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In 2 large, case-control studies published in the New England Journal of Medicine (NEJM), researchers demonstrated that, overall, a woman's use of a selective serotonin-reuptake inhibitor (SSRI) in early pregnancy was not associated with significantly increased risks of congenital heart defects or most other types of birth defects.

Throughout 2007, Formulary's "Focus on" articles have examined 9 newly approved or investigational drugs of interest to pharmacy and therapeutics committee members. Because many readers have said that they frequently reference this column when making formulary decisions for their hospitals, health systems, or managed care organizations, the editors have compiled this review of these agents, along with updates on the regulatory status of each. Of the 9 agents reviewed in 2007, 4 have received final FDA approval; the remaining 5 agents have not yet been approved by FDA.

FDA approval information regarding zoledronic acid (Reclast injection), somatropin (rDNA origin) injection (Norditropin), clopidogrel 300-mg loading dose (Plavix), IV and oral levofloxacin (Levaquin), thrombin, topical (human) (Evithrom), amlodipine/olmesartan (Azor), and docetaxel injection concentrate (Taxotere)

The latest FDA action (through November 2007) related to anecortave depot suspension (Retaane), lamotrigine extended-release (Lamictal XR), pramlintide injection (Symlin), frovatriptan (Frova), lumiracoxib (Prexige), PI-88, C1 inhibitor (Cinryze), Etravirine, IPI-504, Parathyroid hormone (rDNA origin) for injection (Preos), and pafuramidine

Raloxifene was approved on September 13, 2007, for the additional indication of the reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis and in postmenopausal women at high risk for invasive breast cancer.

FDA has approved doripenem, a carbapenem antibiotic, for the treatment of complicated intra-abdominal and urinary tract infections, including pyelonephritis

The important role of Medicaid health plans in states where landmark healthcare reform efforts are under way is highlighted in a new report, Medicaid Health Plans: A Turnkey Solution for Expanding Health Insurance Coverage for the Uninsured. Sponsored by the Association for Community Affiliated Plans (ACAP), the report focuses on health plans in California and Massachusetts – two states breaking ground in expanding coverage to uninsured residents.

To define e-visits, CPT code 0074T was adopted in 2004, says Lynn Gonzalez Monson, director of health information technology for Blue Cross and Blue Shield of Florida. The code requires documentation of history, system review and complexity of medical decision-making similar to those for office visits and consultations, establishing a firm basis for review. Reimbursement is limited to established patients. The Florida Blues allowed payment for the code since its inception, even for fully insured clients, and have reviewed every case it has been billed.

With transparency becoming a given, pharmacy benefit managers (PBMs) have taken a new approach to marketing their services. The primary marketing/sales strategy for Express Scripts, headquartered in St. Louis, is direct sales with a reliance on intermediary consultants and advisors.

An effective use of hospitalists is to have them available to free up general practitioners from hospital rounds. Appropriate use of hospitalists can also enable physicians to visit patients more than once a day in the hospital setting.

Regardless of the structural framework of any nation's healthcare system, a critical measure of its success will depend upon the aligned incentives and objectives of its key constituents.

Pharmacy Benefits Managers (PBMs) have long gotten a bad rap, taking heat for lack of transparency in their dealings with pharmaceutical manufacturers. Some agreements leave health plans in the dark about the true value of their PBMs. Touting benefits, from clinical-based formularies and lower drug costs and to specialty pharmacy benefits and retail networks, may not be enough today to attract business in a competitive marketplace.

Ambulatory Surgical Centers (ASC) represent an unparalleled snapshot of the evolution of healthcare delivery, experts say. The surge in growth of ASCs nationwide affords patients the opportunity for non-emergent surgical and procedural services outside the hospital structure while also yielding cost-effective benefits for managed care organizations.

Earlier this year Susan Andrews, MD, evaluated a broken arm for a long-time patient in her family practice. Without leaving her Memphis office, Dr. Andrews conducted a complete history, assessed the injury and arranged a referral to an orthopedist, even though the patient was actually 2,000 miles away vacationing in the Caribbean.

Private sector organizations are pitching the government on new business, such as the recently embraced special needs plans (SNPs), designed for the costliest populations of seniors. Prompted by the Medicare Modernization Act, there are three SNP models: dual-eligible, institutional care and chronic condition.

As employers search for ways to reduce rising healthcare costs and improve employee productivity, more companies are implementing wellness programs in an attempt to improve employees' health and reduce their own insurance costs. There are a number of different options employers may consider when deciding to institute a wellness program, including offering smoking cessation and weight loss programs, fitness classes, and in some cases, penalizing certain behavior. Employers must be careful, however, to ensure that these programs do not violate certain federal and state laws as they carry certain inherent legal risks.

Pressure is mounting on Capitol Hill once again to ax payments to Medicare Advantage plans. The legislators need to save $10 billion in order to rescind a planned cut in Medicare rates for physicians by year-end. Conveniently, the Congressional Budget Office (CBO) estimates that equalizing payments between MA plans and fee-for-service Medicare will save $50 billion over five years. If Congress wants to expand the State Children's Health Insurance Program (SCHIP) and keep physicians happy, "excessive" MA rates are the prime target.

Dallas-Recently released results of a consumer survey show that a majority of Americans believe more emphasis on preventive medicine is a solution to the increasingly evident problems of the nation's healthcare system.

As the abundance of cliches would indicate, incentives are a powerful force. Health incentives, however, are becoming more sophisticated, and stakeholders need to adopt programs that work.

National Reports-The handful of health plans that represent the largest number of enrollees are publicly traded and therefore likely to have reported salaries and bonuses at the high end of the scale. However the majority of HMO chief executives are not part of these plans, industry experts say.

Washington, D.C.-In the latest salvo against private health plans, Congressional leaders claim that the Medicare Part D drug benefit raised costs for taxpayers and seniors some $15 billion this year due to higher administrative and sales costs and lower rebates from drug companies.

Actor George Clooney was hospitalized recently after a minor motorcycle accident. He cracked a rib, but that wasn't the worst of it. Star-struck hospital employees who weren't involved in his care accessed his medical record, no doubt hoping to find some celebrity gossip.

Patients with early-stage pulmonary arterial hypertension (PAH) and those with either inoperable chronic thromboembolic pulmonary hypertension (CTEPH) or inoperable or post-pulmonary endarterectomy pulmonary hypertension can benefit from treatment with bosentan, according to study results presented at the European Society of Cardiology Congress 2007 in Vienna, Austria.

Thrombolytic therapy with reteplase/abciximab before percutaneous coronary intervention (PCI) (facilitated PCI) has no effect on post-myocardial infarction (MI) complications, including death, but the treatment significantly increases the risk of bleeding compared with primary PCI performed with in-lab abciximab in patients with ST-elevation MI, according to the results of the Facilitated Intervention with Enhanced Reperfusion Speed to Stop Events (FINESSE) study.

In a multicenter, multinational, randomized controlled study, a fixed-dose combination of perindopril/ indapamide was associated with a reduced risk of death and vascular events in patients with type 2 diabetes, many of whom were already taking antihypertensive drugs.

The 2007 Congress of the European Society of Cardiology attracted nearly 30,000 attendees to Vienna, Austria, from September 1 to 5, 2007. The congress offered details of the latest research in various fields of cardiology

Maraviroc is the first CCR5 antagonist approved for the treatment of HIV-1 infection. The use of maraviroc is associated with significant decreases in HIV viral load and increases in CD4 counts in antiretroviral treatment-experienced patients with CCR5-tropic virus when used as an add-on to optimized antiretroviral treatment. In clinical trials, patients with dual- or mixed-tropic virus (which can infect cells using CXCR4 and/or CCR5 receptors) who were treated with maraviroc demonstrated no difference in HIV viral load compared with patients who received placebo. A recent study compared maraviroc plus lamivudine/zidovudine with efavirenz plus lamivudine/zidovudine; maraviroc did not demonstrate noninferiority when undetectable virus was defined as <50 copies/mL; however, maraviroc did meet noninferiority criteria when undetectable virus was defined as <400 copies/mL. Maraviroc is not recommended for patients with CXCR4-tropic, dual-tropic, or mixed-tropic virus; for antiretroviral-naive patients; or for..

An extensive systematic review published in the Annals of Internal Medicine demonstrated that older oral drugs for type 2 diabetes are just as, if not more, effective than newer agents for gylcemic control, lipid control, and other intermediate end points.