January 2015 Policy Coverage Criteria Established for Alemtuzumab (Lemtrada) Highmark Delaware has established new clinical criteria for alemtuzumab (Lemtrada™). This new medical policy will apply to both professional provider and facility claims. The effective date is March 30, 2015. Place of Service: Outpatient Alemtuzumab (Lemtrada) may be considered medically necessary for relapsing-remitting forms of multiple sclerosis in patients who have had an inadequate response to two or more drugs indicated for the treatment of multiple sclerosis. The use of alemtuzumab for all other indications is considered experimental/investigational. Scientific evidence does not support the use of alemtuzumab for any other indication. A participating, preferred, or network provider can bill the member for the denied service. For further information, refer to Medical Policy I-118, Alemtuzumab (Lemtrada). Highmark Blue Cross Blue Shield Delaware is an independent licensee of the Blue Cross and Blue Shield Association. NaviNet is a registered trademark of NaviNet, Inc., which is an independent company that provides a secure, web-based portal between providers and health insurance companies. Medical Policy Update January 2015 Criteria Revised for Electrical Nerve Stimulation Highmark Delaware has revised the criteria for electrical nerve stimulation. The effective date is March 30, 2015. Place of Service: Outpatient The following information has either been revised or added to the electrical nerve stimulation medical policy: Chronic intractable pain is defined as chronic pain that has no significant chance of being altered by usual treatment modalities or natural healing. Examples of Chronic Intractable Pain are as follows: An episode of low back pain that has persisted for three months or longer; and Is not a manifestation of a clearly defined and generally recognizable primary disease entity. For example, there are cancers that, through metastatic spread to the spine or pelvis, may elicit pain in the lower back as a symptom; and certain systemic diseases such as rheumatoid arthritis and multiple sclerosis manifest many debilitating symptoms Transcutaneous electrical nerve stimulation (TENS) is considered medically necessary when the chronic intractable pain causes significant disruption of function when all of the following have been met: The patient is unresponsive to at least three months of conservative medical therapy (i.e., non-steroidal anti-inflammatory medications, ice, rest and/or physical therapy); AND the trial period is monitored by a physician The physicians documentation should include: Initial assessment/evaluation of the nature, duration, and perceived intensity of pain Treatment plan including ongoing medications and proposed use of TENS unit including the frequency and duration of treatment A written order prior to delivery (WOPD) must be obtained before dispensing the TENS. There is to be a minimum trial period of two months (60 days) in which the unit is to be 2 Medical Policy Update January 2015 used in the physician or physical therapists office OR is to be rented by a DME supplier for a minimum of two months to determine whether the patient is likely to derive a significant therapeutic benefit from the continued use of electrical stimulation. Supplies Separate allowance will be made for replacement supplies when they are medically necessary and are used with a covered electrical stimulation device (i.e., TENS, NMES, etc.). Usual utilization is: 2 TENS leads - a maximum of one unit of A4595 per month 4 TENS leads - a maximum of two units of A4595 per month Replacement of lead wires (A4557) more often than every 12 months would rarely be medically necessary. Electrodes Separate allowance will be made for replacement supplies when they are medically necessary and are used with a covered electrical stimulation device (i.e., TENS, NMES, etc.). Usual utilization is: For 2 Lead device, 4 electrodes (A4556, 2 units) per month For 4 lead device, 8 electrodes (A4556,4 units) per month If additional electrodes are needed (due to skin condition, etc.), the referring physician is to clearly document the need in the patient’s medical record AND on the CMN/LMN. This documentation should clearly indicate how many additional units of A4556 are being requested for the patient. Additional units should never be requested in conjunction with an initial rental/purchase order as there is no demonstrated need for additional units, Additional units should be requested sparingly. Please refer to Medical Policy Z-7, Electrical Nerve Stimulation, for a complete version. 3 Medical Policy Update January 2015 Coverage Criteria Established for Fulvestrant (Faslodex) Highmark Delaware has established new clinical criteria for the use of Fulvestrant (Faslodex®). This new medical policy will apply to both professional provider and facility claims. The effective date is March 30, 2015. Place of Service: Outpatient Fulvestrant (Faslodex) may be considered medically necessary for first-line (no prior endocrine therapy within one year) or subsequent-line (following prior endocrine therapy within one year or progression on another endocrine agent) endocrine therapy for postmenopausal women or for premenopausal women treated with ovarian ablation/suppression who have recurrent or metastatic disease. The use of fulvestrant for all other indications is considered not medically necessary. Coverage Criteria Established for Nivolumab (Opdivo) Highmark Delaware has established new clinical criteria for nivolumab (Opdivo®). This new medical policy will apply to both professional provider and facility claims. The effective date is March 30, 2015. Place of Service: Outpatient Nivolumab (Opdivo) may be considered medically necessary for the treatment of melanoma, unresectable or metastatic, as a single agent for disease progression after treatment with ipilimumab and, if BRAF V600 positive, a BRAF inhibitor. The use of nivolumab for all other indications is considered experimental/investigational. Scientific evidence does not support the use of nivolumab for any other indication. A participating, preferred, or network provider can bill the member for the denied service. 4 Medical Policy Update January 2015 For further information, refer to Medical Policy I-120, Oncologic Indications for PD-1 Blocking Antibodies. Coverage Criteria Established for Pembrolizumab (Keytruda) Highmark Delaware has established new clinical criteria for pembrolizumab (Keytruda®). This new medical policy will apply to both professional provider and facility claims. The effective date is March 30, 2015. Place of Service: Outpatient Pembrolizumab (Keytruda) may be considered medically necessary for the treatment of melanoma, unresectable or metastatic, as a single agent for disease progression after treatment with ipilimumab and, if BRAF V600 positive, a BRAF inhibitor. The use of pembrolizumab for all other indications is considered experimental/investigational. Scientific evidence does not support the use of pembrolizumab for any other indication. A participating, preferred, or network provider can bill the member for the denied service. For further information, refer to Medical Policy I-120, Oncologic Indications for PD-1 Blocking Antibodies. Criteria Revised for Lumbar Decompression Highmark Delaware has revised the criteria for Lumbar Decompression. This revised medical policy will apply to both professional provider and facility claims. The effective date is March 30, 2015. Place of Service: Inpatient/Outpatient The following criteria for lumber decompression has been revised for herniated disc: 5 Medical Policy Update January 2015 Lumbar decompression for herniated disc may be considered medically necessary when ALL of the following criteria are met: Neurological deficits (e.g., reflex change in the legs, dermatomal sensory loss, motor weakness) or alternative signs of lumbar nerve root tension (e.g. positive leg raising test) are present on physical examination; and Persistent, debilitating pain radiating from the low back down to the lower extremity is present on a daily basis that limits activities of daily living (ADLs); and Unresponsive to 6 weeks of conservative medical management such as: Activity/lifestyle modification; and Nonsteroidal and/or steroidal medication (unless contraindicated); and Physical therapy, including passive and active treatment modalities; and Epidural steroid injections Lumbar decompression for spinal stenosis may be considered medically necessary when ALL of the following criteria are met: All other sources of low back pain have been ruled out; and Persistent, progressive, debilitating symptoms of neurogenic claudication (with or without back pain) are present on a daily basis that limits activities of daily living (ADLs); and A lumbar spine imaging studies (e.g., CT or MRI) done within the past 6 months shows lumbar spine stenosis that corresponds to the clinical findings on physical examination; and Unresponsive to 3 months of conservative medical management such as: Activity/lifestyle modification; and Nonsteroidal and/or steroidal medication (unless contraindicated); and Physical therapy, including passive and active treatment modalities; and Epidural steroid injections The following lumbar decompression criteria has been revised: 6 Medical Policy Update January 2015 The rapid progression of neurologic impairment (e.g., cauda equina syndrome, foot drop, extremity weakness, saddle anesthesia, sudden onset of bowel or bladder