Patient administrative burden in the US health care system.

OBJECTIVE: To assess the prevalence of patient administrative tasks and whether they are associated with delayed and/or foregone care. DATA SOURCE: March 2019 Health Reform Monitoring Survey. STUDY DESIGN: We assess the prevalence of five common patient administrative tasks-scheduling, obtaining information, prior authorizations, resolving billing issues, and resolving premium problems-and associated administrative burden, defined as delayed and/or foregone care. Using multivariate logistic models, we examined the association of demographic characteristics with odds of doing tasks and experiencing burdens. Our outcome variables were five common types of administrative tasks as well as composite measures of any task, any delayed care, any foregone care, and any burden (combined delayed/foregone), respectively. DATA COLLECTION: We developed and administered survey questions to a nationally representative sample of insured, nonelderly adults (n = 4155). PRINCIPAL FINDINGS: The survey completion rate was 62%. Seventy-three percent of respondents reported performing at least one administrative task in the past year. About one in three task-doers, or 24.4% of respondents overall, reported delayed or foregone care due to an administrative task: Adjusted for demographics, disability status had the strongest association with administrative tasks (adjusted odds ratio [OR] 2.91, p < 0.001) and burden (adjusted OR 1.66, p < 0.001). Being a woman was associated with doing administrative tasks (adjusted OR 2.19, p < 0.001). Being a college graduate was associated with performing an administrative task (adjusted OR 2.79, p < 0.001), while higher income was associated with fewer subsequent burdens (adjusted OR 0.55, p < 0.01). CONCLUSIONS: Patients frequently do administrative tasks that can create burdens resulting in delayed/foregone care. The prevalence of delayed/foregone care due to administrative tasks is comparable to similar estimates of cost-related barriers to care. Demographic disparities in burden warrant further attention. Enhancing measurement of patient administrative work and associated burdens may identify opportunities for assessing quality, value, and patient experience.

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.

Administrative Burden and Costs of Prior Authorizations in a Dermatology Department.

Importance: Insurance companies use prior authorizations (PAs) to address inappropriate prescribing or unnecessary variations in care, most often for expensive medications. Prior authorizations negatively affect patient care and add costs and administrative burden to dermatology offices. Objective: To quantify the administrative burden and costs of dermatology PAs. Design, Setting, and Participants: The University of Utah Department of Dermatology employs 2 full-time and 8 part-time PA staff. In this cross-sectional study at a large academic department spanning 11 clinical locations, these staff itemized all PA-related encounters over a 30-day period in September 2016. Staff salary and benefits were publicly available. Data were analyzed between December 2018 and August 2019. Main Outcomes and Measures: Proportion of visits requiring PAs, median administrative time to finalize a PA (either approval or denial after appeal), and median cost per PA type. Results: In September 2016, 626 PAs were generated from 9512 patient encounters. Staff spent 169.7 hours directly handling PAs, costing a median of $6.72 per PA. Biologic PAs cost a median of $15.80 each and took as long as 31 business days to complete. The costliest PA equaled 106% of the associated visit's Medicare reimbursement rate. Approval rates were 99.6% for procedures, 78.9% for biologics, and 58.2% for other medications. After appeal, 5 of 23 (21.7%) previously denied PAs were subsequently approved. Conclusions and Relevance: Prior authorizations are costly to dermatology practices and their value appears limited for some requests. Fewer unnecessary PAs and appeals might increase practice efficiency and improve patient outcomes.

A Survey of American Psychiatrists Concerning Medication Prior Authorization Requirements.

This study examined opinions of American psychiatrists regarding prior authorization (PA) requirements for third-party payer coverage of medications and quantified perceived impact of these requirements on clinical practice. One thousand selected psychiatrist members of the American Psychiatric Association were invited to participate in a survey. Response rate was 33.1%. Respondents predominantly believed the obligation to obtain PA reduces job satisfaction and negatively impacts patient care. A total of 59.9% of respondents reported employing either diagnosis modification or falsification of previous medication trials at least occasionally in order to obtain PA. A total of 66.6% refrained at least occasionally from prescribing preferred medications due to PA requirement or expectation of one. On multivariate analysis, risk factors for refraining at higher frequency included seeing 300 or more patients in the previous 3 months, engaging more frequently in diagnosis modification, and reporting increased perception that obtaining PA reduces time for patient care.

Streamlining and Reimagining Prior Authorization Under Value-Based Contracts: A Call to Action From the Value in Healthcare Initiative's Prior Authorization Learning Collaborative.

Utilization management strategies, including prior authorization, are commonly used to facilitate safe and guideline-adherent provision of new, individualized, and potentially costly cardiovascular therapies. However, as currently deployed, these approaches encumber multiple stakeholders. Patients are discouraged by barriers to appropriate access; clinicians are frustrated by the time, money, and resources required for prior authorizations, the frequent rejections, and the perception of being excluded from the decision-making process; and payers are weary of the intensive effort to design and administer increasingly complex prior authorization systems to balance value and appropriate use of these treatments. These issues highlight an opportunity to collectively reimagine utilization management as a transparent and collaborative system. This would benefit the entire healthcare ecosystem, especially in light of the shift to value-based payment. This article describes the efforts and vision of the multistakeholder Prior Authorization Learning Collaborative of the Value in Healthcare Initiative, a partnership between the American Heart Association and the Robert J. Margolis, MD, Center for Health Policy at Duke University. We outline how healthcare organizations can take greater utilization management responsibility under value-based contracting, especially under different state policies and local contexts. Even with reduced payer-mandated prior authorization in these arrangements, payers and healthcare organizations will have a continued shared need for utilization management. We present options for streamlining these programs, such as gold carding and electronic and automated prior authorization processes. Throughout the article, we weave in examples from cardiovascular care when possible. Although reimagining prior authorization requires collective action by all stakeholders, it may significantly reduce administrative burden for clinicians and payers while improving outcomes for patients.

Value in Healthcare Initiative: Summary and Key Recommendations.

In spring 2018, the American Heart Association convened the Value in Healthcare Summit to begin an important conversation about the challenges patients with cardiovascular disease face in accessing and deriving quality and value from the healthcare system. Following the summit and recognizing the collective momentum it created, the American Heart Association, in collaboration with the Robert J. Margolis Center for Health Policy at Duke University, launched the Value in Healthcare Initiative-Transforming Cardiovascular Care. Four areas of focus were identified, and learning collaboratives were established and proceeded to conduct concrete, actionable problem solving in 4 high-impact areas in cardiovascular care: Value-Based Models, Partnering with Regulators, Predict and Prevent, and Prior Authorization. The deliverables from these groups are being disseminated in 4 stand-alone articles, and their publication will initiate further work to test and evaluate each of these promising areas of reform. This article provides an overview of the initiative's findings and highlights key cross-cutting themes for consideration as the initiative moves forward.

Benefits of Prior Authorizations.

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

Trends and Factors Associated With Insurer Approval of Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitor Prescriptions.

OBJECTIVES: Proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9is)-innovative yet costly cholesterol-lowering agents-have been subject to substantial prior authorization (PA) requirements and low approval rates. We aimed to investigate trends in insurer approval and reasons for rejection for PCSK9i prescriptions as well as associations between patients' demographic, clinical, pharmacy, payer, and PCSK9i-specific plan/coverage factors and approval. METHODS: We examined trends in PCSK9i approval rates and reasons for rejection using medical and prescription claims from 2015 to 2017 for individuals who received a PCSK9i prescription. We used multinomial logistic regression to estimate quarterly risk-adjusted approval rates for initial PCSK9i prescriptions and approval for any PCSK9i prescription within 30, 90, and 180 days of the initial PCSK9i prescription. For a 2016 subsample for whom we had PCSK9i-specific plan policy data, we examined factors associated with approval including PCSK9i-specific plan formulary coverage, step therapy requirements, and number of PA criteria. RESULTS: The main sample included 12 309 patients (mean age 64.8 years [SD = 10.8], 52.1% female, 51.5% receiving Medicare) and was similar in characteristics to the 2016 subsample (n = 6091). Approval rates varied across quarters but remained low (initial prescription, 13%-23%; within 90 days, 28%-44%). Over time, rejections owing to a lack of formulary coverage decreased and rejections owing to PA requirements increased. Lack of formulary coverage and having ≥11 PA criteria in the plan policy were associated with lower odds of PCSK9i prescription approval. CONCLUSIONS: These findings confirm ongoing PCSK9i access issues and offer a baseline for comparison in future studies examining the impact of recent efforts to improve PCSK9i access.

Prior authorization and its impact on access to obstetric ultrasound.

Prior authorization is a process requiring health care providers to obtain advance approval from a payer before a patient undergoes a procedure for the study to be covered. Prior authorization was introduced to decrease overutilization of ultrasound procedures. However, it has led to unanticipated consequences such as impeding access to obstetric imaging, increased administrative overhead without reimbursement, and contribution to physician frustration and burnout. Payers often use intermediary radiology benefit management companies without providing specialty-specific review in a timely manner as is requisite when practicing high-risk obstetrics. This article proposes a number of potential solutions to this problem: (1) consider alternative means to monitor overutilization; (2) create and evaluate data regarding providers in the highest utilization; (3) continue to support and grow the educational efforts of speciality societies to publish clinical guidelines; and (4) emphasize the importance of practicing evidence-based medicine. Understanding that not all health plans may be willing or able to collaborate with health care providers, we encourage physicians to advocate for policies and legislation to limit the implementation of prior authorization within their own states.

AMCP Partnership Forum: Optimizing Prior Authorization for Appropriate Medication Selection.

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.

The macroeconomic benefits of Tennessee APRNs having full practice authority.

BACKGROUND: To-date, advocacy efforts to advance full practice authority for APRNs have primarily stressed arguments based on evidence on the cost effectiveness and quality of APRN-provided care, as well as the improved care access and patient satisfaction these providers offer. PURPOSE: The economic impact analysis forecasts the additional job and economic output associated with granting Tennessee APRNs full practice authority. METHODS: The IMPLAN software and a variety of data inputs were used to estimate the direct, indirect, and induced economic impact on jobs, labor income, value-added benefits, total output, and tax revenues. FINDINGS: From a 2017 baseline, the cumulative impact of granting Tennessee APRNs full practice authority is a net gain of 25,536 jobs and $3.2 billion in economic impact. DISCUSSION: Granting Tennessee APRNs full practice authority would confer substantial economic benefits and employment opportunities to the state.

Prior authorization as a utilization management tool for elective superficial venous procedures results in high administrative cost and low efficacy in reducing utilization.

OBJECTIVE: Prior authorization (PA) is a process used by payers for safety and cost savings purposes, but it has received criticism for being time-consuming and costly because of administrative burden. Our study evaluated efficacy of PA applied to in-office lower extremity superficial venous procedures. METHODS: All in-office lower extremity venous procedures scheduled to be performed at our institution in 2017 were included in the study. Variables of interest were type of procedure, initial PA status (approved or denied), rationale for the decision, and final status after appeal. Cost analysis was performed using Centers for Medicare and Medicaid Services allowable rates to approximate billing and reimbursement data (proprietary) as well as calculated using industry averages. RESULTS: For 2017, of 1959 procedures scheduled, 57.9% (n = 1134) required PA. Of these, only 6.1% (n = 69) received initial PA denial, and nearly 40% of the denials (n = 27) were overturned after appeal. Of the 42 denials that were upheld, 15 resulted in cancellations; the remainder were performed by patient self-pay (n = 11) or by the provider pro bono (n = 16). Overturned denials were a result of either submission of incomplete clinical data on initial PA request or insufficient documentation of clinical necessity. When Centers for Medicare and Medicaid Services allowable rates were applied for cost analysis, the denials resulted in <$60,000 payer savings. Administrative expenses totaled >$110,000 when industry standards were applied, which far exceeds any calculated payer savings using the same methods. The 15 denials resulting in procedure cancellations (1.3% of all PAs) could be considered a net savings to the health care system but only approximated a mere $30,000. CONCLUSIONS: Our study demonstrates that PA is not a cost-effective measure for utilization management of outpatient superficial venous procedures when surgeon practices are already well aligned with insurance guidelines. For these physicians and physician groups, the administrative cost associated with the PA process exceeds the savings seen by the insurance companies.

TRICARE For Children: Between Medicaid And Marketplace Plans For Comprehensiveness And Cost Sharing.

TRICARE provides health care benefits to nearly two million children of active duty, retired, National Guard, and reserve service members. Child health advocates and congressional reports have raised questions regarding the adequacy of these benefits, compared with other sources of children's health insurance. To help address these questions, we compared TRICARE benefits with benefits from Medicaid and Marketplace plans because they represent alternative sources of coverage for many of the families enrolled in TRICARE. Overall, we found that TRICARE benefits fell in the middle-between Medicaid plans' more comprehensive benefits with no cost sharing and Marketplace plans' more restrictive benefits with higher cost sharing.

Prior Authorization and Utilization Management Concepts in Managed Care Pharmacy.

Formularies that Include prior authorization and utilization management are widely used by managed care organizations (MCOs), Including health plans and pharmacy benefit management companies. Utilization management criteria are essential to optimizing patient outcomes and reducing waste, error, unnecessary drug use, and cost. The Academy of Managed Care Pharmacy (AMCP) Professional Practice Committee has developed the following 9 specific concepts for effective prior authorization practices by MCOs: (1) patient safety and appropriate medication use, (2) clinical decision making, (3) evidence-based review criteria, (4) automated decision support, (5) transparency and advanced notice, (6) emergency access, (7) provider collaboration, (8) need for timeliness and avoiding disruptions in therapy, and (9) cost-effectiveness and value. AMCP supports these concepts to allow for further collaboration between prescribers and payers in order to ensure that patients receive appropriate and timely access to drugs, devices, and other therapeutic agents. DISCLOSURES: No funding was received for the conceptualizing, writing, and/or editing of this manuscript. The Professional Practice Committee is composed of volunteers selected from current Academy of Managed Care Pharmacy members in good standing. Concepts presented in this document were developed by request of the Academy of Managed Care Pharmacy and are not intended to represent the views of committee members' employers or affiliated organizations.

Economic Outcomes Associated with Safety Interventions by a Pharmacist-Adjudicated Prior Authorization Consult Service.

BACKGROUND: The establishment of a formulary management system ensures that health care professionals work together in an integrated patient care process to promote clinically sound, safe, and cost-effective medication therapy. Pharmacists have a foundational role within this system. A pharmacist-adjudicated prior authorization drug request (PADR) consult service has the potential to optimize drug therapy by decreasing medication misuse, minimizing adverse drug events (ADEs), and preventing medication errors. OBJECTIVES: To (a) determine cost avoidance associated with pharmacist-adjudicated PADR safety interventions within the Durham Veterans Affairs Health Care System and (b) evaluate cost savings associated with pharmacist-adjudicated PADRs not approved due to a safety intervention, evaluate cost avoidance and direct cost savings based on clinical specialty of pharmacist adjudicating PADR, and characterize severity of avoided ADEs. METHODS: Pharmacist-adjudicated PADRs not approved between July 1, 2016, and June 30, 2017, because of safety interventions were retrospectively reviewed. Cost avoidance was determined by multiplying the probability of ADE occurrence in the absence of PADR safety intervention by the estimated cost avoided based on the type of intervention. Direct cost savings was calculated by totaling the cost of requested medications not approved for each PADR and subtracting the cost of recommended alternative therapies and cost of pharmacist PADR review. All potential ADEs avoided were reviewed by a panel of 3 clinical pharmacists to validate ADE classification and ADE probability and severity scores. Descriptive statistics were used for all analyses. RESULTS: Of the 910 PADRs that were not approved during the study period, 96 met inclusion criteria. Pharmacist-adjudicated PADR safety interventions resulted in a total cost avoidance of $24,485.34 (mean = $255.06) and a direct cost savings of $288,695.63 (mean = $3,007.25). The practice settings of anticoagulation and infectious diseases PADRs resulted in the largest contribution to cost avoidance and direct cost savings, respectively. Prevented ADEs were classified as major for 64.6% of the PADRs. CONCLUSIONS: Pharmacist-adjudicated PADR safety reviews resulted in substantial economic benefit and prevention of major ADEs. This analysis supports the pharmacist's role in a formulary management system to optimize medication therapy. DISCLOSURES: This research did not receive any specific grant from funding agencies in the public, commercial, or not-for profit sectors. The authors have nothing to disclose.

Coverage of Novel Therapeutic Agents by Medicare Prescription Drug Plans Following FDA Approval.

BACKGROUND: Regulatory approval of novel therapies by the FDA does not guarantee insurance coverage requisite for most clinical use. In the United States, the largest health insurance payer is the Centers for Medicare & Medicaid Services (CMS), which provides Part D prescription drug benefits to over 43 million Americans. While the FDA and CMS have implemented policies to improve the availability of novel therapies to patients, the time required to secure Medicare prescription drug benefit coverage-and accompanying restrictions-has not been previously described. OBJECTIVE: To characterize Medicare prescription drug plan coverage of novel therapeutic agents approved by the FDA between 2006 and 2012. METHODS: This is a cross-sectional study of drug coverage using Medicare Part D prescription drug benefit plan data from 2007 to 2015. Drug coverage was defined as inclusion of a drug on a plan formulary, evaluated at 1 and 3 years after FDA approval. For covered drugs, coverage was categorized as unrestrictive or restrictive, which was defined as requiring step therapy or prior authorization. Median coverage was estimated at 1 and 3 years after FDA approval, overall, and compared with a number of drug characteristics, including year of approval, CMS-protected class status, biologics versus small molecules, therapeutic area, orphan drug status, FDA priority review, and FDA-accelerated approval. RESULTS: Among 144 novel therapeutic agents approved by the FDA between 2006 and 2012, 14% (20 of 144) were biologics; 40% (57 of 144) were included in a CMS-protected class; 31% (45 of 144) were approved under an orphan drug designation; 42% (60 of 144) received priority review; and 11% (16 of 144) received accelerated approval. The proportion of novel therapeutics covered by at least 1 Medicare prescription drug plan was 90% (129 of 144) and 97% (140 of 144) at 1 year and 3 years after approval, respectively. At 3 years after approval, 28% (40 of 144) of novel therapeutics were covered by all plans. Novel therapeutic agents were covered by a median of 61% (interquartile range [IQR] = 39%-90%) of plans at 1 year and 79% (IQR = 57%-100%) at 3 years (P < 0.001). When novel therapeutics were covered, many plans restricted coverage through prior authorization or step therapy requirements. The median proportion of unrestrictive coverage was 29% (IQR = 13%-54%) at 3 years. Several drug characteristics, including therapeutic area, FDA priority review, FDA-accelerated approval, and CMS-protected drug class, were associated with higher rates of coverage, whereas year of approval, drug type, and orphan drug status were not. CONCLUSIONS: Most Medicare prescription drug plans covered the majority of novel therapeutics in the year following FDA approval, although access was often restricted through prior authorization or step therapy and was dependent on plan choice. DISCLOSURES: Funding for this study was contributed by a student research grant awarded to Shaw and provided by the Yale School of Medicine Office of Student Research under National Institutes of Health training grant award T35DK104689. Ross reports research grants to Yale University from the U.S. Food and Drug Administration (U01FD005938, U01FD004585), Medtronic, Johnson & Johnson, Centers for Medicare & Medicaid Services (HHSM-500-2013-13018I), Blue Cross-Blue Shield Association, Laura and John Arnold Foundation, Agency for Healthcare Research and Quality (R01HS022882), and National Institutes of Health (R01HS025164), unrelated to this study. Dhruva has nothing to disclose. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

Pharmacy resident involvement in prior-authorization drug request adjudication.

PURPOSE: Results of a study to determine economic outcomes of pharmacy residents' involvement in prior-authorization drug request (PADR) adjudication within a Veterans Affairs (VA) healthcare system are reported. METHODS: A retrospective review was conducted to identify PADRs adjudicated by pharmacy residents under a preceptor's supervision during the 2015-16 residency year. Only PADRs that were not approved as submitted (i.e., only those requiring formulary intervention) and that met other inclusion criteria were included in the analysis. Prior-authorization requests and adjudication decisions were characterized, and cost savings resulting from those decisions were calculated. RESULTS: Of the total of 752 PADRs adjudicated by 6 pharmacy residents during the study period, 42 met the inclusion criteria. About 90% of included PADRs were categorized as general medicine requests, and 9.5% were for oncology medications. The most common rationale for PADR nonapproval (cited in 60% of requests) was the availability of a preferred formulary alternative; the remainder of nonapprovals were due to medication safety concerns (e.g., contraindication to therapy, drug interaction potential, likelihood of adverse drug event resulting in patient harm, history of allergy to requested medication). Resident adjudication of PADRs resulted in total direct cost savings of $169,877.53 over the 12-month period, a mean of $4,044.70 per request. CONCLUSION: Pharmacy residents' involvement in adjudicating PADRs at a VA healthcare system resulted in substantial cost savings over the course of the residency year.