Medical Device Daily Washington Editor

The Centers for Medicare & Medicaid Services has announced it will review its coverage status for pharmacogenomic testing of patients for sensitivity to the blood thinner warfarin. The issue of bleeding events has been on the agenda for FDA for some time as the agency's revision of the label for the drug last year clearly indicates (Medical Device Daily, Aug. 20, 2007), an action that may have helped prompt CMS's action.

Pharmacogenomic testing as a principle component of personalized medicine is seen as a harbinger of less costly and more effective healthcare, but the science behind such tests is not yet utterly clear. On one hand, a study conducted in 2006 by the Joint AEI/Brookings Center (Washington) suggested that bleeding events due to higher doses than needed cause 17,000 strokes and 85,000 bleeding events annually, costing the economy more than $1 billion each year.

However, clinical lab professionals recently indicated they are not necessarily of the opinion that such tests are ready for full deployment in clinical labs (MDD, July 30, 2008). All the same, industry seems ready to crank out reagents and analyzers for the test.

Michael Murphy, CEO of Paragon Dx (Morrisville, North Carolina), which makes reagents used in tests for warfarin sensitivity, told Medical Device Daily "this is what everyone was waiting for," adding that CMS is obliged to "make a national decision so that there is uniform coverage for this test."

However, Murphy acknowledged some uncertainty about whether the test should be used as a screening tool, remarking, "the question really is whether its cost effective to test everyone to catch the 15%" whose gene sets make they hypo- or hypersensitive to the drug.

Murphy said he would estimate that less than 10% of Medicare eligibles who get warfarin are tested, and noted that some doctors feel that testing for prothrombin time is adequate to screen for warfarin sensitivity.

When asked whether Paragon can turn out the needed reagents should CMS give testing the nod, Murphy said "it really would not be a problem for us. Our production is extremely scalable." He also said that Paragon is not the only firm waiting for the okay. "We're all patiently waiting for them to make that big decision," he said of the diagnostics industry, but cautioned that warfarin sensitivity testing as a screen is "not going to happen overnight." He also said "there's a misconception that what we're trying to do is make genetic testing for warfarin the standard of care. That's not what we're trying to do. We're trying to augment the current standard of care, not replace it."

CMS to pay top dollar for artificial heart

CMS recently gave the nod for coverage for the use of artificial hearts (MDD, May 5, 2008), but did not settle on the rate for reimbursement until more recently. In a July 31 statement, the agency reported that it will cover the use of artificial hearts through its two highest-paying codes.

The agency will use the Medicare Severity Diagnostic Related Groups (MS-DRGs) 001 and 002, which will command the approximate sums of $345,000 and $178,000 respectively. CMS said that this decision is effective retroactive to May 1, 2008. In the July 31 decision, CMS said that its coverage for the CardioWest total artificial heart "fulfills a role that no other mechanical circulatory support device can for patients in irreversible biventricular failure."

CMS also reported that it will pay a new-technology add-on for the CardioWest, made by SynCardia (Tucson, Arizona) beginning Oct. 1. In a statement, Rodger Ford, CEO/president of SynCardia, said "in the past, hospitals and their patients have experienced great success with our device, but hospitals risked taking substantial economic losses in order to bridge these patients to transplant. Now, our certified centers can afford to save thousands of end stage heart failure patients."

The CardioWest, a device which is not fully implanted in the body, costs around $100,000.

FDA seeks orthopedic registry hosts

FDA is interested in boosting the Sentinel program for orthopedic devices by publishing a request for proposal for a series of registries to track outcomes for patients with this class of device.

According to the web site FedBizOpps.gov, FDA wants a national network of registries that "would include, but are not limited to, total hip, total knee, hip resurfacing, intervertebral disk implants, and ankle devices." Such a system should plumb data from existing systems, which would still be under the management of their owners, but searchability of data is one of the key requirements.

FDA says that any response to the RFP "should lead to specific recommendations for further involvement of the most promising data sources and/or environments" and "should also include a value proposition and engagement strategy for registry owners and professional societies." This would likely be a fixed-price award that would be effective six months after the date of the award.

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