PMC advises policymakers on how to regulate, pay for, and encourage the clinical adoption of personalized medicine.
PUBLIC POLICY TOPICS
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).
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.
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.
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.
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.
Reauthorization of FDA's Prescription Drug and Medical Device User Fee Programs
PMC comment letter on Medical Device User Fee Amendments — November 27, 2020 (PDF)
PMC remarks on Medical Device User Fee Amendments — April 21, 2022 (PDF)
PMC remarks on Prescription Drug User Fee Amendments — September 28, 2021 (PDF)
PMC remarks on Prescription Drug User Fee Amendments — July 23, 2020 (PDF)
Medicare Payments for Chimeric Antigen Receptor T-Cell Therapies
PMC comment letter on 2022 Medicare payment proposals — June 28, 2021 (PDF)
PMC comment letter on 2021 Medicare payment proposals — July 10, 2020 (PDF)
PMC comment letter on the need for a permanent Medicare reimbursement solution — April 22, 2020 (PDF)
PMC comment letter on 2020 Medicare payment proposals — June 24, 2019 (PDF)
PMC comment letter on 2019 proposed decision memo — March 17, 2019 (PDF)
PMC comment letter on 2019 Medicare payment proposals — June 25, 2018 (PDF)
PMC comment letter on 2018 national coverage analysis — June 15, 2018 (PDF)
FY 2023 Funding Appropriations for FDA
CMS' Proposal to Discontinue the Use of ICD-10 NOS Reimbursement Codes
CMS' Telehealth Policies
Congress' Cures 2.0 Act
Congress' Precision Medicine Answers for Kids Today Act
CMS' Clinical Laboratory Fee Schedule
Support for the Nomination and Confirmation of FDA Commissioners
Friends of Cancer Research sign-on letter supporting candidacy of Dr. Stephen Hahn — December 2, 2019 (PDF)
Friends of Cancer Research sign-on letter supporting candidacy of Dr. Ned Sharpless — September 3, 2019 (PDF)
FY 2022 Funding Appropriations for NIH
PMC outside witness testimony submitted to Senate appropriators — June 24, 2021 (PDF)
PMC outside witness testimony submitted to House appropriators — May 19, 2021 (PDF)
Ad Hoc Group for Medical Research sign-on letter — Februrary 5, 2021 (PDF)