The development of CT lung cancer screening, the publication of results from the NLST in 2011, and the grade-B recommendation for CT lung cancer screening in high-risk smokers by the USPSTF raise a number of interesting national health policy issues.
Prevention of cancer is a major priority for healthcare stakeholders. Screening tests can prevent cancer development by detecting and treating premalignant lesions or can improve survival by making it possible to detect and treat cancer at an early stage. More people die from lung cancer in the United States than from any other type of cancer, with over 170,000 lung cancer deaths every year. The development of computed tomography lung cancer screening (CTLCS), the publication of results from the National Lung Screening Trial (NLST) in 2011, and the grade-B recommendation for CTLCS in high-risk smokers by the US Preventive Services Task Force (USPSTF) in December 2013 raise a number of interesting national health policy issues:
(1) The Affordable Care Act (ACA) mandates that commercial health insurance plans must provide preventive services rated grade A or grade B by the USPSTF without copayments, while Medicare is required (under a provision of the Social Security Act) to first determine whether those services are “reasonable and necessary.” The Centers for Medicare and Medicaid Services (CMS) will not necessarily cover preventive services rated grade A or B, potentially creating a two-tiered coverage situation under Federal law. Medicare coverage decision-making authority clearly stipulates that standards for coverage are different from and more restrictive than standards for guideline recommendations-yet the ACA equates guidelines and coverage criteria for commercial health insurance plans.
(2) The ACA mandate singles out one guideline-developing body, USPSTF, to be the sole decider of whether a preventive service guideline must be followed, despite the availability of multiple international expert guideline bodies. The potential for conflicting guidelines is not insignificant, as occurred with breast cancer screening guidelines. No mandate for healthcare coverage issues other than that for preventive services is so restrictive, strict, or arbitrary. In addition, healthcare practice guidelines are always considered by clinicians, providers, and patients as “guidance” or “advice,” but never as mandates in all circumstances.
(3) Single clinical trials, when subjected to ongoing scientific scrutiny and when examined in the context of other existing and ongoing new clinical data sources, may lead to revised conclusions. In contrast, legislative mandates may persist much longer than the evidence warrants. Furthermore, interpretations of the same evidence are not always uniform and may conflict.
In this issue of ONCOLOGY, Dr. Grannis provides one analysis of some of the ongoing debate concerning the NLST results and their application to clinical care and coverage. The author emphatically demands that “CMS must incorporate a recommendation for LCS in their Draft Coverage Determination due in November 2014.” That may well happen, but a number of misconceptions about the CMS coverage decision-making process, in this article and elsewhere, warrant clarification.
First, the CMS will comprehensively evaluate all available evidence regarding CTLCS, including not only from the NLST, but also other clinical trials, observational studies, data, and further information. The CMS evaluation is arguably more transparent and comprehensive than any other evidentiary review, including that of the USPSTF. CMS evidentiary standards place greater value on randomized controlled trials (RCTs), but they also consider evidence of lower grades. Public comment is officially solicited and responses are sent at several times during the coverage determination process. The draft National Coverage Determination (NCD) must delineate the CMS analysis and justification of its proposed decision, and any individual/organization may comment on the topic and the proposed determination. CMS makes a final determination after all information and comments have been reviewed. Speculation about what CMS may decide is sometimes incorrect, since many considerations may not be obvious to those outside CMS. Once a final decision is drafted, it must be approved by the CMS leadership. The rest of the Executive Branch and Congress have no authorized role in this process. A reconsideration process is available, whatever the final determination. The overall goal is to achieve an unbiased, evidence-based decision devoid of politics and opinion.
Second, additional advice for this determination was given to CMS via the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC); however, MEDCAC’s role is misunderstood and/or incorrectly characterized. MEDCAC serves CMS in an advisory capacity, and its advice is nonbinding. For some time, MEDCAC has been used to evaluate and advise on the quality of the evidence available to CMS that will be used in its coverage determination process; it is not specifically asked to recommend what coverage determination should be made. At the MEDCAC meeting for CTLCS, the panel expressed low-to-moderate confidence that the evidence reviewed at that meeting supported the use of CTLCS, and high confidence that the evidence was not of high quality with regard to community use outside an RCT. This was not a noncoverage recommendation, as many have interpreted it. Rather, it was a vote of no confidence in the strength of evidence for the three specific questions addressed to the panel. CMS will use MEDCAC’s findings as one element of a more comprehensive review.
Third, Medicare NCDs do not consider cost issues in making a final determination, based on the long-standing HHS General Counsel position that CMS does not have statutory authority to do so. The Medicare Improvements for Patients and Providers Act (MIPPA) of 2008, Section 101, did give CMS the authority to consider costs when making coverage determinations authorized for prevention and screening services recommended by the USPSTF, as in this situation. It is likely that CMS will include at least a discussion of the costs of providing CTLCS in its proposed NCD, possibly using cost-benefit analysis in its proposed decision. Commercial health plans cannot refuse coverage based on cost.
Fourth, as mentioned above, CMS criteria for determining whether CTLCS is reasonable and necessary as a covered Medicare service use two standards: (1) there must be evidence that the service clearly leads to improved health outcomes, and (2) there must be evidence demonstrating improved outcomes specifically in the Medicare population. CMS will be determining whether the evidence meets those two criteria and warrants payment under Medicare, not adopting guidelines. The CMS authority mandates that it not pay for services that do not meet these criteria. In contrast, the USPSTF makes recommendations regarding population health and issues clinical guidelines. In addition to assessing the two major criteria for a “reasonable and necessary” service, CMS evaluates study design, data quality, data analytics, predictive models, and conclusions from available information. Two recent published analyses came to different conclusions on all of these points, one recommending CMS coverage, the other recommending delay pending more information.
It is unclear what proposed coverage determination CMS will post by the statutory deadline of November 10, 2014. In addition to noncoverage vs complete coverage, it can also propose an alternative outcome-either coverage with limitations (eg, restricted to qualified centers) or coverage with evidence development (CED). Given all the controversy on this topic, CED offers CMS the possibility of a politically correct option: to cover CTLCS, but require it to be provided to patients in settings where specific CMS-approved ongoing data collection is performed (RCTs or other studies, registries, etc), possibly accompanied by center-specific or other limitations. Stakeholders will have an additional 30 days to comment on the proposed determination and affect the final determination, which is due by February 8, 2015.
Finally, the national health policy issues that the ACA has created, which are outlined at the beginning of this commentary, are significant and need to be addressed.
Financial Disclosure:The author has no significant financial interest in or other relationship with the manufacturer of any product or provider of any service mentioned in this article.
1. National Lung Screening Trial Research Team, Aberle DR, Adams AM, et al. Reduced lung-cancer mortality with low-dose computed tomographic screening. N Engl J Med. 2011;365:395-409.
2. Screening for Lung Cancer. Clinical summary of US Preventive Services Task Force recommendation. Release Date: December 31, 2013. Available from: http://www.uspreventiveservicestaskforce.org/uspstf13/lungcan/lungcansumm.htm. Accessed October 22, 2014.
3. CMS MEDCAC meeting details, 4/30/2014-lung cancer screening with low dose computed tomography. Available from: http://www.cms.gov/medicare-coverage-database/details/medcac-meeting-details.aspx?MEDCACId=68. Accessed October 22, 2014.
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