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Background Increasing the number of human immunodeficiency virus (HIV) pre-exposure prophylaxis (PrEP) providers expands PrEP access to more eligible patients to help end the HIV epidemic. Previous studies have noted providers perceive financial barriers as a limitation to prescribing PrEP. Objective Describe PrEP medication access and affordability in patients seen at a multidisciplinary PrEP clinic. Method We conducted a single-center, retrospective, cohort study of adults initiating tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) in the Vanderbilt PrEP Clinic between 9/1/2016 and 3/31/2019 with prescriptions filled by Vanderbilt Specialty Pharmacy. Data were gathered from the electronic health records and pharmacy claims. We evaluated three different time periods: initial evaluation to PrEP initiation, prescription of PrEP to insurance approval, and insurance approval to initiation. Treatment initiation was considered delayed when >7 days from initial evaluation, and reasons for delay were recorded. Continuous variables are presented as median (interquartile range, IQR) and categorical variables are presented as percentages. Results We included 63 patients; most were male (97%), White (84%), commercially insured (94%) with a median age of 38 years (IQR 29—47). Primary indication for PrEP was men who have sex with men at high risk for acquiring HIV (97%). Median time from initial appointment to treatment initiation was 7 days (IQR 4—8). Treatment delays occurred in 25% of patients and were mostly driven by patient preference (50%). Insurance prior authorization was required in 27% of patients; all were approved. Median total out-of-pocket medication costs for the entire study period were $0 (IQR $0 – $0). Most patients (86%) used manufacturer copay cards. Conclusion In this cohort of mostly commercially insured men, the majority were able to access PrEP with low out-of-pocket costs facilitated by manufacturer assistance. Though generalizability beyond this population is limited, these results contradict perceived financial barriers to PrEP access.

Background Processes such as prior authorization (PA) for medications, implemented by health insurance companies to ensure that safe, appropriate, cost-effective, and evidence-based care is provided to all members, have created inefficiencies within healthcare systems. Thus, healthcare systems have implemented supplemental processes to reduce burden and ensure efficiency, timeliness, and appropriate care. Objective Evaluate implementation outcomes of two initiatives related to PA for medications: a common record that records all PA-related information that was integrated into the health record and an auto-routing of specialty prescriptions to a hospital-owned specialty pharmacy. Methods We conducted semi-structured interviews with medical staff to understand their experience, acceptability, adoption, and feasibility of these initiatives guided by Proctor’s Framework for Implementation Outcomes. Transcripts were analyzed using consensus coding. Results Eleven medical staff participated in semi-structured interviews. The two initiatives were analyzed together because the findings were similar across both for our outcomes of acceptability, adoption, and feasibility. Participants found the implemented initiatives to be acceptable and beneficial but felt there were still challenges with the new workflow. The initiatives were fully adopted by only one clinic site within the healthcare system, but limitations arose when adopting to another site. Individuals felt the initiatives were feasible and improved workflow, communication, and transparency. However, participants described future adaptations that would help improve this process including improved standardization, automation, and transparency. Conclusion The acceptability, adoption, and feasibility of two initiatives to improve the PA process within the one clinical site were well received but issues of generalizability limited the initiatives adoption system wide.

Dyslipidemia continues to be a major predictor of adverse cardiovascular outcomes in patients with risk factors as well as diagnosed atherosclerotic cardiovascular disease. Recent clinical trials and national guidelines from the US Preventive Services Task Force, American College of Cardiology, and American Heart Association have reinforced a paradigm shift from quantitative reduction of low-density lipoprotein cholesterol targets to prevention and risk factor reduction. Optimized medical therapies have become more inclusive of patients in both the primary and secondary care settings. Although statins continue to be a cornerstone of all recommended therapeutic options, many barriers to patient adherence with medical therapy exist. As medical options change to include the newer lipid-lowering treatments, patient adherence and provider practice challenges can diminish the benefits these medications offer. Although the phenomenon of adherence is complex, multidisciplinary teams, technology, improved communication, prior authorization, step-wise approaches, and the streamlining of the appeal process have shown benefit to mitigate cardiovascular disease-related sequelae. A current overview of practitioner barriers such as organizational restrictions, as well as patient challenges such as poor health literacy and poverty, are examined. Collaborative, multidisciplinary planning and interventions are reviewed with suggestions to increase patient adherence and optimize treatment regimens. This article reinforces existing knowledge while providing new insights to these issues.

BACKGROUND: Patients with substance use disorders (SUD) and chronic hepatitis C virus infection (HCV) have limited access to direct-acting antivirals (DAAs) due to multilevel issues related to providers (eg, concern about reinfection); patients (eg, refusal); payers (eg, prior authorization); and health system structure, although clinical guidelines recommend timely DAA treatment for patients with SUD and HCV. Effects of DAAs on real-world health care utilization and costs among these patients is unknown. OBJECTIVE: To compare changes in medical service utilization and costs related to liver, SUD, and all-cause morbidity in patients with SUD and HCV treated with DAAs (DAA group) vs not treated with DAAs (non-DAA group). METHODS: We conducted a retrospective cohort study using MarketScan Commercial and Medicare Supplemental Claims databases (2012-2018) for newly diagnosed HCV treatment-naive adults with SUD. We used difference-in-differences analyses, stratified by cirrhosis status, to determine the adjusted ratio of rate ratio (RoRR) to assess the difference in the relative changes from the pre- to posttreatment periods between the 2 groups. RESULTS: 6,266 patients with SUD and HCV were identified. Of these patients who also had cirrhosis (n = 607), 49% (n = 298) initiated DAA therapy for HCV, whereas of those without cirrhosis (n = 5,659), 22% (n = 1,219) initiated DAAs. For patients with cirrhosis (n = 607), the liver-related costs decreased by $6,213 (95% CI = -$8,571, -$3,856) for the DAA group and $1,585 (95% CI = -$4,659, $1,490) for the non-DAA group. The relative decreases in the rate of liver-related costs were larger for the DAA group than for the non-DAA group, and the relative changes between groups were significantly different (RoRR = 0.37, 95% CI = 0.19-0.73). There was no difference in the relative changes after DAAs in the rate of SUD-related visits/costs or all-cause costs between the 2 groups. For patients without cirrhosis (n = 5,659), a similar association was observed. Besides, the relative decreases in the rate of SUD-related emergency department (ED) visits (RoRR = 0.54, 95% CI = 0.38-0.77); SUD-related long-term care visits (RoRR = 0.30, 95% CI = 0.13-0.73); all-cause ED visits (RoRR = 0.75, 95% CI = 0.64-0.88); and all-cause long term-care visits (RoRR = 0.36, 95% CI = 0.18-0.72) were larger in the DAA group than in the non-DAA group. CONCLUSIONS: DAAs are associated with a significant decrease in the rate of SUD-related ED visits and liver-related costs without increasing the rate of all-cause costs among patients with SUD and HCV, suggesting that the benefits of DAAs extended beyond liver-related outcomes, especially in this disadvantaged population. DISCLOSURES: Research reported in this publication was supported in part by the National Institute on Drug Abuse of the National Institutes of Health (K01DA045618). The funder did not have a role in the design, the execution, the analyses, the interpretation of the data, or the decision to submit the results of this study. The authors have no potential conflicts of interest.

Background Antipsychotic prescribing to Medicaid-enrolled youth has been the target of numerous policy initiatives, including prior authorization and quality monitoring programs, which often target specific populations. Whether these efforts have changed the level or composition of antipsychotic prescribing is unclear. Methods Using 2014–2018 administrative claims data for Medicaid enrollees aged 21 years and under in Philadelphia, Pennsylvania, we measured antipsychotic prescription fills overall and for youth without an approved indication (autism, bipolar disorder, or psychosis). We then assessed whether trends differed for populations that have been targeted by policy initiatives, including younger children and foster care-enrolled youth. We also identified the most common approved and unapproved indications and examined whether the treatment duration of antipsychotic prescriptions differed based on whether the youth had an approved or unapproved indication. Results Overall, the number of Medicaid youth with an antipsychotic prescription fill halved between 2014 and 2018. Youth aged 17 years and under and foster care-enrolled youth, who were targeted by prior authorization and quality improvement efforts, experienced larger declines. Roughly half of prescriptions were for unapproved indications in both 2014 and 2018; the most common unapproved indication was ADHD, and the treatment duration was shorter for unapproved indications compared to approved indications. Conclusions Antipsychotic prescribing to Medicaid-enrolled youth is declining, particularly among populations that have been targeted by policy initiatives like prior authorization and quality monitoring programs. Despite the fact that these initiatives often assess diagnostic criteria, half of antipsychotic prescriptions were for unapproved indications in both 2014 and 2018. More research is needed to gauge whether this prescribing is appropriate.

Background Malleable [MPP] and inflatable [IPP] penile prosthesis surgery for the management of erectile dysfunction is a reliable treatment option with high success rates and excellent patient satisfaction; however, Medicaid coverage transparency is poor leaving a knowledge gap in this population. Aim The present study seeks to assess Medicaid coverage for MPP and IPP by state as evidenced by inclusion in publicly available physician fee schedules. Methods State Medicaid websites were utilized to access public physician fee schedules. Individual search queries were performed for CPT codes 54400 and 54405 which represent insertion of MPP and IPP, respectively. Data were recorded for each device, including the coverage status, physician fees, and the presence of clear documentation of a prior authorization requirement. Outcomes Medicaid physician fee schedules were accessible for 49 out of 50 US states, and 28 states reported coverage for at least one type of penile prosthesis. RESULTS Two states reported coverage for MPP only, one state reported coverage for IPP only, and 24 states reported coverage for both devices. One state reported that it did not cover either device, but listed coverage for a self-contained IPP (CPT 54401) only. Mean physician reimbursement was $477.15 (290.82–$1175.50) for MPP placement and $691.76 (421.68–$1794.27) for IPP. Eleven states documented prior authorization requirements within their fee schedules, while the remaining 17 states did not. Criteria for approval for prior authorization were not clearly stated in any fee schedule. Clinical Implications Efforts to clearly document approval criteria and educate Men’s Health providers on available coverage could result in a significant improvement in sexual satisfaction in the Medicaid population. Strengths and Limitations Graphical representation of states offering Medicaid penile prosthetic coverage and physician reimbursement ranges are provided with comparison to Medicare rates. Limitations include heterogeneity in fee schedules, lack of prior authorization requirement details, inability to correlate to successful claims data, and the evolving nature of Medicaid coverage for the given procedures. CONCLUSIONS Medicaid coverage exists for penile prosthetic surgery in 28 states, although often with significant, non-transparent prior authorization criteria.

The landscape of payment for genetic testing has been changing, with an increase in the number of laboratories offering testing, larger panel offerings, and lower prices. To determine the influence of payer coverage and out-of-pocket costs on the ordering of NGS panel tests for hereditary cancer in diverse settings, we conducted semi-structured interviews with providers who conduct genetic counseling and order next-generation sequencing (NGS) panels purposefully recruited from 11 safety-net clinics and academic medical centers (AMCs) in California and North Carolina, states with diverse populations and divergent Medicaid expansion policies. Thematic analysis was done to identify themes related to the impact of reimbursement and out-of-pocket expenses on test ordering. Specific focus was put on differences between settings. Respondents from both safety-net clinics and AMCs reported that they are increasingly ordering panels instead of single-gene tests, and tests were ordered primarily from a few commercial laboratories. Surprisingly, safety-net clinics reported few barriers to testing related to cost, largely due to laboratory assistance with prior authorization requests and patient payment assistance programs that result in little to no patient out-of-pocket expenses. AMCs reported greater challenges navigating insurance issues, particularly prior authorization. Both groups cited non-coverage of genetic counseling as a major barrier to testing. Difficulty of access to cascade testing, particularly for family members that do not live in the United States, was also of concern. Long-term sustainability of laboratory payment assistance programs was a major concern; safety-net clinics were particularly concerned about access to testing without such programs. There were few differences between states. In conclusion, the use of laboratories with payment assistance programs reduces barriers to NGS panel testing among diverse populations. Such programs represent a major change to the financing and affordability of genetic testing. However, access to genetic counseling is a barrier and must be addressed to ensure equity in testing.

Background The roles of pharmacy technicians in clinical practice are being explored. Medication prior authorizations (PAs) from insurers can lead to delays in pharmacotherapy. Objective To assess the efficiency of our clinical pharmacy technicians in processing PAs for medications. Practice description Outpatient clinics in a comprehensive health care provider group. Practice innovation PA requests are routed to technicians for initial data collection. Clinical pharmacists can review their work before submission. Evaluation methods Clinical pharmacy staff in 4 clinics recorded information about PA requests from January 21, 2020, to April 21, 2020. In 3 of the clinics, PA requests were primarily processed by clinical pharmacy technicians. In another clinic, requests were processed by a clinical pharmacist. Information collected included the date the request was received, outcomes (e.g., approval, therapy change, or nonapproval), and the date of final outcome. Descriptive statistics were prepared, including number of requests that were approved, number of business days between request and decision, and final outcome. Results Overall, 720 PA requests were received. Of these, 88.6% were approved with first response, and 673 (93.5%) were eventually approved. Median time to first response was 0 business days, regardless of clinic. In 75% of cases, first response was within 1 business day. PA characteristics varied across clinics; however, PA approval percentages were comparable (91.2%–94.3%). Conclusion In an assessment of clinical pharmacy technicians' efficiency in responding to pharmacy plan PA requests, more than 90% were approved, often within one business day. Our results must be interpreted in light of local factors and a virus pandemic during the study. However, results of requests handled by technicians were similar to results when the requests were handled by a clinical pharmacist. Clinical pharmacy technicians can be efficient and cost-effective in this role.

Aims To assess differences in the quality of opioid use disorder (OUD) treatment received by Medicare beneficiaries enrolled in health plans that used prior authorization (PA) for buprenorphine-naloxone compared with those enrolled in plans that did not use PA. Design Cross-sectional observational study. Setting United States. Participants Continuously enrolled beneficiaries (71,294) with an OUD who filled at least one prescription for buprenorphine-naloxone between March 2012 and July 2017. Measurements Percentage of patients tested for hepatis B, hepatis C, HIV, and liver functioning; percentage of patients with urine drug screens and number of urine drug screens; continuous use of buprenorphine-naloxone for at least 180 days; co-use of benzodiazepines; number of outpatient visits with and without an OUD diagnosis. Findings PA was significantly associated with a lower likelihood of testing for hepatitis B (-3.5, 95% CI: -4.4, -2.7) and C (-5.9, 95% CI: -6.9, -4.9), but the findings were inconclusive as to whether or not there was a difference in HIV (-1.1, 95% CI: -2.5, 0.4) or liver function testing (1.3, 95% CI: -0.1, 2.7). PA was associated with a lower likelihood of urine drug screening (-25.5, 95% CI: -26.8, -24.1) and with fewer drug screens (-2.5, 95% CI: -3.0, -2.1). Findings were inconclusive as to whether or not there was a difference in continuous use of buprenorphine-naloxone (0.3, 95% CI: -1.2, 1.8). PA was associated with fewer outpatient visits (-2.1, 95% CI: -3.0, -1.2) and fewer outpatient visits with an OUD diagnosis (-1.7, 95% CI: -2.1, -1.3). PA was associated with a lower likelihood of filling benzodiazepine prescriptions before and after buprenorphine-naloxone induction (-28.9, 95% CI: -29.6, -28.3) but a greater likelihood of only using benzodiazepines after buprenorphine-naloxone induction (10.6, 95% CI: 9.3, 11.8). Conclusions US Medicare patients subject to prior authorization for buprenorphine-naloxone are not more likely to receive high-quality treatment for opioid use disorder than patients not subject to prior authorization.

Purpose The aim of this study was to determine if a clinical decision support (CDS) tool could be used in partnership with a private payer to successfully expedite the prior authorization process for advanced (ie, MRI, CT, PET, nuclear medicine) imaging requests. Methods A single academic institution integrated a commercially available CDS tool utilizing the ACR Appropriateness Criteria into the ordering process for outpatient advanced imaging tests within the electronic health record. Ordering providers could elect to use the CDS tool or ignore the available technology. In partnership with a health care insurance company and a contracted radiology benefits management company, orders deemed as “usually indicated” by the CDS tool underwent expedited prior authorization in a pilot program from June 2018 to October 2019. Results Providers used the CDS tool for 15% (1,453 of 9,640) of outpatient advanced imaging orders. Of these orders with elective CDS scores, 69% (n = 997) qualified for an expedited prior authorization process. Conclusions Under specific circumstances, a commercially available CDS tool was used in partnership with a private payer and a radiology benefits management company to expedite prior authorization of outpatient advanced imaging examination orders deemed likely to be appropriate by multispecialty professional guidelines.

At the heart of all health insurance programs lies ethical tension between maximizing the freedom of patients and clinicians to tailor care for the individual and the need to make healthcare affordable. Nowhere is this tension more fiercely debated than in benefit design and coverage policy for pharmaceuticals. This paper focuses on three areas over which there is the most controversy about how to judge whether drug coverage is appropriate: cost-sharing provisions, clinical eligibility criteria, and economic-step therapy and required switching. In each of these domains we present ‘ethical goals for access’ followed by a series of ‘fair design criteria’ that can be used by stakeholders to drive more transparent and accountable drug coverage.

Stephanie Slat,1 Avani Yaganti,1 Jennifer Thomas,1 Danielle Helminski,1 Michele Heisler,1– 4 Amy Bohnert,2,4,5 Pooja Lagisetty1,2,4 1Department of Internal Medicine, University of Michigan, Ann Arbor, MI, USA; 2Center for Clinical Management and Research, Ann Arbor VA Hospital, Ann Arbor, MI, USA; 3Department of Health Behavior & Health Education, University of Michigan School of Public Health, Ann Arbor, MI, USA; 4Institute for Healthcare Policy and Innovation, University of Michigan, Ann Arbor, MI, USA; 5Departments of Anesthesiology and Psychiatry, University of Michigan, Ann Arbor, MI, USACorrespondence: Stephanie SlatDepartment of Internal Medicine, University of Michigan, NCRC B16-Floor 4, 2800 Plymouth Road, Ann Arbor, MI, 48109, USATel +1 734-755-1574Email stslat@med.umich.eduPurpose: Patients on long-term opioid therapy (LTOT) for pain have difficulty accessing primary care clinicians who are willing to prescribe opioids or provide multimodal pain treatment. Recent treatment guidelines and statewide policies aimed at reducing inappropriate prescribing may exacerbate these access issues, but further research is needed on this issue. This study aimed to understand barriers to primary care access and multimodal treatment for chronic pain from the perspective of multiple stakeholders.Methods: Qualitative, semi-structured phone interviews were conducted with adult patients with chronic pain, primary care clinicians, and clinic office staff in Michigan. Interview questions covered stakeholder experiences with prescription opioids, opioid-related policies, and access to care for chronic pain. Interviews were coded using inductive and deductive methods for thematic analysis.Results: A total of 25 interviews were conducted (15 patients, 7 primary care clinicians, and 3 office staff). Barriers to treatment access were attributed to six themes: (1) reduced clinic willingness to manage prescribed opioids for new patients; (2) lack of time and reimbursement for quality opioid-related care; (3) paucity of multimodal care and coordination between providers; (4) fear of liability and use of new guidelines to justify not prescribing opioids; (5) delayed prescription receipt due to prior authorization and pharmacy issues; and (6) poor availability of effective non-opioid treatments.Conclusion: Issues of policy, logistics, and clinic-level resources converge to disrupt treatment access for patients with chronic pain, as many clinics both do not offer multimodal pain care and are unwilling to prescribe LTOT. The resulting conceptual model can inform the development of policy interventions to help mitigate these access barriers.Keywords: opioid, chronic pain, access, primary care, policy

Uncontrolled hyperlipidemia has been associated with serious cardiovascular events. Statin use may not be optimal either due to low adherence or statin intolerance. Although the definition of statin intolerance remains highly debatable, it can generally be viewed as any adverse reaction that limits its use including but not limited to myopathies and myalgias. After initial approval, utilization of PCSK9 inhibitors remained low, possibly due to cost or overly restrictive coverage criteria. With the reduction in list price by 60% to $5850 annually, and updated clinical outcome data, both alirocumab and evolocumab were more in line with the willingness-to-pay threshold. Managed care pharmacists can ensure coverage criteria are appropriately developed to give access to individuals who would benefit the most, while decreasing barriers to access. Additionally, pharmacists are well positioned to collaborate with other healthcare providers to increase adherence to traditional LDL-C-lowering agents and streamline prior authorization processing to increase approval rates.

Purpose: The purpose of this study is to assess the impact of a clinic embedded Medication Assistance Program (MAP) specialist on the prescription benefit prior authorization (PA) process and provider satisfaction in an adult pulmonary clinic. Methods: In this mixed methods study, a retrospective cohort analysis was done to determine the turnaround time for the PA process from initial referral to approval or final denial in an adult pulmonary clinic. Additionally, a pre- and post-implementation survey to providers was conducted to assess provider satisfaction and perceptions around the prescription benefit PA process. The first study aim assessed PA efficiency by summarizing PA approval rate and PA turnaround time using descriptive statistics. Any prescriptions written by a clinic provider requiring a PA during the timeframe of June 2018 through August 2018 were included. The second study aim assessed change in provider satisfaction, analyzed via the Mann-Whitney U test. Results: The MAP specialist completed 110 PAs over 3 months for 110 unique patients. Median turnaround time was 3 hours, with 76% of PAs approved in less than 24 hours. Initial approval rate was 82.7%, and overall approval rate following the appeals process was 87.3%. A significant difference between the pre- and post-survey responses were identified in 2 of the 17 questions. Conclusion: Implementation of a clinic embedded MAP specialist to complete PAs demonstrated an efficient process while also improving provider satisfaction.

This retrospective study describes a second-opinion review program for the care of children in Washington State who received Medicaid coverage and who were prescribed five or more psychotropic medications, primarily by mental health specialists. In total, 136 second-opinion reviews from 2013 and 169 from 2018 were included in this study. Attention-deficit hyperactivity disorder (ADHD), behavioral difficulties, anxiety, and trauma were prevalent among these children, and participants were commonly prescribed ADHD medications, selective serotonin reuptake inhibitors, and second-generation antipsychotics. The incidence of reviews remained stable over the two periods, but psychosocial treatment increased significantly over this time. This study sheds light on the initiation, maintenance, and identification of polypharmacy psychotropic regimens and highlights psychosocial treatment as an intervention that increases best practice care for at-risk patients.

Objective:This study characterized the use of prior authorization for opioid use disorder medications as compared with that for opioid pain medications in the United States among Medicare Part D pl...

Background Individuals with complex dyslipidemia, or those with medication intolerance, are often difficult to manage in primary care. They require the additional attention, expertise, and adherence counseling that occurs in multidisciplinary lipid clinics (MDLCs). We conducted a program evaluation of the first year of a newly implemented MDLC utilizing the RE-AIM (reach, effectiveness, adoption, implementation, and maintenance) framework to provide empirical data not only on program effectiveness, but also on components important to local sustainability and future generalizability. Methods The purpose of the MDLC is to increase the uptake of guideline-based care for lipid conditions. Established in 2019, the MDLC provides care via a centralized clinic location within the healthcare system. Primary care providers and cardiologists were invited to refer individuals with lipid conditions. Using a pre/post-study design, we evaluated the implementation outcomes from the MDLC using the RE-AIM framework. Results In 2019, 420 referrals were made to the MDLC (reach). Referrals were made by 19% (148) of the 796 active cardiology and primary care providers, with an average of 35 patient referrals per month in 2019 (SD 12) (adoption). The MDLC saw 83 patients in 2019 (reach). Additionally, 50% (41/82) had at least one follow-up MDLC visit, and 12% (10/82) had two or more follow-up visits in 2019 (implementation). In patients seen by the MDLC, we found an improved diagnosis of specific lipid conditions (FH (familial hypercholesterolemia), hypertriglyceridemia, and dyslipidemia), increased prescribing of evidence-based therapies, high rates of medication prior authorization approvals, and significant reductions in lipid levels by lipid condition subgroup (effectiveness). Over time, the operations team decided to transition from in-person follow-up to telehealth appointments to increase capacity and sustain the clinic (maintenance). Conclusions Despite limited reach and adoption of the MDLC, we found a large intervention effect that included improved diagnosis, increased prescribing of guideline-recommended treatments, and clinically significant reduction of lipid levels. Attention to factors including solutions to decrease the large burden of unseen referrals, discussion of the appropriate number and duration of visits, and sustainability of the clinic model could aid in enhancing the success of the MDLC and improving outcomes for more patients throughout the system.

BACKGROUND The BREAST-Q is the only questionnaire specific to bilateral breast reduction that was developed according to federal and international standards. Many payors mandate minimum resection weights for preapproval, despite lacking supportive evidence for this practice. This study aimed to assess changes in BREAST-Q scores after bilateral breast reduction, and determine whether compliance with Schnur requirements impacts improvement in patient-reported outcomes. METHODS Patients presenting for bilateral breast reduction from 2011 to 2017 were asked to complete the BREAST-Q preoperatively and postoperatively. Multivariate regression analysis was performed to isolate factors associated with favorable outcomes. RESULTS Complete data were available for 238 patients. Mean time to postoperative BREAST-Q was 213 days. Complications occurred in 31 patients (13.0 percent). Mean preoperative BREAST-Q scores were below normative values (p < 0.001), and mean postoperative scores were above normative values (p < 0.001 for Satisfaction with Breasts, Psychosocial Well-being, and Sexual Well-being; and p = 0.05 for Physical Well-being). Postoperative Physical Well-being scores were similar to normative values for resections less than Schnur (p = 0.32), but below norms for resections greater than Schnur (p < 0.0001). On multivariate regression (n = 230), complication and surgeon experience were the only independent predictors of lesser improvement on the Satisfaction with Breasts subscale. CONCLUSIONS This study is the largest to include both preoperative and postoperative bilateral breast reduction BREAST-Q scores, and to compare multiple subscales to normative data. Scores overwhelmingly increased, regardless of age or Schnur compliance. Complications negatively impacted degree of BREAST-Q improvement. Interestingly, postoperative Physical Well-being was slightly higher in women with non-Schnur-compliant resections. Bilateral breast reduction substantially improves patient welfare, and our data question the validity of insurer-mandated minimum resections. CLINICAL QUESTION/LEVEL OF EVIDENCE Therapeutic, III.

Purpose A common denial trend that occurs with “outpatient medical benefit drugs” (ie, medications covered by a medical benefit plan and administered in an outpatient visit) is payers not requiring or permitting prior authorization (PA) proactively, yet denying the drug after administration for medical necessity. In this situation, a preemptive strategy of complying with payer-mandated requirements is critical for revenue protection. To address this need, our institution incorporated a medical necessity review into its existing closed-loop, pharmacy-managed precertification and denials management program. Summary Referrals for targeted payers and high-cost medical benefit drugs not eligible for PA and deemed high risk for denial were incorporated into the review. Payer medical policies were evaluated and clinical documentation assessed to confirm alignment. This descriptive report outlines the medical necessity workflow as a component of the larger precertification process, details the decision-making process when performing the review, and delineates the roles and responsibilities for involved team members. A total of 526 drug orders were evaluated from September 2018 to August 2019, with 146 interventions completed. Of the 761 individual claims affected by proactive medical necessity review, 99.2% resulted in payment and less than 1% resulted in revenue loss, safeguarding more than $5.3 million in annual institutional drug reimbursement. At the time of analysis, there were only 3 cases of revenue loss. Conclusion Our institution’s pharmacy-managed medical necessity review program for high-cost outpatient drugs safeguards reimbursement for therapies not eligible for payer PA. It is a revenue cycle best practice that can be replicated at other institutions.

Prescription drug costs exert profound effects on commercial insurance coverage and access to effective therapy. We aimed to assess threshold pricing to achieve budget neutrality of FDA-approved drugs treating irritable bowel syndrome from an insurance perspective, based on cost-savings resulting in decreased healthcare utilization through effective disease management. We constructed a decision-analytic model from an insurance perspective to assess the budget impact of IBS prescription drugs under usual insurance coverage levels in practice: (1) unrestricted drug access or (2) step therapy in a primary care population of middle-age, care-seeking IBS patients. Budget-neutral drug prices were then calculated which resulted in $0 budget impact to insurers with a short-term, one-year time horizon. If used according to FDA labeling, IBS-D drugs cost between $4778 and $16,844 per year and IBS-C drugs cost between $4319 and $4955 per year. These drug costs often exceed insurance expenditures of $6999 for IBS-D and $3929 for IBS-C if left untreated. Therefore, for drugs to have $0 budget impact to insurers, their prices would need to be discounted 36.7–74.2% for IBS-D drugs and 59.3–82.5% for IBS-C. IBS drugs are already priced to support step therapy “failing one of several common, inexpensive IBS treatments with a responder rate > 30–40%,” reflecting the subpopulation with more severe disease and greater healthcare costs. Broader prescription drug coverage for patients failing common, inexpensive IBS treatments to which at least 30–40% of patients would typically respond appears warranted to enable gastroenterologists to offer personalized approaches targeting specific mechanisms of this heterogeneous disease.

OBJECTIVES: On April 6, 2015, the largest private health insurer in the United States implemented a policy requiring prior authorization for all hysterectomies except those done as outpatient vaginal. The purpose of this policy was to increase utilization of vaginal hysterectomy; however, it is unknown whether this policy had its intended effect. We sought to analyze trends in hysterectomy routes before and after implementation of the prior authorization policy to see if utilization of vaginal hysterectomy increased. METHODS: This was a retrospective study using the Optum® Clinformatics Data Mart national claims database of women enrolled in a single national private health insurer who underwent hysterectomy for any indication between January 1, 2010 and June 30, 2016. Per-quarter utilization of hysterectomy routes (abdominal, laparoscopic, vaginal, and laparoscopic-assisted vaginal) were compared between the pre- and post-policy time periods using interrupted time series analyses. RESULTS: Data for 305,139 hysterectomies were available—248,821 in the pre-policy period and 56,318 in the post-period. Outpatient vaginal hysterectomy had the greatest increase in utilization of all routes and types; the average utilization per quarter in the pre-policy period was −0.61% and this increased to 0.21% in the post-policy period (p

Misuse of antibiotics, including unnecessary use or inappropriate selection, may result in side effects and poor outcome in individual patients, as well as contribute to the spread of antimicrobial resistance. Antimicrobial stewardship programs exist to reduce such misuse of antibiotics and ill effect in order to promote patient outcome. The importance of diagnostics, antibiogram data, possible interventions, and impact are reviewed. It is essential for clinical microbiologists and other health care members to understand the field and scope of antimicrobial stewardship, actively participate in, and understand the value they bring to supporting their institution's efforts.

BACKGROUND: Multiple barriers exist for appropriate use of the proprotein convertase subtilisin/kexin type 9 enzyme inhibitors (PCSK9i) in patients with atherosclerotic cardiovascular disease (ASCVD) or familial hypercholesterolemia (FH) with inadequately controlled hypercholesterolemia despite standard therapies. Among these barriers, high payer rejection rates and inadequate prior authorization (PA) documentation by providers hinder optimal use of PCSK9i. OBJECTIVES: To (a) identify and discuss provider and payer discordances on barriers to authorization and use of PCSK9i based on clinical and real-world evidence and (b) align understanding and application of clinical, cost, safety, and efficacy data of PCSK9i. METHODS: Local groups of 3 payers and 3 providers met in 6 separate locations across the United States through a collaborative project of AMCP and PRIME Education. Responses to selected pre- and postmeeting survey questions measured changes in attitudes and beliefs regarding treatment barriers, lipid thresholds for considering PCSK9i therapy, and tactics for improving PA processes. Statistical analysis of inter- and intragroup changes in attitudes were performed by Cox proportional hazards test and Fisher's exact test for 70 mg/dL for patients with ASCVD (78%-83% and 44%-67%, respectively) or FH (22%-39% and 22%-33%). Payers were more agreeable to less stringent PA requirements for patients with FH (33%-72%, P = 0.019) and need for standardized PA requirements (50%-83%, P = 0.034); these considerations remained high (89%) among providers after the meeting. Most participants supported educational programs for patient treatment adherence (83%) and physician/staff PA processes (83%-94%). CONCLUSIONS: Provider and payer representatives in 6 distinct geographic locations provided recommendations to improve quality of care in patients eligible for PCSK9i. Participants also provided tactical recommendations for streamlining PA documentation processes and improving awareness of PCSK9i cost-effectiveness and clinical efficacy. The majority of participants supported development of universal, standardized patient eligibility criteria and PA forms. DISCLOSURES: The study reported in this article was part of a continuing education program funded by an independent educational grant awarded by Sanofi US and Regeneron Pharmaceuticals to PRIME Education. The grantor had no role in the study design, execution, analysis, or reporting. AMCP received grant funding from PRIME to assist in the study, as well as in writing the manuscript. McCormick, Bhatt, Bays, Taub, Caldwell, Guerin, Steinhoff, and Ahmad received an honorarium from PRIME for serving as faculty for the continuing education program. McCormick, Bhatt, Bays, Taub, Caldwell, Guerin, Steinhoff, and Ahmad were involved as participants in the study. Bhatt discloses the following relationships: Advisory board: Cardax, CellProthera, Cereno Scientific, Elsevier Practice Update Cardiology, Level Ex, Medscape Cardiology, PhaseBio, PLx Pharma, Regado Biosciences; Board of directors: Boston VA Research Institute, Society of Cardiovascular Patient Care, TobeSoft; Chair: American Heart Association Quality Oversight Committee; Data monitoring committees: Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute, for the PORTICO trial, funded by St. Jude Medical, now Abbott), Cleveland Clinic (including for the ExCEED trial, funded by Edwards), Contego Medical (Chair, PERFORMANCE 2), Duke Clinical Research Institute, Mayo Clinic, Mount Sinai School of Medicine (for the ENVISAGE trial, funded by Daiichi Sankyo), Population Health Research Institute; Honoraria: American College of Cardiology (Senior Associate Editor, Clinical Trials and News, ACC.org; Vice chair, ACC Accreditation Committee), Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute; RE-DUAL PCI clinical trial steering committee funded by Boehringer Ingelheim; AEGIS-II executive committee funded by CSL Behring), Belvoir Publications (Editor in Chief, Harvard Heart Letter), Duke Clinical Research Institute (clinical trial steering committees, including for the PRONOUNCE trial, funded by Ferring Pharmaceuticals), HMP Global (Editor in Chief, Journal of Invasive Cardiology), Journal of the American College of Cardiology (Guest Editor; Associate Editor), K2P (Co-Chair, interdisciplinary curriculum), Level Ex, Medtelligence/ReachMD (CME steering committees), MJH Life Sciences, Population Health Research Institute (for the COMPASS operations committee, publications committee, steering committee, and USA national co-leader, funded by Bayer), Slack Publications (Chief Medical Editor, Cardiology Today's Intervention), Society of Cardiovascular Patient Care (Secretary/Treasurer), WebMD (CME steering committees); Other: Clinical Cardiology (Deputy Editor), NCDR-ACTION Registry Steering Committee (Chair), VA CART Research and Publications Committee (Chair); Research funding: Abbott, Afimmune, Amarin, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Cardax, Chiesi, CSL Behring, Eisai, Ethicon, Ferring Pharmaceuticals, Forest Laboratories, Fractyl, Idorsia, Ironwood, Ischemix, Lexicon, Lilly, Medtronic, Pfizer, PhaseBio, PLx Pharma, Regeneron, Roche, Sanofi Aventis, Synaptic, The Medicines Company; Royalties: Elsevier (Editor, Cardiovascular Intervention: A Companion to Braunwald's Heart Disease); Site co-investigator: Biotronik, Boston Scientific, CSI, St. Jude Medical (now Abbott), Svelte; Trustee: American College of Cardiology; Unfunded research: FlowCo, Merck, Novo Nordisk, Takeda. Bays' research site has received research grants from 89Bio, Acasti, Akcea, Allergan, Alon Medtech/Epitomee, Amarin, Amgen, AstraZeneca, Axsome, Boehringer Ingelheim, Civi, Eli Lilly, Esperion, Evidera, Gan and Lee, Home Access, Janssen, Johnson and Johnson, Lexicon, Matinas, Merck, Metavant, Novartis, Novo Nordisk, Pfizer, Regeneron, Sanofi, Selecta, TIMI, and Urovant. Bays has served as a consultant/advisor for 89Bio, Amarin, Esperion, Matinas, and Gelesis, and speaker for Esperion. McCormick, Caldwell, Guerin, Ahmad, Singh, Moreo, Carter, Heggen, and Sapir have nothing to disclose.

Third-party payers advocate for prior authorization (PA) to reduce overutilization of health care resources. The impact of PA in elective surgery is understudied, especially in cases where evidence-based clinical practice guidelines define operative candidacy. The objective of this study is to investigate the impact of PA on the incidence of pediatric tonsillectomy.Cross-sectional study.Health claims database from a third-party payer.Any pediatric patient who had evaluation for tonsillectomy from 2016 to 2019 was eligible for inclusion. A time series analysis was used to evaluate the change in incidence of tonsillectomy before and after PA. Lag time from consultation to surgery before and after PA was compared with segmented regression.A total of 10,047 tonsillectomy claims met inclusion and exclusion criteria. Female patients made up 51% of claims, and the mean age was 7.9 years. Just 1.5% of claims were denied after PA implementation. There was no change in the incidence of tonsillectomy for all plan types (A modest number of tonsillectomy claims were denied approval after implementation of PA. The value of PA for pediatric tonsillectomy is questionable, as it did not result in decreased incidence of tonsillectomy in this cohort.

Medicaid prior authorization (PA) policies for treatment of hepatitis C virus (HCV) with direct‐acting antiviral (DAA) therapy are changing. We aimed to evaluate effects of changes in PA requirements on treatment uptake and to determine the factors associated with DAA treatment among Florida Medicaid beneficiaries with HCV. This is a retrospective cohort analysis of Florida’s Medicaid administrative claims and electronic medical records (2013‐2018). A total of 14,063 newly diagnosed patients with HCV were grouped based on human immunodeficiency virus (HIV) co‐infection and/or a substance use disorder (SUD) (7,735 HCV mono‐infected with a SUD, 5,180 HCV mono‐infected without a SUD, 564 HCV/HIV co‐infected with a SUD, and 584 HCV/HIV co‐infected without a SUD). Although the treatment rate increased three‐fold after June 1, 2016, when a fibrosis‐stage restriction was eliminated, only 8% received DAAs. Compared to HCV mono‐infected without a SUD, HCV mono‐infected with a SUD and HCV/HIV co‐infected with a SUD were 47% (adjusted hazard ratio, 0.53; 95% confidence interval, 0.47‐0.60) and 59% (adjusted hazard ratio, 0.41; 95% confidence interval, 0.28‐0.61) less likely to initiate DAAs. Those with HCV/HIV/SUD did not experience a DAA initiation increase after a fibrosis‐stage restriction was eliminated. Compared with Whites, Blacks were less likely to receive DAAs but were more likely to complete treatment. Use of medication‐assisted therapy was low, despite those on medication‐assisted therapy being 60% more likely to initiate DAA therapy and no more likely to discontinue therapy. Conclusion: Despite changes in Florida’s Medicaid PA requirements for DAA treatment, only 8% received treatment. Disparities in treatment access were found among patients with HIV and a SUD, and who were Black., In our retrospective cohort study analysis using Florida Medicaid claims data (2013‐2018), we examined the effects of prior authorization policy on access to direct‐acting antiviral (DAA) treatment and identified factors associated with disparities among Florida Medicaid patients with hepatitis C virus (HCV). Our work shows that the number of Florida Medicaid patients treated for HCV has increased, but treatment rates are still very low (8%); compared to HCV mono‐infected patients without substance use disorders (SUD), HCV mono‐infected patients with SUD and HCV/HIV patients co‐infected with SUD were 47% and 59% less likely to initiate DAAs, but no difference was observed in HCV/HIV patients co‐infected without SUD. Disparities in access to treatment continue among patients with SUD, blacks, and pregnant women among Medicaid patients with HCV.

Introduction: Utilization management (UM) policies are becoming more common among commercial insurance policies. However, little research has been conducted to understand the prevalence of experiencing UM restrictions among patients with psoriatic disease. Objectives: To understand the prevalence of UM policies within the psoriatic patient community and examine their relationship with patient characteristics. Methods: An online survey of 1205 individuals with a psoriatic disease from the National Psoriasis Foundation’s constituent database was conducted. Data were collected from July 7 to July 31, 2019. The main outcomes of interest for the present study were frequency of experiencing UM policies (eg, prior authorization [PA] or step therapy [ST]) from their insurance company, number, and type of UM policies experienced and relationship between patient characteristics and experiencing these policies. Results: Survey respondents reported high rates of experiencing some form of UM restriction (80.5%). Nearly half (45.1%) of the survey respondents indicated their insurer required them to try a therapy other than the therapy originally prescribed by their physician, a practice known as ST or “fail first” and 73% of respondents reported having to receive PA from their insurer before initiating treatment. Conclusions: Individuals with psoriatic disease commonly encounter UM policies from their insurer when attempting to manage their disease. Statistical analyses suggest that UM policies are related to the type of treatment used by patients and the type of psoriatic disease.

Objectives It is unclear on what basis Medicare drug plans impose coverage restrictions on orphan drugs. This study aims to investigate the factors associated with utilization controls in Medicare fee-for-service Part D formularies. Study design Cross-sectional analysis. Methods We used multivariate logistic regression to assess the association between orphan drug characteristics and use of formulary utilization controls in 2016. We controlled for number of beneficiaries per drug, exclusivity expiration, and the number of plans and beneficiaries per formulary. We conducted sensitivity analyses using fixed and random effects. Results On average, 85% of orphan drugs on a formulary were placed on its highest cost-sharing tier and 76% were subject to prior authorization (PA). Orphan drugs with annual costs of $50,000 or more had twice the odds of having PA requirements compared with less expensive ones. Relative to orphan drugs with a single indication, drugs with multiple indications were more likely to have restrictions. Less effective drugs had 1.5 times the odds of highest tier placement relative to more effective drugs. The presence of black box warnings and patient assistance programs were associated with more restricted access. Orphan drugs with generics were less likely to undergo restrictions than those without generics (all P Conclusions Plans are making evidence-based decisions by rewarding more clinically effective and safer orphan drugs. They are penalizing drugs with multiple indications. Surprisingly, plans place fewer restrictions on orphan drugs that have a generic equivalent, which may further discourage generic entry into the orphan space, where competition is already sparse.

Background Increasing hospice need, a growing shortage of hospice providers, and concerns about in-person services because of coronavirus disease 2019 (COVID-19) require hospices to innovate care delivery. Measures This project compared outcomes between hospice reauthorization visits conducted via telehealth and in person. After each visit, providers, patients, and caregivers completed telehealth acceptance surveys, and providers recorded reauthorization recommendations. Intervention Providers conducted 88 concurrent in-person and telehealth visits between June and November 2019. Outcomes No statistically significant differences in reauthorization recommendations were found between telehealth and in-person visits. Satisfaction with telehealth was high; 88% of patients/caregivers and 78% of providers found telehealth services as effective as in-person visits. Conclusions/Lessons Learned Results indicate that telehealth can successfully support clinical decision making for hospice reauthorization. These findings show telehealth to be reliable and acceptable for certain types of hospice care even before COVID-19, which emphasizes its importance both during and after the current public health emergency.

Responding to an opioid crisis in Canada, policy makers have implemented supply-side interventions seldom used in the US, regulating insurance reimbursement to discourage the prescribing of specified opioids. Using national databases of all opioids dispensed through provincial pharmaceutical programs and of opioid hospitalizations from January 2006 through March 2017, we found that requiring physicians to obtain prior authorization for patients to receive reimbursement for OxyContin prescriptions substantially reduced OxyContin fills, particularly among opioid-naive patients; it also reduced overall opioid prescriptions, suggesting limited substitution. "Grandfathering" OxyNeo (an abuse-resistant OxyContin variant), allowing previous OxyContin patients to obtain OxyNeo, increased OxyNeo fills but had no detectable effect on total opioid prescriptions, which points to substantial opioid substitution among chronic users of prescription opioids. We found no effects of regulatory changes on opioid-related hospitalizations. These results suggest that restrictions on pharmaceutical formularies can reduce fills of targeted opioids with the additional benefit of altering treatment of opioid-naive and other patients differently. Canadian policy makers may wish to extend such regulations to more provincial formularies and private insurers, and policy makers in the US and elsewhere could fruitfully follow suit.

Background Evidence demonstrates that medications for treating opioid use disorder (MOUD) —namely buprenorphine, methadone, and extended-release naltrexone—are effective at treating opioid use disorder (OUD) and reducing associated harms. However, MOUDs are heavily underutilized, largely due to the under-supply of providers trained and willing to prescribe the medications. Methods To understand comparative beliefs about MOUD and barriers to MOUD, we conducted a mixed-methods study that involved focus group interviews and an online survey disseminated to a random group of licensed U.S. physicians, which oversampled physicians with a preexisting waiver to prescribe buprenorphine. Focus group results were analyzed using thematic analysis. Survey results were analyzed using descriptive and inferential statistical methods. Results Study findings suggest that physicians have higher perceptions of efficacy for methadone and buprenorphine than for extended-release naltrexone, including for patients with co-occurring mental health disorders. Insurance obstacles, such as prior authorization requirements, were the most commonly cited barrier to prescribing buprenorphine and extended-release naltrexone. Regulatory barriers, such as the training required to obtain a federal waiver to prescribe buprenorphine, were not considered significant barriers by many physicians to prescribing buprenorphine and naltrexone in office-based settings. Nor did physicians perceive diversion to be a prominent barrier to prescribing buprenorphine. In focus groups, physicians identified financial, logistical, and workforce barriers—such as a lack of addiction treatment specialists—as additional barriers to prescribing medications to treat OUD. Conclusions Additional education is needed for physicians regarding the comparative efficacy of different OUD medications. Governmental policies should mandate full insurance coverage of and prohibit prior authorization requirements for OUD medications.

PURPOSE: Proton therapy is increasingly prescribed, given its potential to improve outcomes; however, prior authorization remains a barrier to access and is associated with frequent denials and treatment delays. We sought to determine whether appropriate access to proton therapy could ensure timely care without overuse or increased costs. METHODS: Our large academic cancer center collaborated with a statewide self-funded employer (n = 186,000 enrollees) on an insurance coverage pilot, incorporating a value-based analysis and ensuring preauthorization for appropriate indications. Coverage was ensured for prospective trials and five evidence-supported anatomic sites. Enrollment initiated in 2016 and continued for 3 years. Primary end points were use, authorization time, and cost of care, with case-matched comparison of total charges at 1 month pretreatment through 6 months posttreatment. RESULTS: Thirty-two patients were approved over 3 years, with only 22 actually receiving proton therapy, versus a predicted use by 120 patients ( P < .01). Median follow-up was 20.1 months, and average authorization time decreased from 17 days to < 1 day ( P < .01), significantly enhancing patient access. During this time, 25 patients who met pilot eligibility were instead treated with photons; and 17 patients with > 6 months of follow-up were case matched by treatment site to 17 patients receiving proton therapy, with no significant differences in sex, age, performance status, stage, histology, indication, prescribed fractions, or chemotherapy. Total medical costs (including radiation therapy [RT] and non-RT charges) for patients treated with PBT were lower than expected (a cost increase initially was expected), with no significant difference in total average charges ( P = .82), in the context of overall ancillary care use. CONCLUSION: This coverage pilot demonstrated that appropriate access to proton therapy does not necessitate overuse or significantly increase comprehensive medical costs. Objective evidence-based coverage polices ensure appropriate patient selection. Stakeholder collaboration can streamline patient access while reducing administrative burden.

The lawful sale of Cannabis sativa L. and its extracts including Cannabidiol is not harmonized under European Union law. Such products have in the most part been classified as novel foods and thus illegal for sale in Europe without prior authorization. The regulation of such substances not only spans EU and Member State food laws but also international conventions on illicit drug and psychoactive substances. An understanding of the laws governing the sale of these compounds can help business and academia better understand the challenges consumers may face in selecting products lawfully placed on the market, whilst identifying the unique challenges imposed from the marketing of Cannabis-based foods.

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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 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.