drug rebates Archives - HEALTH & LIFE SCIENCES NEWS

This Week in 340B: January 14 – 20, 2025

Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick summary of relevant updates from the prior week in this industry-shaping body of litigation. Get more details on these 340B cases and all other material 340B cases pending in federal and state courts with the 340B Litigation Tracker.

Issues at Stake: HRSA Audit Process; Contract Pharmacy; Rebate Model; Other

In one Health Resources and Services Administration (HRSA) audit process case, the government filed a motion to dismiss.
In two HRSA audit process cases, the government filed reply briefs in further support of the government’s motion to dismiss.
A drug manufacturer filed suit against HRSA to challenge HRSA’s disapproval of its proposed rebate model.
A 340B covered entity filed suit against HRSA, alleging that HRSA prevented it from accessing the 340B Program.
A 340B covered entity filed suit against HRSA to challenge HRSA’s determination that certain clinics were not eligible for the 340B Program, and, in the same case, the court issued an administrative stay.
In three cases challenging proposed state laws governing contract pharmacy arrangements in Missouri and West Virginia:
- MO: Defendants and intervenors separately filed reply suggestions in support of the motion to dismiss.
- WV: Plaintiffs in two separate cases filed oppositions to defendants’ motions to consolidate

CMS Sneaks 340B Billing Proposals into Medicare Physician Fee Schedule: What 340B Stakeholders Need to Know

On July 10, the Centers for Medicare & Medicaid Services (CMS) released the 2025 Medicare Physician Fee Schedule (MPFS) proposed rule, which includes proposals related to identification of Medicare Part B and Part D claims for 340B drugs in order to exclude them from inflation-related Medicare drug rebates established under the Inflation Reduction Act. Because MPFS is not often on the radar for 340B stakeholders, we want to make sure that folks are aware of the 340B-related provisions in the proposed rule and the deadline for submitting comments. We have excerpted the relevant pages of the MPFS proposed rule for ease of reference (the entire proposed rule is well over 2,000 pages and available here. The proposed rules are generally consistent with guidance materials previously released by CMS.

As described in more detail below, the CMS proposals would eventually require claims-level information reporting to exclude Medicare Part D 340B claims and use claim modifiers to exclude Part B claims. ALL 340B-covered entities are now expected to report claim-line modifiers for separately payable Medicare Part B drugs under guidance that was effective January 1, 2024.

Comments are due on September 9, 2024. We note that in light of the recent US Supreme Court decision in the Loper Bright case and the end of the Chevron doctrine, 340B stakeholders should consider submitting comments (both in support of the proposals and with alternatives that CMS should implement). Legal challenges to whatever rules CMS ultimately implements should be expected, and the [...]

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