By Rob Nahoopie, PharmD, MS, ACE
Greetings, 340B community! It’s been a while since my last blog article. For those who have been with us for many years, you may recall that prior to joining SpendMend and even before the inception of Turnkey Pharmacy Solutions, we had “The 340B Program Blog.” You’ll note, we borrowed theThe from The Ohio State University – it added an air of authority. This blog was our beacon to the 340B Community.
Nowadays, I’m proud to say we’ve expanded our outreach beyond our blog and into webinars, newsletters, speaking at shows, and of course the 340B Unscripted podcast, which I have the pleasure of co-hosting with the world’s best moderator (and coolest dude), Greg Wilson. Add to all of that, we’ve continued to assemble a growing team of experts who have a great deal of experience and a lot to share. As a result, I really only get around to writing one, or maybe two of these blogs per year.
Before diving too deeply into my analysis of current and potential legislation, I want to acknowledge, that as a community, we are very fortunate to have such reliable journalists to serve as our advocates in this increasingly complex (and contentious) space. 340B Health, a membership-based 340B advocacy organization, keeps their finger consistently on the pulse of all things 340B advocacy and legislative. We also have the 340B Report, which always looks out for breaking news and reports to the 340B community. At SpendMend Pharmacy, we see our role as complementing these outlets and sharing our experience, in the trenches, with the covered entities we support.
Although I will be summarizing current legislation, my hope is to add my personal commentary and, where possible, prognostication of where things might go and how that could impact covered entities.
While we are still early in 2023, we have already seen an unfavorable 340B bill introduced. Senator Rosendale (R-MT) introduced H.R. 198 – Drug Pricing Transparency and Accountability Act. It has not made it past introduction and sits in two committees, likely due to it having impact in both the Energy and Commerce and Ways and Means. This bill has a few main goals; 1) to have a 2-year moratorium on non-rural hospital and child site registration, 2) transparency with 340B savings, and 3) modifiers for all Medicaid (FFS and MCO) and Medicare (traditional and managed) claims. This bill has not made it very far, and due to its one-sided nature, likely will not make it through both the House and Senate. With this said, it does create some interesting negotiation points. In fact, if you take a step back, you can see the chess match starting. Move one, introduce a fairly one-sided unfavorable bill to set the negotiation table without offering much in favor of 340B covered entities. Next, we may see a favorable 340B bill that tries to address contract pharmacy restrictions, PBM discrimination, or maybe even Orphan drug exclusion clarifications. It is also possible this step is skipped entirely, and we go right to a mixed bill; one with appropriate give and take for both covered entities and drug manufacturers.
What do we know? On March 2nd, 2023 we heard reports related to the Senate hearing on community health centers (CHCs), and also reported by our 340B outlets noted above, that the National Association of Community Health Centers (NACHC) and the Pharmaceutical Research and Manufacturers of America (PhRMA) may be teaming up to make some combined recommendations to congress that will have both pros and cons for 340B covered entities. Some potential areas in play were announced on March 7th by NACHC as part of their NACHC Capitol Hill Day and a 2-page flyer that was planned for use on March 9th with congress. They outlined five key principles for reform:
- Preserving: Focuses on making sure the 340B program is stable so that it can fulfill its mission. [No specifics here, but good to clarify and confirm]
- Reforming: Essentially stating that covered entities who do not provide significant amounts of care to safety-net patients should be removed from the program. [Hmm, seems to be targeting hospitals or at least some of the recent bad press that has occurred]
- Incorporating: This is targeting contract pharmacy, but in both a manner to allow for contract pharmacy without restrictions and to protect against abuse. [Our CHCs have had significant 340B savings losses due to contract pharmacy restrictions and if they worsen, it could cripple CHCs’ ability to provide the level of charity care they currently provide]
- Establishing: Here is where we get to transparency and accountability and reporting of 340B information. [CHCs are already required to be transparent, so this seems to be another balancing item that will impact hospitals even more]
- Create: This focuses on PBM/Payor 340B discrimination. [Both CEs and PhRMA can get behind this one, sorry PBMs and Payors, this one seems inevitable]
I feel like they missed the boat on a great acronym. If they switch 4 and 5 it is PRICE versus PRIEC. And the tag line could be, “If we don’t act now to reform 340B, the PRICE of lost 340B savings will be felt by patients of our safety net hospitals and clinics.” Also, they should consider changing Create to Creating, my OCD is flaring over here. Just unsolicited advice in case they read this.
Now, I am not sure if this was part of the NACHC and PhRMA joint development, but the pros for covered entities and cons that are more hospital specific are interesting, don’t you think? Regardless, I think it is very possible we see a bill that is in line with these key principles. Think about this: the House is GOP, which is more likely to be in line with something that has a little give and take as outlined above. Then, we have the Senate HELP committee, although Chaired by Bernie Sanders (I-VT), whose Ranking member is Bill Cassidy (R-LA), and Cassidy has been critical of hospitals in the 340B program. So, I am saying there’s a chance!
I initially thought that 340B legislation was a long shot with a GOP House and Democratic Senate; however, there appears to be a deal that can be made here. Currently, the hospitals may be on the outside looking in. It is time for all hands on deck. I am looking at the Senate HELP committee membership right now and I can see I have work to do. Mitt Romney (R-UT) is on the list, so I will be reaching out personally to share how important the 340B program is to our community. Although, I think hospitals need to plan on transparency as the olive branch here. The question is if it is just transparency or use of savings as well.
The fun part about writing a blog article like this is that you get to see if your crystal ball is broken or not. However, this story is not over, you can still make an impact. Don’t just watch things unfold like you are reading a John Grisham novel. Work with your advocacy staff, if you are lucky enough to have one, and if not, then make it happen yourself. Our senators and representatives will only know how important the 340B program is if you help educate them.
Hopefully we get to see many of you at 340B Coalition in San Diego. We have booth 319, SpendMend Pharmacy, back middle-left; come say hello and talk some 340B shop with us. Aloha everyone!
Hold the phone! We were about to hit the publish button and just saw the 340B Health update on the NACHC/PhRMA “potential” recommended changes they may make to congress. And all I can say is “Wow” and not in a good way. On March 9th, this group has come forward with a new name and a 10 point Principles list for ensuring the 340B Program benefits patients and “true” safety-net providers (I added the quotes on “true” as it seems to be an intentional word). The new group is named the Alliance to Save America’s 340B Program (ASAP 340B) and includes NACHC, PhRMA, and ten other organizations. I won’t turn this into a dissertation, and this will be a hot topic as we move forward. So, everyone go and read the 10 principles at asap340b.org. As we are now accustomed to, the main constant with the 340B program is change.