.03 Policy Review and Final Action Process Overview.

A. If the Board makes a preliminary determination that use of the prescription drug product has led or will lead to an affordability challenge, the Board shall commence the policy review process.

B. The purpose of the policy review process is to:

(1) Based on the best available information, confirm the drivers and market conditions causing the affordability challenge phenomena; and

(2) Identify the policies that may address those drivers and redress the affordability challenges.

C. The policy review process includes:

(1) Information gathering:

(a) Informational hearings;

(b) Stakeholder Council input;

(c) Expert testimony hearings;

(d) Board staff research and analysis; and

(e) Eligible governmental entities’ information;

(2) Preliminary policy recommendations:

(a) Policy actions other than UPLs; and

(b) Policy action in the form of a UPL and the process for setting upper payment limits; and

(3) Final actions:

(a) Adoption of the final cost review report;

(b) Adoption of non-UPL policy recommendations; and

(c) Adoption of proposed regulations setting a UPL amount.