S9996, Meals for clinical trial participant and one caregiver/companion
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
- Medical records documentation may be required to assess whether the member meets the clinical criteria for coverage, but it does not guarantee coverage; reference member plan documents and guidelines.
- Clinical trial must have a written protocol that describes a scientifically sound study.
- Clinical trial must have been approved by all relevant institutional review boards (IRBs) before participants are enrolled.
- Providers are not routinely required to submit trial documentation but Aetna may request supporting documentation at any time to confirm trial scientific merit and IRB approvals.
Key Coverage Criteria
- Cover Routine Patient Costs for a Qualifying Individual participating in an Approved Clinical Trial as required by PPACA for plan years starting on/after 2014; benefits include reasonable and necessary items/services to prevent, diagnose, and treat complications arising from participation.
- Medically necessary routine patient care costs in clinical trials are covered in the same manner as routine care for members not in clinical trials.
- Medically necessary treatments for conditions that result as unexpected consequences (complications) of clinical trials are covered.
- Clinical trials that have a written protocol describing a scientifically sound study and that have been approved by all relevant institutional review boards (IRBs) before participants are enrolled qualify for routine care coverage (subject to other policy requirements).
- Category B investigational devices and promising experimental and investigational interventions for terminal illnesses may be covered as exceptions according to Aetna's terminal illness policy and applicable benefit plan descriptions (i.e., certain investigational device Category B/terminal illness exceptions).
- Routine Patient Care Costs/Services related to a clinical trial for a Qualified Individual consistent with the Families First Affordable Care Act (ACA) requirements.
10 Active Policies
UHC-POL-clinical-trials, Clinical Trials
AETNA-CPB-0466, Clinical Trials, Coverage of Routine Patient Care Costs
CIGNA-A003, Clinical Trials – (A003)
ADM1001.027, Clinical Trial Treatment or Therapy
BCBSIL-ADM1001.027, Clinical Trial Treatment or Therapy
Related Codes
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