CMS May Pay for Counseling

The Centers for Medicare and Medicaid Services is studying whether to pay for lifestyle counseling of patients with hypertension, hyperlipidemia, or other cardiac risk factors. Last October, the nonprofit Partnership for Prevention asked the CMS to cover counseling for aspirin as a preventive treatment for cardiovascular disease, noting that the practice had been strongly recommended by the U.S. Preventive Services Task Force. After reviewing the available evidence, the CMS decided in early February to weigh coverage of what it calls “intensive behavioral therapy,” including aspirin and dietary counseling, to prevent heart disease.

The agency expects to make a final coverage decision in November 2011.

For More Heart Rehabilitation

Studies have shown that cardiac rehabilitation reduces morbidity and mortality, and yet only 20%–30% of eligible patients receive the service after hospital discharge for cardiovascular disease. Investigators in Canada found that they could increase participation by 45% if they automatically referred patients to rehabilitation and counseled them on its benefits.

The researchers compared four referral strategies in 2,635 patients who had coronary artery dsease and were seen at 11 hospitals in Ontario: automatic referral, a personal discussion with a nurse or peer, a combination of both, or a customary referral at the discretion of the health provider.

More than 73% of patients who received the combination strategy enrolled, whereas 29% enrolled who were referred at a provider's discretion. All patients who were referred for rehabilitation attended more than 80% of sessions. The authors, who reported no conflicts, published their findings in Archives of Internal Medicine.

Tougher Device Review Needed?

One of the two review processes that the Food and Drug Administration uses for medical devices is faulty and results in more recalls than do more stringent reviews, according to a study published on the Archives of Internal Medicine's Web site.

A team led by Diana Zuckerman, Ph.D., of the advocacy group the National Research Center for Women & Families, found that of 113 device high-risk recalls from 2005 to 2009, 80 were approved through the “510(k) process” and 21 were approved through “premarket approval,” whereas 12 had not been reviewed for various reasons.

The 510(k) category is for devices that are deemed similar to those already on the market, and are determined to involve low or moderate risk, according to the report.

In all, 35 cardiovascular devices were recalled in 2005–2009, and 23 of them had been approved under the 510(k) process.

Stricter Standards for Stroke Care

The American Heart Association and its American Stroke Association are recommending the creation of a specialized class of stroke-care centers in the United States.

Called Comprehensive Stroke Centers, they would be held to stricter standards than are current Primary Stroke Centers, which would continue to exist. For instance, the comprehensive centers would be measured by the time from hospitalization to blood vessel repair for patients with ruptured aneurysms.

“Initiatives such as primary and now comprehensive stroke center certification will greatly help us reach our 2020 goal” of reducing cardiac and stroke deaths by 20%, Dr. Ralph L. Sacco, president of the AHA, said in a statement. The recommendations were published in Stroke: Journal of the American Heart Association.

Stealth Grants to Advocacy Groups

Health advocacy groups are not routinely disclosing their financial ties to pharmaceutical companies, according to a new study.

Researchers led by Sheila Rothman, Ph.D., of Columbia University, New York, studied grants made by Eli Lilly & Co. to such groups in 2007. The company was the first drugmaker to disclose its payouts. During the first half of the year, Lilly gave &dollar;3.2 million to 161 organizations that were generally concerned with diseases that the company's products treat.

Only 25% of those organizations acknowledged getting Lilly grants on their Web sites, and none disclosed the amount. Two-thirds of the funds went to mental health groups. Only 18% of those advocacy groups identified Lilly as a corporate sponsor.

FDA Accelerates Device Reviews

The Food and Drug Administration has proposed a new, accelerated review program for what it terms breakthrough medical devices as part of a broader effort to encourage cutting-edge technologies among device manufacturers. The FDA could conduct reviews within 150 days on devices that are submitted under the new Innovation Pathway – about half the time it now takes the agency to review devices. However, enrollment in the program won't change the standards that the agency currently uses to evaluate medical devices, the FDA said.

A brain-controlled, upper-extremity prosthetic will serve as the first submission to the Innovation Pathway program, the agency said. However, the FDA also is asking for public comment on the new program and plans to hold a hearing in March before finalizing the rules.

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