May 2017 – 340B Insider

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



    RxStrategies Supports Conference as Pinnacle Leader Sponsor

    July 10 – 12 | Washington, D.C.

    This year marks 25 years with the 340B program in place! Along with the celebration, we are also excited and ready to connect with key leaders to discuss solutions and insights into the 340B program. Learn more about the conference >

    Connect with us to schedule a 340B CompliancePlus (self-audit tool) demo, view our newest Dashboard Analytics, schedule a meeting with a RxStrategies’ expert, or stop by booth 45/46 during the conference.

    Not able to attend the 340B Coalition Summer Conference? Submit your questions and we will follow up post-conference.



    This proactive visual analytics tool provides direct access to view your 340B program activity and key drivers. Dashboard Analytics was launched at the 340B Coalition Winter Conference and is currently being rolled out to RxStrategies’ clients. Contact us to learn more.



    Possible 340B Legislation in the Works

    Lawmakers Rep. Chris Collins (R-N.Y.) and Sen. Bill Cassidy (R-La.) spoke at the Alliance for Integrity and Reform of 340B (AIR340B)annual meeting (a pharma-driven anti-340B push). 340B Health reported that Rep. Collins is drafting legislation concerning legislative changes to the 340B program. Attendees also stated 340B will be a part of a bill Sen. Cassidy is working on, addressing high drug prices.

    Read further details from last week’s meeting, based on news articles in 340B Health’s Legislative Update.

    Waxman Shares Perspective on Pharma-Driven Anti-340B Push

    Former Rep. Henry A. Waxman (D-Calif.) was an original author of the 340B law and supported efforts to expand the program to children’s and rural hospitals. He is a past chairman of the House Energy and Commerce and House Oversight and Government Reform Committees. In a recent article, he shared his perspective why Congress — and the pharmaceutical industry — should celebrate and support 340B and its 25 years of achievement in strengthening our health care safety net. Read the article>

    Study Findings: 340B DSH Hospitals vs. non-340B Hospitals and Physicians Offices Treatment of Low-Income Cancer Patients 

    A recent study by Dobson DaVanzo & Associates found that hospitals participating in the 340B drug discount program continue to treat more low-income cancer patients than non-340B providers, confirming the 340B program’s longstanding role in helping hospitals meet the needs of their low-income patients. Read the report>

    Complete your 340B Impact Profile

    It’s more important than ever for Covered Entities to provide clear documentation of how 340B savings are used to benefit vulnerable patients. 340B Health has created a one-page template that’s easy to fill out and maintain. The impact profile can be used for advocacy, media and as a repository for tracking the specifics of your 340B activities. RxStrategies and 340B Health are happy to help you complete your 340B Impact Profile. Contact RxStrategies or Amanda Smith of 340B Health at 202-552-5861 to learn more.

    Managed Medicaid –  A Hot Topic in Many States

    A number of states (e.g., Texas and Washington, D.C.) are actively working to consider changes that may impact the ability to treat and process MCO claims under 340B. In addition to your own Covered Entities’ (CE) efforts to monitor and impact your states’ specific deliberations related to 340B, RxStrategies is working closely with industry leaders on the same. We continue our strong belief that the 340B program intent has always been to enable CEs to process any or all non-Fee For Service prescriptions for 340B consideration. While we continue to support that long-standing belief, as individual state-by-state decisions are rendered on the MCO topic, the RxStrategies’ team stands ready to work closely with our clients to ensure program compliance. Contact us to learn more.

    HRSA Update

    The final rule titled “340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation” was published in the Federal Register on Thursday, January 5, 2017, was previously effective and in March 6, 2017. The effective date for this rule was delayed to May 22, 2017 as specified in the interim final rule (IFR) published in the Federal Register. Read the IFR>

    HRSA 340B Audit Activity on the Rise

    HRSA 340B audit activity is continuing to increase materially in 2017 versus previous years’ levels. HRSA has contracted with Bizzell Group to take the audit lead, and they are working to complete over 300 audits in FY 2017.

    RxStrategies’ Response: CEs should be aware that the 2017 audit approach also appears to be more expansive. In prior year audits, the HRSA audit included typical policy and procedure review, procedure testing and detailed selection/audit testing of 340B validity for 33 claims. In 2017 audits that detailed approach is expanded upon with current audits, and includes:

    • Confirmation/validation of 340B ordering and invoicing activity for each of the 33 selected claims;
    • Review of regular monthly internal audit reviews are taking place and documentation of other supporting compliance activities, as well.

    RxStrategies encourages clients to be proactive by continuing to work their internal audit reviews and other audit prep activities. RxStrategies’ 340B CompliancePlus (self-audit tool) can be an effective tool to help maintain a compliant 340B program. Learn more>

    Walgreens Boots Alliance and Rite Aid Merger

    Last week, Walgreens Boots Alliance and Rite Aid announced that they have certified substantial compliance with the Federal Trade Commission’s Request for Additional Information for completion of their merger agreement under which Walgreens Boots Alliance proposes to acquire all outstanding shares of Rite Aid. This suggests the WAG/Rite Aid merger should be completed by July 1 (340B implications of same to follow). Read the news release>



    Join the RxStrategies’ team at the following upcoming conferences: 

    North Carolina Primary Care Conference
    June 8 – 10 | Winston-Salem, North Carolina
    Learn more.
    340B Coalition Summer Conference
    July 10 – 12 | Washington, D.C.
    Learn more.
    FACHC 2017 Annual Meeting and Education Summit
    July 16 – 19 | St. Petersburg, Florida
    Learn more.