Investigational or Unproven Medical Technologies
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Defines EmblemHealth's positions on investigational or unproven procedures, devices, and laboratory tests and lists technologies with their investigational/coverage status; affects providers submitting requests or claims to EmblemHealth.
No material clinical or coverage changes in this revision.
Coverage Criteria — Investigational / Not Medically Necessary
Scalp cooling — not separately reimbursed
General coverage stance for scalp cooling and similar products:
CPT 0662T, 0663T; HCPCS E0218, E0236 listed
Molecular testing — payer-specific coverage notes
Gene expression profiling and proprietary PLA codes:
Examples: 0046U, 0049U, 0050U
See CPT rows and NGS/Molecular Pathology LCD references
HDE devices — case-by-case review
Devices approved under HDE or requiring case-by-case review:
CPT examples: 33927-33929, L8698, 21499, 61863-61888, 95961-95962; HCPCS L8680-L8689
Investigational / Unproven Designations
Technologies and indications listed below are considered investigational or unproven:
CPT codes 90867-90869 referenced.
Example CPT codes 0778T, 95999.
Exception: VNS is not investigational for epilepsy (see MCG #A-0424) and has TRD coverage nuances for Medicare per NCD/CED; CPT and HCPCS codes listed.
CPT codes 36901-36906 referenced.
Cooling caps and other scalp cooling products are considered incidental to chemotherapy administration and are not separately reimbursed. Items purchased directly by the member (e.g., scalp cooling caps or related supplies) are treated as supplies and are generally excluded from coverage under plans that exclude supplies. Relevant example codes include CPT 0662T, 0663T and HCPCS E0218, E0236.
Proprietary lab analysis (PLA) codes — those ending with the letter 'U' (PLA/'U' codes) — are not covered for Medicaid members because NYS Medicaid does not reimburse these proprietary PLA codes. Examples of PLA codes referenced in the gene expression profiling rows include 0046U, 0049U, 0050U.
Vagus nerve stimulation (VNS) is designated investigational for most indications listed in the database (for example: addictions, Alzheimer disease, anxiety, atrial fibrillation, autism spectrum disorders, chronic pain, headache disorders, essential tremor, and many others). However, VNS is explicitly not considered investigational for epilepsy (see MCG #A-0424) and has a Medicare-specific allowance for Treatment Resistant Depression (TRD) under the Medicare NCD via Coverage with Evidence Development (CED). Providers submitting requests for VNS should reference applicable NCD/MCG policy identifiers and the related CPT/HCPCS device codes listed in the policy when documenting exceptions.
The policy lists multiple examples of procedures and devices that are designated investigational or otherwise require case-specific review. Examples include: cryoablation for chronic rhinitis (unlisted CPT examples 30999, 31299), various applications of transcranial magnetic stimulation (TMS) for neurologic or psychological indications other than depression (CPT 90867–90869), tremor analysis devices (e.g., physiologic tremor recordings using accelerometers, CPT 0778T, 95999), and other miscellaneous unlisted procedure codes used for emerging therapies. These entries are intended to alert providers that such services are generally considered investigational for the enumerated indications.
Technologies and indications listed as investigational or unproven in this document are considered not medically necessary / non-covered when billed for those specified indications. Specific examples called out include: transcranial magnetic stimulation (TMS) for non-depression indications (CPT 90867–90869), tremor analysis devices (CPT 0778T, 95999), vagus nerve stimulation for indications other than epilepsy or Medicare TRD (multiple CPT/HCPCS and implant/device codes listed), and venoplasty for relapsing remitting multiple sclerosis (CPT 36901–36906).
Covered Indications and Specific Tests
Gene expression profiling for AML and related therapeutic management — specific gene tests and payer notes
Coverage may vary by payer; proprietary PLA ('U') codes are not covered for Medicaid members.
Coding — CPT / HCPCS / Device Codes
| 33927 | CPT listed with AbioCor® device row |
| 33928 | CPT listed with AbioCor® device row |
| 33929 | CPT listed with AbioCor® device row |
| L8698 | HCPCS L-code listed with AbioCor® device row |
| 21499 | CPT used in DBS/other device entries |
| 61863 | CPT DBS procedure codes |
| 61864 | CPT DBS procedure codes |
| 61867 | CPT DBS procedure codes |
| 61885 | CPT DBS procedure codes |
| 61886 | CPT DBS procedure codes |
| 0046U | Proprietary lab analysis (PLA) code for gene expression profiling |
| 0049U | Proprietary lab analysis (PLA) code for gene expression profiling |
| 0050U | Proprietary lab analysis (PLA) code for gene expression profiling |
| 81310 | NPM1 |
| 81218 | CEBPA |
| 81245 | FLT3 |
| 81246 | FLT3 |
| 81450 | Genomic sequence analysis panels |
| 81334 | RUNX1 gene expression profiling |
| 92227 | Tele-retinal imaging / diabetic retinopathy telescreening code |
| 30999 | Cryoablation - rhinitis (unlisted CPT examples) |
| 31299 | Cryoablation - rhinitis (unlisted CPT examples) |
| 0778T | Tremor analysis device CPT |
| 95999 | Unlisted neurology code used for tremor analysis device |
| 67299 | Transpupillary thermotherapy for retinoblastoma (unlisted) |
| 90867 | TMS boost codes (psychiatric) |
| 90868 | TMS codes |
| 90869 | TMS codes |
| 38999 | Surgical interventions for lymphedema (unlisted) |
| 67299 | Transpupillary thermotherapy for retinoblastoma (unlisted procedure, retina/vitreous) |
| 0312T | Vagus nerve stimulation service code |
| 0313T | Vagus nerve stimulation service code |
| 0314T | Vagus nerve stimulation service code |
| 0315T | Vagus nerve stimulation service code |
| 0316T | Vagus nerve stimulation service code |
| 0317T | Vagus nerve stimulation service code |
| 61885 | Insertion or revision of cranial neurostimulator lead (listed among VNS-related codes) |
| 61886 | Related neurostimulation code |
| 61888 | Related neurostimulation code |
| 64553 | Insertion or replacement of peripheral neurostimulator lead |
| E1399 | Unclassified miscellaneous HCPCS (report for gammaCore Sapphire) |
| K1020 | HCPCS code referenced for device |
| L8680 | Prosthetic implantable device codes referenced |
| L8681 | Prosthetic implantable device codes referenced |
| L8682 | Prosthetic implantable device codes referenced |
| L8683 | Prosthetic implantable device codes referenced |
| L8684 | Prosthetic implantable device codes referenced |
| L8685 | Prosthetic implantable device codes referenced |
| L8686 | Prosthetic implantable device codes referenced |
| L8687 | Prosthetic implantable device codes referenced |
Provider Actions — Authorization, Documentation, Billing
Pre-certification required — case-by-case review for HDE/investigational devices
Pre-certification requests for devices or technologies listed as investigational or approved under a Humanitarian Device Exemption (HDE) will be reviewed on a case-by-case basis; Medicare member exceptions related to NCD rules may apply. Submit pre-certification/prior authorization for listed device CPT/HCPCS codes when applicable.
Prior authorization and coding alert — investigational/unproven procedure codes
Certain CPT/HCPCS codes listed in the database are associated with procedures designated investigational or unproven and may require prior authorization or may be non-covered when billed for the listed indications.
Step/coverage sequencing for molecular tests — PLA 'U' codes not covered for Medicaid
For molecular testing and gene expression profiling, note that proprietary PLA codes ending in 'U' are not covered for Medicaid members per NYS Medicaid rules; confirm payer-specific coverage and sequencing before ordering.
Placeholder — no provider action specified
(No requirement text available in source for this placeholder.)
Transplant case management review — submit to transplant program for medical director review
All requested transplant services must be submitted to the EmblemHealth transplant program and will be reviewed for medical necessity with the medical director assigned to the transplant case management program; contact the transplant program to request case management services.
- Contact number for transplant case management: 1-800-447-0768
- Evidence-based criteria and medical necessity reviews are applied to all transplant service requests
Documentation for exceptions — cite applicable NCD/CED or coverage policy
When an exception is noted (for example VNS for epilepsy or TRD under Medicare NCD/CED), providers should reference the applicable NCD/MCG policy identifiers and supporting documentation when submitting claims or prior authorization requests.
- VNS is not investigational for epilepsy (see MCG #A-0424) and TRD coverage for Medicare is per NCD with CED — cite the applicable NCD/CED when submitting
- Include references to the applicable policy or NCD/CED documentation in the request
Denial risk — scalp cooling products are incidental to chemotherapy and not separately reimbursed
Cooling caps and other scalp cooling products are considered incidental to chemotherapy and are not separately reimbursed; items purchased by the member are treated as supplies and generally excluded from coverage.
Denial risk — investigational/unproven services may be denied or not covered
Claims for technologies and procedures listed as investigational or unproven for the specified indications risk denial as not medically necessary when billed for those indications; verify coverage stance and obtain prior authorization where applicable.
- Examples of high denial risk items: TMS for non-depression indications (90867–90869), VNS for most indications (0312T–0317T, related HCPCS), tremor analysis devices (0778T, 95999), venoplasty for RRMS (36901–36906).
- Provide thorough clinical justification and prior authorization paperwork to reduce denial risk; absent coverage criteria, claims may be denied.
Ordering Requirements and Program Routing
ORDERING REQUIREMENTS — transplant services routed through EmblemHealth transplant program
Transplant-related orders and requests must be routed through the EmblemHealth transplant program; all transplant services are reviewed with the assigned transplant program medical director.
- Contact the transplant case management program at 1-800-447-0768 to initiate referral or request services.
Not Covered — Specific Exclusions
Proprietary PLA codes (PLA/'U' codes) are not covered for Medicaid members per NYS Medicaid reimbursement rules. This exclusion applies to proprietary PLA codes referenced in gene expression profiling rows (examples: 0046U, 0049U, 0050U); providers should reference the commercial and Medicaid distinctions shown in the coding rows when submitting claims.
Cooling caps and other scalp cooling products used in association with chemotherapy are considered incidental to the chemotherapy administration and are not separately reimbursed. Items purchased by the member are treated as supplies and are generally excluded from coverage under plans that exclude supplies. Relevant example codes include CPT 0662T, 0663T and HCPCS E0218, E0236.
The database lists tremor analysis devices (e.g., physiologic tremor recording using accelerometers, CPT examples 0778T, 95999) and venoplasty for relapsing remitting multiple sclerosis (CPT 36901–36906) as investigational/unproven; these are designated not covered for the specified indications when billed for those uses.
Definitions and Key
Background and Scope
This document summarizes EmblemHealth's positions on investigational or unproven technologies, noting which procedures, devices, and laboratory tests are considered investigational (designated 'N') or allowed (designated 'Y') and identifying payer-specific exceptions. It also references special program notes including Humanitarian Device Exemption (HDE) guidance and transplant case management review processes, and provides associated CPT/HCPCS codes for the listed technologies. The Medical Technologies Database serves as the operational reference for prior authorization, claims adjudication, and provider guidance.
Revision History
Medical Technologies Database version published (June 2026) reflecting current investigational and coverage designations.
Policy effective date set to 2026-06-01 for the Medical Technologies Database.
Gene expression profiling (AML) therapeutic management row updated; CPT and PLA code notes and Medicaid PLA ('U') coverage guidance referenced (entry dated 5/8/2026).
Laser interstitial thermotherapy (LITT) entries updated with review note dated 4/10/2026 marking investigational status for specified indications.
Deep brain stimulation (Reclaim™ DBS™ Therapy) and several gene expression profiling rows annotated with review entries dated 3/13/2026; venoplasty row also records 3/13/2026 in database.
Multiple items (e.g., spinal vertebral stapling, certain tele-retinal imaging entries, tremor/VNS rows) updated with review date 11/14/2025 reflecting investigational determinations.
Microwave thermotherapy and select nasal endoscopy/balloon dilation entries updated with review date 9/12/2025.
RUNX1 gene expression profiling row updated with review date 8/8/2025 documenting coverage notes for that gene test.
Humanitarian Use Device (HUD) population threshold noted to have increased to 8,000 individuals per year (June 7, 2017) and referenced in HDE guidance within the database.
Coding row notes include PLA ('U') code noncoverage for Medicaid members per NYS Medicaid reimbursement guidance (entry referenced 5/8/2026).
Document status recorded as CURRENT with effective date and Medical Technologies Database (June 2026) versioning.
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