ACIP Expands Flu Vaccine Recommendation; Report Shows Adult Vaccine Uptake Needed

During a February 2010 meeting of the Centers for Disease Control and Prevention's (CDC's) Advisory Committee on Immunization Practices (ACIP), members voted to expand the recommendation for annual influenza vaccination to include all persons six months and older in whom the vaccine is not contraindicated. ACIP members also voted to recommend that children who are six weeks to five years of age receive the recently approved 13-valent pneumococcal conjugate vaccine Prevnar 13, in place of the currently used seven-valent Prevnar product. According to the new report “Adult Immunizations: Shots to Save Lives” from the Trust for America's Health, up to 50,000 U.S. adults die each year from vaccine preventable diseases, and the direct health care burden of these diseases in U.S. adults is $10 billion annually. The report recommends that physicians make it standard practice to review adult patients' immunization histories, offer vaccinations during appropriate medical visits, and use electronic health records (EHRs) and immunization registries to improve information sharing among physicians and to generate reminders about recommended vaccinations. For more information, visit https://www.aafp.org/news-now/clinical-care-research/20100303acip-recs.html and https://www.aafp.org/news-now/health-of-the-public/20100308tahreportvaccines.html.

Court of Appeals Reinstates FDA's Authority to Regulate Electronic Cigarettes

A U.S. Court of Appeals ruling has at least temporarily reinstated the U.S. Food and Drug Administration's (FDA's) authority to stop electronic cigarettes (e-cigarettes), which contain nicotine extracted from tobacco, from entering the country. This decision comes after a lower court ruled that the FDA does not have the authority to regulate e-cigarettes, even though Congress granted the FDA the power to regulate tobacco products in 2009. FDA officials, however, say they would prefer to regulate e-cigarettes as drug delivery devices rather than as tobacco products because it would give the FDA far broader control, including the ability to block importation of the devices and their components. In July 2009, the FDA issued a warning about e-cigarettes after known carcinogens and toxic chemicals were detected in samples of the products. For more information, visit https://www.aafp.org/news-now/health-of-the-public/20100302e-cig-fda.html.

AAFP Updates Policy on Retail Health Clinics, Opposes Expanding Services

In February 2010, the American Academy of Family Physicians (AAFP) Board of Directors revised its official policy on retail health clinics to reflect the AAFP's opposition to a growing scope of services provided by many of these clinics. According to the Convenient Care Association, the number of retail clinics has grown to nearly 1,200 nationwide. Two of the nation's largest retail health chains have disclosed to the AAFP their intent to move forward into chronic disease management. In its revised statement, the AAFP says it does not endorse retail health clinics and believes the clinics could interfere with the medical home model of care. The AAFP has discontinued its practice of entering into formal agreements with retail health clinics. For more information, visit https://www.aafp.org/news-now/inside-aafp/20100224retail-policy.html.

MedWatch FDA Issues New Warnings, Advice for Several Medications

The FDA has issued safety warnings for long-acting beta agonists (LABAs) and Maalox. Manufacturers of LABAs must include new warnings on their package labels stating that LABAs should never be used alone to treat asthma in children or adults, but may be used in combination with another asthma controller medication. The warning was issued after FDA analyses of postmarketing clinical trials demonstrated that use of LABAs is associated with an increased risk of severe exacerbation of asthma symptoms, leading to hospitalization and death in some patients. Manufacturers of LABAs also will be required to create a risk evaluation and management strategy to educate physicians and patients about how LABAs can be used safely, and conduct additional studies to evaluate the safety of the drugs when used in combination with inhaled corticoste-roids. The FDA is also warning physicians and patients about the potential for serious adverse effects when the wrong Maalox product is used to treat symptoms. Unlike other Maalox products, the active ingredient in Maalox Total Relief is chemically related to aspirin and may cause adverse effects similar to those that occur with aspirin use. The FDA said patients with a history of gastrointestinal ulcer disease or a bleeding disorder should not use the product, nor should children and teenagers recovering from viral infections and persons who are taking certain medications. Additionally, the FDA has announced that it will present cardiovascular safety data regarding the diabetes mellitus medication rosiglitazone during a public meeting in July 2010, when the agency also plans to provide an updated assessment of the risks and benefits of the medication. For now, the FDA is recommending that patients continue taking rosiglitazone and physicians assess and monitor these patients carefully. For more information, visit https://www.aafp.org/news-now/clinical-care-research/20100224laba-warn.html, https://www.aafp.org/news-now/health-of-the-public/20100223maalox.html, and https://www.aafp.org/news-now/health-of-the-public/20100225rosiglit-rev.html.

No Improvement in Monitoring of Atypical Antipsychotics, Despite Warnings

An FDA warning about atypical antipsychotic drugs and their connection to increased risk of diabetes and hyperglycemia did not make it to primary care physicians, according to a study in the Archives of General Psychiatry. In late 2003, the FDA identified a connection between atypical antipsychotics and an increased risk of diabetes, and the American Diabetes Association and the American Psychiatric Association published a consensus statement describing these risks and establishing a monitoring protocol. The protocol recommends taking a baseline assessment, including fasting plasma glucose level and fasting lipid profile. Subsequently, the FDA sent letters to neuropsychiatric physicians to alert them to the new warning. The consensus statements did not increase baseline testing or monitoring, although the FDA's warning prompted a decline in prescribing of olanzapine (Zyprexa), which is associated with greater metabolic risk. The study authors theorize that primary care physicians may have a lower awareness of the recommendations because the FDA targeted neuropsychiatric health professionals only. For more information, visit https://www.aafp.org/news-now/clinical-care-research/20100309antipsychoticdrugs.html and http://archpsyc.ama-assn.org/cgi/content/full/67/1/17.

HHS Presents Health IT Plan; AAFP Suggests EHR Legislation Modifications to CMS

On March 2, 2010, the U.S. Department of Health and Human Services (HHS) announced a proposed health information technology (IT) rule that would establish certification programs to test EHR systems. The federal proposal calls for establishment of a temporary certification program that eventually would be replaced by a permanent program. Steven Waldren, MD, director of the AAFP's Center for Health IT, said the AAFP would carefully review the proposal before providing comments to HHS. The AAFP has responded to the federal government's December 30, 2009, release of EHR regulations that define the term “meaningful use” with comments detailing how the AAFP would make the regulations more helpful to family physicians. AAFP Board Chair Ted Epperly, MD, of Boise, Idaho, sent a letter to the Centers for Medicare and Medicaid Services (CMS) noting several areas where the AAFP saw opportunities for improvement. Epperly suggested CMS consider offering partial incentives for physicians using less than 100 percent of required criteria, creating parity between first-year requirements for the Medicare and Medicaid programs, changing calculations of meaningful use measures from recording of percentages to absolute counts or allowing for shorter reporting periods, and ensuring incentives for team-based care. For more information, visit https://www.aafp.org/news-now/practice-management/20100309health-it-cert.html and https://www.aafp.org/news-now/practice-management/20100304mean-use-ltr.html.

CMS Notifies Medicare Providers of Billing Glitch on Recent Part B Professional Claims

Recently there was a glitch in CMS' system that occurred when some claims did not cross over to supplemental payers automatically, although the provider remittance advice indicated otherwise. According to CMS, physicians should carefully examine Part B professional claims processed between January 5 and February 12, 2010. Physicians need to take action if the remittance advice was for two or more professional services and if both of the following conditions apply: one service was 100 percent reimbursable, and one service was applied to the Part B deductible and/or carried coinsurance amounts. Physicians with claims that fall within those parameters are responsible for billing the secondary insurer. CMS says the glitch was fixed as of February 12, 2010. For more information, visit https://www.aafp.org/news-now/practice-management/20100301medicare-proc-prob.html.

AAFP Supports ACCME Proposals on Complaints and Inquires Process, Outcomes

The AAFP is supporting two proposals recently made by the Accreditation Council for Continuing Medical Education (ACCME). One would modify the ACCME's complaints and inquiries process with the aim of balancing transparency in the continuing medical education (CME) enterprise with CME providers' confidentiality. The other proposal would acknowledge that CME should facilitate changes in knowledge, competence, performance, and patient outcomes. For more information, visit https://www.aafp.org/news-now/cme-lifelong-learning/20100302accme-ltr.html.

— AFPandAAFP NEWS NOWstaff