Humana Infertility Evaluation and Treatments - Medicare Advantage Form

Please refer to CMS website for the most current applicable CMS Online Manual System (IOMs)/National Coverage Determination (NCD)/ Local Coverage Determination (LCD)/Local Coverage Article (LCA)/ Transmittals. There are no NCDs and/or LCDs for Infertility Evaluation and Treatment Type Title ID Number Jurisdiction Medicare Applicable States/Territories Infertility Evaluation and Treatment Page: 2 of 13 Administrative Contractors (MACs) Internet- Only Manuals (IOMs) Chapter 15 Covered Medical and Other Health Services; Section 20.1 Medicare Benefit Policy Manual 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. • Specialized clinical testing to rule out potential issues associated with infertility include, but may not be limited to: o Endometrial receptivity testing (eg, Endometrial Receptivity Analysis [ERA], E-tegrity test) o 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) o Postcoital testing (PCT), also known as Sims-Huhner test o Postejaculatory urinalysis o Tests that may be performed on semen/sperm include, but may not be limited to: Infertility Evaluation and Treatment Page: 3 of 13  Antisperm antibody testing  Cap-Score Test  Computer-aided semen analysis (CASA)  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)  Sperm hyaluronan-binding assay (HBA) o 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: o Chromotubation of oviducts – Procedure performed in combination with a laparoscopy that involves injecting dye into the uterine cavity and fallopian tubes to evaluate patency. o 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. o 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. o 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. o 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. Infertility Evaluation and Treatment Page: 4 of 13 o Hysteroscopy – Procedure that examines the uterus via a thin telescope-like device (hysteroscope) which is placed through the cervix. o 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). o 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. o Magnetic resonance imaging (MRI) – Noninvasive imaging procedure that uses strong magnetic fields and radiofrequency energy and may be done with or without contrast (dye). o 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. o 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. o 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). o 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. • 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. Infertility Evaluation and Treatment Page: 5 of 13 • 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) – Essentially, this is fertilization of an egg 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. 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. • Leukocyte immunization therapy (LIT) – Treatment whereby white blood cells from the potential father that 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. • 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 (liquid fraction of peripheral blood that has been prepared to include a higher than baseline concentration of platelets) 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. • Prescription drug therapy – Medication administration to correct hormone levels or to be used in conjunction with other assistive reproductive procedures may be appropriate. • 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. • Sperm retrieval procedures include, but may not be limited to: o 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. o 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. Infertility Evaluation and Treatment Page: 6 of 13 o 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: o Metroplasty (hysteroplasty) – Reconstructive surgery used to repair congenital anomalies of the uterus. o Myomectomy – Removal of submucosal or intramural fibroids that distort the uterine cavity. o 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. o Salpingostomy – Creation of an opening into the fallopian tube, but the tube itself is not removed. o 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. • 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. • 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. Coverage Determination Humana follows the CMS requirements that only allows coverage and payment for services that are reasonable and necessary for the diagnosis and treatment of illness or injury or to improve the functioning of a malformed body member except as specifically allowed by Medicare. In interpreting or supplementing the criteria above and in order to determine medical necessity consistently, Humana may consider the following criteria: Infertility Evaluation and Treatment The use of the criteria in this Medicare Advantage Medical Coverage Policy provides clinical benefits highly likely to outweigh any clinical harms. Services that do not meet the criteria above are not medically necessary and thus do not provide a clinical benefit. Medically unnecessary services carry risks of adverse outcomes and may interfere with the pursuit of other treatments which have demonstrated efficacy. Infertility Evaluation and Treatment Page: 7 of 13 Coverage Limitations US Government Publishing Office. Electronic code of federal regulations: part 411 – 42 CFR § 411.15 - Particular services excluded from coverage