Medical Device Daily Washington Editor

The Centers for Medicare & Medicaid Services has confirmed that it will not cover computerized tomography for colonography (CTC) as a screen for colorectal cancer, a decision that was not unexpected. The agency posted a notification in February that unless a compelling argument arose, it would not cover the procedure (Medical Device Daily, Feb. 13, 2009).

The proposed decision memo from February indicates that repeated exposure to X-radiation is one of the agency's concerns, but CMS also stated that much of the supporting data featured patients who were "considerably younger than the Medicare aged population," which led to questions about the generalizeability of the supporting data.

Another set of issues for CMS was that because CTC often misses polyps smaller than 6mm in length and surgeons will usually remove these smaller polyps during an operation, little is known about the rate at which such polyps become cancerous.

Durado Brooks, MD, chief of the division of prostate and colon cancer at the American Cancer Society (ACS; Washington) confirmed that concern in an interview with Medical Device Daily, but held ground nonetheless, stating that ACS "still see[s] CTC as appropriate technology."

The agency's final decision memo states: "Many questions on the use of CT colonography need to be answered with well designed clinical studies that focus on health outcomes for the Medicare population."

In a May 13 statement, Eamonn Quigley, MD, president of the American College of Gastroenterology (Bethesda, Maryland), stated that the decision " underscores the lack of sufficient evidence on the test's potential." He also noted that a positive finding with CTC usually leads to a full conventional colonoscopy, which is still the gold standard for polyp detection. "Until a radiographic test can meet that standard, gastroenterologists will continue to champion the lifesaving potential of colonoscopy," Quigley said.

NIH seeks input on conflict regulations

Conflicts of interest abound in medical research, whether it is funded by private or public funds, and the National Institutes of Health is seeking input on a rewrite of its regulations for that purpose.

According to the May 12 statement, NIH will accept comments until July 7 on the regulations, "with particular interest in potential for expanding the scope of the regulation and disclosure [of] interests." NIH seeks input on other issues as well, including "the definition of 'significant financial interest'," as well as several aspects of institutional conflicts of interest.

The statement quotes acting NIH director Raynard Kington, MD, as saying "these collaborations are increasingly complex and it is important to consider if changes are needed ... to ensure the integrity of science."

Conflicts of interest were the subject of a recent report by the Institute of Medicine (Washington), which concluded that any gifts from industry to researchers should be forbidden (Medical Device Daily, April 29, 2009), but that recommendation might gain little traction, given that the Physician Payment Sunshine Act of 2009 is well under way in the Senate and sets a reporting requirement for gifts valued at $100 or more. A number of states, including Minnesota and Massachusetts, have also passed laws dealing with conflicts of interest in relations between physicians and drug and device makers.

Home oxygen bill resurfaces in House

The Home Oxygen Patient Protection Act of 2007 may have died before seeing the light of day, but it has resurfaced into a bill by more or less the same name in the House. Reps. Tom Price, MD (R-Georgia) and Heath Shuler (D-North Carolina) brought the bill back to life earlier this week, much to the delight of providers of home oxygen services.

The bill, cataloged as H.R. 2373, would wipe out the term limit of home oxygen therapy of 36 months imposed by the Deficit Reduction Act of 2005 (DRA) and allow providers to continue providing services indefinitely. H.R. 2373 would also allow the provider to retain ownership of the equipment, which DRA transferred to the patient after 36 months.

Many Medicare beneficiaries who are on home oxygen suffer from chronic obstructive pulmonary syndrome, a condition in which bronchitis takes root in lungs afflicted with emphysema. Those patients are often home-bound and not in a good position to take the oxygen bottles out for refill.

In a May 13 statement, Tyler Wilson, president of the American Association for Homecare (AAHomecare; Arlington, Virginia), said the bill will "help ensure appropriate oxygen therapy payments for the period of medical need" and will help provide "a greater focus on patient need and on the essential services" needed by patients on home oxygen therapy. "This issue is significant for both Democrats and Republicans and we expect strong support from both parties," Wilson noted.

CMS reschedules Bayesian meeting

CMS has rescheduled to June 17 a meeting addressing the use of Bayesian statistical methodology, originally scheduled for March 18. The agency's notice in the May 13 edition of the Federal Register states that the Medicare Coverage and Evidence Development Advisory Committee will meet from 7:30 a.m. to 4:30 p.m. at CMS headquarters at 7500 Security Blvd. in Baltimore.