Page:United States Statutes at Large Volume 111 Part 1.djvu/558

 Ill STAT. 534 PUBLIC LAW 105-33—AUG. 5, 1997 Records. Reports. "(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 agreement); "(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 regulations. "(B) SERVICE AREA OVERLAP.—In designating a service area under a PACE program agreement under subparagraph (A)(i), the Secretary (in consultation with the State administering agency) may exclude from designation an area that is already covered under another PACE program agreement, in order to avoid unnecessary duplication of services and avoid impairing the financial and service viability of an existing program. " (3) DATA COLLECTION; DEVELOPMENT OF OUTCOME MEAS- URES. — " (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 access to, the records relating to the program, including pertinent financial, medical, and personnel records; and "(III) make available to the Secretary and the State administering agency reports that the Secretary finds (in consultation with State administering agencies) necessary to monitor the operation, cost, and effectiveness of the PACE program under this section and section 1934. " (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 eligible individuals. " (4) OVERSIGHT. — " (A) ANNUAL, CLOSE OVERSIGHT DURING TRIAL PERIOD.— During the trial period (as defined in subsection (a)(9)) with respect to a PACE program operated by a PACE provider, the Secretary (in cooperation with the State administering agency) shall conduct a comprehensive annual review of the operation of the PACE program by

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