HEALTH & LIFE SCIENCES NEWS

This Week in 340B: July 16 – 22, 2024

by Emily Jane Cook, Bryan Frederick, Margaret Houtz, Deepika Raj and Kelsey Reinhardt | Jul 26, 2024 | 340B

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, a subscription product from McDermott+.

Issues at Stake: Contract Pharmacy; Other

In a case challenging a state law governing contract pharmacy arrangements, the plaintiff filed a motion to compel compliance with third-party subpoenas and a covered entity moved to intervene as a defendant.
In a case challenging a state law governing contract pharmacy arrangements, the plaintiff filed a memorandum in support of its motion for preliminary injunctive relief and in opposition to defendants’ motion to dismiss.
In a case challenging a state law governing contract pharmacy arrangements, the defendants filed a motion to dismiss and a memorandum of law in opposition to the plaintiffs’ motion for a preliminary injunction.
In an appealed qui tam action alleging that various drug manufacturers failed to charge accurate ceiling prices to 340B Covered Entities, the plaintiff-realtor filed its opening brief.
In a case challenging a state law governing contract pharmacy arrangements, the defendant filed its answer to the plaintiff’s complaint and the plaintiff filed a motion for preliminary injunction.
A drug [...]

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

by Emily Jane Cook | Jul 23, 2024 | 340B, Reimbursement

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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This Week in 340B: July 9 – 15, 2024

by Emily Jane Cook, Reuben Bank, Bryan Frederick, Margaret Houtz, Patrick Moore and Kelsey Reinhardt | Jul 17, 2024 | 340B

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, a subscription product from McDermott+Consulting.

Issues at Stake: Contract Pharmacy; Medicare Payment

In the consolidated Medicare payment cut case, the government filed a reply in support of its cross motion to dismiss.
In a case challenging proposed state laws governing contract pharmacy arrangements, an amicus brief was filed in support of defendant’s opposition to plaintiff’s motion for a preliminary injunction.
The defendants in four separate cases, all of which challenged a state law concerning contract pharmacy arrangements, filed motions to consolidate their respective cases.
In a case challenging a state law governing contract pharmacy arrangements, advocacy groups representing 340B Covered Entities filed an amicus brief in support of defendants’ motion to dismiss and in opposition to plaintiffs motion for a preliminary injunction.
In a case challenging a state law governing contract pharmacy arrangements, the plaintiff filed a memorandum opposing the defendants’ motion to dismiss.
In a case challenging a state law governing contract pharmacy arrangements, the plaintiff filed an amended complaint.
In a breach of contract claim [...]

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Loper Bright and the 340B Statute

by Emily Jane Cook | Jul 11, 2024 | 340B

In its Loper Bright decision last week, the Supreme Court of the United States likely opened opportunities for further legal challenges to the Health Resources and Services Administration’s (HRSA’s) interpretation and application of the 340B statute. Going forward, we expect that much of the 340B statute will be subject to interpretation by federal courts.

HRSA’s historic policies that are not the “best” interpretation of the statutory language may not survive legal challenges. Where HRSA retains the authority to regulate the 340B program, it will be required to demonstrate that it is acting based on “reasoned decision-making.”

Examples of what the application of the new Loper Bright standard might look like in practice, as applied to provisions in the 340B statute:

Definition of “Patient”: The 340B statute does not define “patient.” The 340B statute states in relevant part that “a covered entity shall not resell or otherwise transfer the drug to a person who is not a patient of the entity.” Under Loper Bright, a court will likely decide, without deference to HRSA, who qualifies as a patient. A court is not required to defer to HRSA’s statutory interpretation.
Requirements for Registration of DSH Hospital Child Sites Prior to Use of 340B Drugs: The 340B statute defines disproportionate share hospital (DSH) hospital covered entities as “a subsection (d) hospital (as defined in section 1886(d)(1)(B) of the Social Security Act) that [meets certain additional requirements set forth in the statute related to ownership, DSH percentage and GPO purchasing].” The 340B statute [...]

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This Week in 340B: July 2 – 8, 2024

by Emily Jane Cook, Bryan Frederick, Margaret Houtz, Patrick Moore and Kelsey Reinhardt | Jul 9, 2024 | 340B

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, a subscription product from McDermott+Consulting.

Issues at Stake: Contract Pharmacy; Medicare Payment

A drug manufacturer filed a challenge to a state law governing contract pharmacy arrangements.
In a case challenging a state law governing contract pharmacy arrangements, the state attorney general filed a motion to dismiss.
In a case challenging a state law governing contract pharmacy arrangements, four amici filed a brief in support of defendant’s opposition to plaintiff’s motion for preliminary injunction.
In a breach of contract claim filed by a 340B Covered Entity against several related party Medicare Advantage plans, the 340B Covered Entity filed its opposition to the Medicare Advantage Plans’ motion to dismiss its first amended complaint.
In a case challenging a state law governing contract pharmacy arrangements, the court denied the plaintiff’s motion for a preliminary injunction and the plaintiff appealed.
In another case challenging a state law governing contract pharmacy arrangements, the plaintiff appealed the court’s prior denial of its motion for preliminary injunction.