GOVERNMENTMedicare coverage decision methods unveiledCMS sets out a more collaborative approach to approving new products and services.By Markian Hawryluk, amednews staff. Oct. 13, 2003. Washington -- Citing lessons learned over the last three years, Medicare is trying to shine a little more light on its coverage decision-making process. The agency was widely accused earlier this year of dragging its feet in bringing the latest medical technology to Medicare beneficiaries. The changes announced last month by the Centers for Medicare & Medicaid Services offer the chance for public comment on coverage determinations and attempt to speed decisions by setting time frames. CMS Administrator Tom Scully said the moves should make the determination process more efficient and ensure that the agency has the relevant information at its disposal. "Our goal is to make the latest advances in medical care available to Medicare beneficiaries more rapidly, while making evidence-based decisions that safeguard the health and safety of patients," Scully said. The CMS notice laid out multiple tracks for making national coverage determinations. Under the standard, collaborative process, the agency will strive to implement a coverage decision within 270 days. Beneficiaries in need of a product or service can request an expedited review that would be completed in 90 days. But that streamlined review will limit input from other parties in order to stay within the specified time frame. The agency will create an online tracking system to allow interested individuals to check what coverage requests are under consideration and where they stand. Interested parties can comment on coverage decisions, and the agency will respond to their comments. CMS also will post documents on its Web site that describe its approach to analyzing clinical and scientific data in developing coverage decisions. "These documents will make our coverage process more open and offer the public a better understanding into our NCD process," CMS stated in the regulation. Critics have complained that CMS has provided little feedback on how it reaches its decisions and what kind of information will support a coverage determination. In a highly controversial decision about implantable defibrillators earlier this year, this behind-closed-doors approach led many to speculate that the agency was shying away from a national coverage decision because of cost implications. The agency ultimately approved the defibrillators for certain patients, although not the entire group identified by a clinical study as potentially benefiting from the device. CMS officials said the decision was not made on the basis of cost but that the potential for substantially increasing Medicare spending prompted the agency to examine the clinical data much more carefully. Manufacturers welcomed the latest announcement, saying it builds on steps the agency has taken in recent years to improve the process. "AdvaMed members are encouraged that the agency continues to open up its process and be more clear in the process steps that companies must take," said AdvaMed Executive Vice President Carol Kelly. "We remain concerned about the length of the process for certain products. We also believe that coding and payment decisions should be made more expeditiously." Although CMS sets time frames for decisions, manufacturers say the agency can still turn the clock on and off, such as when it requests additional data. Approval times have ranged from 15 months to five years, AdvaMed said. ADDITIONAL INFORMATION:Making tracksThe Centers for Medicare & Medicaid Services established three tracks to Medicare national coverage decisions. Request by any party - Collaborative approach that allows physicians, manufacturers and patients to ask for a coverage determination. Implementation deadline is 270 days. Request by an aggrieved party - A streamlined approach that allows for a quick decision. Implementation deadline is 90 days. Request by an internal party - A determination initiated by CMS in the interest of Medicare beneficiaries. Implementation deadline is 270 days. Copyright 2003 American Medical Association. All rights reserved.
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