June 340B Insider

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


    340B UPDATES


    21st Century Cures Act Moves Forward Without 340B Language

    On May 21, the House Energy and Commerce Committee unanimously approved the 21st Century Cures Act (H.R. 6) without the inclusion of language pertaining to the 340B drug pricing program. 340B Health and more than 1,000 member hospitals and health systems successfully urged Congress to protect the 340B drug pricing program.

    Read the press release from 340B Health.
    – View the 21st Century Cures Act summary at congress.gov.

    RxStrategies’ 340B Insider Perspective:

    With the legislative environment in continued flux, RxStrategies’ 340B experts are anticipating the following potential industry impacts:

    1. Modest, yet continued, tightening of the 340B patient definition and eligibility.
    2. Significant increase in compliance and audit activity
    3. Increased tracking and accountability requirements for Covered Entities, including transparency of financial details and how used to increase patient access to health care.
    4. More formal audit requirements are anticipated.
    5. HRSA to increase regulatory authority.

    Contact us to discuss how we can assist your organization maintain compliance and be audit ready.

    SNHPA is Now 340B HEALTH

    340B Health, formerly Safety Net Hospitals for Pharmaceutical Access (SNHPA), is a 501(c)(6) non-profit organization of more than 1000 public and private non-profit hospitals and health systems throughout the U.S. that participate in the 340B drug discount program. Learn more.






    The best way to stay abreast of 340B happenings is to attend the19th Annual 340B Coalition Summer Conference, taking place July 13-15 in Washington, DC. The conference will address hot topics and discussion on the latest trends and implications of HRSA’s stepped up audit activity, other compliance matters and innovative ways. Learn more.

    RxStrategies is proud to support the 340B Coalition as a Premium Sponsor. Contact us to schedule an appointment with a RxStrategies expert or stop by Booth 45/46 during the conference.

    RxStrategies is also participating in the 340B Health Lobby Day on 7/16. It is vital to enhance the knowledge of legislators to the critical nature of the 340B program and the needs of patients depending on this program. Please make plans to join us!




    New Implementation Guidelines Available

    New Implementation Guidelines for our clients are available to help in the onboarding and implementation process of the 340B Program. More.




    HRSA Proposes Changes to Attestations Process

    – HRSA has proposed changes to the attestations hospital authorizing officials must sign during the registration and annual recertification processes. HRSA included these proposed changes in the information collection request published in the Federal Register in April and submitted to the Office of Management and Budget (OMB) for its review and approval.

    – HRSA is asking OMB to approve and renew existing information collections, including collections related to hospital, outpatient facility, and contract pharmacy registration, as well as recertification.

    – Read the complete document in the Federal Register.

    – The first publc comment period ended May 21. For further information, contact paperwork@hrsa.gov or (301) 443-1984.

    Program Integrity: Best Practices for Hospital Registrations

    HRSA has been working to integrate authoritative external data sources with the hospital registration process. Click here to read the March 2015 update.


    340B IN THE NEWS


    MedPAC Discusses 340B Program

    Congressional Quarterly (3/6, subscription publication) reported that the March 5 snowstorm forced the House Energy and Commerce Committee’s health panel to reschedule a hearing on the government’s 340B discount drug program, but Congress’ advisers on Medicare soldiered on with a separate discussion about the issue.

    The Medicare Payment Advisory Commission (MedPAC) plans to include discussion of the 340B program in its June report to Congress. MedPAC Chairman Glenn M. Hackbarth said, however, “We are not yet close to the point of making recommendations.” According to CQ, the Health Resources and Services Administration has been struggling in recent years to come up a comprehensive framework for the 340B program, which allows hospitals and clinics to buy pharmaceuticals at “a steep discount.”

    Op-Ed: Welcomed Movement on 340B Reform

    Stephanie Silverman (The Hill, 3/24) commented “The Alliance for Integrity and Reform (AIR340B), a coalition of patient and provider organizations and biopharmaceutical innovators, believes that the 340B program should remain in place to fulfill its original purpose. … Congress will be well positioned to think through real reforms that can realign the much-needed 340B program with its original intent. That’s why we believe that this week’s hearing is such a vital first step to getting the 340B program on track.”




    Program Funding

    HHS Announces New Access Point Awards – On May 5, HHS Secretary Burwell announced approximately $101 million in Affordable Care Act funding to 164 new health center sites in 33 states and two U.S. Territories for the delivery of comprehensive primary health care services to underserved and vulnerable populations. These new health centers are projected to increase access to health care services for nearly 650,000 patients. View more information on the awards.

    Pioneer ACO Update 

    Touting $380 million in savings from the Affordable Care Act’s first test of accountable care, Medicare says the pilot did well enough to expand. But it’s unclear how participants realized savings and to what extent others can replicate the success. Read more.

    Dr. Karen DeSalvo Tapped for New HHS Post

    The White House has nominated Dr. Karen DeSalvo to be Assistant Secretary for Health at HHS. If confirmed by the Senate, DeSalvo would leave her post as head of the department’s Office of the National Coordinator for Health Information Technology.  Read more.




    Question: What are the audit and compliance requirements under the contract pharmacy guidelines?

    Answer: The covered entity (CE) must have sufficient information to ensure ongoing compliance and the timely recognition of any 340B Program compliance problem at all contract pharmacy (CP) locations.

    • The CE remains responsible for the 340B drugs it purchases and dispenses through a CP.
    • All CEs are required to maintain auditable records and provide oversight of their CP arrangements.
    • HRSA expects that CEs will utilize independent audits as part of fulfilling their ongoing obligation of ensuring 340B Program compliance. 340B Program violations found during internal or independent audits must be disclosed to HRSA along with the CE’s plan to address the violation. Additionally, HRSA audits of include a CE’s contract pharmacies.
    • CP will be removed from the 340B Program if the CE is not providing oversight of its arrangement.

    Question: What are the record-keeping requirements for contract pharmacies?

    Answer: The CE must have fully auditable records that demonstrate compliance with all 340B Program requirements, including drugs dispensed through a CP arrangement.

    • The CP or your Third Party Administrator such as RxStrategies, needs to provide the CE with reports consistent with customary business practices (e.g., quarterly billing statements, status reports of collections and receiving, and dispensing records).
    • The CP, with the assistance of the CE, will establish and maintain a tracking system suitable to prevent diversion of 340B drugs and duplicate discounts on the drugs. Customary business records, which must be readily retrievable, may be used for this purpose.
    • The CE needs to establish a process for a periodic comparison of its prescribing records with the CP’s dispensing records to detect potential irregularities. Records can include: prescription files, velocity reports, and records of ordering and receipt of drugs. These records will be maintained for a period of time required by State law and regulations (75 Fed. Reg. 10272 (Mar. 5, 2010)).

    Question: If our contract pharmacy has been purchased by another pharmacy, do we need to update our records with OPA?

    Answer: If a CP has changed ownership, HRSA considers this to be a new contract pharmacy arrangement.

    • The covered entity must have a written contract in place with the new CP and register the arrangement on the 340B database prior to use.
    • CEs must complete the online portion of the CP registration process during an open registration period. Contact us for information on how to register a contract pharmacy.

    The CE must also terminate the CP relationship established under the previous owners. To effectuate the termination, the CE will need to complete an online termination request. Failure to report a change in ownership may result in a lapse in 340B access through the specific CP.




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

    Mississippi Primary Health Care Association (MPHCA)
    June 10 – 12 | Bay St. Louis, MS
    Learn more.

    Florida Association of Community Health Centers (FACHC)
    July 12-15 | St. Petersburg , FL
    Learn more.

    340B Summer Coalition Conference
    July 13-15 | Washington D.C.
    Learn more.

    NACHC Community Health Institue & Expo
    August 21 – 25 | Orlando , FL
    Learn more.