In the News for the Week of 2-28-06
Clinical news in the headlines
- Study on popular arthritis supplements yields lackluster results
- ACP Journal Club: Early intervention did not improve outcomes for high-risk acute coronary patients
- Medicare gives nod to covering bariatric surgery
Medicare Part D
- Many low-income seniors skeptical of new drug benefit
- FDA approves generic version of Flonase
Pay for performance
- College allays concerns about AMA's deal with Congress
- Physicians can tailor their own diabetes CME program
Maintenance of certification
- ABIM releases four new practice improvement modules
- Center for Practice Innovation now accepting applications
- New College guide helps practices with waived lab testing
- Wanted: internists for 5K Fun Run at Annual Session
Clinical news in the headlines
Study on popular arthritis supplements yields lackluster results
A study involving glucosamine and chondroitin sulfate, both widely used by arthritis sufferers, found that the supplements did nothing to relieve most patients' pain.
In the study, 1,583 patients with knee osteoarthritis were randomly assigned to take 1500 mg of glucosamine, 1200 mg of chondroitin sulfate or both. Comparison groups took either 200 mg of celecoxib daily or placebo. Glucosamine, chondroitin or a combination of the two had no significant effect on pain, except in a small subgroup of patients with moderate to severe pain who benefited from taking the combination dose. The study appeared in the Feb. 23 New England Journal of Medicine (NEJM).
The authors noted that glucosamine and chondroitin sulfate are the most widely used dietary supplements for osteoarthritis, with U.S. sales of $730 million in 2004. Despite the results, the positive effect on people with moderate to severe pain suggests that some might benefit from taking the supplements. However, researchers stressed that more research is needed to test this theory.
It is also possible that another type of glucosamine might be effective, said an expert interviewed in the Feb. 23 New York Times. Some studies have suggested that glucosamine sulfate might be more effective than the glucosamine hydrochloride used in this study.
However, other experts interviewed claimed that the results were convincing and in line with what is known about how the supplements are processed by the body. They noted that the current study was scientifically rigorous, whereas some previous studies have either had flawed methodology or were financed by supplement makers.
Physicians should note that celecoxib was the most efficient in relieving pain during the study, the authors said. The study was funded by the National Center for Complementary and Alternative Medicine and the National Institute of Arthritis and Musculoskeletal and Skin Diseases.
The NEJM abstract is online.
The New York Times is online.
ACP Journal Club: Early intervention did not improve outcomes for high-risk acute coronary patients
Contrary to another large study on acute coronary syndromes, a recent trial concluded that an early invasive strategy did not improve patient outcomes.
In the study, 1,200 patients with symptoms of ischemia, but not acute MI with ST elevation or indication for primary percutaneous coronary intervention (PCI), received either an early invasive strategy-angiography within 24 to 48 hours and PCI when deemed appropriate—or a conservative strategy, which included angiography and, if necessary, revascularization. All patients were given aspirin and enoxaparin plus abciximab during PCI. Many patients also received clopidogrel and intensive lipid-lowering therapy.
After one year, there was no significant difference in death, myocardial infarction or rehospitalization for patients who received early intervention vs. a selective invasive strategy. The results are abstracted in the March-April ACP Journal Club, now available online.
These results contrast with a recent meta-analysis that found an early invasive approach to be superior, said reviewer Michelle Welsford, MD, of McMaster University in Hamilton, Ontario. The main difference between that study and this one is that patients in this study received more aggressive therapy, she wrote. In contrast with this study, for example, none of the patients in the meta-analysis received clopidogrel, which has been shown to benefit high-risk patients.
In addition, this study had much higher rates of mechanical revascularization and recruited fewer patients with diabetes, Dr. Welsford noted. These factors may have contributed to the lower rate of one-year mortality (2.5% in this study vs. between 5.5% and 6.0% in the meta-analysis). She noted that this latest study may prompt a re-evaluation of the current recommendations for an early invasive approach.
Peer ratings for this review: cardiologists, internists and subspecialists, hospitalists, emergency medicine, and family practice: 6/7 stars.
ACP Journal Club is online.
Medicare gives nod to covering bariatric surgery
The CMS last week approved coverage for three types of bariatric surgery, acknowledging that the procedures can be safe and effective in combating obesity.
The new rules state that Medicare will cover the procedures at centers certified by the American College of Surgeons or the American Society of Bariatric Surgery, according to the Feb. 22 Washington Post. To qualify for the benefit, patients must have other health problems related to obesity, such as hypertension, type 2 diabetes or coronary heart disease.
Proponents of bariatric surgery applauded the decision, saying it could pave the way for covering other obesity treatments, such as weight loss programs or drugs, said the Washington Post. Medicare's decision also might lead to many private insurers covering weight-loss interventions.
However, critics interviewed in the article noted that the surgery can be dangerous, especially for elderly patients or patients undergoing procedures at low-volume centers with relatively inexperienced surgeons. Possible serious complications, said the Washington Post, include bleeding, blood clots, leakages and infections, while less serious side effects include nausea, vomiting and diarrhea.
Medicare will cover the procedure for seniors only in high-volume centers that achieve low mortality rates, noted a Feb. 21 CMS news release. In the past, Medicare has covered only gastric bypass surgery but the new ruling expands the list of covered procedures to include open and laparoscopic roux-en-y gastric bypass; laparoscopic adjustable gastric banding; and open and laparoscopic biliopancreatic diversion with duodenal switch.
The Washington Post noted that the number of people undergoing bariatric surgery procedures rose from 16,000 in 1992 to 170,000 in 2005. Those figures have grown despite the surgery's high costs—between $25,000 and $50,000—and the fact that some insurers don't provide coverage.
The CMS news release is online.
The Washington Post is online.
Medicare Part D
Many low-income seniors skeptical of new drug benefit
Enrollment figures for Medicare's new prescription drug program are far lower than expected due to trouble convincing many eligible low-income seniors to sign up, according to recent news reports.
Only 1.4 million low-income beneficiaries who qualify for a drug plan subsidy and who do not qualify for both Medicaid and Medicare have signed up for Medicare Part D coverage, far fewer than the 8 million eligible, said the Feb. 21 Washington Post. The government has launched a $400 million campaign to enroll low-income seniors but officials have found it difficult to convince many to sign up.
The drug plan operates on a tiered system where the poorest beneficiaries pay the least for coverage while those with the highest incomes can choose to purchase plans with monthly premiums and copays, said the Washington Post. About 6 million poor and disabled people were automatically switched from Medicaid to the new Medicare program, the article said, but there have been many challenges in getting beneficiaries whose incomes fall between these two groups to join.
Many in that mid-tier group-who make less than $19,000 a year move frequently, may not speak English or suffer from mental impairments, said the Washington Post. However, by signing up, these beneficiaries qualify for coverage with no premiums, no deductibles and nominal co-payments.
Government officials have asked community groups across the country to help enroll low-income seniors. However, many beneficiaries have been reluctant despite the cost advantages, fearing that other benefits will be taken away.
Social Security Administration offices have been overwhelmed with making field visits and answering calls about the program, said the Washington Post. Since the sign-up campaign began, the office has purchased new computer systems, hired 2,500 employees, participated in 65,000 informational meetings and sent letters to 19 million retirees.
The Washington Post is online.
ACP has created a Medicare Part D Web site with practical information for physicians, staff and patients.
The College has also created a Web site for members to e-mail specific Part D benefit problems and get help from ACP staff. Post questions online or call the ACP Part D helpline at 800-338-2746, ext. 4535.
FDA approves generic version of Flonase
The FDA last week approved the first generic version of the popular allergy spray Flonase, providing a lower-cost alternative for many allergy sufferers.
Flonase, made by GlaxoSmithKline, is among the world's best-selling drugs, according to the Feb. 23 New York Times. The generic version, known as fluticasone propionate nasal spray, is already being shipped by its manufacturer, Roxane Laboratories, a division of Boehringer Ingelheim.
The generic version treats symptoms of seasonal and chronic allergic and nonallergic rhinitis, said a Feb. 22 FDA news release. The product--which contains a synthetic, trifluorinated corticosteroid with anti-inflammatory activity--can produce some side effects including headache, sore throat and nosebleed.
Applications by generic drugmakers to the FDA's Office of Generic Drugs have almost doubled over the past five years, said the New York Times. The agency also has a large backlog of 850 applications.
The FDA release is online.
The New York Times is online.
Pay for performance
College allays concerns about AMA's deal with Congress
The AMA has signed an agreement with Congressional leaders to develop more than 100 standard performance measures linked to improving quality of care.
Under the deal, physician groups would decide on about 140 performance measures covering 34 clinical areas by the end of 2006, according to the Feb. 21 New York Times. Voluntary reporting on between three and five different quality measures per physician would begin in 2007 and doctors who report would be eligible for additional payments.
Some medical specialty groups objected to the agreement, citing concerns that the program would be used to cut Medicare fees and that they could not meet the set timetable, said the New York Times. However, College officials said the agreement is in line with what physician groups have been working toward.
"All the AMA agreed to was to work to get physician groups to develop more measures to allow for voluntary reporting in 2007," said Robert B. Doherty, ACP's Senior Vice President for Governmental Affairs and Public Policy. He pointed out that the commitment to develop more measures and the specified timeframe are reasonable.
"The profession needs to show that it is willing to come to the table to develop evidence-based measures in a timely manner, and to commit to a process that will lead to using such measures in a voluntary reporting program," Mr. Doherty added. "That's the key issue."
The agreement, dated Dec. 16, was signed by the chair of the AMA and three members of Congress: Sen. Charles E. Grassley (R-Iowa), Rep. Bill Thomas (R-Calif.) and Rep. Nathan Deal (R-Ga.).
The New York Times is online.
Physicians can tailor their own diabetes CME program
Physicians can now access a new CME program designed to help them improve their ability to manage diabetes. The program, developed by the National Diabetes Education Program (NDEP), focuses on several essential areas of diabetes care.
Called BetterDiabetesCare, the new program allows physicians to choose among several different diabetes care delivery issues and determine which aspects of diabetes management to focus on. Options include:
- how to create a patient-centered management team;
- how to manage patient records and reports; and
- how to evaluate patient outcomes and make informed decisions about quality improvement.
The online program provides current peer-reviewed literature and evidence-based practice recommendations. It also includes models, links, resources and other tools to help physicians assess their diabetes management needs, develop and implement strategies, and evaluate results. The College is a NDEP partner.
By documenting the process--and paying a nominal fee of $10--participating physicians can receive up to 10 hours of CME credits per year.
The new program is online.
Information about the NDEP is also online.
Maintenance of certification
ABIM releases four new practice improvement modules
The ABIM has just issued four new practice improvement modules (PIMs) that have been designed for general internists, as well as for gastroenterologists and infectious disease specialists. Completing PIMs counts toward ABIM's maintenance of certification program as well as CME credit.
Physicians can use the Web-based PIMs to review current guidelines and conduct a confidential self-evaluation of the care they provide by using their own de-identified patient data and designing a practice improvement plan.
Here are the four new PIMs:
Self-directed PIM. The module allows physicians to use performance measures provided by external groups to complete their practice performance assessment requirement for recertification. Physicians who already receive practice data from health plans or state or medical society quality improvement programs can use those data in the PIM to design a practice improvement program and report changes.
Colonoscopy PIM. Based on current guidelines, the colonoscopy PIM allows practicing physicians to assess their quality in performing colonoscopies.
Hepatitis C PIM. This new PIM gives physicians an opportunity to review patient risk factors, diagnostic testing and treatment options.
HIV PIM. The PIM guides physicians through a review of HIV care to produce better outcomes.
The four new PIMs are in addition to already-established PIMs, which target diabetes, general preventive service and asthma, among other topics.
Center for Practice Innovation now accepting applications
The College's Center for Practice Innovation (CPI) is now accepting applications for practices to participate in its premier project.
The CPI will select between 25 and 50 small- and medium-sized practices from among the applicants to participate. The project will offer customized support and resources to test innovative approaches to practice redesign.
Innovations will focus on four priority areas: clinical quality improvement, practice management, physician education and patient safety/disease management. Participants will be chosen to represent diverse practice settings, size, stage of technology implementation, and patient and payer mix.
The center has posted an online application as well as additional information. The first 100 practices to complete the online application will receive a $50 honorarium. Practices that would like a paper-based application should contact the CPI via e-mail.
Additional funding will permit the Center to expand operations so practices not selected in this first phase will be considered for future projects.
For more information about CPI, see "Help is on the way for small physician practices" in the January-February ACP Observer.
New College guide helps practices with waived lab testing
ACP's Practice Management Center (PMC) has just released a new comprehensive how-to guide for physicians performing waived tests in their practice.
The free publication, "Waived Testing--Doing it Right," provides guidance to practices to help them comply with key quality control recommendations. Recent surveys show big gaps in compliance. According to recent CMS data, for example, 21% of facilities performing waived testing do not perform the quality control required by manufacturers, 12% do not report testing results correctly and 6% are using expired reagents.
The new PMC guide is based on recent CDC recommendations designed to improve those quality statistics. It details what is required in waived testing facilities and suggests how to meet those requirements and establish good laboratory practices. According to the guide, a well-designed quality system should take personnel less than two minutes a day to maintain and will reap major benefits for physicians and patients in assurance of accurate testing.
ACP members can download a free copy of "Waived Testing--Doing It Right" online.
For questions about regulation compliance and accreditation requirements for physician office labs, contact ACP's Medical Lab Evaluation department.
Wanted: internists for 5K Fun Run at Annual Session
ACP is holding its fourth annual 5K "Fun Run and Walk" at Annual Session 2006 to benefit an organization that provides service to underserved populations and trains health professionals.
The 5K event will take place Saturday, April 8, from 6-7 a.m. (Warm-up begins at 5:30 a.m., with shuttle bus service from hotels starting at 5 a.m.) The course begins at Philadelphia's famous Boathouse Row in historic Fairmount Park, site of the 1876 World's Fair. The run parallels the Schuylkill River and offers impressive views of the collegiate boathouses, early morning rowers, wildlife and the city skyscape.
Proceeds from registrations and sponsorships will be donated to Bridging the Gaps, an organization that teaches future health professionals about the connections among a community's socioeconomic structure, its health care system and the health of its population.
Internists attending Annual Session and their guests are welcome to participate and can register on ACP Online or onsite at Annual Session. The donation for the event is $25 per person, and the first 200 registrants will receive a free commemorative T-shirt.
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Copyright 2006 by the American College of Physicians.
A 30-year-old woman is evaluated for difficult-to-treat migraine. She has had severe headaches, usually on the first day of menses, since menarche. The pain is hemicranial, pulsatile, and associated with severe nausea and vomiting but no aura. She frequently awakens with the attack already in progress. A series of drug regimens have become ineffective in controlling pain. Following physical and neurological exams, what is the most appropriate next step in treatment?
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