A Medical Device Daily

Nearly $36 million in funding is being distributed to the 54 State Health Insurance Assistance Programs (SHIPs) to help people with Medicare get more information about their healthcare choices.

The $35.8 million in funding is the first installment of federal grant funds provided to SHIPs by the Centers for Medicare & Medicaid Services (CMS) for the grant year beginning April 1, 2009, and ending March 31, 2010. An additional $1.5 million in performance-based funding will be awarded in September.

SHIPs are state-based programs that use community-based networks to provide Medicare beneficiaries with local, personalized assistance on a wide variety of Medicare and health insurance topics.

"State Health Insurance Assistance Programs serve an important role in providing information and support to people with Medicare where they live," said CMS Acting Administrator Charlene Frizzera. "These funds help ensure SHIPs continue their work with state and local governments, community-based organizations and others to meet the needs, beyond health care, of our Medicare beneficiaries."

CMS said it expects the SHIPs to use the 2009 funding to conduct targeted community-based outreach to people with Medicare who may be unable to access other sources of information. SHIPs will also provide outreach and assistance to current and newly eligible Medicare beneficiaries and their caregivers, with a special emphasis on reaching people who will most likely be eligible for Medicare's low-income subsidy if they enroll in Medicare prescription drug coverage.

Zoll initiates voluntary recall on its AED Plus

Zoll Medical (Chelmsford, Massachusetts), a manufacturer of resuscitation devices and related software solutions, reported that it has initiated a voluntary worldwide field corrective action on its AED Plus automated external defibrillator.

The company said it has determined that some batteries do not work properly when used with AED Plus defibrillators manufactured prior to Feb. 12, 2009. In addition, the version of the AED Plus self-test software installed in these devices does not adequately detect defective batteries. As a result of these two issues, the AED Plus defibrillator may fail to deliver defibrillation shocks during treatment of sudden cardiac arrest. The company's investigation is not complete at this time.

This corrective action applies to about 180,000 units, the company said. Devices installed for at least three years are at the highest risk, a population of about 80,000 it added. Although this issue was identified through customer reports from non-clinical testing, there has been one clinical event reported in which a defibrillation shock was not delivered, the patient subsequently died, and an evaluation of the device found that the batteries experienced the identified problem. At this time Zoll said it has reviewed all reported patient events and found up to three additional cases in which a shock was not delivered to a patient and the battery may have experienced the identified problem. The company was informed that in one of the cases the patient subsequently died.

The required correction is available in the form of a software update, which can be easily downloaded from the company's web site and installed by the user. This new software, which is included in current shipments of the AED Plus, can detect this battery defect condition if it occurs within the maximum five-year standby lifetime, and alert the user to install fresh batteries.

Working with its distributors, Zoll said it began notifying customers with affected devices on Feb. 12, advising the immediate replacement of batteries on a three-year schedule until their device software can be updated. There is no need to remove devices from service pending the corrective action.

Although the root cause investigation is not fully complete, the company said it appears that high internal resistance can develop in some batteries after several years in standby mode. It is possible that this can lengthen charging time beyond specified and clinically acceptable limits, resulting in the failure of the AED Plus to deliver a defibrillation shock. Zoll said tt is difficult to predict which batteries may develop this condition, and the affected devices' self-test does not detect this condition. The FDA has been notified of this problem and is expected to classify it as a recall.

Medicare plans demo to improve nursing homes

Medicare officials reported a new, four-state demonstration to determine if cash incentives will improve the quality of care and efficiency of operations in nursing homes.

Nursing homes in Arizona, Mississippi, New York and Wisconsin will be asked to participate.

"Medicare is always interested in testing new ways to improve the quality of care in nursing homes," said Charlene Frizzera, acting CMS administrator. "We believe this demonstration to provide incentive payments for superior performance will be informative."

Facilities joining the Nursing Home Value-Based Purchasing demonstration will be awarded points for performance on quality measures in four areas: nurse staffing, avoidable hospitalizations, resident outcomes, and the scope and severity of deficiency citations the home has received during inspections. Nursing homes with the highest scores or the greatest improvement in their score will be eligible for a performance payment.

Savings generated by improved performance, such as reducing the number of avoidable hospitalizations, will fund state pools from which payments will be made to qualified nursing homes.

Nursing homes wishing to be in the demonstration will be randomly assigned to a demonstration group or a comparison group. Medicare officials anticipate that at least 100 nursing facilities in each state will apply to be part of this demonstration.

The demonstration is expected to run from July 2009 through June 2012, at which time its effectiveness will be evaluated to inform possible changes to Medicare payment policy.

CMS will mail an application kit to each Medicare-certified nursing home in the demonstration states.

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