S9991, Services provided as part of a phase iii clinical trial
HCPCS/CPT
Prior Authorization
Prior Auth Required
Code explicitly requires 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.
- Documentation that the individual is eligible to participate according to the trial protocol.
- Documentation of EITHER: (a) referral/statement from the referring health care professional that the provider is a participating health care provider and has concluded the individual's participation in the trial would be appropriate, OR (b) medical and scientific information provided by the individual establishing that the individual's participation in the qualified trial would be appropriate.
- Documentation that the trial meets one of the eligible trial criteria (e.g., evidence of federal approval/funding, documentation that study was reviewed and approved through a system of peer review comparable to NIH and assures unbiased review, documentation of an IND reviewed by FDA, or documentation that the drug trial is exempt from an IND) where applicable.
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.
- Routine Patient Care Costs/Services related to a clinical trial for a Qualified Individual consistent with the Families First Affordable Care Act (ACA) requirements.
- The individual must be eligible to participate according to the trial protocol and EITHER of the following conditions must be met: the referring health care professional is a participating health care provider and has concluded that the individual's participation in such trial would be appropriate, OR the individual provides medical and scientific information establishing that the individual's participation in the qualified trial would be appropriate.
- Qualified Individual: A participant or beneficiary in a health plan or with coverage who is eligible to participate in an approved clinical trial according to the trial protocol with respect to the prevention, detection or treatment of cancer or other life threatening disease or condition.
- Covered clinical trial phases: phase I, phase II, phase III or phase IV clinical trials conducted in relation to the prevention, detection or treatment of cancer or other life‑threatening disease or condition.
- Clinical trials that meet ANY of the following criteria: (a) Federally funded trial (approved or funded by NIH, CDC, AHRQ, CMS, a cooperative group/center of those entities, DOD, VA, or a qualified non‑governmental research entity identified in NIH guidelines; or Department of Defense/VA/Department of Energy when BOTH peer review comparable to NIH AND assurance of unbiased review by qualified individuals with no interest in outcome are met), (b) study conducted under an investigational new drug [...]
11 Active Policies
UHC-POL-clinical-trials, Clinical Trials
CIGNA-A003, Clinical Trials – (A003)
ADM1001.027, Clinical Trial Treatment or Therapy
BCBSIL-ADM1001.027, Clinical Trial Treatment or Therapy
BCBSMT-ADM1001.027, Clinical Trial Treatment or Therapy
Related Codes
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