President Donald Trump’s administration has initiated significant changes in U.S. federal healthcare policy through a series of executive orders on the first day of his second term. These actions have reversed several initiatives from the Biden administration and introduced new directives aimed at reshaping regulatory processes and workforce policies affecting healthcare agencies, the industry, and public health.
Regulatory Freeze on HHS Activities
Government-Wide Regulatory Freeze
One of the major moves by the Trump administration was the imposition of a government-wide regulatory freeze for 60 days. This halt interrupts the progression of ongoing healthcare regulations, stopping the immediate issuance of new healthcare rules. During this period, the new Department of Health and Human Services (HHS) leadership will assess and decide which Biden administration regulations to discard, maintain, or modify. Similar regulatory freezes were enacted by previous administrations on their first days in office.
Impact on Key Regulations
Noteworthy regulations facing review include the proposed updates to the Health Insurance Portability and Accountability Act (HIPAA) Security Rule and rules concerning prescribing controlled substances via telehealth. Finalized Biden administration rules yet to take effect will also experience a 60-day delay. The freeze period offers the Trump administration a strategic advantage to align its regulatory priorities distinct from those of the Biden administration.
Implications for Drug Pricing Models
Revocation of Biden’s Drug Pricing Models
President Trump’s executive orders included revoking Biden’s executive order that created three drug pricing models within the Center for Medicare and Medicaid Innovation. These models, launched by Biden in February 2023, aimed to lower drug costs, especially for cell and gene therapies, cap certain generic drug prices at $2 monthly out-of-pocket, and expedite FDA approvals for drugs addressing unmet medical needs.
Potential Shifts in Drug Pricing and Approvals
The implementation of these models was set for January 2027, with successful negotiations already made by CMS with two drug manufacturers under the cell and gene therapy model. Nonetheless, the accelerated FDA approval model drew Republican pushback, with critiques around its potential disincentivization of drug makers and a detriment to research and development. Trump’s rescission of these drug pricing initiatives signaled a potential shift away from reducing out-of-pocket drug costs and accelerating drug approvals, likely inciting Democratic opposition due to possible impacts on drug prices.
Federal Workforce and Hiring Freeze
Overhaul of Federal Workforce Policies
Trump’s administration moved to overhaul federal workforce policies, pivotal to agencies like HHS and the National Institutes of Health (NIH). A hiring freeze was applied across the executive branch, with exemptions in select sectors like the armed forces and national security. The freeze aims to reduce the federal workforce’s size through efficiency improvements and attrition.
Formation of the U.S. Department of Government Efficiency (DOGE)
Guided by a plan from the Office of Management and Budget, the Office of Personnel Management, and a newly formed U.S. Department of Government Efficiency (DOGE), the administration intends to modernize government IT systems and advise on HR best practices, intending to lower headcounts across government agencies. The DOGE, led by Elon Musk and Vivek Ramaswamy, focuses on these modernization efforts.
Withdrawal from WHO
Executive Order to Withdraw from WHO
In a significant public health maneuver, Trump signed an executive order withdrawing the U.S. from the World Health Organization (WHO). The withdrawal, which follows a one-year notice period, includes the cessation of U.S. funding to the WHO. This move, criticized by public health experts, is expected to impede critical data access for U.S. agencies like the CDC and NIH, complicating future pandemic prevention efforts.
Impact on Birthright Citizenship and Insurance Coverage
Executive Order Challenging Birthright Citizenship
Trump’s issuance of an executive order challenging birthright citizenship based on constitutional interpretations sets the stage for legal battles, with lawsuits already emerging from the ACLU and state attorneys general. The order’s implications extend into healthcare, where affected individuals might face difficulties obtaining public program insurance, increasing uninsured rates and placing additional strains on the healthcare system.
Changes to Reproductive Rights Resources
Removal of ReproductiveRights.gov
Post the Dobbs ruling overturning Roe v. Wade, the HHS launched ReproductiveRights.gov to provide reproductive rights resources. However, the Trump administration has removed this website, indicating a divergence from the previous administration’s stance on women’s reproductive health issues.
Reentry into the Paris Climate Agreement
Withdrawal from the Paris Climate Agreement
In environmental policy, Trump pulled the U.S. out of the Paris Climate Agreement for the second time, a move expected to become official within a year, placing the U.S. alongside few other countries outside the treaty. This withdrawal is also accompanied by the rescission of Biden’s Climate Change Support Office and policies oriented towards environmental protection and justice.
New Personnel Appointments
Key Healthcare Roles
In addition to the regulatory and policy shifts, Trump appointed new personnel to several key healthcare roles. Dorothy Fink, M.D., an endocrinologist known for her work on women’s health, was appointed as acting HHS secretary until Robert F. Kennedy Jr.’s confirmation. Within the CMS Innovation Center, Abe Sutton is anticipated to be leading efforts, alongside Chris Klomp as president of the Center for Medicare, reporting to the CMS administrator Mehmet Oz, M.D. The domestic policy council under Trump will include figures such as Theo Merkel and Heidi Overton, M.D.
Transformative Shifts
On the first day of his second term, President Donald Trump’s administration implemented substantial changes to federal healthcare policy through a series of executive orders. These newly introduced directives have overturned several initiatives put in place by the Biden administration and launched new measures that are poised to reshape regulatory processes, workforce policies, and the broader healthcare industry. These changes are aimed at streamlining operations within healthcare agencies and significantly impacting public health. The new regulations seek to address and modify the foundational structures of healthcare policy in a way that aligns more closely with Trump’s vision for healthcare in America.
These executive orders are designed to roll back the previous administration’s policies and introduce a fresh approach to healthcare management and operations. This includes alterations in how regulations are processed and implemented, potentially leading to more efficient and effective governance. Key areas of change may involve the reorganization of healthcare workforce policies to better align with the current administration’s objectives and possibly impact the delivery of care and public health initiatives.
Overall, these significant shifts reflect the Trump administration’s commitment to redefining the landscape of federal healthcare policy, striving for a system that they believe will better serve the American public and health industry stakeholders.
