Commercial

Medical Policy

Notification

Assisted Reproductive Technology for Infertility and Oocyte Cryopreservation

Notification Issued Date:

This policy has been identified for the CPT code update, effective 01/01/2020.

The following code has been deleted from this policy: 0357T.

Title:

Assisted Reproductive Technology for Infertility and Oocyte Cryopreservation

Policy #:

07.10.06i

Policy

State mandates do not automatically apply to self-funded groups; therefore, individual group benefits must be verified.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.

The provision of benefits for all services related to assisted reproductive technology is in accordance with the individual's benefit contract and varies by product and group. Therefore, individual member benefits must be verified. Some services may be subject to state mandates, medical necessity criteria, coverage limits, precertification or preapproval, or existing contractual exclusions.

Coverage eligibility for individuals may depend upon whether the individual has a history of a voluntary sterilization procedure(s) (e.g., vasectomy, tubal ligation).

IN VITRO FERTILIZATION (IVF)

In vitro fertilization (IVF) is considered medically necessary and, therefore, covered when an individual has a congenital absence or anomaly of reproductive organ(s).

In vitro fertilization (IVF) is considered medically necessary and, therefore, covered when all of the following criteria are met:

Individual fulfills one of the following definitions of infertility:

Individual is younger than the age of 35 years and has not achieved a successful pregnancy after at least 12 months of appropriately timed unprotected vaginal intercourse or intrauterine insemination.

Individual is 35 years of age or older and has not achieved a successful pregnancy after at least 6 months of appropriately timed unprotected vaginal intercourse or intrauterine insemination.

In the absence of known tubal disease and/or severe male factor problems (contraindications to insemination cycles), the individual has not achieved a successful pregnancy after three stimulated ovulation inductions (i.e., triggered ovulation/oocyte release) and intrauterine insemination.

Individual has at least one risk factor that includes, but is not limited to the following:

Tubal disease that cannot be corrected surgically

Diminished ovarian reserve

Irreparable distortion of the uterine cavity or other uterine anomaly (when using a gestational carrier)

Male partner with severe male factor infertility

Unexplained infertility

Severe endometriosis

Individual does not have either of the following contraindications:

Ovarian failure: premature (i.e., ovaries stop working before age 40) or menopause (i.e., absence of menstrual periods for 1 year)

Contraindication to pregnancy

GAMETE INTRAFALLOPIAN TRANSFER (GIFT)/ZYGOTE INTRAFALLOPIAN TRANSFER (ZIFT)

Gamete intrafallopian transfer (GIFT) or zygote intrafallopian transfer (ZIFT) are considered medically necessary and, therefore, covered when all of the following criteria are met:

Individual met the criteria for IVF, AND

Individual does not have any of the following contraindications:

Tubal disease

Severe uterine factor

Irreparable distortion of the uterine cavity

Male partner with severe male factor infertility

INTRACYTOPLASMIC SPERM INJECTION (ICSI)

Intracytoplasmic sperm injection (ICSI) is considered medically necessary and, therefore, covered when at least ONE of the following criteria is met:

Diagnosed infertility due to a male factor (e.g., low sperm count, low function of sperm, abnormal morphology of the sperm, obstructive azoospermia, and nonobstructive azoospermia), as defined by values based on the World Health Organization (WHO) semen analysis criteria values, demonstrated on at least two separate semen analyses

A prior failed IVF attempt resulting from polyspermy (an egg that has been fertilized by more than one sperm) or poor fertilization (failed prior standard insemination of mature oocytes) when insemination alone was used

When used with a medically necessary planned preimplantation genetic diagnosis (PGD), as per Company policy, especially for single gene defects

When used to inseminate previously cryopreserved oocytes

ASSISTED EMBRYO HATCHING

Assisted embryo hatching for individuals diagnosed with poor prognosis for implantation (i.e., poor embryo or egg quality, as defined by the zona pellucida (ZP) being thickened, distorted, or too big for the ooplasm) is considered medically necessary and, therefore, covered when EITHER of the following criteria is met:

The individual is 38 years of age or older

The individual has failed at least two implantation attempts using IVF

Assisted hatching may be considered medically necessary on a cryopreserved embryo in those women with a diagnosis of infertility and poor prognosis.

FROZEN EMBRYO TRANSFER (FET)

Frozen embryo transfer (FET) is considered medically necessary and, therefore, covered when the member meets the definition of infertility and either of the following criteria are met:

Individual has cryopreserved embryos from a previous IVF cycle, OR

Individual is receiving cryopreserved donor embryos

TUBAL EMBRYO TRANSFER (TET)

Tubal embryo transfer (TET) is considered medically necessary and, therefore, covered when the member meets the definition of infertility and all of the following criteria are met:

Individual is using fresh embryo(s) from a current IVF cycle or cryopreserved embryo(s) from previous IVF or donor cycle

Individual does not have any of the following contraindications:

Tubal disease

Severe uterine factor

Irreparable distortion of the uterine cavity

Contraindication to pregnancy

SPERM RETRIEVAL TECHNIQUES

Sperm retrieval techniques are considered medically necessary and, therefore, covered when the individual meets the definition of infertility and the following criteria are met:

Individual diagnosed with severe male factor infertility

Individual does not have sperm currently being cryopreserved

Sperm retrieval techniques include, but are not limited to, the following procedures:

Microepididymal sperm aspiration (MESA)

Percutaneous epididymal sperm aspiration (PESA)

Testicular sperm aspiration (TESA)

Testicular sperm extraction (TESE)

Individual is preparing for gonadotoxic therapies due to cancer or other medical diseases.

Individual is undergoing prophylactic oophorectomy due to certain genetic conditions, such as BRCA mutations.

Individual underwent oocyte retrieval for IVF but there was an inability to obtain sperm.

Individual underwent sperm retrieval technique.

Cryopreservation of immature oocytes is considered experimental/investigational and, therefore, not covered because the safety and/or effectiveness of this service cannot be established by review of the available published peer-reviewed literature.

** Cryopreservation, storage, and/or purchase of gametes or embryos are benefit exclusions unless an individual benefit has been purchased. Benefits may be available for preparation of the embryo before and after cryopreservation. Individual benefits must be verified.

Assisted reproductive technology for the purpose of oocyte cryopreservation is considered not medically necessary when the procedure is performed to:

Provide donor oocytes

Conserve future childbearing potential due to reproductive aging

THIRD PARTY REPRODUCTION

Third party reproduction, is not covered by the Company, because it is usually a benefit contract exclusion, and, therefore, not eligible for reimbursement consideration. Individual benefits must be verified.

Third party reproduction includes, but is not limited to, the following procedures:

Monitoring, stimulation and, or retrieval of donor oocytes and treatment of complications an oocyte donor incurs as a result of the process of oocyte donation

Monitoring, stimulation, oocyte retrieval, and fertilization for donor embryos

Monitoring, endometrial stimulation, and embryo transfer to gestational carriers

Where covered, third party ART using donor eggs, sperm, or embryos, and IVF where the embryo is transferred to a gestational carrier or surrogate, is considered medically necessary and, therefore, covered as follows:

Gamete donation is considered medically necessary and, therefore, covered when any of the following criteria are met:

Recipient individual diagnosed with premature ovarian failure.

Recipient individual's partner diagnosed with azoospermia.

Recipient individual or partner is a carrier of a genetically transmitted disorder.

Recipient individual has poor gamete quality in two previous IVF cycles.

Embryo donation is considered medically necessary and, therefore, covered when any of the following criteria are met:

Recipient individual diagnosed with untreatable infertility.

Recipient individual experienced recurrent pregnancy loss thought to be related to embryonic factors.

Recipient individual or partner carries a genetically transmitted disorder.

A gestational carrier is considered medically necessary and, therefore, covered when any of the following criteria are met:

Recipient individual does not have a uterus.

Recipient individual diagnosed with uterine anomalies that cannot be repaired.

Recipient individual diagnosed with a medical condition for which pregnancy may pose a life-threatening risk.

** Cryopreservation, storage, and/or purchase of gametes or embryos are benefit exclusions unless an individual benefit has been purchased. Benefits may be available for preparation of the embryo before and after cryopreservation. Individual benefits must be verified.

Surgery performed for the reversal of a sterilization procedure may be a benefit exclusion. Individual benefits must be verified.

Services provided to a surrogate or gestational carrier may be a benefit exclusion. Individual benefits must be verified.

All other uses for or types of assisted reproductive technology are considered experimental/investigational and, therefore, not covered because their safety and/or effectiveness cannot be established by review of the available published peer-reviewed literature.

CODING GUIDELINES

HCPCS codes identified in the Coding Table representing case rates for ART procedures should not be reported. The appropriate CPT codes should be reported.

Trial (mock) embryo transfer: Separate benefits are not provided for trial (mock) embryo transfer, as it is considered an integral part of the embryo transfer, intrauterine, procedure. Report trial (mock) embryo transfer with "unlisted procedure, female genital system."

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.

Guidelines

Tests for establishing a diagnosis of infertility are generally covered under the member’s basic benefit unless specifically excluded by the member’s group. The procedures described within this policy and services associated with the procedures listed in this policy (i.e. ultrasound monitoring, lab tests, anesthesia etc.) are available only to members whose groups have purchased an Infertility (Assisted Reproductive Therapies [ART]) rider.

Some groups require preauthorization of certain procedures.

Some groups specifically exclude certain of the described procedures.

For groups with the benefit who require preauthorization, benefits must be carefully evaluated before proceeding with the request, for limitations (either dollar limit or cycle limit, as well as how the group counts cycles) and for benefit exclusions.

Coverage for infertility-related medical costs ends at approximately 8 to 12 weeks gestation, whereby a stable pregnancy is usually clinically achieved and documented. At that point, care should transition to the services of a professional provider for the appropriate obstetrical care.

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, assisted reproductive technology is covered under the medical benefits of the Company’s products when the medical necessity criteria listed in this medical policy are met and the member has a benefit.

Coverage eligibility for individuals may depend upon whether the individual has had a history of a voluntary sterilization procedure(s) (e.g., vasectomy, tubal ligation).

The provision of benefits for services related to ART is in accordance with the individual's benefit contract and varies by product and group. Benefit contracts and State Mandates may limit the lifetime number of ART cycles or dollar amount for which an individual is covered. Therefore, individual member benefits must be verified.

MANDATES

This policy is consistent with applicable state mandates. The laws of the state where the benefit contract is issued determine the mandated coverage.

NEW JERSEY INFERTILITY MANDATE
Effective December 1, 2001, the State of New Jersey has mandated coverage for infertility treatment to groups whose coverage is written in New Jersey. The law includes restrictions for employers that provide coverage to fewer than 50 employees, as well as religious exemptions. The benefits under the mandate should be performed at facilities that conform to standards established by the American Society of Reproductive Medicine or the American College of Obstetricians (ACOG).

In accordance with the State of New Jersey’s mandate requiring health insurers to provide coverage for medically necessary expenses incurred in the diagnosis and treatment of infertility, the Company shall provide coverage, which includes, but is not limited to, the following services related to infertility: diagnosis and diagnostic tests, medications; surgery, in vitro fertilization, embryo transfer, artificial insemination, gamete intra fallopian transfer, zygote intra fallopian transfer, intracytoplasmic sperm injection, and four completed egg retrievals per lifetime of the enrollee. The services for in vitro fertilization, gamete intra fallopian transfer and zygote intra fallopian transfer shall be limited to a covered person who: A) has used all reasonable, less expensive and medically appropriate treatments and is still unable to become pregnant or carry a pregnancy; B) has not reached the limit of four completed egg retrievals; and C) is 45 years of age or younger. A carrier shall exclude coverage for in vitro fertilization, embryo transfer, artificial insemination, zygote intrafallopian transfer, gamete intrafallopian transfer, and intracytoplasmic sperm injection at the request of a religious employer only if the required coverage is contrary to the religious employer’s bona fide religious tenets. Mandate coverage is not required beyond 4 completed egg retrievals or for women age 46 or older.

As mandated by the State of New Jersey, the medical expenses of a gestational carrier that are incurred in connection with the treatment of such Covered Person’s infertility, if the Covered Person’s benefits have not been exhausted, will be covered subject to benefit provisions, as if they had been incurred by the Covered Person, including complications related to the infertility treatments rendered under benefits; and the following medical expenses of a surrogate that are incurred in connection with the treatment of the Covered Person’s infertility: egg retrieval, in-vitro fertilization laboratory services, embryo transfers, and artificial insemination will be covered.

This mandate is not applicable to New Jersey residents whose coverage is written in another state.

World Health Organization (WHO) semen-analysis criteria values:

Semen volume 1.5 (1.4–1.7 mL)
Total sperm number 39 (33–46) (106 per ejaculate)
Sperm concentration 15 (12–16) (106 per mL)
Total motility 40 (38–42) (PR+NP, %)
Progressive motility 32 (31–34) (PR, %)
Vitality 58 (55–63) (live spermatozoa, %)
Sperm morphology 4 (3.0–4.0) (normal forms, %)

DEFINITIONS

Assisted hatching (AH): a procedure in which the zona pellucida (outer covering) of the embryo is partially opened, usually by application of an acid or laser, to facilitate embryo implantation and pregnancy.

Assisted reproductive technologies: all treatments that include the handling of eggs and/or embryos. Some examples of ART are in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), pronuclear stage tubal transfer (PROST), tubal embryo transfer (TET), and zygote intrafallopian transfer (ZIFT).

Azoospermia: the absence of sperm present in seminal fluid.

Cryopreservation and storage: the freezing at a very low temperature, such as in liquid nitrogen (-196^oC), to keep embryos, eggs, or sperm viable.

Embryo: the fertilized ovum after it has begun the process of cell division.

Female infertility: a disease defined by the failure to achieve a successful pregnancy after 12 months or more of regular unprotected intercourse or exposure to sperm. Earlier evaluation and treatment may be justified based on medical history and physical findings and is warranted after 6 months for women over age 35 years.

Gametes: the oocytes (eggs) and spermatozoa (sperm).

Intracytoplasmic sperm injection (ICSI): a micromanipulation procedure in which a single sperm is injected directly into an egg to attempt fertilization, used with male infertility or couples with prior IVF fertilization failure.

In vitro fertilization (IVF): a method of assisted reproduction that involves combining an egg with sperm in a laboratory dish. If the egg fertilizes and begins cell division, the resulting embryo is transferred into the woman's uterus, where it will hopefully implant in the uterine lining and further develop.

Male infertility: infertility caused by a problem in the male, for example, inability of ejaculate or insufficient number of sperm.

Micromanipulation: an in vitro fertilization (IVF) laboratory process whereby the egg or embryo is held with special instruments and surgically altered by procedures such as intracytoplasmic sperm injection (ICSI), assisted hatching, or embryo biopsy.

Oocytes: eggs

Oligospermia: a cause of male infertility in which fewer than forty million sperm are present in the semen from one ejaculation.

Polyspermy: an egg that has been fertilized by more than one sperm

Recurrent pregnancy loss: a disease distinct from infertility, defined by two or more failed pregnancies.

Semen analysis: the microscopic examination of semen (the male ejaculate) to determine its volume, the number of sperm (sperm count), their shapes (morphology), and their ability to move (motility), in addition to other parameters.

Sperm: the male sex cells (spermatozoa), which are produced in the testes.

Sperm count: an assessment of the number of sperm present in each milliliter of semen.

Sperm motility: in a semen analysis, the degree to which sperm cells are able to spontaneously propel themselves.

Zona pellucida: the outer protein coat (shell) of an ovum (oocyte), which must be penetrated by a sperm cell for fertilization to take place.

Description

INFERTILITY

Infertility is defined by the American Society of Reproductive Medicine (ASRM) as the inability to achieve a successful pregnancy after at least 12 months of appropriate, timed, unprotected vaginal intercourse or therapeutic donor insemination. The timeframe is reduced to 6 months for women over 35 years old. The ASRM further defines pregnancy as a clinical pregnancy documented by ultrasound or microscopic examination of tissue. Infertility does not include the inability to carry a pregnancy to term.

The causes of infertility are commonly classified into the following underlying contributing factors: female, male, combination of male and female, and unknown. Consequently, treatment options for infertility depend on the cause of infertility and often include assisted reproductive technologies (ART).

ASSISTED REPRODUCTIVE TECHNOLOGY

ART includes all treatments or procedures that involve the in vitro (i.e., outside of the female reproductive system) handling of both human oocytes (eggs) and sperm, or embryos, for the purpose of establishing a pregnancy. ART includes, but is not limited to, in vitro fertilization (IVF) and embryo transfer, gamete intrafallopian transfer, zygote intrafallopian transfer, tubal embryo transfer, gamete and embryo cryopreservation (freezing), oocyte and embryo donation, and gestational surrogacy or carrier. By definition, ART does not include insemination, which is an office procedure in which sperm are placed directly into the vagina, cervix or uterus using a flexible catheter.

IN VITRO FERTILIZATION AND EMBRYO TRANSFER

IVF is the most commonly utilized type of assisted reproduction and is attempted for infertility due to female, male and unknown causes. Fertilization involves penetration of the oocyte by a sperm. During IVF, sperm and oocyte(s) are combined outside of the body in a laboratory dish. An IVF cycle can be “natural”, in which one or more eggs are collected from the ovaries during a spontaneous menstrual cycle without any drug use, or “stimulated” cycle, during which medications are given to a woman to increase the chances of obtaining multiple oocytes. In addition to ovarian stimulation (or ovarian monitoring for natural IVF cycle), the steps in the IVF process include oocyte retrieval, fertilization, embryo culture, and embryo transfer.

Blood hormone levels and ultrasound results during ovarian monitoring/stimulation are utilized to determine the timing of the next step in the IVF process. Oocyte retrieval is a procedure during which follicles in the ovary are aspirated with an ultrasound-guided needle through the vagina and the aspirated material is examined for oocytes. Oocytes can also be retrieved laparoscopically if the ovaries cannot be aspirated transvaginally. An IVF cycle is considered “cancelled” if ovarian stimulation or monitoring is done with the intention of oocyte retrieval, but follicular aspiration never occurs. An IVF cycle may be cancelled for various reasons, including abnormal hormone levels indicating a low ovarian response; poor ovarian stimulation evident by few follicles growing (as seen on ultrasound); premature ovulation prior to retrieval; and/or ovarian hyperstimulation syndrome.

After the oocytes are identified and determined to be satisfactory, the oocytes are prepared for fertilization. Fertilization may be accomplished by insemination, where sperm are placed in the laboratory dish with the oocytes or by intracytoplasmic sperm injection (ICSI), where a single sperm is directly injected into each oocyte. Per the ASRM, ICSI is indicated for the treatment of infertility due to a male factor. ICSI may also be used in conjunction with IVF if poor fertilization occurred in prior cycles where insemination alone was used or if preimplantation genetic diagnosis (PGD) is planned. Despite limited data, ICSI is also the preferred method of fertilizing cryopreserved oocytes due to removal of cumulus cells prior to freezing and possible changes to the zona pellucida. There is no data to support ICSI for routine use or for poor quality oocytes. Furthermore, ICSI does not improve clinical outcomes for low oocyte yield or advanced maternal age.

If fertilization is successful, the oocyte will continue to divide in culture media and become an embryo. A critical factor in preparing an embryo for implantation in the uterus is the embryo hatching at blastocyst stage. Hatching normally results from rupture of the outer shell of the embryo, referred to as the zona pellucida (ZP). Some embryos are unable to induce thinning of the ZP before hatching. It is hypothesized that the ZP sometimes becomes hardened during the in vitro process, thus impairing the escape of the developing embryo. A technique used to improve the successful implantation of the embryo is assisted embryo hatching. The ASRM describes assisted embryo hatching as the artificial thinning or breaching of the ZP, which is usually performed on the third day after fertilization. Various methods are used to create an opening in the zona: drilling with acidified Tyrode's solution, partial zona dissection (PZD) with a glass microneedle, laser photoablation, or use of a piezmicromanipulator. Meta-analysis of available data has demonstrated that assisted embryo hatching improves implantation and pregnancy rates following in vitro fertilization; however, live birth rates are not increased. Per the ASRM, assisted hatching may be beneficial for those individuals with a poor prognosis for implantation, including those with at least two failed IVF cycles, poor embryo quality (poor embryo or egg quality, as defined by the ZP being thickened, distorted, or too big for the ooplasm), or women who are 38 years of age or older. The evidence does not support the routine or universal application of assisted hatching in all IVF cycles at this time.

Embryo transfer (ET) is the final step in an IVF cycle. ET is performed by placing the embryo into the uterus using a special catheter that is inserted through the cervical canal. The chance for multiple pregnancy, a pregnancy of two or more fetuses, increases with the number of embryos transferred. Elective single embryo transfer (ESET) is an approach that is utilized with select populations (e.g., less than 35 years of age, greater than 1 high-grade embryo, undergoing first or second treatment cycle, previous successful IVF, or donor embryo recipient) to significantly reduce the risk of multiple pregnancy. In an effort to reduce the number of higher-order multiple pregnancies, the ASRM issued revised guidelines in 2012 on the recommended limits on the numbers of embryos to transfer. The recommended limits range between 1 – 5 embryos depending upon age, embryonic stage, and the prognostic favorability of implantation. Embryos that are not transferred are subsequently destroyed or cryopreserved for future frozen embryo transfer (FET). ART cycles using cryopreserved embryos are less complex, less expensive, and less invasive compared to a full IVF cycle. Similar to the natural or stimulated approach to IVF, frozen-thawed embryos can be transferred in a natural monitored cycle without drug use or an artificial cycle with drug-induced endometrial development.

GAMETE INTRAFALLOPIAN TRANSFER (GIFT), ZYGOTE INTRAFALLOPIAN TRANSFER (ZIFT), AND TUBAL EMBRYO TRANSFER (TET)

Fertilization typically takes place in the fallopian tubes during unassisted reproduction. Although rarely employed, the following variations of ART use the fallopian tubes, rather than the uterus, as the location for oocyte and sperm or embryo transfer:

Gamete intrafallopian transfer (GIFT): an ART procedure in which both gametes (oocytes and spermatozoa) are transferred to the fallopian tubes.
Zygote intrafallopian transfer (ZIFT): an ART procedure in which zygote(s) (fertilized oocyte) is/are transferred into the fallopian tube.
Tubal embryo transfer (TET): an ART procedure in which one or more embryos are placed in the fallopian tube.

Normal fallopian tube function is a prerequisite for GIFT, ZIFT, and TET. These procedures also require laparoscopic surgery to access the fallopian tubes.

SPERM RETRIEVAL TECHNIQUES

Sperm retrieval techniques offer men with certain reproductive tract obstructions the opportunity for biologic parenthood. Sperm obtained from sperm retrieval techniques can be used immediately or cryopreserved for future use. Sperm retrieved from any of these procedures require ICSI, since none can penetrate the egg. The most common techniques include:

Microepididymal sperm aspiration (MESA): an outpatient microsurgical procedure used to collect sperm in men with blockage of the male reproductive ducts due to cystic fibrosis or infection, or congenital or spontaneous absence of the vas deferens.
Percutaneous epididymal sperm aspiration (PESA): a sperm aspiration procedure in which a needle is inserted into the epididymis (duct that carries sperm from testicle to vas deferens) in order to retrieve sperm.
Testicular sperm aspiration (TESA): a sperm aspiration procedure in which a needle is inserted into the testes in order to retrieve sperm.
Testicular sperm extraction (TESE): a sperm retrieval procedure in which testicular tissue is removed in an attempt to collect living sperm.

GAMETE CRYOPRESERVATION

Cryopreserved sperm have been used in human reproductive medicine for over 50 years. Cryopreservation of oocytes, however, is a more complex process, and in October of 2012 the ASRM removed the experimental label from oocyte cryopreservation and issued guidelines on mature oocyte cryopreservation. The guidelines support the cryopreservation of mature oocytes when medically indicated and not solely to delay childbearing. Indications for gamete cryopreservation include:

Planned use of gonadotoxic therapies due to cancer or other medical diseases
Prophylactic oophorectomy due to certain genetic conditions
Failure to obtain sperm at IVF (oocytes can then be used when sperm are available)

THIRD PARTY REPRODUCTION: DONOR OOCYTES, DONOR EMBRYOS, SURROGATES, AND GESTATIONAL CARRIERS

Note: Except where mandated, these procedures are not covered in any business line.

The donation of oocytes, sperm, or embryos by an individual to an infertile recipient is referred to as “third party reproduction.” Oocyte donation involves oocyte retrieval from a known or anonymous donor, usually during a stimulated cycle, and timed with the endometrial development of the recipient or gestational carrier. Embryo transfer to a gestational carrier is addressed below. Although not ART, oocyte donation also occurs with traditional surrogacy, during which the surrogate conceives a pregnancy by artificial insemination, carries the pregnancy and delivers the baby for the recipient parent(s). Oocyte donation is indicated for the following reasons:

Ovarian failure
Genetically transmitted disease
Declining or absent ovarian function
Advanced reproductive age
Persistent poor oocyte quality in IVF cycles

The use of donated embryos can provide infertile couples a way to conceive that can be less complex and less expensive than gamete donation. Embryo donation is regulated in the United States by the Food and Drug Administration. Indications for embryo donation include:

Untreatable infertility that involves both partners
Untreatable infertility in a single woman
Recurrent pregnancy loss thought to be related to embryonic factors
Genetic disorders affecting one or both partners

The use of a gestational carrier, or gestational surrogate, can provide a woman without a uterus or with a uterine abnormality the opportunity to have her own biologic children. Indications for a gestational carrier include:

Absence of uterus
Uterine anomalies that cannot be repaired and which preclude successful implantation or gestation
Medical condition for which pregnancy may pose a life-threatening risk

References

American College of Obstetricians and Gynecologists. Frequently Asked Questions 136: Evaluating Infertility. January 2020. Available at: https://www.acog.org/patient-resources/faqs/gynecologic-problems/evaluating-infertility. Accessed October 21, 2021.

American College of Obstetricians and Gynecologists. Frequently Asked Questions 137: Treating Infertility. October 2019. Available at: https://www.acog.org/patient-resources/faqs/gynecologic-problems/treating-infertility. Accessed October 21, 2021.

ACOG Committee on Ethics. ACOG Committee Opinion no. 397: Surrogate motherhood. Obstet Gynecol. 2008;111(2 Pt 1):465-470. (Replaced by Committee Opinion No. 660, March 2016).

ACOG Committee on Ethics. ACOG Committee Opinion no. 553: Multifetal pregnancy reduction. Obstet Gynecol. 2013;121(2 Pt 1):405-410. (Reaffirmed 2016; Replaced by Committee Opinion No. 719, September 2017).

ACOG Committee on Ethics. ACOG Committee Opinion no. 660: Family building through gestational surrogacy. Obstet Gynecol. 2016;127:e97–103.

ACOG Committee on Ethics. ACOG Committee Opinion no. 671: Perinatal risks associated with assisted reproductive technology. Obstet Gynecol. 2016;128(3):e61-8.

ACOG Committee on Ethics. Committee Opinion no. 719: Multifetal pregnancy reduction. Obstet Gynecol. 2017;130(3):e158-e163.

ACOG Committee on Ethics. ACOG Committee Opinion no. 660: Family building through gestational surrogacy. Obstet Gynecol. 2016;127:e97-e103. (Replaces Committee Opinion No. 397, February 2008. Reaffirmed 2019).

ACOG Committee on Gynecologic Practice. ACOG Committee Opinion no. 781: Infertility workup for the women's health specialist. Obstet Gynecol. 2019;133(6):e377-e384.

ACOG Committee on Gynecologic Practice. ACOG Committee Opinion no. 773: The use of Antimullerian Hormone in women not seeking fertility care. Obstet Gynecol. 2019;133(4):e274-e278.

ACOG Committee on Obstetric Practice and Committee on Genetics. ACOG Committee Opinion no. 671: Perinatal risks associated with assisted reproductive technology. Obstet Gynecol. 2016;128:e61-e68. (Replaces Committee Opinion No. 324, November 2005. Reaffirmed 2020).

ACOG Committee on Obstetric Practice. ACOG Committee Opinion no. 324: Perinatal risks associated with assisted reproductive technology. Obstet Gynecol. Nov 2005;106(5 Pt 1):1143-1146. (Replaced by Committee Opinion No 671 September 2016).

ACOG Committee on Gynecologic Practice. ACOG Committee Opinion no. 413: age-related fertility decline. Obstet Gynecol. 2008;112(2 Pt 1):409-411. (Replaced by Committee Opinion No. 589 March 2014).

ACOG Committee on Gynecologic Practice. ACOG Committee Opinion no. 584: oocyte cryopreservation. Obstet Gynecol. 2014;123(1):221-222. (Reaffirmed 2016).

ACOG Committee Gynecologic Practice. ACOG Committee Opinion no. 589: Female age-related fertility decline. Obstet Gynecol. 2014;123:719–21. (Reaffirmed 2020).

ACOG Committee on Gynecologic Practice. ACOG Committee Opinion no. 618: ovarian reserve testing. Obstet Gynecol. 2015;125(1):268-273.

Al-Inany HG, Youssef MA, Ayeleke RO, et al. Gonadotrophin-releasing hormone antagonists for assisted reproductive technology. Cochrane Database Syst Rev. 2016;4:CD001750.

American Society for Reproductive Medicine. Assisted Reproductive Technologies: A Guide for Patients. 2018. Available at: https://www.reproductivefacts.org/news-and-publications/patient-fact-sheets-and-booklets/documents/fact-sheets-and-info-booklets/assisted-reproductive-technologies-booklet/. Accessed October 21, 2021.

American Society for Reproductive Medicine. Oversight of Assisted Reproductive Technology. 2010. Available at: http://www.asrm.org/globalassets/asrm/asrm-content/about-us/pdfs/oversiteofart.pdf. Accessed October 21, 2021.

American Society for Reproductive Medicine. Surgical techniques for sperm retrieval: what should I know? 2015. Available at: http://www.reproductivefacts.org/globalassets/rf/news-and-publications/bookletsfact-sheets/english-fact-sheets-and-info-booklets/surgical_techniques_for_sperm_retrieval_factsheet.pdf. Accessed October 21, 2021.

American Society for Reproductive Medicine. Third-party reproduction: Sperm, egg, and embryo donation and surrogacy: A guide for patients. 2018. Available at: https://www.reproductivefacts.org/news-and-publications/patient-fact-sheets-and-booklets/documents/fact-sheets-and-info-booklets/third-party-reproduction-sperm-egg-and-embryo-donation-and-surrogacy/. Accessed October 21, 2021.

ASRM Office of Public Affairs. Press Release: Fertility Experts Issue New Report on Egg Freezing; ASRM Lifts Experimental Label from Technique. 10/22/2012.

Aziminekoo E, Mohseni Salehi MS, Kalantari V, et al. Pregnancy outcome after blastocyst stage transfer comparing to early cleavage stage embryo transfer. Gynecol Endocrinol. 2015;31(11):880-884.

Bay B, Mortensen EL, Hvidtjorn D, et al. Fertility treatment and risk of childhood and adolescent mental disorders: register based cohort study. BMJ. 2013;347:f3978.

Best Practice Policy Committee of the American Urological Association. Male Infertility. Report on optimal evaluation of the infertile male. Fertil Steril. 2006;86(5 Suppl 1):S202-209.

Boulet SL, Mehta A, Kissin DM, et al. Trends in use of and reproductive outcomes associated with intracytoplasmic sperm injection. JAMA. 2015;313(3):255-263.

Carney SK, Das S, Blake D et al. Assisted hatching on assisted conception (in vitro fertilisation (IVF) and intracytoplasmic sperm injection (ICSI). Cochrane Database Syst Rev. 2012;12:CD001894.

Centers for Medicare & Medicaid Services. Medicare Benefit Policy Manual - Chapter 15 section 20.1. (Rev. 1, 10-01-03) . Available at: http://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/bp102c15.pdf. Accessed September 15, 2020.

Cil AP, Bang H, Oktay K. Age-specific probability of live birth with oocyte cryopreservation: an individual patient data meta-analysis. Fertil Steril. 2013;100(2):492-9 e3.

Cobo A, Meseguer M, Remohi J, et al. Use of cryo-banked oocytes in an ovum donation programme: a prospective, randomized, controlled, clinical trial. Hum Reprod. 2010;25(9):2239-2246.

Coding Committee of the American Society for Reproductive Medicine. Correct coding for laboratory procedures during assisted reproductive technology cycles. Fertil Steril. 2016;105(4):e5-8.

Coding Committee of the American Society for Reproductive Medicine. Correct coding for laboratory procedures during assisted reproductive technology cycles. Fertil Steril. 2012; 98(4):808-811.

Dafopoulos K, Griesinger G, Schultze-Mosgau A, et al. Cumulative pregnancy rate after ICSI with cryopreserved testicular tissue in non-obstructive azoospermia. Reprod BioMed Online. 2005;10(4):461-6.

Davies MJ, Moore VM, Willson KJ, et al. Reproductive technologies and the risk of birth defects. N Engl J Med. 2012;366(19):1803-13.

Debrock S, Peeraer K, Spiessens C, et al. The effect of modified quarter laser-assisted zona thinning on the implantation rate per embryo in frozen/vitrified-thawed/warmed embryo transfer cycles: a prospective randomized controlled trial. Hum Reprod. 2011;26(8):1997-2007.

Donnez J, Dolmans MM, Demylle D, et al. Livebirth after orthotopic transplantation of cryopreserved ovarian tissue. Lancet. 2004;364(9443):1405-10.

Ethics Committee of the American Society for Reproductive Medicine. Consideration of the gestational carrier: a committee opinion. Fertil Steril. 2013;99(7):1838-1841.

Ethics Committee of the American Society for Reproductive Medicine. Defining embryo donation: a committee opinion. Fertil Steril. 2013;99(7):1846-1847. (Replaced by 2016;106(1):56-8 article by same name).

Ethics Committee of the American Society for Reproductive Medicine. Oocyte or embryo donation to women of advanced age: a committee opinion. Fertil Steril. 2013;100(2):337-40. (Replaced by 2016;106(5):e3–e7 article by same name).

Ethics Committee of the American Society for Reproductive Medicine. Defining embryo donation: a committee opinion. Fertil Steril. 2016;106(1):56-8.

Ethics Committee of the American Society for Reproductive Medicine. Oocyte or embryo donation to women of advanced age: a committee opinion. Fertil Steril. 2016;106(5):e3–e7.

Ethics Committee of the American Society for Reproductive Medicine. Access to fertility services by transgender persons: a committee opinion. Fertil Steril. 2015; 104(5):1111-15.

Ethics Committee of the American Society for Reproductive Medicine. Access to fertility treatment by gays, lesbians, and unmarried persons: a committee opinion. Fertil Steril. 2013;100(6):1524-7.

Ethics Committee of the American Society for Reproductive Medicine. Fertility preservation in patients undergoing gonadotoxic therapy or gonadectomy: a committee opinion. Fertil Steril. 2013;100(5):1214–23.

Farhi A, Reichman B, Boyko V, et al. Congenital malformations in infants conceived following Assisted Reproductive Technology in comparison with spontaneously conceived infants. J Matern Fetal Neonatal Med. 2013;26(12):1171-9.

Fernandez-Shaw S, Cercas R, Brana C, et al. Ongoing and cumulative pregnancy rate after cleavage-stage versus blastocyst-stage embryo transfer using vitrification for cryopreservation: impact of age on the results. J Assist Reprod Genet. 2015;32(2):177-184.

Fishel S, Timson J, Lisi F, et al. Micro-assisted fertilization in patients who have failed subzonal insemination. Hum Reprod. 1994; 9(3):501-05.

Fritz MA. ASRM Practice Committee response to Rybak and Lieman: elective self-donation of oocytes. Fertil Steril. 2009; 92(5):1513-4.

Gianaroli L, Racowsky C, Geraedts J, et al. Best practices of ASRM and ESHRE: a journey through reproductive medicine. Fertil Steril. 2012;98(6):1380-1394.

Ginström Ernstad E, Bergh C, Khatibi A, et al. Neonatal and maternal outcome after blastocyst transfer: a population-based registry study. Am J Obstet Gynecol. 2016;214(3):378.e371-378.e310.

Glujovsky D, Blake D, Bardach A, et al. Cleavage stage versus blastocyst stage embryo transfer in assisted reproductive technology. Cochrane Database Syst Rev. 2012;7:CD002118.

Glujovsky D, Farquhar C, Quinteiro Retamar AM, et al. Cleavage stage versus blastocyst stage embryo transfer in assisted reproductive technology. Cochrane Database Syst Rev. 2016; (6):Cd002118.

Glujovsky D, Riestra B, Sueldo C, et al. Vitrification versus slow freezing for women undergoing oocyte cryopreservation. Cochrane Database Syst Rev. 2014;9:CD010047.

Hammadeh ME, Fischer-Hammadeh C, Ali KR. Assisted hatching in assisted reproduction: a state of art. J Assist Reprod Genet. 2011;28(2):119-28.

Hansen M, Kurinczuk JJ, Milne E, et al. Assisted reproductive technology and birth defects: a systematic review and meta-analysis. Hum Reprod Update. 2013;19(4):330-53.

Hovatta O. Cryobiology of ovarian and testicular tissue. Best Pract Res Clin Obstet Gynaecol. 2003;17(2):331-42.

Johnson J, Patrizio P. Ovarian cryopreservation strategies and the fine control of ovarian follicle development in vitro. Ann N Y Acad Sci. 2011;1221:40-6.

Kallen B, Finnstrom O, Lindam A, et al. Blastocyst versus cleavage stage transfer in in vitro fertilization: differences in neonatal outcome? Fertil Steril. 2010;94(5):1680-3.

Kanyo K, Zeke J, Kriston R, et al. The impact of laser-assisted hatching on the outcome of frozen human embryo transfer cycles. Zygote. 2016;24(5):742-747.

Kaur P, Swarankar ML, Maheshwari M, et al. A comparative study between cleavage stage embryo transfer at day 3 and blastocyst stage transfer at day 5 in in-vitro fertilization/intra-cytoplasmic sperm injection on clinical pregnancy rates. J Hum Reprod Sci. 2014;7(3):194-197.

Kettner LO, Henriksen TB, Bay B, et al. Assisted reproductive technology and somatic morbidity in childhood: a systematic review. Fertil Steril. 2015;103(3):707-719.

Kervancioglu ME, Saridogan E, Atasu T, et al. Human fallopian tube epithelial cell co-culture increases fertilization rates in male factor infertility but not in tubal or unexplained infertility. Hum Reprod. 1997;12(6):1253-8.

Kim SS, Battaglia DE, Soules MR. The future of human ovarian cryopreservation and transplantation: fertility and beyond. Fertil Steril. 2001;75(6):1049-56.

Kissin DM, Kawwass JF, Monsour M, et al. Assisted hatching: trends and pregnancy outcomes, United States, 2000-2010. Fertil Steril. 2014;102(3):795-801.

Kuohung, W, Hornstein, MD. Overview of infertility. 02/27/2020. Up to Date. [UpToDate Web site]. http://www.uptodate.com/home/index.html. [via subscription only]. Accessed September 15, 2020.

Levi Setti PE, Albani E, Morenghi E et al. Comparative analysis of fetal and neonatal outcomes of pregnancies from fresh and cryopreserved/thawed oocytes in the same group of patients. Fertil Steril. 2013; 100(2):396-401.

Liu HC, Cohen J, Alikani M, et al. Assisted hatching facilitates earlier implantation. Fertil Steril. 1993;60: 871-5.

Lobo RA. Potential options for preservation of fertility in women. N Engl J Med. 2005;353(1):64-73.

Loren AW, Mangu PB, Beck LN et al. Fertility preservation for patients with cancer: American Society of Clinical Oncology clinical practice guideline update. J Clin Oncol. 2013;31(19):2500-10.

Maheshwari A, Kalampokas T, Davidson J, et al. Obstetric and perinatal outcomes in singleton pregnancies resulting from the transfer of blastocyst-stage versus cleavage-stage embryos generated through in vitro fertilization treatment: a systematic review and meta-analysis. Fertil Steril. 2013;100(6):1615-1621.

Massaro PA, MacLellan DL, Anderson PA, et al. Does intracytoplasmic sperm injection pose an increased risk of genitourinary congenital malformations in offspring compared to in vitro fertilization? A systematic review and meta-analysis. J Urol. 2015;193(5 Suppl):1837-1842.

Meirow D, Levron J, Eldar-Geva T, et al. Pregnancy after transplantation of cryopreserved ovarian tissue in a patient with ovarian failure after chemotherapy. N Engl J Med. 2005;353(3):318-21.

Miller, K. Intracytoplasmic sperm injection.08/06/2019. Up to Date. [UpToDate Web site]. http://www.uptodate.com/home/index.html. [via subscription only]. Accessed September 15, 2020.

Myers ER, Eaton JL, McElligott KA, et al. Management of infertility. Comparative effectiveness review number 217 (Prepared by the Duke Evidence-based Practice Center under Contract No. 290-2015-00004-I). 05/2019. AHRQ Publication No. 19-EHC014-EF. Rockville, MD: Agency for Healthcare Research and Quality.

Myers ER, McCrory DC, Mills AA, et al. Effectiveness of Assisted Reproductive Technology. Evidence Report/Technology Assessment No. 167 (Prepared by the Duke University Evidence-based Practice Center under Contract No. 290-02-0025.) AHRQ Publication No. 08-E012. Rockville, MD: Agency for Healthcare Research and Quality. 2008.

National Institute for Health and Clinical Excellence (NICE). Fertility: assessment and treatment; Clinical guideline. [NICE Web site]. Original: 02/20/2013. (Revised: 09/06/2017). Available at: https://www.nice.org.uk/guidance/cg156/resources/fertility-problems-assessment-and-treatment-pdf-35109634660549. Accessed October 21, 2021.

New Jersey (NJ) Legislature. P.L. 2001, Chapter 236. Senate No.1076. Requires health benefits coverage by health insurers and SHBP for Infertility treatment. [NJ State Legislature Web site]. December 1, 2001. Available at: http://www.njleg.state.nj.us/2000/bills/pl01/236_.htm. Accessed October 21, 2021.

Noyes N, Porcu E, Borini A. Over 900 oocyte cryopreservation babies born with no apparent increase in congenital anomalies. Reprod BioMed Online. 2009;18(6):769-76.

Ohl J, de Mouzon J, Nicollet B, et al. Increased pregnancy rate using standardized coculture on autologous endometrial cells and single blastocyst transfer: a multicentre randomized controlled trial. Cell Mol Biol (Noisy-legrand). 2015;61(8):79-88.

Oktay K, Buyuk E, Veeck L, et al. Embryo development after heterotopic transplantation of cryopreserved ovarian tissue. Lancet. 2004;363(9412):837-40.

Oktay K, Cil AP, Bang H. Efficiency of oocyte cryopreservation: a meta-analysis. Fertil Steril. 2006;86(1):70-80.

Palermo G, Joris H, Derde MP, et al. Sperm characteristics and outcome of human assisted fertilization by subzonal insemination and intracytoplasmic sperm injection. Fertil Steril. 1993; 59(4):826-35.

Palermo G, Joris H, Devroey P, et al. Pregnancies after intracytoplasmic injection of single spermatozoon into an oocyte. Lancet. 1992;340(8810):17-8.

Paulson, R. In vitro fertilization. 11/9/2017. Up to Date. [UpToDate Web site]. http://www.uptodate.com/home/index.html. [via subscription only]. Accessed May 13, 2019.

Paulson R. Pregnancy outcome after assisted reproductive technology. [UpToDate Web site]. 06/30/2020. Available at: https://www.uptodate.com/contents/pregnancy-outcome-after-assisted-reproductive-technology?search=gamete intrafallopian transfer&source=search_result&selectedTitle=2~150&usage_type=default&display_rank=2 .[via subscription only]. Accessed on October 21, 2021.

Practice Committee of American Society for Reproductive Medicine. Ovarian tissue cryopreservation: a committee opinion. Fertil Steril. 2014;101(5):1237-43.

Practice Committee of the American Society for Reproductive Medicine. The clinical utility of sperm DNA integrity testing: a guideline. Fertil Steril. 2013;99(3):673-7.

Practice Committee of the American Society for Reproductive Medicine. Testing and interpreting measures of ovarian reserve: a committee opinion. Fertil Steril. 2015:103(3):e9-e17.

Practice Committee of Society for Assisted Reproductive Technology; Practice Committee of American Society for Reproductive Medicine. Elective single-embryo transfer. Fertil Steril. 2012;97(4):835-42.

Practice Committee of American Society for Reproductive Medicine and Society for Assisted Reproductive Technology. Intracytoplasmic sperm injection (ICSI) for non-male factor infertility. Fertil Steril. 2012;98(6) 1395-99.

Practice Committee of American Society for Reproductive Medicine. Intracytoplasmic sperm injection (ICSI). Fertil Steril. 2008;90(5 Suppl):S187.

Practice Committee of Society for Assisted Reproductive Technology. The role of assisted hatching in in vitro fertilization: a review of the literature: a committee opinion. Fertil Steril. 2008;90(5 Suppl):S196-198.

Practice Committee of the American Society for Reproductive Medicine. Aging and infertility in women: a committee opinion. Fertil Steril. 2002;78(1):215-219.

Practice Committee of the American Society for Reproductive Medicine. The management of obstructive azoospermia: A committee opinion. Fertility and Sterility. 2019;111:873–80.

Practice Committee of Society for Assisted Reproductive Technology and Practice Committee of American Society for Reproductive Medicine. Preimplantation genetic testing: a practice committee opinion. Fertil Steril. 2008;90(5 Suppl):S136-143.

Practice Committees of the American Society for Reproductive Medicine and the Society for Assisted Reproductive Technology. Blastocyst culture and transfer in clinical-assisted reproduction: a committee opinion. Fertil Steril. 2013;99(3):667-672.

Practice Committee of American Society for Reproductive Medicine. Gonadotropin preparations: past, present, and future perspectives. Fertil Steril. 2008;90(5 Suppl):S13-20.

Practice Committee of American Society for Reproductive Medicine. Sperm retrieval for obstructive azoospermia. Fertil Steril. 2008; 90(5 Suppl):S213-218.

Practice Committee of American Society for Reproductive Medicine. Use of exogenous gonadotropins in anovulatory women: a technical bulletin. Fertil Steril. 2008;90(5Suppl):S7-12.

Practice Committee of American Society for Reproductive Medicine. Diagnostic evaluation of the infertile female: a committee opinion. Fertil Steril. 2012;98(2):302-307.

Practice Committee of American Society for Reproductive Medicine. Diagnostic evaluation of the infertile female: a committee opinion. Fertil Steril. 2015;103(6):e44-50.

Practice Committee of American Society for Reproductive Medicine. Diagnostic evaluation of the infertile male: a committee opinion. Fertil Steril. 2012;98(2):294-301.

Practice Committee of American Society for Reproductive Medicine. Diagnostic evaluation of the infertile male: a committee opinion. Fertil Steril. 2015;103(3):e18-25.

Practice Committee of American Society for Reproductive Medicine. Definitions of infertility and recurrent pregnancy loss: a committee opinion. Fertil Steril. 2013;99(1):63.

Practice Committee of the American Society for Reproductive Medicine. Effectiveness and treatment for unexplained infertility. Fertil Steril .2006;86(5 Suppl 1):S111-114.

Practice Committee of the American Society for Reproductive Medicine. Guidance on the limits to the number of embryos to transfer: a committee opinion. Fertil Steril. 2017;107(4):901-903.

Practice Committees of the American Society for Reproductive Medicine. In vitro maturation: a committee opinion. Fertil Steril. 2013;99(3):663-6.

Practice Committees of American Society for Reproductive Medicine. Mature oocyte cryopreservation: a guideline. Fertil Steril. 2013;99(1):37-43.

Practice Committee of American Society for Reproductive Medicine. Recommendations for gamete and embryo donation: a committee opinion. Fertil Steril. 2013;99(1):47-62.

Practice Committee of American Society for Reproductive Medicine. Criteria for number of embryos to transfer: a committee opinion. Fertil Steril. 2013 99(1):44-46.

Practice Committee of the American Society for Reproductive Medicine, Practice Committee of the Society for Assisted Reproductive Technology. Role of assisted hatching in in vitro fertilization: a guideline. Fertil Steril. 2014;102(2):348-351.

Reproductive Technology Council. ASSISTED HATCHING: Standards and conditions for approval as an innovative or routine practice under the Human Reproductive Technology Act 1991 (Act). 7/2000. Available at: www.parliament.wa.gov.au/publications/tabledpapers.nsf/displaypaper/3610766ac84b1c14ac3dfe6d48256ae8002783c5/$file/reproductivetech2001.pdf. Accessed October 21, 2021.

Rubio C, Simon C, Mercader A, et al. Clinical experience employing co-culture of human embryos with autologous human endometrial epithelial cells. Hum Reprod. 2000;15(suppl 6):31-8.

Shi W, Hongwei T, Zhang W, et al. A prospective randomized controlled study of laser-assisted hatching on the outcome of first fresh IVF-ET cycle in advanced age women. Reprod Sci. 2016;23(10):1397-1401.

Siegel-Itzkovich J. Woman gives birth after receiving transplant of her own ovarian tissue. BMJ. 2005;331(7508):70.

Smith GD, Serafini PC, Fioravanti J, et al. Prospective randomized comparison of human oocyte cryopreservation with slow-rate freezing or vitrification. Fertil Steril. 2010;94(6):2088-95.

Society for Assisted Reproductive Technology. Topics A-Z (MESA; PESA; TESE). Available at: https://www.sart.org/topics/topics-index/assisted-reproductive-technologies/. Accessed October 21, 2021.

Sonmezer M, Oktay K. Overview of fertility and reproductive hormone preservation prior to gonadotoxic therapy or surgery. 03/02/2020. Up to Date. [UpToDate Web site]. http://www.uptodate.com/home/index.html. [via subscription only]. Accessed October 21, 2021.

Sunkara SK, Siozos A, Bolton VN, et al. The influence of delayed blastocyst formation on the outcome of frozen-thawed blastocyst transfer: a systematic review and meta-analysis. Human Reprod. 2010;25(8):1906-15.

Tournaye H, Goossens E, Verheyen G, et al. Preserving the reproductive potential of men and boys with cancer: current concepts and future prospects. Hum Reprod Update. 2004;10(6):525-32.

Tryde SKL, Yding AC, Starup J, et al. Orthotopic autotransplantation of cryopreserved ovarian tissue to a woman cured of cancer – follicular growth, steroid production and oocyte retrieval. Reprod BioMed Online. 2004;8(4):448-53.

United States Food and Drug Administration. Eligibility determination for donors of human cells, tissues, and cellular and tissue-based products. March 10, 2004. Available at: https://www.federalregister.gov/documents/2004/05/25/04-11245/eligibility-determination-for-donors-of-human-cells-tissues-and-cellular-and-tissue-based-products . Accessed October 21, 2021.

Wong KM, van Wely M, Mol F, et al. Fresh versus frozen embryo transfers in assisted reproduction. Cochrane Database Syst Rev. 2017;3:CD011184.

World Health Organization, Department of Reproductive Health and Research. WHO laboratory manual for the Examination and processing of human semen, 5th edn. Geneva, WHO Press. 2010. Available at: http://whqlibdoc.who.int/publications/2010/9789241547789_eng.pdf. Accessed October 21, 2021.

Youssef MA, Abou-Setta AM, Lam WS. Recombinant versus urinary human chorionic gonadotrophin for final oocyte maturation triggering in IVF and ICSI cycles. Cochrane Database Syst Rev. 2016;4:CD003719.

Zegers-Hochschild F, Adamson GD, de Mouzon J, et al. The International Committee for Monitoring Assisted Reproductive Technology (ICMART) and the World Health Organization (WHO) Revised Glossary on ART Terminology, 2009. Hum Reprod. 2009;24(11):2683-2687.

Coding

CPT Procedure Code Number(s)

ASSISTED REPRODUCTIVE TECHNOLOGY
58970, 58974, 76948, 89250, 89251, 89253, 89254, 89255, 89257, 89260, 89261, 89264, 89268, 89272, 89280, 89281, 89322, 89331

GAMETE INTRAFALLOPIAN TRANSFER (GIFT)
58976

ZYGOTE INTRAFALLOPIAN TRANSFER (ZIFT)
58976

SPERM RETRIEVAL TECHNIQUES
54500, 54505, 54800

INTRACYTOPLASMIC SPERM INJECTION (ICSI)
89280, 89281

THAWING
89352, 89353, 89354, 89356

CRYOPRESERVATION/STORAGE
89258, 89259, 89335, 89337, 89342, 89343, 89344, 89346

THE FOLLOWING CODE IS USED TO REPRESENT TRIAL (MOCK) EMBRYO TRANSFER. SEPARATE BENEFITS ARE NOT PROVIDED
58999

EXPERIMENTAL/INVESTIGATIONAL
THE FOLLOWING CODE IS USED TO REPRESENT CRYOPRESERVATION OF REPRODUCTIVE OVARIAN TISSUE:
89398

THE FOLLOWING CODE IS USED TO REPRESENT CRYOPRESERVATION OF IMMATURE OOCYTE(S):
89398

ICD - 10 Procedure Code Number(s)

N/A

ICD - 10 Diagnosis Code Number(s)

N46.01 Organic azoospermia

N46.021 Azoospermia due to drug therapy

N46.022 Azoospermia due to infection

N46.023 Azoospermia due to obstruction of efferent ducts

N46.024 Azoospermia due to radiation

N46.025 Azoospermia due to systemic disease

N46.029 Azoospermia due to other extratesticular causes

N46.11 Organic oligospermia

N46.121 Oligospermia due to drug therapy

N46.122 Oligospermia due to infection

N46.123 Oligospermia due to obstruction of efferent ducts

N46.124 Oligospermia due to radiation

N46.125 Oligospermia due to systemic disease

N46.129 Oligospermia due to other extratesticular causes

N46.8 Other male infertility

N46.9 Male infertility, unspecified

N97.0 Female infertility associated with anovulation

N97.1 Female infertility of tubal origin

N97.2 Female infertility of uterine origin

N97.8 Female infertility of other origin

N97.9 Female infertility, unspecified

Z31.7 Encounter for procreative management and counseling for gestational carrier

Z31.81 Encounter for male factor infertility in female patient

Z31.83 Encounter for assisted reproductive fertility procedure cycle

Z31.84 Encounter for fertility preservation procedure

Z31.9 Encounter for procreative management, unspecified

THE FOLLOWING CODES ARE USED TO REPRESENT EGG DONOR

Z52.810 Egg (Oocyte) donor under age 35, anonymous recipient

Z52.811 Egg (Oocyte) donor under age 35, designated recipient

Z52.812 Egg (Oocyte) donor age 35 and over, anonymous recipient

Z52.813 Egg (Oocyte) donor age 35 and over, designated recipient

Z52.819 Egg (Oocyte) donor, unspecified

THE FOLLOWING CODES ARE USED TO REPRESENT SPERM RETRIEVAL

N46.01 Organic azoospermia

N46.021 Azoospermia due to drug therapy

N46.022 Azoospermia due to infection

N46.023 Azoospermia due to obstruction of efferent ducts

N46.024 Azoospermia due to radiation

N46.025 Azoospermia due to systemic disease

N46.029 Azoospermia due to other extratesticular causes

N46.11 Organic oligospermia

N46.121 Oligospermia due to drug therapy

N46.122 Oligospermia due to infection

N46.123 Oligospermia due to obstruction of efferent ducts

N46.124 Oligospermia due to radiation

N46.125 Oligospermia due to systemic disease

N46.129 Oligospermia due to other extratesticular causes

N46.8 Other male infertility

N46.9 Male infertility, unspecified

Z31.83 Encounter for assisted reproductive fertility procedure cycle

Z31.84 Encounter for fertility preservation procedure

Z31.9 Encounter for procreative management, unspecified

HCPCS Level II Code Number(s)

IN VITRO FERTILIZATION

S4011 In vitro fertilization; including but not limited to identification and incubation of mature oocytes, fertilization with sperm, incubation of embryo(s), and subsequent visualization for determination of development

S4028 Microsurgical epididymal sperm aspiration (MESA)

S4042 Management of ovulation induction (interpretation of diagnostic tests and studies, nonface-to-face medical management of the patient), per cycle

THE FOLLOWING SERVICES ARE CONSIDERED BENEFIT EXCLUSIONS:

S4026 Procurement of donor sperm from sperm bank

S4027 Storage of previously frozen embryos

S4030 Sperm procurement and cryopreservation services; initial visit

S4031 Sperm procurement and cryopreservation services; subsequent visit

S4040 Monitoring and storage of cryopreserved embryos, per 30 days

THE FOLLOWING HCPCS CODES FOR CASE RATE SHOULD NOT BE REPORTED:

S4013 Complete cycle, gamete intrafallopian transfer (GIFT), case rate

S4014 Complete cycle, zygote intrafallopian transfer (ZIFT), case rate

S4015 Complete in vitro fertilization cycle, not otherwise specified, case rate

S4016 Frozen in vitro fertilization cycle, case rate

S4017 Incomplete cycle, treatment cancelled prior to stimulation, case rate

S4018 Frozen embryo transfer procedure cancelled before transfer, case rate

S4020 In vitro fertilization procedure cancelled before aspiration, case rate

S4021 In vitro fertilization procedure cancelled after aspiration, case rate

S4022 Assisted oocyte fertilization, case rate

S4023 Donor egg cycle, incomplete, case rate

S4025 Donor services for in vitro fertilization (sperm or embryo), case rate

S4037 Cryopreserved embryo transfer, case rate

Revenue Code Number(s)

N/A

MPMiscCodesNarrativesPub

Coding and Billing Requirements

Cross Reference

Policy History

Revisions From 07.10.06i:

11/16/2022	This policy has been reviewed and reissued to communicate the Company's continuing position on Assisted Reproductive Techology for Infertility and Oocyte Cryopreservation.
11/17/2021	This policy has been reissued in accordance with the Company's annual review process.
01/01/2021	This policy has been identified for the CPT code update, effective 01/01/2021. The following code has been deleted from this policy: 0058T.

Revision From 07.10.06h:

10/07/2020	The policy has been reviewed and reissued to communicate the Company’s continuing position on Assisted Reproductive Technology for Infertility.
01/01/2020	This policy has been identified for the CPT code update, effective 01/01/2020. The following codes has been deleted from this policy: 0357T.

Revision From 07.10.06g:

07/15/2019

This version of the policy will become effective 07/15/2019. This policy was updated to communicate the Company’s continuing position on assisted reproductive technologies for infertility and oocyte cryopreservation. Information regarding state-specific mandates was revised.

Revision From 07.10.06f:

01/01/2019

This version of the policy will become effective 01/01/2019. The following CPT code has been removed from this policy: 10021.

Revisions From 07.10.06e

05/07/2018

This version of the policy will become effective 05/07/2018. The intent of this policy remains unchanged.

Effective 10/05/2017 this policy has been updated to the new policy template format.

Version Effective Date:

1/1/2021

Version Issued Date:

12/31/2020

Version Reissued Date:

11/16/2022