CMS’s UDI Claim Form Inclusion Strengthens Medicare Spending
By - The simple concept of labeling is a vital yet overlooked aspect of the healthcare industry. More attention to the identification of medical devices as they are distributed and utilized is needed to strengthen the industry’s collective financial backbone. The mainstreamed adaption of unique device identifiers (UDIs) – the unique labeling of devices which can be read and interpreted by both human eyes and bots – will modernize device postmarket surveillance, advance Medicare beneficiaries’ safety, and accelerate medical device innovation, according to the Food and Drug Administration (FDA).
Thirteen healthcare groups – Health 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 – recently confirmed their advocacy of efforts from the Chairman of the House Ways & Means Subcommittee to secure the inclusion of UDIs for implanted devices in claim forms.
13 healthcare organizations support UDIs in claims
In a June letter thanking Representative Kevin Brady (R-TX), Subcommittee Chair, and Representative Bill Pascrell (D-NJ) for their UDI efforts, the 13 undersigned proclaim an innovative UDI system can significantly improve the healthcare field by allowing providers to more easily identify safety problems and track down recalled products. UDIs must be included within electronic data sources, such as Medicare and private health insurance plans’ insurance claims, to maximize patient protection, the undersigned state.
Claim forms currently lack specific manufacturer information about a model or implant, say the undersigned. They also do not identify which prescription drugs a patient receives. These problems can be rectified with UDI implementation, they say.
“The UDI system can provide claims with needed specificity to allow Medicare and other health plans, researchers and the FDA to conduct the same types of analyses for devices that are currently conducted on drugs and procedures,” they confirm. The benefits of such include increased transparency in Medicare spending and the advancement of alternative payment models. Accountable care organizations (ACOs), hospitals, and health plans across the healthcare delivery continuum are in support of such goals, the undersigned maintain.
UDIs in claims may enhance reimbursement, transparency
In reference to a slew of recent initiatives from both Congress and the Centers for Medicare & Medicaid Services (CMS) to support enhanced Medicare spending’s transparency, the 13 undersigned mention CMS issues regulations to adopt innovative standards for private and public payers’ claim forms. “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,” say the undersigned.
Such transparency will increase healthcare payers’ overall awareness regarding which specific devices can be reimbursed, according to Gregory Daniel, Managing Director at the Engelberg Center for Health Care Reform, et al. UDI implementation will also provide innovate opportunities for value-based purchasing, Daniel, et al, confirm.
“There is a school of thought that claims are for billing adjudication purposes only. However, health plans — including Medicare and Medicaid — pay billions annually for health services involving devices. As part of paying for services, health plans should know what products they are purchasing,” confirms a letter last year from several of the aforementioned undersigned to Karen DeSalvo, MD, MPH, MSc, National Coordinator for Health Information Technology, Margaret Hamburg, MD, FDA Commissioner, and Marilyn Tavenner, RN, MHA, CMS Administrator. “Including UDI in claims would provide health plans with the information necessary to make better coverage and reimbursement decisions,” the letter adds.
CMS urged to add a UDI field to claims forms
The 13 undersigned confirm support for this month’s House Ways and Means Committee mark-up of the medical device tax repeal. Pascrell offered and then withdrew an amendment mandating CMS add a UDI field to claims forms. Brady vowed to move such a request forward to the Committee.
Additionally, Sylvia M. Burwell, Secretary of the Department of Health and Human Services (HHS), confirmed her continuous work with lawmakers on mandating UDI language within claims forms. When asked by Prascrell if she was able to commit to working with the Committee this summer to help progress the policy into action, she stated, “I think that we have made some progress of FDA and CMS are working together on something that will actually be more implementable.”
If health plans, such as Medicare and Medicaid, are paying for procedures but lack sufficient knowledge about what devices were used, this is clearly problematic. Hopefully, the active incorporation of UDI in claims will enhance specificity levels for healthcare payers.
