Patient Assistance Related Functions. a. PSI’s systems, policies, processes, and procedures relating to Patient Assistance Related Functions. This review shall include an assessment of the following: i. PSI’s systems, policies, and practices for ensuring that PSI and the officers, directors, employees and agents of PSI are independent from and do not have any conflicts of interest with Donors or potential Donors. ii. PSI’s systems, policies, and practices relating to disease funds, including: (a) the systems, policies, and practices that PSI uses to establish, delineate, and modify any disease fund. This includes the bases upon which PSI makes decisions about funds (as referenced in Section III.F.1.c of the IA), the definition and type of disease funds, the scope of coverage for disease funds (as referenced in Section III.F.1.d of the IA), the Notification List practices (as referenced in Section III.F.1.f) and the drug coverage methodology used by PSI in connection with its funds (as outlined in Section III.F.1.g); and (b) PSI’s documentation and recordkeeping practices relating to disease funds as outlined in Section III.F.1. iii. PSI’s systems, policies, and practices as they relate to interactions with Donors and potential Donors, including: (a) interactions relating to seeking or receiving donations for any fund (as referenced in Section III.F.2.c); (b) interactions relating to requests for or the provision of data to any Donor (as referenced in Section III.F.2.b); and (c) PSI’s documentation and recordkeeping practices relating to interactions with Donors (as outlined in Section III.F.2). iv. PSI’s systems, policies, and practices as they relate to providing financial assistance to patients, including: (a) the systems, policies, and practices that PSI utilizes in connection with its Screening Process for determining patient eligibility for assistance (as referenced in Sections III.F.3.a-c); (b) the systems, policies, and practices relating to PSI’s award of assistance to patients and the communication about decisions to award financial assistance (as referenced in Sections III.F.3.d and e); and (c) PSI’s documentation and recordkeeping practices relating to providing assistance to patients (as referenced in Section III.F.3).
Appears in 1 contract
Sources: Integrity Agreement
Patient Assistance Related Functions. a. PSITAF’s systems, policies, processes, and procedures relating to Patient Assistance Related Functions. This review shall include an assessment of the following:following:
i. PSITAF’s systems, policies, and practices for ensuring that PSI TAF and the officers, directors, employees and agents of PSI TAF are independent from and do not have any conflicts of interest with Donors or potential Donors.
ii. PSITAF’s systems, policies, and practices relating to disease funds, including:
(a) the systems, policies, and practices that PSI TAF uses to establish, delineate, and modify any disease fund. This includes the bases upon which PSI TAF makes decisions about funds (as referenced in Section III.F.1.c of the IA), the definition and type of disease funds, the scope of coverage for disease funds (as referenced in Section III.F.1.d of the IASection III.F.1.d), the Notification List practices (as referenced in Section III.F.1.f) and the drug coverage methodology used by PSI TAF in connection with its funds (as outlined in Section III.F.1.g); and
(b) PSITAF’s documentation and recordkeeping practices relating to disease funds as outlined in Section III.F.1.III.F.1.
iii. PSITAF’s systems, policies, and practices as they relate to interactions with Donors and potential Donors, including:
(a) interactions relating to seeking or receiving donations for any fund (as referenced in Section III.F.2.c);
(b) interactions relating to requests for or the provision of data to any Donor (as referenced in Section III.F.2.b); and
(c) PSITAF’s documentation and recordkeeping practices relating to interactions with Donors (as outlined in Section III.F.2).
iv. PSITAF’s systems, policies, and practices as they relate to providing financial assistance to patients, including:
(a) the systems, policies, and practices that PSI TAF utilizes in connection with its Screening Process for determining patient eligibility for assistance (as referenced in Sections III.F.3.a-c);
(b) the systems, policies, and practices relating to PSITAF’s award of assistance to patients and the communication about decisions to award financial assistance (as referenced in Sections III.F.3.d and e); and
(c) PSITAF’s documentation and recordkeeping practices relating to providing assistance to patients (as referenced reference in Section III.F.3).
Appears in 1 contract
Sources: Integrity Agreement