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Billing Routine Cost of Clinical Trials

Guidance for Transmittal 1721, dated April 29, 2009 has been rescinded and replaced with transmittal 1743, dated May 22, 2009 to add the “rescind and replace’ statement. Initially, Transmittal 1721 replaced Transmittal 1710 to change the Effective Date for claims with dates of service on or after January 1, 2008, and to remove the last sentence in the last sentence in the Summary of Changes: “Also, for beneficiaries enrolled in a managed care plan, institution providers must not bill outpatient clinical trial services and non-clinical trial services on the same claim.” However, the “rescind and replace” statement was erroneously omitted on Transmittal 1721. All other information remains the same.

Download the Guidance Document

Issued by: Centers for Medicare & Medicaid Services (CMS)

Issue Date: April 29, 2009

DISCLAIMER: The contents of this database lack the force and effect of law, except as authorized by law (including Medicare Advantage Rate Announcements and Advance Notices) or as specifically incorporated into a contract. The Department may not cite, use, or rely on any guidance that is not posted on the guidance repository, except to establish historical facts.