PUBLIC LAW 105-33 —AUG. 5, 1997 111 STAT. 531 or scope and without application of deductibles, copay- ments, coinsurance, or other cost-sharing that would otherwise apply under this title or such title, 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 necessary 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 entity, and to arrange for delivery of those items and services through contracts meeting the requirements of regulations. " (2) QUALITY ASSURANCE; PATIENT SAFEGUARDS. — The PACE program agreement shall require the PACE provider to have in effect at a minimum— "(A) a written plan of quality assursmce and improvement, and procedures implementing such plan, in accordance with regulations; and "(B) written safeguards of the rights of enrolled participants (including a patient bill of rights and procedures for grievances and appeals) in accordance with regulations and with other requirements of this title and Federal and State law that are designed for the protection of patients. " (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 title 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 eligible individusJ (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 accordance with regulations, to be comparable to the health status of individuals who have participated in the PACE demonstration waiver programs. Such determination shall be based upon information on health status and related indicators (such as medical diagnoses and measures of activities of daily living, instrumental activities of daily living, and cognitive impairment) that are part of a uniform minimum data set collected by PACE providers on potential PACE program eligible individuals. "(3) ANNUAL ELIGIBILITY RECERTIFICATIONS. — " (A) IN GENERAL. —Subject to subparagraph (B), the determination 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 during a period in accordance with regulations in those cases where the
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