Sunflower Health Plan Assisted Reproductive Technology (PDF) Form

Diagnostic infertility services to determine the cause of infertility and treatment are covered only when specific coverage is provided under the terms of a member’s/enrollee’s benefit plan. All coverage, including of a partner’s infertility, if applicable, is subject to the terms and conditions of the plan. The following discussion is applicable only to members/enrollees whose Plan covers infertility services. For those with a female reproductive system, infertility is defined as the inability to conceive or produce conception during a period of one year if under the age of 35, or during a period of six months if they are 35 years or older.37 For purposes of meeting the criteria for infertility in this section, if a person conceives but is unable to carry that pregnancy to live birth, the period of time attempted to conceive prior to achieving that pregnancy shall be included in the calculation of the one year or six month period, as applicable. Assisted Reproductive Technologies (ART) encompass a variety of clinical treatments and laboratory procedures, which include the handling of human oocytes, sperm, or embryos, with the intent of establishing pregnancy. The following services are considered medically necessary when performed solely for the treatment of infertility and when meeting the accompanying ART criteria in the Policy/Criteria section. Female Reproductive System: 1. For Food and Drug Administration (FDA) approved medications (including specialty injectables) such as clomiphene, aromatase inhibitors, estrogens, corticosteroids, progestins, metformin, and prolactin inhibitors, gonadotropin releasing hormone (GnRH) agonists, gonadotropins, and GnRH antagonists, see CP.PHAR.131 Infertility and Fertility Preservation and/or other applicable pharmacy policy; 2. Infertility surgery: surgical laparoscopy; removal of myomas, uterine septa, cysts, ovarian tumors, and polyps; open or laparoscopic resection, vaporization, or fulguration of endometriosis implants; adhesiolysis; laparoscopic cystectomy; hysteroscopic adhesiolysis; removal of fallopian tubes; hysteroscopic or fluoroscopic tubal cannulation (fimbrioplasty); selective salpingography plus tubal catheterization, or transcervical balloon tuboplasty, and tubal anastomosis; 3. Sperm washing if partner with male reproductive system has HIV and partner with female reproductive system does not; 4. Intrauterine insemination (IUI) and intracervical insemination (ICI); 5. In vitro fertilization with embryo transfer (IVF-ET); 6. Gamete intrafallopian transfer (GIFT); 7. Zygote intrafallopian transfer (ZIFT); 8. Intracytoplasmic sperm injection (ICSI); Page 1 of 17 CLINICAL POLICY Assisted Reproductive Technology 9. Short duration (up to one year) cryopreservation of embryo(s) and mature oocytes. Male Reproductive System: 1. For FDA approved medications (including specialty injectables) such as corticosteroids, antiestrogens, prolactin inhibitors, cabergoline, thyroid hormone replacement, androgens, aromatase inhibitors (testolactone), GnRH, and gonadotropins, see CP.PHAR.131 Infertility and Fertility Preservation and/or other applicable pharmacy policy; 2. Infertility surgery: varicocelectomy (spermatic vein ligation), transurethral resection of the ejaculatory ducts (TURED), orchiopexy, surgical reconstruction or repair of the vas deferens or epididymis surgery such as vasovasostomy, epididymovasostomy, epididymectomy; 3. Testicular sperm extraction (TESE), micro-TESE, and epididymal sperm extraction; 4. Sperm washing if partner with male reproductive system has HIV and partner with female reproductive system does not; 5. Impotence treatments; 6. Short duration (up to one year) cryopreservation of sperm. Policy/Criteria I. It is the policy of health plans affiliated with Centene Corporation® that Assisted Reproductive Technology (ART) is medically necessary for the following indications when the basic and treatment-specific criteria in A and B are met. Authorized infertility benefits are covered based on the members/enrollees benefit plan contract. Refer to benefit guidelines for coverage limitations. A. Basic Criteria- meets all of the following: 1. ART is performed by a physician board-certified or board eligible in reproductive endocrinology for those with a female reproductive system and by a board-certified or board eligible urologist or reproductive endocrinologist for those with a male reproductive system; 2. There is no untreatable anatomic cause of infertility and modifiable causes of infertility not addressed within this policy have been considered and modified if possible; 3. There is documentation of an inability to conceive during a period of 12 months of cycles exposed to sperm (including intrauterine insemination (IUI)), or six months for those with female reproductive systems ≥ age 35; 4. For those with female reproductive systems ≥ age 40 attempting conception using their own oocytes, documentation that the treating provider has evaluated age, infertility risk factors, measure of ovarian reserve, prior treatment and response, and considers use of the member/enrollee’s own oocytes a viable strategy for attempting conception; 5. Infertility is unrelated to voluntary sterilization or failed reversal of voluntary sterilization of either partner. Evidence of such includes: a. In the case of vasectomy reversal – there must be two recent normal semen analyses within the past three months (sperm count > 20 million/ml; motility > Page 2 of 17 CLINICAL POLICY Assisted Reproductive Technology 50% and normal morphology – > 14% normal forms by Krüger classification or > 30% normal forms by WHO criteria); b. In the case of previous tubal ligation with reanastamosis, documentation by hysterosalpingogram of unilateral or bilateral tubal patency. B. Treatment-Specific Criteria: 1. Artificial Insemination (intracervical insemination (ICI)/intrauterine insemination (IUI))- meets all of the following: a. Unilateral or bilateral tubal patency, and one of the following: i. Mild male reproductive system factor infertility; ii. Cervical factors; iii. Unexplained infertility; iv. Sperm antibodies; v. Endometriosis; vi. Utilization of cryopreserved sperm obtained for the purpose of fertility preservation before commencing non-elective medical or surgical treatment likely to cause infertility; vii. One of the following factors, which don’t require treatment by a board- certified or -eligible reproductive endocrinologist or inability to conceive over six to 12 months as described in I.A.1 and I.A.3: 1) Unable to, or would find it very difficult to, have vaginal intercourse because of a clinically diagnosed physical disability or psychosexual problem and are using partner or donor sperm; 2) Couples in which the partner with a male reproductive system is HIV positive and undergoing sperm washing; 3) Member/enrollees with a female reproductive system and without a partner with a male reproductive system who are using donor sperm. 2. In Vitro Fertilization with Embryo Transfer (IVF-ET) a. Inadequate number of frozen embryos available for transfer*: < 3 for those with a female reproductive system age < 35 years, or < 4 for those with a female reproductive system age ≥ 35 years; and one of the following: i. Barrier to fertilization, one of the following: a) Bilateral fallopian tube absence or obstruction due to prior tubal disease (not voluntary sterilization); b) Endometriosis-associated infertility which failed endometriosis treatment interventions directed by a physician; c) Severe male reproductive system infertility that has failed conservative treatments (sperm concentration < 10 million/mL and/or normal morphology of ≤ 1% by Krüger/≤ 5% by WHO criteria); d) Prior IVF cycle that resulted in failed or poor fertilization of eggs; ii. Unexplained infertility, one of the following: a) ≥ 38 years of age with a female reproductive system; b) For those with a female reproductive system < age 38, failure of at least three cycles of IUI with oral agents (i.e., clomiphene or letrozole); Page 3 of 17 CLINICAL POLICY Assisted Reproductive Technology iii. High response to a medicated cycle intended for IUI, as defined by both of the following, and the cycle in question will be converted to IVF: a) Estradiol level of > 1000 pg/ml; b) Production of at least three follicles ≥ 16mm or four to eight follicles > 14 mm in diameter; iv. Utilization of cryopreserved sperm and an oocyte or embryo(s) obtained for the purpose of fertility preservation before commencing non-elective medical or surgical treatment likely to cause infertility. *Note: Refer to Table 1 below for guidance on number of embryos to transfer per attempt at conception. Table 1. American Society for Reproductive Medicine (ASRM) limits for quantity of embryos to transfer.9 Prognosis Age (years) < 35 35 to 37 38 to 40 41 to 42 Cleavage stage embryos - Euploid Other favorable Embryos not Euploid or Favorable Blastocysts Euploid Other favorable 1 1 1 1 1 1 ≤ 3 ≤ 4 ≤ 2 ≤ 3 ≤ 4 ≤ 5 1 1 1 1 1 1 ≤ 2 ≤ 3 Embryos not Euploid or Favorable ≤ 2 ≤ 2 ≤ 3 ≤ 3 3. Frozen Embryo Transfers (FET)- meets both of the following: a. Number of embryos to transfer per attempt at conception meets the requirements in Table 1 above; b. Frozen embryos must be used prior to authorization of additional IVF cycles in one of the following circumstances: i. Those with a female reproductive system < 35 years of age, with at least 3 embryos available for transfer*; Page 4 of 17 CLINICAL POLICY Assisted Reproductive Technology ii. Those with a female reproductive system ≥ 35 years of age, with at least 4 embryos available for transfer*; iii. Utilization of cryopreserved embryo(s) obtained for the purpose of fertility preservation before commencing non-elective medical or surgical treatment likely to cause infertility. *Note: • If member/enrollee continues to qualify for infertility, FET with less than this number of embryos available for transfer is considered medically necessary. 4. Gamete Intra-Fallopian Transfer (GIFT)/Zygote Intra-Fallopian Transfer (ZIFT)- meets all of the following: a. Member/enrollee has at least one patent fallopian tube; b. One of the following: i. Utilization of cryopreserved sperm and an oocyte or embryo(s) obtained for the purpose of fertility preservation before commencing non-elective medical or surgical treatment likely to cause infertility; ii. Unexplained infertility, one of the following: a) For those with a female reproductive system < 38 years old, failure of 3 cycles of IUI with oral agents (i.e., clomiphene or letrozole); b) For those with a female reproductive system age 38-42, failure of at least 1 cycle of IUI with oral agents (i.e., clomiphene or letrozole); c. Justification that GIFT/ZIFT is preferable to standard IVF. 5. Intracytoplasmic Sperm Injection (ICSI)- meets one of the following: a. Less than 2 million motile spermatozoa per ejaculate; b. Anti-spermatozoan antibodies shown to be contributing to infertility; c. Prior or repeated fertilization failure with standard IVF protocols (< 50% fertilization); d. Washed sperm limited in number and quality; e. Obstruction of the male reproductive tract not amenable to repair necessitating microepididymal sperm aspiration (MESA) or testicular sperm extraction (TESE) (does not include obstruction due to voluntary sterilization); f. Abnormal morphology (≤ 1% normal forms by Kruger; ≤ 5% normal forms by WHO); g. Specific spermatozoan defects impairing spermatozoa-oocyte interaction; h. Fertilization of previously frozen oocytes; i. Utilization of cryopreserved sperm and/or oocyte obtained for the purpose of fertility preservation before commencing non-elective medical or surgical treatment likely to cause infertility. 6. Donor egg cycle- member/enrollee has a female reproductive system and meets one of the following: a. Congenital or surgical absence of ovaries; b. Premature ovarian failure (menopause before age 40); c. Premature diminished ovarian reserve; Page 5 of 17 CLINICAL POLICY Assisted Reproductive Technology d. Ovarian failure following radiation or chemotherapy; e. Previously failed IVF in those with a female reproductive system age >40; f. Gonadal dysgenesis including Turner Syndrome; g. High risk of transmitting genetic disorder from those with a female reproductive system. 7. TESE, micro-TESE and epididymal sperm extraction for those with a male reproductive system with obstructive or non-obstructive azoospermia. 8. Donor sperm, meets one of the following: a. Partner with male reproductive system has bilateral congenital absence of the vas deferens (BCAVD); b. Partner with male reproductive system has obstructive azoospermia; c. Those with a female reproductive system without a partner with a male reproductive system; d. High risk of transmitting an infectious disease from partner with a male reproductive system (such as HIV); e. High risk of transmitting a genetic disorder in the partner with a male reproductive system to the offspring; f. Partner with male reproductive system has non-obstructive azoospermia confirmed through MESA/TESA; g. Couples who are incompatible for red cell antigens (e.g., D, Kell) associated with hemolytic disease of the newborn and with a history of a severely affected infant; h. Partner with male reproductive system has had previous radiation or chemotherapy resulting in abnormal semen analysis; i. Partner with male reproductive system has had two abnormal semen analyses (by Krüger or WHO classification) at least 30 days apart; j. Failure of at least three cycles IVF or ICSI. 9. Cryopreservation of sperm: Short term storage of sperm during the initial year (up to 90 days approved at a time beyond the initial year, after last approved infertility treatment) for member/enrollee with a male reproductive system already in active infertility treatment who has undergone an approved MESA or TESE procedure. Note: see CP.MP.130 Fertility Preservation if undergoing medical treatment that will result in infertility. 10. Cryopreservation of embryos: a. Short term storage of embryos during the initial year (up to 90 days approved at a time beyond the initial year, after last approved infertility treatment) for any of the following: i. Embryos could not be transferred due to high risk of multiple gestation; ii. Embryos could not be transferred due to a potential adverse impact on maternal health (i.e., severe hyper-stimulation syndrome, etc.); iii. Altered endocrine and cardiovascular profile at time of embryo transfer (elevated progesterone, hypertension, etc.); Page 6 of 17 CLINICAL POLICY Assisted Reproductive Technology iv. Fewer embryos are available at one time than are planned to be transferred (low responder); v. Uterine conditions are not ideal for implantation and an approved infertility treatment is planned to increase likelihood of implantation; vi. Implantation should be postponed to allow for testing and treatment of Zika virus in areas affected. Note: see CP.MP.130 Fertility Preservation if undergoing medical treatment that will result in infertility. 11. Cryopreservation of mature oocytes: a. Short-term storage during the initial year (up to 90 days approved at a time beyond the initial year, after the last approved infertility treatment) if meeting one of the indications above for cryopreservation of embryos, but is unable, or unwilling for ethical reasons, to cryopreserve embryos. Note: see CP.MP.130 Fertility Preservation if undergoing medical treatment that will result in infertility. II. It is the policy of health plans affiliated with Centene Corporation® that ART is not medically necessary for the following indications: A. Any experimental infertility procedure; B. Surrogacy; C. Reversal of voluntary sterilization; D. Commercially available over-the-counter home test kits, including but not limited to ovulation prediction and pregnancy test kits; E. Infertility treatment needed as a result of prior voluntary sterilization or unsuccessful sterilization reversal procedure; F. A partner’s infertility services when the partner is not a member/enrollee, unless mandated by benefits; G. Those with a female reproductive system who are ≤ 54 years of age and are menopausal (unless using a donor egg for premature diminished ovarian reserve or premature ovarian failure); H. Those with a female reproductive system who are > 55 years of age; I. Gender selection, chromosomal studies of donor sperm or egg. Background In Vitro Fertilization and Embryo Transfer (IVF-ET) In vitro fertilization (IVF) involves fertilization of an egg with sperm in a dish in a laboratory, rather than inside the body. The resulting embryo is placed into the uterus later. One cycle of IVF-ET includes: • Ovulation stimulation and monitoring- the patient starts ovulation drugs to stimulate the ovaries to produce multiple eggs. Ovulation drugs are given over a period of eight to 14 days. During this time they are monitored for follicular development with frequent ultrasounds and blood tests. The eggs are retrieved before ovulation occurs. Page 7 of 17 CLINICAL POLICY Assisted Reproductive Technology • Oocyte (egg) retrieval is usually accomplished by ultrasound guided aspiration performed in the office. • Sperm preparation and capacitation- sperm are placed together with eggs and stored in an incubator. • Embryo transfer- including frozen embryo transfer (FET) involves embryo transfer to the uterus any time between one to six days after egg retrieval, or after cryopreservation in FET. Gamete Intra-Fallopian Transfer (GIFT) A laparoscope is used to aspirate one or more mature oocytes from the ovaries. Oocytes are then mixed with sperm and transferred to the fallopian tube via a catheter. GIFT, although more invasive than IVF, may be an appropriate choice in patients who, for religious or personal reasons, do not wish to have embryos in the laboratory. It is also appropriate for those who have failed donor insemination or require laparoscopy for other reasons. The success rate is similar to those with IVF. Zygote Intra-Fallopian Transfer (ZIFT) This procedure involves placement of fertilized eggs (zygotes) or embryos into the fallopian tube. It is analogous to GIFT in that laparoscopy is needed to place the zygotes in the fallopian tubes. Whereas overall success rates are similar to IVF, ZIFT may offer some advantages to patients with difficult trans-cervical embryo transfer, uterine abnormalities (such as those caused by diethylstilbestrol (DES) exposure), or recurrent failure with standard IVF. Intra-Cytoplasmic Sperm Injection (ICSI) ICSI involves injecting the sperm into the egg in a dish in the laboratory to fertilize it, rather than letting sperm penetrate the egg naturally. Embryos are then transferred to the uterus as in usual IVF.20 ICSI should be available to patients with previously failed fertilization who demonstrate either abnormal or normal semen profiles and to patients with spermatozoa concentration and motility too low to expect any success with conventional IVF. Patients should be counseled carefully regarding the outcomes and potential risks of ICSI. If there is a risk of adverse neonatal outcome associated with ICSI, it appears to be small.20 Coding Implications This clinical policy references Current Procedural Terminology (CPT®). CPT® is a registered trademark of the American Medical Association. All CPT codes and descriptions are copyrighted 2021, American Medical Association. All rights reserved. CPT codes and CPT descriptions are from the current manuals and those included herein are not intended to be all-inclusive and are included for informational purposes only. Codes referenced in this clinical policy are for informational purposes only. Inclusion or exclusion of any codes does not guarantee coverage. Providers should reference the most up-to-date sources of professional coding guidance prior to the submission of claims for reimbursement of covered services. Infertility Services Requiring Prior Authorization if a covered benefit Page 8 of 17 CLINICAL POLICY Assisted Reproductive Technology CPT® Codes 58321 58322 58323 58970 58974 58976 89250 89251 89254 89255 89257 89258 89259 89260 89261 89264 89268 89272 89280 89281 89290 89291 89337 89352 89353 89356 HCPCS Codes S4011 S4013 S4014 S4015 S4016 S4017 S4018 CPT Codes that Support Medical Necessity Artificial insemination; intra-cervical insemination (ICI) Artificial insemination; intra-uterine insemination (IUI) Sperm washing for artificial insemination Follicle puncture for oocyte retrieval, any method (IVF) Embryo transfer, intrauterine (IVF-ET) Gamete, zygote, or embryo intrafallopian tube transfer; any method (GIFT) Culture of oocyte(s)/embryo(s), less than 4 days Culture of oocyte(s)/embryo(s), less than 4 days; with co-culture of oocyte(s)/ embryo(s) Oocyte identification from follicular fluid Preparation of embryo for transfer (any method) Sperm identification from aspiration (other than seminal fluid) Cryopreservation; embryo(s) Cryopreservation; sperm Sperm isolation; simple prep (eg, sperm wash and swim-up) for insemination or diagnosis with semen analysis Sperm isolation; complex prep (eg, Percoll gradient, albumin gradient for insemination or diagnosis with semen analysis Sperm identification from testis tissue, fresh or cryopreserved Insemination of oocytes Extended culture of oocyte(s)/embryo(s), 4-7 days Assisted oocyte fertilization, microtechnique, less than or equal to 10 oocytes Assisted oocyte fertilization, microtechniques; greater than 10 oocytes. Biopsy, oocyte polar body or embryo blastomere, microtechnique (for pre- implantation genetic diagnosis); less than or equal to 5 embryos Biopsy, oocyte polar body or embryo blastomere, microtechnique (for pre- implantation genetic diagnosis); greater than 5 embryos Cryopreservation, mature oocyte(s) Thawing of cryopreserved; embryo(s) Thawing of cryopreserved; sperm/semen, each aliquot Thawing of cryopreserved; oocytes, each aliquot HCPCS Code s In vitro fertilization; including but not limited to identification and incubation of mature oocytes, fertilization with sperm, incubation of embryo(s), and subsequent visualization for determination Complete cycle, gamete intrafallopian transfer (GIFT), case rate Complete cycle, zygote intrafallopian transfer (ZIFT), case rate Complete in vitro fertilization cycle, not otherwise specified, case rate Frozen in vitro fertilization cycle, case rate Incomplete cycle, treatment canceled prior to stimulation, case rate Frozen embryo transfer procedure canceled before transfer, case rate Page 9 of 17 CLINICAL POLICY Assisted Reproductive Technology HCPCS Codes S4020 S4021 S4022 S4023 S4025 S4026 S4028 S4035 S4037 HCPCS Code s In vitro fertilization procedure canceled before aspiration, case rate In vitro fertilization procedure canceled after aspiration, case rate Assisted oocyte fertilization, case rate Donor egg cycle, incomplete, case rate Donor services for in vitro fertilization (sperm or embryo), case rate Procurement of donor sperm from sperm bank Microsurgical epididymal sperm aspiration (MESA) Stimulated intrauterine insemination (IUI), case rate Cryopreserved embryo transfer, case rate Revision Date 03/14 Approval Date 04/14 05/14 11/14 12/14 04/15 04/15 04/16 04/16 Reviews, Revisions, and Approvals Under basic criteria, clarified that men were to be treated by board- certified urologist. Added IVF, Conversion from IUI to IVF and FET criteria. Restructured sections to more closely resemble other Centene clinical policy. Removed Authorization Protocols section. Added TESE, micro-TESE, and epididymal sperm extraction Added “board eligible” on page 3 under requirements for treatment provided by board certified physician. Clarified criteria language to indicate number of criteria required for each procedure. Additional language clarification to aid in conversion to InterQual Custom Content. Combined inability to conceive for females with and without partners into one bullet point under I.B. Removed FSH requirements from II.B.3 as this is covered in basic criteria. Added clomiphene and aromatase inhibitors to FDA approved medications for female infertility. IUI- added “unable to have vaginal intercourse” and male partner is HIV positive as indications, per NICE guidelines. IVF- clarified wording in 2.a. Donor egg cycle- added indications for ovarian failure post chemo/radiation, gonadal dysgenesis, and high risk of transmitting genetic disorder from female partner. Donor sperm: added following indications: obstructive azoospermia, high risk of transmitting infectious disease from male partner, female without a male partner, high risk of transmitting genetic disorder from male partner, rhesus isoimmunization and female without male partner. Page 10 of 17 CLINICAL POLICY Assisted Reproductive Technology Reviews, Revisions, and Approvals Took out requirement that male partner be a covered member/enrollee. Added indication for cryopreservation of oocytes per ASRM guidelines. Background- added “or after cryopreservation in FET” to the last bullet in the IVF section. Added CPT codes for oocyte cryopreservation and thawing. Reviewed by specialist. References reviewed and updated. ICD-10 codes added. Under general female criteria 8, added cryopreservation of oocytes, and removed requirement that member/enrollee be undergoing active infertility treatment, as that is mentioned in the indication-specific criteria. Added cryopreservation of sperm to general male criteria. Added “sperm washing if male partner has HIV and female partner does not” to list of medically necessary services. In I.A.2., changed “member is presumably fertile” to “fertility is naturally expected of the member.” In basic criteria I.A.3, clarified that demonstration of adequate ovarian reserve is necessary in women attempting conception using their own oocytes. GIFT/ZIFT: Replaced referral to IVF criteria for required number of failed IUI cycles with specific criteria regarding failure of IUI cycles. ICSI: added indications for selected types of female infertility, previously frozen oocytes, and HIV discordant couples. Donor Sperm: added indication after 3 cycles of failed IVF or ICSI. Sperm cryopreservation: clarified initial duration of 1 year, with option of 90 days past last fertility treatment; removed medical treatment as indication, instead referring to CP.MP.130 Fertility Preservation. Embryo cryopreservation: changed wording of cryopreservation of eggs to “cryopreservation of mature oocytes;” clarified that 90 day short-term storage is in addition to the 1 year allowed in general female criteria; removed medical treatment as indication, instead referring to CP.MP.130 Fertility Preservation. Oocyte cryopreservation: removed medical treatment as indication, instead referring to CP.MP.130 Fertility Preservation; added indication for inability to cryopreserve embryos. Removed from I.A.2 the statement: “Or, for females without male partners….using normal quality sperm;” as it is duplicative in this criteria point. Reworded criteria for clarity in IUI conversion to IVF section, and combined with IVF criteria. Corrected definition of severe male factor infertility in IVF section to say sperm concentration <10 million/mL instead of TMS <10 million. Clarified in donor sperm section which indications apply to the male partner. Removed redundant statement in donor egg cycle that the female has an approved ART cycle. References reviewed and updated. Under policy/criteria, change paragraph regarding benefit limitations of 6 cycles for any procedure to referring to benefit plan contract for coverage limitations. Under basic criteria, A.3, changed age requiring documentation of adequate ovarian reserve from > 35 to > 40. Under treatment specific criteria B.7.e., removed age limit of 42. Specialist reviewed. Page 11 of 17 Revision Date Approval Date 04/17 03/18 04/17 03/18 04/18 02/19 02/19 Revision Date 01/20 11/20 Approval Date 01/20 12/20 12/21 12/21 10/22 10/22 01/23 01/23 CLINICAL POLICY Assisted Reproductive Technology Reviews, Revisions, and Approvals References reviewed and updated. Under description of policy, added reference to CP.PHAR 131. Under basic criteria, added reproductive endocrinologist as an acceptable provider for males. Under treatment specific criteria for females, I.B.2. IVF, added “unexplained infertility” for clarification; changed age criteria in ii.a, from < 39 to < 38; changed requirement of gonadotropic stimulation to oral agents (i.e., clomiphene or letrozole); Changed age criteria in ii.b. from 40-42 to 38-42; changed requirement of failure of 1- 2 cycles of IUI with gonadotropic stimulation to failure of at least 1 cycle of IUI with oral agents (i.e., clomiphene or letrozole). Under treatment specific criteria for I.B.4. GIFT/ZIFT, added “unexplained infertility” to 4b for clarification; made the same criteria changes as noted for IVF. Replaced “member” with “member/enrollee” in all instances. References reviewed and updated. Annual review. References reviewed, updated, and reformatted. Changed “review date” in the header to “date of last revision” and “date” in the revision log header to “revision date.” Changed all instances of “female”/ “male” to “female reproductive system”/“male reproductive system”. In II.A, removed “until the procedure becomes recognized as non- experimental” from the statement “Any experimental infertility procedure.” Specialist reviewed. Edited IUI criteria: Added an indication for member/enrollees with a female reproductive system and without a partner with a male reproductive system; noted that couples needing IUI and donor sperm for a psychosexual problem, sperm washing for HIV positive couples, and donor sperm for members with a female reproductive system and without a partner with a male reproductive system don’t have to demonstrate inability to conceive over 6 to 12 months or require treatment by a reproductive endocrinologist. Annual review. updated to include additional coverage information, updated age limits, and updates to reproductive system sections. Added criteria I.A.2., revised verbiage in I.A.3., and replaced clomiphene citrate challenge test in criteria I.A.4. with provider evaluation verbiage. Added “factor” to male reproductive system infertility in I.B.1.a.i. Removed “mild” from I.B.1.a.v. Added "with embryo transfer" to I.B.2. Updated I.B.2.a.i.b) for clarity. Added criteria I.B.2.a.i.d). Revised requirements in criteria I.B.2.a.ii.a) and b). Added new criteria I.B.2.a.iv., note and Table 1 for guidance on number of embryos to transfer. Updated policy statement in I.B.3., added criteria I.B.3.a. "number of embryos to transfer..." and removed this reference from the "Note" under I.B.3. Added it to I.B.3.b.i and I.B.3.b.ii. Added new indication I.B.3.a.iii. Added indication to I.B.4.b. and reformatted criteria. Removed “must be provided” from I.B.4.c. Removed I.B.5.h., “selected types of female reproductive system infertility…” and added Page 12 of 17 Revision Date Approval Date CLINICAL POLICY Assisted Reproductive Technology Reviews, Revisions, and Approvals I.B.5.i., “utilization of cryopreserved sperm and/or oocyte….” Criteria I.B.5.j. regarding HIV discordant couples removed. Previous Criteria I.B.6. regarding assisted hatching removed. Criteria I.B.6.c. updated to remove CCCT and FSH criteria. Minor wording reorder to Criteria I.B.6.d. Criteria I.B.7. removed “applies only if the partner with male reproductive system is a covered member/enrollee and meets the following.” Criteria II.F. updated to include, “unless mandated by benefits.” Criteria II.G. updated to state, “those with a female reproductive system who are ≤ 54 years of age and are menopausal (unless using a donor egg for premature diminished ovarian reserve or premature ovarian failure).” Criteria II.H. added regarding those with a female reproductive system who are > 55 years of age. Background updated with no impact on criteria. CPT Code table updated with header. CPT code 89253 removed from table of CPT Codes that Support Medical Necessity. ICD-10 codes removed. References reviewed and updated. Reviewed by internal specialist and external specialist.