Our new study, recently published online in Medical Care (“Factors Predicting Medicare National Coverage: An Empirical Analysis” (1)), highlights factors underlying Medicare decisions on medical technology.
Interventions considered to be particularly controversial or expected to significantly impact the Medicare program in the United States are considered in National Coverage Determinations (NCDs). Medicare coverage for interventions is limited to eligible items and services deemed “reasonable and necessary” for the diagnosis or treatment of an illness or injury. What constitutes reasonable and necessary has not, however, been clearly defined.
This study is the first of its kind to quantitatively evaluate the factors associated with positive NCDs.
Using the Tufts Medical Center NCD database (2), coverage decisions from 1999 to 2007 (n = 195) were evaluated using the following variables: direction of coverage decision; quality of supporting evidence; availability of alternative interventions; cost-effectiveness of intervention; type of intervention; coverage requestor; and year of decision. Univariate and multivariate logistic regression analysis was used to determine factors associated with positive coverage.
Key findings include:
• CMS favors proven interventions. Compared to interventions with clinical evidence deemed “insufficient”, interventions with good or fair quality supporting evidence were approximately six times more likely to receive a positive decision (p<0.01).
• Interventions with available alternatives are less likely to be covered. Compared with interventions with no available alternative, those for which an alternative was available were approximately eight times less likely to receive a positive decision (p<0.01).
• CMS accounts for value in coverage decisions. Compared with technologies estimated to be dominant, i.e., more effective and less costly than the competing intervention considered, those with no published estimate of cost-effectiveness were approximately five times less likely to receive a positive coverage decision (p<0.05).
• Coverage decisions have become more restrictive over time. Compared with coverage decisions made in the years 1999 to 2001, decisions made from 2002 to 2003 were more than three times less likely to be positive (p<0.05). Decisions made from 2004 to 2005 were also more than three times less likely to be positive (p<0.1), and from 2006 to 2007 decisions were almost ten times less likely to be positive (p<0.01).
This analysis can help the medical community better understand the type of evidence that Medicare considers in NCDs. CMS and other payers may also benefit from this kind of external review of coverage decisions as it can help ensure the consistency of decisions and the integrity and accountability of the coverage process.
By James D. Chambers
1. Chambers JD, Morris S, Neumann PJ, Buxton MJ. Factors Predicting Medicare National Coverage: An Empirical Analysis. Med Care. 2011 Available: here
2. Tufts Medical Center Medicare NCD Database [Database]. Boston, MA: Center for the Evaluation of Value and Risk in Health (CEVR) at Tufts Medical Center.