The Centers for Medicare & Medicaid Services (CMS) home health calendar year 2026 final rule doesn’t just revive Medicare’s competitive bidding program — it rewrites it, with new processes, limitations and products to be included.
The final rule also upends the accreditation processes for durable medical equipment, prosthetics, orthotics and supplies (DMEPOS) suppliers who bill Medicare. Accreditation has been required every third year; it now will become a yearly process.
Published Nov. 28, the final rule had been long awaited by the home medical equipment (HME) industry, whose members vigorously responded to CMS during the proposed rule’s public comment period.
In the end, though, the HME portion of the final rule strongly resembled the proposed rule — a remark made by several industry thought leaders.
Accreditation to be an annual requirement
Accreditation will become a yearly requirement because “we believe that program integrity vulnerabilities have risen substantially in the DMEPOS accreditation program over the years,” CMS said in its Nov. 28 fact sheet on the final rule.
CMS noted that accreditation rules “have not been updated since their original promulgation in 2006.”
The agency expressed concerns that accrediting organizations are accrediting suppliers who don’t meet DMEPOS quality standards, and that suppliers “are falling out of compliance with the quality standards (sometimes for extended periods) after becoming accredited.”
CMS also intends the final rule to provide “stronger oversight of the accrediting organizations.”
The regulations will increase the amount, specificity and frequency of data that accrediting organizations submit to CMS; expand the agency’s ability to monitor and review accrediting organizations’ operations; and strengthen CMS’s ability to respond to accrediting organizations it believes are performing inadequately.
Competitive bidding expansion: Product categories added
Competitive bidding had been largely paused as of 2021, with CMS citing insufficient savings from the program.
But this upcoming version of competitive bidding will be very different from what DMEPOS suppliers experienced in past rounds.
“CMS is finalizing improvements to the DMEPOS competitive bidding program so that we can protect the Medicare trust funds, and beneficiaries can benefit from lower copays,” CMS said in its fact sheet. “We expect to announce the product categories for which we will solicit bids and the specific timeframe for the next competition shortly.”
CMS added a Remote Item Delivery (RID) segment to competitive bidding for items typically provided repeatedly via mail order.
“Contract suppliers for each product category will be responsible for furnishing all items under the product category to all Medicare beneficiaries regardless of where they live,” CMS added. “Only contract suppliers can furnish items included under the nationwide RID CBP [competitive bidding program] that are covered under Medicare Part B.”
All states, territories and the District of Columbia are included in the nationwide RID competitive bidding program.
Included in the RID category list are class II continuous glucose monitors (CGMs) and insulin pumps. CMS said that based on 2024 claims data, “We believe this would result in approximately 10 national contract suppliers for the CGM/insulin pump product category.”
The RID bidding round will also include urological supplies, though hydrophilic catheters won’t be included in that category. CMS listed hydrophilic urinary catheters as a separate RID category.
Ostomy supplies are also listed as a RID product category to be competitively bid.
The final rule also listed tracheostomy supplies as “medical equipment items mandated for inclusion under the DMEPOS competitive bidding program,” though tracheostomy supplies were not included in the final rule list of RID product categories.
CMS received a large volume of public comments asking for urological, ostomy and tracheostomy supplies to be excluded. But the agency said in its final rule announcement, “We do not agree with the commenters that prior competitive bidding demonstrations for urological supplies provide evidence that ostomy, tracheostomy and urologicals are not well suited for inclusion in a competitive bidding program.”
CMS estimated that eight national contract suppliers would be chosen for the urological supplies and ostomy supplies categories.
“The actual number of contract suppliers will be based on 2025 or 2026 claims data and will be announced in late spring/early summer 2026,” the fact sheet said. “If less than 30% of the winning suppliers are small suppliers, additional contracts may be offered towards the goal of meeting the 30% small supplier target.”
Competitive bidding timeline announced
CMS plans to start a pre-bidding supplier awareness program this month. In late spring to early summer 2026, CMS will announce the dates for competitive bidding program registration and bidding, as well as the lead items for product categories and the number of contracts to be awarded for every product category. During that period, CMS will also launch its bidder education program.
In the late summer to early fall 2026, participating companies will obtain user IDs and passwords, and the bidding window will open.
In the late summer-early fall of 2027, contracts will be awarded, and single payment amounts will be announced. CMS will start its beneficiary education program at that time.
No later than Jan. 1, 2028, competitive bidding contracts and single payment amounts are scheduled to go into effect, and the six-month transition period for beneficiaries to switch to contract suppliers will start.
In announcing the program’s timing, CMS said those dates “are target dates.”
CMS added that all bidding-related information and systems have been consolidated into a single Connexion system.
“In past competitive bidding rounds, suppliers submitted bids (Form A and Form B) electronically through DBidS and all other documents through Connexion,” the agency said. “Bidders will no longer have to log into two different systems to submit their bid information. In addition, the bidding system will contain a ‘country of origin’ question to obtain information on where the product(s) is manufactured.”
Single payment amounts (SPAs) will be “calculated using the 75th percentile of winning bids, instead of the maximum winning bid. In addition, the SPAs are updated at the beginning of the second year and third year of the contract period by the percentage change in the consumer price index for all urban consumers for the 12-month period ending six months prior to the start of the second (and third year, if applicable) of the contract period.”
Editor’s note: Read how industry leaders reacted to the final rule.
