Don Thompson, acting deputy director of the hospital and ambulatory policy group at CMS, told attendees at MDMA’s recent reimbursement meeting, that average market prices will remain in use to calculate the payment for new drugs and biologics, but that for combination products, CMS does not necessarily rely on FDA’s categorization of a combination product.

The Office of Combination Products at FDA has a three-step process for deciding which of three centers to send a new combination product to for review, but Thompson said that CMS is not tied to reimbursing a combo product in the same category as it was reviewed by FDA.

Elizabeth Halpern, an associate at the law firm of Hogan & Hartson (Washington), told Medical Device Daily that despite the potential for confusion over whether CMS and FDA will categorize a combo product differently, “it actually could create opportunities for manufacturers to decide which classification is most advantageous for their products.”

If a manufacturer’s product “can meet the statutory requirements to be recognized as a drug, the manufacturer might prefer to apply for pass-through status and coding as a drug instead of as a device” should the reimbursement field favor that classification.

“Manufacturers should think about this decision strategically and should seek help to determine how to present their products to CMS,” Halpern said.

“An example of a product [type] that CMS classifies differently than the FDA are sodium hyaluronate products, which the FDA has approved as devices but are coded and reimbursed as drugs and biologics.”

— MARK McCARTY, Washington Editor