Emerson Consultants Overview: Download PDF (120KB)
Snap shot view of Emerson Consultants and expertise in the areas of reimbursement, regulatory, clinical, and marketing.
Fundamentals of Reimbursement: Download PDF (170KB)
Overview of the reimbursement process with a specific look at the current reimbursement environment for nucleus arthroplasty technology and other new spinal devices.
Integrating Reimbursement into Sales Cycle: Download PDF (170KB)
How and why to use field reimbursement specialists to integrate the economic value proposition into the sales cycle.
Navigating the CMS Pass-Through Maze: Download PDF (170KB)
Overview of the processes CMS uses to determine eligibility for pass-through-payment and how to determine if a technology is eligible.
Reimbursement and Clinical Trial Data: Download PDF (200KB)
Explanation of how and why to structure a clinical trial to collect data that satisfies both regulatory requirements and the requirement of payors.
Reimbursement Strategy: Download PPT (2MB)
Comprehensive presentation on why reimbursement matters and the key drivers of reimbursement strategy: coverage, coding, and payment.
100 Initial Priority Topics for Comparative Effectiveness Research:
Download PDF (41 KB)
A list of the top priorities for comparative effectiveness research prepared by the Institute of Medicine and contained in the report Initial National Priorities for Comparative Effectiveness Research. Topics are listed by quartile according to priority.
Adverse Event Reporting for Medical Devices: Download PDF (830 KB)
Department of Health and Human Services report issued in October 2009 that documents the number of adverse events reported from 2003 to 2007 and assesses manufacturers’ compliance with reporting requirements and FDA use of adverse event data to address safety concerns. Also makes recommendations on how to improve FDA use of adverse event reports to identify and address safety concerns.
Investigator Responsibilities - Protecting the Rights, Safety, and Welfare of Study Subjects: Download PDF (164 KB)
FDA guidance document issued in October 2009 providing an overview of investigator responsibilities to supervise the conduct of drug and device trials to protect the rights, safety, and welfare of participants.
Author: Kelli Hallas
Article about a proposed Medicare policy to deny coverage for artificial discs and call to action to submit comments urging further consideration.
Authors: Kelli Hallas and Barb Peterson
Explanation of differing data requirements for regulatory approval and reimbursement coverage. Also outlines the key drivers payers use to evaluate a new technology to determine coverage.
Author: Patty Curoe Telgener
Description of trends in the current reimbursement environment for continuous glucose monitoring and recommendations on coding and coverage.