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.

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; 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.

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.

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.

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.

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.

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.

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.

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.

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

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.

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

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.

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.

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

• Living; or
• Travel expenses.

Assisted reproductive technology services are generally excluded from standard medical-surgical contracts, and are not eligible for reimbursement. However, all medical, surgical, and diagnostic services performed to diagnose and treat infertility are generally covered unless the individual member’s contract contains exclusion with regard to the diagnosis and treatment of infertility.

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.

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.

Assisted fertilization is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances, including, but not limited to, the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting.

Services that do not meet the criteria of this policy will not be considered medically necessary. A network provider cannot bill the member for the denied service unless: (a) the provider has given advance written notice, informing the member that the service may be deemed not medically necessary; (b) the member is provided with an estimate of the cost; and (c) the member agrees in writing to assume financial responsibility in advance of receiving the service. The signed agreement must be maintained in the provider’s records.

Services that do not meet the criteria of this policy will be considered experimental/investigational (E/I). A network provider can bill the member for the experimental/investigational service. The provider must give advance written notice informing the member that the service has been deemed E/I. The member must be provided with an estimate of the cost and the member must agree in writing to assume financial responsibility in advance of receiving the service. The signed agreement must be maintained in the provider’s records.

Quantity level limits or quantity of supplies that exceed the frequency guidelines listed on the policy will be denied as not medically necessary. A network provider cannot bill the member for the non-covered service.

• Link to Provider Resource Center for the Medical Policy Update

05/2015, Medical Criteria has been Added for Assisted Fertilization Techniques
03/2018, Coverage Criteria Revised for Assisted Reproductive Technology

• Link to Diagnosis Codes

• Link to Table Attachment(s)

• Link to References