• HRSA UPDATES: Hospital Recertification Required

    The annual recertification process is scheduled to begin on Aug. 6 and conclude on Sept. 10, 2014. Hospitals should receive an email containing instructions from HRSA’s Office of Pharmacy Affairs (OPA) around Aug. 1 and will have five (5) weeks to complete the process after it begins on Aug. 6. The purpose of annual recertification is twofold:… Read more »


    340B “Mega-Reg” Update The White House Office of Management and Budget (OMB) began its review of a proposed 340B Drug Pricing Program “Mega-Reg” in April. (See: RIN 0906-AB04). This proposed rule change is expected to cover the definition of an eligible patient and establish comprehensive 340B Drug Pricing Program requirements for participating covered entities and manufacturers.… Read more »

  • 340B Orphan Drug Rule Invalidated

    U.S. District Judge Rudolph Contreras has ruled that HRSA lacks regulatory authority to promulgate regulations expanding access to 340B discounts for so-called Orphan Drugs.   Rules that went into effect in October of 2013 implemented provisions of the Affordable Care Act that excluded orphan drugs from 340B pricing.  In the rules HRSA interpreted the exception… Read more »

  • Family Planning Re-certification Webinar

    RECERTIFICATION: FAMILY PLANNING (3/24/2014) The Office of Pharmacy Affairs (OPA) is required to recertify all participating 340b covered entities annually to ensure 340B database accuracy and promote compliance with 340B program requirements. OPA will hold an informational recertification webinar for Title X Family Planning Grantees on April 2nd, 2014, from 2-3 PM EDT. Conference Number:… Read more »

  • 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 »