Election Outlook 

Though a rematch between President Biden and former President Trump had been expected, on July 21, President Biden announced his withdrawal from the race, endorsing current Vice President Kamala Harris as the Democratic party presidential nominee. Many prominent Democrats have quickly endorsed Vice President Harris, and she is likely to continue securing support of delegates ahead of the August 19–22 Democratic National Convention (DNC), at which point the nominee will be officially confirmed. 

Vice President Harris has yet to name a running mate; on July 15, former President Trump announced that Sen. J.D. Vance will be his running mate. 

When Vice President Harris ran for president in 2020, her healthcare policies (e.g., support for Medicare for All) were more progressive than those of President Biden, who campaigned on shoring up and expanding coverage under the Affordable Care Act (ACA). If Vice President Harris becomes the Democratic nominee for president, it is likely that she will largely continue the healthcare policy priorities of the Biden/Harris administration. However, she may also consider other areas to chart her own path, such as increasing efforts to address anti-competitive practices in healthcare. 

Beyond the race for the presidency, the control of Congress heading into 2025 carries similar uncertainty. In the Senate, the Democratic caucus currently hold a narrow majority (47 Democrats, 4 Independents, 49 Republicans), but 34 seats are up for election, with members in the Democratic caucus defending more than twice as many seats as Republicans (23 vs. 11 seats). In the House, Republicans currently control a narrow majority (220 Republicans, 212 Democrats, 3 vacancies). With all House seats up for election every two years, Democrats would need a net gain of only six seats to take the majority.  

The current state of play across presidential, House, and Senate races raises several possible scenarios for the balance of power between the White House and Congress, which will have important implications for the healthcare policy outlook. With the election less than four months away and the party conventions underway this summer, election milestones are playing out against the backdrop of ongoing regulatory activity, especially as it relates to implementation of the drug pricing provisions under the Inflation Reduction Act (IRA) and upcoming Medicare open enrollment for the 2025 plan year (see Figure 1).  

Figure 1: Timeline of Key Election and Regulatory Health Policy Events

*Government funding bills could be a potential vehicle for access and coverage policies.

CMS: Centers for Medicare and Medicaid Services; FY: Fiscal Year; IPAY: Initial Price Applicability Year; MDRP: Medicaid Drug Rebate Program; MFP: Maximum Fair Price; MOOP: Maximum Out-of-Pocket MPPP: Medicare Prescription Payment Plan 

Upcoming Key Policy Actions 

With several major legislative provisions up for reauthorization and ongoing activity related to other healthcare priorities, the next administration and the 119th Congress will be positioned to consequentially shape healthcare policy for years to come.  

Specifically, both the tax cuts implemented during the Trump administration and the expanded ACA premium tax credits passed under the Biden administration are set to expire at the end of 2025 without further Congressional action.  

Additionally, the recent Supreme Court decision to overturn the Chevron deference doctrine in Loper Bright Enterprises v. Raimondo raises important new questions about how agencies will adjust the rulemaking process moving forward and the need for more prescriptive legislative language. Healthcare issues that may be affected include various FDA regulatory decisions (e.g., Orphan Drug Act and the recent final rule on lab developed tests), Medicare coverage and reimbursement, the 340B program, and nondiscrimination requirements under the ACA. 

As a result, Avalere expects the following key healthcare issues to present a contrast in approaches between Harris and Trump.   

• IRA Implementation and Drug Pricing: If elected president, it is expected that Vice President Harris would continue implementing the IRA’s Medicare drug pricing provisions and potentially explore incremental IRA expansions through legislation, such as insulin copay caps in the commercial market, pending party control in the 119th Congress. In contrast and if elected, the Trump administration may explore its own implementation flexibilities regarding Medicare drug pricing provisions, potentially resurrecting aspects of the “Most Favored Nations” drug pricing proposal focused on international pricing. There is also the potential for incremental legislative reforms (e.g., addressing orphan drug exclusion), pending party control of Congress. 

• ACA/Medicaid Coverage: If elected, Vice President Harris would likely preserve recent efforts to bolster ACA coverage (e.g., restoring Section 1557 nondiscrimination protections) and premium tax credits. A potential Harris administration would also likely continue to look for opportunities to expand and enhance coverage through the exchange market and Medicaid. In a potential second-term Trump administration, we would expect efforts to roll back some Biden-era policies (e.g., regulations on short-term limited duration plans) and otherwise deprioritize exchange and Medicaid coverage expansions.  

Outside of drug pricing, the ACA, and Medicaid, there are several other policy areas that could see legislative or regulatory action regardless of election outcomes due to bipartisan interest or alignment. These could include Medicare Advantage reforms, pharmacy benefit manager (PBM) transparency and regulation, and changes to the 340B program. 

What’s Next 

Ahead of November, healthcare stakeholders should start preparing for the spectrum of potential election outcome scenarios and resulting policy priorities. To learn more about the election outlook and how Avalere can help you prepare, join us for a webinar titled, “Election 2024: What’s at Stake For Healthcare?” on August 14 from 1:30-2:30 PM ET, or connect with us directly.