CurrentEmblemHealthPolicy N/A

Medical Technologies / Transplant-related investigational devices and transplant program case management notes

This document is EmblemHealth's medical technologies database excerpt covering investigational or unproven services, Humanitarian Device Exemption notes, and transplant program case management procedures; it informs medical necessity review and prior authorization practices for transplant-related and other medical technologies.

Policy Summary

PayerEmblemHealth

PolicyMedical Technologies / Transplant-related investigational devices and transplant program case management notes

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionCall the transplant case management line at 1-800-447-0768 to initiate review and coordination for transplant services.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

multipleinvestigational or HDE device/service listings in this excerpt

>=1entries marked investigational/Not covered (N)

case mgmt linetransplant program contact

FEHBP notefederal member applicability statement present

Coverage Criteria and Technology Determinations

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

MRI-guided LITT intracranial indications (Covered)

Covered when ALL of the following are met (for MRI-guided LITT intracranial indications):

LITT intracranial coverage: MRI-guided laser interstitial thermal therapy (LITT) for intracranial indications (e.g., NeuroBlate®, Visualase®) is covered for Commercial and Medicare members when ONE of the following clinical scenarios applies: (1) Epilepsy — disabling seizures despite use of ≥ 2 tolerated antiepileptic drug regimens, and when there are ≤ 2 well‑delineated epileptogenic foci accessible by laser; OR (2) Recurrent brain metastases, recurrent glioblastoma, or radiation necrosis — patient is a poor surgical candidate for craniotomy and resection because open surgery presents prohibitive surgical risk or the tumor is surgically inaccessible.epilepsy: >=2 failed AED regimens; focality: <=2 foci

Source lists these specific covered intracranial indications

Vagus nerve stimulation coverage note

Coverage stance and exceptions

Vagus nerve stimulation (VNS) is considered investigational for all indications except epilepsy (see MCG #A-0424).

Entry explicitly notes investigational status with exception for epilepsy

TMS for non-depression indications

Investigational technologies

Transcranial magnetic stimulation (non-depression indications): Transcranial magnetic stimulation (TMS) for neurologic or psychological indications other than depression (e.g., migraines, strokes, obsessive compulsive disorder, Parkinson's disease, dystonia, tinnitus, auditory hallucinations) is listed as not covered/investigational (N).

Listed as N (not covered)

Venoplasty for MS

Investigational procedures

Venoplasty for relapsing remitting multiple sclerosis is listed as not covered/investigational (N).

See Experimental, Investigational or Unproven Services

Transpupillary thermotherapy

Covered procedures

Transpupillary thermotherapy for retinoblastoma is listed with CPT 67299 and marked as covered (Y).

Entry shows Y (covered)

Cooling caps and other products for scalp cooling are considered incidental to chemotherapy administration and are not separately reimbursed. Items purchased by the member are treated as supplies and generally excluded from coverage under plans that exclude supplies. Associated CPT codes listed in the excerpt are 0662T and 0663T.

Several procedures and technologies shown in the database excerpt are listed as investigational or not covered. Examples include spinal vertebral stapling for idiopathic scoliosis (CPT 22899) and surgical interventions intended to prevent lymphedema (e.g., LYMPHA/SLYMPHA, reverse lymphatic mapping), each marked N (not covered). The excerpt also includes other ENT procedures such as balloon dilation of the eustachian tube with mixed entries that cross-reference the Experimental/Investigational listings.

Multiple entries are explicitly cross-referenced to the Medical Technologies Database section titled Experimental, Investigational or Unproven Services and are marked N (not covered) for the listed indications. Notable cross-referenced examples include transcranial magnetic stimulation (TMS) for indications other than depression and venoplasty for relapsing remitting multiple sclerosis, which are shown as not covered in the rows cited.

Across the excerpt, several individual services and devices are denoted as investigational or N (not covered). These include cryoablation for chronic rhinitis (e.g., ClariFix), certain LITT entries when not meeting coverage criteria, TMS for neurologic/psychologic indications other than depression, and surgical prevention techniques for lymphedema. These designations indicate that the listed items are not supported for routine coverage in the shown indications.

Technologies and procedures marked N (not covered) in the Medical Technologies Database excerpt are considered not medically necessary or investigational when billed for those specific indications. Examples called out include transcranial magnetic stimulation for non-depression neurological or psychological indications and venoplasty for relapsing remitting multiple sclerosis, which would be subject to denial when submitted for those uses.

CPT / HCPCS / Other Codes

AbioCor HDE device codesmixedExperimental

33927	CPT code listed with AbioCor® Implantable Replacement Heart
33928	CPT code listed with AbioCor® Implantable Replacement Heart
33929	CPT code listed with AbioCor® Implantable Replacement Heart
L8698	HCPCS code listed with AbioCor® Implantable Replacement Heart

AbioCor HDE device codes (duplicate source repeat)mixedExperimental

33927	CPT code listed with AbioCor® Implantable Replacement Heart
33928	CPT code listed with AbioCor® Implantable Replacement Heart
33929	CPT code listed with AbioCor® Implantable Replacement Heart
L8698	HCPCS code listed with AbioCor® Implantable Replacement Heart

DBS / neurodevice codesmixedExperimental

21499	CPT - unlisted/associated with Reclaim™ DBS™ Therapy entries
61863	CPT - DBS-related
61864	CPT - DBS-related
61867	CPT - DBS-related
61885	CPT - DBS-related
61886	CPT - DBS-related
61880	CPT - DBS-related
61888	CPT - DBS-related
95961	CPT - neurostim/monitoring related
95962	CPT - neurostim/monitoring related

1–10 of 19

1/2

Scalp cooling CPT codesCPT

0662T	CPT - cooling caps/scalp cooling (listed as incidental)
0663T	CPT - cooling caps/scalp cooling (listed as incidental)

Therapies without specific CPT codes / billing examplesmixed

V5299	Unspecified miscellaneous code (used for TRT as noted)
97039	Physical medicine treatment (used for TRT as noted)
E1399	Durable medical equipment, miscellaneous (used for TRT as noted)

Therapies billing guidance reference codesmixed

E1399	Report code also listed for gammaCore Sapphire in device/neuromodulation entries
K1020	HCPCS listed in device/neuromodulation entries
L8680	HCPCS listed in device/neuromodulation entries

Listed CPT and HCPCS codes for devices/neuromodulationmixed

0312T
0313T
0314T
0315T
0316T
0317T
61885
61886
61888
64553

1–10 of 29

1/3

Other CPT codes in excerptCPT

67299	Transpupillary thermotherapy for retinoblastoma (unlisted ophthalmological procedure)
0778T	Tremor analysis device (physiologic recording) - unlisted
95999	Unlisted nervous system procedure (tremor analysis device)
36901
36902
36903
36904
36905
36906

Provider Actions, Prior Authorization, and Billing Guidance

Prior Authorization

Prior Authorization Required

Pre-certification (prior authorization) is required for investigational devices and HDE technologies; requests are reviewed on a case-by-case basis and may be denied if the technology is marked investigational/not covered.

Prior authorization required for investigational or HDE devices (case-by-case review).
Affected codes: see individual device entries (e.g., CPT 33927-33929, L8698; CPTs and HCPCS in device rows).

Denial Risk

Investigational / Not Covered — Denial Risk

Technologies and procedures listed as investigational or unproven (N) are considered not medically necessary for those indications and are subject to denial.

Entries marked N = investigational/not covered — expect denial when billed for those indications.
Examples: transcranial magnetic stimulation for non-depression indications; venoplasty for relapsing remitting MS (CPT 36901-36906).

Documentation Required

Conservative Therapy Prerequisite

Some covered indications require conservative therapy prerequisites before device therapies are authorized. Document prior conservative treatment and failure when applicable (e.g., epilepsy criteria for MRI‑guided LITT).

MRI-guided LITT for epilepsy requires disabling seizures despite ≥ 2 tolerated antiepileptic drug regimens and ≤ 2 well-delineated foci accessible by laser.
Provide documentation of medication trials and seizure focus localization.

Prior Authorization

Transplant Case Management Routing

All transplant-related service requests must be routed to EmblemHealth’s transplant case management for review and coordination.

Contact transplant case management: 1-800-447-0768.
All transplant services reviewed with the transplant program medical director for medical necessity and evidence-based criteria.

Billing Rule

Billing Guidance for Therapies Without Specific CPT Codes

When a technology or therapy does not have a specific CPT code, bill using appropriate E/M, physical medicine, or therapy codes per guidance; include supporting documentation to justify the service.

Examples: Tinnitus retraining therapy — no specific CPT; use E/M or physical medicine/rehab codes or V5299, 97039, E1399 as appropriate.
When billing unlisted or miscellaneous HCPCS (E1399, V5299), include full documentation and description of services.

Prior Authorization

Code-Associated Authorization

Code-associated authorizations may be required. Specific CPT/HCPCS codes shown in the Medical Technologies Database rows are tied to the technologies and may trigger prior authorization.

Examples: Reclaim™ DBS™ Therapy — CPTs 21499, 61863-61888, 95961-95962; HCPCS L8680–L8688.
See device row codes when submitting prior authorization requests.

Denial Risk

Investigational Device Denial Risk

Providers should be aware that investigational devices—even if FDA-approved as an HDE—remain subject to case-by-case review and possible denial outside specific coverage determinations.

HDE status does not guarantee coverage; review will consider clinical criteria and member line of business.
Example: AbioCor® Implantable Replacement Heart and Reclaim™ DBS™ Therapy reviewed case-by-case.

Denial Risk

Investigational / Not Covered Technologies

Technologies explicitly marked as investigational/unproven (N) in the Medical Technologies Database are not medically necessary for the listed indications and should not be submitted as covered services.

Examples include transcranial magnetic stimulation for indications other than depression and venoplasty for relapsing remitting multiple sclerosis (CPT 36901–36906).
Prior authorization is unlikely to be approved for N-marked indications.

Key Definitions

HUD / HDE definitions

HUD definitionHumanitarian 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.

HDE definitionHumanitarian Device Exemption (HDE): a marketing application for a 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.

Regulatory noteThe HUD population threshold was increased from 4,000 to 8,000 individuals on June 7, 2017.

Vagus nerve stimulation (VNS) — definition and status

VNS investigational statusVagus nerve stimulation (VNS) is considered investigational for all indications except epilepsy.

Epilepsy exceptionVNS is an exception to investigational status for epilepsy — see MCG #A-0424 for coverage guidance.

Scope of ‘multiple conditions’ listingThe listing references many conditions (e.g., addictions, Alzheimer disease, anxiety disorders, atrial fibrillation, autism spectrum disorders, chronic pain, headaches, obesity, tinnitus, stroke, traumatic brain injury, etc.) as examples for which VNS is considered investigational.

OpenPayer

Medical Technologies / Transplant-related investigational devices and transplant program case management notes

Coverage Criteria and Technology Determinations

CPT / HCPCS / Other Codes

Provider Actions, Prior Authorization, and Billing Guidance

Transplant Candidate and Program Requirements

Evaluation and Medical Necessity Review

Transplant Center and Program-Level Requirements

Key Definitions

Background and Scope