Medical Devices Law & Industry Report provides complete in-depth, interdisciplinary news coverage of all major developments in the rapidly changing medical...
By Alex Ruoff
July 18 — The head of the CMS recently moved to support adding medical device identifying data into insurance claim forms, a reversal for an agency that has long warned the move would be expensive for it and hospitals.
In a joint letter to the standards development organization responsible for updating insurance claim forms, Andy Slavitt, acting administrator of the Centers for Medicare & Medicaid Services, and Robert Califf, commissioner of the Food and Drug Administration, urged an update to insurance claim forms that includes a new field for the electronic capture of unique device identifier (UDI) data for certain medical devices, namely implantable devices. The letter signifies that their parent agency, the Department of Health and Human Services, supports adding UDIs to claims if funding is made available by Congress to update Medicare claims processing systems.
“HHS is committed to improving the quality and safety of health care provided to all Americans, and believes that monitoring medical device product safety and performance is critical for ensuring public health and safety,” the pair said in their letter to the McLean, Va.-based ASC (Accredited Standards Committee) X12, which is exploring ways to exchange the UDI data among manufacturers, providers, payers and regulators.
The CMS—which is represented in the ASC X12 group—has warned previously that adding a UDI field to claim forms could be expensive for clearinghouses, providers and Medicare, which would each have to update their claims processing systems to accept the new field. The FDA has long supported the use of UDIs and established the UDI system in 2013, which requires the labels and packages of devices distributed in the U.S. to include a UDI, unless the agency grants an exception or alternative.
Implementing an updated claims form that collects UDI for implantable devices would cost Medicare roughly $300 million, according to an agency spokesman. There would also be additional costs to state governments to implement the updated claims form in their Medicaid claims processing systems.
Supporters of the use of UDIs in electronic health record systems and insurance forms have said the identifiers will make it easier to track medical devices and alert users of the devices of recalls or safety issues.
Supporters for wider use of UDIs told Bloomberg BNA July 18 that if ASC X12 doesn't include the identifier in its update of claims forms this year, the change may not occur until 2030.
Medicare is currently updating its claim process, in which ASC X12 plays a pivotal role, Ben Moscovitch, an officer for the medical device initiative at the Pew Charitable Trusts, told Bloomberg BNA. If the committee agrees with the CMS's recommendation, insurance claims used by Medicare and private payers would include a field for UDIs in 2021.
If the committee doesn't agree with the CMS's recommendation, the change would be unlikely to occur until 2030, Moscovitch said. However, Congress could pass a law adding UDIs to Medicare claims forms, he said.
“We shouldn't wait that long to gain better information on [medical devices],” Moscovitch said.
Groups and lawmakers urging wider use of UDIs told Bloomberg BNA July 18 that the CMS's support may prove pivotal in getting more hospitals, doctors and insurance carriers to use the identifiers.
Adding UDIs to claim forms could benefit health researchers and organizations that examine health-care quality, Moscovitch said. The identifiers would also help the FDA's Sentinel Initiative, which examines electronic health record and claims data for safety information about drugs and devices, he said.
“Claims data today is already used to evaluate drug safety and understand the quality of certain procedures,” he said. “But claims can't be used in the same way to look at specific devices.”
Devices, unlike drugs, for many years lacked standard identification numbers, Blair Childs, senior vice president of public affairs with the health-care purchasing organization Premier, told Bloomberg BNA July 18 in an e-mail. This prevented doctors and patients from having complete information on devices, he said.
The letter from Slavitt and Califf came after a July 13 meeting between the two and House Minority Leader Nancy Pelosi (D-Calif.) over the issue, according to a statement by Rep. Bill Pascrell Jr. (D-N.J.).
Pascrell, a member of the House Ways and Means Committee, has long been an advocate for incorporating UDIs into Medicare claims. He said in his statement that adding UDIs to claims would “improve the safety and quality of patients’ health care, as well as provide important program integrity benefits for Medicare.”
To contact the reporter on this story: Alex Ruoff in Washington at firstname.lastname@example.org
To contact the editor responsible for this story: Kendra Casey Plank at email@example.com
The joint FDA-CMS letter is at http://src.bna.com/gRy.
More information on FDA's unique device identification program is at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/.
Copyright © 2016 The Bureau of National Affairs, Inc. All Rights Reserved.
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