Another brilliant Potpourri, with scintillating health care gems, including revising the FDA’s 510(k) process, the essential benefits package for health exchanges, the future of Medicare Advantage, the lack of labor productivity in health care, variation in elective procedure rates and the OIG’s work plan.
Another Potpourri, with tidbits on the Medicare Star program results for 2012, pain management, blood pressure management, Massachusetts’ physicians’ views on work and health care, online error reporting and the FDA and CMS parallel medical device review process.
A Journal of the American Medical Association article, based on work sponsored by AHRQ, reviews the off-label use of atypical antipsychotics, which are usually very expensive and have significant side effects. While there are occasional benefits to such use, adverse events are common, particularly in the elderly.
October already!! Our 39th Potpourri of the year has many autumnal pleasures including selections on CMS’ Comprehensive Primary Care Initiative, a proposed guidance for FDA to use for mHealth regulation, end-of-life care discussions, CMS’ multi-payer database award, expected 2012 medical trend, and delivery of unnecessary care by doctors.
The Food & Drug Administration releases its strategic plan for regulatory science, identifying priority areas and implementation strategies for each. How the FDA carries out its strategy over the next few years will greatly affect both the medical products industry and overall health spending.
Our current Potpourri contains nuggets on use of robotic surgery for prostate cancer, the effect of mandated rebates in Medicare Part D on patient costs, FDA guidance on device modifications, state Medicaid EHR incentive programs, patient understanding of trial data, and use of FQHC’s by Medicaid enrollees.
The FDA released a draft guidance on how it will regulate mobile and wireless healthcare devices and applications, which to a large extent follows proposed guidance from the mHealth Regulatory Coalition. The guidance may facilitate growth of this industry segment.
About this Blog
The Healthy Skeptic is a website about the health care system, and is written by Kevin Roche, who has many years of experience working in the health industry. Mr. Roche is available to assist health care companies through consulting arrangements through Roche Consulting, LLC and may be reached at [email protected].
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