March 23, 2012
By Allison Cohen and Amy Kaufman*
Diagnostic Medical-Test Patents Limited by U.S. High Court
The U.S. Supreme Court put new limits on the availability of patents for diagnostic medical tests, ruling in favor of the Mayo Clinic in a decision that will shape the growing field of personalized healthcare. The justices Tuesday said two patents owned by Nestle SA's Prometheus unit are invalid because they cover a natural phenomenon. Prometheus argued that the patents concerned an application of a law of nature, not the law itself.
The case tested the types of medical inventions that are eligible for legal protection. Companies, trade groups, and lawyers filed more than two dozen legal briefs, many warning that the court's ruling might have widespread, unintended ramifications. Each side in the case said a defeat might stifle innovation. Writing for the Court, Justice Stephen Breyer pointed to "a concern that patent law not inhibit further discovery by improperly tying up the future use of laws of nature." Patent protection is important for companies that are focusing on personalized medicine. The field involves determining whether a patient is genetically susceptible to a particular disease or would be especially responsive to certain medicines.
The patents covered a method for determining the proper dosage of thiopurine, a stomach medicine, based on the rate at which particular patients metabolize the drug. Doctors can use the method, which involves testing blood for metabolites, to maximize effectiveness and limit toxic side effects while treating Crohn's disease and other inflammatory bowel illnesses.
Prometheus sued two units of the Mayo Clinic, the nonprofit medical practice based in Rochester, MN. Mayo at one point shipped patient samples to Prometheus and paid the company to perform the test. That relationship ended in 2004, when Mayo created its own test.
Mayo contended the patents would give Prometheus a monopoly over all uses of the natural relationship between the metabolites created by thiopurine and the drug's impact on the human body. The patents are so broad they would bar doctors familiar with the Prometheus method from even thinking about the connection between metabolite levels and the proper dosage for a patient, Mayo's lawyers said.
Breyer agreed with that reasoning, saying, "the steps add nothing of significance to the natural laws themselves." The decision reversed a ruling by the U.S. Court of Appeals for the Federal Circuit, which specializes in patent issues. The ruling was surprising and a "real departure" from past Supreme Court cases, said a Washington lawyer who filed a brief on behalf of SAP urging the court not to restrict software and computer patents.
Greg Stohr, Diagnostic Medical-Test Patents Limited by U.S. High Court, Bloomberg News (March 20, 2012).
Med Schools Shift Focus to Team-Based Care
In their first year of medical school, students at the Medical University of South Carolina join with students from all of the university's degree programs, including nursing, pharmacy, and health administration. During a semester, the students work in teams to solve a hypothetical patient sentinel event. They must determine what went wrong and come up with multiple recommendations for the patient's care. The exercise is part of a required course implemented in 2009 to give students their first exposure to interprofessional care.
"The idea is that they learn, for all healthcare providers, what the scope of practice is and what the responsibilities are, so that they can really reach out and use other professionals to the best of their ability," said Amy Blue, PhD, family medicine professor and director of the University's Creating Collaborative Care program.
As the nation shifts toward more team-based care and the medical home model, medical schools are working to provide their graduates with the skills needed to use these approaches in a changing healthcare system. Interprofessional training is offered or being developed at several schools, including East Tennessee State University, the University of California San Diego, Loyola University Chicago, Thomas Jefferson University in Philadelphia, and the University of Kentucky.
In addition, six national associations of health professionals have formed the Interprofessional Education Collaborative. The group's goal is to better integrate and coordinate the education of nurses, physicians, dentists, pharmacists, and other health professionals to provide more collaborative care. "We believe this is the future of quality patient care," said Lucinda Maine, PhD, RPh, executive vice president and chief executive officer of the American Association of Colleges of Pharmacy, which is part of the initiative.
Carolyne Krupa, Med Schools Shift Focus to Team-Based Care, Am. Med News (March 19, 2012).
Aspirin Benefits May Include Cancer Prevention
Regular aspirin use leads to significant reductions in the risk of cancer, metastasis, and cancer mortality, according to one of the largest-ever analyses of published data. Overall, aspirin users had a 38% reduction in the risk of colorectal and other gastrointestinal cancers compared with nonusers. Cancer mortality was 15% lower among regular users of aspirin, and metastasis was 35% to 40% less common.
One of the analyses showed a reduced risk of vascular events in patients taking aspirin, but an increased risk of major bleeding. The effects of aspirin on both outcomes declined over time. Fatal extracranial bleeding occurred significantly less often among aspirin users, as reported online in three articles in The Lancet and The Lancet Oncology.
The findings "add to the case for long-term use of aspirin for cancer prevention in middle age in addition to appropriate dietary and lifestyle interventions," one of the co-authors concluded in one of the Lancet articles. "In view of the very low rates of vascular events in recent and ongoing trials of aspirin in primary prevention, prevention of cancer could become the main justification for aspirin use in this setting, although more research is required to identify which individuals are likely to benefit most."
A spokesperson for the American Cancer Society characterized the analyses as "important new evidence that long-term daily aspirin, even at low doses, may lower the risk of developing cancer." Even so, the decision to initiate regular aspirin use should be individualized after a discussion between patient and physician, he said. "Because these results are new, it will take time for the broader scientific community to evaluate the data in the context of existing knowledge and to consider whether the clinical guidelines should be changed. . . . Clinical guidelines require a systematic analysis of for whom the benefits of aspirin use are likely to outweigh the risks."
Charles Bankhead, Aspirin Benefits May Include Cancer Prevention, MedPage Today (March 21, 2012).
UMMC Saves $3 Million by Monitoring Unnecessary Meds
After monitoring the unnecessary use of antibiotics for three years, the University of Maryland Medical Center (UMMC) in Baltimore shaved $3 million from its annual budget, according to a study published in the April Infection Control and Hospital Epidemiology.
The medical center's seven-year antimicrobial stewardship program, which helped identify when antibiotics are needed and which medicines are most appropriate, slashed antibiotic spending per-patient day by almost 50%, according to information from the Society for Healthcare Epidemiology of America (SHEA). What's more, the study found that the cost savings did not hurt care quality, as the hospital reported no increases in mortality, length of stay, or readmission. But after UMMC ended the program in 2008, antimicrobial costs jumped by 32%, adding up to about $2 million, within two years, the study noted.
Given the success of UMMC's medicine monitoring program, SHEA, the Infectious Diseases Society of America, and the Pediatric Infectious Diseases Society are urging that antimicrobial stewardship be included in the curriculum for all healthcare professionals, according to a policy paper also in next month's Infection Control and Hospital Epidemiology. The groups also want the Centers for Medicare & Medicaid Services to require participating healthcare organizations to develop antimicrobial stewardship programs and interventions.
Meanwhile, with hospital cost savings in mind, a Consumer Healthcare Products Association study released in January suggested that using over-the-counter (OTC) medications could save the healthcare system tens of billions of dollars a year in additional costs. "OTC medicines allow the healthcare system to focus its limited resources on the diagnosis and treatment of more serious diseases that require physician involvement, while providing consumers the opportunity to care for themselves," the study states.
Alicia Caramenico, UMMC Saves $3M by Monitoring Unnecessary Meds, Fierce Healthcare (March 19, 2012).
House Votes to Scrap Medicare Payment Board
The House of Representatives has voted 223-181 to repeal the Independent Payment Advisory Board (IPAB) for Medicare and to restrict medical malpractice lawsuits. The measure is known as HR 5, the Protecting Access to Healthcare Act, and is sponsored by Representative Phil Gingrey, MD (R-GA). It would eliminate the IPAB, the fifteen-member independent panel created under the Patient Protection and Affordable Care Act of 2010 (PPACA).
Starting in 2015, IPAB would be tasked with making binding recommendations on how to reduce Medicare spending. If Congress doesn't agree with the recommended cuts, it would be required to pass its own cuts of the same size.
But Republicans, along with some Democrats, oppose the concept, saying it would lead to rationing of medical care. The Obama Administration has noted that under the law, IPAB is prohibited from recommending changes to Medicare that ration healthcare, restrict benefits, modify eligibility, increase cost-sharing, or raise premiums or revenues.
Several prominent Democrats voiced support for the IPAB repeal earlier in the month, including Representative Frank Pallone (D) of New Jersey and Representative Allyson Schwartz (D) of Pennsylvania, who also authored legislation to repeal the sustainable growth rate formula for physician reimbursement under Medicare. However, after House Republicans added a provision to the IPAB bill that limited the amounts of damages awarded in medical malpractice lawsuits to $250,000, Democratic support appeared to disappear. Historically, Democrats (including President Obama) oppose caps on medical malpractice lawsuits. Republicans said the malpractice cap would discourage frivolous lawsuits against doctors and hospitals.
The American Medical Association (AMA), which supports PPACA as a whole but opposes IPAB, praised the House vote. "We applaud the House for voting to eliminate IPAB, a panel which would have too little accountability and the power to make indiscriminate cuts that adversely affect access to healthcare for patients," said the president-elect of AMA. "This new, arbitrary system is not what we need when patients and physicians are already struggling with a looming cut of nearly 30% from the broken Medicare physician payment formula." The group also spoke in favor of the medical malpractice provision of the bill.
However, the bill is likely dead on arrival in the Senate, and the White House threatened to veto the bill if it does pass the Senate. Obama has called IPAB a crucial component for restraining the growing cost of Medicare.
Emily P. Walker, House Votes to Scrap Medicare Payment Board, MedPage Today (March 22, 2012).
Happy Match Day: For Graduating Med Students at U.S. Schools, Highest Match Rate in Thirty Years
Last Friday was Match Day, and by now medical students across the country have learned where they will spend their residencies after graduation. The National Resident Matching Program, which oversees the process, said last week that of 16,527 applicants graduating from U.S. medical schools, more than 95% were selected for a program this year, the highest rate in thirty years. Fifty-seven percent were matched to their first choice.
The largest increases in available residencies were in internal medicine, anesthesiology, and emergency medicine, according to a press release from the program.
National Public Radio talked to some prominent physicians about their memories of Match Day. They had this from Brigham and Women's surgeon and writer Atul Gawande about his day in 1995:
"It's a strange moment," he remembers. "You stand there in a room with all of your fellow medical students, getting handed a white envelope that tells you what city you're going to live in for the next—for me, seven years of my life in surgical training."
Gawande, who attended Harvard Medical School, matched at Brigham and Women's to the great relief of his pregnant wife, who hoped to continue to see her obstetrician in Boston. Now, Gawande is on the recruiting side of Match Day, so he understands the process from both sides. "The surgical residents, for example . . . will travel to ten, twelve cities to interview," he says. "You kind of size up the joint and then decide, boy, you know, is this somewhere I want to be?"
Chelsea Conaboy, Happy Match Day: For Graduating Med Students at US Schools, Highest Match Rate in 30 Years, Boston Globe (March 16, 2012).
*We would like to thank Allison M. Cohen, Esquire (Washington, DC), and Amy Kaufman, Esquire (In-House Counsel, 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.
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