AMCP’s Policy and Government Relations team including Director Jennifer L Mathieu, MA, Senior Manager Adam Colborn, JD, and Senior Coordinator Tom Casey outlined key pieces of federal legislation and regulatory changes that could affect formularies and medication management decisions by health plans in the upcoming year, in one of the opening AMCP 2022 sessions.

There are currently several proposals have been introduced that could impact managed care pharmacy teams at both the state and federal levels. Some of the most significant federal legislative pieces are as follows:

• Preapproval Information Exchange (PIE) Act (HR 7008): This act would create legislative safe-harbors for proactive PIE between manufactures and payers, as well as clarify previously confusing guidance from the FDA
• Access to Prescription Digital Therapeutics Act of 2022 (S 3791): Designates a new benefit category for digital therapeutics under Medicare/Medicaid
• Equitable Community Access to Pharmacist Services Act (HR 7213): Most recently introduced but could authorize pharmacists to receive reimbursement under Part B for select COVID-19 care, as well as other future public health emergency care

Other federal legislative updates included AMCP recommendations for Cures 2.0, User Fee Amendment Acts (PDUFA VII, BsUFA III, GDUFA III, and MDUFA V), and UFA Riders.

In regards to federal regulation, the AMCP Policy and Government Relations team noted technical changes to Parts C and D which propose point of sale application of nonrebate price concessions under Part D. AMCP has filed opposing comments noting that this policy will not reduce costs and could actually raise premiums. They also expressed that the proposition devalues existing pay-for-performance arrangements. Lastly, AMCP reps stated these technical changes violate the non-interference clause of the Medicare statue relating to negotiations between manufacturers, pharmacies, and Part D sponsors.

Before discussing state affairs, AMCP speakers discussed the pharmacy pay-for-performance principles, which the organization supports if they include performance-based metrics related to the services they provide. Adopting these principles creates an opportunity for the development of quality pharmacy networks, the speakers explained, which reward high performing pharmacies dedicated to improving care and access for patients. Additionally, AMCP’s Public Policy and Professional Practice committees have defined 13 principles which can be found here.

Upcoming state reform updates focused mostly on pharmacy benefit manager (PBM) reform legislation and requirements for electronic prescribing.

PBM reform is incredibly prolific with hundreds of bills introduced each year—242 since January 1, with 65 in 2022 so far. Michigan, West Virginia, North Dakota, and Nebraska are the among the top states with proposed PBM reform.
Commonly proposed provisions include:

• Prohibition of retro-active claims adjustments and adjudication fees
• Prohibition against mandatory mail-order
• Adoption of Any Willing Provider
• Expanded anti-kickback prohibitions on PBM-owned pharmacies
• Prohibition of spread pricing
• Expanded POS discounts

Lastly, the AMCP team shared the latest requirements related to electronic prescribing across the United States. They said, “Lawmakers see this as an opportunity to address the opioid epidemic despite previous objections.”

California, Maryland, Michigan, Nebraska, New Hampshire, and Utah all implemented new requirements in 2022. Illinois has a mandate expected to go into effect January 1, 2023.

AMCP offers numerous resources for navigating all the upcoming changes including guidance for advocacy and materials related to policy which can be found on amcp.org.