Updates in Federal Healthcare Legislature and Regulatory Policy

Several key developments have taken place within the federal legislative and regulatory healthcare landscape in 2022. Considering this, the Academy of Managed Care Pharmacy (AMCP) provided an overview of healthcare legislation recently signed into law, proposals anticipated in the coming year, and associated implications to provide managed care specialists with succinct information on the evolving legislative and regulatory landscape. This session focused heavily on proactive preapproval information exchange (PIE), federal health legislative proposals anticipated in the coming year, and the potential impacts of recent regulatory action on managed care professionals and teams.

The Inflation Reduction Act (H.R. 5376)—originally introduced as the Build Back Better Act by Congressman John Yarmuth (D-KY-03)—passed the Senate on August 7 and the House on August 12 following significant changes, subsequently being signed by the President on August 16. Provisions to drug pricing in the Inflation Reduction Act include inflationary rebates, a redesign of Part D, and a program for drug price negotiation. Beginning in 2026, the drug price negotiation program requires government negotiation of the prices of certain prescription drugs under Medicare. Inflationary rebates require manufacturers to pay rebates for certain drugs paid under Medicare Part B or D if their average price increases faster than the rate of inflation. Other noteworthy impacts of the Inflation Reduction Act include enhancing payments for biosimilars and extending expanded Affordable Care Act tax credits, while delaying the Trump-era Rebate Rule.

The PIE Act (H.R. 7008)—intended to ensure safe harbor for communication of clinical and healthcare economic information on therapies in development between population health decision makers and drug manufacturers before regulatory approval—passed the House on June 8, 2022, in addition to several other “riders,” including amendments to accelerated approvals, pharmaceutical manufacturing, biologics and biosimilars, and diversity and equity in clinical trials. The Senate iteration (S. 4348) passed on July 13, with riders addressing FDA transparency requirements, the infant formula shortage, generic drug competition, and drug importation from Canada, among others. However, PIE was not included in the congressional reauthorization package passed on September 30 under the Continuing Resolution (H.R. 6833). Despite no legislation protecting PIE to date, inclusion in an omnibus bill may be possible by the end of the year. Negotiations between the House and Senate are ongoing and will continue after the midterm election, with a deadline of December 16, as temporary government funding under the Continuing Resolution will then expire, setting the stage for year-end, must-pass legislation with riders.

Other legislative updates included the Access to Prescription Digital Therapeutics (PDT) Act of 2022 (S. 3791/H.R. 7051)—limited to FDA-cleared or authorized PDT—creating a benefit category for PDT in Medicare/Medicaid, as required for coverage under these programs.

The Equitable Community Access for Pharmacist Services Act (H.R. 7213), which authorizes pharmacists to receive reimbursement for certain COVID-19 care under Part B, was introduced in the House on March 24. Notably, this authorizes Part B reimbursement for care given in response to any public health emergency issued under the same authority as the COVID-19 public health emergency. With sponsors and cosponsors in the House and Senate for the Access to PDT Act of 2022, and cosponsors in the House for the Equitable Community Access for Pharmacist Services Act, year-end legislative options are being explored.

While legislation outlines policy change, regulation enforces it. As with legislation, the input of managed care professionals is crucial to advancing regulatory priorities. The Centers for Medicare & Medicaid Services (CMS) has released a Request for Information (RFI) on the Medicare Advantage program, as well as an RFI on how to promote efficiency and equity in CMS programs. AMCP acknowledges that advancements in regulation sought by the organization are impossible without support and encourages AMCP members to continue to exercise their power to benefit the world of managed care pharmacy.

Source:

Mathieu J, Tunstall G. Federal legislative and regulatory update. Presented at: 2022 Academy of Managed Care Pharmacy Nexus Annual Meeting; October 11-14, 2022; National Harbor, MD. Educational session L1.