Lawmakers, medical societies and patient advocacy groups joined the medtech industry last week in urging CMS to reverse its plan to deny coverage for computed tomography colonography to screen for colorectal cancer.

When CMS issued the proposed rule last month, the agency said that health outcomes evidence was not yet sufficient to support national Medicare coverage for the minimally invasive, 10-minute screening procedure (¹ Also see "CMS Seeks Comments On Cost Effectiveness Of Virtual Colonoscopy" - Medtech Insight, 16 February, 2009., p. 21).

"We strongly oppose this action and urge CMS to carefully review the decision that would deny beneficiaries access to a safe, efficient and cost effective screening method that has the potential to save American lives," wrote Reps. Kay Granger, R-Texas, and Patrick Kennedy, D-R.I., last week.

Granger and Kennedy were asking congressional colleagues to sign a letter urging CMS to cover virtual colonoscopy - another name for CT colonography. By last Friday afternoon, 40 other lawmakers had signed the letter to CMS Acting Administrator Charlene Frizzera, which was delivered that day.

Industry Hosts Supporters On Capitol Hill

The "Dear Colleague" letter was circulated during a March 9 briefing on Capitol Hill, co-sponsored by the Medical Imaging Technology Alliance, the American College of Radiology and the patient advocacy group Colon Cancer Alliance.

The groups point to data from the ACR Imaging Network, published last year in the New England Journal of Medicine, that demonstrate the effectiveness of CT colonography in detecting colon cancer (² Also see "CT Colonoscopy Gets Further Support From NCI Study In NEJM" - Medtech Insight, 22 September, 2008., p. 21).

One disadvantage to virtual colonoscopy is that it does not offer the option of immediately removing polyps as they are detected.

Some hospitals and gastroenterologist groups are creating models whereby patients can be screened with a virtual colonoscopy and then have a traditional colonoscopy the same day if needed to remove polyps.

Virtual colonoscopy proponents do not question the effectiveness of traditional colonoscopy; rather they suggest the newer technology offers a way to expand screening, especially for those resistant to the more invasive procedure.

"The Colon Cancer Alliance doesn't recommend any screening method over another," said CEO Andrew Spiegel, "but when elderly people call us and they say things like, 'I'm a little nervous about getting a colonoscopy because I'm older and my systems are a bit weakened,' or they say they're nervous about getting a perforation or they say, 'I'm very nervous about getting anesthesia,' it would be a great thing if we could tell them Medicare covers another test that's just as effective as the traditional colonoscopy."

Spiegel also noted that some patients are resistant to the idea of "getting a six-foot tube inserted into your rectum" with the traditional procedure. "What happens as a result is that they will not get screened for colon cancer. They don't want to hear about it; they don't want to talk about it. It's not an option."

Because deaths from colon cancer are 90% preventable when caught early enough, physician groups and patient advocates support options for increasing screening rates for the disease, which kills more than 50,000 Americans each year.

Screening is particularly important among the Medicare population, said J. Leonard Lichtenfeld, deputy chief medical officer of the American Cancer Society, because that is where the incidence of the disease is the highest.

Interest groups at the Capitol Hill briefing addressed concerns raised in the CMS proposal, such as the risk from radiation that could arise from repeated exposure to CT scans.

Because screening for those at average risk of colon cancer is not typically recommended until age 50, the threat of radiation is minimal compared to what it might be if delivered to a pediatric patient.

"When it comes to low-dose radiation, [the threat] certainly doesn't include Medicare patients," said Beth McFarland, chair of the American College of Radiology's Colon Cancer Committee.

CMS also wanted to know how often CT scans might detect extracolonic findings, or masses picked up on a scan but outside the colon, which could lead to further tests and the potential for unnecessary invasive procedures.

McFarland said that extracolonic findings do not have to be viewed as a negative. The issue, she noted, is whether CT colonography "is showing us things that we don't want to know about outside the colon that cost money, or is it helping us out?"

Few studies have tried to model the benefits of detecting early kidney cancers or abdominal aortic aneurysms through virtual colonoscopy, McFarland said, "because it's hard to do."

An overwhelming majority of public comments in the round due to CMS March 13 recommend the agency reverse its position and offer virtual colonoscopy as a screening tool.

Cost Has No Role In Decision - Industry

In March 6 comments, AdvaMed's Ann-Marie Lynch, executive vice president of payment and health care delivery, criticized CMS for the wording of its proposed rule, which sought comments on the cost effectiveness of CT colonography, should the agency alter its clinical decision.

CMS "does not have the statutory authority to use cost effectiveness in its coverage determination for CT colonography," AdvaMed asserts. While Congress mandated a colon cancer screening benefit in 1997 under the Social Security Act, which also allows for expansion of procedures covered to screen colorectal cancer, "this provision does not contain any express or implied language authorizing the Secretary to consider cost effectiveness when determining whether a procedure or service is appropriately covered for colorectal cancer screening," Lynch said.

The trade group also points out that the statutory language providing coverage for colorectal cancer screening differs from language describing certain preventive services under section 101 of the Medicare Improvements for Patients and Providers Act of 2008, which grants CMS authority to take into account "the relation between predicted outcomes and the expenditures" for certain preventive services (³ Also see "CMS Offers New Path To Coverage For Preventive Services" - Medtech Insight, 28 July, 2008., p. 3).

That language "does not apply to national coverage analysis of CT colonography," AdvaMed maintains.

Last November, the Medicare Evidence Development & Coverage Advisory Committee (MedCAC) determined that virtual colonoscopy was promising, but that the costs would need to come down for the procedure to be cost effective compared with traditional colonoscopy (⁴ Also see "CT Colonography Screening Shows Promise If Cost Lowered, MedCAC Says" - Medtech Insight, 24 November, 2008., p. 17).

AdvaMed maintains that it was inappropriate that the matter of cost effectiveness was brought up at all during the MedCAC meeting and may have misled the committee in making its recommendations.

In separate comments filed March 12, the American College of Gastroenterology and American Society for Gastrointestinal Endoscopy both advise against coverage. The same day, however, the American Gastroenterological Association recommends that CMS offer CT colonography under coverage with evidence development.

Some believe that Medicare coverage of virtual colonoscopy could lead to a turf battle between radiologists and gastroenterologists, who want to hold onto their optical colonoscopy business. But others say there is room for both medical specialties to be involved in colorectal cancer screening, especially if the goal is to extend screening compliance throughout the targeted population.

In Feb. 17 comments to CMS, commercial insurer UnitedHealthcare says any disadvantages to CT colonography "are more than offset by the advantages of improved rates of surveillance for a disease that is readily curable when localized, and exceedingly difficult to treat when it has metastasized."

ACS's Lichtenfeld said there are not enough gastroenterologists available to screen all patients age 50 and older with colonoscopy or sigmoidoscopy procedures.

A combined work force of radiologists and gastroenterologists trained on CT colongraphy would be able to handle demand, especially since not all patients of screening age would necessarily switch from traditional colonoscopy, according to gastroenterologist Amy Patrick of the Mid-Atlantic G.I. Consultants in Delaware.

CMS plans to release its final decision on the matter by May 19.

- Monica Hogan (m.hogan@elsevier.com)

Protests Mount Over CMS Proposal To Deny Virtual Colonoscopy Coverage

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