CG-SURG-35 Intracytoplasmic Sperm Injection (ICSI)

This document addresses the use of intracytoplasmic sperm injection (ICSI) during an infertility treatment cycle. This technique can allow some infertile individuals 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 documents for additional information:

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

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

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.

When services are Not Medically Necessary:
For the procedure codes listed above when criteria are not met or for situations designated in the Clinical Indications section as not medically necessary.

The American Society of Reproductive Medicine (ASRM) (2023) defines infertility as follows:

“Infertility’’ is a disease, condition, or status characterized by any of the following:

Infertility can be caused by the inability to ejaculate or an 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 infertility related to sperm factors occurs in about 30–40% of these cases. The most common cause for reduced sperm production 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) laboratory manual for the examination and processing of human semen (2021) are as follows:

The World Health Organization (2021) considers infertility due to sperm factors to be severe when any of the following semen analysis parameters are present:

ICSI is a potential component of an IVF cycle. This technique has expanded treatment options for infertility, allowing previously infertile individuals 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 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.

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 cycle-based fertility treatments offer clinically significant increases in the pregnancy rate; however, this benefit does not persist indefinitely.

Couples not achieving a pregnancy with medications alone after two cycles or intrauterine insemination (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 2020 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 infertility due to sperm factors. The document also stated that ICSI for unexplained fertility, low oocyte yield and advanced maternal age does not improve clinical outcomes. Their opinion included a statement that ICSI may be beneficial for individuals undergoing IVF with 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 infertility related to sperm factors; currently there is no data to support the routine use of ICSI for other causes of infertility.

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

Infertility: The Practice Committee of the American Society for Reproductive Medicine (ASRM) published their Definition of Infertility in 2023. That definition is:

“Infertility’’ is a disease, condition, or status characterized by any of the following:

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.

Teratozoospermia: The sperm shape is abnormal and incapable of fertilizing the egg, with normal morphology observed in 4% or fewer sperm.

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Subject: Intracytoplasmic Sperm Injection (ICSI)
Guideline #: CG-SURG-35	Publish Date: 10/01/2024
Status: Reviewed	Last Review Date: 08/08/2024

CPT
89280	Assisted oocyte fertilization, microtechnique; less than or equal to 10 oocytes
89281	Assisted oocyte fertilization, microtechnique; greater than 10 oocytes

ICD-10 Diagnosis
	All diagnoses

Status	Date	Action
Reviewed	08/08/2024	Medical Policy & Technology Assessment (MPTAC) review. Revised Discussion/General Information, Definitions, References and Websites for Additional Information sections.
Revised	08/10/2023	MPTAC review. Revised terminology in MN criteria to replace preimplantation genetic diagnosis (PGD) with preimplantation genetic testing (PGT). Updated Discussion/General Information, References and Websites for Additional Information sections.
Reviewed	05/11/2023	MPTAC review. Updated Description, Discussion/General Information, References and Websites for Additional Information sections.
Reviewed	05/12/2022	MPTAC review. Updated Description, Discussion, References and Websites sections.
Revised	05/13/2021	MPTAC review. Removed reference of sex in MN clinical indications section. Updated Description, Discussion, References and Websites sections. Reformatted Coding section.
Reviewed	05/14/2020	MPTAC review. Updated References and Websites sections.
Revised	06/06/2019	MPTAC review. Updated formatting in Clinical Indications section. Clarified MN criteria for severe male factor infertility diagnosed based on semen analysis parameter, teratozoospermia. Updated Description, Discussion, Definition, References and Websites sections.
Reviewed	07/26/2018	MPTAC review. The document header wording updated from “Current Effective Date” to “Publish Date”. Updated References and Websites sections.
Reviewed	08/03/2017	MPTAC review. Updated Discussion, References and Websites sections.
Reviewed	08/04/2016	MPTAC review. Discussion and Websites sections updated. Removed ICD-9 codes from Coding section. Updated formatting in Clinical Indications section.
Revised	08/06/2015	MPTAC review. Clarified medically necessary abbreviation. Discussion and Websites sections updated.
Reviewed	08/14/2014	MPTAC review. Websites updated.
New	08/08/2013	MPTAC review. Initial document development.