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

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

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

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

Evaluation requirements: medical necessity and evidence-based review

Requested transplant services are reviewed for medical necessity using evidence-based criteria to support care coordination and outcomes; providers should engage transplant case management for coordination.

• All requested transplant services undergo medical necessity review using evidence-based criteria.
• Contact transplant case management for coordination of evaluations and care planning.

Center requirements: medical director review and program oversight

All transplant services are reviewed with the medical director assigned to support the transplant case management program; program-level oversight may be required for transplant-related precertification and case management.

• Medical director involvement is required for review of transplant services.
• Transplant program case management provides coordination and oversight for members preparing for or having transplants.