Prior Authorization Approval Research Articles

Outcomes of a multidisciplinary approach to management of mavacamten in obstructive hypertrophic cardiomyopathy.

In an effort to expedite the publication of articles, AJHP is posting manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time. Traditional treatments for obstructive hypertrophic cardiomyopathy (oHCM) include β-blockers, calcium channel blockers, and disopyramide. Mavacamten, a novel cardiac myosin inhibitor, is a promising oHCM therapy but has practical challenges limiting its use. This descriptive study aimed to describe a clinic workflow for mavacamten management in a real-world setting, addressing challenges such as cost, drug interactions, and monitoring requirements. The focus was on reducing patient-level costs while ensuring feasibility and efficiency. A retrospective analysis was conducted on 34 patients with oHCM for whom mavacamten was considered between May 2022 and May 2023. The clinic workflow involved cardiologist assessment, pharmacist evaluation of drug interactions, enrollment in the mavacamten risk evaluation and mitigation strategy program, cost reduction measures, and initiation of monitoring through scheduled echocardiograms. Of the 34 patients, 21 (62%) were initiated on mavacamten and followed for up to 1 year on therapy. The median time from referral to prior authorization approval and first fill was 5 and 22 days, respectively. Patients demonstrated high adherence (99.1%) as measured by the proportion of days covered. Echocardiogram follow-up showed improvements in left ventricular outflow tract parameters with no patients having a decrease in left ventricular ejection fraction to less than 50%. The described workflow effectively addressed challenges associated with mavacamten management, emphasizing roles for clinic personnel, cost reduction strategies, and structured patient monitoring. While the workflow's specifics may need adaptation in different settings, this report provides valuable insights for clinics implementing structured mavacamten management approaches.

Benefit of clinical pharmacists in neurology clinics at an academic medical center

BackgroundPatients with neurologic diseases have complex medical needs and may benefit from the addition of clinical pharmacists in their care. ObjectivesThis study aimed to describe integration and benefit of clinical pharmacists in neuroimmunology and neuromuscular clinics at an academic medical center. MethodsThis retrospective chart review evaluated patients initiated on a neurology medication for a neuroimmunology or neuromuscular disease state before and after pharmacist integration in neurology clinics. The primary outcome measured access to an initially prescribed neuroimmunology or neuromuscular medication within 90 days of prescription. Secondary outcomes included access to an initially prescribed or alternative neurology medication owing to insurance requirements within 90 days, time from initial prescription to start, and description of pharmacist involvement. ResultsThere were 101 patients in the pregroup and 101 patients in the postgroup. The percentage of patients with confirmed initially prescribed medication access at 90 days increased in the postgroup compared with the pregroup (87.1% vs. 72.5%, respectively, P = 0.014). For secondary outcomes, the percentage of patients who started on an initially prescribed or alternative neuroimmunology or neuromuscular medication within 90 days also increased in the postgroup compared with the pregroup (90.0% vs. 73.3%, respectively, P = 0.004). Additional pharmacist involvement occurred in 64 patients (63.4%) in the postgroup and included prior authorization approval assistance, drug information support, and medication liaison interventions, with an average of 4.7 pharmacist interventions at each pharmacy-led encounter. ConclusionThe addition of pharmacists into neuroimmunology and neuromuscular clinics improved operational access to medications for neuroimmunology and neuromuscular conditions. In addition, pharmacists were able to assist with multiple areas of patient care including medication education, monitoring, and serving as a medication liaison. This study supports continuing to offer clinical pharmacy services in neuroimmunology and neuromuscular departments and may support the addition of clinical pharmacists into neurology services at other institutions.

Hepatitis C donor positive to recipient negative solid organ transplants: Early direct acting antiviral insurance approval rates with and without documented viremia

BackgroundCurrent guidelines support early initiation of direct-acting antivirals (DAA) in hepatitis C virus (HCV) donor positive and recipient negative (D+/R-) solid organ transplants (SOTs). According to experts, access to DAA therapy is a key barrier to early treatment. MethodsThis single-center, retrospective study assessed the rate of DAA prescription approval with or without confirmed HCV viremia, time to approval, and reasons for denial in HCV D+/R- SOTs. ResultsAll 51 patients received insurance approval for DAA therapy following transplantation regardless of confirmed HCV viremia at time of prior authorization (PA) submission. Same day PA approval was obtained in 51% of cases. Appeals received approval within a median of 2 days from submission. ConclusionOur findings suggest confirmed HCV viremia may not be as significant of a barrier to DAA access and may encourage other health systems to consider early initiation of DAA therapy in their HCV D+/R- transplants.

Evaluation of prior authorizations in transplant recipients at an urban institution.

Increasing prior authorization (PA) requirements for immunosuppression remain a burden for solid organ transplant (SOT) recipients and transplant staff. The objective of this study was to evaluate the number of PAs required and the approval rates at an academic, urban transplant center. This was a retrospective study of SOT recipients at the University of Illinois Hospital and Health Sciences System (UI Health) that required PAs between 11/1/2019 and 12/1/2020. Inclusion criteria were SOT recipients greater than 18 years of age and prescribed a medication by the transplant team that required PA. Duplicate PA requests were excluded from the analysis. A total of 879 PAs were included in the study. Of these PAs, 85% (747/879) were approved. Seventy-four percent of the denials were overturned by an appeal. Most PAs were in black (45.4%), kidney transplant (62%), Medicare (31.7%), and Medicaid recipients (33.2%). The median approval time was 1 day for PAs and 5 days for appeals. Tacrolimus extended release (XR) (35.4%), tacrolimus immediate release (IR) (9.7%),and mycophenolic acid (7%) required most PAs. Black recipients and immunosuppression were identified as predictors of eventual PA approval, whereas recipients with Medicaid were less likely to obtain approval. At our transplant center, there was a high approval rate of PAs for immunosuppression, which calls into question the utility of PAs in this patient population, where these medications are standard of care. More black recipients and patients with Medicare and Medicaid had increased PA requirements, highlighting further disparities within the current system.

Abstract P4-01-40: Real World Data with Off-Label Insurance Approval of Trastuzumab Deruxtecan in Metastatic Breast Cancer

Abstract Background: Trastuzumab deruxtecan (T-DXd) improves outcomes in HER2-positive, and recently in HER2-low (IHC 1+ or IHC 2+/ISH-) previously treated metastatic breast cancer (MBC) patients. OncoHealth is a digital health care company that leverages managed care-trained, board-certified oncologists and oncology pharmacists to review the appropriateness of prior authorization (PA) requests for cancer treatment regimens. Our objective was to examine the rate of off-label PA approvals for T-DXd in MBC. Methods: We performed a retrospective cross-sectional study of T-DXd PA approvals by OncoHealth for MBC patients between 1/17/2020 – 6/21/2022. Using medical records and utilization management data, we assessed the prevalence of PA approvals for T-DXd in HER2-low and HER2-positive MBC patients according to PA support at the time of approval, whether on-label, off-label NCCN compendium supported, off-label acceptable scientific literature-only (LIT) supported, or approved by clinical justification if off-label/off-NCCN or LIT. Results: We identified 156 patients with MBC with a PA approval for T-DXd. The median patient age range was 60-69 years, 85% had visceral disease, 28% had brain metastases, 93.6% had HER2-positive MBC and remaining were HER2-low MBC. The median line of T-DXd therapy was 6 (range, 1-15) for HER2-low and 3 (range, 1-10) for HER2-positive MBC. All HER2-low T-DXd cases were supported by LIT and approved prior to NCCN guidelines incorporation in 6/21/2022. Among HER2-positive MBC patients, 25% (37/146) of PA approvals were off-label. Of these, 57% (21/37) were supported by NCCN, and the remaining 43% (16/37) were approved off-label/off-NCCN or LIT. The majority of the off-label/off-NCCN or LIT cases (10/16) were approved by clinical judgement based on 2nd line HER2-positive MBC abstract data from DESTINY-Breast03 presented at ESMO on 9/19/21. Conclusions: All off-label PA approvals for T-DXd in HER2-low MBC occurred prior to NCCN’s incorporation, expanding access. One quarter of all T-DXd approvals in HER2-positive MBC were off-label. Leveraging managed care, board-certified oncology clinicians with knowledge of the latest cancer therapies and use of additional coverage determination resources such as NCCN and acceptable scientific literature can help expedite and expand access to off-label anti-cancer drugs that may be beneficial for cancer patients. Table 1: T-DXd Authorization Approvals Citation Format: Laura R. Bobolts, Mark Mangurian, Shanthi Marur, Corey Wise, Melissa Pozotrigo, Hiywete Solomon, Nicole Hartung, Meera Ravindranathan, Rory Makielski, Shika Marur, Andrew Toler. Real World Data with Off-Label Insurance Approval of Trastuzumab Deruxtecan in Metastatic Breast Cancer [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P4-01-40.

Determining Prior Authorization Approval for Lumbar Stenosis Surgery With Machine Learning.

Medical vignettes. Lumbar spinal stenosis (LSS) is a degenerative condition with a high prevalence in the elderly population, that is associated with a significant economic burden and often requires spinal surgery. Prior authorization of surgical candidates is required before patients can be covered by a health plan and must be approved by medical directors (MDs), which is often subjective and clinician specific. In this study, we hypothesized that the prediction accuracy of machine learning (ML) methods regarding surgical candidates is comparable to that of a panel of MDs. Based on patient demographic factors, previous therapeutic history, symptoms and physical examinations and imaging findings, we propose an ML which computes the probability of spinal surgical recommendations for LSS. The model implements a random forest model trained from medical vignette data reviewed by MDs. Sets of 400 and 100 medical vignettes reviewed by MDs were used for training and testing. The predictive accuracy of the machine learning model was with a root mean square error (RMSE) between model predictions and ground truth of .1123, while the average RMSE between individual MD's recommendations and ground truth was .2661. For binary classification, the AUROC and Cohen's kappa were .959 and .801, while the corresponding average metrics based on individual MD's recommendations were .844 and .564, respectively. Our results suggest that ML can be used to automate prior authorization approval of surgery for LSS with performance comparable to a panel of MDs.

APA’s Government, Policy, and Advocacy Update (January 2022)

Back to table of contents Previous article Next article Government & LegalFull AccessAPA’s Government, Policy, and Advocacy Update (January 2022)Search for more papers by this authorPublished Online:23 Dec 2022https://doi.org/10.1176/appi.pn.2023.01.1.44APA, Partners Detail Year-End Requests to Congressional LeadershipIn December, APA and its partner organizations, collectively known as the Group of Six, sent a letter to House and Senate leaders requesting action on several proposals to ensure patients have access to quality and affordable health care. The letter was addressed to Reps. Nancy Pelosi (D-Calif.) and Kevin McCarthy (R-Calif.), and Sens. Chuck Schumer (D-N.Y.) and Mitch McConnell (R-Ky).The Group of Six includes APA, the American Academy of Family Physicians, the American Academy of Pediatrics, the American College of Obstetricians and Gynecologists, the American College of Physicians, and the American Osteopathic Association.The letter outlines numerous actions that the groups urged Congress to take, including the following:Avert cuts to Medicare physician payments.Senate passage of the Improving Seniors’ Timely Access to Care Act (HR 3173), which the House already passed. The legislation would standardize and streamline the prior authorization approval process in the Medicare Advantage program.Extend Medicare telehealth flexibilities through at least 2024, including coverage for audio-only services, to ensure Medicare beneficiaries can continue to access virtual care.Extend funding for the Teaching Health Centers Graduate Medical Education program.Additionally, the letter outlined numerous actions Congress should take to address the mental health and substance use disorder crisis. The Group of Six urged Congress to promote the integration of mental health services with primary care, strengthen the mental health workforce by increasing funding for graduate medical education, increase funding to community health and mental health centers to enhance prevention and early intervention, and enforce the federal mental health parity law.APA and its partner organizations’ letter to Congress Leadership. APA Sends Letter Supporting Bill To Address Children’s Mental HealthIn a letter, APA and its partner organizations expressed support for the Investing in Kids’ Mental Health Now Act (S. 4747), introduced by Sens. Robert Casey (D-Pa.) and Rob Portman (R-Ohio). The bill would incentivize states to increase Medicaid reimbursement for pediatric mental health and substance use disorder treatment services, providing direct support to the pediatric mental health workforce and improving access to children’s mental health care.“Medicaid is the single largest payer of children’s mental health services in the United States, yet states often struggle to maintain an adequate network due to lower reimbursement rates for pediatric mental and behavioral services and an ongoing shortage of pediatric mental health professionals,” the letter stated. “These longstanding issues translate to delayed access to mental health care for children covered by Medicaid across the country.” ■APA’s letter to Senators Robert Casey, and Robert Portman. ISSUES NewArchived

S1018 Prior Authorization of Inflammatory Bowel Disease Prescriptions: A Single System Review of Current Practices and Adverse Events Associated With Delays

Introduction: Since the introduction of the prior authorization (PA) process by health insurances and pharmacy benefit managers (PBM) for a growing number of medications, it has become increasingly challenging for healthcare providers (HCPs) to ensure their patients receive appropriate treatment in a timely manner. Insurers and PBMs justify PA out of concern for unregulated prescription of medications that can have dangerous side effects, interact with other medications, abuse potential, or the availability of less expensive alternatives. HCPs often sacrifice time and resources appealing denials or redesigning management plans. More concerning is potential harm to the patient related to delays in care. While prior studies have looked at subjective HCP viewpoints on PA in Inflammatory Bowel Disease (IBD), there is limited literature in quantification of delays and direct adverse outcomes. This study aims to evaluate practices in PA, potential delays, and adverse effects related to delays in approval for specialty therapy for IBD. Methods: A retrospective review was performed at a single tertiary academic medical center for adult patients with IBD prescribed new IBD medication(s) requiring PA. Data collected from each medical record included time from prescription to PA approval. Negative outcomes were assessed including hospital admission, steroid bridge to the new prescription, or surgery. Results: Of 485 PAs submitted, a review was performed on 42 randomly selected IBD patients with IBD prescription requiring a PA between 9/2021- 3/2022. Mean length of time from prescription to PA approval was 5.8 days (Range: 1-34 days). Of 42 patients, 11 (26%) patients waited longer than 2 business weeks for PA approval, 1 patient (3%) required hospitalization and 3 (7%) patients required steroids during windows of delay. Average time to PA approval for non-commercial vs commercial insurers was 22 vs 6 days. All PAs were ultimately approved. Conclusion: In this descriptive study, the average length of PA approval for a new IBD prescription was 5.8 days, with over 25% with greater than 2 business weeks for PA approval. These results show that the PA process for patients with IBD can benefit from closer, data driven investigation. Further analysis is planned for continuation and dosage changes in therapy requiring PA with the goal of identifying the best practices that can be widely adopted to minimize delays and improve patient care.

Insurance Authorization Barriers in Patients Undergoing Cytoreductive Surgery and HIPEC.

Indications for cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) exist across multiple histologies, but little data exist on the impact of insurance authorization on access to these therapies. Given the evolving role of CRS/HIPEC, we sought to characterize insurance approval and delays in patients undergoing these therapies. A retrospective review was performed at a high-volume tertiary center of patients who received CRS/HIPEC from 2017 to 2021. Collected data included patient demographics, tumor histologic characteristics, insurance type, approval/denial history, and time to prior authorization approval. Descriptive statistics were performed. In total, 367 patients received CRS/HIPEC during the study period. They had a median age of 59 (IQR 49-67) years, 35% were male, and 76% were white. Of the patients requiring prior authorization, 14 of 104 (13%) patients were denied prior authorization and required appeal. Median time between authorization request and approval was 33 (IQR 28-36) days. These cases generated 410 insurance authorization requests, 94 (23%) of which were not initially approved and required appeal. The rate of upfront denial was 21.1% in patients with public insurance compared with 23.4% in patients with private insurance. Gastric cancer was the most common histology among denied cases (55%), followed by colorectal, appendiceal, and gynecologic malignancies. Despite the broadening indications for and data supporting CRS/HIPEC, a significant proportion of patients still face hurdles in attaining insurance approval and coverage for these therapies. Addressing barriers to insurance approval is imperative to decrease therapeutic delay and improve access to data-driven care.

Reply to “Routine Re-screening for Latent Tuberculosis Has Low Utility in Patients With Chronic Immune-Mediated Inflammatory Diseases Treated With Biologics: A Single Center Retrospective Cohort Study”

To the Editor: We thank Ruggiero et al for their interest in our article and emphasizing challenges surrounding current latent tuberculosis infection (LTBI) screening practices in patients taking biologics.1 We strongly agree with the authors that annual LTBI testing is unnecessary in all patients taking biologics and that LTBI screening guidelines need to be updated using research-driven evidence. In the United States, the important determinants that prompt physicians to automatically repeat annual LTBI screening include insurance company mandates requiring annual testing for prior authorization approval of biologic refills and incorporation of annual LTBI screening recommendations for patients on biologics into the Medicare Merit-Based Incentive Payment Systems, which impact physician reimbursement.

Room to Improve Prior Authorization in Children With Complex Medical Needs

Since the 1980s, US health insurers have used prior authorization (PA) to determine whether a health care service or treatment is medically necessary before covering its cost. To initiate this process, a patient’s clinician submits an application that justifies the need for the service or treatment. The insurer then adjudicates necessity. PA was designed to mitigate overuse of expensive health services and treatments that patients may not need, thereby containing health care costs and promoting evidence-based care. PA originated largely from overuse of health services and treatments among elderly Medicare beneficiaries.1 Despite widespread use of PA among public and private insurers for adult patients, there is a paucity of information on PA in children, including the risks and benefits to children who experience it.To advance knowledge on PA in children, Constant and colleagues2 assessed the initiation of expensive biologic medications (eg, antitumor-necrosis factor α) in 190 children with inflammatory bowel disease (IBD). IBD is a complex chronic gastrointestinal condition with a relapsing and remitting disease course that can become debilitating if insufficiently treated. Biologic medications are effective in moderate and severe IBD. The per-member-per-year (PMPY) cost of biologic mediations for pediatric patients with IBD is high (∼$41 100).3 Constant and colleagues found that nearly three-fourths of children experienced PA for use of a biologic medication. Thirteen percent experienced complicated PA, which included peer-to-peer review, letter of appeal, and/or step-therapy before approval was granted. Uncomplicated and complicated PA delayed biologic initiation for IBD by over 1 and 3 weeks, respectively. Children experiencing PA had significantly higher rates of IBD exacerbation that necessitated emergency department use, hospitalization, and exposure to systemic corticosteroids.The findings from this study question the value of PA for biologic medications in children with IBD. On completion of the PA process, biologic medications were approved for all children with IBD in the study, suggesting that no unnecessary use occurred. Despite this, health might have been compromised because of the need to wait for PA approval. Although the retrospective case-control study design cannot be used to infer causal relationship between the need for PA and health outcomes, the imbalance of risk without benefit with PA for biologic medications in children with IBD in the study is evident.Reading the study by Constant and colleagues invoked recollection of myriad PA and insurer-led denial-of-care experiences for children with complex medical needs cared for in our clinical practice. We have had patients with epilepsy experience recurrent seizures while waiting on PA approval for antiepileptic medications. Patients with severe neurologic impairment have vomited and aspirated while waiting on PA for gastroesophageal reflux and gastric promotility medications. One patient hospitalized with hypoxia because of a critical airway who was scheduled for tracheotomy and a laryngotracheal separation was denied hospital coverage because the insurer perceived that the patient’s health problems did not necessitate hospital level of care. Most if not all of these patients received coverage approval by the insurer after significant time and effort justifying need was performed by the patients’ clinicians.With these experiences in mind, the findings from the study by Constant and colleagues complement the disdain expressed by many pediatric clinicians that PA is an administrative nuisance without any clear benefit to children. Multiple initiatives to reform and standardize the PA process have emerged to optimize efficiency and transparency as well as to address variation across insurers. Despite state-level legislation and national efforts from the American Medical Association,4 the burden of PA on clinicians remains heavy. US physicians reportedly spend up to 16 hours weekly on PA tasks. Forty percent of physicians hire office staff dedicated to PA.5 Labor costs for PA processing exceed $500 million annually.6Constant and colleagues remind us that pediatric clinicians have no choice currently but to remain steadfast to complete the PA process for the patients who need it to get them the medications and treatments that require PA approval. This is especially true for general pediatric, complex care, and specialty clinicians caring for large numbers of children with complex and chronic medical needs. These children are at risk for a disproportionate share of PAs to attain needed medications and medical equipment. Strong partnerships among insurers, clinicians, patients, and families are essential when designing and implementing solutions to optimize the value of PA for pediatric patients. Future quality improvement and research endeavors should distinguish and disseminate successful PA collaborations. We should all work together to ensure safe and timely access to pediatric health services and treatments, regardless of their cost.

248: Evaluation of effect on modulator therapy prior authorization approval time after implementation of pharmacy services in a cystic fibrosis clinic

248: Evaluation of effect on modulator therapy prior authorization approval time after implementation of pharmacy services in a cystic fibrosis clinic

Impact of a pharmacy technician and pharmacist on time to inhaled tobramycin therapy in a pediatric cystic fibrosis clinic.

Cystic fibrosis (CF) patients who grow Pseudomonas aeruginosa on respiratory culture are commonly prescribed inhaled tobramycin (TIS) to eradicate the organism. The objective of this study was to determine the impact of a pharmacy technician/pharmacist team, in conjunction with an integrated health-system specialty pharmacy (IHSSP), on the time from positive culture to prescribing and access to TIS in a pediatric CF clinic. A retrospective study of CF patients positive for P. aeruginosa who were prescribed TIS for eradication. The study included 20 patients in the pregroup and 42 patients in the postgroup. Total median (interquartile range) days from positive culture to TIS being shipped to the patient from the pharmacy was significantly different: 15 (10.25-21) days in the pregroup and 9 (7-14) days in the post groups (p = .005). The time from positive culture to TIS prescribing was significantly different: 6 (5-12.75) days in the pregroup and 5 (3.75-6) days in the postgroup (p = .01). In the postgroup median time from prescription to the patient receiving the TIS was significantly different between the two groups 2 (2-5) days IHSSP group versus 6 (3-9) external specialty pharmacy group (p = .003). Time from prescription to prior authorization approval was the same in both groups. The addition of the pharmacy team reduced time from culture to TIS being received by the patient. Patients able to fill at the IHSSP received their medication sooner than an external specialty pharmacy. The study shows the benefit of an integrated pharmacy model in conjunction with an IHSSP.

Abstracts of the 30th Annual Pediatric Pharmacy Association (PPA) Meeting April 21 to 25, 2021

Abstracts of the 30th Annual Pediatric Pharmacy Association (PPA) Meeting April 21 to 25, 2021

Embedding an Advanced Pharmacy Technician in an Adult Specialty Pulmonary Clinic to Complete Prior Authorizations Improves Efficiency and Provider Satisfaction

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.

Analysis of prior authorization success and timeliness at a community-based specialty care pharmacy

BackgroundSpecialty medications may require a prior authorization (PA) before a patient can access the medication. Providers often identify PA approval as a burden for the practice. Pharmacists can facilitate the completion of the PA process. ObjectiveThe primary objective was to evaluate the time to first PA decision (approval or denial) for dermatologic medications dispensed by a community-based specialty pharmacy. A secondary objective was to compare PA timeliness (time to PA approval and time to first medication fill) between a community-based specialty pharmacy and a dermatology provider office.Practice description: Realo Specialty Care is a community-based independent specialty pharmacy that provides comprehensive care to patients with complex and chronic conditions such as plaque psoriasis, hidradenitis suppurativa, and atopic dermatitis. Pharmacy services include PA assistance, comprehensive medication management, patient education, and adherence monitoring. Practice innovationPharmacy dispensing system data were used to conduct a retrospective analysis of the effectiveness at resolving PA requests. PAs are traditionally completed by a provider’s practice, and data are documented within the pharmacy system as a PA task. Evaluation methodsData included PA tasks for dermatology prescriptions for patients aged 18 years or older between January 1, 2017, and June 30, 2019. Initial receipt of the prescription, PA decision, and PA decision date were noted in the PA task and confirmed via fax documentation. The date of first fill was confirmed by prescription data. ResultsThe pharmacy completed 677 PA tasks with a mean time to PA decision of 1.9 days, whereas the provider’s office averaged 20.9 days (P < 0.001). The pharmacy demonstrated a mean time to first fill of 6.6 days, whereas the provider’s office averaged 16.2 days (P < 0.001). ConclusionPharmacies can effectively complete PAs to expedite the filling process for patients and increase medication access. Provider practices could benefit from delegating these tasks to a partnered pharmacy.

S0697 Denied! Analyzing Initial Rejection of Prior Authorization Approval for Biologic Treatment in IBD Patients

INTRODUCTION: Initial attempts to obtain prior authorization (PA) for biologics can result in approval delays or rejection. Delayed initiation of biologic therapy can impact clinical outcomes. There is limited data characterizing initial rejections for biologics. This study evaluated the reasons for insurance rejection of biologics and impact upon the time of medication initiation. METHODS: An IRB approved chart review of IBD patients seen in a university GI clinic over a 5-year period was performed. Patient, gender, race, IBD subtype, biologic use, insurance, initial PA rejection and reason for rejection were recorded in a confidential Microsoft Excel database. Insurance type was classified as private or public (Medicaid; Medicare). The time to approval (TTA) was the day between patient agreement to start a biologic and PA approval. The time to first infusion (TFI) was the day between agreement and first administration. Patients were excluded if the biologic was initiated at another institution or if documentation of TTA or TFI was not apparent. Analysis was performed using t-testing and Fisher's exact test with significance set at P < 0.05. RESULTS: 458 records revealed 66 patients on biologics. 42 had private insurance, 16 Medicaid and 8 Medicare. 15.2% (n = 10) of patients experienced an initial PA rejection. Significantly more public insurance patients had an initial rejection compared to private insurance patients (7 vs 3, P = 0.029). 50% of all rejections and 85.7% of public insurance rejections (n = 5) were for infliximab. The most common reason for initial rejection was not choosing a formulary medication or not unsuccessfully trialing one or more alternative medications. There was no significant difference in rejection based on gender (P = 0.732), race (P = 0.717), or IBD subtype (P = 0.299). Patients with an initial PA rejection had significantly longer mean TTA than those not rejected (60.5 vs 23.1 days, P = 0.001). Patients with an initial denial also had a longer TFI (74.9 vs 40.0 days, P = 0.002). CONCLUSION: Delayed initiation of biologics in IBD patients can lead to poorer clinical outcomes. Patients with public health insurance experienced more PA rejections compared to those with private insurance. Initial rejections were often related to insurance company preference for formulary medications or unsuccessful trials of non-biologic medications. It is critical that physicians insist that biologics are administered based upon clinical considerations and administration occurs without significant delay.

S0696 Private vs Public: Does Insurance Type Play a Factor in the Time to Prior Authorization Approval of Biologics in IBD Patients?

S0696 Private vs Public: Does Insurance Type Play a Factor in the Time to Prior Authorization Approval of Biologics in IBD Patients?

Impact of Removing Medicaid Fee-for-Service Hepatitis C Virus (HCV) Treatment Restrictions on HCV Provider Experience with Medicaid Managed Care Organizations in New York City.

Immediately after the approval of direct-acting antiviral medications for the treatment of hepatitis C virus (HCV) in 2013, state Medicaid programs limited access to these expensive treatments based on liver disease stage, absence of active alcohol or substance use, and prescriber limitations. New York State fee-for-service (FFS) Medicaid eliminated these requirements in May 2016, but the effect on providers and patients obtaining prior authorization (PA) from Medicaid managed care organizations (MCOs) was unknown. We used a mixed methods approach to assess whether the removal of HCV treatment restrictions was associated with changes in Medicaid MCOs' PA approval processes and length of time to treatment initiation at two large urban New York City provider organizations participating in Project INSPIRE, an HCV care coordination demonstration project. At baseline, the top criteria for clinic care coordinators ranking MCOs as being "most difficult" were liver staging criteria, delayed treatment, and requiring a urine toxicology test. At follow-up, liver staging criteria were replaced by medication formulary limitations. Univariate analysis of the Project INSPIRE participant data suggests a decrease in the percentage of participants with insurance/PA-related treatment delays pre- versus post-policy change (23% versus 15%, p value = 0.02). Interrupted time series analysis found a 2 percentage point decrease (p value = 0.02) in the proportion of PAs each month with insurance-related treatment delays that was attributable to policy change. These results from two urban clinics indicate New York State FFS Medicaid's policy change for HCV treatment may have been associated with some changes in Medicaid MCO PA decisions, but MCO PA denials and treatment delays were still observed "on the ground" by clinic staff.

P025 THE PRIOR AUTHORIZATION PREDICAMENT: AN EVALUATION OF TIME TO INITIATION OF BIOLOGIC TREATMENT IN IBD PATIENTS

Abstract Background Biologics are a mainstay in the treatment of moderate-severe IBD. Unlike other IBD medications, biologics typically require prior authorization from insurance providers. There is a paucity of information characterizing the length of the authorization process. Delays in the initiation of biologic therapy have the potential to impact clinical outcomes and quality of life. This study identified the time of biologic prescription and subsequent time for authorization and time of administration at a university medical center. Methods A chart review evaluating IBD patients seen in the GI clinic of a university medical center over a 5-year period was performed. Patient age, gender, race, IBD diagnosis, and biologic use were recorded in a confidential database generated using Microsoft Excel. Biologic agents evaluated included infliximab, adalimumab, vedolizumab and ustekinumab. The agreed upon date (AUD) of starting a biologic, length of time to approval (TTA), and length of time to first infusion (TFI) were recorded. TTA was set as the number of days between agreeing to start a biologic and prior authorization approval. TFI was set as the number of days between agreeing to start a biologic and their first infusion or injection. Patients were excluded if biologic was initiated at another institution or documentation of AUD or TFI was not apparent. Statistical analysis was performed using a t-test with significance set at p&amp;lt;0.05. The study was approved by the institutional IRB. Results 458 total IBD patients were analyzed. 66 are currently being treated with a biologic (32 infliximab, 14 adalimumab, 13 vedolizumab, 7 ustekinumab). 37 patients had ulcerative colitis, 27 Crohn’s disease, and 2 indeterminate colitis. There were 38 men and 28 women (mean age 43.2 years; range 23–76). 32 patients were white, 26 African American, 1 Asian, 5 other/unknown, and 2 declined. Average TTA was 30.5 days (range 1–145) and average TFI was 45.3 days (range 2–166). There was no significant difference in TFI between a specific biologic compared to all others: infliximab (p=0.615), adalimumab (p=0.183), vedolizumab (p=0.804), ustekinumab (p=0.812). There were no significant differences in TFI with regard to gender (p=0.562), race (p=0.575), or IBD diagnosis (p=0.209). Discussion In IBD patients with an indication for biologic treatment, reducing the time to initiation of biologics can result in improved patient outcomes and quality of life. Average wait time for first infusion at our institution was 43.5 days with no difference based on the type of biologic or patient demographics. While a national benchmark does not exist for initiating patients on biologics, there is a need for continued evaluation of the authorization and treatment processes. As new biologic therapies for IBD become available, streamlining the approval process will be of increasing importance.