News

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 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).

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

Proteasome inhibitor approved for treatment of relapsed mantle cell lymphoma

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.

Besides an ongoing trend of mergers and acquisitions, other issues are shaping the PBM market, say experts.

Jerry Rhoads, CEO, Caregiver Management Systems, believes the long-term-care aspect of the U.S. healthcare system is woefully lacking and in desperate need of a major paradigm shift-which is what he and his company have been attempting to do for the past 15 years.

Washington, D.C.-As members of Congress headed out of town for the holidays in December, they managed to push through legislation containing a number of important policy initiatives for health plans and payers. A major tax bill delivered a reprieve for doctors from planned Medicare rate cuts. The bill freezes Medicare fees to physicians for one year, which could lead to an even bigger cut in 2008. It also offers a small bonus to those doctors who comply with quality reporting requirements. And to further bolster pay-for-performance initiatives, the legislation calls for hospitals and clinics to report on quality measures.

Washington, D.C.-Medicare pays private plans too much, and the system needs to be fixed, according to a new report from the Commonwealth Fund. The study finds that the government paid Medicare Advantage plans 12.4% more in 2005 than if the same patients had been enrolled in the traditional fee-for-service program. The extra payments totaled more than $5.2 billion in 2005, or an extra $922 for each of the 5.6 million MA enrollees.

Attention-deficit/hyperactivity disorder (ADHD) is marked by patterns of inattention, careless mistakes, difficulty waiting, forgetfulness and restlessness. People who have ADHD are distracted most of the time. Even when they try to concentrate, they find that it's hard to pay attention. They have trouble organizing things, listening to instructions or remembering details. Someone with this condition is impulsive. They often fidget, don't wait for their turn and interrupt others. In school, children with ADHD may blurt out answers and move around a lot; they seem to be "always on the go."

Although as many as 48% of seniors were subject to some type of drug-coverage deficiency in 2006, only an estimated 4 million of the 22.5 million enrolled in Medicare drug plans were actually expected to hit the infamous donut hole. There could still be financial woes, however, for the 10.8 million Medicare beneficiaries who at least have the potential for out-of-pocket costs in the donut hole gap because they do not qualify for a subsidy, are not covered outside Part D, or did not pay for enhanced gap coverage.

Medicaid Enrolees who suffer from expensive, chronic conditions tend to suffer from so many comorbidities and complicating social problems-such as homelessness and lack of transportation-that isolating a single disease state for intervention is ineffective. And states are beginning to recognize that.

Just like the rest of healthcare, dental and vision ancillary benefit providers are adopting cost-sharing strategies that offer options to employees but demand more skin in the game. With less financial responsibility on the shoulders of employers, ancillary benefits have become more flexible, varied and are more closely tied to the overall health of individuals, who are assuming more risk for their health.

In his job description as executive director of the managed care division for Cleveland Clinic, Michael McMillan is accountable for business relationships with health plans and employers. McMillan is focused on making the Clinic-one of U.S. News & World Report's top three hospitals-available to members of every health plan and managed care organization.

The Supreme Court has referred to U.S. antitrust laws as the Magna Carta of free enterprise-a set of laws as important to the preservation of economic freedom as the Bill of Rights is to the protection of personal freedoms. While these laws are typically enforced by state and federal governments, i.e., the Department of Justice and state attorneys general, they also provide for a private right of action enforceable by persons who have been injured by activities that are forbidden by the antitrust laws.

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..

Methicillin-resistant Staphylococcus aureus (MRSA) strains showing reduced susceptibility to vancomycin (minimum inhibitory concentration [MIC] of 2 mcg/mL) and requiring aggressive empiric vancomycin dosing are highly prevalent among those that cause invasive infections, according to a prospective cohort study.

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).