SAN FRANCISCO - The talented but long-suffering colon cancer screening exam known as CT colonography (CTC) may finally be on the cusp of screening reimbursement, though nothing is certain, according to a Monday presentation at the annual International Symposium on Multidetector-Row CT (MDCT).
All eyes are on the U.S. Preventive Services Task Force (USPSTF), which is poised to recommend CTC (also known as virtual colonoscopy) for payment or not, pending completion of its re-evaluation sometime this summer. For its part, the U.S. Centers for Medicare and Medicaid Services (CMS) is likely to concur with whatever USPSTF recommends, thus paving the way to national screening CTC reimbursement, said Dr. Judy Yee, from the University of California, San Francisco (UCSF), in her talk.
Dr. Judy Yee from UCSF.Characterizing CTC's multiple paths to payment, she said, "I think you'll see the status is currently better than you think it is."
For one thing, even without national coverage, some states require health payors to include CTC as a colorectal cancer screening option, and CTC is almost universally reimbursed after failed colonoscopy or in patients at elevated risk of complications after CTC. But these successes add up to less than a national coverage decision that would follow approval by USPSTF and CMS.
"USPSTF still holds the key," Yee said. Having completed the first and second steps of its re-evaluation, including identifying research targets and systematically reviewing the evidence, "we are, I think, close to step three, where a draft recommendation statement should be announced within the next few months," Yee said. "We currently have an I [incomplete] rating, and the hope is that USPSTF will reassign [CTC] to an A [excellent] or B [good] rating."
Under the Affordable Care Act, screening exams that receive at least a B rating from USPSTF must automatically be approved for nationwide screening reimbursement, as recently occurred for lung cancer screening in long-term smokers. For now, at least the state-by-state picture is bright.
"Since 2008, it's been encouraging in that Medicare and most private payors currently do reimburse [CTC after] failed colonoscopy in 47 states, and most private payors actually reimburse for CTC in patients who are at high risk for undergoing colonoscopy," said Yee, who is professor and vice chair of radiology and biomedical imaging at UCSF and chief of radiology at the San Francisco Veterans Affairs Medical Center.
Big wins, tough losses
CTC has navigated a difficult path to approval ever since its efficacy was first shown in 1994 at a meeting in Hawaii.
Major validation trials took place from 1997 to 2007, showing sensitivities in the 70% to 95% range. Following the 2008 publication of the American College of Radiology Imaging Network (ACRIN) National CT Colonography Trial, in which CTC demonstrated 92% sensitivity for clinically significant colorectal lesions, the American Cancer Society recommended it as a screening option along with colonoscopy, flexible sigmoidoscopy, the fecal occult blood test, and a barium enema.
However, in 2008, USPSTF found "inadequate evidence" to approve CTC nationally for asymptomatic payments ages 50 and older. The decision was a body blow to proponents of the exam, who had been gearing up to implement screening nationally.
USPSTF's 2008 rejection spurred a wave of studies aimed at areas the organization had identified as deficiencies. This mainly involved validating CTC in large numbers of Medicare patients; gathering evidence that the cumulative radiation would not be harmful to screening subjects, even if they underwent several rounds of exams between ages 50 and 80; and confirming that the detection of extracolonic findings would not be harmful to patients overall. At UCSF, the exams now generate about 3 mSv of radiation every five years, an amount roughly equivalent to exposure to the earth's background radiation for one year.
With all the additional studies completed, USPSTF agreed in 2014 to re-evaluate the exam, a process that is pending completion.
Hope as payors increasingly favor CTC
Apart from the USPSTF drama, several bills requiring CTC screening reimbursement have been introduced but then died in Congress since the 2008 coverage rejection. A new one is expected to be introduced this year, Yee said.
Many of the large private payors -- including Blue Cross/Blue Shield in more than a dozen states, Cigna, UniCare, United Healthcare, and Kaiser -- have all adopted policies of reimbursing for CTC screening every five years, she said.
Delaware became the first state to mandate that CTC be covered under all private payor plans operating there in 1999.
CPT codes have been issued for both diagnostic and screening CTC and the relative value units (RVUs) associated with them suggest good reimbursement levels, according to Yee.
And in September 2013, following a special meeting that included its Gastroenterology-Urology Devices Panel, the U.S. Food and Drug Administration (FDA) stated that "given the risks and benefits identified, CTC should be one option for [colorectal cancer] screening of asymptomatic patients," Yee noted.
Finally, the American College of Radiology has revised its appropriateness criteria, rating CTC a 9 out of 10, versus a 6 for a double contrast barium enema and a 4 for MR colonography.
"The ACR is ready," she said. "There is a registry that's been processed for CTC that includes three process measures and three outcomes measures."
These process measures are bowel cleansing and distention, technical adequacy of screening CTC, and technical adequacy of diagnostic CTC. Meanwhile, the three outcomes measures are perforation rate, true-positive detections 10 mm and larger, and significant extracolonic findings.
"The purpose of this registry is to ensure quality and maintenance of the low-dose technique, but also to support credentialing and eventually reimbursement," Yee said.
