August 340B Insider

    Welcome to the August edition of RxStrategies 340B Insider, a concise communication to provide a quick highlight of updates from RxStrategies’ view.




    Recertification Deadline September 9   

    340B Health sent a reminder to Covered Entities (CEs) regarding the Sept. 9 deadline to recertify information in the 340B program database. It is vital to review information to ensure it is complete and accurate, and verify that all program requirements are met. If a CE fails to recertify, they could be removed from the program.

    Need more information?

    Download 340B Health resources: (login required)

    – July 29 recertification webinar rebroadcast
    – Webinar slides
    – 340B Health contact Sam Wilhelm-Ross
    ( or 202-536-2280)

    Contact us for further assistance.


    RxStrategies’ UPDATES


    Perspective: Proposed Mega Guidance

    As the industry awaits HRSA’s Mega Guidance that would cover the definition of a patient, compliance requirements for Contract Pharmacies, and criteria for hospital eligibility in the 340B program,RxStrategies shares the following anticipated key Mega Guidance themes and RxStrategies’ view on working with its clients to prepare:

    1. Anticipated modest tightening of patient definition. Ensure your electronic medical record (EMR) data is complete and current.
    2. Restrictions on the number of Contract Pharmacies a Covered Entity (CE) may have. RxStrategies’ client Contract Pharmacy (CP) networks are within expected standards.
    3. Significant focus on program compliance and audit activities (both internal and external). Providers are encouraged to continue to implement 340B compliance focus (including RxStrategies 340BCompliance Plus).
    4. Increased tracking and accountability requirement on CEs including, required transparency of proceeds details and flow. Senior leadership should implement processes to appropriately document the use of 340B proceeds.
    5. Implementation of formal audit requirements, including:

    – Establish formal retention period (5 years)
    – Increased internal audit within CEs
    – Formally require external third party audit, annually

    It is recommended that CEs establish a 340B team with a designated 340B lead for audit review. That team can work through internal CE program assessement to ensure adequate compliance and self-audit reviews are in place today. 

    Contact us to discuss how RxStrategies can assist your program.


    Ensure Program Integrity: RxStrategies 340B Compliance Plus

    This comprehensive solution assists clients and partners to proactively prepare for the additional oversight and responsibilities associated with a transparent 340B program.

    Our team of 340B program experts works closely with CEs to support your program integrity, including:

    1. Design customized Policies and Procedures with each CE and work with Contract Pharmacy sites to reinforce specific details.
    2. Confirm accurate details of HRSA registration (initial and ongoing updates) and 340B program operations.
    3. On-site consultation with clients to complete CE systemic compliance readiness review.

    Read more about RxStrategies 340B Compliance Plus program or contact us to discuss how to get started.




    HRSA Proposes 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation

    Health Resources and Services Administration (HRSA) issued a proposed rule regarding the formula for the calculation of the ceiling price for drugs in the program as well as how civil monetary penalties will be applied. Read the proposed rule>

    Submit your comments by Aug. 17:

    1. Federal eRulemaking Portal. Follow instructions for submitting comments.This is the preferred method for the submission of comments.
    2. Email: Include 0906–AA89 in the subject line of the message.
    3. Mail: Office of Pharmacy Affairs (OPA), Healthcare Systems Bureau (HSB), Health Resources and Services Administration (HRSA), 5600 Fishers Lane, Mail Stop 08W05A, Rockville, MD 20857.




    Join the RxStrategies’ team at the following upcoming conferences in 2015:

    NACHC Community Health Institute & Expo 
    August 21 – 25 | Orlando, FL
    Booth #212 | Learn more.

    APHCA Annual Conference
    September 22 – 24 | Orange Beach, AL
    Learn more.

    ASHNHA Annual Conference
    September 23 – 25 | Girdwood, AK
    Learn more.

    GAPHC Conference
    October 13 – 15 | Jekyll Island, GA
    Learn more.

    CPCA Annual Conference
    October 15 – 16 | Sacramento, CA
    Learn more.

    ASHP Midyear Clinical Meeting
    December 6 – 10 | New Orleans, LA
    Learn more.