340B Insight 340B Health

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

The Health Resources & Services Administration audits 200 covered entities each year for compliance with 340B rules. We speak with Mark Capuano, senior director of the corporate pharmacy 340B program at New York City Health and Hospitals, about what hospitals should expect when they find out they will be going through a 340B audit.

How a hospital can prepare for a 340B audit

Auditors typically will ask to schedule a pre-site visit call and will provide a data request list for the information the auditor is seeking. Mark says it is important to provide this information in a timely, accurate and concise way, and to make sure you inform key stakeholders at your organization so you can get the subject matter experts involved. He also recommends doing test runs of the audit ahead of time.

What a hospital should expect on the day of an audit

On the day of an audit, the auditor will trace a sample to see how a 340B drug goes from drugmaker to pharmacy to patient. The auditor will assess whether the hospital is following its 340B policies and procedures to make sure the drug went to an eligible patient and does not involve a duplicate discount. Mark says the process can be very stressful but that it also provides an opportunity to reframe the audit to showcase the great work of your hospital.

What hospitals should do if they receive audit findings

If HRSA issues a finding, the hospital must draft and implement a corrective action plan. Mark recommends bringing in legal counsel and 340B consultants to review this document. After HRSA approves the CAP, the hospital will demonstrate to the agency that it is in place to ensure compliance going forward.

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 340B Program Integrity Website

340B sits at an intersection where federal programs and state agencies come together. Maine, Minnesota, and Washington recently enacted new laws requiring hospitals to report 340B information to the states each year. What should health systems know about these new requirements? We speak with Danny Ackert, the director of state government relations at the Minnesota Hospital Association, to learn more about what these requirements look like in his state and what hospitals might expect in other states considering such reporting.

What Minnesota’s reporting law requires

Danny explains that Minnesota’s new reporting law requires 10 aggregated categories of information that hospitals and other covered entities must submit starting this April. Individual hospitals’ reports will not be made public, but an aggregated report due in November will be made available to the state legislature and the public.

Adjusting to an unprecedented system

Minnesota’s new 340B requirements mandate an entirely new reporting system that the 340B program has not been trained to. These new requirements will affect 340B operations for small and large hospitals alike. 

Advocacy advice for hospitals in other states

Danny urges covered entities in other states that might be considering reporting to be speaking up on 340B now. He says talking about 340B can seem complicated because it involves pharmacy benefits, discounts and acquisitions, costs, savings, and more, but it is important for legislators to be educated on how it works.

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
Senate 340B Bipartisan Working Group Discussion DraftStatement on Senate 340B Bipartisan Working Group Discussion DraftSenators Developing 340B Bill Seek More Feedback on Contract Pharmacy, Patient Definition, Child Sites

We are returning to a popular episode format we aired early last year, when we consulted with 340B Health’s expert staff to answer your most pertinent 340B questions. As we start another busy year for 340B, we help you prepare for the action by answering your questions about the Genesis court decision, 340B activity in state legislatures, Medicare Part B repayments, and more. 

Patient Definition After the Genesis Decision 
One listener wonders how the recent Genesis court decision might affect 340B patient definition issues. We discuss the implications, the status of HRSA’s 1996 patient definition guidelines, and expectations for covered entities in the wake of this decision. 

Federal and State 340B Action
In response to listeners’ question, we discuss how 340B might come up on Capitol Hill and in state legislatures this year. After a busy first half of the 118th Congress for 340B, we discuss how the election year may influence issues on Capitol Hill and how lawmakers in numerous statehouses are already considering changes to 340B in their states. 

Timing of Repayments for Medicare Cuts
Listeners inquire about upcoming Medicare Part B repayments, an increase in manufacturer overcharges for 340B drugs, last year’s HRSA 340B audit findings, and the expected effects of the government’s Medicare drug price-setting program under the Inflation Reduction Act. 

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 Stresses Federal Court Decision on Patient Definition Only Applies to Genesis FQHC Implications of Genesis Decision on 340B Patient Definition WebinarState Policy and Advocacy Resource Center Analysis of the Medicare 340B Pay Cut RemedyHRSA Program Integrity WebsiteInflation Reduction Act: Assessing Financial and Operational Challenges Webinar