Part of funding ‘healthcare reform’ in the US–to the tune of $20 billion per year–is a 2.3% tax levied on medical device sales. Now most laymen (and consider most of Congress in that category) believe a ‘medical device’ is a high value heart stent or hip implant. Au contraire! A ‘medical device’ is what the FDA deems it to be, and further classified by risk level (I being the least risky, like wheelchairs, and exempted from the tax; II ‘special controls’; III the riskiest/most impactful on health such as implants). Does that include telehealth and telecare? Yes–most are designated as Class II. FDA’s recent approvals of WellDoc’s Diabetes Manager, Mobisante, Mobile MIM apps, Proteus Biomedical’s patch and others simply confirm this. Sen. Scott Brown (MA) has introduced a bill in the Senate to repeal this tax, especially unpopular in this home state to many medical device companies. MassDevice: Medical device CEOs back Brown’s tax recall bid A device company’s view, ‘from absurdity to reality,’ in MedCityNews.
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