• UPDATE FROM 340B COALITION SUMMER CONFERENCE

    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 »

  • HRSA Stands by Interpretation of Orphan Drug

    On May 23, 2014, the U.S. District Court for the District of Columbia issued a ruling in Pharmaceutical Research and Manufacturers of America v. US Department of Health and Human Services (HHS) (Civil Action No. 13-1501) that vacated the orphan drug regulation on the grounds that HHS lacks the statutory authority to engage in such… Read more »

  • RxStrategies Clinical Insights – July 2014

    We would like to introduce the RxStrategies Clinical Insights a new concise communication to help pharmacy professionals stay up to date on the ever-changing pharmaceutical and pharmacy market place with such topics as new drug product approval information, generic launches, drug product recalls and safety alerts. This will be a frequent communication along with a… Read more »

  • 340B Coalition Meeting – July 14-16, 2014

    Meet  the Team from RxStrategies at the 340B Coalition Meeting – July 14-16th at the Omni Shoreham Hotel 2500 Calvert Street, Northwest  Washington, DC  20008.  RxStrategies will be available in the exhibit hall during all meeting at exhibit space #36.  Hope to see you there.

  • 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 »

  • RxStrategies to Attend NACHC Meeting

    Join RxStrategies at the National Association of Community Health Centers, March 19-21, 20014 at the Washington Marriott Wardman Park. Fran Hodge and Mary Ellen England will be available to answer all of your questions regarding  Rx Strategies.  Stop by booth #515    in the exhibit hall.  We look forward to seeing you there.  

  • 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 »

  • Recertification

    340B Recertification for HRSA and IHS Grantees Initiated February 10 The Health Resources and Services Administration (HRSA) and Office of Pharmacy Affairs (OPA) announced that recertification for tribal and urban Indian entities, HRSA grantees, and CDC STD/TB grantees started on February 10, 2014. The deadline for the completion of the recertification process will be March… Read more »