PUBLIC LAW 105-33 —AUG. 5, 1997 111 STAT. 547 approved unless the Secretary, 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 1894. "(2) USE OF PACE PROTOCOL.— "(A) IN GENERAL.—In issuing such regulations, the Secretary shall, to the extent consistent with the provisions of this section, incorporate the requirements applied to PACE demonstration waiver programs under the PACE protocol. "(B) FLEXIBILITY.—In order to provide for reasonable flexibility in adapting the PACE service delivery model to the needs of particular organizations (such as those in rural areas or those that may determine it appropriate to use nonstaff physicians according to State licensing law requirements) under this section and section 1894, the Secretary (in close consultation with State administering agencies) may modify or waive provisions of the PACE protocol so long as any such modification or waiver is not inconsistent with and would not impair the essential elements, objectives, and requirements 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, integrated 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 received from public and private programs and individuals. "(v) The assumption by the provider of full financial risk. " (3) APPLICATION OF CERTAIN ADDITIONAL BENEFICIARY 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 of title XVIII (or, for periods before January 1, 1999, section 1876) and sections 1903(m) and 1932 relating to protection of beneficiaries and program integrity as would apply to Medicare+Choice organizations under such part C (or for such periods eligible organizations under risk-sharing contracts under section 1876) and to medicaid managed care organizations under prepaid capitation agreements under section 1903(m). "(B) CONSIDERATIONS.— In issuing such regulations, the Secretary shall— "(i) take into account the differences between populations served and benefits provided under this section and under part C of title XVIII (or, for periods before January 1, 1999, section 1876) and section 1903(m); "(ii) not include any requirement that conflicts with carrying out PACE programs under this section; and
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