CMS Seeks Public Comment on Reinstatement of Medicare Coverage with Evidence Development Information Collection

The Centers for Medicare & Medicaid Services (CMS) recently initiated a public comment period concerning the reinstatement of an information collection under its critical Coverage with Evidence Development (CED) program. Published in the Federal Register on September 11, 2026, this notice (CMS-10697) offers stakeholders a crucial 30-day window to provide input on how Medicare evaluates and covers emerging medical technologies. This administrative action is a routine yet significant step under the Paperwork Reduction Act of 1995 (PRA), ensuring transparency and public engagement in the federal government's data collection practices, particularly those impacting the scope of Medicare benefits and the advancement of healthcare innovation.

The Framework of Coverage with Evidence Development

The CED program is a cornerstone of Medicare's approach to incorporating medical advancements. At its core, Medicare requires items and services to be 'reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member,' as stipulated in section 1862(a)(1)(A) of the Social Security Act. However, when initial scientific evidence for a new item or service is not yet fully conclusive, CED provides a pathway for conditional coverage. This pathway leverages a statutory exception found in section 1862(a)(1)(E) of the Act, which permits Medicare payment for items and services utilized in research conducted under section 1142 of the Act. Essentially, CED allows for the coverage of promising technologies, but only on the condition that they are furnished within the framework of approved clinical studies or alongside the collection of additional clinical data. This mechanism ensures that while beneficiaries gain access to cutting-edge treatments, robust evidence continues to be gathered to confirm their long-term benefit and appropriateness for the broader Medicare population. Any study seeking CED approval must meet 17 specific criteria outlined in the CMS Coverage with Evidence Development guidance document.

CMS's Role and Public Engagement Under PRA

The current notice from CMS is an integral part of the federal government's obligation under the Paperwork Reduction Act of 1995. The PRA mandates that federal agencies seek public comment before collecting information from the public, especially when extending or reinstating existing collections. This two-stage comment process allows interested parties to scrutinize the necessity, utility, and clarity of the proposed information collection. For the CMS-10697 collection, the public is invited to comment on aspects such as the estimated burden on respondents, the proper performance of agency functions, and ways to enhance data quality. The comment period is brief, with submissions due to the OMB desk officer by October 13, 2026. This public review process is vital for ensuring that federal data collection is efficient, minimizes respondent burden, and serves a clear public purpose, particularly in a domain as critical as Medicare coverage decisions.

Implications for Healthcare Innovators and Providers

The reinstatement of this information collection directly impacts the 'private sector,' specifically 'not-for-profit institutions' and 'businesses or other for-profits' involved in healthcare innovation and delivery. These entities are the primary respondents, with an estimated 15 organizations expected to contribute information annually, totaling 1,500 hours of burden. For these stakeholders, understanding and participating in the CED process is paramount. It dictates the terms under which their innovative medical devices, drugs, or services might gain Medicare coverage, thereby accessing a significant patient population. The feedback provided during this comment period can influence the administrative efficiency and clarity of the CED application and reporting process, potentially easing the burden on innovators while maintaining CMS's standards for evidence generation. The delicate balance between fostering innovation and ensuring fiscal responsibility and patient safety is continually negotiated through such regulatory processes.