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This paper is dedicated to investigating the application of blockchain in eHealth systems. Unlike the previous work, patients here play a supervisory role and allow medical institutions to legally use their medical data without prior authorization but own the right to manage the medical data. This concept is able to protect the rights and interests of patients without affecting the normal diagnosis and research work of medical institutions. On this basis, a blockchain-based access control scheme for eHealth systems is proposed. To encourage patients to actively share their medical data, an incentive mechanism is also included. Finally, a case study on Ethereum is given to illustrate the feasibility and practicality of the proposed method.

Objective To describe the system-wide implementation of integrated electronic prior authorization (ePA) and its impact within a centralized prior authorization (PA) department in an academic health system. Setting Prescription drugs have been among the fastest growing areas of health care and continue to advance; therefore, costs associated with medications are continually rising. Pharmacy benefit managers implement tools such as PAs in an effort to manage costs. PAs are often viewed as inconvenient and irritating by both patients and clinical staff. Practice description The pharmacy ambulatory clinical care center (PAC3), a centralized PA department, provides PA services to some clinics within the system. Since 2014, the system has worked to optimize the manual (by telephone and fax) PA process. However, it is still a time-consuming, multistep process. Practice innovation A resolution to the PA problems that health systems face is ePA, which involves processing PAs electronically through an online portal or integrated within an electronic health record. The system began the implementation process with the selection of an ePA vendor, followed by implementation within the electronic health record. Once the software was ready, the system took a phased rollout approach and implemented ePA in a few specialty and primary care clinics at a time. Evaluation An average of 24% of PAs processed by PAC3 were completed by ePA. The system saw a 25% increase in the number of PAs processed per month by 1 PA coordinator full-time equivalent. In addition, a 62% decrease in the PA turnaround time allowed patients to receive medications faster. Results Not applicable. Conclusion ePA offers several benefits to the system including decreased turnaround time. This allows patients to receive medications and start therapy earlier. The ePA process also increased efficiency, allowing PAC3 to centrally manage PAs for additional clinics, thereby decreasing the workload in the clinic.

Background Prior authorization of prescription medications is a policy tool that can potentially impact care quality and patient safety. Objective To examine the effectiveness of a mandatory peer-review program in reducing antipsychotic prescriptions among Medicaid-insured children, accounting for secular trends that affected antipsychotic prescribing nationally. Data source Medicaid Analytical eXtracts (MAX) with administrative claims for health services provided between January 2006 and December 2011. Study design This retrospective, observational study examined prescription claims records from Washington State (Washington) and compared them to a synthetic control drawing from 20 potential donor states that had not implemented any antipsychotic prior authorization program or mandatory peer review for Medicaid-insured children during the study period. This method provided a means to control for secular trends by simulating the antipsychotic use trajectory that the program state would have been expected to experience in the absence of the policy implementation. Principal findings Before the policy implementation, antipsychotic use prevalence closely tracked those of the synthetic control (6.17 per 1000 in Washington vs. 6.21 in the synthetic control group). Within two years after the policy was implemented, prevalence decreased to 4.04 in Washington and remained stable in the synthetic control group (6.47), corresponding to an approximately 38% decline. Conclusion Prior authorization program designs and implementations vary widely. This mandatory peer-review program, with an authorization window and two-stage rollout, was effective in moving population level statistics toward safe and judicious use of antipsychotic medications in children.

Purpose The purpose of this report is to describe the activities of critical care and ambulatory care pharmacists in a multidisciplinary transitions-of-care (TOC) service for critically ill patients with pulmonary arterial hypertension (PAH) receiving PAH medications. Summary Initiation of medications for treatment of PAH involves complex medication access steps. In the ambulatory care setting, multidisciplinary teams often have a process for completing these steps to ensure access to PAH medications. Patients with PAH are frequently admitted to an intensive care unit (ICU), and their home PAH medications are continued and/or new medications are initiated in the ICU setting. Inpatient multidisciplinary teams are often unfamiliar with the medication access steps unique to PAH medications. The coordination and completion of medication access steps in the inpatient setting is critical to ensure access to medications at discharge and prevent delays in care. A PAH-specific TOC bundle for patients prescribed a PAH medication who are admitted to the ICU was developed by a multidisciplinary team at an academic teaching hospital. The service involves a critical care pharmacist completing a PAH medication history, assessing for PAH medication access barriers, and referring patients to an ambulatory care pharmacist for postdischarge telephone follow-up. In collaboration with the PAH multidisciplinary team, a standardized workflow to be initiated by the critical care pharmacist was developed to streamline completion of PAH medication access steps. Within 3 days of hospital discharge, the ambulatory care pharmacist calls referred patients to ensure access to PAH medications, provide disease state and medication education, and request that the patient schedule a follow-up office visit to take place within 14 days of discharge. Conclusion Collaboration by a PAH multidisciplinary team, critical care pharmacist, and ambulatory care pharmacist can improve TOC related to PAH medication access for patients with PAH. The PAH TOC bundle serves as a model that may be transferable to other health centers.

Objective:To evaluate whether incorporating mandatory prior authorization for Clostridioides difficile testing into antimicrobial stewardship pharmacist workflow could reduce testing in patients with alternative etiologies for diarrhea.Design:Single center, quasi-experimental before-and-after study.Setting:Tertiary-care, academic medical center in Ann Arbor, Michigan.Patients:Adult and pediatric patients admitted between September 11, 2019 and December 10, 2019 were included if they had an order placed for 1 of the following: (1) C. difficile enzyme immunoassay (EIA) in patients hospitalized >72 hours and received laxatives, oral contrast, or initiated tube feeds within the prior 48 hours, (2) repeat molecular multiplex gastrointestinal pathogen panel (GIPAN) testing, or (3) GIPAN testing in patients hospitalized >72 hours.Intervention:A best-practice alert prompting prior authorization by the antimicrobial stewardship program (ASP) for EIA or GIPAN testing was implemented. Approval required the provider to page the ASP pharmacist and discuss rationale for testing. The provider could not proceed with the order if ASP approval was not obtained.Results:An average of 2.5 requests per day were received over the 3-month intervention period. The weekly rate of EIA and GIPAN orders per 1,000 patient days decreased significantly from 6.05 ± 0.94 to 4.87 ± 0.78 (IRR, 0.72; 95% CI, 0.56–0.93; P = .010) and from 1.72 ± 0.37 to 0.89 ± 0.29 (IRR, 0.53; 95% CI, 0.37–0.77; P = .001), respectively.Conclusions:We identified an efficient, effective C. difficile and GIPAN diagnostic stewardship approval model.

Improvements in health indexes over last few decades have been accompanied by escalating health care costs, with spending on health in the near-term projected to be nearly 20% ([1][1]). All major stakeholders agree that this growth in health care spending requires moderation to ensure sustainable

Medicare covers home health benefits for homebound beneficiaries who need intermittent skilled care. While home health care can help prevent costlier institutional care, some studies have suggested that traditional Medicare beneficiaries may overuse home health care. This study compared home health use in Medicare Advantage and traditional Medicare, as well as within Medicare Advantage by beneficiary cost sharing, prior authorization requirement, and plan type. In 2016 Medicare Advantage enrollees were less likely to use home health care than traditional Medicare enrollees were, had 7.1 fewer days per home health spell, and were less likely to be admitted to the hospital during their spell. Among Medicare Advantage plans, those that imposed beneficiary cost sharing or prior authorization requirements had lower rates of home health use. Qualitative interviews suggested that Medicare Advantage payment and contracting approaches influenced home health care use. Therefore, changes in traditional Medicare home health payment policies implemented in 2020 may reduce these disparities in home health use and spell length.

BACKGROUND Many lower-income communities in the United States lack a full-line grocery store. There is evidence that the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) increases the availability of healthy foods in stores. One national discount variety store chain (DVS) that is often located in low-income neighborhoods became an authorized WIC vendor in 8 pilot stores. OBJECTIVES The objective of this study was to evaluate how implementing WIC in DVS pilot stores affected sales of healthy, WIC-eligible foods. METHODS We used DVS sales data and difference-in-differences regression to evaluate how WIC authorization affected sales of WIC-eligible foods in 8 DVS pilot stores, compared with 8 matched comparison stores. RESULTS DVS added 18 new WIC-approved foods to become an authorized vendor. Results indicate that becoming a WIC vendor significantly increased sales of healthy, WIC-eligible foods that DVS carried before authorization. WIC implementation in DVS led to a 31-unit increase in sales of the original WIC foods per week on average (P

Background Prescription drugs contribute to increased healthcare expenditures in the United States (U.S.). Use of generic drugs has been recognized as an effective tool to control rising prescription drug costs. This study aimed to evaluate the impact of U.S. federal and state generic drug policies on drug use, spending, and patient outcomes. Methods A systematic search was performed in June 2017, using PubMed, Web of Science, PsycINFO, and Business Source Premier. Search was limited to published articles in English language, including human subjects in the U.S., and with at least one outcome measure related to health service utilization, spending, or patient outcomes. Results Thirty-four studies constituting seven key policy domains were included. Medicaid/Medicare Prior Authorization (PA) policies (n = 4) led to increased generic use, reduced patient and payer's spending on prescriptions without causing deterioration in patient's health-related quality of life. Medicare prescription plan's generic drug benefits (n = 4) had impact on increased generic use and generated savings, but the limited access to branded drugs may increase medication use gaps and risks of hospitalizations. State generic substitution laws (n = 3) caused increased generic use and cost savings for both consumers and states. Medicare/Medicaid coverage cap policies (n = 3) were associated with increased patient's out-of-pocket spending (OOP) and reduced prescription spending for payers. Policies lowering cost-sharing (n = 7) were associated with increased patient's medication use and adherence, but the impact varied by therapeutic classes. Existing evidence evaluating Medicare Part D (n = 12) suggested decreased prescription spending for beneficiaries and Medicare. Generic gap coverage reduced patient's OOP and Medicare spending. Finally, early evidence showed reduced consumers' OOP prescription spending after the ACA (n = 2). Conclusions Federal and state policies regarding generic drugs have resulted in reduced spending for consumers and payers. However, the overall impact on patient outcomes remains unclear.

Nonadherence to oral anticancer medications (OAMs) in the United States is as low as 33% for some cancers. The reasons for nonadherence to these lifesaving medications are multifactorial, yet the majority of studies focus on patient‐level factors influencing uptake and adherence. Individually based interventions to increase patient adherence have not been effective, and this warrants attention to factors at the payor, pharmaceutical, and clinical systems levels. Based on the authors' research and clinical experiences, this commentary brings fresh attention to the long‐standing issue of OAM nonadherence, a growing quality‐of‐care issue, from a systems perspective. In this commentary, the key driving factors in pharmaceutical and payor systems (state and federal laws, payor/insurance companies, and pharmaceutical companies), clinical systems (hospitals and providers), and patient contexts that have trickle‐down effects on patient adherence to OAMs are outlined. In the end, the authors' recommendations include examining the influence of laws governing OAM drug pricing, OAM supply, and provider reimbursement; reducing the need for prior authorization of long‐approved OAMs; identifying cost‐effective ways for providers to monitor nonadherence; examining issues of provider bias in OAM prescriptions; and further elucidating in which contexts patients are likely to be able to adhere. These recommendations offer a starting point for an examination of the chain of systems influencing patient adherence and may help to finally resolve persistently high levels of OAM nonadherence., To successfully reduce high rates of oral anticancer medication nonadherence, the systems that govern drug policies and drug supply, provider reimbursement, prescribing biases, and adherence monitoring must be identified and addressed. This commentary highlights these systems and the challenges that they pose for providers and for patients to adhere to oral anticancer medication.

Objective The aim of this study is to evaluate the impact of adopting a pharmaceutical care model on clinical outcomes, patient satisfaction, and cost at a health payer level. Methods All patients with hepatitis C virus (HCV) who were insured by Bupa Arabia, with a direct-acting antivirals prior authorization drug request between April 2015 and October 2018 were included in this retrospective quasi-experimental study. The clinical outcome was the achievement of a sustained virologic response at least 12 weeks from end of treatment. Economic and patients’ satisfaction outcomes were included in this study. The differences in cost of treatment was analyzed by using the paired t test. Stata statistical software package (StataCorp, College Station, TX) was used for data analysis. Results A total of 371 patients were enrolled in this program of which 74% (n = 273) required clinical intervention. Among those, HCV treatment was modified for 64%. The overall cure rate was 97% among 267 patients for which sustained virologic responses were available. The results of the paired t test show that there was a 38% reduction in the mean direct cost of medications before and after intervention (95% confidence interval, 33%-43%; P Conclusions A structured pharmaceutical care program for HCV patients can guide the use of specialty medications to achieve optimal clinical outcomes, with lower expenditures and high patients’ satisfaction. We can conclude that healthcare insurance can play a key role in managing specialty pharmaceuticals like HCV medications. Because this is a preliminary study, further studies are needed in an experimental design to strengthen the evidence behind the effectiveness of such a program.

ObjectiveTo determine the amount of variation in numbers and types of medications requiring prior authorization (PA) by insurance plan and type.MethodsMost health insurance companies require PA for medications to ensure safe and effective use and contain costs. We generated 4 lists of medications that required PA during 2017 for commercial, marketplace, Medicaid, and Medicare plans. We aggregated medications according to the generic medication name equivalent using codes and medication names. We compared these medications to assess how many of the medications required PA by 1, 2, 3, or all 4 of the insurance plans. We counted all prescription orders written for a patient age 18 years or older with health plan insurance during 2017 for any of the medications that appeared on the health plan’s PA lists by querying the electronic health record.ResultsPA was required for 600 unique medications in 2017 across the 4 plans. Of 691,457 prescription orders written for 114,159 members, 31,631 (5%) were written for 1 of the 600 medications that required PA by at least 1 insurance plan. There were 12,540 medication orders (written for 6,642 members) that potentially required PA. The marketplace plan required PA for the greatest number of medications (440), followed by the Medicare (272), commercial (271), and Medicaid (72) plans. The most commonly prescribed classes of medications for which PA was required by at least 1 plan were antihyperlipidemics (22% of orders potentially requiring PA), narcotic analgesics (13%), hypnotics (12%), antidiabetic medications (9%), and antidepressants (9%). For only 25% of medications (151 of 600) was PA required by at least 3 plans, and for only 5% (32 of 600) was PA required by all 4 insurance types.ConclusionMedications requiring PA can differ within a single health insurance company, but this variation may be unavoidable due to external factors.

Among the three medications approved for the treatment of opioid use disorder, methadone has been in use for the longest period and has the most extensive evidence base of effectiveness. Yet it remains underutilized as new insurance policies favor access to buprenorphine and neglect to dismantle barriers to obtaining methadone. In the absence of wholesale regulatory change, private insurance carriers should take the lead in expanding access to this medication. We offer several solutions for private payers, including expanding coverage, removing prior authorization, addressing out-of-pocket costs, increasing provider reimbursement, and incentivizing system integration.

Objectives Proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9is)—innovative yet costly cholesterol-lowering agents—have been subject to substantial prior authorization (PA) requirements and low approval rates. We aimed to investigate trends in insurer approval and reasons for rejection for PCSK9i prescriptions as well as associations between patients’ demographic, clinical, pharmacy, payer, and PCSK9i-specific plan/coverage factors and approval. Methods We examined trends in PCSK9i approval rates and reasons for rejection using medical and prescription claims from 2015 to 2017 for individuals who received a PCSK9i prescription. We used multinomial logistic regression to estimate quarterly risk-adjusted approval rates for initial PCSK9i prescriptions and approval for any PCSK9i prescription within 30, 90, and 180 days of the initial PCSK9i prescription. For a 2016 subsample for whom we had PCSK9i-specific plan policy data, we examined factors associated with approval including PCSK9i-specific plan formulary coverage, step therapy requirements, and number of PA criteria. Results The main sample included 12 309 patients (mean age 64.8 years [SD = 10.8], 52.1% female, 51.5% receiving Medicare) and was similar in characteristics to the 2016 subsample (n = 6091). Approval rates varied across quarters but remained low (initial prescription, 13%-23%; within 90 days, 28%-44%). Over time, rejections owing to a lack of formulary coverage decreased and rejections owing to PA requirements increased. Lack of formulary coverage and having ≥11 PA criteria in the plan policy were associated with lower odds of PCSK9i prescription approval. Conclusions These findings confirm ongoing PCSK9i access issues and offer a baseline for comparison in future studies examining the impact of recent efforts to improve PCSK9i access.

Policy Points This scoping review reveals a growing literature on the effects of certain state opioid misuse prevention policies, but persistent gaps in evidence on other prevalent state policies remain. Policymakers interested in reducing the volume and dosage of opioids prescribed and dispensed can consider adopting robust prescription drug monitoring programs with mandatory access provisions and drug supply management policies, such as prior authorization policies for high-risk prescription opioids. Further research should concentrate on potential unintended consequences of opioid misuse prevention policies, differential policy effects across populations, interventions that have not received sufficient evaluation (eg, Good Samaritan laws, naloxone access laws), and patient-related outcomes. Context In the midst of an opioid crisis in the United States, an influx of state opioid misuse prevention policies has provided new opportunities to generate evidence of policy effectiveness that can inform policy decisions. We conducted a scoping review to synthesize the available evidence on the effectiveness of US state interventions to improve patient and provider outcomes related to opioid misuse and addiction. Methods We searched six online databases to identify evaluations of state opioid policies. Eligible studies examined legislative and administrative policy interventions that evaluated (a) prescribing and dispensing, (b) patient behavior, or (c) patient health. Findings Seventy-one articles met our inclusion criteria, including 41 studies published between 2016 and 2018. These articles evaluated nine types of state policies targeting opioid misuse. While prescription drug monitoring programs (PDMPs) have received considerable attention in the literature, far fewer studies addressed other types of state policy. Overall, evidence quality is very low for the majority of policies due to a small number of evaluations. Of interventions that have been the subject of considerable research, promising means of reducing the volume and dosages of opioids prescribed and dispensed include drug supply management policies and robust PDMPs. Due to low study number and quality, evidence is insufficient to draw conclusions regarding interventions targeting patient behavior and health outcomes, including naloxone access laws and Good Samaritan laws. Conclusions Recent research has improved the evidence base on several state interventions targeting opioid misuse. Specifically, moderate evidence suggests that drug supply management policies and robust PDMPs reduce opioid prescribing. Despite the increase in rigorous evaluations, evidence remains limited for the majority of policies, particularly those targeting patient health-related outcomes.

Dermatology experiences a disproportionately high burden of prior authorizations (PAs).To examine the effect of a centralized pharmacy intervention on the PA process and the impact of PAs on patient outcomes.A retrospective review of PAs submitted for medications before and after implementation of pharmacy intervention was conducted.PA was required for 8.1% of all prescriptions. PAs were most frequently submitted for topical steroids, topical antibiotics and antifungals, and topical retinoids. Most common indications included acne, psoriasis, and dermatitis. Biologic agents (55.2%) and brand-name only medications (42.8%) required PA at higher rates. Pharmacy intervention resulted in shorter time to PA submission (4 days vs 1 day, P .001) and decision (6 days vs 1 day, P .001) and higher approval rates (63.9% vs 80.6%, P .001) but did not decrease the total number of PAs. Patients with approved PAs had higher likelihood of disease improvement vs those with denied PAs (71.1% vs 58.0%, P = .013).Data were collected from a single academic institution. Patient medication compliance was not assessed.The current PA process may result in delays in care and a negative impact on patients. A centralized pharmacy intervention is an effective measure but does not eliminate the overall burden of PAs.

Rationale and Objectives Practice guidelines suggest most patients should wait at least 28 days from the onset of low back pain before receiving imaging. This study evaluates a nondenial prior authorization program's performance in modifying lower back imaging orders. Ordering physicians were asked by a consulting physician to modify any order that did not meet guidelines through collaborative consultation. If original orders were not reinitiated, it could signify that modified orders met clinical objectives. Materials and Methods Prior authorization and claims data from 2014 to 2017 were analyzed to determine the rate of reinitiation within 28 days for modified computed tomography and magnetic resonance imaging orders. Chi-square tests were used to evaluate whether modification or reinitiation was associated with several factors. Results Across the four sequences of interaction between ordering physicians and the program examined, 533,768 orders were placed, leading to 6855 completed consultations (1.3% of orders), 1380 modifications (20.1% of consultations), and 224 reinitiations (16.2% of modifications). Modification led to reinitiation 7.1%–20.6% of the time, depending upon the sequence. Orders from primary care physicians were significantly more likely to be modified. Reinitiation was significantly more likely for urban orders. Conclusion Low back imaging orders modified by the program were infrequently reinitiated within 28 days. Some reinitiation may have been consistent with evidence-based practice, as orders may have been placed after the onset of pain.

TRICARE is the military's health plan that provides coverage to 9.4 million active duty and retired uniformed services personnel and their family members. The TRICARE pharmacy benefit has undergone many changes in the last decade. These changes include assigning newly approved drugs to nonformulary status after regulatory approval, the addition of weight loss medications to the benefit, channel management point-of-service requirements for some medications, and copay increases. Several initiatives have resulted in significant cost avoidance to the Department of Defense (DoD). The purpose of this article is to discuss the changes to the TRICARE pharmacy benefit, describe the continual challenges, and estimate cost savings associated with implementation of these changes. DoD implemented its 3-tier Uniform Formulary in 2005. Since then, many changes have been enacted, including more extensive use of prior authorization, step therapy, and quantity limits; coverage of over-the-counter medications; the retail refund program; coverage of vaccines and smoking cessation agents; mandatory mail/military treatment facility requirements; rapid review and initial nonformulary status for newly approved innovator drugs; revisions to the compounded drug benefit; initial deployment of a new medical record system; coverage of weight loss medications; and the ability to exclude medications from the Uniform Formulary. Although the TRICARE pharmacy benefit has evolved significantly, the focus remains on the beneficiaries, with an overall goal of providing integrated, affordable, and high quality health services for the Military Health System. Challenges for the future include maximizing clinical effectiveness in the face of rising pharmaceutical costs and cost avoidance, while supporting the needs of TRICARE beneficiaries. DISCLOSURES: No outside funding supported this study. The authors declare no conflicts of interest, real or apparent, and no financial interests in any company, product, or service mentioned in this program, including grants, employment, gifts, stock holdings, and honoraria. The information discussed here represents the views of the authors and does not necessarily reflect the views of the Defense Health Agency (DHA), the Department of Defense (DoD), or the Departments of the Army, Navy, and Air Force. The authors have nothing to disclose that presents a potential conflict of interest.

Early career physicians are finding themselves under scrutiny from payers to demonstrate that they deliver high-quality health care. Physicians are expected to balance this on top of competing pressures from patient care, prior authorization, clinical documentation, and electronic health records

To determine the final outcomes of various types of prior authorizations (PAs), and to quantify the administrative and financial burden of PAs on urology practice. PAs are often required before imaging, procedures or medications can be ordered. However, they can delay timely delivery of patient care and place a significant administrative burden on practices. The impact of PAs has been poorly studied, and no studies on PAs burden on urology practice are available.Imaging and medications requiring PAs from an outpatient urology clinic from November 2020 to February 2021 were reviewed (n = 267). Authorization outcomes were tracked to resolution. We calculated the time spent on PAs, and the estimated overall financial burden on the practice.Of the PAs required, 60.6% were for imaging and 39.4% were for medications. Initial decision for PAs took a median of 2 days [IQR: 0-6, Range: 0-36], whereas decisions after an appeal (n = 51) took a median of 10 days [IQR: 5-23, range 0-125 days]. Private insurance compared to Medicare or Medicaid, has an earlier time to decision (P =.001). Initial approval rates were 67.5%, and final approval rates after appeals were 88.2%. Of orders originally denied, a majority (77.3%) were appealed, 13.6% required alternative orders, and 7.6% paid out of pocket. The total cost to the practice was $2206.06, with a $15.11 mean cost of each PA.PAs for imaging studies and medications pose a significant administrative and financial burden to urology patients and practice.

The Food and Drug Administration has granted emergency use authorization to sotrovimab for the treatment of mild to moderate COVID-19 in patients at increased risk for progression to severe illness.Sotrovimab is a monoclonal antibody that works directly against the spike protein of SARS-CoV-2 to block its attachment and entry into a human cell.

OBJECTIVES To assess the effectiveness of a proactive provider intervention in prompting prior authorization (PA) submissions or provider response prior to PA expiration for medically complex Medicaid patients. STUDY DESIGN Pre-post outreach study with data from pharmacy claims and provider outreach. METHODS The intervention and historical comparison (control) groups included expired PAs from December 2019 to February 2020 and from December 2018 to February 2019, respectively. Provider outreach, including telephonic and fax attempts, was conducted over a 2-week period prior to PA expiration. Outcomes were classified as positive or negative based on provider conversation coupled with the result (eg, PA submission) for the intervention group and based solely on pharmacy claims for the control group. The primary end point was the percentage of positive outcomes between the groups, analyzed via χ2 test. The time from PA expiration to the new PA submission was evaluated via t test. RESULTS A total of 342 outreach attempts were conducted for 270 PAs representing 193 unique patients. Outreach was more likely to result in positive outcomes in the intervention group vs no outreach in the control group (87% vs 25%; P

Background Lupus disproportionately affects Black/African American (AA) and Latino/a patients, yet these underrepresented racial/ethnic minority populations often face challenges with accessing quality care.1,2 We aimed to explore patients’ and physicians’ perceptions on the treatment journey for underrepresented patients and identify barriers to quality care. Methods In-depth qualitative interviews were conducted with patients with lupus from underrepresented populations (Black/AA, Latino/a, Native American, Asian/Pacific Islander) and physicians (dermatology or rheumatology). Quota sampling was used to recruit patients from racially and ethnically diverse backgrounds and physicians with varied medical practices. Patient and physician participants provided informed consent. Semi-structured interviews explored patients’ experiences with the healthcare system and physicians’ challenges when treating patients with lupus. Results Interviews were conducted with 33 patients and 20 physicians. Age, region, education, employment status, and type/severity of lupus varied among patients, as did physicians’ work experience and practice settings (table 1). Patients reported challenges at each step of their journey. Prior to diagnosis, patients entered the healthcare system often lacking awareness of lupus disease and reported feeling initially ignored, dismissed, or misdiagnosed, which delayed treatment and triggered mistrust of the healthcare system. Lack of trust was cited by patients as a reason to discontinue treatment, despite persistent symptoms. Some patients reported perceived challenges with access to branded medications due to insurance coverage or delays in prior authorization and were concerned about losing their job and insurance. Patients communicated that treatment access might be improved by establishing support systems for reliable disease information (advocacy groups, community support), increasing cultural sensitivity in physician practices, and enabling an efficient and transparent treatment initiation process. From the physician perspective, barriers to treatment access included delayed diagnoses, patient concerns over side effects and the need for lifelong treatment, communication challenges with patients with limited English proficiency (LEP), and medication costs. Physicians suggested addressing perceived barriers by providing better patient information resources, having a live translator present during visits for patients with LEP, and navigating accessibility to medications through patient assistance programs to ensure access to branded therapies when needed. Conclusions Improving access to quality care for underrepresented patients is essential to reduce health disparities across racial/ethnic groups and build trust in the healthcare system. Increasing disease awareness among these diverse groups and physicians, establishing patient support networks, and improving patient-physician communication should be critical components of health equity efforts. References Arora. Rheum Dis Clin N Am. 2020;46:623-638. Maningding. Arthritis Care Res. 2020;72(5):622-629.

ImportanceMedicaid is a key policy lever to improve opioid use disorder treatment, covering approximately 40% of Americans with opioid use disorder. Although approximately 70% of Medicaid beneficiaries are enrolled in comprehensive managed care organization (MCO) plans, little is known about coverage and prior authorization (PA) policies for medications for opioid use disorder (MOUD) in these plans.ObjectiveTo compare coverage and PA policies for buprenorphine, methadone, and injectable naltrexone across Medicaid MCO plans and fee-for-service (FFS) programs and across states.Design, Setting, and ParticipantsThis cross-sectional study analyzed MOUD data from 266 Medicaid MCO plans and FFS programs in 38 states and the District of Columbia in 2018.Main Outcomes and MeasuresFor each medication, the percentages of MCO plans and FFS programs that covered the medication without PA, covered the medication with PA, and did not cover the medication were calculated, as were the percentages of MCO, FFS, and all (MCO and FFS) beneficiaries who were covered with no PA, covered with PA, and not covered. In addition, MCO plan coverage and PA policies were mapped by state. Analyses were conducted from January 1 through May 31, 2022.ResultsCoverage and PA policies were compared for MOUD in 266 MCO plans and 39 FFS programs, representing approximately 70 million Medicaid beneficiaries. Overall, FFS programs had more generous MOUD coverage than MCO plans. However, a higher percentage of FFS programs imposed PA for the 3 medications (47.0%) than did MCOs (35.9%). Furthermore, although most Medicaid beneficiaries were enrolled in a plan that covered MOUD, 53.2% of all MCO- and FFS-enrolled beneficiaries were subject to PA. Results also showed wide state variation in MCO plan coverage and PA policies for MOUD and the percentage of Medicaid beneficiaries subject to PA.Conclusions and RelevanceThis cross-sectional study found variation in MOUD coverage and PA policies across Medicaid MCO plans and FFS programs and across states. Thus, Medicaid beneficiaries’ access to MOUD may be heavily influenced by their state of residency and the Medicaid plan in which they are enrolled. Left unaddressed, PA policies are likely to remain a barrier to MOUD access in the nation’s Medicaid programs.

Aims: Cancer drugs are increasingly approved through expedited regulatory pathways including the European conditional marketing authorization (CMA). Whether, when taking CMA post-approval confirmatory trials into account, the level of evidence and clinical benefit between CMA and standard approved (SMA) drugs differs remains unknown. Methods: We identified all CMA cancer indications converted to SMA in 2006–2020 and compared these to similar SMA indications with regard to pivotal trial and CMA post-approval confirmatory trial design, outcomes and demonstrated clinical benefit (per the European Society for Medical Oncology Magnitude of Clinical Benefit Scale). We tested for differences in clinical benefit and whether substantial clinical benefit was demonstrated. To account for the clinical benefit of unconverted CMA indications, we performed sensitivity analyses. Results: We included 15 SMA and 15 converted CMA cancer indications (17 remained unconverted). Approval of 11 SMA (73%) and four CMA indications (27%) was supported by a controlled trial. Improved overall survival (OS) was demonstrated for four SMA indications (27%). Improved quality of life (QoL) was demonstrated for three SMA (20%) and one CMA indication(s) (7%). Of subsequent CMA post-approval confirmatory trials, 11 were controlled (79%), one demonstrated improved OS (7%) and five improved QoL (36%). After conversion, CMA indications were associated with similar clinical benefit (P =.31) and substantial clinical benefit as SMA indications (risk ratio 1.4, 95% confidence interval 0.57–3.4). Conclusion: While CMA cancer indications are initially associated with less comprehensive evidence than SMA indications, levels of evidence and clinical benefit are similar after conversion from CMA to SMA.

Objetivo: Analisar na literatura a percepção da puérpera sobre a assistência humanizada de enfermagem prestada durante o ciclo gravídico-puerperal. Métodos: Trata-se de uma revisão integrativa realizada com base na seguinte pergunta norteadora: “Qual a percepção das puérperas sobre a assistência humanizada de enfermagem prestada no ciclo gravídico-puerperal?”. A busca dos artigos foi realizada nas bases de dados BDENF, LILACS e SciELO, a partir dos descritores controlados “Humanização da Assistência”, “Enfermagem Obstétrica” e “Cuidados de Enfermagem”. Resultados: A amostra totalizou 12 artigos, os quais apontaram tanto aspectos positivos quanto negativos da assistência humanizada de enfermagem. Sobre os aspectos positivos, foram evidenciados: no pré-natal, a criação do vínculo entre profissional-paciente e as ações educativas em saúde; no âmbito do parto foi enfatizado a empatia profissional e as boas práticas preconizadas pela Rede Cegonha e Organização Mundial da Saúde; no contexto do puerpério, revelou-se a preocupação dos enfermeiros com o conforto e bem-estar da mulher. Sobre os aspectos negativos, pode-se destacar a execução de procedimentos sem autorização prévia da puérpera, relatos de coerção e violação ao direito de acompanhante, e no puerpério a ausência de ações educativas de saúde direcionadas para a prevenção de intercorrências puerperais e/ou mamárias. Conclusão: O enfermeiro deve estar pautado na humanização, exercendo uma postura idealizadora de caráter cuidador, de modo que possa desempenhar a sua prática com vista à efetivação dos direitos sexuais e reprodutivos das mulheres antes e depois do ciclo gravídico-puerperal.

Reports analyzing the impact of pediatric antimicrobial stewardship programs (ASP) over long periods of time are lacking. We thus report our ASP experience in a pediatric tertiary referral center over a long-term period from 2011 to 2018. Our ASP was implemented in 2011. The program was based primarily on guideline development with key stakeholders, engaging and educating providers, followed by prospective audit with feedback (PAF). Monitored antibiotics included meropenem, piperacillin–tazobactam, and cefepime, followed by the addition of ceftriaxone, ceftazidime, cefotaxime, ciprofloxacin, levofloxacin, linezolid, and vancomycin at various time points. Specifically, the program did not implemented the core strategy of formulary restriction with prior authorization. Process- and outcome-related ASP measures were analyzed. We saw a 32% decrease in overall antibiotic utilization, a 51% decrease in the utilization of antibiotics undergoing PAF, and a 72% reduction in the use of broad-spectrum antibiotics such as meropenem. There was a concomitant increase in organism susceptibility and a reduction in yearly drug purchasing costs of over USD 560,000 from baseline without changes in sepsis-related mortality. Our study highlights that a pediatric ASP based primarily on the principles of guideline development and PAF can improve antibiotic utilization and institutional bacterial susceptibilities without a detrimental impact on patient outcomes by changing the culture of antimicrobial utilization within the institution.

This chapter analyses the unauthorized transfer of a Dronebuster for testing in a fictitious European NATO member state (EUMS). As the Dronebuster had been purchased in the US, it remained subject to US export control regulations, and, prior authorization was warranted. As there had been no requests for prior authorization, this transfer is considered non-compliant behaviour. Using the Problem-Oriented Policing framework, we investigate the underlying causes and conditions. We argue that a coordinated operation of a mix of hard- and soft controls is the optimal response to prevent such behaviour.

Background: Slow uptake of sacubitril/valsartan in patients with heart failure with reduced ejection fraction has been reported, which may negatively impact clinical outcomes. We characterized prior authorization (PA) burden, prescription copayment, and utilization of sacubitril/valsartan by insurance plan type to identify potential barriers to its use. Methods: We conducted a national population-level, cross-sectional study using PA data from an insurance coverage website accessed in March 2019 and IQVIA National Prescription Audit data from August 2018 to July 2019. Primary outcomes were proportion of plans requiring PA, frequency of specific PA criteria, number of sacubitril/valsartan prescriptions, and copayments per insurance plan type. Results: Overall, 48.1% (1394/2896) of insurance plans required PA for sacubitril/valsartan. Fewer Medicare (27.7%) than commercial (57.2%) plans required PA ( P P Conclusions: Despite commercial plans having greater PA requirements than Medicare, population-adjusted use of sacubitril/valsartan was higher in commercial plans. Given that commercial plans had more prescriptions with low copayments than Medicare, copayment policies may be more influential on sacubitril/valsartan use than its PA policies. Low sacubitril/valsartan use in both plan types highlights the multifactorial nature of medication underutilization that includes factors beyond the drug policies that we evaluated.

Background Infusion therapy refers to the intravenous administration of medicines and fluids for the treatment of status migrainosus, severe persistent headaches, or chronic headache. Headache practices and centers offer this treatment for patients as an alternative to the emergency department (ED) setting. However, little information is available in the literature on understanding the operations of an infusion center. Objective We sought to survey the Inpatient Headache & Emergency Medicine specialty section and the Academic Program Directors listserv of the American Headache Society (AHS) to better understand current practices. Methods A survey was advertised and distributed to the listservs of both the Inpatient Headache & Emergency Medicine specialty section and the Academic Program Directors, which combined included both academic and private practices. In addition, the survey was available on laptops at related events at an annual AHS meeting in Scottsdale. Results Of the 127 members of the combined group of both listservs, 50 responded with an overall survey response rate of 39%. Ten out of fifty were from programs with more than one responder completing the survey, leaving 40 unique headache programs. Academic programs made up the majority of programs (85%, 34/40). The total of 40 participating programs is comparable with the 47 academic headache programs listed on the American Migraine Foundation website at the time of the survey. Of the academic programs surveyed, most were hospital based (n = 23) compared with a satellite location (n = 11). Of all programs surveyed, 68% (27/40) offered infusion therapy. Of those that did not have an infusion practice (n = 13), the most common reason cited was insufficient staffing (n = 8). Key highlights of the survey included the following: The majority of programs offering infusions obtain prior authorization before scheduling (70%, 19/27) and offer patient availability 5 days/week (78%, 21/27) typically only during business hours (81%, 22/27). Programs reported that they typically give three to four medications during each infusion session (72%, 18/25). Treatment paradigms varied between programs. Programs surveyed were concentrated in the Northeast and Midwest regions of the United States. Conclusion The limited number of headache infusion centers overall may contribute to the limited ability of headache infusion centers to prevent ED migraine visits. Headache patients can have unpredictable headache onset, and most of the infusion practices surveyed appeared to adapt to this by offering infusions most days during a work week. However, this need for multiple days per week may also explain the most common reason for not having an infusion practice, which is insufficient staffing. Various treatment paradigms are implemented by different practitioners, and future studies will have to focus on investigation of best practice.

Background: Modern hepatitis C virus (HCV) treatment regimens yield cure rates greater than 90%. However, obtaining approval for treatment through the prior authorization (PA) process can be time consuming and require extensive documentation. Lack of experience with this complex process can delay HCV medication approval, ultimately increasing the amount of time before patients start treatment and in some cases, prevent treatment altogether. Objectives: Assess the impact of incorporating clinical pharmacists into specialty pharmacy and hepatology clinic services on medication access, patient adherence, and outcomes in patients being treated for HCV. Methods: We performed a retrospective cohort exploratory study of patients seen in an academic medical center hepatology clinic who had HCV prescriptions filled between 8/1/15 and 7/31/17. Patients were categorized by whether they filled prescriptions prior to (Pre-Group) or after (Post-Group) the implementation of a pharmacist in clinic. The Post-Group was further divided according to whether the patient was seen by a pharmacist in clinic (Post-Group 2) or if the patient was not seen by the pharmacist, but had their HCV therapy evaluated by the pharmacist before seeking insurance approval (Post-Group 1). Results: The mean time from the prescription being ordered to being dispensed was longer in the Pre-Group (50.8 ± 66.5 days) compared to both Post-Groups (22.2 ± 27.8 days in Post-Group 1 vs 18.9 ± 17.7 days in Post-Group 2; P

Background: Prior authorization (PA) of medications is widely used by payers in the United States as a way to promote safe and effective use of medications and to control costs. However, PA-related tasks such as completing forms, submitting forms, researching medical history and submitting required documentation can all contribute to burden on healthcare providers. This study examines how such tasks and affect provider burden and treatment decisions. Methods: We developed and administered a nationwide, cross-sectional online survey of medical providers in the United States in 2020 based on a convenience sample of 100,000 providers (physicians, nurse practitioners, and physician assistants). Path analysis was used to test the associations between provider practice characteristics, step therapy and other health plan requirements, perceived burdens of PA, and communication issues with insurers on prescribing behaviors, which included prescribing a different medication, avoiding prescribing of newer medications, and modifying a diagnosis. Weighted analyses were also conducted to account for sample bias due to non-response. Results: A total of 1173 providers (1.2% response rate) provided 1147 usable surveys. The sample was 49.6% female, and a majority were MD/DO providers (85%). Step therapy requirements had the largest influence on prescribing a different medication than planned (b = .22, 95% CI = .160-.285) and avoiding prescribing a newer medication despite meeting evidence-based guidelines (b = .24, 95% CI = .181-.309). A unit-weighted index of perceived PA burden risk was associated with prescribing a different medication (b = .09, 95% CI = .012-.128) and modifying a diagnosis to obtain PA approval (b = .14, 95% CI = .065-.195). Communication issues were associated with prescribing a different medication (b = .11, 95% CI = .029-.186), while health plan requirements (e.g., clinical documentation) was significantly associated with all three prescribing outcomes. Weighted analyses showed that the study conclusions were unlikely to have been biased by nonresponse. Conclusions: Providers report altering prescribing and modifying diagnoses to avoid PA requirements and related burdens. Processes that reduce the administrative burden of PA through improved communication and transparency as well as standardized documentation may help ensure that PA more seamlessly achieves its goals of safe and effective use of medications. Trial Registration: NA Keywords: clinical decision making, health plan, prior authorization, provider burden, specialty types, workaroundsTrial Registration: NA

Alopecia areata (AA) is a psychologically distressing disorder for which few reliable treatments exist. Although oral tofacitinib has demonstrated efficacy in treating AA, it is not approved by the Food and Drug Administration (FDA) for this indication. To investigate and identify the challenges associated with securing insurance approval for oral tofacitinib for AA. We conducted a retrospective review of patient records from two academic medical centers to identify patients with AA in whom insurance approval was sought for oral tofacitinib from 2015–2019. We recorded information on prior authorization (PA) submissions, appeals, and peer-to-peer reviews. We noted whether patients were documented to experience negative impact on mood/QOL or suicidal ideation (SI) due to their disease. We identified 37 patients in whom insurance approval was sought for oral tofacitinib for the treatment of AA. PAs were initially denied for 36/37 (97%) patients. The most commonly cited reason for denial was “tofacitinib not covered for AA/off-label medication use” (n = 26/36; 72%). 26/37 (70%) patients ultimately failed to obtain coverage. Of the 11 (30%) patients who obtained coverage, 10 (91%) were privately insured, 0 (0%) had Medicare and 1 (9%) had Medicaid. 13 patients (34%) experienced documented diminished QOL/mood (including SI) due to their disease burden; 6/13 (46%) of these patients eventually secured insurance approval. Lack of FDA approval of oral tofacitinib for the treatment of AA creates challenges in caring for patients with this disease. Policymakers should consider the negative implications lack of FDA approval may have for patients with recalcitrant dermatologic conditions.