EBSA-2026-0232-0001, NeoFertility LLC

NeoFertility LLCSupportBusiness
Summary: NeoFertility LLC supports the proposed rule and recommends including specific terminology for "restorative reproductive medicine" (RRM) and recognizing medically-researched apps and scalable training pathways. They argue that their RRM framework can help the Departments meet goals of expanding patient access and the clinical workforce for fertility care.
See Attached for Full Comment. Broadly, NeoFertility can help to accomplish the aims of this proposed rule by providing a framework for diagnosis and treatment of the underlying reasons for infertility, subfertility, recurrent miscarriages, and other reasons for impaired fecundity. NeoFertility also has a proven track record of training healthcare professionals within this RRM framework in an efficient way without any limits to cohort size and the flexibility to accommodate training while still actively practicing medicine. As such, we would propose the following recommendations to address these features within the rule to include: 1.Explicit inclusion of the terminology for benefits to include care within the scope of “restorative reproductive medicine” to include healthcare professionals that are diagnosing and treating the underlying causes that lead to infertility, subfertility, or impaired fecundity. 2.Recognition that medically-researched apps (like Chart Neo) for tracking important biomarkers, alongside utilization of standardized medical protocols can be utilized in a meaningful way to provide care that helps to overcome underlying health conditions that promote infertility. These apps are accessible to the general population and ready to scale with in-app education for starting the process and identification of healthcare professionals with NeoFertility RRM training to connect with, built into the app. 3.Recommend that the Departments would consider the scalability of training pathways to increase the workforce for healthcare professionals who diagnose and treat infertility. RRM pathways like those already built within NeoFertility represent an efficient pathway that can be completed without practice interruption. This stands in contrast to the limitations currently present for training healthcare professionals who offer ART services as they are limited by fellowship spots, funding, and the need to be in full-time fellowship programs that would require returning to subspecialize as a mid-career physician. 4.Delineation of pathway for identification and verification of appropriate training for RRM healthcare professionals. Recommendation would be to recognize the course of training endorsed by dedicated national RRM organizations such as IIRRM which, together with national chapters such as IRRM-US, maintains an RRM Clinician Recognition Program. This allows patients, payers, and policymakers to delineate which care teams are providing RRM care vs. ART or other therapies.

View on Regulations.gov