Program_Memos / 2001 / AB-01-142

Why This Topic Matters

It helps billing and compliance staff understand how Medicare expected qualifying clinical trial routine care to be identified and processed during the applicable time period, while also outlining supporting documentation and operational update requirements.

Article Sections

1. Diagnosis Coding Requirements for UB-92 Billers (Intermediaries and RHHIs)

   Describes the timing of the memorandum’s diagnosis coding guidance and the claims context in which it applies. It addresses Medicare qualifying clinical trial services and general placement of diagnosis information on claims.

2. Local and Regional Medical Review Edits

   Discusses adjustments to review edits and the handling of claims for properly reported routine care clinical trial services. It also notes an operational alternative when service volume does not justify systems changes.

3. Medical Records Documentation Requirements

   Summarizes revised documentation expectations for routine items and services furnished in qualifying clinical trials. It covers the type of supporting information that should be maintained in the medical record and made available for review.

4. Provider Education

   Addresses dissemination of the revised billing and diagnosis coding guidance to providers and suppliers. It mentions the channels through which contractors were instructed to share the information.