Universal Access to Virtual Colonoscopy May Be on the Horizon

Yael Waknine

December 06, 2013

Stronger advocacy efforts are needed to overcome the political wrangling that has long stymied universal access to virtual colonoscopy in the United Sates, write radiologists in a review published in the December issue of the Journal of the American College of Radiology.

The test, CT colonography (CTC), was approved for the screening of colorectal cancer by the US Food and Drug Administration (FDA) in 2009, and has been endorsed by the American Cancer Society, the US Multi-Society Task Force on Colorectal Cancer, and the American College of Radiology (ACR). However, it is not covered for reimbursement by the Centers for Medicare and Medicaid Services' (CMS).

"There's no question in the expert community that CTC has been ready for prime time for a long time," lead author Abraham H. Dachman, MD, professor of radiology at the University of Chicago Medical Center, told Medscape Medical News in an interview.

"I think the public and nongastroenterology community need to be educated to demand CMS reimbursement for CTC.... It makes sense," Dr. Dachman emphasized, citing the large body of peer-reviewed supportive literature and continued need for legislative efforts.

CTC is safe and cost-effective relative to traditional optical colonoscopy (OC), and the procedure can be carried out in a convenient outpatient setting without sedation.

Its coverage by CMS would also extrapolate to third-party carriers, yielding a significant boost to flagging colorectal cancer screening rates, which currently hover around 40%, he added.

According to Dr. Dachman and fellow author Judy Lee, MD, the key to winning CMS approval — denied largely as a result of political controversy from the OC community — lies in upgrading the test's US Preventive Services Task Force (USPSTF) rating. When it was categorized in 2008, evidence for the test was given an I rating, which is considered to be insufficient.

Changing the rating to at least B, denoting a high certainty of moderate to substantial net benefit, would influence CMS. "A lot of third-party providers follow CMS rulings," Dr. Dachman noted, indicating his preference for an A rating, and adding that a C rating would be "devastating."

However, efforts to effect the upgrade have been stuck in a governmental quagmire. "USPSTF claimed their agenda was 'full' last year with more pressing issues and therapies to evaluate, and CTC evaluation was deferred, which put us off at least an extra year," Dr. Dachman explained.

There is good news, however. After a long and torturous journey in muddled waters, the way might finally be clearing; the USPSTF weighed evidence collected by the FDA in a fact-seeking session in September.

The meeting, which involved the agency's Gastroenterology-Urology Panel and the Radiological Devices Panel of the Medical Devices Advisory Committee, included attendees such as Dr. Dachman and Dr. Yee, who presented data on behalf of the ACR.

"It is comforting to know that this federal agency within the US Department of Health and Human Services declared in its executive summary following the meeting that 'all members of the joint panels agreed that given the risks and benefits identified, CTC should be one option for colorectal cancer screening of asymptomatic patients'," Dr. Yee told Medscape Medical News.

"Since CMS and USPSTF take into consideration the risks and benefits of a test, the positive outcome of the evaluation by the FDA will hopefully help to justify reimbursement of CTC for screening," Dr. Yee concluded.

Dr. Yee is professor and vice chair of radiology and biomedical imaging at the University of California, San Francisco; chief of radiology at the San Francisco Veterans Affairs Medical Center; and a member of the ACR Colon Cancer Committee.

A Long and Winding Road Toward CMS Acceptance

CTC was first endorsed by several American medical organizations in 2008.

However, the OC community raised concerns about the procedure, including the continued need for OC in polyp removal; the lower sensitivity of CTC for small polyps and flat lesions; the impact of extracolonic findings, particularly on cost efficacy; and the cumulative radiation risk associated with follow-up visits.

The controversy resulted in an I rating from USPSTF, which was the only agency specifically invited to present its opinion during the Medicare Evidence Development Advisory Committee meeting in November 2008. CMS rejected coverage in May 2009, claiming a lack of evidence on radiation risks and extracolonic finding impact, and demanding — without precedent — proof of efficacy in seniors.

Although these and the original OC objections have long since been satisfied in peer-reviewed publications, CTC advocacy efforts to date have met with limited success.

Still, some CTC reimbursement is available from large carriers such as Cigna and United Healthcare, depending on the state, policy, indication, and other variables, Dr. Dachman said, adding that many diagnostic exams are reimbursed by Medicare if OC findings are incomplete.

Key Evidence Abounds, Researchers Say

In their review, the experts address the concerns that have been voiced about CTC.

When it comes to polyp removal, the current best practice is to offer rapid-interpretation CTC with a same-day OC option, obviating the need for multiple clinician appointments. Only 8% of current CTC screenings require biopsy; the rate is slightly higher (12%) in Medicare-aged patients.

In addition, most extracolonic findings on CTC do not require or undergo further workup; in the vast majority of clinical trials, only 5% to 9% of novel clinically significant findings warranted follow-up, and only 2% of these require surgical intervention.

Although cost-effectiveness is not a metric considered by USPFTF or CMS, published data show that CMS coverage will be cost-effective if reimbursement rates remain below those for OC and screening rates rise; the potential savings are particularly high among seniors.

Finally, CTC radiation doses are now at or below that of natural background radiation in the United States. Even at higher radiation doses, the benefit/risk ratio achieved by improved cancer detection ranged from 24:1 to 35:1.

Dr. Dachman is an instructor of virtual colonoscopy courses for GE Healthcare and reports having received royalties from Hologic and UC Tech. Dr. Yee reports having received research grants from Bracco (Milan, Italy) and EchoPixel, and is chair of the Colon Cancer Committee for the ACR.

J Am Coll Radiol. 2013;10:937-942. Abstract

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