BlueCross and BlueShield of Montana Medical Policy/Codes
Antineoplaston Cancer Therapy
Chapter: Medicine: Treatments
Current Effective Date: September 24, 2013
Original Effective Date: September 24, 2013
Publish Date: June 24, 2013
Description

Antineoplaston therapy is an alternative form of cancer treatment that involves using a group of synthetic chemicals called antineoplastons to protect the body from disease.  Antineoplastons are hypothesized by proponents to have anti-tumor activity.  Antineoplastons are made up mostly of peptides and amino acids originally taken from human blood and urine.  The therapy can be given orally or by injection into a vein.  Proponents claim antineoplaston therapy has been successful in treating many forms of cancer.  They claim people with cancer have a deficiency of naturally occurring antineoplastons, and that this therapy replenishes the body's supply allowing the biochemical defense system of the body to convert cancer cells into normal cells.  There is no scientific evidence to support these claims.

Antineoplaston treatment is offered exclusively in this country by the Burzynski Research Institute in Houston, Texas, and has long been a controversial treatment for various types of malignancy.

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 are any exclusions 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

Antineoplaston therapy for the treatment of cancer is considered experimental, investigational and unproven. This includes, but is not limited to, the following malignancies:

  • brain
  • head, neck and throat
  • breast
  • lung
  • colon
  • blood
  • lymphoma
  • melanoma
  • myeloma
  • sarcoma

Policy Guidelines

There are no specific codes for antineoplaston therapy. Unlisted codes would likely be billed.

Rationale

A search of the literature 2003 through November 2006 did not identify any controlled studies of antineoplaston therapy.  The bulk of the literature consists of case reports, case series and data from single institution phase II trials.  There is inadequate published peer reviewed literature to permit scientific conclusions regarding the efficacy of antineoplaston therapy.

2013 Update

A search of peer reviewed literature through June 2013 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

Experimental, investigational and unproven for all codes.

ICD-10 Codes

Experimental, investigational and unproven for all codes.

Procedural Codes: 96549, J8499
References
  1. Burzynski, S. R., Lewy, R.I., et al.  Phase II clinical trials of antineoplaston A10 and As2-1 infusions in astrocytoma.  Recent Advances of Chemotherapy (1991):  2506-2507.
  2. Cancer Facts; Antineoplastons.  National Cancer Institute.  Bethesda, MD.  (2002 May)  (Web Site):  http://cis.nci.nih.gov (Accessed 5/19/2003)
  3. Badria, F., Mabed, M., et al.  Immune Modulatory Potentials of Antineoplaston A-10 in Breast Cancer Patients.  Cancer Letters (2000 August 31) 157(1):57-63.
  4. Green, S.  Antineoplastons:  an unproved cancer therapy.   Journal of the American Medical Association (1992 June 3) 267(21):  2924-2928.
  5. Burzynski, S.R., Lewy, R.I., et al.  Phase II study of antineoplaston A10 and AS2-1 in patients with recurrent diffuse intrinsic brain stem glioma:  a preliminary report.  Drugs Research and Development (2003) 4(2): 91-101.
  6. Burzynski, S.R.  The present state of antineoplaston research.  Integrated Cancer Therapies (2004 March) 3(1): 47-58.
  7. Burzynski, S.R., Weaver, R.A., et al.  Phase II study of antineoplaston A10 and AS2-1 in children with recurrent and progressive multicentric glioma:  a preliminary report.  Drugs Research and Development (2004) 5(6): 315-26.
  8. Matono, K., Ogata, Y., et al.  Effects of antineoplaston AS2-1 against post-operative lung metastasis in orthotopically implanted colon cancer.  Oncology Report (2005 March) 13(3): 389-95.
  9. Fujii, T., Nakamura, A.M., et al.  Antineoplaston induces G (1) arrest by PKCalpha and MAPK pathway in SKBR-3 breast cancer cells.  Oncology Report (2005 August) 14(2): 489-94.
  10. National Cancer Institute – Antineoplastons (2002 May 20) U.S. National Institutes of Health. Accessed November 2006.  http://www.cancer.gov
  11. American Cancer Society - Antineoplaston Therapy.  2000. Accessed (2006 November).
  12. Burzynski, S.R.  Antineoplaston therapy in treating patients with brain tumors.  National Cancer Institute (NCI) 2006 September). www.clinicaltrials.gov .
History
June 2013  New 2013 BCBSMT medical policy.  Antineoplaston therapy for the treatment of cancer is considered experimental, investigational and unproven.   
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Antineoplaston Cancer Therapy