 114–10, § 106(a)(2)(B), redesig- nated par. (5) as (6). 2003—Subsec. (b)(5)(B). Pub. L. 108–173 substituted ‘‘paragraphs (1), (2), (3), and (4) of section 1395x(r)’’ for ‘‘section 1395x(r)(1)’’. 1997—Pub. L. 105–33 designated existing provisions as subsec. (a), inserted heading, and added subsec. (b). Statutory Notes and Rel

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Federal law — U.S. Code and appendices · legal_authorities

42 U.S.C. § 1395l — Provisions relating to the administration of part A

**(a) In general** The administration of this part shall be conducted through contracts with medicare administrative contractors under [section 1395kk–1 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section1395kk-1&num=0&edition=prelim). **(b) Repealed. Pub. L. 108–173, title IX, § 911(b)(3), Dec. 8, 2003, 117 Stat. 2383** **(c) Prompt payment of claims** (1) Repealed. Pub. L. 108–173, title IX, § 911(b)(4)(A), Dec. 8, 2003, 117 Stat. 2383. (2) (A) Each contract under [section 1395kk–1 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section1395kk-1&num=0&edition=prelim) that provides for making payments under this part shall provide that payment shall be issued, mailed, or otherwise transmitted with respect to not less than 95 percent of all claims submitted under this subchapter— (i) which are clean claims, and (ii) for which payment is not made on a periodic interim payment basis, within the applicable number of calendar days after the date on which the claim is received. (B) In this paragraph: (i) The term “clean claim” means a claim that has no defect or impropriety (including any lack of any required substantiating documentation) or particular circumstance requiring special treatment that prevents timely payment from being made on the claim under this subchapter. (ii) The term “applicable number of calendar days” means— (I) with respect to claims received in the 12-month period beginning October 1, 1986, 30 calendar days, (II) with respect to claims received in the 12-month period beginning October 1, 1987, 26 calendar days, (III) with respect to claims received in the 12-month period beginning October 1, 1988, 25 calendar days, (I

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