340B Insight 340B Health

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 podcast@340bhealth.org.

Resources:
Final Administrative Dispute Resolution (ADR) Rule Adopts Several 340B Health RecommendationsReport: 340B Hospitals Prescribe Medicare Part D Drugs to Greater Shares of Historically Underserved Patients

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 podcast@340bhealth.org.

Resources:
Court-Backed Arkansas Contract Pharmacy Law Prompts Enforcement Action, More Drugmaker Retreats

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 podcast@340bhealth.org.

Resources:
Mississippi Bans Drugmakers’ Contract Pharmacy RestrictionsHRSA Issues Final Rule on Changes to Administrative Dispute Resolution (ADR) Process

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 podcast@340bhealth.org.
Resources
House Bill Would End Drugmakers’ 340B Contract Pharmacy RestrictionsLearn How Stakeholders Weighed in on Draft Senate 340B BillFederal Appeals Court Upholds Arkansas Contract Pharmacy LawWest Virginia Bans Drugmakers’ Contract Pharmacy Restrictions

One of the most important elements of 340B compliance is preventing duplicate discounts. Ensuring there are no duplicate discounts is high on the list of compliance concerns for covered entities, and it is one of the major items that 340B auditors look for. But how do these entities ensure they stay compliant? On this episode, we speak to Melissa Bruce, an ACE-certified compliance analyst for the 340B Programs Team at UNC Health in North Carolina, to learn more. 

Compliance factors can vary state by state

Melissa notes that it is important for covered entities to think through the duplicate discount compliance requirements in their home state, especially if their health system treats many patients from across state borders. A border state, a community that attracts tourists, or a college town are examples of areas in which providers can face different requirements depending on Medicaid rules for the states where those patients reside.

Ensuring compliance can be complex

Ensuring duplicate discount compliance can be complex, especially if a provider has multiple child sites. How does a health system establish a carve-in or carve-out list? Melissa explains that some entities can have manual workflows that involve individuals reviewing Medicaid dispenses, understanding EHRs, and using spreadsheet skills to keep drug purchases compliant. But given the complexity that UNC Health faced under this method, the health system took a different approach.

Workflow automation can increase reliability and instill trust

UNC Health decided to use an automated workflow approach to streamline manual duplicate discount prevention tasks. The team is rolling out the automation to other locations after finding that it improved accuracy and confidence in the process. Melissa notes that each health system will need to determine whether such an automated process makes sense for them.

Check out all 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 podcast@340bhealth.org.

Resources:
New Federal Legislation Would End Drug Company Restrictions on 340BMatsui Introduces Legislation To Protect 340B Drug Pricing ProgramFederal Appeals Court Upholds Arkansas Contract Pharmacy Law

340B hospitals can register certain outpatient locations with the Health Resources & Services Administration (HRSA) as 340B child sites, which allows them to use 340B drugs. HRSA recently announced some changes to how it had been determining this eligibility during the COVID-19 public health emergency. How have these changes affected 340B hospitals, particularly those that had planned new child sites under the previous policy? For the answers to this question and more, we spoke to Chuck Stubbs, a 340B pharmacist with Intermountain Health based in Salt Lake City. 

How new hospital child sites gain 340B eligibility

Chuck explains that 340B child sites are outpatient departments that are not on the main hospital campus but are fully integrated with the hospital parent site. To start using 340B drugs at a new child site, the location must appear on a filed Medicare cost report with associated costs and charges and then be registered with the HRSA Office of Pharmacy Affairs Information System (OPAIS).

What changed during the pandemic

Prior to the COVID-19 pandemic, the process to start using 340B drugs at a new child site could involve up to nearly two years. Chuck notes that during the pandemic, HRSA indicated that child sites that had not yet been registered could begin using 340B drugs right away if they were for eligible patients. Hospitals believed that shift in policy would be permanent.

Where things stand now

The COVID-era child site eligibility changes did not last. In October 2023, HRSA ended what it called a temporary flexibility, citing the termination of the public health emergency in May 2023. Although HRSA granted a grace period for hospitals to come into compliance, that did not provide protections for planned child sites that had not yet been using 340B drugs. Chuck explains how this affected one of Intermountain’s planned sites, and he shares advice for hospitals that are in similar situations.

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 podcast@340bhealth.org.

Resources:
HRSA Announces Policy Restricting Use of 340B at New Child Sites After Transition Period