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July 2011

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Lung Volume Reduction Surgery

Coverage will not be provided for LVRS or reduction pneumoplasty as a treatment for emphysema when any of the following exclusionary criteria are present as this is considered not medically necessary:

·         CT scan evidence of diffuse or homogeneous emphysema.

·         Non-upper lobe predominant emphysema and high maximal post-rehabilitation workload. 

·         Previous LVRS or lobectomy on the same side as the proposed surgery.

·         Giant bulla (greater than 1/3 of the volume of the lung in which bulla is located).

·         Pleural or interstitial disease of any etiology which precludes surgery.

·         Clinically significant bronchitis.

·         Pulmonary hypertension defined as mean pulmonary artery pressure > 35 mmHg or peak pulmonary artery pressure > 45 mmHg.

·         Uncontrolled systemic hypertension (> 200 systolic or diastolic > 110).

·         Significant cardiac disease defined as:

o        Myocardial infarction within 6 months and ejection fraction < 45%.

o        Congestive heart failure within 6 months and EF < 45%.

·         Presence of significant coronary artery disease (CAD) or unstable angina.

·         Lung diffusing capacity for carbon monoxide (DLCO) less than 20% predicted.

·         Oxygen requirement at rest or during exercise > 6 liters per minute to keep oxygen saturation greater than or equal to 90%.

Surgically Implanted Hearing Devices

Semi-implantable and fully implantable middle ear hearing aids have been developed as an alternative to external acoustic hearing aids for individuals with moderate to severe sensorineural hearing loss, who are dissatisfied with the limitations of conventional hearing aids.  These devices directly vibrate the ossicles of the inner ear to produce sound. No coverage will be provided for semi-implantable and fully implantable middle ear hearing aids as these are considered investigational.

 

Endometrial Ablation

No coverage will be provided for intrauterine ablation or resection of the endometrium not meeting criteria as this is considered not medically necessary.
 

Genetic Testing

Gene-Based Tests for Screening, Detection, and/or Management of Prostate Cancer

PCA3 for disease diagnosis and prognosis is considered investigational and not covered.

 

Wound Care

Negative Wound Pressure Therapy in the Outpatient Setting

No coverage will be provided for the use of non-powered negative pressure wound therapy (NPWT) systems for the treatment of other acute or chronic wounds as this is considered investigational.

 

Tumor Markers

Measurement of serum tumor marker Chromogranin A may be considered medically necessary in the evaluation of suspected or known neuroendocrine tumors, including carcinoid and neuroblastoma, or in the assessment of disease progression and treatment efficacy for these conditions.

 

Measurement of serum tumor marker Chromogranin A is considered investigational for all other conditions and is not covered.

 

 

Percutaneous Kyphoplasty, Vertebroplasty and Sacroplasty

No coverage will be provided for percutaneous sacroplasty as it is considered investigational for all indications, including use in sacral insufficiency fractures due to osteoporosis and spinal lesions due to metastatic malignancies or multiple myeloma.

 

Cardiac Rhythm Device

Biventricular Pacemakers for the Treatment of Heart Failure

Biventricular pacemakers with or without an accompanying implantable cardiac defibrillator (i.e., a combined biventricular pacemaker/ICD) may be considered medically necessary as a treatment of heart failure in patients who meet all of the following criteria:

 

New York Heart Association class III or IV

a)   Left ventricular ejection fraction =35%

b)   Sinus rhythm

c)   QRS duration of =120–130* msec; and

d)   Patients treated with a stable pharmacological medical regimen prior to implant, such as an angiotensin-converting enzyme (ACE) inhibitor (or an angiotensin receptor blocker) and a beta blocker (or angiotensin receptor blocker), digoxin, and/or diuretics. 

 

New York Heart Association class II

a)   Left ventricular ejection fraction <30%

b)   Sinus rhythm

c)   QRS duration of =120–130* msec, and

d)   Patients treated with a stable pharmacological medical regimen prior to implant, such as an angiotensin-converting enzyme (ACE) inhibitor (or an angiotensin receptor blocker) and a beta blocker (or angiotensin receptor blocker), digoxin, and/or diuretics

 

* The FDA-labeled indications for QRS duration vary by device.  For some devices, FDA approval is based on QRS duration of =130 (e.g., InSync® device) while for others it is based on QRS duration =120msec (e.g., CONTAK CD® CRT-D System).  These differences in QRS duration arise from differences in the eligibility criteria in the trials on which the FDA approval is based.

 

 

Experimental/Investigative Services Pathology/Laboratory

Fecal Calprotectin Testing

No coverage will be provided for fecal calprotectin testing in the diagnosis and management of intestinal conditions, including the diagnosis and management of inflammatory bowel disease as this is considered investigational.

 

Experimental/Investigative Services Ophthalmologic

Intravitreal Corticosteroid Implants

A dexamethasone intravitreal implant approved by the U.S. Food and Drug Administration (i.e., Ozurdex™) may be considered medically necessary for the treatment of:

a)   Non-infectious ocular inflammation, or uveitis, affecting the posterior segment of the eye, OR

b)   Macular edema following branch or central retinal vein occlusion.

 

All other uses of a corticosteroid intravitreal implant are considered investigational and not covered, including but not limited to the treatment of diabetic macular edema.

 

Experimental/Investigative Services Medicine

Left-Atrial Appendage Closure Devices for Stroke Prevention in Atrial Fibrillation

No coverage will be provided for the use of left-atrial appendage closure devices for the prevention of stroke in atrial fibrillation as this is considered investigational.

 

Experimental/Investigative Services Surgery

Minimally Invasive Lumbar Interbody Fusion

Minimally invasive interbody fusion of the lumbar spine may be considered medically necessary using the following approaches:

 

a)       Anterior lumbar interbody fusion (ALIF)

b)       Posterior lumbar interbody fusion (PLIF)

c)   Transforaminal lumbar interbody fusion (TLIF)

 

All other minimally invasive procedures for lumbar interbody fusion are considered investigational and not covered, including, but not limited to the following:

 

a)   Laparoscopic ALIF

b)   Axial anterior lumbar fusion (AxiaLIF)

c)   Lateral interbody fusion (e.g., XLIF, DLIF)


Endovascular Grafts for Abdominal Aortic Aneurysms

The use of endoprostheses approved by the U.S. Food and Drug Administration (FDA) as a treatment of abdominal aortic aneurysms may be considered medically necessary as a treatment of abdominal aortic aneurysms in any of the following clinical situations:

 

·         an aneurysmal diameter greater than 5.0 cm

·         an aneurysmal diameter of 4–5.0 cm that has increased in size by 0.5 cm in the last 6 months

·         an aneurysmal diameter that measures twice the size of the normal infrarenal aorta

·         a ruptured abdominal aortic aneurysm

 

The use of endoprostheses approved by the FDA as a treatment of abdominal aortic aneurysms is considered investigational for the following clinical situations:

 

·         Treatment of smaller aneurysms that do not meet the current recommended threshold for surgery

·         Treatment of aneuryms that do meet the recommended threshold for surgery in patients who are ineligible for open repair due to physical limitations or other factors