Program_Memos / 2001 / AB-01-130

Why This Topic Matters

Clinical trial claims can be paid, adjusted, or denied differently depending on how they are identified and processed. This memorandum also affects how providers and contractors handle billing, remittance messaging, managed care claims, and documentation expectations.

Article Sections

1. Interim Procedures for Handling Inadvertent Denials of Clinical Trial Services Brought to Your Attention

   Overview of how the memorandum addresses claims that were initially denied and later identified as related to qualifying clinical trial services. Includes broad claim adjustment and contractor workflow guidance.

2. Instructions for Processing Claims for Clinical Trial Services for M+C Enrollees

   Guidance for processing clinical trial claims for managed care enrollees, including general payment handling, contractor routing, and administrative coordination.

3. Clinical Trial Services That Qualify for Coverage

   Coverage framework describing the general categories of trial-related services addressed by the article and the broader requirements referenced by the CMS coverage policy.

4. Billing Requirements

   General billing and claim-reporting instructions for institutional claims, electronic equivalents, and diagnosis reporting in the claim record.

5. Bill on CMS Form CMS-1450 or electronic equivalent.

   Administrative billing format guidance for institutional claims submitted under the form or its electronic equivalent.

6. Applicable Bill Types--All institutional provider bill types (inpatient and outpatient) are applicable.

   Statement of the applicable institutional bill type scope for claims covered by the memorandum.

7. ICD-9-CM Reporting.

   General diagnosis-code reporting guidance for qualifying clinical trial claims across institutional claim formats and electronic claim versions.

8. Payment Requirements

   High-level payment methodology discussion for qualifying clinical trial services, including general payment processing considerations and managed care handling.