CurrentEmblemHealthPolicy N/A

Medical Technologies Database — Investigational, Unproven, HDE, and Transplant Case Management Coverage Criteria

This document lists medical technologies, devices, and procedures that EmblemHealth considers investigational, unproven, or subject to special handling (including HDE and FEHB notes) and describes program-level transplant case management; it affects providers submitting precertification/coverage requests for EmblemHealth members, including transplant program referrals.

Policy Summary

PayerEmblemHealth

PolicyMedical Technologies Database — Investigational, Unproven, HDE, and Transplant Case Management Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionContact transplant case management at 1-800-447-0768 for review and coordination of transplant services and precertification.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

multipleitems listed as investigational/unproven or with special notes

FEHBP/FEPFederal members special assessment rule

1-800-447-0768Transplant case management phone

HDE noteHDE/HUD guidance included

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.

Investigational / Unproven / Conditional Coverage Entries

Entries in the Medical Technologies Database are assigned determinations (Y = covered, N = investigational/unproven, SEE NOTE) and special notes; examples below reflect listed stances and conditional handling.

AbioCor HDE entry: AbioCor Implantable Replacement Heart is listed with HDE status and treated as investigational/SEE NOTE for commercial/Medicaid; precertification requests are reviewed on a case-by-case basis; Medicare coverage may follow the NCD for qualifying clinical study participants.

Scalp cooling / cooling caps: Cooling caps and other scalp-cooling products are considered incidental to chemotherapy and are not separately reimbursed; products purchased by the member are generally considered excluded supplies (CPT 0662T, 0663T) with SEE NOTE distinctions by line of business.

Deep brain stimulation (Reclaim DBS) / HDE devices: Reclaim™ DBS™ Therapy is described as investigational with HDE status; precertification requests for this device will be reviewed on a case-by-case basis.

Gene expression profiling / molecular tests: Specific molecular and gene-expression tests (e.g., RUNX1, NPM1, CEBPA and related panels) are listed with Y determinations in defined contexts to guide therapeutic decision-making per the database entries.

Other investigational procedures: Multiple procedures (e.g., laser interstitial thermotherapy [LITT] for many indications, microwave thermotherapy for chest wall recurrence, venoplasty for relapsing–remitting MS, select cryo/ablation and novel algorithmic imaging tools) are designated N (investigational/not medically necessary) in the Medical Technologies Database rows referenced.

Cooling caps and other scalp cooling products used to prevent chemotherapy-induced alopecia are considered incidental to the administration of chemotherapy and are not separately reimbursed. Items purchased directly by the member (for example, Chemo Cold Cap, DigniCap, ElastoGel, Paxman Scalp Cooling System, Penguin Cold Cap) are treated as supplies and are generally excluded from coverage under plans that exclude supplies. Relevant CPT codes include 0662T and 0663T. (See plan-specific benefit language for any line-of-business exceptions where the entry is marked “SEE NOTE”.)

The Medical Technologies Database lists multiple technologies and procedures as investigational or not medically necessary for specified indications. Examples include laser interstitial thermal therapy (LITT) for indications other than epilepsy and certain intracranial lesions (multiple CPTs such as 19499, 20999, 27599, 32999, 47399, 53899, 55899 designated N), microwave thermotherapy for chest wall recurrence of breast cancer (CPT 19499, N), nasal endoscopy with eustachian tube balloon dilation with mixed determinations depending on the entry, transpupillary thermotherapy for retinoblastoma where noted as Y in specific contexts, and venoplasty for relapsing–remitting multiple sclerosis (CPTs 36901–36906 designated N). The database also identifies other procedures (for example, vertebral stapling for idiopathic scoliosis, tremor analysis devices, and select telescreening algorithms) with investigational or conditional coverage stances; refer to each database row for the LOB-specific determination and effective date.

Relevant CPT / HCPCS / Miscellaneous Codes

AbioCor / HDE related CPT/HCPCSmixed

33927	listed in document for AbioCor
33928	listed in document for AbioCor
33929	listed in document for AbioCor
L8698	listed in document for AbioCor

AbioCor / HDE related CPT/HCPCSmixed

33927	listed in document for AbioCor
33928	listed in document for AbioCor
33929	listed in document for AbioCor
L8698	listed in document for AbioCor

Scalp cooling / Cooling caps CPTCPT

0662T	scalp cooling (mentioned as incidental to chemotherapy)
0663T	scalp cooling (mentioned as incidental to chemotherapy)

Scalp cooling / Cooling caps CPTCPT

0662T	scalp cooling (mentioned as incidental to chemotherapy)
0663T	scalp cooling (mentioned as incidental to chemotherapy)

Deep brain stimulation and related CPTsCPT

21499	listed for DBS (Reclaim) entries
61863	listed for DBS (Reclaim) entries
61864	listed for DBS (Reclaim) entries
61867	listed for DBS (Reclaim) entries
61885	listed for DBS/VNS entries
61886	listed for DBS/VNS entries
61880	listed for DBS (Reclaim) entries
61888	listed for DBS (Reclaim) entries

Deep brain stimulation and related CPTsCPT

21499	listed for DBS (Reclaim) entries
61863	listed for DBS (Reclaim) entries
61864	listed for DBS (Reclaim) entries
61867	listed for DBS (Reclaim) entries
61885	listed for DBS/VNS entries
61886	listed for DBS/VNS entries
61880	listed for DBS (Reclaim) entries
61888	listed for DBS (Reclaim) entries

Additional CPT / molecular / miscellaneous codes referencedmixed

0046U	gene expression / molecular assay CPT listed
0049U	gene expression / molecular assay CPT listed
0050U	gene expression / molecular assay CPT listed
81310	NPM1 testing (listed)
81218	CEBPA testing (listed)
81245	listed
81246	listed
19499	miscellaneous CPT referenced for certain procedures
36901	venoplasty CPT referenced
36902	venoplasty CPT referenced

1–10 of 14

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Additional CPT / molecular / miscellaneous codes referencedmixed

0046U	gene expression / molecular assay CPT listed
0049U	gene expression / molecular assay CPT listed
0050U	gene expression / molecular assay CPT listed
81310	NPM1 testing (listed)
81218	CEBPA testing (listed)
81245	listed
81246	listed
19499	miscellaneous CPT referenced for certain procedures
36901	venoplasty CPT referenced
36902	venoplasty CPT referenced

1–10 of 14

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Precertification, Review Requirements, and Provider Guidance

Prior Authorization

Prior Authorization Required for Investigational / HDE Devices

Precertification / case-by-case review required for investigational or HDE devices listed (including AbioCor® Implantable Replacement Heart). Providers must submit a precertification request for review. Medicare members: costs directly related to services covered by the National Coverage Determination (NCD) will be paid by CMS intermediaries/carriers when beneficiaries are enrolled in a clinical study that meets the NCD criteria.

Affected codes: CPT 33927, 33928, 33929; HCPCS L8698
Commercial lines of business: case-by-case precertification review required
Medicare: see note — CMS payment applies per NCD for qualifying clinical study enrollment

Note

Transplant Case Management Contact

Providers should refer transplant-eligible members to EmblemHealth’s transplant case management program for coordination of services and review. All requested transplant services are reviewed with the medical director supporting the transplant case management program and evaluated for medical necessity using evidence-based criteria.

To request transplant case management services call 1-800-447-0768
All transplant services are reviewed with the transplant program medical director prior to authorization

Documentation Required

Provider Submission Requirements and Documentation

When submitting requests for investigational technologies or devices, include complete documentation of clinical indications, prior therapies/trials (e.g., LVAD consideration), patient age, and rationale for device selection. Incomplete documentation may delay review or result in denial.

Include clinical notes, prior authorization history, and any relevant study enrollment information if applicable
For scalp cooling products: considered incidental to chemotherapy and not separately reimbursed; document accordingly

Prior Authorization

AbioCor® Precertification and Medicare Cost-Review Note

AbioCor® Implantable Replacement Heart is FDA-approved under a Humanitarian Device Exemption (HDE) for a specific, limited patient population; precertification requests will be reviewed case-by-case for all lines of business except Medicare as noted. Ensure documentation confirms patient meets HDE criteria (e.g., <75 years old, severe biventricular end-stage heart disease, not transplant candidates, require multiple inotropic support, not eligible for LVAD destination therapy).

Confirm HDE eligibility criteria in the submission
Codes commonly associated: CPT 33927, 33928, 33929; HCPCS L8698
Medicare: costs related to services covered by the NCD may be paid by CMS when beneficiary is enrolled in qualifying clinical study

Key Definitions and Regulatory Notes

Humanitarian Use Device (HUD) / Humanitarian Device Exemption (HDE) — definition and regulatory context

HUD definitionA Humanitarian Use Device (HUD) is a medical device intended to benefit patients with a disease or condition that affects or is manifested in not more than 8,000 individuals in the United States per year (previously 4,000; increased to 8,000 on June 7, 2017).

HDE definitionA Humanitarian Device Exemption (HDE) is a marketing application for an HUD that is exempt from the FD&C Act effectiveness requirements of Sections 514 and 515 and is subject to specific profit and use restrictions.

Regulatory scopeHDEs allow marketing of devices for rare conditions without demonstrating effectiveness to the same standard as other devices, but remain subject to profit and use limitations.

Annual prevalence thresholdThe HUD designation applies when the condition affects no more than 8,000 individuals in the U.S. per year.

Historical noteThreshold increased from 4,000 to 8,000 individuals on June 7, 2017.

Program Background and Medical Technologies Database

EmblemHealth maintains a Medical Technologies Database that catalogs medical devices, procedures, and technologies and assigns each a coverage determination (for example, Y = covered, N = investigational/not medically necessary, or SEE NOTE for line-of-business exceptions). The database is used to standardize handling of items ranging from Humanitarian Device Exemption (HDE) products and scalp‑cooling devices to molecular testing and various procedural technologies. When services or devices listed as investigational or HDE are requested, precertification requests are reviewed on a case‑by‑case basis and may be escalated to the transplant program medical director or other clinical reviewers as applicable.

Transplant Candidate and Program Review Criteria

Transplant case management review

Transplant program case management and review process applies to members preparing for or having transplants.

Case review: All transplant services are reviewed with the assigned transplant program medical director; requested transplant services are reviewed for medical necessity using evidence-based criteria to support care coordination and outcomes.

Program contact: To request transplant case management services or to coordinate review with the transplant program medical director, members and providers may call 1-800-447-0768.

Post-Transplant and Follow-up Review

transplant services/case management — post-transplant and preparation services subject to program review and contact information

Program scopeEmblemHealth's transplant program manages members with health care needs associated with preparing for or having a solid organ or bone marrow transplant.

Medical director reviewAll transplant services are reviewed with the medical director assigned to support the transplant case management program.

Medical necessity reviewAll requested transplant services are reviewed for medical necessity and evidence-based criteria are utilized to support care coordination and outcomes.

How to request case managementTo request transplant case management services, members and providers may call 1-800-447-0768.

Related guidanceFor additional information on experimental medical technologies, see the Medical Necessity Guidelines: Experimental.

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