According to regulations.gov, when the comment period for CMS’s Calendar Year 2026 Home Health Prospective Payment System and DMEPOS Competitive Bidding Program Proposed Rule closed on August 29, the agency had received over 900,000 comments—an extraordinarily high volume for a CMS regulation and, if confirmed, the largest for any healthcare rule.[1] Fewer than 5,200 of those submissions have been posted to the public docket so far.

It will necessarily take time for CMS, stakeholders, and observers to review these submissions. Advocacy and letter-writing campaigns over the past two months suggest that the proposal to establish a Remote Item Delivery Competitive Bidding Program (RID CBP) for new product categories has received particular attention among respondents.

A New Competitive Bidding Model

The RID CBP would differ significantly from previous competitive bidding rounds. Rather than awarding contracts in individual markets, CMS is considering consolidating them at the national or regional level. Contracted suppliers would be responsible for furnishing products directly to beneficiaries, with remote delivery as the standard approach and in-person pickup as an alternative.

CMS has characterized the model as a mechanism to reduce fraud and generate program savings. The scope of the proposal, however, raises important questions about its implications for patient access, supplier participation, and the structure of the DMEPOS marketplace.

Products Proposed for Inclusion

CMS proposes to include the following categories under the RID CBP:

• Continuous glucose monitors (CGMs) and supplies
• Insulin infusion pumps and related supplies
• Urological supplies, such as intermittent catheters
• Ostomy supplies, including pouching systems and skin barriers
• Tracheostomy supplies
• Certain off-the-shelf orthotics

Several of these categories have been considered for competitive bidding in the past with mixed results. Insulin pumps were initially included in a previous round (Round 1 Recompete) but were later removed due to issues with patient access. A CMS demonstration more than 20 years ago tested bidding for urological supplies and concluded that the category was “not well suited” for the program. Urological, ostomy, and tracheostomy supplies have historically been excluded from competitive bidding, and advocacy organizations argue that CMS lacks statutory authority to include these prosthetic devices in CBP.

Reclassification of Diabetes Technology

The proposed rule would also reclassify CGMs and insulin pumps as “frequently and substantially serviced” items, thereby shifting them from purchase and capped rental categories, respectively, to a continuous rental category. CMS states that this approach will allow beneficiaries to change or upgrade equipment more readily, rather than waiting for the five-year replacement cycle for the base item. However, as a result of the rental model, beneficiaries would never own their equipment.

Stakeholders have cautioned that this change would transfer responsibilities such as device maintenance, software updates, and recall management from manufacturers to suppliers. They also questioned whether suppliers would be able to provide the level of technical support required for these complex devices, raising patient safety concerns. Beneficiaries engaging in the advocacy campaigns have stated that they prefer to own their diabetes management devices.

Stakeholder Perspectives

Because several stakeholder groups have shared their comment letters publicly and engaged in advocacy campaigns over the summer, we have an early indication of the key issues being raised in response to the proposed rule.

Diabetes advocacy groups: Organizations such as the Endocrine Society and the American Diabetes Association recognized CMS’s goal of aligning payment with the pace of technological change in CGMs and insulin pumps. At the same time, they highlighted the need to balance this objective with protections for patient choice and continuity of care, noting that suppliers may face challenges in providing the technical support currently delivered by manufacturers.

Ostomy, urological, and tracheostomy advocates: Key groups, including the United Ostomy Associations of America and the Wound, Ostomy, and Continence Nurses Society, agreed with CMS’s aim of promoting program integrity but stressed that CMS must balance such efforts against the clinical reality that these products are highly individualized. They cautioned that treating them as commodities could undermine patient outcomes, pointing to earlier CMS demonstrations that found limited savings and potential risks.

Suppliers: While the American Association for Homecare (AAHomecare) has expressed support for the agency’s efforts to address fraud and abuse in Medicare, it warned that RID CBP could sharply reduce the number of contractors—from hundreds of current suppliers to as few as 7–10 nationwide—creating risks for patient access. Among other issues it highlighted, the association also objected to reducing the minimum number of contract suppliers and to bid methodologies that could drive reimbursement below sustainable levels. CMS also received comments from suppliers of specific products proposed for inclusion in RID CBP, raising concerns about the potential impact on the patient populations they serve if the policy is implemented as proposed.

Next Steps

CMS must finalize the home health provisions of the proposed rule by November 1, but it is not required to finalize the DMEPOS provisions on the same timeline. The agency has also indicated that it is not proposing a start date for the next round of competitive bidding, leaving open the possibility of delay or modification.

Handling nearly one million comments would present an unprecedented administrative task, and CMS has already signaled its interest in applying Artificial Intelligence tools to support the review process. The agency has developed a Feedback Analysis Solution (FAS) that uses natural language processing and machine learning to sort submissions, identify duplicates, and detect themes and sentiment. HHS has reported favorable results from pilot projects using similar technology, noting both cost savings and improved staff efficiency. Officials emphasize that these systems are intended to supplement, not replace, human judgment and decision-making.[2] Given the scale of feedback on the 2026 Home Health/DMEPOS rule, it is reasonable to expect CMS to employ such tools, in addition to traditional review methods, to ensure that the breadth of stakeholder input is systematically analyzed and incorporated into the rulemaking process.

The volume of comments submitted highlights the significance of the policy decisions at stake. CMS has presented the RID CBP as an initiative to strengthen program integrity and reduce costs. Stakeholders recognize the importance of these objectives but have emphasized the need to ensure that efforts to achieve them do not compromise patient choice, access, or stability in the DMEPOS marketplace. The central policy question is how to balance these priorities in a way that achieves savings and safeguards without repeating challenges seen in earlier iterations of competitive bidding or creating new challenges that did not previously exist.

Applied Policy will continue to closely track developments and provide analysis as CMS finalizes the rule, helping organizations prepare for potential changes in payment and delivery models.

[1] For comparison, one of the most heavily commented health-related rules in recent memory—HHS’s 2018 Title X proposed rule—received more than 500,000 public comments.

[2] See U.S. Department of Health and Human Services, AI Use Case Inventory, available at hhs.gov.