Pharmacy benefit manager reform within Medicaid Managed Care: The pursuit of a model that preserves the intent of the 340B program

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Universal Patient Identifier and Interoperability for Detection of Serious Drug Interactions: Retrospective Study

Background The United States, unlike other high-income countries, currently has no national unique patient identifier to facilitate health information exchange. Because of security and privacy concerns, Congress, in 1998, prevented the government from promulgating a unique patient identifier. The Health and Human Services funding bill that was enacted in 2019 requires that Health and Human Services report their recommendations on patient identification to Congress. While there are anecdotes of incomplete health care data due to patient misidentification, to date there have been insufficient large-scale analyses measuring improvements to patient care that a unique patient identifier might provide. This lack of measurement has made it difficult for policymakers to balance security and privacy concerns against the value of potential improvements. Objective We sought to determine the frequency of serious drug-drug interaction alerts discovered because a pharmacy benefits manager uses a universal patient identifier and estimate undiscovered serious drug-drug interactions because pharmacy benefit managers do not yet fully share patient records. Methods We conducted a retrospective study of serious drug-drug interaction alerts provided from September 1, 2016 to August 31, 2019 to retail pharmacies by a national pharmacy benefit manager that uses a unique patient identifier. We compared each alert to the contributing prescription and determined whether the unique patient identifier was necessary in order to identify the crossover alert. We classified each alert’s disposition as override, abandonment, or replacement. Using the crossover alert rate and sample population size, we inferred a rate of missing serious drug-drug interaction alerts for the United States. We performed logistic regression in order to identify factors correlated with crossover and alert outcomes. Results Among a population of 49.7 million patients, 242,646 serious drug-drug interaction alerts occurred in 3 years. Of these, 2388 (1.0%) crossed insurance and were discovered because the pharmacy benefit manager used a unique patient identifier. We estimate that up to 10% of serious drug-drug alerts in the United States go undetected by pharmacy benefit managers because of unexchanged information or pharmacy benefit managers that do not use a unique patient identifier. These information gaps may contribute, annually, to up to 6000 patients in the United States receiving a contraindicated medication. Conclusions Comprehensive patient identification across disparate data sources can help protect patients from serious drug-drug interactions. To better safeguard patients, providers should (1) adopt a comprehensive patient identification strategy and (2) share patient prescription history to improve clinical decision support.

Universal Patient Identifier and Interoperability for Detection of Serious Drug Interactions: Retrospective Study (Preprint)

BACKGROUND The United States, unlike other high-income countries, currently has no national unique patient identifier to facilitate health information exchange. Because of security and privacy concerns, Congress, in 1998, prevented the government from promulgating a unique patient identifier. The Health and Human Services funding bill that was enacted in 2019 requires that Health and Human Services report their recommendations on patient identification to Congress. While there are anecdotes of incomplete health care data due to patient misidentification, to date there have been insufficient large-scale analyses measuring improvements to patient care that a unique patient identifier might provide. This lack of measurement has made it difficult for policymakers to balance security and privacy concerns against the value of potential improvements. OBJECTIVE We sought to determine the frequency of serious drug-drug interaction alerts discovered because a pharmacy benefits manager uses a universal patient identifier and estimate undiscovered serious drug-drug interactions because pharmacy benefit managers do not yet fully share patient records. METHODS We conducted a retrospective study of serious drug-drug interaction alerts provided from September 1, 2016 to August 31, 2019 to retail pharmacies by a national pharmacy benefit manager that uses a unique patient identifier. We compared each alert to the contributing prescription and determined whether the unique patient identifier was necessary in order to identify the crossover alert. We classified each alert’s disposition as override, abandonment, or replacement. Using the crossover alert rate and sample population size, we inferred a rate of missing serious drug-drug interaction alerts for the United States. We performed logistic regression in order to identify factors correlated with crossover and alert outcomes. RESULTS Among a population of 49.7 million patients, 242,646 serious drug-drug interaction alerts occurred in 3 years. Of these, 2388 (1.0%) crossed insurance and were discovered because the pharmacy benefit manager used a unique patient identifier. We estimate that up to 10% of serious drug-drug alerts in the United States go undetected by pharmacy benefit managers because of unexchanged information or pharmacy benefit managers that do not use a unique patient identifier. These information gaps may contribute, annually, to up to 6000 patients in the United States receiving a contraindicated medication. CONCLUSIONS Comprehensive patient identification across disparate data sources can help protect patients from serious drug-drug interactions. To better safeguard patients, providers should (1) adopt a comprehensive patient identification strategy and (2) share patient prescription history to improve clinical decision support.

Development of quality measures for use of self-injectable biologic therapy in inflammatory bowel disease: An integrated specialty pharmacy initiative

Purpose The development of a tool to measure medication safety, therapeutic efficacy, and other quality outcomes in patients receiving self-injectable biologic therapy for the management of inflammatory bowel disease (IBD) at a health-system specialty pharmacy is described. Summary Through a collaborative initiative by pharmacists, gastro-enterologists, and representatives of a pharmacy benefit manager and a pharmaceutical company, a set of clinical and specialty pharmacy quality measures was developed. The clinical measures are intended for use in assessing patient safety, disease status, treatment efficacy, and healthcare resource utilization during 3 assessments (pre-treatment, on-treatment, and longitudinal). The specialty pharmacy measures can be used to assess medication adherence, medication persistence, specialty pharmacy accreditation, and patient satisfaction. The proposed quality measures provide a foundation for evaluating the quality of IBD care and improving patient outcomes within a health-system specialty pharmacy. Future efforts to validate and implement the tool in clinical practice are planned. Conclusion The proposed quality measures provide a foundation for future inquiry regarding the appropriateness and feasibility of integrating the measures into clinical care. Further work is needed to implement and validate these quality measures and determine their impact in optimizing health outcomes.

An Ethical Analysis of Pharmacy Benefit Manager (PBM) Practices

The high costs associated with pharmaceuticals and the accompanying stakeholders are being closely evaluated in the search for solutions. As a major stakeholder in the U.S. pharmaceutical market, the practices of pharmacy benefit manager (PBM) organizations have been under increased scrutiny. Examples of controversial practices have included incentives driving formulary status and prohibiting pharmacists from disclosing information on lower-cost prescription alternatives. Ethical investigations have been largely omitted within the debate on the responsibilities of these organizations in the health care system. Ethical analysis of organizational practices is justified based on the potential impact during health care delivery. The objective of this study was to analyze several specific PBM practices using multiple ethical decision-making models to determine their ethical nature. This study systematically applied multiple ethical decision-making models and codes of ethics to a variety of practices associated with PBM-related dilemmas encountered in the pharmaceutical environment. The assessed scenarios resulted in mixed outcomes. PBM practices were both ethical and unethical depending on the applied ethical model. Despite variation across applied models, some practices were predominately ethical or unethical. The point of sale rebates were consistently determined as ethical, whereas market consolidation, gag clauses, and fluctuation of pharmacy reimbursements were all predominantly determined as unethical. The application of using provider codes of ethics created additional comparison and also contained mixed findings. This study provided a unique assessment of PBM practices and provides context from a variety of ethical perspectives. To the knowledge of the authors, these perspectives have not been previously applied to PBM practices in the literature. The application of ethical decision-making models offers a unique context to current health care dilemmas. It is important to analyze health care dilemmas using ethics-based frameworks to contribute solutions addressing complexities and values of all stakeholders in the health care environment.