Improving Prior Authorization in Medicare Advantage.

This Viewpoint discusses the potential benefits and harms of prior authorization in Medicare Advantage and the health policy implications and opportunities for improvement.

Patient Participation in Clinical Trials of Oncology Drugs and Biologics Preceding Approval by the US Food and Drug Administration.

Importance: Several studies have estimated the financial inputs for successful drug development. Such analyses do not capture the large investment that patient study participants commit to drug development. Objective: To estimate the volume of patients required to achieve a first US Food and Drug Administration (FDA) approval for a new anticancer drug or biologic therapy. Design, Setting, and Participants: This cohort study included a random sample of prelicense oncology drugs and biologics with a trial site in the United States that were launched into clinical efficacy testing between January 1, 2006, and December 31, 2010. Drugs and biologics were identified using ClinicalTrials.gov registration records. Total patient enrollment was captured over an 8-year span, and each intervention was classified based on whether it received FDA approval and was deemed as having intermediate or substantial value according to the American Society of Clinical Oncology Value Framework (ASCO-VF) score. Secondarily, the association between patient numbers and intervention characteristics was tested. Data were analyzed in February 2020. Main Outcomes and Measure: The prespecified primary outcome was the number of patients enrolled in prelicense trials per FDA approval. Results: A total of 120 drugs and biologics were included in our study, with 84 (70.0%) targeted agents, 20 (16.7%) immunotherapies, and 71 (59.2%) novel agents. A total of 13 drugs and biologics (10.8%; 95% CI, 5.3%-16.8%) in our sample gained FDA approval within 8 years, of which 1 (7.7%) was deemed of intermediate value and 3 (23.1%) were deemed of substantial value using ASCO-VF scoring. Overall, 158 810 patients were enrolled in 1335 trials testing these drugs and biologics, 47 913 (30.2%) in trials that led to FDA approval and 110 897 (69.8%) in trials that did not. An estimated 12 217 (95% CI, 7970-22 215) patient study participants contributed to prelicense trials per FDA approval. The estimated number of patients needed to produce a single FDA-approved drug or biologic of intermediate or substantial ASCO-VF clinical value was 39 703 (95% CI, 19 391-177 991). Conclusions and Relevance: The results of this cohort study make visible the substantial patient investment required for prelicense oncology drug development. Such analyses can be used to devise policies that maximize the clinical impact of research on a per-patient basis.

BREAST-Q Outcomes before and after Bilateral Reduction Mammaplasty.

BACKGROUND: The BREAST-Q is the only questionnaire specific to bilateral breast reduction that was developed according to federal and international standards. Many payors mandate minimum resection weights for preapproval, despite lacking supportive evidence for this practice. This study aimed to assess changes in BREAST-Q scores after bilateral breast reduction, and determine whether compliance with Schnur requirements impacts improvement in patient-reported outcomes. METHODS: Patients presenting for bilateral breast reduction from 2011 to 2017 were asked to complete the BREAST-Q preoperatively and postoperatively. Multivariate regression analysis was performed to isolate factors associated with favorable outcomes. RESULTS: Complete data were available for 238 patients. Mean time to postoperative BREAST-Q was 213 days. Complications occurred in 31 patients (13.0 percent). Mean preoperative BREAST-Q scores were below normative values (p < 0.001), and mean postoperative scores were above normative values (p < 0.001 for Satisfaction with Breasts, Psychosocial Well-being, and Sexual Well-being; and p = 0.05 for Physical Well-being). Postoperative Physical Well-being scores were similar to normative values for resections less than Schnur (p = 0.32), but below norms for resections greater than Schnur (p < 0.0001). On multivariate regression (n = 230), complication and surgeon experience were the only independent predictors of lesser improvement on the Satisfaction with Breasts subscale. CONCLUSIONS: This study is the largest to include both preoperative and postoperative bilateral breast reduction BREAST-Q scores, and to compare multiple subscales to normative data. Scores overwhelmingly increased, regardless of age or Schnur compliance. Complications negatively impacted degree of BREAST-Q improvement. Interestingly, postoperative Physical Well-being was slightly higher in women with non-Schnur-compliant resections. Bilateral breast reduction substantially improves patient welfare, and our data question the validity of insurer-mandated minimum resections. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, III.

Association of Infectious Disease Physician Approval of Peripherally Inserted Central Catheter With Appropriateness and Complications.

Importance: Peripherally inserted central catheters (PICCs) are frequently used to deliver intravenous antimicrobial therapy. However, inappropriate PICC use may lead to patient harm. Objective: To evaluate whether infectious disease physician approval prior to PICC placement for intravenous antimicrobials is associated with more appropriate device use and fewer complications. Design, Setting, and Participants: This cohort study of 21 653 PICCs placed for a primary indication of intravenous antimicrobial therapy between January 1, 2015, and July 26, 2019, was conducted in 42 hospitals participating in a quality collaborative across Michigan among hospitalized medical patients. Main Outcomes and Measures: Appropriateness of PICCs was defined according to the Michigan Appropriateness Guide for Intravenous Catheters as a composite measure of (1) single-lumen catheter use, (2) avoiding use of PICCs for 5 days or less, and (3) avoiding use of PICCs for patients with chronic kidney disease (defined as an estimated glomerular filtration rate <45 mL/min/1.73 m2). Complications related to PICCs included catheter occlusion, deep vein thrombosis, and central line-associated bloodstream infection. The association between infectious disease physician approval, device appropriateness, and catheter complications was assessed using multivariable models, adjusted for patient comorbidities and hospital clustering. Results were expressed as odds ratios with 95% CIs. Results: A total of 21 653 PICCs were placed for intravenous antimicrobials (11 960 PICCs were placed in men [55.2%]; median age, 64.5 years [interquartile range, 53.4-75.4 years]); 10 238 PICCs (47.3%) were approved by an infectious disease physician prior to placement. Compared with PICCs with no documented approval, PICCs with approval by an infectious disease physician were more likely to be appropriately used (72.7% [7446 of 10 238] appropriate with approval vs 45.4% [5180 of 11 415] appropriate without approval; odds ratio, 3.53; 95% CI, 3.29-3.79; P < .001). Furthermore, approval was associated with lower odds of a PICC-related complication (6.5% [665 of 10 238] with approval vs 11.3% [1292 of 11 415] without approval; odds ratio, 0.55; 95% CI, 0.50-0.61). Conclusions and Relevance: This cohort study suggests that, when PICCs were placed for intravenous antimicrobial therapy, infectious disease physician approval of PICC insertion was associated with more appropriate device use and fewer complications. Policies aimed at ensuring infectious disease physician approval prior to PICC placement for antimicrobials may improve patient safety.

Effectiveness of mandatory peer review to reduce antipsychotic prescriptions for Medicaid-insured children.

BACKGROUND: Prior authorization of prescription medications is a policy tool that can potentially impact care quality and patient safety. OBJECTIVE: To examine the effectiveness of a mandatory peer-review program in reducing antipsychotic prescriptions among Medicaid-insured children, accounting for secular trends that affected antipsychotic prescribing nationally. DATA SOURCE: Medicaid Analytical eXtracts (MAX) with administrative claims for health services provided between January 2006 and December 2011. STUDY DESIGN: This retrospective, observational study examined prescription claims records from Washington State (Washington) and compared them to a synthetic control drawing from 20 potential donor states that had not implemented any antipsychotic prior authorization program or mandatory peer review for Medicaid-insured children during the study period. This method provided a means to control for secular trends by simulating the antipsychotic use trajectory that the program state would have been expected to experience in the absence of the policy implementation. PRINCIPAL FINDINGS: Before the policy implementation, antipsychotic use prevalence closely tracked those of the synthetic control (6.17 per 1000 in Washington vs. 6.21 in the synthetic control group). Within two years after the policy was implemented, prevalence decreased to 4.04 in Washington and remained stable in the synthetic control group (6.47), corresponding to an approximately 38% decline. CONCLUSION: Prior authorization program designs and implementations vary widely. This mandatory peer-review program, with an authorization window and two-stage rollout, was effective in moving population level statistics toward safe and judicious use of antipsychotic medications in children.

Benefits of Prior Authorizations.

DISCLOSURES: No funding supported the writing of this article. The author has nothing to disclose.

Prior Authorization Policies and Preferred Drug Lists in Medicaid Plans: Stakeholder Perspectives on the Implications for Youth with ADHD.

This qualitative study describes how Medicaid policies create challenges for the delivery and receipt of mental health treatment for low-income youth in Georgia. We conducted focus groups with caregivers of Medicaid-enrolled children with ADHD and semi-structured interviews with providers and administrators at four safety net clinics that provided mental health care to these youth. Stakeholders reported that prior authorization policies for psychosocial services, restrictiveness of preferred drug lists, and changes in preferred drug lists in Medicaid plans created barriers to treatment continuity and quality for youth with ADHD and led to more administrative burden for safety-net clinics serving these youth.

Clinical Necessity Guidelines for Psychotherapy, Insurance Medical Necessity and Utilization Review Protocols, and Mental Health Parity.

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.

Clinical and Insurance Perspectives on Intermediate Levels of Care in Psychiatry.

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.

Prior Authorization as a Potential Support of Patient-Centered 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.