While many major headlines over the past month have tracked President George Bush's proposed plan to stave off the bankruptcy of the Social Security system, continued bankrolling of the Medicaid system appears to be a problem looming even larger and much more closely. In mid-March, the Senate's rejection of the president's $14 billion budget cut in Medicaid funding was followed by an announcement from the Centers for Medicare & Medicaid Services (CMS; Baltimore) that it is expanding coverage of percutaneous transluminal angioplasty (PTA) of the carotid artery concurrent with stent placement to pati-ents who are at high risk for carotid surgery also known as carotid endarterectomy (CEA). The ex-panded reimbursement goes into effect immediately.
While the expanded coverage falls far short of the potential billions of dollars in new costs for expanded coverage of implantable defibrillators announced earlier this year, it does suggest a more aggressive approach to reimbursements by CMS, especially in the heart disease and vascular sectors, together with a growing emphasis on reliance on clinical trial data. A statement by CMS said the new carotid stenting coverage "reflects the latest evidence on the effective use of stenting, and includes support for development of better evidence in additional uses." CMS Administrator Mark McClellan, MD, said that the agency "is committed to providing broader access to appropriate and innovative care to our beneficiaries in the management of their carotid artery disease. We are working with health professionals and product developers to reduce the occurrence of stroke in our population, and getting the maximum health improvements possible by soliciting and responding to public comments on the most effective way to provide improved coverage."
The national coverage determination expands reimbursement for carotid artery stenting specifically to high-risk patients, defined as having "symptomatic narrowing of carotid artery of 70% or more." Medicare said it also will cover patients who meet the FDA-labeled criteria for carotid stents, who are at high risk for CEA and have symptomatic carotid artery stenosis from 50% to 70% and asymptomatic high risk patients with carotid artery stenosis of 80% or more, in Category B investigational device exemption (IDE) clinical trials. This will come under the category of a routine cost "under the clinical trials policy, or in post-approval studies," CMS said. Under previous policy, CMS only covered carotid artery stenting in clinical trials being conducted prior to FDA approval (so-called Category B IDE clinical trial) and more recently in FDA-required post-approval studies.
CMS said it is working with Guidant (Indianapolis) and the FDA "to expand the scope of post-approval studies [of carotid stenting] and increase the number of participating facilities and study enrollees." Guidant, CMS noted, currently is the only company with an FDA-approved carotid stent and an ongoing post-approval study. Other companies developing carotid stent systems are waiting in the wings and thus also will benefit from the expanded coverage.
Guidant received FDA approval of its Rx Accu-link carotid stent and Rx Accunet embolic protection system to reduce the risk of stroke last September. CMS's commitment to expanding the coverage of the carotid stenting procedure came in a statement from the agency immediately after the Acculink approval. The Acculink system is sold by Guidant's Vascular Intervention (Santa Clara, California) division.
Carotid artery stenting is a less-invasive alternative to CEA. In this strategy, a catheter is used to place a stent that will widen the narrowed artery. Medicare said that to help ensure the best patient outcomes and to evaluate and monitor provider and facility performance, it will limit use of carotid stenting to facilities and providers determined "competent in performing the evaluation, procedure and necessary follow-up care." Sean Tunis, MD, chief medical officer for CMS, said, "The evidence on carotid artery stenting demonstrates its effectiveness in improving net health outcomes for certain patients."
Each year about 700,000 people experience a new or recurrent stroke. More than 70% of stroke victims are over 65 and thus eligible for Medicare. Obstructive lesions in the carotid arteries have the potential to cause stroke, leading to substantial morbidity, mortality and long-term disability. Some medical conditions or anatomical risk factors that increase the risk for CEA include congestive heart failure, unstable angina, and recent heart attack (myocardial infarction).
Schultz all for parallel reviews
Nobody who listened to Daniel Schultz, MD, director of the FDA's Center for Devices and Radiological Health (CDRH) during his appearance at last month's annual meeting of the Advanced Medical Technology Association (AdvaMed; Washington) could say he wasn't responsive to the views of the med-tech industry. When a questioner followed up Schultz's presentation during the closing session of the meeting with a question about his view on the FDA and the CMS conducting parallel reviews of new devices for market approval and reimbursement, respectively, the CDRH head was both swift and decisive in his response. "I'd be more than happy for us to do this," said Schultz. What's more, he added, "If anyone [from industry] tries to do it and gets pushback [from the agency], I would like to know about it."
Noting that the idea of parallel product reviews by the two agencies that ultimately hold the commercialization fate of new med-tech products in their hands is part of former Health and Human Services Secretary Tommy Thompson's concept of "one HHS," Schultz told his questioner: "I really think it is starting to take hold."
Still addressing the parallel review question, he said, "From our point of view, this is something we'd like to engage in. We'd need to decide the respective FDA and CMS areas of review [but] I think it's more of an issue for industry than for us."
During his presentation, Schultz said that CDRH covers "an incredibly broad range of products that present us with scientific and regulatory challenges."
Among those challenges:
- Evaluating smaller and smaller devices.
- Combination drug/device products. "One of the most exciting things happening in this industry today ... and one of the most challenging for us."
- Combined diagnostic and therapeutic products.
- Technology for children.
- Technology he described as being something "we hope we never need," such as anthrax detection kits.
- The proliferation of device companies, which he said numbered 10,000-plus in 1998, but now total more than 14,000.
- The growing complexity of applications addres-sed by products coming out of those companies.
Reporter's death sparks DVT awareness
U.S. senators unanimously passed a resolution early last month in an effort to raise awareness concerning deep-vein thrombosis (DVT). The passage of Senate Resolution 56, co-sponsored by Arlen Specter (R-Pennsylvania) and Byron Dorgan (D-North Dakota), makes March DVT Awareness Month in memory of David Bloom. In 2003, David Bloom, an NBC News correspondent, suffered a fatal and widely publicized pulmonary embolism while in Iraq covering the war. Bloom's widow, Melanie Bloom, is national spokes-person for the Coalition to Prevent DVT (Washington), a group made up of 35 healthcare organizations sponsoring public education concerning the problem.
Deep vein thrombosis occurs when a blood clot forms in one of the large veins, usually in the lower limbs, leading to either partially or completely blocked circulation. The condition may result in health complications such as a pulmonary embolism or death if not diagnosed and treated early on. According to the American Heart Association (Dallas), DVT affects up to 2 million annually in the U.S. Of those who develop pulmonary embolism, up to 200,000 will die each year, more than breast cancer and AIDS combined.
A recent survey by the American Public Health Association (Washington) showed that such an awareness program may have benefit. The survey said 74% of Americans reported having little or no awareness of the condition. "This little-known condition hospitalizes up to 600,000 people each year, causing additional healthcare costs of more than $20,000 per person, per case," said Dorgan, chair of the Congressional Heart and Stroke Coalition. "If we are able to raise awareness, we'll save health care costs, but more importantly, we'll save lives."
DVT can be caused by a variety of factors and triggering events, including restricted mobility, major surgery, cancer and certain heart or respiratory diseases. Confinement in tight quarters on long airplane flights referred to by some as "coach-class syndrome" particularly exacerbates the condition.
Preventive treatments include early mobilization, sequential compression devices to prevent blood clotting and anticoagulants and/or blood-thinning drugs, such as low-molecular-weight heparin, unfractionated heparin and warfarin sodium.
"DVT strikes millions unknowingly each year," Specter said. "With this resolution, we hope to raise public awareness for DVT a serious yet preventable condition so that others, like David Bloom, will not suffer at its hand."
Different tests and methods are used to diagnose DVT, including Doppler ultrasonography, duplex scan- ning and venography.