S9991 — Services provided as part of a phase iii 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
- Written Clinical Trial protocol that describes a scientifically sound study and has been approved by all relevant institutional review boards (IRBs) before participant enrollment; UnitedHealthcare may request documentation about the trial at any time.
- Documentation that the study/investigation is approved or funded by one or more qualifying entities (examples listed): NIH (including NCI), CDC, AHRQ, CMS, cooperative groups/centers of these entities, Department of Defense (DOD), Department of Veterans Affairs (VA), qualified non‑governmental research entities identified by NIH guidelines, or that the study is conducted under an FDA IND or is a drug trial exempt from IND requirements.
- Proof of member eligibility according to the trial protocol (medical records demonstrating the member meets protocol inclusion/exclusion criteria).
Key Coverage Criteria
- Coverage of Routine Patient Costs incurred by a Qualifying Individual who is participating in an Approved Clinical Trial as required by the Patient Protection and Affordable Care Act (PPACA) for plan years starting on or after January 1, 2014.
- Approved Clinical Trial for cancer or other life‑threatening disease or condition (Phase I, Phase II, Phase III, or Phase IV) that meets the 'Criteria for Approved Clinical Trials' (see approved/funded by NIH, CDC, AHRQ, CMS, cooperative groups, DOD, VA, qualified non‑governmental research entities, peer‑reviewed DOE/DOD/VA studies, or conducted under an FDA investigational new drug application (IND) or exempt drug trial).
- Routine Patient Costs associated with the Approved Clinical Trial that are Covered Health Care Services (i.e., typically provided absent a Clinical Trial and medically necessary) including services required solely for: the provision of the investigational item/service (e.g., infusion administration for an investigational drug); clinically appropriate monitoring of the effects of the investigational item/service (e.g., lab tests and imaging when frequency is consistent with signs/symptoms and sta [...]
- Additional (non‑PPACA‑mandated) Clinical Trials covered under UnitedHealthcare's standard Clinical Trial benefit when the trial: is Phase I, II, or III and is conducted in relation to the detection or treatment of non‑life‑threatening cardiovascular disease (cardiac/stroke), surgical musculoskeletal disorders of the spine/hip/knees, and certain other diseases/disorders per plan allowance, provided the trial meets the 'Criteria for Approved Clinical Trials'.
- Qualified Individual criteria: member is covered under the health plan and is eligible to participate in an Approved Clinical Trial according to the trial protocol and either (a) was referred to the Clinical Trial by an in‑network health care professional who concluded participation would be appropriate per the protocol, or (b) provides the plan with medical and scientific information establishing eligibility for the trial per its protocol.
- Certain FDA‑designated Category B devices used within the context of an FDA‑Approved Clinical Trial and used according to the Clinical Trial's approved protocols, provided they fall under a covered benefit category, are not excluded by law/regulation/Medicare guidance, are medically necessary for the member, have medically appropriate amount/duration/frequency, and are furnished in an appropriate setting.
10 Active Policies
CIGNA-A003 — Clinical Trials â (A003)
UHC-POL-clinical-trials — Clinical Trials
UMR-POL-UMR-clinical-trials — Clinical Trials
SUREST-POL-SUREST-clinical-trials — Clinical Trials
BCBSIL-ADM1001.027 — Clinical Trial Treatment or Therapy
Related Codes
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