Revisions to the US Centers for Medicare & Medicaid Services’ (CMS) competitive bidding programme (CBP) have been welcomed by the medtech industry, despite remaining concerns.
The CMS has outlined tweaks to the CBP programme, which target durable medical equipment, prosthetics, orthotics and supplies (DMEPOS), according to a 28 November release. The CBP for DMEPOS is a system by which suppliers compete to offer medical equipment at the lowest cost to Medicare.
Changes to the CBP include a nationwide remote item delivery (RID) CBP being phased into the DMEPOS CBP for items typically furnished on a national mail order basis, and an implementation phase between December 2025 and January 2028, versus full implementation by 2027 previously.
The CMS said the number of contracts offered for each product category under the CBP will be based on 125% of the number of suppliers furnishing at least 3% of total national allowed services for the lead item in 2025.
The product categories are Class II Continuous Glucose Monitors (CGMs) and insulin pumps, urological supplies, ostomy supplies, hydrophilic urinary catheters, and off-the-shelf (OTS) back, knee, and upper extremity braces.
Commenting on the rationale for contracts offered, the CMS said: “We believe this would result in approximately ten national contract suppliers for the CGM/insulin pump product category, eight national contract suppliers for the urological supplies and ostomy supplies product categories, six national contract suppliers for the OTS upper extremity braces and OTS knee braces product categories, and four national contract suppliers for the OTS back braces product category.”
AdvaMed president and CEO Scott Whitaker welcomed the adjusted implementation timeline and updated contract rationale under the CBP.
Whitaker previously wrote a letter to Mehmet Oz in August, urging the CMS administrator to address “serious flaws” in the health agency’s plans to restart the CBP. In December 2023, the scheme was paused due to feasibility issues after the Covid-19 pandemic and because of industry pushback over claims that the CBP was driving prices too low.
One of Whitaker’s key concerns around the provisional CBP programme plans as outlined by the CMS in June, relates to CGMs concerns over patient safety.
The CMS said that contract suppliers must now furnish the brand of CGM or insulin pump ordered by the physician for the beneficiary.
Whitaker commented: “We welcome CMS’s requirement that suppliers furnish the diabetes devices prescribed by physicians, which is essential to ensuring that patients receive the technologies that best meet their clinical needs, a provision we advocated for in our comments and communications with the agency.”
While AdvaMed welcomed revisions to CGM rules under the CBP, the trade body remains concerned that the CBP could impact patient access to critical medical devices.
Whitaker restated that the trade body strongly opposes the inclusion of ostomy, tracheostomy, and urological supplies in the CBP.
He said: “These products are prosthetic devices, not durable medical equipment, and fall outside CMS’ statutory authority for competitive bidding.
“They are highly individualised, and disruptions in access could lead to serious medical complications and costly hospitalisations.”
