The Centers for Medicare & Medicaid Services (CMS; Baltimore, Maryland) last month reported that it will create a new group, titled the Council on Technology and Innovation (CTI), replacing its Medicare Technology Council (MTC). Why the need for a new and revised technology council for CMS? Answer: CTI formation was mandated by the Medicare Modernization Act of 2003 and is an attempt to move new technologies through the coverage process, if not more quickly, at least more openly, according to Sean Tunis, MD, co-chair of the council and director of the Office of Clinical Standards and Quality for CMS.

"We are going to try to work more on the transparency – the visibility – of the issues that are being dealt with by the CDI, so people have more of an idea of what is going on and what is being accomplished," Tunis told The BBI Newsletter. More than anything else, he said, the ultimate mission of CTI is to minimize the barriers to important and effective new technologies so that Medicare beneficiaries have better access. This may not meet the expectation of the device industry which has been clamoring for speedier coverage decisions, he acknowledged.

"We don't look at the mission of the organization as to maximize speed to market of all technologies, and I think that there is a slight difference in view as to whose benefit the CTI was established for," Tunis said. "The CTI was established to benefit the Medicare beneficiary population, not established for the more narrow purpose for promoting the medical device and pharmaceutical industries. Our ultimate stakeholders are the beneficiaries and simply putting new medical devices into the marketplace isn't the goal of the CTI." Something CMS didn't do with the MTC, but will do with the CTI, he said, "is use regular open-door forums as an opportunity to have an exchange about what we're doing and what is going on at CTI meetings. People will have the opportunity to ask questions and make comments."

Tunis said that while the MTC didn't get credit for "doing a lot of stuff," it actually did accomplish a good deal behind the scenes. "We – the MTC – stayed too quiet about what we were doing, and we never got around to engaging outside folks in those discussions," he said. "It really functioned more as an internal coordination body. It got results, but the results weren't particularly visible to everybody." He said that making processes more transparent has been a "cross-cutting theme" at CMS recently.

Going forward, Tunis said, there would be many more opportunities for stakeholders to react to and provide input on new policy development. In that spirit, he said that one of the overriding goals of the CTI would be to "be more explicit" about the kinds of issues it deals with and what the outcomes are. "We are planning to have our first open-door meeting sometime in early October to listen to stakeholders' specific suggestions about what they'd like to see the CTI work on in terms of its portfolio of activities, in addition to the kind of processes people would find helpful in terms of making the process more interactive." He described the "core activity" of the council as an opportunity to do case-specific problem-solving in areas with a coverage, coding or payment component.

CMS Administrator Mark McClellan said the council would work to anticipate new technologies and create ways to make their transition to Medicare coverage "predictable and fast," in addition to providing doctors and patients with better information about benefits and treatment options. The council will be organized into two working groups.

The first, on "Effective Innovation," will develop ways to improve the efficiency and timeliness of the coverage, coding and payment processes. The group also will examine ways the agency can better accommodate new technologies to ensure the overall process is as orderly and timely as possible. CTI will oversee work CMS has already begun to develop the capacity for what the agency calls "horizon scanning" in order to identify high-value technologies and services that may benefit from earlier awareness.

The second working group, on "Better Evidence," will help identify priorities for Medicare-supported clinical research on treatments for which important questions about their effectiveness or cost persist and where additional or better information to answer these questions could help guide more effective decision making by doctors and patients, CMS said. The council will help identify and develop study methods for gathering reliable evidence about the risks and benefits of new and existing medical technologies that can be carried out more easily on a regular basis, such as simple protocols, registries and other study methods.

"For a good long time," Tunis said, "we have been of the view that one of the major barriers to the rapid dissemination of effective technology is information about the clinical utility and effectiveness of new technologies. So we decided that it also belongs in CTI's portfolio in order to be more proactive in using CMS' existing authorities to try and stimulate better-quality research and more evidence." He said that while there has been "some concern" from people who see the focus on evidence as incompatible with quicker decision-making, he believes that the "most potent thing" CMS can do in terms of enhancing beneficiaries' access to new technology is to "identify systematic ways to improve the ability of creating better evidence."

Tunis said CTI also is being established as an "umbrella group for a lot of activities beyond coverage, coding and payment coordination, so a lot of policy initiatives that are priorities for Dr. McClellan are being overseen and managed by the CTI," including development of guidance documents. Because CMS considers improving interaction with patient advocacy organizations a way of improving the process around technology and innovation, that also was included in CTI's portfolio of activities. Tunis said the agency would deploy some additional staff to support the CTI, in comparison to the MTC, which never had any dedicated full-time staff. Along with Tunis, Herb Kuhn, director of CMS's Center for Medicare Management, will serve as executive coordinator and co-chair for the council.

Clinicians offer power wheelchair input

Several occupational and physical therapists, drawn from around the country, last month reported that they have formed a task force designed to provide their input on the current debate surrounding the rules for governmental reimbursement for power wheelchairs. The Clinician Task Force, formed as part of the Coalition to Modernize Medical Coverage of Mobility Products (Washington), is working on what it says will be more useful and relevant guidelines, which it will provide as input to CMS to help the agency better define the pool of individuals who legitimately need the powered vehicles. The effort comes in the wake of CMS's "Operation Wheeler Dealer" program geared up to curb the activities of what it termed unscrupulous providers of power wheelchairs and other mobility products.

Barbara Crane, a Connecticut physical therapist in private practice, told BBI the group's primary purpose is to develop a "clinical definition of need that makes sense, [based on] what we see in day-to-day practice. There are 30 of us, all specializing in wheelchairs, and we work in many practice settings so that we really see and capture what the best practice is." She said that "some of the coverage guidelines have been open to interpretation as to exactly what some of the terms mean. They've adopted a very conservative interpretation of some of these and started locking out people from obtaining appropriate devices." A key effort by the task force, Crane said, would be to develop a clinically based definition of "functional ambulation." That, she said, would be largely based on "what's involved in a wheelchair evaluation. We'll come up with a document that would walk [Medicare] through all the components of an evaluation."

Henry Claypool, co-director of Advancing Independence: Modernizing Medicare and Medicaid (Washington) and former senior advisor for disability policy to the administrator of the Health Care Financing Administration (predecessor to CMS), said a key matter of concern is CMS's criteria that a patient must be "bed- or chair-confined" to obtain Medicare coverage for mobility equipment. He told BBI that Medicare has taken a different stance than previously given on its interpretations of key definitions, adding that the approach is "outmoded and overdue for updating." Claypool also offered the opinion that Medicare needs to do a better job of determining the number of those who either need or don't need the power systems, via its Medicare Current Beneficiary Survey.

He said that CMS's guidance on the issue is expected in November, or no later than before year's end and that guidance "should help us understand how many people are out there who are not getting their needs met, or will be served by their clarification. This is something that is the responsibility of the federal government and not those on the outside to guess how many beneficiaries need these devices." He noted that while CMS often looks askance at outside groups offering their opinions, the new task force of physical therapists ought to be seen as providing an objective view of the issue. "They are interested in trying to give sound advice, based on their clinical experience. That's what's called for."

DoJ probing medical supply arrangements

BD (Becton Dickinson & Co.; Franklin Lakes, New Jersey) late last month reported accusations by a whistle-blower, charging the company with defrauding the U.S. government, and it said that the U.S. Department of Justice (DoJ) is reviewing the possibility of joining in the whistleblower action. BD also disclosed that federal prosecutors have ordered it to turn over documents on dealings with an unnamed company. But it said that no action has been filed against it.

The request for documents is part of what is being described as an expanded investigation of medical suppliers related to billing of Medicare and Medicaid. Various reports indicate that the DoJ reportedly also has demanded records from, among others, Cardinal Health (Dublin, Ohio), Genentech (South San Francisco, California), GE Healthcare (Waukesha, Wisconsin), and Tyco International (Pembroke, Bermuda). The New York Times last month reported that, overall, more than a dozen medical supply companies received subpoenas for information on transactions with group purchasing organization (GPO) Novation (Irving, Texas), which provides supplies totaling $1 billion annually. A Novation spokesperson has said that the company is cooperating with the investigation, but the scope of the enquiry is still not known. Novation and Premier (San Diego), the two largest GPOs, have been under congressional scrutiny following charges of collusion to keep smaller medical suppliers out of the hospital market.

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