Southwest Consulting Associates Blog

The 340B Drug Pricing Program Omnibus Guidance (Mega-Guidance) was published for public comment August 28, 2015.  You can find it HERE. Please note, the comment deadline is quickly approaching as it is TUESDAY, OCTOBER 27, 2015.  While the Mega-Guidance addressed numerous areas of the 340B program, the most significant proposed changes were in the areas of:

Disproportionate Share Hospitals (DSH), Children’s Hospitals and Freestanding Cancer Hospitals participating in the 340B program are subject to GPO prohibition. These hospitals may not purchase 340B covered outpatient drugs through a group purchasing organization (GPO) or other group purchasing arrangement. However, inpatient drugs and non-covered outpatient drugs may be purchased using a GPO.

The proposed guidance added some additional language to the hospital 340B eligibility requirements.  There is some language change in the first category of hospitals; however, the biggest change is in the third category of hospitals which many DSH hospitals fall into.  There are changes in the required elements in the contract that private, non-profit hospitals must have with their State or local government to provide health care services to low income individuals. Hospitals should take note of the changes for their respective category, evaluate what impact the changes will have and submit comments to HHS if necessary. If the Mega-Guidance is finalized as proposed, 340B covered entities will need to ensure their contracts contain the additional language required.

The 340B Drug Pricing Program Omnibus Guidance (Mega­Guidance) was published for public comment August 28, 2015.  This Mega­-Guidance can be found HERE. The proposed Mega-Guidance adds that a child site should have “associated outpatient Medicare cost and charges on the most recently filed Medicare cost report to demonstrate the child site’s eligibility.  This is different from the 1994 Final Notice on Outpatient Hospital Facilities posted in the Federal Register and different from any previous OPA guidance provided in OPA’s FAQs.

The 340B Drug Pricing Program Omnibus Guidance (Mega-Guidance) was published for public comment August 28, 2015.  You can find it HERE.  Please note, comments should be submitted on or before TUESDAY, OCTOBER 27, 2015.  The Mega-Guidance is extremely comprehensive as it addresses numerous aspects of the 340B program but the most significant proposed changes were in the areas of:

• patient definition

• physician administered drugs (stricter guidance)

• record retention standards

• duplicate discounts including Medicaid Managed Care

• contract pharmacy

In this article, we are going to focus on patient definition as it is today and what it would look like if the 340B Mega-Guidance is finalized as proposed.

Many 340B program stakeholders would agree that program integrity was at the forefront of HRSA’s priorities for the 2015 fiscal year.  At the 340B Winter Coalition Conference in February, Captain Krista Pedley (Director of Office of Pharmacy Affairs) gave a presentation addressing the 340B Drug Pricing Program and specifically stated, “…program integrity is our highest priority.”  At the 340B Summer Coalition Conference in July, Michelle Herzog, Deputy Director of the Health Resources and Services Administration Office of Pharmacy Affairs, provided the HRSA update to participants and clearly stated, “Program integrity remains the highest priority in OPA and HRSA intends to advance that mission and ensure that the 340B Program is sustainable in the long term for all of the stakeholders who participate”.

On Monday, September 14, 2015, HRSA posted a manufacturer refund notice on its website regarding Heritage Pharmaceuticals Inc. (Heritage) and 340B pricing for products using NDC labeler code 23155. According to the notice, Heritage did not extend 340B pricing to covered entities on drug purchases made between April 18, 2008 and December 31, 2014.  As a result, a 340B covered entity may have purchased identified Heritage products above the 340B ceiling price.

As you may have heard, the 340B Drug Pricing Program Omnibus Guidance (Mega-Guidance) was published for public comment last Friday, August 28, 2015.  You can find it HERE. Please note, comments should be submitted on or before TUESDAY, OCTOBER 27, 2015.  While the Mega-Guidance addressed numerous areas of the 340B program, the most significant proposed changes were in the areas of:

• patient definition

• physician administered drugs (stricter guidance)

• record retention standards

• duplicate discounts including Medicaid Managed Care

• contract pharmacy

Today, Health Resources and Services Administration (HRSA) released the long-awaited 340B Program Omnibus Guidelines (Mega-Guidance) for public viewing on the Federal Register website.  According to the site, the Mega-Guidance will officially be published on Friday, August 28, 2015 and public comments should be submitted on or before TUESDAY, OCTOBER 27, 2015 (60 days after the Federal Register publication date).  The pre-publication document can be found at:

The Office of Management and Budget (OMB) posted that they concluded their review of the 340B Program Omnibus Guidelines (Mega-Guidance) on August 17, 2015.  If you remember, the Health Resources and Services Administration (HRSA) sent the 340B Mega-Guidance to the OMB on May 6, 2015 and on August 4, 2015, the OMB posted that the review of the Mega-Guidance was extended.