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Recommended practices for the management of embryology, andrology, and endocrinology laboratories: a committee opinion (2014)


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This document provides a general overview for physicians of the qualities and conditions necessary for good management practices within the endocrinology, andrology, and embryology laboratories in the United States. It is intended as an addendum to previously published guidelines that further detail these responsibilities. (Fertil Steril® 2014;102:960–3. ©2014 by American Society for Reproductive Medicine.)

This document provides guidelines for the reproductive endocrinology and infertility (REI) specialist regarding the qualities and qualifications that constitute good management and practice within endocrinology, embryology, and andrology laboratories. It is intended to supplement, but not supplant, information provided in the American Society for Reproductive Medicine (ASRM) document titled ‘‘Revised Guidelines for Human Embryology and Andrology Laboratories’’ (1).

GENERAL GUIDELINES

All laboratories, whether located in university, hospital, or private settings, should be registered, accredited, and certified at the national level, and if located in a state with specific licensure requirements, at the state level (2, 3). It is the responsibility of the laboratory director to ensure that all documentation and licensure requirements are met. This requirement applies to REIs who are listed as the laboratory director, as well as to off site directors who are specifically hired for this duty.

All accredited laboratories must document an ongoing quality control (QC) program for each test and piece of equipment within the laboratory. The laboratory must also participate in a quality assurance program that includes continuous quality improvement (CQI) assessments and participation in proficiency testing for all laboratory testing procedures.

The laboratory must maintain documentation of all activities that are conducted within the laboratory. These include current policy and procedure manuals as well as manuals or documentation of laboratory safety, infection control, disaster plans, Health Insurance Portability and Accountability Act (HIPAA) procedures, chemical hygiene, and laboratory personnel.

In addition, laboratories must employ and maintain a system that provides proper patient preparation and identification; proper patient specimen collection, preservation, transportation, and processing; and accurate reporting of laboratory test and procedural results. This system must assure optimum patient specimen integrity and positive identification throughout the preanalytic (pretesting), analytic (testing), and postanalytic (posttesting) processes, and it must meet the individual test standards (4).

A laboratory director or supervisor who meets the qualifications defined in the Clinical Laboratory Improvement Act of 1988 (CLIA'88) (1, 4) must supervise the activities in all sections of the laboratories, including endocrinology, andrology, and embryology. A laboratory director may supervise the  endocrinology, andrology, and embryology sections of no more than 5 separate CLIA licensed laboratories. Laboratory directors should have an intimate knowledge of all procedures performed in these laboratories and be available to provide consultation when required. Laboratories that participate in high-complexity testing (i.e., quantitative semen analyses and some hormone analyses) must be supervised by a laboratory director who meets the CLIA'88 standards as a high-complexity laboratory director (HCLD; 1, 4). Individuals who have an embryology laboratory director certification and do not have an HCLD certification may not direct high-complexity testing laboratories.

If the laboratory director does not provide day-to-day supervision of testing personnel and reporting of proficiency testing results, the laboratory should have at least one laboratory general supervisor who performs these duties under the direction of the laboratory director. Duties delegated to the supervisor by the laboratory director should be documented. The general supervisor must meet CLIA'88 standards and must be licensed by the state if such licensure isrequired (1, 4).

Testing personnel must also be licensed as per state requirements and must meet CLIA'88 guidelines. Testing personnel are laboratory personnel who are trained to perform specific laboratory procedures but are not certified to perform the duties of the laboratory director or allowed to supervise other laboratory personnel. An individual licensed or certified as an HCLD or general laboratory supervisor automatically meets the requirements for testing personnel and may fill both roles. In smaller laboratories,the laboratory director can function as the general supervisor and testing personnel.

ENDOCRINE LABORATORIES

All high-complexity hormone testing performed in endocrine laboratories as defined by CLIA'88 must be supervised by a certified HCLD (4). If the hormone testing performed in an endocrine laboratory is classified as being of moderate complexity, the laboratory can be supervised by a laboratory supervisor (1, 2).

There must be procedure manuals that specify protocols for specimen handling and processing, testing methodology, QC, CQI, reporting of procedure results, troubleshooting, and documentation of corrective action for laboratory errors. The laboratory director or supervisor is responsible for the maintenance, review, and updating of all the testing methodology; review and follow-up of results; oversight and sign-off on all corrective actions for laboratory errors; and personnel training and compliance issues.

Testing personnel are responsible for test execution as indicated in the procedure manuals; identification of testing issues; maintenance of patient confidentiality; timely reporting of results; maintenance and management of equipment used in testing procedures; inventory control; and reporting abnormal or out-of-range results to the laboratory director or supervisor.

ANDROLOGY LABORATORIES

The andrology laboratory is responsible for the analysis of semen to aid the clinician in the diagnosis of male fertility potential and for the preparation of sperm for intrauterine insemination (IUI), in vitro fertilization (IVF) insemination, and/or sperm cryopreservation (5–8). Some of the testing and clinical procedures that may be performed in an andrology laboratory include:
  1. Semen analysis;
  2. Sperm preparation for IUI and IVF;
  3. Sperm cryopreservation; and
  4. Sperm function testing.

Laboratory personnel who perform the above procedures have been loosely referred to as andrologists. However, the role of an andrologist has not been formally defined by any medical board or medical society. In most andrology laboratories, laboratory personnel are classified as andrologists if they have been trained and certified by the laboratory director to perform all or most of the laboratory's andrology procedures. Laboratories that classify laboratory personnel as andrologists should define their criteria for the title of andrologist in their policy and procedures. These criteria should include a description of the type of training and testing that are required to demonstrate the person's proficiency in performing the required andrology procedures.

Policy and procedure manuals must be readily available for all laboratory procedures. However, it is recognized that there is not a single standardized protocol for all laboratory procedures. In the absence of a standardized protocol, each laboratory must develop its own protocols with controls and methodologies to assure reliable and acceptable results. Currently recognized standards for semen analyses and sperm testing are detailed in the World Health Organization (WHO) Laboratory Manual for the Examination of Human Semen and Semen–Cervical Mucus Interaction (5).

If only qualitative semen analyses are being performed (i.e., reporting only the presence or absence of sperm in the ejaculate), the andrology laboratory does not require oversight by an HCLD. However, if the analyses are quantitative (i.e., reporting of sperm concentration, sperm motility, and/or sperm morphology), then these tests are considered to be of high complexity and must be overseen by a certified HCLD, and laboratory personnel must meet all the qualifications mandated by CLIA'88 (1, 4).

All laboratory personnel are responsible for compliance with HIPAA requirements, the chain of custody for specimen tracking and handling, timely reporting of results, identification of outlying or out-of-bounds results to the supervisor, and informing the director of any proficiency testing, QC, or CQI issues that do not meet laboratory standards.

Laboratories should have a procedure for specimen log-in with the appropriate information on the specimen to allow identification of the sample source as well as the sample recipient (if applicable). The laboratory must document when a specimen was tested and the result, the name of the requesting physician to whom the result or specimen will be issued, and a unique code that identifies the patient. All test records should identify the performing technician and the reference ranges. The laboratory director or supervisor should review results of diagnostic tests, and these records must be kept for at least 2 years. For specimens that have been stored, records should be maintained in accordance with current registry requirements.

EMBRYOLOGY LABORATORIES

Embryology procedures, including the classification of embryo morphology, have not been designated as high complexity tests by CLIA'88. If the embryology laboratory does not perform diagnostic semen analyses, which are considered highly complex procedures, then HCLD certification of the laboratory director is acceptable but not required. An individual certified as an embryology laboratory director or laboratory supervisor can direct an embryology laboratory that does not perform any high-complexity testing (1, 4).

The laboratory director should have expertise and/or specialized training in biochemistry, cell biology, and physiology of reproduction, with experience in experimental design, statistical analysis, and laboratory problem solving. The director should be responsible for formulating the policies and protocols and communicating with the medical director all information concerning patient progress and protocols.

Embryology laboratory procedures include:
  1. Culture media preparation and laboratory QC;
  2. Oocyte isolation and identification;
  3. Oocyte maturity and health status assessment;
  4. Oocyte insemination;
  5. Evaluation of fertilization;
  6. Zygote quality assessment;
  7. Embryo culture and grading;
  8. Embryo transfer;
  9. Gamete or embryo cryopreservation; and
  10. Micromanipulation of gametes and/or embryos, including intracytoplasmic sperm injection, assisted hatching, and embryo biopsy.

Laboratory personnel who perform the above procedures are referred to as embryologists. As is the case with andrologists, the role of an embryologist has not been formally defined by any medical board or medical society. However, in most embryology laboratories, laboratory personnel are classified as embryologists if they have been trained and certified by the laboratory director to perform all or most of the laboratory's embryology procedures. Laboratories that classify personnel as embryologists should define their criteria for the title of embryologist in their policies and procedures. These criteria should include a description of the type of training and testing that are required to demonstrate the person's proficiency in performing the required embryology procedures.

The embryology laboratory director or supervisor must establish the policies and procedures for his/her lab. The challenge in any embryology laboratory is identifying appropriate procedures that will maximize pregnancy outcomes and safety. There are no universally recognized protocols for performing embryology procedures. Therefore, appropriate key performance indicators (KPIs) for laboratory success should be identified and regularly monitored (1, 9, 10). These KPIs should assess characteristics that are essentially under the control of the laboratory. Examples include: fertilization rate, embryo degeneration rate after intracytoplasmic sperm injection, blastulation rate, and cryopreservation survival rate. Review of KPI with clinical personnel should be a routine part of CQI processes. More-specific details for the management and oversight in the embryology laboratory may be found in the Revised Guidelines for Human Embryology and Andrology Laboratories (1).

Due to the limited standardization of assisted reproductive technology (ART) procedures, it may be difficult to identify the source of problems when a program does not produce pregnancy rates comparable to the national success rates as established by the Society for Assisted Reproductive Technology (SART) and the Centers for Disease Control and Prevention (CDC). Pregnancy rates are a collective result of patient characteristics, stimulation protocols, laboratory handling of oocytes/embryos, embryo-transfer technique, and post transfer management of the patient (11–15). Therefore, it is critical that laboratory scientists work closely with the physicians of their program to assess overall pregnancy success rates.

In summary, these guidelines are intended as a synopsis for physicians to assess the overall performance of the laboratories associated with an REI practice. There is no formula that must be followed by every laboratory to achieve the required goal of producing a high-quality laboratory, and variability will exist among laboratories in terms of the actual execution and performance of these guidelines.


Acknowledgments:
This report was developed under the direction of the Practice Committee of the American Society for Reproductive Medicine (ASRM) in collaboration with the Society for Assisted Reproductive Technology (SART) and the Society of Reproductive Biologists and Technologists (SRBT) as a service to its members and other practicing clinicians. Although this document reflects appropriate management of a problem encountered in the practice of reproductive medicine, it is not intended to be the only approved standard of practice or to dictate an exclusive course of treatment. Other plans of management may be appropriate, taking into account the needs of the individual patient, available resources, and institutional or clinical practice limitations. The Practice Committees and the Board of Directors of ASRM, SART, and SRBT have approved this report.

This document was reviewed by ASRM members and their input was considered in the preparation of the final document. All ASRM Practice Committee members disclosed commercial and financial relationships with manufacturers or distributors of goods or services used to treat patients. Members of the Committee who were found to have conflicts of interest based on the relationships disclosed did not participate in the discussion or development of this document. The following members of the ASRM Practice Committee participated in the development of this document:

Samantha Pfeifer, M.D.; Roger Lobo, M.D.; Michael Thomas, M.D.; Margareta Pisarska, M.D.; Eric Widra, M.D.; Mark Licht, M.D.; Jay Sandlow, M.D.; Jeffrey Goldberg, M.D.; Gregory Fossum, M.D.; John Collins, M.D.; Marcelle Cedars, M.D.; Mitchell Rosen, M.D.; Michael Vernon, Ph.D.; Owen Davis, M.D.; Daniel Dumesic, M.D.; Clarisa Gracia, M.D., M.S.C.E.; William Catherino, M.D., Ph.D.; Randall Odem, M.D.; Kim Thornton, M.D.; Robert Rebar, M.D.; Richard Reindollar, M.D.; and Andrew La Barbera, Ph.D.

REFERENCES

  1. The American Society for Reproductive Medicine. 2008 Revised guidelines for human embryology and andrology laboratories. Fertil Steril 2008;90: S30–44.
  2. U.S. Food and Drug Administration. Tissue guidances, rules and related documents. Available at: http://www.fda.gov/cber/tissue/docs.htm. Last accessed June 30, 2014.
  3. American Association of Tissue Banks. Standards for tissue banking. McLean, VA: American Association of Tissue Banks; 2002.
  4. Code of Federal Regulations: Title 42 on CLIA, Volume 3, Part 493. Available at: http://www.gpo.gov/fdsys/pkg/CFR-2003-title42-vol3/xml/CFR-2003-title42-vol3-part493.xml. Last accessed June 30, 2014.
  5. World Health Organization. In: WHO laboratory manual for the examination and processing of human semen. 5th ed. Cambridge: Cambridge University Press; 2010:1–287.
  6. Blasco L. Clinical tests of sperm fertilizing ability. Fertil Steril 1984;41:177–92.
  7. Bronson R, Cooper G, Rosenfeld D. Sperm antibodies: their role in infertility. Fertil Steril 1984;42:171–83.
  8. Kremer J. A simple penetration test. Int J Fertil 1965;10:209–15.
  9. Alpha Scientists in Reproductive Medicine. The Alpha consensus meeting on cryopreservation key performance indicators and benchmarks: proceedings of an expert meeting. Reprod Biomed Online 2012;25:146–67. 
  10. Alpha Scientists in Reproductive Medicine, ESHRE Special Interest Group Embryology. Istanbul consensus workshop on embryo assessment: proceedings of an expert meeting. Reprod Biomed Online 2011;22:632–46.
  11. Hearns-Stokes RM, Miller BT, Scott L, Creuss D, Chakraborty PK, Segars JH.Pregnancy rates after embryo transfer depend on the provider at embryo transfer. Fertil Steril 2000;74:80–6.
  12. Kupka MS, Dorn C, Richter O, Felberbaum R, van der Ven H. Impact of reproductive history on in vitro fertilization and intracytoplasmic sperm injection outcome: evidence from German IVF registry. Fertil Steril 2003;80: 508–16.
  13. Richter KS, Bugge KR, Bromer JG, Levy MJ. Relationship between endometrial thickness and embryo implantation, based on 1,294 cycle of in vitrofertilization with transfer of two blastocyst stage embryos. Fertil Steril 2007;87:53–9.
  14. Hubayter ZR, Muasher SJ. Luteal supplementation in in vitro fertilization: more questions than answers. Fertil Steril 2008;89:749–58.
  15. Schoolcraft WB, Surrey ES, Gardner DK. Embryo transfer: techniques and variables affecting success. Fertil Steril 2001;76:863–70

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Pregnancy Ultrasound

Our practice does routine ultrasounds (sac check- 76817) at the end of an IVF cycle and bill with a diagnosis code O09.081, pregnancy resulting from ART.  View the Answer
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IUI Same Gender

When managing an IUI or IVF cycle for a female same sex couple or a patient that has no exposure to sperm, what ICD 10 diagnosis should be used? View the Answer
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IVF Case Rates

What ICD-10 codes apply to case rates? View the Answer
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Limited Monitoring Ultrasound

What is the appropriate code to use for a limited follow-up follicular transvaginal ultrasound? View the Answer
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Limited Transvaginal Ultrasound

One of our clients received information that a repeat limited transvaginal ultrasound should be billed with a limited pelvic ultrasound code (76857). View the Answer
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Monitoring E&M

Our group would like to know if others are billing an evaluation and management code for ultrasound and blood draw visits? View the Answer
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Monitoring FET

What is the correct diagnosis code to use on the follicle ultrasound (76857) for a patient who is undergoing frozen embryo transfer (FET)? View the Answer
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Monitoring Ovulation Induction By Nurses

We are considering the use of CPT code 99211 for encounters during cycle management as part of ovulation induction.  View the Answer
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Non-REI Board Certified MD Performing REI Procedures

My boss has a few follow up questions about a non-REI board certified MD performing REI procedures.  View the Answer
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In Vitro Maturation

Have CPT codes been established for maturation in vitro? View the Answer
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Embryo Storage Fees For Multiple Cycles

We bill embryo storage 89342 for a year's storage.  View the Answer
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Endometrial Receptivity Analysis

Our physicians are going to start doing an Endometrial Receptivity Analysis. Do you know the appropriate CPT code that should be used?

View the Answer
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Flat Fee For Outside Monitoring

Can our office charge outside monitoring patients a flat fee to be seen?  View the Answer
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Diagnosis Code For Same-Sex Egg Donation

We have a same-sex male couple with insurance coverage for IVF.  View the Answer
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Donor Embryos

Could you give guidance for the correct ICD-10 code(s) to use when a patient is doing an Anonymous Donor Embryo Transfer cycle? View the Answer
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Billing at an Outside Clinic for Lab Services

One of my physicians uses an outside facility to perform the retrievals and transfers.  View the Answer
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Board Certified Vs. Non-Board Certified Billing

Is coding/billing any different when a non-board certified or non-REI provider submits for REI procedure?  View the Answer
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Coding For Placement Of A Cervical Stitch

Physicians at our practice are placing a stitch and dilating the cervix after egg retrievals for those patients that have cervical stenosis.  View the Answer
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Assisted Hatching Billed With Embryo Biopsy

Do you know if both assisted hatching (89253) and embryo biopsy for PGS/PGD/CCS (89290/89291) can be billed during the same cycle?  View the Answer
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Mental-health Services During Assisted Reproduction

A summary of codes for Mental-health Services During Assisted Reproduction compiled by the ASRM Coding Committee View the Coding Summary
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Laboratory Procedures during ART Cycles

A listing of codes, compiled for a fresh ART cycle, transfer, biopsy, cryopreservation of embryos and oocytes, storage, and thawing. View the Coding Summary
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Journal Club Global: Evidence for Immunologic Therapies in Women Undergoing ART

Reproductive immunology is perhaps one of the most controversial and promising fields within ART. View the Video
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Comprehensive guidance for human embryology, andrology, and endocrinology laboratories: management and operations: a committee opinion (2022)

ASRM has published guidance and minimum standards for embryology and andrology laboratories. View the Committee Opinion
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Journal Club Global - Best Practices of High Performing ART Clinics

This Fertility and Sterility Journal Club Global discusses February’s seminal article, “Common practices among consistently high-performing in vitro fertilization programs in the United States: a 10 year update.” View the Video
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Journal Club Global - Fertilization rate as a novel indicator in ART results

This Journal Club Global discusses a provocative article recently published in Fertility and Sterility, discussing the results of a multicenter retrospective cohort study with the objective to appraise the fertilization rate as a predictive factor for cumulative live birth rate (CLBR). View the Video
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Journal Club Global - Are We Approaching Automation in ART?

Some ART diagnostic devices are already available and offer objective tools of evaluation. View the Video
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Guidance on the limits to the number of embryos to transfer: a committee opinion (2021)

ASRM's guidelines for the limits on the number of embryos to be transferred during IVF cycles have been further refined ... View the Committee Opinion
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Role of tubal surgery in the era of assisted reproductive technology: a committee opinion (2021)

This document reviews surgical options for reparative tubal surgery and the factors that must be considered when deciding between surgical repair and IVF.
View the Committee Opinion
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Minimum standards for practices offering assisted reproductive technologies: a committee opinion (2021)

A framework for assisted reproductive technology (ART) programs that meet or exceed the requirements suggested by the Centers for Disease Control View the Committee Opinion
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Journal Club Global - Recurrent Implantation Failures in ART: Myth or Reality?

Classically, implantation failures in ART were believed to result from alterations in embryo or endometrium quality.
View the Video
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The role of immunotherapy in in vitro fertilization: a guideline (2018)

Adjuvant immunotherapy treatments in in vitro fertilization (IVF) aim to improve the outcome of assisted reproductive technology (ART) in both the general ART population as well as subgroups such as patients with recurrent miscarriage or implantation failure. View the Committee Opinion
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Using family members as gamete donors or gestational carriers (2017)

The use of adult intrafamilial gamete donors and gestational surrogates is generally ethically acceptable when all participants are fully informed. View the Committee Document
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Financial ‘‘risk-sharing’’ or refund programs in assisted reproduction: an Ethics Committee opinion (2016)

Financial ‘‘risk-sharing’’ fee structures in assisted reproduction programs charge patients a higher initial fee but provide reduced fees for subsequent cycles and often a partial or complete refund if treatment fails. View the Committee Document
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Correct coding for laboratory procedures during assisted reproductive technology cycles

This document provides updated coding information for services related to assisted reproductive technology procedures. View the Coding Committee Document
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Best practices of ASRM and ESHRE: a journey through reproductive medicine (2012)

ASRM and ESHRE are the two largest societies in the world whose members comprise the major experts and professionals working in reproductive medicine. View the Committee Joint Guideline

Topic Resources

View more on the topic of male fertility and andrology
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Tobacco or marijuana use and infertility: a committee opinion (2023)

In the United States, approximately 21% of adults report some form of tobacco use, although 18% report marijuana use. View Committee Opinion
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Fertility and Sterility On Air - Microdose Interview: Dr. Ranjith Ramaswamy and Dr. Braian Ledesma

Listen to Dr. Ranjith Ramasamy and Dr. Braian Ledesma, who discuss the article "Fertility outcomes in men with prior history of anabolic steroid use." Listen to the Episode
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Resource Roundup: Male Reproductive Health

November is Men’s Health Awareness Month!  View the resource roundup!
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Diagnostic evaluation of sexual dysfunction in the male partner in the setting of infertility: a committee opinion (2023)

It is the responsibility of the clinician to assess for erectile dysfunction, ejaculatory dysfunction, or diminished libido in men presenting for infertility. View the Committee Opinion
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Semen Analysis For Assessment of Fertility

What is the appropriate diagnostic code to use for a semen analysis for the assessment of infertility? View the Answer
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Post Vasectomy Infertility

If a husband has had a vasectomy, does the sterilization code apply to the wife's visits? View the Answer
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Testing With No History of Infertility

What diagnosis codes should  providers submit to insurance carriers while trying to evaluate fertility issues? View the Answer
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Male Consult

My group was wondering if and how to code for a male partner consultation.  View the Answer
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Lab RVUs

Is there a list of RVUs for embryology and andrology laboratory procedures, and if so, where can it be found? View the Answer
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Diagnostic Testing of an Infertile Couple

The Z31.41 is or is not the correct code to use for diagnostic testing of an infertile couple? And If so can if be used as the primary and only code? View the Answer
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Male Infertility

A summary of common codes for Male Infertility compiled by the ASRM Coding Committee View the Coding Summary
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Journal Club Global Live from PCRS - ICSI for Non-Male Factor Infertility

While intracytoplasmic sperm injection (ICSI) has revolutionized the treatment of male factor infertility, a significant controversy still remains regarding its ubiquitous use in all IVF cycles. View the Video
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Optimizing natural fertility: a committee opinion (2022)

This committee opinion provides practitioners with suggestions for optimizing the likelihood of achieving pregnancy in couples... View the Committee Opinion
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Intracytoplasmic sperm injection (ICSI) for non–male factor indications: a committee opinion (2020)

Intracytoplasmic sperm injection is frequently used in combination with assisted reproductive technologies. View the Committee Document
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Diagnosis and treatment of infertility in men: AUA/ASRM guideline part I (2021)

Part I outlines the appropriate evaluation of the male in an infertile couple. View the Guideline
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Diagnosis and Treatment of Infertility in Men: AUA/ ASRM Guideline Part II (2021)

The summary presented is Part II of the two-part series dedicated to the Diagnosis and Treatment of Infertility in Men: AUA/ASRM Guideline. View the Guideline
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Guidance for Providers Caring for Women and Men Of Reproductive Age with Possible Zika Virus Exposure (Updated 2019)

This ASRM guidance specifically addresses Zika virus infection issues and concerns of individuals undergoing assisted reproductive technologies (ART). View the Guideline
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Improving the Reporting of Clinical Trials of Infertility Treatments (IMPRINT): modifying the CONSORT statement (2014)

Clinical trials testing infertility treatments often do not report on the major outcomes of interest to patients and clinicians and the public. View the Guideline