In the News for the Week of 5-31-05
Clinical news in the headlines
- Study finds rosuvastatin more risky than other statins
- Defibrillator maker reports potentially fatal flaw
- Government mails out millions of applications for new drug benefit
- Medicare now accepting applications for new provider IDs
Business of medicine
- Internists in high demand by recruiters
- Outreach project helps caregivers and medical practices
Clinical news in the headlines
A study published online last week found that the cholesterol-lowering drug rosuvastatin carries a higher risk of muscle deterioration and renal failure than other leading statins.
Researchers found that rosuvastatin (AstraZeneca's Crestor) was two to six times more likely to be associated with rhabdomyolysis, proteinuria, nephropathy or renal failure than atorvastatin, simvastatin or pravastatin. The study, which appeared in the May 23 online edition of Circulation, was based on an analysis of adverse event reports submitted to the FDA between October 2003 and September 2004, the drug's first year on the market.
The results are in contrast to the FDA's recent decision to leave rosuvastatin on the market because it appeared to be as safe as other statins, according to the May 24 Washington Post. However, some experts interviewed in the article said they would continue to use rosuvastatin for patients with very high cholesterol levels because the drug is more potent than other statins.
The authors noted that using real-life patient reports overcomes a major drawback of controlled trials, which often exclude patients at risk for certain side effects. The authors also noted several possible limitations of the study: the data reflect only reporting rates, not actual events; physicians tend to make more reports when a drug first comes out; and certain side effects may not be immediately recognized as related to a new drug.
The actual number of serious side effects reported for rosuvastatin was much lower than the number reported for cerivastatin, which was withdrawn from the market in 2001. However, the study authors still advised physicians to be cautious when using rosuvastatin and to try other statins first. When rosuvastatin is used, they recommended prescribing lower doses, considering combination therapy and closely monitoring patients for adverse events.
The Circulation abstract is online.
The Washington Post is online.
Guidant Corp. confirmed last week that one of its defibrillator units has a flaw that could cause it to malfunction, something the company has kept quiet for three years.
The flaw became known after a young man with genetic heart disease collapsed and died after his defibrillator short-circuited, the May 24 New York Times reported. Following the incident, Guidant informed doctors that it knew about 25 other cases in which its Ventak Prizm 2 Model 1861 defibrillator malfunctioned due to the same flaw. The model's failure rate was 0.07%, based on 37,000 units that were manufactured before safety modifications were made three years ago.
While the company said it has changed its manufacturing process to address the flaw, physicians interviewed by the New York Times said the lack of disclosure did not allow them to replace units in patients at high risk of sudden death. A Guidant official told the New York Times that the company did not release the information because the failure rate was low and because patients might incur higher risks by having the devices replaced.
The New York Times said that the event is a reminder that medical device makers do not always release data about problems and are not required to report safety modifications immediately to the FDA. The article noted that earlier this year Medtronic Inc., which also makes defibrillators, reported a problem with the battery in one of its models after receiving nine reports among 87,000 affected units.
The New York Times is online.
The government has begun mailing letters to millions of low-income Medicare beneficiaries, encouraging them to fill out applications to participate in the new prescription drug benefit that takes effect January 2006.
Government officials expect that about half of the almost 15 million eligible beneficiaries will be enrolled automatically through their participation in Medicaid, the May 25 New York Times reported. The other half will be required to enroll in the program by filling out a six-page application, which some senior groups claim will discourage many eligible seniors from applying.
The program provides additional financial assistance to beneficiaries with incomes of up to 150% of the poverty level, while those with incomes up to 135% of the poverty level are eligible for free prescriptions except for copays ranging from $2 to $5.
According to the Social Security Administration, which is conducting the mailing, applicants will be asked to give information about their income and assets and to provide documents such as tax returns, payroll slips, recent Social Security benefits letters or statements of retirement income from other sources. Patients who qualify for the benefit will be asked to select a drug plan in November.
Beneficiaries may go online to find out if they qualify for benefits by using Social Security's "online qualifier". Patients may also call toll free 800-772-1213 to have an application mailed. The electronic version of the application will be posted June 27.
The New York Times is online.
Physicians can now apply for a new national provider number that they can use with every payer they contract with, including Medicare.
The National Plan and Provider Enumeration System, a new unit of the CMS, will issue a new 10-digit national provider identifier (NPI) number for all health care providers. That includes physicians, mid-level providers, group practices, hospitals and other providers designated as covered entities under HIPAA. Unlike old identification numbers, the NPI will contain no letters or geographic clues to identify a provider.
Payers don't have to use the new NPI until May 2007, according to HIPAA provisions. (Small health plans have until May 23, 2008, to begin using the NPI.) But many health plans and insurers have said they may begin using it before then.
Medicare plans to start accepting the NPI in October 2006. There will be a transition period during which Medicare will accept both new and older identification numbers. According to an instructional tool from the CMS, individual health plans, including Medicare, will announce when they will be ready to accept NPIs.
Physicians have three different options for applying for an NPI: with a paper application; via the Web; or through an electronic file interchange process in which physicians can authorize organizations like hospitals and group practices to apply on their behalf.
CMS officials encourage most providers to apply using the Web site, which is now accepting applications. Paper applications will not be available until after July 1. Bulk applications using electronic file interchange will be available in late 2005.
To apply, physicians need to supply the name or names of the providers to be covered by each NPI; employer ID for practices or a Social Security Number for individuals; practice location(s); address(es); phone number(s); date, state and country of birth; gender; license number(s); and state.
Additional information and the application are online.
An instructional CMS Web tool is also online.
More information is on the CMS Web site under "HIPAA Latest News."
Business of medicine
Internal medicine and orthopedic surgery were the specialties in highest demand among recruiters in the year ending March 30, 2005, according to a recent recruiting survey.
Internal medicine slots were also among those that took the longest time to fill over a 12-month period, taking an average of 100 days, according to the "Physician Recruiting Standard" survey produced quarterly by Dallas-based Delta Medical Consulting. The average starting salary for general internists was $166,455, with an average sign-on bonus of $16,143.
Compensation fell by 11% for both ob/gyn and family practice, while psychiatry had the steepest drop, at 19%. Specialties that saw starting-salary increases included general surgery (21%), emergency medicine (15%) and hospital medicine (14%).
According to the survey, the number of employers now offering certain benefits was as follows:
- 35% offered student loan repayments (average amount: $30,800).
- 95% offered relocation expenses (average amount: $7,550).
- 8% provided assistance with tail coverage.
The survey is online.
A program supported by ACP that helps link physicians and other professionals with resources for family caregivers is now entering its third year.
The "Making the Link: Connecting Caregivers with Services through Physicians" program connects physicians and other medical professionals around the country with local agencies on aging to help them identify and provide support for overburdened family caregivers.
According to a 2004 survey by the National Alliance for Caregiving and the AARP, nearly 34 million adults provide unpaid care to patients age 50 or older. The College supports the program in cooperation with the National Association of Area Agencies on Aging.
"Making the Link" helps physicians identify and assist patients who are caregivers. By taking part in the program, physicians and their staff learn about essential services available in their community to which they can refer caregivers.
Ninety-five percent of respondents to an independent evaluation of participating physician practices said the program benefits both patients and family caregivers, while 85% said the project benefits the medical practice as well.
More information about "Making the Link" is online.
To learn more about caregiver resources, contact the agency on aging in your community through the Eldercare Locator online or call 800-677-1116.
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Copyright 2005 by the American College of Physicians.
A 72-year-old woman is evaluated during a routine examination. She has very severe COPD with multiple exacerbations. She has dyspnea at all times with decreased exercise capacity. She does not have cough or any change in baseline sputum production. She is adherent to her medication regimen, and she completed pulmonary rehabilitation 1 year ago. She quit smoking 1 year ago. Her medications are a budesonide/formoterol inhaler, tiotropium, and an albuterol inhaler as needed. Following a physical and pulmonary exam, what is the most appropriate next step in management?
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