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Medicare requiring stronger outcomes evidence before agreeing to pay for new technology


Trend has implication for physicians, patients, and drug and device manufacturers

BOSTON – A new analysis shows that the Centers for Medicare and Medicaid Services (CMS) has been citing lack of evidence of improved health outcomes in its decisions about whether to provide coverage for new technology. Researchers from Tufts Medical Center and the Center for Medical Technology Policy (CMTP) discuss this trend in a perspective published in the New England Journal of Medicine this week.

The Tufts Medical Center-CMTP analysis shows that CMS has in fact followed the guidelines it issued for Medicare national coverage determinations (NCDs) in 2000. The data examined by the researchers suggest that the burden of proof of benefit is shifting, with the agency now beginning its assessments with the presumption that a technology will not be covered without strong evidence of outcomes for its relevant population. Medicare issues roughly 10-15 NCDs a year for technologies projected to have a major impact on care or for which an existing national policy requires updating.  The agency is increasingly citing the importance of clinical trials reporting outcomes that are meaningful to patients, in the memos it issues explaining its decisions.

“In our view, this is a positive and overdue step, but one whose rationale and likely consequences must be better understood by the medical community,” stated the co-authors, Peter Neumann of Tufts Medical Center and Sean Tunis of the Center for Medical Technology Policy.  “Expansions of access to health insurance under the health care reform legislation pending in Congress will almost certainly intensify the emphasis on more relevant and robust evidence.”

These changes have important implications for the medical community and the public.  Some physicians and other stakeholders may view these stricter evidentiary requirements as impeding access to new technology, or as part of a cost containment agenda.  Neumann and Tunis, however, argue that the changes are appropriate and necessary.  They write that both physicians and patients benefit from knowing which technologies are most likely to improve health.  By relying on outcomes data in deciding what services to cover, the agency is also ensuring that public dollars are spent wisely on services providing known benefits. By directing payment to technologies that demonstrate evidence of outcomes improvement, CMS will help provide incentives for research that collects and reports more relevant outcomes data, and that reflects the risks and benefits of services in a broad range of typical patients.  Increased federal funding for comparative effectiveness research should help support the production of this type of information.


About Tufts Medical Center and Floating Hospital for Children

Tufts Medical Center is an exceptional, not-for-profit, 415-bed academic medical center that is home to both a full-service hospital for adults and Floating Hospital for Children. Conveniently located in downtown Boston, the Medical Center is the principal teaching hospital for Tufts University School of Medicine. Floating Hospital for Children is the full-service children's hospital of Tufts Medical Center and the principal pediatric teaching hospital of Tufts University School of Medicine. Tufts Medical Center is affiliated with the New England Quality Care Alliance, a network of more than 1,800 physicians throughout Eastern Massachusetts. For more information, please visit

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