Jessica Larsen-Gallup began her career as a clinical research specialist focused on oncology for a pharmaceutical manufacturer. She had been inspired in her career path by Clarice Starling, Jodie Foster’s character in Silence of the Lambs, a dogged investigator who ultimately puts seemingly unrelated puzzle pieces together to crack the case.
Then, as a clinical research coordinator, Larsen-Gallup handled a similar role at Avera Health until 2009, when Avera McKennan Hospital & University Center became eligible for the Public Health Service Act’s 340(b) program. It requires drug manufacturers to provide medications at a reduced price for outpatient drugs for qualifying hospitals. Because the program is intended to benefit organizations that serve the nation’s most vulnerable patients, Larsen-Gallup knew she had found a new venue for her project management, collaboration, education, and problem-solving skills.
“Since Avera is a network of safety-net hospitals, the 340(b) program helps stretch our federal resources further,” Larsen-Gallup says. “The opportunity to help implement it meant that I could play a role in enabling more of our patients to receive healthcare care close to home. It was very exciting to contribute to the effort.”
The Avera network serves nearly 1 million patients through thirty-three different clinical facilities in one hundred communities throughout South Dakota and parts of Iowa, Minnesota, Nebraska, and North Dakota. A significant portion of those patients who are economically insecure qualify for discounted services at Avera facilities. That’s because most charitable care providers serve individuals who earn up to 150 percent of federal poverty guidelines. However, Avera allows up to 400 percent of the guidelines and also includes other expenses and debt load as part of its charity care qualifying calculations.
The three-year learning curve for setting up 340(b) to be fully operational took Larsen-Gallup somewhat by surprise. “Even working with Dr. Steve Petersen, vice-president of pharmacy services, who has more than thirty years of experience, the process was overwhelming,” she admits. “I see my new hires go through the same experience and tell them it’s all part of the process. With so much complexity, they have to accept the idea that they won’t be experts for a while.”
Her process included identifying and interviewing appropriate subject matter experts, learning a vast array of new and highly nuanced terminology, attending conferences, and researching details with various consulting organizations.
Aside from the complexity of qualifying for and staying in compliance with the program, Larsen-Gallup also discovered the extent to which 340(b) has an impact throughout the healthcare system. “Everyone thinks of it as a pharmacy program, but it goes well beyond that,” she says. “It has an impact—and requires input from—everyone from billing and cost reporting to clinical and information technology staff.”
In 2010, the Affordable Care Act expanded the reach of 340(b). In addition to disproportionate share facilities like Avera McKennan, critical access and community hospitals could also qualify. Because of their experience, Petersen and Larsen-Gallup were tasked with identifying which of the remaining thirty-two Avera locations qualified, and then bringing them into the program.
Even though her expertise had increased exponentially, the new assignment carried even more challenges than the original McKennan initiative because, in addition to subtle operational differences at each facility, they also used different drug wholesalers, automated medication dispensing machines, as well as discrete health information systems.
“The lack of standardization made things difficult,” Larsen-Gallup says. “We couldn’t take boilerplate files from one site and move them to another. Each set and each system had to be rebuilt, retested, and reintegrated.”
By tackling the facilities in groups of five or six at a time, the process was completed within three years. It resulted in a total of twenty-two Avera facilities qualifying for and coming into compliance with existing 340(b) requirements.
Using the same approach, Larsen-Gallup has helped lead a standardization initiative across the Avera network. This includes a single vendor that provides software to manage all 340(b) compliance information. In addition, all locations will be using a single formulary and an enterprise-wide upgraded version of Meditech, both of which are expected to be completed in 2020.
“Standardization will help tremendously with managing 340(b),” Larsen-Gallup says. “Instead of having to replicate processes, we’ll be able to manage activities like drug mapping once and then push them out to all the covered facilities.”
From a much less technical perspective, Larsen-Gallup is constantly aware of the mission that guides the execution of all her responsibilities. Avera is a healing ministry owned by the Benedictine Sisters and Presentation Sisters, and even though 340(b) is a behind-the-scenes activity, she focuses on the impact it has just as if she was involved in caring for patients face-to-face.
“The work my team does and the cost savings we help create translates into keeping local hospitals financially viable and making it possible for a grandmother having a heart attack to be treated locally instead of having to drive one hundred miles for treatment,” she says. “Because of our mission, there’s a grace and a humility in the human condition that we are asked to experience, and I think it makes a difference that our patients can feel.”
340(b) By the Numbers
The Public Health Service Act’s 340(b) program accounts for 5 percent of all medicines purchased in the United States each year. In 2016, that amounted to approximately $16.2 billion. Covered healthcare facilities can provide discounted medicines to all qualified patients, whether they are uninsured, covered by Medicaid, or private insurance.
Photo by Chad Lubbers