HEALTH & LIFE SCIENCES NEWS

This Week in 340B: June 28 – July 1, 2024

by Emily Jane Cook, Bryan Frederick, Jae Hyun Lee, Patrick Moore and Kelsey Reinhardt | Jul 3, 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

Two drug manufacturers filed three separate complaints against two state attorneys general to challenge state laws governing contract pharmacy arrangements.
In four separate cases challenging state laws governing contract pharmacy arrangements:
- - A defendant state attorney general filed a motion to dismiss. In the same case, four proposed amici filed a brief of amici curiae in support of defendant’s opposition to plaintiff’s motion for a preliminary injunction.
  - A separate defendant state attorney general filed a response in opposition to plaintiff’s motion for preliminary injunction.
  - A court denied the plaintiff’s motion for preliminary injunction.
  - Four proposed amici filed a brief of amici curiae in support of a separate defendant state attorney general’s opposition to plaintiff’s motion for a preliminary injunction.

CMS Issues FAQs to Aid Pharmacies in Preparing for Medicare Part B Coverage of PrEP Medications

by Gregory E. Fosheim, Monica Wallace, Emily Jane Cook and Jae Hyun Lee | Jun 26, 2024 | Hospitals & Health Systems, Life Sciences, Managed Care

As we previously advised, the Centers for Medicare & Medicaid Services (CMS) is preparing to issue a national coverage determination (NCD) for pre-exposure prophylaxis (PrEP) using antiretroviral drugs to prevent HIV under Medicare Part B. In response to questions from stakeholders, CMS released FAQs on June 25, 2024, to guide pharmacies through certain enrollment and billing intricacies.

Specifically, pharmacies are instructed that no new Medicare enrollment is needed if pharmacies are already enrolled in Medicare as a Part B pharmacy or a durable medical equipment, prosthetic, orthotics and supplies (DMEPOS) supplier. However, if the pharmacy is not currently enrolled in Medicare, they should consider enrolling as a Part B pharmacy rather than a DMEPOS supplier so that they are not subject to the supplier standards, accreditation and surety bond requirements.

CMS also provides pharmacies with appropriate ICD-10 CM diagnosis codes and J-codes to include with claims and instructs pharmacies that the date the drug is picked up or mailed should be entered as the date of service. Finally, recognizing that some pharmacies will fill orders for injectable PrEP to be administered by qualified practitioners, pharmacies may include a claim for the supplying fee along with a claim for the drug where appropriate. CMS anticipates that the final NCD will be posted and effective in late September 2024. The NCD is expected to be similar to the proposed NCD published on July 12, 2023.

This Week in 340B: June 18 – 24, 2024

by Emily Jane Cook, Reuben Bank, Bryan Frederick, Jae Hyun Lee, Patrick Moore and Kelsey Reinhardt | Jun 25, 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 plaintiffs filed a memorandum opposing the government’s motion to dismiss.
In a case challenging proposed state laws governing contract pharmacy arrangements, a pharmaceutical company filed a motion for preliminary injunctive relief.
In a separate case challenging proposed state laws governing contract pharmacy arrangements, defendant state attorney general filed a motion in opposition to plaintiff’s motion for preliminary injunctive relief.
A drug manufacturer filed two separate complaints against two state attorneys general to challenge state laws governing contract pharmacy arrangements.
A nonprofit organization filed an amicus curiae brief in support of the 340B Covered Entity plaintiff-appellant in a contract pharmacy case.
In five separate cases challenging state laws governing contract pharmacy arrangements:
1. 1. Two plaintiffs filed separate motions for preliminary injunctions;
  2. Two state defendants filed answers to the plaintiffs’ complaints as well as oppositions to the plaintiffs’ motions for a preliminary injunction;
  3. One state [...]
    
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This Week in 340B: June 11 – 17, 2024

by Emily Jane Cook, Patrick Moore and Kelsey Reinhardt | Jun 20, 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 a breach of contract claim related to payments for 340B drugs filed by a 340B Covered Entity against several related party Medicare Advantage plans, the Medicare Advantage plans filed a motion to dismiss.
In a contract pharmacy case, the 340B Covered Entity plaintiff-appellant filed its opening appeal brief.
A drug manufacturer filed a complaint against a state attorney general to challenge a state law governing contract pharmacy arrangements.
In two related cases regarding a state law governing contract pharmacy arrangements, defendant state attorney general filed motions to consolidate the two cases.
In another case regarding a state law governing contract pharmacy arrangements, the parties filed a joint motion for a modified briefing schedule.

This Week in 340B: June 4 – 10, 2024

by Emily Jane Cook, Jae Hyun Lee, Patrick Moore and Kelsey Reinhardt | Jun 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+Consulting.

Issues at Stake: Contract Pharmacy

In five separate stayed cases challenging the Health Resources and Services Administration (HRSA’s) position on 340B contract pharmacy arrangements, the court maintained the stay following the appellate decision in two related cases and ordered a future joint status report.
In three related cases regarding a state law governing contract pharmacy arrangements, intervenor-defendant state primary care association filed responses to plaintiff pharmaceutical companies’ notices of supplemental authority. In one of the three cases, defendant state attorney general also filed a response to plaintiffs’ notices of supplemental authority.