Southwest Consulting Associates Blog

Rich Bucher and Rob Nahoopii, of Turnkey Pharmacy Solutions, a 340B audit and compliance firm, give their highlights and takeaways from the Summer 2017 340B Coalition.

HRSA's OPA announced its current 340B database will be offline beginning August 15, 2017 in anticipation of its new database, Office of Pharmacy Affairs Information System (OPAIS). How will this affect users?

The new 340B database, OPAIS, is expected to be up and running by October 1, 2017. More information on OPAIS and it's specifications can be found here.  

The Health Resources and Services Administration (HRSA)’s Office of Pharmacy Affairs (OPA) has announced it will replace its current database with a new system, the Office of Pharmacy Affairs Information System (OPAIS). When launched, OPAIS will serve as the 340B registration and pricing system for covered entities and manufacturers. Estimated launch date is October 2017. Here are key takeaways of OPAIS from the 2017 340B Coalition Summer Conference session with Josh Volpe, Public Health Analyst at HRSA.

We posted last week that the E&C Committee held a hearing July 18, 2017, with witnesses from the Office of Pharmacy Affairs, the Government Accountability Office and the Office of Inspector General. The purpose of the hearing was to review HRSA’s oversight of the 340B Drug Pricing Program, and how the program specifically impacts patients, providers, manufacturers and other stakeholders.  

The E&C Committee held a hearing July 18, 2017, with witnesses from the Office of Pharmacy Affairs, the Government Accountability Office and the Office of Inspector General. The committee asked pertinent questions administered under oath to the following individuals regarding the 340B program and oversight:

The next 340B quarterly registration period is once again upon us.  The 340B registration window begins on July 1st and will conclude on July 16th.  The traditional 340B enrollment period is usually the 1st through the 15th.  However, in the past, when both the beginning and ending dates fall on a weekend, the window has been extended to include the Monday following the 15th. Eligible entities must register in the 340B Office of Pharmacy Affairs Information System (OPAIS). More information can be found on the Office of Pharmacy Affairs (OPA) website.

The next 340B quarterly registration period is once again upon us.  The 340B registration window will begin on April 1st and conclude on April 17th.  The traditional 340B enrollment period is usually the 1st through the 15th, however, during this particular window, both the beginning and ending dates fall on a Saturday.  Therefore, the window has been extended to include Monday, April 17th according to the Office of Pharmacy Affairs (OPA).

There is a considerable number of moving parts associated with 340B compliance and ongoing monitoring by the covered entity is essential for a successful program. As we perform independent 340B compliance audits across the country, we find that contract pharmacy is by far the highest compliance risk area of the 340B Drug Pricing Program. Over half of all HRSA audit findings are in the 340B contract pharmacy component, as well as paybacks to the drug manufacturers.

Southwest Consulting Associates will be participating in the 33rd Annual Conference of the Texas Association of Community Health Centers (TACHC) this month and we have been looking back over 340B compliance audits that we have performed for CHCs this year to be able to provide some insight on common findings. In 2015, HRSA added some basic 340B compliance questions to the regular grant operational site visit to potentially identify covered entities that need further investigation of their 340B compliance. These questions revolve around 340B policies and procedures, self-auditing and 340B monitoring. Basically, if you don’t have 340B policies and procedures and you have not set up a self-auditing program for 340B compliance monitoring, it is very likely that your entity will move up the list for a HRSA 340B Compliance Audit.

The next 340B quarterly registration period is once again upon us.  The registration window will begin on October 1st and conclude on October 17th.  The traditional 340B enrollment period is usually the 1st through the 15th, however, during this particular window, both the beginning and ending dates fall on a Saturday.  Therefore, the window has been extended to include Monday, October 17th according to the Office of Pharmacy Affairs (OPA).