AdvaMed Cites Patient Safety Concerns in Proposed DME Competitive Bidding Rule

AdvaMed is urging the Centers for Medicare and Medicaid Services (CMS) to fix “serious flaws” in its proposed rule to restart competitive bidding for durable medical equipment in Medicare, citing risks to patient safety, fewer product choices for beneficiaries, and cost increases that would result if the rule stands. 

AdvaMed outlined its concerns in a comment letter to CMS. The letter states: “AdvaMed strongly recommends that CMS address the serious flaws with the proposed rule before proceeding to restart what is described as the DME competitive bidding program.” 

AdvaMed President/CEO described the unintended harms under the proposed rule: “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. 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 said. “Numerous innovators already compete in the same product categories, keeping medtech prices low and often deflationary, unlike most of the health care system.  Reducing incentives to compete would drive highly qualified, established companies and their safe, effective products from Medicare. We have real concerns that the proposed rule, as drafted, prioritizes pricing over patient care and would in fact diminish competition and stifle innovation.” 

“The proposed rule also would introduce unnecessary, significant patient safety risks by miscategorizing sensitive, highly individualized medtech products as broadly applicable products. Ostomy, tracheostomy, and urological supplies serve patients with complex medical conditions and require careful management and sourcing to avoid complications and infections,” Whitaker continued. “Diabetes is a serious condition. Switching diabetes management systems is risky. Delays in getting supplies could cause serious health problems. For all these reasons, AdvaMed urges CMS to substantially revise the proposed rule.” 

The proposed rule would affect a wide segment of medtech critical to Medicare beneficiary care: continuous glucose monitors, insulin infusion pumps, respiratory equipment, and ostomy, urological, and tracheostomy supplies.

The comments in the AdvaMed letter cover various technical aspects of the proposed rule, including:  Unlawful Revision of the Definition of ‘Item’ Related to Medical Supplies; Proposed Use of Inherent Reasonableness Authority that is Out of Compliance with Existing Regulations; Proposal to Move Continuous Glucose Monitors and Durable Insulin Infusion Pumps to a Rental Payment Classification; Poorly Designed Remote Item Delivery (RID) Competitive Bidding Program; and Proposed Bidding and Pricing Methodologies.