Archived Policies - OBGYN
Assisted Reproductive Technologies and Related Services
Coverage of Assisted Reproductive Technologies (ART) is primarily a contract-specific benefit issue. When benefits for ART are available in a benefit contract or summary plan description (SPD) (a written explanation of the eligibility for and benefits available to employees required by ERISA), the services stated as eligible in the coverage section of this policy will be covered, but only if medically necessary.
When the diagnosis and treatment of infertility is eligible for coverage per benefit contract, covered services include, but are not necessarily limited to:
Therapeutic drugs (including but not limited to self injectables) such as hormones, danazol, Parlodel, clomiphene citrate, Pergonal, Metrodin, etc. may be eligible for benefits if ART, AI or IUI are covered benefits. (Check all appropriate pharmacy and medical contract provisions as some pharmacy/medical plans may exclude infertility drugs).
The following services are considered experimental, investigational and unproven:
Note: Cryopreservation of testicular tissue may be considered medically necessary in adult men with azospermia as part of an ICSI procedure. (Check all contract benefits as cryopreservation may be a contract exclusion).
The following related services to ART are not allowed under most benefit contracts. These Related Services include but are not limited to:
Immunotherapy for Recurrent Fetal Loss
Immunologic-based therapies to avoid recurrent spontaneous abortion are considered experimental, investigational, and unproven. Such therapies include but are not limited to:
Note: Refer to the Medical Policy on Natural Killer (NK) Cells for coverage when this testing is performed for a diagnosis of infertility.
ART refers to an array of interventions designed to establish a viable pregnancy for couples who have been diagnosed with infertility, due either to female factors (i.e., pelvic adhesions, ovarian dysfunction, endometriosis, and prior tubal ligation), male factors (i.e., abnormalities in sperm production, function, or transport, or prior vasectomy), a combination of both male and female factors, or unknown causes. In most instances, an ART will incorporate some type of IVF 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. [The latter procedure is also known as zygote intrafallopian transfer (ZIFT)]. 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, a procedure known as gamete intrafallopian transfer (GIFT).
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, i.e., the laboratory procedures, which are performed on the collected oocyte and sperm. The final step is the implantation procedure. Preimplantation genetic diagnosis, which may be performed as an adjunct to ART as a technique to deselect embryos carrying genetic abnormalities, is addressed separately in another policy.
Procedures performed on the Female
Procedures performed on the Male
InVitro Laboratory Procedures
Immunotherapy for Recurrent Fetal Loss
Recurrent spontaneous abortion (RSA) or recurrent fetal loss is defined as three or more pregnancies resulting in a spontaneous abortion prior to 16–20 weeks of gestational age. RSA may be caused by genetic, anatomic, endocrinologic, or autoimmune abnormalities.
Laboratory Tests of Sperm Maturity and Function
Sperm Penetration Assay (SPA)
The SPA is a multistep laboratory test that offers a biological assessment of human sperm fertilizing ability. Specifically, four distinct processes must occur for sperm-oocyte fertilization: capacitation, acrosome reaction, penetration of the ooplasm, and chromatin decondensation within the ooplasm. The SPA uses a zona-free hamster egg as an in vitro model for sperm-oocyte interaction. (The zona pellucida is a thick, glassy membrane surrounding the oocyte that maintains species specificity for fertilization. Removal of the zona pellucida from hamster ova permits their use as a model for sperm oocyte interaction.) The test is performed by incubating a number of zona-free hamster eggs with human sperm for several hours. According to the percentage of ova penetrated, the semen sample is rated as being in a potentially “fertile” or “infertile” range. Aspects of sperm function not assessed by the SPA include the capacity of sperm to penetrate the cervical barrier or their ability to bind to the zona pellucida of human ova. The sperm penetration assay, alternatively referred to as the hamster oocyte penetration test or the zona-free hamster egg test, was initially developed in 1976. Although it has been used as a test for male infertility, the test has been controversial due to variability in procedures used by different laboratories, poor reproducibility of test outcomes, and uncertainty regarding the range of normal values.
Hyaluronan Binding Assay (HBA):
The HBA is a qualitative assay for the maturity of sperm in a fresh semen sample. The assay is based on the ability of mature, but not immature, sperm to bind hyaluronan, the main mucopolysaccharide of the cumulus oophorus matrix and a component of human follicular fluid. Research has shown that hyaluronan-binding capacity is acquired late in the sperm maturation process; immature sperm lack this ability. Therefore, a low level of sperm binding to hyaluronan suggests that there is a low proportion of mature sperm in the sample. Similar to the sperm penetration assay, it has been suggested that the HBA assay may be used to determine the need for a procedure (ICSI) as part of an assisted reproductive technique. The HBA is a laboratory test that has received U.S. Food and Drug Administration (FDA) clearance through the 510(k) approval process. The FDA-labeled indications are as follows:
It is suggested that patients with poor binding capacity bypass intrauterine insemination and traditional IVF and proceed directly to ICSI.
Note: Both of the tests are laboratory tests that are frequently performed as part of an ART. procedure.
The majority of procedure codes describing the various steps in ART procedures are longstanding techniques. Only the relatively new ART techniques, i.e., intracytoplasmic sperm injection, assisted hatching, co-culture of embryos, and cryopreservation of reproductive tissue (i.e., testicular, ovarian, or oocytes) will be discussed in this rationale.
Intracytoplasmic Sperm Injection (ICSI):
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 sub-zonal 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. These rates are very competitive with standard IVF. In 1994, the American Society of Reproductive Medicine issued a policy statement that stated that ICSI could no longer be considered investigational in patients with male factor infertility.
One key component of a successful attempt at IVF is implantation of the embryo in the uterus. Although the exact steps in implantation are poorly understood, one 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 IVF, the zona pellucid 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 (i.e., assisted hatching) has been proposed as a mechanism to improve implantation rates. Schoolcraft and colleagues reported that in patients over the age of 40 or who had failed prior attempts at implantation or when the embryos had a thick zona pellucida, assisted hatching was associated with a clinical pregnancy rate per transferred embryo of 33% compared to 6.5% in a control group. There is no evidence that assisted hatching should be routinely performed as part of IVF procedures.
In routine IVF procedures, the embryo is transferred to the uterus on day two or three of development, when it has between four and eight 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, thus hopefully improving the implantation and pregnancy rate. In addition, if the 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 (i.e., oviducts) to non-human cells (i.e., fetal bovine uterine or oviduct cells) to established cell lines (i.e., 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. For example, Wetzels and colleagues reported on a study that randomized IVF treatments to include co-culture with human fibroblasts or no culture. Patients in the two 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. An updated literature review for the period of 2003 through November 2004 did not identify any additional published studies that would prompt reconsideration of the relevant policy statement.
Culture for Greater than Four Days (i.e., Blastocyst Transfer)
In 2004, a new CPT code (89272) was introduced to describe extended culture of oocytes/embryos, i.e., for greater than four days. The development of commercially available sequential media designed to reproduce the changes in nutrient requirements as the embryo develops has permitted the extended culture of embryos to the blastocyst stage, at which point the embryos are transferred. 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. It should be noted that embryos that progress to the blastocyst stage in vitro have demonstrated improved viability compared to earlier stage embryos, some of which inevitably fail to progress. In essence, blastocyst culture allows one to select the best quality embryos with the highest implantation potential. Therefore, due to this inherent selection bias, the pregnancy rate with blastocyst transfer is expected to be greater than that of day three embryo transfers. The major impact of blastocyst transfer is the anticipated decrease in incidence of multiple gestations. Gardner and colleagues reported on a trial that randomized IVF treatment to either embryo transfer after the eight-cell stage vs. blastocyst stage. While the clinical pregnancy rate was the same in the two groups (66% and 71%, respectively), the mean number of embryos transferred was lower in the blastocyst group (2.2 vs. 3.7, respectively). The authors concluded that the ability to transfer just two blastocysts while maintaining high pregnancy rates will help to eliminate high-order multiple gestations. Karaki and colleagues also reported on a randomized trial comparing day three transfers compared to blastocyst transfer. Significantly fewer embryos were required for transfer at the blastocyst state compared with day three embryos, and the higher order gestation rate was also significantly less with blastocyst transfer (4% vs. 19%). Other randomized studies and case series have also reported that blastocyst transfer is associated with an improved implantation rate and a reduction in the incidence of higher order gestations. It should be noted that not all women undergoing IVF would be considered candidates for blastocyst transfer. For example, if a woman responds poorly to ovarian stimulation therapy and few eggs are harvested (i.e., <3), there is a certain risk of opting for prolonged embryo culture to the blastocyst stage; in some cases, the embryos will die before reaching the blastocyst stage, and thus there will be no embryo to transfer.
Cryopreservation of Ovarian Tissue
Cryopreservation of ovarian tissue 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, and there are a few individual case reports of return of ovarian function using this technique. However, in general, the technique is not standardized, has been investigated more thoroughly in animal models, and has not been widely applied to humans. S.S.Kim and colleagues identify the following unresolved issues:
Cryopreservation of Oocytes
Unlike cryopreservation of ovarian tissue, cryopreservation of oocytes is less commonly performed in the setting of malignancy due to the time constraints inherent in ovarian stimulation. Therefore, oocyte cryopreservation has been primarily investigated as an alternative to embryo cryopreservation due to ethical or religious reasons. 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. Due to these factors, there is a poor survival of cryopreserved oocytes after thawing. Survival after thawing may also be associated with sub lethal damage, which may further impact the quality of the subsequent embryo. While several individual cases of successful pregnancies have been reported, the technique for cryopreservation and thawing of oocytes has not been standardized. It is estimated that the implantation rate of embryos derived from cryopreserved oocytes is about 4%.
Cryopreservation of Testicular Tissue
Testicular sperm extraction (TESE) refers to the collection of sperm from testicular tissue in men with azoospermia. TESE 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. Alternately, the entire tissue sample can be cryopreserved with a 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 of the tissue sample eliminates the need for multiple biopsies to obtain fresh tissue in the event of a failed initial ICSI cycle. However, a unique application of testicular tissue is its use to potentially preserve the reproductive capacity in a prepubertal boy undergoing cancer chemotherapy; the typical cryopreservation of an ejaculate is not an option in these patients. It is hoped that re-implantation of the frozen-thawed testicular stem cells will re-initiate spermatogenesis, or alternatively, spermatogenesis could be attempted in vitro, using frozen-thawed spermatagonia. While these strategies have been explored in animals, there are inadequate human studies.
Laboratory Tests of Sperm Maturity and Function
Sperm Penetration Assay (SPA)
Originally, the SPA was used primarily as a diagnostic technique for male infertility. More recently, the advent of sperm micromanipulation techniques, specifically ICSI, has changed the role of IVF and changed the role of SPA. IVF was originally developed as a treatment option for women with irreversible tubal damage, but the development of sperm micromanipulation techniques as an adjunct to IVF has now expanded the indications for IVF to those with severe male factor infertility. Thus, SPA can be used to identify those normospermic patients who would benefit from ICSI or other adjuncts to IVF. In 2001, Freeman and colleagues reported on the diagnostic accuracy of sperm penetration assay in predicting success of in vitro fertilization. Among 216 couples, the sperm penetration assay predicted IVF with high negative (84%) and positive (98%) predictive value, with correct prediction in 88% of cycles. While there is still concern regarding standardization of the procedure, these results suggest that the results of the SPA can be used to select patients for ICSI.
Hyaluronan Binding Assay (HBA)
The HBA has been proposed as a component of the standard analysis of semen in the diagnosis of suspected male infertility. In addition, it potentially represents a more convenient and reproducible laboratory test for identifying candidates for ICSI. However, published scientific data were inadequate to permit conclusions regarding either of these indications. A literature search identified two published articles that discussed the biologic basis of the HBA, but no articles were identified that established the diagnostic performance of the test (i.e., establishment of positive and negative cut-off values, sensitivity, specificity, positive and negative predictive values) or examined the clinical role of the test. The package insert also does not provide adequate data to evaluate the diagnostic performance of the test.
Paternal or Fetal Antigen Immunotherapy for Recurrent Fetal Loss
This policy was originally based on a 1995 TEC Assessment (1) that concluded that paternal or fetal antigen immunotherapy did not meet the TEC criteria as a treatment of recurrent spontaneous abortion. A search of literature was completed through the MEDLINE database for the period of 1995 through November 2003. The search did not identify any randomized controlled trials published during this period. Therefore the policy statement is unchanged.
IVIG as a treatment of recurrent spontaneous abortion (RSA)
The policy on IVIG as a treatment of RSA is based on a 1998 TEC Assessment, which offered the following conclusions:
Four randomized, blinded, controlled trials of IVIG have focused on this patient population. Only one of these trials showed a significant treatment effect. The treatment effect of the four trials was summarized by meta-analysis; the overall relative risk and odds ratio values and their confidence intervals indicate no significant treatment effect. Two subsequent meta-analyses of five and six trials concluded that IVIG provides no significant beneficial effect over placebo in preventing further miscarriages. A blinded randomized, controlled trial (RCT) of 41 women treated with IVIG or saline placebo found no differences in live birth rates. A multicenter RCT comparing heparin and low-dose aspirin with versus without IVIG in women with lupus anticoagulant, anticardiolipin antibody, or both, found no significant differences. More recently, an RCT of 58 women with at least four unexplained miscarriages tested IVIG versus placebo and analyzed results by intention to treat. The live birth rate was the same for both groups; also, there was no difference in neonatal data. Other non-randomized but controlled trials also report no benefit for IVIG treatment. There is insufficient evidence RCTs or other trials to support benefit in secondary (live birth followed by consecutive spontaneous abortions) versus primary (no prior live births) spontaneous pregnancy loss. A variety of immunologic tests may precede the initiation of IVIG therapy. These tests, including various subsets of lymphocytes, Human Leukocyte Antigen (HLA) (markers that identify cells as "self" and prevent the immune system from attacking) testing, and lymphocyte functional testing (i.e., natural killer cell assays and the embryo cytotoxicity test), are research tools that explore subtle immunologic disorders that may contribute to maternal immunologic tolerance of the fetus. However, there are no clinical data that indicate the results of these tests can be used in the management of patients to reduce the incidence of RSA particularly since IVIG therapy has not been shown to be an effective therapy.
Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply. If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.
Contract limitations may apply, such as dollar caps on infertility benefits.
The information contained in this section is for informational purposes only. HCSC makes no representation as to the accuracy of this information. It is not to be used for claims adjudication for HCSC plans.
Medicare does not have a national position on this service. It is subject to local carrier discretion, Refer to the local carrier for more information.
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|Title:||Effective Date:||End Date:|
|Reproductive Technologies or Techniques and Related Services||10-01-2018||12-31-2018|
|Reproductive Technologies or Techniques and Related Services||10-01-2016||09-30-2018|
|Reproductive Technologies or Techniques and Related Services||11-01-2015||09-30-2016|
|Reproductive Technologies or Techniques and Related Services||07-01-2014||10-31-2015|
|Assisted Reproductive Technologies (ART) and Related Services||05-15-2010||06-30-2014|
|Assisted Reproductive Technologies and Related Services||01-01-2007||05-14-2010|
|Assisted Reproductive Technologies||07-01-1999||12-31-2006|