National Medical Policy

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1 National Medical Policy Subject: Policy Number: HIV Seropositivity and Solid Organ Transplantation NMP9 Effective Date*: July 2003 Updated: June 2016 This National Medical Policy is subject to the terms in the IMPORTANT NOTICE at the end of this document For Medicaid Plans: Please refer to the appropriate State s Medicaid manual(s), publication(s), citation(s), and documented guidance for coverage criteria and benefit guidelines prior to applying Health Net Medical Policies The Centers for Medicare & Medicaid Services (CMS) For Medicare Advantage members please refer to the following for coverage guidelines first: Use Source Reference/Website Link X National Coverage Determination (NCD) Human Immunodeficiency Virus (HIV) Testing (Diagnosis) (190.14): National Coverage Manual Citation Local Coverage Determination (LCD)* Article (Local)* Other None Use Health Net Policy Instructions Medicare NCDs and National Coverage Manuals apply to ALL Medicare members in ALL regions. Medicare LCDs and Articles apply to members in specific regions. To access your specific region, select the link provided under Reference/Website and follow the search instructions. Enter the topic and your specific state to find the coverage determinations for your region. *Note: Health Net must follow local coverage determinations (LCDs) of Medicare Administration Contractors (MACs) located outside their service area when those MACs have exclusive coverage of an item or service. (CMS Manual Chapter 4 Section 90.2) Organ Transplantation in HIV Seropositivity Jun 16 1

2 If more than one source is checked, you need to access all sources as, on occasion, an LCD or article contains additional coverage information than contained in the NCD or National Coverage Manual. If there is no NCD, National Coverage Manual or region specific LCD/Article, follow the Health Net Hierarchy of Medical Resources for guidance. Current Policy Statement Health Net, Inc. considers organ transplantation in patients with HIV seropositivity but without active AIDS medically necessary. To be eligible patients must have: 1. Met the criteria for transplantation of the specific organ; and 2. Been stable on antiviral therapy > 6 months; and 3. No other complications from AIDS such as opportunistic infection (e.g. aspergillus, tuberculosis, coccidioidomycosis, resistant fungal infections except esophageal candidiasis) Kaposi's sarcoma or other neoplasm; and 4. A CD4 cell count > 200 cells/mm 3 for kidney transplant candidates for > 6 months or > 100 cells/mm 3 for liver transplant candidates for > 6 months; and 5. A viral load < 1000 copies/ml for kidney transplant candidates and either a viral load < 1000 copies/ml for liver transplant candidates or patients who are unable to tolerate anti-hiv therapies due to their liver condition. 6. A protocol HIV specialist must explicitly concur with the transplant and determine that after transplantation the individual will be able to construct an effective anti- HIV regimen that will result in maximal viral suppression. Codes Related To This Policy NOTE: The codes listed in this policy are for reference purposes only. Listing of a code in this policy does not imply that the service described by this code is a covered or noncovered health service. Coverage is determined by the benefit documents and medical necessity criteria. This list of codes may not be all inclusive. On October 1, 2015, the ICD-9 code sets used to report medical diagnoses and inpatient procedures have been replaced by ICD-10 code sets. ICD-9 Codes 042 Human immunodeficiency virus [HIV] disease Chronic viral hepatitis B without mention of hepatic coma Chronic viral hepatitis C without mention of hepatic coma Unspecified viral hepatitis without mention of hepatic coma Chronic hepatitis ICD-10 Codes B2Ø Human immunodeficiency virus [HIV] disease B14.0- B19.9 Viral hepatitis Organ Transplantation in HIV Seropositivity Jun 16 2

3 K73.0- K73.9 Chronic hepatitis not elsewhere classified CPT Codes Liver allotransplantation; orthotopic partial or whole from cadaver or living donor any age Liver allotransplantation; heterotopic partial or whole from cadaver or living donor any age Donor nephrectomy with preparation and maintenance of allograft from cadaver donor unilateral or bilateral Donor nephrectomy open from living donor (excluding preparation and maintenance of allograft) Recipient nephrectomy (separate procedure) Renal allotransplantation implantation of graft; excluding donor and recipient nephrectomy Renal allotransplantation implantation of graft; with recipient nephrectomy Removal of transplanted renal allograft Renal autotransplantation reimplantation of kidney HCPCS Codes N/A Scientific Rationale Update June 2016 The National Institute of Health (6/18/2015) notes that the Human Immunodeficiency Virus (HIV) Organ Policy Equity (HOPE) Act requires the Secretary of Health and Human Services to develop and publish criteria for research involving transplantation of HIV infected donor organs in HIV+ recipients. The goals of these criteria are, first, to ensure that research using organs from HIV+ donors is conducted under conditions protecting the safety of research participants and the general public; and second, that the results of this research provide a basis for evaluating the safety of solid organ transplantation (SOT) from HIV+ donors to HIV+ recipients. Scientific Rationale Update June 2015 Muller et al. (2015) The outcome of kidney transplantation in human immunodeficiency virus (HIV)-positive patients who receive organs from HIVnegative donors has been reported to be similar to the outcome in HIV-negative recipients. We report the outcomes at 3 to 5 years in HIV-positive patients who received kidneys from HIV-positive deceased donors. The authors conducted a prospective, nonrandomized study of kidney transplantation in HIV-infected patients who had a CD4 T-cell count of 200 per cubic millimeter or higher and an undetectable plasma HIV RNA level. All the patients were receiving antiretroviral therapy (ART). The patients received kidneys from deceased donors who tested positive for HIV with the use of fourth-generation enzyme-linked immunosorbent assay at the time of referral. All the donors either had received no ART previously or had received only first-line ART. From September 2008 through February 2014, a total of 27 HIV-positive patients underwent kidney transplantation. Survivors were followed for a median of 2.4 years. The rate of survival among the patients was 84% at 1 year, 84% at 3 years, and 74% at 5 years. The corresponding rates of graft survival were 93%, 84%, and 84%. (If a patient died with a functioning graft, the calculation was performed as if the graft had survived.) Rejection rates were 8% at 1 year and 22% at 3 years. HIV infection remained well controlled, with undetectable Organ Transplantation in HIV Seropositivity Jun 16 3

4 virus in blood after the transplantation. Kidney transplantation from an HIV-positive donor appears to be an additional treatment option for HIV-infected patients requiring renal-replacement therapy. (Funded by Sanofi South Africa and the Roche Organ Transplantation Research Foundation.). Scientific Rationale Update September 2010 Liver, kidney, and heart transplantation are the current treatments of choice for advanced organ failure. However, human immunodeficiency virus (HIV) infection was traditionally considered an absolute contraindication for transplantation. One of the principal concerns was that immunosuppression would accelerate HIV/acquired immune deficiency syndrome (AIDS), resulting in increased mortality and a "waste" of organs. Since highly active antiretroviral therapy (HAART) became widely available in 1996, the prognosis of HIV infection has dramatically improved. There have been significant decreases in morbidity and mortality, and for many individuals with well-controlled viral replication, HIV/AIDS is now a chronic manageable disease. Previously, HIV-infected individuals with very advanced disease frequently died from opportunistic infections (OIs). Among such individuals, the presence of chronic diseases, such as renal insufficiency, coronary artery disease, diabetes mellitus, or liver failure (associated with hepatitis B or C virus co-infection), were not significant causes of mortality. The situation is currently quite different, as these co-morbidities as well as others are real medical problems for many individuals with well-controlled HIV replication. Such improvements in the long-term prognosis of those with HIV infection have prompted many transplant programs to reevaluate their policies regarding the exclusion of patients with HIV infection. Stock et al. (2007) The transplant community has been slow to recognize the efficacy of highly active antiretroviral therapy in changing the course of human immunodeficiency virus (HIV) infection to a chronic condition. People infected with HIV are dying less often from progression of HIV to acquired immune deficiency syndrome. Unfortunately, there is an increasing rate of morbidity and mortality from comorbidities resulting in end-stage liver and kidney disease, prompting some transplant centers to eliminate HIV infection as a contraindication to transplantation. Cooper et al. (2008) evaluated the efficacy of raltegravir and the development of viral resistance in two identical trials involving patients who were infected with human immunodeficiency virus type 1 (HIV-1) with triple-class drug resistance and in whom antiretroviral therapy had failed. The authors conducted subgroup analyses of the data from week 48 in both studies according to baseline prognostic factors. Genotyping of the integrase gene was performed in raltegravir recipients who had virologic failure. Virologic responses to raltegravir were consistently superior to responses to placebo, regardless of the baseline values of HIV-1 RNA level; CD4 cell count; genotypic or phenotypic sensitivity score; use or nonuse of darunavir, enfuvirtide, or both in optimized background therapy; or demographic characteristics. Among patients in the two studies combined who were using both enfuvirtide and darunavir for the first time, HIV-1 RNA levels of less than 50 copies per milliliter were achieved in 89% of raltegravir recipients and 68% of placebo recipients. HIV-1 RNA levels of less than 50 copies per milliliter were achieved in 69% and 80% of the raltegravir recipients and in 47% and 57% of the placebo recipients using either darunavir or enfuvirtide for the first time, respectively. At 48 weeks, 105 of the 462 raltegravir recipients (23%) had virologic failure. Genotyping was performed in 94 raltegravir recipients with virologic failure. Integrase mutations known to be associated with phenotypic resistance to raltegravir arose during treatment in 64 patients (68%). Forty-eight of these 64 patients (75%) had two or Organ Transplantation in HIV Seropositivity Jun 16 4

5 more resistance-associated mutations. When combined with an optimized background regimen in both studies, a consistently favorable treatment effect of raltegravir over placebo was shown in clinically relevant subgroups of patients, including those with baseline characteristics that typically predict a poor response to antiretroviral therapy: a high HIV-1 RNA level, low CD4 cell count, and low genotypic or phenotypic sensitivity score. (ClinicalTrials.gov numbers, NCT and NCT ). Barbanti et al. (2008) Since 2003 the National Research Program for Solid Organ Transplantation in patients with human immunodeficiency virus (HIV) is active at our liver transplantation center. Patients with HIV who enter this protocol are assessed by the Consultation Liaison Psychiatry Service. The aim of the present study was to evaluate their psychiatric comorbidity. An observational prospective study was conducted comparing end-stage liver disease (ESLD) patients with and without HIV. After the assessment, the psychiatrist compiled the Transplant Evaluation Rating Scale (TERS) and the Montgomery Asberg Depression Rating Scale (MADRS). Baseline evaluation was made before inclusion on the OLT waiting list and the followup evaluation was made 12 months later. From January 2003 to December 2006 we assessed 553 patients: 39 (6%) with HIV and 361 (94%) without HIV. The 2 groups were homogeneous for gender (75% of male patients; P=not significant [NS]) but not for age (46+/-5 vs 56+/-9; P=NS). Psychiatric history was negative in 176 (49%) patients without HIV and in 6 (15%) patients with HIV (P<.001). At baseline psychiatric comorbidity was present in 33 HIV patients (85%) and in 148 non-hiv patients (41%; P<.001). At follow-up MADRS highlighted an improvement in all of the items for HIV patients. In the non-hiv group, the variation was as follows: baseline, 7.10; follow-up, In the HIV group, the variation was as follows: baseline, 10.20; follow-up, 4.09 (P<.001). The average score at TERS was higher among patients with HIV (43+/-9 vs 35+/-9; P=NS). At baseline HIV patients with ESLD showed a higher rate of psychopathology, but they improved at follow-up; the contrary happened in the non-hiv group. Linden et al. (2009) Solid organ transplantation is one of the most remarkable and dramatic therapeutic advances in medicine during the past 60 years. This field has progressed initially from what can accurately be termed a clinical experiment to routine and reliable practice, which has proven to be clinically effective, life-saving and cost-effective. This remarkable evolution stems from a serial confluence of: cultural acceptance; legal and political evolution to facilitate organ donation, procurement and allocation; technical and cognitive advances in organ preservation, surgery, immunology, immunosuppression; and management of infectious diseases. The current stresses created by the increasing gap between organ supply and demand are in fact because of transplantation's remarkable success rather than its failure. Existing and new challenges toward further improving outcome and access to organ transplantation will no doubt persist; however, there is little reason not to expect the same level of adaptive innovation to meet and overcome these realities. Subramanian et al. (2010) evaluated predictors of pre-transplantation mortality in HIV-positive liver transplant candidates enrolled in the Solid Organ Transplantation in HIV. Multi-Site Study (HIVTR) matched 1:5 by age, sex, race, and HCV infection with HIV-negative controls from the United Network for Organ Sharing. Of 167 HIVTR candidates, 24 died (14.4%); this mortality rate was similar to that of controls (88/792, 11.1%, P =.30) with no significant difference in causes of mortality. A significantly lower proportion of HIVTR candidates (34.7%) underwent liver transplantation, compared with controls (47.6%, P =.003). In the combined cohort, Organ Transplantation in HIV Seropositivity Jun 16 5

6 baseline MELD score predicted pre-transplantation mortality (hazard ratio [HR], 1.27; P <.0001), whereas HIV infection did not (HR, 1.69; P =.20). After controlling for pre-transplantation CD4(+) cell count and HIV RNA levels, the only significant predictor of mortality in the HIV-infected subjects was pre-transplantation MELD score (HR, 1.2; P <.0001). Pre-transplantation mortality characteristics are similar between HIV-positive and HIV-negative candidates. Although lower CD4(+) cell counts and detectable levels of HIV RNA might be associated with a higher rate of pre-transplantation mortality, baseline MELD score was the only significant independent predictor of pre-transplantation mortality in HIV-infected liver transplant candidates. Donor selection practices changed as a consequence of organ shortage. The timeless adage necessity is the mother of invention has always been the ethic in the field of solid organ transplantation, particularly as it pertains to organ supply. As of November 21, 2008 there were 100,745 United Network for Organ Sharing (UNOS) waiting-list candidates for organ transplantation in the United States; 8659 transplants were performed from 9490 donors during the first 8 months of The increasing annual trend in the organ supply deficit for all organ transportation categories in the United States is shown. HIV infection should no longer be an absolute contraindication for transplantation. In selected cases, patients should be eligible for solid organ transplantation if they have well-controlled HIV-infection. The decision to transplant a specific patient should be individualized until the results of prospective studies are available. Scientific Rationale Initial Acquired Immune Deficiency Syndrome (AIDS) is caused by the Human Immunodeficiency Virus (HIV). HIV infection slowly damages a person s immune system and HIV disease becomes AIDS when the immune system becomes seriously compromised. This is usually heralded by a drop in CD4+ cells (also called "T-helper" cells) to < 200 or the occurrence of an opportunistic infection. Healthy patient have between 500 and 1500 CD4+ cells in a milliliter of blood. As patient with HIV are living longer due to the use of combination antiretroviral therapy (Highly Active Anti-Retroviral Therapy or HAART) to suppress HIV viral replication and thereby enabling immune reconstitution, HIV disease has largely been transformed into a chronic manageable illness associated with a rise in death rates from conditions not historically associated with HIV. Prognosis of HIV-infected patients is generally no longer determined by HIV infection itself but rather by the presence of co-existing morbidities notably Hepatitis C and underlying kidney disease or HIV-related harm to the kidneys (called HIV-associated nephrotoxicity or HIVAN). Anti-HIV therapies that are processed through the liver or kidney can also in some cases worsen these conditions and there have been some instances where the damage to the organ has been wholly caused by the side effects of therapies to treat HIV. As most antiretroviral agents are metabolized through the liver varying degrees of hepatotoxicity exacerbated by viral co-infection with Hepatitis B and C is becoming a leading cause of morbidity and mortality among patient living with HIV. Historically HIV has been an absolute contraindication for organ transplantation meaning that if a patient were HIV seropositive they were not considered a candidate to receive an organ transplant. This was based primarily on the concept that the immunosuppression required for organ transplantation would further damage an HIV patient's already embattled immune system and that many patients without HIV Organ Transplantation in HIV Seropositivity Jun 16 6

7 need organs which are already in short supply. In addition, there are notable interactions between anti-rejection medications and antiretrovirals necessitating careful monitoring of the levels of anti-rejection medications and adjusting doses as needed because there is less flexibility in implementing choices around anti-hiv therapy. When patients stop taking anti-hiv medication abruptly their blood levels of the anti-rejection medication may fall dramatically and lead to a serious organ rejection event sometimes causing death. Moreover adherence to medications has even more critical and potentially life-threatening consequences. Implementing a decision to discontinue the use of anti-hiv therapy for example must be done in careful consultation with the transplant team so that dose adjustments for antirejection drugs can be made and carefully monitored. Even the simple act of switching anti-hiv drugs can alter blood levels of anti-rejection drugs and must be done with a higher degree of care. There is no scientific evidence to suggest that HIV patients will experience a worsening of their conditions as a result of organ transplantation. Data from the United States the United Kingdom Japan and elsewhere all suggest that orthotopic liver transplantation is a viable for patients living with HIV/AIDS where otherwise death would be imminent. Patients with kidney disease have slightly greater options including dialysis. When comparing the outcomes of the transplant recipients to the larger population of patient receiving kidney and liver transplants in the UNOS registry survival outcomes thus far appear to be very similar after one year. For the most part studies have shown that liver and kidney transplantation has little to no effect on either viral load or CD4 cell counts. Viral loads that were basically undetectable in both groups pre-transplant and remained so afterwards. Review History July 2003 July 2005 September 2006 September 2010 July 2011 June 2012 June 2013 June 2014 June 2015 June 2016 Medical Advisory Council initial approval Update no changes Update no changes Update. Added Medicare Table. No revisions. Update. Added Revised Medicare Table. No Revisions. Update no revisions Update no revisions. Codes updated. Update no revisions. Codes updated. Update no revisions. Codes updated. Update no revisions. Codes updated. References Update June Bartlett JC, Sax PE. Overview of prevention of opportunistic infections in HIVinfected patients. UpToDate. November 17, National Institute of Health. Human Immunodeficiency Virus (HIV) Organ Policy Equity (HOPE) Act Safeguards and Research Criteria for Transplantation of Organs Infected With HIV. 6/18/2015. References Update June Fishman JA. Evaluation for infection before solid organ transplantation. UpToDate March Muller E, Barday Z, Mendelson M, et al. HIV-positive-to-HIV-positive kidney transplantation--results at 3 to 5 years. N Engl J Med 2015; 372:613. Organ Transplantation in HIV Seropositivity Jun 16 7

8 References Update June Bahirwani R, Barin B, Olthoff K, et al. Chronic kidney disease after liver transplantation in human immunodeficiency virus/hepatitis C virus-coinfected recipients versus human immunodeficiency virus-infected recipients without hepatitis C virus: results from the National Institutes of Health multi-site study. Liver Transpl 2013; 19: Canaud G, Dejucq-Rainsford N, Avettand-Fenoël V, et al. The kidney as a reservoir for HIV-1 after renal transplantation. J Am Soc Nephrol 2014; 25: Tesla P. Solid organ transplantation in HIV-infected individuals. UpToDate. March 17, References Update June Terrault NA, Roland ME, Schiano T, et al. Outcomes of liver transplant recipients with hepatitis C and human immunodeficiency virus coinfection. Liver Transpl 2012; 18:716. References Update June Barcan L, Gadano A, Casetti I, et al. Organ transplants in HIV infected patients. Update and recommendations. Medicina (B Aires). 2011;71(1): Grossi PA, Righi E, Gasperina DD, et al. Report of four simultaneous pancreaskidney transplants in HIV-positive recipients with favorable outcomes. Am J Transplant Apr;12(4): Miró JM, Blanes M, Norman F, Martín-Dávila P. Infections in solid organ transplantation in special situations: HIV-infection and immigration. Enferm Infecc Microbiol Clin Mar;30 Suppl 2: References Update- July Fishman JA. Infection in the solid organ transplant recipient. UpToDate. February 15, Updated September 11, Updated January 30, Locke JE, Segev DL. Renal Transplantation in HIV-Positive Recipients. Curr Infect Dis Rep Jan;12(1): Moreno CN, de Siqueira RC, Noronha IL. Kidney transplantation in HIV infected patients. Rev Assoc Med Bras Jan-Feb;57(1): References Update- September Subramanian A. MELD score is an important predictor of pretransplantation mortality in HIV-infected liver transplant candidates. Gastroenterology. 01-JAN- 2010; 138 (1): Tebas P. Solid organ transplantation in HIV-infected individuals. September 23, UpToDate. Updated March 14, Updated May 6, Blumberg EA. Solid organ transplantation in the HIV-infected patient. Am J Transplant - 01-DEC-2009; 9 Suppl 4: S Linden PK. History of solid organ transplantation and organ donation. Crit Care Clin. 01-JAN-2009; 25(1): , ix. 5. Barbanti SV. What is the biopsychosocial role of human immunodeficiency virus positivity in patients with end-stage liver disease who undergo orthotopic liver transplantation? Transplant Proc - 01-JUL-2008; 40(6): Khamash HA. Gaston RS. Transplant tourism: a modern iteration of an ancient problem. Curr Opin Organ Transplant 13. (4): Organ Transplantation in HIV Seropositivity Jun 16 8

9 7. Moylan CA, Brady CW, Johnson JL, et al. Disparities in liver transplantation before and after introductioin of the MELD Score. JAMA 300. (20): Steigbigel, RT, Cooper, DA, Kumar, PN, et al. Raltegravir with optimized background therapy for resistant HIV-1 infection. N Engl J Med 2008; 359: Cooper, DA, Steigbigel, RT, Gatell, JM, et al. Subgroup and resistance analyses of raltegravir for resistant HIV-1 infection. N Engl J Med 2008; 359: Gulick, RM, Lalezari, J, Goodrich, J, et al. Maraviroc for previously treated patients with R5 HIV-1 infection. N Engl J Med 2008; 359: Fatkenheuer, G, Nelson, M, Lazzarin, A, et al. Subgroup Analyses of Maraviroc in Previously Treated R5 HIV-1 Infection. N Engl J Med 2008; 359: Stock PG. Evolving clinical strategies for transplantation in the HIV-positive recipient. Transplantation. 15-SEP-2007; 84 (5): References Initial 1. Roland ME Stock PG. Review of solid-organ transplantation in HIV-infected patients. Transplantation 2003;75(4): Halpern SD Ubel PA Caplan AL. Solid-organ transplantation in HIV-infected patients. N Engl J Med 2002;347(4): Forman L. et al. The association between hepatitis C infection and survival after orthotopic liver transplantation. Gastroenterology 2002;122: Hogg R. et al. Improved survival among HIV-infected patients after initiation of triple-drug antiretroviral regimens.cmaj 1999;160(5): Mocroft A. et al. AIDS Across Europe : the EuroSIDA study.the Lancet 2000;356: Palella FJ Jr. et al. Declining morbidity and mortality among patients with advanced human immunodeficiency virus infection. HIV Outpatient Study Investigators. N Engl J Med 1998;338(13): Feinberg M. Changing the natural history of HIV disease.lancet 1996;348: Sulkowski M et al. Hepatotoxicity associated with antiretroviral therapy in adults infected with human immunodeficiency virus and the role of hepatitis C or B infection. JAMA 2000;283(1): Bica I et al. Increasing Mortality Due to End-Stage Liver Disease in Patients with Human Immunodeficiency Virus Infection. Clinical Infectious Diseases (CID) 2001;32: Neff G Jayaweera D Tzakis A. Liver transplantation for HIV-infected patients with end-stage liver disease.current Opinion in Liver Transplantation 2002;7(2): Soriano V et al. Impact of chronic liver disease due to hepatitis viruses as cause of hospital admission and death in HIV-infected drug users. European Journal of Epidemiology 1999;15: Reisler R et al. Risk of Grade IV Events and Death in HIV Patients Co-Infected with Hepatitis B and/or Hepatitis C Receiving HAART. in 9th Conference on Retroviruses and Opportunistic Infections Seattle WA. 13. Prachalias A. et al. Liver transplantation in adults coinfected with HIV. Transplantation 2001;72(10): Stock P Roland M et al. Protocol: Clinical Immunologic and Pharmacologic Consequences of Solid Organ Transplantation in Patient with HIV Infection in Cooperative Clinical Trials in Adult Transplantation University of California in San Francisco. 15. Ahuja T Zingman B Glicklich D. Long-Term Survival in an HIV-Infected Renal Transplant Recipient. American Journal of Nephrology 1997;17: Organ Transplantation in HIV Seropositivity Jun 16 9

10 16. Dummer J et al. Infection with human immunodeficiency virus in the Pittsburg Transplant Population.Transplantation 1989;47(1): Berenguer M, et al. Natural history of clinically compensated hepatitis C virusrelated graft cirrhosis after liver transplantation. Hepatology 2000;32: Feray C, et al. European Collaborative Study on Factors Influencing Outcome after Transplantation for Hepatitis C.Gastroenterology : Ghobrial R, et al. Orthotopic liver transplantation for hepatitis C: outcome effect of immunosuppression and causes of retransplantation during an 8-year singlecenter experience. Annals of Surgery 1999;229(6): Pelletier S, et al. Pretransplantation Hepatitis C Virus Quasispecies may be Predictive of Outcome After Liver Transplantation.Hepatology. 2000;32: Pelletier S, et al. Hepatitis C-Induced Hepatic Allograft Injury is Associated with a Pretransplantation Elevated Viral Replication Rate. Hepatology 2000;32: Kuo P, Stock P. Transplantation in the HIV+ patient. American Journal of Transplantation 2001; 1(1): Gow P, Mutimer D. Liver transplantation for an HIV-positive patient in the era of highly active antiretroviral therapy. AIDS 2001;15(2): Keay S, et al. Organ Transplantation in the HIV-Infected Patient. Current Opinion in Organ Transplantation 2000;5(3): Important Notice General Purpose. Health Net's National Medical Policies (the "Policies") are developed to assist Health Net in administering plan benefits and determining whether a particular procedure, drug, service or supply is medically necessary. The Policies are based upon a review of the available clinical information including clinical outcome studies in the peer-reviewed published medical literature, regulatory status of the drug or device, evidence-based guidelines of governmental bodies, and evidence-based guidelines and positions of select national health professional organizations. Coverage determinations are made on a case-by-case basis and are subject to all of the terms, conditions, limitations, and exclusions of the member's contract, including medical necessity requirements. Health Net may use the Policies to determine whether under the facts and circumstances of a particular case, the proposed procedure, drug, service or supply is medically necessary. The conclusion that a procedure, drug, service or supply is medically necessary does not constitute coverage. The member's contract defines which procedure, drug, service or supply is covered, excluded, limited, or subject to dollar caps. The policy provides for clearly written, reasonable and current criteria that have been approved by Health Net s National Medical Advisory Council (MAC). The clinical criteria and medical policies provide guidelines for determining the medical necessity criteria for specific procedures, equipment, and services. In order to be eligible, all services must be medically necessary and otherwise defined in the member's benefits contract as described this "Important Notice" disclaimer. In all cases, final benefit determinations are based on the applicable contract language. To the extent there are any conflicts between medical policy guidelines and applicable contract language, the contract language prevails. Medical policy is not intended to override the policy that defines the member s benefits, nor is it intended to dictate to providers how to practice medicine. Policy Effective Date and Defined Terms. The date of posting is not the effective date of the Policy. The Policy is effective as of the date determined by Health Net. All policies are subject to applicable legal and regulatory mandates and requirements for prior notification. If there is a discrepancy between the policy effective date and legal mandates and regulatory requirements, the requirements of law and regulation shall govern. * In some states, prior notice or posting on the website is required before a policy is deemed effective. For information regarding the effective dates of Policies, contact your provider representative. The Policies do not include definitions. All terms are defined by Health Net. For information regarding the definitions of terms used in the Policies, contact your provider representative. Policy Amendment without Notice. Health Net reserves the right to amend the Policies without notice to providers or Members. In some states, prior notice or website posting is required before an amendment is deemed effective. No Medical Advice. Organ Transplantation in HIV Seropositivity Jun 16 10

11 The Policies do not constitute medical advice. Health Net does not provide or recommend treatment to members. Members should consult with their treating physician in connection with diagnosis and treatment decisions. No Authorization or Guarantee of Coverage. The Policies do not constitute authorization or guarantee of coverage of particular procedure, drug, service or supply. Members and providers should refer to the Member contract to determine if exclusions, limitations, and dollar caps apply to a particular procedure, drug, service or supply. Policy Limitation: Member s Contract Controls Coverage Determinations. Statutory Notice to Members: The materials provided to you are guidelines used by this plan to authorize, modify, or deny care for persons with similar illnesses or conditions. Specific care and treatment may vary depending on individual need and the benefits covered under your contract. The determination of coverage for a particular procedure, drug, service or supply is not based upon the Policies, but rather is subject to the facts of the individual clinical case, terms and conditions of the member s contract, and requirements of applicable laws and regulations. The contract language contains specific terms and conditions, including pre-existing conditions, limitations, exclusions, benefit maximums, eligibility, and other relevant terms and conditions of coverage. In the event the Member s contract (also known as the benefit contract, coverage document, or evidence of coverage) conflicts with the Policies, the Member s contract shall govern. The Policies do not replace or amend the Member s contract. Policy Limitation: Legal and Regulatory Mandates and Requirements The determinations of coverage for a particular procedure, drug, service or supply is subject to applicable legal and regulatory mandates and requirements. If there is a discrepancy between the Policies and legal mandates and regulatory requirements, the requirements of law and regulation shall govern. Reconstructive Surgery CA Health and Safety Code requires health care service plans to cover reconstructive surgery. Reconstructive surgery means surgery performed to correct or repair abnormal structures of the body caused by congenital defects, developmental abnormalities, trauma, infection, tumors, or disease to do either of the following: (1) To improve function or (2) To create a normal appearance, to the extent possible. Reconstructive surgery does not mean cosmetic surgery," which is surgery performed to alter or reshape normal structures of the body in order to improve appearance. Requests for reconstructive surgery may be denied, if the proposed procedure offers only a minimal improvement in the appearance of the enrollee, in accordance with the standard of care as practiced by physicians specializing in reconstructive surgery. Reconstructive Surgery after Mastectomy California Health and Safety Code requires treatment for breast cancer to cover prosthetic devices or reconstructive surgery to restore and achieve symmetry for the patient incident to a mastectomy. Coverage for prosthetic devices and reconstructive surgery shall be subject to the co-payment, or deductible and coinsurance conditions, that are applicable to the mastectomy and all other terms and conditions applicable to other benefits. "Mastectomy" means the removal of all or part of the breast for medically necessary reasons, as determined by a licensed physician and surgeon. Policy Limitations: Medicare and Medicaid Policies specifically developed to assist Health Net in administering Medicare or Medicaid plan benefits and determining coverage for a particular procedure, drug, service or supply for Medicare or Medicaid members shall not be construed to apply to any other Health Net plans and members. The Policies shall not be interpreted to limit the benefits afforded Medicare and Medicaid members by law and regulation. Organ Transplantation in HIV Seropositivity Jun 16 11

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