Transplants, Solid Organ Clinical Coverage Criteria
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Defines Fallon Community Health Plan's coverage policy, prior authorization requirements, and clinical criteria for solid organ transplants (liver, kidney, pancreas, intestine, heart, heart‑lung and related combinations) for applicable Fallon products; affects providers requesting transplant authorization and transplant centers.
Effective March 1, 2025 Fallon Health will use InterQual® Criteria for adult liver, kidney, and heart transplantation medical necessity determinations.
Organ transplants require prior authorization and only members accepted and actively listed by a Transplant Center will be considered.
Coverage and Medical Necessity Criteria
Liver transplantation (adult)
Adult liver transplantation (Community Care members):
InterQual criteria available via Fallon Transparency Tool.
Kidney transplantation (adult)
Adult kidney transplantation (Community Care members):
InterQual criteria available via Fallon Transparency Tool.
Heart transplantation (adult)
Adult heart transplantation (Community Care members):
InterQual criteria available via Fallon Transparency Tool.
SPK transplantation
Simultaneous pancreas-kidney (SPK):
Criteria for pancreas alone do not apply when a kidney is also being transplanted.
Pancreas transplantation (SPK, PAK, PTA)
Pancreas transplantation:
Criteria for pancreas alone are not applicable when member already had a kidney transplant.
Better outcomes associated with younger age (<50 years), BMI <30 kg/m2, and absence of coronary artery disease due to lower operative risk.
Intestinal and multivisceral transplantation
Intestinal and multivisceral transplantation (MassHealth ACO and Community Care members):
Small bowel + liver transplant may be necessary when there is impending end-stage liver failure due to chronic TPN.
Heart-lung transplantation
Heart-lung transplantation (Community Care members):
Pediatric requests (age <18) are reviewed case-by-case.
Pediatric heart transplantation criteria
Pediatric heart transplantation:
AHA Class I = conditions for which transplantation is useful and effective.
Heart-Lung Transplantation (Adult)
Covered when ALL of the following are met for adult Community Care members:
Pediatric (age < 18) requests are reviewed case-by-case.
Medicare NCD applicability
Medicare-determined coverage overrides or makes the Plan criteria inapplicable where NCDs are fully established:
Medicare covers kidney, heart, lung, heart/lung, liver, pancreas, pancreas/kidney, and intestinal/multi-visceral transplants per Medicare policy.
Administrative and payer-specific coverage determination rules
Policy applicability and source hierarchy for medical necessity determinations
Adoption of InterQual criteria for certain adult transplants and added pediatric heart criteria for Community Care members is recorded in policy history.
For adult (age ≥ 18 years) liver, kidney, and heart transplantation medical necessity determinations for Community Care members, Fallon Health will rely on InterQual® CP: Procedures, Transplantation criteria effective for dates of service on or after March 1, 2025. InterQual criteria for each organ (Liver, Renal, Cardiac) are the referenced source for coverage decisions and are made available via Fallon’s Transparency Tool. Pediatric requests (age < 18 years) for these organs will be reviewed on an individual, case-by-case basis in accordance with medical necessity rather than by automatic application of InterQual adult criteria.
The policy explicitly excludes certain services as experimental or not covered. The Heartsbreath Test for Heart Transplant Rejection (CPT 0085T) is considered experimental and is not covered. In addition, allogeneic islet cell transplantation for treatment of type 1 diabetes is considered experimental and investigational and is not covered under this policy.
Coverage under this policy is subject to the terms of the member’s specific benefit plan. Not all services referenced in the policy are covered for all Fallon products or employer groups; a member’s Evidence of Coverage and any plan-specific exclusions or limitations take precedence. If there is a discrepancy between this policy and a member’s benefit plan, the benefit plan provisions govern, except where applicable state or federal mandates take precedence.
Pancreas transplantation guidance distinguishes transplant types: Simultaneous pancreas-kidney (SPK) is medically necessary for members with insulin-dependent diabetes mellitus (IDDM) and end-stage renal disease when kidney transplant criteria are also met. Pancreas after kidney (PAK) is medically necessary for IDDM members after a prior successful kidney transplant. Pancreas transplant alone (PTA) is medically necessary only when all required criteria are met (frequent severe metabolic complications, incapacitating clinical/emotional problems with insulin therapy, and consistent failure of insulin-based management). The PTA selection guidance notes better outcomes in relatively young (<50 years), non-obese (<30 kg/m2) patients without coronary artery disease, and emphasizes balancing benefits of PTA against the risks of immunosuppression for patients without advanced nephropathy.
The Heartsbreath Test for Heart Transplant Rejection (CPT 0085T) is specifically identified as experimental and not covered by this policy; Medicare’s National Coverage Determination for the Heartsbreath Test (NCD 260.10) likewise does not provide coverage for this test.
If a member’s benefit plan excludes a given service, that exclusion overrides medical necessity determinations made under this policy; in other words, even if a service is medically necessary per this policy, it will not be covered when the member’s specific benefit plan excludes the service or contains limiting provisions.
Codes and Age Definitions
| 0085T | Heartsbreath Test for Heart Transplant Rejection |
Prior Authorization, Listing, and Provider Requirements
Prior authorization required
Organ transplants require prior authorization. Only members accepted for transplant by a Transplant Center and actively listed for transplant will be considered for prior authorization; the member must meet the Transplant Center eligibility and be willing and capable of following the post‑transplant treatment plan.
- Prior authorization is required for all organ transplants.
- Member must be accepted and actively listed at an OPTN-member Transplant Center.
Prior authorization and medical necessity review for heart-lung
Fallon Health reviews heart‑lung transplantation requests for adult Community Care members for medical necessity; pediatric (age <18) requests are reviewed on an individual case‑by‑case basis. For Medicare Advantage members, applicable CMS NCDs/LCDs and transplant center approval requirements apply first.
- Adult heart‑lung transplant requests are subject to Fallon Health medical necessity review for Community Care members.
- Pediatric heart‑lung requests are reviewed case‑by‑case.
- Medicare Advantage determinations must follow CMS NCDs/LCDs and related Medicare requirements.
Prior authorization and applicable coverage determinations (Medicare/MassHealth/NaviCare/PACE)
Prior authorization and medical necessity determinations must follow applicable CMS NCDs/LCDs for Medicare Advantage members, follow MassHealth Medical Necessity Guidelines for MassHealth members, and for NaviCare follow Medicare NCDs/LCDs first then MassHealth if Medicare criteria are not applicable; PACE services (except emergency and out‑of‑area urgent care) require authorization by the PACE interdisciplinary team.
- Medicare Advantage: comply with CMS NCDs/LCDs and Medicare statutes/regulations.
- MassHealth: follow MassHealth Medical Necessity Guidelines.
- NaviCare: Medicare rules first, then MassHealth if needed.
- PACE: interdisciplinary team authorization required for non‑emergency services.
Pancreas transplant selection considerations
Pancreas transplant alone (PTA) candidate selection requires IDDM and all of the following: (1) history of frequent, acute, severe metabolic complications requiring medical attention; (2) clinical and emotional problems with exogenous insulin therapy so severe as to be incapacitating; and (3) consistent failure of insulin‑based management to prevent acute complications.
- PTA is considered medically necessary only when all three criteria (metabolic complications; incapacitating insulin therapy problems; failure of insulin management) are satisfied.
- Selection favors younger (<50 years), non‑obese (<30 kg/m2), and no coronary artery disease to minimize operative mortality.
Step therapy (not specified)
Step therapy is not specified in this policy for transplant services.
- No step therapy requirements are described in the referenced sections.
Step therapy (not specified in other chunks)
Step therapy requirements are not provided in the available policy text for other transplant indications.
- Policy does not define step therapy sequencing or prerequisites for the transplant services discussed.
Listing and member capability
Authorization requests must be for members who have been accepted for transplant by a Transplant Center and are actively listed; the member must meet the Transplant Center eligibility criteria and be willing and capable of following the post‑transplant treatment plan.
- Active listing at an OPTN-member Transplant Center is required for consideration.
- Member capability and willingness to adhere to post‑transplant treatment is a condition for consideration.
Site and claims documentation requirements
For Medicare-covered transplants, the procedure must be performed in a hospital with a CMS‑Approved Organ Transplant Program; follow the Medicare Claims Processing Manual, Chapter 3, Section 90 for claims processing and applicable billing requirements when submitting requests.
- Use the QCOR list of CMS‑Approved Organ Transplant Programs to confirm site eligibility.
- Follow Medicare claims processing guidance (Chapter 3, Section 90) for billing transplant services.
Payer-specific determination rules for Medicare Advantage
For Medicare Advantage members, Fallon follows applicable CMS NCDs/LCDs and Medicare statutes/regulations when making medical necessity determinations; when Medicare criteria are not established, Fallon may create internal criteria under specified circumstances.
- Medicare NCDs/LCDs and Medicare law take precedence for Medicare Advantage determinations.
- If Medicare criteria are not fully established, Fallon may apply internal criteria as allowed under §422.101(b)(6).
Prior authorization and active listing required — denial risk
Failure to obtain prior authorization or to have the member accepted and actively listed by a Transplant Center will result in a denial risk for transplant authorization and related claims.
- Prior authorization and active listing are prerequisites for coverage consideration.
- Requests that do not meet these prerequisites may be denied.
Experimental test excluded — Heartsbreath CPT 0085T denial
Requests for the Heartsbreath Test for Heart Transplant Rejection (CPT 0085T) will be denied as experimental and not covered.
- Heartsbreath Test (CPT 0085T) is explicitly listed as experimental and not covered.
- See Medicare NCD 260.10 for the national non‑coverage determination.
Benefit plan governs coverage
Coverage is governed by the member's specific benefit plan; if a member's benefit plan excludes a service, that exclusion controls even if the service meets medical necessity under this policy.
- Consult the member's Evidence of Coverage for plan‑specific exclusions or limitations.
- If policy and benefit plan conflict, the benefit plan provisions govern (subject to applicable state or federal mandates).
Listing, Candidate Selection, and Contraindications
Candidate listing — listing and acceptance criteria
Listing and acceptance:
Member must meet the Transplant Center eligibility and be willing and capable of following the post-transplant treatment plan.
Pancreas-alone candidate criteria (PTA)
PTA candidate criteria (summary):
Consider age, BMI, and coronary artery disease when assessing surgical risk and selection (better outcomes if age <50, BMI <30 kg/m2, no CAD).
Heart-Lung Candidate Criteria (adult)
Adult candidates for heart-lung transplant must have end-stage disease due to one of the specified etiologies.
Pediatric candidates (<18) considered on a case-by-case basis.
For pancreas transplant alone (PTA), selection and contraindication considerations are noted: the presence of obesity, older age, or coronary artery disease are unfavorable factors that influence selection because they are associated with increased operative risk and worse outcomes. These factors inform candidate selection but are not listed as absolute contraindications in this portion of the policy.
No additional contraindications are specified in this portion of the document beyond organ‑ and procedure‑specific selection considerations; Medicare Conditions of Participation and applicable payer rules (for example 42 CFR Part 482 Subpart E for transplant centers) apply to facility and program requirements, and individual transplant centers determine candidate suitability consistent with those regulatory standards.
Pre-Transplant Evaluation and Documentation
Evaluation requirements — Transplant Center eligibility and workup
Transplant centers performing the evaluation must determine member eligibility; the specific evaluation workup is referred to the Transplant Center (and to InterQual for adult liver, kidney and heart where applicable).
- Member must meet the Transplant Center's eligibility criteria and be willing/capable of post‑transplant care.
Evaluation requirements — follow CMS NCDs/LCDs and MassHealth
Follow applicable CMS NCDs/LCDs and MassHealth Medical Necessity Guidelines for required pre‑transplant evaluations when assessing Medicare Advantage, MassHealth, and NaviCare members.
Evaluation requirements — follow applicable external guidelines when available
When external guidance (CMS NCDs/LCDs or MassHealth guidelines) is available, follow those requirements; in their absence, the Transplant Center evaluation and any internal criteria described by Fallon Health apply.
Transplant Center and Site Requirements
Center requirements — OPTN membership and InterQual reference
Transplant Centers must be members of the OPTN network and all organ transplants must be performed at OPTN‑member transplant centers; InterQual criteria are referenced for adult liver, kidney and heart determinations effective March 1, 2025.
- OPTN‑approved centers are listed in the OPTN Member Directory.
- InterQual criteria referenced for adult liver, kidney, and heart are available via Fallon's Transparency Tool.
Post-Transplant Care and Trial Coverage
Key Terms and Definitions
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