CMS Decision Not to Cover Virtual Colonoscopy for Colorectal Cancer Screening Sparks Heated Debate

Roxanne Nelson

May 15, 2009

May 15, 2009 — Virtual colonoscopy using computed tomography (CT) will not be covered by Medicare as an option for colorectal cancer screening in the United States, according to a final decision from the Centers for Medicare and Medicaid Services (CMS). The agency concluded that "the evidence is not sufficient to conclude that screening CT colonography [CTC] improves health benefits for asymptomatic average-risk Medicare beneficiaries."

This finalized the coverage denial proposed in February, when CMS first announced it they intended to deny Medicare beneficiaries access to virtual colonoscopy. Although the CMS memo described virtual colonoscopy as a "promising technology," it also pointed out that many questions about the use of CTC need to be answered with well-designed clinical studies that focus on health outcomes for the Medicare population.

Until the evidence is sufficient, "CMS strongly encourages physicians and beneficiaries to participate in [colorectal cancer] screening by selecting 1 of the several [colorectal cancer] screening tests that are currently covered under Medicare," states the decision memo. These include optical colonoscopy, fecal blood tests, and sigmoidoscopy.

Decision Stirs Debate on Both Sides

The decision has stirred a great deal of debate among professional organizations, medical experts, and advocacy groups. However, during the 30-day comment period following publication of the draft memo, the majority of responses (97%) opposed a blanket denial of coverage. Members of Congress also wrote letters to CMS urging Medicare coverage of the procedure, including 2 letters signed by more than 50 Representatives.

CMS received comments opposing the decision from the American Cancer Society, the American College of Radiology, the American Gastroenterological Association, the Advanced Medical Technology Association, and UnitedHealthcare; letters supporting the decision came from the American College of Gastroenterology, the American College of Preventive Medicine, the American Society for Gastrointestinal Endoscopy, and American's Health Insurance Plans.

"It is disappointing but not unexpected, given their preliminary decision," said David J. Vining, MD, professor of diagnostic radiology at the University of Texas MD Anderson Cancer Center in Houston. "But their rationale behind it is difficult to understand."

Dr. Vining, who performed the first virtual colonoscopy in 1993, told Medscape Oncology that this is going to remain a "hot topic" and is not going to disappear anytime soon. "Congresswoman Kay Granger's [R-Texas] office has issued a press release that they are going to continue to fight it and try to get CMS to reconsider their decision," he said. "This is a worthwhile issue that has multiple facets in terms of economics and politics; it may even become a focal point for healthcare reform."

The Obama administration has emphasized prevention, he pointed out, and unlike mammography and lung cancer screening, colorectal cancer screening can actually prevent cancer by detecting premalignant lesions.

"Everyone needs screening, but not necessarily colonoscopy, and whatever method they take should be supported," Dr. Vining said. "Even gastroenterologists are seeing the handwriting on the wall."

Gastroenterologists appear to be split on the issue. Although they were initially opposed to virtual colonoscopy, the Future Trends Committee of the American Gastroenterological Association (AGA) published a report in October 2006 that demonstrated a change in position. The Committee proposed that gastroenterologists should position themselves to play a role in performing and interpreting CTC. The following year, the AGA issued guidelines listing the minimum requirements that a gastroenterologist must satisfy to become certified to read CTC scans.

However, the American College of Gastroenterology (ACG) has spoken out against virtual colonoscopy, and applauded the decision to not have it covered under Medicare. It said that the decision "underscores the lack of sufficient evidence on the test's potential as an appropriate option for the screening and prevention of colorectal cancer."

"There is no evidence that any radiographic test, including [CTC], prevents the development of colorectal cancer. Colonoscopy is one of the most powerful preventive tools in clinical medicine because of its excellent sensitivity in detecting polyps and its potential for removing them and breaking the sequence of polyp to cancer in a single diagnostic and therapeutic intervention," Eamonn Quigley, MD, FACG, president of the ACG, said in a release.

The American Society for Gastrointestinal Endoscopy, which also supported the CMS decision, stated that even though CTC is a promising addition to colorectal cancer screening, it is premature to endorse the technology. "Because of suggested efficacy in identifying cancers and polyps greater than 9 mm, we believe [CTC] is an appropriate consideration as an alternative test for patients who are unable to have a complete optical colonoscopy because of an anatomic blockage or other medical reason," they wrote in their original comment letter to CMS.

Addition, Not Replacement

Leonard Lichtenfeld, MD, deputy chief medical officer for the American Cancer Society, expressed his disappointment in the decision. "It was an opportunity . . . to start setting the stage on how we can do things the right way in healthcare going forward, which will be a critical part of any reform effort," he wrote in his blog. "In my opinion, we have failed to meet the challenge."

"For me, the issue is reasonably straightforward," he added. "We lose close to 50,000 people every year in this country from colorectal cancer. We could save thousands of lives if we were able to get people screened for this disease. The American Cancer Society believes that we should favor tests that prevent cancer, and has endorsed [CTC] as a reasonable test for this purpose."

Andrew Spiegel, CEO of the Colon Cancer Alliance, a national patient advocacy organization, also believes that this is a rather straightforward issue. "Less than 60% of the Medicare population — which is the population most likely to develop colon cancer — is screened," he told Medscape Oncology. "I'm sure that part of reason is fear of anesthesia or bowel perforation associated with colonoscopy, and just discomfort with the procedure itself."

Many private insurers, including major companies such as Cigna and UnitedHealthcare, already reimburse for CTC, Mr. Spiegel pointed out. Thus, the denial of coverage by Medicare helps reinforce different standards of care for Medicare beneficiaries and for those with private health insurance.

But perhaps most important is the fact that Medicare turned the issue of coverage into a debate about efficacy — pitting optical colonoscopy against virtual colonoscopy. That was a completely wrong way of looking at it, contends Mr. Spiegel, because no one was looking to replace optical colonoscopy with CTC.

"This was about adding another screening option, not replacing the standard," he said. "It was about offering an additional option that is more effective than some of the screening tests that Medicare already pays for, like fecal blood testing and sigmoidoscopy."

Issues Unresolved

In their memo, CMS notes that even though private insurers are offering coverage to people younger than 65 years, there is insufficient evidence on test characteristics and performance of screening CTC, and on health outcomes in older Medicare beneficiaries. There also are no published studies on the impact of adding CTC on colorectal cancer screening rates in older individuals, they write.

In his blog, Dr. Lichtenfeld points out that the CMS decision has made it less likely this evidence is going to be obtained any time soon — if ever. The American Cancer Society had asked CMS to explore other options, and proposed that they consider a "coverage with evidence" decision (CED). This would have permitted CMS and other professional organizations to initiate stringent rules and regulations to follow patients who were screened with CTC, allowing essential data to be obtained from this population that could measure the effectiveness of CTC and answer the questions that have been raised.

"CMS said repeatedly they couldn't do a CED for [CTC] because it is a screening test," writes Dr. Lichtenfeld. "They do have such a program for PET [positron emission tomography] scans, but that is OK in their opinion because PET scans are used in the diagnosis and treatment of disease. So much for preventing cancer, as opposed to treating it."

Another issue raised by CMS is the need for a follow-up optical colonoscopy if lesions are detected. This necessitates the patient undergoing a second bowel prep, and adds the cost of an additional test.

"With the higher prevalence of polyps in the older Medicare population, the rate of referral to optical colonoscopy is extremely important, and also unknown at this point," CMS says in its memo. "If there is a relatively high referral rate, the utility of an intermediate test such as [CTC] is limited."

However, to solve the problem of double bowel preps, some insurers are arranging to have a follow-up colonoscopy, if one is needed, the same day as the CTC. As an example, Blue Cross/Blue Shield in Delaware is now requiring that the follow-up colonoscopy be performed within 2 hours of the completion of the CTC.

Dr. Vining pointed out that only 10% of patients have a significant polyp that needs to be removed, so the number of cases requiring a second procedure would be quite small.

Most of the small polyps less than 5 mm are benign; the gray area is with polyps 6 to 9 mm, he explained. "Some radiologists advocate following those without removal unless 3 or more polyps of this size are detected during [CTC]. Of course, patients with polyps larger than 10 mm should be referred for follow-up colonoscopy."

Ultimately, more definitive practice guidelines need to be established on how to manage small polyps, and better discriminating criteria [are needed] to figure out who needs colonoscopic intervention, he added.

Dr. Lichtenfeld agrees with CMS that more data are needed and that there are unanswered questions, such as those concerning radiation dosage, and extracolonic incidental findings.

Although CTC isn't perfect, it appears to be a very reasonable test, he said. "It is my opinion and the opinion of others that it would expand the opportunity for colorectal cancer prevention and [provide an] early detection strategy to more people throughout the country."

The Battle for Coverage Will Continue

Even though CMS has issued their final decision, the debate is likely to continue. Congresswoman Granger notes in a release that "virtual colonoscopies are an important tool in the battle against colorectal cancer," and has sponsored the Colorectal Cancer Prevention, Early Detection, and Treatment Act (H.R. 1189), which would put in place a national colorectal cancer screening and treatment program.

The CTC Working Group, a coalition of physician providers, colon cancer patient advocates, and imaging-equipment manufacturers, has called on CMS to immediately reopen the rule-making process to consider new clinical data.

If CMS will not reconsider its decision, Mr. Siegel said that they will go to Congress to get it reversed and to push through Medicare funding. "We will call upon the 1.2 million people who currently have colon cancer in the [United States] and ask their voices to unite to mandate coverage for virtual colonoscopy."

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