In one of the opening AMCP Nexus 2022 sessions, the AMCP Policy and Government Relations staff including Jennifer L Mathieu, MA, vice president, Policy and Government Relations and Geni Tunstall, JD, director, Regulatory Affairs highlighted federal legislative and regulatory updates regarding health policy.

At both state and federal levels, several introduced proposals are relevant to managed care pharmacy.

Some of the most significant federal legislative pieces highlighted are as follows:

• Pre-approval Information Exchange (PIE) Act (HR 7008): Creates a legislative safe-harbor for proactive PIE by manufacturers and clarifies scope of permissible communications under 2018 FDA guidance. This act is not included in "clean" UFA reauthorization that was passed on September 30 under the Continuing Resolution (H.R. 6833)
• Access to Prescription Digital Therapeutics Act of 2022 (S 3791/HR 7051): Creates a benefit category for prescription digital therapeutics (PDT) in Medicare/Medicaid.
• Equitable Community Access for Pharmacist Services Act (HR 7213): This act was introduced in March and authorizes pharmacists to receive reimbursement under Part B for certain COVID-19 care. It also authorizes Part B reimbursement for care delivered in response to any future public health emergency (PHE) issued under same authority as the COVID-19 PHE.
• Inflation Reduction Act (HR 5376): This act was most recently introduced and it extends expanded Affordable Care Act (ACA) tax credits, enhances payments for biosimilars, and delays the Rebate Rule. Additionally, drug pricing provisions include a drug price negotiation program, inflationary rebates, and Part D redesign.

“I will say that there is great interest from policy makers in including riders in some bill before the end of the year,” said Ms Mathieu. “PIE was very well received. We’ve heard from both the Senate and the House, democrats, and republicans that if there had been riders included in these review agreements PIE would have been with them. PIE would have been included. So, we are very thankful for that and we are hopeful that we will see PIE passed by the end of 2022.”

AMCP also highlighted User Fee Amendment Acts (UFA) including PDUFA VII, BsUFA III, GDUFA III, and MDUFA V as well as UFA Riders.

When discussing federal regulation, the AMCP Policy and Government Relations team noted this year’s federal guidance has largely fallen under the context of addressing health disparities. They emphasized that to advance regulatory priorities that benefit the industry, the input of managed care pharmacists is crucial.

“AMCP is committed to addressing health disparities and access to care through its regulatory affairs agenda,” said Ms Tunstall.

Ms Tunstall also discussed the Centers for Medicare & Medicaid Services (CMS) request for information seeking public comment on the Medicare Advantage program.

“AMCP commented on the need for greater standardization in the collection of data because that would help in the injustification of gaps and access to care,” said Ms Tunstall. “AMCP also advocated for greater sharing of data between social service agencies, health plans, and providers and commented on the need for expanded access to lower income subsidies and expanding these value-based contracting.”

Lastly, presenters provided insight on the US Department of Health and Human Services’ proposed rule, published on August 4, 2022, that reinstates protections on the basis of gender identity and sexual orientation and aligns sex discrimination requirements with Federal court decisions.

They also highlighted CMS’ proposed rule on streamlining Medicaid eligibility and enrollment as well as the Office of Management and Budget’s listening sessions on federal race and ethnicity standards revision.

For more information on comments submitted by AMCP, visit amcp.org and view the Letters, Statements, and Analysis page.