What s New Medical Policy Updates April 2017

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What s New Medical Policy Updates April 2017 Listed below are the recent changes made to policies within the Geisinger Health Plan Medical Policy Portfolio during the month of March that will become effective May 15, 2017 (unless otherwise specified). The Plan uses medical policies as guidelines for coverage decisions made within the insured individuals written benefit documents. Coverage may vary by line of business and providers and members are encouraged to verify benefit questions regarding eligibility before applying the terms of the policy. MP66 ESWT - REVISED (Added Exclusion) INDICATIONS: Skeletally mature members insured individuals diagnosed with chronic plantar fasciitis of six (6) months duration or more that has been refractory to three (3) conservative treatment options such as rest, antiinflammatory medications, physical therapy, corticosteroid injections and/or heel orthotics. LIMITATIONS: There is inadequate evidence in the published, peer-reviewed medical literature to establish the safety and/or efficacy of Extracorporeal shock wave treatment in the following groups: Insured Individuals Members on anticoagulation therapy Rheumatoid arthritis There is insufficient evidence in the published peer- reviewed medical literature to support ESWT for indications such as, but not limited to, Peyronie's disease, erectile dysfunction, angina pectoris, breast cancer-related lymphedema, and wound healing. There is insufficient evidence in the peer-reviewed published medical literature to establish the effectiveness of this test on health outcomes when compared to established tests or technologies. Use of ESWT for the treatment of these conditions is considered experimental, investigational or unproven and is NOT COVERED. MP75 Tissue Engineered Skin Substitutes - REVISED (Edited Language, Added Exclusions) Integra Dermal Regeneration Template, Matrix Wound, Bilayer Matrix Wound, and Meshed Bilayer Wound Matrix an acellular, biodegradable copolymer matrix coated is considered medically necessary for post-excision treatment of full thickness of deep partial thickness burns when autografting is not feasible due to the lack of suitable healthy tissue or the Insured individuals member s weak physiological state. The use of tissue engineered skin equivalents in any application outside of the current FDA approvals and/or not listed in this policy is considered experimental, investigational or unproven and is NOT COVERED. Due to limited studies, small study populations, variable outcomes and/ or poor study designs, there is insufficient evidence in the current published peer-reviewed medical literature to fully evaluate the clinical utility of any of the following products. Their use is limited to the FDA approved indication. support the use of Celaderm, Cymetra, Alloskin, PriMatrix, Biodesign, Conexa, DermaMatrix, ArthroFlex, BioDfence, FlexHD, GOREBio A, SportMesh, SurgiMend,and TissueMend. These products are considered experimental, investigational or unproven and are NOT COVERED. AlloDerm RTM Ready Conexa Integra Matrix Wound Repriza to Use AlloMax CorMatrix InteguPly Restore Orthobiologic AlloMend CRXa Jaloskin Seamguard

Allopatch HD CryoSkin LiquidGen SportMesh Alloskin Cuffpatch MariGen Omega3 SS Matrix Alloskin RT Cymetra Matriderm Stimulen Collagen AlloWrap DeNovo NT Graft Matristem StrataGraft AmnioCare Dermacell Matrix HD Strattice AmnioExcel Dermadapt Wound MediHoney Suprathel AmnioFix DermaMatrix Medeor SurgiMend Amniomatrix DermaSpan Mediskin Surgisis (including Surgisis AFP Anal Fistula Plug, Surgisis Gold Hernia Repair Grafts, and Surgisis ) AmnioMTM DressSkin Memoderm Talymed AmnioShield Duraform Menaflex TenoGlide Aongen Collagen Duragen XS Meso BioMatrix TenSIX Matrix Architect Extracellular Matrix Duragen Plus Neoform Dermis TheraForm Standard/Sheet ArthroFlex DuraMatrix NEOX 100 Quick- TissueMend Peel Atlas Wound Matrix Durepair NEOX 1k Wound TranzGraft Regeneration Matrix Matrix Avance Nerve Graft Endobon Xenograft NEOX FLO NuCel Unite Granules Avaulta Plus Endoform Neuragen Veritas Collagen Matrix AxoGuard nerve ENDURAgen NeuraWrap X-Repair connector AxoGuard nerve Epicel Neuroflex XCM Biologic protector Biobrane EpiDex NeuroMatrix Xelma BioDDryFlex EpiFix NeuroMend XenMatrix Biodesign Excellagen NuCel Xwrap (Hydro, DRY, and ECM) BioDExCel EZ Derm NuShield BioDfactor FlexHD Oasis BioDfence FloGraft OrthADAPT BioDOptix FortaDerm Wound OsseoGuard BioFiber Gammagraft Ovation C-QUR GORE Bio A Pelvicol Celaderm Grafix CORE Pelvisoft CellerateRX Grafix PRIME Peri-Guard Repair Patch CelluTome GraftJacket Peri-Strips Dry CLARIX 100 Quick- Peel Graftjacket Xpress injectable Permacol

CLARIX 1k HA Absorbent Wound PriMatrix CLARIX FLO Helicoll Promogran CollaFix hmatrix PTFE felt Collamend Hyalomatrix Puracol CollaSorb Inforce Puros Dermis CollaWound Integra Dermal Regeneration Repliform MP217 Polysomnography and Sleep Studies - REVISED (Added Eclusion) INDICATIONS: I. Polysomnography testing may be an eligible benefit when provided in a facility based sleep study laboratory which meets ALL of the following criteria: a. The center is under the direction and control of physicians. Diagnostic testing routinely performed in sleep disorder laboratories may be covered even in the absence of direct supervision by a physician when data is interpreted by a board certified sleep specialist or physician who fulfills eligibility criteria for the sleep medicine certification exam; and b. The insured individual member is referred to the sleep center by a physician after a comprehensive sleep evaluation is completed, and the center maintains a record of the physician s orders and comprehensive sleep evaluation; and c. The need for diagnostic testing is confirmed by medical evidence e.g. medical histories, examinations and laboratory tests; and d. Scheduling of a follow-up visit with a physician to review results is standard. II. The Plan considers facility-based polysomnography medically necessary for ANY of the following: a. The diagnosis of sleep related breathing disorders b. To monitor the response to treatment or adjust treatment c. In combination with multiple sleep latency testing in the evaluation of suspected narcolepsy d. In the evaluation of sleep related behaviors that are violent or potentially injurious to the patient or others e. In certain atypical or unusual parasomnias III. The Plan considers facility-based polysomnography medically necessary in ANY of the following: a. in patients with neuromuscular disorders and sleep related symptoms b. to assist in the diagnosis of paroxysmal arousals or other sleep disruptions thought to be seizure related c. in a presumed parasomnia or sleep related seizure disorder that does not respond to conventional therapy d. when there is a strong indication of periodic limb disorder IV. Polysomnography for CPAP titration is medically necessary to evaluate the response to CPAP treatment in insured individual members who meet EITHER of the following criteria: I. Polysomnography, cardiorespiratory sleep studies, and MSLT are NOT COVERED in the following situations: a. For the diagnosis of chronic insomnia; b. Preoperative evaluation for laser-assisted uvulopalatopharyngoplasty without clinical evidence of obstructive sleep apnea; c. For the diagnosis of chronic lung disease;

d. For the diagnosis of typical, uncomplicated and non-injurious parasomnia when the diagnosis is clearly delineated; e. Documented evidence of epilepsy with no specific complaints consistent with a sleep disorder; f. Documented evidence suggestive of periodic limb movement disorder or restless leg syndrome unless symptoms are suspected of being related to a covered indication; g. For the diagnosis of insomnia when related to depression; h. For the diagnosis of circadian rhythm disorders. II. The Plan considers the use of portable monitoring NOT medically necessary for patients who meet ANY of the following criteria: a. The diagnosis of OSA in patients with significant co-morbid medical conditions that may degrade the accuracy of PM, including but not limited to i. Severe Pulmonary Disease ii. Neuromuscular Disease iii. Congestive Heart Failure iv. Diagnostic evaluation of OSA in patient suspected of having other sleep disorders, including but not limited to: 1. Central Sleep Apnea 2. Periodic limb movement Apnea 3. Circadian rhythm disorders 4. Narcolepsy 5. General Screening of Asymptomatic patients b. Diagnostic evaluation of patients suspected of having co-morbid sleep disorders c. Diagnostic evaluation of patients with non-specific symptoms such as, but not limited to fatigue, malaise, etc., that may stem from other medical or psychological diagnoses. d. General screening of asymptomatic populations III. The Plan considers the use of Home MSLT not medically necessary and NOT COVERED. Home MSLT testing has not been proven to be equivalent to formal MSLT performed in a facility based sleep study laboratory. IV. The Plan considers diagnostic testing that is duplicative of previous sleep testing done by the attending physician NOT COVERED when there have been not significant clinical changes in the insured individual members documented medical history since the previous study. V. The Plan considers portable diagnostic sleep studies by home health agencies or durable medical equipment providers NOT COVERED. Devices /Procedures related to diagnosis sleep apnea The Plan does NOT provide coverage for the following devices/procedures for the diagnosis of OSA or other sleep disorders because they are considered experimental, investigational or unproven. The current body of evidence in the peerreviewed, published medical literature supporting the use of these devices/procedures for patients with sleep disorders is insufficient to allow adequate conclusions regarding their efficacy. (This list may not be all inclusive): SNAP Testing Watch PAT SleepStrip Actigraphy (Requires Program Exception for Medicaid business segment) The following policies have been reviewed with no change to the policy section. Additional references or background information was added to support the current policy. MP01 Neuromuscular Electrical Stim MP10 Blepharoplasty

MP25 Transcatheter Closure Devices MP34 Foot Orthotics MP68 Reduction Mammaplasty MP78 Sexual Dysfunction Therapies MP90 Inj. Bulking Agents/Incontinence MP92 Imp. Cardiac Loop Recorder MP94 Unilateral Pallidotomy MP106 Ultrasound/ Pregnancy MP112 Wireless Capsule Endoscopy MP113 Electrical Stim Wound Healing MP158 Continuous Passive Motion MP172 MicroVas Vascular Treatment System MP174 Exhaled Nitric Oxide for Asthma Management MP176 Meniett Device MP179 Photodynamic Therapy for Esophageal and Lung Cancer MP189 Computer Aided Detection Technology MP196 Convection-Enhanced Drug Delivery MP209 Medical Error Never Events MP261 Aqueous Drainage Shunt MP273 Prolaris Post-Prostatectomy MP280 Whole Exome Sequencing