340B: What to Expect in 2023

As we look forward towards 2023, it’s important to update clients on the changes we anticipate will take place in the coming year. With midterm elections, key priorities of 340B stakeholders, and HRSA audit changes continually altering the landscape, here’s a breakdown of information we’ve gathered on what to expect next year:

1. Manufacturer contract pharmacy lawsuits
The federal government is attempting to sanction multiple manufacturers while drug companies challenge them in court. These court decisions could determine how many contract pharmacies operate in the future, as there are decisions happening for three key outstanding cases in early 2023. The results of these cases will determine whether manufacturers have the right to continue enforcing decisions they’ve previously been allowed to make for contract pharmacies or if significant positive changes will be made

2. Key priorities of 340B stakeholders
According to 340BReport, the focus of many 340B stakeholders in 2023 is anticipated to revolve around a few key topics:

• NACHC is seeking a meeting with HHS secretary Becerra regarding 340B contract pharmacy restrictions after an ADR decision. Once NACHC filed an alternative dispute resolution petition to challenge manufacturers restricting shipments to contract pharmacies, the ADR panel dismissed NACHC’s petition stating that these issues were already addressed in the AstraZeneca district court case.
• There’s been an effort launched to create 340C, a separate drug discount program for health centers and possibly other entities. An ACH 340C one-pager refers to “federally qualified health centers, rural hospitals, and recipients of federal grant dollars” as entities that rely on the 340B program. ACH 340C talking points refer to health centers only, however. According to a description of draft legislation, 340C entities would be entitled to reimbursement at wholesale acquisition cost for all Medicaid drugs, protection against discriminatory network and reimbursement actions by health insurers and pharmacy benefit managers, and use of contract pharmacies as necessary. Currently, NACHC does not endorse this idea for providing relief to health centers.
• A New York Times story has inflamed the debate over whether the 340B program needs to be changed after a Virginia congressman critiqued a local health system for not extending resources to the most disadvantaged community members. Stories like these will continue giving those aligned with the drug industry reason to support lessening 340B. Hospitals and covered entities have responded with reports on how 340B helps patients.

3. 340B Protect Act
One of the only bills to gain some traction this year, the 340B Protect Act addresses the problem of PBM’s discriminatory practices which prohibits them from paying below-market rates. This act requires HHS to contract with a neutral third-party to serve as a claims data clearinghouse, which will hopefully be a step toward transparency and reasonable middle ground for duplicate discounts.

4. Is Your Organization Prepared for the 2023 HRSA Audit Changes?
Keeping up with what’s new and updated requirements for HRSA audits can be challenging. That’s why Nuvem’s audit experts teamed up to present a timely webinar on what entities can expect in 2023 regarding changes and how to remain compliant. Topics including policies and procedures, CE eligibility documentation, purchasing information, contract pharmacy documentation, non-contract pharmacy ownership, and Medicaid billing can be reviewed in the webinar here.