When the Centers for Medicare & Medicaid Services published the Calendar Year (CY) 2026 Home Health Prospective Payment System and DMEPOS Competitive Bidding Program Final Rule on November 28, 2025 (summarized here), it largely mirrored the proposed rule released in July. This was despite the fact that, as Applied Policy reported in September, CMS received more than 900,000 comments [1]on the proposal, many expressing concern about the establishment of a Remote Item Delivery Competitive Bidding Program (RID CBP) for new product categories.
As finalized, the rule will create a nationwide RID CBP or several large regional RID CBPs for new product categories, including all continuous glucose monitors (CGMs) and insulin infusion pumps, urological supplies, ostomy supplies, as well as off-the-shelf braces. Interestingly, CMS also listed hydrophilic urinary catheters as a category, separate from urological supplies, in its fact sheet. New codes for hydrophilic urinary catheters will go into effect on January 1, 2026, distinguishing them from existing intermittent urinary catheters.
CMS also finalized recategorization of CGMs and insulin pumps under the frequent and substantial servicing category, which represents a substantial shift in how these items have been covered and paid under the durable medical equipment program. The recategorization eliminates beneficiary ownership of CGMs and insulin pumps for new patients and shifts payment for these devices, associated supplies, and accessories to a monthly rental model.
In addition, DMEPOS suppliers will be required to be reaccredited annually, which is expected to result in increased administrative burdens for suppliers and accrediting organizations.
Acknowledging concerns that the RID CBP could disadvantage smaller DME suppliers, CMS said it would aim to award at least 30 percent of contracts to small suppliers. However, the program’s nationwide service requirements could present barriers to entry and participation for smaller companies.
On the evening of Tuesday, December 9, HME News reported that the next round of CBP would be limited to the product categories selected for RID CBP, rather than including traditional CBP categories such as CPAP machines and enteral nutrition. On the evening of Tuesday, December 9, HME News reported that the next round of CBP would be limited to the product categories selected for RID CBP, rather than including traditional CBP categories such as CPAP machines and enteral nutrition. While CMS has not issued an official clarification, its minor update to the fact sheet suggests that the next round will include only the listed product categories.
Many stakeholders have expressed disappointment that comments submitted in opposition to the proposed rule did not shift CMS policy. Almost all continue to have questions about implementation.
The United Ostomy Associations of America (UOAA) said the outcome “was not the ruling response we had hoped for.” In a statement released on December 1, the American Association for Homecare (AAHomecare) characterized the rule as “a direct threat to patients and providers,” asserting that CMS’s decision to include diabetes equipment and ostomy, urological, and tracheostomy supplies in the program would place additional stress on the home medical equipment sector.
AdvaMed, a trade association representing medtech manufacturers, commended CMS’s efforts to protect the Medicare Trust Fund, lower out-of-pocket costs, and strengthen program integrity. However, the organization also described the final rule as having “significant shortcomings.”
CMS also announced target program timelines in its fact sheet, with the goal implementation date of January 1, 2028. Applied Policy anticipates that the agency will release additional subregulatory guidance over the next several months.
In the interim, we expect stakeholders to pursue delays and modifications to the policy even as they engage with the agency. AdvaMed stated that it “look[s] forward to continuing to work with CMS and the Administration to ensure the program evolves in a way that protects access to safe, clinically appropriate supplies for beneficiaries managing complex, chronic conditions.” AAHomecare was more direct, noting that it “will continue to engage the Trump Administration, CMS, and Capitol Hill to delay implementation of the DMEPOS-related provisions in the rule.” Noting that it was continuing to review the rule, UOAA said, “Our work is not done!”
[1] The proposed rule included Home Health annual payment update provisions in addition to DMEPOS updates. The total number of comments reflects comments submitted for both DMEPOS and Home Health components in the rule.