By Leah Voigt*
April 23, 2010
Congressional Leaders Praise AHRQ for Funding "Academic Detailing" Program
Lawmakers including Senate Majority Whip Richard Durbin (D-IL) and House Energy and Commerce Committee Chairman Henry Waxman (D-CA) last week commended the Agency for Healthcare Research and Quality (AHRQ) for using economic stimulus funds to support academic detailing programs to disseminate information about treatments.
AHRQ recently announced that it is seeking proposals to fund what are known as academic detailing programs, which provide physicians and other prescribers with a source of information on all prescription drugs based on independent, scientific research. Academic detailing is seen as an alternative to drug company promotion--also known as detailing--to healthcare providers. The academic detailing work is part of AHRQ's funding for comparative effectiveness research.
According to a notice on the FedBizOpps.gov website, AHRQ is seeking contractors who can assist the agency in translating and disseminating comparative effectiveness concepts and content. Funding will come from the American Recovery and Reinvestment Act of 2009. The notice said that one contract will be awarded for a period of three years and the contract will be awarded by September.
When doctors are better informed about the full range of drugs available on the market, they are more likely to prescribe the most effective treatment, as opposed to the latest brand-name blockbuster drug, according to the statement from the Senate Special Committee on Aging. The result is also lower healthcare costs, as generic drugs are more likely to be prescribed. At a committee hearing on academic detailing in March 2008, a former sales representative for pharmaceutical company Eli Lilly shared with the committee his experiences as a drug detailer and discussed the techniques sales representatives employ when marketing drugs to doctors. Other witnesses outlined the concept of academic detailing, shared success stories from state and international programs already under way, and discussed both the documented cost savings of academic detailing programs and how patients stand to benefit when doctors have access to unbiased information.
Bronwyn Mixter, Congressional Leaders Praise AHRQ for Funding "Academic Detailing" Program, BNA's Health Care Daily Report (Apr. 19, 2010) (note: registration is required to view this content).
Indian Tribe Wins Fight to Limit Research of Its DNA
Seven years ago, the Havasupai Indians, who live amid the turquoise waterfalls and red cliffs miles deep in the Grand Canyon, issued a "banishment order" to keep Arizona State University (ASU) employees from setting foot on their reservation--an ancient punishment for what they regarded as a genetic-era betrayal.
Members of the tiny, isolated tribe had given DNA samples to university researchers starting in 1990, in the hope that they might provide genetic clues to the tribe's devastating rate of diabetes. But they learned that their blood samples had been used to study many other things, including mental illness and theories of the tribe's geographical origins that contradict their traditional stories. The geneticist responsible for the research has said that she had obtained permission for wider-ranging genetic studies.
Acknowledging a desire to "remedy the wrong that was done," the ASU Board of Regents on Tuesday agreed to pay $700,000 to forty-one of the tribe's members, return the blood samples, and provide other forms of assistance to the impoverished Havasupai--a settlement that legal experts said was significant because it implied that the rights of research subjects can be violated when they are not fully informed about how their DNA might be used.
The case raised the question of whether scientists had taken advantage of a vulnerable population, and it created an image problem for a university eager to cast itself as a center for American Indian studies. But genetics experts and civil rights advocates say it may also fuel a growing debate over researchers' responsibility to communicate the range of personal information that can be gleaned from DNA at a time when it is being collected on an ever-greater scale for research and routine medical care.
Researchers and institutions that receive federal funds are required to receive "informed consent" from subjects, ensuring that they understand the risks and benefits before they participate. But such protections were designed primarily for research that carried physical risks, like experimental drug trials or surgery. When it comes to mining DNA, the rules--and the risks--are murkier. Is it necessary, for instance, to ask someone who has donated DNA for research on heart disease if that DNA can be used for Alzheimer's or addiction research? Many scientists say no, arguing that the potential benefit from unencumbered biomedical research trumps the value of individual control.
The Havasupai settlement appears to be the first payment to individuals who said their DNA was misused, several legal experts said, and came after the university spent $1.7 million fighting lawsuits by tribe members.
Amy Harmon, Indian Tribe Wins Fight to Limit Research of Its DNA, N.Y. TIMES (Apr. 22, 2010).
Physician Group Adopts Ethics Code for Interactions With For-Profit Companies
In an effort to combat possible conflicts of interest, a physician group this week released a code of ethics for medical specialty societies on appropriate interactions with for-profit companies in the healthcare sector. The Council of Medical Specialty Societies (CMSS), which represents thirty-two leading medical professional societies, said that the voluntary code is designed to ensure that societies' interactions with companies are independent and transparent and advance medical care for the benefit of patients.
"CMSS is committed to encouraging and supporting a culture of integrity, voluntary self-regulation and transparency," said James Scully, CMSS president and chief executive officer (CEO) of the American Psychiatric Association, in a statement. "This code provides a clear benchmark for maintaining integrity and independence." The group said the code has been formally adopted by thirteen medical societies, including the American College of Cardiology, the American College of Radiology, and the American Academy of Pediatrics. CMSS said others plan to adopt it over the coming months, and many members already have "rigorous policies in place that meet or exceed some of the principles in the code."
The code includes seven core principles and detailed guidance on implementation. It requires groups to develop and publicly post policies and procedures to disclose and manage conflicts of interest among those who participate in society activities (e.g., medical meetings, clinical practice guidelines, scientific journals); publicly disclose donations and support received from for-profit companies in the health sector, and disclose board members' financial and uncompensated relationships with companies; and develop and make publicly available policies and procedures to ensure that educational programs, advocacy positions, and research grants are developed independent of industry supporters. The code also prohibits society leaders (presidents, CEOs, and editors-in-chief of society journals) from having direct financial relationships with relevant for-profit companies in the healthcare sector.
Healthcare providers are facing an increased level of scrutiny in their interactions with for-profit companies, and CMSS is not the first group to adopt a voluntary ethics code.
The medical device industry group Advanced Medical Technology Association (AdvaMed) announced in December 2008 an update to its code of ethics on interaction with doctors and other healthcare professionals. The code, which has since been widely adopted and implemented, clarified and distinguished between appropriate and inappropriate activity between healthcare professionals and representatives of AdvaMed member companies. On the state level, a few--including Minnesota, Massachusetts, and Vermont--require some disclosure of ties between doctors and drug and device makers.
The Patient Protection and Affordable Care Act (Pub. L. No. 111-148) includes a physician payment sunshine provision, which requires annual public reporting of any payments made by drug or device manufacturers to physicians, starting March 31, 2013.
Nathaniel Weixel, Physician Group Adopts Ethics Code for Interactions With For-Profit Companies, BNA's Health Care Daily Report (Apr. 22, 2010) (note: registration is required to view this content).
Patient Safety, Quality Experts Hope Healthcare Reform Delivers Substantial Improvements in Care
Most of the attention given to the healthcare reform law has focused on its sweeping changes to the insurance system. But the law also could dramatically change the way that care is delivered, according to experts on patient safety and quality. For example, the overhaul uses pay bonuses and penalties to physicians and hospitals to incentivize the care coordination and safety interventions that can help prevent nosocomial infections and unnecessary hospital readmissions. It also requires an unprecedented level of public reporting on hospital and physician quality performance and could hasten implementation of care improvement practices, experts said.
One element of transparency is public reporting of physician performance data, which is set to start in 2013. Medicare hopes to entice more doctors to take part in its Physician Quality Reporting Initiative (PQRI) with bonuses of 1% next year, dropping to 0.5% through 2014. Starting in 2015, physicians face a 1.5% Medicare pay cut for not participating in PQRI, with a 2% penalty starting in 2016. The American Medical Association (AMA) hopes to eliminate scheduled cuts and maintain bonuses. It is working to ensure that any public reporting of physician quality data is accurate.
Meanwhile, a cost-quality value index included in the law will adjust Medicare payments at the individual physician level and will take effect in 2015. In a December 2009 letter to Senate Majority Leader Harry Reid
(D-NV), AMA Executive Vice President and CEO Michael D. Maves, MD, MBA, said that the AMA opposes the idea because it is based on measures that "are not scientifically valid, verifiable, and accurate." AMA President J. James Rohack, MD, said in a March letter that the AMA will "aggressively work for modifications to reflect the realities of medical practice."
Hospitals with the highest rates of healthcare-associated conditions will have their Medicare pay cut 1% starting in October 2014. Medicare's no-pay policy for such conditions will expand to all state Medicaid programs. But hospitals that excel on quality measures can earn a bonus.
Another major quality target of healthcare reform is hospital readmissions. Studies have found that about 20% of Medicare patients are readmitted to the hospital within thirty days of discharge. Hospitals with high readmission rates will have their payments cut. The change will save Medicare $7 billion over ten years, the Congressional Budget Office estimates.
Kevin B. O'Reilly, Patient Safety, Quality Experts Hope Healthcare Reform Delivers Substantial Improvements in Care, Am. Med. News (Apr. 19, 2010).
HHS to Draft Hospital Visitation Rules Ensuring Rights for Same-Sex Partners
Late last week, President Barack Obama directed the U.S. Department of Health and Human Services (HHS) to issue regulations that would require most of the nation's hospitals to ensure the visitation rights of same-sex partners or other visitors designated by a patient. In a presidential memorandum, President Obama said that the rules should apply to all hospitals participating in Medicare or Medicaid and guarantee that designated visitors "enjoy visitation privileges that are no more restrictive than those that immediate family members enjoy."
President Obama said that those hurt by visitation restrictions can range from widows and widowers without children to members of religious orders, and that "uniquely affected are gay and lesbian Americans who are often barred from the bedsides of the partners with whom they may have spent decades of their lives--unable to be there for the person they love, and unable to act as a legal surrogate if their partner is incapacitated."
In the memorandum, President Obama instructed HHS to ensure designated visitors include those identified in legally valid advance directions and include a prohibition against denying visitation privileges based on race, color, national origin, religion, sex, sexual orientation, gender identity, or disability. The regulations also should account for hospitals' need to "restrict visitation in medically appropriate circumstances as well as the clinical decisions that medical professionals make about a patient's care or treatment," according to the memorandum.
In addition to the regulations, President Obama instructed HHS to provide, within 180 days, additional recommendations about how HHS can address hospital visitation, medical decision-making, or other healthcare issues that affect lesbian, gay, bisexual, and transgender patients and their families.
Access the memorandum.
Sarah Barr, HHS to Draft Hospital Visitation Rules Ensuring Rights for Same-Sex Partners, BNA's Health Care Daily Report (Apr. 19, 2010) (note: registration is required to view this content).
Fish Oil Claims May Be Snake Oil
Claims that fish oil supplements preserve cognition should not be swallowed hook, line, and sinker, researchers recently reported. In a randomized, placebo-controlled trial of nearly 900 septuagenarians, the omega-3 fatty acid supplements had no effect on cognition, according to researchers at the London School of Hygiene and Tropical Medicine.
Over a two-year period, there was no difference in cognitive decline in either the fish oil or placebo arm of the study, the longest yet conducted, the researchers said online in the American Journal of Clinical Nutrition. Still, they cautioned that cognitive function can take years to decline, "and although this is the longest trial of its kind ever conducted, it may be that it was not long enough for any true beneficial effects to be detected among this healthy cohort of older people."
The findings come from the so-called OPAL study (for Older People And omega-3 Long-chain polyunsaturated fatty acids), which enrolled 876 healthy and cognitively sound people in Britain, ages seventy through seventy-nine. They were randomized to get either an olive oil placebo or the combination of 200 milligrams of eicosapentaenoic acid and 500 milligrams of docosahexaenoic acid daily for two years.
Eicosapentaenoic and docosahexaenoic acid are omega-3 long-chain polyunsaturated fatty acids, commonly found in oily fish. They have been associated with cognitive benefits in observational studies, but there was no evidence of a positive effect in a recent six-month randomized trial, the researchers said.
In the current study, participants were tested on a range of cognitive tasks at the beginning of the trial and after twenty-four months, the researchers said. The primary outcome was recall of a sixteen-word list from the California Verbal Learning Test, but the researchers also tested immediate and delayed recall, spatial memory, processing speed, reaction time, and executive function, among other things. After twenty-four months, the researchers found that participants getting the fish oils had more of them in their blood than did those in the placebo arm. At the same time, placebo participants had higher serum concentrations of two omega-6 fatty acids as well as two components of olive oil. But there were no significant differences between the groups on the California Verbal Learning Test, the researchers said.
Michael Smith, Fish Oil Claims May Be Snake Oil, MedPage Today (Apr. 23, 2010).
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 Leah Voigt, Esquire (Squire Sanders & Dempsey LLP, Washington, DC), for providing this week's update.