Various stakeholders have banded together to encourage legislators to push for the addition of implantable medical device unique device identifiers (UDIs) to insurance claims forms. In a June 11 letter co-authored by 13 groups, including The Pew Charitable Trusts, Aetna, The Society of Thoracic Surgeons, and Mercy Health System, the stakeholders thank Rep. Kevin Brady (R–TX) for publicly agreeing to cooperate with Rep. Bill Pascrell (D–NJ) on the UDI issue.
UDIs are being phased in under FDA's UDI rule, which requires the identifiers to be included on device packages and labels. Modifying insurance claims forms to include UDI information is "supported across the health care delivery continuum, including by hospitals, health plans, accountable care organizations, FDA, clinicians and patients," according to the letter authors.
However, CMS has not seen eye-to-eye with these stakeholders on the issue. In late 2014, senators asked CMS to include UDI information on CMS insurance claims forms, but CMS administrator Marilyn Tavenner argued against it. She pointed out the potential technical, operational, cost, and time hurdles in a response letter.
The June 11 letter authors argue that CMS needs to get on board with the idea in order to enable several benefits, such as:
- "FDA evaluations of device safety;"
- "Analyses and care management by health plans;"
- "Enhancements to registries;"
- "Support for alternative payment models;"
- "Transparency in Medicare spending"
The authors write, "Given that CMS approves the claim form used throughout the country, failure of Medicare to support adding UDI to claims would prevent private health plans and hospitals from seeking better data on medical devices."
The issue has received more attention in recent days. During a June 2 meeting of the House of Representatives Ways and Means Committee, Pascrell suggested amending the device tax repeal bill to require CMS to add UDI to Medicare claims forms. Though Pascrell later withdrew his suggestion, Health Subcommittee chair Brady added his support to the idea. Brady said, "Just briefly, I think Mr. Pascrell has a good idea. I think this is an important issue going forward. We'd like to continue to work with you to get it in the right shape. . . we're going to move good health policy in a bipartisan way. We think this fits exactly where the committee ought to be going. Just continue to work with us to just get this in a place where we can move it, Mr. Pascrell."
Earlier this week, HHS secretary Sylvia Burwell also pledged to work with legislators on the issue, saying "I think that we have made some progress of FDA and CMS working together on something that will actually be more implementable . . ."
The full list of letter authors includes: Aetna, American Joint Replacement Registry, Duke Medicine, Geisinger Health System, HL7 International, Intermountain Healthcare, Mercy, National Health Council, Pacific Business Group on Health, The Leapfrog Group, The Pew Charitable Trusts, The Society of Thoracic Surgeons, and Trust for America’s Health.
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