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The Pink Sheet Interview with Apexus President Chris Hatwig - April 14, 2014

The Pink Sheet published an interview with Chris Hatwig, President of Apexus, HRSA’s 340B prime vendor. Apexus serves as one of the key intermediaries between pharmacy manufacturers and covered entities involved with the 340B program. Learn more about the Apexus role in supporting improved access to medications for covered entities, its role in working with and supporting HRSA’s Office of Pharmacy Affairs and pharmaceutical manufacturers in efforts to improve overall program integrity.  (View Details)

340B Mega-Reg Moves One Step Closer to Publication - April 10, 2014

On April 9, the Office of Information and Regulatory Affairs (OIRA) posted that the 340B Omnibus Notice of Proposed Rulemaking (commonly referred to as the “mega-reg”) was currently under review by the Office of Management and Budget (OMB).  The period for OIRA review is limited by Executive Order 12866 to 90 days, and there is no minimum period for review. Under the Executive Order, the review period may be extended indefinitely by the head of the rulemaking agency; alternatively, the OMB Director may extend the review period on a one-time basis for no more than 30 day …  (View Details)

Hospital Registration Overview - April 9, 2014

The Office of Pharmacy Affairs (OPA) understands that registering hospitals and outpatient sites can be challenging. The registration process is more than just paperwork — it is a critical compliance check for entities entering the 340B program. As OPA analysts review each entity for eligibility, they are ensuring that each entity, including hospitals and outpatient sites, are eligible for the program as outlined by the 340B statute. This month, they are taking two important steps toward improving the process for all stakeholders.  (View Details)

Orphan Drug Designation List Revised by OPA - April 1, 2014

On March 27, 2014, the Health Resources and Services Administration (HRSA) Office of Pharmacy Affairs (OPA) revised and posted the Orphan Drug Designation List governing April 1 – June 30, 2014.  (View Details)

Apexus Leads the Charge to Support AIMM - March 3, 2014

The 340B program was the common ground initially for Apexus and the PSPC, and while many teams still have a 340B connection, Apexus sees a bigger picture. AIMM highlights the vision and collaborative efforts of Apexus President, Christopher Hatwig, in this exclusive interview.  (View Details)

340B Coalition Winter Conference Blog Review - February 14, 2014

Major Themes at 340B Coalition Winter Conference Include Contract Pharmacy Oversight, Medicaid Managed Care, and Anticipated 340B “Mega-Reg”.  (View Details)

Apply to 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.  (View Details)

Blog: Walgreens Still Dominates Booming 340B Contract Pharmacy Market, with CVS and Rite Aid Right Behind - February 10, 2014

(2/5, Adam J. Fein, Drug Channels) comments “...With little oversight and big money at stake, I’m not surprised that the program is still expanding at a breakneck pace...This will be a big year for the 340B drug discount program. The [HRSA] promises to (finally) release long-overdue proposed regulations. The [OIG] expects to release a study on ‘program integrity’ of 340B contract pharmacy arrangements. Let’s hope these developments get the 340B contract pharmacy program properly focused on helping needy patients access these medications. But I’m skept …  (View Details)

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