In the News for the Week of 4-25-06
Clinical news in the headlines
- Study finds drug effective in treating prehypertension
- ACP Journal Club: Aspirin plus clopidogrel reduced risk of death after heart attack
- Some free drug programs will continue under Medicare Part D
The business of medicine
- New list spells out 'do-not-use' medication abbreviations
- New product coding will put key drug information online
Clinical news in the headlines
A study published last week concluded that treating patients early for prehypertension significantly reduces the risk that they will go on to develop full-blown hypertension.
In the study, 772 patients—mean age 48.5—had systolic pressure of 130-139 mm Hg and diastolic pressure of 85-89 mm Hg. They were randomly assigned to receive either two years of candesartan (AstraZeneca's Atacand) or placebo, followed by two years of placebo for all. Antihypertensive therapy was initiated when patients' systolic pressure rose to 140 mm Hg or higher and their diastolic pressure to 90 mm Hg or above. All patients were instructed to make appropriate lifestyle changes.
During the first two years of the study, 154 patients developed hypertension in the placebo group compared with 53 in the candesartan group, a relative risk reduction of 66.3%. After four years—with both groups on placebo during the last two years—nearly two-thirds of patients in the placebo group developed stage 1 hypertension compared with just over half in the treatment group, a relative risk reduction of 15.6%. The study appeared in the April 20 New England Journal of Medicine (NEJM).
Treatment with candesartan appeared to be safe, with rates of adverse events similar in both groups, the authors said. They added that the results suggest that treating prehypertension pharmacologically may be more effective than lifestyle modifications alone.
This trial also found that the preventive effects of candesartan lasted up to two years after treatment was discontinued, although its effectiveness progressively diminished. Researchers noted that about 25 million Americans have the same range of blood pressure readings as study participants.
However, an accompanying editorial noted that the difference in the two study groups might have been overestimated. Candesartan appears to have masked rather than prevented development of hypertension in the first phase of the study, as nearly 50% of the participants eventually ended up developing hypertension regardless of which study group they were in.
In addition, the editorial said, candesartan works by inhibiting the renin-angiotensin system, whereas current recommendations for managing pre-hypertension through lifestyle changes, such as healthy diet, physical activity and weight loss, address multiple risk factors. Drug treatment is more convenient than these other interventions, the editorial noted, but the safety and cost implications of recommending drug treatment for such a large population are still unclear.
Adding clopidogrel to aspirin improved outcomes for patients hospitalized for suspected myocardial infarction (AMI), a recent study reported.
The trial involved more than 45,000 patients in China who were hospitalized within 24 hours of AMI symptoms with ST elevation, left bundle branch block or ST depression. Patients were given either 75 mg of clopidogrel daily or placebo, and all patients received 162 mg of aspirin; patients were also allocated to metoprolol or placebo. Patients given clopidogrel had an 8.2% relative risk reduction (number need to treat: 122) for death, reinfarction or stroke compared with those taking aspirin alone. Metoprolol did not affect outcomes compared with placebo.
The study, abstracted in the May-June ACP Journal Club, supports findings from earlier trials, said David Massel, MD, of the London Health Sciences Centre in London, Ontario, Canada. Even though the trial was conducted in China, where invasive procedures are less common than in the United States, study results should apply here based on other studies showing that clopidogrel benefits patients undergoing percutaneous coronary intervention.
Clopidogrel, while expensive, could be cost-effective, said Dr. Massel. Based on this trial, clopidogrel use would result in six fewer deaths per 1,000 treated, as well as fewer recurrent AMIs and no excess strokes, he said. The cost difference over a month of use would be about $100 compared with aspirin alone.
Clopidogrel should be given with aspirin in patients with ST elevation AMI and a low risk of bleeding, Dr. Massel said. He recommended using a 300-mg loading dose followed by 75 mg daily for at least nine to 12 months.
Peer ratings for this review: cardiologists; general internists and subspecialists; hospitalists: 7/7 stars.
Emergency medicine specialists: 6/7 stars.
ACP Journal Club is online.
The government last week approved a program that would allow low-income Medicare beneficiaries to continue to receive free drugs from manufacturers if they meet certain income requirements.
Many drug companies recently said they were stopping the free programs after receiving government warnings about the potential for abuse, said the April 19 New York Times. The companies had offered to continue to pay beneficiaries' drug costs under Medicare's new prescription drug program, which requires participants to pay for prescriptions out-of-pocket during a coverage gap between initial costs and Medicare's catastrophic coverage threshold.
Last November, the U.S. inspector general charged that drug manufacturers could use the programs to promote their own products over potentially cheaper alternatives, thereby increasing Medicare's costs, said the New York Times. However, many low-income patients, who had received free drugs before the Medicare drug benefit took effect, had been relying on company assistance to help cover their costs.
The inspector general approved two specific drug programs to operate outside of the Medicare drug benefit, said the New York Times. Recipients of the free drugs cannot file claims with Medicare, and the cost of the drugs cannot count toward their $3,600 out-of-pocket yearly total. Eligibility for assistance would be based solely on financial need.
The ruling allows Medicare beneficiaries who sign up for the drug benefit to receive drug company assistance if they have annual incomes of less than $14,700 for an individual and $19,800 for a couple, the article said. That would force some drug companies to revise their programs. Schering-Plough, for example, which requested the inspector general's opinion, had set income thresholds at $25,000 for individuals and $33,000 for couples.
The New York Times is online.
The business of medicine
Aetna Inc. announced last week that it is changing some key payment policies in response to a physician class-action lawsuit.
As a result of that lawsuit, Aetna is changing two payment practices pertaining to E/M service codes. The company will now reimburse physicians for two E/M codes that have the same date of service, and for an E&M code with a -57 (decision for surgery) modifier when billed with a major procedure. These changes took effect Feb. 6, 2006.
Providers can refile claims for those E/M services provided 180 days prior to Feb. 6, 2006, by either submitting the denied claims with a cover letter and subject line that reads "Rework Request for E&M Codes" or by calling the Aetna provider service center at 888-632-3862 for claims related to indemnity and PPO plans, or 800-624-0756 for HMO plan claims.
In another step to resolve the class-action suit, Aetna also announced that it is now accepting new and resubmitted claims for four CPT add-on codes related to computer-aided detection (CAD) mammography services and myocardial perfusion testing services. The deadline for submitting new or former claims for payment is July 14, 2006.
Aetna had refused to reimburse physicians for services reported with those add-ons, claiming its computer systems couldn't recognize the codes. In response to the suit, the insurer has modified its computer systems and agreed to pay new and retrospective claims.
The add-on codes in question are:
CAD mammography service codes 76082 and 76083, for services provided to Aetna members between Jan. 1, 2004, and March 31, 2005; and
myocardial perfusion testing service codes 78478 and 78480, for services provided to Aetna members between Jan. 1, 2004, and May 12, 2005.
Aetna is waiving timely filing and appeals deadlines, although late interest and penalty payments will not apply.
More information about the payment changes, including additional processing information, is online.
A series of health insurance industry mergers over the past decade has led to reduced competition and higher premiums in many markets, according to the results of a new AMA study.
The AMA report found that a single insurer had a market share of 30% or more in 95% of the 294 U.S. metropolitan areas surveyed, according to an April 17 AMA news release. In 56% of those markets, a single insurer controlled 50% or more of the market.
Between 1995 and 2005, there were more than 400 health insurance industry mergers, the AMA release said. At the same time, health insurers have posted record-high profit margins and consumer premiums have continued to rise.
The report said that the domination of a few insurers in most markets leaves physicians with very little negotiating power. The majority of physicians are self-employed and in practices with four or fewer physicians, the report said, creating a "severe imbalance in bargaining power."
Insurance companies disputed the report's findings, according to the April 19 Los Angeles Times. Rising premiums are tied to more expensive drugs and treatments, they said, not higher profits.
The AMA report recommended a reexamination of regulations governing health insurance markets. Significant barriers to entry, such as state regulatory requirements and the cost of developing a physician network, have prevented new players from emerging and encouraged existing companies to acquire smaller companies, instead of developing new products and networks.
The AMA news release and link to the report are online.
The Los Angeles Times is online.
A national patient safety organization has posted a comprehensive list of commonly misinterpreted medication abbreviations that should never be used.
The list, compiled by the nonprofit Institute for Safe Medication Practices (ISMP), contains more than two dozen common medical abbreviations. The institute said the abbreviations should never be used in either internal communications about medications or in transmitting prescription information to pharmacies or computerized physician order entry systems.
The list includes the suspect abbreviation, its intended meaning, how it is misinterpreted and the correct abbreviation or language that should be used instead. For many of the abbreviations, the ISMP recommends that physicians instead spell out the word or phrase being abbreviated.
The list was compiled from errors reported to the ISMP, which is a national nonprofit organization dedicated to medication error prevention and patient safety. The ISMP and the FDA intend to launch an intensive educational campaign in June to convince providers to stop using confusing medical abbreviations and dose designations.
The ISMP list flags those abbreviations that have been singled out by the JCAHO on its "do not use" list, but it goes beyond JCAHO requirements in reporting other abbreviations that should be avoided. The list is online.
In a step to promote standardized electronic health records, the FDA last week announced an initiative aimed at making it easier for physicians to access prescription drug information electronically via their computer or hand-held device.
The new program requires drug manufacturers to use a common computer code, known as the Systematized Nomenclature of Medicine (SNOMED), for electronic coding of the medical conditions section of the "highlights" data elements, according to an April 19 FDA news release. Starting June 30, the format will be required on all drugs approved within the last five years and for newly-approved drugs.
The move may alleviate physicians' frustrations with navigating complex government drug information, according to the April 20 Baltimore Sun. Worried that physicians might get inaccurate information from private sources, the FDA in January simplified the wording of drug package inserts in the "highlights" section.
The new coding initiative goes further by requiring manufacturers to present the "highlights" section information in a standardized electronic format. The common format is designed to make it easier to transfer information from private services and government or health system databases to physicians.
As prescription information is converted into the new format, it will be supplied to DailyMed, an interagency online health information clearinghouse sponsored by the National Library of Medicine, according to the FDA release. DailyMed provides the latest information about FDA-regulated products free on its Web site.
The FDA news release is online.
The Baltimore Sun is online.
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Copyright 2006 by the American College of Physicians.
A 38-year-old woman is evaluated during a follow-up visit. She has a history of well-controlled hypertension and type 1 diabetes mellitus. She is at 16 weeks' gestation with her first pregnancy. Prior to conception she was taking lisinopril, which was discontinued in anticipation of the pregnancy, and labetalol was initiated. Other medications are insulin glargine, insulin lispro, and a prenatal vitamin. Following a physical exam and lab studies, what is the most appropriate step in the management of this patient's hypertension? .
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