In May 2009, following a year-long National Coverage Determination process, Medicare decided that it would not extend coverage to CT colonography, also known as virtual colonoscopy, for colorectal cancer screening. Advocates of CTC seem to have been shocked by the decision. CTC is non-invasive; it does not have the procedural risks associated with optical colonoscopy; it is thought to be more acceptable to patients; and it seems about as good as OC at identifying polyps of moderate or larger size — the ones that standard protocols recommend be removed and tested. Furthermore, the American Cancer Society had already recommended that CTC be considered as a primary screening modality and several large private insurers had already provided coverage for it.
The story, documented in detail in Medicare’s decision memorandum, is of course a bit more complicated. While CTC eliminates risks associated with the colonoscopy procedure, it entails some radiation exposure risk. There was no empirical evidence that CTC, which requires the same unpleasant pre-procedure bowel preparation as OC, is actually more acceptable to patients — particularly to older patients. When CTC identifies polyps for removal and biopsy, an OC is required to accomplish the removal, exposing patients to two preparations and the OC procedural risks. Most importantly, however, the available clinical evidence on CTC as a screening modality was deemed inadequate to allow either effectiveness or cost-effectiveness conclusions directly applicable to Medicare’s age 65-and-up beneficiary population.
The battle to secure Medicare coverage for CTC screening is not over. As reported by Auntminnie.com (don’t ask, I have no idea) Oct. 26, advocates are working hard to reverse Medicare’s denial of coverage: A new push for Congressional legislation (to include CTC as a modality under the colon cancer screening provisions of the Social Security Act; a lobbying effort to convince the secretary of the U.S. Dept. of Health & Human Services to override the CMS non-coverage determination; a state-by-state push to require private insurers to cover screenings consistent with ACA guidelines, which include CTC; and "myriad research initiatives to respond to research shortcomings identified by CMS and other U.S. agencies."
Along with the lobbying and research activity, the rhetoric from CTC advocates is heating up. We may be entering the silly season. The program chair for last week’s CTC Symposium in Boston announced that, "The big news this year is that CTC has now clearly moved from the realm of medicine and science to the realm of politics." Referencing that President Obama had opted for CTC over OC to avoid conscious sedation and the need for a temporary transfer of executive power to Vice President Biden, he proclaimed, "On that day everything changed, because what the CMS folks took away last year, Obama gave us back this year: namely, credibility, and maybe more importantly an obligation — as in, if it’s good enough for him, it’s good enough for all of us." If the President had opted for a test or treatment that is not yet generally accepted, or if the rest of us had the same legitimate reason for avoiding conscious sedation, there might be political leverage in this story. But Medicare already acknowledges that the data are good to support CTC for patients of Obama’s age, and his choice of CTC adds nothing to the debate.
A September editorial in the Journal of the American College of Radiology opined that CMS is using the request for data specific to the 65-and-up age cohort as an excuse to deny CTC reimbursement, presumably because of budgetary pressures. Of course, CTC advocates also argue that CTC is no more expensive than OC, even when considering the cost of followup procedures to remove polpys; if that is true, denial of CTC coverage provides no program financial benefit. The editorialst, Dr. Bibb Allen Jr., also speculates on the "widespread outrage" Medicare beneficiaries would feel when they "suddenly found that a covered service at age 64 was unavailable at 65." Dr. Allen notes that stand-alone clinical trials are difficult for the 65-plus cohort because the U.S. Preventive Services Task Force (USPSTF) recommends that colorectal cancer screening be curtailed at age 75 — leaving only a 10-year age range for the Medicare population. And while this argument has some limited merit, his appeal to USPSTF recommendations conveniently ignores that organization’s unwillingness to support CTC as a screening modality for seniors: The task force shares Medicare’s reservations about the applicability of available clinical data to patients older than 65.
Nor is Dr. Allen a careful decision analyst. He argues that "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." Well, no. CMS took the position that the study results couldn’t be extended to the target Medicare population because there was no systematic and statistically valid extrapolation of the data relevant to that population — hardly an unprecedented position. Almost every detailed CMS coverage memorandum contains a separate section evaluating the applicability of available clinical data to the program’s beneficiary population. "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 writes. Well, no. Age as a basis for coverage has been long established in Program rules and guidance, and any group seeking to structure a clinical trial or marshal a Medicare coverage argument has no excuse for not knowing that and planning for it.
Here is the simple truth. Had CTC developers met with CMS early on to discuss their clinical plans and learn about the Agency’s expectations for coverage-related clinical data, and if they had structured their clinical trials to assure a representative cohort of subjects of Medicare age, they would likely have their Medicare screening coverage today. They didn’t do their homework, and they have been playing an expensive game of catch-up ever since. But rather than acknowledge their past failings, they are impugning regulators’ motives — a sure way of securing a more sympathetic hearing the next time around? — and celebrating their newly politicized initiatives. Good luck.
Edward Berger is a senior healthcare executive with more than 25 years of experience in medical device reimbursement analysis, planning and advocacy. He’s the founder of Larchmont Strategic Advisors and the vice president of the Medical Development Group. Check him out at Larchmont Strategic Advisors.
