Rumored presidential candidate Sen. Elizabeth Warren (D-MA) wrote a letter to the administrator of the Centers for Medicare & Medicaid Services focused on an issue of great concern to the med tech employee constituency: Unique Device Identification.
Co-authored with Sen. Charles Grassley (R-IA), the letter to Administrator Marilyn Tavenner urges CMS to side with various medical associations, think tanks and private insurance companies in support of including UDI information in insurance claims forms. Those stakeholders, as well as CMS, form the Accredited Standards Committee X12 (ASC X12), which sets standards for electronic insurance claims forms.
"Claims transactions provide longitudinal data on patient outcomes across healthcare institutions--a critical capability for implanted medical devices as problems might not emerge for several years and patients may seek care in facilities that did not perform the implant procedure," the letter explains.
"We understand, however, that CMS has been a dissenting voice within ASC X12 in regards to the incorporation of UDI information in claims. Given that the same claims form is used by both public and private payers, CMS dissent could prevent other health plans from collecting and utilizing UDI data," the letter warns.
The letter says CMS opposition also puts the agency at odds with the FDA and the Office of the National Coordinator for Health Information Technology, two other government entities responsible for the mammoth initiative designed to track and identify individual medical devices by associating a unique identification code with each device. To that end, the letter inquires about potential collaborations between CMS and those federal counterparts.
CMS buy-in is crucial because most of the potential uses of UDI require the data's incorporation into insurance claims forms. For example, the senators ask how CMS could collect and utilize UDI data to assist with medical device recalls, identify and curb waste and fraud, improve the quality and safety of devices used by Medicare beneficiaries and improve data registries. Besides insurance claims forms, those benefits would also stem from the incorporation of UDIs into electronic health records, the subject of a parallel effort by stakeholders.
Other queries include whether CMS has the authority to require a potential UDI field on the claims form to be completed as a requirement for processing and payment, how the agency can encourage the exchange of UDI information between private insurers, and the cost to the agency of UDI implementation.
Congress mandated the FDA implement a system for unique device identification in 2007 and again in the 2012 FDA Safety and Innovation Act. Now that the FDA has passed the UDI final rule and is more than a year into implementing the system, Congress is turning its attention to another crucial healthcare agency, CMS, to make sure that companies' efforts and compliance actually provide benefits to patients.
The sixth and final question sums up the essence of what the senators want to know. "What actions has CMS taken and what actions does CMS plan to take as a member of ASC X12 in regards to the incorporation of a field for UDIs in claims?" they ask, requesting an answer by Jan. 20, 2015.
- read the letter (PDF)