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MP 4.02.04 Reproductive Techniques

Medical Policy    
Section
OB/Gyn Reproduction 
Original Policy Date
4/1/98
Last Review Status/Date
Reviewed with literature search/4:2014
Issue
4:2014
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Disclaimer

Our medical policies are designed for informational purposes only and are not an authorization, or an explanation of benefits, or a contract.  Receipt of benefits is subject to satisfaction of all terms and conditions of the coverage.  Medical technology is constantly changing, and we reserve the right to review and update our policies periodically.


Description

The policy addresses a variety of techniques available to establish a viable pregnancy for couples who have been diagnosed with infertility and for whom assisted insemination is insufficient.

Background

Infertility can be due either to female factors (ie, pelvic adhesions, ovarian dysfunction, endometriosis, prior tubal ligation), male factors (ie, abnormalities in sperm production, function, or transport or prior vasectomy), a combination of both male and female factors, or unknown causes. Various reproductive techniques are available to establish a viable pregnancy; different techniques are used depending on the reason for infertility.

Assisted reproductive technologies (ART), as defined by the Centers for Disease Control and other organizations, refers to fertility treatments in which both the eggs and sperm are handled. Not included in ART is assisted insemination (artificial insemination) using sperm from either a woman’s partner or a sperm donor. In most instances, ART will involve in vitro fertilization (IVF), a procedure in which oocytes harvested from the female are inseminated in vitro with sperm harvested from the male. Following the fertilization procedure, the zygote is cultured and ultimately transferred back into the female’s uterus or fallopian tubes. In some instances, the oocyte and sperm are collected, but no in vitro fertilization takes place, and the gametes are reintroduced into the fallopian tubes. Examples of ART include, but are not limited to, gamete intrafallopian transfer (GIFT), transuterine fallopian transfer (TUFT), natural oocyte retrieval with intravaginal fertilization (NORIF), pronuclear state tubal transfer (PROST), tubal embryo transfer (TET), zygote intrafallopian transfer (ZIFT), gamete and embryo cryopreservation, oocyte and embryo donation, and gestational surrogacy.

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

Most CPT codes describing the various steps in ART procedures are longstanding techniques. This includes codes for oocyte retrieval, sperm isolation, culture and fertilization of the oocyte, and embryo; zygote; or gamete transfer into the uterus or fallopian tubes. Only the relatively new reproductive techniques (ie, intracytoplasmic sperm injection, assisted hatching, co-culture of embryos) and cryopreservation of reproductive tissue (ie, testicular, ovarian, oocytes) will be considered.

Regulatory Status

There are no medical devices or diagnostic tests related to ART that require U.S. Food and Drug Administration approval or clearance.


Policy

The following reproductive techniques are considered medically necessary:

  • cryopreservation of testicular tissue in adult men with azoospermia as part of an intracytoplasmic sperm injection procedure;
  • intracytoplasmic sperm injection for male factor infertility;
  • blastocyst transfer.

The following reproductive techniques are considered investigational:

  • assisted hatching;
  • co-culture of embryos;
  • cryopreservation of ovarian tissue, or oocytes; cryopreservation of testicular tissue in prepubertal boys; storage and thawing of ovarian tissue, oocytes or testicular tissue.


Policy Guidelines

The following CPT codes describe procedures that would be routinely performed in all assisted reproductive technologies (ART) procedures involving in vitro fertilization (IVF):

58970: Follicle puncture for oocyte retrieval; any method

Either

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

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

Either

89268: Insemination of oocytes; OR

89280-89281: Assisted oocyte fertilization, microtechnique, less than or greater than 10 oocytes, respectively

89260 or 89261: Sperm isolation, simple or complex prep

89255: Preparation of embryo for transfer (any method)

58974: Embryo transfer, intrauterine

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

The following CPT codes describe procedures that would not be routinely performed in all ART procedures involving IVF.

89257: Sperm identification from aspiration (other than seminal fluid). Only performed in patients with oligospermia who have undergone a prior testicular or epididymal aspiration; typically performed as a part of an intracytoplasmic sperm injection procedure (ICSI).

89264: Sperm identification from testis tissue, fresh or cryopreserved. Only performed in patients with oligospermia who have undergone a prior testicular biopsy; typically performed as a part of an ICSI procedure.

89253: Assisted embryo hatching, microtechniques (any method). Only performed in women over the age of 40, or in cases in which prior ART attempts resulted in failed implantation.

89258: Cryopreservation; embryo(s)

89259: Cryopreservation; sperm

89337: Cryopreservation, mature oocyte(s)

89342-89356: Code range, storage, cryopreservation and thawing of various components

The following CPT codes describe procedures that would be routinely performed as part of an intrauterine or intracervical artificial insemination:

58321: Artificial insemination; intra-cervical

58322: Artificial insemination; intra-uterine

58323: Sperm washing for artificial insemination

Note also that “S” codes are available (see Coding section) that describe in vitro fertilization globally.


Benefit Application
BlueCard/National Account Issues

Coverage eligibility of ART is a contract-specific benefit issue.

BlueCard/National Account Issues

Benefits for assisted reproductive techniques may be subject to state mandates and to individual contract exclusions and limitations. Aside from a general review of contracts and state mandates, Plans should review contracts for the following specific issues:

  • Coverage eligibility for couples who have undergone a prior voluntary sterilization procedure (ie, vasectomy or tubal ligation) is variable among contracts/certificates of coverage. Coverage eligibility for reversal of a vasectomy or tubal ligation may be limited in some contracts. In some instances, ART will be performed to overcome a voluntary sterilization procedure. If the male partner has undergone vasectomy, the diagnosis may be recorded as male factor infertility.
  • In some instances, the female partner may be receiving health benefits under a plan that offers infertility benefits, while the male partner is not, or vice versa. For example, procedures performed on the male as part of an ART procedure, ie, epididymal aspiration, may not be eligible for coverage under the female partner’s infertility benefits. Similarly, the workup and diagnosis of infertility of the noncovered partner may not be eligible for coverage under the covered partner’s infertility benefits.
  • Some contracts or certificates of coverage may limit benefits for cryopreservation and storage of embryos or sperm, particularly for cryopreservation of sperm before a voluntary sterilization procedure or when there is no specific plan for an insemination procedure or embryo implantation.
  • Some contracts or certificates of coverage may impose a dollar cap on infertility benefits. In this situation, each Plan must determine, based on contract language, whether the workup and diagnosis of infertility is included in the dollar cap, or whether only the therapy of infertility is included.


Rationale

Literature Review

This policy was originally created in 1998 and was updated regularly with searches of the MEDLINE database. The most recent literature review was conducted through February 24, 2014. Following is a summary of the key literature to date:

Assisted Hatching

One key component of a successful attempt at in vitro fertilization is implantation of the embryo in the uterus. Although the exact steps in implantation are poorly understood, 1 critical component is thought to be the normal rupture of the surrounding zona pellucida with escape of the developing embryo, termed hatching. It is hypothesized that during the in vitro component of the in vitro fertilization (IVF), the zona pellucida becomes hardened, thus impairing the hatching process. Alternatively, some embryos may have some inherent inability to induce thinning of the zona pellucida before hatching. In either case, mechanical disruption of the zona pellucida (ie, assisted hatching) has been proposed as a mechanism to improve implantation rates.

A 2012 systematic review and meta-analysis from the Cochrane collaboration identified 31 randomized controlled trials (RCTs) on assisted hatching with a total of 5728 individuals.(1) Twelve studies included women with a poor prognosis, 12 studies included women with a good prognosis, and the remaining 7 studies did not report this factor. Fifteen studies used laser for assisted hatching, 11 used chemical means, and 5 used mechanical means. Live birth rate was reported in 9 studies with 1921 women. A pooled analysis of data from the 9 studies did not find a statistically significant difference between the groups receiving assisted hatching or a control condition (odds ratio [OR], 1.03; 95% confidence interval [CI], 0.85 to 1.26). The rate of live birth was 313/995 (31%) in the assisted hatching group and 282/926 (30%) in the control group. All 31 trials reported clinical pregnancy rates. In a meta-analysis of all of these trials, assisted hatching improved the pregnancy rate, but the odds ratio just reached statistically significance (OR=1.13; 95% CI, 1.01 to 1.27).

Previously, in 2008, the Practice Committees of the Society for Assisted Reproductive Technology (SART) and the American Society for Reproductive Medicine (ASRM) published a comprehensive review and meta-analysis on assisted hatching.(2) The meta-analysis had similar findings to the 2012 Cochrane review, previously discussed.(1) The review identified 23 RCTs (N=2572) with women undergoing assisted hatching during assisted reproduction. A pooled analysis of the 6 studies that reported live birth rates did not find a statistically significant difference in birth rate with assisted hatching compared with a control condition. Nineteen studies reported a clinical pregnancy rate; pooled analysis of these data found a significantly higher rate of pregnancy with assisted hatching compared with control (OR=1.63; 95%, CI, 1.27 to 2.09). There was significant heterogeneity among studies. The subgroups with the most benefit from assisted hatching in terms of the pregnancy rate were older women and women who had failed prior attempts with assisted reproductive techniques.

Section Summary

RCTs and meta-analyses of these trials have not found that assisted hatching significantly improves the live birth rate compared with a control intervention. Meta-analyses of heterogenous studies have found that the clinical pregnancy rate is improved with assisted hatching.

Embryo Co-Culture

In routine IVF procedures, the embryo is transferred to the uterus on day 2 or 3 of development, when it has between 4 and 8 cells. However, with this approach, the implantation rate is estimated to be between 5% and 30%, potentially related to the fact that under normal conditions the embryo reaches the uterus at a blastocyst stage of development. Embryo co-culture techniques, used successfully in domestic animals, represent an effort to improve the culture media for embryos such that a greater proportion of embryos will reach the blastocyst stage, in hopes of improving the implantation and pregnancy rate. In addition, if co-culture results in a higher implantation rate, fewer embryos could be transferred at each cycle, resulting in a decreased incidence of multiple pregnancies. A variety of co-culture techniques have been investigated, involving the use of feeder cell layers derived from a range of tissues, including the use of human reproductive tissues (ie, oviducts) to nonhuman cells (ie, fetal bovine uterine or oviduct cells) to established cell lines (ie, Vero cells or bovine kidney cells). However, no standardized method of co-culture has emerged, and no controlled trials have evaluated an improved implantation or pregnancy rate associated with co-culture.(3-8) For example, Wetzels et al reported on a study that randomized IVF treatments to include co-culture with human fibroblasts or no culture.(8) Patients in the 2 groups were stratified according to age (older or younger than 36 years) and prior IVF attempts (yes vs no). The authors reported that fibroblast co-culture did not affect the implantation or the pregnancy rate. Updated literature reviews did not identify any additional published studies that would prompt reconsideration of the relevant policy statement.

Section Summary

There is a lack of controlled trials demonstrating improved outcomes with co-culture, and no standardized method of co-culture has emerged in the literature.

Cryopreservation of Ovarian Tissue

Cryopreservation of ovarian tissue or an entire ovary with subsequent auto- or heterotopic transplant has been investigated as a technique to sustain the reproductive function of women or children who are faced with sterilizing procedures, such as chemotherapy, radiation therapy, or surgery, frequently due to malignant diseases. A variety of articles have focused on the technical feasibility of such an option. There are a few individual case reports of return of ovarian function using this technique.(9,10) There are also several case series describing live births using cryopreserved ovarian tissue.(11-13) However, in general, the technique is not standardized and has not been sufficiently studied to determine the success rate.(14,15) In 2011, Johnson and Patrizio commented on whole ovary freezing as a technique of fertility preservation in women with disease or disease treatment that threaten their reproductive tract function.(16) They concluded, “Although theoretically optimal from the point of view of maximal follicle protection and preservation, the risks and difficulties involved in whole ovary freezing limit this technique to experimental situations.”

Section Summary

This technique has not been standardized, and there are insufficient published data that cryopreservation of ovarian tissue is an effective and safe reproductive technique.

Cryopreservation of Oocytes

Cryopreservation of oocytes was originally investigated primarily as an alternative to embryo cryopreservation due to ethical or religious reasons. More recently, it has been examined as a fertility preservation option for reproductive-age women undergoing cancer treatment, both single women and those who do not want the option of embryo cryopreservation. The mature oocyte is very fragile due to its large size, high water content, and chromosomal arrangement. For example, the mature oocyte is arrested in meiosis, and as such, the chromosomes are lined up in a meiotic spindle. This spindle apparatus is easily damaged both in freezing and thawing. Survival after thawing may also be associated with sublethal damage, which may further impact on the quality of the subsequent embryo. Moreover, due to the large amount of water, when the oocyte is frozen, ice crystals can form that can damage the integrity of the cell. To reduce or prevent ice crystals, oocytes are dehydrated using cryoprotectants, which replace the water in the cell. There are 2 primary approaches to cryopreservation, a controlled-rate slow-cooling method and a flash-freezing process known as vitrification. Vitrification, the newer method, is faster, yet requires a higher concentration of cryoprotectants.

No studies were identified that compared outcomes after embryo cryopreservation versus oocyte cryopreservation.

In 2013, the Practice Committees of ASRM and SART published an updated guideline on mature oocyte cryopreservation.(17) A systematic review of the literature, conducted as part of guideline development, identified 4 RCTs comparing outcomes of assisted reproduction with cryopreserved and fresh oocytes. All of the trials were conducted in Europe. In these studies, fertilization rates ranged from 71% to 79%, and the clinical pregnancy rates per transfer ranged from 36% to 61%. The largest RCT cited in the guideline (n=600) was published by Cobo et al in Spain in 2010.(18) This study included oocyte recipients who were between 18 and 49 years old and who failed fewer than 3 previous IVF attempts. The primary outcome was the ongoing pregnancy rate; this was defined as the presence of at least 1 viable fetus 10 to 11 weeks after embryo transfer. In an intention-to-treat analysis, the ongoing pregnancy rate was 43.7% in the vitrification group and 41.7% in the fresh oocyte group. Vitrification was considered noninferior to fresh oocyte transfer according to a prespecified margin of difference. Cobo et al did not discuss whether any of the participants had cancer or were undergoing chemotherapy. The guideline noted that the available data may not be generalizable to the United States, to clinics with less experience with these techniques or to other populations eg, older women or cancer patients. The authors stated that data from the United States are available only from a few clinics and report on young highly selected populations. Pregnancy outcomes and rates of congenital anomalies were not discussed in the publication.

Also published in 2013, after the ASRM/SART guideline, was an observational study by Levi Setti et al in Italy.(19) This study compared outcomes in pregnancies achieved with fresh or frozen oocytes in the same patient population. The investigators identified 855 patients in an Italian database who had become pregnant using fresh and/or cryopreserved and thawed oocytes. The 855 patients had a total of 954 clinical pregnancies, 197 were obtained with frozen oocytes and 757 with fresh oocytes. There were 687 pregnancies from fresh cycle oocytes only, 129 pregnancies with frozen oocytes only and 138 pregnancies from both fresh and frozen oocyte cycles. The live birth rate was 68% (134/197) from frozen/thawed oocytes and 77.2% (584/757) fresh oocyte cycles. The live birth rate was significantly higher after fresh cycle oocytes (p=0.008).

In addition to the above literature, several meta-analyses have compared the 2 main approaches to cryopreservation; slow-cooling cryopreservation and vitrification. A 2013 study by Cil et al analyzed individual patient data from 10 studies with a total of 1805 patients.(20) There were 328 clinical pregnancies that resulted in 224 live births, 163 after slow-freeze cryopreservation and 61 after vitrification. Oocyte survival rates and fertilization rates were lower after slow-freeze cryopreservation (65% and 74%, respectively) than with vitrification (85% and 79%, respectively; p<0.001). Moreover, after vitrification, implantation rates were higher (p=0.002) and miscarriage rates were lower (p=0.005) compared with slow-freeze cryopreservation. The authors created models to estimate the probability of live birth as a function of age and the number of oocytes frozen and thawed. For example, the probability of a live birth for a 30 year-old woman with 2 to 6 oocytes thawed was 9.1% to 10.5% after slow-freeze cryopreservation and 21.4% to 24.1% after vitrification. In general, the likelihood of successful live birth declined with maternal age, and, when controlling for the number of thawed and injected oocytes and for the number of embryos transferred, the probability of live birth was higher after vitrification than slow-freeze cryopreservation regardless of age group.

In 2009, Wennerholm et al searched for studies that reported neonatal information and identified data on 148 children born after slow freezing of oocytes and 221 children born after vitrification (total N=369).(21) Most of these reported limited information on obstetric and neonatal outcomes. Birth weight was reported for 41 infants born after slow-freezing of oocytes and was normal in all cases. For vitrification, 200 of 221 cases were reported in a single study that included 151 singletons and 49 multiples. Eighteen percent of singletons and 80% of multiples were low birth weight, and the congenital anomalies were reported in 2.5% of infants.

Also in 2009, Noyes identified published reports of 609 live births after oocyte cryopreservation.(22) An additional 327 births were identified from communications with fertility centers, for a total of 936 live births. Of these, 532 resulted from slow frozen oocytes, 392 from vitrified oocytes, and 12 from a combination of the 2 techniques. There were a total of 12 congenital anomalies, 8 major and 4 minor, for an overall incidence of 1.3%. The incidence in the births from slow frozen oocytes was 6 of 532 (1.1%) and from vitrification births 6 of 392 (1.5%). The author stated that this compared favorably with the 3% rate of congenital anomalies in the general U.S. population, according to the Centers for Disease Control and Prevention. The incidence of ventricular septal defects was 0.3% (3/936) on the oocyte cryopreservation population and 1 of 125 (0.8%) naturally conceived newborns. The author acknowledges that not all reports were from peer-reviewed publications and limited outcome data were available.

Section Summary

There are insufficient published data on the safety and efficacy of cryopreservation of oocytes; data are only available from select clinical settings and select populations. There is a lack of published data on success rates with cryopreserved oocytes in women who froze oocytes because they were undergoing chemotherapy.

Blastocyst Transfer

This refers to the extended culture of oocytes/embryos, ie, for greater than 4 days. The rationale behind blastocyst transfer is that embryos progressing to the blastocyst stage have a much greater chance of implanting successfully in the uterus and resulting in an ongoing pregnancy. Due to the higher probability of implantation, it is thought that fewer blastocysts can be transferred, ultimately resulting in a decreased incidence of triplets and higher-order pregnancies.

Several systematic reviews of studies comparing outcomes associated with blastocyst stage transfer compared with earlier stage transfer have been published. Only the Cochrane review, published in 2012, included RCTs.(23) The Cochrane review identified a total of 23 RCTs; 12 of these reported on the rate of live birth per couple. A pooled analysis of these trials found a significantly higher live birth rate with blastocyst transfer (292/751, 39%) compared with cleavage-stage transfer (237/759, 31%). The OR for live birth was 1.40 (95% CI, 1.13 to 1.74). There was not a significant difference in the rate of multiple pregnancies in the 2 treatment groups (16 RCTs; OR=0.92; 95% CI, 0.71 to 1.19). In addition, there was not a significant difference in the miscarriage rate (14 RCTs; OR=1.14; 95% CI, 0.84 to 1.55).

A 2013 systematic review identified 8 observational studies analyzing singleton births following embryo transfer at the blastocyst- or cleavage-stage and reporting obstetric and/or perinatal outcomes.(24) A meta-analysis of 6 studies found a significantly higher rate of preterm delivery less than 37 weeks after blastocyst-stage transfer compared with cleavage-stage transfer (risk ratio [RR], 1.27; 95% CI, 1.22 to 1.31); the absolute increase in risk was 2% (95% CI, 1% to 4%). Other pooled analysis of 2 to 3 studies each did not find significantly increased rates of low birth weight less than 1500 g, congenital anomies or perinatal mortality following blastocyst-stage versus cleavage-stage embryo transfer.

A 2010 retrospective cohort study reported on risks associated with blastocyst transfer. Data were taken from the Swedish Medical Birth Register. There were 1311 infants born after blastocyst transfer and 12,562 born after cleavage-stage transfer.(25) There were no significant differences in the rates of multiple births, which were 10% after blastocyst transfer and 8.9% after cleavage-stage transfer. Among singleton births, the rate of preterm birth (<32 weeks) was 18 of 1071 (1.7%) in the blastocyst transfer group and 142 of 10,513 (1.35%) in the cleavage-stage transfer. In a multivariate analysis controlling for year of birth, maternal age, parity, smoking habits, and body mass index, the adjusted OR was 1.44 (95% CI, 0.87 to 2.40). The rate of low birth weight singletons (<1500 g or <2500 g) did not differ significantly in the blastocyst transfer compared with the cleavage-stage transfer groups. There was a significantly higher rate of relatively severe congenital malformation (eg, spina bifida, cardiovascular defects, cleft palate, etc.) after blastocyst transfer (61/1311, 4.7%) than cleavage-stage transfer (509/12,562, 4.1%; adjusted OR=1.33; 95% CI, 1.01 to 1.75). The 2 groups did not differ significantly in their rates of low APGAR scores, intracranial hemorrhage, respiratory diagnoses, or cardiovascular malformations. Respiratory diagnoses were given to 94 of 1311 (7.2%) infants born after blastocyst transfer and 774 of 12,562 (6.2%) after cleavage-stage transfer (OR=1.15; 95% CI, 0.90 to 1.47). The study was not randomized and, although the investigators adjusted for some potential confounders eg, age and parity, there may have been other differences in the 2 groups that affected outcomes.

The Practice Committees of SART and ASRM issued a Committee Opinion on blastocyst transfer in 2008.(26) They stated that, in trials with good prognosis patients, blastocyst transfer has been found to result in a higher live birth rate compared with transfer of equal numbers of cleavage stage transfer. However, cumulative live birth rates may not differ when frozen and fresh embryos from a given cycle are considered because extended culture yields fewer surplus embryos, and the postthaw survival rate is lower for blastocysts than for cleavage stage embryos that have been frozen.

Section Summary

According to evidence from RCTs, observational studies and meta-analyses of published studies, blastocyst transfer results in higher live birth rates compared with cleavage stage transfer. One meta-analysis found a significantly higher rate of preterm birth after blastocyst stage versus cleavage stage transfer, but not increased risks of other outcomes including low birth rate and perinatal mortality.

Intracytoplasmic Sperm Injection for Male Factor Infertility

Intracytoplasmic sperm injection (ICSI) is performed in cases of male factor infertility when either insufficient numbers of sperm, abnormal morphology, or poor motility preclude unassisted in vitro fertilization. Using ICSI, fertilization rates of up to 76% have been reported, considerably better than the competing technique of subzonal insemination (up to 18%), in which sperm are injected into the perivitelline space (as opposed to into the oocyte itself), and by definition better than the negligible to absent fertilization rates seen in patients with male factor infertility. Fertilization rates represent an intermediate outcome; the final outcome is the number of pregnancies per initiated cycle or per embryo transfer, reported in the largest series as 44.7% and 49.6%, respectively.(27-31) These rates are very competitive with those of the standard IVF. A 2012 committee opinion of the ASRM and SART stated that ICSI is a safe and effective treatment for male factor infertility.(32) The document also stated that ICSI for unexplained fertility, low oocyte yield, and advanced maternal age does not improve clinical outcomes. The opinion included a statement that ICSI may be beneficial for patients undergoing in vitro fertilization with preimplantation genetic testing, in vitro matured oocytes and cryopreserved oocytes.

Section Summary

There are data indicating that ICSI for male factor infertility has a relatively high rate of successful pregnancy.

Cryopreservation of Testicular Tissue

Testicular sperm extraction refers to the collection of sperm from testicular tissue in men with azoospermia. Extraction of testicular sperm may be performed at the time of a diagnostic biopsy or performed as a subsequent procedure, specifically for the collection of spermatozoa. The spermatozoa may be isolated immediately and a portion used for an ICSI procedure at the time of oocyte retrieval from the partner, with the remainder cryopreserved. Alternatively, the entire tissue sample can be cryopreserved with portion thawed and sperm isolation performed at subsequent ICSI cycles. This technique appears to be a well-established component of the overall ICSI procedure; cryopreservation of either the isolated sperm or the tissue sample eliminates the need for multiple biopsies to obtain fresh tissue in the event of a failed initial ICSI cycle.(33) However, a unique application of cryopreservation of testicular tissue is its use to potentially preserve the reproductive capacity in prepubertal boys undergoing cancer chemotherapy; the typical cryopreservation of an ejaculate is not an option in these patients. It is hoped that reimplantation of the frozen-thawed testicular stem cells will reinitiate spermatogenesis, or alternatively, spermatogenesis could be attempted in vitro, using frozen-thaw spermatogonia. While these strategies have been explored in animals, there are inadequate human studies.(34,35)

Section Summary

Cryopreservation of testicular tissue in adult men with ozoospermia is a well-established component of the ICSI procedure.

Potential Adverse Effects to Offspring Associated With Reproductive Techniques

Several systematic reviews of the risk of birth defects associated with use of assisted reproductive technologies were published in 2012 and 2013.(36-38) The review with the largest amount of data was published by Hansen et al.(37) They examined 45 cohort studies with outcomes in 92,671 infants born following ART and 3,870,760 naturally conceived infants. In a pooled analysis of the data, there was a higher risk of birth defects in infants born using reproductive techniques (RR=1.32; 95% CI 1.24 to 1.42). The risk of birth defects was also elevated when the analysis was limited to the 6 studies that were conducted in the United States or Canada (RR=1.38; 95% CI, 1.16 to 1.64). A review by Davies et al included data on 308,974 live births in Australia, 6163 of which followed use of ART.(38) There was a higher rate of birth defects after assisted conception (8.3%) compared with births to fertile women that did not involve assisted conception (5.8%) (unadjusted OR=1.47; 95% CI, 1.33 to 1.62). The risk of birth defects was still significantly elevated but was lower in an analysis that adjusted for other factors that might increase risk eg, maternal age, parity, maternal ethnicity, maternal smoking during pregnancy, and socioeconomic status (OR=1.28; 95% CI, 1.16 to 1.41).

Another systematic review published in 2013 addressed risk of childhood and adolescent mental disorders following assisted reproduction.(39) Data from a Danish birth registry, which included 524 children born after IVF or ICSI and 22,009 children born after spontaneous conception, were used for the analysis. In an analysis adjusted for potential confounders, compared with spontaneously conceived children, there was not a statistically significant increase in mental retardation, disorders of psychological development (including autism spectrum disorders, speech and language disorders and others), attention deficit hyperactivity disorder or conduct, emotional or social disorders.

Clinical Input Received Through Physician Specialty Societies and Academic Medical Centers

In response to requests, input was received through 4 physician specialty societies and 2 academic medical centers while this policy was under review in 2012. While the various physician specialty societies and academic medical centers may collaborate with and make recommendations during this process, through the provision of appropriate reviewers, input received does not represent an endorsement or position statement by the physician specialty societies or academic medical centers, unless otherwise noted. There was general agreement that intracytoplasmic sperm injection and cryopreservation of testicular tissue in adult men with azoospermia as part of an intracytoplasmic sperm injection procedure may be considered medically necessary. Three of 5 reviewers who responded agreed that co-culture of embryos is considered investigational. In addition, 4 of 5 reviewers did not agree that blastocyst transfer is investigational; these reviewers considered blastocyst transfer to be medically necessary to decrease multiple gestations. Three of 6 reviewers agreed with the statement that cryopreservation of ovarian tissue or oocytes is investigational. The other 3 reviewers thought that cryopreservation of oocytes, but not ovarian tissue, is medically necessary. Clinical input on other policy statements was more variable.

Summary

Intracytoplasmic sperm injection (ICSI) has a relatively high rate of successful live births for treatment of male factor infertility due to low sperm count and/or impaired sperm motility. ICSI for male factor infertility and cryopreservation of testicular tissue in adult men with azoospermia as part of an ICSI injection procedure received support from clinical reviewers. These techniques may be considered medically necessary. Based on evidence from randomized controlled trials of a higher live birth rate than cleavage-stage embryo transfer, as well as on supportive clinical input, blastocyst transfer may be considered medically necessary. The evidence is insufficient to permit conclusions concerning the effectiveness of the following reproductive techniques: assisted hatching; co-culture of embryos; cryopreservation of ovarian tissue or oocytes; cryopreservation of testicular tissue in prepubertal boys; and storage and thawing of ovarian tissue, oocytes, or testicular tissue. For these procedures, there are insufficient published data on live birth rates and the incidence of multiples and neonatal and child outcomes, compared with established reproductive techniques. Cryopreservation of oocytes has been endorsed by several national guidelines, especially for use by women facing infertility due to chemotherapy. There are limited data on cryopreservation of oocytes and a lack of studies in this population. Therefore, the above procedures are considered investigational.

Practice Guidelines and Position Statements

In 2013, the American Society for Reproductive Medicine (ASRM) and the Society for Assisted Reproductive Technology (SART) published a joint guideline on mature oocyte cryopreservation.(17)

The guideline stated “evidence indicates that oocyte vitrification and warming should no longer be considered experimental” and included the following 4 recommendations:

    • “In patients facing infertility due to chemotherapy or other gonadotoxic therapies, oocyte cryopreservation is recommended with appropriate counseling”
    • “More widespread clinic-specific data on the safety and efficacy of oocyte cryopreservation in donor populations are needed before universal donor oocyte banking can be recommended”
    • “There are not yet sufficient data to recommend oocyte cryopreservation for the sole purpose of circumventing reproductive aging in healthy women”
    • “More data are needed before this technology should be used routinely in lieu of embryo cryopreservation”

In 2014, The American College of Obstetricians and Gynecologists issued a Committee Opinion endorsing the ASRM-SART joint guideline on mature oocyte cryopreservation.(40)

In 2013, the American Society of Clinical Oncology updated a guideline on fertility preservation for patients with cancer.(41) The guideline included the following recommendations.

Males:

“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...”

Females:

“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 patients who do not have a male partner, do not wish to use donor sperm, or have religious or ethical objections to embryo freezing..”.

In May 2008, Agency for Healthcare Research and Quality (AHRQ) published the evidence report/technology assessment, Effectiveness of Assisted Reproductive Technology.(42) The report reviewed the evidence regarding the outcomes of interventions used in ovulation induction, superovulation, and IVF for the treatment of infertility. The authors concluded that interventions for which there was sufficient evidence to demonstrate improved pregnancy or live birth rates included: (a) administration of clomiphene citrate in women with polycystic ovarian syndrome; (b) metformin plus clomiphene in women who fail to respond to clomiphene alone; (c) ultrasound-guided embryo transfer, and transfer on day 5 postfertilization, in couples with a good prognosis; and (d) assisted hatching in couples with previous IVF failure. There was insufficient evidence regarding other interventions. Infertility itself is associated with most of the adverse longer term outcomes. Consistently, infants born after infertility treatments are at risk for complications associated with abnormal implantation or placentation; the degree to which this is due to the underlying infertility, treatment, or both, is unclear. Infertility, but not infertility treatment, is associated with an increased risk of breast and ovarian cancer. The authors concluded that despite the large emotional and economic burden resulting from infertility, there is relatively little high-quality evidence to support the choice of specific interventions. AHRQ’s conclusion was based primarily on studies that had pregnancy rates as the primary end point, not live births. In addition, studies used multiple assisted hatching techniques.

Medicare National Coverage

There is no national coverage determination (NCD). In the absence of an NCD, coverage decisions are left to the discretion of local Medicare carriers.

References:

 

  1. Carney SK, Das S, Blake D et al. Assisted hatching on assisted conception (in vitro fertilisation (IVF) and intracytoplasmic sperm injection (ICSI). Cochrane Database Syst Rev 2012; 12:CD001894.
  2. Practice Committee of Society for Assisted Reproductive Technology Practice, Committee of American Society for Reproductive Medicine. The role of assisted hatching in in vitro fertilization a review of the literature: A Committee Opinion. Fertil Steril 2008; 90(suppl 5):S196-8.
  3. Kervancioglu ME, Saridogan E, Atasu T et al. Human fallopian tube epithelial cell co-culture increases fertilization rates in male factor infertility but not in tubal or unexplained infertility. Hum Reprod 1997; 12(6):1253-8.
  4. Tucker MJ, Morton PC, Wright G et al. Enhancement of outcome from intracytoplasmic sperm injection: does co-culture or assisted hatching improve implantation rates? Hum Reprod 1996; 11(11):2434-7.
  5. Veiga A, Torello MJ, Menezo Y et al. Use of co-culture of human embryos on Vero cells to improve clinical implantation rate. Hum Reprod 1999; 14(suppl 2):112-20.
  6. Wiemer KE, Cohen J, Tucker MJ et al. The application of co-culture in assisted reproduction: 10 years of experience with human embryos. Hum Reprod 1998; 13(suppl 4):226-38.
  7. Rubio C, Simon C, Mercader A et al. Clinical experience employing co-culture of human embryos with autologous human endometrial epithelial cells. Hum Reprod 2000; 15(suppl 6):31-8.
  8. Wetzels AM, Bastiaans BA, Hendriks JC et al. The effects of co-culture with human fibroblasts on human embryo development in vitro and implantation. Hum Reprod 1998; 13(5):1325-30.
  9. Tryde SKL, Yding AC, Starup J et al. Orthotopic autotransplantation of cryopreserved ovarian tissue to a woman cured of cancer – follicular growth, steroid production and oocyte retrieval. Reprod BioMed Online 2004; 8(4):448-53.
  10. Oktay K, Buyuk E, Veeck L et al. Embryo development after heterotopic transplantation of cryopreserved ovarian tissue. Lancet 2004; 363(9412):837-40.
  11. Meirow D, Levron J, Eldar-Geva T et al. Pregnancy after transplantation of cryopreserved ovarian tissue in a patient with ovarian failure after chemotherapy. N Engl J Med 2005; 353(3-Jan):318-21.
  12. Siegel-Itzkovich J. Woman gives birth after receiving transplant of her own ovarian tissue. BMJ 2005; 331(7508):70.
  13. Donnez J, Dolmans MM, Demylle D et al. Livebirth after orthotopic transplantation of cryopreserved ovarian tissue. Lancet 2004; 364(9443):1405-10.
  14. Kim SS, Battaglia DE, Soules MR. The future of human ovarian cryopreservation and transplantation: fertility and beyond. Fertil Steril 2001; 75(6):1049-56.
  15. Lobo RA. Potential options for preservation of fertility in women. N Engl J Med 2005; 353(1):64-73.
  16. Johnson J, Patrizio P. Ovarian cryopreservation strategies and the fine control of ovarian follicle development in vitro. Ann N Y Acad Sci 2011; 1221:40-6.
  17. Practice Committees of American Society for Reproductive Medicine and the Society for Assisted Reproductive Technology. Mature oocyte cryopreservation: a guideline. Fertil Steril 2013; 99(1):37-43.
  18. Cobo A, Meseguer M, Remohi J et al. Use of cryo-banked oocytes in an ovum donation programme: a prospective, randomized, controlled, clinical trial. Hum Reprod 2010; 25(9):2239-46.
  19. Levi Setti PE, Albani E, Morenghi E et al. Comparative analysis of fetal and neonatal outcomes of pregnancies from fresh and cryopreserved/thawed oocytes in the same group of patients. Fertil Steril 2013; 100(2):396-401.
  20. Cil AP, Bang H, Oktay K. Age-specific probability of live birth with oocyte cryopreservation: an individual patient data meta-analysis. Fertil Steril 2013; 100(2):492-9 e3.
  21. Wennerholm UB, Soderstrom-Anttila V, Bergh C et al. Children born after cryopreservation of embryos or oocytes: a systematic review of outcome data. Human Reprod 2009; 24(9):2158-72.
  22. Noyes N. Over 900 oocyte cryopreservation babies born with no apparent increase in congenital anomalies. Reprod BioMed Online 2009; 18(6):769-76.
  23. Glujovsky D, Blake D, Farquhar C et al. Cleavage stage versus blastocyst stage embryo transfer in assisted reproductive technology. Cochrane Database Syst Rev 2012; 7:CD002118.
  24. Maheshwari A, Kalampokas T, Davidson J et al. Obstetric and perinatal outcomes in singleton pregnancies resulting from the transfer of blastocyst-stage versus cleavage-stage embryos generated through in vitro fertilization treatment: a systematic review and meta-analysis. Fertil Steril 2013; 100(6):1615-21 e1-10.
  25. Kallen B, Finnstrom O, Lindam A et al. Blastocyst versus cleavage stage transfer in in vitro fertilization: differences in neonatal outcome? Fertil Steril 2010; 94(5):1680-3.
  26. Practice Committee of Society for Assisted Reproductive Technology, Practice Committee of American Society for Reproductive Medicine. Blastocyst culture and transfer in clinical-assisted reproduction:A Committee Opinion. Fertil Steril 2008; 90(suppl 5):S174-7.
  27. Van Steirteghem AC, Liu J, Joris H et al. Higher success rate by intracytoplasmic sperm injection than by subzonal insemination. Report of a second series of 300 consecutive treatment cycles. Hum Reprod 1993; 8(7):1055-60.
  28. Palermo G, Joris H, Devroey P et al. Pregnancies after intracytoplasmic injection of single spermatozoon into an oocyte. Lancet 1992; 340(8810):17-8.
  29. Palermo G, Joris H, Derde MP et al. Sperm characteristics and outcome of human assisted fertilization by subzonal insemination and intracytoplasmic sperm injection. Fertil Steril 1993; 59(4-Jan):826-35.
  30. Van Steirteghem A. C., Nagy Z., Jori H et al. High fertilization and implantation rates after intracytoplasmic sperm injection. Hum Reprod 1993; 8(7):1061-6.
  31. Fishel S, Timson J, Lisi F et al. Micro-assisted fertilization in patients who have failed subzonal insemination. Hum Reprod 1994; 9(3):501 05 00.
  32. Practice Committee of American Society for Reproductive Medicine and Society for Assisted Reproductive Technology. Intracytoplasmic sperm injection (ICSI) for non-male factor infertility. Available online at: http://www.sart.org/uploadedFiles/ASRM_Content/News_and_Publications/Practice_Guidelines/Committee_Opinions/Intracytoplasmic_sperm.pdf. Last accessed March, 2014.
  33. Dafopoulos K, Griesinger G, Schultze-Mosgau A et al. Cumulative pregnancy rate after ICSI with cryopreserved testicular tissue in non-obstructive azoospermia. Reprod BioMed Online 2005; 10(4):461-6.
  34. Hovatta O. Cryobiology of ovarian and testicular tissue. Best Pract Res Clin Obstet Gynaecol 2003; 17(2):331-42.
  35. Tournaye H, Goossens E, Verheyen G et al. Preserving the reproductive potential of men and boys with cancer: current concepts and future prospects. Hum Reprod Update 2004; 10(6):525-32.
  36. Farhi A, Reichman B, Boyko V et al. Congenital malformations in infants conceived following Assisted Reproductive Technology in comparison with spontaneously conceived infants. J Matern Fetal Neonatal Med 2013.
  37. Hansen M, Kurinczuk JJ, Milne E et al. Assisted reproductive technology and birth defects: a systematic review and meta-analysis. Hum Reprod Update 2013.
  38. Davies MJ, Moore VM, Willson KJ et al. Reproductive technologies and the risk of birth defects. N Engl J Med 2012; 366(19):1803-13.
  39. Bay B, Mortensen EL, Hvidtjorn D et al. Fertility treatment and risk of childhood and adolescent mental disorders: register based cohort study. BMJ 2013; 347:f3978.
  40. American College of Obstetricians and Gynecologists (ACOG). Committee opinion no. 584: oocyte cryopreservation. Obstet Gynecol 2014; 123(1):221-2.
  41. Loren AW, Mangu PB, Beck LN et al. Fertility preservation for patients with cancer: American Society of Clinical Oncology clinical practice guideline update. J Clin Oncol 2013; 31(19):2500-10.
  42. Agency for Healthcare Research and Quality (AHRQ). Effectiveness of Assisted Reproductive Technology. Available online at: http://www.ahrq.gov/research/findings/evidence-based-reports/er167-abstract.html. Last accessed March, 2014.

 

Codes

Number

Description

CPT  54500  Biopsy of testis, needle 
  54800  Biopsy of epididymis, needle 
  55400  Vasovasostomy, vasovasorrhaphy 
  55870  Electroejaculation 
  58321  Artificial insemination; intra-cervical 
  58322  Artificial insemination; intra-uterine 
  58323  Sperm washing for artificial insemination 
  58970  Follicle puncture for oocyte retrieval, any method 
  58974  Embryo transfer, intra-uterine 
  58976  Gamete, zygote, or embryo intra-fallopian transfer, any method 
  89240 unlisted miscellaneous pathology test
  89250  Culture of oocyte(s)/embryo(s), less than 4 days 
  89251  Culture of oocyte(s); with co-culture of embryos 
  89253  Assisted embryo hatching, microtechniques (any method) 
  89254  Oocyte identification from follicular fluid 
  89255  Preparation of embryo for transfer (any method) 
  89257  Sperm identification from aspiration (other than seminal fluid) 
  89258  Cryopreservation; embryo(s) 
  89259  Cryopreservation; sperm 
  89260 – 89261  Sperm isolation, code range 
  89264  Sperm identification from testis tissue, fresh or cryopreserved 
  89268  Insemination of oocytes 
  89272  Extended culture of oocyte(s)/embryo(s), 4-7 days 
  89280–89281  Assisted oocyte fertilization, microtechnique; less than or more than 10 oocytes, respectively 
  89335  Cryopreservation, reproductive tissue, testicular 
  89337 Cryopreservation, mature oocyte(s)
  89342–89346  Yearly storage of various reproductive tissues code range 
  89352  Thawing of cryopreserved embryo (s) 
  89353  Thawing of cryopreserved; sperm/semen, each aliquot 
  89354  Thawing of cryopreserved reproductive tissue, testicular/ovarian 
  89356  Thawing of cryopreserved oocytes, each aliquot 
ICD-9 Procedure  62.11  Closed biopsy of testis 
  62.91  Aspiration of testis 
  63.01  Biopsy of spermatic cord, epididymis, or vas deferens 
  63.09  Other diagnostic procedures on spermatic cord, epididymis, and vas deferens 
  63.81 – 63.89  Suture of laceration of vas deferens and epididymis 
  63.92  Epididymotomy 
  64.99  Other operations on male genital organs 
  65.99  Other operations on ovary 
  69.92  Artificial insemination 
  71.9  Other operations on female genital organs 
  99.96  Collection of sperm for artificial insemination 
  99.99  Other miscellaneous procedures 
ICD-9 Diagnosis  606.0–606.9  Male infertility, code range 
  614.6  Pelvic peritoneal adhesions, female 
  617.3  Endometriosis of pelvic peritoneum 
  628.0 – 628.9  Female infertility, code range 
HCPCS  S4011  In vitro fertilization: including but not limited to identification and incubation of mature oocytes, fertilization with sperm, incubation of embryo(s), and subsequent visualization for determination of development 
  S4013  Complete cycle, gamete intrafallopian transfer (GIFT), case rate 
  S4014  Complete cycle, zygote intrafallopian transfer (ZIFT), case rate 
  S4015  Complete in vitro fertilization cycle, case rate 
  S4016  Frozen in vitro fertilization cycle, case rate 
  S4017  Incomplete cycle, treatment canceled prior to stimulation, case rate 
  S4018  Frozen embryo transfer procedure cancelled before transfer, case rate 
  S4020  In vitro fertilization procedure cancelled before aspiration, case rate 
  S4021  In vitro fertilization procedure cancelled after aspiration, case rate 
  S4022  Assisted oocyte fertilization, case rate 
  S4023  Donor egg cycle, incomplete, case rate 
  S4025  Donor services for in vitro fertilization (sperm or embryo), case rate 
  S4026  Procurement of donor sperm from sperm bank 
  S4027  Storage of previously frozen embryos 
  S4028  Microsurgical epididymal sperm aspiration 
  S4030, S4031  Sperm procurement and cryopreservation services, initial and subsequent visit, respectively 
  S4035  Stimulated intrauterine insemination, case rate 
  S4036  Intravaginal culture (IVC), case rate 
  S4037  Cryopreserved embryo transfer, case rate 
  S4040  Monitoring and storage of cryopreserved embryos, per 30 days 
  S4042  Management of ovulation induction (interpretation of diagnostic tests and studies, non-face-to-face medical management of the patient), per cycle 
ICD-10-CM (effective 10/1/15)  N46.01-N46.9 Male infertility, code range  
    73.6 Female pelvic peritoneal adhesions  
    N80.1-N80.9 Endometriosis code range  
    N97.1-N97.9   Female infertility, code range  
  N99.4 Postprocedural pelvic peritoneal adhesions  
ICD-10-PCS (effective 10/1/15)    ICD-10-PCS codes are only used for inpatient services.  
   0V993ZX, 0V994ZX, 0V9B3ZX, 0V9B4ZX, 0V9C3ZX, 0V9C4ZX Surgical, drainage, testis, diagnostic, code by body part (right, left or bilateral) and approach (percutaneous, percutaneous endoscopic)  
   0V9B3ZZ, 0V9C3ZZ, 0V993ZZ Surgical, drainage, testis, percutaneous, code by body part (right, left or bilateral) and approach (percutaneous, percutaneous endoscopic)  
   0VB93ZX, 0VB94ZX, 0VBB3ZX, 0VBB4ZX, 0VBC3ZX, 0VBC4ZX Surgical, excision, testis, diagnostic, code by body part (right, left or bilateral) and approach (percutaneous, percutaneous endoscopic)  
   0V9F0ZX, 0V9F3ZX, 0V9F4ZX, 0V9G0ZX, 0V9G3ZX, 0V9G4ZX, 0V9H0ZX, 0V9H3ZX, 0V9H4ZX Surgical, drainage, spermatic cord, diagnostic, code by body part (right, left or bilateral) and approach (open, percutaneous, percutaneous endoscopic)  
   0V9J0ZX, 0V9J3ZX, 0V9J4ZX, 0V9K0ZX, 0V9K3ZX, 0V9K4ZX, 0V9L0ZX, 0V9L3ZX, 0V9L4ZX  Surgical, drainage, epididymis, diagnostic, code by body part (right, left or bilateral) and approach (open, percutaneous, percutaneous endoscopic)  
    0V9N0ZX, 0V9N3ZX, 0V9N4ZX, 0V9P0ZX, 0V9P3ZX, 0V9P4ZX, 0V9Q0ZX, 0V9Q3ZX, 0V9Q4ZX  Surgical, drainage, vas deferens, diagnostic, code by body part (right, left or bilateral) and approach (open, percutaneous, percutaneous endoscopic)  
    0VBF0ZX, 0VBF3ZX, 0VBF4ZX, 0VBG0ZX, 0VBG3ZX, 0VBG4ZX, 0VBH0ZX, 0VBH3ZX, 0VBH4ZX Surgical, excision, spermatic cord, diagnostic, code by body part (right, left or bilateral) and approach (percutaneous, percutaneous endoscopic)  
    0VBJ0ZX, 0VBJ3ZX, 0VBJ4ZX, 0VBK0ZX, 0VBK3ZX, 0VBK4ZX, 0VBL0ZX, 0VBL3ZX, 0VBL4ZX  Surgical, excision, epididymis, diagnostic, code by body part (right, left or bilateral) and approach (percutaneous, percutaneous endoscopic)  
    0VBN0ZX, 0VBN3ZX, 0VBN4ZX, 0VBP0ZX, 0VBP3ZX, 0VBP4ZX, 0VBQ0ZX, 0VBQ3ZX, 0VBQ4ZX  Surgical, excision, vas deferens, diagnostic, code by body part (right, left or bilateral) and approach (percutaneous, percutaneous endoscopic)  
   0VJM0ZZ   Surgical, inspection, epididymis and spermatic cord, open  
   0VJR0ZZ Surgical, inspection, vas deferens, open  
   0VQJ0ZZ, 0VQJ3ZZ, 0VQJ4ZZ, 0VQK0ZZ, 0VQK3ZZ, 0VQK4ZZ, 0VQL0ZZ, 0VQL3ZZ, 0VQL4ZZ  Surgical, repair, epididymis, code by body part (right, left or bilateral) and approach (percutaneous, percutaneous endoscopic)  
   0VQN0ZZ, 0VQN3ZZ, 0VQN4ZZ, 0VQP0ZZ, 0VQP3ZZ, 0VQP4ZZ, 0VQQ0ZZ, 0VQQ3ZZ, 0VQQ4ZZ  Surgical, repair, vas deferens, code by body part (right, left or bilateral) and approach (percutaneous, percutaneous endoscopic)  
   0V1N07J, 0V1N07K, 0V1N07N, 0V1N07P Surgical, bypass, right vas deferens, open, autologous tissue substitute, code by qualifier (right or left epididymis, right or left vas deferens)  
   0V1N0JJ, 0V1N0JK, 0V1N0JN, 0V1N0JP  Surgical, bypass, right vas deferens, open, synthetic substitute, code by qualifier (right or left epididymis, right or left vas deferens)  
   0V1N0KJ, 0V1N0KK, 0V1N0KN, 0V1N0KP Surgical, bypass, right vas deferens, open, nonautologous tissue, code by qualifier (right or left epididymis, right or left vas deferens)  
   0V1N0ZJ, 0V1N0ZK, 0V1N0ZN, 0V1N0ZP Surgical, bypass, right vas deferens, open, no device, code by qualifier (right or left epididymis, right or left vas deferens)  
   0V1N47J, 0V1N47K, 0V1N47N, 0V1N47P Surgical, bypass, right vas deferens, percutaneous endoscopic, autologous tissue substitute, code by qualifier (right or left epididymis, right or left vas deferens)  
   0V1N4JJ, 0V1N4JK, 0V1N4JN, 0V1N4JP Surgical, bypass, right vas deferens, percutaneous endoscopic, synthetic substitute, code by qualifier (right or left epididymis, right or left vas deferens)  
  0V1N4KJ, 0V1N4KK, 0V1N4KN, 0V1N4KP  Surgical, bypass, right vas deferens, percutaneous endoscopic, nonautologous tissue, code by qualifier (right or left epididymis, right or left vas deferens)  
  0V1N4ZJ, 0V1N4ZK, 0V1N4ZN, 0V1N4ZP  Surgical, bypass, right vas deferens, open, no device, code by qualifier (right or left epididymis, right or left vas deferens)  
  0V1P07J, 0V1P07K, 0V1P07N, 0V1P07P  Surgical, bypass, left vas deferens, open, autologous tissue substitute, code by qualifier (right or left epididymis, right or left vas deferens)  
   0V1P0JJ, 0V1P0JK, 0V1P0JN, 0V1P0JP Surgical, bypass, left vas deferens, open, synthetic substitute, code by qualifier (right or left epididymis, right or left vas deferens)  
   0V1P0KJ, 0V1P0KK, 0V1P0KN, 0V1P0KP Surgical, bypass, left vas deferens, open, nonautologous tissue, code by qualifier (right or left epididymis, right or left vas deferens)  
   0V1P0ZJ, 0V1P0ZK, 0V1P0ZN, 0V1P0ZP Surgical, bypass, left vas deferens, open, no device, code by qualifier (right or left epididymis, right or left vas deferens)  
   0V1P47J, 0V1P47K, 0V1P47N, 0V1P47P   Surgical, bypass, left vas deferens, percutaneous endoscopic, autologous tissue substitute, code by qualifier (right or left epididymis, right or left vas deferens)  
   0V1P4JJ, 0V1P4JK, 0V1P4JN, 0V1P4JP  Surgical, bypass, left vas deferens, percutaneous endoscopic, synthetic substitute, code by qualifier (right or left epididymis, right or left vas deferens)  
   0V1P4KJ, 0V1P4KK, 0V1P4KN, 0V1P4KP Surgical, bypass, left vas deferens, percutaneous endoscopic, nonautologous tissue, code by qualifier (right or left epididymis, right or left vas deferens)  
   0V1P4ZJ, 0V1P4ZK, 0V1P4ZN, 0V1P4ZP   Surgical, bypass, left vas deferens, open, no device, code by qualifier (right or left epididymis, right or left vas deferens)  
   0V1Q07J, 0V1Q07K, 0V1Q07N, 0V1Q07P  Surgical, bypass, bilateral vas deferens, open, autologous tissue substitute, code by qualifier (right or left epididymis, right or left vas deferens)  
   0V1Q0JJ, 0V1Q0JK, 0V1Q0JN, 0V1Q0JP  Surgical, bypass, bilateral vas deferens, open, synthetic substitute, code by qualifier (right or left epididymis, right or left vas deferens)  
   0V1Q0KJ, 0V1Q0KK, 0V1Q0KN, 0V1Q0KP  Surgical, bypass, bilateral vas deferens, open, nonautologous tissue, code by qualifier (right or left epididymis, right or left vas deferens)  
   0V1Q0ZJ, 0V1Q0ZK, 0V1Q0ZN, 0V1Q0ZP   Surgical, bypass, bilateral vas deferens, open, no device, code by qualifier (right or left epididymis, right or left vas deferens) 
   0V1Q47J, 0V1Q47K, 0V1Q47N, 0V1Q47P  Surgical, bypass, bilateral vas deferens, percutaneous endoscopic, autologous tissue substitute, code by qualifier (right or left epididymis, right or left vas deferens)  
   0V1Q4JJ, 0V1Q4JK, 0V1Q4JN, 0V1Q4JP   Surgical, bypass, bilateral vas deferens, percutaneous endoscopic, synthetic substitute, code by qualifier (right or left epididymis, right or left vas deferens)  
   0V1Q4KJ, 0V1Q4KK, 0V1Q4KN, 0V1Q4KP Surgical, bypass, bilateral vas deferens, percutaneous endoscopic, nonautologous tissue, code by qualifier (right or left epididymis, right or left vas deferens)  
   0V1Q4ZJ, 0V1Q4ZK, 0V1Q4ZN, 0V1Q4ZP  Surgical, bypass, bilateral vas deferens, open, no device, code by qualifier (right or left epididymis, right or left vas deferens) 
   0VQN0ZZ, 0VQN3ZZ, 0VQN4ZZ, 0VQP0ZZ, 0VQP3ZZ, 0VQP4ZZ, 0VQQ0ZZ, 0VQQ3ZZ, 0VQQ4ZZ Surgical, repair, vas deferens, code by body part (right, left or bilateral) and approach (open, percutaneous, or percutaneous endoscopic)  
   0VPR0DZ, 0VPR3DZ, 0VPR4DZ, 0VPR7DZ, 0VPR8DZ  Surgical, removal, vas deferens, intraluminal device, code by approach (open, percutaneous, percutaneous endoscopic, via natural or artificial opening, or via natural or artificial opening endoscopic)  
   0V9J00Z, 0V9J0ZZ, 0V9J30Z, 0V9J3ZZ, 0V9J40Z, 0V9J4ZZ, 0V9K00Z, 0V9K0ZZ, 0V9K30Z, 0V9K3ZZ, 0V9K40Z, 0V9K4ZZ, 0V9L00Z, 0V9L0ZZ, 0V9L30Z, 0V9L3ZZ, 0V9L40Z, 0V9L4ZZ Surgical, drainage, epididymis, code by body part (right, left or bilateral), approach (open, percutaneous, percutaneous endoscopic) and device (drainage device or no device)  
   0VCJ0ZZ, 0VCJ3ZZ, 0VCJ4ZZ, 0VCK0ZZ, 0VCK3ZZ, 0VCK4ZZ, 0VCL0ZZ, 0VCL3ZZ, 0VCL4ZZ Surgical, extirpation, epididymis, code by body part (right, left or bilateral), and approach (open, percutaneous, percutaneous endoscopic)  
   0WQM0ZZ, 0WQM3ZZ, 0WQM4ZZ, 0WQMXZZ Surgical, repair, male perineum, code by approach (open, percutaneous, percutaneous endoscopic or external)  
   0WWM07Z,WWM0KZ, 0WWM37Z, 0WWM3KZ, 
0WWM47Z, 0WWM4KZ
Surgical, revision, male perineum, code by approach (open, percutaneous, percutaneous endoscopic) and device (autologous tissue substitute, nonautologous tissue substitute)  
   0U804ZZ, 0U814ZZ, 0U824ZZ Surgical, division, ovary, percutaneous endoscopic, code by body part (right, left or bilateral)  
     3E0P3LZ, 3E0P7LZ Administration, physiological systems and anatomical regions, introduction, female reproductive, sperm, code by approach (percutaneous or via natural or artificial opening)  
   3E0P3Q0, 3E0P7Q0, 3E0P3Q1, 3E0P7Q1 Administration, physiological systems and anatomical regions, introduction, female reproductive, fertilized ovum, code by approach (percutaneous or via natural or artificial opening) and qualifier (autologous or nonautologous) 
   0WQN0ZZ, 0WQN3ZZ, 0WQN4ZZ, 0WQNXZZ   Surgical, repair, female perineum, code by approach (open, percutaneous, percutaneous endoscopic or external)  
   8E0VX63   Other procedure, male reproductive system, external, collection, sperm 
Type of Service  Ob-Gyn; Reproductive 
Place of Service  Physician Office 


Index

Assisted Hatching
Assisted Oocyte Fertilization
Assisted Reproductive Technologies
Cryopreservation, Oocyte, Ovarian Tissue
Electroejaculation
Embryo Co-culture
ICSI
Intracytoplasmic Sperm Injection
In Vitro Fertilization
Zona Drilling
 


Policy History

Date Action Reason
04/01/98 Add to Medicine section New policy
07/10/98 Replace policy This policy was revised to correct a typo
11/15/98 Replace policy Policy review; revised based on new 1999 CPT code
10/08/02 Replace policy Policy updated with literature review; review focused on co-culture techniques; policy statement unchanged
12/17/03 Replace policy Policy updated with literature review; additional policy statements added regarding cryopreservation, storing and thawing of ovarian tissue and oocytes (investigational). Additional CPT codes and HCPCS codes added.
03/15/05 Replace policy Policy updated with literature search; policy statement unchanged; references added (No. 25, 26)
04/25/06 Replace policy Policy updated with literature search; policy statement revised to include statement regarding cryopreservation of testicular tissue; references 28-32, 35-39 added. Coding references updated.
02/14/08 Replace policy  Policy updated with literature search; references 40, 41 added policy statements unchanged
04/24/09 Replace policy  Policy updated with literature search through January 2009; reference numbers 41-43 added; policy title change from “Assisted Reproductive Technologies” to “Reproductive Techniques”; policy statements unchanged
03/08/12 Replace policy Policy updated with literature review through January 2012. Rationale re-written; reference numbers 8, 17-20, 28 30-33 added; other references re-numbered/ removed. Clinical input added. Policy statement changed to include blastocyst transfer as medically necessary.
4/11/13 Replace policy Policy updated with literature review through March 12, 2013. Reference numbers 1, 22, 31 and 35-37 added; other references re-numbered/removed. In the medically necessary policy statement, ‘intracytoplasmic sperm injection’ changed to ‘intracytoplasmic sperm injection for male factor infertility.”
06/13/13 Replace policy - correction only Reference 21 added. This is a 2013 guideline on mature oocyte cryopreservation from the American Society of Reproductive Medicine (ASRM) and the Society for Assisted Reproductive Technology (SART).
4/10/14 Replace policy Policy updated with literature review through February 24, 2014. Reference numbers 18-20, 24, and 39-41 added. Policy statements unchanged.