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«PacifiCare’s medical management guidelines represent the recommendation of the PacifiCare Medical Management Guideline (MMG) committee. They are ...»

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G0101 Cervical or vaginal cancer screening; pelvic and clinical breast examination G0123 Screening cytopathology, cervical or vaginal (any reporting system), collected in preservative fluid, automated thin layer preparation, screening by cytotechnologist under physician supervision G0124 Screening cytopathology, cervical or vaginal (any reporting system), collected in preservative fluid, automated thin layer preparation, requiring interpretation by physician G0143 Screening cytopathology, cervical or vaginal (any reporting system), collected in preservative fluid, automated thin Cervical Cancer Screening - Commercial Medical Management Guideline layer preparation, with manual screening and rescreening by cytotechnologist under physician supervision G0144 Screening cytopathology, cervical or vaginal (any reporting system), collected in preservative fluid, automated thin layer preparation, with screening by automated system, under physician supervision G0145 Screening cytopathology, cervical or vaginal (any reporting system), collected in preservative fluid, automated thin layer preparation, with screening by automated system and manual rescreening under physician supervision G0147 Screening cytopathology smears, cervical or vaginal, performed by automated system under physician supervision G0148 Screening cytopathology smears, cervical or vaginal, performed by automated system with manual rescreening P3000 Screening Papanicolaou smear, cervical or vaginal, up to three smears, by technician under physician supervision P3001 Screening Papanicolaou smear, cervical or vaginal, up to three smears, requiring interpretation by physician Q0091 Screening Papanicolaou smear; obtaining, preparing and conveyance of cervical or vaginal smear to laboratory

CPT Codes:

58999 Unlisted procedure, female genital system (nonobstetrical) 87620 Infectious agent detection by nucleic acid (DNA or RNA); papillomavirus, human, direct probe technique 87621 Infectious agent detection by nucleic acid (DNA or RNA); papillomavirus, human, amplified probe technique 87622 Infectious agent detection by nucleic acid (DNA or RNA); papillomavirus, human, quantification 88141 Cytopathology, cervical or vaginal (any reporting system), requiring interpretation by physician 88142 Cytopathology, cervical or vaginal (any reporting system), collected in preservative fluid, automated thin layer preparation; manual screening under physician supervision 88143 Cytopathology, cervical or vaginal (any reporting system), collected in preservative fluid, automated thin layer preparation; with manual screening and rescreening under physician supervision 88147 Cytopathology smears, cervical or vaginal; screening by automated system under physician supervision 88148 Cytopathology smears, cervical or vaginal; screening by automated system with manual rescreening under physician supervision 88150 Cytopathology, slides, cervical or vaginal; manual screening under physician supervision 88152 Cytopathology, slides, cervical or vaginal; with manual screening and computer-assisted rescreening under physician supervision 88153 Cytopathology, slides, cervical or vaginal; with manual screening and rescreening under physician supervision 88154 Cytopathology, slides, cervical or vaginal; with manual screening and computer-assisted rescreening using cell selection and review under physician supervision 88160 Cytopathology, smears, any other source; screening and interpretation 88161 Cytopathology, smears, any other source; preparation, screening and interpretation 88164 Cytopathology, slides, cervical or vaginal (the Bethesda System); manual screening under physician supervision 88165 Cytopathology, slides, cervical or vaginal (the Bethesda System); with manual screening and rescreening under physician supervision Cervical Cancer Screening - Commercial Medical Management Guideline 88166 Cytopathology, slides, cervical or vaginal (the Bethesda System); with manual screening and computer-assisted rescreening under physician supervision 88167 Cytopathology, slides, cervical or vaginal (the Bethesda System); with manual screening and computer-assisted rescreening using cell selection and review under physician supervision 88174 Cytopathology, cervical or vaginal (any reporting system), collected in preservative fluid, automated thin layer preparation; screening by automated system, under physician supervision 88175 Cytopathology, cervical or vaginal (any reporting system), collected in preservative fluid, automated thin layer preparation; with screening by automated system and manual rescreening or review, under physician supervision This information is being distributed to you for personal reference. The information belongs to UnitedHealthcare and unauthorized copying, use and distribution are prohibited. This information is intended to serve only as a general reference resource regarding our Medical Policies and is not intended to address every aspect of a clinical situation. Physicians and patients should not rely on these Medical Policies in making health care decisions. Physicians and patients must exercise their independent clinical discretion and judgment in determining care. The enrollee's specific benefit documents supercede these policies and are used to make coverage determinations. These Medical Policies are believed to be current as of the date noted.

Confidential and Proprietary, © UnitedHealthcare, Inc. 2009 Cervical Cancer Screening - Commercial Medical Management Guideline TITLE: Chelation Therapy Authorized By: Medical Management Guideline Committee





Adoption Date: 07/27/09 Revision Date:

Disclaimer This medical management guideline represents the recommendation of the PacifiCare Medical Management Guideline (MMG) committee. It is based on the MMG committee's review of the available evidence as of the date of this medical management guideline.

This medical management guideline contains clinical practice and utilization criteria to assist professionals in PacifiCare’s medical management practice when making medical necessity determinations prior to, subsequent to, or concurrent with the provisions of health care services. This medical management guideline is intended to support consistent, appropriate medical necessity determinations, but it does not replace an individualized case-by-case review and medical necessity determination for each PacifiCare member.

Member benefit coverage and limitations may vary based on the member’s benefit plan.

ADOPTED FROM UNITEDHEALTHCARE FOR PACIFICARE USE

This information is being distributed to you for personal reference. The information belongs to UnitedHealthcare and unauthorized copying, use and distribution are prohibited. This information is intended to serve only as a general reference resource regarding our Medical Policies and is not intended to address every aspect of a clinical situation. Physicians and patients should not rely on these Medical Policies in making health care decisions. Physicians and patients must exercise their independent clinical discretion and judgment in determining care. The enrollee's specific benefit documents supercede these policies and are used to make coverage determinations. These Medical Policies are believed to be current as of the date noted.

–  –  –

Description After evaluating relevant benefit document language (exclusions or limitations), refer to Coverage sections of this document to determine coverage.

This policy describes the treatment of heavy metal poisoning with medications which bind with metals (such as iron, lead, copper, or aluminum), allowing them to be excreted by the body. This type of therapy is called chelation therapy.

Chelation therapy has also been proposed for treatment of other chronic, progressive diseases such as cardiacvascular Chelation Therapy - Commercial Medical Management Guideline disease and rheumatoid arthritis.

Coverage All reviewers must first identify member eligibility, any federal or state regulatory requirements and the plan benefit coverage prior to use of this policy.

Coverage Rationale Chelation therapy is proven for the treatment of heavy metal (e.g., iron, copper, lead, aluminum) poisoning.

Chelation therapy is unproven for the treatment of chronic, progressive diseases (not involving heavy metal poisoning)

including but not limited to:

• Alzheimer's disease

• apoplectic coma

• autism spectrum disorder

• cancer

• cardiovascular disease

• chronic fatigue syndrome

• chronic renal insufficiency

• defective hearing

• diabetes

• diabetic ulcer

• cholelithiasis

• gout

• erectile dysfunction

• multiple sclerosis

• osteoarthritis

• osteoporosis

• Parkinson's disease

• Raynaud's disease

• renal calculus

• rheumatoid arthritis

• schizophrenia

• scleroderma

• snake venom poisoning

• varicose veins

• vision disorders (glaucoma, cataracts, etc) Much of the evidence supporting chelation treatment for other chronic progressive disease is based on testimonials and single-case studies. Thus, there still is no scientific evidence that demonstrates any benefit from this form of therapy.

This position is supported by the American Medical Association and the American Heart Association. (American Medical Association, 1997; American Heart Association) Chelation therapy is unproven for the treatment of "mercury toxicity" from dental amalgam fillings. Randomized controlled trials do not identify a causal association between amalgam fillings and various systemic symptoms and disorders attributed to mercury.

Regulatory Requirements Chelation Therapy - Commercial Medical Management Guideline

U.S. Food and Drug Administration (FDA):

Iron Overload: Desferal which is the trade name for DFO (deferoxamine mesylate, deferoxamine B mesylate, deferoxamine, desferroxamine, desferrioxamine) and Exjade (deferasirox) are FDA-approved chelators for iron overload.

Dimercaprol (BAL oil) is also approved for the heavy metal chelation of iron. Deferiprone (Ferriprox) has received orphan drug status by the FDA, but is not yet approved for marketing. This drug is designated an orphan drug for the treatment of iron overload in patients with hematologic disorders requiring chronic transfusion therapy.

Lead Overload: The following lead chelators are approved by the FDA:

- Edetate calcium disodium, also called EDTA (ethylenediamine tetraacetic acid or edetic acid), or calcium disodium versenate, also called CaNa2EDTA or calcium EDTA, is approved for the treatment of lead poisoning in adults and children.

- BAL (British Anti Lewisite) in oil, also called by the generic name dimercaprol.

- Meso 2,3-dimercaptosuccinic acid (DMSA), also called succimer or Chemet, is approved for the treatment of lead poisoning in pediatric patients with blood lead levels greater than 45 mg/dL.

Copper Overload: The copper chelating agent penicillamine (Cuprimine® and Depen®FDA approved for the treatment of Wilson's disease. Syprine is approved for the treatment of patients with Wilson's disease who are intolerant or inadequately responsive to penicillamine. Dimercaprol (BAL oil) is also approved for the heavy metal chelation of copper. Zinc acetate or GalzinTM (Gate Pharmaceuticals) is approved for maintenance treatment of patients who have been initially treated with a chelating agent.

Aluminum Overload: Deferoxamine, or DFO (Desferal) is FDA approved for the treatment of transfusion-dependent anemias.

The FDA approved dexrazoxane (Zinecard®marketing in parenteral form to reduce the incidence and severity of cardiomyopathy associated with doxorubicin administration in women with metastatic breast cancer who have received an accumulative doxorubicin dose of 300 mg/kg and who, in their physician's opinion, would benefit from continuing therapy with doxorubicin.

Additional information is available at: http://www.fda.gov/cder/ob/default.htm. Accessed February 24, 2009.

Research Evidence Background Chelation therapy involves the administration of naturally occurring or chemically designed molecules to bind and excrete a specific toxin in the body. The specific medication, route, method and site of administration of the chelating agent varies depending on the specific agent used, the level of toxicity, and other clinical indications. Heavy metal toxicity most often treated with chelation therapy includes that caused by iron, lead, copper, aluminum, and mercury.

Iron Overload: Transfusional iron overload may develop in patients with inherited hemoglobinopathies who require red blood cell transfusions. These disorders include sickle cell anemia and b-thalassemia, also called thalassemia major or Cooley's anemia.

Deferoxamine mesylate, deferoxamine B mesylate, deferoxamine (DFO), desferroxamine, or desferrioxamine is used for the treatment of acute iron intoxication and chronic iron overload. Treatment lasts for the duration of the patient's life.

Lead Overload: Lead poisoning continues to an environmental threat to children in the United States.

Histopathologically, lead poisoning results in the segmental demyelination of motor neurons and destruction of Schwann cells ultimately resulting in motor neuron dysfunction.

Chelation Therapy - Commercial Medical Management Guideline

Three lead chelators are currently available: edetate calcium disodium, also called EDTA (ethylenediamine tetraacetic acid or edetic acid), or calcium disodium versenate, also called CaNa2EDTA or calcium EDTA; BAL in oil, also called by the generic name dimercaprol; and meso 2,3-dimercaptosuccinic acid (DMSA), also called succimer or Chemet.

Copper Overload: Wilson's disease is a rare hereditary condition in which an abnormal amount of copper accumulates in the body, particularly in the liver, cornea, and brain. Without diagnosis and medical intervention, Wilson's disease is fatal. Chelation therapy removes excess accumulated copper and prevents further accumulation; this therapy must be lifelong.

Penicillamine is an oral copper-chelating agent commonly used as first-line treatment for patients with Wilson's disease.

For patients who cannot tolerate penicillamine, treatment is continued with trientine (Syprine®also be a treatment option;

zinc does not act as a chelator, but rather blocks absorption of copper by the intestines.



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