Humana Infertility Evaluation and Treatment Form

Description

Infertility is a condition defined by the failure to achieve conception. Primary infertility is a term applied when pregnancy has never been achieved; secondary infertility is the inability to conceive after already having a successful birth. Both types of infertility have similar causes and treatments.

For purposes of determining when evaluation and treatment for infertility is appropriate, pregnancy is defined as a clinical pregnancy documented by ultrasonography or histopathologic examination.

Evaluation

Diagnostic investigation of infertility includes physical examinations and several types of testing. Some issues are able to be corrected during the particular diagnostic intervention as well.

Infertility Evaluation and Treatment

Effective Date: 04/27/2023
Revision Date: 04/27/2023
Review Date: 04/27/2023
Policy Number: HUM-0452-036

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

• Specialized clinical testing to rule out potential issues associated with infertility include, but may not be limited to:
  1. Endometrial receptivity testing (eg, Endometrial Receptivity Analysis [ERA], E-tegrity test) (Refer to Coverage Limitations section)
  2. Laboratory studies collected by blood sample include, but may not be limited to:
     • Antimullerian hormone (AMH)
     • Clomiphene challenge test
     • Estradiol (E2)
     • FSH (may include a cycle day three FSH)
     • Luteinizing hormone (LH)
     • Progesterone
     • Prolactin
     • Testosterone levels
     • Thyroid stimulating hormone (TSH)
  3. Postcoital testing (PCT), also known as Sims-Huhner test
  4. Postejaculatory urinalysis
  5. Tests that may be performed on semen/sperm include, but may not be limited to:
     • Antisperm antibody testing
     • Cap-Score Test (Refer to Coverage Limitations)
     • Computer-aided semen analysis (CASA) (Refer to Coverage Limitations)
     • Quantification of leukocytes (white blood cells) in semen
     • Semen analysis
     • Semen biochemistry (semen fructose)
  6. Semen culture
  7. Sperm function tests (eg, hypo-osmotic swelling [HOS] test, sperm viability testing or Zona free hamster oocyte penetration test)
  8. Sperm hyaluronan-binding assay (HBA) (Refer to Coverage Limitations)
  9. Y chromosome microdeletion analysis – Laboratory procedure that aids in determining the source of infertility in males which is typically offered to men with azoospermia (absence of sperm in semen) or severe oligozoospermia (low sperm count). This is the second most commonly known genetic cause of male infertility.
• Imaging studies or other procedures for determining abnormalities that could impact fertility include, but may not be limited to:
  1. Chromotubation of oviducts – Procedure performed in combination with a laparoscopy that involves injecting dye into the uterine cavity and fallopian tubes to evaluate patency.
  2. Endometrial (uterine lining) biopsy – Procedure in which a small piece of tissue is removed for examination under a microscope.

The endometrium can be prone to chronic low grade infections, gland overgrowth resulting in polyps or even endometrial cancer which may impact fertility.

• Fluoroscopic/hysteroscopic selective tubal cannulation – Procedure used to confirm or exclude proximal fallopian tubal occlusion suggested by other tests (such as hysterosalpingogram [HSG]) and provides the means for possible treatment via recanalization using specialized catheter systems.
• Hysterosalpingo-contrast sonography (HyCoSy) – Procedure which involves a transvaginal ultrasound investigation of the fallopian tubes both before and after the injection of an echo-enhancing agent into the tubes via the uterine cavity.
• Hysterosalpingography (HSG) – Procedure involving insertion of a tube into the cervix in order to inject a dye which should pass into the uterus and the fallopian tubes if no blockages are present; the dye allows visualization via X-ray.
• Hysteroscopy – Procedure that examines the uterus via a thin telescope-like device (hysteroscope) which is placed through the cervix.
• Intrauterine foam – A novel contrast agent for use with transvaginal ultrasound as an adaptation of the HyCoSy. This new procedure using the foam will be referred to as the hysterosalpingo-foam sonography (HyFoSy). (Refer to Coverage Limitations)
• Laparoscopy – Surgical procedure which utilizes a lighted viewing instrument and 1 or more small cuts (incisions) in the abdomen that can be utilized for further evaluation or treatment for an individual with infertility.
• Magnetic resonance imaging (MRI) – Noninvasive imaging procedure that uses strong magnetic fields and radiofrequency energy and may be done with or without contrast (dye).
• Sonohysterography (SHG) – Ultrasound procedure used to evaluate the uterine cavity. It involves filling the uterine cavity with saline solution using a catheter prior to an ultrasound examination.
• Testicular biopsy – Procedure in which a small portion of testicle is removed for examination. It is conducted when a semen analysis suggests that there is abnormal sperm and other tests have not found the cause.
• Ultrasound – Noninvasive diagnostic exam that uses sound waves to produce images to assess organs and structures (eg, pelvic [cervix, fallopian tubes, ovaries, uterus], scrotal, testicular, transrectal, transvaginal).
• Vasography – X-ray study that is performed to determine patency (degree of openness) of the vas deferens (duct that conveys sperm).

Treatment

Infertility treatment may involve a series of procedures and other interventions in an attempt to address the cause(s) of infertility. Some of these procedures and interventions include, but may not be limited to:

• Artificial insemination (AI), donor insemination or intrauterine insemination (IUI) – Method used to deliver sperm directly to the cervix or uterus.

• Sometimes sperm are prepared or washed to increase the likelihood of conception.
• Donor embryo(s), oocyte(s) or sperm/semen – For some assistive reproductive techniques such as AI/IUI or in vitro fertilization, embryos, oocytes or sperm/semen may be obtained from one individual for use in another. (Refer to Coverage Limitations section)
• Embryo transfer (ET) – Procedure which involves the placement of an embryo into the uterus. This is typically performed for a subsequent round of in vitro fertilization (using a thawed embryo) or when a donor embryo is utilized.
• Gamete intrafallopian transfer (GIFT) – Technique that may be used instead of in vitro fertilization for an individual with open fallopian tubes. After an egg retrieval, the eggs are inseminated (mixed with sperm) then immediately injected into the fallopian tubes for fertilization.
• In vitro fertilization (IVF) – Process by which oocytes are retrieved and then fertilized by sperm outside the body in a laboratory dish or test tube. The embryo is then instilled into the uterus via a tiny catheter. The general components of an IVF cycle are pharmacologic ovarian stimulation (eg, ovulation induction or superovulation), oocyte aspiration, fertilization and embryo transfer. There are other potential interventions that may also be necessary which include, but may not be limited to: assisted embryo hatching, intracytoplasmic sperm injection (ICSI), sperm retrieval, uterine embryo lavage, etc.
• In vitro maturation (IVM) – Eggs are retrieved before they are considered mature. In this process they are allowed to mature outside the body in a petri dish whereas in IVF the maturation is induced inside the uterus and involves injectable hormones. (Refer to Coverage Limitations section)
• INVOcell intravaginal IVF technology – Small device holding an egg and sperm is placed in the vagina for 3–5 days, allowing the individual to become an incubator for gametes during fertilization and for embryos during preimplantation development. Embryos are then transferred into the uterus. (Refer to Coverage Limitations section)
• Leukocyte immunization therapy (LIT) – Treatment whereby white blood cells from the potential father are injected into the skin of the prospective mother to purportedly promote fertility by developing the immune system’s tolerance to genetically foreign pregnancy tissues, especially in those with a history of failed IVF cycles and suspected immunologic reasons for failed implantation. (Refer to Coverage Limitations section)
• Low tubal ovum transfer – Procedure in which oocytes are transferred past a blocked or damaged section of the fallopian tube to an area closer to the uterus.
• Platelet rich plasma (PRP) – PRP is under investigation as an adjunctive treatment in assisted reproductive technology (ART) to purportedly improve reproductive outcomes through stimulating endometrial tissue growth or increasing the availability of viable eggs. (Refer to Coverage Limitations section)
• Prescription drug therapy – Medication administration to correct hormone levels or to be used in conjunction with other assistive reproductive procedures may be appropriate (coverage for infertility medications are subject to the terms and conditions found in the infertility and/or pharmacy benefits section of the member’s individual certificate).
• Reversal of elective sterilization – Individual has previously chosen to have an elective sterilization procedure (eg, tubal ligation, vasectomy) and later desires to have the procedure reversed.

(Refer to Coverage Limitations section)

• Sperm retrieval procedures include, but may not be limited to:
  1. Electro-ejaculation – An electric probe is inserted into the rectum, adjacent to the prostate gland. This probe creates a stimulus voltage which excites nearby nerves, resulting in contraction of the pelvic muscles and ejaculation.
  2. Microsurgical epididymal sperm aspiration (MESA) – Technique for collecting sperm that involves using a surgical microscope to open the small tubes within the epididymis to look for sperm.
  3. Testicular sperm aspiration (TESA) – Procedure where a needle is inserted in the testicle and sperm are aspirated.
• Surgical procedures to correct issues that may hinder fertility or assisted reproduction technology efforts include, but may not be limited to:
  1. Metroplasty (hysteroplasty) – Reconstructive surgery used to repair congenital anomalies of the uterus.
  2. Myomectomy – Removal of submucosal or intramural fibroids that distort the uterine cavity.
  3. Salpingectomy – Performed to treat fallopian tube occlusion or prior to ART to prevent ectopic pregnancy; 1 or both of the fallopian tubes may be removed.
  4. Salpingostomy – Creation of an opening into the fallopian tube, but the tube itself is not removed.
  5. Varicocelectomy – Removes swollen veins inside the scrotum (varicocele) which may be restricting blood flow that could be impacting sperm or testosterone production.

Surrogacy – Arrangement in which an individual (the surrogate) agrees to carry and give birth to a child on behalf of another person or couple. (Refer to Coverage Limitations section)

Uterine transplant – Major surgical procedure currently in clinical trials where a healthy uterus from one individual is placed into another individual’s body in order to replace an absent or diseased uterus and allow that individual to possibly become pregnant. (Refer to Coverage Limitations section)

Zygote intrafallopian transfer (ZIFT) – Used when a blockage in the fallopian tubes prevents the normal binding of sperm to the egg. Eggs are removed from ovaries and fertilized. The resulting zygote is placed into the fallopian tube by laparoscopy.

For information regarding other proposed evaluation methods and treatments for infertility not addressed in this policy, please see the following Medical Coverage Policies:

• Evaluation Method and/or Treatments - Corresponding Medical Coverage Policy
• Acupuncture - Acupuncture
• Direct-to-consumer testing for evaluating fertility status - Code Compendium (Laboratory) or Digital Therapeutics
• Erectile dysfunction treatments - Erectile Dysfunction and Peyronie’s Disease Treatments
• Preimplantation genetic testing - Preimplantation Genetic Testing

Recurrent pregnancy loss is a condition distinct from infertility, defined by 2 or more miscarriages. It may be the result of several unknown or underlying factors.

For information regarding recurrent pregnancy loss, please refer to Recurrent Pregnancy Loss Medical Coverage Policy.

Coverage Determination

Any state mandates for infertility evaluation and treatments take precedence over this medical coverage policy.

Please refer to the member’s applicable pharmacy benefit to determine benefit availability and the terms and conditions of coverage for medication for the treatment of infertility.

Evaluation and treatment for infertility may be excluded by certificate. Please consult the member’s individual certificate regarding Plan coverage.

Infertility Evaluation and Treatment

Effective Date: 04/27/2023
Revision Date: 04/27/2023
Review Date: 04/27/2023
Policy Number: HUM-0452-036
Page: 9 of 38

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

General Criteria for Infertility Evaluation and Treatment

Humana members may be eligible under the Plan for infertility evaluation and treatment when the following criteria are met:

• For a female 34 years of age or younger – Failure to achieve conception after at least 12 months of unprotected heterosexual intercourse* or at least 12 cycles of medically supervised donor insemination; OR
• For a female 35 years of age or older – Failure to achieve conception after at least 6 months of unprotected heterosexual intercourse* or at least 6 cycles of medically supervised donor insemination; AND
• For a female 40 years of age or older who has not experienced natural menopause (unmedicated day 3 follicle stimulating hormone [FSH] is less than 19 mIU/ml)

*Unprotected heterosexual intercourse is defined as the absence of using a birth control method. Birth control methods include, but may not be limited to, barrier protection (eg, condom, diaphragm), medication, surgical tubal ligation and vasectomy.

Criteria for Specific Infertility Evaluation and Treatment

The following tests and/or procedures must meet the above General Criteria for Infertility Evaluation and Treatment in addition to any criteria outlined below.

EVALUATION

Humana members may be eligible under the Plan for the following infertility evaluations when the above General Criteria for Infertility Evaluation and Treatment are met:

• Diagnostic tests include, but may not be limited to:
  • Labs obtained by blood collection:
  • Antimullerian hormone (AMH)
  • Clomiphene challenge test
• Infertility Evaluation and Treatment Effective Date: 04/27/2023
  Revision Date: 04/27/2023
  Review Date: 04/27/2023
  Policy Number: HUM-0452-036
  Page: 10 of 38
• Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.
• Estradiol (E2)
• FSH (may include a cycle day three FSH)
• Luteinizing hormone (LH)
• Progesterone
• Prolactin
• Testosterone levels
• Thyroid stimulating hormone (TSH)

• Postcoital testing (PCT), also known as Sims-Huhner test
• Postejaculatory urinalysis
• Procedures for determining abnormalities of uterine anatomy or function and/or fallopian tube occlusive diseases.

• These procedures include, but may not be limited to:
• Chromotubation of oviducts
• Endometrial (uterine lining) biopsy
• Fluoroscopic/hysteroscopic selective tubal cannulation
• Hysterosalpingo-contrast sonography (HyCoSy)
• Hysterosalpingography (HSG)
• Hysteroscopy
• Laparoscopy with or without chromotubation
• Serial transvaginal ultrasounds
• Sonohysterography
• Ultrasound (eg, pelvic, transvaginal)
• Specialized clinical tests that may be performed on semen include, but may not be limited to:
• Antisperm antibody testing
• Quantification of leukocytes (white blood cells) in semen
• Semen analysis
• Semen biochemistry (semen fructose)
• Semen culture
• Sperm function tests (eg, hypo-osmotic swelling [HOS] test, sperm viability testing or Zona free hamster oocyte penetration test)
• Testicular biopsy
• Ultrasound (eg, scrotal, transrectal)
• Vasography
• Y chromosome microdeletion analysis when the General Criteria for Infertility Evaluation and Treatment and additional following criteria are met:
• Pre- and post-test genetic counseling; AND
• Individual diagnosed with nonobstructive azoospermia or severe oligozoospermia (less than 5 million sperm/mL); AND
• Testing performed prior to assisted reproductive technologies (ART)
• TREATMENT Commercial Plan members: After the initial in vitro fertilization (IVF) procedure, any requests for further IVF or IVF related services (eg, assisted embryo hatching, embryo transfer, intracytoplasmic sperm injection, thawing) require review by a medical director.
• Humana members may be eligible under the Plan for the following infertility treatments when the above General Criteria for Infertility Evaluation and Treatment are met:
• Artificial insemination (AI) or intrauterine insemination (IUI)
• Embryo transfer (ET)**
• Gamete intrafallopian transfer (GIFT)**
• In vitro fertilization (IVF)**
• Assisted embryo hatching˄
• Intracytoplasmic sperm injection (ICSI)
• Low tubal ovum transfer**
• Sperm retrieval procedures (eg, electro-ejaculation, MESA, TESA)
• Surgical procedures to correct issues that may hinder fertility or assisted reproduction technology efforts include, but may not be limited to:
• Laparoscopy
• Metroplasty for uterine anomalies
• Myomectomy for submucosal or intramural fibroids that distort the uterine cavity (for coverage determination/limitations for indications other than infertility, please refer to Uterine Fibroid Surgical Treatments Medical Coverage Policy)
• Salpingectomy
• Salpingostomy
• Varicocelectomy (requests for varicocele treatment unrelated to fertility status are not subject to this policy criteria)
• Thawing of embryo(s), oocyte(s) or sperm/semen as part of an approved, medically necessary infertility treatment
• Uterine embryo lavage
• Zygote intrafallopian transfer (ZIFT)**

Infertility Evaluation and Treatment Effective Date: 04/27/2023
Revision Date: 04/27/2023
Review Date: 04/27/2023
Policy Number: HUM-0452-036
Page: 11 of 38
Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.
Infertility Evaluation and Treatment Effective Date: 04/27/2023
Revision Date: 04/27/2023
Review Date: 04/27/2023
Policy Number: HUM-0452-036
Page: 12 of 38
Infertility Evaluation and Treatment Effective Date: 04/27/2023
Revision Date: 04/27/2023
Review Date: 04/27/2023
Policy Number: HUM-0452-036
Page: 13 of 38

Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Humana members may be eligible under the Plan for IVF regardless of the individual’s fertility status if criteria are met for preimplantation genetic testing. For information regarding coverage determination/limitations, please refer to Preimplantation Genetic Testing Medical Coverage Policy.

**The number of embryos transferred should follow the recommendations of the American Society of Reproductive Medicine (ASRM) Guidance on the Limits to the Number of Embryos to Transfer: A Committee Opinion.³⁰†Assisted embryo hatching is considered integral to the primary IVF procedures and is not separately reimbursable.

Coverage Limitations

Humana members may NOT be eligible under the Plan for infertility evaluation or treatment for any indications other than those listed above. This is considered experimental/investigational as it is not identified as widely used and generally accepted for any other proposed use as reported in nationally recognized peer-reviewed medical literature published in the English language.

Humana members may NOT be eligible under the Plan for home pregnancy tests, home sperm tests or home ovulation test kits. Although they may be prescribed by a health care practitioner, these home tests are also available without a prescription and may be obtained over-the-counter (OTC) and are therefore generally excluded by certificate. In the absence of a certificate exclusion for over the counter items, these tests are considered not medically necessary as defined in the member’s individual certificate. Please refer to the member’s individual certificate for the specific definition.

Humana members may NOT be eligible under the Plan for the following infertility services:

• Cap-Score Test
• Computer-aided semen analysis (CASA)
• Early Embryo Viability Assessment (Eeva)

Infertility Evaluation and Treatment Effective Date: 04/27/2023

Revision Date: 04/27/2023

Review Date: 04/27/2023

Policy Number: HUM-0452-036

Page: 14 of 38

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

• Endometrial Receptivity Analysis (ERA)
• E-tegrity test for the evaluation of uterine receptivity
• In vitro maturation (IVM)
• Intrauterine foam (eg, ExEm Foam)
• INVOcell intravaginal IVF technology
• Leukocyte immunization therapy (LIT)
• Platelet rich plasma (PRP)
• Sperm hyaluronan-binding assay (HBA)
• Uterine transplant

These are considered experimental/investigational as they are not identified as widely used and generally accepted for the proposed uses as reported in nationally recognized peer-reviewed medical literature published in the English language.

Humana members may NOT be eligible under the Plan for costs of an egg/sperm donor or payment for medical services rendered to a surrogate for the purpose of childbirth. This is considered not medically necessary as defined in the member’s individual certificate. Please refer to the member’s individual certificate for the specific definition.

Humana members may NOT be eligible under the Plan for the following infertility services:

• Reversal of elective sterilization (services are not considered treatment of a disease)
• Storage and preservation (eg, cryopreservation, freezing) of oocyte(s), embryo(s)and sperm/semen^^

Infertility Evaluation and Treatment Effective Date: 04/27/2023

Revision Date: 04/27/2023

Review Date: 04/27/2023

Policy Number: HUM-0452-036

Page: 15 of 38

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version.

Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

These are generally excluded by certificate. In the absence of a certificate exclusion for these services, these are considered not medically necessary as defined in the member’s individual certificate. Please refer to the member’s individual certificate for the specific definition.

Humana members may NOT be eligible under the Plan for the following infertility services:

• Storage, preservation (eg, cryopreservation, freezing) and thawing of reproductive tissue (eg, ovarian/testicular)

These are general excluded by certificate. In the absence of a certificate exclusion for these services, these are considered experimental/investigational as they are not identified as widely used and generally accepted for the proposed uses as reported in nationally recognized peer-reviewed medical literature published in the English language.

Fertility preservation services (eg, cryopreservation, storage, thawing) for individuals facing potential iatrogenic infertility or in an effort to circumvent aging are not in scope for this policy and may be excluded by the Plan.

Background

Additional information about infertility may be found from the following websites:

• American College of Obstetricians and Gynecologists
• American Society for Reproductive Medicine
• National Library of Medicine

Medical Alternatives

Physician consultation is advised to make an informed decision based on an individual’s health needs.

Any CPT, HCPCS or ICD codes listed on this medical coverage policy are for informational purposes only. Do not rely on the accuracy and inclusion of specific codes. Inclusion of a code does not guarantee coverage and or reimbursement for a service or procedure.