May 28, 2010
By Allison Cohen and Leah Voigt*
Lawmakers Tell FDA to Consider Industry, Innovation in 510(k) Process
Senator Amy Klobuchar (D-MN) and Representative Erik Paulsen (R-MN) this week sent a letter to the Food and Drug Administration (FDA) expressing concerns about potential changes to the agency's regulatory process for clearing medical devices for marketing. FDA is currently reviewing the 510(k) premarket notification process by which most medical devices reach the market, with an internal FDA working group as well with an external review by the Institute of Medicine, both already under way. Paulsen and Klobuchar called on FDA "to reject proposals that unduly burden small businesses and suppress the development of promising medical breakthroughs."
Klobuchar is the chair of the Senate Commerce Subcommittee on Competitiveness, Innovation and Export Promotion, while Paulsen is the co-chair of the Medical Technology Caucus. Medical devices hold particular importance for Minnesota. According to the letter, their state has led medical innovation for more than sixty years and is host to more than 400 medical device companies that together employ over 50,000 people. In the letter, addressed to FDA Commissioner Margaret Hamburg, the Minnesota lawmakers said they support the agency's goal to improve its policies and procedures to ensure only safe and effective devices reach the marketplace.
However, Klobuchar and Paulsen wrote, "we are concerned that some policy changes under consideration by the FDA would add new and unnecessary regulations, resulting in an even longer and more complicated approval process. In addition to creating an undue regulatory burden, these changes would increase the time, cost and risk associated with developing new medical technology." Bringing a new medical device to market typically involves millions, sometimes hundreds of millions, of dollars in upfront research and development costs, the letter stated. "The suggested changes [to 510(k)] could threaten the availability of often relied on equity investments," the lawmakers said.
Access the letter.
Lawmakers Tell FDA to Consider Industry, Innovation in 510(k) Process, BNA's Health Care Daily Report (May 28, 2010) (note: registration is required to view this content).
Flood of Test Results Prompts New Attention on How to Manage Flow
With more medical tests being ordered, the odds are greater that findings requiring follow-up action will fall through the cracks. New recommendations in The Joint Commission Journal on Quality and Patient Safety highlight what physician practices and hospitals can do to reduce the risk of missing test results.
The paper by physicians at the Michael E. DeBakey Veterans Affairs Medical Center in Houston draws upon a growing body of research about how frequently test results are missed. It also outlines best practices on how to ensure that critical and abnormal findings get to the right doctor and, that the right action is taken. Health information technology solutions are critical to reducing missed tests, but adopting the right procedures for handling test results is a necessary first step to improvement, said the co-author of the paper's new recommendations.
The focus on test-result mishaps comes as hospitals struggle to meet a 2005 Joint Commission National Patient Safety Goal requiring that hospitals "report critical results of tests and diagnostic procedures on a timely basis." More than a quarter of hospitals surveyed in 2009 failed to comply with the goal, the commission said. Experts said the sheer magnitude of tests contributes to the problem.
In addition, some patients never hear about abnormal findings. A study of 5,434 medical records at twenty-three physician practices in the Midwest and on the West Coast found that doctors failed to inform patients of abnormal test results 7% of the time. Experts said a key to properly following up on test results is establishing which physician is responsible for doing so. Determining who should act on abnormal findings is not always clear for patients being cared for by a primary care doctor and multiple subspecialists.
Kevin B. O'Reilly, Flood of Test Results Prompts New Attention on How to Manage Flow, Am. Med. News (May 24, 2010).
National Coordinator Guides Billions of Stimulus Dollars to Help Doctors and Hospitals Adopt Electronic Medical Records
Dr. David Blumenthal was not happy to find a new computer installed on his desk when he showed up for work one morning eight years ago at Massachusetts General Hospital in Boston. He knew the hospital had been hard at work on developing an electronic medical record (EMR) system, but Blumenthal wasn't keen on changing practices that had served him and his patients just fine over the years. Quickly, though, he found himself to be odd man out at staff meetings where younger colleagues eagerly exchanged tips on how to retrieve patient histories, test results and consults with other physicians.
"I realized I was going to have to get on board," Blumenthal recalled in an interview. Still, he approached the task of converting paper-based notes and patient records to the electronic system as more obligatory than clinically useful. The "aha" moment, which Blumenthal frequently mentions in speeches, came on the day he entered orders for a CT scan and his computer screen flashed a reminder that the patient had already had one. "We had particularly advanced computerized decision support software," Blumenthal says. "I realized that not only was it changing my practice, but I could see that it had the potential to change the practice of medicine."
Blumenthal is now charged with just that task. As the Obama administration's National Coordinator for Health Information Technology in the Department of Health and Human Services, he is guiding the deployment of up to $27 billion in federal stimulus money over ten years to help healthcare professionals and organizations overcome the uneasiness that underpinned his own resistance to change at his hospital.
Appointed in March 2009, Blumenthal has spent the last year refining Congress' blueprint to encourage doctors and hospitals to adopt EMRs. He says those who "get on board" will be paid more by Medicare and Medicaid, beginning in 2011. But in 2016 the subsidies disappear and those still using paper records risk sanctions, including reduced Medicare fees. Some critics say five years isn't enough time for healthcare professionals to achieve a government standard called "meaningful use." Proponents, including Blumenthal, say the healthcare system has dallied long enough on EMRs, and that having an electronic infrastructure for better system-wide information exchange is critical to achieving goals of medical care quality and cost-control.
Irene M. Wielawski, David Blumenthal Guides Billions Of Stimulus Dollars To Help Doctors And Hospitals Adopt Electronic Medical Records, Kaiser Health News (May 24, 2010).
Tighter Criteria Introduced for Aspirin Use in Diabetes
A more conservative approach to aspirin for primary prevention in adults with diabetes is called for in a joint statement issued this week by diabetes and cardiovascular associations. Low-dose aspirin can be considered reasonable for diabetes patients with a cardiovascular disease risk above 10% over ten years and no excess bleeding risk, according to the statement released by the American Heart Association, the American Diabetes Association, and American College of Cardiology.
That group of patients will include most men older than fifty and women over sixty with at least one major risk factor in addition to diabetes—smoking, hypertension, dyslipidemia, family history of premature cardiovascular disease, or albuminuria. This represents an update from the 2007 joint recommendation for low-dose aspirin (seventy-five to 162 mg per day) as primary prevention in diabetes patients over forty years of age or who have additional risk factors.
Patients currently on aspirin who no longer fit into one of the recommended categories should discuss with their physician whether this is the right choice, noted the statement co-author and a spokesperson for the American Stroke Association. The organizations decided to refine the guidelines after two recent randomized controlled trials performed specifically in diabetes patients "raised questions about the efficacy of aspirin for primary prevention in diabetes," they wrote online in Circulation: Journal of the American Heart Association.
Crystal Phend, Tighter Criteria Introduced for Aspirin Use in Diabetes, MedPage Today (May 27, 2010).
Strategies Shared to Reduce Hospital Readmissions
Patients who return to the hospital within a month of being discharged represent one of the most persistent and costly, yet preventable, problems in American healthcare. But few solutions have been implemented on a widespread scale.
On Wednesday, more than 200 hospital administrators, doctors, nurses, and others met with national experts at the Union League in Center City to learn about strategies to reduce hospital readmissions in the five-county Philadelphia area. One approach is to use nurses to proactively treat the highest-risk patients—older people with multiple chronic illnesses—who cost the most money. Another idea was to use a computer-animation program nicknamed "Louise" to prepare patients and their families for the return home. And yet a third was to use "transition coaches" to help patients better manage their own care after a hospitalization.
The initiative is part of a third group: the Partnership for Patient Care, a joint project of Independence, the improvement foundation, and the hospitals. The effort—dubbed Preventing Avoidable Episodes or PAVE&mdashhas a goal to eliminate ten percent of hospital readmissions in Southeastern Pennsylvania over eighteen months. That could result in substantial savings for the broader health system. In 2008, the Pennsylvania Health Care Cost Containment Council reported, there were 57,852 readmissions within thirty days of initial discharge, leading to $2.5 billion in hospital charges. Of those, more than 22,000 were related to complications of care and infections. Those second hospitalizations led to bills totaling more than $1 billion. Moreover, the cost containment council found that readmissions in Pennsylvania have held steady at about nineteen percent for the most recent five-year period examined. National studies have made similar findings, concluding that one in five hospitalized patients are readmitted within a month of discharge.
Josh Goldstein, Strategies Shared to Reduce Hospital Readmissions, PHILADELPHIA INQUIRER, May 27, 2010.
FDA's Clearance of H1N1 Test Allows Continued Use After Emergency
This week the Food and Drug Administration (FDA) said it cleared for marketing the Simplexa diagnostic test for the 2009 H1N1 influenza virus (swine flu), for use in patients with signs and symptoms of respiratory infection. The Simplexa test is manufactured by Focus Diagnostics Inc. in Cypress, CA, which is a wholly owned subsidiary of Quest Diagnostics. Quest separately announced the FDA's clearance of the test under the 510(k) or premarket notification program.
Until this agency action, tests for swine flu were only available through an Emergency Use Authorization (EUA), which allows FDA, based on the evaluation of available data, to authorize the use of unapproved or uncleared medical products or unapproved or uncleared uses of approved or cleared medical products, during the time a declaration of emergency is in effect. FDA in April 2009 issued EUAs to make available to public health and medical personnel diagnostic and therapeutic tools for identifying and responding to the swine flu virus. EUAs for devices will cease to be effective when the public health emergency declaration expires, FDA said. Jeffrey Shuren, director of FDA's Center for Devices and Radiological Health, said in a statement that the availability of the newly cleared test will not be affected when the public health emergency expires.
According to FDA, the Simplexa Influenza A H1N1 (2009) test simultaneously amplifies and detects two regions of the influenza virus genome and an internal control. A positive result indicates that the patient is infected with the 2009 H1N1 influenza virus, but the test does not indicate the stage of infection. A negative result does not preclude influenza virus infection.
Nathaniel Weixel, FDA's Clearance of H1N1 Test Allows Continued Use After Emergency, BNA's Health Care Daily Report (May 28, 2010) (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 Allison Cohen, Esquire (Health Law and Policy LLM Candidate at American University Washington College of Law, Washington, DC), and Leah Voigt, Esquire (Squire Sanders & Dempsey LLP, Washington, DC), for providing this week's update.