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    ASHP Lessons Learned: 3 Regulatory Changes Hospital Pharmacy Leaders Can’t Ignore in 2023

    Posted by: Valerie Bandy | January 24, 2023

    ASHP Lessons Learned

    Pharmaceutical handling, management and tracking are strictly mandated by federal and state regulations, which are constantly evolving. During the American Society of Health-System Pharmacists (ASHP) Midyear Clinical Meeting and Exhibition held December 4–8, 2022, in Las Vegas, regulators, health system pharmacy leaders and other industry stakeholders presented on the latest trends and their implications for U.S. hospital pharmacies.

    Here are three changes on the horizon that will have a significant impact on pharmacy supply chain in 2023 and beyond.

    1. Medicaid Reimbursement Trends Increase 340B Program Complexity

    Compliance with the 340B Program is already a tremendous burden on hospital pharmacies, with covered entities having to navigate federal and state Medicaid requirements for claims billed using 340B. For example, if a hospital is found to have diverted 340B drugs to ineligible patients or taken advantage of duplicate discounts, the Health Resources and Services Administration (HRSA) may require that it refund drug manufacturers for the unauthorized savings.

    Emerging Medicaid reimbursement trends on the state level aimed at preventing duplicate discounts are making it even harder for hospital pharmacies to comply, putting them at increased risk for penalties. For example, some states are converting pharmacy benefits covered under Medicaid managed care organizations (MCO) to fee-for-service (FFS) and hospitals must ensure they are submitting claims accordingly.

    Adding to the complexity, on November 30, 2022, HRSA published a proposed rule to revise the current 340B administrative dispute resolution (ADR), which is designed to resolve claims by covered entities that they have been overcharged by manufacturers and claims by manufacturers that covered entities have diverted 340B drugs or accepted duplicate discounts.

    Covered entities, aka hospitals taking part in the 340B Program, are subject to audit by manufacturers and the federal government. Going into 2023, pharmacy leaders should ask themselves:

    • Do I have technology and processes in place to accurately track drug dispensing to eligible patients and claim only for qualified discounts?
    • Can I quickly assess whether my facility is compliant in the face of changing regulations, and make the necessary changes?
    • In the event of an audit, can I produce the data I need to demonstrate compliance and avoid penalties?

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    2. New USP Compounding Standards Complicate Drug Receiving and Handling

    Enforcement of the highly anticipated U.S. Pharmacopeial Convention (USP) Chapter 800 standards for safe handling of hazardous drugs (HD) was delayed due to the COVID-19 pandemic. But in his presentation, The Joint Commission’s (TJC) Robert Campbell, PharmD, BCSCP, Director, Standards Interpretation Group Director, Medication Management, said TJC is updating its standards and survey processes to reflect USP 800 requirements, which are scheduled to become official on November 1, 2023.

    USP Chapter 800 standards impact how hospital pharmacies receive, compound, store, manage, administer and dispose of HDs (sterile and nonsterile) to protect both patients and staff from potential harm. They reclassify HD drugs based on the latest National Institute for Occupational Safety and Health (NIOSH) HD list.

    To achieve compliance with the standards, hospital pharmacies must be able to identify all HDs in their inventory, document when new items on the HD list enter their facilities and perform an annual assessment of risk for every HD they dispense. This means having full visibility and control from drug receipt through to use.

    In preparing for the official rollout later this year, hospital pharmacists should ask themselves:

    • Do I have complete visibility to all HDs in my inventory across all storage locations?
    • Can I quickly and accurately identify drugs classified as HD to ensure staff are handling them appropriately?
    • At the time of a TJC accreditation survey, can I produce evidence of compliance to avoid certification risks?

    3. Final DSCSA Requirements Driving Pharmacy Supply Chain Advancements 

    On November 27, 2023, the U.S. Food and Drug Administration’s (FDA) final Drug Supply Chain Security Act (DSCSA) enhanced drug distribution security requirements go into effect, requiring all parties in the pharmaceutical supply chain, including drug dispensers, to have in place technology and processes to verify and track products at the package level electronically — “paper-based methods of product tracing will no longer be permitted.”

    Hospital pharmacies that already have in place an enterprise-wide, electronic and automated supply chain management (SCM) solution to track item-level product details from receipt through use should be set up to comply with DSCSA requirements in a relatively straightforward manner.

    But for those still managing drug inventory manually within disjointed systems, or worse, in Excel spreadsheets or on paper, they have a huge task to undertake in the next 11 months. They should ask themselves:

    • Do I have a way to exchange transaction information and statements in a secure, interoperable, electronic manner and verify products at the package level with my drug distributors and manufacturers?
    • Can I quickly provide accurate and complete product tracing information and verification to the FDA during an investigation of suspect or illegitimate product or in response to a recall?

    2023 Goals: Visibility, Control and Compliance

    Current and emerging regulations are requiring hospital pharmacy leaders to expand their oversight of drug inventory, from the time a product enters their facility through to when it is dispensed to a patient.

    Pressures to report on drug product status quickly and accurately at each stage of the process are driving pharmacy directors to implement technology solutions proven effective by their medical-surgical healthcare supply chain leader counterparts.

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