Overview “Te earlier they start in planning for their reimburse-
ment strategy, the more time they will save and the more money they will save,” says Kay Fuller , president of MDRS LLC (Ann Arbor, MI), a global regulatory and clinical re- search consulting firm.
Coverage Not Automatic Device makers whose products will be used mostly by
those 65 and older will want to pursue reimbursement ap- proval from the Centers for Medicare and Medicaid Services (CMS), the largest purchaser of medical technology in the US. Many technological advances don’t need a new coverage determination, code change and/or payment decision by CMS, but for those that do there are two paths to get this approval— and both processes can take a year or longer. About 80% of devices are approved for reimbursement
through “local” coverage determinations (LCDs) by CMS’ Medicare Administrative Contractors (MACs). Tere are currently 13 MACs that issue LCDs and process claims for Medicare parts A and B, but CMS wants to consolidate them to 10, according to information supplied by CMS for this article. In addition, there are four durable medical equipment MACs that are responsible for coverage of medical devices used in the home.
NCD is final, and means the future for a device not approved is bleak at best. But try telling that to the hospitals and imaging cen-
ters that use radiopharmaceuticals with positron emission tomography (PET) to diagnose, stage and monitor progress of treatment for people with cancer. Cancer and nuclear medicine specialists at those facilities joined with CMS and several professional medical societies, including ones for oncology, radiology and nuclear medicine, to create the National Oncologic PET registry. Under a coverage with evidence development (CED)
scheme, CMS agreed to cover PET to assess tumor metabo- lism using F-18 fluorodeoxyglucose (FDG) only for Medicare enrollees who were entered into the registry. Te registry started in 2006, and CMS expanded coverage for FDG-PET in 2009. In 2011, CMS agreed to a CED strategy for using PET with another radiopharmaceutical, sodium fluoride F-18 (NaF), which is used to detect bone metastasis. As of June 2012 there were about 300,000 PET scans in the registry. Gail Rodriguez , executive director of the Medical
Imaging & Technology Alliance, whose 60-plus members manufacture big-ticket devices like PET scanners and medi- cal linear accelerators, cites the oncologic PET registry as a model for getting coverage.
Medical manufacturers are wise to plot strategies to collect meaningful data while their ideas are still in the R&D stage.
Tis coverage process is flexible enough to provide timely
access to new technology, according to CMS. It also supports the continued study of devices, and allows contractors the flexibility to adapt their policies as medicine evolves. Less flexible is the national coverage determination (NCD)
process, which is subject to statutory timeframes and trans- parency requirements, and also makes the process more resource-intensive. To help streamline processes, the FDA and CMS started
a two-year pilot program implementing parallel review for NCDs in October 2011. “Oſten, device sponsors focus solely on obtaining FDA approval, only to find that Medicare cover- age is not automatically forthcoming,” according to a press release about the program. Te first approval under parallel review came in May
2012, for catheter-based aortic valve replacements. With the decision, devices for the procedure that get pre-market approval from the FDA, among other criteria, will be eligible for CMS reimbursement. Once CMS develops an NCD on a topic, it oſten is reluc-
tant to reopen it until the body of evidence on the technology has changed significantly as reflected through peer-reviewed medical publication. Reimbursement consultants oſten say an
20 Medical Manufacturing 2013 “CMS requires a lot of evidence,” she says. “Sometimes the
best, most logical partner for seeking coverage would be a society.” By “society,” Rodriguez means a professional medical organization, such as the American College of Cardiology or the American Academy of Orthopaedic Surgeons. Unfortunately, CED isn’t currently used with LCDs, says
Joseph Rolley , vice president of Global Government Affairs & Health Policy for ConvaTec Inc. (Skillman, NJ), a spinoff of Bristol-Myers Squibb Company. “While many developers of innovations covered under
NCDs dislike coverage with evidence development because it is seen as burdensome and slowing the coverage process, it could add more predictability and earlier patient access to technolo- gies covered under LCDs,” says Rolley. “It actually could provide a clearer path to coding, coverage and payment for innovations covered under LCDs than is currently the case.” CMS is working on revisions to its CED program, and was
in the process of collecting public comments earlier this year. Te timing of an NCD is critical. A review initiated
prematurely, before the manufacturer has been able to build a sufficient body of data for CMS’ review, could result in a noncoverage determination that denies patients access to the technology and discourages further investment in research
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