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October 2011

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Transplant
Corneal Transplantation
Corneal transplant may be considered medically necessary for the following indications: 
a)Pseudophakic corneal edema
b) Aphakic corneal edema
c) Stromal corneal dystrophies
d) Primary corneal endotheliopathies
e) Ectasias/thinnings
f) Congenital opacities
g) Viral/post-viral keratitis
h) Microbial/post-microbial keratitis
i) Noninfectious ulcerative keratitis or perforation
j) Corneal degenerations
k)Chemical injuries
l) Mechanical trauma, non-surgical
m) Regraft related to allograft rejection
n) Regraft unrelated to allograft rejection
o) Other causes of corneal opacification/distortion
p) Mechanical complication of corneal graft
q) Complications of transplanted organ 

Corneal transplant for indications other than those listed above are considered not medically necessary and are not covered. 

Small Bowel/Liver and Multivisceral Transplant
A small bowel/liver transplant or multivisceral transplant is not medically necessaryand not coveredin patients with the following absolute contraindications: 

  1. Known current malignancy, including metastatic cancer;
  2. Recent malignancy with a high incidence of recurrence;
  3. Untreated systemic infection making immunosuppression unsafe, including chronic infection; or
  4. Other irreversible end-stage disease not attributed to intestinal failure.

 Candidates should meet the following criteria:

  1. Adequate cardiopulmonary status;
  2. Documentation of patient compliance with medical management.

HIV-positive patients who meet the following criteria, as stated in the 2001 guidelines of the American Society of Transplantation, could be considered candidates for small bowel/liver or multivisceral transplantation:

  1. CD4 count >200 cells per cubic millimeter for >6 months
  2. HIV-1 RNA undetectable
  3. On stable anti-retroviral therapy >3 months
  4. No other complications from AIDS (e.g., opportunistic infection, including aspergillus, tuberculosis, coccidiosis mycosis, resistant fungal infections, Kaposi’s sarcoma, or other neoplasm), and meeting all other criteria for transplantation.

Positron Emission Tomography
Cardiac Applications of PET Scanning

Cardiac PET scanning may be considered medically necessary:

-To assess myocardial perfusion and thus diagnose coronary artery disease in patients with indeterminate SPECT scan; or in patients for whom SPECT could be reasonably expected to be suboptimal in quality on the basis of body habitus.

-For the diagnosis of cardiac sarcoidosis in patients who are unable to undergo magnetic resonance imaging (MRI) scanning.  Examples of patients who are unable to undergo MRI include, but are not limited to, patients with pacemakers, automatic implanted cardioverter-defibrillators (AICDs), or other metal implants.

Electrical Bone Growth Stimulator
Bone growth stimulation is the technique of promoting bone growth in difficult to heal fractures by applying a low electrical current or ultrasound to the fracture. The following statements have been added to indicate the proper denial reason when policy criteria have not been met: 

- Noninvasive electrical bone growth stimulation is considered not medically necessary as a treatment of fracture non-unions or congenital pseudoarthroses in the appendicular skeleton when policy guidelines have not been met.

- Invasive and non-invasive methods of electrical bone growth stimulation are considered not medically necessary as an adjunct to lumbar spinal fusion surgery in patients not meeting criteria for high risk fusion failure.

Cosmetic Procedures vs. Reconstructive Procedures
Autologous Fat Grafting to the Breast and Adipose-derived Stem Cells
Coverage will not be provided for the use of autologous fat grafting and adipose-derived stem cells for augmentation or reconstruction of the breast as this is considered investigational.

Genetic Testing
Gene Expression Testing to Predict Coronary Artery Disease
Coverage will not be provided for gene expression testing to predict coronary artery disease as this is considered investigational.

Preimplantation Genetic Testing
Coverage will not be provided for preimplantation genetic screening (PGS) as an adjunct to in vitro fertilization (IVF) as it is considered investigational in members/couples who may have a benefit and are undergoing IVF in all situations.

Experimental/Investigative Services Pathology/Laboratory
Intracellular Micronutrient Analysis
Coverage will not be provided for Intracellular micronutrient panel testing offered by SpectraCell Laboratories as SPECTROX® and IntraCellular Diagnostics as Exa Test as this is considered investigational.

Experimental/Investigative Services Radiology
Magnetoencephalography/Magnetic Source Imaging
Magnetoencephalography/magnetic source imaging as part of the preoperative evaluation of patients with intractable epilepsy (seizures refractory to medical therapy) may be considered medically necessarywhen standard techniques, such as MRI, are inconclusive.

Magnetoencephalography/magnetic source imaging is considered investigationaland not covered for all other indications. 

Experimental/Investigative Services Medicine
Acoustic Cardiography
No coverage will be provided for acoustic cardiography for the diagnosis of heart failure and for the optimization of CRT hemodynamic parameters as this is considered investigational.

Uses of Monoclonal Antibodies for the Treatment of Non-Hodgkin Lymphoma, including Chronic Lymphocytic Leukemia, and Acute Myeloid Leukemia in the Non-Hematopoietic Stem-Cell Transplant Setting
Rituximab (Rituxan®) may be considered medically necessary to treat patients with B-cell non-Hodgkin lymphoma (NHL) in any of the following clinical situations:

a) for follicular lymphoma:

  1. as first-line therapy (as combination therapy or as monotherapy)
  2. as second or subsequent therapy (as combination therapy or as monotherapy)
  3. as single-agent maintenance therapy (first- or second-line) in patients who achieve a complete or partial response to Rituxan in combination with chemotherapy

b) when used with CHOP or other anthracycline-based chemotherapy as first-line treatment for patients with diffuse large B-cell lymphoma (DLBCL)
c) for recurrent, aggressive CD20-positive NHL
d) for previously untreated or relapsed/refractory mantle cell lymphoma
e) as combination therapy in previously untreated and previously treated B-cell chronic lymphocytic leukemia (B-CLL).

Experimental/Investigative Services Medicine
Endovascular Stent Grafts for Thoracic Aortic Aneurysms or Dissections

Endovascular stent grafts using devices approved by the U.S. Food and Drug Administration may also be considered medically necessaryin the treatment of acute, complicated (organ or limb ischemia or rupture) Type B thoracic aortic dissection.

Endovascular stent grafts are considered investigational and not covered for the treatment of thoracic aortic arch aneurysms.

Experimental/Investigative Services Therapy
Diagnosis and Treatment of Chronic Cerebrospinal Venous Insufficiency in Multiple Sclerosis

No coverage will be provided for the identification and subsequent treatment of chronic cerebrospinal venous insufficiency (CCSVI) in patients with multiple sclerosis as this is considered investigational.

Inhaled Nitric Oxide
Coverage will be provided for inhaled nitric oxide when medically necessary.

Inhaled nitric oxide may be considered medically necessary as a component of treatment of hypoxic respiratory failure in neonates born at more than 34 weeks of gestation.

Other indications for inhaled nitric oxide are investigational, including, but not limited to, its use in premature neonates born at less than or equal to 34 weeks of gestation, adults and children with acute hypoxemic respiratory failure and postoperative management of pulmonary hypertension in children with congenital heart disease.

Tumor Markers
Serum Tumor Markers for Breast and Gastrointestinal Malignancies
Measurement of serum tumor markers CA15-3 or CA 27.29 is considered not medically necessary and not covered when performed for patients with non-malignant diagnoses.

No coverage will be provided for measurement of serum tumor marker CA 72-4 when performed for patients with cancer diagnoses as it is considered investigational.

No coverage will be provided for measurement of serum tumor marker CA 72-4 when performed for patients with non-malignant diagnoses as it is considered not medically necessary.

No coverage will be provided for measurement of other tumor markers described by CPT code 86316 (Immunoassay for tumor antigen) when performed for patients with cancer diagnoses as these are considered investigational.

No coverage will be provided for measurement of other tumor markers described by CPT code 86316 (Immunoassay for tumor antigen) when performed for patients with non-malignant diagnoses as it is considered not medically necessary.

Chondral Defects of the Knee
Autologous Chondrocyte Implantation and Other Cell-based Treatments of Focal Articular Cartilage Lesions
Autologous chondrocyte implantation (ACI) involves harvesting chondrocytes from healthy tissue, expanding the cells in vitro, and implanting the expanded cells into the chondral defect under a periosteal or fibrin patch. The absence of meniscal pathology as a criterion for ACI is no longer required.

Osteochondral Autografts and Allografts in the Treatment of Focal Articular Cartilage Lesions
This policy no longer requires the absence of meniscal pathology as a criterion for osteochondral autografting.

Cryosurgical Ablation and Radiofrequency Ablation (RFA)
Radiofrequency Ablation of Primary or Metastatic Liver Tumors
Radiofrequency ablation of primary hepatocellular carcinoma (HCC) is considered investigationalwhen used to downstage (downsize) hepatocellular carcinoma (HCC) in patients being considered for liver transplant.

Radiofrequency ablation may be considered medically necessary as a primary treatment of hepatic metastases 5 cm or less in diameter from colorectal cancer in the absence of extrahepatic metastatic disease when all tumor foci can be adequately treated.

Cardiac Rhythm Devices
Implantable Cardioverter Defibrillator (ICD)
The use of the automatic implantable cardioverter-defibrillator (ICD) may be considered medically necessary for primary prevention in patients who meet the following criteria:

  1. Ischemic cardiomyopathy with New York Heart Association (NYHA) functional class II or class III symptoms, a history of myocardial infarction at least 40 days before ICD treatment and left ventricular ejection fraction of 35% or less; or
  2. Ischemic cardiomyopathy with NYHA functional class I symptoms, a history of myocardial infarction at least 40 days before ICD treatment, and left ventricular ejection fraction of 30% or less; or
  3. Nonischemic dilated cardiomyopathy and left ventricular ejection fraction of 35% or less, after reversible causes have been excluded, and the response to optimal medical therapy has been adequately determined

Coverage will be provided for an automatic implantable cardioverter-defibrillator in pediatric patients when medically necessary.

The use of the ICD may be considered medically necessaryin children who meet any of the following criteria:

  1. Survivors of cardiac arrest, after reversible causes have been excluded;
  2. Symptomatic, sustained ventricular tachycardia in association with congenital heart disease in patients who have undergone hemodynamic and electrophysiologic evaluation; or
  3. Congenital heart disease with recurrent syncope of undetermined origin in the presence of either ventricular dysfunction or inducible ventricular arrhythmias.

The use of the ICD is considered investigational and not covered for all other indications in pediatric patients.

Hematopoietic Stem-Cell Transplantation
Donor Lymphocyte Infusion for Malignancies Treated with an Allogeneic Hematopoietic Stem-Cell Transplant
Coverage will be provided for donor lymphocyte infusion when medically necessary.

Donor lymphocyte infusion may be considered medically necessaryfollowing allogeneic-hematopoietic stem cell transplantation (HSCT) that was originally considered medically necessary for the treatment of a hematologic malignancy that has relapsed or is refractory, to prevent relapse in the setting of a high risk of relapse, or to convert a patient from mixed to full donor chimerism. Settings considered high risk for relapse include T-cell depleted grafts or nonmyeloablative (reduced-intensity conditioning) allogeneic HSCT.

Donor lymphocyte infusion is considered investigational and not coveredfollowing allogeneic-hematopoietic stem cell transplantation (HSCT) that was originally considered investigational for the treatment of a hematologic malignancy.

Donor lymphocyte infusion is considered investigationaland not coveredas a treatment of nonhematologic malignancies following a prior allogeneic HSCT.

Genetic modification of donor lymphocytes is considered investigational and not covered.