CMS moves to speed Medicare approval for expanded uses of medical technology

Washington -- Physicians who want Medicare to start paying for new uses of cutting-edge medical technology much more quickly than it has in the past could be finally getting their wish. But doctors had better be prepared to do some extra work for it.

Federal officials recently proposed expanding Medicare coverage of implantable cardioverter defibrillators (ICDs), which have been approved for more than a year for use in a limited number of patients with coronary disease. The Centers for Medicare & Medicaid Services anticipates that the list of qualified recipients will jump by one-third, to nearly a half-million as a result.

The ICD move comes right on the heels of another high-profile coverage extension. Medicare soon will begin paying for positron emission tomography scans when they are used to help diagnose some dementia patients who might have Alzheimer's disease.

CMS officials say that both decisions reflect a new commitment to speed the approval of medical technology for new uses within the Medicare community even if it has yet to be determined how much the recipients will benefit from the treatment.

In return, doctors prescribing preventive defibrillators to the new class of heart attack risk patients will be required to enter the seniors into a national registry for the purposes of further study. Physicians who want to order PET scans for people exhibiting signs of early dementia first must have the seniors enrolled in an upcoming CMS clinical trial on Alzheimer's disease.

Encouraging such a commitment from doctors by tying it to Medicare coverage eventually will help patients by producing more clinical information for study, said Sean Tunis, MD, the agency's chief medical officer.

"Going in this direction of trying to expedite access to new technology but linking that to more formal and systematic real-world evaluations like we're doing in these cases is an important trend, and you're probably going to be seeing more of that," Dr. Tunis said. "The significance of that for the practicing physicians may be that an increasing part of the practice of medicine will be getting involved in this real-world data-gathering activity."

Dr. Tunis joined Carolyn Clancy, MD, director of the Agency for Healthcare Research & Quality, in authoring an article in the Sept. 24, 2003 Journal of the American Medical Association that stresses the need to improve policy-making by enhancing clinical research within the health care delivery system. "It's not coincidental that the PET decision and the ICD decision are following the model laid out in there," Dr. Tunis said.

By securing pledges from physicians to stay involved with the research that CMS says is necessary to support new technology applications, the agency is free to react faster to early clinical data.

In the case of the defibrillator decision, promising results that the National Institutes of Health unveiled in March from the largest-ever ICD trial prompted Medicare officials to expand coverage. The NIH results, however, have not been peer-reviewed or published in a medical journal.

Basing a major proposed national coverage determination on data that hasn't yet been published is a first for CMS, Dr. Tunis said. It is also a reflection of a multiyear process of ramping up the agency's resources to process new research developments within an expedited time frame, he added.

Back in early 2000, the agency had only about a dozen staffers dedicated to this type of work and relatively little technical expertise, Dr. Tunis explained. A concerted effort since then to build up staff levels and develop more internal knowledge of biostatistics and evidence-based medicine is evident in the quick turnaround on ICDs.

The coverage determination process also has become more transparent in recent years to physicians and other stakeholders, said Stephen Hammill, MD, director of heart rhythm services at the Mayo Clinic in Rochester, Minn. Dr. Hammill reported that the professional society over which he presides, the Heart Rhythm Society, was included in an unprecedented number of face-to-face meetings and conference calls with Medicare officials before the defibrillator announcement.

In addition, CMS recently formed the Council on Technology and Innovation, which was mandated by last year's Medicare reform act as a means of further expediting the application of new medical devices and practices. One of the council's first actions was to propose changes to the way Medicare will develop code sets for new technologies starting in 2006. The move was a response to complaints that the current coding process takes too much time.

Doctors wary about their new role?

Some physicians might not be immediately up to the task of contributing to the continuing research required by the federal government, however.

The establishment of the ICD patient registry, for instance, is necessary to ensure that Medicare is paying for the best patient care but could prove problematic for smaller cardiology practices, Dr. Hammill said. Large facilities, such as the Mayo Clinic, already have sophisticated registries and employ data abstractors who are tasked with entering the appropriate information.

"You can't just rely on the physicians and their teams and their nurses. They are so busy," Dr. Hammill said. "They may well say, 'Well, this Friday, we'll enter the data on all these patients,' but it's not their primary focus, so the accuracy is in question. And if it's not accurate data going in, then it's very difficult to rely on it."

If this is the case, it could be some time before Medicare realizes the downside of counting on doctors who might not have the resources necessary to provide the most accurate information. Researchers will get the best data on new defibrillator patients four to six years down the road, Dr. Hammill said, when analysts can determine who received necessary therapy from the device and who did not.

The procedures themselves also carry risks. The CMS decision to limit the therapies to specific classes of patients and to require additional treatment prerequisites stems from the risk of side effects, such as reactions to the radioactive materials used in PET scans or accidental shocks in the case of the ICDs.

Architects of the new approach nevertheless are confident that the overall results will outweigh any system weaknesses encountered along the way, CMS' Dr. Tunis said.