From federal funding to pricing transparency to drug pricing regulations, the 2024 U.S. election is poised to impact stakeholders across the nation’s healthcare landscape. In preparation, L.E.K. Consulting has identified 10 policies that healthcare stakeholders should be aware of as November 5 approaches, four of which they should be creating strategies to address now (see Figure 1).
Four policies to establish relevant strategy for imminently
Given their support by both Democrats and Republicans, stakeholders should view the passage of the following four healthcare policies as imminent and should already be drawing up related plans:
1. Expansion of Centers for Medicare & Medicaid Services (CMS) value-based care (VBC) programs
VBC initiatives aim to enhance care quality and reduce healthcare costs by developing coordinated care models. Both parties support augmenting these programs but disagree on the level of federal involvement required to support and expand the Center for Medicare and Medicaid Innovation (CMMI). This expansion would further reduce spend through the evolution of existing programs and development of new ones; for example, CMMI is working on the Cell and Gene Therapy Access Model, which looks to increase access to high-cost treatments through a risk-sharing and outcomes-based agreement between payers and hospitals.
These initiatives may incentivize biopharma companies to generate real-world evidence and track long-term outcomes to inform future VBC models. In parallel, as hospitals integrate more VBC initiatives, they must improve their coordination of care, likely using technology data analytics, to maintain efficiency and invest in health management of underserved or high-risk populations to optimize incentives.
2. Increased hospital pricing transparency
- New bipartisan legislation, such as the Lower Prices, More Transparency Act, requires hospitals to publicly report standard charges and comply more strictly with requirements set by the 2021 Hospital Transparency Rule. The goal is to provide patients with a clear breakdown of healthcare costs and enable them to compare and cross-shop hospital services. As pricing transparency improves, regulators anticipate increased competition among hospitals and narrowing price variations. Hospitals may also face diminished negotiating power when contracting with payers that may steer patients toward lower-cost facilities.
3. Increased pharmacy benefit manager (PBM) pricing transparency
- Bipartisan proposals like the PBM Reform Act seek to increase transparency within PBMs by requiring detailed reports on drug costs, prohibiting spread pricing, or mandating that all discounts are passed through to patients. All PBM pricing transparency legislation intends to lower costs throughout the healthcare value chain. This could significantly alter the PBM revenue model and lead to restructuring of drug formularies, with biopharma companies gaining greater negotiation power in the contracting process. Many PBMs are already exploring new pricing models, such as the cost-plus rebate pass-through models or pricing guarantees, to get ahead of legislation.
4. Restriction of contracting with foreign biotech companies
The BIOSECURE Act, another critical piece of bipartisan legislation, could prevent the federal government from contracting with certain foreign biotech firms, such as WuXi AppTec and WuXi Biologics, or biotech companies working with named firms. This policy reflects growing concerns over national security and U.S. reliance on foreign biotechnological innovation, especially from countries perceived as potential threats.
As a consequence, biotechs already working with named firms will have until 2032 to establish contingency plans such as finding new partners or investing in infrastructure for manufacturing; biotechs that were planning on working with them will need to consider alternatives. In a similar vein, companies looking to license innovative products and/or to leverage clinical trial data in China to accelerate drug development timelines may want to weigh their options as well.
Preparing for election outcomes
Stakeholders across the healthcare ecosystem — from providers to payers, biotech and pharmaceutical companies alike — should be preparing for a range of election scenarios and, in some cases, establishing strategies now around the changes in healthcare policy that are all but guaranteed to follow.
L.E.K. Consulting can help stakeholders across the healthcare spectrum navigate the impacts of this legislation and take tangible steps to position themselves for success irrespective of the election’s outcome. To set up a meeting, please fill out this brief contact form.
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