Inequality and Innovation: Barriers and Facilitators to 17P Administration to Prevent Preterm Birth among Medicaid Participants.

Objectives Strategies to prevent preterm birth are limited. 17 Alpha-Hydroxyprogesterone Caproate (17P) injections have been shown to be effective, but the intervention is under-used. This mixed methods study investigates barriers and facilitators to 17P administration among Medicaid and CHIP participants enrolled in Strong Start for Mothers and Newborns, a federal preterm birth prevention program. Methods Twenty-seven awardees with more than 200 sites in 30 states, the District of Columbia, and Puerto Rico enrolled approximately 46,000 women in Strong Start from 2013 to 2016. Participant data, including data on preterm birth and 17P, was collected for each woman. Intensive interviews (n = 211) conducted with Strong Start program staff and providers (n = 314) included questions about 17P provision. Results Of women whose data included a valid response regarding 17P initiation, 3919 had a prior preterm birth and current singleton pregnancy; 14.95% received 17P. Barriers to 17P administration include late entry to prenatal care, administrative burden of preauthorization, cost risks to providers, limits in scope of practice for non-physician providers, and social barriers among participants. Facilitators for provision include streamlined work flows and the option of home administration. Conclusions for Practice A universal insurance authorization process could mitigate many barriers to 17P use. Providers need continuing education regarding the effectiveness of 17P, and expanding scope of practice for non-physician prenatal care providers would increase access. Targeted program interventions can help to overcome social barriers Medicaid participants face in accessing care. Streamlined work processes and the option of home health services are two effective program-based facilitators for providing 17P to a Medicaid population.

Evaluation of Progesterone Utilization and Birth Outcomes in a State Medicaid Plan.

OBJECTIVES: Progesterone (hydroxyprogesterone caproate injection and vaginal progesterone) has been shown to reduce preterm birth (PTB) rates by a third among pregnant women at high risk. The purpose of this analysis is to report birth outcomes and medication adherence among Massachusetts Medicaid (MassHealth) members receiving progesterone, evaluate the association between member characteristics and birth outcomes and medication adherence, and compare cost of care with a prior preterm pregnancy. METHODS: This retrospective cohort study used medical claims, pharmacy claims, and prior authorization (PA) request data for MassHealth members who had a PA submitted for progesterone between January 1, 2011, and March 31, 2015. Members were excluded due to breaks in coverage, progesterone was not indicated for prevention of PTB, and if current gestational week or date of delivery was unavailable. MAIN RESULTS: A total of 418 members were screened for inclusion of whom 190 met criteria and 169 filled progesterone. Mean age was 29.2 years (SD = 5.23), and clinical comorbidities were identified in 90.5% of members. Consistent with clinical trials on progesterone effectiveness, 62.1% of members had a term delivery (37 wks of gestation). Among members with prior gestational age at delivery available, the average difference in gestational age between pregnancies was 8.25 weeks (SD = 6.11). In addition, 66.3% of members were adherent to progesterone based on proportion of days covered (PDC) of 0.8 or higher. The overall mean PDC was 0.79 (SD = 0.26). CONCLUSION: Despite similar birth outcomes in clinical trials and national trends, medication adherence is low in this state Medicaid program. Therefore, members may benefit from adherence support.

17α-hydroxyprogesterone caproate access in the Louisiana Medicaid population.

Preterm birth and its associated neonatal morbidities remain pertinent health care and economic issues in the United States. Progesterone supplementation in the form of 17α-hydroxyprogesterone caproate has been reported to reduce the risk for recurrent preterm birth in women with a prior spontaneous preterm delivery, but several barriers contribute to its underutilization. The Affordable Care Act has increased the number of women receiving insurance coverage for pre- and perinatal care. However, the increase in insurance coverage has not necessarily facilitated access to standard therapies such as progesterone for the prevention of preterm birth. Data from Louisiana illustrate this point, and the state has responded by developing educational programs and the nation's first pay-for-performance strategy targeting the initiation of progesterone therapy.

Risk and liabilities of prescribing compounded medications.

Complications resulting from the use of compounded medications have become a troubling trend nationwide. There is a significant potential for patients to suffer serious harm from the use of substandard medications prepared by compounding pharmacies, and the reality of this problem has been demonstrated in several well-publicized incidences of serious medical complications, including patient deaths, that directly resulted from the use of medications prepared at compounding pharmacies. Unlike US Food and Drug Administration (FDA)-approved drugs, compounded products are not required to meet evidentiary standards for establishing safety and efficacy. Moreover, these products are not held to Good Manufacturing Practices, which require regular inspections, quality control testing, and rejection of material not meeting specifications. Physicians, as well as other prescribers, need to be aware that when a patient suffers harm from using a compounded medication, those injured patients may bring negligence and malpractice claims, not only against the pharmacy and the pharmacist responsible for preparing the medication, but also against the prescribing physician and the physician's practice. Consequently, the best way for physicians to manage professional risk and avoid both litigation and potential negative patient outcomes related to compounded pharmaceuticals is to not use these products if there is an FDA-approved product available. However, if the use of a compounded medication is medically necessary, then physicians should adhere to the FDA guidance concerning traditional compounding. Moreover, it would be prudent for any physician who intends to either resell or participate in the distribution of compounded products beyond the direct treatment of their patients to consider obtaining the appropriate insurance coverage for this activity.

The safety of progesterone and 17-hydroxyprogesterone caproate administration for the prevention of preterm birth: an evidence-based assessment.

The safety of supplemental progestin therapy during pregnancy reflects whether an agent exclusively promotes or potentially inhibits progestational cellular functions and whether treatment incites a metabolic derangement or other pathophysiology to initiate rare untoward events. No safety signal has been identified from intravaginal administration of natural progesterone from phase III clinical trials. The Food and Drug Administration has identified a legitimate safety signal regarding second-trimester miscarriage and stillbirth with exposure to 17-hydroxyprogesterone caproate (17-OHPC). Results from recent phase II and III trials in multiples also demonstrates concern with exposure to this synthetic for fetal loss and increased severe respiratory distress in neonates (one study each), as well as repeated significant associations for shorter duration of pregnancy and poorer fetal growth in others. The biological plausibility for 17-OHPC to be associated with adverse outcomes can be suggested from pharmacogenomic observations, ex vivo experimentation, and clinical observations. Further data are needed interrogating the potential for rare fetal or maternal adverse events/safety outcomes with exposure to progestins. Safety concerns should be incorporated into prescribing decisions.

17α Hydroxyprogesterone caproate for prevention of recurrent spontaneous preterm birth.

Use of 17-alpha-hydroxyprogesterone caproate for the prevention of spontaneous preterm birth in women at risk is reviewed. Early studies regarding this topic reached contradicting conclusions, however recent studies showed that weekly injections of 17-alpha-hydroxyprogesterone caproate beginning at 16-20 weeks' gestation resulted in a substantial reduction in the rate of spontaneous recurrent preterm birth. Long-term follow-up of children exposed in-utero to the drug has shown normal growth and development and normal scores for gender specific roles. In conclusion, 17-alpha-hydroxyprogesterone caproate is currently the only drug with sufficient evidence to support its use for prevention of spontaneous recurrent preterm birth.

Impact of 17P usage on NICU admissions in a managed medicaid population--a five-year review.

OBJECTIVE: To evaluate whether providing 17 alpha-hydroxyprogesterone caproate (17P) to high-risk pregnant women who have a history of preterm delivery in a Medicaid managed care population reduces the rate of recurrent preterm delivery and neonatal intensive care unit (NICU) admissions. STUDY DESIGN: A 2004-2009 longitudinal review of birth outcomes in 193 singleton pregnant women with a history of spontaneous preterm delivery that were treated with 17P versus a control group. METHODOLOGY: Intervention included offering 17P as a benefit to pregnant women who had a history of spontaneous preterm delivery and who were deemed to be appropriate candidates by their doctor. Members for this study were identified by claims review and obstetrical (OB) case managers in the health plans. A process of early identification, using a variety of data sources, was established along with an educational program aimed at physicians, their office staff, and plan members in order to increase 17P utilization in appropriate candidates. RESULTS: Deliveries with a gestational age of less than 35 weeks decreased significantly from 41.67% in the control group to 26.42% in the 17P group when 17P was initiated by 28 weeks of gestation. The NICU admission rate decreased from 45% in the control group to 33.68% in this 17P group, and was nearly significant. CONCLUSION: Offering 17P as a benefit does have a positive effect on reducing the rate of recurrent preterm delivery and rate of NICU admission in a managed Medicaid population. There was no decrease in effectiveness with delay in initiation of 17P as long as it was started by 28 weeks of gestation.