CMS proposes changes to bid form, replacement requirements, infusion coverage

WASHINGTON – The Centers for Medicare & Medicaid Services (CMS) has proposed revising the reporting form for its competitive bidding program (CBP) – known as Form C – to include a new “country of origin” field for lead items furnished by contract suppliers.

The form collects product information such as manufacturer name, model name and model number, which is then displayed in the Medicare Supplier Directory on Medicare.gov.

“The new country of origin information also would be added to the Medicare Supplier Directory, giving Medicare beneficiaries and other interested parties the country of origin for their medical equipment included in the DMEPOS CBP,” CMS states. “Suppliers can typically identify the country of origin from product markings (e.g., “Made in [Country]”), as required by U.S. Customs and Border Protection rules, or by obtaining documentation such as manufacturer certifications, commercial invoices, or customs entry records.”

CMS says full details about the Form C update will be shared through official notices under Office of Management and Budget (OMB) Control Number 0938-1408 (CMS-10744) before providers are required to report this information.

The proposal was included in the agency’s 2027 Home Health Prospective Payment System proposed rule.

Also in the proposed rule:

F2F clarification for replacement items

CMS has proposed to clarify that an additional comprehensive beneficiary “face-to-face” examination to gather “subjective and objective information associated with diagnosing, treating, or managing a clinical condition for which the DMEPOS is ordered” is not necessary when the item being ordered and furnished is a replacement item.

“If a claim for a replacement DMEPOS item is audited, the provider must nevertheless submit documentation from the original face-to-face encounter to demonstrate that medical necessity, billing, and coverage requirements have been satisfied,” CMS states. “Accordingly, the intent of 42 C.F.R. 410.38, which requires a face-to-face encounter for certain DMEPOS items, would continue to apply when the item is initially furnished; however, this clarification would make clear that the face-to-face encounter would not need to be repeated solely for replacement items.”

Expanded coverage for infusion pumps

CMS has proposed to expand coverage under the DME benefit to certain external infusion pumps and associated home infusion drugs that would be considered appropriate for home use if certain criteria are met, such as the requirement for the drug to be administered by or under the supervision of a healthcare professional, starting April 1, 2027.

• Related: CMS proposed rule seeks to tighten provider enrollment provisions.