White Paper: American Gastroenterological Association Position Statement: The Future of IBD Care in the United States-Removing Barriers and Embracing Opportunities.

Despite incredible growth in systems of care and rapidly expanding therapeutic options for people with inflammatory bowel disease, there are significant barriers that prevent patients from benefiting from these advances. These barriers include restrictions in the form of prior authorization, step therapy, and prescription drug coverage. Furthermore, inadequate use of multidisciplinary care and inflammatory bowel disease specialists limits patient access to high-quality care, particularly for medically vulnerable populations. However, there are opportunities to improve access to high-quality, patient-centered care. This position statement outlines the policy and advocacy goals that the American Gastroenterological Association will prioritize for collaborative efforts with patients, providers, and payors.

Prior authorization requirements in the office-based laboratory setting are administratively inefficient and threaten timeliness of care.

OBJECTIVE: The objective of this study was to investigate the administrative and clinical impacts of prior authorization (PA) processes in the office-based laboratory (OBL) setting. METHODS: This single-institution, retrospective analysis studied all OBL PAs pursued between January 2018 and March 2022. Case, PA, and coding information was obtained from the practice's scheduling database. RESULTS: Over the study period, 1854 OBL cases were scheduled; 8% (n = 146) required PA. Of these, 75% (n = 110) were for lower extremity arterial interventions, 19% (n = 27) were for deep venous interventions, and 6% (n = 9) were for other interventions. Of 146 PAs, 19% (n = 27) were initially denied but 74.1% (n = 7) of these were overturned on appeal. Deep venous procedures were initially denied, at 43.8% (n = 14), more often than were arterial procedures, at 11.8% (n = 13). Of 146 requested procedures, 4% (n = 6) were delayed due to pending PA determination by a mean 14.2 ± 18.3 working days. An additional 6% (n = 8) of procedures were performed in the interest of time before final determination. Of the seven terminally denied procedures, 57% (n = 4) were performed at cost to the practice based on clinical judgment. CONCLUSIONS: Using PA appeals mechanisms, while administratively onerous, resulted in the overturning of most initial denials.

Advanced Therapies for Inflammatory Bowel Disease: Navigating Payor and Financial Challenges.

PURPOSE OF REVIEW: In the United Sates the cost of managing Crohn's disease and ulcerative colitis, the two most common inflammatory bowel diseases, is a major factor that can alter the course of treatment. The increasing use of advanced therapies such as biologics and oral small molecules is a driver of these costs. Many IBD providers find navigating the payor and non-insurance cost assistance processes to be a significant challenge in care management. We aim to clarify these processes and provide an outline for success. RECENT FINDINGS: Insurance companies use various processes to manage medication costs and while they may not ultimately be cost-effective, the processes have continued and are increasingly complex. This complexity has led to measurable delays in care and negative outcomes. With a deeper understanding of payor and non-insurance cost-assistance processes we have developed a workflow for navigating the use of advanced therapies in the treatment of IBD.

Burden with No Benefit: Prior Authorization in Congenital Cardiology.

Prior authorization is a process that health insurance companies use to determine if a patient's health insurance will cover certain medical treatments, procedures, or medications. Prior authorization requests are common in adult congenital and pediatric cardiology (ACPC) due to need for advanced diagnostics, complex procedures, disease-specific medications, and the heterogeneity of the ACPC population. Prior authorizations in ACPC are rarely denied, but nonetheless, they are often accompanied by significant administrative burden on clinical care teams and delays in patient care. Prior authorizations have been implicated in worsening care inequities. The prior authorization process is insurer specific with differences between commercial and public insurers. Prior authorization rejections were previously found to be more common for women, racial minorities, those with low education, and in low-income groups. Prior authorization unduly burdens routine diagnostics, routine interventional and surgical procedures, and routine cardiac specific medication use in the ACPC population. This manuscript highlights the burdens of prior authorization and advocates for the elimination of prior authorization for ACPC patients.

Prior Authorization Leads to Administrative Burden and Delays in Treatment in Primary Total Joint Arthroplasty Patients.

BACKGROUND: The prior authorization (PA) process is often criticized by physicians due to increased administrative burden and unnecessary delays in treatment. The effects of PA policies on total hip arthroplasty (THA) and total knee arthroplasty (TKA) have not been well described. The purpose of this study was to analyze the use of PA in a high-volume orthopaedic practice across 4 states. METHODS: We prospectively collected data on 28,725 primary THAs and TKAs performed at our institution between 2020 and 2023. Data collected included patient demographics, payer approval or denial, time to approval or denial, the number of initial denials, the number of peer-to-peer (P2P) or addenda, and the reasons for denial. RESULTS: Seven thousand five hundred twenty eight (56.4%) patients undergoing THA and 8,283 (54%) patients undergoing TKA required PA, with a mean time to approval of 26.3 ± 34.6 and 33.7 ± 41.5 days, respectively. Addenda were requested in 608 of 7,528 (4.6%) THA patients and 737 of 8,283 (8.9%) TKA patients. From a total of 312 (4.1%) THA patients who had an initial denial, a P2P was requested for 50 (0.7%) patients, and only 27 (0.4%) were upheld after the PA process. From a total of 509 (6.1%) TKA patients who had an initial denial, a P2P was requested for 55 (0.7%) patients, and only 26 (0.3%) were upheld after the PA process. The mean time to denial in the THA group was 64.7 ± 83.5, and the most common reasons for denial were poor clinical documentation (25.9%) and lack of coverage (25.9%). The mean time to denial in the TKA group was 63.4 ± 103.9 days, and the most common reason for denial was not specified by the payer (46.1%). CONCLUSIONS: The use of PA to approve elective THA and TKA led to increased surgical waiting times and a high administrative burden for surgeons and healthcare staff.

Access to clinically indicated genetic tests for pediatric patients with Medicaid: Evidence from outpatient genetics clinics in Texas.

PURPOSE: Little is known about how Medicaid coverage policies affect access to genetic tests for pediatric patients. Building upon and extending a previous analysis of prior authorization requests (PARs), we describe expected coverage of genetic tests submitted to Texas Medicaid and the PAR and diagnostic outcomes of those tests. METHODS: We retrospectively reviewed genetic tests ordered at 3 pediatric outpatient genetics clinics in Texas. We compared Current Procedural Terminology (CPT) codes with the Texas Medicaid fee-for-service schedule (FFSS) to determine whether tests were expected to be covered by Medicaid. We assessed completion and diagnostic yield of commonly ordered tests. RESULTS: Among the 3388 total tests submitted to Texas Medicaid, 68.9% (n = 2336) used at least 1 CPT code that was not on the FFSS and 80.7% (n = 2735) received a favorable PAR outcome. Of the tests with a CPT code not on the FFSS, 60.0% (n = 1400) received a favorable PAR outcome and were completed and 20.5% (n = 287) were diagnostic. The diagnostic yield of all tests with a favorable PAR outcome that were completed was 18.7% (n = 380/2029). CONCLUSION: Most PARs submitted to Texas Medicaid used a CPT code for which reimbursement from Texas Medicaid was not guaranteed. The frequency with which clinically indicated genetic tests were not listed on the Texas Medicaid FFSS suggests misalignment between genetic testing needs and coverage policies. Our findings can inform updates to Medicaid policies to reduce coverage uncertainty and expand access to genetic tests with high diagnostic utility.

Patterns of Unnecessary Insurer Prior Authorization Denials in a Complex Surgical Oncology Practice.

INTRODUCTION: Insurance prior authorization (PA) is a determination of need, required by a health insurer for an ordered test/procedure. If the test/procedure is denied, a peer-to-peer (P2P) discussion between ordering provider and payer is used to appeal the decision. The objective of this study was to measure the number and patterns of unnecessary PA denials. METHODS: This was a retrospective review at a quaternary cancer center from October 2021 to March 2022. Included were all patients with outpatient imaging orders for surgical planning or surveillance of gastrointestinal, endocrine, or skin cancer. Primary outcome was unnecessary initial denial (UID) defined as an order that required preauthorization, was initially denied by the insurer, and subsequently overturned by P2P. RESULTS: Nine hundred fifty seven orders were placed and 419 required PA (44%). Of tests requiring authorization, 55/419 (13.1%) were denied. Variability in the likelihood of initial denial was seen across insurers, ranging from 0% to 57%. Following P2P, 32/55 were overturned (58.2% UID). The insurers most likely to have a UID were Aetna (100%), Anthem (77.8%), and Cigna (50.0%). UID was most common for gastrointestinal (58.9%) and endocrine (58.3%) cancers. Average P2P was 33.5 min (interquartile range 28-40). CONCLUSIONS: The majority of imaging studies initially denied were overturned after P2P. If all UIDs were eliminated, this would represent 108 less P2P discussions with an estimated time-savings of 60.3 h annually within a high-volume surgical oncology practice. Combined personnel costs to the health systems and stress on patients with cancer due to image-associated PAs and P2P appear hard to justify.

Insurance Approval Delay of Biologic Therapy Dose Escalation Associated with Disease Activity in Patients with Inflammatory Bowel Disease.

BACKGROUND: Dose escalation of self-injectable biologic therapy for inflammatory bowel diseases may be required to counteract loss of response and/or low drug levels. Payors often require completion of a prior authorization (PA), which is a complex approval pathway before providing coverage. If the initial PA request is denied, clinic staff must complete a time and resource-intensive process to obtain medication approval. AIMS: This study measured time from decision to dose escalate to insurance approval and evaluated impact of approval time on disease activity. METHODS: This was a single-center retrospective analysis of adult patients with IBD prescribed an escalated dose of biologic therapy at an academic center with an integrated specialty pharmacy team from January to December 2018. Outcomes included time to insurance approval and the association between approval time and follow-up C-reactive protein (CRP) and Short Inflammatory Bowel Disease Questionnaire (SIBDQ) scores. Associations were tested using linear regression analyses. RESULTS: 220 patients were included, median age 39, 53% female, and 96% white. Overall median time from decision to dose escalate to insurance approval was 7 days [interquartile range (IQR) 1, 14]. Approval time was delayed when an appeal was required [median of 29 days (IQR 17, 43)]. Patients with a longer time to insurance approval were less likely to have CRP improvement (p = 0.019). Time to insurance approval did not significantly impact follow-up SIBDQ scores. CONCLUSION: Patients who had a longer time to insurance approval were less likely to have improvement in CRP, highlighting the negative clinical impact of a complex dose escalation process.

The impact of prior authorization review on orthopaedic subspecialty care: a prospective multicenter analysis.

BACKGROUND: Prior authorization review (PAR), in the United States, is a process that was initially intended to focus on hospital admissions and costly high-acuity care. Over time, payors have broadened the scope of PAR to include imaging studies, prescriptions, and routine treatment. The potential detrimental effect of PAR on health care has recently been brought into the limelight, but its impact on orthopedic subspecialty care remains unclear. This study investigated the denial rate, the duration of care delay, and the administrative burden of PAR on orthopedic subspecialty care. METHODS: A prospective, multicenter study was performed analyzing the PAR process. Orthopedic shoulder and/or sports subspecialty practices from 6 states monitored payor-mandated PAR during the course of providing routine patient care. The insurance carrier (traditional Medicare, managed Medicare, Medicaid, commercial, worker's compensation, or government payor [ie, Tricare, Veterans Affairs]), location of service, rate of approval or denial, time to approval or denial, and administrative time required to complete process were all recorded and evaluated. RESULTS: Of 1065 total PAR requests, we found a 1.5% (16/1065) overall denial rate for advanced imaging or surgery when recommended by an orthopedic subspecialist. Commercial and Medicaid insurance resulted in a small but statistically significantly higher rate of denial compared to traditional Medicare, managed Medicare, worker's compensation, or governmental insurance (P < .001). The average administrative time spent on a single PAR was 19.5 minutes, and patients waited an average of 2.2 days to receive initial approval. Managed Medicare, commercial insurance, worker's compensation, and Medicaid required approximately 3-4 times more administrative time to process a PAR than to traditional Medicare or other governmental insurance (P < .001). After controlling for the payor, we identified a significant difference in approval or denial based on geographic location (P < .001). An appeal resulted in a relatively low rate of subsequent denial (20%). However, approximately a third of all appeals remained in limbo for 30 days or more after the initial request. CONCLUSIONS: This is the largest prospective analysis to date of the impact of PAR on orthopedic subspecialty care in the United States. Nearly all PAR requests are eventually approved when recommended by orthopedic subspecialists, despite requiring significant resource use and delaying care. Current PAR practices constitute an unnecessary process that increases administrative burden and negatively impacts access to orthopedic subspecialty care. As health care shifts to value-based care, PAR should be called into question, as it does not seem to add value but potentially negatively impacts cost and timeliness of care.

Health Policy Views and Political Advocacy of Arthroplasty Surgeons: A Survey of the American Association of Hip and Knee Surgeons Members.

BACKGROUND: The American Association of Hip and Knee Surgeons (AAHKS) is the largest specialty society for arthroplasty surgeons in the United States and is dedicated to education, research, and advocacy. The purpose of this study was to identify the health policy views of AAHKS members and better characterize their advocacy participation. METHODS: A 22 question survey was electronically distributed multiple times via email link to all 3,638 United States members of AAHKS who were in practice or training in 2022. Study results were analyzed using descriptive statistics. RESULTS: There were 311 responses (9%), with 18% of respondents being within 5 years of practice and 38% having more than 20 years of practice. Respondents identified as Republicans (40%), Independents (37%), and Democrats (21%). Top policy issues included preserving physician reimbursement and equitable fee schedule representation (95%), the burden of prior authorization (53%), the impact of Center of Medicare and Medicaid Services regulations (39%), and medical liability and tort reform (39%). Members ranked maintaining appropriate physician reimbursement (44%) and advocating for patients (37%) as the top benefits to participation in advocacy. A majority of respondents (81%) stated that they spend more time on presurgery optimization now than 10 years ago. The most common barrier to advocacy participation was a lack of time (77%). CONCLUSION: Responding AAHKS members are well-informed, politically engaged, patient-oriented, and eager for a voice in policy decisions that affect the professional future of arthroplasty surgeons. These results can be used to help direct strategic efforts of the AAHKS Advocacy Committee to further increase advocacy efforts.

Patients Who Have Kellgren-Lawrence Grade 3 and 4 Osteoarthritis Benefit Equally From Total Knee Arthroplasty.

BACKGROUND: Recently, some payers have limited access to total knee arthroplasty (TKA) to patients who have Kellgren-Lawrence (KL) grade 4 osteoarthritis only. This study compared the outcomes of patients who have KL grade 3 and 4 osteoarthritis after TKA to determine if this new policy is justified. METHODS: This was a secondary analysis of a series originally established to collect outcomes for a single, cemented implant design. A total of 152 patients underwent primary, unilateral TKA at two centers from 2014 to 2016. Only patients who had KL grade 3 (n = 69) or 4 (n = 83) osteoarthritis were included. There was no difference in age, sex, American Society of Anesthesiologists score, or preoperative Knee Society Score (KSS) between the groups. Patients who had KL grade 4 disease had a higher body mass index. KSS and Forgotten Joint Score (FJS) were collected preoperatively and at 6 weeks, 6 months, 1 year, and 2 years postoperatively. Generalized linear models were used to compare outcomes. RESULTS: Controlling for demographics, improvements in KSS were comparable between the groups at all time points. There was no difference in KSS, FJS, and the proportion that achieved the patient acceptable symptom state for FJS at 2 years. CONCLUSION: Patients who had KL grade 3 and 4 osteoarthritis experienced similar improvement at all time points up to 2 years after primary TKA. There is no justification for payers to deny access to surgical treatment for patients who have KL grade 3 osteoarthritis and have otherwise failed nonoperative treatment.

Prior Authorization in Total Joint Arthroplasty: A Survey of the American Association of Hip and Knee Surgeons Membership.

BACKGROUND: This study surveyed the impact that prior authorization has on the practices of total joint arthroplasty (TJA) members of the American Association of Hip and Knee Surgeons (AAHKS). METHODS: A 24-question survey was approved by the AAHKS Advocacy Committee and distributed to all 2,802 board-certified members of AAHKS. RESULTS: There were 353 survey responses (13%). Ninety-five percent of surgeons noted a 5-year increase in prior authorization. A majority (71%) of practices employ at least 1 staff member to exclusively work on prior authorization. Average time spent on prior authorization was 15 h/wk (range, 1 to 125) and average number of claims peer week was 18 (range, 1 to 250). Surgeries (99%) were the most common denial. These were denied because nonoperative treatment had not been tried (71%) or had not been attempted for enough time (67%). Most (57%) prior authorization processes rarely/never changed the treatment provided. Most (56%) indicated that prior authorization rarely/never followed evidence-based guidelines. A majority (93%) expressed high administrative burden as well as negative clinical outcomes (87%) due to prior authorization including delays to access care (96%) at least sometimes. DISCUSSION: Prior authorization has increased in the past 5 years resulting in high administrative burden. Prior authorizations were most common for TJA surgeries because certain nonoperative treatments were not attempted or not attempted for enough time. Surgeons indicated that prior authorization may be detrimental to high-value care and lead to potentially harmful delays in care without ultimately changing the management of the patient.

Should We Aim to Help Patients "Feel Better" or "Feel Good" After Total Hip Arthroplasty? Determining Factors Affecting the Achievement of the Minimal Clinically Important Difference and Patient Acceptable Symptom State.

BACKGROUND: Recent attempts have been made to use preoperative patient-reported outcome measure (PROM) thresholds as prior authorization criteria based on the assumption that patients who have higher baseline scores are less likely to achieve the minimal clinically important difference (MCID). This study aimed to identify factors affecting the achievement of MCID and patient acceptable symptom state (PASS) after total hip arthroplasty (THA), and to determine the overlap between the two outcomes. METHODS: We identified 3,581 primary, unilateral THAs performed at a single practice in 2015-2019. PROMs including Hip Disability and Osteoarthritis Outcome Score for Joint Replacement (HOOS-JR) and 12-item Short Form Health Survey were collected preoperatively and 1-year postoperatively. The likelihood of attaining PASS according to attainment of MCID was assessed. Multivariable regression was used to identify independent predictors of MCID and PASS. RESULTS: In total, 79.8% achieved MCID and 73.6% achieved PASS for HOOS-JR. Approximately 1 in 7 patients who achieved MCID did not eventually achieve PASS. Worse preoperative HOOS-JR (odd ratio 0.933) was associated with MCID attainment. Better preoperative HOOS-JR (odd ratio 1.015) was associated with PASS attainment. Men, lower body mass index, better American Society of Anesthesiologists score, and better preoperative 12-item Short Form Health Survey mental score were predictors of MCID and PASS. Age, race, ethnicity, Charlson Comorbidity Index, and smoking status were not significant predictors. CONCLUSION: Preoperative PROMs were associated with achieving MCID and PASS after THA, albeit in opposite directions. Clinicians should strive to help patients "feel better" and "feel good" after surgery. Preoperative PROMs should not solely be used to prioritize access to care.

State legislative trends related to biomarker testing.

Comprehensive biomarker testing has become the standard of care for informing the choice of the most appropriate targeted therapy for many patients with advanced cancer. Despite evidence demonstrating the need for comprehensive biomarker testing to enable the selection of appropriate targeted therapies and immunotherapy, the incorporation of biomarker testing into clinical practice lags behind recommendations in National Comprehensive Cancer Network guidelines. Coverage policy differences across insurance health plans have limited the accessibility of comprehensive biomarker testing largely to patients whose insurance covers the recommended testing or those who can pay for the testing, and this has contributed to health disparities. Furthermore, even when insurance coverage exists for recommended biomarker testing, patients may incur burdensome out-of-pocket costs depending on their insurance plan benefits, which may also create barriers to testing. Prior authorization for biomarker testing for some patients can add an administrative burden and may delay testing and thus treatment if it is not done in a timely manner. Recently, three states (Illinois, Louisiana, and California) passed laws designed to improve access to biomarker testing at the state level. However, there is variability among these laws in terms of the population affected, the stage of cancer, and whether the coverage of testing is mandated, or the legislation addresses only prior authorization. Advocacy efforts by patient advocates, health care professionals, and professional societies are imperative at the state level to further improve coverage for and access to appropriate biomarker testing.

A Policy Approach to Reducing Low-Value Device-Based Procedure Use.

Policy Points Low-value care is common in clinical practice, leading to patient harm and wasted spending. Much of this low-value care stems from the use of medical device-based procedures. We describe here a novel academic-policymaker collaboration in which evidence-based clinical coverage for device-based procedures is implemented through prior authorization-based policies for Louisiana's Medicaid beneficiary population. This process involves eight steps: 1) identifying low-value medical device-based procedures based on clinical evidence review, 2) quantifying utilization and reimbursement, 3) reviewing clinical coverage policies to identify opportunities to align coverage with evidence, 4) using a low-value device selection index, 5) developing an evidence synthesis and policy proposal, 6) stakeholder engagement and input, 7) policy implementation, and 8) policy evaluation. This strategy holds significant potential to reduce low-value device-based care.

The Paradox of Patient-Reported Outcome Measures: Should We Prioritize "Feeling Better" or "Feeling Good" After Total Knee Arthroplasty?

BACKGROUND: The use of preoperative patient-reported outcome measure (PROM) thresholds for patient selection in arthroplasty care has been questioned recently. This study aimed to identify factors affecting achievement of the minimal clinically important difference (MCID) and patient acceptable symptom state (PASS) after total knee arthroplasty (TKA) and determine the overlap between the two outcomes. METHODS: We identified 1,239 primary, unilateral TKAs performed at a single institution in 2015-2019. PROMs including the Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS-JR) and 12-item Short Form Health Survey (SF-12) were collected preoperatively and 1-year postoperatively. The likelihood of attaining PASS as per attainment of MCID was assessed. A multivariable regression was used to identify predictors of MCID and PASS. RESULTS: In total, 71.3% achieved MCID and 75.5% achieved PASS for KOOS-JR. Only 7.7% achieved MCID but not PASS, whereas almost twice this number did not achieve MCID but did achieve PASS (11.9%). Poorer preoperative KOOS-JR (OR 0.925), better SF-12 physical (OR 1.025), and mental (OR 1.027) were associated with MCID attainment. In contrast, better preoperative KOOS-JR (OR 1.030) and SF-12 mental (OR 1.025) were associated with PASS attainment. Age, gender, race, ethnicity, body mass index, Charlson index, American Society of Anesthesiologists classification, and smoking status were not significant predictors. CONCLUSION: Preoperative PROMs were associated with achieving MCID and PASS after TKA, albeit some positively and some negatively. In the era of value-based care, clinicians should not only strive to help patients "feel better" but also ensure that patients "feel good" after surgery. This study does not support the use of PROMs in prioritizing access to care.

Challenges and Potential Improvements to Patient Access to Pharmaceuticals: Examples From Cardiology.

Patient access to a drug after US regulatory approval is controlled by complex interactions between governmental and third-party payers, pharmacy benefit managers, distributers, manufacturers, health systems, and pharmacies that together mediate the receipt of goods by patients after prescription by clinicians. Recent medication approvals highlight why and how the distribution of clinically beneficial novel therapies is controlled. Although imposed limitations on availability may be rational considering the fiduciary responsibilities of payers and escalating spending on health care and pharmaceuticals, transparency and communication are lacking, and some utilization management may disproportionately affect vulnerable populations. Analysis of the current health insurance landscape suggests mechanisms by which patient access to appropriate medications can be improved and patient and clinician frustration reduced while acknowledging the financial realities of the pharmaceutical marketplace. We propose creation of a shared, standardized, and transparent process for coverage decisions that minimizes administrative barriers and is defensible on the basis of clinical and cost-effectiveness evidence. These reforms would benefit patients and improve the efficiency of the pharmaceutical system.

Thinking Beyond the "Core" Antibiotic Stewardship Interventions: Shifting the Onus for Appropriate Antibiotic Use from Stewardship Teams to Prescribing Clinicians.

United States guidance for hospital antibiotic stewardship has emphasized prospective audit and feedback and prior authorization of select antibiotics as core interventions. These remain the most common interventions implemented by stewardship programs. Although these approaches have been shown to reduce unnecessary antibiotic use, they incorrectly put the onus for appropriate antibiotic use on the stewardship team rather than the prescribing clinician. We propose that a primary focus of stewardship programs should be implementation of broader interventions that engage frontline clinicians and equip them with tools to integrate antibiotic stewardship into their own daily practice, thus reducing the need for day-to-day stewardship team oversite. We discuss a framework of broader interventions and policies that will facilitate this paradigm shift.

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.

Price Is Right: Exploring Prescription Drug Coverage Barriers for Irritable Bowel Syndrome Using Threshold Pricing Analysis.

BACKGROUND: Prescription drug costs exert profound effects on commercial insurance coverage and access to effective therapy. AIMS: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.