News

Recent FDA action (through May 2008) related to ceftobiprole, sugammadex, romiplostim, Gardasil, and amrubicin.

NME: Bendamustine (Treanda), an alkylating agent, was approved on March 20, 2008, for the treatment of chronic lymphocytic leukemia (CLL).

Experts urged a “return to statins” after hearing the final results of the Ezetimibe and Simvastatin in Hypercholesterolemia Enhances Atherosclerosis Regression (ENHANCE) trial, which demonstrated no slowing of carotid atherosclerosis progression with the addition of ezetimibe to simvastatin therapy.

Antibiotics in deveopment for the treatment of complicated skin and skin structure infections, community-acquired pneumonia, and infectious diarrhea

According to results from the Ongoing Telmisartan Alone and in Combination with Ramipril Global Endpoint Trial (ONTARGET), the angiotensin receptor blocker (ARB) telmisartan is as effective as the angiotensin-converting enzyme (ACE) inhibitor ramipril in preventing adverse cardiovascular events in high-risk patients with cardiovascular disease but without heart failure.

At a March 5, 2008, commission meeting, the Medicare Payment Advisory Commission (MedPAC) discussed the feasibility of requiring pharmaceutical companies and medical product manufacturers to report financial relationships and gifts to physicians on a national basis.

Approximately 1.7 million healthcare-associated infections (HAIs) occur in US hospitals each year. These HAIs, which include pneumonia, bloodstream infections (BSIs), and urinary tract infections (UTIs), account for approximately 99,000 deaths and $5 billion in additional healthcare costs.

Much to the surprise of most close FDA observers, Janet Woodcock, MD, agreed in March to resume control of the Center for Drug Evaluation and Research (CDER). Dr Woodcock headed CDER for 10 years before becoming deputy commissioner and, more recently, FDA’s chief medical officer. But when CDER director Steven Galson, MD, MPH, left last year, Dr Woodcock served as the temporary CDER chief. Now, after a long search for a replacement, she has decided to accept the position herself.

Recent Milliman analysis of employer programs that offer employees a choice of consumer-directed health plans or non-CDHPs, shows that when offered as a new choice, CDHPs deliver a modest 1.5% in savings beyond non-CDHPs based on typical risk- and benefit-adjustment factors.

How much attention is being paid to abuse of prescription drugs? One group, pharmacy benefit managers, are beginning to take a closer look by creating programs to identify members who may be abusing prescription drugs.

Higher-than-expected enrollment has challenged the budget and the administration of public health coverage in Massachusetts ever since its universal health plan took effect in April 2006. Christina Severin, executive director of Network Health in Medford, Mass., a private plan that covers subsidized Commonwealth Care members as well as MassHealth Medicaid members, believes programs will continue to struggle until one particular problem is solved: enrollment churning.

Many healthcare entities have explored certain alternative risk transfer arrangements as a means for insuring, or perhaps self-insuring, various exposures. The use of captive insurance arrangements has been a common approach, and thus, "protected cell companies" have become popular vehicles.

A few hospital systems already are improving work process by implementing Lean and Six-Sigma management principles. Implementing Lean Sigma (a complementary combination of Lean and Six-Sigma) in a hospital setting is not about fixing problem employees who fail to improve their work. It's about fixing the broken systems and processes that hinder medical professionals from doing what they do best.

As employers continue to cut back on health insurance for retirees (and might even stop offering it to new employees), early retirees are stuck in an expensive conundrum. More and more this group of retirees is turning to consumer-driven solutions.

The health-quality measurement bandwagon is picking up steam these days as both public and private payers struggle to deal with rising costs and the need to ensure quality care. Medicare has greatly enhanced its "Hospital Compare" Web site by posting the results of a patient survey on satisfaction with care during hospital stays.

Washington, D.C. - Health insurers and medical groups have agreed to work together to develop national standards for rating physician performance.

Long debates in Congress over mental health parity laws position the most human of health needs up against stretched budgets and market disagreements on treatment value. At the moment, arguments center on insurers' coverage obligations, but few are addressing another debate that is certain to follow.

Commonwealth Fund State Performance Ranking (2007): 3

Attracting the right candidate and landing that talented employee for your organization are challenges. As the labor market continues to tighten, healthcare employers need to focus on long-term recruitment and retention strategies.

Case managers provide services at critical junctures, whether facilitating discharge from acute care to a sub-acute facility or coordinating home healthcare services for an individual to prevent hospital readmissions.

On Dec. 29, 2007, President George W. Bush signed the multi-faceted Medicare, Medicaid, and SCHIP Extension Act of 2007. Section 111 of the bill, titled, Medicare Secondary Payor (MSP), mandated that effective Jan. 1, 2009, all Group Health Plans (GHP) or any related entity (i.e. insurer or third party administrator) serving on behalf of the GHP will be responsible for identifying and submitting "situations where the group health plan is or has been a primary plan to the program," according to Medicare.

Congress is looking to give the Food and Drug Administration the controversial and complex job of controlling tobacco marketing and advertising. FDA would not be able to ban cigarettes or require zero nicotine products, under legislation recently approved by a key House committee. But it would gain authority to approve cigarette labeling, limit certain promotional claims and curb marketing to minors. The measure provides legal authority for a regulatory approach devised more than 10 years ago under former FDA Commissioner David Kessler, but subsequently struck down by the courts.

The rate of obesity in the United States has doubled in the last 30 years, and is weighing down companies’ bottom lines, according to a new report from the Conference Board, a business membership and research organization in New York.

Blue Cross of California, one of the state’s largest health plans, has changed its name to Anthem Blue Cross, the San Francisco Business Times reports. Anthem Blue Cross has 8.4 million members in California.

WellPoint Inc.’s acquisition of Resolution Health Inc., a data analytics-driven personal healthcare guidance company, is yet another reflection of the interest in consumer-driven tools such as EHRs, PHRs, and health-related search engines, among others.

Medicare Advantage plans will see payment rates increase by 3.6% in 2009, slightly higher than last year’s rise of 3.5%, but not as much as the 3.7% boost previously predicted. This slight drop from earlier estimates is a result of lower-than-expected plan expenditures for 2007, according to analysis by the Centers for Medicare and Medicaid Services (CMS).

P&T committees can create evidence-based formularies with a variety of tools and proven methods of evaluation

The Food and Drug Administration Amendments Act (FDAAA) enacted in September 2007 requires new initiatives to expand information on the risks and benefits of prescription drugs. One goal established in FDAAA is the modernization of FDA’s system for detecting adverse drug events (ADEs); therefore, the current system is being reviewed so limitations and capabilities can be identified.