WASHINGTON, DC (November18, 2021) – 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 November 17 regarding changes to the Medicaid Drug Rebate Program (MDRP) to facilitate value-based purchasing (VBP) arrangements: “We are pleased that CMS took this important step toward facilitating patients’ access to transformative gene therapies and we support the development of further guidance as CMS, states, and innovators work to establish and implement the infrastructure needed to make value-based purchasing arrangements successful.
“IGT believes that clear pathways to value-based purchasing (VBP) arrangements, like those set forth in this Final Rule, are essential. Without them, manufacturers, payers and providers would be saddled with onerous administrative burdens, little flexibility, and opaque regulatory guidance, that would inhibit the delivery of potentially life-saving therapies to patients.
“Under the Final Rule, which will now go into effect in July 2022, 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. It’s important to note that CMS is not requiring payers to enter VBP arrangements, but instead, facilitating the creation of these arrangements where they will benefit patients’ access.
“IGT is encouraged by this advancement and looks forward to continuing work with CMS on regulatory guidance and new VBP policies that will help advance current and future gene therapies.” ### 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.