• RxStrategies Clinical Insights – December 2014, Issue 1

    Welcome to the December edition of RxStrategies Clinical Insights, a concise communication to help pharmacy professionals stay up to date on the ever-changing pharmaceutical and pharmacy market place.   New Drug Approval Blincyto™ (blinatumomab) December 3, 2014 – The U.S. Food and Drug Administration approved Blincyto™(blinatumomab) to treat patients with Philadelphia chromosome-negative precursor B-cell acute… Read more »

  • December 340B Insider

    340B Winter Coalition Conference Mark your calendars for the 11th Annual 340B Coalition Winter Conference, from Feb. 4 to 6, 2015 at the Hyatt Regency Embarcadero in San Francisco. RxStrategies invites you to schedule a meeting time or stop by our booth #18-19 in the exhibit hall. Our team will greet you and answer any… Read more »

  • RxStrategies Clinical Insights – November 2014, Issue 2

    Welcome to the second November edition of RxStrategies Clinical Insights, a concise communication to help pharmacy professionals stay up to date on the ever-changing pharmaceutical and pharmacy market place.   New Drug Approvals Lemtrada™ (alemtuzumab) November 14, 2014—The U.S. Food and Drug Administration has approved Lemtrada™ (alemtuzumab) as a disease-modifying therapy for people with relapsing forms of Multiple… 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 »

  • HRSA 340B Program Registration

    HRSA- 340B Discounted Drug Pricing Program Open enrollment begins April 1 and runs through the 15th .  All new entities and new contract pharmacy arrangements should be finalized before the deadline of midnight April 15. For further information  call Mary Ellen England -954-602-5166

  • HRSA Describes Proposed 340B User Fee

    In its annual budget justification to Congress, HRSA provided a summary of attributes of a possible 340B User fee. Purpose: The user fee provides the resources needed to improve program integrity and implement statutory provisions while reducing the government expenditure of taxpayer dollars. It will also help address recommendations by the Office of Inspector General… Read more »

  • White House reverses $10B in cuts to ACA cost-sharing subsidies

    By Paul Demko Posted: March 13, 2014 – 6:30 pm ET  Modern HealthCare Tags: Costs, Healthcare Reform, Insurance Exchanges, Insurance, Medicare   The White House has decided to reverse roughly $10 billion in cuts to the cost-sharing subsidies that were part of the Patient Protection and Affordable Care Act. That program was originally expected to be slashed by 7.3 % in… Read more »

  • Drug Shortages –A Manufactured Problem or a Manufacturing Problem?

    Thomas Finn – October 29, 2013 7:14 AM | Categories: Commodities, drug manufacturers, drug wholesaling and distribution, General News and Commentary, government policy, Healthcare Providers, Intermediaries/GPOs +, Procurement, sourcing services, Supply Chains Tags: congress and GPOs in healthcare, GPOs blames for drug shortages, GPOs in healthcare and drug shortages, healthcare supply chain, physicians blame GPOs… Read more »

  • 340B Refunds to Manufacturers? An Interesting New Twist

    As entities contact manufacturers with a need to repay the manufacturers, manufacturers are not sure how to best handle these requests. Read this post to learn some thoughts on this situation, as shared by a consulting firm to the industry. http://cis-partners.com/cis-compliance-blog/340b-refunds-to-manufacturers-an-interesting-new-twist/

  • HRSA published final rule on Orphan Drugs

    On July 23, 2013, the Health Resources and Services Administration (HRSA) published a final rule to clarify how section 340B(e) of the Public Health Service Act (PHSA) will be implemented (“Exclusion of Orphan Drugs for Certain Covered Entities under 340B Program”, (78 Fed. Reg. 44016 (July 23, 2013)). The final rule only applies to Critical… Read more »