The Advanced Medical Technology Association (AdvaMed) has called on the US Centers for Medicare & Medicaid Services (CMS) to address “serious flaws” in the health agency’s proposed rule to restart the competitive bidding programme (CBP) for certain devices in Medicare.
The proposed rule would target durable medical equipment, prosthetics, orthotics and supplies (DMEPOS). The CBP for DMEPOS is a system by which suppliers compete to offer medical equipment at the lowest cost to Medicare. In December 2023, the programme 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.
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In June, the CMS outlined a proposed rule to restart the CBP. The agency said the action, mooted for implementation by 2027, would function as a tool to remove fraudulent DME suppliers from the Medicare programme and reduce Medicare expenditures on the device category.
AdvaMed’s president and CEO Scott Whitaker disagrees with the agency’s take. In a letter to CMS administrator Mehmet Oz, he wrote: “Unfortunately, a poorly designed competitive bidding programme will have the opposite effect.
“The medtech market is intensely competitive, with numerous innovative companies routinely bringing similar types of products to market […] and market dynamics have demonstrated medtech prices tend to be deflationary over time.”
According to Whitaker, competitive bidding to further reduce Medicare payments for DME is liable to “reduce incentives” for companies to continue to innovate and will “drive established, high-quality suppliers from the programme”.
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Whitaker went on to highlight concerns around the CMS’s proposed changes to the CBP. A key change the CMS has suggested lies in broadening the definition of ‘item’ in a manner that could encompass prosthetic devices – a matter Whitaker claims “exceeds the authority” granted to the CMS by Congress and would raise “significant” legal concerns.
Whitaker explained: “AdvaMed strongly opposes the proposed redefinition of ‘item’ to include ostomy, tracheostomy, and urological supplies due to the patient safety and access risks, lack of authority, and lack of appropriate information to base bids from.
“We believe that without explicit Congressional action, this change lacks a valid statutory foundation and could create substantial legal uncertainty for suppliers, reduce market transparency, and potentially impact beneficiary access to these necessary products.”
Another key issue Whitaker focused on was the CMS’s plans to provide payment for Continuous Glucose Monitors (CGM) and durable insulin infusion pumps.
While stating that AdvaMed supports the CMS’s goals of increasing choice and access to a range of CGMs and insulin pumps, Whitaker highlighted concerns that the proposal was “not consistent” with the US Food and Drug Administration’s (FDA) regulatory status and labelling of the devices.
He pointed out that CGMs, including sensors, transmitters, and readers, and durable insulin pumps, are regulated by the FDA as Class II medical devices and are typically cleared through the 510(k) pathway for prescription use.
He commented: “Importantly, CGM systems and durable insulin pumps are not FDA-cleared or approved for refurbishment, reprocessing, or multi-patient use.”
Whitaker also highlighted that such devices require precise handling of proprietary parts, software updates, calibration protocols, and safety checks, all of which fall outside the traditional scope of DME supplier operations.
He continued: “Most suppliers have not historically needed technical expertise or facilities to inspect, repair, reconfigure, or validate the safety and performance of returned devices before placing them back into service.
“Expecting suppliers to take on refurbishment responsibilities without a clearly defined process or technical support framework raises concerns about patient safety, device reliability, and equitable access to high-quality equipment.”
Closing out his letter, Whitaker called on the CMS to “substantially revise” its proposed rule.
