CAM 40202

Paternal or Fetal Antigen Immunotherapy for Recurrent Fetal Loss

Category:Ob/Gyn/Reproduction   Last Reviewed:January 2018
Department(s):Medical Affairs   Next Review:January 2999
Original Date:March 1996    

Description:
This procedure involves the artificial stimulation of the protective maternal immune response using biological preparations containing paternal or fetal antigens to help prevent spontaneous abortion when no detectable cause can be identified. Three techniques are used: seminal plasma, trophoblast membranes and paternal leukocytes. Paternal leukocytes have been used most commonly.

  • Seminal Plasma:
    Seminal plasmas and blood specimens from normal donors are capsulated and administered as vaginal suppositories on days 7, 14 and 21 of the monthly cycle and continued twice weekly after the first missed menses until 30 weeks into pregnancy.
  • Trophoblast Membrane:
    Extracts are prepared from placentas collected at delivery from healthy-term pregnancies. Villous tissue is separated from other placental components. The sieved solution is centrifuged. Membrane pellets are resuspended in sterile, pyrogen-free saline, then UV-irradiated, washed, re-homogenized and lyophilized for storage. Membrane pellets are then reconstituted and administered with saline.
  • Paternal Leukocytes:
    Paternal whole blood is subjected to density gradient centrifugation. Mononuclear leukocytes are removed from the gradient, washed and resuspended in normal saline. Patients are immunized with the paternal leukocytes and then encouraged to conceive within a short time frame.

Policy:
Paternal and fetal antigen immunotherapy using seminal plasma, trophoblast membrane or paternal leukocyte applications to prevent recurrent fetal loss is considered INVESTIGATIONAL.

Policy Guidelines
Recurrent spontaneous abortion (RSA) is defined as three or more consecutive pregnancies with the same sexual partner, each ending in miscarriage before 20 weeks’ gestation. RSA may be caused by genetic, anatomic, endocrinologic or autoimmune abnormalities.

Benefit Application
BlueCard®/National Account Issues
Couples who experience recurrent fetal loss are technically not infertile, since pregnancy is initiated. Therefore, plans may wish to consider whether any benefits/contracts exclusions or limitations for infertility may apply to treatment of recurrent spontaneous abortion
.

Rationale
2002-3 Update
This policy was originally based on a 1995 TEC Assessment (1) that concluded that paternal or fetal antigen immunotherapy did not meet the TEC criteria as a treatment of recurrent spontaneous abortion. A search of literature was completed through the MEDLINE database for the period of 1995 through November 2003. The search did not identify any randomized controlled trials published during this period. Therefore, the policy statement is unchanged. In general, research interest in immunotherapy as a treatment of recurrent spontaneous abortion has focused on the use of intravenous immunoglobulin. This therapy is considered separately in policy No. 80105
.

References:

  1. TEC Assessments 1995: Tab 18

Coding Section

Codes Number Description
CPT No Code  
ICD-9 Procedure 96.49 (Seminal plasma) suppository insertion 
  99.29 (Trophoblast membrane) injection or other therapeutic or prophylactic substance
ICD-9 Diagnosis 646.3 Habitual aborter
HCPCS No Code    
ICD-10-CM (effective 10/01/15)   O2620 Pregnancy care for patient with recurrent pregnancy loss, unspecified trimester
  O2621  Pregnancy care for patient with recurrent pregnancy loss, first trimester
  O2622  Pregnancy care for patient with recurrent pregnancy loss, second trimester
  O2623  Pregnancy care for patient with recurrent pregnancy loss, third trimester
Type of Service Reproduction/Fertility    
Place of Service Outpatient, Physician's Office     

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

Index
Fetal and Paternal Antigen Immunotherapy for Recurrent Fetal Loss
Fetal Loss, Recurrent
Immunotherapy for Fetal Loss
Paternal or Fetal Antigen Immunotherapy for Recurrent Fetal Loss
Recurrent Fetal Loss

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, Blue Cross and Blue Shield Association technology assessment program (TEC) and other non-affiliated technology evaluation centers, reference to federal regulations, other plan medical policies and accredited national guidelines.

"Current Procedural Terminology© American Medical Association.  All Rights Reserved" 

History From 2013 Forward     

01/30/2019 

Annual review, no change to policy intent. 

01/29/2018 

Annual review, no change to policy intent. 

01/19/2017 

Annual review, no change to policy intent. 

01/19/2016 

Annual review, no change to policy intent. Updating coding. 

09/23/2015 

Added ICD-10 coding to policy. 

01/20/2015 

Annual review, no change to policy intent. Added coding. 

01/09/2014

NEW POLICY 


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