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March 2013

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Transplant
Liver Transplant
Liver transplantation may be considered medically necessaryin patients with unresectable hilar cholangiocarcinoma.

Liver retransplantation may be considered medically necessaryin patients with:

a) primary graft non-function

b) hepatic artery thrombosis

c) chronic rejection

d) schemic type biliary lesions after donation after cardiac death

e) recurrent non-neoplastic disease causing late graft failure

Liver transplantation is considered investigational in the following patients:

a) Patients with intrahepatic cholangiocarcinoma

b) Patients with neuroendocrine tumors metastatic to the liver

Durable Medical Equipment (DME)
Outpatient Use of Limb Pneumatic Compression Devices for Venous Thromboembolism Prophylaxis

Coverage will be provided for the outpatient use of limb pneumatic compression devices for venous thromboembolism prophylaxis when medically necessary.

  1. Limb pneumatic compression devices may be considered medically necessary after major orthopedic surgery in patients with a contraindication to pharmacological agents i.e., at high-risk for bleeding; or
  2. After major non-orthopedic surgery in patients who are at moderate or high risk of venous thromboembolism with a contraindication to pharmacological agents i.e., at high-risk for bleeding.

Coverage will not be provided for the outpatient use of limb pneumatic compression devices for venous thromboembolism prophylaxis for the following as these are considered investigational:

  1. After major orthopedic surgery in patients without a contraindication to pharmacological prophylaxis.
  2. After major non-orthopedic surgery in patients who are at moderate or high risk of venous thromboembolism without a contraindication to pharmacological prophylaxis and in patients who are at low-risk of venous thromboembolism.
  3. After all other surgeries.

Coverage will not be provided for outpatient use of limb pneumatic compression devices for venous thromboembolism prophylaxis for periods longer than 30 days post-surgery as this is considered not medically necessary.

Genetic Testing
Assays of Genetic Expression in Tumor Tissue as a Technique to Determine Prognosis in Patients with Breast Cancer

This policy has been updated to include statements for the use of Oncotype DX in bilateral disease and DCIS as well as clarifying the use of other gene expression assays.

All other indications for the 21-gene RT-PCR assay (Oncotype DX™), including determination of recurrence risk in breast cancer patients who are lymph node-positive or patients with bilateral disease, are considered investigational and not covered.

Use of a subset of genes from the 21-gene RT-PCR assay for predicting recurrence risk in patients with noninvasive ductal carcinoma in situ (i.e., Oncotype DX DCIS) to inform treatment planning following excisional surgery is considered investigational and not covered.

The use of other gene expression assays (e.g., MammaPrint 70-gene signature, Mammostrat Breast Cancer Test, the Breast Cancer Index, the BreastOncPx, NexCourse Breast IHC4, or PAM50 Breast Cancer Intrinsic Classifier) for any indication is considered investigational and not covered.

Basic Coverage Criteria for Genetic Testing
Genetic testing not meeting the policy criteria is considered not medically necessary and not covered.

Sequencing-based Tests to Determine Trisomy 21 from Maternal Plasma DNA
Coverage will be provided for nucleic acid sequencing-based testing of maternal plasma for trisomy 21 when medically necessary.

  1. Nucleic acid sequencing-based testing of maternal plasma for trisomy 21 (e.g., MaterniT21™, verifi®, or Harmony™) may be considered medically necessaryin women with high-risk singleton pregnancies undergoing screening for trisomy 21.

NOTE:  High-risk singleton pregnancies, as defined by the American College of Obstetricians and Gynecologists (ACOG) Committee Opinion, Number 454, December 2012 include women who meet at least one of the following criteria:

  • Maternal age 35 years or older at delivery;
  • Fetal ultrasonographic findings indicating increased risk of aneuploidy;
  • History of previous pregnancy with a trisomy;
  • Standard serum screening test positive for aneuploidy;
  • Parental balanced robertsonian translocation with increased risk of fetal trisomy 13 or trisomy 21.
  1. Nucleic acid sequencing-based testing of maternal plasma for trisomy 21 in women who do not meet the above criteria is considered not medically necessary and not covered.
     
  2. Nucleic acid sequencing-based testing of maternal plasma for trisomy 21 is considered investigational and not covered in women with twin or multiple pregnancies.

Epidermal Growth Factor Receptor (EGFR) Mutation Analysis for Patients with Non-Small Cell Lung Cancer (NSCLC)
Except as noted below, analysis of two types of somatic mutation within the EGFR gene (small deletions in exon 19 and a point mutation in exon 21) (L858R) – may be considered medically necessaryto predict treatment response to erlotinib in patients with advanced NSCLC of non-squamous cell type.

Measurement of TPMT
Genotypic analysis of TPMT or analysis of the 6-TG and 6-MMP metabolite markers not meeting the criteria outlined above is considered not medically necessary and not covered.

Cardiac Event Monitors
Ambulatory Event Monitors and Mobile Outpatient Cardiac Telemetry
The use of patient-activated or auto-activated external ambulatory event monitors may be considered medically necessary and coveredin patients with atrial fibrillation who have been treated with catheter ablation, and in whom discontinuation of systemic anticoagulation is being considered.

Other uses of ambulatory event monitors are considered investigational and not covered, including but not limited to monitoring effectiveness of antiarrhythmic medications, for patients with cryptogenic stroke, and detection of myocardial ischemia by detecting ST segment changes.

Continuous ambulatory monitors that record and store information for periods longer than 72 hours are considered investigational and not covered.

No coverage will be provided for other uses of outpatient cardiac telemetry, including but not limited to monitoring effectiveness of antiarrhythmic medications, for patients with cryptogenic stroke, and detection of myocardial ischemia by detecting ST segment changes, as these are considered investigational.

Wound Care
Bio-Engineered Skin and Soft Tissue Substitutes

Several additional products below are being added to the investigational list since the evidence is limited on many of these products and relatively few have been compared with the standard of care:

  • Epifix®
  • Grafix® core
  • Grafix® prime
  • hMatrix®

Experimental/Investigative Services Medicine
Confocal Laser Endomicroscopy
No coverage will be provided for the use of confocal laser endomicroscopy as this is considered investigational.

Bariatric Surgery
Bariatric Surgery
No coverage will be provided for the following surgical procedures as they are considered investigational as a treatment of morbid obesity:

  1. Vertical-banded gastroplasty;
  2. Two-stage bariatric surgery procedures (e.g., sleeve gastrectomy as initial procedure followed by biliopancreatic diversion at a later time);
  3. Endoscopic procedures (e.g., insertion of the StomaphyX™ device) as a primary bariatric procedure or as a revision procedure, (i.e., to treat weight gain after bariatric surgery to remedy large gastric stoma or large gastric pouches).
  4. Any morbid obesity surgical procedure when performed for patients with a BMI less than 35 kg/m².

Intensity-Modulated Radiation Therapy (IMRT)
Intensity-Modulated Radiation Therapy (IMRT): Abdomen and Pelvis
When dosimetric planning with standard 3-D conformal radiation predicts that the radiation dose to an adjacent organ would result in unacceptable normal tissue toxicity, intensity-modulated radiation therapy (IMRT) may be considered medically necessary for the treatment of cancer of the abdomen and pelvis, including but not limited to:

  1. stomach (gastric);
  2. hepatobiliary tract;
  3. pancreas;
  4. rectal locations; or
  5. gynecologic tumors (including cervical, endometrial, and vulvar cancers).

Intensity-modulated radiation therapy (IMRT) as a technique to deliver radiation therapy is considered not medically necessary and not covered for all other uses in the abdomen and pelvis.