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It would seem that any healthcare entity able to introduce lower costs and greater convenience would be welcomed with open arms, if not a genuine ticker-tape parade. Yet, walk-in retail clinics, new players built on low cost and convenience, are struggling to gain a national foothold, and experts aren't sure the new guy will even make it in the end.

The federal False Claims Act (FCA) is the government's primary weapon to combat fraud. It empowers the federal government to file actions against those alleged to have knowingly submitted false or fraudulent claims to the government. Since 1986, the Department of Justice has recovered more than $15 billion under the law.

The new House leadership delivered on one of its prime campaign promises last month by pushing through legislation requiring the Health and Human Services (HHS) secretary to negotiate directly with pharmaceutical companies on prices for medications covered by the Medicare drug benefit. The bill (HR 4) repeals the so-called "non-interference" clause in the Medicare Modernization Act (MMA) and replaces it with a provision requiring the secretary to negotiate prices that manufacturers may charge prescription drug plans (PDPs) and Medicare Advantage drug plans (MA-PDs).

An annual government analysis of healthcare spending indicates that outlays for healthcare rose only 6.9% in 2005, continuing a three-year slow-growth trend. Total U.S. healthcare spending reached almost $2 trillion, or $6,697 per person, but this reflects the slowest growth in outlays since 1999, when "enrollment in more tightly managed care plans peaked," according to analysts at the Centers for Medicare and Medicaid Services (CMS).

Everyone is jumping into the pool-the state-purchasing pool that is. States are beginning to dive into healthcare overhaul with almost artistic creativity, coming up with state-specific, collectively funded plans to fix the leaks in coverage.

When health savings accounts (HSAs) are attached to high-deductible health plans, employers find the accounts' low cost and high employee accountability attractive. They can bring in lower health insurance premiums, reduce payroll taxes and, for employees, serve as tax incentives and an additional source of retirement savings.

Schizophrenia is a chronic disease usually diagnosed when patients are in their mid- to late 20s; therefore, patients may receive decades of exposure to antipsychotic agents over their lifetime. Whenever long-term pharmacotherapy is required for a disease, the cardiovascular implications of that therapy need to be considered. This fact was recently highlighted by the removal of the cyclo-oxygenase-2 inhibitors rofecoxib and valdecoxib from the US market because of marked elevations in cardiovascular risk.

The chronic and excessive use of alcohol adversely affects the healthcare system, work productivity, and familial and social relationships. Alcohol misuse accounts for 85,000 deaths per year in the United States, and the overall financial costs related to alcohol dependence are more than $100 billion annually. The reduction of alcohol misuse can be measured as an increase in the frequency of abstinence or a reduction in the frequency of relapses. The recommendation for alcohol dependence treatment is a combination of psychosocial support therapy and pharmacologic treatment. Currently, there are only 3 FDA-approved agents for the treatment of alcohol dependence: naltrexone, acamprosate, and disulfiram.

Men who suffer from migraines are at increased risk for cardiovascular (CV) events, according to new data from the Physicians' Health Study. These observations follow similar reports that women with symptoms associated with migraines are at higher risk for CV disease.

Data indicate that oral rifaximin can prevent recurrences of Clostridium difficile-associated diarrhea (CDAD) in patients treated previously with vancomycin, said presenters at the American College of Gastroenterology Annual Scientific Meeting (ACG) in Las Vegas, Nev.

A once-daily formulation of mesalamine that relies on multimatrix (MMX) technology is effective at inducing and maintaining remission in patients with ulcerative colitis (UC), with no significant gender difference in the response rate, according to studies presented at Digestive Disease Week (DDW) 2006 in Los Angeles, Calif, and at the American College of Gastroenterology (ACG) Annual Scientific Meeting in Las Vegas, Nev.

Combination therapy with ezetimibe and simvastatin for 6 weeks provides greater reductions in low-density lipoprotein cholesterol (LDL-C) compared with rosuvastatin at the usual starting, next highest, and maximum doses of each drug, according to a randomized, double-blind, parallel-group, multicenter trial published in the journal Current Medical Research and Opinion.

According to an observational study recently published in the American Journal of Cardiology, use of a statin was associated with a 46% decrease in patients' odds of death compared with the risk of death in those not receiving a statin, despite the fact that statin users were in general at a higher risk for death. Furthermore, the magnitude of the observed mortality benefit associated with statin use appeared to increase as a patient's number of coronary heart disease risk factors increased.

A large, propensity score-adjusted cohort study recently published in the Journal of the American Medical Association (JAMA) demonstrated that statins were associated with a statistically significant reduction in the risks of death and hospitalization for heart failure when administered to patients with chronic heart failure (CHF). Although the ability of statins to lower cholesterol and prevent coronary heart disease in the general population is well known, the current finding that statins can reduce both morbidity and mortality in this broad CHF population is novel.

Pipeline Preview

17 alpha-hydroxyprogesterone (Gestiva, Adeza) for the prevention of preterm labor

Paroxetine oral suspension 10 mg/5 mL equiv base (equiv to Paxil oral suspension 10 mg/5 mL equiv base)

FDA Actions in Brief

FDA granted tentative approval to a combination of valsartan and amlodipine (Exforge, Novartis) for the treatment of hypertension (approval pending the expiration of market exclusivity and patent protection for amlodipine).

Bevacizumab

Angiogenesis inhibitor approved as part of combination therapy for first-line treatment of nonsquamous NSCLC

Kunecatechins

Botanical agent approved for topical treatment of external genital and perianal warts

For more than three decades, clinicians have routinely conducted prenatal ultrasound screenings to detect congenital anomalies, multiple-gestation pregnancies, fetal growth disorders, placental abnormalities and errors in the estimation of gestational age. When managed care was born, executives realized the importance of providing benefit coverage for this test because they recognized prenatal ultrasound is one of the earliest tools in the disease management arsenal to promote fetal, neonatal, and maternal health. In an era where medical costs are surging, and in response, healthcare premiums of employers and their workers have climbed twice as fast as wages and inflation in 2006, the evidence-based benefits of prenatal ultrasound is gaining momentum and medical community recognition as a disease management tool.