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The high-profile health policy issues for the new Congress are to reduce Medicare prescription drug prices and expand federal government funding for embryonic stem cell research. Congressional leaders want to enact legislation that will permit the federal government to negotiate drug prices (see Newswire), a move that eventually could alter the role of private plans in providing healthcare benefits to seniors.

Obesity is the new smoking. While states are increasingly outlawing public smoking, no one is ready to initiate similar measures targeted at people who are obese. It's just not polite.

There is no doubt about it-transmitting claims and other healthcare information electronically saves time and money.

The False Claims Act (FCA), 31 U.S.C. 3729, et seq., is about to become the worst-kept secret of the healthcare industry. One of the nation's oldest statutes, the FCA has allowed the government to recover more than $3.1 billion in the first nine months of 2006, including an eye-popping $900 million dollar settlement with Tenet Healthcare-the largest FCA recovery ever. And, as if these staggering numbers were not enough to garner attention, as of January 1, 2006, entities that receive $5 million or more per year in Medicaid payments will be required to inform their employees about the FCA. Because employees are the most likely whistleblowers in an FCA lawsuit, the FCA's prominence in the healthcare industry should increase over the next few years.

Oxybutynin extended-release tablets, 15 mg (equiv to Ditropan XL extended-release tablets, 15 mg)

Imatinib (Gleevec, Novartis) was approved for relapsed/refractory Philadelphia chromosome-positive acute lymphoblastic leukemia, certain forms of myelodysplastic/myeloproliferative diseases, aggressive systemic mastocytosis, hypereosinophilic syndrome and/or chronic eosinophilic leukemia, and unresectable, recurrent, and/or metastatic dermatofibrosarcoma protuberans.

Telbivudine was approved on October 25, 2006, for the treatment of chronic hepatitis B virus (HBV) in adult patients with evidence of viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.

The US Department of Justice (DOJ) and Medco Health Solutions, a large pharmacy benefit manager (PBM) based in Franklin Lakes, NJ, reached a settlement over allegations that the PBM had submitted false claims to the federal government, had paid kickbacks to health plans to obtain business, and had both solicited and accepted kickbacks from pharmaceutical companies.

The Oklahoma City Veterans Affairs Medical Center restructured its formulary system in 2003, creating a system of restrictive criteria for certain drugs to improve pharmaceutical cost effectiveness by enforcing evidence-based indications in the prescription system. The new criteria-restriction system required the use of formulary drugs as first-line therapy; prescriptions for nonpreferred, criteria-restricted drugs had to be justified by the prescriber at the time of prescription in accordance with the criteria established by the pharmacy and therapeutics (P&T) committee. To determine the effects of the system on cost avoidance and prescriber opinion, we analyzed drug utilization statistics and surveyed prescribers. Analysis demonstrated that the criteria-restriction system was an effective cost-avoidance tool because inappropriate prescriptions for restricted, high-cost drugs were curtailed in favor of lower-cost formulary alternatives. The total cost avoidance observed after placing 15 outpatient drugs in..

The American Heart Association (AHA) Scientific Sessions comprise the world's largest conference for scientists and healthcare professionals focusing on cardiovascular disease. The 2006 AHA Scientific Sessions, which took place Nov. 12–15 in Chicago, Ill, featured invited lectures and investigative reports. The conference included presentations on trials that evaluated investigational therapeutic agents, existing drugs and drug-related devices, and approved agents in alternative regimens or for alternative indications.

Cardiac function is regulated in part by the renin-angiotensin-aldosterone system, and current cardiovascular therapies work to antagonize this system by inhibiting the generation or action of angiotensin II. Aliskiren is the first drug to be reviewed by FDA in a new class of antihypertensive agents that directly inhibit the action of renin.

Women who take prescribed non-steroidal anti-inflammatory drugs (NSAIDs) in early pregnancy, specifically the first trimester, may increase their risk of giving birth to a child with congenital anomalies, especially cardiac septal anomalies, compared with women who do not take NSAIDs during this period, according to a recent study published in Birth Defects Research (Part B).

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

Infliximab was approved on October 13, 2006, for the reduction of signs and symptoms, induction and maintenance of clinical remission and mucosal healing, and elimination of corticosteroid use in patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy.

Pramipexole was approved on November 7, 2006, for the treatment of moderate-to-severe primary restless legs syndrome (RLS).

Telbivudine was approved on October 25, 2006, for the treatment of chronic hepatitis B virus (HBV) in adult patients with evidence of viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.

Review of agents in late-stage development for the treatment of ankylosing spondylitis, osteoarthritis, and related pain (December 2006).

When you're in the innovation business, you take some risks and temper your expectations. When one of your innovations produces $100 million in annual savings, you know you're doing something right.

We've come a long way, baby. Yes, women in the workplace, in the board room, in political office-and in healthcare-have come a long way. A status report on Health Plan Employer Data and Information Set (HEDIS) measures specifically targeting women is showing upward trends, or at least steady statistics. Private health plans showed improvement in 35 out of 42 effectiveness of care HEDIS measures in 2005.

With business moving faster than ever, fragmented communications are typical. This leaves managers to wonder how to keep everyone in sync and correctly informed. Change management can play a key role toward ensuring success in major change events; however, it's critical to define what change management is. As defined by Prosci, a premier change management research organization, change management is the process of proactively managing the people side of change.

Price is paramount to survival in the current healthcare market. With skyrocketing premiums, moving toward an affordable level for both the employer and the employee/member is essential, experts agree.

The rise in popularity of consumer-driven healthcare (CDHC) will challenge HMOs to be at the top of their game, say industry watchers.

When you're in the innovation business, you take some risks and temper your expectations. When one of your innovations produces $100 million in annual savings, you know you're doing something right.

Health insurance is one of the most regulated industries in the world. Within its comprehensive regulatory scheme, there are several laws that are designed to assure the solvency of health insurance companies and HMOs. These laws limit and restrict the types of investments that these companies may own, dictate the level of capitalization they must maintain, and establish other solvency measures.

Like the wide-eyed toddlers who will stare in awe at their stack of holiday gifts this year, healthcare consumers certainly have a few surprises to get excited about as 2006 comes to a close.

When employees can't work because of sickness or injury, both employers and employees suffer. By using a holistic approach to maintaining a healthy workforce, employees are more secure, productivity improves and the cost of running a business can dramatically decrease.

Wherever you go, you can see technology's impact on our society. Household bills are paid online, satellites can locate your home from space, and cell phones have the ability to send and receive e-mail. Another area of society seeing a surge in technological advancement is the healthcare sector. From applying transactional data management for disaster recovery to implementing real-time analysis software to improving systems management, hospitals are adopting technology to ensure that their most important information-patient data is accessible and secure.

Low levels of testosterone are associated with an increased risk of mortality from coronary heart disease (CHD) in postmenopausal women, reported Gail A. Laughlin, PhD.