Fact Sheet: President Donald J. Trump Announces Actions to Lower Costs and Expand Access to In Vitro Fertilization (IVF) and High-Quality Fertility Care
Action Summary
- MFN Pricing for Fertility Medications: Establishes an agreement with EMD Serono to align U.S. drug prices with the lowest developed nation prices, applying the MFN pricing model to fertility drugs such as GONAL-F.
- Deep Discounts for Targeted Groups: Provides a 796% deal price discount for direct purchases via TrumpRx.gov, with an additional 2,320% discount for low- and middle-income women (below 550% of the Federal poverty level).
- Cost Savings Impact: Expected to save women up to $2,200 per cycle on fertility drugs, which typically account for about 20% of the overall IVF treatment cost.
- Additional Manufacturer Commitments: Includes offering other medicines at deep discounts, ensuring MFN prices on new innovative therapies, repatriating increased foreign revenue, and extending MFN pricing to every State Medicaid program; also, EMD Serono will begin U.S. manufacturing of IVF drugs.
- Regulatory Expediency: The FDA will include a lower-cost fertility drug in the Commissioner’s National Priority Review Voucher program, significantly reducing review times from 10-12 months to 1-2 months to boost competition and further decrease costs.
- New Benefit Option for Fertility Coverage: Creation of a standalone fertility benefits package option for employers, enabling coverage for a range of fertility-related services, including IVF, with rulemaking efforts by the Departments of Labor, Health and Human Services, and Treasury to expand these benefits.
- Support for Family Formation: Reinforces President Trump’s commitment to lowering IVF costs and expanding access, complementing previous policies like the Working Families Tax Cuts and enhanced Child Tax Credits, aimed at tackling financial barriers for American families.
Risks & Considerations
- The executive order’s focus on reducing fertility drug costs and expanding access to IVF could lead to increased demand for fertility treatments. This may require Vanderbilt University Medical Center (VUMC) to evaluate its capacity to meet potential increases in patient volume and adjust its services accordingly.
- The introduction of a new benefit option for fertility coverage by employers could influence the benefits landscape, prompting Vanderbilt to reassess its employee benefits packages to remain competitive in attracting and retaining talent.
- The emphasis on manufacturing IVF drugs in the United States may present opportunities for collaboration with pharmaceutical companies, potentially impacting research and development initiatives at Vanderbilt.
- Vanderbilt’s research programs in reproductive health and fertility may see increased funding opportunities as a result of the administration’s focus on expanding access to fertility care.
- There is a potential risk of regulatory changes affecting the university’s compliance requirements, particularly in relation to healthcare and employee benefits.
Impacted Programs
- Vanderbilt University Medical Center (VUMC) may need to expand its fertility services and infrastructure to accommodate increased demand resulting from lower drug costs and expanded access to IVF.
- The Department of Obstetrics and Gynecology at Vanderbilt could see increased research opportunities and collaborations with pharmaceutical companies focused on fertility treatments.
- Human Resources at Vanderbilt may need to review and potentially enhance employee benefits packages to include fertility benefits, aligning with the new legal pathways for offering such benefits.
- The School of Medicine may experience increased interest in reproductive health and fertility research, potentially leading to new academic and research initiatives.
Financial Impact
- The reduction in fertility drug costs and expanded access to IVF could lead to increased patient volume at VUMC, potentially boosting revenue from fertility services.
- Vanderbilt may need to allocate resources to expand its fertility services and infrastructure, which could involve significant financial investment.
- There may be opportunities for increased funding and grants for research in reproductive health and fertility, benefiting Vanderbilt’s research programs.
- The potential changes in employee benefits packages to include fertility coverage could impact the university’s financial planning and budgeting for employee benefits.
Relevance Score: 3 (The order presents moderate risks involving compliance and potential transformations in healthcare services and employee benefits.)
Key Actions
- Vanderbilt University Medical Center (VUMC) should explore partnerships with EMD Serono to leverage the new MFN drug pricing for fertility treatments. This could enhance the affordability of fertility care for patients and position VUMC as a leader in accessible reproductive health services.
- The Office of Federal Relations should monitor developments in the FDA’s National Priority Review Voucher program to identify opportunities for collaboration on research and development of lower-cost fertility drugs. Engaging in this initiative could provide Vanderbilt with a competitive edge in fertility research.
- Vanderbilt’s Human Resources Department should consider offering standalone fertility benefit packages to employees, in line with the new legal pathways announced. This could improve employee satisfaction and attract top talent by providing comprehensive health benefits.
- The Department of Health Policy should conduct research on the impact of expanded fertility benefits on family formation and stability. This research can inform policy recommendations and enhance Vanderbilt’s role as a thought leader in health policy.
- Vanderbilt’s Financial Aid Office should assess the potential impact of the Working Families Tax Cuts on student demographics and financial aid needs. Understanding these shifts will be essential for adapting financial aid strategies to support a diverse student body.
Opportunities
- The executive order presents an opportunity for Vanderbilt’s School of Medicine to expand its research and development of innovative fertility treatments. By leveraging its expertise in reproductive health, the school can contribute to the design and evaluation of effective fertility care programs.
- Vanderbilt can capitalize on the increased focus on fertility benefits by developing new programs and partnerships with fertility benefit companies. This could include joint research initiatives and collaborative curriculum development, enhancing Vanderbilt’s reputation in the health sector.
- The emphasis on supporting family formation through tax cuts offers an opportunity for Vanderbilt’s Center for Child and Family Policy to engage in policy analysis and advocacy. By providing evidence-based recommendations, the center can influence how these policies are implemented to support family stability.
- By engaging with the broader healthcare community and policymakers, Vanderbilt can position itself as a leader in the national conversation on fertility care. Hosting conferences, workshops, and public forums on the implications of fertility policies can further establish Vanderbilt as a hub for innovative health thought and practice.
Relevance Score: 4 (The order presents the potential for major process changes required for Vanderbilt’s programs due to impacts on fertility care and employee benefits.)
Timeline for Implementation
- Expedited FDA Priority Review Voucher program: 1-2 months from application submission for review, intended to shorten the process from 10-12 months.
No other explicit deadlines or timelines were provided, as the remaining directives rely on market agreements or rulemaking without predefined timeframes.
Relevance Score: 4
Impacted Government Organizations
- Centers for Medicare and Medicaid Services (CMS): CMS is tasked with ensuring that State Medicaid programs benefit from the most-favored-nation drug pricing agreement for EMD Serono products, directly impacting cost savings for women undergoing fertility treatments.
- Food and Drug Administration (FDA): The FDA plays a key role by including a lower-cost fertility drug in the Commissioner’s National Priority Review Voucher program, expediting its review process and potentially enhancing competition in the market.
- Department of Labor (DOL): The DOL, in collaboration with other agencies, is involved in facilitating the new benefit option that allows employers to offer standalone fertility benefits to their employees.
- Department of Health and Human Services (HHS): HHS is central to the initiative by helping shape rulemaking and expanding access to fertility care, ensuring that the benefits reach American families effectively.
- Department of the Treasury: The Treasury is engaged in the effort to expand fertility benefits and oversees aspects of the financial implications related to these cost-saving measures.
Relevance Score: 2 (A moderate number of federal agencies are directly impacted by the actions detailed in the fact sheet.)
Responsible Officials
- Food and Drug Administration (FDA) Commissioner – Responsible for expediting the review process under the Commissioner’s National Priority Review Voucher program to include a lower-cost fertility drug.
- Secretaries of Labor, Health and Human Services, and the Treasury – Charged with implementing rulemaking and establishing a new legal pathway for employers to offer standalone fertility benefit packages.
Relevance Score: 5 (Directives impact senior Cabinet-level officials overseeing multiple key regulatory and benefit expansion policies.)
