On August 25th the Centers for Medicare and Medicaid Services (CMS) announced a national coverage determination (NCD) for counseling to prevent tobacco use (CAG-00420N). Here at CEVR we maintain the Tufts Medical Center NCD database, which includes data on various parameters on each NCD made since 1999. The decision memo for CAG-00420N was reviewed for inclusion in this database.
This coverage decision is particularly interesting as it includes the review of a cost-utility study.
The recent health care reform legislation appeared to be a hammer blow to the use of quality adjusted life years (QALYs) for decision making. Text from the Patient Protection and Affordable Care Act (ACA) is as follows:
“…the Patient Centered Outcomes Research Institute … shall not develop or employ a dollars per quality adjusted life year (or similar measure that discounts the value of a life because of an individual’s disability) as a threshold to establish what type of health care is cost-effective or recommended. The Secretary shall not utilize such an adjusted life year (or such a similar measure) as a threshold to determine coverage, reimbursement, or incentive programs under title XVIII...”
This has been interpreted by many as a signal that the QALY, and maybe even the use of cost-effectiveness analysis, in general, has little future in US health care decision making. However, the NCD for counseling to prevent tobacco use included the review of Solberg et al 2006, a cost-utility study evaluating this intervention. With respect to this study the following was stated in the decision memo:
“Solberg, et al.’s (2006) detailed study of the health impact and cost effectiveness of cessation counseling – part of the evidence base for the U.S. DHHS PHS 2008 Guideline recommendation (Strength of Evidence = A) for cost effectiveness of tobacco dependence interventions, including counseling – further concluded that repeated clinical tobacco-cessation counseling was one of the most cost-effective preventive services that can be provided in medical practice.”
An additional clarification was provided by CMS in a footnote:
“Although Solberg, et al’s. (2006) evaluation regarding the cost-effectiveness of cessation counseling used quality-adjusted life years (QALYs), CMS does not have and is not establishing in this decision memorandum a coverage threshold for QALYs.”
The fact that a cost-utility study was featured in CMS’s deliberations suggests that QALYs may indeed have a future in the US, at least in CMS coverage decisions for preventative services. The language used above, however, seems to confirm that such evidence will not be used in conjunction with a cost-per-QALY threshold. We continue to follow future developments with interest.
By James D. Chambers