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Hemo Alliance Newsletters

Notes from Joe, October 2022

Notes from Joe

340B Blues
by Joe Pugliese, President and CEO

Congress passed the Veterans Health Care Act that created the 340B Program in 1992 and if you are having trouble sleeping you may want wade through the link. The 340B Program has been controversial since its inception. Ironically covered entities were remarkably slow to take advantage of the obvious benefit of the federally-mandated drug discount program. Based on personal experience, for the first two decades the pharma industry simply considered the program a cost of doing business. However, as many have noted, the program has grown substantially in the last decade. Critics describe this growth using pejorative terms, like “an explosion” and say that the program needs guardrails. PhRMA, the industry trade group, devotes a significant amount of time to eviscerating the program and calling for changes, though they fail to mention that their members would be the direct beneficiary of any curtailment of the program, perhaps an important disclosure.

Recently, the pharmaceutical industry has taken a more proactive approach to limiting the program by instituting restrictions on access to discounted products if you use contract pharmacy providers. As usual, our manufacturing partners have not applied these restrictions to HTCs. The bleeding disorders community is very appreciative of their unwavering support. Generally, the restrictions have been focused on the hospital participants in 340B (either because they are DSH (disproportionate share hospitals) and/or children’s hospitals). PhRMA and hospitals have gone to court over this restriction. Everyone agrees the restrictions are hurting the ability of covered entities to generate revenue to support patient care and services.

Historically all of the covered entities – hospitals and grantees – have consistently presented a single voice regarding the obvious value of the 340B program in stretching scarce federal resources and providing care for vulnerable populations. HTCs are grantees under the HRSA SPRANS Program (Special Programs of Regional and National Significance). Recently some of the grantees have broken with this tradition and are calling for changes to the program.

As the smallest participant in the 340B drug discount program, we have long worried that we could be harmed by these debates. We are closely watching these events unfold to make sure that we can mitigate threats. But, we are also aware that change is likely and with change comes opportunity. We are looking for opportunities to build on a program that has been pivotal in providing the financial support for HTCs to provide outstanding clinical care for the bleeding disorders community. (see studies here and here).

Also in this Issue…

Alliance Update
· Meet Jennifer Anders!
· Finding Talent Within the Bleeding Disorders Community!
· Update re: Re-Accreditation of Gene Therapy Modules Developed by Partners

Legal Update
· How to Compliantly Increase Visibility of HTCs and the Comprehensive Care Model

Washington Update
· Webinar on Implementation of the Hemophilia Skilled Nursing Facility Access Act Available

Payer Update
· Payer Trends: What You Need to Know

Notes from the Community
· Illinois Ultra-Rare Bleeding Disorders Event a Success

Team Alliance Contact Information

We work for you! Please don’t hesitate to contact any of us with any questions or concerns:

NameEmailPhone
Jeff Blakejeff@hemoalliance.org317-657-5913
Jennifer Borrillo, MSW, LCSW, MBAborrillo@hemoalliance.org504-376-5282
Jeff Amondamond@hemoalliance.org608-206-3132
Jennifer Andersjennifer@hemoalliance.org954-218-8509
Angela Blue, MBAangela@hemoalliance.org651-308-3902
Karen Bowe-Hausekaren@hemoalliance.org717-571-0266
Zack Duffyzack@hemoalliance.org503-804-2581
Michael B. GlombMGlomb@ftlf.com202-466-8960
Johanna Gray, MPAjgray@artemispolicygroup.com703-304-8111
Kiet Huynhkiet@hemoalliance.org917-362-1382
Elizabeth Karanelizabeth@karanlegalgroup.com612-202-3240
Kollet Koulianos, MBAkollet@hemoalliance.org309-397-8431
Roland P. Lamy, Jr.roland@hemoalliance.org603-491-0853
Dr. George L. Oestreich, Pharm.D., MPAgeorge@gloetal.com573-230-7075
Theresa Parkertheresa@hemoalliance.org727-688-2568
Mark Plencnermark@hemoalliance.org701-318-2910
Ellen Rikereriker@artemispolicygroup.com202-257-6670