- The President signed the Consolidated Appropriations Act of 2008 (HR 2764) into law today. It turns out that there's a fly in the ointment for employer sponsored health plans. This massive law includes a provision that gives the Secretary of Health and Human Services carte blanche to collect Medicare secondary payer data from health plans and employers according to Business Insurance. This provision takes effect in 2009.
- The Healthcare Information Technology Standards Panel (HITSP) has approved another set of healthcare information technology interoperability specifications to the American Health Information Community, which is the next step in the process leading to Secretary of HHS approval. The new specifications relate to the following topics:
-- Consumer Access to Clinical Information will assist patients in making decisions regarding care and healthy lifestyles. Accessible information could include registration information, medication history, lab results, current and previous health conditions,
allergies, summaries of healthcare encounters, and diagnoses. (see sample:
-- Quality indicators will benefit providers by providing a collection of data for inpatient and ambulatory care, and will benefit clinicians by providing realtime or near-realtime
feedback regarding quality indicators and contra-indications for specific patients.
-- Emergency Responder-Electronic Health Record will track and provide on-site emergency care professionals, medical examiner/fatality managers, and public health
practitioners with needed information regarding care, treatment, or investigation of emergency incident victims.
The Chairman of HITSP has his own blog here.
- Another legal battle between a brand name drug manufacturer and a generic drug manufacturer has erupted. Teva Pharmaceuticals has launched a generic version of Wyeth's blockbuster heartburn medicine Protonix according to the New York Times. Wyeth has announced plans to sue Teva for patent infringement. For the time being, however, Teva has stopped distributing its generic verision while the parties discuss settlement. According to the Wall Street Journal, "Some analysts said the launch puts pressure on Wyeth to settle with Teva to allow marketing of a generic pill before the patent expires" in mid -2010. The Journal also reports that another generic manufacturer Sun Pharmaceutical Industries Ltd., of India, is putting pressure on Wyeth over its anti-depressant Effexor patent, which is Wyeth's best seller and also expires in mid-2010. North Jersey.com explains that
Sun Pharmaceutical Industries Ltd., a generics manufacturer in India, has applied for U.S. Food and Drug Administration approval to sell a drug with the same active ingredient as Effexor XR, but with an important difference: It's an extended-release tablet, not a capsule.
FDA approval of what is likely to be a lower-priced drug from Sun might come when patent protection for Effexor's active ingredient, venlafaxine, runs out in June 2008. Patent protection for the capsule formulation expires later. Sun's different formulation should allow it to sidestep Wyeth's patent rights, and Wyeth already has told Sun it won't sue for patent infringement.