johns hopkins healthcare llc policy number cms23.07 ... › johns_hopkins...8. intravenous...

Version 0.0.156

Policy Number CMS23.07

Effective Date 07/01/2019

Johns Hopkins HealthCare LLCMedical PolicyMedical Policy

Review Date 05/21/2019

Revision Date 05/21/2019Subject

Infertility Evaluation and Treatment of 15

This document applies to the following Participating Organizations:

EHP Johns Hopkins Advantage MD Priority Partners US Family Health Plan

Keywords: In vitro fertilization, Infertility, IUI, IVF

Table of Contents Page Number

I. ACTION 1II. POLICY DISCLAIMER 1III. POLICY 1IV. POLICY CRITERIA 2V. DEFINITIONS 5VI. BACKGROUND 7VII. CODING DISCLAIMER 8VIII. CODING INFORMATION 9IX. REFERENCE STATEMENT 13X. REFERENCES 13XI. APPROVALS 15

I. ACTIONX New Policy CMS23.07

Revising Policy Number

Superseding Policy Number

Archiving Policy Number

X Retiring Policy Number(s) CMS23.02; CMS09.02(Effective 07/01/2019)

II. POLICY DISCLAIMERJohns Hopkins HealthCare LLC (JHHC) provides a full spectrum of health care products and services for Employer HealthPrograms, Priority Partners, Advantage MD and US Family Health Plan. Each line of business possesses its own uniquecontract and guidelines which, for benefit and payment purposes, should be consulted first to know what benefits are availablefor coverage.

Specific contract benefits, guidelines or policies supersede the information outlined in this policy.

III. POLICYFor Advantage MD see:

• Local Coverage Determination (LCD) specific to infertility treatment does not exist at this time (Accessed 11/08/2018).• Local Coverage Determination (LCD) Services That Are Not Reasonable and Necessary (L35094) https://www.cms.gov• National Coverage Determination (NCD) for infertility services does not exist at this time (Accessed 11/08/2018).• Medicare Benefit Policy Manual, Chapter 15 - Covered Medical and Other Health Services 20.1 - Physician Expense for

Surgery, Childbirth, and Treatment for Infertility: https://www.cms.gov

© Copyright 2019 by The Johns Hopkins Health System Corporation and/or The Johns Hopkins University

https://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?LCDId=35094&ver=197&CoverageSelection=Both&ArticleType=All&PolicyType=Final&s=Maryland&KeyWord=not+reasonable&KeyWordLookUp=Title&KeyWordSearchType=And&bc=gAAAACAAAAAA&

https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/bp102c15.pdf

Version 0.0.156







For Employer Health Programs (EHP) see:

• Plan specific Summary Plan Descriptions (SPD's)For Priority Partners (PPMCO) see:

• Code of Maryland Regulations (COMAR) 10.09.67.27 Benefits - Limitations http://www.dsd.state.md.us/For Uniformed Services Family Health Plan (USFHP) see:

• TRICARE Policy Manual 6010.60-M, April 1, 2015 Chapter 4, Section 17.1 Female Genital System https://manuals.health.mil/

• TRICARE Policy Manual 6010.60-M, April 1, 2015 Chapter 4, Section 15.1 Male Genital System https://manuals.health.mil/

• TRICARE Policy Manual 6010.60-M, April 1, 2015 Chapter 7, Section 2.3 Family Planning https://manuals.health.mil/• TRICARE Policy Manual 6010.60-M, April 1, 2015 Chapter 6, Section 1.1 Pathology and Laboratory

IV. POLICY CRITERIAA. General Considerations: When benefits are provided under the member's contract, the general conditions below apply for

the evaluation or treatment of infertility. *Refer to member's Plan documents for any applicable wait periods.1. A covered member must meet the JHHC definition of infertility:

a. Failure to achieve conception after 12 months or more of unprotected heterosexual intercourse for women <35 years of age, OR:

b. Failure to achieve conception after 6 months or more of unprotected heterosexual intercourse for women ≥35 years of age, OR;

c. Failure to achieve conception after at least 12 cycles of medically supervised donor insemination for women <35 years of age without a male partner, OR;

d. Failure to achieve conception after at least 6 cycles of medically supervised donor insemination for women ≥35 years of age without a male partner, OR;

e. Known medical diagnosis causing infertility including, but not limited to:i. Stage III or IV endometriosisii. Exposure in utero to diethylstilbestrol (DES)iii. Blockage or surgical removal of one or both fallopian tubes (excluding voluntary sterilization procedures)iv. Abnormal male factors, including oligospermiav. Two or more miscarriages prior to 22 completed weeks of gestational age AND;

2. In all cases of infertility, the sequence of diagnostic and treatment services must follow a logical and cost-effectiveapproach. (For example: when feasible, intrauterine insemination (IUI) prior to in vitro fertilization (IVF); frozenembryo IVF cycle prior to new fresh IVF cycle)

3. In general JHHC Plans cover medically necessary services and procedures required to evaluate the etiology ofinfertility and to correct an identified physical cause of infertility (e.g. varicocele, pituitary disease, adhesions, anddisorders of sperm transport). For covered benefits and limitations refer to the member's Plan specific documents.

4. If covered, the level of benefit coverage may differ by Plan for artificial insemination (AI), intrauterine insemination(IUI) and assistive reproductive technologies (ART); coverage, limitations, and applicable wait periods must beverified through the member's Plan specific documents.

5. Assistive reproductive technologies (ART) must be performed at a facility that conforms to the standards set by theAmerican Society for Reproductive Medicine (ASRM).

6. If there is a discrepancy between this policy and a member's benefit plan document, the benefit plan document willgovern.


http://www.dsd.state.md.us/comar/comarhtml/10/10.09.67.27.htm

https://manuals.health.mil/





Version 0.0.156







B. Evaluation and Diagnosis of Etiology of Infertility: When benefits are provided under the member's contract, JHHC

considers the following services medically necessary for evaluation and diagnosis of the cause of infertility:1. Testing & Diagnosis of Infertility - Female

a. History/physical/menstrual historyb. Hysterosalpingogramc. Hysterosonogramd. Hysteroscopye. Laparoscopyf. Ultrasounds (Pelvic, Transvaginal)g. Serum hormone laboratory tests (examples below):

i. Follicle-stimulating hormone (FSH)ii. Luteinizing hormone (LH)iii. Thyroid stimulating hormone (TSH)iv. Prolactinv. Progesteronevi. Antimullerian hormone (AMH)vii. Estradiol

h. Endometrial biopsyi. Cultures for infectionsj. Clomiphene citrate challenge test

2. Testing & Diagnosis of Infertility - Malea. History and physicalb. Vasographyc. Ultrasounds (Transrectal, Scrotal, Prostate)d. Testicular biopsye. Serum hormone laboratory tests (examples below):

i. Follicle-stimulating hormone (FSH)ii. Estradioliii. Total serum testosteroneiv. Luteinizing hormone (LH)v. Prolactin

f. Cultures for infectionsg. Post-ejaculatory urinalysish. Semen tests (examples below): (Refer to Section H. for non-covered tests)

i. Semen analysisii. Antisperm antibody testingiii. Semen fructoseiv. Quantification of leukocytes in semenv. Sperm vitality testing

C. Treatment of Infertility: When benefits are provided under the member's contract, JHHC considers the following services

medically necessary for the treatment of infertility. When a covered benefit, indicated limitations are applicable to allJHHC Plans:1. Treatment of Infertility - Female

a. Intrauterine Insemination (IUI) or Artificial Insemination (AI) is limited to six cycles per lifetime inclusive ofnatural and induced cycles.


Version 0.0.156







b. Assistive Reproductive Technologies (ART) is limited to three cycles total per lifetime, including naturalcycles, using any combination of the following:i. In Vitro Fertilization (IVF)ii. Gamete Intrafallopian Transfer (GIFT) proceduresiii. Zygote Intrafallopian Transfer (ZIFT) proceduresiv. Pronuclear Stage Tubal Transfer (PROST)v. Tubal Embryo Transfer (TET)vi. Assistive Reproductive Technologies (ART) frozen cycles

2. Treatment of Infertility - Male a. Sperm extraction procedures:

i. Testicular sperm extraction (TESE)ii. Testicular sperm aspiration (TESA)iii. Testicular fine needle aspiration (TEFNA)iv. Percutaneous epididymal sperm aspiration (PESA)v. Vasal sperm aspirationvi. Seminal vesicle sperm aspirationvii. Electroejaculation

b. Intracytoplasmic sperm injection (ICSE)

D. Genetic Testing: For genetic testing (including pre-implantation genetic testing), refer to CMS07.03 Genetic TestingPolicy: https://www.hopkinsmedicine.org/johns_hopkins_healthcare

E. Fertility Medications: Medications related to the treatment of infertility are subject to the member's specific Plandocuments and Plan Formularies.1. Advantage MD Plans: Drugs used to promote fertility are excluded by Medicare. Refer to Plan specific Formularies:

https://www.hopkinsmedicare.com/members/2018-rx-coverage2. EHP Plans: Consult Plan specific Formulary: https://www.ehp.org/plan-benefits/pharmacy/3. PPMCO: Pharmacy Formulary: https://www.ppmco.org/benefits/pharmacy/4. USFHP: Utilizes the TRICARE Pharmacy Formulary: https://www.express-scripts.com/

F. Fertility Preservation: When benefits are provided under the member's contract, JHHC considers oocyte harvesting and

sperm retrieval for fertility preservation related to gonadotoxic cancer treatments medically necessary and covered underthe medical benefit. Cryopreservation/freezing and storage are not covered.

G. Limitations and Exclusions: Unless benefits are provided under the member's contract, JHHC considers the followinginfertility services not reasonable or not medically necessary, and therefore not covered:1. Infertility treatment when infertility is caused or related to a previous voluntary sterilization procedure2. Reversal of voluntary sterilization for the purposes of infertility treatment3. Infertility treatment for a post-menopausal woman4. Cryopreservation/freezing or storage of oocytes, sperm, embryos5. Services associated with use of a surrogate or gestational carrier.6. Infertility services for a Plan member who is not infertile (e.g. ovarian stimulation for an egg donor, except as noted

in F. above)7. Supplies that can be purchased over-the-counter (e.g. ovulation or pregnancy test kits).

H. Experimental and Investigational: Unless benefits are provided under the member's contract, JHHC considers the

following services experimental and investigational and therefore, not covered.


https://www.hopkinsmedicine.org/johns_hopkins_healthcare/downloads/updated_policies/cms_07_03_genetic_testing_2017.pdf

https://www.hopkinsmedicare.com/members/2018-rx-coverage-overview/

https://www.ehp.org/plan-benefits/pharmacy/

https://www.ppmco.org/benefits/pharmacy/

https://www.express-scripts.com/static/formularySearch/2.9.2/#/formularySearch/drugSearch

Version 0.0.156







1. Cryopreservation/freezing or storage of testicular tissue or ovarian tissue2. Reimplantation of cryopreserved ovarian or testicular tissue3. Leukocyte immunization (inoculation of a woman with husband's white blood cells)4. Microdissection of the zona or sperm microinjection5. Co-culture of oocytes/embryos6. In vitro maturation of oocytes7. Growth hormone for infertility treatment8. Intravenous immunoglobulins for treatment of infertility9. Intravenous fat emulsions for treatment of infertility10. Uterine and endometrial receptivity testing:

a. Endometrial receptivity analysis (e.g. Igenomix)b. Uterine receptivity test for ß3 (e.g. E-tegrity)

11. Uterine transplantation12. Laser-assisted necrotic blastomere removal of cryopreserved embryos13. The following sperm function tests:

a. Acrosome reaction testb. Comet assayc. Computer-assisted sperm analysis (CASA) or computer-assisted sperm motion analysisd. Hemizona assaye. Hyaluronan binding assayf. Hypososmotic swelling testg. In vitro testing of sperm penetrationh. Reactive oxygen species (ROS) testi. Sperm chromatin assayj. Sperm DNA condensation testk. Sperm DNA fragmentation assayl. Sperm nucleus maturation

14. In vitro maturation15. Any infertility service determined to be investigational or experimental

V. DEFINITIONSAssisted Hatching: An ART procedure in which the zona pellucida of an embryo is either thinned or perforated by chemical,mechanical, or laser methods (Zeigers-Hochschild, 2017).

Assistive Reproductive Technologies (ART): All treatments which include the handling of eggs and sperm and/or embryos.Some examples of ART are in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), pronuclear stage tubal transfer(PROST), tubal embryo transfer (TET), and zygote intrafallopian transfer (ZIFT) (ASRM, 2018). In general, ART proceduresinvolve surgically removing eggs from a woman’s ovaries, combining them with sperm in the laboratory, and returning themto the woman’s body or donating them to another woman. They do not include treatments in which only sperm are handled(i.e., intrauterine insemination (IUI) or artificial insemination (AI)), or procedures in which a woman takes medicine only tostimulate egg production without the intention of having eggs retrieved (CDC, 2018).

Attempt: Any implantation of the fertilized oocyte into the uterus and not the act of stimulating the ovaries to extrude oocytes.Each attempt is called a cycle.


Version 0.0.156







Canceled ART Cycle: An ART cycle in which ovarian stimulation or monitoring has been initiated with the intention to treat,but which did not proceed to follicular aspiration or in the case of a thawed or warmed embryo did not proceed to embryotransfer (Zegers-Hochschild, 2017).

Cryopreservation: The process of slow freezing or vitrification to preserve biological material, (i.e. gametes, zygotes, embryos)at extremely low temperatures (Zegers-Hochschild, 2017).

Embryo Transfer Cycle: An ART cycle in which one or more fresh or frozen/thawed embryos are transferred into the uterus orfallopian tube (Zegers-Hochschild, 2017).

Endometriosis: A disease characterized by the presence of endometrium-like epithelium and stroma outside the endometriumand myometrium. Intrapelvic endometriosis can be located superficially on the peritoneum (pertitoneal endometriosis),can extend 5 mm or more beneath the peritoneum (deep endometriosis) or can be present as an ovarian endometriotic cycts(endometrioma) (Zegers-Hochschild, 2017).

Gamete Intrafallopian Transfer (GIFT): An ART procedure which involves transferring eggs and sperm into the woman'sfallopian tube. So fertilization occurs in the woman's body (HHS, 2018).

Gestational Carrier: A woman uses her own egg. It is fertilized by the man's sperm and the embryo is placed inside the carrier'suterus (HHS, 2018).

Infertility: A disease of the reproductive system defined by the failure to achieve a clinical pregnancy after 12 months or moreof regular unprotected sexual intercourse (WHO), or six months if a woman is 35 or older (ASRM, 2018).

Intrauterine Insemination (IUI): A procedure where laboratory processed sperm is placed directly into the uterine cavity when awoman is ovulating to attempt pregnancy (Zegers-Hochschild, 2017).

Intracytoplasmic Sperm Injection (ICSI): A procedure in which a single sperm is injected into the oocyte cytoplasm(Zegers-Hochschild, 2017).

In Vitro Fertilization (IVF): An assisted reproduction technology (ART) where fertilization of eggs occurs outside of the body.Eggs are extracted and combined with a sperm sample in a laboratory. Embryos produced are then transferred into the woman'suterus bypassing the fallopian tubes (ASRM, 2018).

In Vitro Maturation (IVM): A term that refers to the maturation culture of immature oocytes after their recovery from folliclesthat may or may not have been exposed to exogenous follicle stimulating hormone (FSH) but were not exposed to eitherexogenous luteinizing hormone (LH) or human gonadotropin (hCG) prior to retrieval to induce meiotic resumption. (ASRM2013)

Luteal Phase Defect: A poorly defined abnormality of the endometrium presumably due to abnormally low progesteronesecretion or action on the endometrium (Zegers-Hochschild, 2017).

Ovarian Reserve: A term generally used to indicate the number and/or quality of oocytes, reflecting the ability to reproduce(Zegers-Hochschild, 2017).

Ovarian Stimulation: Pharmacological treatment with the intention of inducing the development of ovarian follicles. It can beused for two purposes: 1) for times intercourse or insemination; 2) in ART, to obtain multiple oocytes at follicular aspiration(Zegers-Hochschild, 2017).


Version 0.0.156







Premature Ovarian Insufficiency: A condition characterized by hypergonadotropic hypogonadism in women youngerthan age 40 years. Also known as premature or primary ovarian failure. It includes women with premature menopause(Zegers-Hochschild, 2017).

Pronuclear Stage Tubal Transfer (PROST): ART procedure similar to ZIFT, where fertilization occurs in the laboratory, but thefertilized egg is transferred to the fallopian tube before cell division occurs (UofMI, 2018).

Surrogacy: A woman who agrees to become pregnant using the man's sperm and her own egg (HHS, 2018).

Tubal Embryo Transfer (TET): Fertilization occurs in the laboratory. Then the embryo is transferred to the fallopian tubeinstead of the uterus (HHS, 2018).

Zygote Intrafallopian Transfer (ZIFT): An ART procedure where fertilization occurs in the laboratory, then the very youngembryo is transferred to the fallopian tube instead of the uterus (HHS, 2018).

VI. BACKGROUNDAccording to The American Society of Reproductive Medicine (ASRM), infertility is a condition sufficiently at variance withthe usual state of health to make it appropriate for a person who normally is expected to be fertile to seek medical consultationand treatment. A condition sufficiently at variance with the usual state of health is defined as the inability to conceive a clinicalpregnancy following 1 year of regular timed unprotected intercourse or therapeutic donor insemination or following 6 monthsof unprotected intercourse or therapeutic donor insemination for females over 35 years of age.

One approach in measuring infertility rates is using the entire population that is of reproductive age, regardless of theirintentions for clinical pregnancy. Infertility rates have been estimated to be between 6%-18% (CDC, 2014; Macaluso, 2010).The fertility of women decreases gradually but significantly beginning around age 32 years and decreases more rapidly afterthe age of 37 years. The number and quality of oocytes in the ovaries decreases progressively with age in association withgradual increase in the circulating level of follicle-stimulating hormone and other hormonal changes (ACOG). Due to decreasesin reproductive potential with age, formal evaluation of infertility is generally recommended to begin after six months ofunsuccessful attempts at conception for couples when the woman is over 35 years and immediately when the woman is olderthan 40 years. In males, age may also impact fertility as increased age is known to reduce the quality and number of spermproduced (NIH).

Causes of infertility include aging, genetic abnormalities, acute and chronic conditions, treatments for certain conditions,male factors, female factors, and exposure to environmental, occupational, recreational, and infectious agents. The causes ofinfertility are attributed to female factors 40% of the time, male factors 40% of the time and causes of infertility cannot bedetermined in up to 10- 20% of couples (Optum). Female factors can be categorized as tubal, ovulatory, uterine, and cervical.Medical conditions that may contribute to female infertility include endometriosis, polycystic ovarian syndrome, prematureovarian failure, pelvic inflammatory disease, and uterine fibroids. Male factor infertility is often caused by low sperm count,abnormal sperm motility or blockages preventing the delivery of sperm. Contributory medical conditions impacting malefertility include varicocele, infection, hormonal imbalances, and chromosome defects. Non-optimal weight can also adverselyaffect fertility for males and females. Women with a BMI of less than 18.5 experience a 4-fold longer time to pregnancy whilewomen with a BMI of 30 or greater experience a 2-fold longer time to pregnancy when compared to women with the optimalBMI. Data regarding the effects of nonsurgical weight loss on outcomes of infertility is limited. There is also a lack of studiesregarding the effects on bariatric surgery on the responsiveness to infertility (Kominiarek, 2017). Other life-style choices (i.e.cigarette smoking, excessive alcohol consumption) can also adversely affect fertility for males and females.


Version 0.0.156







Reasonable and necessary services associated with treatment for infertility are covered under Medicare. Medicare considersinfertility a condition sufficiently at variance with the usual state of health to make it appropriate for a person who normally isexpected to be fertile to seek medical consultation and treatment.

Services and treatment for infertility range from counseling to medication use to surgery. The CDC reports that the mostcommon medical services received by women with infertility problems are advice (29%), testing of female and male factors(27%), ovulation medications (20%), intrauterine insemination (7%), surgery or treatment of tubal obstruction (3%), andassisted reproductive technologies (3%) (CDC, 2014).

The various components of ART and implantation into the uterus can be broadly subdivided into oocyte harvesting procedures,which are performed on the female partner; sperm collection procedures, which are performed on the male partner; and the invitro component which are performed on the collected oocyte and sperm. The final step is the implantation procedure.

In women with PCOS, successful ovulation is the first step toward pregnancy. In cases where the woman is overweight orobese, weight loss often accomplishes this goal. Medications also may be used to cause ovulation. While ovarian surgery hasbeen used when other treatments do not work, the long-term effects of these procedures are not clear (ACOG, 2017).

In women with non-cavity distorting myomas, myomectomy is generally not advised to improve pregnancy outcomes. However, myomectomy may be reasonable in some cases such as in severe distortion of the pelvic architecture complicatingaccess to the ovaries for oocyte retrieval (ASRM, 2017).

VII. CODING DISCLAIMERCPT Copyright 2018 American Medical Association. All rights reserved. CPT is a registered trademark of the AmericanMedical Association.

Note: The following CPT/HCPCS codes are included below for informational purposes and may not be all inclusive. Inclusionor exclusion of a CPT/HCPCS code(s) below does not signify or imply that the service described by the code is a covered ornon-covered health service. Benefit coverage for health services is determined by the member’s specific benefit plan documentand applicable laws that may require coverage for a specific service. The inclusion of a code does not imply any right toreimbursement or guarantee of payment. Other policies and coverage determination guidelines may apply.

Note: All inpatient admissions require preauthorization.

Compliance with the provision in this policy may be monitored andaddressed through post payment data analysis and/or medical review audits

Employer Health Programs(EHP) refer to specificSummary Plan Description(SPD). If there is no criteriain the SPD, apply the MedicalPolicy criteria.

Priority Partners (PPMCO)refer to COMAR guidelinesthen apply the Medical Policycriteria.

US Family Health Plan(USFHP), TRICARE MedicalPolicy supersedes JHHCMedical Policy. If there is noPolicy in TRICARE, applythe Medical Policy Criteria.

Advantage MD, LCDand NCD Medical Policysupersedes JHHC MedicalPolicy. If there is no LCDor NCD, apply the MedicalPolicy Criteria.


Version 0.0.156







VIII. CODING INFORMATION

CPT CODES DESCRIPTION

0357T Cryopreservation; immature oocyte(s)

0058T Cryopreservation; reproductive tissue, ovarian

54500 Biopsy of testis, needle (separate procedure)

54505 Biopsy of testis, incisional (separate procedure)

55400 Vasovasostomy, vasovasorrhaphy

55870 Electroejaculation

58100 Endometrial sampling (biopsy) with or without endocervical sampling (biopsy) without cervical dilation,any method (separate procedure)

58110 Endometrial sampling (biopsy) performed in conjunction with colposcopy (List separately in addition tocode for primary procedure)

58321 Artificial insemination; intra-cervical

58322 Artificial insemination; intra-uterine

58323 Sperm washing for artificial insemination

58340 Catheterization and introduction of saline or contrast material for saline infusion sonohysterography (SIS) orhysterosalpingography

58345 Transcervical introduction of fallopian tube catheter for diagnosis and/or re-establishing patency (anymethod), with or without hysterosalpingography

58350 Chromotubation of oviduct, including materials

58555 Hysteroscopy, diagnostic (separate procedure)

58559 Hysteroscopy, surgical; with lysis of intrauterine adhesions (any method)

58660 Laparoscopy, surgical; with lysis of adhesions (salpingolysis, ovariolysis) (separate procedure)

58662 Laparoscopy, surgical; with fulguration or excision of lesions of the ovary, pelvic viscera, or peritonealsurface by any method

58670 Laparoscopy, surgical; with fulguration of oviducts (with or without transection)

58672 Laparoscopy, surgical; with fimbrioplasty

58673 Laparoscopy, surgical; with salpingostomy (salpingoneostomy)

58750 Tubotubal anastomosis

58970 Follicle puncture for oocyte retrieval, any method

58974 Embryo transfer, intrauterine

58976 Gamete, zygote, or embryo intrafallopian transfer, any method

74440 Vasography, vesiculography, or epididymography, radiological supervision and interpretation

74740 Hysterosalpingography, radiological supervision and interpretation


Version 0.0.156







76830 Ultrasound, transvaginal

76831 Saline infusion sonohysterography (SIS), including color flow Doppler, when performed

76856 Ultrasound, pelvic (nonobstetric), real time with image documentation; complete

76857 Ultrasound, pelvic (nonobstetric), real time with image documentation; limited or follow-up (eg, forfollicles)

76870 Ultrasound, scrotum and contents

76872 Ultrasound, transrectal

80415 Chorionic gonadotropin stimulation panel; estradiol response This panel must include the following:Estradiol (82670 x 2 on 3 pooled blood samples)

80426 Gonadotropin releasing hormone stimulation panel This panel must include the following: Folliclestimulating hormone (FSH) (83001 x 4) Luteinizing hormone (LH) (83002 x 4)

81224 CFTR (cystic fibrosis transmembrane conductance regulator) (eg, cystic fibrosis) gene analysis; intron 8poly-T analysis (eg, male infertility)

82670 Estradiol

82757 Fructose, semen

83001 Gonadotropin; follicle stimulating hormone (FSH)

83002 Gonadotropin; luteinizing hormone (LH)

83003 Growth hormone, human (HGH) (somatotropin)

83498 Hydroxyprogesterone, 17-d

83520 Immunoassay for analyte other than infectious agent antibody or infectious agent antigen; quantitative, nototherwise specified

84144 Progesterone

84146 Prolactin

84402 Testosterone; free

84403 Testosterone; total

84443 Thyroid stimulating hormone (TSH)

86255 Fluorescent noninfectious agent antibody; screen, each antibody

87015 Concentration (any type), for infectious agents

88230 Concentration (any type), for infectious agents

89250 Culture of oocyte(s)/embryo(s), less than 4 days;

89251 Culture of oocyte(s)/embryo(s), less than 4 days; with co-culture of oocyte(s)/embryos

89253 Assisted embryo hatching, microtechniques (any method)

89254 Oocyte identification from follicular fluid

89255 Preparation of embryo for transfer (any method)

89257 Sperm identification from aspiration (other than seminal fluid)


Version 0.0.156







89258 Cryopreservation; embryo(s)

89259 Cryopreservation; sperm

89260 Sperm isolation; simple prep (eg, sperm wash and swim-up) for insemination or diagnosis with semenanalysis

89261 Sperm isolation; complex prep (eg, Percoll gradient, albumin gradient) for insemination or diagnosis withsemen analysis

89264 Sperm identification from testis tissue, fresh or cryopreserved

89268 Insemination of oocytes

89272 Extended culture of oocyte(s)/embryo(s), 4-7 days

89280 Assisted oocyte fertilization, microtechnique; less than or equal to 10 oocytes

89281 Assisted oocyte fertilization, microtechnique; greater than 10 oocytes

89290 Biopsy, oocyte polar body or embryo blastomere, microtechnique (for pre-implantation genetic diagnosis);less than or equal to 5 embryos

89291 Biopsy, oocyte polar body or embryo blastomere, microtechnique (for pre-implantation genetic diagnosis);greater than 5 embryos

89300 Semen analysis; presence and/or motility of sperm including Huhner test (post coital)

89310 Semen analysis; motility and count (not including Huhner test)

89320 Semen analysis; volume, count, motility, and differential

89321 Semen analysis; sperm presence and motility of sperm, if performed

89322 Semen analysis; volume, count, motility, and differential using strict morphologic criteria (eg, Kruger)

89325 Sperm antibodies

89329 Sperm evaluation; hamster penetration test

89330 Sperm evaluation; cervical mucus penetration test, with or without spinnbarkeit test

89331 Sperm evaluation, for retrograde ejaculation, urine (sperm concentration, motility, and morphology, asindicated)

89335 Cryopreservation, reproductive tissue, testicular

89337 Cryopreservation, mature oocyte(s)

89342 Storage, (per year); embryo(s)

89343 Storage, (per year); sperm/semen

89344 Storage, (per year); reproductive tissue, testicular/ovarian

89346 Storage, (per year); oocyte

89352 Thawing of cryopreserved; embryo(s)

89353 Thawing of cryopreserved; sperm/semen, each aliquot

89354 Thawing of cryopreserved; reproductive tissue, testicular/ovarian

89356 Thawing of cryopreserved; oocytes, each aliquot


Version 0.0.156







HCPCSCODES

DESCRIPTION

G0027 Semen analysis; presence and/or motility of sperm excluding Huhner

S3655 Antisperm antibodies test (immunobead)

S4011 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 ofdevelopment

S4013 Complete cycle, gamete intrafallopian transfer (GIFT), case rate

S4014 Complete cycle, zygote intrafallopian transfer (ZIFT), case rate

S4015 Complete in vitro fertilization cycle, NOS case rate

S4016 Frozen in vitro fertilization cycle, case rate

S4017 Incomplete cycle, treatment canceled prior to stimulation, case rate

S4018 Frozen embryo transfer procedure canceled before transfer, case rate

S4020 In vitro fertilization procedure cancelled before aspiration, case rate

S4021 In vitro fertilization procedure cancelled after aspiration, case rate

S4022 Assisted oocyte fertilization, case rate

S4023 Donor Egg cycle, incomplete, case rate

S4025 Donor services for in vitro fertilization (sperm or embryo), case rate

S4026 Procurement of donor sperm from sperm bank

S4027 Storage of previously frozen embryos

S4028 Microsurgical epididymal sperm aspiration (MESA)

S4030 Sperm procurement and cryopreservation services; initial visit

S4031 Sperm procurement and cryopreservation services; subsequent visit

S4035 Stimulated intrauterine insemination (IUI), case rate

S4037 Cryopreserved embryo transfer, case rate

S4040 Monitoring and storage of cryopreserved embryos, per 30 days

S4042 Management of ovulation induction (interpretation of diagnostic tests and studies, non-face-to-face medicalmanagement of the patient), per cycle

ICD10CODES

DESCRIPTION

N46.01 - N46.9 Male infertility

N80.0 - N80.9 Endometriosis


Version 0.0.156







N97.0 - N97.9 Female infertility

IX. REFERENCE STATEMENTAnalyses of the scientific and clinical references cited below were conducted and utilized by the Johns Hopkins HealthCareLLC (JHHC) Medical Policy Team during the development and implementation of this medical policy. The Medical PolicyTeam will continue to monitor and review any newly published clinical evidence and revise the policy and adjust the referencesbelow accordingly if deemed necessary.

X. REFERENCESAetna. (2018). Infertility, Policy Number: 0327; http://www.aetna.com

American College of Obstetricians and Gynecologists. (2014). Female Age-Related Fertility Decline, Clinical Guideline,Committee Opinion #589. Retrieved: www.acog.org/Clinical-Guidance.

American Society for Reproductive Medicine Practice Committee. (2015). Current Clinical Irrelevance of Luteal PhaseDeficiency: A Committee Opinion. Fertility and Sterility, Vol. 103, Issue 4. Retrieved: www.fertstert.org.

American Society for Reproductive Medicine Practice Committee. (2015). Diagnostic Evaluation of the Infertile Female: ACommittee Opinion. Fertility and Sterility, Vol. 103, Issue 6. Retrieved: www.fertstert.org.

American Society for Reproductive Medicine Practice Committee. (2015). Diagnostic Evaluation of the Infertile Male: ACommittee Opinion. Fertility and Sterility, Vol. 103, Issue 3. Retrieved: www.fertstert.org

American Society for Reproductive Medicine Practice Committee. (2012). Endometriosis and Infertility: A CommitteeOpinion. Fertility and Sterility, Vol. 98, Issue 3. Retrieved: www.fertstert.org.

American Society for Reproductive Medicine Practice Committee. (2012. Evaluation of the azoospermic male: a committeeopinion. Fertility and Sterility, Vol. 109, Issue 5. Retrieved: www.fertstert.org

American Society of Reproductive Medicine. (ASRM). (2018). In vitro fertilization (IVF). Retrieved: http://www.reproductivefacts.org.

American Society of Reproductive Medicine. (ASRM). (2018). Assisted Reproductive Technologies. Retrieved: https://www.asrm.org/topics/topics-index/assisted-reproductive-technologies/

American Society of Reproductive Medicine. (ASRM). (2017).Removal of myomas in asymptomatic patients to improveinfertility and/or reduce miscarriage rate. Fertility & Sterility. Volume 108, Issue 3, p. 416.

Canis M, Donnez J, Guzick D, et al. Revised American Society for Reproductive Medicine classification of endometriosis:1996. Fertil Steril.1997;67:817–821.

Centers for Disease Control and Prevention. National Public Health Action Plan for the Detection, Prevention, andManagement of Infertility, Atlanta, Georgia: Centers for Disease Control and Prevention; June 2014.

Centers for Disease Control and Prevention (2018). What is Assistive Reproductive Technology (ART). Retrieved: https://www.cdc.gov/art/whatis.html.


https://www.aetna.com/

https://www.acog.org/Clinical-Guidance-and-Publications/Committee-Opinions/Committee-on-Gynecologic-Practice/Female-Age-Related-Fertility-Decline

https://www.fertstert.org/article/S0015-0282(15)00042-4/fulltext

https://www.fertstert.org/article/S0015-0282(15)00224-1/fulltext#sec9




https://www.reproductivefacts.org/?vs=1


https://www.asrm.org/topics/topics-index/assisted-reproductive-technologies/

https://www.asrm.org/topics/topics-index/assisted-reproductive-technologies/

https://www.cdc.gov/art/whatis.html

https://www.cdc.gov/art/whatis.html

Version 0.0.156







Hayes Technology Brief. (2012). E-tegrity® Test for Evaluation of Uterine Receptivity. Hayes Inc. Retrieved: www.hayesinc.com/subscribers.

Hayes Technology Brief. (2017). Ovarian Tissue Cryopreservation for Preservation of Fertility in Patients UndergoingGonadotoxic Cancer Treatment. Hayes Inc. Retrieved: www.hayesinc.com/subscribers

Helmerhorst, F.M., Huib, A. et al. (2005). Intra-uterine Insemination versus Timed Intercourse or Expectant Management forCervical Hostility in Subfertile Couples. cochranelibrary-wiley.com.

Kominiarek MA, Jungheim ES, et al. American Society for Metabolic and Bariatric Surgery position statement on the impactof obesity and obesity treatment on fertility and fertility therapy Endorsed by the American College of Obstetricians andGynecologists and the Obesity Society. Surg Obes Relat Dis. 2017 May;13(5):750-757.

Kuohung, W., Hornstein, M.D. (2018). Overview of Infertility. Retrieved: www.uptodate.com.

Kuohung, W., Hornstein, M.D. (2018). Treatments for Female Infertility. Retrieved: www.uptodate.com.

Macaluso M, Wright-Schnapp TJ, Chandra A, Johnson R, Satterwhite CL, Pulver A, Berman SM, Wang RY, Farr SL, PollackLA. A public health focus on infertility prevention, detection, and management. Fertil Steril. 2010;93:16.E1-E10.

Medicare Benefit Policy Manual, Chapter 15 – Covered Medical and Other Health Services; https://www.cms.gov.

National Institute of Health. (2018). What Age-related Factors May be Involved with Infertility in Females and Males?Retrieved: www.nichd.nih.gov.

Optum, Clinical Performance Guideline Infertility, https://www.myoptumhealthcomplexmedical.com

The American Society of Reproductive Medicine (ASRM) http://www.reproductivefacts.org

Tanbo T, Fedorcsak P. Endometriosis-associated infertility: aspects of pathophysiological mechanisms and treatment options.Acta Obstet Gynecol Scand. 2017 Jun;96(6):659-667

United Healthcare Coverage Summary, Policy Number: I-002; https://www.unitedhealthcareonline.com

University of Michigan, Michigan Medicine. (2018). Gamete and Zygote Intrafallopian Transfer (GIFT and ZIFT) forInfertility. Retrieved: https://www.uofmhealth.org/health-library/hw202763

U.S. Department of HEalth & Human Services (HHS), Office of Women's Health. (2018). Infertility. Retrieved: https://www.womenshealth.gov/a-z-topics/infertility

Wong, L.F. Porter, T.F., Scott, J.R. (2014). Immunotherapy for Recurrent Miscarriage. Cochrane Database of SystemicReviews. Retrieved: cochranelibrary-wiley.com.

World Health Organization. (2016). Sexual and Reproductive Health. Retrieved: www.who.int.

Xu H, Deng K, Luo Q, et al. High Serum FSH is Associated with Brown Oocyte Formation and a Lower Pregnancy Rate inHuman IVF Practice. Cell Physiol Biochem 2016;39:677-684

Zegers-Hochschild, Fernando, Adamson, G. D., Dyer, S. et al. (2017). The International Glossary on Infertility and FertilityCare, 2017. Retrieved: www.asrm.org/globalassets/asrm/


https://www.hayesinc.com/subscribers/displaySubscriberArticle.do?articleId=11900&searchStore=%24search_type%3Dall%24icd%3D%24keywords%3Dinfertility%24status%3Dall%24page%3D1%24from_date%3D%24to_date%3D%24report_type_options%3D%24technology_type_options%3D%24organ_system_options%3D%24specialty_options%3D%24order%3DasearchRelevance#home

https://www.hayesinc.com/subscribers/articleList.do?query=infertility&keyword_type=all&status=all&tf_from_date=&tf_to_date=

http://cochranelibrary-wiley.com/doi/10.1002/14651858.CD002809.pub2/abstract

https://www.uptodate.com/contents/overview-of-infertility#!

https://www.uptodate.com/contents/treatments-for-female-infertility?topicRef=5445&source=see_link

https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/bp102c15.pdf

https://www.nichd.nih.gov/health/topics/infertility/conditioninfo/causes/age

https://www.myoptumhealthcomplexmedical.com/gateway/public/welcome.jsp


https://www.unitedhealthcareonline.com/b2c/CmaAction.do?viewKey=PreLoginMain&forwardToken=PreLoginMain

https://www.uofmhealth.org/health-library/hw202763

https://www.womenshealth.gov/a-z-topics/infertility

https://www.womenshealth.gov/a-z-topics/infertility

http://cochranelibrary-wiley.com/doi/10.1002/14651858.CD000112.pub3/full

http://www.who.int/reproductivehealth/topics/infertility/multiple-definitions/en/

https://www.asrm.org/globalassets/asrm/asrm-content/news-and-publications/practice-guidelines/for-non-members/international_glossary_on_infertilty_and_fertility_care-2017-noprint.pdf

Version 0.0.156







XI. APPROVALSHistorical Effective Dates:7/01/2019


johns hopkins healthcare llc policy number cms23.07 ... › johns_hopkins...8. intravenous...

Documents