By Reesa Benkoff*
March 20, 2009
Obama Nominates Former New York City Health Chief Hamburg as FDA Commissioner, Baltimore Health Commissioner Sharfstein as Deputy
President Barak Obama in his weekly radio and Internet address on Saturday said that he would nominate former New York City Health Commissioner Margaret Hamburg as FDA commissioner and Baltimore Health Commissioner Joshua Sharfstein as the agency's principal deputy commissioner. Obama said that the Bush administration's inability to protect the nation against contaminated foods created a "hazard to public health" and pledged that his administration would address these shortcomings. He said, "There are certain things only a government can do," adding that "one of those things is ensuring that the foods we eat, and the medicines we take, are safe and do not cause harm."
In addition to serving as New York City Health Commissioner, Hamburg also was assistant secretary of Department of Health and Human Services (HHS) during the Clinton administration. She now works at the think tank Nuclear Threat Initiative and is a board member for the medicalequipment wholesaler Henry Schein. "Dr. Hamburg brings to this vital position not only a reputation of integrity but a record of achievement in making Americans safer and more secure," Obama said. He added that Hamburg "brought new life to a demoralized agency" as commissioner of the New York City Department of Health and Mental Hygiene. The nomination requires Senate confirmation. Sharfstein, a pediatrician, also served as a health policy aide to House Energy and Commerce Committee Chair Henry Waxman and gained national attention for his efforts to challenge the safety of cough-and-cold medicine for children. Obama cited his work on the cough-and-cold issue and on a program to ensure people with disabilities have access to medications.
Kaiser Daily Health Policy Report, Obama Nominates Former New York City Health Chief Hamburg as FDA Commissioner, Baltimore Health Commissioner Sharfstein as Deputy, Henry J. Kaiser Fam. Fdn. (March 16, 2009).
Medtronic Says Heart Device Tied to Thirteen Deaths
Medtronic's Sprint Fidelis defibrillator leads continue to be a source of trouble for the medicaldevice maker and patients who have the implants, despite removal of the product from the market in October 2007. On Friday, the company sent a letter to physicians raising the number of estimated deaths in conjunction with the leads from five to thirteen. The leads were recalled seventeen months ago after a review determined that the devices sometimes delivered inappropriate shocks to patients' hearts. Patients who had already received the implants were advised by the device maker not to remove them, as the risk of surgery may outweigh the risk of the device malfunctioning.
About 268,000 patients worldwide have received the Sprint Fidelis defibrillator lead implants. Food and Drug Administration (FDA) has received reports of 107 deaths that are suspected to be the result of lead malfunctions. Medtronic officials reviewed eighty-nine of those reports and determined that thirteen deaths may have resulted from problems with the device, according to the letter sent to physicians. Minneapolis-based Medtronic said four of those deaths could be traced back to surgery to remove the leads. The correspondence came two days after a U.S. District Court judge in Minnesota dismissed a classaction lawsuit filed against the company by shareholders who accused Medtronic of suppressing information about the defective leads.
Shawn Rhea, Medtronic Says Heart Device Tied to 13 Deaths, Modern Healthcare's Daily Dose (March 16, 2009) (note: registration is required to view this content).
Men and Women Get Different Benefits from Daily Aspirin
The benefit of daily aspirin appears to differ by gender—for men it means fewer heart attacks. In women it reduces the risk of stroke, according to the U.S. Preventive Services Task Force (USPSTF). The gender disparity emerged in studies reported after 2002, and the new information led the guideline agency to tweak its recommendation on aspirin, recommending a daily dose for men ages forty-five to seventy-nine to prevent myocardial infarction (MI), and for women ages fifty-five to seventy-nine to reduce risk of ischemic strokes. The new recommendation, published in the March 17 issue of Annals of Internal Medicine, addresses primary prevention in men and women who have no history of coronary heart disease or stroke.
In both cases, the potential benefit—reducing heart attacks in men and strokes in women—should be weighed against the risk of gastrointestinal (GI) hemorrhage, the guideline writers said. "The USPSTF recommends against the use of aspirin for stroke prevention in women younger than fifty-five years and for myocardial infarction prevention in men younger than forty-five years," wrote Ned Calonge, MD, MPH, of the Colorado Department of Public Health and Environment. Dr. Calonge chaired the task force. The panel said there was "insufficient evidence" to make a recommendation for aspirin use in men and women eighty or older.
Although 81 mg daily—the so-called baby aspirin—is a commonly recommended dose, the new USPSTF guideline does not name an optimum dose, noting that primary prevention trials "have demonstrated benefits with various regimens, including doses of 75 mg and 100 mg/d and 100 and 325 mg every other day." It does, however, state that the risk of GI bleeding increases as the dose increases and that a "dose of approximately 75 mg/d seems as effective as higher doses."
Filling in some of the blanks on the precise dose, a second paper in Annals—a post-hoc analysis from the Clopidogrel for High Atherothrombotic Risk and Ischemic Stabilization, Management, and Avoidance (CHARISMA) investigators—found that aspirin doses of 100 mg or alone higher did not benefit patients with established cardiovascular disease. Further, when patients were given dual antiplatelet therapy with 75 mg of clopidogrel (Plavix) and 100 mg or more of aspirin, there was a decrease in the efficacy of clopidogrel and a slight increase in bleeding risk, although the differences were not statistically significant. Steven R. Steinhubl, MD, of the Medicines Company in Balsburg, Switzerland, and the CHARISMA co-investigators, concluded that "daily aspirin doses of 100 mg or greater are not associated with clear benefit and may cause harm, and that daily aspirin doses of 75 to 81 mg may provide the optimal balance between efficacy and safety in patients with known cardiovascular events or those who are at risk for events but require aspirin therapy."
In an editorial that accompanied both papers, Shamir R. Mehta, MD, MPH, of McMaster University and Hamilton General Hospital in Hamilton, Ontario, wrote that a key concern for physicians is "when to recommend against taking aspirin." One approach is straightforward: when the rate of harm (bleeding events) exceeds the rate of benefit (reduction in risk of heart attacks or strokes), recommend against taking aspirin. But that approach, he warned, "assumes that patients place the same value on avoiding a bleeding event as they do on avoiding a stroke or MI. Depending on the site of the bleeding, some patients would rather avoid a stroke than avoid a bleeding event and would prefer to take aspirin."
Dr. Mehta said that a "valuable feature" of the USPSTF recommendation is an emphasis on shared decision-making. That means not only discussing risks and benefits, but also individualizing that discussion to the specific patient or situation.
This study is available online:
U.S. Preventive Services Task Force, Agency for Healthcare Research and Quality, Rockville, MD, Aspirin for the Prevention of Cardiovascular Disease: U.S. Preventive Services Task Force Recommendation Statement, Annals of Internal Medicine (2009).
Peggy Peck, Men and Women Get Different Benefits from Daily Aspirin, MedPage Today (March 16, 2009).
OIG Finds No Grounds for Penalties on SNF's Transportation Proposal for Residents' Family
A proposed arrangement by a skilled nursing facility (SNF) to offer complimentary local transportation for friends and families of its residents would not constitute grounds for imposing civil money penalties (CMP), HHS Office of Inspector General (OIG) said in an advisory opinion (No. 09-01) posted on March 13, 2009. Offering transportation to the SNF could generate prohibited payment under the anti-kickback statute if the requisite intent to induce or reward referrals of federal healthcare program business were present, but the OIG said in the advisory opinion that it would not impose administrative sanctions on the SNF.
According to the nonprofit SNF, part of a large, integrated healthcare system serving a metropolitan area, its facility is not easily accessible by public transportation for family and friends living within its primary historical service area. Also, it said that it is separated from part of the area by a bridge that requires a $9 toll. The SNF said it will provide the transportation in a van it owns that will be driven by a SNF employee.
The proposed arrangement does not present the usual circumstances involving free transportation where passengers are patients receiving treatment, the OIG said. Nevertheless, the proposed arrangement potentially implicates the anti-kickback statute and the CMP prohibiting inducements to Medicare and Medicaid beneficiaries because some of the transportation will be provided to members of a resident's household. Therefore, the proposed arrangement may result in an actual or expected economic benefit to the resident in the form of savings on household transportation costs.
The value of the transportation per household may exceed $50 annually, but the OIG said it would not subject the SNF to administrative sanctions in connection with the proposed arrangement for several reasons. For example, the proposed arrangement will not involve transportation for the SNF's residents to receive federally payable items or services from the SNF, its affiliates, or any other provider, or for the benefit of the SNF's referral sources, such as physicians or other providers. In addition, the proposed arrangement will not limit eligibility to target populations of federal healthcare program beneficiaries—all friends and family will be able to use the transportation services uniformly. Under the proposed arrangement, the SNF will only offer reasonable transportation locally and only advertise the proposed arrangement locally. The SNF certified that the availability of local public transportation is limited, pointing out that part of its service area is separated by the toll bridge, a further limit on transportation options. Further, the proposed arrangement will be consistent with the SNF's mission as a nursing home to provide residents with quality care in a residential setting through increased companionship with friends and families. Finally, the cost of the transportation will not be claimed directly or indirectly on any federal healthcare program cost report or claim, the opinion said.
The OIG said it will not proceed against the SNF with respect to any action that is part of the proposed arrangement taken in good faith reliance upon the advisory opinion, as long as all the material facts have been fully, completely, and accurately presented.
Access a copy of Advisory Opinion 09-01.
OIG Finds No Grounds for Penalties on SNF's Transportation Proposal for Residents' Family, BNA'S HEALTH L. REP. (March 19, 2009) (note: registration is required to view this content).
Potentially Faulty AEDs Recalled
More than 14,000 automatic external defibrillators have been voluntarily recalled, Welch Allyn Protocol, the device maker, announced. The company said that select AED 10 and MRL JumpStart external defibrillators manufactured between October 3, 2002, and January 25, 2007, may have serious defects that are subject to a Class I recall. The FDA said that this is the most serious type of recall and is used in situations "in which there is a reasonable probability that use of the product will cause serious injury or death."
There have been twenty reports of low energy shock, eight of electromagnetic noise interference, and eleven of unexpected device shutdown, any of which may prevent defibrillation and lead to death, the company said. There is also the possibility of blown fuses, loss of voice prompts, or shutdown in cold temperatures. Welch Allyn Protocol advised its customers to continue using recalled units until they receive a replacement, either through an exchange for a similar device or the discounted purchase of a newer one.
Customers can look up their defibrillator by serial number to see if it been recalled.
Todd Neale, Potentially Faulty AEDs Recalled, MedPage Today (March 17, 2009).
HHS Chooses Comparative-Effectiveness Panelists
HHS named the members of its new Federal Coordinating Council for Comparative Effectiveness Research, established to oversee and manage $1.1 billion in research funds allocated through the American Recovery and Reinvestment Act of 2009. The council was formed to make recommendations to the HHS secretary about different treatment options, including medications and surgical procedures, and aims to present the "best information" possible to doctors and patients as they make healthcare choices, said Carolyn Clancy, a physician who is the director of the Agency for Healthcare Research and Quality (AHRQ). That information is "too often lacking," she said during a teleconference. Clancy was one of the members named to the new council.
AHRQ will use $300 million of the allocated funds to extend its comparative-effectiveness research programs. The National Institutes of Health and HHS each receive $400 million in funding for research through the stimulus law. The federal council is required by the law to submit an operations plan by July 30, 2009, that outlines its priorities for the research spending.
Jean DerGurahian, HHS Chooses Comparative-Effectiveness Panelists, Modern Healthcare's Daily Dose (March 19, 2009) (note: registration is required to view this content).
AHLA Teaching Hospital Updates are intended to provide quick summaries of cutting-edge issues of interest to teaching hospitals and their counsel. Additional information and more in-depth coverage on these topics may be available from AHLA Health Lawyers weekly and appropriate AHLA Practice Groups.
*We would like to thank Reesa Benkoff, Esquire (Hall Render Killian Heath & Lyman PLLC, Troy, MI) for writing this email alert.