Description

For the purpose of this policy infertility is defined as a condition (an interruption, cessation, or disorder of body functions, systems, or organs) of the reproductive tract which prevents the conception of a child or the ability to carry a pregnancy to delivery. This is evidenced by the failure to achieve a successful pregnancy after twelve (12) months or more of appropriate, timed unprotected intercourse or therapeutic donor insemination. Earlier evaluation and treatment may be justified based on medical history and physical findings and is warranted after six (6) months for women over age 35 years.

Infertility may include:

• Absent or incompetent uterus;
• Damaged, blocked, or absent fallopian tubes;
• Damaged, blocked, or absent male reproductive tract;
• Damaged, diminished, or absent sperm;
• Damaged, diminished, or absent oocytes;
• Damaged, diminished, or absent ovarian function;
• Endometriosis;
• Hereditary genetic disease, or condition that would be passed to offspring;
• Adhesions;
• Uterine fibroids;
• Sexual dysfunction impeding intercourse;
• Teratogens or idiopathic causes;
• Polycystic ovarian syndrome;
• Inability to become pregnant, or cause pregnancy of unknown etiology;
• Two or more pregnancy losses, including ectopic pregnancies; and
• Uterine congenital anomalies, including those caused by diethylstilbestrol (DES).
• Iatrogenic infertility is defined as an impairment of fertility due to surgery, radiation, chemotherapy, or other medical treatment.

Infertility for this policy does not include voluntary sterilization or reversal of voluntary sterilization.

Artificial Insemination is a procedure, also known as intrauterine insemination (IUI); or intracervical/intravaginal insemination (ICI), by which sperm is directly deposited into the vagina, cervix or uterus to achieve fertilization and pregnancy.

Assisted Reproductive Technology (ART) includes all treatments or procedures that involve the in vitro (i.e., outside of the living body) handling of both human oocytes (eggs) and sperm, or embryos, for the purpose of establishing a pregnancy.  Treatments and procedures include, but are not limited to:

• In vitro fertilization (IVF) and embryo transfer
• Gamete intrafallopian transfer (GIFT)
• Zygote intrafallopian transfer (ZIFT)
• Tubal embryo transfer (TET)
• Peritoneal ovum sperm transfer
• Zona drilling
• Sperm microinjection
• Gamete and embryo cryopreservation (freezing)
• Oocyte and embryo donation
• Gestational surrogacy or carrier
  • Gestational surrogacy is an arrangement in which a woman carries and delivers a baby for another person or couple

ART does not include artificial insemination in which sperm are placed directly into the vagina, cervix or uterus.

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

Criteria

Coverage is subject to the specific terms of the member’s benefit plan.

In Vitro Fertilization (IVF)

IVF may be considered medically necessary when ALL of the following criteria are met:

• Individual has a congenital absence or anomaly of reproductive organ(s); or
• Individual fulfills ONE of the following definitions of infertility:
  • Individual is less than the age of 35 years and has not achieved a successful pregnancy after at least twelve (12) months of appropriately timed unprotected vaginal intercourse or intrauterine insemination; or
  • Individual is 35 years of age or older and has not achieved a successful pregnancy after at least six (6) months of appropriately timed unprotected vaginal intercourse or intrauterine insemination;

AND

• 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 as described above which includes at least three (3) intrauterine insemination cycles; and
• Individual has at least ONE risk factor that includes, but is not limited to the following:
  • Tubal disease that cannot be corrected surgically; or
  • Diminished ovarian reserve; or
  • Irreparable distortion of the uterine cavity or other uterine anomaly (when using a gestational carrier); or
  • Male partner with severe male factor infertility, excluding post-voluntary sterilization or reversal of sterilization; or
  • Unexplained infertility; or
  • Stage 4 endometriosis as defined by the American Society of Reproductive Medicine.

AND

• 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); or
  • Contraindication to pregnancy.

IVF for any other indication than listed above will be considered not medically necessary.

Procedure Codes

Gamete Intrafallopian Transfer (GIFT)/Zygote Intrafallopian Transfer (ZIFT)

GIFT or ZIFT may be considered medically necessary 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; or
  • Severe uterine factor; or
  • Irreparable distortion of the uterine cavity; or
  • Male partner with severe male factor infertility

Procedure Codes

Intracytoplasmic Sperm Injection (ICSI)

ICSI may be considered medically necessary when the individual has 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.

Procedure Codes

Gamete/Oocyte Cryopreservation

Assisted reproductive technology for the purpose of gamete/oocyte cryopreservation may be considered medically necessary when ANY of the following criteria are met:

• Individual is preparing for gonadotoxic therapies due to cancer or other medical diseases; or
• Individual is undergoing prophylactic oophorectomy due to certain genetic conditions, such as BRCA mutations; or
• Individual underwent oocyte retrieval for IVF but there was an inability to obtain sperm; or
• Individual underwent sperm retrieval technique.

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

• Provide donor oocytes; or
• Conserve future childbearing potential due to reproductive aging.

Procedure Codes

Tubal Embryo Transfer (TET)

TET may be considered medically necessary 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; and
• Individual does not have any of the following contraindications:
  • Tubal disease; or
  • Severe uterine factor; or
  • Irreparable distortion of the uterine cavity; or
  • Contraindication to pregnancy.

TET for any other indication than listed above will be considered not medically necessary.

Procedure Codes

Frozen Embryo Transfer (FET)

FET may be considered medically necessary when the member meets the definition of infertility and EITHER of the following criteria is met:

• Individual has cryopreserved embryos from a previous IVF cycle; or
• Individual is receiving cryopreserved donor embryo.

Procedure Codes

Ovulation Induction Management

Ovulation induction management (cycle management) involves the medical management of the patient where medication is used to stimulate development of mature follicles within the ovaries.

It may be performed as part of an assisted fertilization program or as a treatment for infertility outside of an assisted fertilization program.

This service may be reported using an appropriate evaluation and management procedure code; provided that there is patient/physician interaction and all of the components of the evaluation and management (E&M) code have been met.

Ovulation induction management performed without a face-to-face patient/physician encounter (e.g., conducted via telephone) may be considered an eligible
service.

When performed for treatment of infertility, global payment for non-face-to-face ovulation induction management is limited to twelve times (12 cycles) within a twelve (12) month period.

When assisted fertilization is successful, payment can be made for managing the pregnancy and delivery.

Ovulation induction management for any other indication than listed above will be considered not medically necessary.

Procedure Codes

Immunotherapy for Recurrent Fetal Loss

Immunologic-based therapies to avoid recurrent spontaneous abortion are considered experimental/investigation and, therefore, non-covered due to the lack of
scientific evidence for efficacy and safety.

Procedure Codes

The procedures listed on the Table Attachment, Table A, are assisted fertilization procedures that may be reported as part of an assisted fertilization program.

Procedure Codes

Refer to Table B, Laboratory Services, in the attachments for the quantity of laboratory services per cycle that may be considered medically necessary.

More than two (2) progesterone measurements may be considered medically necessary for infertile women with irregular and prolonged menstrual cycles.

For infertile women with regular menstrual cycles, a mid-luteal serum progesterone measurement (day 21 of a 28-day cycle) may be considered medically necessary.

For infertile women with irregular menstrual cycles, this test would need to be repeated at the mid-luteal phase and weekly thereafter until the next menstrual cycle starts.

Quantities of laboratory services that exceed the frequency guidelines listed on Table B, Laboratory Services, will be denied as not medically necessary.

Procedure Codes

The following are non-covered professional services because there is no physician service rendered. Charges for cryopreservation, storage, procurement, and
thawing of specimens are generally facility charges which should be processed in accordance with the member’s benefits:

• Cryopreservation of oocytes
• Cryopreservation; immature oocyte(s)
• Cryopreservation of embryo(s)
• Cryopreservation of sperm
• Cryopreservation of reproductive ovarian tissue
• Cryopreservation of reproductive testicular tissue
• Storage of oocyte
• Storage of embryo(s)
• Monitoring and storage of cryopreserved embryos
• Storage of previously frozen embryos
• Storage of sperm/semen
• Storage of ovarian/testicular reproductive tissue
• Procurement of donor sperm from sperm bank
• Sperm procurement and cryopreservation services
• Thawing of oocytes
• Thawing of cryopreserved embryo(s)
• Thawing of sperm/semen
• Thawing of reproductive tissue

Procedure Codes

The following reproductive techniques or services are considered experimental/investigational and, therefore, non-covered due to the lack of scientific evidence for efficacy and safety.

• Assisted embryo hatching; or
• Co-culture of embryos; or
• Tests of sperm DNA integrity, including but not limited to, sperm chromatin assays and sperm DNA fragmentation assays.

Procedure Codes

The following related services to reproductive technologies/techniques are considered not medically necessary:

• Reversal of voluntary sterilization (tuboplasty or vasoplasty); or
• Payment for surrogate service fees for purposes of child birth; or
• Costs associated with cryopreservation and storage of sperm, eggs, and embryos; or
• Costs associated with the procurement of sperm, or harvesting of eggs and embryos from a donor.

Procedure Codes

The following related services to reproductive technologies/techniques are considered not medically necessary:

• Living; or
• Travel expenses.

Procedure Codes

Once it has been established that the ultimate goal for the infertile patient is assisted reproductive technology (IVF, GIFT, ZIFT, etc.), all subsequent related diagnostic, medical, and surgical services are considered part of the assisted reproductive technology program, and are non-covered when the member does not have an assisted reproductive technology benefit.

Related services, including but not limited to lab work and ultrasound, performed in preparation for or in conjunction with assisted reproductive technology services should be reported with the appropriate diagnosis code for IVF, GIFT, ZIFT, etc. in order to distinguish them as services associated with assisted reproductive technology program. Such services are non-covered when the member does not have the benefit for assisted reproductive technology.

When reported, assisted reproductive technology program management should be processed under the appropriate procedure codes for the services rendered.
Assisted reproductive technology program management generally includes, but is not limited to such services as:

• A history and physical; and
• Daily visits; and
• Consultations for medication adjustment; and
• Counseling.

Report the appropriate diagnosis code for IVF, GIFT, ZIFT, etc. in order to distinguish them as services associated with an assisted reproductive program. Such services are non-covered when the member does not have an assisted reproductive technology benefit.

Artificial insemination services (58321, 58322) must be submitted with either ICD 10 diagnosis codes Z31.7 or Z31.89 along with other diagnosis codes as appropriate.  Benefit plan exclusions may apply.

Procedure Codes

Gestational Carrier/Surrogate

Medical services or supplies rendered to a gestational carrier or surrogate may be considered medically necessary if the member has ANY of the following indications:

• Congenital absence of a uterus; or
• Uterine anomalies that cannot be repaired; or
• A medical condition for which pregnancy may pose a life-threatening risk.

Services provided to a surrogate or gestational carrier may be a benefit exclusion.

Diagnosis Codes

Covered Diagnosis Codes

Non-Covered Diagnosis Codes

Refer to Table and Table B for information regarding Laboratory Testing.

U-5 Assisted Fertilization Table Attachments

Table A: Assisted Fertilization Procedures

NOTE: This is not an all-inclusive list. The coverage of these procedures may vary according to group specific benefits.

Table B: Laboratory Services

Key:

IUI: intra-uterine insemination                                               FET: frozen embryo transfer
Inj: injection                                                                                 PM: pregnancy monitoring
IVF: in-vitro fertilization                                                           FSH: follicle stimulating hormone
GIFT: gamete intra-fallopian transfer                                    LH: luteinizing hormone
hCG: human chorionic gonadotropin

*Note:

More than 2 progesterone measurements may be considered for infertile women with irregular and prolonged menstrual cycles.

For infertile women with regular menstrual cycles, a mid-luteal serum measurement (day 21 of a 28-day cycle) may be considered medically necessary.

For infertile women with irregular menstrual cycles, this test would need to be repeated at the mid-luteal phase and weekly thereafter until the next menstrual cycle starts.