Medical Device Reimbursement: ReGARDD Forum Notes

ReGARDD medical device and drug research forum notes

Perspectives on Medical Reimbursement By JR Associates What should medical device researchers know about premarket FDA submissions? And what should they understand about reimbursement in early stages of product development?  These core questions inspired the first educational seminar hosted by ReGARDD (Regulatory Guidance for Academic Research of Drugs and Devices) in April 2017, where our…

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Bundled Payments: Implications for Medical Device & Drug/Biologic Companies

Bundled Payments for Medical Technology

Perspectives on Medical Reimbursement By JR Associates Recently, the trade press and mainstream news have been paying a lot of attention to bundled payments. Stories have focused primarily on how this shift in medical reimbursement will affect patients, providers and payers. Payers and provider networks are creating internal systems to identify the cost of treating…

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Proposed Changes In MPFS IDE Clinical Trial Coverage Rule: Comments to CMS

Perspectives on Medicare Policies By JR Associates SUBJECT: Medicare Physician Fee Schedule Rule: Proposed Changes for the Process for Covering Items and Services in an Investigational Device Exemption (IDE), Centers for Medicare and Medicaid Services (CMS) 78 Fed. Reg. 43282, 43342-47, 43523-25 (July 19, 2013) OVERVIEW: JR Associates is concerned about CMS’ proposed changes to…

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