By 340B Health
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The podcast currently has 103 episodes available.
The 340B drug pricing program is designed to give hospitals the flexibility to use their savings toward the types of patient care and support that their communities need the most. How does that work for hospitals that decide to use their access to 340B to provide the discounts directly to patients who cannot afford their drugs? Paul Orth, 340B program manager at University Health Kansas City Truman Medical Center, sits down with us to discuss how his health system’s direct drug savings program is helping both uninsured and underinsured patients.
How the program works
Orth says his system’s direct savings program is built into the system that prescribes medication electronically from its clinics and its hospitals’ electronic medical records system. When the prescriptions that generate from those visits are sent to a system pharmacy, 340B eligibility codes are attached that allows the pharmacy to know that they are eligible to receive the drugs at the 340B-discounted price plus a dispensing fee.
Underinsured patients also benefit
Orth says University Health describes its direct savings model as an uninsured program because that describes the key patient population that benefits from receiving the 340B price. But that assistance also is available for underinsured patients who otherwise would be expected to pay more in prescription drug copays than the 340B price.
Drugmaker restrictions are a barrier
Orth says this program is the difference between patients receiving a needed medication and going without one, which prevents hospital readmissions and emergency department visits. But he also notes that drug company restrictions limiting 340B pricing to a single contract pharmacy are negatively affecting the program, ultimately adding another barrier for access to care.
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This marks the time of year when 340B hospitals complete the recertification process to maintain their eligibility for 340B. But why is this recertification needed, and what do hospitals need to know before undergoing recertification?
Steven Miller, the vice president of pharmacy services for 340B Health, describes what is at stake when it comes to hospitals completing recertification every year. Failure to do so could take a hospital months to correct and cost it millions of dollars – resources that the hospital could be using towards services for patients who need help the most.
The key players
Miller says the hospital’s authorizing official (AO) and primary contact (PC) are two of the most important figures for recertification. These individuals will be key to verifying and submitting information to the government during the process, and there are important rules governing their roles and responsibilities.
Preparing for recertification
Miller says hospitals should have their “ducks in a row” and be ready to undergo recertification as soon as the period begins. This involves having the necessary staff involved, having required documentation on hand, and being prepared to respond quickly to any inquiries from the Health Resources & Services Administration (HRSA).
Hospital best practices
Miller has tips for hospitals that want to navigate the recertification process efficiently and accurately. This includes advice on ensuring all the information in the HRSA Office of Pharmacy Affairs Information System is correct, fixing any discrepancies that could lead to future audit findings, and documenting needed changes to make sure they take effect.
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Artificial intelligence is a hot topic in 2024. Discussions about AI in health care continue to grow, including about the potential for such technology to improve care and save lives. What role might AI play in the 340B world? We speak with WVU Medicine Enterprise 340B Program Coordinator Elizabeth Gibson to learn how one health system is exploring this potential.
What Can a 340B “Bot” Do?
Gibson’s team uses artificial intelligence to improve its 340B internal auditing processes. What they call “the bot” can streamline the process by pulling data from the health system’s electronic medical records system and automating the administrative tasks required to set up an audit. The bot also can make the process more effective by increasing the number of audited claims and flagging potential problem areas. She noted this makes the team more prepared for the data they must collect for external 340B audits as well.
Lessons Learned During Implementation
Gibson said installing the bot for 340B use was a very “trial and error” approach, though the team was able to make quick changes to fix any issues they encountered. She said one of the biggest growing pains of the AI-based system was the time needed to make the tool operational. She also notes the bot may be clunkier than a product they would have purchased through an outside vendor because it is designed to allow the team to customize and modify as needed.
Opening Eyes to the Benefits of Automation
Gibson said this new tool has led to her team re-evaluating other 340B processes that they can automate, even if that does not involve AI. WVU also is considering potential bots that will look specifically at Medicaid claims and help conduct retail audits. She urged health systems to consider the concept of automation more broadly than AI, bots, and machine learning, as collaborating with other departments that can share automation skills could help improve overall 340B processes.
We have released several episodes in recent months in which we have discussed federal and state legislative efforts on 340B. But what does it take to get 340B protections through a state legislature and to the governor’s desk? In this episode, we speak with Ryan Cross, vice president of governmental affairs with Franciscan Missionaries of Our Lady Health System, based in Baton Rouge, La. This system operates 10 hospitals in Louisiana and Mississippi. Both states recently enacted contract pharmacy protection laws. Ryan says there were three factors involved with getting these state protections over the legislative finish line:
Relationships — Ryan says the relationships 340B advocates formed with other hospitals, lawmakers, and public policy staff contributed to their successes at the state level. The first time to discuss 340B with these individuals cannot be when a bill is going up for consideration, much less when stakeholders are on defense and trying to explain the importance of 340B in the wake of legislation that would harm covered entities.
Messaging — Ryan explains how the messaging that resonated in the states during the 340B contract pharmacy debate focused on how big pharma is trying to take money away from not-for-profit hospitals and drive it to out-of-state shareholders. By emphasizing the variety of patient programs and support that are possible because of 340B without making it a referendum on the federal program at large, that case mostly sells itself.
Grassroots — Ryan notes that there are roughly 18,000 members of his health system across Louisiana and Mississippi. These are physicians, nurses, pharmacy techs, and other health care professionals with representatives that they can contact. Knowing when to deploy these grassroots supporters to make phone calls and send emails is important, because that can get attention and results when timed well.
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While significant 340B actions have happened at the federal level, state legislatures also have made big moves in the world of 340B so far this year. We are joined by Amanda Sellers Smith, 340B Health’s legal counsel, to explain more.
More states ban drug company restrictions on 340B contract pharmacies
Following the lead of Arkansas and Louisiana, five additional states have enacted contract pharmacy protection laws so far this year. Some states enacted standalone contract pharmacy laws, while others paired these laws with PBM non-discrimination bills. Another bill is with the governor in Missouri after passing the state legislature.
Court battles continue despite early wins for state 340B laws
The pharmaceutical industry continues to fight state 340B protection laws in federal courts, with most challenges focusing on whether federal 340B law preempts such state laws. So far, none of those lawsuits have succeeded, with one federal district court and one federal appeals court rejecting the preemption arguments.
More states consider requiring 340B hospital savings data
Last year, Maine, Minnesota, and Washington enacted 340B reporting laws at the state level. And while no additional reporting packages have passed out of state legislatures so far this year, several considered doing so, and Minnesota added even more requirements for hospitals. These reporting requirements add burdens to covered entities and raise concerns about how states will use this information in the future.
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The world of 340B has seen significant developments on the state and national levels in recent months. A second federal appeals court decision on 340B contract pharmacies came down in recent weeks, a new bill in Congress threatens to impose significant restrictions on hospital participation in 340B program, and more states move to protect covered entities from drugmaker restrictions. To understand these new developments, 340B Health President and CEO Maureen Testoni joins us to explain more.
A second federal appeals court rules for drug companies
In May, the D.C. Circuit Court of Appeals ruled that the 340B statute does not categorically prohibit drug manufacturers from imposing their own conditions on 340B. However, the court did note that manufacturers cannot impose a condition that effectively prevents a covered entity from purchasing a particular drug at the 340B price. This raises the importance of entities demonstrating situations in which they are cut off from all 340B access to a drug. Another appeals court based in Chicago has yet to issue a decision in its 340B contract pharmacy case.
More states ban 340B restrictions as the industry increases state lobbying efforts
So far this year, Kansas, Maryland, Minnesota, Mississippi, and West Virginia have joined Arkansas and Louisiana in enacting laws to prohibit contract pharmacy restrictions on covered entities. But the pharmaceutical industry has become much more active in opposing ongoing legislative efforts in other states. A “dark money” group also has been running ads opposing these state bills by accusing covered entities of laundering taxpayer money to subsidize care for undocumented immigrants.
New pharma-backed bill in Congress would slash 340B hospital eligibility
U.S. House lawmakers recently introduced a bill known as the 340B ACCESS Act. The legislation is backed by the Pharmaceutical Research & Manufacturers of America (PhRMA) and the National Association of Community Health Centers (NACHC). It would impose significant restrictions on 340B hospital eligibility and access to savings, including by restricting 340B usage for insured patients and tying participation in the 340B program directly to levels of charity care.
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1. Statement on New Federal Legislation To Restrict 340B Hospital Eligibility
2. Statement on D.C. Circuit Appeals Court Decision on Drug Companies’ 340B Restrictions
3. Report: 340B Hospitals Prescribe Medicare Part D Drugs to Greater Shares of Historically Underserved Patients
4. House Energy and Commerce Oversight and Investigations Subcommittee Hearing on 340B June 4
The finalized 340B administrative dispute resolution (ADR) rule is set to go into effect on June 18 and will create a process to settle certain disputes between covered entities and drug manufacturers. But what should covered entities know about this process before it launches? Jason Reddish, a 340B expert with the Powers Pyles Sutter & Verville health care practice group, joins us to discuss.
How the ADR is intended to work
Jason notes that the ADR will use a panel of government officials to arbitrate certain types of disputes between covered entities and manufacturers. This process can allow covered entities to bring complaints against manufacturers for overcharging, and it can allow manufacturers to bring complaints against previously audited covered entities relating to allegations of diversion or duplicate discounts. The panel collects evidence from both sides and issues a binding decision in the dispute.
The pros and cons of the final rule
Jason says there are aspects of the final rule that are favorable to covered entities and some areas they might find lacking. The panels will be able to hear a wider range of complaints against drug companies, will have lower barriers to entry, and will avoid potential conflicts of interest in choosing their members. But they also will be able to take up to a year to issue decisions, will not be required to publish their findings, and will be able to hear certain controversial cases about alleged duplicate discounts.
Having offensive and defensive strategies
Jason recommends that covered entities be prepared for navigating the ADR process as both the filer of a complaint and as the subject of a complaint. Both parties must engage in good-faith efforts to resolve the dispute and drugmakers cannot file a complaint against a covered entity without conducting an approved audit first, so an ADR complaint should not come as a surprise to either party. Entities should consult legal counsel before making decisions related to any dispute.
Check out all of our episodes on the 340B Insight podcast website. You also can stay updated on all 340B Health news and information by visiting our homepage. If you have any questions you’d like us to cover in this podcast, email us at [email protected].
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Hospitals throughout the U.S. use their 340B savings in innovative ways to care for their patients in need. In some cases, they can take that care outside the walls of the hospital to meet patients where they learn, live, and play. We speak with Heather Armstrong with Comanche County Medical Center in central Texas to tell us how her health system invests 340B savings into innovative approaches to community care.
Improving student health on campus
Since the end of 2022, Comanche County Medical Center has been operating a school campus-based program that pairs onsite diagnostic equipment with telehealth visits to keep students and staff healthy without requiring families to miss school and work. The program has decreased absenteeism and enabled faster recoveries for the patients it serves.
Putting community care on wheels
Comanche County Medical Center has a fully equipped mobile van clinic that it can deploy wherever the community needs care. By bringing the clinic to food drives, sporting events, and areas affected by wildfires, the center has been able to provide many more residents with preventive services, medications, and other vital care that they otherwise would not have accessed.
Expanding the reach through pharmacy partners
The community pharmacies that Comanche County Medical Center partners with, combined with prescription delivery services, has greatly expanded the numbers of patients whom the center can connect to needed prescription drugs. But drugmaker restrictions on contract pharmacies has had substantial negative impacts on that access and has affected the center’s plans for health services growth.
Check out all of our episodes on the 340B Insight podcast website. You also can stay updated on all 340B Health news and information by visiting our homepage. If you have any questions you’d like us to cover in this podcast, email us at [email protected].
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340B savings can help hospitals and other covered entities better serve patients and improve their health outcomes. But how can these entities make the best use of 340B funds for their institutions? We sat down with Matt Webber, director of pharmacy business at Novant Health based in North Carolina, to learn more.
340B optimization strategies
One way that Novant Health optimized its 340B program was through a multidisciplinary team that includes data analysts and auditors. Matt says that while this team prioritizes compliance above all else, it also can focus on technology and data to increase 340B efficiency and to find opportunities to increase patient access to the drugs and care they need.
How 340B optimization helps patients
Novant Health was able to use their 340B optimization team to find cases in which patients receive a prescription from the hospital but use a non-contracted pharmacy to fill their medication. The team found out where this was occurring and used the information to expand their contract pharmacy footprint and better meet patients’ needs where they are.
The complexity of optimizing
Matt says health systems can encounter numerous systemic challenges in pursuing 340B optimization, including navigating individuals’ choice, rising drug costs for patients, and complex reimbursement issues. Still, Novant’s optimization efforts are paying off for patients by measurably improving their health outcomes and connecting them to more affordable drugs and care.
Check out all of our episodes on the 340B Insight podcast website. You also can stay updated on all 340B Health news and information by visiting our homepage. If you have any questions you’d like us to cover in this podcast, email us at [email protected].
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The 340B community has seen major activity on several fronts since the start of 2024 – the introduction of new legislation on Capitol Hill, movement on legislation in the states, and key developments in the courts. 340B Health President and CEO Maureen Testoni returns to the show to help us make sense of these developments and how they might affect stakeholders.
Federal bills could help covered entities but also limit 340B’s scope
One new bill introduced in the House of Representatives would restore access for covered entities to 340B pricing through their community and specialty pharmacies, as well as protecting access to discounted pricing at in-house pharmacies. The bill would tackle drug company restrictions that have been in place for nearly four years by authorizing the government to impose civil monetary penalties for drug companies that cut off this access.
But another draft bill under discussion in the U.S. Senate could have more mixed effects on covered entities. The Senate legislation would address the community and specialty pharmacy dispute, but it also could include additional provisions that would limit hospital eligibility for 340B and the types of patients that could receive 340B drugs. 340B Health was among the many stakeholder groups that submitted comments on the Senate bill discussion draft.
Major ruling by federal court is a big win for 340B advocates
The U.S. Court of Appeals for the Eighth Circuit recently ruled in favor of an Arkansas law that protects covered entity access to 340B discounts through specialty and community pharmacies. The pharmaceutical industry had sued to try to block the law in Arkansas as well as a similar law that Louisiana recently enacted. The decision will apply to any additional states within the Eighth Circuit jurisdiction that might enact their own 340B protections. Other federal appeals courts hearing drug industry challenges also will take note of this decision when considering those lawsuits.
West Virginia becomes the third state to protect 340B pharmacy access
The West Virginia governor recently signed into law a new 340B law that closely resembles the statute on the books in Louisiana. 340B hospitals in the state had worked closely with state lawmakers to advocate for the measure and drive it toward enactment. More than 20 states are considering such legislation during their current legislative sessions, so the number of states with 340B pharmacy access laws on the books could grow before the end of the year.
Check out all of our episodes on the 340B Insight podcast website. You also can stay updated on all 340B Health news and information by visiting our homepage. If you have any questions you’d like us to cover in this podcast, email us at [email protected].
Resources
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