Inflation Reduction Act, Health Equity at Forefront of Federal Policy Action Amid Midterm Elections, Panel Says

Recent federal legislative and regulatory updates in managed care pharmacy have prioritized topics ranging from expedited access to novel therapeutics to the health disparities and equity concerns affecting patient populations nationwide, but progress on these developments will depend on the impact of the upcoming midterm elections, according to stakeholders of a Wednesday panel discussion at the Academy of Managed Care Pharmacy (AMCP) Nexus 2022 meeting.

Jennifer L. Mathieu, vice president of Policy & Government Relations, AMCP, opened the proceedings by discussing the influence politics have already played in regards to the Pre-approval Information Exchange (PIE) Act (HR 7008), which was initially included as Section 810 in the House of Representatives’ User Fee (UFA) Reauthorization package (HR 7667).

Mathieu explained that the PIE act seeks to proactively allow payers to concurrently review clinical trial, economics, and scientific information provided by manufacturers to the FDA before a therapy is approved while it's going through the review process, as well as clarify the scope of permissible communications under 2018 FDA guidance.

“Currently, how the process works is once the FDA approves the therapy, it's similar to a relay race. At that point, the baton is passed to payers who can now get the information on the trial data and [everything] they need to determine best patient populations to receive a particular therapy, as well as coverage decisions,” said Mathieu. “This is really critical when it comes to the cell and gene therapy pipeline—those are very complicated drugs with a long review process.”

Despite substantial bipartisan support—the House voted 392 to 28 to pass the legislation on June 8—the PIE Act was not included in the "clean" UFA Reauthorization passed by the Senate on September 30 under the continuing resolution (HR 6833), in part due to Senate Minority Leader Mitch McConnell’s (R-Kentucky) influence on the decision to not allow policy writers on the final bill after the approval of HR 5376, the Inflation Reduction Act (IRA).

UFAs for prescription drugs (PDUFA VII), biosimilars (BsUFA III), generic drugs (GDUFA III), and medical devices (MDUFA V) were included in the “clean” UFA Reauthorization allowing FDA to collect fees from companies that produce these therapeutics until September 2027.

“Negotiations are still ongoing between the House and the Senate and the intent is to pursue those policy writers that were not included in the lame-duck post-midterm election work that the Senate is going to be doing. We are very hopeful that because of the continuing resolution, as well as the number of health and tax extenders will expire on December 16, that there will be an opportunity to include those writers in whatever shape that bill takes,” she noted.

Mathieu added that there's also opportunities for other policy primers that were originally attached to UFA agreements, including policies on the accelerator approval pathway, clinical trial diversity, generic drug competition, and the supply chain.

Other federal legislative and regulatory updates that were highlighted by Mathieu include:

• 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): Authorizes pharmacists to receive reimbursement under Part B for certain COVID-19 care and authorizes Part B reimbursement for care delivered in response to any future public health emergency issued under same authority as COVID-19
• IRA: Enhances the Part B add-on payment for qualifying biosimilars from 6% to 8% of the reference product’s average sales price (ASP) for a 5-year period, extends the temporary Affordable Care Act (ACA) premium tax credit expansions that were included in the American Rescue Plan Act through 2025, and delays the Trump-era rebate rule until January 1, 2032

Speaking further on the IRA, a scaled-back version of the Build Back Better Act, Mathieu noted that the bill also creates provisions regarding drug pricing, including: a drug price negotiation program that requires government negotiation of the prices of certain prescription drugs under Medicare beginning in 2026; inflationary rebates that require manufacturers to pay rebates for certain drugs paid under Medicare Parts B or D if their average price increases faster than the rate of inflation; and a Medicare Part D redesign.

“Midterm elections will play a very big part in what happens to IRA. Between now, 2022, and 2026, we have 2 midterm elections and one general election—there’s a lot that can change,” cautioned Mathieu.

“Last Friday, a handful of GOP leaders introduced a bill called the Protecting Drug Innovation Act that would repeal all the drug price provisions in the IRA. So, we will see what’s going to happen with it, and it may or may not be decided on November 8.”

Eugenia Tunstall, JD, director of Regulatory Affairs, AMCP, who spoke about the regulatory side, added that CMS recently released several guidance documents on the implementation of provisions in the IRA that will go into effect on January 1, 2023, specifically those regarding insulin products and cost-sharing requirements for new adult vaccines.

These CMS requirements on insulin and vaccines apply to Medicare Part D plans, whereas Medicare-Medicaid Plans (MMP) and Minnesota Senior Health Options Plans (MSHO) must update member materials to meet the vaccine requirements solely and Part D Seniors Savings (PDSS) member materials must be updated to comply with the insulin requirements as well.

“The documents must be updated by October 15, so this week,” said Tunstall.

Tunstall added that CMS established a group to structure the implementation of the drug price negotiation program requirements.

“CMS is proposing 6 different divisions to form the various needed functions and is basically proposing the addition of more than 200 full time employees from pharmaceuticals, economics health policy, research, social science, and information technology (IT).”

AMCP’s strategic priorities for regulatory action is also placing a particular focus on health disparities and access to care, she said, with the organization submitting comments on several requirements or changes being considered by CMS, HHS, and other regulatory agencies:

• CMS request for information on Medicare Advantage: CMS is asking for input on ways to ensure all parts of Medicare are working towards a future where people with Medicare receive more equitable, high quality, and person-centered care that is affordable and sustainable
• HHS notice of proposed rulemaking: Reinstates protections on the basis of gender identity and sexual orientation and aligns sex discrimination requirements with Federal court decisions, as well as clarifies the applicability of Section 1557 nondiscrimination requirements to health insurance issuers
• CMS RFI on promoting efficiency and equity in CMS programs: CMS is seeking feedback on challenges and opportunities for embedding health equity into its efforts encouraging innovation, reducing burden, and creating efficiencies across the health care system
• CMS proposed rule on streamlining medicaid eligibility & enrollment: rule would simplify the processes for eligible individuals to enroll and retain eligibility in Medicaid, the Children’s Health Insurance Program (CHIP), and the Basic Health Program
  

“A variety of populations are more likely to experience disparate health outcomes based on things such as race and ethnicity, gender and gender identity, disability, limited English proficiency. Social determinants of health can also play a role in health disparities, such as income and employment, education, housing, and transportation. AMCP is committed to addressing these issues,” said Tunstall.