Orals in the bundle: a policy framework.

Oral prescription drugs for treatment of bone and mineral disorders (phosphate binders and calcimimetics) in patients undergoing dialysis (i.e., those with ESRD) will be integrated into the Medicare Part B ESRD bundled payment system in 2016. Payment will be denied under Medicare Part D. Integrating Part D drugs into Part B payment at this level of scale lacks any policy precedent. Providers and patients have serious concerns about the potential for inadequate funding, and the Centers for Medicare & Medicaid Services (CMS) has been silent about the methods and other critical policy used to guide its decisions. We believe an adequate policy framework to support valuation of the targeted oral drugs depends on use of the most recent available Medicare Part D data, measurement of mean utilization for all target drugs based on a minimum of 6 months of complete data for prescriptions and dialysis treatments, use of appropriate price proxies to monetize drug volume to dialysis provider acquisition cost, adjustment to account for change in adherence due to change in patient out-of-pocket expenses, inclusion of valuation for dispensing and administrative cost, and a mechanism for adjusting payment to future changes in adherence.