The medtech association cites risks to patient safety, reduced competition, and potential cost increases if the rule is implemented as is.
AdvaMed, the trade association representing medical technology companies, has urged the Centers for Medicare and Medicaid Services (CMS) to address what it calls “serious flaws” in a proposed rule to restart competitive bidding for durable medical equipment (DME) in Medicare. In a formal comment letter, the organization detailed concerns that the rule could risk patient safety, limit product choices for beneficiaries, and lead to increased costs.
The proposed rule would affect a range of medical technologies, including continuous glucose monitors, insulin infusion pumps, respiratory equipment, and ostomy, urological, and tracheostomy supplies.
“While CMS attempts to restart what it describes as the DME ‘competitive bidding’ program, the reality is, this is not competitive bidding. The current market is already highly competitive,” says Scott Whitaker, AdvaMed president and CEO, in a release. “While so-called competitive bidding is intended to reduce costs, this proposed rule would have the opposite effect on durable medical equipment while reducing treatment options for Medicare beneficiaries.”
Whitaker argues that the rule could push established companies and their products out of the Medicare market by reducing incentives to compete, ultimately diminishing innovation.
Patient Safety and Product Categorization Concerns
A key concern raised by AdvaMed is the potential for patient safety risks due to the miscategorization of certain medical products. The association contends that the rule treats sensitive, highly individualized devices as broadly applicable commodities.
“Ostomy, tracheostomy, and urological supplies serve patients with complex medical conditions and require careful management and sourcing to avoid complications and infections. Diabetes is a serious condition. Switching diabetes management systems is risky. Delays in getting supplies could cause serious health problems,” Whitaker says in the release. “For all these reasons, AdvaMed urges CMS to substantially revise the proposed rule.”
In its letter to CMS, AdvaMed also outlined several technical issues with the proposal, including what it describes as an unlawful revision of the definition of “item” for medical supplies, the proposed use of inherent reasonableness authority, and a proposal to move continuous glucose monitors and insulin pumps to a rental payment classification.
