Technological Innovation

Under-utilization of fertility benefits negatively impacts patients and practices

One fertility savings program proves a useful tool for patients and practices.

This News Digest Story is paid featured content. The advertiser has had editorial input and control over its creation. However, the views and opinions expressed in this article do not necessarily represent the views of Inside Reproductive Health. The sponsorship of this content does not imply an endorsement by Inside Reproductive Health.

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BY NATASHA SPENCER-JOLLIFFE

Reproductive Medicine Associates of New York (RMANY) has had to counsel their fair share of patients who have exhausted their fertility benefits. 

“Patients may not be fully educated on the medical criteria of their fertility benefits, which plays a vital role,” said Romain Singramdoo, Finance Manager at RMANY.

In “cases where implantation needs to occur within a certain time frame, the patient was not fully educated, and did the implantation past the allowed time,” Singramdoo said. In this instance, the finance coordinator informed the patient that their Global Health Insurance (GHI) policy mandated her to have her frozen embryo transfer (FET) cycle within 60 days of the retrieval. “When the implantation happened past the allowed time, the implantation cycle counted as ‘another try’,” Singramdoo added. 

Patients may see a total dollar amount ‘covered’ and want to use the entirety of that coverage as soon as possible to afford fertility treatment without understanding their potential treatment path. “They may need more than one cycle to achieve their goal, based on their individual circumstance”, Amanda Travis, Director of Brand Marketing, US Fertility at EMD Serono, said. “Or that the medication part of the treatment costs may be extracted and paid out of pocket”.


Fertility LifeLines™ enrolled nearly 139,000 patients from 2013-2023, saving them approximately $69 million in total*.

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In a recent study, perceived cost was the most commonly reported barrier for respondents not seeking treatment (42% of patients (n=207))1. EMD Serono’s Fertility LifeLines™ program offers savings on EMD Serono medications for eligible patients.

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*Data on File, EMD Serono Inc.
1. Domar, et al. Barriers and factors associated with significant delays to initial consultation and treatment for infertile patients and partners of infertile patients, RBMO, VOLUME 43, ISSUE 6, 2021


Often, patients meet with the appropriate staff member at the fertility clinic to ask the important questions: How much will this cost me, and how much will my insurance pay? Typically, at this point, patients have “a minimal understanding of how their ‘coverage’ can be best and most efficiently leveraged”, Travis shared. 

By the very nature of fertility treatment, patients experience a range of emotions, not to mention challenges, one of which is the affordability of expensive fertility treatment programs. “Couple these complexities with what a patient seeking infertility treatment may be feeling at the point in time when they’re exploring costs; they are overwhelmed and feeling ‘challenged’ from the start,” Travis said. 

The underutilization or misutilization of fertility benefits is devastating for patients, who have to pay the extra costs out of pocket. 

But forward-thinking fertility centers like RMANY have also found ways to help patients maximize their fertility benefits efficiently. Whether they “had a specific dollar amount of $25,000 to utilize for IVF”, or other stipulations and amounts, Singramdoo said. 

Benefit challenges impact fertility centers and patients

“Insurance and coverage are foundationally complex, regardless of how and where a patient is accessing it,” Amanda Travis, Director of Brand Marketing, US Fertility at EMD Serono, said. 

Confusion over how to optimize benefits can also impact patients’ fertility treatments and entitlements. “Patients may be paying more than they should be to achieve the outcome they are looking for,” Travis shared. “They may miss the chance to apply for a manufacturer or pharmacy savings program for their medications if they choose to entirely pay through their insurance coverage or plan,” Travis added.

Limited knowledge of fertility benefits can also impact the patient’s fertility center. “Frustration could lead to bad reviews for the finance team for not giving clarity, or patients may begin to lose trust in the practice,” said Singramdoo. Financial counselors and patient navigators face several hurdles when allocating benefit coverage. “Insurance reps tend to be very vague and inconsistent when explaining benefits, leaving the practice to relay information that may be incorrect,” Singramdoo detailed. 

How fertility centers can help their patients get the most from their benefits

Fertility clinics can help their patients properly navigate, optimize, and advise their patients. “Insurance coverage is a good starting point for the financial conversations, but prepare a process and questions to best educate and set the patient up for success,” said Libby Horne, Senior Vice President of US Fertility & Endocrinology at EMD Serono.

Bespoke fertility benefit packages are available to clinics. In today's fertility sector, it's recommended that clinics implement a process that builds in personalization and doesn’t treat all patients with ‘coverage’ the same.

Expanding supply chains to involve pharmacies in patients’ fertility treatment plans can optimize operations for facilities. “If the clinic doesn’t have the process or personnel to do this effectively with every patient, outsourcing to their pharmacy may be an effective idea,” Horne said. 

Three-way calls with patients, insurance providers, and fertility practices help clarify benefits. “Asking the patient to get their written certificate of coverage or provide us with a concierge number for their benefits can also assist in clarifying benefits,” Singramdoo noted.

EMD Serono’s savings program saves eligible fertility patients an average of $1,700

EMD Serono encourages all eligible patients to apply to see their potential savings and confer with their EMD Serono network pharmacy if they do not immediately qualify to see if there is potential for other savings.

The biopharmaceutical company hosts a Fertility LifeLines Resource Hub featuring program descriptions, patient materials, program logos, and patient-facing instructional videos for clinics to educate patients on Fertility LifeLines. 

Fertility LifeLines is a program for eligible patients who will be paying out-of-pocket for EMD Serono fertility medications. EMD Serono offers a Compassionate Care program to support certain eligible patients’ access to affordable fertility treatment. 

On average, eligible patients save over $1,700 on EMD Serono Fertility medication, but some may save more. The savings patients can expect to make are based on several factors, including financial need, number of dependents, and military status.

This News Digest Story is paid featured content. The advertiser has had editorial input and control over its creation. However, the views and opinions expressed in this article do not necessarily represent the views of Inside Reproductive Health. The sponsorship of this content does not imply an endorsement by Inside Reproductive Health.


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IVF centers moving from “pay per treatment” to “pay for baby” model

Fertility clinic pricing strategies enter a new era with assistance from AI company 

This News Digest Story is paid featured content. The advertiser has had editorial input and control over its creation. However, the views and opinions expressed in this article do not necessarily represent the views of Inside Reproductive Health. The sponsorship of this content does not imply an endorsement by Inside Reproductive Health.

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AIVF™

 
 

BY NATASHA SPENCER-JOLLIFFE

With the prominence of sophisticated artificial intelligence (AI) systems like AIVF’s EMA progressing the fertility industry from standardization to personalization, fertility clinics can shift to a “pay for baby model” over the traditional “pay per treatment” pricing structure.

Today’s fertility industry has struggled to keep up with treatment demands. In the US, clinics are only serving 20% of the need for IVF, leaving 80% of patients giving up on starting the process of having a child, Daniella Gilboa, CEO and co-founder of AIVF, conveyed

However, as AI-powered scoring systems, such as AIVF’s EMA, lower uncertainties, expedite embryo evaluation, and provide clear, accurate information, clinics now have the potential to meet this demand. Clinics utilizing AIVF’s software have seen a 30% increase in success rates, Gilboa said in a July 2023 New York post article.

Non-invasive AI systems analyze multiple parameters that, when put together, give much more predictive information about embryo development. 

The in-depth operating systems help doctors understand implantation failures and multiple failed cycles. 

The timing of the cell divisions, the evenness of the cell divisions and the amount fragmentation of certain features will give us ideas as to the embryo’s true quality and genetic potential,” Dr Conor Harrity, Consultant Gynecologist and Subspecialist in Reproductive Medicine at Rotunda and Beaumont hospitals in Dublin, Ireland, told Inside Reproductive Health. 

Predictive power

Dr. Harrity sought a non-invasive tool that would provide more information on blastocysts than standard morphology. “AIVF stands out because it gives us much more information about the potential of the embryo without the need to biopsy the embryo with the extra risk of embryo damage or the extra cost involved with preimplantation genetic testing technology (PGT),” said Dr. Harrity.

If the embryo is not good enough, you can modify and personalize the regime,” said Dr Harrity. Therefore, AIVF helps clinicians identify scenarios where good embryos haven’t worked, and they need to modify the transfer regime. With AI scoring, the tool also lets clinicians see that embryos they thought were good morphologically weren’t as good as they had thought. 

AIVF gives more confidence to both the doctor and the patient about how to shorten their journey to either success or to knowing why it’s not working, and then changing tack and doing something that will help them succeed,” said Dr. David Walsh, Director of FirstIVF.

The use of AI and tools like AIVF indicate a move to a 'pay per baby' pricing model over a 'pay per treatment' model, Walsh confirmed. “The closer you can get to a higher probability of outcome and shared risk between the fertility clinic and patient, the more likely we are to see the move to a ‘pay per baby model”, Walsh said. 

Due to its expense, clinics cannot afford to return this cost to patients, Walsh said, if treatment does not result in pregnancy. “Anything that gets closer to the prediction of outcome allows clinics to make calculated outcomes, therefore increasing their predictive power”. 

Time-lapse capabilities 

Progressing beyond PGT, AIVF enables retrospective use by recording time-lapse videos. Over the past year, Dr. Harrity confirmed that the industry has started to see instances where it has been very useful to look retrospectively at embryos and learn more about previous failed transfers.

AIVF’s EMA uses time-lapse monitoring to understand an embryo’s development. Several cameras record the embryo to give a multi-dimensional view of the embryo’s growth. The system shows how the embryo divides from a single cell into multiple cells until it forms a blastocyst.

Rather than just using snapshots at certain points of development, embryologists continuously monitor the embryo’s growth over five to six days until it reaches the blastocyst stage, providing much more information.

Non-clinical benefits

EMA’s automated embryo evaluation and quality scoring modules (AIVF Day-3, AIVF Day-5 and AIVF Genetics) automate the embryo evaluation process, entirely replacing manual steps, such as visual inspections, morphokinetic and morphological annotations, and manual data recording and transfer into the electronic medical record (EMR). 

The integrated system directly transfers all embryo evaluations and scores from the time-lapse incubator to the EMR through the EMA platform, eliminating redundant data recording and transfer between multiple operating systems within the IVF laboratory. “It is documented in the patient’s information record, another data point,” said Walsh.

A 2023 research study found the average manual evaluation and recording time without and with EMA was 3.1 minutes versus 30.9 seconds per embryo, respectively. Overall, using AIVF reduces the average embryo evaluation time per cycle by 83%, a case study on efficiency revealed.

By utilizing EMA's automated messaging dashboard, IVF analytics tool, and laboratory documentation for performance monitoring and calculation, clinics can also lower administrative time for each cycle from 9.0 hours to just 5.58 hours, a 38% reduction. (1)

AIVF audits field transfers; offering information about embryos that did not implant.

Developers are adding features to AVIF’s time-lapsed five-minute videos to increase predictive power. Standing out in a way that isn’t true for all other non-invasive programmes, Walsh said, “AIVF is constantly learning, so it is getting better over time”.

The big thing about non-invasive testing is that it can become universal,” said Walsh. It is accessible to everybody going through a fertility lab because it is relatively low cost, particularly compared to genetic testing. As long as the information is stored securely, non-invasive testing enables clinicians to look back in time and use it in the future. Clinicians can receive that information and run the data. “It’s eternal,” said Walsh.

While a move to subscription pricing models is uncertain at the moment, Walsh said, “clinics may justify this move based on confidence and outcomes”. He said confidence in AI technology like AIVF and its outcomes will help clinics move to different financial models, with ‘pay for baby’ treatment a permissible and viable alternative to the 'pay for baby' treatment option.

(1) Validated by AIVF partners. Internal data on file

This News Digest Story is paid featured content. The advertiser has had editorial input and control over its creation. However, the views and opinions expressed in this article do not necessarily represent the views of Inside Reproductive Health. The sponsorship of this content does not imply an endorsement by Inside Reproductive Health.


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Fertility Clinics Across Globe Grow Egg Freezing Programs with AI-led Tool

Programs scale access to fertility preservation using Future Fertility’s oocyte assessment tool, Violet

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Future Fertility

 
 

BY Natasha Spencer-Jolliffe

The number of women electing to freeze their eggs in the US increased to 12,438 in 2020, up from 7,193 just four years prior in 2016, The Society for Assisted Reproductive Technology reported. 

However, a limiting factor to fertility clinics’ egg-freezing programs has remained: patient confidence. Practitioners could not tell patients the quality of their eggs, making egg freezing programs an expensive and stressful gamble.  

Some fertility clinics have been able to dramatically improve their egg freezing programs leveraging an AI-based oocyte assessment tool, Violet. This technology measures egg quality to gain an objective view of the probability of successful fertilization and blastocyst development to help clinics guide egg freezing cycles, empowering patients with personalized insights and improving confidence in clinic decision-making.

Growing clinics’ egg freezing programs through a stronger patient experience

The AI tool informs patients about their fertility health, helping to guide patients’ next steps and aiding practitioners in attracting patients to their egg freezing programs.

Professor Alison Campbell, Chief Scientific Officer at Care Fertility Group, first heard of Violet several years ago following a presentation by Future Fertility’s co-founder Dr. Dan Nayot, a reproductive endocrinologist. “I had to investigate!”, she shared. 

I was very skeptical about the power of AI to predict quality or viability potential from a photograph of oocytes in the IVF laboratory,” Professor Campbell added. With no standardized visual scoring system in place, evaluating oocyte quality had previously not been possible by embryologists.

Professor Campbell’s clinic network, Care, went on to become the first in the UK to adopt Violet and is now using the tool in all egg freezing cycles. “Having data like this from Violet helps clinic staff have more meaningful conversations with patients to support their decision-making and fertility planning,” she continued.

The first question all patients opting for the oocyte freezing programs have, is how many oocytes they need to freeze to have a viable embryo,” said Dr. Ernesto Escudero, Gynecology Fertility Specialist at Inmater, a fertility clinic in Peru that has been using Violet for over a year now.

Violet is a very helpful tool to show patients the real number of oocytes they need to store for, not just their age, but also for the viability of each oocyte,” he added.

These insights are guiding counselling conversations and helping patients connect the clinician’s treatment recommendations with their own personalized data – for example, when egg quality is lower than expected for their age and additional retrievals are recommended to give them the best chance of reaching their family planning goals. 

Violet is also filling a gap in ensuring patients have appropriate expectations for the usage of the frozen eggs in the future – information that, until now, has been shared only in terms of general estimates, based on population health statistics that consider only the patient’s age and number of mature eggs retrieved. 

Delivering this level of information and building a relationship of trust means these patients are more likely to return for future treatments, enabling clinics to grow their programs. This also helps create a positive reputation in the patient community, helping to attract new clients through differentiated service levels. 

Dr. Sergio Papier, Medical Director and CEO of CEGYR in Argentina, attests to this approach – his clinic has adopted Violet as part of every freezing cycle as the clinic expands its precision medicine program. “It is a tool that we have quickly incorporated for all patients,” he says. 

AI tools scale access to fertility preservation through standardization and repeatability

AI has the potential to improve reliability, accuracy, efficiency, and reproducibility in the IVF lab and wider clinic,” Professor Campbell relayed. Using advanced deep learning technology to evaluate oocyte images, Violet answers the need for more certainty regarding oocyte quality. 

My concern has always been to have an objective biomarker that can evaluate oocyte quality, the most important variable in the results of ART,” said Dr. Papier. It was this interest that led Dr. Papier to discover Violet. The AI tool not only informs treatment planning but also provides clinics with new research projects, exploring the impact of clinical and lab variables on oocyte quality.

It’s very important in a lab to have tools that will help achieve better pregnancy rates and reduce time to pregnancy – AI is the future for that,” comments Dr. Escudero.

Future Fertility’s technology has also proven to integrate seamlessly with existing lab set-ups and workflows. “It doesn’t need to alter what the clinical embryologists do with the eggs, in terms of cryopreservation, and it can help the team counsel patients, set their expectations, and aid their decision-making,” said Professor Campbell.

Future Fertility makes AI accessible to IVF laboratories,” she highlighted, detailing how the company stands out as the go-to AI egg-freezing tool. 

They have a strong expert team and work closely with clinics to educate staff and implement their technology,” added Professor Campbell. Care Fertility has seen its egg freezing program grow since implementing the tech.

Without a doubt, Violet is a very useful tool for evaluating oocyte quality and gives doctors, biologists and patients a more objective perspective of potential future results,” shared Dr. Papier.

This News Digest Story is paid featured sponsor content, where the Advertiser has editorial control. They do not reflect the views of Inside Reproductive Health.


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20 Years After Toft Report, Most Fertility Centers Have Yet to Automate

90% OF Fertility Centers Still Doing Manual Witnessing, Exec Says

 

BYNATASHA SPENCER-JOLLIFFE

A boom in demand for fertility treatment means more embryologists are turning to management to invest and implement processes and systems to modernize fertility care through implementing automated technologies.

“As the UK regulator of fertility treatments, we expect clinics to have robust systems in place to ensure eggs, sperm, and embryos are safely stored for patients,” Rachel Cutting, Embryologist and Director of Compliance & Information at the Human Fertilisation & Embryology Authority (HFEA) told Inside Reproductive Health.  

Long-standing, antiquated, manual tools have traditionally been the process of choice, despite the risks associated with being prone to human error and inconsistencies that subsequently compromise the standard of care. 

However, some fertility managers and embryologists are changing their approaches to embrace automation and ensure they continue to deliver a standard of care to patients that provide cell transparency and safety. For example, managers want to automate the tracking and storage of frozen eggs and embryos.

Swapping antiquated for automated

Regarding IVF laboratories, the main problem with automation and artificial intelligence (AI) is “a lack of standardization”, Danilo Cimadomo, Science and Research Manager of GeneraLife IVF, told Inside Reproductive Health. 

While there is a “very good concordance and reliability”, among people working within the same IVF center, the same is not true across different centers. “When it comes to the procedures as well as to the assessments that we make, there is not very much concordance between embryologists,” says Cimadomo.

Global managers are exploring automation in response to the estimated over 300 million anticipated to be born from IVF by 2100. Automation enables them to continue to provide cell transparency and safety – while ensuring compliance. 

“Advances in technology have meant greater success for patients using cryopreserved eggs and embryos and therefore, more patients are storing them for treatment or to preserve their fertility,” Cutting shares.  

“Even now, around more than 90% of fertility centers around the world are still not using any form of electronic witnessing,” says Matt Pettit, Chief Scientific Officer at IMT International, responsible for developing and implementing Matcher, an electronic witnessing and quality management system. Many fertility centers still handwrite Petri dishes, test tubes, and items.

“It is still a problem within the industry, still a change that needs to take place,” says Pettit. Serious adverse events are still happening, he continues. There are still reported incidents, year after year, where incorrect sample handling means babies are born to the wrong parents or embryos have been discarded.

As a result, today, we are seeing “a paradigm shift towards the use of electronic systems”, Pettit notes, continuing, “we are seeing a big wave now where there has been a very rapid 
adoption of electronic systems”. “Covid has expedited that realization,” Pettit adds.

Despite the release of the Toft Report almost two decades ago, implementing new automation-led processes and systems to support the fertility sector has been slow to adopt. Yet, increasingly, managers are conducting audits to recognize risks in manual systems and seeking tech to reduce the risks of these existing systems. 

Managers are exploring tech with specific features to improve digital tracking, robotic automation, and 24/7 remote monitoring to take the burden off of manual staff procedures and overcome identified risks. They see the benefits of automating embryo tracking and storage to reduce errors and ensure their infrastructure is robust to meet patient demand. 

Advancing tech encourages acceptance and adoption

Electronic tech innovations are entering the reproductive health space and finding acceptance in the wider healthcare sphere, helping to foster trust and uptake among managers of fertility centers and donor banks. 

With a focus on automation, transparency, and standardization, the tech connects to the company’s software, which assigns a unique identifier for each specimen and captures real-time information. It aims to reduce most manual inputs that risk failure in the existing cryogenic process.  

“Systems such as electronic witnessing systems and other automated technologies are becoming more commonly used, and clinics will use these to ensure security and safety is optimized,” Cutting details. 

Electronic witnessing systems are currently “the easiest and most effective way” for fertility centers to embrace automation and AI, Cimadomo says, describing it as “one of the most impactful automation tools” he has seen implemented in his clinic.

Fertility centers and donor bank managers are implementing automated patient tracking information to reduce errors, like Matcher IVF electronic witnessing technology. Described as a double-checking system, IMT’s Matcher tech is a barcode-based electronic witnessing, labeling, scheduling, traceability, and data insights system.

Teaming up with academia to provide education on the potential of automation in IVF is a priority for fertility researchers, clinicians, and embryologists. The electronic witnessing system’s upgrade is in response to an increasing number of treatments that require labeling, identifying, selecting, and matching a specific embryo for a predetermined fate, such as biopsy, transfer, cryopreservation, or disposal.

In an MIT Technology Review, researchers found almost three-quarters of health professionals (72%) show significant interest in implementing AI in their work. Embracing the technology appears more likely as professionals perceive it to be an extension rather than an extinction of professional capacity in health care. Research has found that the number of AI publications in medicine and health has also grown, with 61.6% of the papers dated between 2008 and 2017.

Encouraging change through embracing convenience 

Sharing information between databases is a powerful tool. It enables centers to cross-reference data across different systems and use that to effectively help drive further efficiencies, mitigate error, and for root cause analysis. 

Describing this realization as “probably the tipping point”, Pettit continues, it means people will “very rapidly adopt these types of technologies because it is more about the collection of data and that knowledge is power than it is about the prospective error prevention”, says Pettit. 

“The real advantage of automation will be for smaller centers that do not get the same experience as centers that are managing large volumes in terms of procedures,” says Cimadomo. However, cost-effectiveness remains a barrier to implementation. “That perhaps is the reason why we still do not have any automatic tool in the IVF laboratory, you need an investment in terms of money that should be justified from the volumes you have,” Cimadomo adds.

The use of technology and its specific applications varies from lab to lab. Research labs, for example, may require automatic timing and sanitation, whereas a lab engaging in clinical activities may not need this data. Therefore, the technology and the strategies need to be framed for the country, the regulations applied, the population of patients, and the specific center’s needs. 

“There is not really any effective automatic tool in the lab, it is still very manual the activity that we do, but that doesn't mean that there's no research,” says Cimadomo.

Automation

However, researchers have found that the answer does not have to lie in automation. Scientists developed an embryo tracking system (ETS) with six control steps to see if it increased the safety, efficacy, and scalability of massively parallel sequencing-based preimplantation genetic testing (PGT). The researchers found that the ETS approach precluded error-prone manual checks and did not impact preimplantation embryos’ genomic landscape.

Yet, increasingly, the benefits of automation in assisted reproduction technology (ART) are being recognized. Researchers of the review, Paving the Way for the Future of Infertility Treatment, said in August 2022 that implementing novel technologies to automate ART “will soon become a reality”. 

On 13th May 2023, the Italian Society of Embryologists Reproduction (SIERR) is dedicating its 2023 event to understanding the role of AI in IVF, demonstrating the growing interest in the possibilities of automation in fertility. Understanding how AI applications in embryology and reproductive medicine work and defining the state of the art is the goal of the 2023 event.

“We thought it was about time to talk about AI because there are lots of companies commercializing tools and are approaching us in the laboratories, and there are people who do not know what AI is”, says Cimadomo, a member of the Italian Society of Embryologists at Production and Research.

The themes reported in this publication are those of the news. They do not reflect the views of Inside Reproductive Health, nor of the Advertiser

 
 

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External links are being provided as a convenience and for informational purposes only; they do not constitute an endorsement or an approval by Fertility Bridge or Inside Reproductive Health of any of the products, services or opinions of the corporation or organization or individual. Neither Fertility Bridge nor Inside Reproductive Health bears responsibility for the accuracy, legality or content of the external site or for that of subsequent links. Contact the external site for answers to questions regarding its content.