Southwest Consulting Associates Blog

The Senate Health, Education, Labor and Pensions (HELP) Committee held a hearing March 15, 2018, with witnesses from America's Essential Hospitals, Carolina Health Centers, Inc., American Society of Health-System Pharmacists, and the Pharmaceutical Research and Manufacturers of America. The committee asked pertinent questions regarding the purpose and transparency of the 340B drug discount program to the following individuals:

Southwest Consulting Associates is pleased to announce their Associate Membership with HAPevolve, of the Hospital & Healthsystem Association of Pennsylvania (HAP) effective immediately. The partnership is expected to enhance the value the Hospital & Health System Association of Pennsylvania offers its hospital members through reimbursement savings optimization programs and education provided by Southwest Consulting Associates.

It is fitting that the month of Thanksgiving also begins the 4th year of SCA's healthcare blog. We thank you, the readers, for being a part of our story as we share the latest in Medicare DSH reimbursement, Worksheet S-10 uncompensated care and 340B drug pricing program news. You trust us with your time, and we appreciate being a source of insight in this ever-changing industry. As we celebrate our 3rd anniversary and start to our 4th year, let's take a look at how far we have come, together.

The Government Accountability Office (the audit, evaluation, and investigative arm of Congress) examines the use of public funds; evaluates federal programs and policies; and provides analyses, recommendations, and other assistance to help Congress make informed oversight, policy, and funding decisions. As part of their mandate, they monitor and review the 340B drug discount program to determine if there are any issues with integrity and oversight and offer recommendations for greater compliance. In 2011, the GAO gave specific recommendations for HRSA. How much has been done and what is next for the 340B program?

HRSA's Office of Pharmacy Affairs announced webinar dates for information on the registration portion of the new 340B drug discount program database, 340B OPAIS (Office of Pharmacy Affairs Information System). The registration part of 340B OPAIS will be released mid-September. Webinar date and times are as follows:

On Thursday, August 17, 2017, CMS posted a notice regarding the execution of a settlement agreement entered into August 16, 2017 on its website concerning Mylan Inc. and Mylan Specialty L.P., and 340B pricing for EpiPen. According to the notice, Mylan will reclassify EpiPen Auto-Injector and EpiPen Jr. Auto-Injector as brand name drugs consistent with the Medicaid statute and regulations. Mylan will use the reference price of the 3rd quarter of 1990 for the purpose of calculating inflationary payment rebates under the Medicaid Drug Rebate program. The changes will be retroactive to April 1, 2017.

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.