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Soon after the National Lung Screening Trial, organizations began to endorse low-dose computed tomography (LCDT) screening for lung cancer in high-risk patients. Concerns about the risks versus benefits of screening, as well as the logistics of identifying and referring eligible patients, remained among physicians. This study aimed to examine primary care physicians' knowledge, attitudes, referral practices, and associated barriers regarding LDCT screening. We administered a national survey of primary care physicians in the United States between September 2016 and April 2017. Physicians received up to 3 mailings, 1 follow-up email, and received varying incentives to complete the survey. Overall, 293 physicians participated, for a response rate of 13%. We used weighted descriptive statistics to characterize participants and their responses. Over half of the respondents correctly reported that the US Preventive Services Task Force recommends LDCT screening for high-risk patients. Screening recommendations for patients not meeting high-risk criteria varied. Although 75% agreed that the benefits of LDCT screening outweigh the risks, fewer agreed that there is substantial evidence that screening reduces mortality (50%). The most commonly reported barriers to ordering screening included prior authorization requirements (57%), lack of insurance coverage (53%), and coverage denials (31%). The most frequently cited barrier to conducting LDCT screening shared decision making was patients' competing health priorities (42%). Given the impact of physician recommendations on cancer screening utilization, further understanding of physicians' LDCT screening attitudes and shared decision-making practices is needed. Clinical practice and policy changes are also needed to engage more patients in screening discussions., Highlights • Most physicians had five or less lung cancer screening referrals in the past year • Recommendation strategies varied, but often aligned with USPSTF or NCCN guidelines • Physicians were uncertain about the efficacy and cost-effectiveness of screening • Insurance coverage and costs were commonly cited as barriers to screening referral • A common barrier to performing SDM was patients' competing health priorities

Many insurers are using formulary design to influence opioid prescribing, but it is unclear if these changes lead to reduced use or just substitution between opioids. We evaluated the effect of a new prior authorization process implemented in July 2015 for extended-release (ER) oxycodone by Blue Shield of California. Compared to other commercially insured Californians, among 880,000 Blue Shield enrollees, there was a 36 percent drop in monthly rates of ER opioid initiation relative to control-group members, driven entirely by decreases in ER oxycodone initiation and without any substitution toward other ER opioids. This reduction was offset by a 1.4 percent relative increase in the rate of short-acting opioid fills. There was no significant change in the overall use of any opioids prescribed, measured as morphine milligram equivalents. This suggests that though insurers can play a meaningful role in reducing the prescribing of high-risk ER opioids, a formulary change focused on ER opioids alone is insuffi...

Prior authorization (PA) and step therapy (ST) are utilization management tools that have been in use by managed care organizations for decades. These processes require that health care providers obtain advanced approval to qualify a specific product for coverage from a health plan before it is delivered to the patient. These tools are intended to ensure that patients have access to evidence-based medications while payers remain good stewards of limited health care resources. PA and ST are growing in use to support appropriate use of medications and manage associated costs but may pose challenges related to administrative burden and access to care. In June 2019, the Academy of Managed Care Pharmacy (AMCP) conducted a multistakeholder forum to identify processes for optimizing PA and ST utilization management programs. Health care leaders representing academia, health plans, integrated delivery systems, pharmacy benefit managers, employers, federal government agencies, national health care provider organizations, and patient advocacy organizations participated in the forum. Participants explored current operations of these programs, evaluated stakeholder perspectives on opportunities to improve these programs, and provided recommendations for next steps. They also reviewed current federal and state legislative and regulatory activities to reform PA and ST processes and offered guidance to support program improvements. The goal of the forum was to gather stakeholder input to inform the development of recommendations to improve efficiencies around PA and ST processes; provide recommendations to address administrative burdens; increase the visibility of the clinical and economic value of PA and ST utilization management programs; collect, review, and disseminate data-driven, real-world experiences of PA programs that support clinical and economic value; collect and disseminate best practices around PA appeals and denial processes; and improve channels of communications between health insurance providers, health care professionals, and patients to minimize care delays and improve clarity of coverage authorization requirements. DISCLOSURES: This AMCP Partnership Forum was sponsored by Mallinckrodt Pharmaceuticals, Merck, the National Pharmaceutical Council, and Takeda. These proceedings were prepared as a summary of what occurred at the forum to represent common themes; they are not necessarily endorsed by all attendees nor should they be construed as reflecting group consensus.

Z razvojem notranjega trga EU je bilo neizogibno, da se bodo razvile tudi pravice na področju zdravstvenih storitev v drugih državah članicah. Zdravstvo je sicer v domeni vsake članice, a kadar gre za prehajanje med državami članicami, ima EU pristojnost urejati takšna razmerja. Raziskave kažejo, da večina Evropejcev ne pozna pravic glede zdravljenja v tujini in povračila stroškov za zdravljenje. Ljudje se odločajo za čezmejno zdravljenje, če živijo na obmejnem področju ali kadar gre za visoko specializirano oskrbo, bližino družinskih članov, ki prebivajo v drugi državi članici, dostop do drugačnega načina zdravljenja, kot ga imajo v državi članici zdravstvenega zavarovanja ter zaradi kakovostnejše storitve. Zavarovana oseba se mora pozanimati, ali je za zdravljenje, ki ga želi opraviti v drugi državi članici, potrebna predhodna odobritev. Ta se lahko uveljavlja na podlagi Uredbe 883/2004 ali Direktive 2011/24/EU. Kadar se uveljavlja čezmejno zdravljenje na podlagi Uredbe 883/2004, je predhodna odobritev vedno pogoj za takšno zdravljenje. Odobri se, ko gre za storitve iz košarice pravic, hkrati pa so izčrpane vse možnosti zdravljenja, zdravljenje doma ni na voljo ali v primeru predolgih čakalnih dob. Stroški v višini dejanske vrednosti se povrnejo le v primeru predhodne odobritve in sicer jih plača nosilec socialnega zavarovanja neposredno izvajalcu storitve, zdravstvene storitve pa se lahko uveljavljajo samo pri izvajalcih v javni mreži. V primeru Direktive 2011/24/EU se predhodna odobritev uporablja le za določene storitve iz košarice pravic (bolnišnično zdravljenje, zahtevne in drage storitve, storitve z večjim tveganjem, vprašanje varnosti in kakovosti). Stroški se povrnejo za vse primere predhodne odobritve, a le v vrednosti zdravstvene storitve v državi nosilki zavarovanja. Zavarovanec prosto izbira med zdravstvenimi storitvami javnih in zasebnih izvajalcev, katerim tudi sam plača, nosilec socialnega zavarovanja pa mu nato vrne znesek, do katerega je upravičen na podlagi izračunov. With the development of the EU internal market it was a matter of time for the rights to healthcare in other Member States to be claimed. Healthcare is in the domain of each EU Member State, with the exception when it comes to transitions between Member States. In that case EU has competence of regulation. Surveys show that most Europeans do not know their rights in respect of medical treatment abroad and possibility of reimbursement for treatment. People opt for cross-border treatment, if they live close to border area, or when it comes to highly specialized care, proximity to family members residing in another Member State, access to a different method of treatment than they have it in the Member State of affiliation or for the reason of quality services. The insured person has to inquire whether the treatment he wishes to obtain in another Member State is subject to prior authorization. The latter can be obtained on the basis of Regulation 883/2004 or Directive 2011/24 / EU. If cross-border treatment is claimed on the basis of Regulation 883/2004, prior authorization is always a requirement for the treatment. It shall be granted when it comes to service from the health care basket and all treatment options in the domestic Member State are exhausted, treatment is not available in the domestic Member State or in case of excessively long waiting periods. Costs in the amount of the actual value are repaid only in case of approval of prior authorisation and are paid by the social security institution directly to service provider. It is mandatory for service provider to be the part of public system. In the case of Directive 2011/24 / EU prior authorization only applies to certain healthcare services (hospitalization, complicated and expensive services, with a higher risk, the issue of safety and quality). Costs for cases subjected to prior authorisation are reimbursed according to price of the same or comparable health service in the Member State of affiliation. The insured person is free to choose between public or private health service providers and has to cover the costs by himself to be refunded later but only in the amount as if the service was provided in the Member State of affiliation.

Background and aims In response to the opioid overdose epidemic, US state Medicaid programs have adopted restrictive policies for opioid analgesics, yet effects on prescribing patterns and health outcomes are uncertain. This study aimed to examine effects of a prior authorization policy for extended-release/long-acting (ER/LA) opioids on opioid use in the Oklahoma, USA state Medicaid program. Design Retrospective difference-in-differences design study comparing changes in opioid use in Oklahoma Medicaid to control (Oregon Medicaid). Setting Oklahoma and Oregon, USA. Participants Medicaid beneficiaries in the Oklahoma and Oregon fee-for-service Medicaid programs between July 2007 and June 2009 (33 724 in Oklahoma and 13 520 in Oregon) MEASUREMENTS: The primary outcome was incident opioid-naive ER/LA opioid use. Secondary outcomes included other opioid and non-opioid pain medication use. We also examined indicators of high-risk prescribing (e.g. high-dosage opioid use) and opioid-related hospitalizations or emergency department (ED) visits. Findings The prior authorization policy was associated with a 0.7 percentage point reduction in the likelihood of incident opioid-naive ER/LA opioid use [95% confidence interval (CI) = -1.16 to -0.33 percentage points; 70% pre-policy mean reduction, a 1.4 percentage point decrease in likelihood of any new ER/LA opioid prescriptions (95% CI = -2.1 to -0.7 percentage points; 33% pre-policy mean reduction) and a decline of 0.16 in total ER/LA opioid prescriptions per enrollee (PPE) (95% CI = -0.29 to -0.04 PPE)]. There was a significant increase in the number of short-acting opioids filled after the policy (0.36; 95% CI = 0.22-0.50 PPE), increases in likelihood of having overlapping opioids and benzodiazepines, but significant reductions in likelihood of having overlapping opioids. No significant changes in opioid-related hospitalizations or ED visits were observed. Conclusions In Oklahoma, USA's July 2008 prior authorization policy for extended-release/long-acting opioids appears to have reduced the number of opioid-naive patients initiating extended-release/long-acting opioid use by more than half, but may also have increased short-acting opioid prescriptions by 7%.

Objective We assessed how commonly prior authorization results in treatment delay or missed doses in children with epilepsy. Methods Parents of 462 children followed in a pediatric epilepsy clinic were surveyed regarding prior authorization in the preceding year. Epilepsy and insurance details were collected. If prior authorization was required, parents were asked whether it resulted in (1) delayed initiation of a newly-prescribed antiepileptic drug, and/or (2) lapse in coverage of a current medication. Prior authorization was defined as smooth if there was a less than seven day delay in starting a new antiepileptic drug and no lapse in coverage of a current medication. Results A total of 164 families (35%) returned completed surveys. Mean age of the children was 11.2 (S.D. 5.3) years and 67.4% experienced seizures more than every three months despite trials of two or more antiepileptic drugs. Primary insurance was private in 82.9% and Medicaid in 15.2%. Prior authorization was required in 63 (38.4%) cases, and proceeded smoothly in only 31 (49.2%). Twenty-three children experienced a delay of seven days or more in starting a new drug, and 24 experienced a lapse in coverage of their current medication, 11 of whom missed doses. Of these 11, seven had increased seizures, and one required hospital admission for status epilepticus. Conclusions Prior authorization of antiepileptic drugs is common but problematic, often resulting in either a delay of initiation of a new antiepileptic drug or a lapse in coverage of a currently-used antiepileptic drug, with a negative impact on seizure control.

Politicians, especially executives, regularly seek to project their influence into new policy domains. In some instances, they do so only after having secured the requisite statutory authority; in others, they intervene without prior authorization, hoping that their actions henceforth serve as precedent for future policy involvement. To investigate the conditions under which politicians pursue one strategy versus another, we study a stylized model of authority acquisition that recognizes the electoral pressures under which executives operate. We show that politicians seek authority that is both more secure and broader in scope as the public support for their policy position increases even if- indeed, precisely because|their opponent stands to benefit from this authority if elected to office. Far from tying their opponents' hands, as a number of literatures suggests, incumbents have electoral incentives to liberate them.

Purpose The implementation and quality assessment of a pharmacy services call center (PSCC) for outpatient pharmacies and specialty pharmacy services within an academic health system are described. Summary Prolonged wait times in outpatient pharmacies or hold times on the phone affect the ability of pharmacies to capture and retain prescriptions. To support outpatient pharmacy operations and improve quality, a PSCC was developed to centralize handling of all outpatient and specialty pharmacy calls. The purpose of the PSCC was to improve the quality of pharmacy telephone services by (1) decreasing the call abandonment rate, (2) improving the speed of answer, (3) increasing first-call resolution, (4) centralizing all specialty pharmacy and prior authorization calls, (5) increasing labor efficiency and pharmacy capacities, (6) implementing a quality evaluation program, and (7) improving workplace satisfaction and retention of outpatient pharmacy staff. The PSCC centralized pharmacy calls from 9 pharmacy locations, 2 outpatient clinics, and a specialty pharmacy. Since implementation, the PSCC has achieved and maintained program goals, including improved abandonment rate, speed of answer, and first-call resolution. A centralized 24-7 support line for specialty pharmacy patients was also successfully established. A quality calibration program was implemented to ensure service quality and excellent patient experience. Additional ongoing evaluations measure the impact of the PSCC on improving workplace satisfaction and retention of outpatient pharmacy staff. Conclusion The design and implementation of the PSCC have significantly improved the health system’s patient experiences, efficiency, and quality.

The founding members of the Coalition for Psychotherapy Parity present Clinical Necessity Guidelines for Psychotherapy, Insurance Medical Necessity and Utilization Review Protocols, and Mental Health Parity. These guidelines support access to psychotherapy as prescribed by the clinician without arbitrary limitations on duration or frequency. The authors of the guidelines first review the evidence that psychotherapy is effective, cost-effective, and often provides a cost-offset in decreased overall medical expenses, morbidity, mortality, and disability. They highlight the disparity between clinicians' knowledge of generally accepted standards of care for mental health and substance use disorders and the much more limited "crisis stabilization" focus of many insurance companies. The clinical trials that health insurers cite as justification for authorizing only brief treatment for all patients involve highly selected, atypical populations that are not representative of the general population of patients in need of mental health care, who typically have complex conditions and chronic, recurring symptoms requiring ongoing availability of treatment. The standard for other medical conditions reimbursed by insurance is continuation of effective treatment until meaningful recovery, which is therefore the standard required by the Mental Health Parity and Addiction Equity Act for mental health care. However, insurance companies frequently evade the legal requirement to cover treatment of mental illness at parity with other medical conditions. They do this by applying inaccurate proprietary definitions of medical necessity and imposing utilization review procedures much more restrictively for mental health treatment than for other medical care to block access to ongoing care, thus containing insurance company costs in the short term without consideration of the adverse sequelae of undertreated illness (eg, increased costs of other medical services and increased morbidity, mortality, and costs to society in increased disability). The authors of the guidelines conclude that, given appropriate medical necessity guidelines at parity with other medical care, consistent with provider expertise and a broad range of psychotherapy research, there would be no need or place for utilization review protocols. Individuals and psychotherapy organizations are invited to visit the website psychotherapyparity.org to sign on to the guidelines to indicate agreement and support.

Background: The process of obtaining approval for hepatitis C virus (HCV) treatment may be time consuming and complicated due to prior authorizations and the need to appeal denials. Pharmacists are poised to play a critical role in the acquisition and management of oral direct acting antivirals (DAAs) for the treatment of HCV infection; however, the time expended in this activity requires assessment. Objective: The objective of this study was to assess time expenditures by pharmacists to acquire DAAs for HCV therapy. Methods: Patients were enrolled in the Northwestern University Viral Hepatitis Registry, a prospective, observational cohort of ambulatory, adult patients living with human immunodeficiency virus (HIV) coinfected with chronic hepatitis B and/or C virus, and recruited since 2013 from the Infectious Disease Center at Northwestern Memorial Hospital, Chicago, IL. Patients were included in the current study if they were referred to the pharmacist for HCV DAA acquisition, drug-drug interaction management, and adherence counseling between February 1, 2014, and April 30, 2015. Patient demographics, virus-specific characteristics, and time required to secure HCV DAA treatment, counsel patients, and follow-up therapy were collected. Results: Among 54 HIV/HCV coinfected patients referred for treatment, all eventually received approval for DAA therapy. However, 87% (n = 47) required prior authorization. Pharmacists dedicated 2.1 hours/patient (interquartile range 1.5-2.8 hours; range 0.75-6.5 hours) to manage DAA therapy. Conclusion: Successful acquisition of HCV DAA therapy relied heavily on pharmacist effort, reflecting the vital role that pharmacists play in this process. Dedicated resources for medication access should be considered to ensure timely DAA acquisition.

CONTEXT: The 2008 Mental Health Parity & Addiction Equity Act (MHPAEA) sought to improve access to behavioral health care by regulating health plans’ coverage and management of services. Health plans have some discretion in how to achieve compliance with MHPAEA, leaving questions about its likely effects on health plan policies. OBJECTIVE: To determine how private health plans’ coverage and management of behavioral health treatment changed after the federal parity law’s full implementation. METHODS: A nationally representative survey of commercial health plans was conducted in 60 market areas across the continental United States, achieving response rates of 89% in 2010 (Weighted N: 8,431) and 80% in 2014 (Weighted N: 6,974). Senior executives at responding plans were interviewed regarding behavioral health services in each year, and (in 2014) regarding changes. -Student’s t-tests were used to examine changes in services covered, cost-sharing and prior authorization requirements, for both behavioral health and general medical care. RESULTS: In 2014, 67.7% of insurance products reported having expanded behavioral health coverage since 2010. Exclusion of eating disorder coverage was eliminated between 2010 (22.6%) and 2014 (0%). However, more products reported excluding autism treatment in 2014 (24.2%) than 2010 (7.7%). Most plans reported no change to prior authorization requirements between 2010 and 2014. CONCLUSIONS: Implementation of federal parity appears to have been accompanied by continuing improvement in behavioral health coverage. We did not find evidence either of widespread non-compliance or of unintended effects which some had feared, such as dropping coverage of behavioral health care altogether.

Background High dosage opioid use is a risk factor for opioid-related overdose commonly cited in guidelines, recommendations, and policies. In 2012, the Oregon Medicaid program developed a prior authorization policy for opioid prescriptions above 120 mg per day morphine equivalent dose (MED). This study aimed to evaluate the effects of that policy on utilization, prescribing patterns, and health outcomes. Methods Using administrative claims data from Oregon and a control state (Colorado) between 2011 and 2013, we used difference-in-differences analyses to examine changes in utilization, measures of high risk opioid use, and overdose after introduction of the policy. We also evaluated opioid utilization in a cohort of individuals who were high dosage opioid users before the policy. Results Following implementation of Oregon's high dosage policy, the monthly probability of an opioid fill over 120 mg MED declined significantly by 1.7 percentage points (95% confidence interval [CI]; -2.0% to -1.4%), whereas it increased significantly by 1.0 percentage points (95% CI 0.4% to 1.7%) for opioid fills < 61 mg MED. Fills of medications used to treat neuropathic pain also increased by 1.2 percentage points (95% CI 0.7% to 1.8%). The monthly probability of multiple pharmacy use declined by 0.1 percentage points (-0.2% to -0.0) following the prior authorization, but there were no significant changes in ED encounters or hospitalizations for opioid overdose. Among individuals who were using a high dosage opioid before the policy, there was a 20.3 percentage point (95% CI -15.3% to -25.3%) decline in estimated probability of having a high dosage fill after the policy. Conclusions Oregon's prior authorization policy was effective at reducing high dosage opioid prescriptions. While multiple pharmacy use also declined, we found no impact on opioid overdose were observed.

Obtaining prior authorization (PA) approval for the new direct-acting antiviral (DAA) hepatitis C medications is time consuming and requires specific expertise. Our primary care-based program treats hepatitis C virus (HCV)-infected patients at an urban academic medical center and employs patient navigators trained in the PA process who collaborate with a nurse and specialty pharmacy to manage the PA process.To demonstrate the rate of PA approvals for our programmatic model and determine potential predictors of PA approval.We conducted a review of program databases and medical records of patients for whom DAA hepatitis C medications were ordered between November 1, 2014, and October 31, 2015 (n = 197). We first evaluated patient characteristics associated with the number of steps to approval. Then we used a multivariable ordinal regression to determine independent predictors of fewer steps to approval. Using Kaplan-Meier methods, we assessed patient characteristics associated with approval time and then fit a multivariable Cox regression model to determine independent predictors of time to approval.Of the 197 patients, 69% (n = 136) had Medicaid; 12% (n = 24) had Medicare; 10% (n = 19) had both Medicaid and Medicare; 5% (n = 10) had private insurance; and 4% (n = 8) were uninsured. Ninety-three percent of the patients were eventually approved for HCV treatment. The steps in the PA cascade were approval on first submission (37%; mean days = 30.7; SD = 29.9); approval after internal appeal (45%; mean days = 66.8; SD = 70.5); approval after external appeal (11%; mean days = 124.7; SD = 60.2); and no approval obtained (7%). Unadjusted factors found to have a P value0.200 in relation to fewer steps in the PA cascade were older age, female gender, non-Medicaid insurance, comorbid hypertension, comorbid diabetes, being domiciled, and being nongenotype 2. After adjustment, non-Medicaid insurance and nongenotype 2 remained significant. In survival analysis, non-Medicaid insurance and mid-range fibrosis were associated with fewer days to PA approval.Our program obtained 93% of PA approvals for hepatitis C medications. Patient navigators collaborating with a nurse and specialty pharmacy as a program may improve the PA approval process, although further research with a control group is necessary.The RespectfulEquitable Access to Comprehensive Healthcare (REACH) program receives funding from the Robin Hood Foundation and the New York State Department of Health AIDS Institute. Weiss receives grant support from Gilead Sciences and has served as a consultant for AbbVie and Gilead Sciences. Vu reports speaker fees from Peer View Institute. All other authors report no conflict of interest. Study design and concept were contributed by Chasan, Sigel, Vu, and Weiss. Riazi, Ciprian, Giardina, and Gibbs collected the data, which were interpreted by Toribio, Amory, Chasan, and Sigel. The manuscript was written by Vu and Weiss and revised by Parrella, Cambe, Camacho, and Vu. Research from this study was presented as an abstract poster on November 14, 2016, at the AASLD Liver Meeting in Boston, Massachusetts.

Cigarette smoking prevalence among Medicaid enrollees (25.3%) is approximately twice that of privately insured Americans (11.8%), placing Medicaid enrollees at increased risk for smoking-related disease and death (1). Medicaid spends approximately $39 billion annually on treating smoking-related diseases (2). Individual, group, and telephone counseling and seven Food and Drug Administration (FDA)-approved medications* are effective in helping tobacco users quit (3). Although state Medicaid coverage of tobacco cessation treatments improved during 2014-2015, coverage was still limited in most states (4). To monitor recent changes in state Medicaid cessation coverage for traditional (i.e., nonexpansion) Medicaid enrollees, the American Lung Association collected data on coverage of a total of nine cessation treatments: individual counseling, group counseling, and seven FDA-approved cessation medications† in state Medicaid programs during July 1, 2015-June 30, 2017. The American Lung Association also collected data on seven barriers to accessing covered treatments, such as copayments and prior authorization. As of June 30, 2017, 10 states covered all nine of these treatments for all enrollees, up from nine states as of June 30, 2015; of these 10 states, Missouri was the only state to have removed all seven barriers to accessing these cessation treatments. State Medicaid programs that cover all evidence-based cessation treatments, remove barriers to accessing these treatments, and promote covered treatments to Medicaid enrollees and health care providers would be expected to reduce smoking, smoking-related disease, and smoking-attributable federal and state health care expenditures (5-7).

Aim Our aim was to compare physician-reported barriers to sublingual buprenorphine (BUP) and extended-release naltrexone (XR-NLT) prescribing in U.S. office-based practices, and to identify potential policies for minimizing these barriers. Only one previous qualitative study has examined physician-reported barriers to prescribing XR-NLT and no qualitative study has compared physician-reported barriers between the two medications. Methods Researchers conducted individual semi-structured and in-depth interviews with 20 licensed physicians in four U.S. states between January 2016 and May 2017. Interview questions included general barriers to addiction treatment in office-based settings, barriers specific to BUP and XR-NLT prescribing, and potential government policies to decrease barriers. Researchers conducted thematic analysis of transcribed interviews. They developed and pilot tested a coding template based on a sample of transcripts, independently coded transcripts in Dedoose software, conducted consensus coding to eliminate coding discrepancies, and then assessed data for themes using research questions as a guide. Results General barriers to office-based OUD treatment included limited physician education, limited insurance reimbursement, stigma, and perceptions of "difficult" patients. Barriers specific to BUP prescribing included regulatory restrictions, liability fears, and restrictions imposed by the criminal justice system. Barriers specific to XR-NLT prescribing included limited access to medically-supervised opioid detoxification, lack of awareness of the medication, and patient fears or disinterest. Participants without experience prescribing either medication emphasized barriers to treating OUD in general. Participants with experience prescribing BUP and/or XR-NLT described barriers to treating OUD in general as well as barriers specific to each medication. Policy makers should increase access to addiction medicine education, mandate insurance coverage of both medications and inpatient detoxification, prohibit excessive insurance prior authorization requirements, increase insurance reimbursement for behavioral healthcare, and incentivize interdisciplinary collaboration. Conclusions While overlap exists, some barriers to BUP prescribing differ from barriers to XR-NLT prescribing.

Background Antibiotic stewardship programs improve clinical outcomes and patient safety and help combat antibiotic resistance. Specific guidance on resources needed to structure stewardship programs is lacking. This manuscript describes results of a survey of US stewardship programs and resultant recommendations regarding potential staffing structures in the acute care setting. Methods A cross-sectional survey of members of 3 infectious diseases subspecialty societies actively involved in antibiotic stewardship was conducted. Survey responses were analyzed with descriptive statistics. Logistic regression models were used to investigate the relationship between stewardship program staffing levels and self-reported effectiveness and to determine which strategies mediate effectiveness. Results Two-hundred forty-four respondents from a variety of acute care settings completed the survey. Prior authorization for select antibiotics, antibiotic reviews with prospective audit and feedback, and guideline development were common strategies. Eighty-five percent of surveyed programs demonstrated effectiveness in at least 1 outcome in the prior 2 years. Each 0.50 increase in pharmacist and physician full-time equivalent (FTE) support predicted a 1.48-fold increase in the odds of demonstrating effectiveness. The effect was mediated by the ability to perform prospective audit and feedback. Most programs noted significant barriers to success. Conclusions Based on our survey's results, we propose an FTE-to-bed ratio that can be used as a starting point to guide discussions regarding necessary resources for antibiotic stewardship programs with executive leadership. Prospective audit and feedback should be the cornerstone of stewardship programs, and both physician leadership and pharmacists with expertise in stewardship are crucial for success.

This column compares a clinical perspective on the continuum of care for mental health and substance use disorders with a different perspective derived from publicly available insurance company documents and experience dealing with managed care utilization reviewers. The latter perspective tends to determine the need for access to levels of care based on the need for crisis stabilization, whereas the generally accepted clinical standard is more nuanced than the need for crisis stabilization alone. The column proposes that this discrepancy in perspectives makes a substantial contribution to disagreements between treating clinicians, such as therapists, and insurance utilization reviewers concerning the medical necessity of various requested levels of care.

We discuss the role of prior authorization (PA) in supporting patient-centered care (PCC) by directing health system resources and thus the ability to better meet the needs of individual patients. We begin with an account of PCC as a standard that should be aimed for in patient care. In order to achieve widespread PCC, appropriate resource management is essential in a healthcare system. This brings us to PA, and we present an idealized view of PA in order to argue how at its best, it can contribute to the provision of PCC. PA is a means of cost saving and as such it has mixed success. The example of the US demonstrates how implementation of PA has increased health inequalities whereas best practice has the potential to reduce them. In contrast, systems of universal coverage, like those in Europe, may use the cost savings of PA to better address individuals' care and PCC. The conclusion we offer therefore is an optimistic one, pointing towards areas of supportive overlap between PCC and PA where usually the incongruities are most evident.

The impact of formulary restriction and preauthorization (FRPA) on prescribing trends was examined over a 5-year period at an academic medical center. Ordinary least squares regression was used to identify hospital units demonstrating statistically significant trends in prescription of restricted agents. Significant decreases in restricted drug use were seen on 2 of 7 medicine units subject to FRPA, whereas a significant increase was seen in 1 of 4 surgical units subject to FRPA.

Tissues from deceased donors provide important data for genomic research and Organ Procurement Organizations (OPOs) play a significant role. To understand the decisions of families who donated for transplantation and made decisions about donation to the Genotype-Tissue Expression Project (GTEx), we examined donation decisions of family decision makers (FDMs). 413 families were interviewed by telephone. The OPO staff who made the transplant and research requests completed self-administered surveys; a total of 309 matching surveys from 99 OPO staff were obtained. 76.8% of families donated to the GTEx project. Logistic regression analysis found that FDM consent to GTEx donation was associated with endorsement of policies to promote biobanking (OR = 1.35), positive attitudes about medical research (OR = 1.1), lack of concern regarding a breach of confidentiality (OR = 1.54), comfort with tissue donation (OR = 1.24), and prior authorization to solid organ donation (OR = 3.17). OPO staff characteristics associated with GTEx donation included being female (OR = 3.57), White (OR = 4.97), comfort with hospital staff role in donation (OR = 1.61), and number of topics discussed with families (OR = 57.9). Donor type, FDM attitudes, OPO staff sociodemographics, OPO comfort with the GTEx authorization process, and intensity of discussing research-specific issues were significantly associated with GTEx donation decisions.

Objective To quantify and explain variation in use of long-acting injectable antipsychotics (LAIs) in the United States, and understand the relationship between patient characteristics, drug reimbursement policies, and LAI prescribing after relapse. Methods A cohort of recently relapsed patients with schizophrenia ages 18 to 64, were identified immediately after discharge from a related inpatient hospitalization, partial hospitalization, or emergency room visit, drawn from 2004 to 2006 Medicaid claims, and followed for 90 days until LAI initiation. Data on state-level Medicaid prior authorization (PA) policies for LAIs were collected. Sequential longitudinal Poisson regression models were developed to understand the relationship between patient and PA policy variables and LAI prescribing, including prior adherence to oral antipsychotics, demographics, clinical variables, and presence of PA policy for LAI. Results Among 36 282 patients, 3.1% received risperidone LAI, and 3.8% received a first-generation (FGA) LAI with wide variation across states. Prior adherence ranged from 29% to 89% but was marginally associated with initiation and did not explain variation for LAI prescribing. FGA initiation was associated with geography and race/ethnicity but not PA policy. For risperidone LAI initiation, demographics and clinical factors explained, respectively, 5.0% and 3.0% of the variation; PA policy had a large negative association with initiation (RR = 0.41; 95%CI 0.20-0.87) and explained 8.4% of the variation. Conclusions PA policies may represent a major treatment barrier for risperidone LAI among relapsed patients. Non-adherence plays a little role in predicting which patients receive LAIs. Policy makers and health insurers will need to consider these findings when guiding the use of LAIs. KEY POINTS Among a nationwide cohort of relapsed schizophrenia patients enrolled in US Medicaid, 3.1% received Risperdal Consta, a long-acting injectable antipsychotic (LAI), and 3.8% initiated a first-generation first-generation LAI within 90 days after discharge. During 2004 to 2006, there was marked variation in 90 day post-relapse initiation of Risperdal-Consta-a newly marketed medication during this period-and also marked variation in 90 day post-relapse initiation of any first-generation LAI, which appeared to be associated with race/ethnicity and geography. Prior authorization policies were associated with substantially lower initiation of Risperdal Consta in this cohort of relapsed patients even after accounting for clinical indication (non-adherence), relapse history, demographics, adjunctive medication, and mental health service use.

6 Background: The past decade has seen a dramatic increase in the number of Food and Drug Administration approvals of oral anti-cancer drugs (OACDs). Most OACD prescriptions require coordination between payers and providers, which can delay drug receipt. In May 2021, two bills were introduced in the US House of Representatives (HR 3173 and HR 3258) to streamline the prior authorization (PA) process. In this study, we examined clinical and process-related factors associated with PA and time to drug receipt (TTR) for patients who received a new OACD prescription. Methods: We prospectively collected data on all new OACD prescriptions for adult oncology patients from 1/1/2018 to 12/31/2019. We collected patient demographic, medical, and insurance data, drug type (hormonal, chemotherapy, targeted), and specialty pharmacy interactions with payers and financial assistance groups, including PA information. TTR was defined as the number of days from OACD prescription to patient receipt of the drug. We used multivariable logistic regression to separately assess factors associated with TTR and factors associated with PA for patients who received a new OACD prescription. Results: The cohort for both models included 883 patients who were prescribed 1014 new OACDs. Of these prescriptions, 72.3% (N=733) required PA. The median age was 66 and 44% identified as White. The median TTR was 7 days (IQR 0 – 142; 25% ≥ 14 days; and 5% ≥ 30 days). In unadjusted analyses, PA was associated with insurance and drug type and delayed TTR was associated with PA and insurance type. In a multivariable analysis, patients with Medicaid insurance were more likely to require PA compared to patients with Medicare (OR 1.93 (1.14 – 3.32), p=0.03). In addition, patients prescribed targeted and hormone therapies were more likely to require PA than those prescribed oral chemotherapy (targeted: OR 3.33 [2.38 – 4.68], p

322 Background: Natural language processing (NLP) algorithms can be leveraged to better understand prevailing themes in healthcare conversations. Sentiment analysis, an NLP technique to analyze and interpret sentiments from text, has been validated on Twitter in tracking natural disasters and disease outbreaks. To establish its role in healthcare discourse, we sought to explore the feasibility and accuracy of sentiment analysis on Twitter posts (‘’tweets’’) related to prior authorizations (PAs), a common occurrence in oncology built to curb payer-concerns about costs of cancer care, but which can obstruct timely and appropriate care and increase administrative burden and clinician frustration. Methods: We identified tweets related to PAs between 03/09/2021-04/29/2021 using pre-specified keywords [e.g., #priorauth etc.] and used Twarc, a command-line tool and Python library for archiving Twitter JavaScript Object Notation data. We performed sentiment analysis using two NLP models: (1) TextBlob (trained on movie reviews); and (2) VADER (trained on social media). These models provide results as polarity, a score between 0-1, and a sentiment as ‘’positive’’ (>0), ‘’neutral’’ (exactly 0), or ‘’negative’’ (

100 Background: The coronavirus (COVID-19) pandemic transformed norms and approaches to delivering cancer care in the US throughout 2020. While initial reports in regional and single institution studies suggest postponement or modification of cancer treatments, limited evidence exists on the long-term national impact of COVID-19 on cancer treatment throughout the year. Methods: Using de-identified OptumLabs Data Warehouse data, which includes data from the Optum Cancer Guidance Program’s electronic prior authorization (ePA) platform, we compared monthly rates (per 100,000 person-months) of requests for authorization for insurance coverage of systemic cancer therapy in January-December 2020 (COVID) versus January-December 2019 (non-COVID). Results: We identified a total of 94,726 prior-authorization requests for chemotherapy in 2020 compared to 106,272 requests in 2019, indicating a 10.8% overall decline during the pandemic. Prior-authorization request rates were 6.3% higher in March 2020 as many stay-at-home orders were implemented across states (Table). Prior authorization requests then significantly declined in April and May 2020 (3.3% and 14.4% lower rates in 2020 vs. 2019) during the stay-at-home orders before briefly increasing again in June. As COVID-19 infections and deaths increased throughout the fall, requests for prior-authorization significantly declined in each month from August through December 2020. Conclusions: The COVID-19 pandemic led to significant overall declines in requests for prior authorizations for chemotherapy in 2020 versus 2019. While requests rebounded somewhat in early spring and summer of 2020, rates were markedly lower, relative to those in 2019, during COVID-19’s second wave. Overall, these results suggest continued modifications or delays in cancer treatment that may result in worse outcomes for individuals with cancer in 2020 and should be evaluated in future studies. [Table: see text]

O presente trabalho tem por objetivo analisar o julgamento do Agravo Regimental no Recurso Extraordinário com Agravo nº 1.165.456/SE pelo Supremo Tribunal Federal, que declarou incompatível com a Constituição Federal a autorização prévia do Chefe do Poder Executivo para o ajuizamento, por parte da Advocacia Pública, de ação de improbidade administrativa. Serão analisados os efeitos decorrentes dessa decisão em face da autonomia técnica e independência da Advocacia pública, bem como isso resulta em ampliação do campo de controle de legalidade dos atos estatais e fortalece institucionalmente a própria Advocacia Pública.

Background Multi-disciplinary engagement and education remain key measures for Antimicrobial Stewardship Programs (ASPs). Over 3 years, our ASP has undergone key changes to pre-authorization review, post-prescriptive activities, and core team members, coinciding with a 30% increase in stewardship interventions. The objectives of this study were to evaluate the familiarity of Nursing, Pharmacy and Prescribers at our academic medical center regarding ASP activities and services, as well as perceived impact on patient care and value. Secondary objectives were to determine what resources are currently utilized and areas for improvement. Methods Distinct surveys were distributed to three participant groups: Nurses, Pharmacists, and Prescribers (Housestaff, Advanced Practice Providers, and staff physicians). Questions were developed to assess familiarity, perceived value, and overall satisfaction with the ASP. Additional items included questions on the current use of ASP resources and educational engagement. Survey results were compared to a similar survey conducted 3 years amongst the same participant groups. Results The survey was delivered electronically to 3367 Prescribers, Nurses and Pharmacists. 403 responders completed the survey (208 Nurses, 181 Prescribers, and 18 Pharmacists). Familiarity was lowest amongst Nurses, but almost doubled compared to 2016 (Figure). Prescribers cited “restricted antibiotic approval”, “de-escalation”, and “alternative therapies relative to allergies” as the three most common interaction types, similar to 2016. ASP interactions continued to be rated “moderate” or “high” value (88.4% vs 89.15% in 2016), however, face-to-face interactions were preferred by only 4% of responders (unchanged compared to 2016). Prescribers also responded uncommon use of ASP online resources (20%) and clinical decision support tools (34%). 78% of responders expressed desire for increased ASP-related education. Conclusion As ASPs evolve, it is important to constantly evaluate impact and value, and identify areas for growth. Despite ASP familiarity being high and interactions valued, we need to further optimize ASP provided resources, clinical support tools, and educational offerings. Disclosures All Authors: No reported disclosures

Background Antimicrobial stewardship program (ASP) interventions have been reported to reduce unnecessary antimicrobial use (AMU). In this study, we investigated the difference in the use of carbapenems by ASP intervention in Japanese healthcare facilities. Methods Data on two components of AMU and ASP registered in Japan Surveillance for Infection Prevention and Healthcare Epidemiology (J-SIPHE) from January to December 2019, were used. Facilities with an infection control team in addition to an antimicrobial stewardship team responsible for the proper use of antimicrobial agents were included in the study. AMU data (such as DOT [Days of Therapy / 100 patient days]) are entered semi-automatically from medical fee statement (receipt) file at each facility. ASP intervention is divided into four categories 1) pre-authorization, 2) prospective audit and feedback (PAF), 3) PAF and required notification (RN), 4) RN. The Kruskal-Wallis test is performed to see overall difference and the Dunn test with the Bonferroni correction is done for each pair of categories. Results A total of 114 hospitals were included in the analysis. The median number of beds at participating facilities were 430 [IQR: 281–602], the median average hospital stay was 13.0 days [IQR: 11.4–15.2] and total number of inpatients per month was 10087 [6247–14536]. PAF and RN were the most common ASP interventions for carbapenems (62.5%), followed by RN (33.6%). The median DOT [IQR] of participating facilities were 2.1 [1.2–3.1] and 1) 0.7 [0.2–1.1], 2) 2.7 [2.1–3.4], 3) 2.1 [1.4–3.1] and 4) 2.0 [1.2–3.5] by ASP categories. There are significant differences between 1) and 2), 1) and 3), and 1) and 4) (p=0.014, p< 0.01 and p< 0.01, respectively) while the differences between 2) and 3), 2) and 4), and 3) and 4) are not significant (p=1.00). Table 1. Summary statistics of healthcare facilities by ASP Interventions Figure 1. DOT by ASP Interventions Conclusion Only 3.5% of ASP interventions belong to 1) pre-authorization category and this might be due to the complexity of registration process. This category was found to have the lowest DOT among all ASP interventions in Japanese healthcare facilities. The variances of DOT were especially large in categories 3) and 4), and more detailed analyses would be necessary to evaluate their efficacies accurately. Disclosures All Authors: No reported disclosures