Note regarding Federal members The Federal Employee Health Benefit Program (FEHBP/FEP) requires that procedures, devices or laboratory tests approved by the U.S. Food and Drug Administration (FDA) may not be considered investigational for the purposes approved and thus these procedures, devices or laboratory tests may be assessed only on the basis of their medical necessity. Note regarding Humanitarian Device Exemption (HDE) • Humanitarian Use Device (HUD) — a medical device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in not more than 8,000 individuals in the United States per year. (Previously 4000 individuals; increased to 8000 on June 7, 2017) • Humanitarian Device Exemption (HDE) — a marketing application for an HUD. An HDE is exempt from the effectiveness requirements of Sections 514 and 515 of the FD&C Act and is subject to certain profit and use restrictions. Note regarding Transplant Program Case Management EmblemHealth's transplant program manages members with health care needs associated with having or preparing for a solid organ or bone marrow transplant. All transplant services are reviewed with the medical director assigned to support the transplant case management program. All requested transplant services are reviewed for medical necessity and evidence-based criteria are utilized to support the best care coordination and outcomes for EmblemHealth transplant members. To request transplant case management services for the EmblemHealth transplant program, members and providers may call 1-800-447-0768. For additional information pertaining to experimental medical technologies please see Medical Necessity Guidelines: Experimental, Investigational or Unproven Services EmblemHealth’s Medical Guidelines are accessible through hyperlinks within the database or by clicking here Key N = No Y = Yes FFS = fee for service HDE = humanitarian device exemption TECHNOLOGY COMMERCIAL MEDICARE MEDICAID LAST REVIEW AbioCor® Implantable Replacement Heart Note: This investigational device is FDA-approved as a Humanitarian Device Exemption (HDE) for the treatment of severe biventricular end stage heart disease patients who are not cardiac transplant candidates and who Are < 75 years old, require multiple inotropic support, are not treatable by LVAD destination therapy, and are not weanable from biventricular support if on such support. Pre certification requests when presented as such will be case by case reviewed for all LOBs EXCEPT for Medicare members, whose SEE NOTE SEE NOTE SEE NOTE 4/9/2021 costs relating directly to the provision of services related to the National Coverage Determination (NCD) (that were non-covered services prior to the issuance of the NCD) will be paid by CMS intermediaries and carriers when beneficiaries are enrolled in a clinical study that meets the criteria put forth within the NCD. CPT (33927, 33928, 33929, L8698) Acticon™ Neosphincter artificial bowel sphincter (See also Fecal Incontinence Treatment) Y Y Y 5/7/2021 CPT (No specific code) Actigraphy as a stand-alone measurement parameter for the diagnosis of obstructive sleep apnea N Y N 2/12/2021 (See also Obstructive Sleep Apnea Diagnosis and Treatment) CPT (95803) SEE SEE SEE Allogeneic hematopoietic stem cell transplantation (HSCT) for multiple Transplant Transplant myeloma, myelofibrosis, and sickle cell disease Program Case CMS Program Case 4/9/2021 Management NOTE Management Note: Medicare members, whose costs relating directly to the provision of services related to the CMS Decision Memo for Stem Cell Transplantation (that were non- covered services prior to the issuance of the Memo) will be paid by CMS intermediaries and carriers, as part of the Coverage with Evidence Development (CED) program, when beneficiaries are enrolled in a clinical study that meets the criteria put forth within the Memo. (See also National Coverage Determinations Manual for complete Medicare coverage information regarding medically necessary clinical conditions for stem cell transplantation) CPT (38205, 38240, 38242, 38243, S2142, S2150) AlloSure® Kidney Donor-Derived Cell-Free DNA Test to assess probability of allograft rejection in kidney transplant recipients N Y N 4/9/2021 (See also Medicare LCD: AlloSure® Donor-Derived Cell-Free DNA Test) CPT (81479) Altered auditory feedback devices (E.g., SpeechEasy®/FluencyMaster) (See also ACG: A-0896 ([AC]) N N N 4/9/2021 CPT (No specific code) HCPCS (E1399) Anatomic model 3D-printing N N N 5/7/2021 CPT (0559T, 0560T, 0561T, 0562T) Antibody assay testing for detecting neutralizing antibodies against interferon beta (Betaseron) for multiple sclerosis patients N N N 1/8/2021 (E.g., Bab Screen, NabFeron®) CPT (86382) Apheresis therapy with selective high-density lipoprotein (HDL) dilapidation and plasma reinfusion N N N 4/9/2021 CPT (0342T) Apos (All Phase of Step) Therapy® (AposTherapy®) Note: Covered for CNY PPO members only using codes T1999 and T1999- U1 SEE NOTE N N 8/13/2021 CPT (No specific code) Atherectomy — peripheral, open, or percutaneous, infrainguinal atherosclerotic arterial occlusive disease Y Y Y 3/12/2021 CPT (37225, 37227, 37229, 37231) Atherectomy — peripheral, open, or percutaneous, of arterial vasculature N N N 4/9/2021 (E.g., abdominal aorta, brachiocephalic, iliac, renal, etc.) CPT (0234T, 0235T, 0236T, 0237T, 0238T) Aqueous Shunts/implants for primary open angle glaucoma (FDA- approved external approach insertion) (E.g., Ahmed glaucoma implant, Baerveldt seton, Ex-PRESS mini glaucoma shunt, Glaucoma pressure regulator Krupin-Denver valve implant, Molteno implant, Schocket Y Y Y 1/8/2021 shunt, e.g., ExPRESS® Ophthalmic Glaucoma Device) (See also Glaucoma Surgery) CPT (See policy) Aqueous shunts/implants for primary open angle glaucoma (without FDA approval and/or internal approach insertion) (E.g., CyPass®[Alcon recall Aug. 8, 2018, see also Potential Eye Damage From Alcon N SEE NOTE N 1/8/2021 CyPass Micro-Stent Used to Treat Open-Angle Glaucoma: FDA Safety Communication], iStent®, iStent Supra, Eyepass, or DeepLight SOLX® Gold Shunt, AqueSys XEN45 Gel Stent) (See also Glaucoma Surgery) Note: When the glaucoma guideline criteria are met, the Hydrus® Microstent, iStent, iStent Inject and XEN45 devices are covered exceptions CPT (0191T, 0253T, 0376T, 0449T, 0450T, 0474T) Argus II Retinal Prosthesis System for advanced retinitis pigmentosa Note: The Argus II is an investigational device that is FDA-approved as a Humanitarian Device Exemption (HDE) for use in adults, age 25 years or older, with severe to profound RP who have bare light perception (can perceive light, but not the direction from which it is coming) or no light perception in both eyes, evidence of intact inner layer retina function, and a previous history of the ability to see forms. Patients must also be willing SEE NOTE SEE NOTE SEE NOTE 4/9/2021 and able to receive the recommended post-implant clinical follow-up, device fitting, and visual rehabilitation. Therefore, pre-certification requests when presented as such will be reviewed on a case-by-case basis. CPT (0100T, 0472T, 0473T, L8608) Arthroscopic knee surgery with primary diagnosis of osteoarthritis . Arthroscopic lavage used alone for the osteoarthritic knee . Arthroscopic debridement for osteoarthritic patients presenting with knee pain only . Arthroscopic debridement and lavage with or without debridement for N N N 3/12/2021 patients presenting with severe osteoarthritis as defined in the Outerbridge classification scale, grades III and IV. CPT (29870, 29871, 29877) HCPCS (G0289) Assisted Embryo Hatching (See Infertility Services — Commercial) Y N N 12/11/2020 CPT (See policy) Audiometry — pure tone/speech (threshold), automated N N N 4/9/2021 CPT (0208T, 0209T, 0210T, 0211T, 0212T) Autologous adipose-derived regenerative cell therapy for scleroderma in the hands N N N 10/9/2020 CPT (0489T, 0490T) Autologous blood-derived products/platelet growth factors/platelet rich plasma for bone/tissue injury/inflammation (including surgically created wounds and non-unions, muscle, tendon, and ligament injuries) (E.g., Achilles/patellar tendinopathy or rupture, anterior cruciate ligament, carpal tunnel syndrome, chronic low back pain, epicondylitis or type II shoulder impingement, plantar fasciitis, osteoarthritis, rotator cuff, etc.) Note: N SEE NOTE N 4/9/2021 . For Medicare members RE musculoskeletal injuries and/or joint conditions see LCD: Platelet Rich Plasma . For Medicare members RE chronic non-healing diabetic, pressure, and/or venous wounds see Coverage with Evidence Development Autologous Platelet-Rich Plasma CPT (0232T, 0481T) HCPCS (S9055, G0460) Autologous bone marrow cell therapy, intramuscular, with preparation of harvested cells, multiple injections, one, leg, including ultrasound guidance (if performed) N N N 4/9/2021 CPT (0263T, 0264T, 0265T) Autologous cellular implant derived from adipose tissue for the treatment of osteoarthritis of the knees; tissue harvesting and cellular N N N 11/11/2010 implant creation/injection of cellular implant into knee joint including ultrasound guidance, unilateral CPT (0565T, 0566T) Automated evacuation of Meibomian glands — heat and intermittent pressure N N N 4/9/2021 (E.g., LipiFlow [TearScience®]) CPT (0207T, 0563T) Avise MCV™ for the diagnosis and prognosis of rheumatoid arthritis (See also Gene Expression Profiling) 1/8/2021 CPT (83520) N N N MCV+ 1/8/2021 CPT (83520, 86200) Avise® MTX (aka Avise PG) for measuring methotrexate polyglutamates for rheumatoid arthritis