Systemic Barriers to Fertility Preservation for Sexually and Gender Diverse Populations.

Fertility preservation is the process of collecting and storing oocytes, sperm, or reproductive tissue so that a person may retain their ability to have biologically related children. In instances of infertility caused by medical intervention or an underlying medical condition, this procedure is often sought by affected patient populations. U.S. Title 21 regulations have produced disparities in access, disproportionately restricting services for sexually and gender diverse subpopulations capable of producing sperm. This article examines policies contributing to these disparities, explores how these policies may translate to real-world health care delivery, and proposes policy changes that would increase equitable access to care.

Financial decision analysis based on "willingness to pay" for surgical sperm retrieval approaches among men with non-obstructive azoospermia in the United States.

OBJECTIVE: To determine the most financially optimal surgical approach for testicular sperm retrieval for men with non-obstructive azoospermia. DESIGN: A decision tree was created examining five potential surgical approaches for men with non-obstructive azoospermia pursuing one cycle of intracytoplasmic sperm injection. An expected financial net loss was determined for each surgical option based on couples' willingness to pay for one cycle of intracytoplasmic sperm injection resulting in pregnancy. The branch with the lowest expected net loss was defined as the most optimal financial decision (minimizing loss to a couple). Fresh testicular sperm extraction implied testicular sperm extraction was performed in conjunction with programmed ovulation induction. Frozen testicular sperm extraction implied testicular sperm extraction was performed initially, and ovulation induction/intracytoplasmic sperm injection was canceled if sperm retrieval failed.  The surgical options included fresh conventional testicular sperm extraction, with and without "back-up" sperm cryopreservation, fresh microsurgical testicular sperm extraction, with and without "back-up" sperm cryopreservation, and frozen microsurgical testicular sperm extraction. Success was defined as pregnancy after one intracytoplasmic sperm injection cycle. MATERIALS AND METHODS: Probabilities of successful sperm retrieval with conventional testicular sperm extraction/microsurgical testicular sperm extraction, post-thaw sperm cellular loss following frozen microsurgical testicular sperm extraction, ovulation induction/intracytoplasmic sperm injection cycle out-of-pocket costs, intracytoplasmic sperm injection pregnancy rates for men with non-obstructive azoospermia, standard conventional testicular sperm extraction cost and average willingness to pay for intracytoplasmic sperm injection cycle were gathered from the systematic literature review. Costs were in USD and adjusted to inflation (as of April 2020). Two-way sensitivity analysis was performed on varying couples' willingness to pay for one cycle of intracytoplasmic sperm injection and varying microsurgical testicular sperm extraction out-of-pocket costs. RESULTS: According to our decision tree analysis (assuming minimum microsurgical testicular sperm extraction cost of $1,000 and willingness to pay of $8,000), the expected net loss for each branch was as follows: -$17,545 for fresh conventional testicular sperm extraction, -$17,523 for fresh microsurgical testicular sperm extraction, -$9,624 for frozen microsurgical testicular sperm extraction, -$17,991 for fresh conventional testicular sperm extraction with "backup", and -$18,210 for fresh microsurgical testicular sperm extraction with "backup". Two-way sensitivity analysis with a variable willingness to pay values and microsurgical testicular sperm extraction and in-vitro fertilization costs confirmed that frozen microsurgical testicular sperm extraction consistently presented the lowest net loss compared to other options. Interestingly, when directly comparing fresh microsurgical testicular sperm extraction and conventional testicular sperm extraction with "back-up", scenarios with decreasing willingness to pay and lower microsurgical testicular sperm extraction costs demonstrated fresh conventional testicular sperm extraction with "back-up" as more optimal than fresh microsurgical testicular sperm extraction with "back-up". CONCLUSIONS: For those couples who must pay out of pocket, our study suggests that frozen microsurgical testicular sperm extraction is the most financially optimal decision for the surgical management of non-obstructive azoospermia, regardless of microsurgical testicular sperm extraction cost and the couple's willingness to pay.

Venture capital investment in urology, 2011 to mid-2021.

INTRODUCTION: To characterize venture capital (VC) investments in urology in the past decade that represent promising innovations in early-stage companies. MATERIALS AND METHODS: A retrospective analysis of deals made between VC investors and urologic companies from January 1, 2011, through June 28, 2021, was conducted by using a financial database (PitchBook Platform, PitchBook Data Inc). Data on urologic company and investor names; company information and funding categories (surgical device, therapeutic device, drug discovery/pharmaceutical, and health care technology companies); and deal sizes (in US dollars) and dates were abstracted and aggregated. Descriptive and linear regression analyses were conducted. RESULTS: Urology-related VC funding fluctuated from 2011 through mid-2021, but no substantial change was observed in funding over time. In total, 191 distinct deals were made involving urologic companies, totaling $1.1 billion. The four largest funding categories together accounted for $848 million and comprised therapeutic devices ($373 million), surgical devices ($187 million), drug discovery/pharmaceuticals ($185 million), and health care technology ($102 million). At least $450 million (41% of total investments) was invested in companies developing minimally invasive surgical devices. CONCLUSIONS: Urologic VC investments did not increase in the past decade and were allocated more toward devices than pharmaceuticals or health care technology. Given relative patterns within urology, VC investments may shift toward health care technology and away from pharmaceuticals but remain stable for devices. Further investments in promising technologies may help urologists more effectively manage urologic disease while optimizing outcomes.

Impact of Index Surgical Care Setting on Perioperative Outcomes and Cost Following Penile Prosthesis Surgery.

BACKGROUND: Penile prosthesis surgery has witnessed a migration from the inpatient to ambulatory surgical care setting. However, little is known about the cost savings afforded by this change in care setting and whether or not these savings come at the expense of worse perioperative outcomes. AIM: The aim of this study was to identify predictors of index penile prosthesis (PP) surgery care setting, and whether ambulatory vs inpatient surgery is associated with comparable perioperative outcomes and costs. METHODS: This was a retrospective cohort study using all-payer claims data from the 2014 Healthcare Cost and Utilization Project State Databases from Florida and New York. Patient demographics, regional data, total charges (converted to costs), and 30-day revisit rates were abstracted for all patients undergoing index placement of an inflatable or malleable PP. Multivariable logistic and linear regression adjusted for facility clustering was utilized. OUTCOMES: The outcomes were index surgical and 30-day postoperative costs, as well as 30-day revisit rates. RESULTS: Of the 1,790 patients undergoing an index surgery, 394 (22.0%) received care in the inpatient setting compared to 1,396 (78.0%) in the ambulatory setting. Adjusted index procedural ($9,319.66 vs $ 10,191.35; P < .001) and 30-day acute care costs ($9,461.74 vs $10,159.42; P < .001) were lower in the ambulatory setting. The underinsured experienced lower odds of receiving surgery in the ambulatory setting (Medicaid vs private: odds ratio [OR] 0.19; 95% CI 0.06-0.55; P < .001). There was no difference in risk-adjusted odds of experiencing a 30-day revisit between patients undergoing surgery in the ambulatory vs inpatient settings (OR 1.31; 95% CI 0.78-2.21; P = .3). CLINICAL TRANSLATION: Ambulatory PP surgery confers significant cost savings and is associated with comparable perioperative outcomes relative to inpatient-based surgery. CONCLUSIONS: Both clinical and nonclinical factors predict the care setting of index PP surgery. Notably, underinsured patients experienced lower odds of undergoing ambulatory surgery. Ambulatory surgery was less costly with similar 30-day revisit rates relative to inpatient-based care. Berger A, Friedlander DF, Herzog P, et al. Impact of Index Surgical Care Setting on Perioperative Outcomes and Cost Following Penile Prosthesis Surgery. J Sex Med 2019;16:1451-1458.