Public Policy

PMC advises policymakers on how to regulate, pay for, and encourage the clinical adoption of personalized medicine.

PUBLIC POLICY TOPICS

  • Evidence-Based Medicine

    PMC advises organizations on the development of evidence-based standards and measures that are used to help assess the quality of health care. In 2021, for example, PMC encouraged the National Committee for Quality Assurance (NCQA) to adopt changes to its colorectal cancer (CRC) screening measure that would help align the measure with the value that molecularly guided testing strategies can provide for CRC patients in the era of personalized medicine.

  • Government Funding & Appropriations

    PMC advocates for public investments that will help drive safe and effective personalized medicine tests and treatments to the market. For example, PMC submits yearly testimonies to Congressional lawmakers on the importance of robust and sustained funding increases for biomedical research at the National Institutes of Health (NIH) and regulatory oversight programs at the Food and Drug Administration (FDA).

  • Government Innovation

    PMC advises lawmakers and administration officials on opportunities to advance personalized medicine through legislation and executive action. In 2016, for example, PMC sent a letter to the sponsors of a proposed bill called the 21st Century Cures Act, outlining how key provisions in the bill could help expand the frontiers of personalized medicine. The Cures Act became law on December 13, 2016.

  • Intellectual Property

    PMC helps policymakers understand how decisions related to the scope and quality of certain patents can influence the extent of progress in personalized medicine. Strong legal protections for key patents, for example, can help encourage business leaders to invest in the development of new tests and treatments. In 2011, PMC published a review of intellectual property court cases that have implications for the future of personalized medicine.

  • Regulation

    PMC advises regulators on public policies that can help facilitate the efficient review of personalized medicine products. For example, PMC explained how certain enhancements to the U.S. Food and Drug Administration (FDA)’s drug and medical device user fee programs could help advance personalized medicine while participating in a series of public workshops FDA convened to discuss the user fee programs in 2020, 2021, and 2022. Many of PMC’s recommended changes went into effect with the passage of new user fee reauthorization laws in 2022.

  • Reimbursement

    PMC advises Medicare and Medicaid officials on reimbursement policies that can help ensure sustainable patient access to personalized medicine. In 2020, for example, PMC began advocating for increased Medicare payment rates for hospitals that provide chimeric antigen receptor T-cell therapies, a potentially life-saving class of personalized cancer treatments. PMC’s recommended payment solution is still in place today.

  • Value in Health Care

    PMC advises value assessment institutions on how to assess the clinical and economic value of personalized medicine. In 2019, for example, PMC wrote a letter to the Institute for Clinical and Economic Review (ICER) to outline how certain changes to ICER’s value assessment methodology would help the institution gain a clearer picture of the value that personalized medicine tests and treatments can provide for patients and health systems.

PUBLIC POLICY WORK PRODUCTS

You can use the search bar provided below to browse PMC’s Public Policy work by topic area.

FDA Guidance on Pharmacogenomic Data Submissions

U.S. House of Representatives Ways and Means Health Subcommittee Hearing on Policies That Inhibit Innovation and Patient Access

Legislation to Ensure Predictable and Sustainable Medicare Payments for Laboratory Services/Saving Access to Laboratory Services Act

A Proposal to Expand the World Trade Organization's Trade-Related Aspects of Intellectual Property (TRIPS) Waiver for COVID-19 Vaccines to Also Cover COVID-19 Diagnostics and Therapies

Congressional Pharmacogenomics Legislative Package/Right Drug Dose Now Act/Pharmacogenomics Research and Education Act

Inflation Reduction Act/Medicare Drug Price Negotiation Program

Congress' Right Drug Dose Now Act

Legislation to Enable Medicare Reimbursement for Genetic Counselors