BlueCross and BlueShield of Montana Medical Policy/Codes
Brain Tissue Transplantation, Neurotransplantation for Treatment of Parkinsons Disease
Chapter: Surgery: Procedures
Current Effective Date: October 25, 2013
Original Effective Date: October 25, 2013
Publish Date: October 25, 2013
Description

Parkinson's disease is a degenerative disease that includes symptoms of resting tremor, rigidity, and bradykinesia.  The condition usually appears after age 40 years and progresses slowly over many years.  Drug treatment with levodopa can usually restore smooth motor function for up to 5–10 years after onset of Parkinson's disease by permitting surviving dopaminergic cells to bypass a rate-limiting enzyme, tyrosine hydroxylase, and thus produce enough dopamine to maintain adequate motor function.  Eventually, more dopaminergic cells die, leading to progressive disability.

In an effort to modify motor disability of advanced Parkinson's disease, embryonic mesencephalic (midbrain) tissue containing dopamine-producing cells is implanted into the caudate and putamen of the candidate's brain.

The transplantation of adrenal medullary tissue to the corpus striatum is intended to ameliorate the motor and postural dysfunctions of Parkinson’s disease.  Striatal dopamine is depleted in Parkinson’s disease patients.  The rational for the procedure is that adrenal tissue may restore dopamine activity in the corpus striatum.  Adrenal-to-brain transplantation can involve either autografts or fetal allografts.

Autotransplantation entails simultaneous adrenalectomy and craniotomy with subsequent implantation of adrenal medullary tissue.  Adrenal tissue is usually implanted in fragments into the caudate nucleus at the margin of the lateral ventricle, such that the tissue is exposed to cerebrospinal fluid (CSF).  Tissue fragments can be anchored in place with surgical staples or with Gelfoam®.  Besides the caudate nucleus, the putamen has also been used as an implantation site.  Open microsurgical insertion of the tissue has been used in addition to stereotactic localization and implantation using a cannula.

Allografts

Allografting involves harvesting adrenal tissue from an aborted fetus.  The surgical techniques are the same as autotransplantation, with the exception of the adrenalectomy.

Policy

Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions.  Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there is any exclusion or other benefit limitations applicable to this service or supply.  If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.

Coverage

Brain tissue transplantation or Neurotransplantation for the treatment of Parkinson’s disease is considered experimental, investigational and unproven when performed by any method, including but not limited to:

  • Adrenal-to-brain transplantation with autograft or fetal allograft; or
  • Human or xenogeneic fetal mesencephalic transplantation.

Xenotransplantation and/or heterotransplantation (between different species) such as fetal porcine and/or swine brain cells is considered experimental, investigational and unproven for the treatment of Parkinson's disease.

Rationale

This policy is based on a 2001 Blue Cross Blue Shield Technology Evaluation Center (TEC) Assessment, which updated a prior 1995 TEC Assessment   The 2001 TEC Assessment offered the following observations and conclusions:

Most of the studies published since the 1995 TEC Assessment consist of uncontrolled open trials, examining clinical outcomes in small groups of patients.  As such, they lack the strength conferred by study designs with control groups, randomization, and double-blinding protocol. However, these studies report minor to moderate improvement in motor function in at least some patients in each study.  Magnitude of the treatment effect, however, is variable.

There has been one randomized controlled trial, reporting clinical outcomes for 33 patients. Clinical outcomes among these patients were variable, moderate in magnitude, and were in part affected by age.  The primary outcome variable, a patient-scored global rating, showed no significant difference at 12 months after surgery between patients treated with transplantation and those undergoing sham surgery.

A 2005 updated search of the literature found publications on two randomized controlled trials (RCT) addressing health outcomes for Parkinson’s disease patients receiving embryonic mesencephalic transplantation.  The publications identified included results from the National Institute of Health (NIH) RCT and an RCT sponsored by the National Institute of Neurological Disorders and Stroke (NINDS).

In the NIH study, Olanow and colleagues reported on a double-blind, placebo-controlled trial of fetal-nigral (the layer of gray substance separating the tegmentum of the midbrain from the crus cerebri) transplantation in 34 patients with advanced Parkinson’s disease followed prospectively for 24 months.  Patients were randomized to one of four donor bilateral transplantation or a placebo procedure.  The authors reported no significant difference in overall effect (p=0.244) and persistent dyskinesia in 56% of patients in the transplant group.  While a treatment effect was seen in milder patients (p=0.006), the authors concluded the results did not support fetal nigral transplantation as a recommended therapy for Parkinson’s disease.

In the NINDS double-blind, placebo-controlled RCT, 40 patients with Parkinson’s disease were randomized to receive bilateral 4-donor implantation of embryonic mesencephalic cells or a placebo procedure and followed for one year.  Gordon and colleagues reported that patients in the NINDS trial improved significantly on reaction and movement times twelve months post transplantation (p=0.005) while patients in the placebo group deteriorated.  The authors concluded reaction time analyses can be useful in identifying subtle motor performance changes over time.

McRae and colleagues reported on a portion of the NINDS RCT that evaluated quality of life (QOL) of 30 of the 40 study patients at baseline, four, eight, and twelve months post procedure.  The authors reported a strong placebo effect, since all patients reported better scores if they believed they had received the transplant.

Trott and colleagues reported on cognition one year post-procedure in the NINDS study.  The authors reported no significant differences in cognitive performance at follow-up for the transplant or placebo group as performance for most measures remained the same.

2011 Update

A search of peer reviewed literature through July 2011 identified no new clinical trial publications or any additional information that would change the coverage position of this medical policy.

Coding

Disclaimer for coding information on Medical Policies

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations.

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps. 

ICD-9 Codes
02.99, 332.0, 331.2
ICD-10 Codes
G20
Procedural Codes: 64999, S2103
References
  1. Fetal mesencephalic transplantation for the treatment of Parkinson’s disease.  Chicago, Illinois: Blue Cross Blue Shield Association – Technology Evaluation Center Assessment Program (1995).
  2. Embryonic mesencephalic for the treatment of Parkinson’s disease.  Chicago, Illinois:  Blue Cross Blue Shield Association – Technology Evaluation Center Assessment Program (2001).  
  3. Olanow, C.W., Goetz, C.G., et al.  A double-blind controlled trial of bilateral fetal nigral transplantation in Parkinson’s disease.  Annals of Neurology (2003) 54(3):403.14.
  4. Trott, C.T., Fahn, S., et al.  Cognition following bilateral implants of embryonic dopamine neurons in PD:  a double blind study.  Neurology (2003) 60(12):1938-43.
  5. Gordon, P.H., Yu, Q., et al.  Reaction time and movement time after embryonic cell implantation in Parkinson disease.  Archives of Neurology (2004 June) 61(6):858-61.
  6. McRae, C., Cherin, E., et al.  Effects of perceived treatment on quality of life and medical outcomes in a double-blind placebo surgery trial.  Arch Gen Psychiatry (2004) 61(4):412-20.
  7. Fetal Mesencephalic Transplantation for the Treatment of Parkinson's disease.  Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (2009 November) Surgery: 7.01.10.
  8. Adrenal-to-Brain Transplantation-Archived.  Chicago, Illinois:  Blue Cross Blue Shield Association Medical Policy Reference Manual (2011 February) Surgery 7.01.43.
History
September 2013  New 2013 BCBSMT medical policy.  Brain tissue transplantation or Neurotransplantation for the treatment of Parkinson’s disease is considered experimental, investigational and unproven when performed by any method.
BCBSMT Home
®Registered marks of the Blue Cross and Blue Shield Association, an association of independent Blue Cross and Blue Shield Plans. ®LIVE SMART. LIVE HEALTHY. is a registered mark of BCBSMT, an independent licensee of the Blue Cross and Blue Shield Association, serving the residents and businesses of Montana.
CPT codes, descriptions and material only are copyrighted by the American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS Restrictions Apply to Government Use. CPT only © American Medical Association.
Brain Tissue Transplantation, Neurotransplantation for Treatment of Parkinsons Disease