Between the federal appropriations process, regulatory policy proposals, the upcoming midterm elections, and congressional legislation, there is much to follow in federal health policy. To help break down what is on the horizon for health policy in 2022 and which pieces could shape the policy landscape, three members of the Washington, D.C. government affairs firm Thorn Run Partners – Yul Edwards, Jessie Brairton, and Brittany Argote – joined the Society for Women’s Health Research’s (SWHR) Policy Advisory Council March 2022 meeting. Within the firm, Edwards, Brairton, and Argote serve as partner, senior vice president, and health policy associate, respectively.
Overarching Policy Landscape
Edwards, Brairton, and Argote began by reviewing broader items that could have a bearing on federal health policy – namely, federal appropriations, reconciliation (a tool to get tax- and spending-related legislation passed with a simple majority), and the 2022 midterm elections. (Since the time of the Council meeting, Congress passed and the president signed into law the fiscal year 2022 omnibus package, containing all 12 federal spending bills; emergency funding for Ukraine and COVID-19; and other provisions.) With respect to the reconciliation bill, the “Build Back Better Act,” negotiations are currently being labeled as “paused” after Sen. Joe Manchin (D-WV) announced his opposition to the bill as it currently stands. The original Build Back Better legislation touched several key areas of health policy, including paid family and medical leave and drug pricing, an area which Sen. Manchin continues to elevate, so attempts to revive the stalled negotiation talks could have bearing on those issues. Finally, the speakers touched on the midterm elections, which have the potential to shape federal health policy through shifting the makeup of the House and Senate. Historically, Edwards noted, a sitting president’s party has been more likely to lose seats in a midterm election regardless of the president’s favorability. The Senate is currently considered a “toss up,” and in the House, retirements in the Democratic and Republican Caucuses and redistricting could all play a role in shifting which party controls the chamber.
What to Watch for in 2022
The following represent snapshots of some “areas to watch in 2022” that were identified by the panelists:
- Drug Pricing Reform. The Biden Administration’s Fall 2021 Unified Regulatory Agenda included notable changes to the 340B Drug Program. The proposed rule would replace the Administration Dispute Resolution currently in effect and apply it to all drug manufacturers and covered entities that participate in the Program and would establish new requirements and procedures for the 340B Program’s ADR process. The 2022 omnibus bill also provided temporary extensions for Disproportionate Share Hospitals’ eligibility for the 340B Program.
- Provider Reimbursement. Both Democratic and Republican lawmakers have expressed interest in establishing a maximum Average Sales Price (ASP) add-on for Medicare Part B drugs. ASP is a “market-based price that reflects the weighted average of all manufacturer sales prices and includes all rebates and discounts that are privately negotiated between manufacturers and purchasers (with the exception of Medicaid and certain federal discounts and rebates).” Also of bipartisan interest are Part B add-on payments to promote biosimilar products uptake. While this provision was included in the Build Back Better Act (BBBA), should BBBA not pass the Senate, the provision could pass Congress via another, less politically-charged bill.
- FDA User Fees. “User fee” agreements that fund the Food and Drug Administration’s (FDA) activities –including Prescription Drug User Fee Agreements (PDUFA) and Medical Device User Fee Agreements (MDUFA) – are set to expire at the end of fiscal year 2022. The House Energy & Commerce Committee has gotten an early start on Health Subcommittee hearings on drug agreements. While the Senate Health, Education, Labor & Pensions Committee is moving more slowly, Chair Murray (D-WA) and Sen. Burr (R-NC) are intent on continuing their bipartisan effort in this space. On March 9, an “agreement in principle” was reached between FDA and industry on a framework for MDUFA V, though details of that agreement have yet to be released.
- Value-Based Care and Related Payment Models. There is also strong bipartisan interest in creating an option for states to pay for outpatient drugs through risk-sharing value-based agreement; under these proposals, the Centers for Medicare and Medicaid Services (CMS) would certify that projected payments would not exceed the traditional rebate agreement and manufacturers would be required to justify list and launch prices. Argote noted during her presentation that on March 8, a group of lawmakers penned a letter to CMS urging the agency to incentivize provider participation by “rapidly adopting modifications” to existing alternative payment models. (SWHR’s policy principles for health care value assessment can be accessed here.)
- COVID-19 Relief and Pandemic Preparedness. There will likely continue to be movement with respect to public health emergency (PHE) flexibilities in 2022. Some flexibilities, such as telehealth, were included in the fiscal year 2022 omnibus, but it is likely that lawmakers will continue listening to health care providers and asserting their opinions about how these PHE flexibilities have supported their communities during the pandemic.
- Medical Devices. The administration’s Unified Regulatory Agenda outlined several forthcoming regulatory priorities related to medical devices, such as Harmonizing and Modernizing Regulation of Medical Device Quality Systems and Clinical Holds in Medical Device Investigations. One priority that is already in progress, the FDA in February 2022 issued a proposed rule to amend the device current good manufacturing practice (CGMP) requirements within the Quality System Regulation to align more closely with the quality management system requirements used by other countries.
Whether in the legislative or regulatory health care realm, there is much to watch for in 2022. While it will likely be a significant year for health policy given high-level administration and congressional priorities, policymakers will also be working against the midterm congressional elections, which are likely to divert their attention. SWHR will continue to advocate for policies that promote women’s health and women’s health research—advancing SWHR’s vision of making women’s health mainstream.
For questions, please email SWHR Chief Advocacy Officer Lindsey Horan.