Clinical UM Guideline


Subject:  Intracytoplasmic Sperm Injection (ICSI)
Guideline #:  CG-SURG-35Current Effective Date:  10/14/2014
Status:ReviewedLast Review Date:  08/14/2014

Description

This document addresses the use of intracytoplasmic sperm injection (ICSI) during an infertility treatment cycle, allowing couples with male factor infertility to attain live birth rates, similar to those achieved with in vitro fertilization (IVF) using conventional methods of fertilization.

Note: Please see the following related document for additional information:

Clinical Indications

Medically Necessary:

A maximum of three (3) cycles of ICSI per attempted pregnancy is considered medically necessary in covered individuals who meet ANY of the following criteria:

  1. Severe male factor infertility diagnosed based on any of the following semen analysis parameters;
    1. Asthenozoospermia (less than 40% moving sperm) (see definition section); or
    2. Oligozoospermia (less than 15 million/ml); or
    3. Teratozoospermia (Kruger less than or equal to 4%); or
  2. Previous IVF treatment cycle has resulted in failed or poor fertilization (equal to or greater than 50% of oocytes unfertilized in a prior cycle); or
  3. Anti-sperm antibodies have been documented; or
  4. Spinal cord injury individuals requiring electroejaculated sperm; or
  5. Surgically retrieved sperm (epididymal or testicular); or
  6. When using cryopreserved sperm for individuals in remission from cancer; or
  7. When completing preimplantation genetic diagnosis (PGD) (e.g. for single gene defect).

    Note: Two semen analyses are required prior to categorization of the male infertility. A comprehensive semen analysis must be completed prior to infertility treatment cycles.

Not Medically Necessary:

More than three (3) cycles of ICSI per attempted pregnancy is considered not medically necessary.

ICSI is considered not medically necessary when the criteria above are not met including, but not limited to all of the following:

Coding

The following codes for treatments and procedures applicable to this guideline 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 
89280Assisted oocyte fertilization, microtechnique; less than or equal to 10 oocytes
89281Assisted oocyte fertilization, microtechnique; greater than 10 oocytes
  
ICD-9 Diagnosis[For dates of service prior to 10/01/2015]
 All diagnoses
  
ICD-10 Diagnosis[For dates of service on or after 10/01/2015]
 All diagnoses
  
Discussion/General Information

The American Society of Reproductive Medicine (ASRM) (2012) defines infertility as the inability to achieve a successful pregnancy after 12 months or more of regular unprotected intercourse. Male infertility is defined as the inability to ejaculate or insufficient number of sperm. Work-up for the diagnosis of infertility should include a comprehensive medical, reproductive, and family history and a physical exam. Laboratory testing and diagnostic evaluation may also be appropriate with emphasis on a systematic, expeditious manner and the least invasive method for diagnosis of infertility.

According to the National Institutes of Health (NIH), approximately one in six couples has difficulty conceiving. It is estimated that male infertility is a factor in about 30–40% of these cases. The most common cause for infertility in men is an enlarged mass of veins in the spermatic cord within the scrotum. The spermatic cord is made up of veins, arteries, lymphatic vessels, nerves, and the duct that carries sperm from the testes to the seminal vesicles.

Normal semen parameters established by the World Health Organization (WHO) are as follows:

Severe male factor infertility is defined by any of the following semen analysis parameters:

ICSI is a potential component of IVF cycle; this alternate technique has revolutionized treatment of severe male infertility, allowing previously infertile couples to conceive. The procedure is completed under a microscope using a microscopic glass needle to inject a single sperm directly into the egg. Once the egg is fertilized, it is transferred to the female partner's uterus. ICSI is used for individuals who have very poor semen quality or lack of sperm in the semen caused by an obstruction or testicular failure. In some cases, sperm may be surgically extracted from the testicles or epididymis for this procedure.

According to the Society for Assisted Reproductive Technology (2008) "If a woman gets pregnant naturally, there is a 1.5% to 3% chance that the baby will have a major birth defect. The chances of birth defects after ICSI are rare. Certain conditions that have been associated with the use of ICSI (Beckwith-Wiedemann syndrome, Angelman syndrome, hypospadias, or sex chromosome abnormalities) are thought to occur in far less than 1% of children conceived using this technique. Some of the problems that caused your infertility may be genetic. Therefore, boys conceived with the use of ICSI may have infertility issues as adults."

Smith and colleagues (2010) reported results from a prospective fertility cohort study of 408 couples undergoing cycle based treatment in the United States. The authors concluded that study data suggests that cycle-based fertility treatments offer clinically significant increases in the pregnancy rate; this benefit does not persist indefinitely. "Couples not achieving a pregnancy with medications alone after two cycles or IUI after three cycles may be best counseled to pursue a higher level of infertility treatment. Those failing IVF after two cycles may want to consider other treatment strategies, such as donor sperm, donor egg, or further modifications in the IVF or ICSI protocol because additional cycles seem less likely to increase reproductive success as much as earlier cycles."

A 2012 committee opinion of the American Society of Reproductive Medicine and Society for Assisted Reproductive Technology stated that ICSI is a safe and effective treatment for male factor infertility. The document also stated that ICSI for unexplained fertility, low oocyte yield and advanced maternal age does not improve clinical outcomes. The opinion included a statement that ICSI may be beneficial for individuals undergoing IVF with preimplantation genetic testing (PGT), fertilization after in vitro matured oocytes and cryopreserved oocytes. The authors concluded that the use of ICSI is a safe and effective therapy for the treatment of male factor infertility; currently there is no data to support the routine use of ICSI for non-male factor infertility.

Definitions

Azoospermia: Lack of live spermatozoa in the semen; classified as obstructive or nonobstructive depending on whether cause is blockage of the tubules or ducts.

Intracytoplasmic sperm injection (ICSI): A fertility treatment that is used to treat sperm related problems by injecting a single sperm into a mature egg. The fertilized egg is then placed in a woman's uterus or fallopian tube.

Oligospermia: Decreased number of spermatozoa in the semen.

References

Peer Reviewed Publications:

  1. Anderson JE, Farr SL, Jamieson DJ, et al. Infertility services reported by men in the United States: national survey data. Fertility and Sterility 2009; (6):2466–2470.
  2. Kathiresan AS, Ibrahim E, Aballa TC, et al. Comparison of in vitro fertilization/intracytoplasmic sperm injection outcomes in male factor infertility patients with and without spinal cord injuries. Fertil Steril. 2011; 96(3):562-566.
  3. Pandian Z, Bhattacharya S, Ozturk O, et al. Number of embryos for transfer following in-vitro fertilization or intra-cytoplasmic sperm injection. Cochrane Database of Systematic Reviews 2009, Issue 2. Art. No.: CD003416. DOI:10.1002/14651858.CD003416.pub3.
  4. Smith JF, Eisenberg ML, Millstein SG, et al. Fertility treatments and outcomes among couples seeking fertility care: data from a prospective fertility cohort in the United States. Fertil Steril. 2011; 95:79–84.

Government Agency, Medical Society, and Other Authoritative Publications:

  1. American Society for Reproductive Medicine. Diagnostic evaluation of the infertile female: a committee opinion. 2012. Available at: http://www.asrm.org/Guidelines. Accessed on June 17, 2014.
  2. Cooper TG, Noonan E, von Eckardstein S, World Health Organization reference values for human semen characteristics. Human Reproduction Update. 2010; 16, (3)231–245.
  3. National Institute for Health and Clinical Excellence (NICE). Clinical guideline 156. Assessment and treatment for people with fertility problems. February 2013. Available at: http://www.nice.org.uk/nicemedia/live/14078/62769/62769.pdf. Accessed on June 17, 2014.
  4. Practice Committees of American Society for Reproductive medicine and Society for Assisted Reproductive Technology. Intracytoplasmic sperm injection (ICSI) for non-male factor infertility: a committee opinion. Fertil Steril. 2012; 98(6):1395-1399.
  5. Practice Committee of the American Society for Reproductive Medicine in collaboration with the Society for Male Reproduction and Urology. Evaluation of the azoospermic male. Fertil Steril. 2008; 90: 74-77.
  6. Practice Committee of the American Society for Reproductive Medicine in collaboration with the Society for Male Reproduction and Urology. The management of infertility due to obstructive azoospermia. Fertil Steril. 2008; 90:121-124.
Websites for Additional Information
  1. American Society for Reproductive Medicine. Available at: http://www.asrm.org/. Accessed on June 17, 2014.
  2. American Society for Reproductive Medicine. Patient's fact sheet: diagnostic testing for male factor infertility. Revised 2008. Available at: http://www.asrm.org/uploadedFiles/ASRM_Content/Resources/Patient_Resources/Fact_Sheets_and_Info_Booklets/Testing_Male-Fact.pdf. Accessed on June 17, 2014.
  3. Medline Plus. Male Infertility. Available at: http://www.nlm.nih.gov/medlineplus/maleinfertility.html. Accessed on June 17, 2014.
  4. Society for Assisted Reproductive Technology. Intracytoplasmic sperm injection (ICSI) fact sheet. Revised 2008. Available at: http://www.sart.org/Intracytoplasmic_Sperm_Injection_factsheet/. Accessed on June 17, 2014.
Index

Intracytoplasmic sperm injection (ICSI)

The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

History

Status

Date

Action

Reviewed08/14/2014Medical Policy & Technology Assessment Committee (MPTAC) review. Websites updated.
New08/08/2013MPTAC review. Initial document development.