Articles by Edward Black
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Understanding (And Securing) Medicare Coverage During Med Device Clinical Trials
6/3/2016
Obtaining coverage during clinical trials should be considered as part of a comprehensive reimbursement plan, coordinated with the clinical studies and regulatory plans, all of which are necessary parts of a complete business plan.
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The Medical Science Liaison Officer: A Smart Addition To The Medtech Team
5/3/2016
A medical science liaison officer (MSLO) has long been a common, highly valued position in pharmaceutical companies, healthcare systems, and clinical research organizations. This role is designed to bridge the gap between the company’s perspective, medical science, healthcare professionals, patients, and payers. As non-medical people have less access to health plan medical policy people, the MSLO role has expanded to the medtech and biotech industries.
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How To Build Strong Medtech Payer Relations
3/24/2016
“Payer relations” is a broad term that describes the process of working with payers to obtain, maintain, or expand positive coverage decisions. This article will focus on initiation of that process, and the important aspects of planning and executing this critical component of an overall reimbursement strategy.
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Procedure Coding: An Integral Component In New Product Development
2/18/2016
The reimbursement process has become confusing and complex, often involving protracted timelines to achieve optimal results. It is imperative to incorporate reimbursement early in the NPD process, when requirements can be fully integrated into the product design, regulatory, clinical, and marketing strategies.
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New Year: New Rules — Understanding Hospital And Physician Payment Changes In 2016
1/11/2016
As 2016 dawns, it’s time for the Centers for Medicare and Medicaid Services (CMS) to implement new rules for the device, drug, and health care provider industries. We’ll take a look here at how those changes will impact hospitals, physicians, and consumers — none of them will be very pleased.
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Medical Device, Drug, Or Biologic? A Reimbursement Strategy Lesson
12/3/2015
Bioengineered skin substitutes (BSS) expose more areas of potential confusion between the FDA, CMS, and industry than almost any other “device” sector. Manufacturers of these products face all the classic challenges of medtech reimbursement – coding, coverage, and payment — and then some. If you need a viable reimbursement strategy to bring your biological "device" to market, a look at the complications surrounding BSS is a good place to begin.
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The Medtech Reimbursement Conundrum: How Did We Get Here?
10/29/2015
Not unlike the FDA, whose pendulum sways back and forth between consumer protection and technological advancement, private payer medical directors have dual roles in supporting clinical advancement while managing costs. The Patient Protection and Affordable Care Act (PPACA) has not changed the rules so much as it has emboldened private insurers to force the issue on cost effectiveness.