The next 340B quarterly registration period is once again upon us. The 340B registration window began on July 1st and will conclude on July 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.
All covered entities (CE) and child sites are required by the 340B statute, administered by HRSA, to recertify annually for the 340B program. Failure to do so, will result in removal from the 340B program. The 2018 recertification window runs from August 15, 2018 - September 12, 2018.
On Tuesday, June 19, 2018, the Senate HELP Committee held a hearing on the “Effective Administration of the 340B Drug Pricing Program”, featuring the testimony of only Captain Krista Pedley, Director of HRSA Office of Pharmacy Affairs. The theme of the hearing focused on HRSA’s oversight of the 340B program and the necessary data points needed to measure the program according to its Congressional intent.
HHS Secretary, Alex Azar, appeared before the Senate HELP committee on Tuesday, June 12, 2018 to provide testimony regarding the details of the Trump Administration’s drug pricing blueprint. The hearing was more of a launching point to further the discussion on the topic of lowering drug costs. No definitive action plans were outlined, but a myriad of potential target areas were discussed.
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:
On January 23, 2015, Michael Newell, SCA’s President, authored a blog article entitled 340B meets S-10, which can be found HERE. The impetus for this article was a report published by the Alliance for Integrity and Reform of 340B (AIR340B). In this article, the authors concluded that 340B hospitals appear to provide only a minimal amount of charity care thus calling into question whether or not Congress’ intentions for the 340B program are being met. The data used to reach this conclusion was derived from the Medicare Cost Report, CMS-2552-10, S-10 – the very data that CMS currently uses as the basis to allocate the uncompensated care pool for the Medicare DSH/uncompensated care program.
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.