M1396, Patients on a therapeutic clinical trial
HCPCS/CPT
Prior Authorization
No Prior Auth Required
Code is covered without prior authorization (high confidence)
Medicare Pricing
Work RVU
0.00
Facility
N/A
Non-Facility
N/A
Documentation Required
- Informed Consent: a signed document detailing trial length, required visits, medications, procedures, expected outcomes, potential benefits and risks.
- Treating physician's determination that the clinical trial relates to prevention, detection, or treatment of cancer or another life‑threatening disease/condition.
- Documentation of the trial phase (I–IV) and evidence of sponsor/approval/funding (may include in‑kind contributions) for the clinical trial.
- Record the study's objective, number of participants, and key study characteristics in the medical record
Key Coverage Criteria
- Illinois (per Public Act 103-0458 / HB3809): Coverage for therapy, diagnostic testing, and equipment necessary to increase quality of life for children clinically or genetically diagnosed with any disease, syndrome, or disorder that includes low tone neuromuscular impairment, neurological impairment, or cognitive impairment.
- Louisiana (for HCSC members residing in Louisiana, per R.S. 22:1044): Coverage of patient costs incurred because of a cancer treatment provided in accordance with a clinical trial, including costs for health-related services.
- Routine patient care services and items (devices, tests, procedures, medications, technology) that would customarily be provided outside a clinical trial are considered routine patient care for members enrolled or participating in a clinical trial.
- Routine care services within approved clinical trials that are used in the direct clinical management of the patient and are covered consistent with the Patient Protection and Affordable Care Act and applicable state mandates.
- Diagnostic Trials — studies to evaluate new or improved tests or procedures for diagnosing a particular disease or condition.
- Epidemiological Studies — studies that identify patterns, causes, and control of disorders in populations (observe disease distribution and risk factors).
5 Active Policies
ADM1001.027, Clinical Trial Treatment or Therapy
BCBSIL-ADM1001.027, Clinical Trial Treatment or Therapy
BCBSMT-ADM1001.027, Clinical Trial Treatment or Therapy
BCBSNM-ADM1001.027, Clinical Trial Treatment or Therapy
BCBSOK-ADM1001.027, Clinical Trial Treatment or Therapy
Related Codes
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