A former U.S. Food and Drug Administration (FDA) leader is sounding the alarm over the 2026 home health proposed payment rule. If it’s finalized later this year, the proposal will give new life to competitive bidding for durable medical equipment, prosthetic devices, prosthetics, orthotics and supplies (DMEPOS).
And that, the official argues, could endanger patients and stifle innovation in critical medical supplies.
In a recent MedPage Today op-ed, Peter Pitts, a former FDA associate commissioner and current president of the Center for Medicine in the Public Interest, said that specifically including urological, tracheostomy and ostomy supplies in the Medicare competitive bidding program is a “big mistake.”
Broadly, the competitive bidding program was established in 2003 via the Medicare Modernization Act. The idea was to have suppliers submit bids to provide medical equipment at lower rates, with Medicare beneficiaries required to use CMS-contracted suppliers.
At that time, those aforementioned categories – urological, tracheostomy and ostomy supplies – were carved out of competitive bidding.
“I was at the FDA when that legislation was implemented. It was the result of thoughtful negotiation and bipartisan consensus, informed by public health data and the lived experience of patients and providers,” Pitts wrote. “Congress made an explicit decision to protect ostomy, urological and tracheostomy supplies from market dynamics that reward cost-cutting over clinical appropriateness. Now, CMS is attempting to reverse that decision by administrative rule.”
“That is not only bad policy; it is bad governance and will drive poor medical outcomes,” he emphasized.
Congress originally exempted urological, ostomy and tracheostomy supplies from bidding in the 2003 Medicare Modernization Act after a brief pilot in Florida showed negative outcomes.
In his op-ed, Pitts noted that the pilot, which took place in Polk County Florida, “showed a reduction in supplier participation.” It also revealed restricted product availability, he explained.
“The data was clear and Congress acted swiftly to exclude these categories from future bidding rounds,” Pitts continued. “CMS is now ignoring that evidence, and in doing so, placing short-term savings over long-term safety.”
In his op-ed, Pitts speculated that the harsh competitive bidding proposal comes directly from “Operation Gold Rush,” where federal watchdogs uncovered billions in health care fraud.
“The scope of that fraud was staggering, and it demands a serious response,” Pitts wrote. “But competitive bidding is the wrong tool for the job.”
Beyond patient safety and fraud concerns, Pitts warned the policy could have a chilling effect on medical innovation. A lowest-bid approach will “undercut the incentive for companies to invest in next-generation technologies, harming both current and future patients,” he argued.
Pitts closed by urging CMS to reverse course: “This is not just a matter of budget mechanics. It is a test of whether we are willing to listen to patients, honor clinical judgment, and uphold the core principle that public policy should never come at the expense of public health.”
Pitt’s op-ed adds to a mountain of public backlash to CMS’ competitive bidding proposal.
After the proposed rule’s public comment window closed, CMS had received 952,483 comments from a variety of DMEPOS and home health stakeholders.
“Based upon personal experience as a caretaker for a quadriplegic spouse, I adamantly oppose any restrictions or limitations that would include trach, ostomy, urological and/or incontinence supplies in the upcoming round of competitive bidding,” one commenter wrote.
“Making these categories competitive bid will have devastating effects on many ostomy and urological patients,” another commenter explained. “I foresee intermittent catheter patients reusing catheters because their shipment hasn’t come in (leading to urinary tract infections and hospitalizations). Ostomy patients will suffer because competitive bidding will eliminate many of their product options.”
