The Medicare Advantage (MA) Program, home to nearly half of the eligible Medicare population, has recently come under increased scrutiny. Recent investigations conducted by the United States Senate Committee on Finance and Centers for Medicare & Medicaid Services (CMS) have uncovered marketing practices of MA insurance agents that \"were not complying with current regulation and unduly pressuring beneficiaries, as well as failing to provide accurate or enough information to assist a beneficiary in making an informed enrollment decision.\" These findings come at a time in which MA programs are under investigation for denials of prior authorization requests that fall within Medicare guidelines for covered health services. In this Commentary we consider the backdrop for the growing scrutiny of the MA program and the implications thereof to its future trajectory.

Little is known about the extent of prior authorization requirements in otolaryngology. We performed a secondary analysis of data comparing prior authorization (PA) policies across 5 major Medicare Advantage insurers to estimate the counterfactual proportion of 2021 Medicare Part B fee-for-service spending and utilization for commonly performed otolaryngologic procedures that would have required PA. The counterfactual proportion of spending (range: 20.4%-27.6%) and utilization (range: 1.8%-4.5%) requiring PA was relatively consistent across insurers and largely attributable to rhinologic procedures. However, PA requirements for specific services varied widely among insurers. Among the 70 (of 196; 35.7%) services subject to PA by any insurer, nearly half were subject to PA by a single insurer (n = 34; 48.6%). Only 10 (14.3%) services were subject to PA by 4 (n = 6; 8.6%) or 5 (n = 4; 5.7%) insurers. These discrepancies illustrate the challenges of navigating discordant insurer policies for otolaryngologists and raise concerns about the validity of certain PA requirements.

UNASSIGNED: In the United States (US), prescription drug coverage is subject to prior authorization (PA) criteria, which may vary between health plans and may exceed drug label requirements. This study aimed to characterize profiles and treatment history of patients with treatment-resistant depression (TRD) who initiated esketamine nasal spray, by stringency of their health plans\' PA criteria relative to the esketamine label.
UNASSIGNED: Adults with evidence of TRD (≥2 antidepressant courses of adequate dose and duration) prior to initiating esketamine were identified using US insurance claims data (03/2016-02/2022). Based on health plan PA criteria for esketamine obtained from Managed Markets Insight & Technology data (05/2020-02/2022), patients were grouped into stringent (PA criteria exceeds label) and non-stringent (PA criteria less stringent or equal to label) cohorts. Patient treatment history before esketamine initiation was compared using Wilcoxon rank sum and Fisher\'s exact tests.
UNASSIGNED: The stringent cohort included 168 patients (mean age: 45 years, 63% female) and the non-stringent cohort included 400 patients (mean age: 45 years, 70% female). During the ongoing major depressive episode before esketamine initiation, the stringent versus non-stringent cohort completed 3.9 versus 3.8 antidepressant treatment courses, on average (p = 0.217); 94.6% versus 96.8% used augmentation therapy (p = 0.240), including 59.3% versus 58.1% with an antipsychotic (p = 0.844), respectively.
UNASSIGNED: Regardless of health plan stringency, on average, patients exceeded US label-mandated number of antidepressant trials before esketamine initiation, which questions the need for health insurance plans PA criteria above label.

Managed care plans, which contract with states to cover three-quarters of Medicaid enrollees, play a crucial role in addressing the drug epidemic in the United States. However, substance use disorder benefits vary across Medicaid managed care plans, and it is unclear what role states play in regulating their activities. To address this question, we surveyed thirty-three states and Washington, D.C., regarding their substance use disorder treatment coverage and utilization management requirements for Medicaid managed care plans in 2021. Most states mandated coverage of common forms of substance use disorder treatment and prohibited annual maximums and enrollee cost sharing in managed care. Fewer than one-third of states forbade managed care plans from imposing prior authorization for each treatment service. For most treatment medications, fewer than two-thirds of states prohibited prior authorization, drug testing, \"fail first,\" or psychosocial therapy requirements in managed care. Our findings suggest that many states give managed care plans broad discretion to impose requirements on covered substance use disorder treatments, which may affect access to lifesaving care.

UNASSIGNED: Anti-vascular endothelial growth factor (VEGF) intravitreal injections, a mainstay of treatment for many retinal diseases to optimize visual outcomes, have been included in prior authorization (PA) initiatives. However, if clinicians are extremely accurate in their use of anti-VEGF medications, such administrative burdens may need reconsideration.
UNASSIGNED: To quantify PA for anti-VEGF medications (aflibercept, ranibizumab, and bevacizumab) that were approved and determine associated administrative burdens experienced by retina practices.
UNASSIGNED: Prospective multicenter quality improvement study conducted from January 2022 through June 2022, and participants were 9 private retina practices across the US.
UNASSIGNED: Overall rate of approval of PA requests, reasons for requesting PA, and overall rate of delay of care resulting from PA procedures.
UNASSIGNED: In total, 2365 PA requests were recorded, 2225 of which met inclusion criteria. Overall, 2140 (96.2%) requests were approved. The most common reason for requesting PA, at 64% (1423 of 2225 requests), was reauthorization for a previously utilized medication. Of the 2140 approvals, 59.6% (1277) resulted in a delay in care greater than 24 hours, and 40% (863) were given on the date of service. In a granular analysis of a subset of delayed approvals, 23.9% (173 of 725) were approved within 1 day, 15.9% (115 of 725) were approved within 2 to 3 days, 21.5% (156 of 725) were approved within 4 to 7 days, 26.3% (191 of 725) were approved within 8 to 31 days, and 12.4% (90 of 725) were approved within more than 31 days. Overall, PA denial for step therapy was 2.9% (65 of 2225) of requests and uncovered diagnoses was 0.9% (20 of 2225) of requests. The median staff time spent to obtain a single PA was 100 (range, 0-200) minutes.
UNASSIGNED: In this study, PA requests were almost always approved but led to a delay in patient care in most patients. The current study suggests that the PA process may not be effective for retina specialists if these results can be generalized to other practices in the US and if less burdensome and less costly approaches could result in similar approval rates. Potential short-term solutions may include eliminating the PA process for bevacizumab and reauthorizations for established patients.

BACKGROUND: Despite advances in atopic dermatitis (AD) treatments, many patients face challenges obtaining medications. This study aimed to determine the frequency and causes of insurance coverage delays and denials for AD prescriptions and characterize the associated wait times and extent to which patients understand what to do when faced with a coverage issue.
METHODS: This was a cross-sectional, observational study in which adult U.S. residents (aged 18+ years) with AD or caregivers of pediatric U.S. patients with AD (aged 0-17 years) completed an online survey (3 June-16 July 2021).
RESULTS: Respondents (N = 978) were primarily adults with AD (81.8%), female (67.7%), and white (70.2%). There were 645 insurance delays or denials for AD prescriptions, with 48.1% (470/978) of respondents experiencing at least one delay/denial in the past year. Most delays/denials were for topical steroids (39.2%, 253/645), the most highly used prescription treatment class (83.9%, 821/978). However, the highest rate of delay/denials was for biologics, of which 43.6% (109/250) of all prescriptions faced a delay or denial. Denials were caused primarily by step therapy (27.6%) and delays by prior authorization (55.1%). Only 56.0% of respondents said they would know what to do if they faced an issue with AD prescription coverage.
CONCLUSIONS: Patients with AD frequently experience insurance-related barriers to obtaining recommended therapies, and many do not know how to respond when these barriers arise. Strategies to improve timely therapeutic access are needed.

This Viewpoint discusses the provisions and potential of the new Centers for Medicare and Medicaid Services (CMS) Interoperability and Prior Authorization Final Rule.

The Prior Authorization Task Force of the American Academy of Allergy, Asthma & Immunology (AAAAI), a presidential initiative of David Khan, MD, FAAAI, was established to develop an AAAAI position statement outlining ways to improve health care for our patients, to support legislation that advocates for prior authorization (PA) reform and identify the impact PA has on its membership using a questionnaire survey. This article describes the results of this survey. An electronic anonymous survey questionnaire was developed to assess the impact and burden of PA on AAAAI members and their staff and patients. Surveys were sent to randomly selected members and fellows of the AAAAI in the United States. Descriptive statistics were used to analyze the results by the Information Services team of the AAAAI and the authors of this work group report. The questionnaire responses from allergy immunology specialists demographically reflected the AAAAI membership and indicate that PAs can significantly affect patient care delivery and increase administrative burden to clinical practices, leading to serious adverse events in some circumstances. Differential responses regarding PAs for various medication classes likely reflect the physician\'s patient population, which can shift prescribing patterns. Prior authorization is a serious health care problem that is wasting financial resources and needlessly placing patients in danger when they are unable to access medications or medical services required for clinical management. The results of this questionnaire study support the recommendations made in the recent AAAAI position statement on PA.

US health care administrative spending is approximately $1 trillion annually. A major operational area is the financial transactions ecosystem, which has approximately $200 billion in spending annually. Efficient financial transactions ecosystems from other industries and countries exhibit 2 features: immediate payment assurance and high use of automation throughout the process. The current system has an average transaction cost of $12 to $19 per claim across private payers and providers for more than 9 billion claims per year; each claim on average takes 4 to 6 weeks to process and pay. For simple claims, the transaction cost is $7 to $10 across private payers and providers; for complex claims, $35 to $40. Prior authorization on approximately 5000 codes has an average cost of $40 to $50 per submission for private payers and $20 to $30 for providers. Interventions aligned with a more efficient financial transactions ecosystem could reduce spending by $40 billion to $60 billion; approximately half is at the organizational level (scaling interventions being implemented by leading private payers and providers) and half at the industry level (adopting a centralized automated claims clearinghouse, standardizing medical policies for a subset of prior authorizations, and standardizing physician licensure for a national provider directory).

BACKGROUND: Long-acting injectable buprenorphine (LAI-bup) formulations have advantages over transmucosal buprenorphine (TM-bup), but barriers may limit their utilization. Several policies shifted during the COVID-19 pandemic to promote buprenorphine access. The federal government expanded telemedicine treatment for opioid use disorder and Kentucky (KY) Medicaid lifted prior authorization requirements (PAs) for LAI-bup (i.e., Sublocade®). This retrospective cohort study evaluated changes in LAI-bup access, utilization, and retention before and after these policy changes in KY.
METHODS: Individual-level TM-bup and LAI-bup dispensing record data from KY\'s prescription drug monitoring program examined LAI-bup utilization and retention, without a >30-day gap in coverage, for patients starting a new episode of LAI-bup treatment. Two key time periods were examined: pre-policy changes (Apr 1, 2019 - Dec 31, 2019) and post-policy changes (Apr 1, 2020 - Dec 31, 2020). Data on PA requests among Medicaid managed care organizations and availability of LAI-bup Risk Evaluation and Mitigation Strategy (REMS)-certified pharmacies were also obtained. A multivariable Cox proportional hazard regression model analysis compared pre- versus post-policy period treatment discontinuation.
RESULTS: The number of patients initiating LAI-bup increased from 211 to 481 over the two periods. By the end of the post-policy period, 24.3 % of eligible patients were retained on LAI-bup, versus 12.5 % in the pre-policy change period. The adjusted hazard ratio, comparing discontinuation during the post- versus pre-policy change periods, was 0.70 (95 % confidence interval: 0.55-0.89). There were also more REMS-certified pharmacies and providers in the post-policy change period.
CONCLUSIONS: LAI-bup access, utilization, and retention increased after several policy changes.