Warren, Grassley Renew Call for Inclusion of Medical Device Identifiers on Medicare Claim Forms

WASHINGTON, June 15 -- The office of Sen. Elizabeth Warren, D-Massachusetts, issued the following news release:

United States Senators Elizabeth Warren (D-Mass.) and Chuck Grassley (R-Iowa) sent a letter to Food and Drug Administration (FDA) Commissioner Scott Gottlieb to reiterate the importance of including medical device identifiers on the updated Medicare claim form and to urge the agency to maintain its support for this change.

In its recently-released Medical Device Safety Action Plan, the FDA outlined the agency's efforts to ensure that medical devices meet the agency's gold standard, which includes maintaining a "vigilant postmarket surveillance system" that can quickly identify any safety issues that emerge in medical devices being used by patients and clinicians. This action plan emphasized the importance of unique device identifiers (UDI) to ensuring device safety and helping to collect data on medical device performance.

In their letter to Commissioner Gottlieb, the senators noted that incorporating device identifier information on the Medicare claim form would enhance the FDA's capacity to carry out key priorities in its Medical Device Safety Action Plan.

"As we have repeatedly contended, a critical aspect of ensuring the quality and completeness of postmarket data is incorporating device identifier information into the Medicare claim form," the senators wrote. "In addition to reducing risks to patient safety, including device identifier information on the Medicare claim form would improve the integrity of the Medicare program by helping the Centers for Medicare and Medicaid Services (CMS) track manufacturer credits owed on recalled devices and collect them from hospitals."

The senators' letter also pointed out that the inclusion of device identifier information on the Medicare claim form is supported by the Medicare Payment Advisory Commission, the Department of Health and Human Services Office of Inspector General, as well as the standards committee charged with updating the Medicare claim form. Noting that the FDA itself expressed support for this change in 2016, the senators called on Commissioner Gottlieb to maintain the agency's support for the inclusion of device identifier information on the Medicare claim form.

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.

In November of 2017, Senators Warren and Grassley sent a letter to CMS to request that the agency clarify its position on the inclusion of medical devices' device identifiers on Medicare claim forms.