June 23, 2014

Politicians: Keep Out

This past week, 150 Congressmen sent a letter to the Centers for Medicare and Medicaid Services (CMS), urging that it approve reimbursement for lung cancer screening with lowdose CT scans. These legislators are trying to exercise their political muscle in an arena where they have no business intervening. Medicare has a fair, transparent, and extremely thoughtful process for deciding what tests to cover. The attempt to destroy this honest, objective, and time-tested process by injecting political pressure is reprehensible.

The Medicare program is required by statute to limit coverage to tests and services that are “reasonable and necessary” for the treatment of illness.  Most “coverage decisions” continue to be made by local intermediaries, the regional contractors that function as Medicare’s agents throughout the country. But occasionally, for particularly important decisions, Medicare issues a National Coverage Determination which is then binding on all its intermediaries.  A few months ago, CMS was asked to make a decision about paying for lung cancer screening using low-dose CT scans. It has diligently been conducting a thorough, comprehensive assessment.

What Medicare often does is to ask MEDCAC, the Medicare Evidence Development and Coverage Advisory Committee, to collect information about the procedure it is supposed to evaluate and to discuss, publicly, its evaluation of the information. MEDCAC is an independent panel of 100 people, drawn from medicine, industry, science, ethics, public health, economics, and the public, from whom up to 15 people are chosen to address any particular issue that comes up. Medicare asked MEDCAC to review low-dose CT screening and on April 30,  the committee had an all day meeting. The agenda is available on line. The evidence was presented and discussed. The committee voted—each person’s vote is public and each person was asked to explain the rationale for his vote. What the committee concluded was that the evidence supporting the use of low-dose CT scanning to screen for lung cancer in the Medicare population just wasn’t there. The transcript of the entire meeting is on line. It runs to 310 pages.

To be precise, the committee members were asked “how confident are you there is adequate evidence to determine if the benefits are greater than the harms” for Medicare enrollees. They could vote  from “1” (little confidence) to “5” (high confidence). The average vote was 2.33. But the US Preventive Services Task Force, another independent body of experts, had recently given low dose CT scanning a “B” grade, recommending that it be used in people ages 55-79 who have a 30 pack-year smoking history and are currently smoking or have quit within the last 15 years. How could MEDCAC vote no and USPSTF vote yes?

It turns out that the members of the USPSTF didn’t exactly vote yes. They suggested excluding people with “a health problem that substantially limits life expectancy or the ability or willingness to have curative lung surgery.” The reason for this caveat is that screening for lung cancer, like screening tests in general, only makes sense if early detection leads to cure or at least more effective treatment. And the only truly effective treatment for the vast majority of cases of lung cancer in smokers is surgery. Major surgery: removal of all or part of a lung. So the question for Medicare is whether doing major surgery in older people with lung cancer is a good idea. 

The single study on which the USPSTF recommendation was principally based, the National Lung Screening Trial, though it included 52,000 high risk individuals randomized to screening with low-dose CT or screening with an old fashioned chest x-ray, included relatively few people over 65 (26%), very few people over 70 (9%), and few individuals with other health conditionsSo when this study, which by the way was funded by the National Cancer Institute, part of the National Institutes of Health, reported that the death rate was 20% higher in people screened with a conventional x-ray than in those screened with low-dose CT scan (based on a reduction in the death rate from lung cancer from 309/100,000 to 247/100,000 in 6.5 years), its conclusion rested on the 79 excess lung cancer deaths (425 vs 346) in those getting regular x-rays. In other words, 320 people had to be screened to prevent one death. We do not know how many of these 79 deaths were in older people; we do not know how many of these 79 deaths were in people with other serious illnesses such as heart disease or diabetes; and we do not know, for those who survived their lung cancer, how many would go on to die of other illnesses in the near future.

It was based on this kind of analysis that MEDCAC determined there just wasn’t enough evidence to justify ordering Medicare to reimburse for the screening of high risk older individuals with low-dose CT scanning. It didn’t say low-dose CT scanning doesn’t work at all: it said we don’t have enough information about older, sicker patients. It didn’t say low dose CT scanning won’t work in older people: it said there isn’t compelling enough reason to mandate reimbursement for this test and treating such patients for lung cancer with surgery, the only treatment associated with a high cure rate, might in fact do more harm than good to such individuals.

The specific reasons that MEDCAC chose to vote no to Medicare reimbursement are not actually terribly important—though I’ve included some to give a sense of the reasons that were invoked, and all the reasons are publicly available—what is most important is that the rigorous, evidence-based process on which the decision was based be honored. Medicare has yet to issue an “NCD” (National Coverage Decision). It could still be swayed by political pressure, by lobbyists, by emotional personal stories of individuals whose lung cancers were detected by low-dose CT scanning and who believe their survival hinged on this. The 150 lawmakers who are pressuring Medicare are hoping to achieve exactly this end. If Medicare is to remain the excellent insurance program that it in many ways is, it must do what all third party insurers have to do: decide what to cover and what not to cover. And it should make that decision based on the facts, not on the ignorant screed of politicians.

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