Colonography denial leads to new tactics

Angry backers of CT colonography for colorectal cancer screening are regrouping after the Centers for Medicare and Medicaid Services repulsed their efforts to secure Medicare coverage for the procedure.

CMS's final decision against reimbursement on May 12 stirred an impassioned protest from the American College of Radiology. In a written statement, Dr. James Thrall, chair of the ACR Board of Chancellors, predicted that the decision may lead to tens of thousands of unnecessary deaths from
colorectal cancer, particularly among minority and underserved populations.

Dr. Otis W. Brawley, chief medical officer of the American Cancer Society, expressed disappointment in the decision, stating that more options are needed to compensate for a shortage of gastroenterologists available to perform conventional optical colonography.

"Additional options are absolutely necessary," Brawley said in a written statement.

Andrew Spiegel, chief executive officer of the Colon Cancer Alliance, stressed the need to communicate with the Obama White House that the decision contradicts its policies favoring medical procedures that save costs and prevent disease.

"By denying (access for Medicare beneficiaries), what they are doing is separating the haves from the have-nots, those who have private health insurance that covers virtual (CT) colonoscopy from the less fortunate with Medicare that does not allow virtual colonoscopy," he said.

Siegel joined Thrall and other supporters in pressing for federal legislation mandating Medicare coverage. As of June 1, no federal legislation had been introduced, but the Colorectecal Cancer Screening and Detection Coverage Act of 2009, a bill introduced by Rep. Dan Boren (D-OK) in March, would require private insurers to cover CTC and other types of colorectal cancer screening.

Colonography's detractors ex-pressed satisfaction with the decision. In a perspective appearing in the May 28 New England Journal of Medicine, Dr. Rita Redberg, a vociferous critic of Medicare's acceptance of cardiac CT in 2008, was pleased that CMS held CTC to a new higher standard. The University of California, San Francisco cardiologist stressed the need to require more data on women, the poor, and racial minorities in future trials as well. CTC researchers are addressing CMS's demand for more information.

Dr. C. Daniel Johnson, radiology chair at the Mayo Clinic in Scottsdale, AZ, was immediately concerned with meeting CMS's demand for efficacy data specifically geared to the 62-years-and-older population. Johnson is principal investigator of the National CT Colonography Trial, coordinated by the ACR Imaging Network. The multicenter trial showed that CT colonography is as effective as optical colonoscopy for screening early-stage colorectal cancer.

According to the May 12 memo declining payment, CMS analysts wrote that the generalizability of the ACRIN trial and other research by Drs. Perry Pickhardt and David H. Kim was pivotal for its decision against the procedures. The average age of subjects in their studies was 57 to 58.3 years. The average age of Medicare beneficiaries in 2007 was 75.5 years.

That shortcoming is fairly easily addressed, Johnson said in an interview. More than 500 of more than 2500 asymptomatic subjects in the ACRIN trial were at least 62 years old. Johnson plans to extract and analyze data for publication by mid-2010.

The age discrepancy wasn't considered earlier because nothing in clinical experience suggested that the effectiveness of screening would change from asymptomatic individuals in their 50s and 60s, Johnson said.

"That concern would be valid if we understood that the histology and biologic behavior were different in seniors, but they are not," Johnson said. "We know that the behaviors of the tumors in seniors (who qualify for Medicare) are the same as for people under the age of 65."

It is not clear whether CMS officials informed Johnson and other researchers before the ACRIN trial that results specifically for Medicare beneficiaries would be their key consideration.

CMS analysts and other government officials met in Washington, DC, during the planning stage, "to make sure the ACRIN trial was going to answer all their concerns," Johnson said. He deflected a question on whether CMS had later modified its approval requirement, saying only that he thought CMS had been instructed to follow the U.S. Preventive Task Force recommendation against CTC screening.

"It is hard to predict what CMS will need the next time around," Johnson said. "I think they are more interested in not spending money for increased colorectal screening than (in) carefully looking at the data.