Medical Affairs Policy

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1 Medical Affairs Policy Service: Infertility and Recurrent Pregnancy Loss Testing and Treatment PUM Medical Policy Committee Approval 06/16/17 Effective Date 10/01/17 Prior Authorization Needed Yes Disclaimer: This policy is for informational purposes only and does not constitute medical advice, plan authorization, an explanation of benefits, or a guarantee of payment. Benefit plans vary in coverage and some plans may not provide coverage for all services listed in this policy. Coverage decisions are subject to all terms and conditions of the applicable benefit plan, including specific exclusions and limitations, and to applicable state and federal law. Some benefit plans administered by the organization may not utilize Medical Affairs medical policy in all their coverage determinations. Contact customer services as listed on the member card for specific plan, benefit, and network status information. Medical policies are based on constantly changing medical science and are reviewed annually and subject to change. The organization uses tools developed by third parties, such as the evidence-based clinical guidelines developed by MCG to assist in administering health benefits. This medical policy and MCG guidelines are intended to be used in conjunction with the independent professional medical judgment of a qualified health care provider. To obtain additional information about MCG, medical.policies@wpsic.com. Note: Refer to member health plan for definitions, exclusions, benefits, and preauthorization requirements for the diagnosis and treatment of infertility and / or recurrent pregnancy loss including: determining the cause (etiology) of the condition, treatment of the presumed cause of the condition, limits to the number of courses of treatment (such as courses of in-vitro fertilization), treatment related to voluntary sterilization or failed reversal of voluntary sterilization, and whether complications related to a non-covered service are a benefit. Description: Infertility: When not defined by the member s health plan, infertility is defined as the physical inability to achieve a pregnancy after a year of regular, unprotected intercourse if the woman is under age 35, or after six months, if the woman is over age 35. When not specified by the member health plan, the diagnosis phase includes efforts to determine the cause of infertility up until infertility treatment is started. Also, once a patient is prescribed an ovulation inducing medication, (e.g. Clomid) they are considered to have the ended the diagnosis stage of infertility and are receiving treatment. Testing is typically performed on both partners to diagnose the cause of the infertility, and treatment is provided in an effort to successfully conceive. These tests, procedures, and treatments are referred to as infertility as well as fertility services. When there is a health plan benefit, infertility treatments may include procedures such as ovulation induction, artificial insemination (AI) and intra uterine insemination (IUI), and assisted reproductive technologies (ART). Infertility treatments or procedures that are Page 1 of 7

2 considered experimental, investigational, and unproven to affect health or pregnancy outcomes are not covered. Recurrent Pregnancy Loss (RPL): Recurrent pregnancy loss is also known as recurrent spontaneous abortion (RSA) and recurrent miscarriage. It is a condition distinct from infertility although some diagnostic tests and treatments are used in both conditions. When not defined by the health plan, RPL is defined as two or more failed clinical pregnancy outcomes (includes ectopic pregnancy) documented by ultrasonography or histopathologic examination. Assisted Reproductive Technology (ART) includes all fertility treatments in which both eggs and embryos are handled. In general, ART procedures involve surgically removing eggs from a woman s ovaries, combining them with sperm in the laboratory, and returning them to the woman s body or donating them to another woman. They do NOT include treatments in which only sperm are handled (i.e., intrauterine or artificial insemination) or procedures in which a woman takes medicine only to stimulate egg production without the intention of having eggs retrieved. ART is used for conception for infertility as well as situations such as when infertility is not an issue for the couple. Preimplantation Genetic Diagnosis and Testing (Preimplantation Genetic Diagnosis and Preimplantation Genetic Screening PGD and PGS) is performed on cells from a preimplantation embryo or polar body of an oocyte. PGD and PGS use preimplantation procedures, diagnostic genetic laboratory technologies, and ART for conception. PGD and PGS are proposed to reduce the risk of conceiving a child with a genetic abnormality carried by one or both parents (PGD) or to identify de-novo aneuploidy (PDS) in embryos of couples with no known chromosomal abnormality. These technologies may be used in infertility treatment and when infertility may not be an issue for the couple. In-vitro fertilization (IVF) with PGD and PGS may be used in treatment of infertility and RPL. Indications of Coverage: I. Infertility Genetic tests (when a covered benefit) require prior authorization and must meet test validity and medical necessity criteria for the condition. Note: Preconception Cystic Fibrosis Screening (e.g. ACMG/ACOG guidelines) is considered medically necessary regardless of infertility benefit. Cystic Fibrosis diagnostic testing requires prior authorization. If testing to determine the etiology (cause) of the infertility is a benefit, the following services may be considered medically necessary when performed solely to establish the etiology of the infertility: Page 2 of 7

3 A. History and physical examination B. Laboratory tests as appropriate: thyroid stimulating hormone (TSH); prolactin; follicle stimulating hormone (FSH); luteinizing hormone (LH); estradiol; progesterone; total and free testosterone; antisperm antibodies; post-ejaculatory urinalysis; Semen analysis: two specimens at least one month apart, to evaluate semen volume, concentration, motility, ph, fructose, leukocyte count, microbiology, and morphology C. Ultrasound of the pelvis D. Hysteroscopy E. Hysterosalpingography F. Sonohysterography G. Diagnostic laparoscopy with or without chromotubation H. Trans rectal ultrasound (TRUS), scrotal ultrasound I. Vasography and testicular biopsy in individuals with azoospermia J. Scrotal exploration K. CTFR Gene and Mutation Carrier genetic testing for cystic fibrosis in individuals with congenital bilateral absence of vas deferens; azoospermia; severe oligospermia (i.e. <5 million sperm/millimeter) with palpable vas deferens L. Karyotyping for chromosomal abnormalities in individuals with nonobstructive azoospermia or severe oligospermia M. Y-chromosome microdeletion testing in individuals with nonobstructive azoospermia or severe oligospermia (sperm concentration less than 5 million/ml), Cytogenic karyotyping negative for chromosomal abnormalities associated with infertility (e.g. Klinefelter syndrome), AND no evidence of hypogonadotropic hypogonadism (e.g. Kallman syndrome) N. If infertility treatment is a benefit of the plan: sperm penetration assay (hamster penetration test, zona free hamster oocyte test) for those with male factor infertility who are considering IVF cycles and Intracytoplasmic Sperm Injection (ICSI) II. Recurrent Pregnancy Loss: If testing or treatment is a benefit, the following service may be considered medically necessary after two consecutive pregnancy losses Page 3 of 7

4 A. Testing 1. Peripheral karyotypic analysis of parents 2. screening for lupus anticoagulant 3. screening for anticardiolipin antibodies (IgG, IgM) and Lupus anticoagulant using standard assays 4. anti-b2 glycoprotein I 5. sonohysterogram, hysterosalpingogram, and/or hysteroscopy 6. screening for thyroid or prolactin abnormalities 7. karyotypic analysis of products of conception 8. Pelvic Ultrasound to assess uterine anatomy and morphology (if not performed with the first pregnancy B. Treatment 1. Treatment of clearly established antiphospholipid syndrome (APS) can be treated with a combination of prophylactic doses of unfractionated heparin and low dose aspirin 2. Surgical treatment of structural uterine abnormalities 3. Appropriate control of overt Diabetes Mellitus, thyroid dysfunction, and Poly Cystic Ovary Syndrome) (PCOS) is medically necessary and would not be considered an infertility benefit Limitations of Coverage: A. Review health plan and endorsements for exclusions and prior authorization or benefit requirements. B. Tests may be repeated once in the diagnostic workup for infertility testing. Additional testing after the initial and repeat tests is considered not medically necessary. C. After an infertility diagnosis has been established or treatment started, any infertility testing or treatment service, including evaluation and management services (office visits), radiology procedures, lab testing, etc. is considered part of the treatment and is subject to the infertility treatment benefits/exclusions of the policy. For example, if the Page 4 of 7

5 policy has no benefits for infertility treatment, there would also be no benefit for a lab test after the infertility diagnosis has been established or treatment started. D. However, once the patient becomes pregnant, medications (e.g. progesterone) used for the maintenance of the pregnancy would not be subject to the infertility treatment benefits/exclusions of the policy. E. Cryopreservation of sperm/ova, also known as elective fertility preservation, embryo accumulation/banking procedures: if not an exclusion of the certificate, are considered not medically necessary per the certificate definition. F. When preimplantation genetic testing is planned, assisted reproductive technology (ART) must be used for conception even if infertility is not an issue for the couple. Consequently, Preimplantation Genetic Diagnosis and Preimplantation Genetic Screening (PGD and PGS) and/or IVF with PGD are subject first to certificate benefits and limitations related to ART. If there is a certificate benefit for ART, determination requires Medical Director review. G. The following tests and treatments for RPT are considered experimental investigational and unproven to affect health/pregnancy outcomes. 1. Aspirin, heparin, or low-molecular-weight heparin to treat unexplained RPL 2. Cytokine testing 3. Intravenous immunoglobulin-glucocorticoids (IVIG) 4. Intralipid infusion. There are clinical trials in progress for RPL and recurrent implantation failure 5. Paternal cell immunization 6. Screening for thyroid antibodies 7. Testing for peripheral blood or uterine natural killer cells 8. Third-party donor leukocytes 9. TORCH screening 10. Treatment of suppression of high levels of luteinizing hormone 11. Trophoblast membrane infusion 12. Use of steroids in treating miscarriage associated with APS syndrome Page 5 of 7

6 13. Testing for Factor V Leiden unless there are risk factors for thrombophilia (see MCG: Factor V Leiden Thrombophilia-F5 Gene) Documentation Required: Office notes Procedure reports References: 1. Agency for Healthcare Research and Quality. Effectiveness of Assisted Reproductive Technology. Evidence Report/technology Assessment Number 167. May Available at: Accessed 24 Feb UpToDate Overview of infertility. Last Updated Sep 11, 2014; Apr 07, UpToDate Causes of female infertility. Last Updated Jun 23, 2014; Feb 01, 2016; July 26, UpToDate Evaluation of female infertility Last Updated Mar 06, 2015; Apr 07, 2016; Sep 26, 2016; 5. UpToDate Treatments for female infertility. Last Updated Oct 10, 2016 Literature review current through Apr UpToDate Causes of male infertility. Last Updated April 29, 2014; Jan 05, UpToDate Evaluation of male infertility. Last Updated April 9, 2014; Sept 16, UpToDate Treatment of male infertility. Last Updated Jan 12, 2015; Jan 22, UpToDate Unexplained infertility. Topic last updated: Mar 29, 2017; May 18, UpToDate In vitro fertilization. Last Updated Mar 29, Literature review current through Apr 2017 Page 6 of 7

7 11. UpToDate Pre-implantation Genetic Diagnosis. Last Updated Dec 19, 2016, Nov 18, UpToDate Inherited thrombophilias in pregnancy. Last Updated Mar 11, 2015, Nov 18, MCG 21 st Edition. AC-RMG R-0193 Infertility-Referral Management 14. MCG 21 st Edition. ACG A-0803 Male Infertility-Y Chromosome Microdeletion Analysis 15. MCG 21 st Edition. ACG: A-0597 Cystic Fibrosis-CFTR Gene and Mutation Panel 16. Dahdouh EM, Balayla J, Audibert F, et.al. technical Update: Preimplantation genetic Diagnosis and Screening J Obstet Gynaecol Can May; 37(5): Hayes Search and Summary. Intravenous Intralipid for treatment of Recurrent Pregnancy Loss May 11, 2017 WPS/Arise Review History: Implemented 07/15/15, 10/01/16, 10/01/17 Medical Policy 06/13/14, 06/12/15, 06/03/16, 06/16/17 Committee Approval Reviewed 06/13/14, 06/12/15, 06/03/16, 06/16/17 Revised 06/12/15, 06/03/16, 06/16/17 Developed Note: For review/revision history prior to 2014 see previous Medical Policy or Coverage Policy Bulletin Approved by the Medical Director Page 7 of 7