Sens. Chuck Grassley, Elizabeth Warren ask CMS to clarify position on unique device identifiers by Dec. 1

U.S. Senators Chuck Grassley, R-Iowa, and Elizabeth Warren, D-Mass., penned a Nov. 8 letter to CMS Administrator Seema Verma, asking Ms. Verma to clarify the agency's position on including information related to unique device identifiers on Medicare claims forms.

The inclusion of unique device identifier information on claim forms would enable Medicare to track medical devices for post-market surveillance, which could reduce Medicare costs and protect beneficiaries in the long-run. Mr. Grassley and Ms. Warren cited a September report by the HHS Office of Inspector General, which found Medicare spent $1.5 billion to replace medical devices that failed prematurely or were recalled between 2005 and 2014.

The OIG recommended CMS continue to work with the Accredited Standards Committee X12 to ensure this information is included on the next version of claim forms, since Medicare does not currently collect unique medical device information about products implanted in Medicare beneficiaries. In response to the recommendation, CMS officials said the policy was "under consideration,"according to Mr. Grassley and Ms. Warren.

The senators noted CMS officials have provided a range of responses when asked to speak on unique device identifiers. While some CMS officials have highlighted how the addition to Medicare claims forms might help the agency track and reduce costs related to poorly-performing medical devices, other agency representatives have emphasized CMS is still reviewing the policy recommendation.

To clarify the agency's position on unique device identifiers, the senators asked Ms. Verma to respond to three questions by Dec. 1.

1. Does CMS support capturing the device identifier portion of the unique device identifier for implantable devices on Medicare claim forms?

2. Will CMS follow the recommendations of the OIG and the Medicare Payment Advisory Commission and work with the Accredited Standards Committee X12 to ensure device identifiers are included on the next version of claim forms?

3. If CMS' position on the inclusion of device identifiers on the Medicare claim form is still under review, what exact issues are under review, and what is the timeline for completing this review?

"We have long supported this recommendation, repeatedly urging stakeholders, including CMS, to support the inclusion of device identifiers on the Medicare claim form," the senators wrote. "It is essential that the Medicare system support the post-market surveillance of risky medical devices, both to improve patient care and to support program integrity."

To access the senators' letter, click here.

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