Senators give CMS deadline to decide its stance on unique device identifiers

Sens. Chuck Grassley and Elizabeth Warren are giving the agency until Dec. 1 to decide whether CMS will follow OIG recommendations to ensure UDI is included on Medicare claim forms.
By Jessica Davis
12:41 PM
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UDI on Medicare forms

Sen. Chuck Grassley on the Senate floor Nov. 1. Credit: C-span

Sens. Chuck Grassley, R-Iowa, and Elizabeth Warren, D-Massachusetts, are calling on Centers for Medicare and Medicaid Services Administrator Seema Verma to decide by Dec. 1 whether the agency will include unique device identifiers on Medicare claim forms.

The senators are also asking whether the agency plans to follow the recommendations by the U.S. Department of Health and Human Services’ Office of the Inspector General and MedPAC to make sure UDIs are included.

Further, they want CMS to provide a planned timeline for the completion of agency’s review of the policy.

[Also: Warren to CMS: Medical device identifier requirements should be a 'no-brainer']

“We urge you to… act to ensure that Medicare is better able to track poorly performing medical devices," the senators wrote in a letter to Verma. “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."

The letter to Verma follows the series of inconsistent statements from CMS on its UDI stance.

CMS showed support of including UDI to Medicare claims in 2016. But the agency has not only failed to make an official stance on the policy, CMS has sent numerous mixed messages.

In an OIG report last month, the agency recommended CMS at least partially adopted the policy of adding UDI in the next version of Medicare claim forms. CMS said the agency would review its policy, but Verma appeared to suggest it wouldn’t happen.

In the following days, CMS put out another statement that said UDIs on claim forms would “reduce Medicare costs by identifying poorly performing devices more quickly while protecting patients from unnecessary costs.”

But another statement by CMS a few days later contradicted the prior stance and said the statement was wrong, and the agency is still reviewing the UDI policy.

Proponents of UDI say the policy will make it easier to track faulty medical devices and help providers choose the best model for their patients. Warren has been pushing for the inclusion of UDI for years.

Just last week, Warren grilled CMS during a Senate HELP committee: “Alright, let me just say: This should be a no-brainer… And I’ll be blunt: We’re going to keep pushing on this. It is time for CMS to step up to protect payments and to protect the Medicare system.”

Twitter: @JessieFDavis
Email the writer: jessica.davis@himssmedia.com