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 includes:

• 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.

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.

Standard fertility preservation services mean procedures consistent with established medical practices and professional guidelines published by professional medical organizations, including the American Society for Clinical Oncology and the American Society for Reproductive Medicine.

Assisted Reproductive Technology 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:

• Intrauterine insemination
• Assisted hatching
• Cryopreservation and thawing of eggs, sperm, and embryos
• Cryopreservation of ovarian tissue
• Cryopreservation of testicular tissue
• Embryo biopsy
• Consultations and diagnostic testing
• Fresh and frozen embryo transfers
• Six (6) completed egg retrievals per lifetime, with unlimited embryo transfers in accordance with the guidelines of the American Society for Reproductive Medicine, using single embryo transfer (SET) when recommended and medically appropriate.
• In vitro fertilization (IVF)
• Intracytoplasmic sperm injection (ICSI)
• Medications
• Ovulation induction
• Storage of oocytes, sperm, embryos, and tissue
• Surgery
• Medical and laboratory services that reduce excess embryo creation through egg cryopreservation and thawing in accordance with an individual’s religious or ethical beliefs
• Gamete intrafallopian transfer
• Zygote intrafallopian transfer
• Tubal embryo transfer
• Peritoneal ovum sperm transfer
• Zona drilling
• 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.

Delaware Mandate

Effective 6/30/2018, Delaware law requires that all large group fully insured accounts and direct pay policies and plans issued or renewed on or after June 30, 2018 shall provide coverage for fertility care services and fertility preservation services for individuals diagnosed with infertility or at risk of infertility due to surgery, radiation, chemotherapy or other medical treatment. Pursuant to 18 Del. C. §§ 3342 and 3556, the Delaware mandate is applicable to individual and large group fully insured health benefit plans that are issued or renewed on or after June 30, 2018.  A religious employer may request, and a carrier must grant, an exclusion from coverage if the coverage conflicts with the religious organization’s bona fide religious beliefs and practices.

In Vitro Fertilization (IVF)

IVF may be considered medically necessary when 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 up to 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.

For IVF services, retrievals must be completed before the individual is 45 years old and transfers must be completed before the individual is 50 years old.

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 BOTH of the following criteria are met:

• 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; and
• Individual meets the other criteria for IVF.

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.

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 following criteria are met:

• Individual meets the definition of infertility; and
• Individual is under the age of 50; and
• 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 (E/I) and, therefore, non-covered because the safety and/or effectiveness of this service cannot be established by the available peer-reviewed literature.

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.

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 (E/I) and, therefore, non-covered because the safety and/or effectiveness of this services cannot be established by the available published peer-reviewed literature.

• 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, vasoplasty, or epididymovasostomy) undergone after the covered individual successfully procreated with the covered individual’s partner at the time the reversal is desired; or
• Payment for surrogate service fees for purposes of child birth.

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

• Living; or
• Travel expenses.

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.