Sens. Grassley, Warren Call for Inclusion of Medical Device Identifiers on Medicare Claim Forms
Sens.
In its recently-released Medical Device Safety Action Plan, the
In their letter to Commissioner Gottlieb, the senators noted that incorporating device identifier information on the Medicare claim form would enhance the
"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
The senators' letter also pointed out that the inclusion of device identifier information on the Medicare claim form is supported by the
Grassley and Warren have been pressing for inclusion of device information on claims forms since 2014.
In December of 2014, Grassley and Warren wrote to CMS Administrator
In March of 2016, Grassley and Warren wrote (http://ct.symplicity.com/t/wrn/c0eb05d19827b5caab3ff3063c123f24/2057710565/realurl=http:/ct.symplicity.com/t/wrn/5879b49d5129bd5a44c94261b3cac11e/2057710565/realurl=http:/www.grassley.senate.gov/sites/default/files/news/upload/2016_03_09%20CEG%20to%20HHS%20regarding%20UDI.PDF) to HHS Secretary
In August of 2016, Grassley and Warren wrote another letter (http://ct.symplicity.com/t/wrn/c0eb05d19827b5caab3ff3063c123f24/2057710565/realurl=http:/ct.symplicity.com/t/wrn/5879b49d5129bd5a44c94261b3cac11e/2057710565/realurl=http:/www.warren.senate.gov/files/documents/2016-8-29_UDI_letter_to_ASC_X12.pdf) 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 (https://www.warren.senate.gov/?p=press_release&id=1426) on the proposal.
In November of 2017, Grassley and Warren sent a letter (https://www.warren.senate.gov/newsroom/press-releases/warren-grassley-press-cms-to-clarify-position-on-medical-device-identifiers-on-medicare-claim-forms) to CMS to request that the agency clarify its position on the inclusion of medical devices' device identifiers on Medicare claim forms.
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