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Clinical Research Billing Training

June 23, 2008

Dear Colleagues:

On July 1, Johns Hopkins Medicine will launch an important new billing initiative for Medicare beneficiaries who are enrolled in clinical trials. Our goal is to ensure that federal payers are properly billed by both the Health System and University according to federal regulations. Many people have been working for well over a year to develop the new system and the support processes to help investigators and their study teams in this process. Oncology and Radiation Oncology were the first users and have helped us refine the clinical research billing function. We are very grateful for their partnership.

Recognizing the tremendous job you, our clinical researchers, are doing and the significant challenges you face, we have developed this new process to minimize the additional work we are asking of the study teams. We are confident that the improvements will help you manage your clinical research studies, participants and budgets.

All clinical research studies submitted to the IRB on or after July 1, 2008, for which participants may be receiving services, will be supported by the new clinical research billing operation. If research subjects also have Johns Hopkins patient ID, they are covered by this policy. Therefore, we are asking principal investigators and their study teams to learn about the new process by completing the 20-minute online "Clinical Research Billing Orientation" course before initiating their studies.

The link is . Course Title: Clinical Research Billing Orientation.

Because all clinical faculty who bill professionally will potentially submit bills for services provided to research participants (covering for research physicians or addressing potential adverse events/toxicities), we are asking all clinical faculty to complete the orientation by Oct. 1, regardless of whether they are currently participating in an active study.

If you have any questions, we have a team of knowledgeable experts who are ready and willing to help you get started.

Please feel free to contact the following people:

Mike Amey, Associate Dean for Research Administration, 410- 955 1566,
Daniel Ford, Vice Dean for Clinical Investigation, 443 287 4234,
Karen Roz, Associate Director of Support Services, 410- 955 7682,
Pat Travis, Associate Director of Contracting, 410-502 0233,
artha Weiner, Senior Director of Billing Quality Assurance, 410-502 0780,
Kenneth Wilczek, Associate Dean for the Clinical Practice Association, 410-955 2600,

Edward D. Miller, M.D.
Dean and CEO
Johns Hopkins Medicine