Medicare changes, joint meetings spell progress for VC

Virtual colonoscopy providers around the world are working to optimize exam methods and ensure a reliable exam for colorectal cancer and polyps. But the money that pays for the exam is hardly global. It comes from national treasuries, in the case of industrialized countries with national healthcare systems, and from the pockets of the patients themselves in some others.

In the U.S., where ballooning deficits have left Congress queasy about maintaining current healthcare spending levels, let alone authorizing broad new programs, the coverage decisions of local Medicare providers are far likelier to drive incremental changes in reimbursement.

As a result of local coverage decisions (LCD), for example diagnostic (but not screening) CT colonography (CTC or virtual colonoscopy [VC]) is now reimbursed in most states, though the symptoms and conditions for such reimbursement indications are a mishmash of odd limitations and reasonable conditions that vary widely from region to region.

Some local carriers allow diagnostic VC only after a failed optical colonoscopy that was undertaken for diagnostic purposes in symptomatic patients, for example, while others permit VC after failed optical colonoscopy that was undertaken for either screening or diagnostic purposes. And on it goes. VC providers have taken on the task of coordinating with the conditions under which the exam may be performed.

Despite the geographically uneven coverage conditions that result, one CMS executive told AuntMinnie.com that the local coverage approach actually has some advantageous, first because it sidesteps the need to fund broad coverage decisions at once, and two, because it gives local and regional players the opportunity to work through any questionable policies before they rise to the national level.

This system also, inevitably, rewards providers with close ties to their local carriers, which is why VC advocates encourage providers to communicate with their local payors.

"To date, 46 states have passed local coverage decisions for Medicare reimbursement for specific clinical vignettes for CTC (largely CTC for incomplete colonoscopy)," wrote Dr. Elizabeth McFarland in an e-mail to AuntMinnie.com."These efforts were greatly facilitated by radiologists who worked with the chief medical directors of the carriers to promote local coverage decisions for specific indications. Local efforts make a difference, and the American College of Radiology provides an outreach network for both Medicare (Carrier Advisory Conference or CAC) and private payors (MCN)."

McFarland is an adjunct professor at the Mallinkrodt Institute of Radiology in St. Louis and a radiologist with Diagnostic Imaging Associates/CDI at St. Luke's Hospital in Chesterfield, MO.

One would be hard put to name a region with more active VC providers than the Midwest, where Dr. Perry Pickhardt and his colleagues at the University of Wisconsin Hospital and Clinics (UWHC) in Madison have succeeded in obtaining reimbursement for VC screening exams from several providers, performing thousands of reimbursed VC exams for both screening and diagnostic purposes.

As for local Medicare coverage, a new draft policy will broaden both Part A and Part B Medicare coverage for diagnostic VC. The proposed changes were worked out over the summer with officials from the local Medicare payor, Madison-based Wisconsin Physicians Service Insurance Corporation (WPS Health Insurance), but won't be finalized until their publication in October. The changes will affect patients throughout a four-state region that includes Wisconsin, Illinois, Michigan, and Minnesota, according to the VC team at UWHC.

Readers are cautioned that the pending new coverage details in this article are as yet unpublished, and could not be verified with WPS officials by press time. The current policy can be found on the company's local coverage Web site.

"Basically, we started with a fairly restrictive policy of Medicare coverage for diagnostic VC," wrote radiologist Dr. Perry Pickhardt, a professor of radiology at the University of Wisconsin who heads the VC program at UWHC. "As a result of a June 8 meeting (with WPS) we were able to significantly broaden the LCD for both Part A and Part B. In addition to relaxing the restrictions on what constitutes an incomplete diagnostic optical colonoscopy, coverage was included for patients with coagulopathies or on anticoagulation, history of optical colonoscopy complications, 'difficult colon' (e.g., extreme tortuosity), and submucosal abnormalities. Most of the ambiguity in coverage was removed."

At this point the changes can be said to apply only to Medicare Part B coverage, cautioned Holly C. Casson, RN, virtual colonoscopy program coordinator at UWHC. Casson said she is hopeful that the corresponding Part A coverage changes will conform, but has not yet received final approval for these changes in writing.

"Medicare Part A had the broader policy to begin with, so we made the most headway with Part B," Casson wrote in an e-mail to AuntMinnie.com.

Importantly, WPS dropped a two-month time limit whereby patients had to have their virtual colonoscopy exam within two months of the failed diagnostic optical colonoscopy for it to be covered on the Part B side, Casson explained. Part A did not have the two-month restriction.

"This is huge because many patients would fall just outside this two-month window," she wrote. "Now patients won't have to be put through a subsequent invasive colonoscopy that will most likely be unsuccessful again, and put themselves at increased risk for perforation if they have gone beyond two months."

Screening VC is never covered by Medicare because this is a Centers for Medicare and Medicaid Services (CMS) issue, Casson added, but UWHC was able to clarify that if a screening colonoscopy fails and a condition is found or complications are met that require the conversion to a diagnostic colonoscopy, then a VC exam is indicated.

Diagnostic VC will also be indicated as an alternative to a diagnostic conventional colonoscopy exam if the patient has a condition previously documented, usually by barium enema, that would make optical colonoscopy unsafe (for example, extreme tortuosity, abdominal adhesions).

"Diagnostic VC could also be considered following an optical colonoscopy with serious complications due to a condition that is unlikely to improve," Casson wrote.

Previously, symptomatic patients who were on anticoagulation therapy that was deemed dangerous to discontinue qualified for VC coverage. Now symptomatic patients with serious coagulopathies also qualify for diagnostic VC.

Some general diagnostic diagnosis codes were also added so the codes in the VC policy would be identical to the International Classification of Diseases (ICDs) in the diagnostic colonoscopy local coverage decision. Evaluation of submucosal abnormalities and use in preoperative cancer staging remains in the policy, and was unchanged.

"Overall, I think that the experience of meeting with the Medicare Medical Directors for our LCD was very positive and constructive," Casson wrote. "You never know what you are able to accomplish for patients until you ask. Overall, we have achieved great success with third-party reimbursement in our area.... In order to establish virtual colonoscopy as a covered screening method with CMS, it is going to take the combined efforts of several centers across the United States to show how effective this approach is."

The national scene

For the U.S. as a whole, VC reimbursement for screening purposes will require the approval of major organizations that shape public policy on the issue of colorectal health, including but not limited to the American Cancer Society (ACS), the Agency for Healthcare Research and Quality (AHRQ), the American Gastroenterological Association (AGA), and finally Congress and CMS.

Amid signs that some national organizations are warming to the idea of noninvasive colorectal cancer screening with VC, they are considered unlikely to commit to widespread VC screening pending additional data proving its efficacy from upcoming multicenter trials such as the ACRIN II trial (protocol 6664), and the SIGGAR I trial under way in the U.K.

Finally, the subject of colorectal screening in the U.S. cannot be separated from turf issues. Gastroenterologists and their representatives have been accused by radiologists of seeking to hinder widespread VC screening for economic and political reasons.

A July paper, reviewed and approved by the board of directors of the American College of Gastroenterology (ACG) and published in the American Journal of Gastroenterology, raised concerns among some VC providers who consider it unnecessarily pessimistic with regard to VC's future prospects. "ACG Colorectal Cancer Prevention Action Plan: Update on CT Colonography" by Dr. Douglas Rex and Dr. David Lieberman concluded that the many uncertainties surrounding VC's efficacy meant that they could not recommend it for routine clinical use, while promising to closely monitor future developments (AJG, July 2006, Vol. 101:7, pp. 1410-1413).

Among the many points covered in the article, the team noted that multicenter trials have had widely varying results, but held out hope for better results in the ACRIN II and SIGGAR1 trials.

"These trials will provide important information about the technical factors that result in high polyp detection rates and whether high detection rates can be achieved on a widespread basis," Rex and Lieberman wrote. "Computer-aided diagnosis might help to reduce interobservation between radiologists and improve the efficiency of reading CTC studies."

Other statements, in particular those dealing with surveillance standards and the natural history of polyps, brought disagreement from radiologists.

"The issue of management of small polyps detected by CTC is of great importance with regard to cancer outcomes and the cost of CTC as a strategy," Rex and Lieberman wrote. "The importance of referring polyps < 1 mm in size for colonoscopy and polypectomy has been debated. In essence, the natural history of polyps < 1 cm in size is poorly understood. Since it is not clear whether small polyps should be removed by polypectomy, some radiologists have decided to not report polyps ≤ 5 mm in size and to recommend CT follow-up of polyps in the 6-9 mm range by repeat CTC at one- to two-year intervals. These practices are unlikely to be cost-effective and will expose patients to colorectal cancer risk and radiation risk."

They note that the meta-analysis by Mulhall et al (Annals of Internal Medicine April 2005, Vol. 142:8, pp. 635-350) suggested that CTC detection rates are inadequate, responded the University of Wisconsin's Pickhardt. "I disagree. From the two meta-analyses to date (Mulhall et al, and Halligan et al, Radiology, December 2005, Vol. 237:3, pp. 893-904), the CTC sensitivities for both large and medium-sized polyps are clearly acceptable. Even Dr. Rex himself stated in a Gastroenterology editorial (Gastroenterology, August 2003, Vol. 125:2, pp. 608-610) that: 'A new colorectal cancer screening test does not have to outperform current screening strategies in all or even any category to be accepted....'"

The ACG article offered "a rather negative perspective of this very powerful and effective screening tool," Pickhardt wrote.

McFarland noted that the paper "outlines several issues which will be important for further CTC implementation. Improved patient compliance with current and minimal bowel preparation and low-dose radiation protocols continue to show promise in the CTC literature. Cost-effectiveness of CTC will be under scrutiny, as well as that of colonoscopy."

The key issues will be the determination of what size polyp is clinically significant and what surveillance intervals will be, McFarland continued. "Currently the C-RADS reporting system by Zalis et al (Radiology, July 2005, Vol. 236:1, pp. 3-9) promotes a standardized structure to describe location and size of colorectal polyps, categorize extracolonic findings, and recommend preliminary guidelines on surveillance."

The ACG article offered an opinion on the surveillance of small polyps, but further multidisciplinary evaluation will be performed this fall, McFarland wrote.

At the upcoming American Cancer Society meeting September 18-19 in Washington, DC, the U.S. Multisociety Task Force on Colorectal Cancer and American College of Radiology representatives will meet as part of a series of meetings to discuss the five-year update of colorectal screening guidelines. McFarland and Pickhardt will be among the six radiologists who will attend on behalf of the ACR.

Combining the ACS, Multisociety Task Force on Colorectal Cancer, and ACR together, "hopefully will be a productive means to address and provide consensus of some of these key issues affecting CTC, in perspective with the other colorectal screening tests currently offered," McFarland wrote.

By Eric Barnes
AuntMinnie.com staff writer
September 4, 2006

Related Reading

Gastroenterologist surveys target lesions, VC practice, March 20, 2006

Politics matters in the real world of virtual colonoscopy, November 5, 2003

Midwest weighs incremental Medicare gain for VC, May 26, 2005

VC gets long-awaited reporting standards, November 2, 2004

Gastroenterology warning: Prepare for VC or regret it, October 6, 2004

Copyright © 2006 AuntMinnie.com

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