Why PIE and the Prescription Digital Therapeutics Act Matter: Recap of AMCP Legislative Days

On May 18, AMCP hosted our annual Legislative Days event and met virtually with U.S. Senators and Representatives to advocate for our two top policy priorities: Pre-approval Information Exchange (PIE) (Section 810 of H.R. 7667) and the Access to Prescription Digital Therapeutics Act of 2022 (S. 3791/H.R. 7051).  

These were highly productive meetings that reminded us of how crucial engagement with congressional staff is to promote new laws that will enhance the practice of managed care pharmacy and benefit patients across the country. Constituent meetings are one of the most powerful ways to inform elected officials’ positions, especially when the constituents have the specialized expertise of AMCP members. Your voice matters!  

Understanding Pre-approval Information Exchange (PIE) 

PIE is a long-standing policy priority of AMCP’s. The bill includes provisions that will empower companies to share critical information with health plans and payers sooner, which can help expedite delivery of treatment to millions of patients. Originally introduced as the Pre-approval Information Exchange Act of 2022 (H.R. 7008), this legislative language was recently incorporated into the House of Representatives’ bipartisan Food & Drug Amendments of 2022 package to reauthorize the various User Fee Acts (UFA). On June 8, the House passed the PIE Act as part of H.R. 7667 with a strong bipartisan vote of 392 to 28. We thank our members and Legislative Days participants for their hard work towards this achievement.  

AMCP continues to advocate for the inclusion of PIE provisions in the Senate’s UFA reauthorization package, Food & Drug Administration Safety & Landmarks Advancements Act (S. 4348). If enacted, this bipartisan provision would clarify and codify the Food & Drug Administration’s (FDA) 2018 guidance regarding pre-approval communications between drug manufacturers and health payers.  

Unfortunately, existing guidance includes vague language which requires new legislation to guarantee that parties can proactively exchange key clinical and economic information used in formulary development before products receive market authorization. If left unchanged, patients could experience significant delays in access to potentially lifesaving treatments while waiting for clinical evidence to be evaluated and purchasing agreements negotiated. 

Understanding Prescription Digital Therapeutics Act of 2022 

The Access to Prescription Digital Therapeutics Act of 2022 is a bipartisan bill that will help expand access to prescription digital therapeutics (PDTs), a growing class of innovative treatments. PDTs are software-based therapies that deliver a clinical mechanism of action, either alone or in combination with other standard-of-care treatments to improve outcomes. PDTs are reviewed and authorized by the FDA and prescribed by health care providers, such as a primary care physician.  

Currently, there is limited-to-no coverage of PDTs under Medicare or Medicaid, which are generally restricted from covering products and services not included in the statutory list. This bill would add PDTs to the list of products eligible for coverage and reimbursement and help grant access to millions of Americans. The bill does not compel either program to cover PDTs but instead gives them the flexibility to do so if they consider it appropriate. This bill is needed because previous regulatory efforts, such as the Medicare Coverage of Innovative Technology rule, have failed to authorize PDT coverage. 

Get Involved: Your Voice Matters 

This year, AMCP’s member advocates met with 54 Members of Congress from 17 states on both sides of the aisle to ask them to co-sponsor and vote for our legislative priorities. As a congressional staff speaker said during the event, a constituent request to co-sponsor or vote in favor of a bill is the best way to get a Member of Congress’s attention.  

Support from AMCP members is critical to advancing our policy priorities. We’re grateful to our volunteer leaders who joined us for Legislative Days 2022 and look forward to continuing our work to improve managed care pharmacy policy. Please visit AMCP’s Action Center to get involved.