Transplant Service Documentation Requirements Form

Page 1 of 10 Clinical Policy: Transplant Service Documentation Requirements Reference Number: CP.MP.247

 Coding Implications

Date of Last Revision: 10/25
Revision Log

See Important Reminder at the end of this policy for important regulatory and legal information.

Description
The pre-transplant evaluation provides the opportunity to identify conditions that can affect an individual’s ability to have a successful transplant. Identifying those who may benefit from a transplant involves many factors; overall health and disease stage are all extremely important considerations in the evaluation process. The pre-transplant evaluation phase includes covered diagnostic tests and consultations performed by a provider that are necessary to assess and evaluate transplant candidacy for acceptance into a transplant program. The determination of medical necessity for transplant procedures is based on a combination of clinical data and the presence of indicators that would complicate surgery and affect postoperative recovery. The following policy outlines clinical documentation required for review of all solid organ and stem cell/bone marrow transplant evaluation and listing requests. Transplant admission requests are subject to separate prior authorization per plan-adopted guidelines. Note: • For corneal transplant, pancreatic islet cell auto-transplant after pancreatectomy, or parathyroid auto-transplant after thyroidectomy requests, please complete the Health Plan specific prior authorization form located on the Health Plan website. • This policy notes documentation requirements only for solid organ and stem cell transplant requests. Please refer to plan-approved medical necessity criteria for solid organ and stem cell transplant requests. • For criteria applicable to Medicare plans, please see MC.CP.MP.247 Transplant Service Documentation Requirements. Policy/Criteria I. It is the policy of health plans affiliated with Centene Corporation® that requests for transplant evaluation or consultation for stem cell or solid organ transplants or transplant listing at a participating facility are medically necessary when all the following clinical documentation is included: A. For transplant evaluation requests, all the following:

1. Appropriate prior authorization form;
2. Complete history and physical within one year. Note:
   • A complete history and physical includes a history of present illness, including a list of all current medications, past medical history, pertinent family history and social history, a complete review of systems, and physical examination, including height, weight and body mass index (BMI); • Approved requests for transplant evaluation are effective for six months. After six months have passed, a new authorization is required.

CLINICAL POLICY Transplant Service Documentation Requirements Page 2 of 10 • All evaluation requests for sickle cell anemia and beta thalassemia require medical director review for evaluation of relevant symptoms and medical history. B. For initial and subsequent autologous stem cell transplants or initial and subsequent allogeneic stem cell or solid organ transplant listing requests, all the following:

1. Appropriate prior authorization form;
2. Letter of medical necessity from a transplant service provider with signature;
3. Complete history and physical performed by a transplant service provider within 12 months of kidney transplant requests or six months of other transplant requests, including: a. History of present illness, including a list of all current medications; b. Past medical history, pertinent family history and social history; c. Complete review of systems, physical examination, including height, weight and BMI;
4. Complete chemistry panel, liver function tests, and complete blood count within 12 months for kidney transplants or six months for other transplants;
5. Appropriate testing, imaging, and documentation for the requested transplant: a. Liver – international normalized ratio (INR), Model for End Stage Liver Disease (MELD) or Pediatric End Stage Liver Disease Model (PELD) score, hepatitis serologies, imaging studies (MRI, CT, ultrasound), and liver biopsy as indicated; b. Kidney – glomerular filtration rate (GFR) or creatinine clearance if not on dialysis; c. Heart – echocardiogram, right cardiac catheterization results, including pulmonary vascular resistance (PVR) results,. NYHA Class and peak VO2 results; d. Lung – pulmonary function tests, imaging (chest x-rays and/or CT scans), and six- minute walk test; e. Pancreas – history of insulin treatment; f. Intestine/multivisceral - documentation of failed total parenteral nutrition (TPN); g. Stem cell – most recent bone marrow biopsy as indicated, most recent Eastern Cooperative Oncology Group (ECOG) score or Karnofsky score, lumbar puncture if clinically indicated (e.g. acute lymphoblastic leukemia), and documentation of donor identification for allogeneic transplants;
6. Annual dental evaluation and clearance documented by one of the following: a. Transplant clearance from DDS; b. Panoramic dental x-ray with clearance from MD;
7. Routine health screening exams as per standards of care (e.g., breast cancer screening, cervical cancer screening, and/or colon cancer screening);
8. Appropriate comorbidity testing/clearance,
9. Cardiology testing/clearance including an echocardiogram, EKG, and/or additional testing if clinically indicated;
10. Serum or urine drug screen results within 90 days of request;
11. Infectious disease screening, all of the following: a. Cytomegalovirus (CMV) and Varicella-zoster virus (VZV) within one year unless baseline IgG antibody positive; b. EBV (Epstein Barr virus) within one year, unless baseline IgG antibody positive; c. Toxoplasma titer for heart transplant recipients;

CLINICAL POLICY Transplant Service Documentation Requirements Page 3 of 10 d. Results of annual purified protein derivative (PPD), T-Spot, or QuantiFERON for all solid organ transplants, unless previously positive; e. Hepatitis B testing within one year, unless baseline surface antibody positive; f. Hepatitis C testing within one year unless baseline results are positive; Note: If baseline results are positive, a viral load test is required within three months. g. Rapid plasma reagin (RPR) within one year;
h. Human immunodeficiency virus (HIV) within one year, unless baseline results are positive; Note: If baseline results are positive, a CD4 count and a viral load test are required within three months.

12. Detailed psychosocial evaluation and clearance within 12 months for kidney transplants and six months for other transplants. Note:
    • Approved requests for transplant listings are effective for 12 months. After 12 months have passed, a new authorization with updated clinical documentation is required. • Inpatient admissions for transplants require separate authorization from evaluation or listing authorizations. C. For post-transplant follow up office visits, all the following:
13. Appropriate prior authorization form;
14. Discharge summary or history and physical from the inpatient hospital stay for the transplant admission; Note: For authorization requirements for services unrelated to post-transplant follow up office visits, please check the health plan’s prior authorization tool. D. Requests for continuity of care listing authorizations, all the following:
15. Documentation of previous insurer coverage, such as if previously covered by state Medicaid fee for service;
16. Documentation of authorization for transplant listings by previous insurer;
17. Copy of United Network for Organ Sharing (UNOS) listing for solid organ transplants. II. It is the policy of health plans affiliated with Centene Corporation that authorizations for transplant services at multiple facilities for a single member/enrollee or requests for additional evaluations following transplant listing, or transplant evaluation approval has already been rendered, are considered medically necessary for either of the following: A. Member/enrollee has an episode of illness resulting in a change to transplant eligibility status; B. Member/enrollee is admitted to a geographically closer facility and is not stable for transfer to the previously approved facility due to declining medical status. Background According to the United Network for Organ Sharing (UNOS), more than 48,000 organ transplants were performed in 2024, continuing the annual record setting trend.4 Annual records were set for kidney, liver, and heart transplants with the 40,000-transplant milestone exceeded for the first time. The Health Resources and Services Administration (HRSA) reports that 5,073 unrelated and 4,276 related bone marrow and cord blood transplants were performed in the

CLINICAL POLICY Transplant Service Documentation Requirements Page 4 of 10 United States in 2021 and reported to the Center for International Blood and Marrow Transplant Research CIBMTR.3 The Organ Procurement and Transplantation Network (OPTN) reports that there are more than 105,000 people on the national transplant waiting list with a new name added to the list approximately every nine to ten minutes.1,2 There are more people in need of transplants than there are donors, and 13 people die each day waiting for an organ transplant.4 Organ donation from one donor can save eight lives and enhance more than 75 lives.1,2,4,5 Solid Organ Transplantation Chronic diseases, such as cardiovascular, kidney, and liver disease, as well as, cancer, and diabetes are primary causes of morbidity and mortality in the United States.6 Solid organ transplantation is the treatment of choice for several types of organ failure.7 Most available organ donations come from deceased donors, but more than 6,000 transplants come from healthy, living donors each year. A series of tests must be completed to ensure the donor and recipient blood and tissue types are compatible.8 A pretransplant evaluation identifies the risk for post- transplant infections and evaluates exposure history, prior infections, serologic testing for distant exposures, cultures to identify colonization patterns, and administration of vaccines. Active infections, such as HIV, hepatitis B and C, and severe acute respiratory syndrome coronavirus 2 are evaluated near the time of transplantation as well.7 Additional factors that may be considered during the process are the patient’s current medical status, geographical location, and time on the transplant list.9 Organ transplantation can still occur in the absence of donor and recipient blood and tissue match; however, special treatments are needed to prevent rejection of the organ.8 Infection and malignancy are two complications that result from the life-long immunosuppression required to maintain allograft function following transplantation. Since established infection is more challenging to treat in the immunocompromised transplant recipient, the pretransplant evaluation is essential to treatment and must be comprehensive.7 Stem Cell/Bone Marrow Transplantation Autologous hematopoietic cell transplantation (HCT) describes the use of a patient’s own cells to rebuild bone marrow following intensive chemotherapy and/or radiation therapy to treat cancer. Treatment outcomes are dependent upon indicated risks and the underlying disease process. Diseases that can be treated include but are not limited to, multiple myeloma, Hodgkin lymphoma, acute myeloid leukemias and amyloidosis. Pretransplant evaluation prior to autologous HCT should include an assessment of comorbid conditions and the status of the underlying cancer. The evaluation should also include a clinical assessment, laboratory studies, and infectious disease screening, as well as cardiac and pulmonary assessments, and a bone marrow and central nervous system evaluation. An assessment of functional status is also recommended using either the Eastern Cooperative Oncology Group (ECOG) scale or Karnofsky Performance Status. Eligibility criteria varies between institutions but should include comorbidities, organ function, functional status, psychosocial status and disease state.10 Allogeneic hematopoietic cell transplantation (HCT) describes the use of hematopoietic cells from another healthy person (e.g., sibling, relative, volunteer donor, umbilical cord blood) to treat a variety of hematologic cancers and nonmalignant marrow disorders, including inborn error of metabolism. Variation exists in eligibility requirements across countries and institutions. Diseases that can be treated include, but are not limited to, acute myeloid leukemia (AML), chronic lymphoblastic leukemia (ALL), follicular lymphoma, nonhematologic malignancies, and

CLINICAL POLICY Transplant Service Documentation Requirements Page 5 of 10

nonmalignant inherited and acquired marrow disorders. A pretransplant assessment evaluates the extent of disease and severity of comorbidities to determine the appropriateness of the candidate. The assessment includes a detailed history and physical examination, chest x-ray, electrocardiogram, pulmonary function tests, cardiac function study, and laboratory tests, inclusive of an assessment of prior exposure to infectious agents. Although numerous scoring systems are available for estimating mortality risk in patients considering allogenic HCT, the European Group for Blood and Marrow Transplantation (EBMT) risk assessment score for allogeneic transplantation and the Hematopoietic Cell Transplantation - Specific Comorbidity Index (HCT-CI) are most frequently used. Future studies are needed to validate the various scoring systems, however, all scoring systems, including the Karnofsky performance status, can help patients understand mortality risk following allogeneic HCT. Pretransplant counseling is also suggested to support end-of-life advance care planning, fertility preservation, and patient expectations.11 Coding Implications This clinical policy references Current Procedural Terminology (CPT®). CPT® is a registered trademark of the American Medical Association. All CPT codes and descriptions are copyrighted 2024, American Medical Association. All rights reserved. CPT codes and CPT descriptions are from the current manuals and those included herein are not intended to be all-inclusive and are included for informational purposes only. Codes referenced in this clinical policy are for informational purposes only. Inclusion or exclusion of any codes does not guarantee coverage.
Providers should reference the most up-to-date sources of professional coding guidance prior to the submission of claims for reimbursement of covered services. Reviews, Revisions, and Approvals Revision Date Approval Date New policy created based on CC.UM.18.06 Required Clinical Documentation Transplant Service Authorization. Internal specialist reviewed. 11/22 11/22 Adjusted time requirement to reflect 12 months for kidney transplants and 6 months for other transplants in I.B.3., 4., and 11. Added “with updated clinical documentation” to Note after I.B.11. 12/22 12/22 Annual review. Minor rewording throughout Criteria with no impact on criteria. Criteria I.B.2. and Criteria I.B.3. updated to say “provider” instead of “physician.” Criteria I.B.5. updated to include documentation. C-peptide removed from Criteria I.B.5.e. Criteria I.B.5.f. updated to remove “no specific additional testing” and added documentation of failed total parenteral nutrition. Criteria I.B.10.g. updated to say rapid plasma reagin. Background updated with no impact on criteria. References reviewed and updated. Reviewed by internal specialist. 11/23 11/23 Annual review. Background updated with no impact on criteria. References reviewed and updated. Reviewed by internal specialist and external specialist. 10/24 10/24 Clarified in description that the policy applies to transplant evaluation and listing requests. Added to the description and in a note after I.B.11 that transplant admissions require separate authorization. 02/25

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Reviews, Revisions, and Approvals Revision Date Approval Date Added requirements for post-transplant follow up visits and note in same section regarding other requests. 03/25 03/25 Updated policy statement I. regarding transplant evaluations by removing “following the first human leukocyte antigen…” 07/25 07/25 Annual review. Added notes under Description regarding plan-approved criteria for medical necessity criteria for solid organ and stem cell transplant requests and criteria applicable to Medicare plans. Added transplant consultation to Criteria I. Updated verbiage in Criteria I.A.2. for clarity. Changed criteria I.A.2.a.-c. into a note. Added additional note under Criteria I.A.2. regarding evaluation requests for sickle cell anemia and beta thalassemia. Updated Criteria I.B. to specify initial and subsequent autologous stem cell transplants or initial and subsequent allogeneic stem cell or solid organ transplant listing requests. Updated verbiage in Criteria I.B.4. for clarity. Removed BMI from Criteria I.B.5.e. since BMI is addressed in Criteria I.B.3.c. Updated Criteria I.B.5.g. to include lumbar puncture when clinically indicated. Verbiage updated in Criteria I.B.6. for clarity. Updated verbiage in Criteria I.B.7. to “breast cancer screening”, “cervical cancer screening,” and “colon cancer screening” and removed note that routine health screenings per standards of care are not required for autologous stem cell transplants. Removed “including cardiology” from Criteria I.B.8. Added Criteria I.B.9. regarding cardiology testing/clearance. Removed verbiage specifying only solid organ or allogeneic stem cell transplants in Criteria I.B.11. Updated verbiage in Criteria I.B.11., I.B.11.f., and I.B.11.h. for clarity. Updated verbiage in Criteria I.D., I.D.2., and I.D.3. for clarity. Background updated with no impact to criteria. References reviewed and updated. Reviewed by internal specialist. 10/25 10/25 References

1. United Network for Organ Sharing (UNOS). All-time records again set in 2021 for organ transplants, organ donation from deceased donors. https://unos.org/news/2021-all-time- records-organ-transplants-deceased-donor-donation/. Published January 11, 2022. Accessed August 25, 2025.
2. United Network for Organ Sharing (UNOS). UNOS fast facts. https://unos.org/about/fast- facts/. Accessed August 26, 2025.
3. Health Resources & Services Administration (HRSA). Donation ad transplantation statistics. March 2024. https://bloodstemcell.hrsa.gov/data/donation-and-transplantation- statistics#:~:text=In%202021%2C%205%2C073%20unrelated%20and,States%20and%20rep orted%20to%20CIBMTR. Updated September 2025. Accessed September 11, 2025.
4. Health Resources & Services Administration (HRSA). Organ donation statistics. March
5. https://www.organdonor.gov/learn/organ-donation-statistics. Updated May 2025. Accessed September 17, 2025.

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5. LifeSource Organ, Eye and Tissue Donation. Fast facts: January through March 2023. https://www.life-source.org/latest/fast-facts/. Published April 18, 2023. Accessed September 09, 2025.
6. Chronic Disease Research Group (CDRG). Chronic disease research. Minneapolis, MN: Hennepin Healthcare Research Institute. https://www.cdrg.org/expertise/chronic-disease- research/. Accessed September 05, 2025.
7. Fishman JA. Evaluation for infection before solid organ transplantation. UpToDate. www.uptodate.com. Updated April 15, 2024. Accessed September 05, 2025.
8. Watson S. Organ donation and transplant. WebMD. https://www.webmd.com/a-to-z- guides/organ-transplant-donor-information. Updated March 19, 2024. Accessed September 11, 2025.
9. United Network for Organ Sharing (UNOS). UNOS frequently asked questions. https://unos.org/transplant/frequently-asked-questions/. Accessed September 17, 2025.
10. Holmberg LA, Sandmaier BM. Determining eligibility for autologous hematopoietic cell transplantation. UpToDate. www.uptodate.com. Updated November 14, 2024. Accessed September 05, 2025.
11. Deeg HJ, Sandmaier BM. Allogeneic hematopoietic cell transplantation: Indications, eligibility, and prognosis. UpToDate. www.uptodate.com. Updated August 05, 2025. Accessed September 11, 2025.
12. Rossi AP, Cheng XS. Kidney transplantation in adults: evaluation of the potential kidney transplant recipient. UpToDate. www.uptodate.com. Updated September 04, 2025. Accessed September 16, 2025.
13. Foundation for the Accreditation of Cellular Therapy (FACT) and Joint Accreditation Committee ISCT and EBMT (JACIE). International standards for hematopoietic cellular therapy product collection, processing and administration. 8th Ed.Version 8.1. Published December 14, 2021. Accessed September 16, 2025.
14. Hachem RR. Lung transplantation: an overview. UpToDate. www.uptodate.com. Updated May 23, 2024. Accessed September 11, 2025.
15. United Network for Organ Sharing (UNOS). MELD and PELD information for liver transplants. https://unos.org/policy/liver/. Accessed September 17, 2025.
16. Organ Procurement and Transplantation Network(OPTN). Organ distribution policies and bylaws. https://optn.transplant.hrsa.gov/policies-bylaws/. Accessed September 17, 2025.
17. Mancini D. Heart transplantation in adults: Indications and contraindications. UpToDate. www.uptodate.com. Updated October 25, 2024. Accessed September 11, 2025.
18. Chadban SJ, Ahn C, Axelrod DA, et al. KDIGO Clinical Practice Guideline on the Evaluation and Management of Candidates for Kidney Transplantation. Transplantation. 2020;104(4S1 Suppl 1):S11-S103. doi:10.1097/TP.0000000000003136
19. Leard LE, Holm AM, Valapour M, et al. Consensus document for the selection of lung transplant candidates: An update from the International Society for Heart and Lung Transplantation. J Heart Lung Transplant. 2021;40(11):1349-1379. doi:10.1016/j.healun.2021.07.005
20. National coverage determination: adult liver transplantation (260.1). Centers for Medicare and Medicaid Services Web site. http://www.cms.hhs.gov/mcd/search.asp. Published June 21, 2012. Accessed August 30, 2025.

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21. National coverage determination: pediatric liver transplantation (260.2). Centers for Medicare and Medicaid Services Web site. http://www.cms.hhs.gov/mcd/search.asp. Published April 12, 1991. Accessed September 17, 2025.
22. National coverage determination: heart transplants (260.9). Centers for Medicare and Medicaid Services Web site. http://www.cms.hhs.gov/mcd/search.asp. Published May 01,
23. Accessed September 17, 2025.
24. National coverage determination: pancreas transplants (260.3). Centers for Medicare and Medicaid Services Web site. http://www.cms.hhs.gov/mcd/search.asp. Published April 26,
25. Accessed September 17, 2025.
26. National coverage determination: intestinal and multi-visceral transplantation (260.5). Centers for Medicare and Medicaid Services Web site. http://www.cms.hhs.gov/mcd/search.asp. Published May 11, 2006. Accessed September 05,
28. National coverage determination: stem cell transplantation (formerly 110.8.1) (110.23). Centers for Medicare and Medicaid Services Web site. http://www.cms.hhs.gov/mcd/search.asp. Published March 06, 2024. Accessed September 17, 2025.
29. United Network for Organ Sharing (UNOS). Guidance on requested deceased donor information. https://optn.transplant.hrsa.gov/media/2528/opo_boardreport_201806_guidance.pdf. Published June 2018. Accessed September 17, 2025.
30. Wingard JR. Evaluation for infection before hematopoietic cell transplantation. UpToDate. www.uptodate.com. Updated March 05, 2025. Accessed September 17, 2025.
31. National Comprehensive Cancer Network® . NCCN Clinical Practice Guidelines in Oncology: Acute Lymphoblastic Leukemia (Version 2.2025). Updated June 27, 2025. Accessed September 23, 2025.
    Important Reminder This clinical policy has been developed by appropriately experienced and licensed health care professionals based on a review and consideration of currently available generally accepted standards of medical practice; peer-reviewed medical literature; government agency/program approval status; evidence-based guidelines and positions of leading national health professional organizations; views of physicians practicing in relevant clinical areas affected by this clinical policy; and other available clinical information. The Health Plan makes no representations and accepts no liability with respect to the content of any external information used or relied upon in developing this clinical policy. This clinical policy is consistent with standards of medical practice current at the time that this clinical policy was approved. “Health Plan” means a health plan that has adopted this clinical policy and that is operated or administered, in whole or in part, by Centene Management Company, LLC, or any of such health plan’s affiliates, as applicable. The purpose of this clinical policy is to provide a guide to medical necessity, which is a component of the guidelines used to assist in making coverage decisions and administering benefits. It does not constitute a contract or guarantee regarding payment or results. Coverage decisions and the administration of benefits are subject to all terms, conditions, exclusions and limitations of the coverage documents (e.g., evidence of coverage, certificate of coverage, policy,

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contract of insurance, etc.), as well as to state and federal requirements and applicable Health Plan-level administrative policies and procedures. This clinical policy is effective as of the date determined by the Health Plan. The date of posting may not be the effective date of this clinical policy. This clinical policy may be subject to applicable legal and regulatory requirements relating to provider notification. If there is a discrepancy between the effective date of this clinical policy and any applicable legal or regulatory requirement, the requirements of law and regulation shall govern. The Health Plan retains the right to change, amend or withdraw this clinical policy, and additional clinical policies may be developed and adopted as needed, at any time. This clinical policy does not constitute medical advice, medical treatment or medical care. It is not intended to dictate to providers how to practice medicine. Providers are expected to exercise professional medical judgment in providing the most appropriate care and are solely responsible for the medical advice and treatment of members/enrollees. This clinical policy is not intended to recommend treatment for members/enrollees. Members/enrollees should consult with their treating physician in connection with diagnosis and treatment decisions. Providers referred to in this clinical policy are independent contractors who exercise independent judgment and over whom the Health Plan has no control or right of control. Providers are not agents or employees of the Health Plan. This clinical policy is the property of the Health Plan. Unauthorized copying, use, and distribution of this clinical policy or any information contained herein are strictly prohibited.
Providers, members/enrollees and their representatives are bound to the terms and conditions expressed herein through the terms of their contracts. Where no such contract exists, providers, members/enrollees and their representatives agree to be bound by such terms and conditions by providing services to members/enrollees and/or submitting claims for payment for such services.
Note: For Medicaid members/enrollees, when state Medicaid coverage provisions conflict with the coverage provisions in this clinical policy, state Medicaid coverage provisions take precedence. Please refer to the state Medicaid manual for any coverage provisions pertaining to this clinical policy. Note: For Medicare members/enrollees, to ensure consistency with the Medicare National Coverage Determinations (NCD) and Local Coverage Determinations (LCD), all applicable NCDs, LCDs, and Medicare Coverage Articles should be reviewed prior to applying the criteria set forth in this clinical policy. Refer to the CMS website at http://www.cms.gov for additional information.
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