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.

Anticholinergics have been used in the treatment of overactive bladder (OAB), but their use is limited by poor tolerability and anticholinergic-related side effects. Increasingly, providers are discontinuing anticholinergic prescribing because of growing evidence of the association of anticholinergic use with increased risk of cognitive decline and other adverse effects. Newer medications for OAB, the β3-adrenergic receptor agonists mirabegron and vibegron, do not have anticholinergic properties and are typically well tolerated; however, many insurance plans have limited patient access to these newer OAB medications by requiring step therapy, meaning less expensive anticholinergic medications must be trialed and/or failed before a β3-agonist will be covered and dispensed. Thus, many patients are unable to easily access these medications. Step therapy and other drug utilization strategies (e.g., prior authorization) are often used to manage the growing costs of pharmaceuticals, but these policies do not always follow treatment guidelines and may harm patients as a result of treatment delays, discontinuations, or related increases in adverse events. Medical professionals have called for reform of drug utilization strategies through partnerships that include clinicians and policymakers. This narrative review discusses prescribing patterns for OAB treatment and the effect of switching between drugs, as well as the costs of step therapy and prior authorization on patients and prescribers.

BACKGROUND: Specialty drugs are identified by high monthly costs and complexity of administration. Payers use utilization management strategies, including prior authorization and separate tiers with higher cost sharing, to control spending. These strategies can negatively impact patients\' health outcomes through treatment initiation delays, medication abandonment, and nonadherence. OBJECTIVE: To examine the effect of patient cost sharing on specialty drug utilization and the effect of prior authorization on treatment delay and specialty drug utilization. METHODS: We conducted a literature search in the period between February 2021 and April 2022 using PubMed for articles published in English without restriction on date of publication. We included research papers with prior authorization and cost sharing for specialty drugs as exposure variables and specialty drug utilization as the outcome variable. Studies were reviewed by 2 independent reviewers and relevant information from eligible studies was extracted using a standardized form and approved by 2 reviewers. Review papers, opinion pieces, and projects without data were excluded. RESULTS: Forty-four studies were included in this review after screening and exclusions, 9 on prior authorization and 35 on cost sharing. Patients with lower cost sharing via patient support programs experienced higher adherence, fewer days to fill prescriptions, and lower discontinuation rates. Similar outcomes were noted for patients on low-income subsidy programs. Increasing cost sharing above $100 was associated with up to 75% abandonment rate for certain specialty drugs. This increased level of cost sharing was also associated with higher discontinuation rates and odds. At the same time, decreasing out-of-pocket costs increased initiation of specialty drugs. However, inconsistent results on impact of cost sharing on medication possession ratio (MPR) and proportion of days covered (PDC) were reported. Some studies reported a negative association between higher costs and MPR and PDC; however, MPR and PDC of cancer specialty drugs did not decrease with higher costs. Significant delays in prescription initiation were reported when prior authorization was needed. CONCLUSIONS: Higher levels of patient cost sharing reduce specialty drug use by increasing medication abandonment while generally decreasing initiation and persistence. Similarly, programs that reduce patient cost sharing increase initiation and persistence. In contrast, cost sharing had an inconsistent and bidirectional effect on MPR and PDC. Prior authorization caused treatment delays, but its effects on specialty drug use varied. More research is needed to examine the effect of cost sharing and prior authorization on long-term health outcomes.

A common denial trend that occurs with \"outpatient medical benefit drugs\" (ie, medications covered by a medical benefit plan and administered in an outpatient visit) is payers not requiring or permitting prior authorization (PA) proactively, yet denying the drug after administration for medical necessity. In this situation, a preemptive strategy of complying with payer-mandated requirements is critical for revenue protection. To address this need, our institution incorporated a medical necessity review into its existing closed-loop, pharmacy-managed precertification and denials management program.
Referrals for targeted payers and high-cost medical benefit drugs not eligible for PA and deemed high risk for denial were incorporated into the review. Payer medical policies were evaluated and clinical documentation assessed to confirm alignment. This descriptive report outlines the medical necessity workflow as a component of the larger precertification process, details the decision-making process when performing the review, and delineates the roles and responsibilities for involved team members. A total of 526 drug orders were evaluated from September 2018 to August 2019, with 146 interventions completed. Of the 761 individual claims affected by proactive medical necessity review, 99.2% resulted in payment and less than 1% resulted in revenue loss, safeguarding more than $5.3 million in annual institutional drug reimbursement. At the time of analysis, there were only 3 cases of revenue loss.
Our institution\'s pharmacy-managed medical necessity review program for high-cost outpatient drugs safeguards reimbursement for therapies not eligible for payer PA. It is a revenue cycle best practice that can be replicated at other institutions.

Alopecia areata (AA) is a psychologically distressing disorder for which few reliable treatments exist. Although oral tofacitinib has demonstrated efficacy in treating AA, it is not approved by the Food and Drug Administration (FDA) for this indication. To investigate and identify the challenges associated with securing insurance approval for oral tofacitinib for AA. We conducted a retrospective review of patient records from two academic medical centers to identify patients with AA in whom insurance approval was sought for oral tofacitinib from 2015-2019. We recorded information on prior authorization (PA) submissions, appeals, and peer-to-peer reviews. We noted whether patients were documented to experience negative impact on mood/QOL or suicidal ideation (SI) due to their disease. We identified 37 patients in whom insurance approval was sought for oral tofacitinib for the treatment of AA. PAs were initially denied for 36/37 (97%) patients. The most commonly cited reason for denial was \"tofacitinib not covered for AA/off-label medication use\" (n = 26/36; 72%). 26/37 (70%) patients ultimately failed to obtain coverage. Of the 11 (30%) patients who obtained coverage, 10 (91%) were privately insured, 0 (0%) had Medicare and 1 (9%) had Medicaid. 13 patients (34%) experienced documented diminished QOL/mood (including SI) due to their disease burden; 6/13 (46%) of these patients eventually secured insurance approval. Lack of FDA approval of oral tofacitinib for the treatment of AA creates challenges in caring for patients with this disease. Policymakers should consider the negative implications lack of FDA approval may have for patients with recalcitrant dermatologic conditions.

Rapid growth of antipsychotic use among children and adolescents at the turn of the 21st century led Medicaid programs to implement 3 types of system-wide interventions: antipsychotic monitoring programs, clinician prescribing supports, and delivery system enhancements. This systematic review assessed the available evidence base for and relative merits of these system-wide interventions that aim to improve antipsychotic treatment and management.
Using PRISMA guidelines, eligible studies were written in English and evaluated system-wide interventions to monitor antipsychotic treatment or promote antipsychotic management among children and adolescents (0-21 years of age). Studies were identified through Ovid MEDLINE and PsychInfo (years 1990-2018) and an environmental scan. From an initial review of 824 publications, 17 studies met eligibility criteria. Two authors independently conducted quality assessments using the Crowe Critical Appraisal Tool. Findings were summarized descriptively.
Identified studies (n = 17) evaluated prior authorization programs (n = 10), drug utilization reviews (n = 2), quality improvement (n = 4), care coordination programs (n = 1), and multimodal initiatives (n = 2). Studies were predominantly pre-post analyses, without a comparison group. With the exception of care coordination and drug utilization reviews, more than half of the interventions in each category were associated with significant reduction in antipsychotic treatment or promotion of best practice parameters.
This evidence review concludes that evaluations of prior authorization programs demonstrate reductions in antipsychotic treatment, though evidence of impact of other system-wide interventions and other outcomes is limited. Additional research is necessary to investigate whether interventions influenced antipsychotic prescribing independent of secular trends, the comparative effectiveness and cost-effectiveness of interventions, the effect on functional outcomes, and the potential for unintended consequences.

Prior authorization of prescription medications is a policy tool that can potentially impact care quality and patient safety.
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.
Medicaid Analytical eXtracts (MAX) with administrative claims for health services provided between January 2006 and December 2011.
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.
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.
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.

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BACKGROUND: Dermatology experiences a disproportionately high burden of prior authorizations (PAs).
OBJECTIVE: To examine the effect of a centralized pharmacy intervention on the PA process and the impact of PAs on patient outcomes.
METHODS: A retrospective review of PAs submitted for medications before and after implementation of pharmacy intervention was conducted.
RESULTS: PA was required for 8.1% of all prescriptions. PAs were most frequently submitted for topical steroids, topical antibiotics and antifungals, and topical retinoids. Most common indications included acne, psoriasis, and dermatitis. Biologic agents (55.2%) and brand-name only medications (42.8%) required PA at higher rates. Pharmacy intervention resulted in shorter time to PA submission (4 days vs 1 day, P < .001) and decision (6 days vs 1 day, P < .001) and higher approval rates (63.9% vs 80.6%, P < .001) but did not decrease the total number of PAs. Patients with approved PAs had higher likelihood of disease improvement vs those with denied PAs (71.1% vs 58.0%, P = .013).
CONCLUSIONS: Data were collected from a single academic institution. Patient medication compliance was not assessed.
CONCLUSIONS: The current PA process may result in delays in care and a negative impact on patients. A centralized pharmacy intervention is an effective measure but does not eliminate the overall burden of PAs.

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.