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To examine the use of step therapy, prior authorization, and Part D formulary exclusion by 4 large Medicare Advantage (MA) insurers to manage 20 physician-administered drugs with the highest total Medicare expenditures (top 20 drugs).We collected data for United Healthcare, CVS/Aetna, Humana, and Kaiser plans to create a database of 2020 Part B coverage restrictions and conducted a retrospective analysis of 2018-2020 Part D formularies.For each insurer, we calculated the number of top 20 physician-administered drugs subject to prior authorization and step therapy. For physician-administered drugs for which there were no similar or interchangeable alternatives, we examined which insurers required prior authorization or step therapy. Finally, we examined whether insurers restricted access to physician-administered drugs by reducing coverage on Part D formularies.Of the top 20 physician-administered drugs, 17 were subject to prior authorization and 10 were subject to step therapy by at least 1 insurer. For 5 physician-administered drugs without a similar or interchangeable alternative, none were subject to step therapy and all were subject to prior authorization by at least 1 insurer. Across the 4 insurers, 16 physician-administered drugs were covered on all or some of the Part D formularies in 2018, which decreased to 6 in 2020.Four large MA insurers managed access to expensive physician-administered drugs with a combination of prior authorization, step therapy, and Part D formulary design. When a low-cost alternative exists, these tools can help reduce wasteful spending, but the administrative barriers may also reduce access.

Understanding the extent to which beneficiaries can “realize” access to reported provider networks is imperative in mental health care, where there are significant unmet needs. We compared listings of providers in network directories against provider networks empirically constructed from administrative claims among members who were ages sixty-four and younger and enrolled in Oregon’s Medicaid managed care organizations between January 1 and December 31, 2018. “In-network” providers were those with any medical claims filed for at least five unique Medicaid beneficiaries enrolled in a given health plan. They included primary care providers, specialty mental health prescribers, and nonprescribing mental health clinicians. Overall, 58.2 percent of network directory listings were “phantom” providers who did not see Medicaid patients, including 67.4 percent of mental health prescribers, 59.0 percent of mental health nonprescribers, and 54.0 percent of primary care providers. significant discrepancies between the providers listed in directories and those whom enrollees can access suggest that provider network monitoring and enforcement may fall short if based on directory information.

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.

To examine US commercial health plans' adoption of 2018 FDA-approved drugs.Database analysis.We identified novel drugs that the FDA approved in 2018 and categorized them as follows: cancer treatment, orphan drug, included in an expedited review program, and biosimilar. Using a data set of 17 large health plans' drug coverage policies and formularies, we examined coverage 1 year following FDA approval.The FDA approved 66 drugs in 2018 (5 were not yet marketed 1 year following approval). For 60 of 61 drugs, some plans issued coverage policies whereas other plans included the drug in their formularies. Plans imposed restrictions (eg, step therapy) in 37% (275/742) of coverage policies. Plans covered biosimilars, orphan drugs, and cancer treatments more generously than drugs not in those categories (P .05). Plans imposed restrictions in their policies with different frequencies (range, 7%-52%). Plans imposed utilization management (UM) in 82% (3837/4697) of formulary entries. Of those entries, plans required prior authorizations in 98%, included drugs on the highest patient co-payment tier in 70%, and imposed step therapy in 3%. Plans most often placed orphan drugs and cancer treatments on the highest cost-sharing formulary tiers (68% and 64% of the time, respectively). Plans imposed UM in their formularies with different frequencies (range, 62%-100% of entries).Health plans imposed fewer coverage restrictions on cancer treatments, orphan drugs, and biosimilars than on drugs not in those categories. Some plans covered 2018 FDA-approved drugs more generously than others, which has implications for patients' access to innovative therapies.

BACKGROUND Delays in advancing to biologic therapies are associated with adverse outcomes in inflammatory bowel disease (IBD). Insurer-mandated prior authorizations have been linked to prolonged medication initiation times. We hypothesized that prior authorizations are associated with prolonged biologic initiation time and increased IBD-related healthcare utilization among children with IBD. METHODS We performed a retrospective cohort study of 190 pediatric patients with IBD initiating biologics at a tertiary care hospital to measure the association between prior authorization, biologic initiation time (physician recommendation to first dose), and healthcare utilization (hospitalization, surgery, or emergency department visit). Demographic, insurance, and disease severity–related covariables were collected. Multivariable linear regression was used to measure the association between prior authorization and biologic initiation time. Propensity score methods were used to measure the associations between prior authorization and IBD-related healthcare utilization within 180 days and corticosteroid dependence at 90 days, with adjustment for insurance type, demographics, and disease severity–related characteristics. RESULTS Median biologic initiation time was 21 days. Prior authorization and complicated prior authorizations (requiring appeal, step therapy, or peer-to-peer review) were associated with 10.2-day (95% confidence interval [CI] 8.2 to 12.3) and 24.6-day (95% CI 16.4 to 32.8) increases in biologic initiation time, respectively. Prior authorizations increased the likelihood of IBD-related healthcare utilization within 180 days by 12.9% (95% CI 2.5 to 23.4) and corticosteroid dependence at 90 days by 14.1% (95% CI 3.3 to 24.8). CONCLUSIONS Prior authorizations are associated with prolonged biologic initiation time and increased IBD-related healthcare utilization. Minimizing prior authorization–related delays may expedite biologic delivery and reduce the risk of IBD-related healthcare utilization.

Some Medicare-reimbursed services are overused or improperly used, resulting in payments for unnecessary services.To determine if prior authorization of services vulnerable to improper use is associated with reduced use and costs without changing patient access or health outcomes.This study involved repeated cross-sectional evaluation with a state-level matched control group construction and inverse propensity score weighting at the Medicare beneficiary level. Eight states plus the District of Columbia requiring prior authorization were compared with 13 matched comparison group states not subject to prior authorization. Observations on approximately 1.7 million Medicare beneficiaries spanned January 2012 through December 2019. Depending on their state of residence, this included 3 or 4 preintervention years and 4 or 5 postintervention years. Data analysis was performed from September 2020 to July 2021.Ambulance suppliers were directed to request prior authorization for Repetitive, Scheduled, Non-Emergent Ambulance Transport (RSNAT) services; failure to do so resulted in prepayment claim review. The goal of prior authorization is to reduce use of nonemergency ambulance transports that do not meet Medicare coverage criteria.Primary outcomes included total cost of care, RSNAT use rates and expenditures, unplanned hospital admission, emergency department admission, and emergency ambulance use per beneficiary-year. All measures were constructed from Medicare claims.Approximately 1.7 million Medicare beneficiaries were observed in the study (mean [SD] age, 71 [15] years; 50% female beneficiaries; 30% Black beneficiaries, 64% White beneficiaries; 20% rural residence; 35% dually eligible for Medicare and Medicaid; 58% with end-stage renal disease; and 44% with severe [stage 3 or 4] pressure ulcers). After controlling for covariates, the results showed that prior authorization was associated with a 2.4% reduction in total annual expenditures for a total of $1530 per beneficiary-year (95% CI, -$1775 to -$1285;In this difference-in-differences analysis of Medicare beneficiaries, the results suggest that the RSNAT Prior Authorization Model was associated with reduced costs with little or no change in the quality or access indicators examined. Targeted approaches to prior authorization may be an appropriate control measure for Medicare services vulnerable to improper use.

Objectives Many payers and health care providers are either currently using or considering use of prior authorization schemes to redirect patient care away from hospital outpatient departments toward free-standing ambulatory surgical centers owing to the payment differential between these facilities. In this work we work with a medium size payer to develop and lay out a process for analysis of claims data that allows payers to conservatively estimate potential savings from such policies based on their specific case mix and provider network. Study Design We analyzed payment information for a medium-sized managed care organization to identify movable cases that can reduce costs, estimate potential savings, and recommend implementation policy alternatives. Methods We analyze payment data, including all professional and institutional fees over a 15-month period. A rules-based algorithm was developed to identify episodes of care with at least one alternate site for each episode, and potential savings from a site-of-service policy. Results Data on 64,884 episodes of care were identified as possible instances that could be subject to the policy. Of those, 7,679 were found to be attractive candidates for movement. Total projected savings was approximately $8.2 million, or over $1,000 per case. Conclusions Instituting a site-of-service policy can produce meaningful savings for small and medium payers. Tailoring the policy to the specific patient and provider population can increase the efficacy of such policies in comparison to policies previously established by other payers.

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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