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.
If a new proposal is adopted, New Jersey would be the fourth state to enact mandatory coverage. About 1.4 million residents currently are uninsured.
The Medicare Payment Advisory Commission (MedPAC) has been examining the feasibility of requiring hospitals and medical product manufacturers to report financial relationships with physicians on a national basis.
Medicare Advantage plans are supporting efforts to halt inappropriate marketing tactics, partly to head off more stringent federal and state oversight designed to stop abusive practices. Last month, America’s Health Insurance Plans (AHIP) adopted a proposal urging enactment of new rules to prohibit certain marketing practices that violate Medicare policy.
Federal law allows insurers to pass along disidentified health information to employer plan sponsors, however, a law that went into effect in Texas in January now forces insurers to pass the information along.
Data from EPITHET presented at the International Stroke Conference 2008 demonstrates that extending the standard 3-hour window for tPA could benefit patients who suffer a stroke and have a perfusion-diffusion mismatch.
Label updates and warnings through April 2008 related to epoetin alfa and darbepoetin alfa, darunavir, and tiotropium.
Study shows no significant differences in safety risks between off-label use of drug-eluting stents (DES) and off-label use of bare-metal stents (BMS) and a decreased risk of repeat PCI with use of off-label BMS.
How-to guide for creating drug monographs and drug class reviews for evidence-based formulary consideration.
Treatment of diabetes with DPP-IV inhibitors; sitagliptin, vildagliptin, alogliptin, and saxagliptin.
Recent FDA approvals and indications (through April 2008) related to Xyntha, Simcor, Aloxl, Humira, Abilify, Avastin, Nexium, and Luvox.
Recent FDA action (through April 2008) related to Rotavirus vaccine, live, oral; istradefylline; olanzapine long-acting injection; mycobacterial cell wall-DNA complex; talactoferrin; levodopa/carbidopa intestinal gel; prasugrel; eltrombopag; difluprednate ophthalmic emulsion; EUR-1008; ARG201; MGCD0103; triphendiol; ADH-1; and levofloxacin solution for inhalation.
NME: Desvenlafaxine (Pristiq), a selective serotonin and norepinephrine reuptake inhibitor was recently approved for the treatment of major depressive disorder.
Drugs in development for the treatment of Huntington disease, Parkinson disease, and amyotrophic lateral sclerosis
The practice of shared decision making (SDM)-the collaboration between patients and caregivers to arrive at an informed, value-based healthcare decision when treatment options have features that patients value differently-is gaining recognition among health plans as a key function of a patient-centric model of care.
In a consumer-driven healthcare marketplace where Americans are taking a closer look at healthcare options and are comparing quality, price, and access between the United States and overseas, many are finding it pays to take that trip abroad.
National reports-Recently approved legislation to boost insurance coverage of care for mental health disorders could have just the opposite effect, according to insurers.
National reports-As more health information becomes available in electronic formats, it is not surprising that companies such as Google, Microsoft and Revolution Health Group have latched on to this business opportunity in the form of personal health records (PHRs).
Despite widespread enthusiasm for establishing interoperative electronic health records, progress has been slow in developing the standards, protocols and rules needed to move from small initiatives to a national e-health system. To stimulate action, the Bush administration and major players in the e-health community are promoting electronic prescribing systems as an achievable step toward broader interconnectivity. Health plans and insurers are backing these efforts as a way to prevent medication errors and improve quality of care.
Healthcare executives have seen a significant increase in efforts by unions to organize nurses in the last few years. The national rate of unionized nurses currently exceeds 23%; in 1998, that number was less than 17%. In contrast, the national rate of unionized workers is just 12%.
Using drugs for conditions other than what's on the label is not new, but it may receive more encouragement if draft guidance from the Food & Drug Administration (FDA) is approved. Allowing more off-label use might also increase payers' pharmacy costs.
Few words have become as vilified as "outsourcing." For some Americans, it might bring to mind low-paid and poorly trained workers working at an overseas call center. As competition and cost pressures worsen and the talk of recession continues, outsourcing is becoming an increasingly attractive option for healthcare payers. When done correctly, it can be both efficient and cost-effective. Despite popular belief, outsourced work doesn't have to go overseas; in some cases, the work can go across the city, or even across the street.
Employers are finding themselves between a rock and hard place when it comes to health benefits. If they reduce or eliminate benefits, they lose quality workers as well as productivity. If they maintain or increase benefits, they're almost certain to spend beyond their budgets year after year. In trying to strike a happy medium, more employers are now remodeling their health benefit plans dramatically, hoping to see better results.
When the former owner of the NFL's Cleveland Browns announced he was moving the team to Baltimore in 1996, not only were Cleveland fans outraged, ironically, so were Pittsburgh Steelers fans-their biggest rivals. For the two seasons that the Browns franchise remained dark, the Steelers missed the Browns because they had enjoyed the competitive rivalry. The Browns team and its followers were the people they loved to hate.
Professionals with problematic and tarnished credentials pose serious risk to healthcare consumers and create financial exposure – in the form of CMS fines -- for the institutions that unknowingly employ them. This black cloud now extends to health plans.
Commonwealth Fund Overall Rank (2007): 39
Adding bevacizumab to treatment with paclitaxel does not prolong overall survival among patients with metastatic breast cancer; however, the combination therapy is associated with a significant improvement in progression-free survival, according to the results of a trial published in the New England Journal of Medicine (NEJM).
The campaign against drug TV advertising and marketing seems to be accelerating in Washington and around the country. The latest salvo comes from leaders of the House Energy & Commerce Committee who want information from pharmaceutical companies and the Food and Drug Administration about questionable marketing campaigns.
The Centers for Medicare and Medicaid Services (CMS) has announced it will end Phase I of Medicare Health Support (MHS) program upon completion of the three-year pilot, meant to provide beneficiaries additional care-management services. Expansion to Phase II of any pilot is contingent upon improving the clinical quality of care, improving beneficiary satisfaction and achieving targets for savings.
This article discusses pharmacologic options for the treatment of Crohn's disease, including aminosalicylates, corticosteroids, immunosuppresant agents, and biologic agents.
