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Infertility Diagnosis and Treatment

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Infertility

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MEDICAL POLICY

INFERTILITY DIAGNOSIS AND TREATMENT
Policy Number: 2011T0270H
Effective Date: July 1, 2011
Table of Contents

Page

COVERAGE RATIONALE...........................................
BENEFIT CONSIDERATIONS....................................
BACKGROUND...........................................................
CLINICAL EVIDENCE.................................................
U.S. FOOD AND DRUG ADMINISTRATION...............
CENTERS FOR MEDICARE AND MEDICAID
SERVICES (CMS).......................................................
APPLICABLE CODES.................................................
REFERENCES............................................................
POLICY HISTORY/REVISION INFORMATION..........

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Related Medical
Policies:
None
Related Coverage
Determination
Guidelines:
• Reproduction
Services

Policy History Revision Information

COVERAGE RATIONALE
INSTRUCTIONS FOR USE
This Medical policy provides assistance in interpreting UnitedHealthcare benefit plans. When
deciding coverage, the enrollee specific document must be referenced. The terms of an
enrollee's document (e.g., Certificate of Coverage (COC) or Summary Plan Description (SPD))
may differ greatly. In the event of a conflict, the enrollee's specific benefit document supersedes
this medical policy. All reviewers must first identify enrollee eligibility, any federal or state
regulatory requirements and the plan benefit coverage prior to use of this Medical Policy. Other
Policies and Coverage Determination Guidelines may apply. UnitedHealthcare reserves the right,
in its sole discretion, to modify its Policies and Guidelines as necessary. This Medical Policy is
provided for informational purposes. It does not constitute medical advice.
COVERAGE RATIONALE
Diagnostic Procedures
The following procedures are proven for use in diagnosing infertility in female patients:
• Chromotubation of oviduct
• Cultures (cervical, vaginal, uterine)
• Hormone assay (luteinizing hormone (LH), follicle stimulating hormone (FSH),
progesterone, prolactin, estradiol, thyroid, clomiphene citrate challenge test)
• Hysterosalpingogram
• Hysteroscopy
• Laparoscopy
• Pelvic ultrasound (abdominal or vaginal)
• Sonohysterography or saline contrast hysterosonography

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The following procedures are proven for use in diagnosing infertility in male patients:
• Antisperm antibodies
• Cultures (genital)
• Hormone assay (LH, FSH, prolactin, testosterone)
• Leukocyte count in semen
• Rectal ultrasound (indicated when ejaculatory duct obstruction is suspected)
• Scrotal ultrasound
• Semen analysis
• Testicular biopsy
• Vasography
The following tests are unproven for diagnosing infertility:
• Computer-assisted sperm analysis (CASA)
• Hemizona assay test
• Hyaluronan binding assay (HBA)
• Sperm DNA integrity testing (e.g. Sperm Chromatin Structure Assay (SCSA), Comet
assay, sperm DNA fragmentation assay, TUNEL assay, Sperm DNA Decondensation™
Test (SDD))
• Sperm penetration tests such as postcoital cervical mucus penetration, sperm
penetration assay (SPA), zona-free hamster egg assay or sperm acrosome reaction
assay
• Uterine/endometrial receptivity testing (e.g., E-tegrity® and Endometrial Function Test®
(EFT))
There is insufficient evidence to permit conclusions regarding the use of these tests. More studies
are needed to support improved outcomes (i.e., increased successful pregnancies with delivery of
liveborn children) with use of these diagnostic tests.
Therapeutic Procedures
The following procedures are proven for the treatment of infertility:
• Ovulation induction
• Insemination procedures (intrauterine insemination (IUI) and artificial insemination (AI)
including sperm washing)
• Assisted reproductive technologies (gamete intrafallopian transfer (GIFT), in vitro
fertilization (IVF), and zygote intrafallopian transfer (ZIFT))
• Assisted embryo hatching
• Intracytoplasmic sperm injection (ICSI) for treatment of male factor infertility
• Sperm retrieval techniques (including microsurgical epididymal sperm aspiration (MESA),
percutaneous epididymal sperm aspiration (PESA), and testicular sperm extraction
(TESE), and electroejaculation)
The following procedures to correct underlying disorders are proven for the treatment of
infertility:
• Ablation or lysis of adhesions and/or surgical treatment of endometriosis, laparoscopic or
open
• Drainage of ovarian cyst
• Fimbrioplasty
• Transurethral resection of ejaculatory ducts for treatment of ejaculatory duct obstruction
• Varicocele repair
• Wedge resection of ovary or ovarian drilling in women with polycystic ovary syndrome
The following procedures are unproven for treating infertility:
• Co-culture of embryos
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EmbryoGlue®
Partial zonal dissection (PZD)
Subzonal sperm insertion (SUZI) (also referred to as SCI)
Wurn Technique (Clear Passage Therapies)

Studies describe different techniques of co-culture of embryos, but no standardized method of coculturing has been defined. The use of co-cultures may improve blastocyst development but may
not result in an improved pregnancy or delivery rate. There is inadequate published scientific data
to permit conclusions regarding the use of EmbryoGlue. Intracytoplasmic sperm injection (ICSI)
has largely replaced partial zonal dissection (PZD) and subzonal sperm insertion (SCI, SUZI)
procedures. While results of one study are promising for the use of the Wurn Technique, there
were no other studies to substantiate or replicate these results. There is no research to indicate
that biomechanical dysfunction is a barrier to pregnancy.
Cryopreservation of sperm, semen or embryos is proven for individuals who are infertile
or are planning to undergo therapies that threaten their reproductive health such as
cancer chemotherapy.
Cryopreservation of oocytes (eggs) is unproven.
Although oocyte banking can be an option for women who have no partner at the time of cancer
diagnosis, research indicates that unfertilized oocytes are more prone to damage during
cryopreservation procedures than embryos, and as a result, the overall pregnancy rates may be
lower than standard in vitro fertilization (IVF) procedures. New methods are developing rapidly;
however, their use as a means to have a child after cancer treatment must be considered
investigational and offered only with appropriate informed consent in a research setting and under
the auspices of an institutional review board (IRB).
Cryopreservation of ovarian or testicular tissue is unproven.
Ovarian tissue banking remains a promising clinical technique because it avoids ovarian
stimulation and provides the opportunity for preserving gonadal function in prepubertal, as well as
adult patients. However, this procedure has produced very few live births. Testicular tissue or
testis xenografting are in the early phases of experimentation and have not yet been successfully
tested in humans.
BENEFIT CONSIDERATIONS
Legislative mandates and the member-specific benefit document should be reviewed when
determining benefit coverage for infertility services. Where legislative mandates exist, they
supersede benefit plan design. Benefit coverage for testing and treatment of infertility are
available only for the person(s) who are covered under the benefit document, and only when the
member's specific plan provides benefits for infertility diagnosis and/or treatment. The memberspecific document should be reviewed for applicable benefits, limitations and/or exclusions.
Services related to the use of a gestational carrier in pregnancy, whether the member is infertile
or otherwise, are not related to medical treatment of the infertile woman and are therefore NOT
covered. However, if a woman who is an insured member is pregnant, her prenatal, delivery and
postnatal pregnancy care are a covered health service, regardless of whether she is functioning
as a gestational carrier.
Services that correct the underlying cause of infertility, when proven, are covered even if there is
an infertility benefit exclusion. Interventions to reverse elective sterilization may be excluded.
Legislative mandates and the member-specific benefit document should be reviewed for
mandates of benefits, limitations, and exclusions.
In vitro fertilization for the prevention of disease in offspring is not covered as an infertility benefit
since this service is not a treatment for infertility.
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Cryopreservation services are subject to the limitations or exclusions of infertility benefits, if they
exist, and if the individual has a diagnosis of infertility. In most Certificates of Coverage (COC)
and Summary Plan Descriptions (SPD), storage after cryopreservation of sperm, oocytes (eggs),
embryos or ovarian tissue is excluded, as it does not meet the definition of a covered health
service. However, some states mandate benefit coverage for certain infertility services, including
cryopreservation.
BACKGROUND
Infertility is defined as a failure to achieve pregnancy after 12 months of unprotected sexual
intercourse in opposite-sex partners. The cause of infertility can originate in either partner, or can
be from unknown factors or a combination of factors. In some cases, environmental factors may
contribute to infertility. In other cases, genetic conditions or other health problems are the main
cause of infertility (NIH, 2006).
Cryopreservation is the process of cooling and storing cells, tissues or organs at very low or
freezing temperatures to save them for future use. It is used to preserve sperm, semen, oocytes
(eggs), embryos, ovarian tissue or testicular tissue as an option for men and women who wish to
or must delay reproduction for various reasons, including the need to undergo therapies that
threaten their reproductive health such as cancer treatment. Cryopreservation is also used to
preserve unused gametes or zygotes produced through various artificial reproductive techniques
for use at a later time.
CLINICAL EVIDENCE
Diagnostic Procedures
Computer-Assisted Sperm Analysis (CASA)
One clinical trial reported that the prognostic accuracy of computer-assisted sperm analysis was
similar to manual techniques and that CASA system data was preferred by the laboratories
(Irvine, 1994). More studies are needed to support improved outcomes (i.e., increased successful
pregnancies) with use of CASA.
The National Institute for Health and Clinical Excellence (NICE) states that unless there is
azoospermia, the predictive value of subnormal semen variables is limited. No functional test has
yet been established that can unequivocally predict the fertilizing capacity of spermatozoa. Sperm
function tests such as computer-assisted semen analysis have not been found to be more
predictive (NICE, 2004).
Hemizona Assay (HZA) Test
There is inadequate published scientific data to permit conclusions regarding the use of the
hemizona assay test. A literature search identified one clinical trial that evaluated the value of
HZA as a predictor of pregnancy in patients undergoing controlled ovarian hyperstimulation
(COH) and intrauterine insemination (IUI). Semen analysis and HZA were performed within 3
months of starting COH/IUI therapy. Results of the study indicated that HZA predicted pregnancy
in the IUI setting with high sensitivity and negative predictive value in couples with male factor
infertility (Arslan, 2006).
Hyaluronan Binding Assay (HBA)
There is inadequate published scientific data to permit conclusions regarding the use of HBA. A
literature search identified one study that investigated the relationship between HBA and
fertilization rate in conventional IVF in 175 IVF patients. Both the standard semen analysis and
the HBA were performed on the same ejaculated sperm samples used for IVF treatments. While
both normal sperm morphology and HBA scores were statistically significantly related to
fertilization rates, the HBA was less significant than normal sperm morphology. The investigators
concluded that the clinical predictive value of HBA for sperm-fertilizing ability in vitro is limited
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(Ye, 2006).
Sperm DNA Integrity Testing (Sperm Chromatin Structure Assay (SCSA), Comet Assay,
Sperm DNA Fragmentation Assay, TUNEL assay)
A meta-analysis performed by Li et al. (2006) concluded that sperm DNA damage as assessed
by SCSA had no significant effect on the chance of clinical pregnancy after in vitro fertilization
(IVF) or intracytoplasmic sperm injection (ICSI) treatment.
Another meta-analysis concluded that SCSA was significantly predictive for reduced pregnancy
success using in-vivo, intrauterine insemination (IUI) and routine IVF (Evenson, 2006).
A study conducted by Gandini et al. (2004) found no differences in SCSA parameter values
between patients initiating pregnancies and not doing so in ICSI or IVF. Pregnancy was obtained
even with high levels of DNA fragmentation index.
A cross-sectional prospective study concluded that there is a moderate correlation between
sperm motility and SCSA parameters and supported the assumption that motility and SCSA can
be relatively independent predictors of infertility (Giwercman, 2003).
Sperm Penetration Tests
Aoki et al. (2005) evaluated the relationship between SPA scores and polyspermy rates during
conventional IVF cycles in 1350 consecutive IVF patients. A significant positive relationship was
observed between SPA score and polyspermy rate. Clinical pregnancy and implantation rates
improved slightly as SPA score increased and there was a decrease in the rate of spontaneous
abortion as SPA score increased.
A prospective study by Freeman et al. (2001) evaluated the diagnostic accuracy of the sperm
penetration assay (SPA) and standard semen parameters for subsequent fertilization in 216
couples undergoing IVF. The SPA predicted IVF fertilization with 84% negative predictive value
and 98% positive predictive value, with overall correct prediction in 88% of cycles. In contrast,
sperm concentration, motility, morphology, and complete sperm analysis showed poor predictive
accuracy. Results suggest that SPA can predict which couples are likely to have success with
normal fertilization in IVF and which might benefit from intracytoplasmic sperm injection.
A meta-analysis by Oehninger et al. (2000) used data from 2906 patients in 34 prospective,
controlled studies to evaluate the predictive value of four categories of sperm functional assays,
including SPA, for IVF outcome. In this analysis, the sperm-zona pellucida binding assay and the
induced-acrosome reaction assay had a high predictive value for fertilization outcome. SPA had a
relatively high positive predictive value (more than 70%), but the negative predictive value was
variable, ranging from 11% to 100%, with most studies reporting NPV less than 75%. The authors
noted that this assay was limited by the need for standardization.
Uterine Receptivity Testing
Results of available studies provide evidence that low levels of beta-3 integrin are correlated with
infertility. Although the most thorough of the available studies found that the correlation between
reduced beta-3 expression and infertility is reproducible, these studies fail to provide convincing
evidence that assessment of beta-3 expression improves patient management or clinical
outcomes. Since the E-tegrity Test has not been shown to provide definitive diagnostic
information, its clinical role cannot be defined. Additional studies are needed to determine
whether the test provides information that alters patient management or improves clinical
outcomes, such as restoration of fertility (Hayes, 2010).
Several studies of uterine receptivity testing indicate that even though integrins may be important
markers of endometrial receptivity and provide additional information, more study is needed
before uterine receptivity testing can be considered a clinically useful test (Thomas, 2003;
Lessey, 2000).
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Creus et al. (2002) found a clear dissociation in the temporal expression of the most cited
markers of endometrial receptivity believed to define the window of implantation.
Professional Societies
American Society for Reproductive Medicine (ASRM)
ASRM states that sperm DNA damage may contribute to poor reproductive performance.
However, current methods for evaluating sperm DNA integrity do not reliably predict treatment
outcomes and no treatment for sperm DNA damage has proven value (ASRM, 2008a).
Removal of the zona pellucida from hamster oocytes allows human sperm to fuse with hamster
ova. The sperm penetration assay (SPA) should be reserved for patients in whom results will
influence treatment strategy. For penetration to occur, sperm must undergo capacitation, the
acrosome reaction, fusion with the oolemma and incorporation in the ooplasm. Many versions of
the SPA have been used clinically and the value of the test results depends, in part, on the
experience of the laboratory performing the assay (ASRM, 2006).
Specialized tests on semen, such as zona-free hamster egg assay or computer-aided sperm
analysis, are not required for diagnosis of male infertility. They may be useful in a small number
of patients for identifying a male factor contributing to unexplained infertility, or for selecting
therapy, such as assisted reproductive technology. Less commonly used specialized tests on
semen, such as acrosome reaction assay, are important investigative tools, but are not necessary
for the routine evaluation of men with infertility (ASRM, 2006).
Routine postcoital testing to examine the interaction between sperm and cervical mucus is
unnecessary. Abnormal sperm-mucus interaction is rarely the principal cause of infertility.
Furthermore, controversies exist regarding technique, timing and interpretation of the test (ASRM,
2006).
Therapeutic Procedures
Assisted Embryo Hatching
According to ASRM, the published evidence does not support the routine or universal application
of assisted hatching in all IVF cycles. However, assisted hatching may be useful in patients with a
poor prognosis (i.e., patients who have failed 2 or more IVF cycles, patients who have poor
embryo quality or women 38 years of age or older) (ASRM, 2008b).
Co-Culturing of Embryos
Studies describe different techniques of co-culture, but no standardized method of co-culturing
has been defined.
In a meta-analysis of 17 prospective, randomized trials, Kattal et al. (2008) evaluated the role of
coculture in human IVF. Primary outcomes measured were implantation rates and pregnancy
rates (clinical and ongoing). Secondary outcomes included evaluation of pre-embryo
development based on average number of blastomeres per embryo. The pooled data of human
trials on coculture demonstrate a statistically significant improvement in blastomere number,
implantation rates and clinical and ongoing pregnancy rates. However, the authors
acknowledged that confounding factors such as heterogeneity of cell lines and variability in
culture media used limit the conclusions.
A comparative study evaluated 517 women undergoing cumulus co-culture and cumulus-aided
embryo transfer with those who underwent cumulus co-culture but did not undergo cumulus-aided
embryo transfer. The study results demonstrated a significant increase in the implantation rate in
the study group of 25.6% versus 14.5% in the control group and a significant increase in the
pregnancy rate in the study group of 47.6% versus 34% in the control group (Parikh, 2006).

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Another study evaluated the effectiveness of autologous endometrial co-culture (AECC) in 1,030
consecutive cycles of in vitro fertilization-embryo transfer. Embryos were randomly grown on
endometrial co-culture or conventional media if more than 6 oocytes were normally fertilized.
Otherwise, all embryos were grown on AECC. The study results demonstrated a significant
improvement in embryo quality with endometrial co-culture (Spandorfer, 2004).
Johnson et al. (2007) evaluated whether culture of immature human oocytes with and without
autologous cumulus cells (CCs) in standard culture medium would provide additional oocytes for
use in IVF procedure in 61 women. This study demonstrated good maturation of metaphase I (MI)
oocytes but poor maturation of germinal vesicle (GV) oocytes in standard culture medium. The
investigators concluded that these extended culturing techniques were inefficient in maturing and
providing additional oocytes/embryos for patient use.
Ebner et al. (2006) evaluated the influence of adhering CCs on further preimplantation
development and concluded that co-culture of oocytes with attached CCs may enhance
preimplantation development.
EmbryoGlue
In a single center, prospective randomized study (n=224), Hazlett et al. (2008) found that routine
use of EmbryoGlue did not significantly improve pregnancy or implantation rates in nonselected
patients receiving either a day 3 or day 5 embryo transfer compared with standard culture media.
Future prospective randomized studies are needed to determine whether EmbryoGlue is
beneficial in a selected patient population.
In a prospective randomized clinical trial, Valojerdi et al. (2006) evaluated the efficacy of
EmbryoGlue. A total of 815 patients were randomly allocated to the test group (embryos were
treated with EmbryGlue prior to intrauterine transfer) (n=417) and the control group (embryos
were not treated with EmbryoGlue) (n=398). The clinical pregnancy and implantation rate
increased significantly in the test group compared to the control group. More studies are needed
to evaluate the effectiveness and safety of EmbryoGlue.
Wurn Technique (Clear Passage Therapies)
Wurn et al. (2004) evaluated 53 infertile patients who received a 10- to 20-hour series of sitespecific manual physical therapy treatments. Seventeen patients hoped to achieve a natural
pregnancy; 36 planned to undergo IVF within 15 months. Of the 14 patients (in the natural
pregnancy group) available for follow-up, 10 (71.4%) became pregnant within 1 year, and 9
(64.3%) reported full-term deliveries. Of the 25 patients (in the pre-IVF group) available for followup, clinical pregnancies were documented in 22 of 33 embryo transfers vs. the US Centers for
Disease Control and Prevention 2001 age-adjusted expected number of 12.7. While these results
are promising, there were no other studies to substantiate or replicate these results. There is no
research to indicate that biomechanical dysfunction is a barrier to pregnancy.
Cryopreservation
In a meta-analysis, Oktay, et al. (2006) studied the efficiency of oocyte cryopreservation relative
to in vitro fertilization (IVF) with unfrozen oocytes. Compared to women who underwent IVF after
slow freezing (SF), IVF with unfrozen oocytes resulted in significantly better rates of fertilization.
Although oocyte cryopreservation with the SF method appears to be justified for preserving
fertility when a medical indication exists, its value for elective applications remains to be
determined. Pregnancy rates using a vitrification (VF) method appear to have improved, but
further studies are needed to determine the efficiency and safety of this technique.
Cryopreservation of oocytes and ovarian tissue represent uncertain efficacy at present. Access to
such innovative techniques should be limited to carefully designed research settings where
efficacy and outcomes can be assessed (FIGO, 2006).

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In an evidence-based report, the National Institute for Health and Clinical Excellence (NICE)
makes the following recommendations (NICE, 2004):
• Men and adolescent boys preparing for medical treatment that is likely to make them
infertile should be offered semen cryostorage because the effectiveness of this procedure
has been established.
• Women preparing for medical treatment that is likely to make them infertile should be
offered oocyte or embryo cryostorage as appropriate if they are well enough to undergo
ovarian stimulation and egg collection, provided that this will not worsen their condition
and that sufficient time is available.
• Women preparing for medical treatment that is likely to make them infertile should be
informed that oocyte cryostorage has very limited success, and that cryopreservation of
ovarian tissue is still in an early stage of development.
Bedaiwy et al. (2008) performed a systematic review of reproductive function after ovarian tissue
transplantation (OTT) for fertility preservation in women at high risk of premature ovarian failure
(POF). Women with follicle-stimulating hormone (FSH) >30 IU/l at the time of OTT were included
in a meta-analysis to evaluate the time to re-establishment of ovarian function (ROF). Secondary
outcomes included short-term (<12 months) and long-term (>12 months) ovarian function (OVF)
and pregnancy after OTT. Transplantation of ovarian tissue can re-establish OVF after POF;
however, the efficacy of OTT using cryopreserved tissues is not yet equivalent to that of fresh
grafts. A prospective, controlled multicenter trial with sufficient follow-up is needed to provide
valid evidence of the potential benefit of this procedure.
Borini et al. (2004) studied the pregnancies and births in 68 women after undergoing assisted
reproduction procedures for infertility problems using cryopreserved oocytes. Fifteen of the
women became pregnant, there were 3 spontaneous abortions, and 13 healthy babies (one set of
twins) were delivered.
Quintans (2002) reported on a series of in vitro fertilizations in twelve women using oocytes that
had been cryopreserved in an alternative freezing medium. Six clinical pregnancies resulted, one
of these was ectopic and three aborted spontaneously. Two healthy babies were born.
Radiation therapy and chemotherapy treatments may cause temporary or permanent infertility.
These side effects are related to a number of factors including the patient's sex, age at time of
treatment, the specific type and dose of radiation therapy and/or chemotherapy, the use of single
therapy or many therapies and length of time since treatment. Patients who are concerned about
the effects of cancer treatment on their ability to have children should discuss this with their
doctor before treatment. The doctor can recommend a counselor or fertility specialist who can
discuss available options and help patients and their partners through the decision-making
process. Options may include freezing sperm, eggs or ovarian tissue before cancer treatment
(National Cancer Institute, 2010).
Professional Societies
American Cancer Society (ACS)
Preserving Fertility in Women
Embryo freezing is the most common and successful method of preserving fertility today. Mature
eggs are removed from the woman's ovaries and fertilized in the lab via in vitro fertilization (IVF).
The embryos are then frozen for future use after successful cancer treatment. However, some
women who have fast-growing cancers cannot wait 2 to 3 weeks to begin treatment. Successful
pregnancy rates vary from center to center. Centers with the most experience usually have better
success rates.
Egg freezing involves removing mature eggs with the same procedure used for embryo freezing,
but the eggs are frozen without being fertilized. Few babies have been born as a result of egg
freezing, and the procedure remains investigational. This may be an option for women who have
no partner at the time of cancer diagnosis.
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Ovarian tissue freezing involves surgically removing all or part of one ovary. The ovarian tissue is
usually divided into small strips, frozen and stored to be transplanted back into the woman's body
after treatment. Usually the eggs produced by the tissue would need to be collected and fertilized
in the laboratory. In a few cases, the whole ovary has been frozen with the idea of transplanting it
back. This procedure is experimental and has produced very few live births (ACS, 2010).
Preserving Fertility in Men
Sperm banking is an effective way for men who have gone through puberty to store sperm for
future use. In sperm banking, one or more samples of semen are collected, tested, frozen and
stored. The success rates of infertility treatments using frozen sperm vary and depend on the
quality of the sperm after it is thawed. In general, sperm collected before cancer treatment is just
as likely to start a pregnancy as sperm from men without cancer. Sperm banking has resulted in
thousands of pregnancies, without unusual rates of birth defects or health problems in the
children. Once sperm is stored, it remains good for many years (ACS, 2010).
American College of Obstetricians and Gynecologists (ACOG)
A number of techniques have been used to protect the ovaries and preserve fertility in women at
risk of losing ovarian function prematurely as a consequence of cancer therapy. In vitro
fertilization (IVF) with cryopreservation of embryos is a proven method and is the most successful
approach. Ovarian tissue cryopreservation and oocyte cryopreservation are two options with the
potential to preserve fertility. Although these methods are developing rapidly, their use as a
means to have a child after cancer treatment must be considered investigational and offered only
with appropriate informed consent in a research setting and under the auspices of an institutional
review board (ACOG, 2008).
American Society for Reproductive Medicine (ASRM)/Society for Assisted Reproductive
Technology (SART)
Semen samples may be frozen at a sperm bank or fertility center before starting chemotherapy or
radiation therapy. Samples can be stored for years and used later for insemination.
Cryopreservation of eggs is investigational, expensive, invasive and may delay cancer treatment.
If used, eggs are collected as for in vitro fertilization (IVF) but are frozen before they are fertilized.
Theoretically, frozen eggs may be stored, thawed, fertilized and used for embryo transfer. Actual
success with this method is very limited, and few babies have been born with this technique
(ASRM, 2004).
Embryo banking is a proven method but requires both available sperm and several weeks of
preparation. Oocyte banking avoids some of the disadvantages of embryo banking, although
investigations of the application of this technology have been hampered historically by poor
oocyte survival, fertilization and resulting pregnancy rates. Ovarian tissue banking remains a
promising clinical technique because it avoids ovarian stimulation and provides the opportunity for
preserving gonadal function in prepubertal, as well as adult patients. In the case of patients who
are facing infertility due to chemotherapy, oocyte cryopreservation may be one of the few options
available. It might therefore be acceptable under these circumstances with appropriate informed
consent in an investigational protocol under the auspices of an IRB. Although currently
investigational, ovarian tissue cryopreservation and oocyte cryopreservation hold promise for
future female fertility preservation, particularly following aggressive chemotherapy and/or
radiotherapy treatment protocols (ASRM, 2008c).
American Society of Clinical Oncology (ASCO)
Preservation of Fertility in Males
The available evidence suggests that sperm cryopreservation is an effective method of fertility
preservation in males treated for cancer. In contrast, testicular tissue or spermatogonial
cryopreservation and transplantation or testis xenografting are in the early phases of
experimentation and have not yet been successfully tested in humans. Sperm cryopreservation is
the most established technique for fertility preservation in men. Due to recent advances in in-vitro
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fertilization (IVF) technology and sperm banking procedures, even men with extremely reduced
sperm count and motility are candidates for sperm cryopreservation (Lee, 2006).
Preservation of Fertility in Females
Fertility preservation options in females depend on the patient's age, type of treatment, diagnosis,
whether she has a partner, the time available and the potential that cancer has metastasized to
her ovaries. Embryo cryopreservation is considered an established fertility preservation method
as it has routinely been used for storing surplus embryos after in vitro fertilization for infertility
treatment. This approach typically requires approximately two weeks and may entail a delay in
cancer treatment.
Cryopreservation of unfertilized oocytes is another option for fertility preservation, particularly in
patients for whom a partner is unavailable, or who have religious or ethical objections to embryo
freezing. The oocytes are thawed later and fertilized in vitro. Research indicates that unfertilized
oocytes are more prone to damage during cryopreservation procedures than embryos, and as a
result, the overall pregnancy rates may be lower than standard IVF procedures. Further research
is needed to delineate the current success rates and safety, as well as to improve the efficiency
of this procedure.
Ovarian tissue cryopreservation is an investigational method of fertility preservation but has the
advantage of requiring neither a sperm donor nor ovarian stimulation. Ovarian cryopreservation
and transplantation procedures should only be performed in centers with the necessary expertise
under IRB approved protocols that include follow-up for recurrent cancer (Lee, 2006).
U.S. FOOD AND DRUG ADMINISTRATION (FDA)
Sperm DNA integrity testing (Sperm Chromatin Structure Assay (SCSA)), Comet assay, sperm
DNA fragmentation assay, TUNEL assay, Sperm DNA Decondensation Test and E-tegrity uterine
receptivity testing is regulated under the Clinical Laboratory Improvement Amendments (CLIA) of
1988. Premarket approval from the FDA is therefore not required for this laboratory testing.
In November 2003, the FDA approved the use of Sperm-Hyaluronan Binding Assay for the
following indications: 1) as a component of the standard analysis of semen in the diagnosis of
suspected male infertility and 2) as a component of analyses for determining the proper course of
in vitro fertilization (IVF) treatment of infertility. Additional information is available at:
http://www.accessdata.fda.gov/cdrh_docs/reviews/K032874.pdf. Accessed April 26, 2011.
Products and media used for cryopreservation of reproductive tissue are too numerous to list.
See the following web site for more information (use product code MQL). Available at:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm. Accessed April 26, 2011.
CENTERS FOR MEDICARE AND MEDICAID SERVICES (CMS)
Medicare covers reasonable and necessary services associated with the treatment of infertility.
Medicare does not have a National Coverage Determination (NCD) for Infertility. See the
Medicare Benefit Policy Manual, Chapter 15, Physician Expense for Surgery, Childbirth, and
Treatment for Infertility. Refer to the Non Covered Services Local Coverage Determinations
(LCD) for non covered infertility services.
Medicare does not have a National Coverage Determination (NCD) for cryopreservation of
reproductive tissues. Local Coverage Determinations (LCDs) exist and compliance with these
policies is required where applicable. Refer to the Non Covered Services LCD.
(Accessed February 22, 2011)

Infertility Diagnosis and Treatment: Medical Policy

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APPLICABLE CODES
The codes listed in this policy are for reference purposes only. Listing of a service or device code
in this policy does not imply that the service described by this code is a covered or non-covered
health service. Coverage is determined by the benefit document. This list of codes may not be all
inclusive.
CPT® Code
54500
54505
55300
58340
58345
58350
58555
74440
74740
74742
76856
76857
76831
76870
76872
80415
82670
83001
83002
83498
83499
84144
84146
84402
84403
84443
87070
87071
89300

Description
Diagnostic (Proven)
Biopsy of testis, needle (separate procedure)
Biopsy of testis, incisional (separate procedure)
Vasotomy for vasograms, seminal vesiculograms, or
epididymograms, unilateral or bilateral
Catheterization and introduction of saline or contrast material for
saline infusion sonohysterography (SIS) or hysterosalpingography
Transcervical introduction of fallopian tube catheter for diagnosis
and/or re-establishing patency (any method), with or without
hysterosalpingography
Chromotubation of oviduct, including materials
Hysteroscopy, diagnostic (separate procedure)
Vasography, vesiculography, or epididymography, radiological
supervision and interpretation
Hysterosalpingography, radiological supervision and interpretation
Transcervical catheterization of fallopian tube, radiological
supervision and interpretation
Ultrasound, pelvic (nonobstetric), real time with image documentation;
complete
Ultrasound, pelvic (nonobstetric), real time with image documentation;
limited or follow-up (e.g., for follicles)
Saline infusion sonohysterography (SIS), including color flow Doppler,
when performed
Ultrasound, scrotum and contents
Ultrasound, transrectal
Chorionic gonadotropin stimulation panel; estradiol response This
panel must include the following: Estradiol (82670 x 2 on three pooled
blood samples)
Estradiol
Gonadotropin; follicle stimulating hormone (FSH)
Gonadotropin; luteinizing hormone (LH)
Hydroxyprogesterone, 17-d
Hydroxyprogesterone, 20
Progesterone
Prolactin
Testosterone; free
Testosterone; total
Thyroid stimulating hormone (TSH)
Culture, bacterial; any other source except urine, blood or stool,
aerobic, with isolation and presumptive identification of isolates
Culture, bacterial; quantitative, aerobic with isolation and presumptive
identification of isolates, any source except urine, blood or stool
Semen analysis; presence and/or motility of sperm including Huhner
test (post coital)

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89310
89320
89321
89322
89325
89329
89330
89398
52402
55530
55535
55550
55870
58321
58322
58323
58345
58559
58660
58662
58672
58673
58740
58760
58800
58805
58920
58970
58974
58976
76948
84830
89250
89253
89254
89255
89257
89260

Semen analysis; motility and count (not including Huhner test)
Semen analysis; volume, count, motility, and differential
Semen analysis; sperm presence and motility of sperm, if performed
Semen analysis; volume, count, motility, and differential using strict
morphologic criteria (eg, Kruger)
Sperm antibodies
Diagnostic (Unproven)
Sperm evaluation; hamster penetration test
Sperm evaluation; cervical mucus penetration test, with or without
spinnbarkeit test
Unlisted reproductive medicine laboratory procedure
Treatment (Proven)
Cystourethroscopy with transurethral resection or incision of
ejaculatory ducts
Excision of varicocele or ligation of spermatic veins for varicocele;
(separate procedure)
Excision of varicocele or ligation of spermatic veins for varicocele;
abdominal approach
Laparoscopy, surgical, with ligation of spermatic veins for varicocele
Electroejaculation
Artificial insemination; intra-cervical
Artificial insemination; intra-uterine
Sperm washing for artificial insemination
Transcervical introduction of fallopian tube catheter for diagnosis
and/or re-establishing patency (any method), with or without
hysterosalpingography
Hysteroscopy, surgical; with lysis of intrauterine adhesions (any
method)
Laparoscopy, surgical; with lysis of adhesions (salpingolysis,
ovariolysis) (separate procedure)
Laparoscopy, surgical; with fulguration or excision of lesions of the
ovary, pelvic viscera, or peritoneal surface by any method
Laparoscopy, surgical; with fimbrioplasty
Laparoscopy, surgical; with salpingostomy (salpingoneostomy)
Lysis of adhesions (salpingolysis, ovariolysis)
Fimbrioplasty
Drainage of ovarian cyst(s), unilateral or bilateral, (separate
procedure); vaginal approach
Drainage of ovarian cyst(s), unilateral or bilateral, (separate
procedure); abdominal approach
Wedge resection or bisection of ovary, unilateral or bilateral
Follicle puncture for oocyte retrieval, any method
Embryo transfer, intrauterine
Gamete, zygote, or embryo intrafallopian transfer, any method
Ultrasonic guidance for aspiration of ova, imaging supervision and
interpretation
Ovulation tests, by visual color comparison methods for human
luteinizing hormone
Culture of oocyte(s)/embryo(s), less than 4 days;
Assisted embryo hatching, microtechniques (any method)
Oocyte identification from follicular fluid
Preparation of embryo for transfer (any method)
Sperm identification from aspiration (other than seminal fluid)
Sperm isolation; simple prep (eg, sperm wash and swim-up) for

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89261
89264
89268
89272
89280
89281
89251
89258
89259
89335
89342
89343
89344
89346
89352
89353
89354
89356

insemination or diagnosis with semen analysis
Sperm isolation; complex prep (eg, Percoll gradient, albumin gradient)
for insemination or diagnosis with semen analysis
Sperm identification from testis tissue, fresh or cryopreserved
Insemination of oocytes
Extended culture of oocyte(s)/embryo(s), 4-7 days
Assisted oocyte fertilization, microtechnique; less than or equal to 10
oocytes
Assisted oocyte fertilization, microtechnique; greater than 10 oocytes
Treatment (Unproven)
Culture of oocyte(s)/embryo(s), less than 4 days; with co-culture of
oocyte(s)/embryos
Cryopreservation
Cryopreservation; embryo
Cryopreservation; sperm
Cryopreservation, reproductive tissue, testicular
Storage, (per year); embryo(s)
Storage, (per year); sperm/semen
Storage, (per year); reproductive tissue, testicular/ovarian
Storage, (per year); oocyte(s)
Thawing of cryopreserved; embryo(s)
Thawing of cryopreserved; sperm/semen, each aliquot
Thawing of cryopreserved; reproductive tissue, testicular/ovarian
Thawing of cryopreserved; oocytes, each aliquot
®

CPT is a registered trademark of the American Medical Association.

Proven HCPCS Code
J0725
J3355
S0122
S0126
S0128
S0132
S3655
S4011
S4013
S4014
S4015
S4016
S4017
S4018
S4021
S4022
S4023
S4025
S4026
S4027
S4028
S4030
S4031

Description
Injection, chorionic gonadotropin, per 1,000 USP units
Injection, urofollitropin, 75 IU
Injection, menotropins, 75 IU
Injection, follitropin alfa, 75 IU
Injection, follitropin beta, 75 IU
Injection, ganirelix acetate 250 mcg
Antisperm antibodies test (immunobead)
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 of
development
Complete cycle, gamete intrafallopian transfer (GIFT), case rate
Complete cycle, zygote intrafallopian transfer (ZIFT), case rate
Complete in vitro fertilization cycle, case rate not otherwise specif
Frozen in vitro fertilization cycle, case rate
Incomplete cycle, treatment canceled prior to stimulation, case rate
Frozen embryo transfer procedure cancelled before transfer, case
rate
In vitro fertilization procedure cancelled after aspiration, case rate
Assisted oocyte fertilization, case rate
Donor egg cycle, incomplete, case rate
Donor services for in vitro fertilization (sperm or embryo), case rate
Procurement of donor sperm from sperm bank
Storage of previously frozen embryos
Microsurgical epididymal sperm aspiration (mesa)
Sperm procurement and cryopreservation services; initial visit
Sperm procurement and cryopreservation services; subsequent visit

Infertility Diagnosis and Treatment: Medical Policy

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S4035
S4037
Unproven HCPCS
Code
0058T
0059T
S4040

Stimulated intrauterine insemination (IUI), case rate
Cryopreserved embryo transfer, case rate
Description
Cryopreservation; reproductive tissue, ovarian
Cryopreservation; oocyte(s)
Monitoring and storage of cryopreserved embryos, per 30 days

Coding Clarification
Cryopreservation may be done to preserve reproductive tissue for use at a later time. Some
treatments for cancer and other conditions may impact an individual's fertility. For example, the
diagnosis code range for cancer is 140 - 239.8.
REFERENCES
American Cancer Society (ACS). Fertility and cancer: what are my options? September 2010.
Available at:
http://www.cancer.org/docroot/MBC/MBC_2x_Fertility_and_Cancer.asp?sitearea=&level=.
Accessed April 27, 2011.
American College of Obstetricians and Gynecologists (ACOG). Committee Opinion #405. Ovarian
tissue and oocyte cryopreservation. Obstet Gynecol. 2008 May;111(5):1255-6.
American Society for Reproductive Medicine (ASRM). The clinical utility of sperm DNA integrity
testing. Fertil Steril. 2008a Nov;90(5 Suppl):S178-80.
American Society for Reproductive Medicine (ASRM). The role of assisted hatching in in-vitro
fertilization: a review of the literature. A Committee opinion. Fertil Steril. 2008b Nov;90(5
Suppl):S196-8.
American Society for Reproductive Medicine (ASRM). Ovarian tissue and oocyte
cryopreservation. Fertil Steril. 2008c Nov;90(5 Suppl):S241-6.
American Society for Reproductive Medicine (ASRM). Fertility preservation and reproduction in
cancer patients. Fertil Steril. 2005 Jun;83(6):1622-8.
American Society for Reproductive Medicine (ASRM). Patient Factsheet. Cancer and fertility
preservation. 2004. Available at:
http://www.asrm.org/uploadedFiles/ASRM_Content/Resources/Patient_Resources/Fact_Sheets_
and_Info_Booklets/cancer.pdf. Accessed April 27, 2011.
Aoki V.W. Peterson C.M. Parker-Jones K. Hatasaka H.H. Gibson M. Huang I. Carrell D.T.
Correlation of sperm penetration assay score with polyspermy rate in in-vitro fertilization. Journal
of Experimental and Clinical Assisted Reproduction. 2005;2(1):3.
Arslan M, Morshedi M, Arslan EO et al. Predictive value of the hemizona assay for pregnancy
outcome in patients undergoing controlled ovarian hyperstimulation with intrauterine insemination.
Fertil Steril. 2006 Jun;85(6):1697-707.
Bedaiwy MA, El-Nashar SA, El Saman AM, et al. Reproductive outcome after transplantation of
ovarian tissue: a systematic review. Hum Reprod. 2008 Dec;23(12):2709-17.
Borini A, Bonu MA, Coticchio G, et al. Pregnancies and births after oocyte cryopreservation. Fertil
Steril 2004;82(3):601-5.
Infertility Diagnosis and Treatment: Medical Policy

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Creus M, Ordi J, FF et al. alphavbeta3 integrin expression and pinopod formation in normal and
out-of-phase endometria of fertile and infertile women. Hum Reprod. 2002 Sep;17(9):2279-86.
Ebner T, Moser M, Sommergruber M, Shebl O, Tews G. Incomplete denudation of oocytes prior
to ICSI enhances embryo quality and blastocyst development. Hum Reprod. 2006
Nov;21(11):2972-7.
ECRI Institute. Hotline Response. Cryopreservation of Reproductive Tissue. December 2009.
ECRI Institute. Hotline Response. Co-culture to improve embryo quality and implantation in
infertility patients. February 2008.
ECRI Institute. Hotline Response. Sperm-Hyaluronan-Binding Assay (HBA) [HYDAK®] for
Assessment of Sperm Quality. November 2004.
Engin-Uml Stun, Korkmaz C, Duru NK, BaI. Comparison of three sperm retrieval techniques in
spinal cord-injured men: pregnancy outcome. Gynecol Endocrinol. 2006 May;22(5):252-5.
Evenson D, Wixon R. Meta-analysis of sperm DNA fragmentation using the sperm chromatin
structure assay. Reprod Biomed Online. 2006 Apr;12(4):466-72.
FIGO Committee for the Ethical Aspects of Human Reproduction and Women's Health. Ethical
considerations and recommendations on oocyte and ovarian cryopreservation. Int J Gynaecol
Obstet. 2006 Mar;92(3):335-6.
Freeman MR. Archibong AE. Mrotek JJ. Whitworth CM. Weitzman GA. Hill GA. Male partner
screening before in vitro fertilization: preselecting patients who require intracytoplasmic sperm
injection with the sperm penetration assay. Fertility & Sterility. 2001;76(6):1113-1118
Gandini L, Lombardo F, Paoli D, et al. Full-term pregnancies achieved with ICSI despite high
levels of sperm chromatin damage. Hum Reprod. 2004 Jun;19(6):1409-17.
Giwercman A, Richthoff J, HjH, et al. Correlation between sperm motility and sperm chromatin
structure assay parameters. Fertil Steril. 2003 Dec;80(6):1404-12.
Hayes Inc. Health Technology Brief. E-tegrity® Test (Hologic Inc.; distributed by Sepal
Reproductive Devices) for Evaluation of Uterine Receptivity. December 2010.
Hazlett WD, Meyer LR, Nasta TE, et al. Impact of EmbryoGlue as the embryo transfer medium.
Fertil Steril. 2008 Jul;90(1):214-6.
Irvine DS, Macleod IC, Templeton AA, Masterton A, Taylor A. A prospective clinical study of the
relationship between the computer-assisted assessment of human semen quality and the
achievement of pregnancy in vivo. Hum Reprod. 1994 Dec;9(12):2324-34.
Johnson CW, Bingham JB, Goluboff ET, Fisch H. Transurethral resection of the ejaculatory ducts
for treating ejaculatory symptoms. BJU Int. 2005 Jan;95(1):117-9.
Johnson JE, Higdon Iii HL, Boone WR. Effect of human granulosa cell co-culture using standard
culture media on the maturation and fertilization potential of immature human oocytes. Fertil
Steril. 2007 Oct 20;
Kadioglu A, Cayan S, Tefekli A, Orhan I, Engin G, Turek PJ. Does response to treatment of
ejaculatory duct obstruction in infertile men vary with pathology? Fertil Steril. 2001 Jul;76(1):138Infertility Diagnosis and Treatment: Medical Policy

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Kattal N, Cohen J, Barmat LI. Role of coculture in human in vitro fertilization: a meta-analysis.
Fertil Steril. 2008 Oct;90(4):1069-76.
Lee SJ, Schover LR, Partridge AH, et al. American Society of Clinical Oncology
recommendations on fertility preservation in cancer patients. J Clin Oncol. 2006 Jun
20;24(18):2917-31.
Lessey BA, Castelbaum AJ, Wolf L, et al. Use of integrins to date the endometrium. Fertil Steril.
2000 Apr;73(4):779-87.
Li Z, Wang L, Cai J, Huang H. Correlation of sperm DNA damage with IVF and ICSI outcomes: a
systematic review and meta-analysis. J Assist Reprod Genet. 2006 Sep-Oct;23(9-10):367-76.
National Cancer Institute (NCI). Sexuality and reproductive issues PDQ. November 2010.
Available at: http://www.cancer.gov/cancertopics/pdq/supportivecare/sexuality/patient/allpages.
Accessed April 27, 2011.
National Institute for Clinical Excellence (NICE). Fertility: assessment and treatment for people
with fertility problems. February 2004. Available at:
http://www.nice.org.uk/nicemedia/pdf/CG011niceguideline.pdf. Accessed March 12, 2010.
National Institutes of Health (NIH). Infertility/Fertility. October 2006. Available at:
http://www.nichd.nih.gov/health/topics/infertility_fertility.cfm. Accessed March 12, 2010.
Oehninger S. Franken DR. Sayed E. Barroso G. Kolm P. Sperm function assays and their
predictive value for fertilization outcome in IVF therapy: a meta-analysis. Human Reproduction
Update. 2000;6(2):160-168.
Oktay K, Cil AP, Bang H. Efficiency of oocyte cryopreservation: a meta-analysis. Fertil Steril.
2006 Jul;86(1):70-80.
Paick J, Kim SH, Kim SW. Ejaculatory duct obstruction in infertile men. BJU Int. 2000
Apr;85(6):720-4.
Parikh FR, Nadkarni SG, Naik NJ, et al. Cumulus coculture and cumulus-aided embryo transfer
increases pregnancy rates in patients undergoing in vitro fertilization. Fertil Steril. 2006
Oct;86(4):839-47.
Quintans CJ, Donaldson MJ, Bertolino MV, et al. Birth of two babies using oocytes that were
cryopreserved in a choline-based freezing medium. Human Reproduction. 2002;17(12):31493152.
Spandorfer SD, Pascal P, Parks J, et al. Autologous endometrial coculture in patients with IVF
failure: outcome of the first 1,030 cases. J Reprod Med. 2004 Jun;49(6):463-7.
Thomas K, Thomson A, Wood S, et al. Endometrial integrin expression in women undergoing in
vitro fertilization and the association with subsequent treatment outcome. Fertil Steril. 2003
Sep;80(3):502-7.
Valojerdi MR, Karimian L, Yazdi PE, et al. Efficacy of a human embryo transfer medium: a
prospective, randomized clinical trial study. J Assist Reprod Genet. 2006 May;23(5):207-12.
Wurn BF, Wurn LJ, King CR, Heuer MA, Roscow AS, Scharf ES, Shuster JJ. Treating female
infertility and improving IVF pregnancy rates with a manual physical therapy technique.
Infertility Diagnosis and Treatment: Medical Policy

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MedGenMed. 2004 Jun 18;6(2):51.
Ye H, Huang GN, Gao Y, Liu de Y. Relationship between human sperm-hyaluronan binding
assay and fertilization rate in conventional in vitro fertilization. Hum Reprod. 2006 Jun;21(6):154550.
Yurdakul T, Gokce G, Kilic O, Piskin MM. Transurethral resection of ejaculatory ducts in the
treatment of complete ejaculatory duct obstruction. Int Urol Nephrol. 2007 Sep 26.
POLICY HISTORY/REVISION INFORMATION
Date

07/02/2011






07/01/2011








Action/Description
Corrected code list entry error; removed CPT code 76857 from
the list of applicable (proven) treatment codes and added it to the
list of applicable (proven) diagnostic codes
Revised list of proven procedures for diagnosing infertility in
female patients; removed endometrial biopsy
Revised list of proven procedures for diagnosing infertility in male
patients; replaced “antisperm antibodies (semen only)” with
“antisperm antibodies”
Revised list of unproven tests for diagnosing infertility;
o Removed serum or cervical mucus antisperm antibodies
o Added sperm penetration tests such as postcoital cervical
mucus penetration
Revised list of proven procedures for correcting underlying
disorders for the treatment of infertility; removed salpingostomy,
tubotubal anastamosis, vasoepididymostomy and vasovasostomy
Updated list of proven CPT codes:
o Added 52402, 55530, 55535, 55550, 58559, 58660,
58662, 58800, 58805, 58920, 76870, 76872, 83498,
83499, 84146, 84402, 84403, 84443, 87070, 87071,
89321 and 89322
o Removed 55899, 58100, 58110, 58750 and 58770
Updated list of unproven CPT codes;
o Added 89398
o Removed 55400
Updated list of proven HCPCS codes; added J0725, J3355,
S0122, S0132, S4011, S4015, S4016, S4017, S4018, S4021,
S4022, S4023, S4025, S4026, S4027, S4035 and S4037
Updated list of unproven HCPCS codes; added 0058T and 0059T
Archived previous policy version 2011T0270G

Infertility Diagnosis and Treatment: Medical Policy

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