The AMCP Policy & Government Relations staff reviewed the latest federal activity related to health policy including prescription digital therapeutics, performance-based reimbursement, and other legislative roads being pursued. 

Jennifer L. Mathieu, MA, senior vice president, professional and government affairs, AMCP, kicked off the session highlighting the recently enacted Preapproval Information Exchange (PIE) Act (HR 9297), which creates a safe harbor for the exchange of both clinical and economic data between manufacturers and payers, and clarifies previous communication guidance from 2018. 

The PIE Act was passed as part of the omnibus spending bill (HR 2617) on December 2, 68 to 29 in the senate and 225 to 201 in the house, then signed by President Biden on December 29. “Americans now live under a law that AMCP helped pass,” noted Ms Mathieu, adding that it took 6 years, and would not have been possible without the support of AMCP and its members.

Recently Passed or Must-Pass Legislation

A notable piece of legislation reintroduced March 8, 2023 is the Prescription Digital Therapeutics (PDT) Act of 2023 (S.723/H.R.1458). 

Ms Mathieu emphasized the significance of the robust bipartisan support of the Access to PDTs Act, particularly during a time of great political divide in the United States. 

“The PDT bill will create a benefit category” which necessary for reimbursement and “It is limited to digital therapeutics that are reviewed/cleared by FDA and prescribed by health care providers,” Ms Mathieu explained.  

Key points of the Access to PDTs act include the following:

• It does not require CMS to cover a specific PDT or PDTs as a class of products under Medicare/Medicaid
• Programs use normal formulary decision processes to ascertain
• appropriateness of including PDTs in their formularies
• Direct CMS to establish framework for HCPCS coding

The Access to PDT Act is needed, Ms Mathieu points out, because CMS does not currently have the necessary authority to cover PDTs. Medicare/Medicaid also do not have the flexibility to cover products like PDTs beyond the statutorily defined benefit categories. 

The Biosimilars Research Fund and National Biosimilars Project Act are both dedicated to securing funds for large population, epidemiological research on biosimilars for 2023/2024

The Equitable Community Access for Pharmacist Services Act (ECAPS) is anticipated to be reintroduced March 23, 2023 or soon after. The goal of ECAPS is to authorize pharmacists to receive reimbursement under Part B for certain COVID-19 care beyond the end of the public health emergency (PHE). It is also designed for Part B reimbursement for care under any future PHE issued under the same Public Readiness and Emergency Preparedness (PREP) Act authority as the COVID-19 PHE. 

Another piece of new legislation is the Pharmacy Benefit Manager Transparency Act of 2023 (S 127), which would prohibit PBM’s from charging health plans different amounts for a prescription than what is reimbursed to a pharmacy, among other restrictions. 

The Inflation Reduction Act, signed by President Biden on August 16, 2022 and in effect this year, has several components related to drug price negotiation, inflationary rebates, Part D redesign, enhanced payments for biosimilars, ACA premium tax credit extensions through 2025, and rebate rule delay until January 1, 2025. 

“The timing of this presentation is very early in the 118^th congress,” noted Ms Mathieu. “There was a delay in appointing the house speaker and then organizing all of the committees. So although it is March 22, it is still early for congress’ work. In fact, March 6 was the first time they actually began work.”

She continued, “The reality is, we have a split congress. Both margins in the house and the senate are very narrow … Highly partisan legislation is likely not going to pass. Fortunately the PDT bill and ECAPs are both bipartisan pieces of legislation but we do expect it to be tougher than the 117^th congress.”

Ms Mathieu concluded her portion of the session noting there are definitely more pieces of health-related legislation on the horizon but we may have to wait a few weeks for more solid information.

“We do think we’re going to see the house/congress take up legislation around utilization legislation,” she added. “Beyond that, it is still unclear but over the next 4 weeks we’ll get a better sense on what they’re pushing/advocating for and how and where we can partner.”