Changes to Medicare Coverage for Clinical Research Services: What the New Draft Guidance Means for You

Practices: Health Care

Teleconference Overview

On April 10, 2007, the Centers for Medicare & Medicaid Services (CMS) released its much-anticipated draft guidance to revise Medicare coverage for clinical research services. The initial Medicare coverage policy, issued in 2000, has profoundly affected participation in and funding for the conduct of clinical trials but has also provoked numerous controversies over the years. The draft guidance indicates CMS' intent not just to resolve controversies, but also to undertake a major overhaul of its coverage policy. The public has an opportunity to comment now before finalized guidance is issued later this year.

Our teleconference will discuss:

1. clarifications of current policy;

2. key changes proposed in the draft guidance;

3. the favorable and unfavorable impact of those proposed changes; and

4. the controversies left unresolved.

Principal investigators, clinical sites, research sponsors and clinical research organizations all need to understand the changes and the potential impact of those changes on their activities.

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