In the News for the Week of 1-31-06
Health care forecast
- College advances "medical home" to avert looming primary care crisis
Part D update
- CMS creates new Medicare Part D resources
Clinical news in the headlines
- FDA approves first inhalable insulin
- Heart surgery drug found to double risk of kidney failure
- ACP Journal Club: Eplerenone reduces mortality after acute MI
- Smoking puts blacks at greater lung cancer risk than whites
Flu season update
- CDC promises to address vaccine distribution problems
Business of medicine
- Study: Specialty hospitals don't deliver cost savings or quality
Conflicts of interest
- Physician group calls for ban on drug company gifts
- Quality experts to meet, share best practices
- "Internists as Artists" program seeks entries for Annual Session
- New free ACP video helps patients deal with asthma
- Wanted: young physicians interested in networking at Annual Session
Health care forecast
During its annual report on the "State of the Nation’s Health Care" this week in Washington, the College presented recommendations to avert what ACP leaders called the looming collapse in primary care medicine. ACP's proposals would fundamentally change the way primary care is organized, delivered, financed and valued.
“We’ve developed a comprehensive plan of action to reverse the downward trend in primary care medicine before it is too late,” announced ACP President C. Anderson Hedberg, FACP. “Our recommendations would not only change the way that primary care is delivered, but how it is financed by Medicare and other payers.”
College leaders told member of the press that ACP was calling on policy-makers to:
- implement and evaluate a new model for financing and delivering primary care called the "advanced medical home."
- make fundamental reforms in the way Medicare determines the value of physician services under the Medicare fee schedule.
- provide sustained and sufficient financial incentives for physicians to participate in programs to continuously improve, measure and report on care quality and efficiency.
- replace the sustainable growth rate (SGR) with an alternative that would ensure adequate, predictable updates for all physicians.
The briefing showcased the new ACP position paper on the advanced medical home, a model College leaders said could resolve some of the major problems in the U.S. health care system and physician workforce.
The paper recommends voluntary certification and recognition of primary care and specialty medical practices that would:
- provide patient-centered care based on the principles of the chronic care model;
- use evidence-based guidelines;
- apply appropriate health information technology; and
- demonstrate the use of best practices to consistently and reliably meet the needs of patients while being accountable for care quality and value.
Information about the press briefing, as well as the advanced medical home position paper, is online.
Part D update
In an effort to resolve widespread problems with the new Medicare prescription drug benefit, the CMS last week announced new resources physicians and pharmacists can use to verify patients' coverage and fill needed prescriptions.
In a letter to health care professionals, the CMS said it has now created an online exceptions and appeals contact list for each prescription Medicare Part D plan. In addition, the CMS has created an exceptions and appeals process Web site, with materials for patients that describe that process.
Also new from the CMS is an e-mail option physicians can use to communicate directly with the CMS about specific Part D problems.
The CMS has also designed a fax form physicians and pharmacists can use to expedite their communications on drug formularies and options. That form is online.
And the CMS has set up dedicated lines for pharmacists to help answer questions on billing and enrollment. The agency is also requiring plans to cover a standard 30-day supply of transitional medications, and is offering a point of sale option for patients eligible for Medicare or Medicaid to join a plan at the pharmacy to get the drugs they need.
Medicare patients are also being urged to use the 800-MEDICARE hotline when they encounter problems filling prescriptions.
The CMS' letter to health care professionals is online.
More information is available on ACP's Part D Web site.
Clinical news in the headlines
The FDA last week approved the first inhalable form of insulin to treat diabetes, marking the first alternative to injections since the hormone was discovered in the 1920s.
The inhaled insulin, to be marketed as Exubera by Pfizer Inc., will not entirely replace the need for injections, said the Jan. 28 Philadelphia Inquirer. In addition, people with diabetes still will have to prick their finger to test their blood-sugar levels.
In clinical trials, the inhalable version worked as well as injected insulin, but the FDA advised diabetics to continue with occasional injections because needles are a better way to control dosage, the Philadelphia Inquirer reported. A Jan. 27 FDA news release noted that Type 2 diabetics may be able to use the inhaled insulin alone, with pills that control blood sugar, or with longer-acting injectable insulin.
As with the injectable version, low blood sugar is a side effect of Exubera, said the FDA. Other side effects include cough, shortness of breath, sore throat and dry mouth.
The FDA also said that diabetics who have smoked within the past six months should not use Exubera and that it is not recommended for patients with asthma, bronchitis or emphysema. Physicians should perform baseline tests for lung function, the FDA release said, before beginning treatment and every six to 12 months thereafter.
Pfizer has agreed to perform continuing, long-term safety studies to monitor the safety of Exubera in patients with underlying lung disease, according to the FDA. The new drug provides an alternative to more than 5 million Americans who currently take insulin injections.
The FDA news release is online.
The Philadelphia Inquirer is online.
A recent study concluded that a drug commonly given during cardiac surgery to limit blood loss significantly increases patients' risk of renal failure and heart attack.
In the study, 4,374 surgery patients at 69 sites worldwide were given either aprotinin, aminocaproic acid or tranexamic acid. Aprotinin doubled the risk of renal failure in patients undergoing complex coronary-artery surgery or primary surgery (odds ratio, 2.59; 95% confidence interval, 1.36 to 4.95). The drug was also associated with a 55% increase in risk of myocardial infarction and a 181% increase in the risk of stroke in primary surgery patients.
The authors advised physicians to stop using Bayer Corp.’s aprotinin, estimating that its use has led to kidney dialysis for more than 11,000 patients each year. They advised switching to the much less expensive generic drugs aminocaproic acid and tranexamic acid, which were effective in limiting blood loss without causing similar safety concerns. The study appears in the Jan. 26 New England Journal of Medicine (NEJM).
FDA officials said they are reviewing the study and will make recommendations soon, according to the Jan. 26 Washington Post. The study highlights problems with assessing safety after a drug has been approved, the article said. Clinical trials performed in the pre-approval phase often enroll many healthy volunteers but do not adequately assess how a drug will affect sick patients, and there is no system set up to assess safety on an ongoing basis.
While studies have been done on aprotinin since it was approved in 1993, those studies focused on its effectiveness in preventing blood loss, said the Washington Post. The current research—which was conducted by the California-based Ischemia Research and Education Foundation, an independent nonprofit foundation—was not a randomized controlled trial. An accompanying editorial noted, however, that the trial's large size makes the results convincing.
Aprotinin, derived from bovine lung tissue, is thought to cause damage because it stays in the kidneys for 24 hours, said the Washington Post. The other two drugs used in the study generally are excreted quickly.
The Washington Post is online.
The NEJM abstract is online.
A large international trial demonstrated that giving patients an aldosterone inhibitor following an acute myocardial infarction (MI) significantly reduced mortality.
In the trial, 6,632 patients with acute MI complicated by left ventricular systolic dysfunction and heart failure were given either 25 mg of eplerenone or placebo at three to 14 days post-MI. After 30 days, patients in the eplerenone group had a relative risk reduction in all-cause mortality of 31% compared with the placebo group (from 4.6% to 3.2%, NNT 72). The study is abstracted in the January-February ACP Journal Club.
This trial, known as EPHESUS, was the basis for the October 2003 approval of eplerenone by the FDA, said Journal Club reviewers Carey D. Moyer, MD, and Peter B. Berger, MD, of the Duke Clinical Research Institute in Durham, N.C. Based on these positive results, they said, eplerenone might be beneficial if started even sooner than three days after an acute MI.
However, clinicians should remember to look for hyperkalemia before administering the drug, the reviewers said. They suggested using the “rule of ones”: checking potassium levels before initiating therapy and at one day, one week and one month after initiation.
A subsequent analysis indicated that the adjunct treatment is cost effective, according to the reviewers. The incremental cost-effective ratio ranged between $10,400 and $21,876, compared with the generally accepted threshold of $50,000 per life-year gained. Based on EPHESUS results, reviewers said, physicians should be encouraged to initiate therapy with eplenerone after an acute MI.
Peer ratings for this review: hospitalists and cardiologists, 6/7 stars
ACP Journal Club is online.
Fueling the debate over the role of biology in racial health disparities, a new study has determined that blacks are more likely than whites to get lung cancer from moderate smoking.
In the eight-year study, researchers followed 183,813 black, Japanese-American, Latino, Native Hawaiian, and white men and women. Among light and moderate smokers, relative risk for lung cancer ranged between 45% and 57% among whites, compared to African Americans. There was no significant difference in risk among heavy smokers (30 or more cigarettes a day). The study appears in the Jan. 26 New England Journal of Medicine (NEJM).
The study also found that Latinos and Asians had a reduced risk of developing the disease compared with whites, and that women generally had a lower risk than men. Blacks and native Hawaiian men appeared to be at increased risk for lung cancer despite smoking fewer cigarettes per day than whites.
The results add to a longstanding debate over whether race makes people more susceptible to certain diseases, said the Jan. 26 Washington Post. Proponents of racial causes for disparities said the new research should encourage a greater focus on the role of genetic variations in racial health disparities, while others contended that the study could foster unnecessary racial stereotyping.
One possible explanation for the differences in risk is how different groups metabolize nicotine, which affects their uptake of carcinogens, study authors said. Blacks were found to have higher cotinine levels than whites and Hispanics after smoking the same number of cigarettes, and blacks have been reported to inhale more nicotine per cigarette than the other groups.
The authors recommended that future studies on smoking-related lung cancer focus on the differences in the metabolism of nicotine and tobacco carcinogens between different ethnic groups.
The Washington Post is online.
A NEJM abstract is online.
Flu season update
The CDC last week conceded problems with the flu vaccine distribution system and promised to take a larger role in buying and tracking the supply.
Speaking at a major flu vaccine summit last week, CDC officials said they had little control over distribution because the government does not own the supply. The CDC purchased about 11.5 million doses out of the 86 million produced by private industry this flu season, the Jan. 25 Boston Globe reported.
Public health officials at the summit said they were concerned about the current fragmented distribution system, the article said. Without an organized network to track the available supply, they said, the nation would be ill-equipped to deal with a flu pandemic.
The CDC said it is considering implementing a detailed tracking system that would ensure that available vaccine goes where it is most needed, said the Boston Globe. However, such efforts have been hindered by drug companies' reluctance to disclose the details of their customers’ vaccine orders.
After one major production facility closed down in 2004, leading to a vaccine shortage, GlaxoSmithKline entered the market and produced 7.5 million shots for the current season, the Boston Globe said. GlaxoSmithKline plans to boost its production to 30 million doses for next season, part of an estimated total of 120 million shots manufacturers expect to produce.
The Boston Globe is online.
Business of medicine
A small study conducted by the Center for Studying Health System Change (HSC) found that purchasers in three communities with specialty hospitals—often devoted to cardiac or orthopedic care—believe these hospitals are driving up health care costs, not fostering more competition, as proponents of specialty hospitals argue. The survey also found that purchasers are not finding better quality in using specialty hospitals.
The HSC talked with health plans and employers in Indianapolis, Little Rock, Ark., and Phoenix. Researchers were especially interested in the impact of specialty hospitals on employer-sponsored health coverage and market dynamics.
While some purchasers in those markets said they received significant discounts on some cardiac or orthopedic services—attributing this to competition related to specialty-hospital options—others did not report lower prices. Some survey participants told researchers they believed referring physicians, particularly those with a financial interest in specialty hospitals, drove up volume by referring patients for elective procedures.
The survey also found that purchasers had few opinions on specialty hospitals' performance, even though some specialty hospitals had been in the community for some time. Some respondents did indicate that specialty hospitals performed well on uncomplicated cases, with less success on more difficult cases.
It also found that local employers were not demanding that health plans include specialty hospitals in their coverage package.
The findings are online.
Conflicts of interest
In a statement published last week, a group of influential physicians came out in favor of banning gifts from drug companies to physicians.
Medical schools and teaching hospitals should take the lead in implementing the ban, although all physicians should eventually comply, according to the statement in the Jan. 25 Journal of the American Medical Association (JAMA). The authors estimated that drug companies spend tens of billions of dollars a year on gifts to doctors or on consulting arrangements.
Funding for the statement was provided by the ABIM Foundation and the New York-based Institute on Medicine as a Profession. Among the 11 statement authors were Troyen A. Brennan, FACP, Governor-elect for ACP's Massachusetts Chapter, and David Blumenthal, ACP Member, of Harvard Medical School; as well as Jordan J. Cohen, MACP, of the Association of American Medical Colleges.
While companies are forbidden by federal law from paying doctors directly to prescribe drugs or devices, gifts and consulting contracts are not regulated, said the Jan. 25 New York Times. A recent lawsuit provided details of a consulting contract in which device maker Medtronic paid a Wisconsin surgeon $400,000 for eight days of consulting.
Most doctors, however, receive small gifts, such as office supplies or drug samples, and many say these do not affect their medical judgment, said the New York Times. However, the JAMA statement claimed that even small gifts can have a negative impact on care and should be banned.
The JAMA article also recommends disallowing all “no strings attached” consulting arrangements and posting other agreements between companies and physicians on Web sites. Physicians also should refuse to take free drug samples, the statement said, suggesting that a system of vouchers for low-income patients could replace the practice.
The New York Times is online.
The JAMA statement is online.
A meeting next month in Miami will bring together many of the nation's leading quality experts to discuss the challenges of quality improvement in a rapidly changing business and clinical environment. The forum is the annual meeting of the American Health Quality Association, a nonprofit organization that is working to improve health care quality through local, independent quality evaluation and improvement programs.
The meeting, being held Feb. 20-24, will bring together leaders of quality improvement organizations, clinicians, informatics professionals, and state and federal policy-makers.
ACP's Michael S. Barr, FACP, Vice President for Practice Advocacy and Improvement and Director of the College's new Center for Practice Innovation, will present at the meeting.. Dr. Barr's session will focus on redesigning small and medium-sized practices, with an emphasis on changing practice culture and systems to improve care quality.
Other sessions will cover how to improve patient outcomes and cut costs, especially for Medicare patients. In addition, presentations will explore implementing health information technology and pay for performance, integrating resident-centered care in nursing homes, and achieving better care through the new Medicare Part D drug benefit.
Information on meeting registration is online.
More information about the Center for Practice Innovation is also online.
ACP is seeking internists with talents in the visual arts who want to display their work at Annual Session 2006 in Philadelphia. Entries for ACP's national "Internists as Artists" program are being accepted through Feb. 10.
Submissions can take the form of painting, sculpture, photography, mixed media, woodworking, jewelry, crafts or ceramics. The exhibit will be located in the Pennsylvania Convention Center Exhibit Hall during Annual Session, and entries will judged by program jury members.
Members may submit up to two entries, and must submit an application form and send either a photograph or an electronic image of their artwork. This second-annual "Internists as Artists" program is modeled on an Evergreen Award-winning event established by ACP's Virginia Chapter.
Completed application forms and electronic or photographic images should be sent to: Helen Canavan, ACP "Internists as Artists" Program, 190 N. Independence Mall West, Philadelphia, PA 19106-1572. Application forms are available from Ms. Canavan via e-mail or by calling 800-523-1546, ext. 2663. Forms may also be downloaded from ACP Online.
ACP has just released "Living with asthma: A guide for African American families," the newest in its collection of patient education DVDs and videos. The free DVD and accompanying handbook help educate patients on how to manage asthma and prevent complications.
The DVD features Olympic gold medalists Vonetta Flowers of the U.S. bobsled team and basketball star Sheryl Swoopes, and helps patients discover asthma triggers, prevent breathing problems and understand asthma medications.
Members can order the free DVD and guidebook (a shipping and handling fee apply) online or by contacting ACP Customer Service at 800-523-1546, ext. 2600 (product code 700460010).
The College's Council of Young Physicians invites young internists attending this year's Annual Session to network and get advice from experienced colleagues during a breakfast meeting on Friday, April 7, in Philadelphia.
Mentors at the breakfast meeting will offer personal guidance on topics such as recertification, career-family balance, women in medicine, advocacy, academic medicine, and new practice start-up. Mentors will be seated at round tables designated for small group discussions on different topics. Signs on tables will announce the topics, with attendees selecting those that interest them.
While there is no charge for the breakfast, interested attendees are asked to pre-register online by March 17.
About ACP ObserverWeekly
ACP ObserverWeekly is a weekly newsletter produced by the staff of ACP Observer. It is automatically sent to all College members who have an e-mail address on file with ACP.
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Copyright 2006 by the American College of Physicians.
A 53-year-old woman is evaluated for a 3-month history of swelling of the face, hands, and feet. She has untreated hepatitis C virus infection. She takes lithium for bipolar disorder. She has no additional symptoms. After a physical exam, lab results and kidney biopsy, what is the most likely cause of this patient's nephrotic syndrome?
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