Institute for Gene Therapies Comments on CMS Final Rule on Value-based Purchasing Arrangements

WASHINGTON, DC (December 23, 2020) – Today, the Institute for Gene Therapies (IGT) Chairman Congressman Erik Paulsen issued the following statement regarding the Centers for Medicare & Medicaid Services (CMS) Final Rule issued on December 21, 2020 regarding changes to the Medicaid Drug Rebate Program (MDRP) to facilitate value-based purchasing arrangements:


“Value-based purchasing (VBP) arrangements are vital for patients who need access to current and future gene therapies. Until now, clear pathways for enabling the development of these innovative payment mechanisms did not exist. The CMS Final Rule issued this week is a significant outcome for facilitating VBP arrangements as it bolsters transparency, flexibility, and innovation in drug pricing without onerous administrative burden.


“Under the Final Rule, manufacturers offering a VBP arrangement to all states will be permitted to report a Best Price that includes varying Best Price points for a single dosage form and strength. Importantly, CMS is not requiring payers to enter into VBP arrangements. Rather the new policy facilitates the creation of VBP arrangements as a negotiating tool.


“IGT is pleased that multiple aspects of the Final Rule align with the Institute’s request for flexibility in defining VBP arrangements to accommodate the expected growth in gene therapies approved by the Food and Drug Administration.


“IGT also appreciates that the Final Rule does not resolve all aspects of VBP policies. IGT looks forward to continuing its work with CMS on additional regulatory guidance and new VBP policies in the future.”


About the Institute for Gene Therapies

The Institute for Gene Therapies brings together experts from across the healthcare system to advocate for a modernized policy framework that encourages innovations and promotes patient access to the treatments they need. We represent innovators and patients, business leaders and academics working to ensure policies reflect medical advances, creating a new reality for patients. Follow us on Twitter @gene_therapies.



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The Institute for Gene Therapies advocates for a modernized regulatory and reimbursement framework that encourages the development of transformative gene therapies and promotes patient access. 

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