CMS rejects Medicare coverage for virtual colonoscopy

In the past I have blogged about virtual colonoscopy and concern over how in the future this may diminish the number of colon biopsies done to be reviewed.  Others have argued this might actually increase the number of colonoscopies performed and subsequent biopsies, citing a number of reasons, including more people getting at least virtual colonoscopy when age appropriate rather than putting off the more invasive procedure or not getting one at all.  Yesterday CMS rejected the latest proposal to pay for this sevice claiming it wasn't ready for "prime time", as the radiology community has felt. 

So, for the time being it looks like this is not an immediate threat to GI pathologists (if you believe as I do), although I can see the arguments for reimbursement and how this technology may cost costs and save lives. Gastroenterologists are safe from the CT scan as well for now.

As the digital pathology community advances the technology, garners FDA clearances for clinical use and promotes reimbursement for these services, I wonder how CMS will address the issue. 

CPT codes are in place for image assisted IHC interpretation, providing a driver to use the technology with appropriate validation perhaps but will scanned archives, image-linked or enhanced reports, image repositories for data mining or content based image retrieval or enterprise wide PACS image uploads be"compensated".  I think there will be some opportunities to have these services paid for to pathologists and laboratories but will require a tremendous amount of validation of the technologies and will not likely occur for many years to come, particularly if virtual colonoscopy is any indicator.

The U.S. Centers for Medicare and Medicaid Services (CMS) today rejected a proposal to pay for virtual colonoscopy (also known as CT colonography or CTC) for routine colon cancer screening of Medicare patients in the U.S., saying that VC, while promising for detecting colorectal polyps and cancer, is "not yet ready for widespread screening use."

"The evidence is inadequate to conclude that CT colonography is an appropriate colorectal cancer screening test under §1861(pp)(1) of the Social Security Act. CT colonography for colorectal cancer screening remains noncovered," the May 12 memo states.

The decision comes as a blow to advocates of CTC, who held out hope that the agency would reverse its proposed February 11 decision to deny reimbursement for screening CTC based on the body of evidence presented to it since the analysis of CTC as a screening tool began last year.

Advocates for virtual colonoscopy were quick to criticize the decision.

"The news is obviously disappointing, but not unexpected, given the inseparable politics and purse strings involved," said Dr. Perry Pickhardt, associate professor of radiology at the University of Wisconsin in Madison. "In the end, CTC will ultimately prevail as a highly effective screening test — it's simply too good to hold down for much longer."

Dr. James Thrall, chair of the American College of Radiology Board of Chancellors, was even more emphatic.

“Make no mistake: If it stands, this CMS decision not to pay for CT colonography will cost lives. More than 140,000 Americans are diagnosed with colorectal cancer each year. Nearly 50,000 of them die due to late detection. How can CMS ignore the fact that people are dying because they do not want to have the tests that are currently covered?” Thrall said in a statement to the American College of Radiology.

“For CMS to turn its back to a technology that can attract more patients to be screened and save countless lives is deeply concerning," he continued. "CMS should reverse this determination immediately, or Congress should step in and vote to mandate coverage of CTC."

"The decision is understandable in these tough economic times," said Dr. Judy Yee, professor and vice chair of radiology and biomedical imaging at the University of California, San Francisco. "The decision is unacceptable when considering the large body of scientific evidence clearly documenting that CTC has been proven to be as effective as colonoscopy for the detection of clinically significant polyps in adults."

While CMS states that the evidence is insufficient to conclude that CTC improves health outcomes, "the same can be stated for other colorectal cancer screening tests that are currently covered by CMS," Yee told AuntMinnie.com in an e-mail. "We know that colorectal cancer is preventable. We know that a very large percentage of the American public remains unscreened for colorectal cancer. A positive decision from CMS could have helped to change this."

Dr. Abraham Dachman, professor and chair of radiology at the University of Chicago, told AuntMinnie.com that VC utilization is inseparable from efforts to cut healthcare costs.

"CTC experts strongly believe that current data support use of screening CTC in the Medicare aged population as do a large bipartisan group of members of Congress who signed a letter urging CMS to approve coverage of CTC for screening," Dachman wrote in an e-mail. "Even as the nation discusses ways to reign in the cost of healthcare, CTC screening makes sense. Use of CTC for colorectal cancer screening is consistent with President Obama's push for prevention and use of new technology to benefit patients. The public and the medical community at large should work to get this decision reversed."

Radiologists should work to publish data focused on individuals ages 65 and older, he said, and third-party payors should encourage CTC use as radiologists continue to attend courses to ensure that CTC providers continue to offer high-quality services.

"The public and the medical community at large should work to get this decision reversed," Dachman wrote. … I am confident that CTC will eventually achieve full reimbursement status."

Urgency of screening

Colorectal cancer is the third most commonly diagnosed cancer and the second most common cause of cancer deaths in the U.S. The U.S. Centers for Disease Control and Prevention (CDC) estimates that as many as 60% of deaths caused by colorectal cancer could be prevented if all Americans older than 50 years of age underwent regular screening.

The issue is particularly critical for older patients. Of the approximately 75 million Americans older than 50 who are eligible for colorectal cancer screening, fewer than 50% present for screening due to myriad factors that include, for some, a fear of invasive examination with a colonoscope, which virtual colonoscopy avoids.

Yet patient surveys also suggest that it is the purgative bowel preparation, generally required for virtual colonoscopy and always needed for conventional optical colonoscopy, that patients most dislike about colorectal cancer screening.

Some adults eligible for screening refuse to be examined with optical colonoscopy or cannot undergo the procedure due to contraindications. Virtual colonoscopy advocates believe that Medicare access to VC would improve screening compliance and reduce the death toll from colorectal cancer. Because 90% of colon cancers are diagnosed in people older than 50, they note, colorectal cancer screening is critical for Medicare recipients, who are denied the noninvasive screening option as a result of today's decision.

Private insurance more promising

Although national Medicare coverage may be off the table for now, VC has fared better among private payors. Twenty-six states already mandate that patients with private healthcare coverage are ensured access to virtual colonoscopy. Many regions also cover virtual colonoscopy exams under Medicare local coverage decisions.

Based on early results of the multicenter ACRIN 6664 trial that found equivalent sensitivities for virtual and optical colonoscopy exams, the American Cancer Society (ACS) added CTC to its five-year colon screening guidelines in March 2008.

Other ACS-approved screening exams include optical colonoscopy (every 10 years), flexible sigmoidoscopy (every five years), double contrast barium enema (every five years), annual guaiac fecal occult blood testing (gFOBT), annual fecal immunochemical testing (FIT), and stool DNA testing.

Of these, only virtual colonoscopy remains ineligible for Medicare reimbursement following today's decision. In addition to many physicians and public health advocates, Medicare coverage for CTC is supported by the American College of Radiology, the American Gastroenterological Association, and the U.S. Multisociety Task Force on Colorectal Cancer.

Detractors argue that the evidence remains insufficient to recommend VC screening as a cost-effective alternative to colonoscopy.

In March, the U.S. House of Representatives passed Congressional Resolution 60, calling for increased support for colorectal cancer screening for Americans ages 50 and older. Forty-two representatives also signed a letter to CMS expressing their concerns with CMS' proposed denial of coverage for routine screening with CTC.

The lobbying group CTC Coalition, which includes the Colon Cancer Alliance, the American College of Radiology, and the Medical Imaging and Technology Alliance, argued that Medicare coverage for VC screening would break down barriers to screening for the populations most at risk of the disease.

Observers of all persuasions have complained that a protracted tug-of-war between radiology and gastroenterology interests is more about who will make a living from colorectal cancer screening than the adequacy of CTC. For now, at least, the gastroenterology interests appear to have the upper hand.

Related Reading

Pressure builds on CMS to pay for VC, April 2, 2009

CMS rejects case for virtual colonoscopy reimbursement, February 12, 2009

MedCAC panel members question VC's effectiveness, November 25, 2008

CMS announces VC evidence meeting, September 26, 2008