— Draft non-coverage policy changed, noting the role played by an adapted comparative effectiveness report from the Agency for Healthcare Quality and Research and the New England Council public votes —

Boston, Mass., January 30, 2012 –The Medicare Administrative Contractor for most of New England, NHIC, Corp, has issued a final local coverage decision granting first-in-the-nation Medicare coverage for repetitive transcranial magnetic stimulation (rTMS) for patients with treatment-resistant depression. The new coverage policy, which takes effect in March, reverses a non-coverage draft policy posted in November 2011, and represents the first positive local Medicare coverage policy for rTMS in the nation. In describing the factors considered for this policy change, the Medicare Contractor cited numerous comments and statements received from patients and clinicians, several of which cited the comparative effective review produced by the federal Agency for Healthcare Research and Quality (AHRQ), supplementary analyses of this report prepared for the New England Comparative Effectiveness Public Advisory Council (CEPAC), and the votes taken by the CEPAC as part of its public deliberation on the evidence.  

CEPAC convened in Providence, Rhode Island in December 2011 to consider the evidence on the comparative clinical effectiveness and comparative value of a variety of nonpharmacologic interventions for patients with treatment-resistant depression. CEPAC is the central component of a project funded by AHRQ and directed by staff from the Institute for Clinical and Economic Review (ICER), a leading academic comparative effectiveness research group based at the Massachusetts General Hospital’s Institute for Technology Assessment in Boston.  

“Our goal in creating CEPAC was to improve the application of good evidence to policy decisions by regional health insurers, and to encourage the use of evidence by clinicians and patients as well,” stated Steven D. Pearson, MD, MSc, President of ICER. “We are gratified that the AHRQ report, our supplemental analyses, and CEPAC’s deliberation and voting were all noted by stakeholders engaged in the coverage process, and ultimately cited by the Medicare Contractor as influential elements in his final coverage decision for the use of rTMS in treatment-resistant depression.  Having an independent group of physicians and public representatives deliberate on these issues and render specific judgments about the evidence is an important step in reaping the benefits of comparative effectiveness research.”

The full coverage policy from the Medicare Administrative Contractor is available online. NHIC, Corp is the Medicare Administrative Contractor for Jurisdiction 14, which covers Maine, Massachusetts, New Hampshire, Rhode Island, and Vermont, serving 1.3 million Medicare beneficiaries and more than 53,000 healthcare providers.  

At its December 2011 meeting, CEPAC voted 10 to 5 that the evidence was adequate to demonstrate that for patients with treatment-resistant depression rTMS was as good, or better, than usual care (i.e. general supportive psychotherapy with or without continued use of antidepressant medication). CEPAC also voted 9 to 6 that the evidence was adequate to demonstrate equivalent or superior outcomes for rTMS compared to electroconvulsive therapy (ECT). CEPAC then reviewed evidence on the cost-effectiveness and potential budget impact of rTMS and the majority voted that, at current Medicare reimbursement rates, the use of TMS represents “reasonable value” when compared to usual care and a “low value” when compared to ECT. The final CEPAC meeting report includes supplementary analyses to augment the AHRQ review of nonpharmacologic interventions for treatment-resistant depression in adults. The report also reviews the results of all the votes taken by CEPAC on the adequacy of evidence to demonstrate the comparative clinical effectiveness and value of different approaches to treatment-resistant depression.  

About CEPAC

CEPAC is a regional body whose goal is to provide objective, independent guidance on the application of medical evidence to clinical practice and payer policy decisions across New England. Supported by a federal grant from the Agency for Healthcare Research and Quality (AHRQ), and with backing from a consortium of New England state health policy leaders, CEPAC holds public meetings to consider evidence reviews of medical tests and treatments and provide judgments regarding how the evidence can best be used across New England to improve the quality and value of health care services. CEPAC consists of practicing physicians with experience in evaluating and using evidence in the practice of healthcare, as well as patient/public members with experience in health policy, patient advocacy and public health.

ICER is managing the day-to-day operations of CEPAC as part of its federally funded RAPiD (Regional Adaptation for Payer Policy Decisions) initiative meant to develop and test new ways to adapt federal evidence reviews to improve their usefulness for patients, clinicians, and payers. Nominations are currently open for new members of CEPAC. A list of CEPAC members, information on nominations and other information about the project, is available online at cepac.icer-review.org.

About ICER

The Institute for Clinical and Economic Review (ICER), based at the Massachusetts General Hospital’s Institute for Technology Assessment (ITA) and an affiliate of Harvard Medical School, provides independent evaluation of the clinical effectiveness and comparative value of new and emerging technologies. Structured as a fully transparent organization, ICER seeks to achieve its ultimate mission of informing public policy and spurring innovation in the use of evidence to improve the value of health care for all.  For more information, please visit www.icer-review.org

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