ACCP Supports Pharmacy-Wide Effort to Advance PIE Act

March 18, 2022

ACCP joined with our pharmacy colleagues to applaud Congressman Brett Guthrie (R-KY-02) on the introduction of the Pre-approval Information Exchange (PIE) Act of 2022 (H.R. 7008).

The effort, let by the Academy of Managed Care Pharmacy (AMCP) was also endorsed by our colleagues at the American Society of Health-System Pharmacists (ASHP) and a diverse range of organizations that includes the Blue Cross Blue Shield Association, and Humana.

The bipartisan PIE Act is intended to build on existing Food & Drug Administration (FDA) policy to create a statutory safe harbor for the proactive dissemination of certain clinical and economic information to health payers regarding new therapies or new indications of existing therapies not yet approved by the FDA.

The PIE ACT will enhance patient access to emerging pharmaceuticals and devices by authorizing pharmaceutical manufacturers to proactively share certain health care economic and scientific information about products with health payers ahead of FDA approval. This allows payers to incorporate new therapies into their formularies for the plan year in which approval is anticipated. Public payers like Medicare and Medicaid will especially benefit from PIE due to their limited authority to modify formularies during a plan year.

Read the sign-on letter here.

For more information please refer to the following resources shared across the pharmacy community by our colleagues at AMCP:

• Bill text (link + congress.gov link)
• Congressman Guthrie press release (link)
• AMCP PIE issue brief (link)
• AMCP PIE FAQ (link)
• AMCP PIE Process graphic (link)