HCM Marketplace

AUDIOCONFERENCE ON TAPE OR CD

Sponsored by Compliance Officer’s Handbook

presented on May 23, 2007

Proposed changes to CMS’ Clinical Trial Research Policy coverage determination could mean big changes to which services Medicare will cover as part of clinical trials.

What sort of changes should we expect?

Under the new rules, CMS will likely restrict coverage for investigational new drug-application-exempt drug studies. This move will affect investigator-initiated clinical trials. CMS announced its full list of proposed changes on April 10. The draft rule proposes the following changes and clarifications:

• Requiring investigators to register all studies on the NIH ClinicalTrials.gov website before beginning enrollment
• Adding FDA post-approval studies and coverage with evidence development (CED) to studies that would qualify under this policy
• Requiring studies to publish their results
• Paying for investigational clinical services if they are covered by Medicare outside the trial or required under an CED through the national coverage determination process
• Expanding the “deeming” agencies to include all Department of Health and Human Services agencies, the Veterans Administration, or the Department of Defense

Comply with CMS’ proposed clinical trial coverage changes and billing rules

Many hospital compliance officers may not be involved with clinical trials. But that doesn't mean their facility is safe from compliance enforcement. Academic medical centers must be on the lookout—and smaller facilities also need to comply.

During this audioconference our experienced speakers, Ryan D. Meade, Esq., partner in the law firm of Meade & Roach, LLP and F. Lisa Murtha, J.D., CHC, managing director of Huron Consulting Group, help you take the guesswork out of what to expect from proposed CMS regulatory changes. They explain the ins and outs of the regulations and help compliance professionals and auditors identify high-risk areas in their own clinical trials billing.

At the conclusion of this program, participants will be able to:

• Understand proposed changes to the CMS Clinical Trial Research Policy national coverage determination
• Anticipate how the proposed could affect their facility
• Develop a roadmap, which can be used to implement operations under the new national coverage determination

Don’t become the next headline: Ensure proper reimbursement and compliance

The federal government, Congress, and the media are raising the regulatory stakes and part of the recent scrutiny has focused on compliance with coverage and billing rules. “Clinical research billing update” will keep you from becoming the next headline.

Note: Participants should have a basic familiarity with current CMS rules regarding billing for clinical trials.

TAKE A LOOK AT OUR AGENDA

1. CMS’s Clinical Trial Research Policy coverage determination
   1. Current billing rules for clinical trials
      
      
   2. CMS proposed changes to the coverage determination
      • Impact on investigator-initiated trials
        • Potential money loss for hospitals
        • How to comply with updated rules
      • Clarification on humanitarian use devices (HUDs)
        
        
   3. How to assess what new rules mean for providers
      
      • Top risk areas for larger hospitals
      • Top risk areas for community hospitals
        
        
   4. Five immediate steps for improving clinical billing compliance
      
      
2. A question and answer session follows the presentation

FEATURED SPEAKERS

Ryan D. Meade, Esq., is a partner in the law firm of Meade & Roach, LLP in Chicago. He focuses his legal practice and consulting work on regulatory compliance matters for healthcare organizations, concentrating principally on Medicare/Medicaid billing compliance, clinical trial research compliance, and health information management/HIPAA compliance. Ryan also provides legal advice in healthcare fraud and abuse analysis.

F. Lisa Murtha, J.D., CHC, is managing director of Huron Consulting Group in New York City. She focuses her practice in clinical research compliance (human subject protections, effort reporting, scientific misconduct, conflicts of interest, and clinical trial billing and process improvement), revenue cycle work, billing and coding issues, internal investigations, corporate governance/ethics, and HIPAA work.

WHO SHOULD LISTEN?

• Compliance officers
• Auditors
• General counsel
• CFOs
• Research coordinators
• IRB members
• Physicians
• Physician office administrators

BONUS MATERIALS INCLUDED IN YOUR MATERIAL PACKET!

In addition to the expertise and advice presented during this audioconference, you'll also receive a slide presentation of the program materials along with helpful takeaway tools. These materials are provided with PDF links. Purchase a tape or CD of the program and listen when you can. It's also a perfect training tool for new staff or as a refresher for veteran staff.

• Audioconferences

• Other Corporate Compliance Products