PUBLIC LAW 105-33—AUG. 5, 1997 111 STAT. 541 of this section) during which an entity has operated a PACE demonstration waiver program shall be counted under subparagraph (A) as a contract year during which the entity operated a PACE program as a PACE provider under a PACE program agreement. "(10) REGULATIONS.— For purposes of this section, the term 'regulations' refers to interim final or final regulations promulgated under subsection (f) to carry out this section and section 1894. "(b) SCOPE OF BENEFITS; BENEFICIARY SAFEGUARDS. — "(1) IN GENERAL. —Under a PACE program agreement, a PACE provider shall— "(A) provide to PACE program eligible individuals, regardless of source of payment and directly or under contracts with other entities, at a minimum— "(i) all items and services covered under title XVIII (for individuals enrolled under section 1894) and all items and services covered under this title, but without any limitation or condition as to amount, duration, or scope and without application of deductibles, copay- ments, coinsurance, or other cost-sharing that would otherwise apply under such title or this 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 assurance 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 designed for the protection of patients. " (c) ELIGIBILITY DETERMINATIONS.— "(1) IN GENERAL. — The determination of— "(A) whether an individual is a PACE program eligible individual shall be made under and in accordance with the PACE program agreement, and "(B) who is entitled to medical assistance under this title shall be made (or who is not so entitled, may be made) by the State administering agency.
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