Patient Assistance Related Functions. For each of the Reviewed Policies and Procedures identified in Section II.A.1 above, the report shall include the following items:
1. a description of the documentation (including policies) reviewed and any personnel interviewed;
2. a detailed description of Good Days’ systems, policies, processes, and procedures relating to the items identified in Section II.A.1 above, including a general description of Good Days’ control and accountability systems (e.g., documentation and approval requirements, and tracking mechanisms) and written policies regarding the Reviewed Policies and Procedures;
3. a description of the manner in which the control and accountability systems and the written policies relating to the items identified in Section II.A.1 above are made known or disseminated within Good Days;
4. findings and supporting rationale regarding any weaknesses in Good Days’ systems, processes, policies, and procedures relating to the Reviewed Policies and Procedures, if any; and
5. recommendations to improve any of the systems, policies, processes, or procedures relating to the Reviewed Policies and Procedures, if any.
Patient Assistance Related Functions a. TAF’s systems, policies, processes, and procedures relating to Patient Assistance Related Functions. This review shall include an assessment of the following:
i. TAF’s systems, policies, and practices for ensuring that TAF and the officers, directors, employees and agents of TAF are independent from and do not have any conflicts of interest with Donors or potential Donors.
ii. TAF’s systems, policies, and practices relating to disease funds, including:
(a) the systems, policies, and practices that TAF uses to establish, delineate, and modify any disease fund. This includes the bases upon which 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), the Notification List practices (as referenced in Section III.F.1.f) and the drug coverage methodology used by TAF in connection with its funds (as outlined in Section III.F.1.g); and
(b) TAF’s documentation and recordkeeping practices relating to disease funds as outlined in Section III.F.1.
iii. TAF’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) TAF’s documentation and recordkeeping practices relating to interactions with Donors (as outlined in Section III.F.2).
iv. TAF’s systems, policies, and practices as they relate to providing financial assistance to patients, including:
(a) the systems, policies, and practices that 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 TAF’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) TAF’s documentation and recordkeeping practices relating to providing assistance to patients (as reference in Section III.F.3).
Patient Assistance Related Functions.
1) Pfizer’s systems, policies, processes, and procedures relating to arrangements and interactions with (including donations to and sponsorship of) Independent Charity PAPs. This review shall include an assessment of the following:
a. Pfizer’s organizational structure as it relates to arrangements and interactions with Independent Charity PAPS, including:
i. the identification of those individuals, departments, or groups within Pfizer (e.g., the Independent Charity Group, legal, compliance) that have responsibility for, or involvement with, such arrangements and interactions;
ii. the respective scope and nature of the responsibilities of each individual, department, or group with responsibility for, or involvement with, arrangements and interactions with Independent Charity PAPs;
iii. the identification of those individuals, departments, or groups within Pfizer (e.g., the commercial business units) that are precluded from involvement with arrangements and interactions with Independent Charity PAPs; and
iv. methods that Pfizer uses to separate Independent Charity PAP- related responsibilities from the commercial business units.
b. Pfizer’s written policies and procedures as they relate to arrangements and interactions with Independent Charity PAPs, including:
i. the criteria governing whether and under what circumstances Pfizer would donate to an Independent Charity PAP or any specific disease state fund of such a PAP;
ii. communications (including any limitations on such communications) between any representatives of Pfizer and any Independent Charity PAP (including the identity of individuals authorized to engage in such communications, the circumstances of such communications, and the subject matter of such communications including the exchange of any data);
iii. communications (including any limitations on such communications) between those individuals, departments, or groups within Pfizer with responsibility for Independent Charity PAPs and the commercial business units of Pfizer (including the identity of individuals authorized to engage in such communications, the circumstances of such communications, and the subject matter of such communications); and
iv. communications (including any limitations on such communications) between representatives of Pfizer and health care providers or patients regarding assistance available through any Independent Charity PAP.
c. Pfizer’s policies and practices as they relate to the budgeting process applicabl...
Patient Assistance Related Functions.
1. PANF’s systems, policies, processes, and procedures relating to Patient Assistance Related Functions. This review shall include an assessment of the following:
a. PANF’s systems, policies, and practices for ensuring that PANF and the officers, directors, employees and agents of PANF are independent from and do not have any conflicts of interest with Donors or potential Donors, including:
(1) the systems, policies, and practices relating to disclosure and recusal by directors who may have a conflict of interest relating to any particular decision of the Board of directors.
b. PANF’s systems, policies, and practices relating to disease funds, including:
(1) the systems, policies, and practices that PANF uses to establish, delineate, and modify any disease fund. This includes the bases upon which PANF 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
Patient Assistance Related Functions. For each of the Reviewed Policies and Procedures identified in Section II.A.1 above, the report shall include the following items:
a. a description of the documentation (including policies) reviewed and any personnel interviewed;
b. a detailed description of PSI’s systems, policies, processes, and procedures relating to the items identified in Section II.A.1 above, including a general description of PSI’s control and accountability systems (e.g., documentation and approval requirements, and tracking mechanisms) and written policies regarding the Reviewed Policies and Procedures;
c. a description of the manner in which the control and accountability systems and the written policies relating to the items identified in Section II.A.1 above are made known or disseminated within PSI;
d. findings and supporting rationale regarding any weaknesses in PSI’s systems, processes, policies, and procedures relating to the Reviewed Policies and Procedures, if any; and
e. recommendations to improve any of the systems, policies, processes, or procedures relating to the Reviewed Policies and Procedures, if any.
Patient Assistance Related Functions.
1. Good Days’ systems, policies, processes, and procedures relating to Patient Assistance Related Functions. This review shall include an assessment of the following:
a. Good Days’ systems, policies, and practices for ensuring that Good Days and the officers, directors, employees and agents of Good Days are independent from and do not have any conflicts of interest with Donors or potential Donors.
b. Good Days’ systems, policies, and practices relating to disease funds, including:
(1) the systems, policies, and practices that Good Days uses to establish, delineate, and modify any disease fund. This includes the bases upon which Good Days 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), the Notification List practices (as referenced in Section III.F.1.f) and the drug coverage methodology used by Good Days in connection with its funds (as outlined in Section III.F.1.g); and
(2) Good Days’ documentation and recordkeeping practices relating to disease funds as outlined in Section III.F.1.
c. Good Days’ systems, policies, and practices as they relate to interactions with Donors and potential Donors, including:
(1) interactions relating to seeking or receiving donations for any fund (as referenced in Section III.F.2.c);
(2) interactions relating to requests for or the provision of data to any Donor (as referenced in Section III.F.2.b); and
(3) Good Days’ documentation and recordkeeping practices relating to interactions with Xxxxxx (as outlined in Section III.F.2).
d. Good Days’ systems, policies, and practices as they relate to providing financial assistance to patients, including:
(1) the systems, policies, and practices that Good Days utilizes in connection with its Screening Process for determining patient eligibility for assistance (as referenced in Sections III.F.3.a-c);
(2) the systems, policies, and practices relating to Good Days’ 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
(3) Good Days’ documentation and recordkeeping practices relating to providing assistance to patients (as reference in Section III.F.3).
Patient Assistance Related Functions. For each of the Reviewed Policies and Procedures identified in Section II.A.1 above, the report shall include the following items:
a. a description of the documentation (including policies) reviewed and any personnel interviewed;
b. a detailed description of TAF’s systems, policies, processes, and procedures relating to the items identified in Section II.A.1 above, including a general description of TAF’s control and accountability systems (e.g., documentation and approval requirements, and tracking mechanisms) and written policies regarding the Reviewed Policies and Procedures;
c. a description of the manner in which the control and accountability systems and the written policies relating to the items identified in Section II.A.1 above are made known or disseminated within TAF;
d. findings and supporting rationale regarding any weaknesses in TAF’s systems, processes, policies, and procedures relating to the Reviewed Policies and Procedures, if any; and
e. recommendations to improve any of the systems, policies, processes, or procedures relating to the Reviewed Policies and Procedures, if any.
