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President-elect Donald Trump is expected to maintain his strong stance on deregulation and prioritize policies that address healthcare access and costs. Looking ahead, the Trump administration intends to uphold campaign promises for the health sector with four key themes:
President-elect Trump’s second term marks a significant shift in the political landscape that could have considerable implications for the health industry. It is important to consider how the landscape has changed since President-elect Trump’s first administration. For example, efforts to repeal and replace the Affordable Care Act (ACA) no longer retain the level of political or public support they did in 2016. Instead, recent comments from President-elect Trump have suggested he takes credit for “saving” the ACA; this may indicate more focus on technical fixes across the sector rather than sweeping reforms.
The new Trump administration will also need to navigate working with a Republican party with significant intraparty tensions between traditional, establishment Republicans and the more populist Republicans who are increasingly skeptical of the traditional Republican platform regarding pro-business, small government ideology. For example, despite the traditional GOP stance against government interventionalist policies, President-elect Trump has vowed to “take on big pharma” and to address perceived anticompetitive activity. Likewise, Vice-President elect J.D. Vance has expressed support for FTC Commissioner Lina Khan as recently as August 2024 and remains a supporter of mandates such as a $35 cap on insulin across commercial plans. Indeed, this presents a paradox; while the campaign has emphasized deregulatory priorities throughout the election, the administration’s policies may stray further from the traditional GOP approach than in past years.
As many organizations continue scenario planning for the impact of the election, a wide breadth of possibilities exist. On one end, policy shifts can move at a snail's pace with seemingly dramatic proposals tamed over the course of debate, judicial proceedings and ultimate implementation. On the other end, however, lies the nexus of a right-leaning Supreme Court, a White House with fewer GOP traditionalists influencing decisions and a set of broad reaching, dynamic proposals. Debates within the Republican party also introduce an additional layer of uncertainty given prominent agendas that either embrace a disbelief in government (and interest in deconstructing its core foundations) or an interest in leveraging the entirety of governmental power towards a more populist agenda.
One indicator to forecast headwinds will be the selection of agency leadership and policy advisors, including those not subject to Senate confirmation. Nonconventional backgrounds, experiences and priorities that the appointees bring with them to the executive branch may signal the potential degree of disruption or uncertainty. Equally indicative of impact will be the length of time each appointee remains in their position as short tenures will limit ability to implement significant changes or create influence.
Monitoring events closely and modifying scenario planning accordingly can help organizations prepare for shifts as the Trump administration seeks to fulfill campaign promises, continue unfinished business from the president-elect's previous term and potentially set the trajectory of the Republican party for the future.
The Trump administration is expected to shift toward deregulation and a market-driven system that could alter the landscape of healthcare policy in a manner reminiscent of his previous term while also addressing contemporary conservative priorities such as the ‘America First’ agenda. The administration is likely to prioritize reducing federal oversight and regulatory burdens, aiming to foster competition and innovation. By decentralizing control, the administration may seek to empower states to design and implement healthcare solutions tailored to their unique needs, thereby helping reduce bureaucratic inefficiencies and promoting localized innovation yet potentially creating a more fragmented regulatory landscape.
The Trump administration is expected to emphasize budget-focused proposals in an effort to reduce federal healthcare expenditures while maintaining or enhancing quality of care. President-elect Trump’s focus on fiscal responsibility and market-driven solutions may create shifts in both funding and regulatory requirements in the near term while simultaneously working to lower taxes.
Throughout the election, attention has been given to policy proposals put forth by conservative think tanks ready to supply the Trump administration with a ready-made playbook. While these remain available as a starting point if the administration were to take an interest, to date, Trump has particularly distanced himself from these. Trump’s own comments throughout the election, along with his campaign statements may point to a clearer vision of how Trump currently plans to make an impact.
Source: PwC analysis of President-elect Trump's healthcare agenda
President-elect Trump’s campaign did not release a specific plan for his first 100 days. However, discussions among GOP leaders indicate that a key priority will be preparing for the extension of the 2017 Tax Cuts and Jobs Act, set to expire at the end of 2025. President-elect Trump plans to bring together key stakeholders to develop a holistic legislative roadmap that can help address tax cuts, spending cuts and regulatory reforms while securing funding for immigration priorities. Additionally, President-elect Trump intends to implement various measures designed to help bolster national security and economic stability.
While his primary focus during the first 100 days may not be directly on healthcare, GOP leaders have cited both the cost of healthcare and healthcare transparency as priorities to be addressed later in the year. Likewise, comments from President-elect Trump in late October indicate a strong interest in addressing chronic disease and introducing reforms to the FDA such as addressing funding from User Fee Negotiations. As such, we may see movement during early days of the term; the exact approach is unclear.
The Trump campaign also outlined a series of initiatives aimed at reshaping various aspects of the healthcare industry and broader economic policies that could become administration priorities. These initiatives can be grouped into four primary buckets: deregulation, flexibility/choice, accessibility and national security.
Initiatives aimed at securing the financial stability of Medicare can have significant impacts on payers, including those covering private insurance, traditional Medicare plans and Medicare Advantage plans. A shift in Medicaid’s funding structure, such as transitioning to block grants or per capita caps, could also create shifts in the broader marketplace. This change would likely influence how services are provided and funded by giving states more flexibility to design and manage their Medicaid programs according to local needs. Though, reducing government mandates on plan and benefit structures could introduce more flexibility for payers, enabling them to innovate and tailor services more effectively to meet the diverse needs of their populations.
Expanding access to primary care and age-in-place services could significantly enhance the quality of care for seniors, promoting preventative care and reducing hospital admissions. This approach aims to keep seniors healthier for longer periods, thus controlling long-term healthcare costs and improving overall patient outcomes.
Adjusting to Biden-era regulations as they are modified will be important for stakeholders. Potential transparency provisions could confirm that consumers are better informed about their healthcare options and costs, fostering a more competitive and efficient marketplace. By enhancing transparency, consumers can make more informed decisions, potentially driving down costs through increased competition among providers and payers.
Payers should stay up to date on changes in Medicare regulations and confirm compliance through regular audits and staff training. Additionally, payers should reevaluate reimbursement strategies and payment models to adapt to changes in Medicare and Medicaid funding, confirming they remain sustainable and effective. Implementing pricing transparency initiatives will be crucial to meet regulatory demands and provide consumers with clear information on healthcare costs.
Moreover, payers can develop and diversify Medicare Advantage and supplemental Medicare plans to better meet the needs of the aging population and capitalize on increased enrollment. By offering a broader range of tailored plans, payers can attract and retain beneficiaries, confirming holistic coverage and improving patient satisfaction.
Efforts to safeguard the financial stability of Medicare can impact healthcare providers, including hospitals, clinics, and individual practitioners. This could involve new compliance requirements and auditing processes, necessitating investments in administrative systems and staff training. However, deregulation efforts will generally decrease reporting requirements and administrative burdens, helping providers to allocate more resources directly to patient care.
Expanding access to primary care and age-in-place services will likely increase the focus on preventive care, requiring providers to adjust their service offerings to meet these new priorities. Resources might be strained if Medicare reforms, such as block grants, were to be implemented, as these market-based solutions and budget-focused policies often create added challenges for providers, particularly those in rural settings who tend to rely more on federal support.
Providers should stay up to date on Medicare regulations and confirm compliance through regular audits and staff training programs. Conducting financial planning and analysis will help provide an understanding of how changes in Medicare policies can impact revenue streams and operational costs.
Changes proposed by the Trump campaign to reduce out-of-pocket expenses for consumers could result in changes to revenue calculations as it strives to make prescription medications even more affordable than with the previous administration. Additionally, product life cycle management decisions may be influenced by IRA policies set to take effect in 2025. The possibility that the Trump administration might modify the approach CMS takes to IRA provisions adds an element of uncertainty to long-term planning. Furthermore, potential reforms to the 340B and PBM marketplaces necessitate continuous monitoring of legislative developments throughout 2025. This transparency would likely necessitate regular audits and detailed reporting, adding to the administrative burden.
Pharmaceutical companies can take several strategic actions to prepare for upcoming changes. They can reevaluate pricing models to align with the Inflation Reduction Act's goals, considering both how they launch new drugs in the post-IRA world and manage on-market products given expected declines in Medicare and Medicaid (i.e. AMP cap removal) net pricing. Longer term, companies can start to realign their R&D pipelines, BD/M&A activity, and portfolio strategy to the realities of the current post-IRA world with consideration for future expansion. Enhancing manufacturing and supply chain processes to reduce production costs and maintain profitability despite capped pricing is also important. Holistic financial planning can help understand the potential impact on revenue and profitability, facilitating effective resource allocation.
Pharma companies should also monitor deregulatory activity, particularly in the first 100 days, as this may alter requirements related to health equity, social determinants of health (SDOH), women's health, and patient-reported outcomes (PRO). These changes could have significant implications for compliance and operational strategies.
Pharma companies should also reassess the geolocation of manufacturing and supply chain collaboration given geopolitical tensions, policies that may incentivize domestic manufacturing and potential shifts in tax and import regulations.
The shift towards self-governance in AI oversight, prioritizing domestic production and confirming independence in essential goods can significantly impact many medtech companies. With less stringent federal regulations, these companies may face a reduced compliance burden, allowing more flexibility in adopting and implementing AI technologies. However, they will need to collaborate with industry stakeholders to develop and adhere to self-imposed standards and leading practices for AI use, which could result in varying levels of compliance and quality across the industry. Self-governance may also lead to increased liability and accountability for AI-related errors or biases, necessitating significant investments to confirm the accuracy, fairness, and transparency of AI systems.
Medtech companies can take several actions to address these impacts. Without stringent federal oversight, effective internal risk management strategies will be essential for the safe and ethical use of AI. Investments in AI auditing, monitoring, and governance frameworks will be necessary to help mitigate risks. Further, establishing holistic internal guidelines and leading practices that focus on transparency, fairness, and accountability in AI usage is important.
Overall, medtech companies should implement risk management strategies to help mitigate potential liabilities and confirm operational continuity. Developing contingency plans to address supply chain disruptions and regulatory changes is also essential.
Medicare’s financial stability can help maintain or improve patient access to healthcare services by providing sustainable funding for the program. Expanding access to primary care and age-in-place services can lead to a greater emphasis on preventive care, thereby improving long-term health outcomes for patients. Additionally, price transparency would benefit patients by allowing them to make more informed decisions about their healthcare options, potentially lowering costs and increasing access to necessary treatments.
Reduced regulatory oversight may lead to variability in the quality of care and safety of medical products, impacting patient trust and outcomes. However, deregulation could also reduce barriers to accessing certain health services and medications, potentially lowering costs for patients.
Increasing flexible benefits can allow patients to choose the services and coverage that meet their individual needs, leading to more personalized and effective care.
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