• Funding Priorities Emerge for HRSA’s 340B Program

    By: Apexus 340BPVP In its annual budget justification to Congress, HRSA provided the four key areas on which the Office of Pharmacy Affairs funding priorities will focus. Non-compliance with the 340B pricing requirements Support the 340B pricing system Publish policies for 340B ceiling price computation Establish systematic quarterly comparison: 340B ceiling prices vs. 340B selling… Read more »

  • CMS orders insurers to accept Ryan White premium assistance

      Modern Healthcare By Joe Carlson Posted: March 14, 2014 – 6:15 pm ET The CMS ordered all insurance companies selling plans through insurance exchanges to accept premium payments and co-payment assistance from federal programs like the Ryan White HIV/AIDS program. But the government continued to urge insurers to reject premium assistance provided by hospitals, drug companies and devicemakers. Full… Read more »

  • HHS-OIG Criticizes 340B Drug Discount Program

    Posted By Theresa C. Carnegie on February 11th, 2014Posted in Hospitals & Health Systems, Payors & PBMs, Pharma & Medical Devices, Pharmacies, State & Federal Audits, Investigations & Litigation Written by:  Ellyn L. Sternfield I recently posted that 2014 is expected to be a year of major developments in the 340B Drug Discount Program, with HRSA receiving enhanced funding, stepping up audit activity, and drafting regulations in response to… Read more »

  • Become a 340B Peer to Peer Recognized Site

    February 12, 2014 The American Pharmacists Association (APhA) is seeking 340B entities of all sizes and types to apply for the prestigious status as a 340B Peer-to-Peer Leading Practice site. Join the existing network of sites participating in the Peer-to-Peer Program and apply for status as a nationally recognized provider of 340B Peer-to-Peer technical assistance.… Read more »

  • Is 2014 a Game Changer for the 340B Drug Discount Program

    As reported in Health Law and Policy Matters January 31, 2014 (1/29, Ellyn L. Sternfield, Health Law & Policy Matters) reports “…The year 2014 looks to be a year of major developments for the 340B Drug Discount Program. We have seen (1) a first in terms of the Health Resources and Services Administration (HRSA) imposing… Read more »

  • 340B Recertification for HRSA and IHS Grantees Underway

    The Health Resources and Services Administration (HRSA) and Office of Pharmacy Affairs (OPA) has announced that re-certification for Tribal and Urban Indian entities, HRSA grantees, and CDC STD/TB grantees is scheduled to begin on February 10, 2014. The deadline for the completion of the re-certification process will be March 14, 2014. Each covered entity’s Authorizing… Read more »

  • FDA approves $84,000 a treatment hepatitis C drug

    By Associated Press Posted: December 7, 2013 – 9:30 am ET Tags: Associated Press (AP), Pharmaceuticals, Physicians, U.S. Food and Drug Administration (FDA)   U.S. health officials have approved a highly anticipated hepatitis C drug from Gilead Sciences that is expected to offer a faster, more palatable cure to millions of people infected with the liver-destroying virus. The Food and… Read more »

  • 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)