National Medical Policy

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1 National Medical Policy Subject: Policy Number: Infertility, Diagnosis and Treatment NMP20 Effective Date*: July 2006 Updated: January 2016 This National Medical Policy is subject to the terms in the IMPORTANT NOTICE at the end of this document VERY IMPORTANT NOTE Health Net, Inc. considers specific infertility services below medically necessary, unless specific limitations or exclusions of these services exist in the member s particular benefit plan as stated in the certificate of coverage. Therefore, The following is applicable only to members whose plans cover infertility services. Each benefit plan contains its own specific provisions for coverage and exclusions. Not all benefits that are determined to be medically necessary below will be covered benefits under the terms of the benefit plan. Some plans may provide no benefits. Some plans may provide some coverage, but specific limitations or exclusions may exist in the applicable plan language. Some plans may impose dollar limits on these services. If there is a discrepancy between this National Medical Policy and the plan certificate language, the provisions of the benefits plan will govern. However, applicable state mandates will take precedence with respect to fully insured plans and self-funded non-erisa (e.g., government, school boards, church) plans. Unless otherwise specifically excluded, Federal mandates will apply to all plans. Please go to this Internet site for an up-to-date list of state laws: The contract agreement for coverage must have a benefit for the specific reproductive technology procedure requested (i.e., IVF, GIFT, or ZIFT). When the contract does not include coverage for any of the aforementioned, benefits are not provided for any of the services. Contracts may have a limit on the number of treatment cycles per pregnancy or lifetime. If the contract has a cycle limit per pregnancy, the limit will be renewed if a pregnancy has been confirmed by a pregnancy test from an accredited laboratory, by ultrasonography, by a spontaneous abortion documented by pathology report, or by a live birth. Infertility services are considered not medically necessary once pregnancy is established and a fetal heartbeat is detected. Infertility services beyond eight weeks of pregnancy are not considered medically necessary. For Medicaid Plans: Please refer to the appropriate State s Medicaid manual(s), publication(s), citation(s), and documented guidance for coverage criteria and benefit guidelines prior to applying Health Net Medical Policies The Centers for Medicare & Medicaid Services (CMS) For Medicare Advantage members please refer to the following for coverage guidelines first: Use Source Reference/Website Link Infertility Diagnosis and Treatment Jan 16 1

2 National Coverage Determination (NCD) National Coverage Manual Citation Local Coverage Determination (LCD)* Article (Local)* X Other Medicare Benefit Policy Manual. Chapter 15 Covered Medical and Other Health Services. Table of Contents (Rev. 157, ): Guidance/Guidance/Manuals/downloads/bp102c15.pd f None Use Health Net Policy Instructions Medicare NCDs and National Coverage Manuals apply to ALL Medicare members in ALL regions. Medicare LCDs and Articles apply to members in specific regions. To access your specific region, select the link provided under Reference/Website and follow the search instructions. Enter the topic and your specific state to find the coverage determinations for your region. *Note: Health Net must follow local coverage determinations (LCDs) of Medicare Administration Contractors (MACs) located outside their service area when those MACs have exclusive coverage of an item or service. (CMS Manual Chapter 4 Section 90.2) If more than one source is checked, you need to access all sources as, on occasion, an LCD or article contains additional coverage information than contained in the NCD or National Coverage Manual. If there is no NCD, National Coverage Manual or region specific LCD/Article, follow the Health Net Hierarchy of Medical Resources for guidance. Current Policy Statement Depending on the infertile couple s special circumstance, Health Net, Inc. considers the following standard diagnostic services, tests and treatments medically necessary: Diagnosis of Infertility (Please refer to Evidence of Coverage language for the definition of infertility as it may vary by plan) 1. Diagnosis of infertility may be made for patients with any of the following: Inability of a heterosexual couple with the female partner < 35 years of age to achieve conception after one year (12 months) of frequent, unprotected intercourse* Inability of a heterosexual couple with the female partner > 35 years of age to achieve conception after 6 months of frequent, unprotected intercourse Inability of a woman without a male partner to achieve conception after six (6) cycles of artificial donor insemination under medical supervision Note: 85% of couples who will achieve pregnancy without assistance succeed within this interval of time. 2. Earlier evaluation at 6 months indicated in women with any of the following: Infertility Diagnosis and Treatment Jan 16 2

3 Age over 35 years History of oligo/amenorrhea Known or suspected uterine/tubal disease or endometriosis 3. Earlier evaluation at 6 months indicated in males with any of the following: Male infertility risk factors such as a history of bilateral cryptorchidism are known to be present Female infertility risk factors, including advanced female age (over 35 years) are suspected Major causes of infertility include male factors, ovarian dysfunction, tubal disease, endometriosis, and uterine or cervical factors. Evaluation of Female Infertility 1. Office visits for complete medical and surgical history, menstrual history and physical examination* 2. Laboratory studies: CBC, liver function tests (LFT), RPR, HIV, cultures for chlamydia trachomatis and gonorrhea Anti-sperm antibodies (e.g., immunobead or mixed antiglobulin method) Post-coital testing (PCT) (Simms-Huhner test) of cervical mucus Fasting and 2 hours post 75 gram glucose challenge levels Lipid panel (total cholesterol, HDL cholesterol, triglycerides) Rubella serology Measurement of mid-luteal progesterone level, urinary luteinizing hormone using home prediction kit, and basal body temperature charting to document ovulation Karyotype testing for couples with recurrent pregnancy loss (two or more consecutive spontaneous abortions) Prothrombin gene factor II for couples with recurrent pregnancy loss (two or more consecutive spontaneous abortions) Serum hormone levels Gonadotropins (serum FSH, LH) for women with irregular menstrual cycles or age-related ovulatory dysfunction A high FSH level correlates with ovarian failure Human chorionic gonadotrophin (hcg) assay Prolactin for women with oligo/anovulation, galactorrhea, luteal phase inadequacy or a pituitary tumor Progestins (progesterone, 17-hydroxyprogesterone) Estrogens (estradiol) Urinary luteinizing hormone (LH) for women with irregular menstrual cycles or age-related ovulatory dysfunction Thyroid stimulating hormone (TSH) to rule out hypothyroidism Adrenocortitropic hormone (ACTH) for ruling out Cushings syndrome or Addison s disease in women who are amenorrheic A cycle day 3 serum follicle stimulating hormone (FSH) for determination of menopausal status Women older than 35 years also may benefit from ovarian reserve testing of follicle-stimulating hormone and estradiol levels on day 3 of the menstrual cycle, the clomiphene citrate challenge test, or pelvic ultrasonography for antral follicle count to determine treatment options and the likelihood of success Infertility Diagnosis and Treatment Jan 16 3

4 Measurement of 17 alpha-hydroxyprogesterone and androgens (total and fractionated testosterone, androstenedione, dehydroepiandrosterone sulfate (DHEA-S) if there is evidence of hyperandrogenism (e.g., hirsuitism, acne, menstrual irregularities, increased libido, clitoromegaly, signs of virilization) or ovulatory dysfunction for diagnosis of late-onset congenital adrenal hyperplasia and androgen-secreting tumors * Note: Details of the menstrual cycle can help determine whether the cycles are ovulatory or anovulatory. A menstrual cycle length of 22 to 35 days suggests ovulatory cycles, as does the presence of mittelschmerz and premenstrual symptoms. Substance use history, including caffeine intake, is also required. Note: Partners should be evaluated together and separately, because each person may want to reveal information about which their partner is unaware, such as previous pregnancy or sexually transmitted disease. Important topics to address include the frequency and timing of intercourse, and the use of lubricants or other products that may impair fertility. The duration of infertility and history of previous fertility for the couple and for each partner individually also need to be addressed, because they affect prognosis and may help in determining etiology. Health Net Inc. consider the following tests not medically necessary: 1. Postcoital testing as it has not been shown to improve pregnancy outcome 2. The usefulness of the progesterone challenge test is limited because of high false-positive and false-negative rates with respect to the presence or absence of estrogen production 3. Urinary FSH testing (serum, not urinary, FSH is the standard of care for determination of menopausal status) 4. Circulating serum inhibin B levels and the gonadotropin-releasing hormone test for routine use in the assessment of ovarian reserve because of limited data regarding their prognostic value 5. Antiprothrombin antibodies 6. Embryotoxicity assay 7. Endometrial function test (EFT) (cyclin E and p27) 8. Prothrombin gene factor II if there has not been recurrent pregnancy loss. Diagnostic Procedures for the Female 1. Transvaginal ultrasonography to assess tubes, uterus, and pelvis for disease 2. Hysterosalpingography (hysterosalpingogram [HSG] or tubogram) or hysterosalpingo-contrast-ultrasonography if tubal dysfunction suspected or evaluation otherwise unrevealing when any of the following is met: Woman fails to get pregnant after 1 year of trying Attempting conception with history of condition placing patient at increased risk for tubal disease (history of pelvic inflammatory disease, septic abortion, ruptured appendix, tubal surgery, or ectopic pregnancy) Recurrent miscarriages Donor insemination after 3 to 6 cycles of artificial insemination donor (AID) without pregnancy History of tubal reversal without conception History of uterine surgery (i.e., myomectomy, septum excision), endometrial polyps Infertility Diagnosis and Treatment Jan 16 4

5 Abnormal uterine bleeding (pregnancy having been ruled out) Prior to treatment with Clomiphene Citrate (Clomid) to confirm patent fallopian tubes Contraindications to HSG include: Possible pregnancy Abnormal uterine bleeding, abnormal last menstrual period (rule out pregnancy) Acute pelvic inflammatory disease Recent curettage or active genital tract infection Nontoxic goiter Endemic iodine deficiency 3. Salpingoscopy (falloscopy), hydrotubation if results of hysterosalpingography suggest tubal abnormality 4. Hysteroscopy if results of hysterosalpingography suggest intrauterine abnormality 5. Laparoscopy if any of the following is met: Pelvic endometriosis or adhesions are suspected Laparoscopy and chromotubation using methylene blue or indigo carmine to assess tubal, and other pelvic or abdominal pathology Note: If no abnormality is found on HSG, laparoscopy is not needed, but rather gonadotropin Intrauterine Insemination treatment should be offered. 6. CT or MR imaging of sella turcica to rule out pituitary adenoma if prolactin is elevated 7. Monitoring of ovarian response to ovulatory stimulants: Serial ovarian ultrasounds for cycle monitoring Estradiol FSH only if Clomiphene Citrate Challenge Test (CCCT) is done hcg quantitative LH assay Progesterone Evaluation of Male Infertility 1. Office visits for complete medical and surgical history, and physical examination: Coital practices Developmental history Medical history (e.g., genetic disorders, chronic illness, genital trauma, orchitis) Medications (e.g., sulfasalazine [Azulfidine], methotrexate, colchicine, cimetidine [Tagamet], spironolactone [Aldactone]) Potential sexually transmitted disease exposure, symptoms of genital inflammation (e.g., urethral discharge, dysuria) Previous fertility Recent high fever Substance use Surgical history (e.g., previous genitourinary surgery) Toxin exposure Genital infection (e.g., discharge, prostate tenderness) Hernia Presence of vas deferens Infertility Diagnosis and Treatment Jan 16 5

6 Signs of androgen deficiency (e.g., increased body fat, decreased muscle mass, decreased facial and body hair, small testes, Tanner stage < 5) Testicular mass Varicocele 2. Laboratory evaluation: Complete blood cell count (if infection suspected) Renal and liver function studies Gonorrhea and chlamydia cultures, urinalysis (if genital infection suspected) Semen analysis x 2 and separated by a time period of at least 1 to 4 months. Normal semen analysis values include: Volume: 1.5 to 5 ml Count: > 20 million/ml Total count: > 40 million sperm per ejaculate Live/dead 60% Motility: > 50% at one hour ph: Round Cell Differentiation: WBC < 1 million/ml White cell vs. germinal: germinal < 4 million/ml Motile sperm per ejaculate: > 20 million Microscopy for debris and agglutination: none to minimal Viscosity: normal (not thick) 3. If hypogonadism is suspected based on the semen analysis (severe oligospermia or azoospermia), evaluation of morning follicle-stimulating hormone (FSH) and total serum testosterone levels can help distinguish between primary and secondary causes. Elevated levels of FSH in the presence of low total and free testosterone levels correlate with primary hypogonadism. Low levels of both hormones suggest secondary hypogonadism. Measurement of prolactin levels is indicated if secondary hypogonadism is suspected, to rule out hyperprolactinemia as the underlying cause. 4. Transrectal ultrasonography (TRUS) of the prostate, seminal vesicles, and ejaculatory duct when any of the following is met: Suspected ejaculatory duct obstruction There is a motility of < 30% in the absence of any other explanation with or without a decreased sperm count Azoospermic patients with palpable vasa and low ejaculate volumes to determine if ejaculatory duct obstruction exists Oligospermic patients with low volume ejaculates < 1.0 ml, palpable vasa and normal testicular size, to determine if ejaculatory duct obstruction is present Perineal pain associated with ejaculation One of the above plus a physical exam which is suggestive of a cyst of either the seminal vesicle or prostate, or with non-palpable vas deferens or epididymides 5. Scrotal ultrasonography is indicated in those patients in whom physical examination of the scrotum is difficult or inadequate or in whom a hydrocele or testicular tumor is suspected Infertility Diagnosis and Treatment Jan 16 6

7 6. Post-ejaculatory urinalysis to diagnose possible retrograde ejaculation, lack of emission, ejaculatory duct obstruction, hypogonadism or congenital bilateral absence of the vasa deferentia (CBAVD) in patients with low-volume (< 1.0 ml) or absent ejaculate 7. Genetic testing in infertile males with severe oligospermia (less than 5-10 million sperm/ml) or nonobstructive azoospermia (absence of sperm in semen) is medically necessary to rule out congenital or developmental testicular disorder (e.g., Klinefelter syndrome) Note: Any condition that results in impaired sperm quality, quantity, or both can lead to male factor infertility. Testicular failure or dysfunction, also referred to as primary hypogonadism, is the most common identifiable cause. Less common causes are hypothalamic-pituitary dysfunction, also referred to as secondary hypogonadism, and conditions that affect sperm transport. The etiology remains unclear in nearly one half of cases. Infertility attributed to ovulatory dysfunction often can be treated with oral ovulation-inducing agents. Options for the treatment of male factor infertility include gonadotropin injections, intrauterine insemination, and in vitro fertilization (IVF) with or without intra-cytoplasmic sperm injection, using testicular sperm extraction if indicated. Pharmacologic Treatments of Female Infertility Health Net, Inc. considers any of the following medications medically necessary: 1. To achieve ovulation, oral clomiphene citrate (Clomid, Serophene), a nonsteroidal estrogen receptor antagonist, in an initial dosage of 50 mg per day is administered starting on day 3 to day 5 of the menstrual cycle and continued for five days in patients with any of the following: Ovulatory dysfunction Polycystic ovary syndrome (PCOS), now more commonly known as polycystic ovary disease (PCOD) Anovulatory, infertile woman in whom the cause of anovulation is secondary and not due to primary ovarian failure Hypothalamic amenorrhea Amenorrhea-galactorrhea syndrome Psychogenic amenorrhea Post-oral-contraceptive amenorrhea Certain cases of secondary amenorrhea of undetermined etiology Note: Clomiphene therapy is not recommended for women with premature ovarian failure due to low success rates. Note: Many plans exclude or limit coverage for infertility injectable medications; Please check plan documents for details. 2. Oral or intramuscular progestins and progesterone vaginal suppositories for luteal phase deficiency (deficiency in progesterone action) and IVF/GIFT/ZIFT 3. Human chorionic gonadotropin (hcg) for example, Profasi, Pregnyl and Novarel a hormone which induces the final maturation of the oocyte and then triggers Infertility Diagnosis and Treatment Jan 16 7

8 ovulation in patients who have not responded to clomiphene, but in whom follicular development appears normal. 4. Human menopausal gonadotropins (hmg) for example, Pergonal, Repronex, and Menogon, a mixture of LH and FSH derived from the urine of menopausal women 5. Urofollitropins (e.g., Metrodin, Fertinex, Bravelle) are purified FSH extracted from the urine of postmenopausal women Note: Human menopausal gonadotropins are medically necessary for any of the following: Clomiphene treatment is not successful in inducing ovulation Induction of ovulation and pregnancy in anovulatory infertile patients in whom the cause of infertility is functional and not due to primary ovarian failure. In conjunction with hcg, hmg is indicated for multiple follicular development (controlled ovarian stimulation) and ovulation induction in patients who have previously received pituitary suppression. Development of multiple follicles in ovulatory patients participating in an Assisted Reproductive Technology (ART) program. 6. In conjunction with hcg, hmg is indicated for multiple follicular development (controlled ovarian stimulation) and ovulation induction in patients who have previously received pituitary suppression or pituitary deficiency of gonadotropin (rare) it is recommended only after the doctors are sure that ovulation problems, not problems with sperm or fallopian tubes, are the cause of infertility. 7. Gonadotropin-releasing hormone (GnRH) for example, Factrel, Lutrepulse - also called luteinizing hormone-releasing hormone, is a hormone produced by the hypothalamus that signals the anterior pituitary gland to begin secreting luteinizing hormone and follicle-stimulating hormone and can act as an alternative to gonadotropins in cases of low gonadotropin and estrogen levels given for absent periods due to improper function of the hypothalamus. Note: Gonadotrophin use in ovulation induction therapy for ovulatory disorders is medically necessary for any of the following: Ovulation disorders such as polycystic ovary syndrome who do not ovulate with clomiphene citrate (or tamoxifen) Patients with polycystic ovary syndrome who ovulate with clomiphene citrate but have not become pregnant after 6 months of treatment should be offered clomiphene citrate-stimulated intrauterine insemination Note: For pituitary down-regulation as part of in vitro fertilization treatment, using gonadotrophin-releasing hormone agonist in addition to gonadotrophin stimulation facilitates cycle control and results in higher pregnancy rates than the use of gonadotrophins alone. The routine use of gonadotrophin-releasing hormone agonist in long protocols during in vitro fertilization is therefore recommended. 9. Gonadotropin-releasing hormone agonists (GnRHa) for example, Lupron, Synarel, Zoladex - medically necessary for reduction of size of fibroids and prevention of premature release of eggs for IVF/GIFT 10. Prolactin inhibitors (bromocriptine (Parlodel), cabergoline (Dostinex), peroglide (Permax)) for women with ovulatory disorders due to hyperprolactinemia Infertility Diagnosis and Treatment Jan 16 8

9 11. Bromocriptine (Parlodel) and Cabergoline (Dostinex) for abnormal bleeding and infertility due to elevated prolactin levels - restores menstrual cycles in 90 percent of women with hyperprolactinemia - for women with elevated prolactin but normal menstrual cycles, bromocriptine alone is less likely to be beneficial. 12. Pulsatile gonadotropin-releasing hormone, although rarely used now, is medically necessary for any of the following: Patients unresponsiveness to Clomiphene Citrate - should be documented Women with World Health Organization Group I ovulation disorders (hypothalamic pituitary failure, characterized by hypothalamic amenorrhea or hypogonadotropic hypogonadism) should be offered pulsatile administration of gonadotrophin-releasing hormone or gonadotrophins with luteinizing hormone activity because these are effective in inducing ovulation. 13. Metformin (Glucophage) combined with clomiphene citrate for anovulatory women secondary to polycystic ovarian disease who have not responded to clomiphene citrate Note: Diethylstilbestrol (DES) should not be used at all. Health Net, Inc. considers all of the following not medically necessary: 1. Women with polycystic ovary syndrome who are being treated with gonadotrophins should not be offered treatment with gonadotrophin-releasing hormone agonist concomitantly because it does not improve pregnancy rates, and it is associated with an increased risk of ovarian hyperstimulation. 2. The use of gonadotrophin-releasing hormone antagonists is associated with reduced pregnancy rates and is therefore not recommended outside a research context. 3. The effectiveness of pulsatile gonadotrophin-releasing hormone in women with clomiphene citrate-resistant polycystic ovary syndrome is uncertain and is therefore not medically necessary outside a research context 4. The use of adjuvant growth hormone treatment with gonadotrophin-releasing hormone agonist and/or human menopausal gonadotrophin during ovulation induction in women with polycystic ovary syndrome who do not respond to clomiphene citrate because it does not improve pregnancy rates 5. Leukocyte immunization (immunizing the female partner with the male partner's leukocytes) 6. FSH manipulation of women with elevated FSH levels because it has not been proven to be affected by interventions to reduce FSH levels. Pharmacologic Treatments for Male Infertility 1. Gonadotrophins for men with hypogonadotropic hypogonadism because these drugs have been shown to be effective in improving fertility 2. Dopamine agonists such as bromocriptine (Parlodel) can be useful in patients with hyperprolactinemia Health Net., considers all of the following not medically necessary: Infertility Diagnosis and Treatment Jan 16 9

10 Men with idiopathic semen abnormalities should not be offered antiestrogens, gonadotrophins, androgens, bromocriptine, or kinin-enhancing drugs, because they have not been shown to be effective. The effectiveness of systemic corticosteroids is uncertain. Men with leukocytes in their semen should not be offered antibiotic treatment unless there is an identified infection, because there is no evidence that this improves pregnancy rates. Operative Procedures for the Female Health Net, Inc. considers any of the following procedures medically necessary to improve the chance of pregnancy: Laparoscopic surgical ablation or resection of endometriosis plus laparoscopic adhesiolysis in women with minimal or mild endometriosis Laparoscopy for treatment of endometriosis or periadnexal adhesions in women with moderate to severe endometriosis Open surgical treatment in women with moderate or severe endometriosis Laparoscopic cystectomy in women with ovarian endometriomas Laparoscopic ovarian drilling in women with polycystic ovary syndrome who have not responded to clomiphene citrate because it is as effective as gonadotrophin treatment and is not associated with an increased risk of multiple pregnancy Women with hydrosalpinges should be offered salpingectomy, preferably by laparoscopy, before in vitro fertilization treatment because this improves the chance of a live birth. Salpingo-ovariolysis Terminal salpingostomy Fimbrioplasty Balloon tuboplasty Note: In many circumstances, many of these procedures have been replaced by Assisted Reproductive Technologies (ART) where live birth rates are much higher than surgery. Health Net, Inc. considers all of the following operative procedures for the female not medically necessary: The use of gamete intrafallopian transfer or zygote intrafallopian transfer in preference to in vitro fertilization in couples with unexplained fertility problems or male factor fertility problems because there is insufficient evidence in the medical literature to validate its effectiveness. Medical treatment of minimal and mild endometriosis in subfertile women to enhance fertility Postoperative medical treatment in women with moderate to severe endometriosis because it does not improve pregnancy rates Infertility Diagnosis and Treatment Jan 16 10

11 Tubal Surgery Health Net, Inc. consider any of the following medically necessary: Tubal microsurgery and laparoscopic tubal surgery in women with mild tubal disease, as it may be more effective than no treatment, especially in centers where necessary expertise is available Infertility treatment after a reversal of tubal ligation if there is a diagnosis of infertility unrelated to the previous sterilization procedure Selective salpingography plus tubal catheterization, or hysteroscopic tubal cannulation for women with proximal tubal obstruction because these treatments improve the chance of pregnancy. Uterine Surgery Health Net, Inc. considers hysteroscopic adhesiolysis medically necessary in women with amenorrhea who are found to have intrauterine adhesions because this is likely to restore menstruation and improve the chance of pregnancy. Ovulation Induction Health Net, Inc. considers ovulation induction medically necessary when any of the following is met: Ovulatory dysfunction, unknown cause Polycystic ovary disease (PCOD) Hyperprolactinemia Hypothalamic amenorrhea Premature ovarian failure Surgery* for Varicoceles Health Net, Inc. considers surgery for varioceles medically necessary as a form of fertility treatment, when all of the following conditions are met: The female partner has normal fertility or a potentially correctable cause of infertility; The couple has documented infertility; A varicocele is palpable or, if suspected, is corroborated by ultrasound; The male partner has one or more abnormal semen parameters or sperm function test results. *Note The above guidelines are recommended by The Male Infertility Best Practice Policy Committee of the American Urological Association. Therapeutic Donor Insemination (TDI) Health Net, Inc. consider donor insemination medically necessary in managing fertility problems associated with any of the following conditions: Obstructive azoospermia Infertility Diagnosis and Treatment Jan 16 11

12 Non-obstructive azoospermia Infectious disease in the male partner (such as HIV) Severe rhesus isoimmunization Severe deficits in semen quality in couples who do not wish to undergo intracytoplasmic sperm injection Donor insemination in certain cases where there is a high risk of transmitting a genetic disorder to the offspring Up to a maximum of six cycles of donor insemination without ovarian stimulation in women who are ovulating regularly to reduce the risk of multiple pregnancy and its consequences Women without partners Lesbian couples Note: TDI involves timed insemination from an anonymous or a known donor. Since success rates for cycles with frozen sperm are slightly less than with fresh sperm, this treatment should be continued for three to six cycles before consideration of adding or changing therapy. Health Net, Inc. considers any of the following not medically necessary: 1. Bed rest of more than 20 minutes duration following embryo transfer because it does not improve the outcome of in vitro fertilization treatment. 2. Replacement of embryos into a uterine cavity with an endometrium of less than 5 mm thickness because it is unlikely to result in a pregnancy Gonadotropin Intrauterine Insemination (IUI) Health Net, Inc. considers gonadotropi9n intrauterine insemination (IUI) medically necessary when any of the following is met: Ovulatory disorders Cervical abnormalities Mild male factor Minimal endometriosis Unexplained infertility (e.g., no abnormalities found on HSG) Couples with mild male factor fertility problems, unexplained fertility problems, or minimal to mild endometriosis should be offered up to six cycles of intrauterine insemination because this increases the chance of pregnancy Where intrauterine insemination is used to manage unexplained fertility problems, fallopian sperm perfusion for insemination (a large-volume solution, 4 ml) should be offered because it improves pregnancy rates compared with standard insemination techniques. Note: Success rates range 2-20% per cycle. Male partner s sperm is collected, concentrated, and injected into the female partner s cervix at the time of ovulation. Ovulation is timed using an over-the-counter ovulation kit, blood LH levels, or Infertility Diagnosis and Treatment Jan 16 12

13 ultrasound. Clomiphene citrate is often taken on days five to nine increasing the success rate of this treatment. Single rather than double insemination should be offered. Note: We consider ultrasound-guided embryo transfer in women undergoing in vitro fertilization treatment medically necessary because this improves pregnancy rates Assisted Reproductive Technologies Health Net, Inc. considers assisted reproductive technologies medically necessary in individuals who have met all of the following: 1. The patient has a normal day three FSH/E2 and is 44 years old or younger. 2. The couple meets the definition of infertility above 3. The couple has tried all reasonable less invasive therapies for which the therapeutic intervention is proven to be more efficacious than no intervention; 4. The likelihood of a success, defined as taking home a live-born infant, is at least 5%. * Note: The definition of ART according to the American Society of Reproductive Medicine (ASRM) and the Center for Disease Control (CDC) is fertility treatment in which both eggs and sperm are handled. An ART cycle is a process over an interval of approximately 2 weeks, rather than a procedure at a single point in time, in which: (1) an ART procedure is carried out; or (2) a woman has undergone ovarian stimulation or monitoring with the intent of having an ART procedure; or (3) frozen embryos have been thawed with the intent of transferring them to a woman. A cycle begins when a woman begins taking fertility drugs or having her ovaries monitored for follicle production. * A canceled cycle is an ART cycle in which ovarian stimulation was carried out but which was stopped before eggs were retrieved, or in the case of frozen embryo cycles, before embryos were transferred. Artificial Insemination For Female Infertility Health Net, considers artificial insemination for female infertility medically necessary when any of the following is met: Cervical factors Mild endometriosis Unexplained infertility Routine diagnostic tests that must be performed and deemed necessary prior to AI include all of the following: Testing for chlamydia, gonorrhea, syphilis, and AIDS HSG level Documentation of tubal patency and normal configuration of the uterine cavity (e.g., hysterosalpingography) Final diagnosis includes any of the following: Anatomic defects of the vagina Infertility Diagnosis and Treatment Jan 16 13

14 Defects of ovaries Cervical mucus abnormalities Contraindications for AI in females include, but are not limited to, any of the following which are not medically necessary: Infection such as acute cervicitis, endometriosis, salpingo-oophoritis, tubal obstruction Pregnancy Unexplained uterine bleeding Presence of venereal disease AIDS Artificial Insemination (AI) For Male Infertility Health Net, Inc. consider AI for male infertility medically necessary when all of the following are met: 1. A comprehensive urological evaluation must be performed or deemed unnecessary prior to initiating AI 2. Male factor infertility is diagnosed by semen analysis x 2 separated by an interval of at least 3 months showing any of the following: Low sperm count (< 20 million/ml) Low motility Oligo-asthenospermia Low percentage of normal forms Teratospermia Aspermia Seminal fluid liquefacation defect Retrograde ejaculation Contraindications for AI in males include, but are not limited to, any of the following which are not medically necessary: Infection such as prostatitis or epididymitis Presence of venereal disease AIDS Sperm Washing Health Net, Inc. considers sperm washing medically necessary when it is in preparation for a medically necessary procedure. Assisted Reproductive Therapy (ART) Health Net, Inc. considers the following services medically necessary for IUI, IVF, IVF with donor egg, GIFT, and ZIFT therapy: Infertility Diagnosis and Treatment Jan 16 14

15 Procurement, processing, and temporary storage (associated with each IVF attempt) of donor sperm Professional and ancillary fees ICSI (intracytoplasmic sperm injection) Cryopreservation of embryos (cryopreserved embryos left after the fourth IVF cycle and fees for storage in the event that pregnancy occurs are not considered medically necessary) Thaw cycles, but must occur prior to the initiation of a subsequent IVF cycle. In Vitro Fertilization (IVF) Health Net, Inc. considers in vitro fertilization medically necessary when any of the following is met: Bilateral fallopian tube absence or obstruction due to prior tubal disease and failure of conventional therapy Severe adhesive endometriosis after failed surgical and medical therapy Male factor infertility Unexplained infertility of one year s duration Note: IVF involves controlled ovarian hyperstimulation, which is aimed at producing multiple oocytes. Once the oocytes are mature, human chorionic gonadotropin (hcg) is administered, and 34 to 36 hours later they are retrieved under ultrasound guidance with the patient under light general anesthesia. The oocytes are then combined with sperm in a Petri dish to allow for fertilization. The embryos are incubated in growth medium and then transferred back into the female partner s uterus three to five days later. Note: Ultrasound monitoring of ovarian response is an integral part of the in vitro fertilization treatment cycle. Monitoring estrogen levels during ovulation induction as part of the IVF cycle is medically necessary because a low estradiol level even with the presence of few or multiple follicles is a predictor of poor outcome. More importantly, estrogen level may help predict and prevent ovarian hyperstimulation syndrome, a possible lethal condition, and help alert the physician to a premature ovulation that may lead to cycle cancellation. Health Net, considers any of the following not medically necessary for ovarian stimulation during in vitro fertilization treatment: Natural cycle in vitro fertilization in place of clomiphene citrate-stimulated and gonadotrophin-stimulated in vitro fertilization because it has lower pregnancy rates per cycle of treatment, except in the rare circumstances where gonadotrophin use is contraindicated. The use of adjuvant growth hormone with gonadotrophins during in vitro fertilization cycles because it does not improve pregnancy rates Recombinant human chorionic gonadotrophin because it achieves similar results to urinary human chorionic gonadotrophin in terms of pregnancy rates and incidence of ovarian hyperstimulation syndrome. Infertility Diagnosis and Treatment Jan 16 15

16 Cryoembryo Transfer Health Net, Inc. considers cryoembryo transfer medically necessary for patients who have undergone a cycle of IVF in which excess eggs were cryopreserved. Note: In this procedure, the excess cryopreserved fertilized embryos from the previous IVF may be transferred at a later time. The advantage of this procedure is that a repeat ovarian stimulation can be avoided. In addition, this procedure allows a woman with advanced maternal age to use embryos that were fertilized with oocytes from when she was younger. IVF with Donor Eggs (Oocytes) Health Net, Inc. considers IVF with donor eggs (oocytes) medically necessary when any of the following is met: Congenital absence of ovaries Premature ovarian failure Gonadal dysgenesis (e.g., Turner syndrome) Bilateral oophorectomy Ovarian failure following chemotherapy or radiotherapy Perimenopause* * Note: The patient must have had menopause occurring prior to age 40 (premenopausal). Note: The donor may either be anonymous or selected by the couple. A legal contract is needed between the donor and the recipient couple prior to initiation of the procedure. Intracytoplasmic Sperm Injection (ICSI) Health Net, Inc. consider intracytoplasmic sperm injection for the treatment of malefactor infertility medically necessary when any of the following is met: Congenital absence of the vas deferens Obstructive and non-obstructive azoospermia or men with less than one million total motile sperm Previous vasectomy Severe deficits in semen quality For couples in whom a previous in vitro fertilization treatment cycle has resulted in failed fertilization Note: ICSI involves direct injection of a single sperm into the cytoplasm of an oocyte. Success has been reported even with immotile and immature sperm. Success rates are the same as those reported for IVF, i.e., approximately 35% per embryo transfer. If there is an absence of sperm, surgical extraction procedures are performed. Microsurgical epididymal sperm aspiration (MESA) Health Net, Inc. considers microsurgical epididymal sperm aspiration medically necessary for congenital absence or congenital obstruction of the vas deferens only. Infertility Diagnosis and Treatment Jan 16 16

17 Note: This service is not considered medically necessary status-post vasectomy or attempted/actual reversal of vasectomy. Note: MESA is used when sperm are unable to move through the genital tract. In this procedure, the epididymis is exposed through an incision in the scrotum, and then an operating microscope is used to dissect individual epididymal tubules. Specially prepared micropipettes are then used to aspirate sperm from these tubules. The sperm is then given to the lab personnel for processing. This procedure may be done at the same time as the egg retrieval or prior to the retrieval. Sperm aspirated prior to the egg retrieval are cryopreserved and stored until the day of the egg retrieval. MESA procedures typically yield enough sperm for multiple in vitro fertilization procedures. Sperm may also be extracted from the testicles in a procedure called testicular sperm aspiration (TESA). Note: Where necessary expertise is available, men with obstructive azoospermia should be offered surgical correction of epididymal blockage because it is likely to restore patency of the duct and improve fertility. Surgical correction should be considered as an alternative to surgical sperm recovery and in vitro fertilization. Assisted hatching Health Net, Inc. considers assisted hatching medically necessary to improve embryonic implantation rates in women who: Have thick zona pellucidae Have failed to achieve embryonic implantation after several IVF cycles and who are over 38 years old Have elevated baseline follicle stimulating hormone levels Have poor quality embryos or embryos that are behind in development Note: The embryo is surrounded by a soft shell called the zona pellucida. The zona pellucida protects the embryo during early development. As the embryo develops, the zona pellucida thins. The embryo must hatch out of the zona pellucida prior to implantation into the uterine wall. It has been suggested that some unsuccessful cycles of assisted reproduction are due to the inability of the embryo to hatch out of the zona pellucida or delayed hatching which prevents the embryo from subsequently implanting into the uterine wall during the implantation "window of opportunity. Assisted hatching is a form of embryo micromanipulation in which a small hole is created in the zona pellucida of the embryo to enhance the probability of achieving pregnancy. In addition, hatching can be achieved by thinning the zona with chemicals. Mechanically assisted fertilization (MAF) may be performed as part of an IVF procedure. Such procedures include Zona "drilling" or (PZD) where the zona pellucida of the oocyte is mechanically interrupted so as to assist sperm entry, and intracytoplasmic sperm insertion (ICSI). Important Note: GIFT and ZIFT are rarely used now because IVF has given better live birth results and it does not require performance of laparoscopy. Gamete Intrafallopian Transfer (GIFT) Infertility Diagnosis and Treatment Jan 16 17

18 Health Net, Inc. considers gamete intrafallopian transfer medically necessary when any of the following is met: Unexplained infertility of one year s duration Endometriosis after failed conservative surgery/medical therapy (providing the patient has one normal fallopian tube and unilateral absence or damage of the fallopian tube) Intra-Cytoplasmic Sperm Injection (ICSI) for male factor infertility (abnormal semen) Note: The GIFT procedure is similar to IVF. With GIFT, however, fertilization occurs in the body, as opposed to IVF where fertilization occurs outside the body in a Petri dish. Ovaries are stimulated to produce multiple eggs, which are retrieved with ultrasound guidance. Eggs and sperm are transferred to the Fallopian tube by laparoscopy immediately following aspiration of all follicles. A catheter is threaded into the outer opening of the tube, into which up to four mature eggs and 300,000 motile sperm are deposited. If the number of mature eggs retrieved exceeds the desired number for the GIFT procedure, the extra eggs may be inseminated in vitro and resulting embryos can be frozen for a future treatment cycle. Zygote Intrafallopian Transfer (ZIFT) Health Net, Inc. considers zygote intrafallopian transfer medically necessary when any of the following is met: Unexplained infertility Endometriosis after failed conservative surgery/medical therapy (providing the patient has one normal fallopian tube) Male factor infertility Note: This procedure is usually performed when there is a need to document fertilization because of male factor infertility. Note: Zygote Intrafallopian transfer (ZIFT) or In Vitro Fertilization with Pronuclear Stage Embryo Transfer (PROST) - in some cases it is desirable to document that fertilization is taking place (which is not known when GIFT is done unless pregnancy results). As with GIFT or IVF, ovaries are stimulated to produce multiple eggs, which are retrieved with ultrasound guidance. Fertilization is accomplished in vitro when one pronucleus containing the genetic material from the sperm and the other pronucleus containing the genetic material from the oocyte fuse into a one cell zygote. Normal fertilization is confirmed by observation of two pronuclei. Shortly after normal fertilization is confirmed, the embryos are loaded into a catheter and transferred to the fallopian tube by laparoscopy. If couples have more embryos than they intend to transfer, freezing the additional embryos for a future transfer is an option. Health Net, Inc. considers IVF, IVF with donor egg, GIFT, ZIFT treatments not medically necessary when any of the following is met: Donor egg transfer for women who are menopausal, except those women who are experiencing menopause at a premature age. Infertility Diagnosis and Treatment Jan 16 18

19 If the patient s follicle stimulating hormone (FSH) level is greater than 15 international units/milliliter (IU/ml)* * Note: This test indicates how the patient s anterior pituitary gland and ovaries are functioning. If the patient s FSH level is less than 15 miu/ml, there s a reasonable chance that she will respond well to IVF. This test is required on days two through four of the patient s menstrual cycle for all patients age 38 and older. Oocyte, Sperm and Embryo Donation for Freezing /Cryostorage** Health Net, Inc. considers oocyte, sperm and embryo donation medically necessary for any of the following: Before commencing chemotherapy or radiotherapy likely to affect fertility, or management of post-treatment fertility problems. Men and adolescent boys preparing for medical treatment that is likely to make them infertile should be offered semen cryostorage** because the effectiveness of this procedure has been established. *Note Cryotherapy, also known as cryosurgery, is a technique that uses an extremely cold liquid or instrument to freeze and destroy abnormal skin cells that require removal, while preserving the surrounding skin from injury. **Note Cryostorage is the method used to cryopreserve semen used in sperm banks. In sperm banking, sperm are frozen or cryopreserved. Semen samples can be safely stored in this frozen state for 10 years or longer. Gestational Carrier Health Net, Inc. considers gestational carrier medically necessary when any of the following is met: Women without a uterus Women with a medical condition that preclude carrying a pregnancy to term Male homosexual couples Note: This involves IVF with transfer of the embryos to a gestational carrier, who is a woman with a uterus who will carry the pregnancy to term. To avoid custody lawsuits, when oocytes are needed, use of a separate oocyte donor, (i.e., an individual who is different from the gestational carrier) is recommended. This is particularly important for male homosexuals or for women who lack functional ovaries or uterus or who have a medical contraindication to pregnancy. Surrogate Carriers are different in that they are inseminated with the male partner's sperm and go on to carry the pregnancy. Health Net, Inc. considers any of the following not medically necessary: Acrosome reaction of human sperm Administration of cyclofenil Analysis of ATP concentration (adenosine triphosphate) in ejaculate. Anti-zona pellucida antibodies Infertility Diagnosis and Treatment Jan 16 19

20 Assessment of sperm movements, including the use of videomicrography, cinematography, time exposure photography, etc. Assessments of the ability of sperm to interact with heterologous or homologous oocytes Benefits for reversal of voluntary sterilization are not covered unless otherwise stated by the member certificate Blastocyst transfer Co-culture of embryos Coverage for women without documented infertility who do not have exposure to sperm (a minimum of 6 intrauterine inseminations cycles supervised by a physician that does not result in conception is required as evidence of infertility) Direct intraperitoneal insemination (DIPI) Donation/ storage/ banking of member or donor sperm for future use Donor eggs for women with genetic oocyte defects Donor sperm for men with genetic sperm defects Donor sperm without documented male factor infertility proven with abnormal semen analysis Egg harvesting or other infertility treatment performed during an operation not related to an infertility diagnosis Embryo freezing and storage Embryo toxic factor test (ETFL) Gender selection Genetic engineering Human zona pellucida binding assay (hemizona test) Infertility services for women who are menopausal or perimenopausal or who are not naturally expected to be fertile Infertility treatment needed as a result of prior voluntary sterilization or unsuccessful sterilization reversal procedure Microvolume straw technique Ovulation kits Partner s diagnosis and treatment, if the partner is not covered by Health Net, Inc. Peritoneal ovum and sperm transfer (POST) Reactive oxygen species (ROS) Serum anti-sperm antibody testing Sperm creatine kinase Sperm washing is not eligible for coverage when used in preparation for a noncovered procedure. Surrogacy or gestational carriers if the prenatal and postpartum care is covered by the couple Tamoxifen administration Tubaloscopy Unless otherwise stated in the certificate, the testing, storage, and transport fees or any other charges incurred. Diagnostic tests still considered experimental and investigational in nature by the American Society of Reproductive Medicine, the American College of Obstetrics and Gynecology and evidence-based guidelines from a number of professional societies: Sperm Penetration Assay Human zona binding assay (hemizona test) Infertility Diagnosis and Treatment Jan 16 20

21 Assessment of sperm movements, including the use of videomicrography, cinematography, time-exposure photography, etc. Assessments of the ability of sperm to interact with heterologous or homologous oocytes Analysis of ATP concentration (adenosine triphosphate) in ejaculate. Anti-zona pellucida antibodies Antisperm antibodies screening (e.g., immunobead or mixed antiglobulin method) because there is no evidence of effective treatment to improve fertility Serum inhibin B to measure ovarian reserve because it has limited sensitivity and specificity in predicting fertility Antiprothrombin antibodies Embryotoxocity assay Antiphospholipid antibody testing, except as part of the infertility work up for repeated miscarriages Acrosome reaction of human sperm Sperm creatine kinase Reactive oxygen species (ROS) Co-culture of embryos Embryo toxic factor test (ETFL) Tubaloscopy Chromosome studies of a donor sperm or egg Preimplantation genetic diagnosis (PGD) Microvolume straw technique Post-coital testing of cervical mucus based on: a. The limited correlation to fertility b. The confusion about standardized normal values c. The controversies about follow-up treatment d. The tendency of abnormal tests to create further testing without an apparent significant effect on the pregnancy rate e. The increasing use of empiric superovulation and intrauterine insemination treatment in infertility makes the post-coital test superfluous. Codes Related To This Policy NOTE: The codes listed in this policy are for reference purposes only. Listing of a code in this policy does not imply that the service described by this code is a covered or noncovered health service. Coverage is determined by the benefit documents and medical necessity criteria. This list of codes may not be all inclusive. On October 1, 2015, the ICD-9 code sets used to report medical diagnoses and inpatient procedures have been replaced by ICD-10 code sets. ICD-9 Codes Tuberculosis of genitourinary system, other female genital organs Uterine leiomyoma Benign neoplasm pituitary gland and craniopharyngeal duct (pouch) Carcinoma in situ, endocrine gland [any] Infertility Diagnosis and Treatment Jan 16 21