HIGHMARK COMMERCIAL MEDICAL POLICY - PENNSYLVANIA

 
 

Medical Policy:
U-5-027
Topic:
Assisted Reproductive Technology
Section:
Maternity
Effective Date:
July 5, 2021
Issued Date:
July 5, 2021
Last Revision Date:
June 2021
Annual Review:
June 2021
 
 

For the purpose of this policy infertility is defined as an interruption, cessation, or disorder of body functions, systems, or organs of the reproductive tract which prevents an individual or couple from the conception of a child or the ability to carry a pregnancy to delivery after regular, unprotected sexual intercourse without medical intervention or as diagnosed by a licecensed physician based on the individual\s medical, sexual, and reproductive history, age, physical findings, and/or diagnostic testing. 

Infertility may include:

  • Absent or incompetent uterus; or
  • Damaged, blocked, or absent fallopian tubes; or
  • Damaged, blocked, or absent male reproductive tract; or
  • Damaged, diminished, or absent sperm; or
  • Damaged, diminished, or absent oocytes; or
  • Damaged, diminished, or absent ovarian function; or
  • Endometriosis; or
  • Hereditary genetic disease, or condition that would be passed to offspring; or
  • Adhesions; or
  • Uterine fibroids; or
  • Sexual dysfunction impeding intercourse; or
  • Teratogens or idiopathic causes; or
  • Polycystic ovarian syndrome; or
  • Inability to become pregnant, or cause pregnancy of unknown etiology; or
  • Two or more pregnancy losses, including ectopic pregnancies; or
  • Uterine congenital anomalies, including those caused by diethylstilbestrol (DES); or
  • Iatrogenic infertility is defined as an impairment of fertility due to surgery, radiation, chemotherapy, or other medical treatment.

Standard fertility preservation services mean procedures consistent with established medical practices and professional guidelines published by professional medical organizations, including the American Society for Clinical Oncology and the American Society for Reproductive Medicine.

Assisted Reproductive Technology (ART) includes all treatments or procedures that involve the in vitro (i.e., outside of the living body) handling of both human oocytes (eggs) and sperm, or embryos, for the purpose of establishing a pregnancy. Treatments and procedures include, but are not limited to:

  • Intrauterine insemination (IUI); or
  • Intracervical/vaginal insemination (ICI); or
  • Assisted hatching; or
  • In vitro fertilization (IVF) and embryo transfer; or
  • Intracytoplasmic sperm injection (ICSI); or
  • Gamete intrafallopian transfer (GIFT); or
  • Zygote intrafallopian transfer (ZIFT); or
  • Tubal embryo transfer (TET); or
  • Frozen Embryo transfer (FET); or
  • Peritoneal ovum sperm transfer; or
  • Zona drilling; or
  • Sperm microinjection; or
  • Gamete and embryo cryopreservation (freezing); or
  • Cryopreservation of ovarian tissue; or
  • Cryopreservation of testicular tissue; or
  • Oocyte and embryo donation; or
  • Ovulation induction:
  • Gestational surrogacy or carrier:
    • Gestational surrogacy is an arrangement in which a woman carries and delivers a baby for another person or couple.

Artificial Insemination is a procedure by which sperm is directly deposited into the vagina, cervix or uterus to achieve fertilization and pregnancy which may be reported as part of an assisted fertilization program.

 

Policy Position

Assisted reproductive technology services are generally excluded from standard medical-surgical contracts and are only eligible for reimbursement as noted below. However, all medical, surgical, and diagnostic services performed to diagnose and treat infertility short of assisted reproductive technologies as defined above may be covered unless the individual's contract contains exclusion with regard to the diagnosis and treatment of infertility.

When the benefit exists, all medical, surgical, and diagnostic services performed to diagnose and treat infertility, excluding assisted reproductive technologies as defined in this policy, may be considered medically necessary.

If the goal for the infertile individual is assisted reproductive technology services as described below, all subsequent related diagnostic, medical, and surgical services are considered part of assisted reproductive technology services.

Report the appropriate diagnosis code for ART, in order to distinguish them as services associated with an assisted reproductive program. Such services are non-covered when the individual does not have an assisted reproductive technology benefit.

 


In Vitro Fertilization (IVF): 35 Years of Age or Older

IVF may be considered medically necessary for an individual age 35 or older with ANY ONE (1) of the following conditions:

  • Congenital absence of reproductive organs; or
  • Tubal disease that cannot be corrected surgically; or
  • Severe male factor infertility; or
  • Irreparable distortion of the uterine cavity or other uterine anomaly (when using a gestational carrier); or
  • Diminished ovarian reserve; or
  • Endometriosis, stage IV (four); or
  • Unexplained infertility; or
  • No known tubal disease or male factor and ONE of the following:
    • Six (6) months of appropriately timed unprotected intercourse; or
    • Three (3) cycles of IUI and/or superovulation cycles; or

AND

  • Individual does not have EITHER of the following contraindications:
    • Ovarian failure: premature (i.e., ovaries stop working before age 40) or menopause (i.e., absence of menstrual periods for 1 year); or
    • Contraindication to pregnancy.

IVF: 34 Years of Age or Younger

IVF may be considered medically necessary for an individual age 34 and younger with ANY ONE (1) of the following conditions:

  • Congenital absence reproductive organs; or
  • Tubal disease that cannot be corrected surgically; or
  • Diminished ovarian reserve; or
  • Severe male factor infertility; or
  • Endometriosis, stage IV (four); or
  • Unexplained infertility; or
  • Irreparable distortion of the uterine cavity or other uterine anomaly (when using a gestational carrier); or
  • No known tubal disease or male factor and ONE of the following:
    • Twelve months of appropriately timed unprotected intercourse; or
    • Three (3) cycles of IUI and/or superovulation cycles.

AND

  • Individual does not have EITHER of the following contraindications:
    • Ovarian failure: premature (i.e., ovaries stop working before age 40) or menopause (i.e., absence of menstrual periods for 1 year); or
    •  Contraindication to pregnancy.

IVF not meeting the criteria as indicated in this policy is considered not medically necessary.

58974

S4011

S4015

S4016

S4017

S4020

S4021




Gamete Intrafallopian Transfer (GIFT)/Zygote Intrafallopian Transfer (ZIFT)

GIFT or ZIFT may be considered medically necessary when ALL of the following criteria are met:

  • Individual meets the criteria for IVF; and
  • Individual does not have ANY of the following contraindications:
    • Tubal disease; or
    • Severe uterine factor; or
    • Irreparable distortion of the uterine cavity; or
    • Male partner with severe male factor infertility.

GIFT/ZIFT not meeting the criteria as indicated in this policy is considered not medically necessary.

58976

S4013

S4014

 

 

 

 




Intracytoplasmic Sperm Injection (ICSI)

ICSI may be considered medically necessary when BOTH of the following criteria are met:

  • Individual has diagnosed infertility due to a male factor as defined by values based on the World Health Organization (WHO) semen-analysis criteria values, demonstrated on at least two separate semen analyses.  Infertility male factors include, but are not limited to, the following:
    • Low sperm count; or
    • Low function of sperm; or
    • Abnormal morphology of sperm; or
    • Obstructive azoospermia: or
    • Non-obstructive azoospermia; and
  • Individual meets the other criteria for IVF.

ICSI not meeting the criteria as indicated in this policy is considered not medically necessary.

89280

89281

 

 

 

 

 




Gamete/Oocyte Cryopreservation
 
Assisted reproductive technology for the purpose of gamete (oocyte or sperm) or embryo cryopreservation may be considered medically necessary when ANY of the following criteria are met:

  • Individual is preparing for gonadotoxic therapies due to cancer or other medical diseases; or
  • Individual is undergoing oophorectomy or orchiectomy due to:
    • Certain genetic conditions for treatment of disease; or
    • Underoing gender affirmation treatmetns, including surgery; or
  • Individual underwent oocyte retrieval for IVF but there was an inability to obtain sperm; or
  • Individual underwent sperm retrieval technique.

Assisted reproductive technology for the purpose of gamete/oocyte cryopreservation is considered not medically necessary when the procedure is performed to provide donor oocytes.

Gamete or embryo cryopreservation not meeting the criteria as indicated in this policy is considered not medically necessary.

89258

89259

89337

89398

 

 

 




Tubal Embryo Transfer (TET)

TET may be considered medically necessary when the individual meets the definition of infertility and ALL of the following criteria are met:

  • Individual is using fresh embryo(s) from a current IVF cycle or cryopreserved embryo(s) from previous IVF or donor cycle; and
  • Individual does not have any of the following contraindications:
    • Tubal disease; or
    • Severe uterine factor; or
    • Irreparable distortion of the uterine cavity; or
    • Contraindication to pregnancy.

TET not meeting the criteria as indicated in this policy is considered not medically necessary.

58976

 

 

 

 

 

 




Frozen Embryo Transfer (FET)

FET may be considered medically necessary when the individual meets the definition of infertility and EITHER of the following criteria is met:

  • Individual has cryopreserved embryos from a previous IVF cycle; or
  • Individual is receiving cryopreserved donor embryo.

FET not meeting the criteria as indicated in this policy is considered not medically necessary.

58974

58976

S4018

S4037

 

 

 




Ovulation Induction Management

Ovulation induction management performed without a face-to-face individual/physician encounter (e.g., conducted via telephone) for EITHER of the following may be considered medically necessary:

  • An assisted fertilization program; or
  • A treatment for infertility outside of an assisted fertilization program.

Ovulation induction management not meeting the criteria as indicated in this policy is considered not medically necessary.

Note: This service may be reported using an appropriate evaluation and management (E&M) procedure code; provided that there is individual/physician interaction and all of the components of the E&M code have been met.

Quantity Level Limit

When performed for the treatment of infertility, global payment without a face-to-face ovulation induction management is limited to twelve cycles within a twelve-month period.

Quantities of ovulation induction management cycles greater than those identified are considered not medically necessary.

S4023

S4042

 

 

 

 

 




Immunotherapy for Recurrent Fetal Loss

Immunologic-based therapies may be considered medically necessary to avoid recurrent spontaneous abortion.

Immunologic-based therapies not meeting the criteria as indicated in this policy is considered experimental/investigational (E/I) and therefore non-covered because the safety and and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.

90283

 

 

 

 

 

 




Assisted Fertilization Procedures

The procedures listed on the Table Attachment, Table A, are assisted fertilization procedures that may be reported as part of an assisted fertilization program.

 

55870

58321

58322

58323

58970

58974

58976

76948

84702

89250

89253

89254

89255

89257

89258

89259

89260

89261

89264

89268

89272

89280

89281

89290

89291

89337

S4028

S4035

S4042

 

 

 

 

 

 




Laboratory Services

Refer to Table B, Laboratory Services, in the attachments for the quantity of laboratory services per cycle that may be considered medically necessary.

More than two (2) progesterone measurements may be considered medically necessary for infertile women with irregular and prolonged menstrual cycles. 

For infertile women with regular menstrual cycles, a mid-luteal serum progesterone measurement (day 21 of a 28-day cycle) may be considered medically necessary. 

For infertile women with irregular menstrual cycles, this test would need to be repeated at the mid-luteal phase and weekly thereafter until the next menstrual cycle starts.

Quantities of laboratory services that exceed the frequency guidelines listed on Table B, Laboratory Services, are considered not medically necessary.

76830

82670

83001

83002

84144

84702

 




Cryopreservation, Storage, Procurement, and Thawing

Charges for cryopreservation, storage, procurement, and thawing of specimens are generally facility charges which should be processed in accordance with the individual’s benefits:

  • Cryopreservation of oocytes; or
  • Cryopreservation immature oocyte(s)or
  • Cryopreservation of embryo(s)or
  • Cryopreservation of spermor
  • Cryopreservation of reproductive ovarian tissueor
  • Cryopreservation of reproductive testicular tissueor
  • Storage of oocyteor
  • Storage of embryo(s)or
  • Monitoring and storage of cryopreserved embryosor
  • Storage of previously frozen embryosor
  • Storage of sperm/semenor
  • Storage of ovarian/testicular reproductive tissueor
  • Procurement of donor sperm from sperm bankor
  • Procurement of donated oocyte; or
  • Procurement of a donated embryo; or
  • Sperm procurement and cryopreservation servicesor
  • Thawing of oocytesor
  • Thawing of cryopreserved embryo(s)or
  • Thawing of sperm/semenor
  • Thawing of reproductive tissue.

89258

89259

89335

89337

89342

89343

89344

89346

89352

89353

89354

89356

89398

S4025

S4026

S4027

S4030

S4031

S4040

 

 




Gestational Carrier/Surrogate

Medical services or supplies rendered to a gestational carrier or surrogate may be considered medically necessary if the individual has ANY of the following indications:

  • Congenital absence of a uterus; or
  • Uterine anomalies that cannot be repaired; or
  • A medical condition for which pregnancy may pose a life-threatening risk; or
  • Is the carrier for reciprocal IVF; or
  • Is male or assigned male at birth.

Services provided to a surrogate or gestational carrier may be a benefit exclusion.

Medical services or supplies rendered to a gestational carrier or surrogate not meeting the criteria as indicated in this policy is considered not medically necessary.


The following reproductive techniques or services are considered experimental/investigational and, therefore, non-covered because the safety and/or effectiveness of these services cannot be established by the available published peer-reviewed literature:

  • Co-culture of embryos; or
  • Tests of sperm deoxyribonucleic acid (DNA) integrity, including but not limited to:
    • Sperm chromatin assays; and
    • Sperm DNA fragmentation assays.

88182

89240

89251

 

 

 

 




The following related services to reproductive technologies/techniques are considered not medically necessary:

  • Reversal of voluntary sterilization (tuboplasty, or vasoplasty, or epididymovasostomy); or
  • Payment for surrogate service fees for purposes of childbirth.; or
  • Expenses related to living or travel.

54900

54901

58750

S9977

S9986

 

 




Related Policies

Refer to Pharmacy Policy J-1, Fertility - Commercial and Select Healthcare Reform Plans, for additional information.

Refer to Medical Policy L-115, Preimplantation Genetic Screening and Diagnosis for additional information.  


Professional Statements and Societal Positions Guidelines

American Society for Reproductive Medicine and Society for Assisted Reproductive Technology – 2019

In 2019, the American Society for Reproductive Medicine (ASRM) released a 2019 committee opinion on fertility preservation in [individuals] undergoing gonadotoxic therapy. The committee included several relevant opinions:

  • Embryo, oocyte, and ejaculated or testicular sperm cryopreservation remain the principle established modalities for fertility preservation.
  • Ovarian tissue cryopreservation is no longer considered experimental and can be used in prepubertal patients or when there is not time for ovarian stimulation
  • Testicular tissue cryopreservation in prepubertal males is still considered experimental and should be conducted under research protocols when no other options are feasible.

ASRM and joint ASRM/Society for Assisted Reproductive Technology (SART) opinions and recommendations on other assisted reproductive technologies are as follows:

Planned oocyte cryopreservation (OC) for preserving future reproductive potential (2018):

  • The committee states the process is ethical and “serves women’s legitimate interests in reproductive autonomy.”
  •  Women who choose OC should be informed of its efficacy, safety, benefits, and risks, and possible long-term health effects on the child.
  • Providers should also provide their clinic’s statistics for successful freeze-thaw and live birth.
  • Women should know that this relatively new technology is still emerging and not all benefits and harms are fully understood.

Assisted hatching (2014): Assisted hatching should not be used routinely for all patients undergoing IVF.

Blastocyst transfer (2013; reaffirmed in 2018): "Evidence supports blastocyst transfer in ‘good prognosis' [individuals]."

American College of Obstetricians and Gynecologists – 2016

The American College of Obstetricians and Gynecologists endorsed the 2013 ASRM-SART joint guidelines on mature oocyte cryopreservation. The endorsement was affirmed in 2016.

American Society of Clinical Oncology – 2018

The American Society of Clinical Oncology updated its 2013 guidelines (with no changes to its recommendations) on fertility preservation for [individual's] with cancer. The guidelines included the following recommendations for males and females, respectively.

  • “Recommendation 2.1. Sperm cryopreservation: Sperm cryopreservation is effective, and health care providers should discuss sperm banking with postpubertal males receiving cancer treatment.
  • Recommendation 2.2. Hormonal gonadoprotection: Hormonal therapy in men is not successful in preserving fertility. It is not recommended.
  • Recommendation 2.3. Other methods to preserve male fertility: Other methods, such as testicular tissue cryopreservation and reimplantation or grafting of human testicular tissue, should be performed only as part of clinical trials or approved experimental protocols....”
  • “Recommendation 3.1. Embryo cryopreservation: Embryo cryopreservation is an established fertility preservation method, and it has routinely been used for storing surplus embryos after in vitro fertilization.
  • Recommendation 3.2. Cryopreservation of unfertilized oocytes: Cryopreservation of unfertilized oocytes is an option, particularly for [individuals] who do not have a male partner, do not wish to use donor sperm, or have religious or ethical objections to embryo freezing….”


Covered Diagnosis Codes

Z31.7

Z31.81

Z31.83

Z31.84

Z31.89

Z31.9

 

Non-Covered Diagnosis Codes for Procedure Codes: 54900, 54901, 58750

Z31.0

 

 

 

 

 

 



Place of Service: Outpatient

Experimental/Investigational (E/I) services are not covered regardless of place of service.

Assisted fertilization is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances, including, but not limited to, the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting.


The policy position applies to all commercial lines of business



Links






This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical or other circumstances may warrant individual consideration, based on review of applicable medical records, as well as other regulatory, contractual and/or legal requirements.

Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect Highmark's reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract, and subject to the applicable laws of your state.


Highmark retains the right to review and update its medical policy guidelines at its sole discretion. These guidelines are the proprietary information of Highmark. Any sale, copying or dissemination of the medical policies is prohibited; however, limited copying of medical policies is permitted for individual use.

Discrimination is Against the Law
The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer:

  • Provides free aids and services to people with disabilities to communicate effectively with us, such as: 
    • Qualified sign language interpreters
    • Written information in other formats (large print, audio, accessible electronic formats, other formats)
  • Provides free language services to people whose primary language is not English, such as: 
    • Qualified interpreters
    • Information written in other languages

If you need these services, contact the Civil Rights Coordinator. 

If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295, TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you. 

You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at: 

U.S. Department of Health and Human Services 
200 Independence Avenue, SW 
Room 509F, HHH Building 
Washington, D.C. 20201 
1-800-368-1019, 800-537-7697 (TDD) 

Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html. 

Insurance or benefit/claims administration may be provided by Highmark, Highmark Choice Company, Highmark Coverage Advantage, Highmark Health Insurance Company, First Priority Life Insurance Company, First Priority Health, Highmark Benefits Group, Highmark Select Resources, Highmark Senior Solutions Company or Highmark Senior Health Company, all of which are independent licensees of the Blue Cross and Blue Shield Association, an association of independent Blue Cross and Blue Shield plans. 





Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.

Discrimination is Against the Law
The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer:

  • Provides free aids and services to people with disabilities to communicate effectively with us, such as:
  • Qualified sign language interpreters
  • Written information in other formats (large print, audio, accessible electronic formats, other formats)

  • Provides free language services to people whose primary language is not English, such as:
  • Qualified interpreters
  • Information written in other languages
  • If you need these services, contact the Civil Rights Coordinator.

    If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295 , TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you.

    You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:

    U.S. Department of Health and Human Services
    200 Independence Avenue, SW
    Room 509F, HHH Building
    Washington, D.C. 20201
    1-800-368-1019, 800-537-7697 (TDD)

    Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.