In the News for the Week of 12-14-04
- CMS announces awards for chronic care pilot programs
Clinical news in the headlines
- FDA orders warnings for valdecoxib
- Newer drug delivers better results than tamoxifen for breast cancer
- Highlights of ACP Journal Club
- HHS purchases flu vaccine from Germany
- PIER passes 350th module milestone
- College urges MedPAC to champion Medicare payment changes
- ACP's medical laboratory program wins national award
The CMS last week announced awards to 10 different health plans and disease management companies nationwide to participate in the first phase of Medicare chronic care demonstration pilot project being launched next year.
The College had backed proposals from two of the companies given awards: Health Dialog Services Corp. for a pilot program in Pennsylvania and McKesson Health Solutions in Mississippi. ACP will partner with those companies to implement physician-directed chronic care models in those states.
The chronic care pilot program—which was authorized by Medicare reform legislation in 2003—may enroll as many as 300,000 Medicare beneficiaries with multiple chronic diseases, including congestive heart failure, complex diabetes and chronic obstructive pulmonary disease, in several states.
The CMS will identify potential program participants through claims data and assign patients to either an intervention or control group, according to a Dec. 8 CMS fact sheet. Patient participation in the pilot program is voluntary, and several of the programs are slated to begin in spring 2005.
Contractors given the awards will work with patients' physicians to coordinate care, including making sure patients seek care when necessary, communicating clinical information, and managing all comorbidities, referrals and pharmaceutical needs.
The pilot phase of the program, which will last three years, will determine whether adhering to evidence-based practices and coordinating care can improve patients' health and save Medicare dollars. The CMS estimates, for instance, that beneficiaries with congestive heart failure account for only 14% of the Medicare population but 43% of total Medicare costs.
The CMS fact sheet is online.
Links to two College press releases applauding the Health Dialog and McKesson awards are online.
Clinical news in the headlines
The FDA last week ruled that label warnings must be placed on the painkiller valdecoxib (Pfizer's Bextra). One bolded warning will state that the drug is contraindicated in patients undergoing coronary artery bypass graft surgery, while a boxed warning relates to the drug's risk of life-threatening skin reactions.
The bolded contraindication is based on a Pfizer study of more than 1,500 heart surgery bypass patients, according to the Dec. 10 Los Angeles Times. A Dec. 9 FDA release noted that patients who took valdecoxib, a COX-2 inhibitor, were more likely than patients on placebo to suffer thromboembolic events such as myocardial infarction, stroke, deep vein thrombosis and pulmonary embolism.
The black-box warning includes information about patients' risk of developing severe skin reactions, including Steven-Johnson Syndrome and toxic epidermal necrolysis, which are most likely to occur in the first two weeks of treatment, according to the FDA. The agency said the drug should still be considered for relieving pain associated with osteoarthritis, rheumatoid arthritis and dysmenorrhea.
The FDA release is online.
The Los Angeles Times is online.
Findings published last week from a long-term international study of women with breast cancer concluded that aromatase inhibitors are more effective than tamoxifen in preventing recurrence and metastasis.
The study involved 9,366 postmenopausal women with hormone receptor-positive localized breast cancer who took either tamoxifen or anastrozole, an aromatase inhibitor. After a median follow-up of 68 months, anastrozole was found to significantly prolong disease-free survival and reduce distant metastases and contralateral breast cancers. Findings were published in the Dec. 8 online edition of The Lancet.
The results strongly suggest that postmenopausal women with breast cancer should take an aromatase inhibitor immediately following surgery, radiation and chemotherapy, said researchers, according to the Dec. 9 Washington Post. However, some experts cautioned that it is still unclear whether some women should take tamoxifen first.
Tamoxifen blocks the effects of estrogen, which often promotes cancer growth. It has also been found to reduce the risk of osteoporosis, but it cannot be taken for more than five years and carries a higher risk of blood clots. Aromatase inhibitors block estrogen formation without those side effects, but they do not reduce the risk of osteoporosis.
The American Society of Clinical Oncology (ASCO) has recommended that aromatase inhibitors become part of standard breast cancer treatment, but it stopped short of recommending that tamoxifen use should be phased out, the Washington Post reported. More studies are needed, said ASCO and other experts, to determine the best strategy and timing for using the two drugs.
A Lancet summary is online. (Free registration is required.)
The Washington Post is online.
Adding antileukotriene to inhaled corticosteroids has little effect on controlling symptoms in chronic asthma patients, according to a recent review.
The analysis included 27 randomized controlled trials comparing antileukotriene plus inhaled corticosteroids with either the same dose of inhaled corticosteroids, double the dose of inhaled corticosteroids or a tapered dose of inhaled corticosteroids in patients over age 2 with recurrent or chronic asthma.
Antileukotriene plus inhaled corticosteroids reduced exacerbations only when antileukotriene doses were higher than in the current licensed range. The meta-analysis was abstracted in the November-December ACP Journal Club.
The findings are problematic because higher doses of antileukotriene are associated with increased risk of abnormal liver function, the reviewer noted. The results confirm an earlier review by the same authors suggesting that licensed doses of antileukotriene produce only a small effect on peak flow.
The analysis had several shortcomings, the reviewer pointed out. Most of the trials did not have a sufficient run-in period to reduce inhaled corticosteroids to a minimum effective dose before the active part of the trial. In addition, the longest study lasted only 20 weeks, too short to adequately monitor side effects and exacerbations.
While one recent study suggested that antileukotriene may protect against exacerbations as effectively as long-acting beta-agonists, this updated review indicates that antileukotriene continues to have a limited role in treatment, the reviewer concluded.
The ACP Journal Club review is online.
The CMS last week announced that it had carved the country into 34 different regions to delineate private insurer participation in the new Medicare prescription drug benefit program, which begins January 2006.
The boundaries were designed to maximize participation by private insurers in the new program, which was mandated by 2003 Medicare reform, the Dec. 7 New York Times reported. Regions vary significantly in size and in the number of covered beneficiaries, with several large single-state regions (such as California, Florida and Texas); one large seven-state region in the Midwest and northern Plains, which will cover 1.9 million beneficiaries; and several much smaller regions covering one or more states, such as New Mexico with 260,000 beneficiaries, and Maine and New Hampshire with a combined 420,000 beneficiaries.
Under the new program, beneficiaries in traditional fee-for-service Medicare can sign up with a private insurer in their region to receive subsidized drug coverage only, according to the New York Times. Alternatively, they can choose to join a Medicare preferred provider organization plan that covers patients' hospital and physician use, as well as drug benefit coverage. The government also mapped out 26 preferred provider organization regions that correspond to the drug plan regions.
Health plans had a mixed reaction to the new configurations, the New York Times said. While some plans claimed it would be difficult for different plans to work together in multistate regions, others said the new regions may make it possible for them to offer more products and services as part of the Medicare program.
Links to maps showing the preferred provider and Medicare drug benefit regions are online.
The New York Times is online.
According to a Government Accountability Office (GAO) report issued last week, Medicare beneficiaries who call a widely publicized Medicare telephone help line to get information about new Medicare benefits, including drug discount cards, get accurate information only 60% of the time.
The Dec. 8 report said that beneficiaries who use the 1-800-MEDICARE help line get inaccurate information 29% of the time and no response 10% of the time, even though the help line is supposed to operate 24 hours a day. Further, GAO investigators who posed questions about the $600 prescription drug credit available this year and next to low-income beneficiaries received inaccurate information 79% of the time.
To improve the accuracy of help line information, the GAO recommended assessing and revising customer representatives' scripts, as well as monitoring representatives' accuracy rate. To ensure that beneficiaries get some response, the GAO recommended that procedures be revised so the company that holds the contract for the 800-MEDICARE help line won't switch calls to other contracted companies during off-hours.
The New York Times also reported that according to another recent GAO report, physicians calling Medicare help lines with billing questions received correct information only 4% of the time. Customer service representatives gave wrong information to 54% of those with billing questions and incomplete information to 42%.
While the CMS is working with ACP and other physician organizations to improve the content and usefulness of its Medicare educational materials, the agency continues to struggle with having to fix its poor carrier call center and customer service problems.
An abstract of the GAO report is online.
The New York Times is online.
For more information about new prescription drug benefits, see "Drug card program turns spotlight on seniors' cost" in the December ACP Observer.
The HHS last week announced plans to buy 1.2 million doses of flu vaccine from Germany to alleviate the U.S. shortage.
The vaccine is not licensed in the United States but the government stressed that it is licensed in Europe and used in 30 countries, according to the Dec. 8 Washington Post.
Patients who receive the German-made vaccine, which is manufactured by GlaxoSmithKline, will be required to sign a consent form. Use of the vaccine in the United States will be under an investigational new drug application, according to a Dec. 7 HHS news release.
The new vaccine doses will cost the government $8.4 million and patients will have to pay about $15 to $20 per shot, the Washington Post reported. A CDC expert quoted in the article said the new vaccine would be used as a last resort after the supply of FDA-licensed vaccine is depleted.
At the same time, the HHS missed last week's deadline for reporting to Congress on importing prescription drugs, the Washington Post said. The failure ignited criticism from some legislators who said the FDA is sending mixed signals by importing flu vaccine while warning states that drug imports are too dangerous.
The HHS news release is online.
The Washington Post is online.
ACP's Physicians' Information and Education Resource (PIER) is pleased to announce the publication of its 350th module: screening for dementia. This marks another milestone in PIER's ongoing effort to provide ACP members with a comprehensive, continually updated, evidence-based point of care medical knowledge resource.
In addition to building the list of new PIER topics, PIER has also recently facilitated better integration with other College publications. There are now prominent direct reciprocal links between PIER modules and full text articles in Annals of Internal Medicine and ACP Journal Club.
ACP members are invited to visit PIER online to see its expanded content and new features.
In two recent letters to the Medicare Payment Advisory Commission (MedPAC), ACP has asked the advisory group to recommend significant changes to the Medicare physician reimbursement system. MedPAC advises Congress on matters related to Medicare.
The first letter, authored by College President Charles K. Francis, FACP, and sent Dec. 6, detailed many of the problems with the current reimbursement system and outlines strategies to correct them. The current system, the letter stated, penalizes physicians for investing in information technology, undervalues primary care services and fails to recognize—or pay for—work that falls outside a specific procedure or visit.
To remedy those problems, the College is urging MedPAC to recommend the following:
- Replace the sustainable growth rate formula (SGR) with one linking payment updates to the costs of providing services.
- Authorize additional Medicare payments to support the use of electronic medical records and other technology.
- Expand existing demonstration projects to give physicians more information technology investment incentives.
- Explore a severity of care adjustment factor for treating patients with chronic diseases.
- Authorize a chronic care management fee, as well as separate payments for e-mail and phone consultations.
In the second letter, dated Dec. 8, the College joined 45 other professional medical organizations in asking MedPAC to avoid recommending budget neutral payment systems in any proposed pilot projects or pay-for-performance initiatives.
The letter also pointed out that the SGR must be changed because additional patient visits related to chronic care will trigger physician payment cuts under the flawed formula.
Links to the two letters are online.
ACP's Medical Laboratory Evaluation (MLE) service won a first-place "Innovative Solution" award in the 2004 Process Innovation Awards competition. The awards, given to six different organizations, honor superior applications of information technology for their effectiveness in returning significant business benefits.
MLE received the award for combining imaging-based data capture and Web-based data entry for medical laboratory testing, automating the processing of paper-based test results quickly and accurately.
ACP's MLE division helps nearly 3,000 medical labs remain CMS-certified through rigorous testing of lab performance. In the first quarter of 2004, MLE added Web-based data entry, integrated with a scanning-based capture solution, which enables physicians to submit test data online.
MLE's new Web Data Entry System helps meet customer demand, accelerate processing and maintain a high degree of accuracy, without adding administrative burdens.
More information about ACP's Medical Laboratory Evaluation service is available on ACP Online.
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Copyright 2004 by the American College of Physicians.
A 32-year-old woman is evaluated at a well-patient visit. Both her parents have a history of nonmelanoma skin cancer within the past year, and she is seeking counseling regarding skin cancer prevention. She has a history of remote sunburns and had previously tanned as a teenager. She requests advice on how to approach sun protection to limit both future skin cancer risk as well as to prevent wrinkles and cosmetic photodamage. Following a physical exam, what is the most appropriate advice for this patient?
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