Lung and Lobar Lung Transplant
No coverage will be provided for lung transplantation in patients with the following absolute contraindications as this is considered not medically necessary:
a) Known current malignancy, including metastatic cancer;
b) Recent malignancy with a high incidence of recurrence;
c) Untreated systemic infection making immunosuppression unsafe, including chronic infection; or
d) Other irreversible end-stage disease not attributed to lung disease.
The following changes have been made to the policy guidelines:
-Patients must meet UNOS guidelines for lung allocation score (LAS) greater than zero.
-Bilateral lung transplantation is typically required when chronic lung infection disease is present, i.e., associated with cystic fibrosis and bronchiectasis. Some, but not all, cases of pulmonary hypertension will require bilateral lung transplantation.
-Bronchiolitis obliterans is associated with chronic lung transplant rejection, and thus may be the etiology of a request for lung retransplantation.
-Relative contraindications to lung transplantation:
a) History of cancer with a moderate risk of recurrence;
b) Systemic disease that could be exacerbated by immunosuppression;
c) Psychosocial conditions or chemical dependence affecting the ability to adhere to therapy;
d) Coronary artery disease not amenable to percutaneous intervention or bypass grafting, or associated with significant impairment of left ventricular function*; or
e) Colonization with highly resistant or highly virulent bacteria, fungi or mycobacteria.
*Some patients may be candidates for combined heart-lung transplantation
Positron Emission Tomography (PET)
Positron Emission Mammography (PEM)
No coverage will be provided for the use of positron emission mammography (PEM) as this is considered investigational.
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 necessary to predict treatment response to erlotinib in patients with advanced NSCLC.
-Analysis of two types of somatic mutation within the EGFR gene – small deletions in exon 19 and a point mutation in exon 21 (L858R) is considered investigational for patients with advanced NSCLC of squamous cell-type.
-Analysis for other mutations within exons 18-24, or other applications related to NSCLC, is considered investigational.
KIF6 Genotyping for Predicting Cardiovascular Risk and/or Effectiveness of Statin Therapy
KIF6 Genotyping for predicting cardiovascular risk and/or the effectiveness of statin therapy is considered investigational and is not covered.
Plasma Exchange and Apheresis Therapy
Extracorporeal Photopheresis as a Treatment of Graft-versus-Host Disease, Autoimmune Disease, and Cutaneous T-Cell Lymphoma
Extracorporeal photopheresis is considered investigational and therefore not covered as a technique to treat either the cutaneous or visceral manifestations of autoimmune diseases, including but not limited to scleroderma, systemic lupus erythematosus, rheumatoid arthritis, pemphigus, psoriasis, multiple sclerosis, diabetes, or autoimmune bullous disorders.
Experimental/Investigative Services Pathology/Laboratory
Intravenous Antibiotic Therapy and Associated Diagnostic Testing for Lyme Disease
Determination of levels of the B lymphocyte chemoattractant CXCL13 for diagnosis or monitoring treatment is considered investigational and not covered.
Serologic Diagnosis of Celiac Disease
Serologic measurement of deamidated gliadin peptide antibodies is considered investigational and not covered in patients with signs or symptoms suggestive of celiac disease.
MRI of the Breast
No coverage will be provided for the use of computer-aided evaluation (CAE, formerly CAD) for interpretation of magnetic resonance imaging (MRI) of the breast as this is considered investigational.
Implantable Bone-Conduction and Bone-Anchored Hearing Prosthesis
Implantable Bone-Conduction and Bone-Anchored Hearing Aids
Unilateral or bilateral implantable bone-conduction (bone-anchored) hearing aid (s) may be considered medically necessary as an alternative to an air-conduction hearing aid in patients five years of age and older with conductive or mixed hearing loss who also meet at least one (1) of the following medical criteria:
a) Congenital or surgical induced malformations (e.g., atresia) of the external ear canal or middle ear;
b) Chronic external otitis or otitis media;
c) Tumors of the external canal and/or tympanic cavity; or
d) Dermatitis of the external ear canal.
In addition to the above medical criteria, the following audiologic criteria must be met:
a) A pure tone average bone-conduction threshold measured at 0.5, 1, 2, and 3 kHz of better than or equal to 45 dB (OBC and BP100 devices), 55 dB (Intenso device) or 65 dB (Cordele II device).
b) For bilateral implantation, patients should meet the above audiologic criteria, and have a symmetrically conductive or mixed hearing loss as defined by a difference between left and right side bone conduction threshold of less than 10 dB on average measured at 0.5, 1, 2 and 3 kHz, or less than 15 dB at individual frequencies.
An implantable bone-conduction (bone-anchored) hearing aid may be considered medically necessary as an alternative to an air-conduction CROS hearing aid in patients five years of age and older with single-sided sensorineural deafness and normal hearing in the other ear. The pure tone average air conduction threshold of the normal ear should be better than 20 dB measured at 0.5, 1, 2, and 3 kHz.
Hematopoietic Stem-Cell Transplantation
Hematopoietic Stem-Cell Transplantation for Solid Tumors of Childhood
No coverage will be provided for tandem autologous-autologous stem-cell transplantations for treatment of pediatric solid tumors as this is considered investigational.
No coverage will be provided for allogeneic (myeloablative or nonmyeloablative) hematopoietic stem-cell transplantation for treatment of pediatric solid tumors as this is considered investigational.