Sunflower Health Plan Fertility Preservation (PDF) Form

Fertility may be transiently or permanently affected by medical treatments such as gonadotoxic therapy, cytotoxic chemotherapy, or radiation therapy, as well as by other iatrogenic causes. Rates of permanent infertility and compromised fertility after medical treatment vary and depend on many factors, including the drug, size and location of the radiation field if applicable, dose, dose-intensity, method of administration (oral versus intravenous), disease, age, treatment type and dosages, and pretreatment fertility. Policy/Criteria I. It is the policy of health plans affiliated with Centene Corporation® that, when a covered benefit under the member’s/enrollee’s benefit plan contract, any of the following procedures are medically necessary for adults and adolescents with a female reproduction system prior to commencing treatment that is likely to cause infertility (excluding voluntary sterilization): A. Embryo cryopreservation; B. Cryopreservation of mature oocytes; C. Ovarian transposition (oophoropexy); D. Radiation (gonadal) shielding; E. Conservative gynecologic surgery including but not limited to the following: 1. Radical trachelectomy in early stage cervical cancer (i.e., stage IA2 to IB cervical cancer with diameter <2 cm and invasion <10 mm); 2. Ovarian cystectomy for early-stage ovarian cancer. II. It is the policy of health plans affiliated with Centene Corporation that, when a covered benefit under the member’s/enrollee’s benefit plan contract, the following procedures are medically necessary for adults and adolescents with a male reproductive system prior to commencing treatment that is likely to cause infertility (excluding voluntary sterilization): A. Cryopreservation of sperm; B. Radiation (gonadal) shielding. III.It is the policy of health plans affiliated with Centene Corporation that there is insufficient evidence in the published peer-reviewed literature to support the use of the following procedures for adults and adolescents with a female reproduction system prior to commencing treatment that is likely to affect fertility: A. Cryopreservation of immature oocytes; B. Ovarian tissue cryopreservation and transplantation procedures; C. Ovarian suppression with gonadotropin releasing hormone (GnRHa) or antagonists. IV. It is the policy of health plans affiliated with Centene Corporation that there is insufficient evidence in the published peer-reviewed literature to support the use of the following Page 1 of 8 CLINICAL POLICY Fertility Preservation CEN"l'.'ENE" ~·orporatwn procedures for adults and adolescents with a male reproductive system prior to commencing treatment that is likely to affect fertility: A. Testicular suppression with GnRHa or antagonists; B. Testicular tissue or spermatogonial cryopreservation; C. Reimplantation or grafting of human testicular tissue. Background The most frequent cause of impaired fertility in cancer survivors with a male reproductive system is chemotherapy or radiation-induced damage to sperm. The fertility of survivors with a female reproductive system may be impaired by any treatment that damages immature eggs, affects the body’s hormonal balance, or injures the reproductive organs. Fertility preservation is an essential part of the management of adolescents and young adults who are at risk for infertility due to cancer treatments, or bilateral ovary or testicular removal for treatment of disease. Embryo cryopreservation is an established fertility preservation method, and it has routinely been used for storing surplus embryos after in vitro fertilization. Cryopreservation of unfertilized oocytes is also an option. Success rates for this procedure have improved significantly, with some reproductive specialty centers reporting success rates comparable to those obtained using unfrozen eggs, especially in younger individuals. Like embryo cryopreservation, this technique also requires ovarian stimulation and ultrasound-guided oocyte retrieval. The effectiveness of ovarian suppression with GnRHa or antagonists is inconclusive. There is conflicting evidence to recommend GnRHa as a method of fertility preservation. Studies to date have not provided definitive data demonstrating that GnRHa preserves fertility, and it remains the subject of ongoing research. American Society of Clinical Oncology (ASCO) ASCO’s recommends discussing fertility preservation with all patients of reproductive age (and with parents or guardians of children and adolescents) if infertility is a potential risk of therapy, as early as possible, before treatment starts. For those with a male reproductive system who express an interest in fertility preservation, sperm cryopreservation is the only established fertility preservation method. ASCO notes that in these patients hormonal therapy has not shown to be successful in preserving fertility. Per ASCO, other methods, including testicular tissue cryopreservation for the purpose of future reimplantation or grafting of human testicular tissue are experimental. For those with a female reproductive system who express an interest in fertility preservation, both embryo and oocyte cryopreservation are established fertility preservation methods. Other options include ovarian transposition (oophoroexy) when pelvic radiation therapy for cancer treatment is performed or conservative gynecological surgery and radiation options. ASCO notes that evidence for ovarian tissue cryopreservation for the purpose of future transplantation is experimental. They note also, there is insufficient evidence regarding the effectiveness of ovarian suppression (gonadotropin-releasing hormone analogs) to preserve fertility. Page 2 of 8 CLINICAL POLICY Fertility Preservation CEN"l'.'ENE" ~·orporatwn The ASCO guidelines continue to note that there is conflicting evidence to recommend GnRHa and other means of ovarian suppression for fertility preservation. However, the Panel recognizes that, when proven fertility preservation methods are not feasible, and in the setting of young patients with breast cancer, GnRHa may be offered in the hope of reducing the likelihood of chemotherapy-induced ovarian insufficiency. GnRHa should not be used in place of proven fertility preservation methods. The panel notes that the field of ovarian tissue cryopreservation is advancing quickly and may evolve to become standard therapy in the future, although at the time of publication, it remains experimental.9 For children, ASCO recommends using established methods of fertility preservation (semen cryopreservation and oocyte cryopreservation) for post pubertal minor children, with patient assent, if appropriate, and parent or guardian consent.1 For prepubertal children, the only fertility preservation options are ovarian and testicular cryopreservation, which are investigational.9 National Comprehensive Cancer Network (NCCN) NCCN guidelines on Adolescent and Young Adult Oncology note that mature oocyte cryopreservation is no longer considered investigational, however, embryo cryopreservation is preferred if there is an identified sperm donor.2 Ovarian tissue cryopreservation is a promising, but less well-studied strategy for fertility preservation when there is insufficient time for oocyte or embryo cryopreservation and/or the patient is prepubertal. While tissue cryopreservation is still considered investigational at some institutions, it may be discussed as an option for fertility preservation.2 Some data suggest that menstrual suppression with GnRHa may protect ovarian function. However, evidence that menstrual suppression with GnRHa protect ovarian function is insufficient, so this procedure is not currently recommended as an option for fertility preservation.2 American College of Obstetricians and Gynecologists (ACOG) For young individuals with a female reproductive system who have completed sexual development, GnRHa, such as leuprolide acetate, have been used to induce ovarian quiescence to preserve ovarian function and fertility after cytotoxic treatment. Leuprolide acetate is not recommended prior to puberty. There still is no conclusive evidence that demonstrates efficacy of GnRHa, and studies are primarily observational regarding their effectiveness in fertility preservation. The use of GnRHa should be considered and discussed with premenopausal patients who will be treated with chemotherapeutic agents. Because GnRHa have mixed results in fertility preservation with trends toward more favorable outcomes, GnRHa therapy may be recommended as an adjuvant to chemotherapy. A meta-analysis of those 14–45 years of age demonstrated that co-treatment with GnRH agonists during chemotherapy was associated with increased odds of maintaining ovarian function and achieving pregnancy after treatment.10 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 2020, American Medical Association. All rights reserved. CPT codes and CPT descriptions are Page 3 of 8 CLINICAL POLICY Fertility Preservation CEN"l'.'ENE" ~·orporatwn 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. CPT® Codes 00840 57531 58825 58970 76856 76948 77334 82670 83001 83002 84144 84702 89250 89251 89254 89258 89259 89268 89272 89280 89281 89320 89337 89352 89353 99000 99001 99070 Anesthesia for intraperitoneal procedures in lower abdomen including laparoscopy; not otherwise specified Radical trachelectomy, with bilateral total pelvic lymphadenectomy and para-aortic lymph node sampling biopsy, with or without removal of tube(s), with or without removal of ovary(s) Transposition, ovary(s) Follicle Puncture for oocyte retrieval, any method Ultrasound, pelvic (nonobstetric), real time with image documentation; complete Ultrasonic guidance for aspiration of ova, imaging supervision and interpretation Treatment devices, design and construction, complex (irregular blocks, special shields, compensators, wedges, molds or casts) Estradiol; total Gonadotropin; follicle stimulating hormone (FSH) Gonadotropin; luteinizing hormone (LH) Progesterone Gonadotropin; chorionic (hCG); quantitative 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)/embryos Oocyte identification from follicular fluid Cryopreservation, embryo(s) (freezing services, not storage) Cryopreservation; sperm Insemination of oocytes Extended culture of oocytes/embryo(s), 4-7 days Assisted oocyte fertilization, microtechnique; less than or equal to 10 oocytes Assisted oocyte fertilization, microtechnique; greater than 10 oocytes Semen analysis; volume, count motility and differential Cryopreservation, mature oocyte(s) Thawing of cryopreserved; embryo(s) Thawing of cryopreserved; sperm/semen, each aliquot Handling and/or conveyance of specimen for transfer from office to a laboratory Handling and/or conveyance of specimen for transfer from the patient in other than an office to a laboratory (distance may be indicated) Supplies and materials (except spectacles), provided by the physician or other qualified health care professional over and above those usually included with the office visit or other services rendered (list drugs, trays, supplies, or materials provided) Page 4 of 8 CLINICAL POLICY Fertility Preservation CEN"l'.'ENE" ~·orporatwn CPT® Codes 99078 99199 Physician or other qualified health care professional qualified by education, training, licensure/regulation (when applicable) educational services in a group setting (eg, prenatal, obesity, or diabetic instructions) Unlisted special service, procedure or report HCPCS Codes S4030 S4031 Sperm procurement and cryopreservation services; initial visit Sperm procurement and cryopreservation services; subsequent visit CPT Codes Considered Investigational CPT® Codes 89335 89398 Cryopreservation, reproductive tissue, testicular Unlisted reproductive medicine laboratory procedure - ICD-10-CM Diagnosis Codes that Support Coverage Criteria ICD 10 CM Code - Neoplasms C00.0-D49 Benign neoplasm of right ovary D27.0 Benign neoplasm of left ovary D27.1 Neoplasm of uncertain behavior of ovary D39.10-D39.12 Neoplasm of uncertain behavior of testis D40.10-D40.12 Acute salpingitis and oophorits N70.01- N70.03 Chronic salpingitis and oophoritis N70.11- N70.13 N83.511-N83.519 Torsion of ovary and ovarian pedicle Z31.84 Encounter for fertility preservation procedure Reviews, Revisions, and Approvals Policy adopted from Health Net NMP512, Fertility Preservation in Cancer Patients. Expanded criteria to include iatrogenic causes of infertility. Added the following ICD-10 codes: D27.0, D27.1, N70.03, N70.13, N83.51. Added the following to medical necessity statements in I. and II: “when a covered benefit under the member’s benefit plan contract.” References reviewed and updated. Codes updates Clarified I.B. that cryopreservation is medically necessary for “mature” oocytes; Under III, added A. Cryopreservation of immature oocytes, as investigational; Updated recommendations from professional societies in the background; references reviewed and updated; codes reviewed. Annual review completed. Codes reviewed. References reviewed and updated. Specialty review completed. Removed CPT 0375T – code deleted 1/1/20 Revision Date 9/16 Approval Date 10/16 09/17 10/17 09/18 09/18 09/19 09/19 04/20 Page 5 of 8 CLINICAL POLICY Fertility Preservation Reviews, Revisions, and Approvals References reviewed and updated. Replaced ‘members” with “members/enrollees” in all instances. Specialty review completed. Revised description of CPT-82670. CPT-0058T deleted in 2021. “Experimental/investigational” verbiage replaced with descriptive language in policy statement III and IV. Annual review. References reviewed and updated. Changed “review date” in the header to “date of last revision” and “date” in the revision log header to “revision date.” Annual review. Replaced all instances of female and male with descriptive, gender-neutral verbiage. Added code 89398 to table of CPT codes considered investigational. References reviewed and updated. In description, removed “male and female” from introductory sentence about medical causes of impaired fertility. CEN"l'.'ENE" ~·orporatwn Revision Date 09/20 Approval Date 09/20 02/21 09/21 09/21 05/22 05/22 09/22