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Coverage criteria policies

Investigational services - list of non-covered services

These services may or may not be covered by your HealthPartners plan. Please see your plan documents for your specific coverage information. If there is a difference between this general information and your plan documents, your plan documents will be used to determine your coverage.

Administrative Process

Prior authorization is not applicable for Investigational services listed on this policy.

Note: Prior authorization is required for any potentially investigational service not listed on this policy, as noted in the related Investigational Services policy. Services that meet the definition of investigational are not eligible for coverage.

Coverage

Services that are considered to be investigational/experimental are not covered. The provider and facility will be liable for payment unless:

  1. The provider notifies the member that a specific service has been determined by HealthPartners to be investigational/experimental,
  2. The member signs a waiver agreeing to pay for the specific non-covered service being rendered and
  3. The claim has been billed with a GA modifier indicating such. If the member has signed a waiver agreeing to pay for the specific service then the member will be liable for payment.

Indications that are not covered

  1. Contractual benefits prohibit the coverage of investigational/experimental services. HealthPartners routinely reviews new technology to determine effectiveness.
  2. Services, technologies, treatments or devices considered investigational/experimental includes, but is not limited to, the following list:

Codes typically used

Name of device or procedure – See CPT manual for full descriptions

Category

20999, 22899, 23929, 26989, 27299, 27599, 27899

ABMG - Autologous Bone Marrow Grafting (ABMG) for Osteonecrosis. Osteonecrosis/avascular necrosis is bone death caused by poor blood supply to the area. It is most common in the hip and shoulder, but can affect other large joints such as knee, elbow, wrist and ankle. Autologous bone marrow grafting (ABMG) – bone marrow is aspirated from a donor. For the purposes of this policy, the donor bone marrow is applied to the necrotic (dead) bone area via surgical techniques to facilitate growth of healthy bone and healing of the osteonecrosis.

Other Procedures

93799

Acoustic cardiography, including automated analysis of combined acoustic and electrical intervals

Cardiovascular Tests or Procedures

95803

Actigraphy testing, recording, analysis, interpretation, and report.

Other Testing

41512

AIRVance - Tongue and Hyoid Suspension System (Medtronic Xomed Inc.) -Tongue base suspension, permanent suture technique for treatment of sleep disorders – (previously named “Repose”)

Other Procedures

86849

Antiprothrombin Antibody - Antiprothrombin (phospholipid cofactor) antibody, each Ig class

Other Testing

0253T, 0474T

Aqueous drainage device for use in Minimally Invasive Glaucoma Surgery (e.g. CyPass micro stent)

Other Procedures

0449T, 0450T

Aqueous drainage device for use in Minimally Invasive Glaucoma Surgery (e.g. XEN Gel stent)

Other Procedures

0195T, 0196T, 22586

AxiaLIF – axial lumbar interbody fusion system - Arthrodesis, pre-sacral interbody technique, without instrumentation, imaging (when performed), and discectomy to prepare interspace, lumbar; single interspace

Spine Procedures

0358T

Bioelectrical Impedance Analysis (BIA) – Noninvasive technique to measure body composition, body fat in relation to lean body mass

Other Testing

J3490

Bio-identical Hormone Replacement for treatment of menopause

Other Procedures

0239T

Bioimpedance Spectroscopy for the Assessment of Lymphedema

Other Procedures

S8948, 99199

Breathe Right Laser Treatment for smoking cessation. Low level laser therapy (AKA cold laser) for any condition. Application of a modality (requiring constant provider attendance) to one or more areas; low-level laser; each 15 minutes

Other Procedures

0266T, 0267T, 0268T, 0269T, 0270T, 0271T, 0272T, 0273T

Carotid sinus baroreflex activation device services & treatment. A surgically implanted device for the treatment of medically resistant hypertension that delivers chronic stimulation to baroreceptors located within the carotid sinus.

Other Procedures

C1821

Coflex interlaminar implant / stabilization device. Interspinous process distraction device (implantable)

Spine Procedures

0126T

93895

Common carotid intima-media thickness (IMT) study for evaluation of atherosclerotic burden or coronary heart disease risk factor assessment.

Cardiovascular Tests or Procedures

0402T

Corneal Collagen Crosslinking (also known as corneal crosslinking, CXL, C3-R and KXL) for treatment of keratoconus

Other Procedures

92145

Corneal hysteresis determination, by air impulse stimulation, unilateral or bilateral, with interpretation and report

Other procedures

0501T-0504T

Coronary fractional flow reserve, non-invasive, including analysis, interpretation, and report (e.g. HeartFlow FFRct Analysis)

Cardiovascular Tests or Procedures

E1399 and others

Cranial Electrotherapy Stimulation (also called transcranial electrical stimulation, cranial transcutaneous electrical nerve stimulation (TENS), electrosleep and neuroelectric therapy, Alpha-Stim 100)) for all conditions including but not limited to pain, anxiety, insomnia, depression. Low levels of electrical current are received through electrodes attached the ear lobes or behind the ears.

Behavioral Health

19105

Cryoablation treatment of benign breast fibroadenomas - Ablation, cryosurgical, of fibroadenoma, including ultrasound guidance, each fibroadenoma. The Visica System™ (Sanarus Medical, Inc.) purports to use cryoablation (cold therapy) to freeze and destroy benign, non-cancerous tumors of the breast called fibroadenomas. During the procedure, a small instrument is guided by ultrasound and inserted into the breast fibroadenoma. The tip of the instrument becomes extremely cold and freezes the fibroadenoma.

Other Procedures

17260-17264

Cryoablation treatment for malignant breast tumor. The associated procedure codes are considered investigational when used to report this treatment.

Other procedures

no specific code

CVProfilor (Hypertension Diagnostics, Inc., Eagan, MN, USA) is a device intended for vascular disease screening. It is designed to measure the elasticity of arteries by analyzing the waveform of BP measurements (the rate at which pressure rises and falls during the cardiac cycle).

Cardiovascular Tests or Procedures

S2348

Decompression procedure, percutaneous, of nucleus pulposus of intervertebral disc, using radiofrequency energy, single or multiple levels, lumbar

Spine Procedures

S9090

Decompression therapy – traction - for low back pain is described as an alternative, noninvasive, nonsurgical procedure of applying traction to the spine via a computer-driven table which controls the level of disc decompression. Examples includeVertical Axial Decompression Table(VAX-D), Decompression Reduction Stabilization (DRS) System, DRX9000, LORDEX Lumbar Spine System, Tru Tac 401 and the NuChoice Medical Healthstar Elite Decompression Therapy

Spine Procedures

23929, 24999, 26989, 27299, 27310, 27599’ 27899, 28899

DeNovo®NT Natural Tissue Graft (This product is an off-the-shelf human tissue, consisting of viable, juvenile hyaline cartilage pieces and is intended for the repair of articular cartilage defects in a single-stage procedure. It is being studied for use in various joints, including knee and ankle.)

Other Procedures

97799

Dry needling – intramuscular needling- Intramuscular Stimulation (IMS) is a system of "dry needling" that involves the direct insertion of needles into myofascial trigger points to deliver electrical current into the painful area. This stimulation may lead to fatigue in the nerves transmitting the pain signal, resulting in pain relief. The word dry indicates that nothing is injected through the needle. Dry needling differs from traditional acupuncture in the location of the insertion points and the theories for pain relief. Acupuncture practitioners insert needles according to theories of energy flow. While in Dry Needling, needles are inserted into the painful areas, or trigger points

Other Procedures

0206T

EKG analysis - Algorithmic analysis, remote, of electrocardiographic-derived data with computer probability assessment, including report

Cardiovascular Tests or Procedures

93799

Endo-PAT2000 System is a noninvasive method to evaluate endothelial function. The test involves the measurement of blood flow in the fingertips following compression of the upper arm with an inflatable cuff. Code is for unlisted cardiovascular service or procedure.

Cardiovascular Tests or Procedures

C9724, 43499

Endoscopic gastroplasty / gastroplication for gastro-esophageal reflux disease (GERD) (examples include EsophyX™, BARD™ Endoscopic Sutruring System (BESS) - EndoCinch™, Syntheon ARD Plicatior). Endoscopic gastroplasy/gastroplication procedures are minimally invasive procedures that use different devices to repair or remove the tissue in the area that is causing the GERD symptoms.

Other Procedures

0207T

Evacuation of meibomian glands, automated, using heat and intermittent pressure, unilateral (examples include LipiView and LipiFlow).

Other Procedures

E1399

Exoskeleton – ReWalk personal system for home use in spinal cord injury

DME (Durable Medical Equipment)

0101T

0102T

20999

28890

Extracorporeal shock wave treatment (ESWT) for musculoskeletal conditions

Other Procedures

0071T, 0072T

Focused ultrasound ablation of uterine leiomyomata/fibroids, including MR guidance; total leiomyomata volume less than 200 cc of tissue. Focused ultrasound ablation for other conditions is also investigational.

Other Procedures

Q4132, Q4133

Grafix Core/GrafixPL Core, Grafix Prime/GrafixPL Prime skin substitute for wound care

Other procedures

28291, L8699,

C1776

Hallux rigidus correction, with implant; when used to describe treatment of first MTP joint arthritis using a synthetic cartilage implant (e.g. Cartiva SCI).

Other procedures

33999

Heart Volume Reduction surgery, which is the removal of heart tissue in an attempt to improve the overall function of an enlarged heart. It is also known as the Batista procedure or partial ventriculectomy. Codes is unlisted procedure, cardiac surgery

Other Procedures

No specific code used

High Level-laser light (also known as class IV laser) is administered with a hand held device and is thought to provide deeper penetration over a larger surface area. These are not the same as surgical lasers.

Other Procedures

S8940

Hippotherapy - Equestrian/hippotherapy, per session

Other Procedures

83090

Homocysteine for screening – a laboratory test that may also be used to determine cardiac risk.

Cardiovascular Tests or Procedures

86141

HS-CRP – high sensitivity C-reactive protein for screening – a laboratory test that may also be used to determine cardiac risk.

Cardiovascular Tests or Procedures

Q4117

Hyalomatrix hyaluronic acid wound care device

Other procedures

0228T, 0229T

0231T

Injection(s), anesthetic agent and/or steroid, transforaminal epidural, with ultrasound guidance, cervical, thoracic, or lumbar; single level or additional levels

Spine Procedures

64505

Injection, anesthetic agent, sphenopalatine ganglion

Other Procedures

E1399, S8130, S8131

Interferential Current therapy (IFC) is also known as Sympathetic Therapy or is referred to by the name of an IFC device called the Dynatron STS™ (sympathetic therapy system). IFC is similar to a TENS unit.

DME (Durable Medical Equipment)

0205T

Intravascular catheter-based coronary vessel or graft spectroscopy (eg, infrared) during diagnostic evaluation and/or therapeutic intervention including imaging supervision, interpretation, and report, each vessel (List separately in addition to code for primary procedure)

Cardiovascular Tests or Procedures

28899 and others

Laser treatment for nail fungus. Brand names include PinPointe Footlaser (PinPointe USA, Inc.), and GenesisPlus laser (Cutera, Inc.)

Other Procedures

S2080

LAUP - Laser-assisted uvulopalatoplasty (LAUP) is a procedure using a laser to progressively enlarge the oropharyngeal airway by altering the shape of the uvula, soft palate, and pharyngeal pillars.

Other Procedures

43284

LINX reflux management system for gastro-esophageal reflux disease (GERD) – Laparoscopy, surgical, esophageal sphincter augmentation with device (eg, magnetic band)

Other Procedures

97610

Low frequency, non-contact, non-thermal ultrasound, including topical application(s), when performed, wound assessment, and instruction(s) for ongoing care, per day

Other Procedures

0398T

Magnetic resonance image guided high intensity focused ultrasound (MRgFUS), stereotactic ablation lesion, intracranial for movement disorder (e.g. essential tremor)

Other procedures

0198T

Measurement of ocular blood flow - by repetitive intraocular pressure sampling, with interpretation and report.

Other Testing

33254-33255, 33257-33258, 33265-33266

Minimally invasive Maze procedure/Wolf MiniMaze procedure - Operative tissue ablation and reconstruction of atria, limited (e.g., modified maze procedure)

Cardiovascular Tests or Procedures

No specific code used

Motor cortex stimulation, implantable, for treatment of chronic pain.

Other Procedures

0406T

0407T

Nasal endoscopy, surgical, ethmoid sinus, placement of drug eluting implant or placement of drug eluting implant with biopsy, polypectomy or debridement. (e.g. Propel and Propel Mini). Used to report an in-office, stand-alone procedure.

Other procedures

86382

Neutralizing Antibodies to Interferon Beta

Other Testing

83704

NMR LipoProfile® Test forAtherosclerosis / Coronary Heart Disease - Lipoprotein, blood, quantification of lipoprotein particle numbers and lipoprotein particle sub classes (e.g., by nuclear magnetic resonance spectroscopy)

Cardiovascular Tests or Procedures

E0761

Non-thermal pulsed electromagnetic therapy (PEMT) for wound therapy OR rehabilitation and pain control. Pulsed electromagnetic devices that are used for wound therapy utilize generators designed to create radiofrequency signals that are typically delivered through coils which do not directly contact the skin. Examples for rehab or pain control - the OrthoCor Active Knee System which is used for adjunctive use in the palliative treatment of post-operative pain and edema in superficial soft tissue. It is also used to treat patients with muscle and joint aches and pain associated with overexertion, strains, sprains, and arthritis.

DME (Durable Medical Equipment)

C9727, 42299

Palatal Implants (Pillar™ System) are intended for use in stiffening the soft palate tissue, to decrease the airway obstruction in patients suffering from obstructive sleep apnea.

Other Procedures

0213T, 0214T, 0215T, 0216T, 0217T, 0218T

Paravetebral facet (zygapophyseal) joint (or nerves innervating that joint) injection(s), diagnostic or therapeutic agent, with ultrasound guidance, several variations

Spine Procedures

0387T, 0388T, 0389T, 0390T, 0391T

Permanent leadless pacemaker including insertion, replacement, removal, programming, and device evaluation (e.g. MicraTranscather Pacing System).

Cardiovascular Tests or Procedures

0424T

Phrenic nerve neurostimulation (e.g. Remede implantable system) for treatment of central sleep apnea; insertion or replacement of complete system (transvenous placement of right or left stimulation lead, sensing lead, implantable pulse generator).

Other procedures

P9020, 0232T

Platelet rich plasma, each unit. Injection(s), platelet rich plasma, any tissue, including image guidance, harvesting and preparation when performed

Other Procedures

E2120

Portable pulse generator system for tympanic treatment of inner ear endolymphatic fluid (e.g. Meniett device)

DME (Durable Medical Equipment)

92548

Posturography - Computerized dynamic posturography has been used for both diagnosis and treatment of balance disorders. To undergo CDP, the patient stands on a platform that records postural adjustments. In conjunction with computer software, patient postural adjustments are observed, recorded and measured with the patient’s eyes open, eyes shut, or while wearing specialized goggles for controlled visual stimulation.

Other Testing

69799

Procedure of the middle ear, when used to describe the Esteem totally implantable middle ear hearing system. The Esteem® system consists of three implantable components (sound processor, sensor, and driver), external testing and programming instruments, and other unique accessories.

Other Procedures

S9055

Procuren or other growth factor preparation to promote wound healing

Other Procedures

M0076

Prolotherapy is also known as proliferative injection therapy or sclerotherapy. Prolotherapy is treatment that involves injecting sclerosing solutions into muscles and ligaments for treatment of chronic head, neck, and low back pain. This is thought to stimulate healing of the injured area.

Other Procedures

E1399

Provent Sleep ApneaTherapy device for obstructive sleep apnea (OSA) treatment

Other Procedures

0106T – 0110T; G0255

QST - Quantitative Sensory Testing is a technique used to measure the amount of stimuli necessary to produce the perception of specific sensations (such as touch-pressure, vibration, coolness, warmth, and pain) in persons with a neurological deficit. Examples of specific QST devices include: Neurometer® Current Perception Threshold (Neurotron, Inc), Medi-Dx 7000® (Neuro Diagnostic Associates), Nk Pressure-Specified Sensory Device ™, Physitemp NTE-2A, sNCT, sensory nerve conduction testing, Neural-Scan™, NCSs System™. Sensory Nerve Conduction Threshold (sNCT), also called Current Perception Threshold (CPT), is a type of QST that uses electrical stimulation (rather than touch) to elicit a sensory response. Voltage-actuated Sensory Nerve Conduction Threshold (VsNCT) is another type of QST which measures the voltage amplitude necessary to cause a nerve impulse.

Other Testing

64600

Radiofrequency ablation used to treat cervicogenic headache or occipital neuralgia

Other procedures

S3650

Saliva test, hormone level, during menopause

Other Testing

23929

Shoulder Resurfacing – code is unlisted procedure, shoulder. Shoulder resurfacing is a surgical procedure that involves implantation of a prosthesis that covers and partially replaces the humeral (large upper arm bone) head. The prostheses developed for this procedure are metal and shaped like a simple hemisphere or a hemisphere with a small stem that protrudes from the inner concave face of the device. After surgical removal of bone from the outer portion of the humeral head, the prosthesis is attached with the outer, convex face of the prosthesis serving as the ball in the ball-and-socket joint, taking the place of the damaged humeral head.

Other Procedures

0233T

Skin advanced glycation endproducts (AGE) measurement by multi-wavelength fluorescent spectroscopy

Other Testing

91112

SmartPill gastrointestinal monitoring system; Gastrointestinal tract transit and pressure measurement, stomach through colon, wireless capsule, with interpretation and report

Other Procedures

43257

Stretta endoscopic treatment for gastroesophageal reflux. The Stretta system delivers radiofrequency energy to the lower esophageal sphincter and gastric cardia in order to remodel muscle tissue to improve barrier function and decrease reflux events

Other Procedures

E1399

Tinnitus retraining therapy, also known as tinnitus feedback therapy or habituation therapy (e.g the Levo System).

DME (Durable Medical Equipment)

A4575, E0446

Topical hyperbaric oxygen chamber, disposable; Topical oxygen delivery system, not otherwise specified, includes all supplies and accessories. Topical hyperbaric oxygen therapy is a technique of delivering 100% oxygen directly to an open, moist wound at a pressure slightly higher than atmospheric pressure

DME (Durable Medical Equipment)

E0762

Transcutaneous electrical joint stimulation is the application of a signal-specific electrical current (at a low amplitude and low frequency) to the joint tissue to relieve the signs and symptoms of osteoarthritis and rheumatoid arthritis. The device system, includes all accessories. The BioniCare® Knee Device (ArthroWave Medical Technologies LLC, formerly the BIO-1000™ System, BioniCare Medical Technologies Inc.), and the J-Stim 1000™ (Pain Management Technologies, Inc.) are examples of this technology.

DME (Durable Medical Equipment)

0278T

Transcutaneous electrical modulation pain reprocessing (eg, scrambler therapy), each treatment session (includes placement of electrodes). Calmare Pain Therapy is an example of this device.

Other Procedures

E1399

Transcutaneous nerve stimulator to treat headaches (i.e., Cefaly, gammaCore device or other similar products also listed on TENS policy as not covered)

DME (Durable Medical Equipment)

55899

Transurethral balloon dilation of the prostate

Other Procedures

No specific code

Unicondylar spacer device (OrthoGlide)- cobalt- chrome knee implant which replaces lost cartridge in an osteoarthritic knee and is intended as an alternative to partial or total knee replacement

Other procedures

55899

WIT - Water-induced thermotherapy for BPH (WIT) - Unlisted procedure, male genital system. Water-Induced Thermotherapy (WIT) - a minimally invasive outpatient technique using a heated water catheter balloon set that delivers heat and pressure to the enlarged prostate tissue. Expected outcomes from this procedure include reduction prostate size, improvement in urinary flow, and reduction in symptoms

Other Procedures

No specific code used

X-Close™ Tissue Repair System (Anulex Technologies, Inc) – a method of soft tissue re-approximation of the anulus fibrosus after a lumbar discectomy procedure

Spine Procedures

CPT Copyright American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.

Products

This information is for most, but not all, HealthPartners plans. Please read your plan documents to see if your plan has limits or will not cover some items. If there is a difference between this general information and your plan documents, your plan documents will be used to determine your coverage. These coverage criteria may not apply to Medicare Products if Medicare requires different coverage. For more information regarding Medicare coverage criteria or for a copy of a Medicare coverage policy, contact Member Services at 952-883-7979 or 1-800-233-9645.

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Policy activity

  • 01/07/2010 - Date of origin
  • 07/17/2018 - Effective date
Review date
  • 12/2017
Revision date
  • 07/17/2018

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