12/12/17. I. Liver transplantation for children and adults (initial or retransplantation) - must satisfy the following: A and B

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1 Reference #: MC/T004 Page: 1 of 8 PRODUCT APPLICATION: PreferredOne Administrative Services, Inc. (PAS) ERISA PreferredOne Administrative Services, Inc. (PAS) Non-ERISA PreferredOne Community Health Plan (PCHP) PreferredOne Insurance Company (PIC) Individual PreferredOne Insurance Company (PIC) Large Group PreferredOne Insurance Company (PIC) Small Group Please refer to the member s benefit document for specific information. To the extent there is any inconsistency between this policy and the terms of the member s benefit plan or certificate of coverage, the terms of the member s benefit plan document will govern. Benefits must be available for health care services. Health care services must be ordered by a physician, physician assistant, or nurse practitioner. Health care services must be medically necessary, applicable conservative treatments must have been tried, and the most cost-effective alternative must be requested for coverage consideration. PURPOSE: The intent of this criteria document is to ensure services are medically necessary. GUIDELINES: Medical Necessity Criteria - must satisfy: I and none of II I. Liver transplantation for children and adults (initial or retransplantation) - must satisfy the following: A and B A. Request is for one of the following indications: Cholestatic diseases any of the following: a-d a. Biliary atresia b. Familial cholestatic syndromes c. Primary biliary cirrhosis d. Primary sclerosing cholangitis with development of secondary biliary cirrhosis 2. Hepatocellular disease any of the following: a-e a. Alcoholic cirrhosis b. Chronic active hepatitis with cirrhosis [hepatitis B or C] c. Cryptogenic cirrhosis d. Idiopathic autoimmune hepatitis e. Post-necrotic cirrhosis due to hepatitis B surface antigen negative state 3. Malignancies any of the following: a f a. Primary hepatocellular carcinoma (HCC) must meet all of the following: i v i. Lung metastases must be responsive to chemotherapy; and ii. Member is not a candidate for subtotal liver resection; and iii. Member meets UNOS criteria for tumor size and number; and iv. There is no identifiable extra-hepatic spread of tumor to surrounding lymph nodes, abdominal organs, bone or other sites; and v. Absence of macrovascular involvement.

2 Reference #: MC/T004 Page: 2 of 8 b. Hepatoblastoma must satisfy all of the following: i-iii i. Member is not a candidate for subtotal liver resection; and ii. Member meets UNOS criteria for tumor size and number; and iii. Absence of identifiable extra-hepatic spread of tumor to surrounding lungs, abdominal organs, bone or other sites. [Note: Spread of hepatoblastoma to veins and lymph nodes does not disqualify a member for coverage of a liver transplant.] c. Epithelioid hemangioendothelioma d. Intra-hepatic cholangiocarcinoma (ie, cholangiocarcinoma confined to the liver) e. Large, unresectable fibrolamellar HCC f. Metastatic neuroendocrine tumor (eg, carcinoid tumors, apudomas, gastrinomas, glucagonomas) must meet all of the following: i-iii i. Presence of severe symptoms; and ii. Metastases restricted to the liver; and iii. Appropriate medical, pharmacologic, or surgical therapy is ineffective, unavailable, or not applicable. 4. Vascular disease any of the following: a or b a. Budd-Chiari syndrome b. Veno-occlusive disease 5. Metabolic disorders and metabolic liver diseases with cirrhosis any of the following: a-e a. Alpha 1-antitrypsin deficiency b. Hemochromatosis c. Inborn errors of metabolism d. Protoporphyria e. Wilson s disease 6. Familial amyloid polyneuropathy 7. Polycystic disease of the liver 8. Porto-pulmonary hypertension (pulmonary hypertension associated with liver disease or portal hypertension) in persons with a mean pulmonary artery pressure (MPAP) by catheterization of less than 35mm Hg 9. Toxic reactions (fulminant hepatic failure due to mushroom poisoning, acetaminophen overdose, etc.) 10. Trauma 11. Hepato-pulmonary syndrome must satisfy all of the following: a-c a. Arterial hypoxemia (PaO2 less than 60mm Hg or AaO2 gradient greater than 20mm Hg in supine or standing position); and b. Chronic liver disease with non-cirrhotic portal hypertension; and c. Intrapulmonary vascular dilation (as indicated by contrast-enhanced echocardiography, technetium-99 macroaggregated albumin perfusion scan, or pulmonary angiography)

3 Reference #: MC/T004 Page: 3 of 8 B. Selection criteria - must satisfy one of the following: 1 or 2 1. For adolescents, older than 12 years of age, and adults must satisfy one of the following: a or b a. The member has a Model of End-Stage Liver Disease (MELD) score greater than 10; or b. The transplant is approved by the United Network for Organ Sharing (UNOS) Regional Review Board. 2. For children less than or equal to 12 years of age (initial or retransplantation) the transplant is approved by UNOS Regional Review Board. II. Contraindications - none of the following: A or B 1. Absolute contraindications 1. A pattern of demonstrated patient noncompliance which would place a transplanted organ at serious risk of failure. 2. Active alcohol or substance abuse 3. Smoking when the transplant center determines that the member s smoking status will compromise the transplant outcome 4. Uncontrolled psychiatric disorder that impairs the member s ability to give informed consent and/or be compliant with treatment regimen. 5. Presence of local or systemic disease, such as, but not limited to, systemic infection and co-existing medical conditions such as advanced heart or lung disease) likely to limit survival. 6. Inadequately treated malignancies outside of the liver with substantial likelihood of recurrence. 7. Nonmetastatic hepatocellular carcinoma with one lesion greater than or equal to 5 cm or greater than or equal to three lesions all less than 3 cm. 8. Presence of hepatitis B surface antigen (HBsAG) or hepatitis B e antigen (HbeAg) with fulminant hepatitis which is not responsive to antiviral therapy, such as, but not limited to, lamivudine 9. Inadequately controlled HIV/AIDS infection, defined as all of the following: a - d a. CD4 count less than 200 cells/mm3 for more than 6 months b. HIV-1 RNA (viral load) detectable c. Not on stable antiviral therapy for more than 3 months d. Other complications from AIDS, such as opportunistic infection, eg, aspergillus, tuberculosis, coccidioidomycosis, resistant fungal infections or neoplasms, eg, Kaposi's sarcoma. 10. Presence of any factors likely to limit/hinder one of the following: a or b a. Rehabilitation potential b. Ability to comply with pre- and post-transplant protocols

4 Reference #: MC/T004 Page: 4 of 8 B. Relative contraindications 1. Retransplantation when first transplant rejected due to noncompliance issues 2. Portal vein and superior mesenteric vein thrombosis EXCLUSIONS: The following is considered investigative (see Investigative List): Xenotransplantation DEFINITIONS: Abuse: A maladaptive pattern of use leading to clinically significant impairment or distress Active alcohol or substance abuse: Absence of formal behavioral/psychological treatment (for abuse) and has not been abstinent from alcohol or other substance/s for at least 3 (three) months prior to transplant. Multivisceral transplant: Includes the stomach, duodenum, pancreas, small intestine, and liver (liver is excluded if recipient liver is normal) Reduced-size liver transplant: A portion of a liver is cut to fit the needs of a small patient (predominantly pediatric patients) and implanted into the recipient. Split-liver transplant: Adult cadaver donor is split into two grafts maintaining its vascular and biliary pedicles and used for two recipients. BACKGROUND: This criteria document is based on expert professional practice guidelines and/or available reliable evidence. The three sources of donor livers are living related donors, living unrelated donors, and cadaver donors, although most come from cadaver donors. Transplanted livers may be whole or partial. Living adult donors may donate a portion of their liver. Guidelines for living donor and cadaver transplants are the same if medical/scientific evidence supports the procedure as standard/acceptable treatment for a specific condition and is not investigative. A designated transplant center/center of excellence may be required by the terms of the member s benefit plan for maximum benefit coverage. There are often many clinical trials and studies associated with transplants (where transplant is considered standard of care). Any component of the transplant that is part of a clinical trial or a study is not eligible for coverage. Refer to benefit plan and medical policy for transplant and re-transplantation benefits, limitations and exclusions, non-coverage explanation of investigational and study generated protocol services, and eligible/non-eligible benefits for the donor.

5 Reference #: MC/T004 Page: 5 of 8 When an absolute contraindication is present, the transplant will not be approved. The decision regarding the appropriateness of transplantation in the presence of one or more relative contraindications will be left up to transplanting facility. All approved transplants will be reviewed annually for medical necessity and to assess new medical/scientific evidence addressing the therapeutic benefit and safety of the transplant procedure or new contraindications to performing the transplant. All transplant requests require physician review. See Attachment A for documentation required before sending request to physician review.

6 Reference #: MC/T004 Page: 6 of 8 FOR INTERNAL USE ONLY COVERAGE: Prior Authorization: Yes Coverage is subject to the member s contract benefits. CODING: CPT Liver allotransplantation; orthotopic, partial or whole, from cadaver or living donor, any age CPT codes copyright 2017 American Medical Association. All Rights Reserved. CPT is a trademark of the AMA. The AMA assumes no liability for the data contained herein RELATED CRITERIA/POLICIES: Process Manual: UR015 Use of Medical Policy and Criteria Medical Policy: MP/C009 Coverage Determination Guidelines Medical Policy: MP/I001 Investigative Services Medical Policy: MP/T006 PreferredOne Designated Transplant Network Provider REFERENCES: 1. Boudi FB. Pediatric. Medscape Retrieved from Accessed October 19, Cross TJ, Antoniades CG, Muiesan P et al. Liver transplantation in patients over 60 and 65 years: An evaluation of long-term outcomes and survival. Liver Transpl Oct;13(10): Murray KF, & Carithers RL. AASLD Practice Guidelines: Evaluation of the patient for liver transplantation American Association for the Study of Liver Diseases (AASLD). Hepatology. DOI /hep Centers for Medicare & Medicaid Services. National Coverage Determination (NCD) for Adult Liver Transplantation (260.1) Retrieved from sota&keyword=liver+transplant&keywordlookup=title&keywordsearchtype=and&bc=gaaaabaaaa AAAA%3d%3d& 5. Centers for Medicare & Medicaid Services. National Coverage Determination (NCD) for Pediatric Liver Transplantation (260.2) Retrieved from sota&keyword=liver+transplant&keywordlookup=title&keywordsearchtype=and&bc=gaaaabaaaa AAAA%3d%3d& 6. Dove LM, Brown Jr RS. Patient selection for liver transplantation. In: UpToDate, Travis AC (Ed), UpToDate, Waltham, MA. (Accessed on June 16, 2014.) 7. Martin P, DiMartini A, Feng S, Brown Jr R, Fallon M. Evaluation for liver transplantation in adults: 2013 practice guideline by the American Association for the Study of Liver Diseases and the American Society of Transplantation. Hepatology. 2014;59(3). Retrieved from _2015.pdf. Accessed October 19, Squires RH, Ng V, Romer R, et al. Evaluation of the pediatric patient for liver transplantation: 2014 practice guideline by the American Association for the Study of Liver Diseases, American Society of Transplantation and the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition. Hepatology. 2014;60(1): Retrieved from

7 Reference #: MC/T004 Page: 7 of 8 Accessed October 19, DOCUMENT HISTORY: Created Date: 07/99 Reviewed Date: 11/27/07, re-adopted 07/10/12, 07/09/13, 06/16/14, 06/16/15, 06/16/16, 11/15/16, 10/19/17 Revised Date: 11/16/04, 11/15/05, 11/28/06, 07/10/12, 08/06/13, 08/14/15, 08/16/16, 11/15/16, 10/19/17

8 Reference #: MC/T004 Page: 8 of 8 Attachment A Required documentation must have all of the following before sending to physician review: A - E A. Letter of medical necessity outlining the member s medical and treatment history and rationale for the proposed transplant. B. Formal transplant evaluation including, but not limited to, cardiac, pulmonary, and renal function. C. Recent relevant imaging reports. D. Recent relevant laboratory studies. E. Current psychosocial studies documented by a formal psychological or psychosocial evaluation. Attachment B Standard questions for physician review: A-G A. Is this procedure for this indication the subject of an ongoing Phase I, II, or III clinical trial? B. Do consensus opinions or recommendations in relevant scientific and medical literature, peer-reviewed journals, or reports of clinical trial committees and other technology assessment bodies (reliable evidence) support conclusively that this procedure is proven effective for this indication? C. Does reliable evidence suggest a high probability of improved outcomes compared to standard treatment (eg, significantly increased life expectancy or significantly improved function)? D. Does reliable evidence suggest conclusively that beneficial effects outweigh any harmful effects? E. Does the applicable NCCN (National Comprehensive Cancer Network) guideline support this procedure for this indication? [Include if this for an oncology diagnosis] F. Does reliable evidence suggest that this treatment is medically appropriate for this member? G. Are there any contraindications to this procedure for this member?

9 PreferredOne Community Health Plan Nondiscrimination Notice PreferredOne Community Health Plan ( PCHP ) complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. PCHP does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. PCHP: Provides free aids and services to people with disabilities to communicate effectively with us, such as: Qualified sign language interpreters Written information in other formats (large print, audio, accessible electronic formats, other formats) Provides free language services to people whose primary language is not English, such as: Qualified interpreters Information written in other languages If you need these services, contact a Grievance Specialist. If you believe that PCHP has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Grievance Specialist PreferredOne Community Health Plan PO Box Minneapolis, MN Phone: (TTY: ) Fax: customerservice@preferredone.com You can file a grievance in person or by mail, fax, or . If you need help filing a grievance, a Grievance Specialist is available to help you. You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights, electronically through the Office for Civil Rights Complaint Portal, available at or by mail or phone at: U.S. Department of Health and Human Services 200 Independence Avenue, SW Room 509F, HHH Building Washington, D.C , (TDD) Complaint forms are available at Language Assistance Services NDR PCHP LV (10/16)

10 PreferredOne Insurance Company Nondiscrimination Notice PreferredOne Insurance Company ( PIC ) complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. PIC does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. PIC: Provides free aids and services to people with disabilities to communicate effectively with us, such as: Qualified sign language interpreters Written information in other formats (large print, audio, accessible electronic formats, other formats) Provides free language services to people whose primary language is not English, such as: Qualified interpreters Information written in other languages If you need these services, contact a Grievance Specialist. If you believe that PIC has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Grievance Specialist PreferredOne Insurance Company PO Box Minneapolis, MN Phone: (TTY: ) Fax: customerservice@preferredone.com You can file a grievance in person or by mail, fax, or . If you need help filing a grievance, a Grievance Specialist is available to help you. You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights, electronically through the Office for Civil Rights Complaint Portal, available at or by mail or phone at: U.S. Department of Health and Human Services 200 Independence Avenue, SW Room 509F, HHH Building Washington, D.C , (TDD) Complaint forms are available at Language Assistance Services NDR PIC LV (10/16)