Lowering Drug Prices by Once Again Putting Americans First

4/15/2025

Executive Orders

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Action Summary

Purpose: Revitalize first-term policies to lower prescription drug prices by putting Americans first; counter the Biden Administration’s modifications including the Inflation Reduction Act.
Policy Objective: Optimize Federal healthcare programs, intellectual property protections, and safety regulations to ensure affordable access to prescription drugs.
Enhancing Medicare Drug Price Negotiation:
- Within 60 days, HHS to propose guidance to improve transparency and prioritization of high-cost drugs while minimizing innovation impacts.
- Proposal to modify Medicare Drug Price Negotiation to align small molecule drug rules with those for biological products.
Medicare Part D Stabilization: Recommendations due within 180 days to stabilize and reduce Part D premiums, addressing inflated premiums and reduced coverage.
High-Cost Drugs for Seniors: Develop a rulemaking plan within one year to test payment models that obtain better value for expensive drugs within Medicare.
Acquisition Cost Adjustments: Conduct a survey and propose adjustments to align Medicare payments with actual hospital acquisition costs for outpatient drugs.
Medicaid Drug Payment Oversight: Within 180 days, provide recommendations to ensure accurate drug rebates, promote payment innovation, and link payments to value in Medicaid.
Affordability of Life-Saving Medications: Ensure, within 90 days, that future grants under the Public Health Service Act are conditioned on health centers offering discounted insulin and injectable epinephrine to low-income patients.
Reevaluating Middlemen: Within 90 days, review and recommend improvements to create a more competitive, efficient, and transparent pharmaceutical supply chain.
Accelerating Competition:
- Report within 180 days to accelerate the approval of generics, biosimilars, combination products, and second-in-class drugs.
- Improve the process for reclassifying prescription drugs as over-the-counter medications.
Drug Importation: Streamline the Importation Program within 90 days to increase the availability of lower-cost prescription drugs without compromising safety or quality.
Cost of Care for Seniors: Evaluate and possibly propose regulations, within 180 days, to prevent shifting drug administration from cost-effective physician office settings to more expensive hospital outpatient departments.
Pharmacy Benefit Manager Transparency: Within 180 days, establish regulations to enhance employer health plan transparency regarding PBM fee structures.
Combating Anti-Competitive Behavior: Conduct joint public listening sessions and provide recommendations within 180 days to curb anti-competitive practices by pharmaceutical manufacturers.
General Provisions: Establish that the order does not impair legal authority or create enforceable rights, to be implemented consistent with applicable laws and appropriations.

Risks & Considerations

The executive order aims to lower prescription drug prices, which could impact Vanderbilt University Medical Center’s (VUMC) procurement costs and pricing strategies for medications. This may require adjustments in budgeting and financial planning.
Changes in Medicare and Medicaid drug payment methodologies could affect reimbursement rates for VUMC, potentially impacting revenue streams and necessitating strategic financial adjustments.
The focus on promoting generics and biosimilars may lead to increased competition in the pharmaceutical market, affecting partnerships and collaborations with drug manufacturers.
Efforts to increase transparency and reduce anti-competitive behavior in the pharmaceutical industry could lead to regulatory changes that VUMC must comply with, potentially increasing administrative burdens.
Potential shifts in drug importation policies could affect the availability and cost of certain medications, impacting treatment options and patient care strategies at VUMC.

Impacted Programs

Vanderbilt University Medical Center may need to reassess its drug procurement and pricing strategies to align with new federal policies aimed at reducing drug costs.
The Department of Health Policy at Vanderbilt could see increased demand for research and analysis on the impacts of drug pricing reforms and healthcare policy changes.
Vanderbilt’s School of Medicine may need to update its curriculum to reflect changes in pharmaceutical regulations and healthcare policy, ensuring that students are prepared for the evolving landscape.
The Office of Research might explore new funding opportunities related to drug pricing and healthcare policy research, leveraging changes in federal priorities.

Financial Impact

Potential reductions in drug costs could lead to decreased expenses for VUMC, but may also result in lower reimbursement rates, affecting overall financial performance.
Changes in Medicare and Medicaid payment models could impact revenue streams, necessitating adjustments in financial planning and resource allocation.
Increased competition in the pharmaceutical market may lead to cost savings, but could also affect existing partnerships and collaborations with drug manufacturers.
Regulatory changes aimed at increasing transparency and reducing anti-competitive behavior may require additional administrative resources, impacting operational budgets.

Relevance Score: 4 (The order presents a need for potential major changes or transformations of programs.)

Key Actions

Vanderbilt University Medical Center (VUMC) should prepare for potential changes in drug pricing and availability by closely monitoring the implementation of the Medicare Drug Price Negotiation Program and other related policies. This will help ensure that VUMC can adapt its procurement strategies to maintain cost-effective access to necessary medications.
The Office of Federal Relations should engage with policymakers to advocate for equitable treatment of small molecule prescription drugs in comparison to biological products. This advocacy could help influence legislative changes that align with Vanderbilt’s interests in pharmaceutical research and innovation.
Vanderbilt’s School of Medicine should explore opportunities to participate in research and development initiatives focused on generic and biosimilar alternatives. By contributing to these efforts, the university can enhance its role in promoting affordable healthcare solutions.
The Department of Health Policy should conduct research on the impact of drug importation policies and the reclassification of prescription drugs as over-the-counter medications. This research can provide valuable insights into the potential benefits and challenges of these policies for the healthcare system.
Vanderbilt’s Financial Aid Office should assess the potential impact of changes in drug pricing on student healthcare costs and insurance plans. Understanding these shifts will be essential for adapting financial aid strategies to support students’ healthcare needs.

Opportunities

The executive order presents an opportunity for Vanderbilt’s Center for Health Services Research to engage in policy analysis and advocacy related to drug pricing transparency and the role of pharmacy benefit managers. By providing evidence-based recommendations, the center can influence how these policies are implemented and improve healthcare affordability.
Vanderbilt can capitalize on the increased focus on pharmaceutical innovation by developing new partnerships with industry leaders and government agencies. This could include joint research initiatives, clinical trials, and collaborative projects aimed at improving drug affordability and access.
The emphasis on reducing anti-competitive behavior in the pharmaceutical industry offers an opportunity for Vanderbilt’s Law School to engage in legal research and advocacy. By analyzing the legal implications of these policies, the law school can contribute to shaping a more competitive and fair pharmaceutical market.
By engaging with the broader healthcare community and policymakers, Vanderbilt can position itself as a leader in the national conversation on drug pricing reform. Hosting conferences, workshops, and public forums on the implications of these policies can further establish Vanderbilt as a hub for innovative healthcare thought and practice.

Relevance Score: 4 (The order presents the potential for major process changes required for Vanderbilt’s healthcare programs due to impacts on drug pricing and availability.)

Average Relevance Score: 3.8

Timeline for Implementation

60 days: Guidance on the Medicare Drug Price Negotiation Program must be proposed and seek comment (Section 3(a)).
90 days: Actions include ensuring insulin and injectable epinephrine affordability, streamlining drug importation, and providing recommendations on pharmaceutical value chain improvements (Sections 7, 8, and 10).
180 days: Multiple directives including recommendations to stabilize Medicare Part D premiums, publishing a survey plan for acquisition costs, joint recommendations on Medicaid drug payments, a report on accelerating competition, evaluations to prevent cost shifting in Medicare, transparency improvements for pharmacy benefit managers, and public listening sessions to address anti-competitive behavior (Sections 3(b), 5, 6, 9, 11, 12, and 13).
1 year: Development and implementation of a rulemaking plan for improving value in Medicare for high-cost drugs (Section 4).

Relevance Score: 3

Impacted Government Organizations

Department of Health and Human Services (HHS): Tasked with issuing guidance on the Medicare Drug Price Negotiation Program, implementing payment model changes, and ensuring lower drug costs for patients, along with coordinating multiple related initiatives.
Office of Management and Budget (OMB): Required to work with HHS and the White House policy team to provide recommendations on Medicare Part D premium stabilization and to assist with broader economic policy related to pharmaceutical pricing.
Department of Labor: Instructed to propose regulations aimed at increasing transparency of pharmacy benefit manager fee disclosures under the Employee Retirement Income Security Act of 1974.
Food and Drug Administration (FDA): The Commissioner is mandated to accelerate the approval of generics, biosimilars, and other prescription drugs, as well as improve the drug importation process, thereby influencing drug competition and safety standards.
Department of Justice (DOJ): Called to participate in public listening sessions and provide recommendations to combat anti-competitive behaviors by prescription drug manufacturers.
Department of Commerce: Also involved in the joint effort to address anti-competitive behaviors within the pharmaceutical industry.
Federal Trade Commission (FTC): Required to collaborate with other agencies in joint public listening sessions to offer recommendations on reducing anti-competitive practices in the pharmaceutical sector.

Relevance Score: 3 (Six to ten federal agencies are impacted by this presidential order.)

Responsible Officials

Secretary of Health and Human Services – Charged with proposing guidance on the Medicare Drug Price Negotiation Program, rulemaking for high-cost drugs, and conducting cost and acquisition surveys for Medicare.
Assistant to the President for Domestic Policy – Responsible for coordinating recommendations on stabilizing Medicare Part D premiums, promoting a competitive pharmaceutical value chain, and working on other domestic policy initiatives alongside key officials.
Director of the Office of Management and Budget (OMB Director) – Tasked with collaborating on recommendations to stabilize Medicare Part D premiums, improve Medicaid drug payment oversight, and advise on policy changes in coordination with other presidential aides.
Assistant to the President for Economic Policy – Involved in coordinating efforts with domestic policy and budget officials to provide recommendations on Medicare Part D and other pricing and payment reforms.
Commissioner of Food and Drugs – Responsible for issuing reports and taking steps to streamline prescription drug competition, reclassification as over-the-counter, and improving the drug importation program.
Secretary of Labor – Charged with proposing regulations to enhance transparency into pharmacy benefit manager fee disclosures under employer health plans.
Secretary or His Designee – Directed to conduct joint public listening sessions with representatives from the Department of Justice, Department of Commerce, and the Federal Trade Commission to address anti-competitive practices by pharmaceutical manufacturers.

Relevance Score: 5 (Directives affect multiple Cabinet-level officials and White House advisors, with broad strategic implications.)