JOHNSON AND JOHNSON and Bristol Myers Squibb Co. are among the drugmakers who will have to pay rebates to Medicare if they increase the price of medications used to treat cancer and other illnesses faster than inflation starting Oct. 1 — part of the Biden administration’s broader effort to bring down prescription drug costs, Nyah Phengsitthy reports.

• The US Department of Health and Human Services announced Monday that some Medicare enrollees will pay a lower coinsurance rate for 54 drugs administered in doctor’s offices and hospitals from Oct. 1 to Dec. 31 under the Medicare Prescription Drug Inflation Rebate Program.
• Some drugs on list include J&J’s Rybrevant, Bristol Myers Squibb’s Abecma, Astella Pharma Inc.'s Cresemba, and Amgen Inc.’s Evenity. More than 822,000 Medicare enrollees use the drugs annually, according to HHS. People with Medicare have seen savings on over 100 drugs under the rebate program since April 1, 2023, the agency said.
• The CMS intends to begin invoicing prescription drug companies for rebates no later than fall 2025. The rebate program is one of the 2022 Inflation Reduction Act’s provisions aimed at lowering drug costs. Last month, the administration announced agreements with drug manufacturers for 10 drugs under Medicare’s price negotiation program’s first round. Read More

Also Read: J&J Drops Plan to Dispense Discounted Drugs Through Rebate Model

JUDGES ARE clashing over what counts as creditor consent after the US Supreme Court left that question open when throwing out Purdue Pharma’s bankruptcy plan, Evan Ochsner reports.

• The court held that liability shields for Purdue’s Sackler family member owners were illegal because they were granted without the consent of opioid victims and other creditors. But in his majority opinion, Justice Neil M. Gorsuch declined to specify what qualifies as “consent,” leading bankruptcy judges to produce a varied landscape that can make it harder for lawyers to discern which venues they should file bankruptcies in.
• The main issue is whether “opt-out” releases, through which creditors voting on a plan are deemed to accept releases unless they check a box on their ballot explicitly stating otherwise, can be considered consensual. Creditors should have to affirmatively consent to a release for a court to grant it, the Justice Department’s bankruptcy watchdog, has said.
• In the US Bankruptcy Court for the Northern District of Texas, two judges reached conflicting answers a month apart. Judge Scott W. Everett struck down releases in Ebix Inc.'s plan, saying Purdue rendered opt-out liability shields impermissible. Down the hall, Judge Stacey Jernigan, found opt-out releases in Eiger Biopharmaceuticals’ bankruptcy plan were legal even after Purdue. Read More

A DEBATE over the usefulness of a half-century-old Supreme Court standard for proving bias when there’s no direct evidence in employment discrimination cases is being fueled by recent US appellate rulings finding that it’s been misapplied, Khorri Atkinson reports.

• The high court’s 1973 decision in McDonnell Douglas Corp. v. Green established a three-step alternative method for plaintiffs to prove bias when direct evidence — like explicit discriminatory statements connected to race, gender, and other protected characteristics — isn’t available.
• It was initially created to help plaintiffs find discrimination by employers amid judicial reluctance when there were no jury trials under Title VII of the 1964 Civil Rights Act, according to Judge Harris L. Hartz of the Tenth Circuit. But it has eventually become “a favorite of the defense bar” as employers use it to challenge the sufficiency of a claim before they progress to more costly litigation stages, he said.
• The Eleventh and Tenth circuits recently cautioned district courts against an overly rigid or erroneous application of McDonnell Douglas, saying plaintiffs only need to present a plausible claim to survive early dismissal. The high court has repeatedly made the point that McDonnell Douglas is merely an evidentiary framework, but many appeals courts have established variations in its application.
• “It’s interesting to me that courts are still struggling,” said Marcia L. McCormick, an employment law and women’s and gender studies professor at Saint Louis University School of Law. “It requires either Congress to come back and amend” Title VII and “provide instructions to courts about how they ought to view complaints in this area,” or for the justices to offer additional guidance, she said. Read More

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