• FAQ for Medicaid FFS

     Medicaid Fee for Service can now claim Medicaid rebates for managed care claims. Does this mean that you have to bill managed care claims at acquisition for 340B products? A: The answer depends upon the billing agreement and is not determined by section 340B. Covered entities are required to ensure that they do not bill… Read more »

  • TogetherRx Access Closes Doors on 2M customers

    Originally posted by SNHPA- 11/20/13   TogetherRx Access, a drug discount card program sponsored by drug companies, is being discontinued as of Feb. 28, 2014. The reason? Big Pharma says participants will get a better deal on prescriptions by getting insured through the Affordable Care Act or Medicaid. “We have determined that individuals and families… Read more »

  • HRSA Audits of 340B Entities: Lessons Learned

    On November 4, HRSA posted 7 additional audit results on its website, bringing the grand total to 49 published audit results. As HRSA continues to post 340B audit findings on its website, there are several important lessons 340B enrolled entities should be taking away from this information. Each 340B entity needs to ensure that every… Read more »

    1. 340B drugs dispensed at ineligible sites and/or written by an ineligible provider
    2. 340B drug dispensed which was not supported by a medical record
    3. 340B drug dispensed to an inpatient
    4. 340B drugs dispensed to a non-patient at a contract pharmacy

    Entity must maintain records to demonstrate responsibility of care remained with the entity.
    If an individual has a referral, the CE still needs to maintain responsibility of care.
    340B University Sample Policies/Procedures
    340B University Policy to Practice: Referral Relationships
    340B University Policy to Practice: Physician Contracts
    FAQs (search on specific keyword)

    Duplicate Discount

    1. Billing Medicaid contrary to the HRSA Medicaid Exclusion File listing
    2. 340B drugs used for Medicaid patients at a contract pharmacy, with no arrangement to prevent duplicate discounts
    3. Medicaid claims incorrectly coded when provided to the state, or submitted without state required NPIs or UD modifiers
    4. Incorrect Medicaid or NPI in the HRSA Medicaid Exclusion File
    5. Outpatient sites incorrectly listed in the HRSA Medicaid Exclusion File

    The importance of the practice matching the policy and procedures and the HRSA Medicaid Exclusion File matching is critical.
    HRSA website, Medicaid section
    HRSA Medicaid Policy Release
    340B U Notes, Medicaid Section (pg. 15)
    FAQs (search on specific keyword)

    Eligibility, Auditable Records

    1. Incorrect Authorizing Official
    2. Primary location and contact information incorrect
    3. Closed child sites remained registered
    4. Incorrect name listed for a child site
    5. Incorrect address for facility
    6. Incorrect ship-to address
    7. Pharmacy listed as an entity with a 340B ID
    8. No written contract in place for a contract pharmacy

    HRSA website (registration section, OPA Database Guide for Entities)
    340B U Notes (pgs. 20, 40, 42, 43)
    FAQs (search on specific keyword)


  • HRSA Announced Recertification Delay

    November 18, 2013 HRSA announced that Recertification for CDC STD/TB and HRSA Ryan White Program entities will be delayed until the first quarter of 2014. HRSA suggests entities continue to review covered entity’s records in the 340B Program database for accuracy to ensure that the authorizing official receives their user name and password at the… Read more »

  • Ipsen Pharmaceuticals-Supply Interruptions

    May 2013 Re: IMPORTANT SUPPLY INTERRUPTION INFORMATION Ipsen Biopharmaceuticals, Inc. (“Ipsen”) markets Increlex® (mecasermin [rDNA origin] injection), NDC-15054-1040-5, as a 10 mg per mL sterile solution in multiple dose vials (40 mg per vial). Due to operational problems at our third-party manufacturer, Ipsen has been forced to limit purchases of Increlex. The remaining product supply… Read more »

  • Improved medication use could have saved $200 billion, IMS study shows

    By Jaimy Lee Posted: June 19, 2013 – 8:00 am ET An estimated $200 billion could have been saved last year if patients and clinicians improved the way they use medications, according to a new study from the IMS Institute for Healthcare Informatics.Medication nonadherence, misuse of antibiotics and other so-called “avoidable costs” lead to millions of unnecessary… Read more »

  • HRSA Recertification Update

    RECERTIFICATION UPDATE (06/11/2013) Recertification for all hospital types (DSH/CAH/PEDS/RRC/CAN/SCH) will begin in August 2013. Participating entities need to verify their Authorizing Official and Primary Contact information in the 340B database prior to August, as important information and recertification user names/passwords will be sent exclusively via e-mail. Failure to complete recertification by the specified deadlines will… Read more »

  • FDA takes action to ease neonatal drug shortage

    By Matthew Perrone / Associated Press Posted: May 29, 2013 – 1:00 pm ET   Federal health regulators are allowing overseas imports of critical intravenous drugs used to nourish premature infants, amid a shortage that has affected hospitals nationwide.The Food and Drug Administration said Wednesday new supplies of drugs used in total parenteral nutrition, a ubiquitous hospital staple, will… Read more »

  • CMS proposes 1.1% payment bump for hospices

     Rich Daly Modern Healthcare Posted: April 29, 2013 – 7:15 pm ET Hospices would receive a $180 million boost from Medicare in the next fiscal year under a proposed rule issued Monday (PDF). The proposed rule would provide a 1.1% increase in fiscal 2014 payments to hospices, which treated more than 1.3 million Medicare beneficiaries in… Read more »

  • Aging U.S. to drive up heart-related health costs: study

    By Susan Heavey WASHINGTON | Wed Apr 24, 2013 2:18pm EDT (Reuters) – The costs linked to heart failure in the United States are expected to more than double within the next two decades as the population ages and treatments help patients with the disease live longer, a study released on Wednesday found. The American Heart Association… Read more »