JACR editorial: Medicare used double standard in VC decision

Sep 21, 2009

A new editorial questions whether the U.S. Centers for Medicare and Medicaid Services (CMS) really needs new age-specific clinical trials before approving reimbursement for virtual colonoscopy screening -- or whether the agency is merely using the new stance as an excuse to deny VC reimbursement.

Authors of CMS' May 12 coverage denial had applauded the agency's apparent new direction in an earlier opinion piece. But in a new editorial in the Journal of the American College of Radiology, Dr. Bibb Allen Jr. criticizes CMS' new age-specific orientation and ponders what might happen if Medicare beneficiaries suddenly found that a covered service at age 64 was unavailable at 65. The most likely result would be widespread outrage, he suggests in the piece (JACR, September 2009, Vol. 6:9, pp. 606-608).

Less than two weeks after CMS published its decision denying coverage for virtual colonoscopy (also known as CT colonography or CTC), an editorial in the New England Journal of Medicine by CMS medical officers lauded the agency's "landmark decision" to deny coverage as an "unprecedented endorsement of evidence-based medicine" -- while dismissing those who disagreed with the denial of coverage as "radiologist groups" applying "now familiar" political pressure, wrote Allen, a radiologist at Trinity Medical Center in Birmingham, AL.

The pivotal concern underlying CMS denial, Allen wrote of the NEJM article, was that data from the large multicenter trials showing a benefit from CTC had focused on individuals younger than the average Medicare recipient -- and, as a result, new data on older individuals would be needed before the decision could be revisited.

If the prevalence of clinically significant polyps was too high for older individuals, CMS' thinking went, the referral to colonoscopy would be too high, and VC's utility would be limited due to the risk and cost of duplicative tests. The "generalizability" of recent trial data is "often a matter of judgment," the CMS authors' NEJM piece added.

Allen countered that in the past, "CMS has inferred applicability to the Medicare population for many new technologies and treatments. Clinical evidence for recent lifesaving technological innovations for cardiovascular disease has been generalized to the Medicare population despite age discrepancies in the cohorts of clinical trials," in which the mean participant age of 60 years was younger than the Medicare population, he wrote.

The U.S. Preventive Services Task Force (USPSTF) recommends that colorectal cancer screening be curtailed at age 75 -- leaving a 10-year age range for the Medicare population, Allen noted. He added that it is unreasonable to suggest that clinical trials should be tailored for that narrow age range, "and equally disappointing that CMS cannot infer applicability" from the existing data.

In addition, University of Wisconsin researchers evaluated a Medicare-aged subset of 577 individuals from a total of 5,243 who were screened. The patients in this subset, with an average age of 69.2 years, were referred to colonoscopy at a rate of 14.5%, "meaning that 85% of Medicare patients would not have required follow-up optical colonoscopy," Allen wrote.

For its part, the Reston, VA-based American College of Radiology (ACR) has called for additional research in the screening of older individuals, calling on the U.S. Congress to approve "coverage with evidence development" to pay for VC screening, while collecting additional information in data registries and trials to provide the data CMS may suggest it needs most.

But owing to the vast difference of opinion between the CMS panel and organizations that support VC coverage, even collecting information on the subset of older individuals won't allow coverage without "another tedious coverage determination process," Allen wrote.

In its decision, "CMS has taken the unprecedented step of concluding that studies containing significant cohorts of Medicare beneficiaries are not applicable to the target Medicare population because the mean ages of the study participants are below the average Medicare beneficiary," according to Allen.

But CMS' reasons for requiring separate trials aren't clear. "Perhaps CMS is using the lack of Medicare-specific studies as a convenient reason for not covering CTC for screening," he wrote. "Given the current pressure to reduce Medicare spending, this is certainly a plausible if not likely consideration."

Meanwhile, the authors of the NEJM editorial, two of whom participated in the CMS decision, applauded the "landmark" CMS denial as if they were "disinterested observers" and went on to suggest that previous Medicare decisions be subjected to the same scrutiny, without acknowledging that "many reputable researchers do not share their opinion" regarding CTC's benefits, Allen wrote.

Other technology assessment groups, for example the Blue Cross/Blue Shield Technology Evaluation Center, have concluded that the evidence supports CTC screening, another fact left unacknowledged by the NEJM authors, according to Allen.

Though the real reasons for the CMS panel may never be known, he concluded, it is "the overall health of the individual patient, not the chronological age, [that] should determine which forms of treatment would be best."

"For CMS to embark on a strategy of using age as a basis for coverage has the potential to become a slippery slope as we embark on healthcare reform," Allen wrote.

By Eric Barnes
AuntMinnie.com staff writer
September 22, 2009

CTC advocates urge CMS to scrap decision, May 14, 2009

CMS rejects Medicare coverage for virtual colonoscopy, May 12, 2009

VC/AAA screening combo cost-effective in older adults, March 26, 2009

American Cancer Society recognizes virtual colonoscopy screening benefit, March 5, 2008