Medicare Is Scrutinizing Evidence More Tightly For National Coverage Determinations

Abstract

We examined Medicare national coverage determinations for medical interventions to determine whether or not they have become more restrictive over time. National coverage determinations address whether particular big-ticket medical items, services, treatment procedures, and technologies can be paid for under Medicare. We found that after we adjusted for the strength of evidence and other factors known to influence the determinations of the Centers for Medicare and Medicaid Services (CMS), the evidentiary bar for coverage has risen. More recent coverage determinations (from mid-March 2008 through August 2012) were twenty times less likely to be positive than earlier coverage determinations (from February 1999 through January 2002). Furthermore, coverage during the study period was increasingly and positively associated both with the degree of consistency of favorable findings in the CMS reviewed clinical evidence and with recommendations made in clinical guidelines. Coverage policy is an important payer tool for promoting the appropriate use of medical interventions, but CMS's rising evidence standards also raise questions about patients' access to new technologies and about hurdles for the pharmaceutical and device industries as they attempt to bring innovations to the market.

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“…In 2000, the CMS noted that their decisions on service coverage would take into account the quality of the studies used as evidence and their relevance to Medicare patients. Following this change, approvals of new services decreased considerably; no doubt the delay in approving coverage for CT colonography was affected by this policy shift (13,14). As I have noted in the past, in our journal we predominantly see small, singlecenter exploratory type studies.…”

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“…In keeping with CMS's stated new emphasis on quality of evidence, the most important factor that affects the more recent coverage decisions was the number of clinical trials with consistent results. Without such consistency, statements from highly respected organizations-even from large numbers of them-generally had little effect (15). This represents a substantial change to have received any low-value services varied dramatically, from 25% to 42%, while the costs of the low-value services as a percentage of Medicare spending for the study cohort varied from 0.6% to 2.7% (9).…”

“…However, in 2000, the CMS, which administers the program, specified that to meet these criteria, services would have to lead to better health outcomes, not just be safe and effective. CMS also spelled out for the first time that their decisions would take into account the quality of the studies used as evidence and their relevance to Medicare patients (15). (They frequently do this through the advice of the Medicare Evidence Development & Coverage Advisory Commission [16].)…”

“…(They frequently do this through the advice of the Medicare Evidence Development & Coverage Advisory Commission [16].) After these policy changes, approvals of new services dropped off dramatically: National coverage determinations were 20 times less likely to be favorable in the period from mid-March 2008 to August 2012 than in the period from February 1999 to January 2002, according to a rigorous analysis (15).…”

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“…Even countries that do not explicitly use CEA may do so implicitly because relatively fixed budgets can lead to rough cost comparisons across treatments. For example, U.S. Medicare does not explicitly use CEA, but Chambers et al () find that a treatment's coverage chances are positively related to whether it has a cost‐effectiveness estimate. They also show that the probability of a positive Medicare coverage decision has declined since the early 2000s, about the time when HTA and CEA started growing strongly (see our Figure ).…”