By Jennifer Viegas*
September 25, 2009
Measure Pushes Stricter Background Checks
The Senate Finance Committee paved the way for stricter background checks for nursing home workers, building on a Centers for Medicare & Medicaid Services (CMS) pilot program and adding an extra layer of security to a vulnerable patient population.
The provision to the Senate health bill mirrors the Patient Safety and Abuse Prevention Act. A version of that bill was approved by the committee last year. Under the amendment, the program would expand nationwide, and would put the onus on states to conduct screening and criminal history background checks and ensure that long term care facilities are compliant.
The stepped-up background checks would impact those workers who have direct access to patients. Meantime, the committee also approved a measure that would bar public officials, including the heads of the Department of Health and Human Services and the National Institutes of Health, from being on the board for the proposed Patient-Centered Outcomes Research Institute (PCORI). Senator Charles Grassley (R-IA) authored the health bill amendment, which was one of the few Republican efforts that got the green light from the Democratic majority. Grassley has a long history of tightening governance rules in the nonprofit sector. The PCORI would be charged with conducting comparative-effectiveness research.
Matthew DoBias, Measure Pushes Stricter Background Checks, Modern Healthcare's Daily Dose (Sep. 24, 2009) (note: registration is required to view this content).
Hospital Did Not Breach Contract by Renewal for Less than Full Term, Maine Court Says
On September 15, 2009, Maine's highest state court held that a hospital did not breach the terms of the contract created by its medical staff bylaws when it denied a physician reappointment to its medical staff after twice extending a provisional appointment for less than a full term.
The Maine Supreme Judicial Court held that the medical staff bylaws of defendant Down East Community Hospital (DECH) did not require reappointment of Dr. F. James Whalen's full, active staff privileges for a full two years following his placement on provisional status. A trial court that found the bylaws ambiguous in this regard erred, the court said.
Whalen is an orthopedic surgeon who had been a member of DECH's medical staff since 1979. Under the hospital's bylaws, physicians must apply for reappointment to the medical staff every two years. In 2006, when Whalen applied for a two-year reappointment, he was instead given a one-year provisional appointment based on a low "profiling assessment" score, according to the court.
Whalen reapplied for a full appointment when his provisional appointment expired in November 2007. However, at that time, the hospital was in the midst of investigating whether the physician had improperly disclosed privileged peer review materials to a state investigator. With the investigation incomplete, the credentials committee of the medical staff recommended that Whalen be given an appointment that would expire on February, 29, 2008. On February 26, 2008, the staff members extended the appointment to March 31, 2008.
The investigation ended on February 27, 2008, and the hospital trustees suspended Whalen's staff privileges for a period of sixty days. The credentials committee subsequently recommended that Whalen's application for reappointment to full staff privileges be denied. The medical staff executive committee accepted the recommendation and subsequently, so did the full medical staff. A hearing committee of the medical executive committee agreed and, following appellate review, the full board of trustees upheld the decision.
Whalen filed a complaint against the hospital in a Maine trial court, alleging breach of contract. The trial court found that the contract created by the medical staff bylaws was ambiguous as to whether a medical staff appointment could be made for less than the full two-year term. After construing the contract as a matter of law, the trial court said that the contract required reappointment for the full two years and, therefore, the hospital breached the contract when it reappointed Whalen for the three-month and one-month terms in early 2008. The trial court entered an injunction prohibiting DECH from denying Whalen's reappointment to the medical staff. The hospital appealed. The Maine Supreme court said that the trial court erred in its key finding that Whalen had been reappointed to full active staff membership in December 2007 and that the medical staff bylaws did not permit appointments for less than two years.
As an initial matter, the court said, the trial court correctly found that the bylaws created a contract between the physician and the hospital. However, it said, the trial court erred in finding an ambiguity in that contract.
Whalen, the court pointed out, was given a one-year provisional appointment in 2006 that expired in November 2007. According to the bylaws, the hospital then had the option of renewing that provisional appointment for a period not to exceed one year, it said. The hospital exercised the option by renewing the provisional appointment for three months, then for an additional month.
The court acknowledged that letters sent by the hospital to Whalen about the extension of his reappointments referred to membership on the active medical staff. But, it said, the letters also clearly stated termination dates for the reappointments that were considerably less than the two years extended for active medical staff appointments. "Reading each letter as a whole, . . . they announced, that Dr. Whalen had privileges at DECH, but for a limited time--in other words, they announced extensions of his provisional appointment," the court stated.
Additionally, it noted that the terms of Whalen's provisional appointment in 2006 put him on notice that he would be subject to heightened scrutiny until he received a regular appointment. "That backdrop further reinforces a conclusion that the three-month and one-month appointments were extensions of the ongoing provisional process, not belated attempts to rescind a regular, two-year appointment," the court said.
The court concluded that DECH acted within its bylaws as to Whalen's medical staff privileges. It reversed the judgment for Whalen and vacated the injunction.
Hospital Did Not Breach Contract by Renewal For Less Than Full Term, Maine Court Says, BNA'S HEALTH L. REP. (Sep. 24, 2009) (note: registration is required to view this content).
FTC, Department of Justice to Examine Merger Guidelines
The Federal Trade Commission (FTC) and the Department of Justice (DOJ) announced that they will explore the possibility of updating their jointly issued merger guidelines in order to reflect legal and economic changes since 1992, the last time they were substantially revised.
In a speech this morning to a global antitrust symposium, FTC Chairman Jon Leibowitz said that the guidelines clearly exaggerate the degree to which the agencies follow a rigid, step-by-step approach in merger analysis and that, in reality, the enforcers center the inquiry on one key question: is the merger under review likely to substantially lessen competition?
In order to demystify the way the agencies answer that question, they will seek commentary in response to a set of questions to be issued later today and then hold a series of workshops beginning December 3, 2009, in Washington, followed by others in Chicago, New York, San Francisco, and a second in the nation's capital.
Gregg Blesch, FTC, Justice to Examine Merger Guidelines, Modern Healthcare's Daily Dose (Sep. 22, 2009) (note: registration is required to view this content).
For First Time, AIDS Vaccine Shows Some Success
Scientists said Thursday that a new AIDS vaccine, the first ever declared to protect a significant minority of humans against the disease, would be studied to answer two fundamental questions: why it worked in some people but not in others, and why those infected despite vaccination got no benefit at all.
The vaccine--known as RV 144, a combination of two genetically engineered vaccines, neither of which had worked before in humans--was declared a qualified success after a six-year clinical trial on more than 16,000 volunteers in Thailand. Those who were vaccinated became infected at a rate nearly one-third lower than the others.
However, it will still take years of work before a vaccine that could end the epidemic, which has killed about twenty-five million people, can even be contemplated. Experts generally disdain vaccines that do not protect at least 70-80% of recipients. And, this vaccine did not lower the viral loads of people who were vaccinated but caught the virus anyway, which was baffling because even mismatched vaccines usually do that.
Simply repeating the trial to confirm the results would be pointless, experts agreed.
The trial, the largest AIDS vaccine trial in history, cost $105 million and followed 16,402 Thai volunteers. The men and women, ages eighteen to thirty, were recruited from two provinces southeast of Bangkok, from the general population rather than from high-risk groups like drug injectors or sex workers. One half of the participants were given six doses of two different vaccines; the other half were given placebos.
For ethical reasons, all were offered condoms, taught how to avoid infection, and promised lifelong antiretroviral treatment if they got AIDS. They were then regularly tested for three years; seventy-four of those participants who got placebos became infected, but only fifty-one of those who got the vaccines did.
Although the difference was a mere twenty-three people, Col. Jerome H. Kim, a physician and the manager of the Army's H.I.V. vaccine program, said it was statistically significant and that it meant that the vaccine was 31.2% effective.
Donald McNeil, For First Time, AIDS Vaccine Shows Some Success, N.Y. TIMES, Sep. 24, 2009.
Intervention Linked to Reduced Burnout in Primary-Care Doctors
Primary-care physicians who took part in a continuing medical education program (CME) emphasizing reflection about their clinical experiences reported improvements in burnout and mood, researchers found. The program centered on improving physicians' mindfulness, or the state of being fully attentive, when interacting with patients.
Researchers thought such a program would combat burnout, which they characterized in September 23/30 issue of the Journal of the American Medical Association as emotional exhaustion, depersonalization, and a feeling that work is not meaningful.
The skills cultivated in the mindful communication program appeared to lower participants' reactivity to stressful events and help them adopt greater resilience in the face of adversity. Still, researchers indicated that in recognition of the nonrandomized nature of the intervention, further study will be necessary to investigate the effects on practice efficiency, patients' experience of care, and clinical outcomes.
Burnout affects up to 60% of physicians, according to the researchers, and it has been associated with poorer quality of care, decreased patient satisfaction, increased medical errors and lawsuits, a reduced ability to express empathy, and a variety of personal problems.
The researchers tested an intervention designed to improve physician well-being through enhanced mindfulness. The CME course involved an eight-week intensive phase comprising a weekly two-and-a-half-hour session followed by a seven-hour retreat. Physicians learned techniques of mindfulness meditation, narrative medicine, and appreciative inquiry aimed at increasing attention and awareness.
The initial phase was followed up with a ten-month maintenance phase consisting of a monthly two-and-a-half-hour session. Seventy physicians from the Rochester area participated and completed a mean of 33.6 out of a possible fifty-two hours.
Based on the results of self-administered surveys, there was overall improvement in several domains from baseline to the fifteen-month follow-up. There was small to moderate improvement in several aspects of mood--total score, depression, anger, fatigue, and vigor--as well as two personality factors, conscientiousness and emotional stability. Several short-term improvements did not persist, including indicators of physician empathy, mood states, and personality factors such as extraversion, agreeableness, and openness. The positive changes in mindfulness were significantly correlated with gains in total mood disturbance, which combines six different mood elements, suggesting a benefit from the intervention.
Even so, the researchers said that because before-and-after designs limit inferences about intervention effects, these findings warrant randomized trials involving a variety of practicing physicians. Aside from not being a randomized, controlled trial, the study had several limitations, according to the researchers, including the use of physicians from a single location.
Also, the participants were more likely to be family physicians or to practice in rural areas, compared with nonparticipants. The investigators were unable to track how improvements over time affected clinical care, nor could they establish that the improvements were caused by intervention.
Zalman S. Agus, Intervention Linked to Reduced Burnout in Primary Care Docs, MedPage Today (Sep. 22, 2009).
*We would like to thank Jennifer P. Viegas, Esquire (Hall Render Killian Health & Lyman PC, Troy, MI), 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.