UPMC Health Plan

UPMC Health Plan POLICY AND PROCEDURE MANUAL POLICY NUMBER: MP .041 REVISION DATE: 5/2008 ANNUAL APPROVAL DATE: 8/2008 PAGE NUMBER: 1 of 8 SUBJECT: INDEX TITLE: ORIGINAL DATE: Transplant: Renal Medical Management 6/1998 This policy applies to the following lines of business: (Check those that apply.) Commercial: HMO ( ) Fully Insured ( ) Medicare Select ( ) DPW-MA: Health Choices ( ) CMS-MA: HMO ( X) PPO ( ) PID-CHIP: Free ( ) POS ( ) Self-funded/ASO ( ) Medicare Supplement ( ) Voluntary ( ) Specialty Needs Plan (X ) Sub ( ) Part D ( ) PFFS (X ) PPO ( ) HSA ( ) OOA/DOC ( ) All ( X) All ( X ) All ( ) All ( X ) I. POLICY It is the policy of UPMC Health Plan to authorize payment for services that are medically necessary and covered under the member’s benefit plan. UPMC Health Plan recognizes renal transplantation as appropriate and consistent with good medical practice. Coverage for members requesting renal transplant services will be considered on an individual basis for the specific indications detailed in this policy. All requests for renal transplantation are reviewed by a UPMC Health Plan Medical Director. In addition to established guidelines for the procedure, the physician reviewer applies his/her clinical knowledge, judgment and expertise to each case, taking into account the specific needs of the member. All denials are based on medical necessity and appropriateness as determined by a UPMC Medical Director (Medical Director). II. DEFINITIONS HIV – (Human Immunodeficiency Virus) is the virus that causes AIDS (Acquired Immunodeficiency Syndrome). HAART- Highly Active Antiretroviral Therapy (also known as “Triple Drug Cocktail”) It is the combination of at least three anti retroviral (ARV) drugs (a protease inhibitor, and two other drugs called reverse transcriptase inhibitors) that attack different parts of Proprietary and Confidential Information of UPMC Health Plan POLICY NUMBER: MP .041 REVISION DATE: 5/2008 ANNUAL APPROVAL DATE: 8/2008 PAGE NUMBER: 2 of 8 HIV or stop the virus from entering blood cells. Even among people who respond well to HAART, the treatment does not get rid of HIV. The virus continues to reproduce, but at a slower pace. III. PURPOSE The purpose of this policy is to define the criteria for renal transplantation. IV. SCOPE This policy applies to various UPMC Health Plan Departments as indicated by the Benefit and Reimbursement Committee. These include but are not limited to Medical Management, Benefit Configuration and Claims Departments. V. PROCEDURE A. Medical Description A renal transplant refers to the surgical procedure that involves the placement of a kidney from another individual into a recipient because of failure of the recipient’s own kidneys. Renal transplantation is the treatment of choice for members with end-stage renal disease (ESRD). The two sources of donor kidneys are living donors and deceased donors. B. Specific Indications Members requesting Renal Transplantation must meet the criteria for recipient characteristics and the specific criteria for the transplant. Recipient Characteristics Transplant recipients must meet BOTH of the following: 1. Medically compliant – the recipient must be capable of following a complex medical regimen for the rest of his/her life post-transplantation; AND 2. Emotionally stable with realistic attitude demonstrated to past and current illness. Specific Criteria for Renal Transplant Clinical indications for renal transplantation include at least ONE of the following: 1. Congenital Disorders • Aplasia or hypoplasia • Horseshoe Kidney 2. Toxic Nephropathies • Lead nephropathy • Analgesic nephropathy Proprietary and Confidential Information of UPMC Health Plan POLICY NUMBER: MP .041 REVISION DATE: 5/2008 ANNUAL APPROVAL DATE: 8/2008 PAGE NUMBER: 3 of 8 3. Metabolic Disorders • Hyperoxaluria or oxalosis • Nephrocalcinosis • Gout nephritis • Amyloidosis • Cystinosis 4. Hereditary Nephropathies • Alport’s syndrome • Polycystic kidney disease • Medullary cystic disease 5. Irreversible Acute Renal Failure • Cortical necrosis • Hemolytic uremic syndrome • Acute and subacute glomerulonephritis • Anaphylactoid purpura (Henoch-Schonlein) 6. Irreversible Chronic Renal Failure • Chronic pyelonephritis • Diabetic nephropathy • Chronic glomerulonephritis • Hypertensive nephrosclerosis • Goodpasture’s disease (Anti- glomerular base-membrane disease) • Hypocomplementemic nephritis • Toxic nephropathy (including nephropathy related to cyclosporine/tacrolimus toxicity) 7. Tumors Requiring Nephrectomy • Renal carcinoma • Wilm’s tumor • Tuberous sclerosis 8. Vascular Diseases • Renal artery occlusion • Renal vein thrombosis • Polyarteritis (periarteritis nodosa) • Scleroderma 9. Obstructive Nephropathy • Acquired • Congenital Proprietary and Confidential Information of UPMC Health Plan POLICY NUMBER: MP .041 REVISION DATE: 5/2008 ANNUAL APPROVAL DATE: 8/2008 PAGE NUMBER: 4 of 8 10. Trauma requiring nephrectomy 11. Other Indications • Multiple Myeloma • Lupus Erythematosus (SLE) • Macroglobulinemia • Wegner’s Granulomatosis • Etiology unknown (documented chronic renal failure of at least 6-8 weeks duration) • HIV-associated nephropathy Specific Criteria for Renal Transplant in HIV+ Members Renal transplantation in HIV+ members are considered medically necessary when all of the following conditions are met: 1. The member has a life expectancy of at least 5 years, 2. CD4 count ≥200 cells/mL for at least 6 months, 3. Undetectable HIV viremia for 6 months, 4. Adherence to HAART regiment for ≥ 6 months, 5. Treatable with HAART post transplant C. Limitations 1. General contraindications include any the following: • Blood type A, B or O (ABO) type and screen incompatibility between recipient and donor (unless the recipient is in a desensitization protocol). • Ongoing alcohol or drug abuse. • Active infection (recipients developing infections while on a waiting list may become temporarily inactive and may return to active status if the infection resolves). • Active malignancy; recipients with a history of malignancy must have had definitive therapy. Follow-up prior to eligibility is variable, and is a function of the specific cancer (females should have a negative Pap smear and mammography within the last year). • Contraindication to immunosuppressive drugs. • Morbid obesity. • Absence of appropriate social support group. • History or probability of non-compliance with medical regimen. 2. Renal specific contraindications include: • Irreversible non-renal organ dysfunction, including: o Significant untreatable coronary artery disease or left ventricular dysfunction; o Severe limiting chronic pulmonary disease • Advanced dialysis dementia. • Active alcoholic hepatitis. Proprietary and Confidential Information of UPMC Health Plan POLICY NUMBER: MP .041 REVISION DATE: 5/2008 ANNUAL APPROVAL DATE: 8/2008 PAGE NUMBER: 5 of 8 4. HIV+ specific contraindications include: • Documented history of progressive multifocal leukoencephalopathy (PML), • EBV (Epstein-Barr virus) and HHV8 (Human Herpesvirus 8) related lymphpoproliferative disorders (lymphomas and multi-centric Castleman’s disease), • Persistent viremia despite HAART therapy, • Kaposi’s Sarcoma or lymphomas, • Demonstrated non compliance with HAART therapy, • Females: Positive Pregnancy test, • Unable to and unwilling to use contraception, • Unwilling to comply with anti-fungal and antiviral prophylaxis as required, • If co-infected with Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV), there is evidence of cirrhosis on liver biopsy. D. Information Required for Review General Documentation In order to assess medical necessity for renal transplantation adequate information must be furnished by the transplant center. Necessary documentation includes the following: 1. Member’s age, clinical history, physical and functional status; 2. Documentation of diagnosis, staging, and treatment history; 3. Documentation of any history of substance abuse, including smoking; 4. Documentation of any history of emotional instability or non-compliance with medical management; 5. Social service evaluation; 6. Results of pre-transplant testing including: • Electrocardiogram (EKG), chest x-ray (CXR), echocardiogram; • Ultrasound of native kidneys and right upper quadrant (gallbladder); • Skin testing (purified protein derivative standard (PPD) tuberculosis test, mumps, trichophyton); • Diabetic members > 50 years: • Adenosine or persantine thallium stress test, • For women: • Gynecological evaluation with pap smear, • A breast exam and, • For those over the age of 35, a mammogram, • For men: • Testicular exam and, • For those over the age of 50, measurement of prostatic specific antigen (PSA) and a digital rectal exam, • Members over 50 years old or if qualifying family history: • Colonoscopy, Proprietary and Confidential Information of UPMC Health Plan POLICY NUMBER: MP .041 REVISION DATE: 5/2008 ANNUAL APPROVAL DATE: 8/2008 PAGE NUMBER: 6 of 8 Voiding cystourethrogram and flat plate of abdomen (males = 50 years old or anuric > 6 months, or urologic history involving bladder). 7. Results of laboratory studies and serologic testing, including: • ABO type and screen; • Complete blood count (CBC) and chemistry profile (including blood urea; nitrogen (BUN), creatinine, electrolytes, glucose, calcium (Ca), phosphorus uric acid, magnesium (Mg), total protein, albumin, amylase); • 24-hour creatinine clearance; • Prothrombin Time /Partial Thromboplastin Time (PT/PTT); • Glycosylated hemoglobin (for diabetes member); • Liver function tests (LFT) and lipid panel; • Histocompatibility antigens (HLA) typing; • Serology testing for cytomegalovirus, varicella virus, herpes simplex virus; Epstein Barr virus, Rapid Plasma Reagin (RPR), and hepatitis virus A, B and C; • Human immunodeficiency virus (HIV) antibody; • Urine culture. Documentation for HIV + Members In addition to the above documentation, the following information should be furnished: 1. The member’s life expectancy, 2. CD4 count for the last 6 months, 3. Documentation to show absence of HIV viremia for 6 months,, 4. Indication that the member is treatable with HAART post transplant, 5. Demonstrated compliance with anti-fungal and HAART regimen for ≥ 6 months 6. Willingness to use contraception, 7. Documentation to support the absence of Kaposi’s Sarcoma or lymphomas, 8. Females: A negative pregnancy test, 9. If co-infected with HBV or HCV, there is no evidence of cirrhosis on liver biopsy E. Review Process 1. The Medical Management staff assigned to review obtains the clinical information, to determine if there is adequate clinical information. 2. All requests for transplantation are referred the Medical Director for review. 3. The Medical Director reviews the request and determines if the requested service is medically necessary and appropriate. The Medical Director reviews each case on an individual basis. If the case meets the specific indications without any contraindications, the transplant is approved. If there are contraindications, the Medical Director consults with the transplant surgeon to determine if the transplant is appropriate for that member. 4. The Medical Management staff completes the review process and communicates the review decision according to the member’s benefit plan. • Proprietary and Confidential Information of UPMC Health Plan POLICY NUMBER: MP .041 REVISION DATE: 5/2008 ANNUAL APPROVAL DATE: 8/2008 PAGE NUMBER: 7 of 8 F. Variations N/A G. References 1. Steinman TI, Becker BN, Frost AE, et al. Guidelines for the referral and management of patients eligible for solid organ transplantation. Transplantation. 2001; 71(9):11891204. 2. United Network for Organ Sharing – Data report. Organ datasource – kidney. http://www.tranplantliving.org/organdatasource/about.asp?display=kidney. 3. Barker CF, Brayman, KL, et. al. Transplantation of abdominal organs – Renal transplantation. Townsend: Sabiston Textbook of Surgery, 16th ed., W.B. Saunders Company, 2001, 429-32. 4. Barry JM. Current status of renal transplantation: patient evaluations and outcomes. Urologic Clinics of North America. 2001; 28(4): 677-86. 5. Ramos E, Sayegh MH, Brennan DC. Evaluation of the potential renal transplant recipient. Up To Date 2003. [On-line] Available at: http://www.uptodate.com. 6. Dr Sanjay Bhagani and Dr Paul Sweny, Guidelines for Kidney Transplantation in Patients with HIV Disease, HIV specific inclusion criteria. British Transplantation Society Standards Committee, Department of HIV Medicine, and the Renal Unit Royal Free Hospital, London, Central Middlesex Hospital, London. http://www.bts.org.uk/Forms/HIV%20Renal%20Transplant%20guidelines%202005 %20final.doc 7. Centers for Disease Control and Prevention, What is HIV?, http://www.cdc.gov/hiv/resources/qa/qa1.htm 8. Global Health Reporting.org; What is HAART? http://www.globalhealthreporting.org/diseaseinfo.asp?id=261 Proprietary and Confidential Information of UPMC Health Plan POLICY NUMBER: MP .041 REVISION DATE: 5/2008 ANNUAL APPROVAL DATE: 8/2008 PAGE NUMBER: 8 of 8 Disclaimer: UPMC Health Plan medical payment and prior authorization policies do not constitute medical advice and are not intended to govern or otherwise influence the practice of medicine. The policies constitute only the reimbursement and coverage guidelines of UPMC Health Plan and its affiliated managed care entities. Coverage for services varies for individual members in accordance with the terms and conditions of applicable Certificates of Coverage, Summary Plan Descriptions, or contracts with governing regulatory agencies. UPMC Health Plan reserves the right to review and update the medical payment and prior authorization guidelines in its sole discretion. Notice of such changes, if necessary, shall be provided in accordance with the terms and conditions of provider agreements and any applicable laws or regulations. These policies are the proprietary information of UPMC Health Plan. Any sale, copying, or dissemination of said policies is prohibited. Proprietary and Confidential Information of UPMC Health Plan