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April 2010

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Transplants
Hematopoietic Stem-Cell Transplantation (HSCT) for Breast Cancer 
The following statements are added to the policy:

  • Single or tandem autologous hematopoietic stem-cell transplantation to treat any stage of breast cancer is considered not medically necessary and is not covered.
  • Allogeneic hematopoietic stem-cell transplantation to treat any stage of breast cancer is considered investigational and is not covered.

Hematopoietic Stem-Cell Transplantation for Chronic Myelogenous Leukemia
The following covered/medically necessary indications are added to the policy:

  • Allogeneic stem-cell transplantation using a myeloablative conditioning regimen as a treatment of chronic myelogenous leukemia.
  • Allogeneic SCT using a reduced-intensity conditioning (RIC) regimen may be considered as a treatment of chronic myelogenous leukemia in patients who meet clinical criteria for an allogeneic SCT but who are not considered candidates for a myeloablative conditioning allogeneic SCT.

Allergy Testing
Leukocyte Histamine Release Test 
No coverage is provided for the following allergy tests since they are considered not medically necessary:

  • Leukocyte histamine release test as a technique for the diagnosis and management of allergic disorders.
  • Cytotoxic food testing.
  • Provocative testing (e.g., Rinkel)

Implantable Bone-Conduction and Bone-Anchored Hearing Prosthesis
Implantable Bone-Conduction and Bone-Anchored Hearing Aids
The following statement now specifies “five years of age and older.”  This addition is based on literature and FDA labeling.
Coverage will be provided for an implanted bone-conduction (bone-anchored) hearing aid as an alternative to an air-conduction hearing aid in patients five years of age and older with conductive or mixed hearing loss, who meet at least one of the following criteria:

  • Congenital or surgical induced malformations (e.g. atresia) of the external ear canal or middle ear;
  • Chronic external otitis or otitis media;
  • Tumors of the external canal and/or tympanic cavity; or
  • Dermatitis of the external ear canal.

Cryosurgical Ablation and Radiofrequency Ablation (RFA)
Endoscopic Radiofrequency Ablation or Cryoablation for Barrett’s Esophagus

  • Radiofrequency ablation may now be considered medically necessary for Barrett’s esophagus with high-grade dysplasia.  Policy language has been revised to include this covered indication.
  • Radiofrequency ablation may be considered medically necessary to treat Barrett’s esophagus with high-grade dysplasia. 
  • Radiofrequency ablation for Barrett’s esophagus without dysplasia or with low-grade dysplasia is considered investigational and is not covered. 

Surgical Treatment of Varicose Veins
A new medical policy is added.

Coverage will be provided for the following surgical treatment of symptomatic varicose veins when conservative measures have failed:

  • Surgical ligation (including SEPS) or endoluminal ablation of incompetent perforator veins as a treatment of leg ulcers associated with chronic venous insufficiency when the following conditions have been met:
    • there is demonstrated perforator reflux; and
    • the superficial saphenous veins have been previously eliminated; and
    • ulcers have not resolved following combined superficial vein treatment and compression therapy for at least three months; and
    • the venous insufficiency is not secondary to deep venous thromboembolism.
  • Sclerotherapy of symptomatic varicose tributaries as an adjunct to prior or concomitant surgical treatment of venous reflux disease.
  • Stab avulsion, hook phlebectomy, and transilluminated powered phlebectomy as a component of the treatment of symptomatic varicose veins.
  • Endoluminal radiofrequency or laser ablation of the greater or lesser saphenous veins as a treatment of symptomatic varicose veins/venous insufficiency.
  • Endoluminal radiofrequency ablation or laser ablation of accessory saphenous veins as a treatment of symptomatic varicose veins/venous insufficiency when the greater or lesser saphenous veins have been previously eliminated.

The following procedures are considered investigational and are not covered:

  • Ligation or ablation of incompetent perforator veins for all other conditions;
  • Endoluminal radiofrequency or laser ablation of tributary veins;
  • Endoluminal cryoablation;
  • Sclerotherapy of incompetent perforator veins as an adjunct to prior or concomitant surgical treatment of venous reflux disease;
  • Sclerotherapy as the sole treatment of varicose tributaries with documented reflux of the saphenofemoral junction or reflux isolated to the perforator veins of the upper thigh;
  • Sclerotherapy of greater saphenous vein with or without associated ligation of the saphenofemoral junction.

The following procedures are considered not medically necessary and are not covered: ligation or ablation of incompetent perforator veins concurrent with superficial venous surgery.

The following procedures are considered experimental/investigational and members are responsible for any charges for treatment for:

Medicine
Low-Level Laser Therapy (LLLT)
Policy language has been expanded to include other musculoskeletal conditions and wound healing in addition to carpal tunnel syndrome. Low-level laser therapy for all indications including, but not limited to treatment of carpal tunnel syndrome is considered investigational and is not covered.

Non-pharmacologic treatment of Rosacea
The following indication has been added to the policy: Non-pharmacologic treatment of rosacea, including but not limited to laser and light therapy, surgical debulking and electrosurgery is considered investigational and is not covered.

Miscellaneous
Aqueous Shunts and Devices for Glaucoma
The following statements are added to the policy and address established aqueous shunts as well as emerging surgical treatments (i.e., canaloplasty and shunts that are currently in FDA-trials): 

  • Canaloplasty as a method to reduce intraocular pressure in patients with glaucoma is considered investigational and is not covered.
  • The use of an aqueous shunt for all other conditions, including patients with glaucoma when intraocular pressure is controlled by medications is considered investigational is not covered.

Keratoprosthesis
Keratoprostheses may now be considered to be medically necessary when certain criteria are met. The following statements are added to the policy to revise the investigational language:

  • Except for the Boston Keratoprosthesis (BostonKpro) for the treatment of corneal blindness under the following conditions:
    • the cornea is severely opaque and vascularized; and
    • the patient has had two or more prior failed corneal transplants

All other types of permanent keratoprosthesis for all other conditions are considered investigational and are not covered.


Pathology/Lab
Laboratory Testing for HIV Tropism
Policy language was revised to clarify investigational applications of HIV tropism testing.

The following statement was removed from the policy:

  • HIV tropism testing using other assay techniques, excluding phenotypic assay, is investigational for selecting patients for treatment with HIV co-receptor antagonists such as maraviroc.

The following statement was added to the policy:

  • HIV Tropism testing using assay techniques other than phenotypic assay is considered investigational and is not covered.

Genetic Testing for Warfarin Dose
Policy language has been revised to include managing the administration and dosing of warfarin as an investigational application. Genotyping to determine cytochrome p4502C9 (CYP2C9) and vitamin K epoxide reductase sub unit C1 (VKORC1) genetic polymorphisms for the purpose of managing the administration and dosing of warfarin, including use in guiding the initial warfarin dose to decrease time to stable International Normalized Ratio (INR) and reduce the risk of serious bleeding is considered investigational and is not covered.

Radiology
Magnetoencephalography/Magnetic Source Imaging
Language was revised to clarify experimental indications of magnetoencephalography/ magnetic source imaging:

  • Magnetoencephalography/magnetic source imaging for all other indications, including localization of seizure focus for patients undergoing evaluation for surgical treatment of intractable seizures; EXCEPT for the purpose of determining the laterality of language function, as a substitute for the Wada test, in patients being prepared for surgery for epilepsy, brain tumors, and other indications requiring brain resection is considered investigational and is not covered.

Surgery
Plugs for Fistula Repair
Fistula plugs are biosynthetic devices being evaluated to promote healing and prevent recurrence of anal fistula.  There is little data concerning the impact of these devices on outcomes; they are considered investigational and are not covered. 
Biosynthetic fistula plugs, including plugs made of porcine small intestine submucosa or of synthetic material for all indications including, but not limited to, repair of anal and rectal fistulas are considered investigational and are not covered.

Hip Resurfacing
Language has been revised to clarify medically necessary and investigational applications of hip resurfacing. All other types and applications of hip resurfacing are considered investigational and not covered except the following:

  • Metal-on-metal total hip resurfacing with an FDA-approved device as an alternative to total hip replacement when the patient:
    • Is a candidate for total hip replacement; and
    • Is likely to outlive a traditional prosthesis; and
    • Does not have a contraindication for total hip resurfacing.

Partial hip resurfacing with an FDA-approved device in patients with osteonecrosis of the femoral head who have one or more contraindications for metal-on-metal implants and meet the following criteria:

  • The patient is a candidate for total hip replacement; and
  • Is likely to outlive a traditional prosthesis; and
  • The patient has known or suspected metal sensitivity or concern about potential effects of metal ions; and
  • There is no more than 50% involvement of the femoral head; and
  • There is minimal change in acetabular cartilage or articular cartilage space identified on radiography.