EBSA-2026-0232-0001, Canadian Institute for Restorative Reproductive Medicine

COMMENT ON EXCEPTED FERTILITY BENEFITS Docket EBSA-2026-0232 I submit this comment as President of the Canadian Institute for Restorative Reproductive Medicine and as a Canadian physician with approximately 30 years of experience caring for patients with infertility and related conditions. I strongly support the proposed Excepted Fertility Benefits and its recognition that coverage may include the diagnosis, mitigation, and treatment of infertility and infertility-related reproductive health conditions. To ensure this produces meaningful access to diagnosis-directed care rather than defaulting primarily to assisted reproductive technology, the final rule should explicitly identify restorative reproductive medicine (RRM) as an eligible category of care. RRM is a comprehensive medical and surgical approach that investigates and treats the male and female pathologies contributing to impaired reproductive function. Published cohort studies report meaningful live-birth outcomes, including after failed IVF, with very low multiple-pregnancy rates and favourable neonatal outcomes. RRM may therefore offer an effective, lower-cost pathway for appropriate patients while reducing costs associated with repeated procedures, multiple gestation, prematurity, and low birth weight. We support further research and welcome independent prospective and comparative studies of effectiveness, safety, patient selection, and cost-effectiveness. Canadian experience shows why benefit design matters. Quebec introduced broad public IVF funding in 2010, but annual costs reportedly rose from approximately C$16 million to more than C$80 million by 2012. Full coverage was withdrawn in 2015, with limited coverage later reinstated. This is not an argument against IVF, which remains necessary for some patients. It demonstrates the fiscal risk of building fertility policy too narrowly around a high-cost procedure without also supporting lower-cost diagnostic and restorative pathways. It is often asserted that RRM-type evaluation and treatment already occurs routinely before IVF. Real-world evidence does not support that assumption. A recent claims analysis of approximately five million commercially insured U.S. patients found that IVF initiation frequently outpaced completion of guideline-recommended evaluation and treatment. By nine months, IVF use commonly exceeded 70–85%, while many recommended evaluations and treatments remained below 40%, and several below 15%. RRM must therefore be specifically named; otherwise, patients may technically have fertility coverage while still lacking comprehensive diagnosis-directed care. The Canadian Institute for Restorative Reproductive Medicine is a national chapter of the International Institute for Restorative Reproductive Medicine (IIRRM) and upholds high professional, educational, ethical, and evidence standards. Coverage should distinguish professionally delivered RRM from generic wellness services or ordinary pre-IVF care. Eligible clinicians should have documented postgraduate RRM training and formal professional recognition or designation through IIRRM or a recognized national chapter. We also recommend use of the IIRRM consensus understanding of infertility: a clinical condition recognized by inability to conceive through sexual intercourse or to sustain a pregnancy, indicating underlying male and/or female pathology. This definition appropriately connects the symptom of infertility with the duty to investigate and treat its causes. I respectfully request that the final rule explicitly list RRM; include comprehensive male and female diagnostic, medical, surgical, and supportive RRM care; recognize appropriately trained and professionally designated RRM clinicians; and adopt the consensus pathology-based definition of infertility. U.S. policy will also affect international access. Over three decades, I have cared for many American patients who travelled to Canada because they could not obtain this care at home. Explicit inclusion of RRM would expand patient choice, strengthen quality, and support more sustainable fertility-care systems on both sides of the border. Tracey A. Parnell, MD President Canadian Institute for Restorative Reproductive Medicine References Boyle PC, de Groot T, Andralojc KM, Parnell TA. Healthy singleton pregnancies from restorative reproductive medicine after failed IVF. Front Med. 2018;5:210. Morin V. Outrage at planned changes to Quebec IVF. CMAJ. 2015;187(2). doi:10.1503/cmaj.109-4966. Parnell TA, Minjeur M, Turczynski C, Pistilli T. Real-world fertility evaluation and care prior to IVF: a retrospective five-million-patient claims-based care-gap analysis.2026. Minjeur, M., Parnell, T., Stanford, J., Boyle, P., Arraztoa, J. A., Horodenchuk, Z., Suszczewicz, N., & McCarthy, K. (2026). Definition of Infertility and Indications for Fertility Evaluation: Consensus Document. Journal of Restorative Reproductive Medicine, 2, 1-7.