We may soon see a provision in the 2015 final rule addressing the utilization of end-stage renal disease related drugs and biologics come into action in the next few months. Specifically, the oral-only drug Sensipar may transition to bundled payment and become reclassified as a Medicare Part B covered drug should a non-oral form be approved by the FDA. Prescribers and dispensers should be aware that a transition is possible and will likely impact reimbursement for this product.

The drug Sensipar is currently considered an oral-only drug product. However, in 2015, a biopharmaceutical company submitted a new drug application for a calcimimetic agent that can be administered intravenously. Under the final rule, approval of this product would likely reclassify the oral-only form as a non-oral-only product and subject it to inclusion in a bundled payment. In other words, if an IV form is approved by the FDA, it will be in a transition period for two years while CMS evaluates the utilization of both the oral and IV forms. If the oral form remains with no FDA-approved IV form, the oral will continue to be paid separately under Medicare Part D.

FDA approval of the IV form is anticipated prior to the end of 2016.