March 2010 Issues

Healthcare Information and Management Systems Society (HIMSS)

Summary: There is no bolus of customers in the near future for vendors, but there is slow, steady adoption of CPOE and EMRs. ♦ Hospital CIOs are focused on CPOE, and their budgets are up and sufficient to get the job done. However, vendors offering addon software may have a hard time in this environment. ♦ Some of the major HIT vendors are a little further along in the certification process, but that isn.t causing CIOs to switch vendors; most CIOs believe all the major vendors will have compliant systems by the government deadline . and it is generally too late in the game for a change. ♦ Doctors are adopting EMRs very slowly, with only about 6% having a fully functional EMR today. That is expected to increase 50% over the next year, but that still would be only ~9% of doctors. ♦ The lack of clarity on the government's definition of meaningful use and the certification criteria is a big issue, but many CIOs and doctors don.t believe the penalties will be enforced, at least not in 2015. ♦ Vendor pricing is relatively flat. There are fewer incentives being offered, but more vendors are helping with financing.

Medicare Advisory Committee: ESAs Possibly Overused in Chronic Kidney Disease Patients -- Quick Pulse

Summary:The Centers for Medicaid and Medicare Services (CMS) convened a meeting of its Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) to consider the safety of erythropoiesis stimulating agents (ESAs) in anemia related to kidney disease. Amgen's Epogen (epoetin alfa) and Aranesp (darbepoetin alfa) and Johnson & Johnson's Procrit (epoetin alfa manufactured by Amgen). The purpose of the meeting was simply to gather information, not to change policy -- at least not yet.

American Academy of Dermatology (AAD)

Summary: Aesthetic procedure volume is down compared to 2009 but likely to pick up very slightly during 2010. ♦ Most dermatologists are holding off on any big capital expenditures, and laser sales may be hard hit. ♦ Medicis's Dysport is catching on slowly, but users are very satisfied, and market share is expected to double over the next year. ♦ Allergan's Juvederm XC with lidocaine appears to be a non-event, replacing regular Juvederm but not expanding the market or giving Allergan more market share. ♦ Dermatologists have little interest in devices to help detect melanoma. ♦  Among dermatologists, the preferred biologic therapy for psoriasis remains Amgen's Enbrel. Johnson & Johnson's Stelara is launching slowly, with little market growth expected in 2010. ♦ Industry is hopeful about the outlook for 2010 but very concerned about tight credit for their customers.

FDA Advisory Committee Recommends Approval of Drug to Treat Hepatic Encephalopathy -- Quick Pulse

Summary: The FDA.s Gastrointestinal Drugs Advisory Committee voted overwhelmingly that Salix Pharmaceuticals. Xifaxan (rifaximin) is safe and effective and has a positive risk:benefit profile in hepatic encephalopathy (HE). The FDA briefing documents released four days before the panel meeting painted a rather bleak picture of the drug, raising numerous questions about both safety and efficacy, but the panel mostly waived those concerns away.

FDA Public Hearing - but Little Progress - on 510(k) Reform -- Quick Pulse

Summary: There is still a wide gap between FDA and industry on how to reform the premarket notification, or 510(k), approval process for medical devices. Industry appears to like the status quo, but the FDA wants - and is likely to impose - some more rigorous requirements.