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According to Senator Charles (Chuck) Grassley, the Medicare Modernization Act of 2003 (MMA) has worked out better than expected, but he still keeps a close watch to ensure healthcare dollars are well spent. As chairman of the Senate Finance Committee, Grassley has tremendous clout in Washington. His committee is responsible for tax policy, Social Security, Medicare and Medicaid, which made him a central player in developing and enacting MMA.

Washington, D.C.-The campaign to expand healthcare coverage to all Americans took a big hit this summer. New data from the U.S. Census Bureau indicated that the population without healthcare coverage grew by more than 1 million people in 2005 compared with the previous year. Even though more individuals actually had insurance coverage in 2005 (247.3 million, up from 245.9 million in 2004), the percentage of uninsured rose from 15.6% in 2003 to 2004 to the current 15.9%.

Would you pay $19,900 to add another year to your life? If only it were that simple. The New England Journal of Medicine (NEJM) recently published a study that concluded between 1960 and 2000, we paid an average of $19,900 in medical costs per year of life gained during that time. In 1960, a newborn's life expectancy was 69.9 years, and in 2000, it was 76.87 years, according to the study.

A drug use evaluation at Wake Forest University Baptist Medical Center (WFUBMC) was initiated following a change in institution-approved guidelines for the administration of amphotericin B lipid complex injection (ABLC) (Abelcet, Enzon). This study was conducted to determine compliance with the new guidelines among prescribers and to characterize the population of patients receiving ABLC. A total of 153 patients received ABLC from April 2001 through December 2002. One hundred thirty-three patients (87%) met 1 or more of the institutional criteria for ABLC administration and 20 (13%) receiving ABLC did not meet the guidelines. The mean baseline serum creatinine (SCr) value among patients meeting institutional guidelines (n=133) was 2.0 mg/dL (range, 0.5–5.0 mg/dL). Among patients who did not meet the guidelines (n=20), the mean baseline SCr level was 1.7 mg/dL (range, 0.6–2.9 mg/dL). The use of new guidelines, which were less stringent than previous guidelines, resulted in earlier administration..

This study evaluates the appropriateness and cost implications of using epoetin alpha for transfusion reduction in Hartford Hospital's (Hartford, Conn) intensive care units (ICUs), with the goal of implementing a protocol for use in this setting. We conducted a literature review to determine the efficacy, safety, and clinical outcomes of epoetin alpha for transfusion reduction in the ICU. We also evaluated the safety and supply of red blood cell (RBC) transfusions and the cost considerations of epoetin alpha. The literature review demonstrated that epoetin alpha can reduce blood transfusions in the ICU setting but its use provided no difference in mortality or any other clinical outcome. Our epoetin alpha expenditure for transfusion reduction was $112,067 annually to theoretically save $14,349 in blood transfusion costs. The pharmacy and therapeutics (P&T) committee subsequently recommended that epoetin alpha not be used for transfusion reduction in the ICUs and requested that a drug use evaluation (DUE) be performed to monitor compliance, adverse effects, and cost avoidance. One year after implementation of the epoetin alpha DUE program, the compliance rate was >90%, there were no reported adverse events with blood transfusions or problems with blood supply, and a cost avoidance of $104,562 was realized. (Formulary. 2006;41:442?449.)

FDA issued a proposed rule late last month that would allow pharmaceutical manufacturers to register and list products electronically in an effort to minimize the paper-based element of the process, allowing the agency to host a comprehensive national database of medications and to be more flexible in its role of monitoring the safety of medications for sale, according to officials.

Intravenous (IV) moxifloxacin followed by oral (PO) moxifloxacin, both dosed once-daily, is at least as effective in the treatment of complicated intra-abdominal infections (cIAIs) as piperacillin-tazobactam and amoxicillin-clavulanate comparator regimens dosed multiple times per day, researchers reported in the Annals of Surgery.

The selective estrogen-receptor modulator (SERM) raloxifene reduces the risks of invasive breast cancer and vertebral fracture in postmenopausal women but also increases the risks of venous thromboembolism and fatal stroke, a study in the New England Journal of Medicine (NEJM) concluded.

Raloxifene, a second-generation selective estrogen receptor modulator (SERM) approved to treat osteoporosis, fared as effectively against breast cancer as tamoxifen in 2 related comparison studies published in the Journal of the American Medical Association (JAMA).

A drug use evaluation at Wake Forest University Baptist Medical Center (WFUBMC) was initiated following a change in institution-approved guidelines for the administration of amphotericin B lipid complex injection (ABLC) (Abelcet, Enzon). This study was conducted to determine compliance with the new guidelines among prescribers and to characterize the population of patients receiving ABLC. A total of 153 patients received ABLC from April 2001 through December 2002. One hundred thirty-three patients (87%) met 1 or more of the institutional criteria for ABLC administration and 20 (13%) receiving ABLC did not meet the guidelines. The mean baseline serum creatinine (SCr) value among patients meeting institutional guidelines (n=133) was 2.0 mg/dL (range, 0.5–5.0 mg/dL). Among patients who did not meet the guidelines (n=20), the mean baseline SCr level was 1.7 mg/dL (range, 0.6–2.9 mg/dL). The use of new guidelines, which were less stringent than previous guidelines, resulted in earlier administration..

A variety of clinical approaches are utilized in the management of poor glycemic control in patients with type 2 diabetes. Sitagliptin (Januvia, Merck), a novel drug in a new medication class known as dipeptidyl peptidase-IV (DPP-IV) inhibitors, offers a new mechanism by which to achieve glycemic control. Although stimulation of receptors by the glucagon-like peptide-1 (GLP-1) enhances the body's ability to produce insulin in response to elevated blood glucose concentrations, rapid degradation of GLP-1 by DPP-IV limits its clinical effectiveness. The development of medications to reduce this degradation is being pursued by numerous manufacturers. An NDA for the first of these medications, sitagliptin, was submitted to FDA in February 2006. Currently available clinical studies have demonstrated improved glycemic control with sitagliptin therapy in patients who have not achieved target glucose levels with diet and oral medications. (Formulary. 2006;41:434–441.)

Approvable designations; Priority review; Fast-track designations; Orphan drug designations; Nonapprovable designations

When the Academy for International Health Studies traveled to Prague in April for its annual trade/study mission, little did the delegates know they were about to enter a healthcare war zone. Weeks in advance of a contentious national election, the country's prime minister recently had fired the minister of health and named a successor with a mandate to implement some quick fixes. Insurers managed their strained cash flows by slowing payments to providers while the new minister, seemingly arbitrarily, mandated price reductions. The result was a physician-organized strike and thousands of angry, untreated patients.

As CMS has begun to promote its quality agenda through pay-for-performance (P4P) initiatives, private payers should consider certain regulatory issues in establishing such programs.

Winona Health, a locally owned and operated nonprofit organization in Winona, Minn., had an outdated and cumbersome technology infrastructure, which hampered its ability to serve its community. With more than 900 employees at Winona Health and its affiliates, Winona's financial and billing systems couldn't keep up with the firm's growth or increasingly complex reporting and tracking requirements. Of particular importance was automating Winona Health's human resources and payroll processes-employee hours were being logged manually, making the maintenance of labor law requirements for overtime, weekends and holidays time-intensive.

With radiology costs in the United States growing to more than $100 billion annually, diagnostic imaging is the second-largest and fastest-growing expense for health plans behind pharmaceuticals. Unmanaged, radiology spending is expected to continue growing at a rate of 20% annually. Factors driving this growth include fragmentation of care, the continual advances in diagnostic imaging technology, the affordability of imaging equipment leading to adoption and utilization in more care settings, direct advertising to patients, and an aging population. As a result, radiology utilization management has become a top priority for health plans.

One of the things I love about living in the suburbs is the close proximity of retail when I need to get my errands done. In a three-mile stretch, I can eat lunch, hit the ATM, buy a gift, fill up my gas tank and replenish my groceries. At the grocery store, I can buy stamps and drop off my dry cleaning, too.

As the healthcare industry strives to establish appropriate and effective standards for the public reporting of clinical data, providers may lose sight of how they can make a critical difference in ensuring new reporting standards do not distract from, but rather aid in, achieving the primary goal of improving patient care.

New incretin-based therapies will soon enter the therapeutic armamentarium for type 2 diabetes. Two dipeptidyl peptidase (DPP)-IV inhibitors in phase 3 clinical trials, vildagliptin and sitagliptin, are oral agents that can be used once daily as monotherapy or in combination with other oral antidiabetic agents to reduce levels of hemoglobin A1c (HbA1c) with few side effects, little risk of hypoglycemia, and no promotion of weight gain, researchers reported at the 66th scientific sessions of the American Diabetes Association (ADA) in Washington, DC.