In the News for the Week of 1-24-06
Payment reform update
- College issues FAQs on the 2006 payment and claims process
- ACP's "State of the Nation's Health Care" report to focus on payment reform
Flu season alert
- Citing drug resistance, CDC advises physicians to stop using two common antivirals
- Study fuels hopes for speedy approval of combination HIV pill
Clinical news in the headlines
- Annals: New antibiotic implicated in severe liver problems
- ACP Journal Club: Vitamin E does not prevent heart disease or cancer in women
- Report: Radiology services produce highest hospital error rate
- FDA aims for clarity with new drug insert format
Health care disparities
- Quality gap narrows, except for Hispanics
- ACP's Latino heart health campaign reaches 32+ million viewers
- College issues new hospital medicine recertification module
- ACP calls for changes in new Part B drug-buying program
- New ACP Officers and Regents elected
Payment reform update
ACP has posted replies to a list of frequently asked questions (FAQs) about the initial 2006 fee reduction in physician payments and the anticipated return to 2005 payment levels once Congress reconvenes. Congress adjourned last month without halting the 4.4% pay cuts, but is expected to reverse those cuts by passing legislation early next month.
The new ACP guidance is based on information released by the CMS. Some highlights of the new information include:
Physicians will not have to resubmit claims made while the 4.4% pay cuts are in effect. The CMS will automatically reprocess all 2006 claims that are submitted before new legislation is passed.
The agency will pay the difference between the reduced fee schedule and the one based on 2005 rates no later than July 1, 2006.
Most Medigap plans and some secondary insurers will also make automatic adjustments, although physicians may have to resubmit some claims to secondary insurers.
The CMS plans to offer physicians an additional enrollment period to allow them to reconsider their Medicare participation. That extended period will last 45 days and will begin as soon as the legislation is enacted.
The College is asking all members to contact their representatives and urge them to take immediate action, upon their return to Congress, to reverse the pay cuts retroactive to Jan. 1. You can contact your representative through ACP's Legislative Action Center.
The FAQ list is online.
In its annual "State of the Nation’s Health Care" report, ACP leaders will outline problems with the current Medicare payment system and present recommendations for payment reform.
The press conference for the national media, which will be held Jan. 30 in Washington, will highlight growing evidence that the number of U.S. physicians is in decline, particularly in general internal medicine and family medicine practices. According to a Jan. 13 press release, that decline is due to the current dysfunctional payment system, which calls for yearly cuts in physician fees, including the current 4.4% cut that took effect Jan. 1.
At the briefing, ACP will release recommendations for reforming how primary care is financed, delivered and reimbursed. Reform recommendations are designed to achieve higher care quality and efficiency, while safeguarding patients' access to care.
More information on ACP policies is online.
Flu season alert
Citing drug resistance, the CDC last week advised physicians against prescribing two common antivirals during the current flu season.
CDC lab tests have determined that the influenza A virus (H3N2) strain is resistant to amantadine and rimantadine, said a Jan. 14 CDC news release. More than 90% of the influenza A isolates tested indicated resistance to these antivirals, up from only 11% last year and less than 2% the year before.
The CDC recommended that physicians prescribe oseltamivir (Tamiflu) and zanamivir (Relenza) instead of the other two drugs, said the release. These drugs were found to be effective against all H3 and H1 viruses tested to date.
The CDC news release is online.
More information is on the ACP's Adult Immunization Web site.
A new study found that a single pill combining three HIV drugs was effective in treating patients and produced few side effects.
The study could lead the FDA to approve a combination pill for HIV by the end of the year, according to the Jan. 19 Washington Post. Approval is expected to be relatively easy because all the drugs have been approved individually and the new pill may encourage more patients to continue treatment.
In the study, 517 HIV patients were randomly assigned to receive either tenofovir disoproxil fumarate, emtricitabine and efavirenz once a day or a fixed dose of zidovudine and lamivudine twice daily plus efavirenz once a day. After 48 weeks, the tenofovir-emtricitabine group had slightly better results than the group taking zidovudine-lamivudine, another common treatment regimen. The study appears in the Jan. 19 New England Journal of Medicine (NEJM).
The approval of a combination pill would be a milestone in treating HIV infection, which affects about 40 million people worldwide, said the Washington Post. When treatments first came on the market in the 1990s, patients sometimes had to take as many as 60 pills several times a day.
Now, some patients can take only two pills—one that combines two drugs and another single-drug pill, said the Washington Post. However, they still have to pay two copays that can reach $50 a month per drug.
A single pill has been elusive partly because different companies owned the rights to different drugs, the article said. However, two companies recently announced that they will collaborate and are running tests on a combination pill. The pill, if approved, would still carry the risk of resistance, the Washington Post noted, which could force some patients eventually to switch to more complex regimens.
The NEJM abstract is online.
The Washington Post is online.
Clinical news in the headlines
In an early Annals release posted online last week, researchers have detailed three cases of liver problems linked at one medical center to the antibiotic telithromycin (Ketek).
Two of the patients at Carolinas Medical Center in Charlotte, N.C., experienced liver failure while the third had drug-induced hepatitis. One patient died, another needed and received a liver transplant, while the third recovered from hepatitis after the antibiotic was stopped.
The authors pointed out that the research does not provide enough data to justify major changes in antibiotic prescribing, and said their data do not prove that the antibiotic caused the liver impairment. However, they urged physicians prescribing telithromycin to look for signs of malaise, weakness or jaundice in patients. They also said that patients' liver problems became evident after they began taking the antibiotic.
The authors also called for more research on the relationship between telithromycin and alcohol use. While two of the three patients reported some use of alcohol, none had any prior noted liver damage.
Telithromycin was approved by the FDA in 2004 to treat acute bacterial infections such as chronic bronchitis, acute bacterial sinusitis and community-acquired pneumonia. A macrolide, it appears to be effective against some pneumonia strains that are resistant to older antibiotics.
The online article will be published in Annals' March 21 print edition.
Recent results from the Women’s Health Study showed that vitamin E did not help prevent cancer or heart disease in healthy women age 45 or older.
In the 10-year study, almost 40,000 women with no history of cancer, heart disease or other major chronic illness were assigned to take either 600 IU of alpha-tocopherol every other day or placebo. There was no significant difference in the percentage of women in either group who suffered a major cardiovascular event or developed invasive cancer. The study is abstracted in the January-February ACP Journal Club.
While the results were conclusive for women age 45-64, they may not apply to older women, who made up only 10% of study participants, said Journal Club reviewer Laura Rees Willett, FACP, of the Robert Wood Johnson Medical School in New Brunswick, N.J. Subgroup analyses and well-established epidemiologic data on diets high in vitamin E also suggest that the supplement may help prevent heart disease in older women.
The bottom line for physicians is that healthy women under age 65 do not benefit from long-term use of vitamin E, Dr. Willett said. However, future studies should focus on the effects in older women.
Peer ratings for this review: internal medicine and its subspecialties, and hospitalists: 5/7 stars; general internal medicine-primary care (U.S.): 6/7 stars. ACP Journal Club is online.
Harmful medication errors are much more likely to occur in radiology departments than in any other section of a hospital, according to a new report.
The rate of errors that caused harm was seven times higher for radiological services than the overall percentage of hospital medication errors reported in 2000-2004, according to a Jan. 18 news release from U.S. Pharmacopeia (USP), a nonprofit group that sets drug industry standards. The group’s sixth annual "MEDMARX Data Report" found that 12% of the 2,032 medication errors reported in radiological services resulted in patient harm. MEDMARX is an anonymous program used by hospitals to report and track medication errors.
The report attributed the higher error rate in large part to breakdowns in communication, according to the Jan. 18 Washington Post. Patients scheduled for procedures are often transferred from one department to another without adequate communication between radiology staff and attending physicians and nurses.
Miscommunication can have serious consequences because these patients often receive potentially dangerous drugs such as dyes, sedatives and blood thinners, the Washington Post said. Patients may receive the wrong drug or dose, or fail to receive a needed drug.
The issue is also significant because more procedures are being performed in radiology departments, said the Washington Post. Besides X-rays, patients are being sent to radiology to have abscesses drained, gastric feeding tubes and arterial stents inserted, and angioplasties performed.
The USP news release is online.
The Washington Post is online.
In an effort to reduce errors and avoid confusion about prescription drugs, the FDA last week said it would require drugmakers to comply with a new, more readable format for all package inserts.
The new inserts will highlight the most important drug information, according to a Jan. 18 FDA news release. Research cited by the agency found that prioritizing warning information can significantly reduce preventable errors.
The label revisions, the first in more than 25 years, require package inserts to include:
- a “highlights” section listing the most important information about benefits and risks;
- a table of contents referring physicians and patients to safety and efficacy details;
- the date of initial product approval;
- a toll-free number and Web site for reporting adverse events or side effects; and
- a section on patient counseling information to help guide physicians in advising patients about medication use and about managing potential risks.
The information will also be integrated into the FDA’s DailyMed, an online health information clearinghouse, the FDA release said. While the labeling requirements will be phased in gradually for drugs approved within the past five years, the agency is urging drug companies to voluntarily adopt the requirements immediately.
The FDA news release is online.
Health care disparities
New government reports find that the gap in quality and accessibility of health care between whites and Hispanics has widened.
While overall health care quality for Americans improved by 2.8%, Hispanics saw declines in several areas, according to the 2005 "National Healthcare Quality" and "National Healthcare Disparities" reports compiled by the HHS’ Agency for Healthcare Research and Quality (AHRQ). Racial disparities narrowed for the most part, the reports said, with Hispanics a notable exception.
The overall rate of improvement remained steady compared with the previous year, according to a Jan. 9 AHRQ news release. There was a 10.2% annual improvement in core patient safety areas and a 5.4% improvement in quality measures for diabetes, heart disease, respiratory conditions, nursing home care, and maternal and child health.
The reports relied upon a variety of public and private sources with the most recent data ending in 2002-2003. While progress is being made, the reports noted that most improvements fall far short of the government’s "Healthy People 2010" goals. Examples of other findings included:
- Among patients treated for hypertension, the percentage who had gotten their hypertension under control increased from 23% in 1988-94 to 29% in 1999-2002.
- The percentage of adults age 65 and older who have ever received a pneumococcal vaccine increased from 49.9% in 1999 to 55.7% in 2003.
- The overall rate of late-stage breast cancer has not changed over the past 10 years.
- More than a third of patients hospitalized for a heart attack who smoke reported that their doctor did not advise them to quit smoking.
The AHRQ news release is online.
More than 32 million television viewers throughout the U.S. had their awareness of heart disease prevention and treatment raised thanks to a national ACP media campaign.
ACP worked with Novartis Pharmaceuticals to promote the College's latest patient education video, "Guide to a Healthy Heart for Latinos." Oscar Murillo, FACP, of Hillside Internal Medicine in Hanover, Pa., served as the national spokesperson for the campaign and appeared in the educational video.
Dr. Murillo appeared via satellite interview on 16 television stations, including CNN En Espanol, Telemundo and Univision in markets such as Los Angeles, New York, Miami, Austin and El Paso. He also recorded a radio news release that resulted in over 100 radio news stories, and was quoted in articles in Latino newspapers throughout the country. Several other ACP members also spoke about the program in cities with large Latino populations, including San Diego, San Francisco, Houston, San Antonio, Phoenix and Boston.
The campaign was designed to promote messages about heart health for Latinos and TO drive consumers to ACP's patient education Web site, www.doctorsforadults.com, where they could view a sample of the video and download the accompanying guidebook in English or Spanish. (More than 2,000 guidebooks were downloaded). The media campaign also raised awareness about ACP and the role of doctors of internal medicine.
A short video containing campaign highlights and links to patient education materials is on the doctorsforadults.com Web site.
A new MKSAP recertification module dedicated entirely to hospital medicine is now available at no charge for MKSAP subscribers. The new module, based on content from MKSAP 13, is the fifth in the series of electronic knowledge self-evaluation modules that MKSAP subscribers can download at no charge.
According to ABIM rules, recertification candidates must earn 100 self-evaluation points, including at least 20 knowledge self-evaluation points and at least 20 practice improvement self-evaluation points.
The other 60 points are optional and can be obtained in either the knowledge or practice improvement category. Up to 80 knowledge self-evaluation points can be earned by using any four of the five MKSAP modules, each of which counts for 20 knowledge self-evaluation points.
All five recertification modules are available on ACP Online.
The College is urging the CMS to modify its final rule on a new program that offers an alternative to purchasing drugs administered in physician offices.
Under the new competitive acquisition program, which will take effect this July, drug manufacturers—not physicians—will bill Medicare to be reimbursed for those drugs.
In a Jan. 3 letter to CMS Administrator Mark B. McClellan, FACP, the College noted that the program offers an alternative to physicians who may no longer want to purchase those drugs themselves, bill Medicare for them and collect copays from patients.
However, the College pointed out several modifications that need to be made to make the alternative drug-purchasing program less of a burden to physicians. Those recommendations include:
The CMS should establish a minimum 30-day claims-billing period after drugs have been administered, instead of the 14-day period now included in the rule.
The CMS needs to pay physician practices more to cover additional administrative costs. Participating in the program, ACP said, will force practices to spend more on staffing and inventory. Physicians will have to include more information on drug order forms, for example, as well as return drugs that are not administered and either appeal denials or provide appeal-support information to ensure that vendors get paid.
At a minimum, the CMS needs to collect data to determine the actual administrative costs of participating in the program and then modify payments accordingly.
If the CMS does not compensate physicians for those added administrative burdens, the letter said, physicians—particularly in smaller practices—will not choose to participate.
The College also urged the CMS to provide more information about the program, particularly because physician enrollment will begin this spring.
And the College pressed the CMS to remove Part B drug expenses from the sustainable growth rate (SGR) formula calculation. That inclusion, the letter said, would reduce the legislative expense of replacing the flawed SGR.
The letter is online.
The College last week announced election results for the President-elect, Chair-elect of the Board of Regents and Chair-elect of the Board of Governors, as well as for open Regents seats. Terms of the new Officers and Regents become effective at the end of the Annual Business Meeting at Annual Session on Saturday, April 8, 2006.
New Officers include: David C. Dale, FACP, 2006-07 President-elect; Joel S. Levine, FACP, 2006-07 Chair-elect of the Board of Regents; and David L. Bronson, FACP, 2006-07 Chair-elect of the Board of Governors.
Regents elected for a second term (expiring in 2009) include Angeline A. Lazarus, FACP; Clement J. McDonald, FACP; Joseph W. Stubbs, FACP; and Frederick E. Turton, FACP.
Regents elected to their first term (expiring in 2009) include Michele G. Cyr, FACP, and Kevin B. Weiss, FACP, from the non-Governor pool, and Faith T. Fitzgerald, MACP, from the Governor pool.
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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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