Stakeholders at the Academy of Managed Care Pharmacy (AMCP) 2022 Nexus Meeting Consider Federal Legislative and Regulatory Updates in Managed Care Pharmacy and the Impact the Upcoming Midterm Elections Will Have on These provisions.
Recent federal legislative and regulatory updates in managed care pharmacy have prioritized topics ranging from accelerated access to new therapies to health disparities and equity issues affecting patient populations in the scale, but progress on these developments will depend on the impact of the upcoming midterm elections, according to stakeholders in a panel discussion Wednesday at the Academy of Managed Care Pharmacy (AMCP) Nexus 2022 meeting.
Jennifer L. Mathieu, Vice President of Policy and Government Relations, AMCP, opened the proceedings by discussing the influence that politics has already played with regards to the Pre-Target Information Exchange Act. Approval (PIE) (HR 7008), which was originally included as Section 810 in the House of Representatives User Fee Reauthorization (UFA) package (HR 7667).
Mathieu explained that the PIE Act is intended to proactively allow payers to simultaneously review clinical trials, economics, and scientific information provided by manufacturers to the FDA before a therapy is approved during the approval process. review, as well as clarifying the scope of permitted communications. according to 2018 FDA guidelines.
“Currently the process works once the FDA approves the therapy, it’s similar to a relay race. At that point the baton is passed to the payers who can now get the trial data information and [everything] they need to determine the best patient populations to receive a particular treatment, as well as coverage decisions,” Mathieu said. “It’s really critical when it comes to the cell and gene therapy pipeline – these 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 UFA’s “clean” reauthorization passed by the Senate on September 30 under of the continuing resolution (HR 6833), in part due to Senate Minority Leader Mitch McConnell (R-Kentucky)’s influence on the decision not to 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) have been included in the “clean” UFA reauthorization allowing the 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 sue policy writers who were not included in the lame post-election midterm job that the Senate is going to do. We’re hopeful that due to the ongoing resolution, as well as the number of health and tax expansions expiring on December 16th, it will be possible to include these writers in whatever form this takes. bill,” she noted.
Mathieu added that there are also opportunities for other policy primers that were originally attached to the UFA agreements, including policies on accelerator approval pathway, clinical trial diversity, competition from generic drugs and the supply chain.
Other federal legislative and regulatory updates highlighted by Mathieu include:
- Digital Prescription Therapy Access Act of 2022 (S 3791/HR 7051): Creates a Benefit Category for Digital Prescription Therapies (PDTs) in Medicare/Medicaid
- Fair Community Access to Pharmacists’ Services Act (HR 7213): allows pharmacists to receive Part B reimbursement for certain COVID-19-related care and allows Part B reimbursement for care provided in response to any future public health emergencies issued under the same authority as COVID-19
- IRA: Enhances Part B Additional Payment for Qualifying Biosimilars from 6% to 8% of Average Selling Price (ASP) of Reference Product for 5 Years, Extends Temporary IRA Tax Credit Extensions Affordable Care Act (ACA) premiums that were included in the American Rescue Plan Act until 2025 and delays the Trump-era reimbursement rule until January 1, 2032
Speaking in more detail about the IRA, a scaled-down version of the Build Back Better Act, Mathieu noted that the bill also creates provisions regarding drug pricing, including: a drug price negotiation program which obliges the government to negotiate the prices of certain prescription drugs under Medicare from 2026; inflationary rebates that require manufacturers to pay rebates for certain drugs paid for under Medicare Parts B or D if their average price increases faster than the rate of inflation; and an overhaul of Medicare Part D.
“The mid term elections will play a very important role in what happens to the IRA. By 2022 and 2026 we have 2 mid term elections and a general election there is a lot that can change “warned Mathieu.
“Last Friday, a handful of GOP leaders introduced a bill called the Protecting Drug Innovation Act that would repeal all drug pricing provisions in the IRA. So, we’ll see what’s going to happen with that, and it may or may not be decided on November 8th. »
Eugenia Tunstall, JD, Director of Regulatory Affairs, AMCP, who spoke on the regulatory side, added that CMS recently published several guidance documents on the implementation of the provisions of the IRA which will come into force on January 1, 2023 , particularly those regarding insulin products and cost-sharing requirements for new adult vaccines.
These CMS insulin and vaccine requirements apply to Medicare Part D plans, while Medicare-Medicaid (MMP) plans and Minnesota Senior Health Options (MSHO) plans must update member materials to meet vaccine requirements only and Part D Seniors Savings (PDSS) member materials must also be updated to meet insulin requirements.
“Documents must be updated by October 15, so this week,” Tunstall said.
Tunstall added that CMS has established a group to structure the implementation of the drug price negotiation program requirements.
“CMS offers 6 different divisions to form the various functions needed and essentially proposes the addition of more than 200 full-time employees from the pharmaceutical, economic, health policy, research, social sciences and information technology (IT) sectors. ).”
GCPA’s strategic priorities for regulatory action also focus on health disparities and access to care, she said, with the organization submitting comments on several requirements or changes. considered by CMS, HHS and other regulatory bodies:
- CMS Request for Information on Medicare Advantage: CMS seeks input on ways to ensure that all Medicare parties are working toward a future where people with Medicare receive more equitable, high-quality, person-centered care, affordable and sustainable
- Notice of Proposed HHS Rulemaking: Restores Protections on the Basis of Gender Identity and Sexual Orientation and Aligns Sex Discrimination Requirements with Federal Court Rulings, and Clarifies the Applicability of Non-Discrimination Requirements – discrimination of article 1557 against issuers of health insurance
- CMS RFI on Promoting Efficiency and Equity in CMS Programs: CMS invites feedback on the challenges and opportunities of integrating health equity into its efforts to encourage innovation, reduce burden and create efficiencies across the health care system
- CMS has proposed a rule on streamlining Medicaid eligibility and enrollment: the rule would streamline processes for eligible individuals to enroll and maintain eligibility for Medicaid, the Children’s Health Insurance Program ( CHIP) and basic health program
“A variety of populations are more likely to experience disparate health outcomes based on factors such as race and ethnicity, sex 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,” Tunstall said.