For many years, EBG Advisors has worked with multiple medical device, diagnostics, and pharmaceutical manufacturers to help them best position their products and related procedures to obtain favorable coverage, coding, and reimbursement. We understand that the environment for each item or service is unique and that various strategies may be needed if a product is used in multiple sites of service.
We have extensive experience working with the leadership of several strategically important components of Centers for Medicare & Medicaid Services (“CMS”), including the Coverage and Analysis Group, the Hospital and Ambulatory Policy Group, the Provider Enrollment Group, the Office of General Counsel, and the HCPCS Workgroup. Our experience also includes:
- Leading multiple meetings in our offices with those key leaders and hosting presentations by selected CMS officials
- Coordinating multiple meetings at which manufacturers and stakeholders have met with senior CMS staff
- Acting as a liaison to resolve regulatory issues that may arise
- Serving as the lead advisors and counsel for several requests for new or updated Medicare National Coverage Determinations, including two recent matters approved under the Coverage with Evidence Development option
- Serving as an advisor or counsel to medical device and diagnostics manufacturers seeking new or revised Local Coverage Determinations