As we head into the fall season, 340B Health invited members and corporate partners, including Sentry Data Systems, to come together to learn about congressional, administration and judicial initiatives impacting the 340B program and network with old and new colleagues. The meeting took place September 25 at Fairview Pharmacy Services in Minneapolis, Minnesota. The room was filled to capacity, with just over 50 attendees from the Midwest and beyond. Chuck Cooper, 340B Health board member and longstanding 340B program leader for Fairview Health, greeted attendees and introduced the 340B Health presenters: Rob Miller, Senior Vice President of Business Development, Strategic Planning, and Operations, and Steven Miller, Vice President of Pharmacy Services.
Politics at play
The 340B Health team kicked off the four-hour lunch-and-learn program with a review of the year’s activities, from the introduction of the congressional report on 340B to the more recent bills introduced by the House HELP committee, along with a newly introduced lawsuit from the American Hospital Association (AHA). There was an introduction to the 340B stewardship principles that the AHA recently announced, and discussions of the 340B Health impact reports that hospitals have been encouraged to prepare. The good news is, if you have your impact report, you have already started down the path to the 340B stewardship principles!
There was also speculation on the future of upcoming the House and Senate votes and discussion of the influence certain states’ votes will have on committees such as the Ways and Means, Finance, and HELP committees, which may introduce changes through their jurisdiction.
The hospitals in Minnesota have been excellent stewards of the 340B program and have done a phenomenal job educating their House and Senate leaders on the impact 340B has in their communities. The work must continue in order for hospitals to remain great stewards and advocates for the program—to both Congress and the administration.
Once the political landscape was reviewed, the conversation shifted to audit and compliance, with an emphasis on recent changes in how HRSA reviews data in preparation for their onsite visit to those hospitals that are selected for a random or targeted audit.
Some new points to consider due to these recent HRSA audit changes include:
- Hospitals should ensure their paperwork for covered entity eligibility determination is documented; in particular, they should be sure to note any exclusions to the patient definition
- Hospitals should contact the government official listed for their internal audit and surveillance monitoring to verify the phone number and email contact
- Hospitals should able to demonstrate if the hospital is government-owned or granted government powers
- Hospitals’ change logs should be able to demonstrate what was done and provide an audit trail
- Auditor focus has shifted to review how hospitals are operationalizing their policy related to date administered versus date written
- Auditors are now focusing on NPI for each state in which they provide 340B; if you do business in five states and use one NPI, each state must now be listed
- For those covered entities with contract pharmacy locations, a copy of the pharmacy services agreement must show each CE location tied to the pharmacy and must mirror the HRSA database
While we have nearly another month of political jockeying until the midterm elections, a clear message can be heard if one reviews the actions of the administration and Congress collectively regarding 340B—something is around the corner. While Congress has indicated they have no intention of providing HRSA with additional regulatory authority in the coming months, the expectation has been set that HRSA should move forward with the regulations they do have authority over. That includes civil monetary penalties, database transparency for pricing, and administrative dispute resolution, to name a few. Organizations like Sentry are working with our resources and partners, such as 340B Health, to ensure covered entities have a seat at the table. We all know 340B is on the menu.