Diagnostics & Imaging Week Washington Editor

The sharp rise in the amount of imaging services done under Medicare Part B has not gone unnoticed in the last days of the 110th Congress, and in an attempt to take the edge off that growth clip, Sen. Chuck Grassley (R-Nebraska) has proposed a bill that would force physicians to disclose to their Medicare patients any interest they may have in imaging services the doctor recommends.

The bill did not make it into the Medicare bill recently passed by Congress, but the expectation is that the 111th Congress will have to address the matter, especially given the interest in this issue on the part of the Medicare Payment Advisory Commission.

The Medicare imaging cost question has been on Congress's plate for several years, and the same can be said for the Centers for Medicare & Medicaid Services, which attempted to zero in on the "pod lab" arrangement two years ago. A pod lab is one that operates near a doctor's office – sometimes in the same building – and is owned in part by the doctor making the referral.

The Government Accountability Office recently reported that Medicare imaging under Part B skyrocketed from $6.9 billion in 2000 to $14.1 billion in 2006. In the summary for the June 13 report, GAO states, "the proportion of Medicare spending on imaging services performed in office rose from 58% to 64%," and doctors "obtained an increasing share of their Medicare revenue from imaging services."

In keeping with other healthcare spending trends, geographic variability for Medicare imaging expenditures was huge by GAO's reckoning, averaging $62 per beneficiary in Vermont, but $472 in Florida.

Grassley's bill, the Medicare Imaging Disclosure Sunshine Act of 2008 (S. 3343), would force doctors to disclose their interests in provider of prescribed imaging services, and requires doctors to tell patients about any alternative providers. But whether this would spur action on the part of a patient is unclear.

Grassley said in a July 25 statement that the bill would not hinder access, but would give patients "information about financial relationships in a way that's neither onerous nor overly prescriptive."

Rep. Carolyn McCarthy (D-New York) introduced a companion bill under the same name (H.R. 1293), but neither bill is likely to go anywhere this year due to the short time left for the 110th Congress.

Maureen Zilly, director of government relations for the National Electrical Manufacturers Association (NEMA; Rosslyn, Virginia), told Diagnostics & Imaging Week "overall we would support the concept of the Grassley bill in terms of transparency," but she alluded to the possibility that it might have a negligible impact on the overall rate of imaging.

"Based on estimates we've done, self referral is about 4% of imaging referrals," she said, adding "we would think [the effect of such a bill] would be a change in the site of service rather than a reduction in services."

CMS to investigate warfarin sensitivity coverage

The Centers for Medicare & Medicaid Services reported that 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, an action that may have helped prompt the CMS 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. 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 D&IW, "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, saying, "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 reagent, 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 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."