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Policy and Health Issues in the News
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Am Fam Physician. 2010 Nov 1;82(9):1041-1042.
Most Toddler Vaccination Rates are Close to HHS' Healthy People 2010 Goals
Toddlers are being immunized at or near the U.S. Department of Health and Human Services' (HHS') Healthy People 2010 goals for longer-standing recommended vaccines, according to the results of the 2009 National Immunization Survey. Results showed that coverage for poliovirus (92.8 percent); measles, mumps, and rubella (90 percent); hepatitis B (92.4 percent); and varicella (89.6 percent) vaccines remained at or near the 90 percent goals for each vaccine. Live rotavirus vaccine, which was licensed in 2006, was included in the survey for the first time, and 43.9 percent of children had received the vaccine. Coverage with at least one dose of measles, mumps, and rubella vaccine dipped slightly, from 92.3 percent in the 2007 survey to 90 percent in the 2009 report. Coincidentally, a 2008 outbreak of measles affected more than 100 patients in more than a dozen states. As of September 14, 2010, California had more than 4,000 reported cases of pertussis with nine infant deaths linked to the outbreak. However, this large spike in cases might have more to do with adolescent and adult vaccination rates, according to Assistant Surgeon General Anne Schuchat, MD, director of the Center for Disease Control and Prevention's National Center for Immunization and Respiratory Diseases. Schuchat said although it is important for infants and toddlers to receive diphtheria, tetanus, and pertussis vaccine, the principle challenge is ongoing pertussis transmission in teens, adults, and infants younger than two months, who cannot yet receive the vaccine. Among children 19 to 35 months of age, coverage with three doses of the vaccine fell slightly from 96.2 percent in 2008 to 95 percent in 2009, whereas coverage with four doses fell from 84.6 percent to 83.9 percent. For more information, visit http://www.aafp.org/news-now/clinical-care-research/20100927toddlervaccs.html and http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5936a2.htm.
MedWatch: FDA Restricts Rosiglitazone Use, Requests Withdrawal of Sibutramine
In response to data that suggest an elevated risk of cardiovascular events in patients using the diabetes mellitus medication rosiglitazone (Avandia), the U.S. Food and Drug Administration (FDA) recently placed new restrictions on its use. According to the FDA, rosiglitazone will only be available to patients who cannot control their diabetes on other medications, and physicians will be required to attest to and document a patient's eligibility for its use. The FDA is requiring manufacturer GlaxoSmithKline to develop a restricted access program under a risk evaluation and mitigation strategy, in which physicians have to enroll patients in order for them to continue receiving rosiglitazone. Those not already taking it may do so only if other drugs have not provided adequate glycemic control and if they decide for medical reasons not to use pioglitazone (Actos), the only other thiazolidinedione. Additionally, the FDA asked Abbott Laboratories to voluntarily withdraw from the market its weight-loss drug sibutramine (Meridia), based on recent data showing increased cardiovascular risks with its use. The FDA recommends that physicians stop prescribing sibutramine; contact patients taking it and ask them to stop taking it; assess patients taking it who present with signs or symptoms of cardiovascular disease; and inform patients of the risks associated with its use and discuss alternative weight-loss strategies. Physicians and patients are encouraged to report adverse effects related to the use of rosiglitazone or sibutramine to the FDA's MedWatch program (https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm). For more information, visit http://www.aafp.org/news-now/health-of-the-public/20100924avandiarestrictions.html and http://www.aafp.org/news-now/clinical-care-research/20101012meridiawithdrawn.html.
Cholesterol Levels in Women Vary with Menstrual Cycle Phase, Study Says
Physicians testing a woman's cholesterol levels may need to take into account the phase of her menstrual cycle, according to a study published in the Journal of Clinical Endocrinology and Metabolism. Researchers found that high-density lipoprotein levels among the women studied rose in concert with estrogen levels, peaking at the time of ovulation. Conversely, total cholesterol, low-density lipoprotein, and triglyceride levels started to decline a few days after ovulation began and reached their lowest levels just before onset of menstruation. The total cholesterol levels of participants varied by nearly 20 percent during the course of their cycles. Study coauthor Erique Schisterman, PhD, said that when preliminary test results indicate high cholesterol, physicians often order a follow-up test for confirmation. He suggested that physicians could instead take one test at the end of a woman's cycle, when cholesterol levels are lowest. The researchers, however, acknowledged that further study could help clarify the optimal time for physicians to test a woman's cholesterol levels. For more information, visit http://www.aafp.org/news-now/clinical-care-research/20100830cholesterolmenstrual.html and http://jcem.endojournals.org/cgi/content/abstract/jc.2010-0109v1.
HHS Proposed Rule Imposes Medicare Application Fee on Some in Health Care
An HHS proposed rule recently published in the Federal Register initially may appear to impose an application fee on the treatment of Medicare patients. However, this fee may not apply to most physicians because it appears to be limited to hospitals, facilities, and suppliers of durable medical equipment, prosthetics, orthotics, and supplies, according to Robert Bennett, the American Academy of Family Physician's (AAFP's) federal regulatory manager. If approved, the rule would implement the following: provisions regarding procedures under which screening is conducted for health care professionals and suppliers in Medicare, Medicaid, and the Children's Health Insurance Program; an application fee for certain providers and suppliers; a framework by which temporary moratoria would be imposed under certain circumstances to combat fraud, waste, and abuse; guidance for states regarding the standing of providers enrolled in one of the three programs but terminated by another; and requirements for suspension of payments to providers and suppliers pending credible allegations of fraud in the Medicare and Medicaid programs. The AAFP is reviewing the proposed rule and will submit official comments to HHS before their November 16, 2010, deadline. Family physicians are encouraged to offer HHS their personal comments on the rule. For more information, visit http://www.aafp.org/news-now/practice-management/20100927medicarefee.html and http://www.gpo.gov/fdsys/pkg/FR-2010-09-23/pdf/2010-23579.pdf.
Physicians Must File with CMS to Recoup Vaccine, Medication Payments Owed Them
Earlier this year, the Centers for Medicare and Medicaid Services (CMS) released new pricing files for vaccines and medications covered under Medicare Part B; those changes were effective on July 1, 2010, and were retroactive to July 2009. However, it now appears that CMS is requiring physicians to point out any necessary billing adjustments to their Medicare carriers to ensure proper payment. Cynthia Hughes, CPC, an AAFP coding and compliance specialist, recommends physicians review billing records to compare the rates in CMS' revised pricing files with how much Medicare paid them during the time period in question. Vaccines that may be affected by the new pricing include pneumococcal polysaccharide; seasonal influenza; hepatitis B; a tetanus booster when indicated due to injury; and rabies, although this is rare. Physicians who discover they are owed money should contact their Medicare contractors for instructions on how to get those claims reprocessed, and should avoid refiling claims without prior contractor instructions because the claims could be rejected as duplicate claims, Hughes said. For more information, visit http://www.aafp.org/news-now/practice-management/20100927vaccpayment.html and http://www.cms.gov/transmittals/downloads/R1922CP.pdf.
Pfizer Recalls Some Lots of Atorvastatin Based on Reports of Unusual Odor
Pfizer Inc. recently recalled more than 190,000 bottles of its cholesterol-lowering drug atorvastatin (Lipitor) following reports of an uncharacteristic odor related to the bottles in which the medication is packaged. The FDA said the source of the odor has been identified as 2,4,6-tribromoanisole, which is the same pesticide and flame retardant responsible for a massive recall of nonprescription drugs by McNeil Consumer Healthcare earlier this year. The atorvastatin recall affects 40 mg tablets packed in 90-count bottles. The following lots are affected: 0855020, 0819020, 0842020, 0843020, and 0854020. Pfizer said it does not expect any shortages of its product to result from the recall. For more information, visit http://www.aafp.org/news-now/health-of-the-public/20101013lipitorrecall.html and http://www.fda.gov/Safety/Recalls/ucm228998.htm.
Recession Forced U.S. Medical Schools to Take New Tack, According to Study
The economic recession that began in 2008 forced many U.S. medical schools to cut costs, consolidate, reorganize, and, in some instances, change their cultures for a more secure future, according to a recent study from the Association of American Medical Colleges. Reductions in state support were the most common source of revenue losses for public schools. For private schools, the most common losses were in investment earnings from endowments and other sources. All schools took short-term actions in response, including consolidating departments and administrative functions; increasing tuition and student fees; delaying capital projects and implementation of strategic priorities; changing benefit plans and compensation; and implementing voluntary retirement programs or buyouts. A few schools also took long-term, strategic approaches that included changes to and cuts in their operations. For more information, visit http://www.aafp.org/news-now/resident-student-focus/20100920aamc-medschl-study.html and http://www.aamc.org/download/128414/data/2008economicrecessionimpact-krakower201005.pdf.pdf.
— AFP and AAFP NEWS NOW staff
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