42 U.S.C. § 1395eee — Payments to, and coverage of benefits

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 Page 3975 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395eee whose enrollment ceases for any reason (in- cluding that the individual no longer quali- fies as a PACE program eligible individual, the termination of a PACE program agree- ment, or otherwise), the program provides assistance to the individual in obtaining necessary transitional care through appro- priate referrals and making the individual’s medical records available to new providers. (3) ‘‘PACE provider’’ defined (A) In general For purposes of this section, the term ‘‘PACE provider’’ means an entity that— (i) subject to subparagraph (B), is (or is a distinct part of) a public entity or a pri- vate, nonprofit entity organized for chari- table purposes under section 501(c)(3) of the Internal Revenue Code of 1986; and (ii) has entered into a PACE program agreement with respect to its operation of a PACE program. (B) Treatment of private, for-profit providers Clause (i) of subparagraph (A) shall not apply— (i) to entities subject to a demonstration project waiver under subsection (h); and (ii) after the date the report under sec- tion 4804(b) of the Balanced Budget Act of 1997 is submitted, unless the Secretary de- termines that any of the findings described in subparagraph (A), (B), (C), or (D) of paragraph (2) of such section are true. (4) ‘‘PACE program agreement’’ defined For purposes of this section, the term ‘‘PACE program agreement’’ means, with re- spect to a PACE provider, an agreement, con- sistent with this section, section 1396u–4 of this title (if applicable), and regulations pro- mulgated to carry out such sections, between the PACE provider and the Secretary, or an agreement between the PACE provider and a State administering agency for the operation of a PACE program by the provider under such sections. (5) ‘‘PACE program eligible individual’’ defined For purposes of this section, the term ‘‘PACE program eligible individual’’ means, with respect to a PACE program, an individual who— (A) is 55 years of age or older; (B) subject to subsection (c)(4), is deter- mined under subsection (c) to require the level of care required under the State med- icaid plan for coverage of nursing facility services; (C) resides in the service area of the PACE program; and (D) meets such other eligibility conditions as may be imposed under the PACE program agreement for the program under subsection (e)(2)(A)(ii). (6) ‘‘PACE protocol’’ defined For purposes of this section, the term ‘‘PACE protocol’’ means the Protocol for the Program of All-inclusive Care for the Elderly (PACE), as published by On Lok, Inc., as of April 14, 1995, or any successor protocol that may be agreed upon between the Secretary and On Lok, Inc. (7) ‘‘PACE demonstration waiver program’’ de- fined For purposes of this section, the term ‘‘PACE demonstration waiver program’’ means a demonstration program under either of the following sections (as in effect before the date of their repeal): (A) Section 603(c) of the Social Security Amendments of 1983 (Public Law 98–21), as extended by section 9220 of the Consolidated Omnibus Budget Reconciliation Act of 1985 (Public Law 99–272). (B) Section 9412(b) of the Omnibus Budget Reconciliation Act of 1986 (Public Law 99–509). (8) ‘‘State administering agency’’ defined For purposes of this section, the term ‘‘State administering agency’’ means, with respect to the operation of a PACE program in a State, the agency of that State (which may be the single agency responsible for administration of the State plan under subchapter XIX in the State) responsible for administering PACE program agreements under this section and section 1396u–4 of this title in the State. (9) ‘‘Trial period’’ defined (A) In general For purposes of this section, the term ‘‘trial period’’ means, with respect to a PACE program operated by a PACE provider under a PACE program agreement, the first 3 contract years under such agreement with respect to such program. (B) Treatment of entities previously oper- ating PACE demonstration waiver pro- grams Each contract year (including a year oc- curring before the effective date of this sec- tion) during which an entity has operated a PACE demonstration waiver program shall be counted under subparagraph (A) as a con- tract year during which the entity operated a PACE program as a PACE provider under a PACE program agreement. (10) ‘‘Regulations’’ defined For purposes of this section, the term ‘‘regu- lations’’ refers to interim final or final regula- tions promulgated under subsection (f) to carry out this section and section 1396u–4 of this title. (b) Scope of benefits; beneficiary safeguards (1) In general Under a PACE program agreement, a PACE provider shall— (A) provide to PACE program eligible indi- viduals enrolled with the provider, regard- less of source of payment and directly or under contracts with other entities, at a minimum— (i) all items and services covered under this subchapter (for individuals enrolled under this section) and all items and serv- ices covered under subchapter XIX, but without any limitation or condition as to Page 3976 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395eee amount, duration, or scope and without application of deductibles, copayments, co- insurance, or other cost-sharing that would otherwise apply under this sub- chapter or such subchapter, respectively; and (ii) all additional items and services specified in regulations, based upon those required under the PACE protocol; (B) provide such enrollees access to nec- essary covered items and services 24 hours per day, every day of the year; (C) provide services to such enrollees through a comprehensive, multidisciplinary health and social services delivery system which integrates acute and long-term care services pursuant to regulations; and (D) specify the covered items and services that will not be provided directly by the en- tity, and to arrange for delivery of those items and services through contracts meet- ing the requirements of regulations. (2) Quality assurance; patient safeguards The PACE program agreement shall require the PACE provider to have in effect at a min- imum— (A) a written plan of quality assurance and improvement, and procedures implementing such plan, in accordance with regulations; and (B) written safeguards of the rights of en- rolled participants (including a patient bill of rights and procedures for grievances and appeals) in accordance with regulations and with other requirements of this subchapter and Federal and State law that are designed for the protection of patients. (3) Treatment of medicare services furnished by noncontract physicians and other enti- ties (A) Application of medicare advantage re- quirement with respect to medicare serv- ices furnished by noncontract physicians and other entities Section 1395w–22(k)(1) of this title (relat- ing to limitations on balance billing against MA organizations for noncontract physi- cians and other entities with respect to serv- ices covered under this subchapter) shall apply to PACE providers, PACE program eli- gible individuals enrolled with such PACE providers, and physicians and other entities that do not have a contract or other agree- ment establishing payment amounts for services furnished to such an individual in the same manner as such section applies to MA organizations, individuals enrolled with such organizations, and physicians and other entities referred to in such section. (B) Reference to related provision for non- contract providers of services For the provision relating to limitations on balance billing against PACE providers for services covered under this subchapter furnished by noncontract providers of serv- ices, see section 1395cc(a)(1)(O) of this title. (4) Reference to related provision for services covered under subchapter XIX but not under this subchapter For provisions relating to limitations on payments to providers participating under the State plan under subchapter XIX that do not have a contract or other agreement with a PACE provider establishing payment amounts for services covered under such plan (but not under this subchapter) when such services are furnished to enrollees of that PACE provider, see section 1396a(a)(66) of this title. (c) Eligibility determinations (1) In general The determination of whether an individual is a PACE program eligible individual— (A) shall be made under and in accordance with the PACE program agreement; and (B) who is entitled to medical assistance under subchapter XIX, shall be made (or who is not so entitled, may be made) by the State administering agency. (2) Condition An individual is not a PACE program eligi- ble individual (with respect to payment under this section) unless the individual’s health status has been determined by the Secretary or the State administering agency, in accord- ance with regulations, to be comparable to the health status of individuals who have partici- pated in the PACE demonstration waiver pro- grams. Such determination shall be based upon information on health status and related indicators (such as medical diagnoses and measures of activities of daily living, instru- mental activities of daily living, and cognitive impairment) that are part of a uniform min- imum data set collected by PACE providers on potential PACE program eligible individuals. (3) Annual eligibility recertifications (A) In general Subject to subparagraph (B), the deter- mination described in subsection (a)(5)(B) for an individual shall be reevaluated at least annually. (B) Exception The requirement of annual reevaluation under subparagraph (A) may be waived dur- ing a period in accordance with regulations in those cases where the State administering agency determines that there is no reason- able expectation of improvement or signifi- cant change in an individual’s condition dur- ing the period because of the severity of chronic condition, or degree of impairment of functional capacity of the individual in- volved. (4) Continuation of eligibility An individual who is a PACE program eligi- ble individual may be deemed to continue to be such an individual notwithstanding a deter- mination that the individual no longer meets the requirement of subsection (a)(5)(B) if, in accordance with regulations, in the absence of continued coverage under a PACE program the individual reasonably would be expected to meet such requirement within the succeeding 6-month period. Page 3977 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395eee (5) Enrollment; disenrollment (A) Voluntary disenrollment at any time The enrollment and disenrollment of PACE program eligible individuals in a PACE program shall be pursuant to regula- tions and the PACE program agreement and shall permit enrollees to voluntarily disenroll without cause at any time. (B) Limitations on disenrollment (i) In general Regulations promulgated by the Sec- retary under this section and section 1396u–4 of this title, and the PACE pro- gram agreement, shall provide that the PACE program may not disenroll a PACE program eligible individual except— (I) for nonpayment of premiums (if ap- plicable) on a timely basis; or (II) for engaging in disruptive or threatening behavior, as defined in such regulations (developed in close consulta- tion with State administering agencies). (ii) No disenrollment for noncompliant be- havior Except as allowed under regulations pro- mulgated to carry out clause (i)(II), a PACE program may not disenroll a PACE program eligible individual on the ground that the individual has engaged in non- compliant behavior if such behavior is re- lated to a mental or physical condition of the individual. For purposes of the pre- ceding sentence, the term ‘‘noncompliant behavior’’ includes repeated noncompli- ance with medical advice and repeated failure to appear for appointments. (iii) Timely review of proposed nonvol- untary disenrollment A proposed disenrollment, other than a voluntary disenrollment, shall be subject to timely review and final determination by the Secretary or by the State admin- istering agency (as applicable), prior to the proposed disenrollment becoming ef- fective. (d) Payments to PACE providers on capitated basis (1) In general In the case of a PACE provider with a PACE program agreement under this section, except as provided in this subsection or by regula- tions, the Secretary shall make prospective monthly payments of a capitation amount for each PACE program eligible individual en- rolled under the agreement under this section in the same manner and from the same sources as payments are made to a Medicare+ Choice organization under section 1395w–23 of this title (or, for periods beginning before Jan- uary 1, 1999, to an eligible organization under a risk-sharing contract under section 1395mm of this title). Such payments shall be subject to adjustment in the manner described in sec- tion 1395w–23(a)(2) of this title or section 1395mm(a)(1)(E) of this title, as the case may be. (2) Capitation amount The capitation amount to be applied under this subsection for a provider for a contract year shall be an amount specified in the PACE program agreement for the year. Such amount shall be based upon payment rates established for purposes of payment under section 1395w–23 of this title (or, for periods before January 1, 1999, for purposes of risk-sharing contracts under section 1395mm of this title) and shall be adjusted to take into account the compara- tive frailty of PACE enrollees and such other factors as the Secretary determines to be ap- propriate. Such amount under such an agree- ment shall be computed in a manner so that the total payment level for all PACE program eligible individuals enrolled under a program is less than the projected payment under this subchapter for a comparable population not enrolled under a PACE program. (3) Capitation rates determined without regard to the phase-out of the indirect costs of medical education from the annual Medi- care Advantage capitation rate Capitation amounts under this subsection shall be determined without regard to the ap- plication of section 1395w–23(k)(4) of this title. (e) PACE program agreement (1) Requirement (A) In general The Secretary, in close cooperation with the State administering agency, shall estab- lish procedures for entering into, extending, and terminating PACE program agreements for the operation of PACE programs by enti- ties that meet the requirements for a PACE provider under this section, section 1396u–4 of this title, and regulations. (B) Numerical limitation (i) In general The Secretary shall not permit the num- ber of PACE providers with which agree- ments are in effect under this section or under section 9412(b) of the Omnibus Budg- et Reconciliation Act of 1986 to exceed— (I) 40 as of August 5, 1997; or (II) as of each succeeding anniversary of August 5, 1997, the numerical limita- tion under this subparagraph for the pre- ceding year plus 20. Subclause (II) shall apply without regard to the actual number of agreements in ef- fect as of a previous anniversary date. (ii) Treatment of certain private, for-profit providers The numerical limitation in clause (i) shall not apply to a PACE provider that— (I) is operating under a demonstration project waiver under subsection (h); or (II) was operating under such a waiver and subsequently qualifies for PACE pro- vider status pursuant to subsection (a)(3)(B)(ii). (2) Service area and eligibility (A) In general A PACE program agreement for a PACE program— (i) shall designate the service area of the program; Page 3978 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395eee (ii) may provide additional requirements for individuals to qualify as PACE pro- gram eligible individuals with respect to the program; (iii) shall be effective for a contract year, but may be extended for additional contract years in the absence of a notice by a party to terminate and is subject to termination by the Secretary and the State administering agency at any time for cause (as provided under the agree- ment); (iv) shall require a PACE provider to meet all applicable State and local laws and requirements; and (v) shall contain such additional terms and conditions as the parties may agree to, so long as such terms and conditions are consistent with this section and regula- tions. (B) Service area overlap In designating a service area under a PACE program agreement under subpara- graph (A)(i), the Secretary (in consultation with the State administering agency) may exclude from designation an area that is al- ready covered under another PACE program agreement, in order to avoid unnecessary duplication of services and avoid impairing the financial and service viability of an ex- isting program. (3) Data collection; development of outcome measures (A) Data collection (i) In general Under a PACE program agreement, the PACE provider shall— (I) collect data; (II) maintain, and afford the Secretary and the State administering agency ac- cess to, the records relating to the pro- gram, including pertinent financial, medical, and personnel records; and (III) make available to the Secretary and the State administering agency re- ports that the Secretary finds (in con- sultation with State administering agen- cies) necessary to monitor the operation, cost, and effectiveness of the PACE pro- gram under this section and section 1396u–4 of this title. (ii) Requirements during trial period During the first 3 years of operation of a PACE program (either under this section or under a PACE demonstration waiver program), the PACE provider shall provide such additional data as the Secretary specifies in regulations in order to perform the oversight required under paragraph (4)(A). (B) Development of outcome measures Under a PACE program agreement, the PACE provider, the Secretary, and the State administering agency shall jointly cooperate in the development and implementation of health status and quality of life outcome measures with respect to PACE program eli- gible individuals. (4) Oversight (A) Annual, close oversight during trial pe- riod During the trial period (as defined in sub- section (a)(9)) with respect to a PACE pro- gram operated by a PACE provider, the Sec- retary (in cooperation with the State admin- istering agency) shall conduct a comprehen- sive annual review of the operation of the PACE program by the provider in order to assure compliance with the requirements of this section and regulations. Such a review shall include— (i) an on-site visit to the program site; (ii) comprehensive assessment of a pro- vider’s fiscal soundness; (iii) comprehensive assessment of the provider’s capacity to provide all PACE services to all enrolled participants; (iv) detailed analysis of the entity’s sub- stantial compliance with all significant re- quirements of this section and regulations; and (v) any other elements the Secretary or State administering agency considers nec- essary or appropriate. (B) Continuing oversight After the trial period, the Secretary (in co- operation with the State administering agency) shall continue to conduct such re- view of the operation of PACE providers and PACE programs as may be appropriate, tak- ing into account the performance level of a provider and compliance of a provider with all significant requirements of this section and regulations. (C) Disclosure The results of reviews under this para- graph shall be reported promptly to the PACE provider, along with any rec- ommendations for changes to the provider’s program, and shall be made available to the public upon request. (5) Termination of PACE provider agreements (A) In general Under regulations— (i) the Secretary or a State admin- istering agency may terminate a PACE program agreement for cause; and (ii) a PACE provider may terminate an agreement after appropriate notice to the Secretary, the State agency, and enrollees. (B) Causes for termination In accordance with regulations estab- lishing procedures for termination of PACE program agreements, the Secretary or a State administering agency may terminate a PACE program agreement with a PACE provider for, among other reasons, the fact that— (i) the Secretary or State administering agency determines that— (I) there are significant deficiencies in the quality of care provided to enrolled participants; or (II) the provider has failed to comply substantially with conditions for a pro- Page 3979 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395eee gram or provider under this section or section 1396u–4 of this title; and (ii) the entity has failed to develop and successfully initiate, within 30 days of the date of the receipt of written notice of such a determination, a plan to correct the deficiencies, or has failed to continue im- plementation of such a plan. (C) Termination and transition procedures An entity whose PACE provider agreement is terminated under this paragraph shall im- plement the transition procedures required under subsection (a)(2)(C). (6) Secretary’s oversight; enforcement author- ity (A) In general Under regulations, if the Secretary deter- mines (after consultation with the State ad- ministering agency) that a PACE provider is failing substantially to comply with the re- quirements of this section and regulations, the Secretary (and the State administering agency) may take any or all of the following actions: (i) Condition the continuation of the PACE program agreement upon timely execution of a corrective action plan. (ii) Withhold some or all further pay- ments under the PACE program agreement under this section or section 1396u–4 of this title with respect to PACE program serv- ices furnished by such provider until the deficiencies have been corrected. (iii) Terminate such agreement. (B) Application of intermediate sanctions Under regulations, the Secretary may pro- vide for the application against a PACE pro- vider of remedies described in section 1395w–27(g)(2) (or, for periods before January 1, 1999, section 1395mm(i)(6)(B) of this title) or 1396b(m)(5)(B) of this title in the case of violations by the provider of the type de- scribed in section 1395w–27(g)(1) (or section 1395mm(i)(6)(A) of this title for such periods) or 1396b(m)(5)(A) of this title, respectively (in relation to agreements, enrollees, and re- quirements under this section or section 1396u–4 of this title, respectively). (7) Procedures for termination or imposition of sanctions Under regulations, the provisions of section 1395w–27(h) of this title (or for periods before January 1, 1999, section 1395mm(i)(9) of this title) shall apply to termination and sanctions respecting a PACE program agreement and PACE provider under this subsection in the same manner as they apply to a termination and sanctions with respect to a contract and a Medicare+Choice organization under part C (or for such periods an eligible organization under section 1395mm of this title). (8) Timely consideration of applications for PACE program provider status In considering an application for PACE pro- vider program status, the application shall be deemed approved unless the Secretary, within 90 days after the date of the submission of the application to the Secretary, either denies such request in writing or informs the appli- cant in writing with respect to any additional information that is needed in order to make a final determination with respect to the appli- cation. After the date the Secretary receives such additional information, the application shall be deemed approved unless the Sec- retary, within 90 days of such date, denies such request. (f) Regulations (1) In general The Secretary shall issue interim final or final regulations to carry out this section and section 1396u–4 of this title. (2) Use of PACE protocol (A) In general In issuing such regulations, the Secretary shall, to the extent consistent with the pro- visions of this section, incorporate the re- quirements applied to PACE demonstration waiver programs under the PACE protocol. (B) Flexibility In order to provide for reasonable flexi- bility in adapting the PACE service delivery model to the needs of particular organiza- tions (such as those in rural areas or those that may determine it appropriate to use nonstaff physicians according to State li- censing law requirements) under this section and section 1396u–4 of this title, the Sec- retary (in close consultation with State ad- ministering agencies) may modify or waive provisions of the PACE protocol so long as any such modification or waiver is not in- consistent with and would not impair the es- sential elements, objectives, and require- ments of this section, but may not modify or waive any of the following provisions: (i) The focus on frail elderly qualifying individuals who require the level of care provided in a nursing facility. (ii) The delivery of comprehensive, inte- grated acute and long-term care services. (iii) The interdisciplinary team approach to care management and service delivery. (iv) Capitated, integrated financing that allows the provider to pool payments re- ceived from public and private programs and individuals. (v) The assumption by the provider of full financial risk. (C) Continuation of modifications or waivers of operational requirements under dem- onstration status If a PACE program operating under dem- onstration authority has contractual or other operating arrangements which are not otherwise recognized in regulation and which were in effect on July 1, 2000, the Sec- retary (in close consultation with, and with the concurrence of, the State administering agency) shall permit any such program to continue such arrangements so long as such arrangements are found by the Secretary and the State to be reasonably consistent with the objectives of the PACE program. Page 3980 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395eee (3) Application of certain additional bene- ficiary and program protections (A) In general In issuing such regulations and subject to subparagraph (B), the Secretary may apply with respect to PACE programs, providers, and agreements such requirements of part C (or, for periods before January 1, 1999, sec- tion 1395mm of this title) and sections 1396b(m) and 1396u–2 of this title relating to protection of beneficiaries and program in- tegrity as would apply to Medicare+Choice organizations under part C (or for such peri- ods eligible organizations under risk-sharing contracts under section 1395mm of this title) and to medicaid managed care organizations under prepaid capitation agreements under section 1396b(m) of this title. (B) Considerations In issuing such regulations, the Secretary shall— (i) take into account the differences be- tween populations served and benefits pro- vided under this section and under part C (or, for periods before January 1, 1999, sec- tion 1395mm of this title) and section 1396b(m) of this title; (ii) not include any requirement that conflicts with carrying out PACE pro- grams under this section; and (iii) not include any requirement re- stricting the proportion of enrollees who are eligible for benefits under this sub- chapter or subchapter XIX. (4) Construction Nothing in this subsection shall be con- strued as preventing the Secretary from in- cluding in regulations provisions to ensure the health and safety of individuals enrolled in a PACE program under this section that are in addition to those otherwise provided under paragraphs (2) and (3). (g) Waivers of requirements With respect to carrying out a PACE program under this section, the following requirements of this subchapter (and regulations relating to such requirements) are waived and shall not apply: (1) Section 1395d of this title, insofar as it limits coverage of institutional services. (2) Sections 1395e, 1395f, 1395l, and 1395ww of this title, insofar as such sections relate to rules for payment for benefits. (3) Sections 1395f(a)(2)(B), 1395f(a)(2)(C), and 1395n(a)(2)(A) of this title, insofar as they limit coverage of extended care services or home health services. (4) Section 1395x(i) of this title, insofar as it imposes a 3-day prior hospitalization require- ment for coverage of extended care services. (5) Paragraphs (1) and (9) of section 1395y(a) of this title, insofar as they may prevent pay- ment for PACE program services to individ- uals enrolled under PACE programs. (h) Demonstration project for for-profit entities (1) In general In order to demonstrate the operation of a PACE program by a private, for-profit entity, the Secretary (in close consultation with State administering agencies) shall grant waivers from the requirement under sub- section (a)(3) that a PACE provider may not be a for-profit, private entity. (2) Similar terms and conditions (A) In general Except as provided under subparagraph (B), and paragraph (1), the terms and condi- tions for operation of a PACE program by a provider under this subsection shall be the same as those for PACE providers that are nonprofit, private organizations. (B) Numerical limitation The number of programs for which waivers are granted under this subsection shall not exceed 10. Programs with waivers granted under this subsection shall not be counted against the numerical limitation specified in subsection (e)(1)(B). (i) Miscellaneous provisions Nothing in this section or section 1396u–4 of this title shall be construed as preventing a PACE provider from entering into contracts with other governmental or nongovernmental payers for the care of PACE program eligible in- dividuals who are not eligible for benefits under part A, or enrolled under part B, or eligible for medical assistance under subchapter XIX of this title. (Aug. 14, 1935, ch. 531, title XVIII, § 1894, as added Pub. L. 105–33, title IV, § 4801, Aug. 5, 1997, 111 Stat. 528; amended Pub. L. 106–554, § 1(a)(6) [title IX, § 902(a)], Dec. 21, 2000, 114 Stat. 2763, 2763A–582; Pub. L. 108–173, title II, § 236(a)(2), Dec. 8, 2003, 117 Stat. 2210; Pub. L. 110–275, title I, § 161(c), July 15, 2008, 122 Stat. 2569; Pub. L. 111–148, title III, § 3201(i)(1), Mar. 23, 2010, 124 Stat. 453; Pub. L. 111–152, title I, § 1102(a), Mar. 30, 2010, 124 Stat. 1040.) Editorial Notes REFERENCES IN TEXT The Internal Revenue Code of 1986, referred to in sub- sec. (a)(3)(A)(i), is classified generally to Title 26, Inter- nal Revenue Code. Section 4804(b) of the Balanced Budget Act of 1997, re- ferred to in subsec. (a)(3)(B)(ii), is section 4804(b) of Pub. L. 105–33, which is set out as a note below. Section 603(c) of the Social Security Amendments of 1983, referred to in subsec. (a)(7)(A), is section 603(c) of Pub. L. 98–21, title VI, Apr. 20, 1983, 97 Stat. 168, which was not classified to the Code and was repealed by Pub. L. 105–33, title IV, § 4803(d), Aug. 5, 1997, 111 Stat. 550, subject to transition provisions. Section 9220 of the Consolidated Omnibus Budget Reconciliation Act of 1985, referred to in subsec. (a)(7)(A), is section 9220 of Pub. L. 99–272, title IX, Apr. 7, 1986, 100 Stat. 183, which was not classified to the Code and was repealed by Pub. L. 105–33, title IV, § 4803(d), Aug. 5, 1997, 111 Stat. 550, subject to transition provisions. Section 9412(b) of the Omnibus Budget Reconciliation Act of 1986, referred to in subsecs. (a)(7)(B) and (e)(1)(B)(i), is section 9412(b) of Pub. L. 99–509, title IX, Oct. 21, 1986, 100 Stat. 2062, which was not classified to the Code and was repealed by Pub. L. 105–33, title IV, § 4803(d), Aug. 5, 1997, 111 Stat. 550, subject to transition provisions. For the effective date of this section, referred to in subsec. (a)(9)(B), see section 4803 of Pub. L. 105–33, set out below. Page 3981 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395eee AMENDMENTS 2010—Subsecs. (h) to (j). Pub. L. 111–148, § 3201(i)(1), which directed addition of subsec. (h) and the redesig- nation of former subsecs. (h) and (i) as (i) and (j), re- spectively, was repealed by Pub. L. 111–152, § 1102(a). Prior to repeal, text of subsec. (h) read as follows: ‘‘With respect to a PACE program under this section, the following provisions (and regulations relating to such provisions) shall not apply: ‘‘(1) Section 1395w–23(j)(1)(A)(i) of this title, relat- ing to MA area-specific non-drug monthly benchmark amount being based on competitive bids. ‘‘(2) Section 1395w–23(d)(5) of this title, relating to the establishment of MA local plan service areas. ‘‘(3) Section 1395w–23(n) of this title, relating to the payment of performance bonuses. ‘‘(4) Section 1395w–23(o) of this title, relating to grandfathering supplemental benefits for current en- rollees after implementation of competitive bidding. ‘‘(5) Section 1395w–23(p) of this title, relating to transitional extra benefits.’’ See Effective Date of 2010 Amendment note below. 2008—Subsec. (d)(3). Pub. L. 110–275 added par. (3). 2003—Subsec. (b)(3), (4). Pub. L. 108–173 added pars. (3) and (4). 2000—Subsec. (f)(2)(C). Pub. L. 106–554 added subpar. (C). Statutory Notes and Related Subsidiaries CHANGE OF NAME References to Medicare+Choice deemed to refer to Medicare Advantage or MA, subject to an appropriate transition provided by the Secretary of Health and Human Services in the use of those terms, see section 201 of Pub. L. 108–173, set out as a note under section 1395w–21 of this title. EFFECTIVE DATE OF 2010 AMENDMENT Repeal of section 3201 of Pub. L. 111–148 and the amendments made by such section, effective as if in- cluded in the enactment of Pub. L. 111–148, see section 1102(a) of Pub. L. 111–152, set out as a note under sec- tion 1395w–21 of this title. EFFECTIVE DATE OF 2003 AMENDMENT Amendment by Pub. L. 108–173 applicable to services furnished on or after Jan. 1, 2004, see section 236(c) of Pub. L. 108–173, set out as a note under section 1395cc of this title. EFFECTIVE DATE OF 2000 AMENDMENT Pub. L. 106–554, § 1(a)(6) [title IX, § 902(c)], Dec. 21, 2000, 114 Stat. 2763, 2763A–583, provided that: ‘‘The amendments made by this section [amending this sec- tion and section 1396u–4 of this title] shall be effective as [if] included in the enactment of BBA [Pub. L. 105–33].’’ RURAL PACE PROVIDER GRANT PROGRAM Pub. L. 109–171, title V, § 5302, Feb. 8, 2006, 120 Stat. 51, as amended by Pub. L. 109–432, div. B, title II, § 205(a), Dec. 20, 2006, 120 Stat. 2989, provided that: ‘‘(a) DEFINITIONS.—In this section: ‘‘(1) CMS.—The term ‘CMS’ means the Centers for Medicare & Medicaid Services. ‘‘(2) PACE PROGRAM.—The term ‘PACE program’ has the meaning given that term in sections 1894(a)(2) and 1934(a)(2) of the Social Security Act (42 U.S.C. 1395eee(a)(2); 1396u–4(a)(2)). ‘‘(3) PACE PROVIDER.—The term ‘PACE provider’ has the meaning given that term in section 1894(a)(3) or 1934(a)(3) of the Social Security Act (42 U.S.C. 1395eee(a)(3); 1396u–4(a)(3)). ‘‘(4) RURAL AREA.—The term ‘rural area’ has the meaning given that term in section 1886(d)(2)(D) of the Social Security Act (42 U.S.C. 1395ww(d)(2)(D)). ‘‘(5) RURAL PACE PILOT SITE.—The term ‘rural PACE pilot site’ means a PACE provider that has been ap- proved to provide services in a geographic service area that is, in whole or in part, a rural area, and that has received a site development grant under this section. ‘‘(6) SECRETARY.—The term ‘Secretary’ means the Secretary of Health and Human Services. ‘‘(b) SITE DEVELOPMENT GRANTS AND TECHNICAL AS- SISTANCE PROGRAM.— ‘‘(1) SITE DEVELOPMENT GRANTS.— ‘‘(A) IN GENERAL.—The Secretary shall establish a process and criteria to award site development grants to qualified PACE providers that have been approved to serve a rural area. ‘‘(B) AMOUNT PER AWARD.—A site development grant awarded under subparagraph (A) to any indi- vidual rural PACE pilot site shall not exceed $750,000. ‘‘(C) NUMBER OF AWARDS.—Not more than 15 rural PACE pilot sites shall be awarded a site develop- ment grant under subparagraph (A). ‘‘(D) USE OF FUNDS.—Funds made available under a site development grant awarded under subpara- graph (A) may be used for the following expenses only to the extent such expenses are incurred in re- lation to establishing or delivering PACE program services in a rural area: ‘‘(i) Feasibility analysis and planning. ‘‘(ii) Interdisciplinary team development. ‘‘(iii) Development of a provider network, in- cluding contract development. ‘‘(iv) Development or adaptation of claims proc- essing systems. ‘‘(v) Preparation of special education and out- reach efforts required for the PACE program. ‘‘(vi) Development of expense reporting required for calculation of outlier payments or reconcili- ation processes. ‘‘(vii) Development of any special quality of care or patient satisfaction data collection ef- forts. ‘‘(viii) Establishment of a working capital fund to sustain fixed administrative, facility, or other fixed costs until the provider reaches sufficient enrollment size. ‘‘(ix) Startup and development costs incurred prior to the approval of the rural PACE pilot site’s PACE provider application by CMS. ‘‘(x) Any other efforts determined by the rural PACE pilot site to be critical to its successful startup, as approved by the Secretary. ‘‘(E) APPROPRIATION.— ‘‘(i) IN GENERAL.—Out of funds in the Treasury not otherwise appropriated, there are appro- priated to the Secretary to carry out this sub- section for fiscal year 2006, $7,500,000. ‘‘(ii) AVAILABILITY.—Funds appropriated under clause (i) shall remain available for expenditure through fiscal year 2008. ‘‘(2) TECHNICAL ASSISTANCE PROGRAM.—The Sec- retary shall establish a technical assistance program to provide— ‘‘(A) outreach and education to State agencies and provider organizations interested in estab- lishing PACE programs in rural areas; and ‘‘(B) technical assistance necessary to support rural PACE pilot sites. ‘‘(c) COST OUTLIER PROTECTION FOR RURAL PACE PILOT SITES.— ‘‘(1) ESTABLISHMENT OF FUND FOR REIMBURSEMENT OF OUTLIER COSTS.—Notwithstanding any other provision of law, the Secretary shall establish an outlier fund to reimburse rural PACE pilot sites for recognized outlier costs (as defined in paragraph (3)) incurred for eligible outlier participants (as defined in paragraph (2)) in an amount, subject to paragraph (4), equal to 80 percent of the amount by which the recognized outlier costs exceeds $50,000. ‘‘(2) ELIGIBLE OUTLIER PARTICIPANT.—For purposes of this subsection, the term ‘eligible outlier partici- pant’ means a PACE program eligible individual (as Page 3982 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395eee defined in sections 1894(a)(5) and 1934(a)(5) of the So- cial Security Act (42 U.S.C. 1395eee(a)(5); 1396u–4(a)(5))) who resides in a rural area and with re- spect to whom the rural PACE pilot site incurs more than $50,000 in recognized costs in a 12-month period. ‘‘(3) RECOGNIZED OUTLIER COSTS DEFINED.— ‘‘(A) IN GENERAL.—For purposes of this sub- section, the term ‘recognized outlier costs’ means, with respect to services furnished to an eligible outlier participant by a rural PACE pilot site, the least of the following (as documented by the site to the satisfaction of the Secretary) for the provision of inpatient and related physician and ancillary services for the eligible outlier participant in a given 12-month period: ‘‘(i) If the services are provided under a con- tract between the pilot site and the provider, the payment rate specified under the contract. ‘‘(ii) The payment rate established under the original Medicare fee-for-service program for such service. ‘‘(iii) The amount actually paid for the services by the pilot site. ‘‘(B) INCLUSION IN ONLY ONE PERIOD.—Recognized outlier costs may not be included in more than one 12-month period. ‘‘(3)[two pars. (3) have been enacted] OUTLIER EX- PENSE PAYMENT.— ‘‘(A)[no subpar. (B) has been enacted] PAYMENT FOR OUTLIER COSTS.—Subject to subparagraph (B), in the case of a rural PACE pilot site that has in- curred outlier costs for an eligible outlier partici- pant, the rural PACE pilot site shall receive an outlier expense payment equal to 80 percent of such costs that exceed $50,000. ‘‘(4) LIMITATIONS.— ‘‘(A) COSTS INCURRED PER ELIGIBLE OUTLIER PAR- TICIPANT.—The total amount of outlier expense pay- ments made under this subsection to a rural PACE pilot site with respect to an eligible outlier partici- pant for any 12-month period shall not exceed $100,000 for the 12-month period used to calculate the payment. ‘‘(B) COSTS INCURRED PER PROVIDER.—No rural PACE pilot site may receive more than $500,000 in total outlier expense payments in a 12-month pe- riod. ‘‘(C) LIMITATION OF OUTLIER COST REIMBURSEMENT PERIOD.—A rural PACE pilot site shall only receive outlier expense payments under this subsection with respect to costs incurred during the first 3 years of the site’s operation. ‘‘(5) REQUIREMENT TO ACCESS RISK RESERVES PRIOR TO PAYMENT.—A rural PACE pilot site shall access and exhaust any risk reserves held or arranged for the provider (other than revenue or reserves main- tained to satisfy the requirements of section 460.80(c) of title 42, Code of Federal Regulations) and any working capital established through a site develop- ment grant awarded under subsection (b)(1), prior to receiving any payment from the outlier fund. ‘‘(6) APPLICATION.—In order to receive an outlier ex- pense payment under this subsection with respect to an eligible outlier participant, a rural PACE pilot site shall submit an application containing— ‘‘(A) documentation of the costs incurred with re- spect to the participant; ‘‘(B) a certification that the site has complied with the requirements under paragraph (4); and ‘‘(C) such additional information as the Secretary may require. ‘‘(7) APPROPRIATION.— ‘‘(A) IN GENERAL.—Out of funds in the Treasury not otherwise appropriated, there are appropriated to the Secretary $10,000,000 to carry out this sub- section for the period of fiscal years 2006 through 2010. ‘‘(B) AVAILABILITY.—Funds appropriated under subparagraph (A) shall remain available for obliga- tion through fiscal year 2010. ‘‘(d) EVALUATION OF PACE PROVIDERS SERVING RURAL SERVICE AREAS.—Not later than 60 months after the date of enactment of this Act [Feb. 8, 2006], the Sec- retary shall submit a report to Congress containing an evaluation of the experience of rural PACE pilot sites. ‘‘(e) AMOUNTS IN ADDITION TO PAYMENTS UNDER SO- CIAL SECURITY ACT.—Any amounts paid under the au- thority of this section to a PACE provider shall be in addition to payments made to the provider under sec- tion 1894 or 1934 of the Social Security Act (42 U.S.C. 1395eee; 1396u–4).’’ FLEXIBILITY IN EXERCISING WAIVER AUTHORITY Pub. L. 106–554, § 1(a)(6) [title IX, § 903], Dec. 21, 2000, 114 Stat. 2763, 2763A–583, provided that: ‘‘In applying sections 1894(f)(2)(B) and 1934(f)(2)(B) of the Social Secu- rity Act (42 U.S.C. 1395eee(f)(2)(B), 1396u–4(f)(2)(B)), the Secretary of Health and Human Services— ‘‘(1) shall approve or deny a request for a modifica- tion or a waiver of provisions of the PACE protocol not later than 90 days after the date the Secretary re- ceives the request; and ‘‘(2) may exercise authority to modify or waive such provisions in a manner that responds promptly to the needs of PACE programs relating to areas of employment and the use of community-based pri- mary care physicians.’’ TRANSITION; REGULATIONS Pub. L. 105–33, title IV, § 4803, Aug. 5, 1997, 111 Stat. 549, as amended by Pub. L. 106–554, § 1(a)(6) [title IX, § 901], Dec. 21, 2000, 114 Stat. 2763, 2763A–582, provided that: ‘‘(a) TIMELY ISSUANCE OF REGULATIONS; EFFECTIVE DATE.—The Secretary of Health and Human Services shall promulgate regulations to carry out this subtitle [subtitle I (§§ 4801–4804) of title IV of Pub. L. 105–33, en- acting this section and section 1396u–4 of this title, amending sections 1396b, 1396d, 1396r–5, and 1396v of this title, and enacting provisions set out as notes under this section and section 1395b–6 of this title] in a timely manner. Such regulations shall be designed so that en- tities may establish and operate PACE programs under sections 1894 and 1934 of the Social Security Act [42 U.S.C. 1395eee, 1396u–4] (as added by sections 4801 and 4802 of this subtitle) for periods beginning not later than 1 year after the date of the enactment of this Act [Aug. 5, 1997]. ‘‘(b) EXPANSION AND TRANSITION FOR PACE DEM- ONSTRATION PROJECT WAIVERS.— ‘‘(1) EXPANSION IN CURRENT NUMBER AND EXTENSION OF DEMONSTRATION PROJECTS.—Section 9412(b) of the Omnibus Budget Reconciliation Act of 1986 [see sub- sec. (d) below], as amended by section 4118(g) of the Omnibus Budget Reconciliation Act of 1987, is amend- ed— ‘‘(A) in paragraph (1), by inserting before the pe- riod at the end the following: ‘, except that the Secretary shall grant waivers of such requirements to up to the applicable numerical limitation speci- fied in sections 1894(e)(1)(B) and 1934(e)(1)(B) of the Social Security Act’ [42 U.S.C. 1395eee(e)(1)(B), 1396u–4(e)(1)(B)]; and ‘‘(B) in paragraph (2)— ‘‘(i) in subparagraph (A), by striking ‘, including permitting the organization to as- sume progressively (over the initial 3-year period of the waiver) the full financial risk’; and ‘‘(ii) in subparagraph (C), by adding at the end the following: ‘In granting further extensions, an organization shall not be required to provide for reporting of information which is only required because of the demonstration nature of the project.’ ‘‘(2) ELIMINATION OF REPLICATION REQUIREMENT.— Section 9412(b)(2)(B) of such Act, as so amended, shall not apply to waivers granted under such section after the date of the enactment of this Act [Aug. 5, 1997]. ‘‘(3) TIMELY CONSIDERATION OF APPLICATIONS.—In considering an application for waivers under such Page 3983 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395fff section before the effective date of the repeals under subsection (d), subject to the numerical limitation under the amendment made by paragraph (1), the ap- plication shall be deemed approved unless the Sec- retary of Health and Human Services, within 90 days after the date of its submission to the Secretary, ei- ther denies such request in writing or informs the ap- plicant in writing with respect to any additional in- formation which is needed in order to make a final determination with respect to the application. After the date the Secretary receives such additional infor- mation, the application shall be deemed approved un- less the Secretary, within 90 days of such date, denies such request. ‘‘(c) PRIORITY AND SPECIAL CONSIDERATION IN APPLICA- TION.—During the 3-year period beginning on the date of the enactment of this Act [Aug. 5, 1997]: ‘‘(1) PROVIDER STATUS.—The Secretary of Health and Human Services shall give priority in processing applications of entities to qualify as PACE programs under section 1894 or 1934 of the Social Security Act [42 U.S.C. 1395eee, 1396u–4]— ‘‘(A) first, to entities that are operating a PACE demonstration waiver program (as defined in sec- tions 1894(a)(7) and 1934(a)(7) of such Act [42 U.S.C. 1395eee(a)(7), 1396u–4(a)(7)]); and ‘‘(B) then to entities that have applied to operate such a program as of May 1, 1997. ‘‘(2) NEW WAIVERS.—The Secretary shall give pri- ority, in the awarding of additional waivers under section 9412(b) of the Omnibus Budget Reconciliation Act of 1986 [see subsec. (d) below]— ‘‘(A) to any entities that have applied for such waivers under such section as of May 1, 1997; and ‘‘(B) to any entity that, as of May 1, 1997, has for- mally contracted with a State to provide services for which payment is made on a capitated basis with an understanding that the entity was seeking to become a PACE provider. ‘‘(3) SPECIAL CONSIDERATION.—The Secretary shall give special consideration, in the processing of appli- cations described in paragraph (1) and the awarding of waivers described in paragraph (2), to an entity which as of May 1, 1997, through formal activities (such as entering into contracts for feasibility stud- ies) has indicated a specific intent to become a PACE provider. ‘‘(d) REPEAL OF CURRENT PACE DEMONSTRATION PROJECT WAIVER AUTHORITY.— ‘‘(1) IN GENERAL.—Subject to paragraph (2), the fol- lowing provisions of law are repealed: ‘‘(A) Section 603(c) of the Social Security Amend- ments of 1983 (Public Law 98–21) [97 Stat. 168]. ‘‘(B) Section 9220 of the Consolidated Omnibus Budget Reconciliation Act of 1985 (Public Law 99–272) [100 Stat. 183]. ‘‘(C) Section 9412(b) of the Omnibus Budget Rec- onciliation Act of 1986 (Public Law 99–509) [100 Stat. 2062]. ‘‘(2) DELAY IN APPLICATION TO CURRENT WAIVERS.— ‘‘(A) IN GENERAL.—Subject to subparagraph (B), in the case of waivers granted with respect to a PACE program before July 1, 2000, the repeals made by paragraph (1) shall not apply until the end of a transition period (of up to 36 months) that begins on the initial effective date of such regulations, and that allows sufficient time for an orderly transition from demonstration project authority to general authority provided under the amendments made by this subtitle [subtitle I (§§ 4801–4804) of title IV of Pub. L. 105–33, enacting this section and section 1396u–4 of this title and amending sections 1396b, 1396d, 1396r–5, and 1396v of this title]. ‘‘(B) STATE OPTION TO SEEK EXTENSION OF CURRENT PERIOD.—A State may elect to maintain the PACE programs which (as of the date of the enactment of this Act [Aug. 5, 1997]) were operating in the State under the authority described in paragraph (1) until a date (specified by the State) that is not later than 4 years after the initial effective date of regulations described in subsection (a). If a State makes such an election, the repeals made by paragraph (1) shall not apply to the programs until the date so speci- fied, but only so long as such programs continue to operate under the same terms and conditions as apply to such programs as of the date of the enact- ment of this Act, and subparagraph (A) shall not apply to such programs.’’ PACE PROGRAMS; STUDY AND REPORTS Pub. L. 105–33, title IV, § 4804(a), (b), Aug. 5, 1997, 111 Stat. 551, provided that: ‘‘(a) STUDY.— ‘‘(1) IN GENERAL.—The Secretary of Health and Human Services (in close consultation with State ad- ministering agencies, as defined in sections 1894(a)(8) and 1934(a)(8) of the Social Security Act [42 U.S.C. 1395eee(a)(8), 1396u–4(a)(8)]) shall conduct a study of the quality and cost of providing PACE program serv- ices under the medicare and medicaid programs under the amendments made by this subtitle [subtitle I (§§ 4801–4804) of title IV of Pub. L. 105–33, enacting this section and section 1396u–4 of this title and amending sections 1396b, 1396d, 1396r–5, and 1396v of this title]. ‘‘(2) STUDY OF PRIVATE, FOR-PROFIT PROVIDERS.— Such study shall specifically compare the costs, qual- ity, and access to services by entities that are pri- vate, for-profit entities operating under demonstra- tion projects waivers granted under sections 1894(h) and 1934(h) of the Social Security Act [42 U.S.C. 1395eee(h), 1396u–4(h)] with the costs, quality, and ac- cess to services of other PACE providers. ‘‘(b) REPORT.— ‘‘(1) IN GENERAL.—Not later than 4 years after the date of the enactment of this Act [Aug. 5, 1997], the Secretary shall provide for a report to Congress on the impact of such amendments on quality and cost of services. The Secretary shall include in such report such recommendations for changes in the operation of such amendments as the Secretary deems appro- priate. ‘‘(2) TREATMENT OF PRIVATE, FOR-PROFIT PRO- VIDERS.—The report shall include specific findings on whether any of the following findings is true: ‘‘(A) The number of covered lives enrolled with entities operating under demonstration project waivers under sections 1894(h) and 1934(h) of the So- cial Security Act is fewer than 800 (or such lesser number as the Secretary may find statistically suf- ficient to make determinations respecting findings described in the succeeding subparagraphs). ‘‘(B) The population enrolled with such entities is less frail than the population enrolled with other PACE providers. ‘‘(C) Access to or quality of care for individuals enrolled with such entities is lower than such ac- cess or quality for individuals enrolled with other PACE providers. ‘‘(D) The application of such section has resulted in an increase in expenditures under the medicare or medicaid programs above the expenditures that would have been made if such section did not apply.’’ § 1395fff. Prospective payment for home health services (a) In general Notwithstanding section 1395x(v) of this title, the Secretary shall provide, for portions of cost reporting periods occurring on or after October 1, 2000, for payments for home health services in accordance with a prospective payment system established by the Secretary under this section. (b) System of prospective payment for home health services (1) In general The Secretary shall establish under this sub- section a prospective payment system for pay-