Adrenal-to-Brain Transplantation (Adrenal Medullary Tissue to Brain)
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Policy governs coverage stance for adrenal medullary tissue transplantation to the brain (autograft or fetal allograft) for treatment of Parkinson's disease and notifies providers of coding and benefit variability across product lines.
No material clinical or coverage changes in this revision.
Coverage Criteria
Coverage stance
Coverage stance by product:
Not covered for Medicare Advantage Plans: adrenal-to-brain transplantation (autograft or fetal allograft) because the evidence is insufficient to determine the effects of the technology on health outcomes.
Considered not medically necessary for Commercial Products: adrenal-to-brain transplantation (autograft or fetal allograft) given insufficient evidence to determine the effects of the technology on health outcomes.
For Commercial Products, adrenal-to-brain transplantation (autograft or fetal allograft) is considered not medically necessary due to insufficient evidence of effectiveness to support improved health outcomes.
Coding
| S2103 | Adrenal tissue transplant to brain |
Provider Actions & Billing Guidance
Prior authorization not applicable
Prior authorization does not apply to this policy; no prior authorization is required for adrenal-to-brain transplantation under this medical policy.
No step therapy or medical-criteria requirements
There are no medical criteria or step therapy requirements for adrenal-to-brain transplantation under this policy.
Benefit verification and documentation
Verify member benefits and eligibility using the member's Benefit Booklet, Evidence of Coverage, or Subscriber Agreement; benefits and coverage may vary by group/contract and those documents supersede this policy.
- For member-specific benefit questions, contact the provider call center as noted in the policy.
- This policy is informational and is not a guarantee of payment; the subscriber agreement or employer agreement determines coverage.
Denial risk: adrenal-to-brain transplantation
Claims for adrenal-to-brain transplantation (autograft or fetal allograft) are at risk of denial: they are not covered for Medicare Advantage Plans and are considered not medically necessary for Commercial Products.
- Medicare Advantage: procedure is not covered due to insufficient evidence of effectiveness.
- Commercial Products: procedure is considered not medically necessary due to insufficient evidence of effectiveness.
- Benefits may vary by contract; refer to the Benefit Booklet or Evidence of Coverage for applicable coverage determinations.
Background
Adrenal-to-brain transplantation implants adrenal medullary tissue into the corpus striatum (for example, the caudate nucleus or putamen) with the intent of restoring depleted striatal dopamine and ameliorating motor and postural dysfunction in Parkinson's disease. Techniques include autotransplantation (simultaneous adrenalectomy and craniotomy with implantation of the patient’s own adrenal medullary tissue, often placed at the margin of the lateral ventricle and exposed to cerebrospinal fluid) and fetal allografting (harvesting adrenal tissue from an aborted fetus and implanting it into the recipient’s striatum). Surgical approaches described include open microsurgical insertion and stereotactic cannula placement.
Definitions
Contraindications
Professional guidance and a systematic review have identified a lack of efficacy and substantial morbidity associated with adrenal-to-brain transplantation. The Agency for Healthcare Research and Quality (AHRQ, 2003) noted insufficient evidence of benefit and significant morbidity, and the American Academy of Neurology (1999) recommended that the procedure is not acceptable for safety reasons; these findings support the policy decision to consider the procedure not medically necessary or not covered.
Evaluation Requirements
No evaluation/workup criteria provided
No specific pre-procedure evaluation, workup, or eligibility criteria are provided in the policy; the literature is scarce and efficacy has not been established.
- Professional reviews (AHRQ) noted lack of efficacy and substantial morbidity; AAN advised the procedure is not acceptable for safety reasons.
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