Legislative & Regulatory Issues
Lead Federal Issues
Pre-approval Information Exchange (PIE)
Pre-approval Information Exchange (PIE) allows manufacturers and health-care decision makers to proactively share health care economic and clinical information (HCEI) about products before Food & Drug Administration (FDA) approval. PIE enables health plans and payers to incorporate new treatments into their formularies for the plan year in which approval is anticipated, which shortens the time between market approval and patient access to new treatment. FDA guidance does not specify whether PIE can be conducted proactively by manufacturers, and it creates a conflict with the relevant statute regarding what types of information are communicable. The bipartisan Pre-approval Information Exchange Act of 2022 (H.R. 7008) will address this legal uncertainty by confirming that the proactive dissemination of HCEI does not violate the prohibitions against pre-approval promotion and clarify what forms of information are protected under the safe harbor.
Digital Therapeutics Benefit Category
Prescription digital therapeutics (PDTs) are interventions driven by software programs to prevent, manage, or treat a medical order or disease. PDTs have the potential to revolutionize population health management and help patients live healthier lives by enhancing current medical treatments and expanding care delivery options. However, certain barriers prevent coverage of PDTs under Medicare and Medicaid, limiting access to these promising interventions for millions of patients. Medicare and Medicaid coverage requires that a product or service fit into a statutorily defined benefit category; currently, no existing category includes PDTs. While the Medicare Coverage of Innovative Technology (MCIT) rule tried to create a new coverage pathway for innovative technologies like PDTs, the rule was repealed due to issues in the rulemaking process. Legislation creating a benefit category for PDTs is the best was to ensure patient access to these valuable therapies. The bipartisan Access to Prescription Digital Therapeutics Act of 2022 (S. 3791/H.R. 7051) will unambiguously allow Medicare and Medicaid to cover PDTs for their beneficiaries, expanding the use of innovative technologies and improving patient access.
Biosimilar Research Fund/National Project
Biosimilars are biologic products that are highly similar to and have no clinically meaningful differences from another biologic that is already approved by the FDA. Biosimilars present an opportunity to expand access to many important common therapies, such as insulin, as well as more complex and costly biologic therapies. Expanded availability and use of real-world evidence will improve care for patients receiving biologic and biosimilar drugs and improve provider knowledge of the clinical benefits of these products. AMCP established the Biologics & Biosimilars Collective Intelligence Consortium (BBIC) in 2015 to address anticipated needs for post-marketed evidence generation for novel biologics and their corresponding biosimilars. However, there are funding and coordination obstacles to conducting this research. AMCP supports legislation establishing a research fund and national research project that will generate sustained progress in real-world evidence for biologics and biosimilars utilizing the expertise and leadership of federal research agencies.
Pay-for-Performance Principles
Performance-based contracts and payments between payers and pharmacies help to lower patient and system costs while incentivizing high-quality care. Pharmacies and the pharmacists whom they employ can help to improve the efficient delivery of high-quality care through participation in performance-based programs. The development of quality pharmacy networks rewards high performing pharmacies that deliver improved care to patients while protecting patient access. In 2021, AMCP released the Pharmacy Pay-for-Performance Principles to help policymakers improve health care payment systems by incentivizing high-quality, high-value care. AMCP will advocate for CMS to develop a core set of standardized pharmacy performance metrics for the Medicare Part D program, while preserving flexibility for plan sponsors to utilize additional measures.
Learn more by reading AMCP’s Pay-for-Performance Principles document.