CurrentAlliance HealthPolicy Clinical Coverage Policy No: 11B-4

Kidney (Renal) Transplantation

North Carolina Medicaid clinical coverage policy defining medical necessity, eligibility, exclusions, prior approval, provider and billing requirements for deceased and living donor kidney transplantation.

Policy Summary

PayerAlliance Health

PolicyKidney (Renal) Transplantation

Policy CodePolicy Clinical Coverage Policy No: 11B-4

Change TypeNo material clinical changes

Effective Date197-07-01

Next Review Date

Key ActionDocument progressive, irreversible deterioration in renal function over the prior six months and confirm dialysis status or measured/calculated GFR thresholds, transplant-center eligibility, and beneficiary/caregiver ability to follow the posttransplant plan.

SourceLink

GFR thresholds by ageCoverage GFR cutoffs (adult vs pediatric)

No prior approvalPrior approval requirement for transplant

MultipleExplicit non-coverage contraindications listed

Medical Necessity Criteria for Kidney Transplantation

Medically Necessary / Coverage Criteria

Kidney transplantation (deceased or living donor) is covered when ALL of the following are met:

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ALL of the following

Renal insufficiency with uremia or current end stage renal disease (ESRD) with poor renal function documented by progressive and irreversible deterioration in renal function over the previous six (6) consecutive months
AND at least one of the GFR/dialysis criteria below
ONE of
- Currently on dialysisdialysis status
- For beneficiaries 18 years and older: measured or calculated GFR < 20 mL/minmeasured or calculated GFR < 20 mL/min (age 18+)
- For beneficiaries 17 years and younger: measured or calculated GFR < 30 mL/minmeasured or calculated GFR < 30 mL/min (age ≤17)
The beneficiary has completed an evaluation and meets the eligibility criteria for the transplant center performing the procedure
The beneficiary and caregiver are willing and capable of following the posttransplant treatment plan
Re-transplantation
- Kidney re-transplant after a failed primary kidney transplant may be considered medically necessary if beneficiary meets the criteria for kidney transplantation
If HIV-positive, ALL additional criteria must be met
- CD4 count greater than 200 cells/mm3 for more than six (6) consecutive monthsCD4 > 200 cells/mm3 for > 6 consecutive months
- HIV-1 RNA undetectableHIV-1 RNA undetectable
- On stable antiretroviral therapy for more than three (3) consecutive monthsOn stable antiretroviral therapy > 3 consecutive months
- No other complications from HIV (e.g., opportunistic infections, Kaposi's sarcoma, other neoplasm)
- Meets all standard transplantation criteria listed above (items 1–4)

Not Covered / Contraindications

Kidney transplantation is not covered if ANY ONE of the following contraindications is present:

ANY of the following

Beneficiary does not meet Section 2.0 eligibility requirements
Beneficiary does not meet the criteria listed in Section 3.0
Procedure duplicates another provider's procedure, product, or service
Procedure, product, or service is experimental, investigational, or part of a clinical trial
Futility due to comorbid disease or expected significant worsening of comorbid conditions from posttransplant care
Serious cardiac or other ongoing insufficiencies that create inability to tolerate transplant surgery
Active drug or alcohol use
Active tobacco use
Active, potentially life-threatening malignancy
Life-threatening extra-renal congenital abnormalities
Active infection
Active vasculitis
Untreated or irreversible end-stage illnesses
Untreated coagulation disorder
Inability to comply with post-transplant regimen
Organs sold rather than donated to a beneficiary
Artificial organs or human organ transplant service for which the cost is covered or funded by governmental, foundation, or charitable grants

Coding, Claim Forms, and Donor Billing Guidance

Coding and Billing Guidancemixed

CPT/HCPCS/ICD-10	Policy refers providers to use the most specific CPT, HCPCS, ICD-10-CM/PCS, and UB-04 revenue codes in effect at time of service. Specific codes are not enumerated in the policy.
Unlisted Procedure	If no specific CPT/HCPCS code exists, report appropriate unlisted procedure or service with special report per current codebook instructions.

Place of Serviceother

Acute inpatient hospital

Designated place of service for kidney transplant

Institutional and professional claim submission requirements are specified in Attachment A. Use Professional (CMS-1500/837P) for professional claims and Institutional (UB-04/837I) for institutional claims; unless directed otherwise, Institutional claims must be billed according to National Uniform Billing Guidelines. Providers must report ICD-10-CM and PCS codes to the highest level of specificity that supports medical necessity and must use the current ICD-10 edition in effect at the time of service. Similarly, use the most specific CPT, HCPCS, and UB-04 revenue codes in effect at the time of service; if no specific CPT/HCPCS code exists, report the appropriate unlisted procedure or service code with special report per current codebook instructions. The designated place of service for kidney transplantation is Acute inpatient hospital.

Donor-related billing follows Attachment A distinctions between cadaveric (deceased) and living donors. Donor transplant-related medical expenses are billed on the Medicaid beneficiary's transplant claim using the beneficiary's Medicaid identification number, and Medicaid reimburses only for the beneficiary's actual donor transplant-related medical expenses. For cadaveric/deceased donations, procurement/harvesting and associated surgical and laboratory costs are covered. For living donors, transplant-related donor expenses are covered only for an approved living donor and reimbursed only for actual donor transplant-related medical expenses. Providers must follow NCTracks, Medicaid bulletins, fee schedules, and other applicable claims guidance when billing donor expenses.

Prior Auth, Documentation & Billing Actions for Providers

Prior Authorization

Prior approval requirement

No prior approval is required for cadaveric or living donor kidney transplantation.

Documentation Required

Medical necessity and evaluation documentation

Document progressive, irreversible deterioration in renal function over the previous six consecutive months, completion of the transplant center evaluation and eligibility, the beneficiary's dialysis status or measured/calculated GFR meeting policy thresholds, and that the beneficiary and caregiver are willing and capable of following the posttransplant treatment plan.

Documentation Required

HIV-specific documentation

For HIV-positive beneficiaries, document the following: CD4 count, HIV-1 RNA, duration/stability of antiretroviral therapy, absence of HIV-related complications, and confirmation that the beneficiary meets all standard transplantation criteria.

CD4 count > 200 cells/mm3 for more than six consecutive months
HIV-1 RNA undetectable
On stable antiretroviral therapy for more than three consecutive months
No other complications from HIV (e.g., opportunistic infections, Kaposi's sarcoma, other neoplasm)
Meets all standard transplantation criteria (items 1–4 in policy)

Billing Rule

Billing donor transplant-related expenses

Bill donor transplant-related medical expenses on the Medicaid beneficiary's transplant claim using the beneficiary's Medicaid identification number; Medicaid reimburses only actual donor transplant‑related medical expenses and only for approved living donors.

Note

Use of FDA-approved implants/devices

Use FDA‑approved procedures, products, and devices for implantation and comply with all FDA requirements current at the time of surgery.

Billing Rule

Claim forms and coding standards

Use CMS-1500/837P for professional claims and UB-04/837I for institutional claims; institutional claims must follow National Uniform Billing Guidelines and all claims must comply with national coding standards and report codes to the highest specificity.

Clinical Background

Kidney transplantation implants a healthy kidney from either a living or deceased donor into a beneficiary with kidney failure (ESRD). Living-donor transplants are preferable because they generally shorten waiting time, allow pretransplant testing, typically function immediately after transplant, and tend to last longer; ABO-compatible living-donor transplantation is considered the gold standard. Transplantation is the best treatment for many children with ESRD; pediatric renal disease often reflects congenital renal or urologic anomalies and children frequently undergo primary or preemptive transplantation, where transplant is performed before dialysis as the first mode of treatment.

Clinical Thresholds and Timeframes

Coverage Thresholds

Adult GFR thresholdMeasured or calculated GFR < 20 mL/min (age 18+)

Pediatric GFR thresholdMeasured or calculated GFR < 30 mL/min (age 17 and younger)

Progression documentation windowProgressive and irreversible deterioration over previous 6 consecutive months

HIV CD4 requirementCD4 count greater than 200 cells/mm-3 for more than six (6) consecutive months

HIV viral load requirementHIV-1 RNA undetectable

HIV ART stabilityOn stable antiretroviral therapy more than three (3) consecutive months

Policy Summary

PayerAlliance Health

PolicyKidney (Renal) Transplantation

Policy CodePolicy Clinical Coverage Policy No: 11B-4

Change TypeNo material clinical changes

Effective Date197-07-01

Next Review Date

SourceLink

On This Page

OpenPayer

Kidney (Renal) Transplantation

Medical Necessity Criteria for Kidney Transplantation

Coding, Claim Forms, and Donor Billing Guidance

Prior Auth, Documentation & Billing Actions for Providers

Clinical Background

Defined Terms

Clinical Thresholds and Timeframes

Kidney (Renal) Transplantation

Medical Necessity Criteria for Kidney Transplantation

Coding, Claim Forms, and Donor Billing Guidance

Prior Auth, Documentation & Billing Actions for Providers

Clinical Background

Defined Terms

Clinical Thresholds and Timeframes

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