October 14, 2011
By Amy Kaufman*
Patient Helicopter Transport Expensive, Not Always Better
Contrary to popular belief, transporting patients between hospitals by helicopter is not always the best option, according to researchers from Massachusetts General Hospital and Harvard Medical School in a study published in the online journal PLoS ONE.
Transporting a patient by helicopter can cost up to $25,000, while ground transport costs between $800 and $2,000, according to a press release yesterday. Researchers looked at 167 neurosurgical patients transferred to an emergency department to see if transporting them by helicopter, versus ground ambulances, improved patient outcomes. They found that for 60% of the patients, driving time was less than an hour, although it was not clear whether helicopter transport would have been better.
The researchers, however, noted that 63% of the transferred patients did not need immediate attention and could have been stabilized at the original hospital and then transferred by ground transportation.
"In an area of rising healthcare costs and expenditure scrutiny, it is necessary to make evidence-based decisions to optimize patient care in an efficient way," said Dr. Brian Walcott of Harvard Medical School and the Massachusetts General Hospital, in the press release. "This study provides preliminary data that brings into question the efficacy of helicopter transport for interfacility hospital transfer--a practice that is costly and has been increasingly utilized."
As hospitals continue to look in all areas of the organization to cut costs, some may want to reevaluate the patient benefits of transportation. For example, researchers recommend telemedicine for neurosurgical evaluation as one way to improve air triage. "In a time when there is growing interest in health care cost containment, practitioners must exercise discretion in the selection of patients for air ambulance transport-particularly when it may not bear influence on clinical outcome," the study states.
Karen Cheung, Patient Helicopter Transport Expensive, Not Always Better, Fierce Healthcare (Oct. 13, 2011).
Senators Propose Relaxing FDA Conflict Rules
A bill that would loosen conflict of interest rules for advisers to the U.S. Food and Drug Administration (FDA) has been proposed by three Senators seeking to speed up review times for medical devices.
The measure would reverse 2007 legislation that barred experts who had financial ties to a company or its competitor from serving on an advisory panel without a waiver. There is also a limit on the number of waivers that keeps decreasing. A senior FDA drugs office official testified in August that the agency was having difficulty in recruiting highly qualified people for its advisory panels.
The legislation also comes as medical device makers such as Boston Scientific and Stryker have criticized FDA for strangling innovation with inconsistent regulation and lagging device approvals.
"The legislation would restore the appropriate balance to conflicts of interest requirements by requiring the FDA to be subject to the same conflicts of interest requirements as the rest of the federal government," according to a statement issued by the senators. Federal regulations allow those with conflicts to serve as advisers as long as the conflict is publicly disclosed and is "unavoidable."
"It is critical that we don't allow regulatory burdens to get in the way of delivering lifesaving products to the patients who need them," said Senator Amy Klobuchar, (D-MN). "This legislation will help ensure that we have processes that promote safe, pioneering technologies that help save lives and create good jobs in Minnesota." Minnesota, home to devicemaker Medtronic, has about 30,000 jobs in the medical device industry, according to AdvaMed, an industry trade group.
Patient and consumer groups contend FDA is simply not looking hard enough to find experts, and worry loosening the rules could jeopardize the independence of panels. They also point out that FDA does not use up all of its allotted waivers.
Anna Yukhananov, Senators Propose Relaxing FDA Conflict Rules, Chicago Tribune (Oct. 13, 2011).
Medicare Tests Monthly Incentives for Innovative Primary Care
Medicare will partner with private insurers to offer physicians patient management fees and the opportunity to share savings under a primary care payment initiative led by the Centers for Medicare & Medicaid Services (CMS).
The Comprehensive Primary Care Initiative is a new collaboration between public and private payers to strengthen primary care, CMS officials said during a September 28 news conference. The Center for Medicare & Medicaid Innovation is inviting insurers to join government health plans in trying a new approach to paying for primary care starting in 2012.
"We believe that if we can give primary care clinicians the time and resources to take care of their patients and coordinate their care across the spectrum, in the end we'll get happier and healthier patients," said Richard Gilfillan, MD, acting director of the innovation center. "We know we'll get providers who feel more fulfilled. And we know over time we'll improve overall costs of the system and make the system more sustainable."
The initiative is designed to enhance the work being done by payors who have developed innovative models to pay for coordinated care and higher-quality services, such as the patient-centered medical home. The Medicare agency wants to pay more for outpatient services that keep patients healthier and prevent costlier inpatient care. For instance, care coordination in the Community Care of North Carolina program, which initially launched as a Medicaid medical home project, has been able to lower preventable hospitalizations significantly for patients with chronic conditions, according to CMS.
Once the participating private payors are selected, interested physician practices will be asked to apply through CMS to participate. CMS will require practices to provide comprehensive primary care services to Medicare patients and to those with coverage from a participating payor. Preference will be given to practices that have achieved meaningful use of an electronic medical record system, according to the application materials.
"Practices will receive patient management fees to pay for the new health care delivery methods," said Richard Baron, MD, director of the Seamless Care Models Group at the innovation center. This fee is expected to average about $20 per month for each patient covered by one of the participating payers. CMS also will provide practices with patient and resource use data so patients have more information on the quality of their care and their physicians' performance. Any savings that might be generated for the Medicare program would be shared with the practices.
Charles Fiegl, Medicare Tests Monthly Incentives for Innovative Primary Care, Am.Med News (Oct. 10, 2011).
Hospitals, Health Groups Use Purchasing Power to Push for Greener Medical Products
Hospitals and health systems are organizing the industry's vast purchasing power to push manufacturers of medical products to make them with safer chemicals and to be more environmentally friendly.
Five large groups that buy $130 billion of these products every year on behalf of hospitals and other healthcare facilities have adopted a standard set of questions they want vendors to answer. Those questions are designed to encourage manufacturers to produce "greener and safer products for workers, patients and the environment," said Gina Pugliese, vice president of the Premier healthcare alliance, which has a division that does group purchasing. The move is significant because the groups represent more than 4,000 hospitals and thousands of other healthcare organizations, including doctor's offices, labs and long-term care facilities. They already leverage the collective buying power of hospitals and other facilities to negotiate discounts on products.
"What we buy matters," said Anna Gilmore Hall, executive director of Practice Greenhealth, a member organization of 1,100 hospitals, including the corporate parent of Georgetown University Hospital and Washington Hospital Center. "It sends a signal to the industry that . . . these are the baseline things you should be thinking about, that there shouldn't be any horrible toxins and if at all possible, to use recyclable materials," Pugliese said.
The nation's chemical laws, created thirty-five years ago, make it extremely difficult for the federal government to ban or restrict a chemical's use. Congress and the Environmental Protection Agency "have been deadlocked in managing chemicals so far," Igrejas said. He said the efforts of healthcare purchasing organizations will send a signal about the way chemicals should be managed that goes beyond healthcare customers and workers.
Lena Sun, Hospitals, Health Groups Use Purchasing Power to Push for Greener Medical Products, Wash. Post (Oct. 12, 2011).
FDA Working with Drugmakers to Prevent Shortages
Health professionals across the country have been scrambling for alternatives to critical medications affected by this year's record number of drug shortages. There were about 200 shortages as of Sept. 30, according to the U.S. Food and Drug Administration (FDA). That marks an increase from the nation's previous record of 178 such events in 2010.
Contributing to the shortages are production delays, discontinuation of medications, and manufacturing and quality problems, FDA said. The agency aims to prevent shortages by working with manufacturers to address the issue and helping other companies ramp up production of the drugs, said Capt. Valerie Jensen, RPh, associate director of the Drug Shortage Program within FDA's Center for Drug Evaluation and Research.
But she said there often is little the agency can do to avert a deficit of needed medication. "We have limited authority with shortages," Jensen said during a Sept. 30 webinar on prescription drug shortages. "The key to preventing shortages is receiving early notification. If we don't hear about the problem before it is a shortage, we can't prevent [it]."
Complicating matters is that companies rarely have to notify FDA of drug manufacturing issues, she said. The exception is when a company plans to discontinue a lifesaving drug for which it is the only manufacturer. If FDA knows that information ahead of time, it can help ensure that health professionals continue to have access to the medication by such measures as temporarily importing the drug from another country.
There is no penalty for companies that fail to inform the FDA of plans to stop producing critical medication. However, more companies have been voluntarily reporting manufacturing problems this year than they did in 2010, Jensen said. That information has enabled the FDA to prevent more than ninety-nine shortages.
Christine S. Moyer, FDA Working with Drugmakers to Prevent Shortages, Am.Med News (Oct. 10, 2011).
Blue Cross to Remain Nonprofit Entity
Blue Cross Blue Shield of Massachusetts has decided to remain a nonprofit public charity after examining whether it should seek a different legal status given its extensive business operations as the state's largest health insurer. The inquiry was spurred by outrage over Blue Cross's $11 million payout to its former chief executive, Cleve L. Killingsworth, and the five-figure annual fees paid to members of its board of directors. The controversy raised the question of whether an organization that rivals some of the state's biggest companies in revenues should be considered a public charity.
Blue Cross chief executive Andrew Dreyfus and other executives consulted with about fifty community leaders between May and June about the Blue Cross "identity crisis.'' They ultimately concluded that they would not pursue a change. Before the consultations began, the Blue Cross board indefinitely suspended compensation for directors, and there are no plans to reinstate the pay.
Dreyfus said he sees the Boston-based insurance carrier as a hybrid organization-more a nonprofit business than a public charity. Its research showed that, while many insurers have a nonprofit status, Blue Cross Blue Shield of Massachusetts is the only health plan in the nation classified as a public charity.
But he added that he and Blue Cross directors determined that their top priority should be reining in escalating health care costs. Seeking a change in the carrier's legal classification could prove a time-consuming distraction, he said. "We're a nonprofit business, which might sound oxymoronic in one sense,'' Dreyfus said during an interview with The Boston Globe's editorial board. "But that's who we are."
Robert Weisman, Blue Cross to Remain Non-Profit Entity, Boston Globe (Oct. 12, 2011).
*We would like to thank Amy Kaufman, Esquire (Nashville, TN) for providing this week's update.
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.