Download Allomap Test PAY.100.MH - MedStar Provider Network

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