Examining Veterans' Experiences With In Vitro Fertilization Provided Under P.L. 114-223.

We conducted in-depth qualitative interviews between May-September 2021 with Veterans and their spouses who had been approved by VA to receive ART services since October 2018. The study team received a list of 714 Veterans and their spouses from the VA Office of Community Care (OCC)/VA Office of Women’s Health who had been approved for ART. Four hundred and ten Veterans and spouses were randomly selected for an interview, and of these, 166 Veterans and spouses responded and agreed to participate (40% response rate). Of this number, 96 Veterans and spouses were interviewed. Those who agreed to participate but did not interview failed to respond to requests to set up an interview time. Veterans and their spouses were able to participate in the interviews either by calling into the Microsoft Teams number or by participating by video. Interviews were between 30 and 60 minutes in length. Interviews were digitally recorded for later qualitative analyses. In addition, we analyzed the approximate distance between the ZIP codes of all Veterans who had been approved for ART services at any time between 2018-2021 and the ZIP code of the nearest available VA-contracted fertility clinic as of October 2021. These ZIP codes were obtained from the VA Office of Community Care and mapped using ArcMap version 10.5. Shapefiles from the US Census Bureau Database were used to create ZIP code boundary polygons 13 . The ArcMap Service Areas tool was used to calculate driving time and distance between Veteran ZIP codes and the distance to the closest approved infertility clinic. We were able to match 700 of 707 Veteran ZIP codes (99%) to a known ZIP code for mapping. Of 1,359 unique IVF clinic ZIP codes, we were able to match 1,357 (99%) to a known ZIP code for mapping. Of the 700 ZIP codes that matched, 625 were unique and included in our analysis. This study was deemed a quality improvement assessment by the VA and therefore did not undergo formal VA IRB approval. A semi-structured telephone interview guide was developed by the study team, including clinical and programmatic input from the VA Office of Women’s Health Services (WHS) and VA Office of Community Care (OCC), and used to document Veterans’ experiences with IVF care provided by community providers, including barriers and facilitators to the receipt of IVF ( Table 1 ). Audio-recordings of all interviews were transcribed and entered into Atlas.Ti qualitative analysis software. Two research staff members read each transcript twice, first to familiarize themselves with the text and then, using the coding template described below, to identify important concepts that emerged from the language and assign codes to segments of text. The transcripts were analyzed for major themes related to the use of IVF care, including challenges with IVF approval, locating providers, and satisfaction with IVF benefits. A template approach was used to code the data using an a priori code list, based on input from clinical stakeholders in the Office of Women’s Health Services, to sort and catalog key concepts for subsequent interpretation and analysis. Additional codes not represented in our a priori coding template, and which emerged from the data were added to the final codebook. Corresponding quotations for each code were selected to identify the salient themes. Using the constant comparative method 14 , research staff then met to examine the prominent themes that emerged in the interviews, discuss and coalesce coding discrepancies, and to compare the variety of perspectives. Emergent themes related to Veteran’s experiences with IVF care arose from this analysis. Those themes, and associated quotes, are outlined in detail below.

Overall, 166 Veterans or spouses of Veterans responded to our study invitation, and we conducted 96 interviews with Veterans ( Table 1 ). Of the 96 interviews we conducted, 82 were Veterans alone and 14 interviews included both Veteran and spouse. Sixty-five percent of the Veterans interviewed were female, white (58%), and had served in the Army (34%). All of the Veteran spouses who participated in interviews were female. The Veterans included in these interviews represented 62 VA medical centers (VAMC) across 18 Veterans Service Integrated Networks (VISN) (data not shown). Tables 2 and 3 illustrate the service-connected conditions that contributed to infertility for male and female Veterans, with 17% of male Veterans experiencing “deformity of the penis” and 25% of female Veterans experiencing endometriosis. Figure 1 demonstrates a visual representation of the location of Veterans eligible for IVF care and VA-contracted IVF providers. We found that Veterans would have to travel an average of 32.4 miles to the nearest VA-approved fertility clinic, with a minimum distance of 0.4 miles and a maximum distance of 365.1 miles. Similarly, approximate travel time in minutes ranged from a minimum of 1 minute to a maximum of 362 minutes, with a mean travel time of 37 minutes. Six major themes arose from these interviews, including: (1) need for improved communication regarding IVF benefits; (2) need for expanded IVF benefits; (3) lack of a comprehensive care coordination program; (4) poor access to IVF providers in some areas of the country; and (5) special services needed for Veterans with spinal cord injuries; and (6) the IVF policy may be discriminatory in nature to single and LGBTQ Veterans. We detail guidance from VHA Directive 1334, which provides authorization for IVF policy, for context in each of the relevant sections below. Table 4 provides a summary of the themes and illustrative quotes, and full discussion of themes is below. A majority of Veterans interviewed experienced poor communication regarding IVF benefits from VA. Problems with communication of benefits focused on four major areas included in the IVF benefits package: cryopreservation and storage, pharmacy medications, genetic testing, and treatment for mental health conditions associated with IVF treatment. VHA Directive 1334: “ VHA will cover costs of cryopreservation and storage at an independent community laboratory indefinitely ”. More than 40% of Veterans interviewed mentioned problems related to receiving accurate information regarding VHA cryopreservation and storage benefits. Some Veterans were told that they would only receive one year of cryopreservation for their embryos, while other Veterans were not told that cryopreservation was a covered VHA benefit at all. A 38-year old male Veteran from Florida noted: I paid for cryopreservation and storage out of pocket, then I found out two weeks ago that they’re not going to reimburse me. Now I am being charged again, I currently have two bills for long-term storage. VHA Directive 1334: “When supplementary VHA prescription fulfillment services are not available at the time they are needed, arrangements will be made to provide them utilizing a non-VHA pharmacy in the community. A reimbursement to the patient requires prior approval in accordance with current local medical facility policy”. A substantial majority of Veterans and spouses interviewed indicated that the VHA pharmacy was not able to get fertility medications in a timely manner and therefore Veterans had to get their medications from community pharmacies and pay out of pocket. One 32-year old Veteran from California noted: There were a couple times when my wife needed a medication, and the VA didn’t have it so we had to get it special ordered and that was stressful because we were not sure if they were going to make it on time. Once or twice the VA did not carry the medication at all, and we had to go to Walgreens and pay out of pocket. A 46-year old female Veteran from New York said: They did not always have the medicines readily available so sometimes it took a bit longer and I had to pay out of pocket for the first few days until they got it in. Sometimes a couple hundred dollars. And they say specifically that if you purchase any medications, you’re basically on your own. They do not consider fertility medications emergency situations, so I would have to pay out of pocket. VHA Directive 1334 states that “ genetic counseling and testing ” is covered, but 13% of Veterans mentioned problems regarding payment for genetic testing. In several instances, Veterans had to pay out of pocket for genetic testing because they were told that it wasn’t covered by the laboratory used by the IVF provider. One 31-year-old female spouse of a Veteran from California noted: I started having issues with the genetic testing, even though I was told from the start that it was definitely a covered benefit, the clinic would only accept cash payments. Another 40-year old female Veteran from New York concurred: One of the things we encountered was the VA will pay for the genetic testing but the company that they sent me through for IVF, their genetic testing places doesn’t accept VA’s insurance. VHA Directive 1334: “The Veteran and/or spouse may receive behavioral health services when VHA determines they are necessary as part of the IVF treatment episode and needed to optimize the outcome of the IVF.” Many Veterans and spouses noted the substantial mental health toll taken during the process of IVF treatment. However, Veterans and spouses said they were unaware that spouses were eligible for mental health treatment during the IVF process. A 68-year-old male Veteran from New York noted: My wife is not the talkative type – and I could tell that she was getting depressed. I called VA and asked about counseling, but they told me it was not authorized for her. A 36-year-old male Veteran from Utah added: I wish there was more support for the mental aspect of it. The fertility centers just monitor what they need to, but the mental health aspect is not supported. VHA Directive 1334: "Over the lifetime of the Veteran, the Veteran is eligible for 6 attempts to create embryos to achieve the 3 embryo transfer episodes of care. If after 6 attempts no embryos are created for transfer, no additional IVF services will be authorized." Some Veterans had gone through three unsuccessful embryo transfer cycles and were no longer eligible for the IVF benefit. One Veteran noted that the VHA should consider the level of physical disability and age when making decisions regarding the number of embryo transfers, as some Veterans might need more time to have a successful transfer. One 41-year-old female spouse of Veteran from Louisiana said: When it came time for the third transfer the nurse called to remind me that this was my last chance. I don’t understand how you can get 6 retrievals and only 3 transfers. A 41-year-old female Veteran from Ohio concurred: I only have one transfer left but was authorized for 6 retrievals. That doesn’t make any sense. VHA Directive 1334: “VHA bars the use of donated sperm, oocytes, or embryos, or gestational surrogacy. Thus, IVF services are only available to a cisgender opposite-sex legally married couple or other legally married couple with opposite-sex gametes/reproductive organs.” A number of Veterans were ineligible for IVF benefit because their eggs or sperm were not viable. In some instances, male Veterans who had testicular cancer and did not bank sperm before chemotherapy or radiation had no viable sperm for IVF. In other cases, female Veterans who had experienced fibroids or endometriosis went through several IVF cycles only to be told that they would only be successful if they could use donated eggs. A 46-year-old female Veteran from New York noted: If you need to use donor eggs, nothing is covered. It’s not always the Veterans fault that we can’t get pregnant. A 36-year-old male Veteran from Florida concurred: By this time my wife is 44 years old and the IVF specialist told us that because of her age, we couldn’t use her eggs. We’re now going to have to come out of pocket 30K and that’s our only option. Veterans and spouses noted that there was nobody in VA they could call with questions related to IVF, especially for matters that required a coordinated response from the IVF clinic and VHA (e.g., prescription medications). Many Veterans observed that it seemed that most VA Community Care offices didn’t have any one person with specialized knowledge in IVF and many VA facilities had never worked with Veterans who had been approved for IVF. One Veteran noted that the VHA provided these benefits but that “ they make it so hard to use the benefit that it doesn’t really seem like they want us to use the benefits at all ”. Another 34-year old female Veteran from Ohio noted: The nurse from Community Care has not spoken to me since the first time I ever talked with her. I called a couple weeks ago because they were billing wrong and she basically told me not to call her, that I should call my primary care. Approximately 37% of Veterans and spouses mentioned problems related to geographic accessibility to IVF clinics. A substantial number of Veterans and spouses had to travel several hours in each direction to access IVF clinics. This distance is particularly problematic for Veterans and spouses undergoing IVF due to the need to get frequent blood tests prior to egg stimulation. One 38-year old male Veteran from Oklahoma noted: We had to drive 2.5 hours for a 10-minute visit. It’s worth it in the end but it’s a lot. A 38-year old female Veteran from Arkansas said: With my endometriosis I could not travel out of state and have a successful IVF treatment. It was never going to work. But at that time the only possible place was 5.5-6 hours away from me. So I gave up at that point and decided not to go further. It was really mentally draining. We spoke to seven Veterans with spinal cord injuries who utilized IVF benefits. Though all of the Veterans we spoke with received annual care at one of the 25 SCI Centers, only a few of them received information regarding IVF benefits from the SCI centers. Spouses of these Veterans noted that when the Veterans went to IVF providers to begin the IVF process, some of the IVF providers had not worked with quadriplegic or paraplegic individuals before, and therefore were unfamiliar with the limitations that these Veterans may have. A 38-year old spouse from Georgia said: The VA here has a really good spinal cord injury unit, and my husband does all of his care there. It would be great if they had information about IVF services and the spinal cord unit. Another 41-year old spouse from Virginia: I don’t think it’s very common for folks with spinal cord injuries to seek infertility care. The only thing I can think of is better education at the VA Spinal Cord Injury Centers, anticipating that a lot of us are going to experience this challenge. One 33-year old spouse from California noted: We found out about the IVF program through our Veterans Caregiver program coordinator. The VA Spinal Cord Injury center was not aware of the benefit. Several Veterans recommended policy changes that would allow VA to be more inclusive for all Veterans needing healthcare access. Veterans pointed specifically to unmarried Veterans and LGBTQ Veterans who were not able to access VA IVF resources. One 37-year-old female Veteran said: Same-sex, partnered but not married and single parent IVF benefits are needed. The rules around this benefit are in direct conflict with the way I live my day-to-day life and how I see the world. Another 36-year-old male Veteran said: The VA should allow donor sperm and eggs. One of my friends was turned down because he has testicular cancer and has no sperm. His family member was willing to donate to the couple but they were ineligible because it requires Veterans’ own sperm. Finally, a third 32-year-old Veteran commented: I find it discriminatory to require couples to be heterosexual and to require that they are married.

To the best of our knowledge, this is the first study to evaluate Veterans’ experiences with the IVF benefit allowed under P.L. 114-223. One of the most common themes that arose from our interviews was Veterans’ perceptions that the VA was not able to clearly communicate the full range of IVF benefits to Veterans. Veterans were left uncertain regarding the extent of their pharmacy, genetic counseling, mental health, and cryopreservation benefits. In VA, all non-VA contracted care is authorized and, ideally, communicated and coordinated through the VA Office of Community Care at each facility. However, given the extraordinarily small number of Veterans eligible for this benefit at any given VA facility, many Veterans were left working with VA Community Care staff who were unknowledgeable about the benefit and therefore unable to communicate the full extent of the benefit to Veterans. Veterans noted that a simple statement of benefits, a toll-free number to call, and/or a website that described the benefits would have answered many questions about IVF care. Because these information sources didn’t exist, many Veterans were left paying out of pocket for benefits such as prescription medications, genetic counseling, and cryopreservation and storage that should have been covered under the existing VA benefit package. Other Veterans noted that communication of IVF benefits should be given more broadly to VA primary care and specialty providers, so that more VA providers were knowledgeable about these benefits. Women Veterans in our study noted that their women’s health providers and women’s clinics were excellent sources of information for IVF benefits, but similarly, some male Veterans noted that the best available source for IVF benefits was often in the women’s clinics, but that this information should be distributed to providers who see male Veterans, such as urologists, as well. After being approved for IVF, a number of Veterans in our study were ultimately unable to conceive, and in some cases this may have been due to policy limitations imposed by P.L. 114-223. For example, some Veterans were unable to conceive after three unsuccessful embryo transfer cycles, whereas other Veterans discovered that their or their spouses’ eggs or sperm were not viable. In these instances, Veterans questioned why donor eggs or sperm could not be used to facilitate pregnancy, or why additional embryo transfer cycles were not allowed. Some Veterans noted that they had siblings or family friends who would be willing to donate eggs or sperm on their behalf and were frustrated that the VA did not allow them to do this. Notably, many Veterans interviewed expressed concern about the discriminatory nature of P.L. 114-223, as it expressly prohibited same-sex couples, or single Veterans, from the IVF benefit. Veterans noted that the VA should expand IVF benefits to allow for egg and sperm donation, which would allow Veterans having trouble conceiving to have additional options for conception and would also allow same sex couples and single Veterans to participate in the IVF program. Our finding regarding the special needs of Veterans with spinal cord injuries is important to consider. The VA operates a series of 25 Spinal Cord Injuries and Disorders (SCI/D) Centers across the country. Each Center has highly trained providers including doctors, nurses, social workers, therapists, psychologists and others who deal with unique problems that can affect people with a spinal cord injury or disorder. Veterans in our study noted that they did not receive any information regarding IVF benefits from the SCI/D Centers, and rather had to receive this information from primary care providers at their VA. Veterans with SCI in the study, as well as their spouses, noted some of the special challenges Veterans with SCI had with sperm donation, and indicated that the VA might develop a list of IVF centers with expertise in working with individuals with SCI. To date, a few studies 15 - 18 have evaluated IVF and fertilization among men with spinal cord injuries, and so further research should examine Veterans with SCI and their experiences with IVF treatment. Finally, as more Veterans become eligible for IVF, VA should continue to work with its contracted provider networks to ensure there are sufficient numbers of IVF providers to ensure that Veterans have access to IVF services within a reasonable driving time. Our map of Veterans eligible for IVF services superimposed with contracted IVF providers shows regional differences in accessibility to nearby providers, especially for Veterans living in the Mountain States and Midwest. At present, VHA has contracted with 1,175 IVF clinics in every state but Wyoming and Alaska, so access problems still remain in certain areas of the country. Some rural Veterans in our study noted the closest IVF clinic was hours away, and with the frequent need to return to the clinic to administer trigger shots and check hormone levels, Veterans and spouses often have to make multiple trips over the course of a few days to complete their IVF cycles. Some Veterans and spouses in our study had to fly to the nearest VA-contracted IVF provider. Our study has several strengths and limitations. First, we were able to access the complete list of all Veterans and spouses who had been approved for IVF in the VA, so our study sample was nationally representative of Veterans seeking IVF care. Our study also offered Veterans both telephone and video interview options, so Veterans were able to participate in interviews, along with their spouses, from their homes. Finally, because our study included all Veterans who had been approved for IVF over the past four years, we were able to assess how access to IVF services and communication of benefits may have improved since the law was passed from the perspective of Veterans who had utilized the IVF benefit several times on successive pregnancies. Our study also had several limitations. One limitation is that some Veterans who received IVF services shortly after the passage of P.L. 114-223 may have experienced recall bias, given their IVF services may have taken place several years ago. Another limitation is that while most Veterans and spouses participated in interviews by video, a small number did participate by telephone. Disadvantages of participating by telephone might include that facial expressions, body language and other non-verbal signs may not be observed during the interview and therefore some important non-verbal information may be lost. An additional limitation is that contracted IVF provider information is for 2021 and is not able to reflect changes in the Community Care Network (CCN) overtime. This may mean that Veterans using the IVF benefit early in the study period (e.g. 2019) had access to fewer providers than Veterans using the benefit in 2021, given that the number of CCN providers continues to increase. Additionally, our GIS mapping procedures were imprecise due to privacy limitations on using exact Veteran addresses for calculating distance and time to nearest infertility clinic; however, our results provide an estimated travel time for Veterans to nearest approved clinic. Finally, the current study was narrowly focused on IVF, and therefore has limited generalizability to other forms of ART. Future studies should continue to examine access to IVF services, with a special focus on access for rural populations and Veterans with SCI. Research should also examine strategies to allow Veterans to use donated eggs and sperm if they are not able to conceive using their or their partners eggs or sperm, and strategies should also be identified to allow same sex couples and single Veterans to participate in the IVF program.

Infertility prevalence and reproductive assistance needs among Veterans are understudied topics. Several studies have examined self-reported infertility among Veterans 1 - 5 , while other studies have sought to examine Department of Veterans Affairs (VA) regulations related to infertility care 6 , 7 . The VA is authorized by its general treatment authority, 38 U.S.C. § 1710, as implemented by 38 C.F.R. § 17.38 (VA’s medical benefits package) and VHA Directive 1332, to provide Veterans who are enrolled in VA’s health care system with full infertility evaluation and many infertility treatments. Until recently, these regulations excluded in vitro fertilization (IVF). In September 2016, Congress passed the Continuing Appropriations and Military Construction, Veterans Affairs and Related Agencies Appropriations Act, 2017 and Zika Response and Preparedness Act, P.L. 114-223 § 260 (2016), which allowed VA to provide Assisted Reproductive Technology (ART), including IVF to certain eligible Veterans. The law authorized VA to provide these services to cisgender opposite-sex legally married couples or legally married couples with opposite-sex gametes/reproductive organs. Veterans interested in the IVF benefit must also have a documented service-connected disability in their VA medical records that results in their inability to procreate without the use of fertility treatment. The IVF benefit, as outlined in VHA Directive 1334, allows for a lifetime maximum of six egg retrieval cycles and three embryo transfer cycles 8 . Nearly four years after P.L. 114-223 allowed Veterans to receive IVF benefits from VA, more than 700 Veterans and their spouses had been approved for the IVF benefit. Unlike individuals seeking IVF care in the private sector, Veterans and their spouses may face numerous unique challenges accessing IVF services included in the VA benefit. When the IVF benefit was first introduced, the VA did not have a widely established network of ART/IVF providers, contracted through VA’s Community Care Network (CCN), especially in less urban areas, and therefore some Veterans experienced sizable geographic challenges in finding an IVF provider near them. Also, unlike the private sector, unmarried Veterans, as well as LGBTQ Veterans with a same-sex spouse, were prohibited from utilizing the benefit. These challenges, in addition to challenges faced by privately insured patients during IVF, including psychological distress 9 , 10 , 11 arising during the process of IVF, which may impact marital satisfaction and quality of life for both partners 12 . Given IVF services are a relatively new VA benefit to eligible Veterans and has yet to be evaluated, the goal of this study was to examine Veterans’ perceptions and experiences with the IVF benefit, and to understand what Veterans’ recommendations are for improving access to, and utilization of, this benefit.