340B Archives - Page 2 of 17 - HEALTH & LIFE SCIENCES NEWS

This Week in 340B: September 10 – 16, 2024

by Emily Jane Cook, Margaret Houtz, Jae Hyun Lee, Patrick Moore, Deepika Raj and Kelsey Reinhardt | Sep 18, 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: ADR Rule; Medicare Payment; Contract Pharmacy; Other

In a case concerning the ADR Rule, the parties filed a joint status report.
In a breach of contract claim filed by a 340B Covered Entity against several related party Medicare Advantage plans, the court set trial for April 2026.
In an antitrust case filed by a Covered Entity against a group of drug manufacturers, the manufacturers filed a joint brief of defendant-appellees.
In a breach of contract claim filed by a complainant, the court issued a formal mandate for final judgment.
In 12 cases challenging a proposed state law governing contract pharmacy arrangements in West Virginia, Maryland, Mississippi, Missouri, and Kansas:
1. WV: Defendants in three cases filed notices of supplemental authority. In one of those cases, plaintiffs filed a response.
2. MD: Defendants filed a memorandum opposing plaintiff’s motion for expedited discovery.
3. MS: Plaintiffs in each of two cases filed their opening briefs in the Fifth [...]

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This Week in 340B: September 3 – 9, 2024

by Emily Jane Cook, Bryan Frederick, Margaret Houtz, Patrick Moore, Deepika Raj and Kelsey Reinhardt | Sep 11, 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: Medicare Payment; HRSA Audit Process; Contract Pharmacy

In a breach of contract claim filed by a 340B Covered Entity against several related party Medicare Advantage plans, the Medicare Advantage plans filed its answer to the Covered Entity’s first amended complaint.
A 340B Covered Entity filed a complaint against HRSA challenging HRSA’s decision to approve a manufacturer’s request to audit the Covered Entity.
In seven cases challenging a proposed state law governing contract pharmacy arrangements in West Virginia, Mississippi, Arkansas, Minnesota, Maryland, and Missouri:
- WV: Defendants filed a reply in support of their motion to dismiss.
- MS: The court granted the parties’ joint motion to stay proceedings.
- MN: The defendant filed a motion to dismiss the plaintiff’s amended complaint.
- AR:
  ○ The intervenor filed a reply in support of its motion to dismiss.
  ○ An amicus filed a brief in support of the petitioner’s petition for a writ of certiorari
  before the US Supreme Court.
- MD: The defendants [...]
  
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This Week in 340B: August 27 – September 2, 2024

by Emily Jane Cook, Bryan Frederick, Margaret Houtz, Patrick Moore and Deepika Raj | Sep 4, 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

In seven cases challenging a proposed state law governing contract pharmacy arrangements in Arkansas, Missouri, Maryland, and West Virginia:
- AR: The plaintiff filed an opposition to the intervenor’s motion to dismiss.
- MO: The plaintiff filed a response in opposition to defendant’s motion to dismiss and a response in opposition to defendant’s motion to transfer venue. In the same case, a group of three amici filed an amicus brief in support of the defendant’s motion to dismiss and opposition to plaintiff’s motion for a preliminary injunction.
- MD: The defendants filed a reply in support of their motion to dismiss the plaintiff’s complaint.
- WV: In two cases, defendants filed answers to plaintiff’s complaints, and plaintiffs filed replies in support of their motions for preliminary injunctions. In a third case, defendants filed an answer to plaintiff’s complaint. In a fourth case, plaintiff filed a combined memorandum in support of its motion for a preliminary injunction and in opposition to [...]
  
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This Week in 340B: August 20 – 26, 2024

by Emily Jane Cook, Bryan Frederick, Margaret Houtz, Jae Hyun Lee, Patrick Moore, Kelsey Reinhardt and Deepika Raj | Aug 28, 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; Medicare Payment; Other

In a case challenging HRSA’s position on contract pharmacy arrangements, the parties filed a joint status report.
In a breach of contract and unfair business practices case related to the activities of the 340B Prime Vendor, the United States Court of Appeals for the Ninth Circuit ruled in favor of the defendant, ruling that the plaintiff did not have a private right of action.
In a breach of contract claim filed by a 340B Covered Entity against several related party Medicare Advantage plans, the court denied the defendants’ motion to dismiss the first amended complaint.
In 16 cases challenging proposed state laws governing contract pharmacy arrangements in Arkansas, the District of Columbia, Maryland, Minnesota, Missouri, and West Virginia:
- AR: The court denied the plaintiff’s motion to compel compliance with certain subpoenas and denied the respondents’ motion to quash those subpoenas.
- DC:
  1. In two cases challenging state laws governing contract pharmacy arrangements, the [...]
    
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This Week in 340B: August 13 – 19, 2024

by Emily Jane Cook, Bryan Frederick, Margaret Houtz and Patrick Moore | Aug 21, 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

In seven cases challenging proposed state laws governing contract pharmacy arrangements:
- The plaintiff filed an opposition to the respondents’ motion to quash its subpoenas; the court granted a purported intervenor’s motion to intervene; the intervenor filed a motion to dismiss; the intervenor filed an answer in intervention to the plaintiff’s amended complaint; and a respondent filed an additional motion to quash a subpoena issued by the plaintiff.
- Defendants filed omnibus memorandums in support of their motions to dismiss PhRMA’s claims and opposing PhRMA and AbbVie’s preliminary injunction motions in three related cases. In one of those three cases, defendants additionally filed a motion to dismiss for lack of subject matter jurisdiction.
- The plaintiff filed an amended complaint and a reply memorandum in support of its motion for preliminary injunction.
- The plaintiff filed a motion for leave to file a surreply in response to defendants’ reply in support of their motion to dismiss, and defendants filed a [...]
  
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This Week in 340B: August 6 – 12, 2024

by Emily Jane Cook, Bryan Frederick, Patrick Moore and Deepika Raj | Aug 14, 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

In a case challenging proposed state laws governing contract pharmacy arrangements, the plaintiff filed a motion for a preliminary injunction and suggestion in support of the motion.
In 5 cases challenging proposed state laws governing contract pharmacy arrangements:
- The plaintiff filed a motion to compel compliance with a subpoena and a putative intervenor filed a reply in support of its motion to intervene;
- The plaintiff filed a writ of certiorari to the Supreme Court;
- Defendants filed omnibus memorandums in support of their motions to dismiss PhRMA’s claims and opposing PhRMA and AbbVie’s preliminary injunction motions in three related cases. In one of those three cases, defendants additionally filed a motion to dismiss for lack of subject matter jurisdiction.

This Week in 340B: July 30 – August 5, 2024

by Emily Jane Cook, Bryan Frederick, Margaret Houtz, Kelsey Reinhardt and Deepika Raj | Aug 8, 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

A drug manufacturer filed suit against the Kansas attorney general to challenge a state law governing contract pharmacy arrangements.
A 340B Covered Entity filed suit against HRSA to challenge HRSA’s authorization of an audit request by a drug manufacturer.
In six separate cases challenging state laws governing contract pharmacy arrangements:
1. 1. A defendant filed a motion to dismiss and a notice of related cases;
  2. A defendant filed a motion to dismiss and a notice of related cases;
  3. A plaintiff filed an opposition to a putative intervenor’s motion to intervene; a putative intervenor filed a motion for leave to file a reply in support of its motion to intervene; four respondents filed a joint motion to quash subpoenas seeking non-party discovery; and a plaintiff filed a motion to compel compliance with a subpoena;
  4. Defendants filed a reply brief in support of their motion to dismiss the plaintiff’s complaint.
  5. A group of five amici filed [...]
    
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This Week in 340B: July 23 – 29, 2024

by Emily Jane Cook, Bryan Frederick, Margaret Houtz, Deepika Raj and Kelsey Reinhardt | Jul 31, 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

A drug manufacturer filed suit against the Kansas attorney general to challenge a state law governing contract pharmacy arrangements.
In an appealed qui tam action arguing that private parties can bring suits to enforce the 340B Statute, the appellant-relator filed its opening brief, and four amicis filed briefs in support of the appellant-relator.
In four cases challenging separate state laws governing contract pharmacy arrangements:
1. The defendants filed a reply brief in support of their motion to dismiss plaintiff’s complaint, and the plaintiff filed a response to defendants’ motion to consolidate this case with three other similarly situated cases;
2. The defendants filed a memorandum in support of their motion to dismiss plaintiff’s complaint;
3. The parties filed a joint motion to stay proceedings; and
4. The defendant filed a motion to stay proceedings.

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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