Senators Express Concern About Conflicting Statements, Urge CMS to Support Inclusion of UDIs on Claim Forms

Text of the letter available here (PDF)

WASHINGTON – U.S. Senators Elizabeth Warren (D-Mass.) and Chuck Grassley (R-Iowa) today sent a letter to the Centers for Medicare & Medicaid Services (CMS) requesting that CMS clarify its position on the inclusion of medical devices' device identifiers (DIs) on Medicare claim forms.

After the Department of Health and Human Services (HHS) Office of Inspector General (OIG) released a report recommending that CMS work to ensure that device identifier information is captured on Medicare claim forms, CMS made a series of conflicting statements about the proposed policy. When questioned on the issue during a recent hearing before the Senate Committee on Health, Education, Labor, and Pensions, CMS Chief Medical Officer Kate Goodrich was unable to answer whether or not the agency supported the recommendations of the OIG's report.

The senators' letter expresses concern about CMS's conflicting statements and urges CMS to support the inclusion of device identifier information on the Medicare claim form in order to better track faulty devices.

"We urge you to follow the recommendation of the Department of Health and Human Services' (HHS) Office of Inspector General (OIG) and act to ensure that Medicare is better able to track poorly performing medical devices," 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 better understand the agency's position on the inclusion of device identifiers on the Medicare claim form, the senators are seeking answers to the following questions from CMS:

  • If CMS supports capturing the device identifier portion of unique device identifiers on the Medicare claim form;
  • If CMS will follow the recommendations of the HHS OIG and work to ensure that device identifiers are included on the next version of claim forms;
  • If the policy is still under review, what exact issues are being reviewed and what is the timeline for completing the review.

Last month, after the HHS OIG recommended that CMS work to add device identifiers to Medicare claims, Senators Warren and Grassley responded and urged CMS to heed the OIG's recommendations.

Senators Warren and Grassley have been pressing for inclusion of device information on claims forms since 2014.

In December of 2014, Senators Grassley and Warren wrote to CMS Administrator Marilyn Tavenner to express support for the inclusion of unique device identifiers (UDIs) in claims forms and press CMS to work with other stakeholders to realize the benefits of a UDI system. In August 2015, the Senators wrote another letter to the HHS Inspector General Daniel Levinson, asking him to provide information about his review of the cost to Medicare incurred by defective medical devices and the challenges of obtaining this data absent a way to track medical devices through claims forms.

In March of 2016, Senators Grassley and Warren wrote to HHS Secretary Sylvia Burwell, CMS Acting Administrator Andy Slavitt and Food and Drug Administration (FDA) Commissioner Robert Califf to inquire about progress that had been made in adding the UDI of medical devices to health insurance claim forms. In a July, 2016 response to their letter, Secretary Burwell stated that "HHS affirmatively supports adding the device identifier (DI) portion of the UDI for claims for implantable devices." In addition, Administrator Slavitt and FDA Commissioner Califf expressed their support for including device identifiers on claims forms.

In August of 2016, Senators Warren and Grassley wrote another letter asking the Accredited Standards Committee X12 about steps it was taking to include medical devices' UDI on health insurance claim forms. And in October of 2016, following the preliminary results of the HHS OIG ongoing review, the Senators again urged CMS and X12 to include device identifiers on health insurance claim forms.

In February of 2017, X12 released a draft update to health insurance claims forms that includes device identifiers. The senators commented on the proposal.

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