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MedStar Health, Inc. POLICY AND PROCEDURE MANUAL POLICY NUMBER: PAY.100.MH REVISION DATE: 09/11 ANNUAL APPROVAL DATE: 11/11 PAGE NUMBER: 1 of 5 SUBJECT: INDEX TITLE: ORIGINAL DATE: AlloMap® Molecular Expression Test Medical Management November 2010 This policy applies to the following lines of business: (Check those that apply.) COMMERCIAL CMS-MA MedStar Select ( X ) I. MedStar Medicare Choice ( X ) POLICY It is the policy of MedStar Health, Inc. to cover the AlloMap® Molecular Expression Test when it is medically necessary (Refer to CRM .015- Medical Necessity policy) as detailed in this policy and covered under the member’s specific benefit plan. II. DEFINITIONS N/A III. PURPOSE The purpose of this policy is to provide the indications for coverage of the AlloMap® Molecular Expression Test. IV. SCOPE This policy applies to various MedStar Health, Inc. Departments. V. PROCEDURE A. Medical Description / Background Acute cellular rejection (ACR) is the most common complication following heart transplants and monitoring for this is very important as its reversal depends on early and accurate detection. AlloMap® Molecular Expression Testing is a nonUPMC Health Plan and Evolent Health provide administrative functions and services on behalf of MedStar Health, Inc.. and its affiliates. Proprietary and Confidential Information of UPMC Health Plan © 2013 UPMC All Rights Reserved POLICY NUMBER: PAY.100.MH REVISION DATE: 09/11 ANNUAL APPROVAL DATE: 11/11 PAGE NUMBER: 2 of 5 invasive in vitro molecular diagnostic blood test that helps identify heart transplant recipients who might be at risk for organ rejection. The test, which is FDA approved, was developed and is performed by XDX-Expression Diagnostics. It measures the expression of twenty specific immune system genes using a quantitative real-time polymerase chain reaction (PCR) and reports the results as a composite score (0-40). The score is associated with a negative predictive value and the lower the score, the lower the probability of rejection at the time the test was drawn. Higher scores on the test correlate with a greater likelihood of acute cellular rejection and could prompt an invasive endomyocardial biopsy (EMB). The score also correlates with the International Society for Heart & Lung Transplant’s grading system assessment for EMB for severity of rejection. The AlloMap® test is intended for non-invasive monitoring of patients post-heart transplant in conjunction with standard clinical evaluation. It can assist ysicians in individualizing patient care and reduce invasive monitoring and their risks/complications. Results of the Invasive Monitoring Attenuation through Gene Expression (IMAGE) clinical trial demonstrated that the AlloMap® test was not inferior to conventional EMB for monitoring post-heart transplant patients with respect to clinical outcomes. The use of the test as part of overall post-transplant management resulted in significantly fewer biopsies compared to the current standard of routine biopsies (12-14 the first year and 4 the second year). B. Indications The AlloMap® test is indicated for heart transplant patients 15 years of age or older in lieu of EMB when one of the following inclusion criteria is met as well as none of the exclusions listed in limitations: Patients receiving Campath induction 1. Starting at 6months post-transplant 2. WBC Over 3000 Tolerating mycophenolate mofetil (MMF) at 500 BID for one month No filgrastim in past 30 days Patients receiving non-campath induction (induction with other agents where neutropenia will not be an issue) - starting at 3 months post transplant Patients receiving no type of induction (patients who do not get induction with any agents) – starting at 3 months post transplant An echocardiogram is to be performed the same day as a clinic visit when the AlloMap® test will be drawn. UPMC Health Plan and Evolent Health provide administrative functions and services on behalf of MedStar Health, Inc.. and its affiliates. Proprietary and Confidential Information of UPMCHealth Plan © 2013 UPMC All Rights Reserved POLICY NUMBER: PAY.100.MH REVISION DATE: 09/11 ANNUAL APPROVAL DATE: 11/11 PAGE NUMBER: 3 of 5 C. Limitations: Rejection 1. Signs and symptoms of acute cellular rejection (ACR) 2. Recurrent grade ≥ 2R 3. Biopsy is part of follow-up for rejection or as part of an immunosuppressive conversion 4. Recent history of antibody mediated rejection (AMR) 5. Transplanted against a crossmatch/high risk AMR Timing 1. Less than 2 months post-transplant 2. Patients < 15 years of age 3. As above per induction therapy Concurrent conditions 1. Any patient currently an inpatient 2. Pregnancy 3. Re-transplantation 4. Multi-organ transplant In combination with heart After heart 5. Dialysis – hemo dialysis or peritoneal dialysis Therapies 1. In the past 30 days – blood products or neupogen 2. Steroids IV or oral pulse for rejection within past 21 days On ≥ 20 mg/day prednisone 3. Unwilling to obtain follow-up biopsy if indicated 4. Patients in whom surveillance biopsies would not be performed by current protocol, e.g. those who are stable and over 3 years posttransplant Other considerations for usage outside of above guidelines – must be discussed with primary cardiologist and documented: 1. Difficult access 2. Inability to tolerate biopsy 3. Inability to pass biotome into the right ventricle 4. Concurrent with biopsy to establish a trend in anticipation of above issues UPMC Health Plan and Evolent Health provide administrative functions and services on behalf of MedStar Health, Inc.. and its affiliates. Proprietary and Confidential Information of UPMCHealth Plan © 2013 UPMC All Rights Reserved POLICY NUMBER: PAY.100.MH REVISION DATE: 09/11 ANNUAL APPROVAL DATE: 11/11 PAGE NUMBER: 4 of 5 AlloMap® test results 1. Low risk threshold score Month 2-6 : 30 Month 6-12 : 34 Month 12+ : 34 2. Interpretation of results Score < threshold, no biopsy Score ≥ threshold, biopsy within 5 days of result (>34) Score ≥ threshold, after 3 prior scores ≥ 34 1. Resume biopsies 2. Defer and screen with echo and clinical assessment, but only after discussion with primary cardiologist Note: Rarely if a patient has 3 Allomap scores over 34 and does not show rejection on any of the follow-up EMBs, then further Allomap testing is not warranted. D. Codes The following codes for treatments and procedures applicable to this policy are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member. CPT Description 86849 Unlisted immunology procedure ICD 428.0 428.9 996.83 V42.1 Description Congestive heart failure, unspecified Heart failure, unspecified Complications of heart transplant Heart replaced by transplant E. Variations N/A F. Quality Audit UPMC Health Plan and Evolent Health provide administrative functions and services on behalf of MedStar Health, Inc.. and its affiliates. Proprietary and Confidential Information of UPMCHealth Plan © 2013 UPMC All Rights Reserved POLICY NUMBER: PAY.100.MH REVISION DATE: 09/11 ANNUAL APPROVAL DATE: 11/11 PAGE NUMBER: 5 of 5 Quality Audit may monitor policy compliance or billing accuracy at the request of the MedStar Health, Inc.. G. Records Retention Records Retention for documents, regardless of medium, are provided within the MedStar Health, Inc. Policy and Procedure CORP.028.MH Records Retention. H. References 1. XDx Expression Diagnostics, AlloMap® Molecular Expression Testing, 20042011; www.allomap.com 2. ECRI Institute Target Report, Gene expression profiling to monitor acute heart transplant rejection, 09/2007 3. California Technology Assessment Forum, Gene Expression Profiling for the Diagnosis of Heart Transplant Rejection – A Technology Assessment, 10/2006 4. The New England Journal of Medicine 362:1932-1933, Fear of Rejection – Monitoring the Heart Transplant Recipient, 05/20/2010 5. International Society for Heart & Lung Transplantation, Results of IMAGE Study Demonstrating Non-Inferiority of AlloMap® to Routine Biopsy for Routine Surveillance after Heart Transplantation, 04/22/2010 6. University of Pittsburgh Medical Center, AlloMap Protocol, 2010 UPMC Health Plan and Evolent Health provide administrative functions and services on behalf of MedStar Health, Inc.. and its affiliates. Proprietary and Confidential Information of UPMCHealth Plan © 2013 UPMC All Rights Reserved