![]() Covered entities with on-site pharmacies that opt not to provide the requested CLD will no longer be eligible to place “ship to/bill to” replenishment orders for these DAAs dispensed through any of their 340B contract pharmacies. No other prescription drugs commercialized by Gilead Sciences, including its antiretroviral products for HIV treatment and prevention, are subject to its CLD reporting requirements at this time.Ĭovered entities that register and provide the requested CLD will be able to continue to use the contract pharmacies of their choice. ![]() This blog outlines the potential impact of this requirement on 340B covered entities providing viral hepatitis care that work with contract pharmacies.Įffective May 2, 2022, Gilead Sciences will begin requiring all 340B covered entities to register with 340B ESP and upload CLD for prescriptions of Epclusa (sofosbuvir/velpatasvir), Harvoni (ledipasvir/sofosbuvir), Sovaldi (sofosbuvir) and Vosevi (sofosbuvir/velpatasvir/voxilaprevir) dispensed from contract pharmacies. ![]() Central to this initiative is a requirement for 340B covered entities with contract pharmacies to register and provide claim level data (CLD) via 340B ESP, an online portal operated by the prescription drug information technology company Second Sight Solutions, contracted by several manufacturers. NASTAD is aware of a Maletter to 340B covered entities from Gilead Sciences regarding the company’s “Pharmacy Integrity Initiative” pertaining to its direct acting antiviral (DAA) products for hepatitis C.
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