In the News for the Week of 2-24-04
Access to care
- HHS: Hospitals can discount rates for low-income and uninsured patients
- New FDA campaign aims to cut drug sales from Canada
- FDA proposes high-tech fight against counterfeit drugs
- ACP wants stronger risk warnings in consumer advertising for drugs and devices
Clinical news in the headlines
- Statin treatment may help heart failure patients
- Higher cumulative use of antibiotics associated with greater breast cancer risk
Health care disparities
- Premature heart disease death rates highest among minorities
- ACP and ABIM launch pilot CME project for Practice Improvement Modules
- New ACP Medicine reference text released
HHS: Hospitals can discount rates for low-income and uninsured patients
In a letter sent last week to the American Hospital Association (AHA), HHS Secretary Tommy G. Thompson said that hospitals do not violate federal fraud and abuse laws by extending discounted fees to uninsured patients or to Medicare beneficiaries who cannot pay copays or deductibles.
Mr. Thompson's guidance, as well as a document issued earlier this month by the Office of the Inspector General (OIG), were in response to a request made by the AHA in December for clarification. The AHA claimed that Medicare policy required hospitals to maintain the same price lists for all patients, preventing hospitals from giving discounts to patients with financial hardships.
Mr. Thompson responded, however, that there is nothing in Medicare regulations that prohibits offering discounts, and he encouraged hospitals to extend discounts or waivers to patients who need them. In its clarification, the OIG said that hospitals can offer Medicare patients waivers for their portion of Medicare cost-sharing obligations as long as those waivers were not part of an advertising campaign to solicit new patients.
According to the Feb. 20 New York Times, AHA officials said the guidance left unanswered questions about how large a discount can be offered to patients whose income exceeds the federal poverty level.
The HHS' letter is online at http://www.hhs.gov/news/press/2004pres/20040219.html.
The New York Times article is online at http://www.nytimes.com/2004/02/20/politics/20INSU.html.
More information from the AHA, as well as a link to the OIG document, is online at http://www.hospitalconnect.com.
New FDA campaign aims to cut drug sales from Canada
FDA officials last week teamed up with a pharmacy trade group in California to launch an information campaign that would discourage Californians from buying prescription drugs from Canadian pharmacies.
According to the Feb. 18 San Francisco Chronicle, the California campaign--in which 1 million information packets will be distributed to consumers throughout the state--is similar to one begun by the FDA in Illinois. The goal of the campaign is to convince patients that buying drugs from Canadian pharmacies, particularly over the Internet, is unsafe.
The new campaign comes as local and state officials in California are considering ways to reimport drugs from Canada to save money. Several other municipalities and states around the country are challenging the federal ban on reimporting medications from Canada.
The San Francisco Chronicle is online at www.sfgate.com/cgi-bin/article.cgi?file=/chronicle/archive/2004/02/18/BUGRI52OFO1.DTL.
In related news, the drug tracking firm IMS Health Inc. released a study last week that found that sales of prescription drugs reimported from Canada in 2003 reached $1.1 billion, double the value of reimportation sales the previous year. (According to IMS, overall U.S. prescription sales last year grew by 11.5%, to $216.4 billion.)
According to IMS officials quoted in the Feb. 18 Philadelphia Inquirer, the trend toward buying reimported drugs is leveling off, due partly to increased FDA enforcement efforts and to drug companies' restricting drug supplies to Canadian pharmacies.
An IMS news release is online at www.imshealth.com.
The Philadelphia Inquirer article is online at: www.philly.com/.
FDA proposes high-tech fight against counterfeit drugs
In a new report, the FDA urged drug manufacturers, distributors and pharmacists to begin using electronic tracking chips and other drug-identification technologies to protect against counterfeit drugs.
The February report recommends replacing paper-based systems that track drugs from production to dispensing with technologies such as radio frequency identification tags embedded in drug labels or boxes, according to the Feb. 19 Washington Post.
The report also recommends other measures to help prevent counterfeiting, including using other types of chemical or ink markers, and adoption of stronger anti-counterfeiting state laws and regulations. The FDA set a deadline of 2007 for the technology to be in place, although FDA officials said the new technologies would not be mandatory. The drug industry would oppose regulations that would mandate anti-counterfeiting measures.
While the problem of counterfeit drugs is not widespread, the FDA report said it is growing. More than 20 counterfeit drug investigations have taken place every year since 2000, up from an average of five per year in the 1990s.
In related news, the ACP last week agreed to participate in the FDA's counterfeit action network, to alert College members about specific counterfeit drug investigations and to let members know what they can do to identify counterfeit drugs and report suspect medications.
The FDA report is online at www.fda.gov/oc/initiatives/counterfeit/report02_04.html.
The Washington Post is online at: www.washingtonpost.com/ac2/wp-dyn/A52784-2004Feb18.
ACP wants stronger risk warnings in consumer advertising for drugs and devices
In a Feb. 18 letter, College President Munsey S. Wheby, FACP, asked the FDA to expand its proposed guidance published earlier this month on medication and medical device advertising to consumers.
When it comes to drug advertising, the letter said the College applauds the FDA's efforts to release further guidance on direct-to-consumer advertising. However, Dr. Wheby pointed out that the College does not agree with the FDA proposal to have advertising include risk information about only the most serious side effects of a medication. Such limited information, the letter said, might not warn patients about potential drug interactions.
If the FDA proceeds with its proposal, the College asks that advertising include a "Highlights" section that would include the most serious and common drug reactions, as well as a statement pointing out that the risk information is not comprehensive. The statement should also include a toll-free telephone number where consumers could get full risk information.
The letter also said that device advertising should "fully disclose" the potential harms and benefits of any advertised device.
The letter is online at www.acponline.org/hpp/doc_man.htm.
Statin treatment may help heart failure patients
Researchers from the University of California, Los Angeles (UCLA) have found that patients with heart failure may benefit from statin treatment. The findings suggest the possibility of a novel treatment for heart failure patients, according to a Feb. 17 UCLA press release.
In the study, published in the Feb. 18 Journal of the American College of Cardiology (JACC), statin use reduced the mortality rate of heart failure patients by 55%. The results were not related to the cause of patients' heart failure or their cholesterol levels.
Researchers analyzed medical records of 551 ischemic and non-ischemic heart failure patients, comparing patients who took statins for one year to patients who did not. Currently, only one-third of all heart failure patients are being treated with statins.
While the underlying reasons for statins' effectiveness are not clear, researchers theorized that the drugs may reduce inflammation, help block dilation of the ventricles, and decrease over-activity of the sympathetic nervous system that occurs during heart failure, leading to harmful levels of adrenaline.
The results indicate that statin use may reduce mortality as well as the need for urgent heart transplantation for heart failure patients.
A JACC abstract is online at www.cardiosource.com/content/library/journals/journal/article/abstract?acronym=JA.
The UCLA news release is online at www.newsroom.ucla.edu/page.asp?RelNum=4932.
Higher cumulative use of antibiotics associated with greater breast cancer risk
Researchers have found that long-term antibiotic use may be associated with a greater risk of breast cancer.
The study, published in the Feb. 18 Journal of the American Medical Association (JAMA), examined the medical records of 10,000 adult women in Washington state, more than 2,200 of whom had breast cancer. According to the Feb. 17 Washington Post, women who filled more than 25 separate antibiotic prescriptions over an average period of 17 years had twice the risk of developing breast cancer than women who took no antibiotics. Findings were consistent for all types of antibiotics.
The authors stressed, however, that no causal link was found between antibiotic use and breast cancer, and that more research is needed. They did not rule out the possibility that women who use more antibiotics are naturally predisposed to breast cancer because of weaker immune systems or hormonal imbalances, the Washington Post said.
Researchers did conclude that findings bolstered the need for "prudent long-term" antibiotic use.
A JAMA abstract is online at jama.ama-assn.org/cgi/content/full/291/7/827.
The Washington Post is online at www.washingtonpost.com/ac2/wp-dyn/A46452-2004Feb16.
Premature heart disease death rates highest among minorities
While the number of premature deaths from heart disease dropped in the United States in 2001, there were significant disparities in that decline among different racial and ethnic groups.
According to the CDC's Feb. 20 Morbidity and Mortality Weekly Report (MMWR), heart disease caused 29% of U.S. deaths in 2001, with almost 17% of those deaths occurring to patients younger than 65.
CDC statistics indicate that premature deaths from heart disease were highest among American Indians/Alaska Natives (36%) and blacks (31.5%), and lowest among whites (14.7%). Asians/Pacific Islanders and Hispanics also had higher premature heart disease death rates than whites.
Premature deaths from heart disease also varied by state, with Rhode Island having the lowest proportion (12.4%) and Alaska having the highest (35.7%). Other states with high premature heart disease death rates included Nevada, Georgia, South Carolina and Louisiana. The CDC report noted that some of those states also had among the highest state rates of smoking, high blood pressure, physical inactivity and obesity.
The CDC recommended improved health promotion and heart disease prevention strategies to decrease the disparity among different population groups.
The MMWR is online at www.cdc.gov/mmwr/preview/mmwrhtml/mm5306a2.htm.
ACP, ABIM and AMA launch pilot CME project for Practice Improvement Modules
Internists who complete (or have completed) a Practice Improvement Module from the American Board of Internal Medicine (ABIM) can now receive 20 Category 1 CME credits and credit toward maintenance of certification through a joint pilot project being launched by the College, the ABIM and the AMA.
The project is sponsored by the AMA, which will issue credits directly during the pilot. If the project is successful, ACP will be approved to issue CME credit for Practice Improvement Module completion. The pilot focuses on new ways of offering CME credit, particularly for activities related to quality improvement and practice performance.
Practice Improvement Modules are a new, elective option developed by ABIM as part of its Continuous Professional Development program. These computer-based tools guide physicians through a confidential review of the care they provide to their patients with a specific disease or condition.
Current modules focus on preventive cardiology, diabetes and asthma. Additional modules under development include heart failure, hypertension, general prevention, care of the elderly and care of patients with acute myocardial infarction. Each module leads physicians through a review of current clinical practice guidelines and their own practice patterns.
New ACP Medicine reference text released
Internists now have access to an ACP-approved, comprehensive internal medicine reference. ACP Medicine, developed from WebMD® Scientific American® Medicine, is a high-quality, current reference written specifically for practicing physicians.
ACP Medicine helps clinicians problem-solve challenging cases and obtain background information about complex conditions. Sections on epidemiology, pathogenesis, diagnosis and treatment are designed to meet high standards of daily practice and patient care. ACP Medicine's consistent organization and detailed illustrations make the information easily accessible for busy physicians.
ACP Medicine is available in CD-ROM format, on the Web or as a printed volume. Purchasers can choose to receive monthly, quarterly or yearly updates. Through March 31, 2004, ACP members can save $50 on any item ordered through the ACP Medicine Web site at www.acpmedicine.com/ or by calling 800-545-0554.
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Copyright 2004 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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