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More religious-based college employers, and for-profit businesses with moral objections to contraceptive coverage, will be able to issue health plans denying intrauterine device and birth control coverage to their employees and students starting in 2018, under the administration's Oct. 6-issued "conscience rights" exemptions from Affordable Care Act (ACA) requirements. The interim final rules could dampen sales of IUDs and implants that have risen 5% in the last year at Bayer Healthcare and Allergan.
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Industry groups told the US Medicare agency it should seek the input of a broader array of stakeholders – including medtech companies – in developing future episode-of-care pay models. They also argued that participation in the programs should be voluntary, and that the pay models should account for patient outcomes longer than 90 days following initial care. The responses came in comments to CMS following its proposal to scale back its joint replacement bundled payments program and eliminate a cardiac-care version.
The association of the IVD industry in the UK, BIVDA, is undergoing a rebrand and proactively positioning itself to reinforce the value proposition that diagnostics represent for stakeholders. A new whitepaper on the theme was one of the highlights of an upbeat 2017 annual general meeting, in which Brexit and the EU IVDR for once were not the "stars" of the show.
The UK National Institute for Health and Care Excellence is working on a new database of pre-launch-phase medtech products. The aim is to give NHS providers enough time to plan for the uptake of innovative technologies and, generally, to improve the pathway between development and adoption, says NICE medtech programs director Mirella Marlow.
Medicare lost $1.5bn in claims over a 10-year period to cover procedures to fix or replace seven faulty cardiac devices due to the lack of product-specific information on its claims form for malfunctioning defibrillators and pacemakers, says the US HHS Office of Inspector General. Recalls of Medtronic, Boston Scientific and Abbott/St. Jude Medical cardiac rhythm management devices are likely behind most of the cost.
Abbott Laboratories and Boston Scientific recently logged approvals that bring the firms closer to parity with Medtronic in being able to market their cardiac rhythm management devices as compatible with MRI scans. But CMS, the US Medicare agency, is currently considering a coverage policy that make so-called "MR-conditional" product labeling less significant.
In a busy week for Brexit watchers, the UK government has initiated an inquiry into the effects of future regulatory systems that will potentially impact medical technology and other health-care products in the UK after the country has left the EU.
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