The Academy of Managed Care Pharmacy (AMCP) is pushing for passage of federal legislation that would clear the way for Medicare and Medicaid coverage of prescription digital therapeutics, AMCP officials said today at a legislative update session at the group’s annual meeting.
The group is also lobbying alongside other pharmacy groups for a bill that would mean pharmacists would get Medicare Part B payment for COVID-19 testing, treatment and vaccinations beyond the conclusion of the COVID-19 public health emergency, which is scheduled to end May 11.
But AMCP is just monitoring the hot-button legislation introduced in the Senate that would increase regulation of pharmacy benefit managers.
And it is not yet taking a position on the controversial 340B program, which gives some safety-net hospitals discounted prices on drugs. Jennifer L. Mathieu, M.A., senior vice president, professional and government affairs, for AMCP and one of two AMCP speakers at the legislative update session, said the AMCP board listened to an hourlong presentation on 340B yesterday and that group’s government affairs would be doing a deep dive into the program.
Mathieu said the slim Democratic majority in the Senate and the slim Republican one in the House means Congress will be looking to pass bills with bipartisan support, which the PDT legislation, known formally as the Prescription Digital Therapeutics Act of 2023, and the pharmacist Part B payment legislation, called the Equitable Community Access to Pharmacist Services Act, or ECAPS, both have.
The 2024 presidential election is also likely create an appetite for bipartisan legislation, she said.
“It looks really good for both parties if they can point to legislative action that they partnered on as a sign of getting things done for the American people, so they are going to be looking for bipartisan legislation,” Mathieu said. “Fortunately, the PDT bill and ECAPS are two bipartisan pieces of legislation, so that works out nicely for us.”
At the same time, Mathieu tamped down expectations that the bills would pass Congress and become law this year. She noted that, historically, for legislation that does become law, there is an eight to 10 year period between when it is introduced and when it is passed.
Mathieu also discussed the new chairs of the health-related committees in the two houses of Congress.
In the Senate, Sen. Bernie Sanders, the independent from Vermont who caucuses with the Democrats, is the new chair of the Health, Education, Labor and Pensions committee. According to Mathieu, Sanders has said that Medicare for all and drug importation are his priorities.
In the House, Rep. Brett Guthrie, a Kentucky Republican, is the new chair of the Health Subcommittee on the House Energy and Commerce Committee. Mathieu said that AMCP worked closely Guthrie’s staff on the Pre-approval Information Exchange (PIE) Act, which passed last year and was signed into law by President Joe Biden in December. Mathieu has indicated that his priorities are bringing value-based agreements to the Medicaid program and the PBM transparency legislation, Mathieu said.
The PDT legislation, which was reintroduced earlier this month, was first introduced in 2020 and the ECAPS legislation, which Mathieu said would be reintroduced soon during this Congress, was first introduced last year. Neither bill has been assessed for its budgetary impact, or “scored,” by the Congressional Budget Office, which is necessary step for passage.
Still, Mathieu said the PDT bill has a lot going for it politically, and AMCP is asking members to take an active role in supporting it. The bill’s sponsors in the House and Senate include both Democrats and Republicans. She said it was noteworthy that Rep. Kevin Hern, an Oklahoma Republican, was taking the lead on the House version of the bill because Hern is conservative and a chair of the Republican Study Committee. The lead sponsor of the reintroduced bill in Senate is Sen. Jeanne Shaheen, a New Hampshire Democrat.
Mathieu emphasized that although the PDT bill would create a benefit category for PDTs for Medicare and Medicaid, it does not require CMS or state Medicaid programs to cover specific PDTs or PDTs as a class. In her presentation, Mathieu said the programs would continue to use normal formulary decision processes to make PDT overage decisions.
The PDT legislation would limit the new benefit category to digital therapeutics that are prescribed and have been reviewed and cleared or authorize by the FDA.
Geni Tunstall, J.D., director of regulatory affairs for AMCP, also spoke at the well-attended legislative update session. Tunstall told the audience about details of the implementation of the healthcare provisions of the Inflation Reduction Act and, in particular, the parts of the law that authorize CMS to negotiate the prices of a limited number of drugs. Tunstall said CMS is scheduled to announce the list of the first 10 Part D drugs by Sept. 1 of this year, the “maximum fair price” for those drugs by Sept. 1, 2024, and then implementatoin of those prices started Jan 1., 2026.
Mathieu also mentioned d the Biosimilars Research Fund and the National Biosimilars Project Act. The research fund would start with a $40 million appropriation for population heath and epidemiologic studies of biosimilars that would be parceled out as grants ranging from $2 million and $5 million. The National Biosimilars Project Act would set up a dedicated fund for biosimilars research and change the definition of interchangeability to allow for biosimilar-to-biosimilar switching.