New and Emerging Technologies Coverage Status - PacificSource

New and Emerging Technologies Coverage Status

State(s): Idaho

Montana Oregon Washington Other:

LOB(s): Commercial

Medicare

Medicaid

Enterprise Policy

Clinical Guidelines are written when necessary to provide guidance to providers and members in order to outline and clarify coverage criteria in accordance with the terms of the Member's policy. This Clinical Guideline only applies to PacificSource Health Plans, PacificSource Community Health Plans, and PacificSource Community Solutions in Idaho, Montana, Oregon, and Washington. Because of the changing nature of medicine, this list is subject to revision and update without notice. This document is designed for informational purposes only and is not an authorization or contract. Coverage determination are made on a case-by-case basis and subject to the terms, conditions, limitations, and exclusions of the Member's policy. Member policies differ in benefits and to the extent a conflict exists between the Clinical Guideline and the Member's policy, the Member's policy language shall control. Clinical Guidelines do not constitute medical advice nor guarantee coverage.

Background

New and emerging medical procedures, medications, treatments and technologies are often prescribed by physicians and/or marketed to the public before governmental agency approval, evidence based guidelines and positions of leading national health professional organizations or research is available in the peer reviewed literature to document efficacy, safety, and long term positive outcomes. New technologies are reviewed by the New Technologies and Operational Criteria (NTOC) committee and Health Services department, and a recommendation is made regarding PacificSource coverage based upon then available literature reviews, standards of care and coverage, consultations with advisors and experts as needed, and other authoritative sources, as well as PacificSource group and individual contracts. Procedures are written when necessary to outline and clarify coverage criteria. Because of the changing nature of medicine, this list is subject to revision and update without notice. This document is designed for informational purposes only and is not an authorization or contract. Coverage determinations are made on a case-by-case basis and subject to the terms, conditions, limitations, and exclusions of the member's policy.

Medicaid and Medicare use this policy as a resource to determine coverage, when there are no Medicaid or Medicare Coverage criteria guidelines (e.g. NCD/LCD and/or Medicaid defined criteria)

Criteria

COVERAGE STATUS TABLE: PROCEDURE

4K Score testing for prostate cancer

CPT HCPCS 0010M, 81539

Ablation, Pulmonary Tumor(s) 0340T Cryoablation

COVERAGE STATUS

Not covered (Experimental/Investigational/Unproven). Not covered (Experimental/Investigational/Unproven).

PROCEDURE

Accufill Bone Substitute Material

AccuraScope minimally invasive discectomy neural decompression

Actigraphy Testing, recording, analysis, interpretation & report Afirma Genomic Sequencing Classifier (GSC)

Agendia Breast Cancer Test Suite (MammaPrint and Blueprint)

Alair Bronchial Thermoplasty System (Asthmatx, Inc.) ALCAT Food Intolerance Test

AlloDerm Skin Substitute used during septoplasty/rhinoplasty Alpha2 Macroglobulin (A2M)/Alpha 2 Macroglobulin Human Plasma (platelet poor plasma) AlphaStim - - for craniotherapy, back pain, post CVA pain

CPT HCPCS No specific code 29876, 29999 No specific code 63055, 63056, 63057, 63075 95803

No specific code 81210, 81275, 81311, 81401, 81406, 81455 No specific code S3854, 81521, 81599 31660, 31661

No specific 83516 Q4116

No specific code S2150

No specific code: E1399

COVERAGE STATUS

Not covered (Experimental/Investigational/Unproven).

Not covered (Experimental/Investigational/Unproven).

Not covered (Experimental/Investigational/Unproven). Not covered (Experimental/Investigational/Unproven).

Not covered (Experimental/Investigational/Unproven).

Not covered (Experimental/Investigational/Unproven). Not covered (Experimental/Investigational/Unproven). Not covered (Experimental/Investigational/Unproven). Not covered (Experimental/Investigational/Unproven).

Not covered (Experimental/Investigational/Unproven).

Ambry GeneticTM PancNext panel AM (morning) aligner

No specific code S8262

AmnioExcel/BioDexcel (skin substitute-amniotic extracellular membrane) AmnioFix amniotic membrane (both wrap and injectable forms)

AmnioMatrix or BioDMatrix ? for all indications Amniotic Fluid Injections

Annulotomy (coblation assisted microdiscectomy, Arthrocare plasma disc decompression (PDD) Anodyne Therapy System

Q4137

No specific code Q4135 J3590 Q4139

No specific code: 17999 62287

No specific code. E0221 97799

Anorectal Fistula Plugs (Biodesign? Surgisis? AFPTM Anal Fistula Plug, GORE BIO-A? Fistula Plug and SIS Fistula Plug)

46707 code not specific Q4100

Not covered (Experimental/Investigational/Unproven). Not covered (Experimental/Investigational/Unproven). Not covered (Experimental/Investigational/Unproven).

Not covered (Experimental/Investigational/Unproven).

Not covered (Experimental/Investigational/Unproven). Not covered (Experimental/Investigational/Unproven). Code is not specific to annulotomy. Requires Preauthorization

Not covered. E/I due to lack of controlled studies and long term evidence. 97026 (infrared therapy) and 97032 (electrical stimulation) covered when used as PT modalities. Not covered (Experimental/Investigational/Unproven).

PROCEDURE

Anser IFX & Anser ADA, Anser UST,

Anser VDZ (Prometheus Labs)

Infliximab

&

adalimumab,

ustekinumab & vedolizumab

antibody detection

ArthroFlex Decellularized Dermal

Allograft

Artificial Intervertebral Disc Lumbar

(i.e., INMOTION?, ProDisc?-L )

Artificial Retina

AspirinWorks? Test

Athletic Pubalgia (Sports Hernia) Surgery (open or laparoscopic) AurixTM aka AutoloGel?

Autologous Tears for dry eye conditions Automated Percutaneous Lumbar Discectomy (APLD) Automatic Nerve Conduction Studies/Noninvasive Nerve Conduction Testing Avance Nerve Graft (nerve allograft)

Axia-Lif (Axial Lumbar Interbody

Fusion) indicated for use in

degenerative

disc

disease,

pseudoarthroses

(unsuccessful

previous fusion) and spondylolisthesis.

Balloon Dilation of Eustachian Tube

Baroreflex Stimulation Devices

Berkley HeartLabs

Biacuplasty of the spine (e.g. Bialys TransDiscal System) Bio4th aka BIO?

BioCartilage TM Bioelectrical Impedance Bioimpedence Spectroscopy

CPT HCPCS No specific code: 84999, 80299

Q4125

0163T 0164T, 0165T, 22857, 22862, 22865 0100T, C1841

84431

No specific code No specific code G0460, P9020 No specific code No specific code 95905 or nonspecific code 95999 64910, 64912, 64913 0309T, 22586, 22899

No specific code 69799 C9745 0266T, 0267T, 0268T, 0269T, 0270T, 0271T, 0272T, 0273T 0111T, 83698, 83701, 83704, 83719 No specific code: 22899 No specific code 20930, 20999 No specific code 29999 0358T

0239T, 93702

COVERAGE STATUS

Not covered (Experimental/Investigational/Unproven).

Not covered (Experimental/Investigational/Unproven). Not covered (Experimental/Investigational/Unproven).

Not covered (Experimental/Investigational/Unproven). Not covered (Experimental/Investigational/Unproven). Not covered (Experimental/Investigational/Unproven). Not covered (Experimental/Investigational/Unproven).

Not covered (Experimental/Investigational/Unproven). Not covered (Experimental/Investigational/Unproven). Not covered (Experimental/Investigational/Unproven).

Not covered (Experimental/Investigational/Unproven). Not covered (Experimental/Investigational/Unproven).

Not covered (Experimental/Investigational/Unproven).

Not covered (Experimental/Investigational/Unproven).

Not covered (Experimental/Investigational/Unproven).

Not covered (Experimental/Investigational/Unproven). Not covered (Experimental/Investigational/Unproven).

Not covered (Experimental/Investigational/Unproven). Not covered (Experimental/Investigational/Unproven). Not covered (Experimental/Investigational/Unproven).

PROCEDURE

Blood Brain Barrier Disruption (BBBD) for the treatment of Central Nervous System (CNS) tumors BluePrint Breast Cancer genomic profile

Bone Marrow Aspirate Concentrate(BMAC) /Bone Marrow Aspirate for spinal fusion

Bone Marrow Aspirate Concentrate for Ankle Arthrodesis Bone Marrow Aspirate Concentrate for treatment of lower extremity bone nonunions Boston Heart Cardiovascular Risk Panel ? Genetic test (Boston Heart Diagnostic?)

Boston Heart Labs Statin-induced myopathy genotype testing Brachytherapy, Electronic for all indications BRCAplus Ambry Genetics TM

Breast Cancer Index (BCI) (bioTheranostics Inc.)

Breast Thermography

BreastNext Generation Ambry GeneticsTM Breath Test for Heart Transplant Rejection (Heartsbreath test) BROCA Cancer Risk Panel

Cardiac Panel of Molecular Tests (Vantari Genetics, LLC) CardioMEMSTM HF System (St Jude Medical) measures and monitors the pulmonary artery (PA) pressure and heart rate in certain heart failure patients. CardioNext

Carotid intima-media thickness (IMT) Cartiva Synthetic Cartilage Implant

CPT HCPCS No specific code 96549

No specific code S3854, 81599 No specific codes 20936 20999, 38220 38232, 38241 No specific codes 38220 No specific code 38220

No specific codes 81225, 81240, 81241 81400, 81401 No specific code 81400 0394T, 0395T

No specific codes Code not specific to test: 81479, S3854 Code not specific to breast: 93740, 93799 No specific codes 0085T

No specific codes No specific codes C9741, C2624 Non-specific codes 93799

No specific code 81280, 81282, 81403, 81404, 81405, 81406, 81407, 81408 0126T and 93895 C1763, no specific code

COVERAGE STATUS

Not covered (Experimental/Investigational/Unproven).

Not covered (Experimental/Investigational/Unproven).

Not covered (Experimental/Investigational/Unproven).

Not covered (Experimental/Investigational/Unproven). Not covered (Experimental/Investigational/Unproven).

Not covered (Experimental/Investigational/Unproven).

Not covered (Experimental/Investigational/Unproven). Not covered (Experimental/Investigational/Unproven). Not covered (Experimental/Investigational/Unproven). Not covered (Experimental/Investigational/Unproven).

Not covered (Experimental/Investigational/Unproven).

Not covered (Experimental/Investigational/Unproven). Not covered (Experimental/Investigational/Unproven). Not covered (Experimental/Investigational/Unproven). Not covered (Experimental/Investigational/Unproven). Not covered (Experimental/Investigational/Unproven).

Not covered (Experimental/Investigational/Unproven).

Not covered (Experimental/Investigational/Unproven). Not covered (Experimental/Investigational/Unproven).

PROCEDURE

Cefaly Antimigraine Headband

Cell Culture Drug Resistance Testing (CCDRT) Chemoresistance assay

CellSearch Circulating Tumor Cell Test

CPT HCPCS No specific codes E1399 Code not specific: 86849, 89240 86152 86153, 89240, S3711

COVERAGE STATUS

Not covered (Experimental/Investigational/Unproven). Not covered (Experimental/Investigational/Unproven).

Not covered (Experimental/Investigational/Unproven).

Cerament Bone void Filler Chelation therapy

No specific code 20900, C1713

M0300

Chromosome Analysis, High Resolution (Telomere Analysis) ClariVein Mechanochemical Ablation (MOCA) clonoSEQ assay

Coflex Interlaminar Device (Paradigm Spine), Dynamic Stabilization Devices

Cold Caps (scalp hypothermia)

ColoNext (Ambry Genetics)

ColonSentry

Comprehensive Arthroscopic Management (CAM) for the Shoulder Comprehensive Molecular Genetic Survey MTLTM Panels Compression Garment for Trunk (i.e. Bellise Bra (JoViPak) or Tribute vest (Solaris) for lymphedema) Computed Tomography (CT) of the Knee for pre-operative mapping or planning

88289

No specific code 37799 No specific code 81479 Code not specific to device: 2286722870 No specific code E1399, A9273 No specific code No specific codes 81479, 81599 No specific code 29999 No specific code No specific code: E1399

No specific code: 73700 73702

Computerized thermal imaging (temperature gradient studies) (eg, cephalic thermogram; peripheral thermogram) ConfirmMDx for Prostate Cancer (MDxHealth)

Continuous Passive Motion (CPM) for joints other than knee Continuous Passive Motion for Knee

93740

No specific code 81479, 88387 E0936 E0935

Not covered (Experimental/Investigational/Unproven).

Requires preauthorization. Reviewed on a case-by-case basis. Not covered (Experimental/Investigational/Unproven). Not covered (Experimental/Investigational/Unproven). Not covered (Experimental/Investigational/Unproven). Not covered (Experimental/Investigational/Unproven).

Not covered (Experimental/Investigational/Unproven).

Not covered (Experimental/Investigational/Unproven). Not covered (Experimental/Investigational/Unproven).

Not covered (Experimental/Investigational/Unproven). Not covered (Experimental/Investigational/Unproven). Not covered (Experimental/Investigational/Unproven).

Not covered (Experimental/Investigational/Unproven). Except for Legacy Employee Health Plan (LEHP) for Makoplasty (Experimental/Investigational/Unproven).ex cept for certain specialized breast diagnostics

Not covered (Experimental/Investigational/Unproven).

Not covered (Experimental/Investigational/Unproven). Not covered (Experimental/Investigational/Unproven). Except for LEHP

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