Rep. Pascrell, Sen. Warren Lead Call to Improve Medical Device Safety

WASHINGTON, July 23 -- Rep. Bill Pascrell Jr., D-New Jersey, issued the following news release on July 22, 2021:

U.S. Reps. Bill Pascrell, Jr. (D-NJ-09), Brian Fitzpatrick (R-PA-01), and Lloyd Doggett (D-TX-35), and U.S. Sens. Elizabeth Warren (D-MA) and Chuck Grassley (R-IA) have sent a letter to Health and Human Services (HHS) Secretary Xavier Becerra and Centers for Medicare & Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure requesting that they commit to including medical devices' unique device identifier (UDI) in Medicare claims forms. Doing so would improve quality of care for millions of patients that rely on medical devices and enable more efficient tracking of medical device outcomes, saving lives and money.

"We believe that HHS and CMS should expeditiously take steps to add the device identifier portion of UDIs in Medicare claims, and we ask you to commit to finalizing this change as soon as possible," write the lawmakers. "We look forward to working with you and your staff on a bipartisan basis to ensure that the device identifier portions of UDIs are included in Medicare claims forms."

The letter follows Secretary Becerra's recent comments to Congress on the importance of tracking device outcomes in Medicare claims, as well as President Biden's support for UDIs in his FY2022 budget.

Currently, when a device fails or is recalled, it can be difficult to identify which patients will be affected, leading to risks of complications and increased costs to the health care system. Medical device failures can cause serious health problems and financial costs: a 2017 HHS-Office of Inspector General (OIG) report found that recalls or premature failures of just seven faulty cardiac devices resulted in $1.5 billion in Medicare payments to providers and $140 million in out-of-pocket costs to beneficiaries.

UDIs are the serial numbers used to identify specific types of medical devices, including implantable devices like pacemakers or artificial joints. On July 6, 2021, the Food and Drug Administration released its Final Guidance on UDI Form and Content, which outlines the requirement that the UDI must be presented in two forms on the device label and device packages: (1) easily readable plain-text; and (2) automatic identification and data capture (AIDC) technology (essentially a barcode). This is another important step towards making sure that all medical devices bear a standardized device identifier.

For UDIs to be included in Medicare claims, X12, which sets standards for claims transactions, must first submit a formal recommendation to the National Committee on Health and Vital Statistics (NCHVS)--an HHS advisory body--urging CMS to do so. NCHVS must then, after assessing the recommendation, officially recommend to CMS that they include UDIs in claims. Finally, CMS must add UDIs to Medicare claims through the rulemaking process.

For years, Rep. Pascrell has led efforts in Congress to improve and modernize medical device safety protocols since 2015. In June 2015, Pascrell called for adding UDI to claims during a markup of H.R. 160, the Protect Medical Innovation Act. In April 2016, Pascrell wrote to then-House Ways and Means Health Subcommittee Chairman Pat Tiberi (R-OH-12) and committee leadership in support of adding UDI to Medicare claims. After Rep. Pascrell held numerous meetings and calls with the Accredited Standards Committee X12, the agency finally recommended in October 2019 that UDIs be included on medical claims. In November 2019, Pascrell and Sens. Warren and Grassley wrote to HHS and CMS highlighting the X12's recommendation and urging them to promulgate regulations to implement the change. In February 2020, Pascrell grilled then-HHS Sec. Alex Azar to finalize the recommendation to include device identifiers on claims data which was in the Trump budget request. And In June 2021, Pascrell pressed Sec. Becerra during a hearing if he would commit to finalizing the UDI in claims language.

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July 21, 2021

To: The Honorable Xavier Becerra, Secretary, Department of Health and Human Services (HHS), 200 Independence Avenue, S.W., Washington, D.C. 20201

The Honorable Chiquita Brooks-LaSure, Administrator, Centers for Medicare & Medicaid Services (CMS), 7500 Security Boulevard, Baltimore, MD 21244

Dear Secretary Becerra and Administrator Brooks-LaSure:

We write today to ask you to commit to including the device identifier portion of a medical device's unique device identifier (UDI) in Medicare claims forms. Doing so will improve safety and quality of care for millions of patients that rely on medical devices. It will also enable more efficient tracking of medical device outcomes, saving lives and money throughout our nation's healthcare system. We were encouraged by Secretary Becerra's recent comments to Congress on the importance of tracking device outcomes in Medicare claims, as well as President Biden's support for UDIs in his FY2022 budget and hope you will expeditiously push this important policy forward.

When medical device failures occur, they can create serious health problems and pose significant financial costs. In 2017, the Office of the Inspector General (OIG) at the Department of Health and Human Services (HHS) sought to analyze "the costs that Medicare and its beneficiaries incur to replace recalled or prematurely failed medical devices."/1 The OIG struggled to capture the full cost of faulty medical devices, noting that "Medicare claim forms do not contain a field for reporting medical device-specific information."/2 However, after a "complex and labor intensive auditing procedure," the office found that premature failures and recalls from just seven cardiac devices resulted in $140 million in out-of-pocket costs to beneficiaries and $1.5 billion in taxpayer-funded Medicare payments./3 OIG ultimately concluded that "including the DI [device identifier] on claims forms" would help policymakers "more effectively identify and track Medicare's aggregate costs related to recalled or prematurely failed devices" and "provide additional patient safety benefits."/4 It recommended that the Centers for Medicare and Medicaid (CMS) "work to ensure that the DI is included on the next version of claims forms."/5

For UDIs to be included in Medicare claims, X12, which sets standards for claims transactions, must first submit a formal recommendation to the National Committee on Health and Vital Statistics (NCHVS)--an HHS advisory body--urging CMS to do so. NCHVS must then, after assessing the recommendation, officially recommend to CMS that they include UDIs in claims. Finally, CMS must add UDIs to Medicare claims through the rulemaking process.

For years, bipartisan groups of lawmakers have advocated for the inclusion of UDIs in Medicare claims,/6 and health officials in Democratic and Republican Administrations have expressed support for doing so./7 Since 2020, X12 has included requirements regarding the inclusion of the device identifier portion of UDIs in its published implementation guides, and we were happy to learn from X12 in April that the Committee is "finalizing its recommendation related to the adoption of new versions of the health care claim transactions and expects to present that recommendation of [NCVHS] this summer."/8

We believe that HHS and CMS should expeditiously take steps to add the device identifier portion of UDIs in Medicare claims, and we ask you to commit to finalizing this change as soon as possible. We have been encouraged by the Administration's comments in recent months regarding the policy. Specifically, we were pleased by Secretary Becerra's recent acknowledgment to the House Ways and Means Committee that "we've got to make sure that through. Medicare claims we can track" device outcomes, and his commitment to stay engaged with Congress and other stakeholders as the X12 process proceeds./9 Meanwhile, Administrator Brooks-LaSure committed during her confirmation process to "look into this issue further" and stay in touch with lawmakers throughout the process./10 President Biden also expressed support for UDIs in the U.S. Food and Drug Administration's FY22 budget, noting that the "establishment of the UDI system has been a tremendous milestone in building a stronger, more modernized medical device safety net."/11

We look forward to working with you and your staff on a bipartisan basis to ensure that the device identifier portions of UDIs are included in Medicare claims forms. Please do not hesitate to reach out to us or our staff as the process continues.

See co-signers and footnotes here: https://www.warren.senate.gov/imo/media/doc/2021.07.21%20Letter%20to%20HHS%20and%20CMS%20re%20UDI%20&%20Claims.pdf