Policy & Compliance
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June 14, 2024
3rd Circ. Merges 3 Challenges To Medicare Drug Price Talks
The Third Circuit will hear three separate appeals challenging Medicare's drug price negotiations together, according to a new order consolidating cases brought by AstraZeneca, Bristol-Myers Squibb and Janssen Pharmaceuticals in New Jersey and Delaware federal courts.
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June 13, 2024
Justices Hand Abortion Advocates An Incomplete Win
The U.S. Supreme Court's rejection Thursday of a challenge to the abortion drug mifepristone will do little to safeguard long-term access to the medication while suggesting that it will be up to voters, not judges, to settle some of the nation's abortion debates, attorneys say.
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June 13, 2024
Thomas Targets Group Standing In Mifepristone Ruling
U.S. Supreme Court Justice Clarence Thomas joined his colleagues Thursday to unanimously uphold broad access to the abortion medication mifepristone for now, but he wrote separately to challenge a standing rule that often serves as the key to the courthouse doors for litigants of all varieties.
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June 13, 2024
Feds Get $4.6M In Deal Over Telehealth Billing Fraud Probe
A multi-state network of behavioral health companies and their CEO have agreed to pay nearly $4.6 million to settle allegations that they submitted fraudulent claims for payment to Medicare and Connecticut's Medicaid program for telehealth services for nursing home residents, federal investigators said Thursday.
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June 13, 2024
Teva Wins Pause Of Order Ousting Patents From Orange Book
A New Jersey federal judge ordered on Thursday a 30-day stay of his Monday ruling that a handful of patents covering Teva-brand asthma inhalers were improperly listed in the federal Orange Book, saying he wanted the matter to reach the Federal Circuit in the most orderly way possible.
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June 13, 2024
CVS Dodges Discovery Audit In Generic Drug Collusion Suit
A federal judge declined to make CVS hire a forensic auditor to evaluate its compliance with information demands in a lawsuit alleging it colluded with drugmakers to keep Medicare beneficiaries from accessing certain generic drugs, despite a whistleblower bemoaning "woefully deficient" discovery on the pharmacy chain's part.
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June 13, 2024
Health Co. Execs Charged In $100M Adderall Sales Scheme
Two California digital healthcare company executives were charged in a first-of-its-kind case Thursday with scheming to sell Adderall through deceptive advertising, allegedly bringing in $100 million in illicit profits.
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June 13, 2024
EU Makes First Ever Formal Pharma Price-Fixing Complaint
European Union antitrust authorities issued their first ever price-fixing complaint in the pharmaceutical industry Thursday, going after the only company that did not agree to a €13.4 million ($14.4 million) settlement in October.
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June 13, 2024
Abortion Medication Case Ends 'With A Whimper' At High Court
A case that threatened to cut off access to a widely used abortion medication while disrupting the U.S. Food and Drug Administration's authority over drugs and medical devices ended Thursday at the U.S. Supreme Court with a decision concerned solely with challengers' right to sue.
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June 12, 2024
32 AGs Urge Justices Take Up Okla. PBM Law Fight
Thirty-two attorneys general urged the U.S. Supreme Court to take up Oklahoma's petition for review of a Tenth Circuit decision holding that federal law preempted portions of a state law regulating pharmacy benefit managers, arguing the justices needed to intervene to resolve a circuit split.
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June 12, 2024
Sen. Dems Seek Criminal Penalties For PE Hospital 'Looters'
A pair of Democratic senators are targeting private equity's role in the healthcare industry, introducing new legislation Tuesday that would give federal and state enforcers new tools to go after firms they say are "looting" hospital systems and other providers, including possibly jailing executives if patient deaths result.
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June 11, 2024
6th Circ. Judge Doubts Clinic's Standing To Block Bias Law
During Sixth Circuit arguments Tuesday probing whether a Christian medical clinic can block Michigan from targeting it for refusing to facilitate gender transitions, one judge searched for evidence that the clinic is actually at risk of being prosecuted under the state's civil rights law.
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June 11, 2024
Doc-Patient Privilege, The Four Tops, And A Win For Humana
Humana wins a round in a Medicare Advantage lawsuit. The high court takes up hospital "dish" payment case. A Motown legend sues a Michigan hospital. Law360 looks at those and other legal cases from the past week.
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June 11, 2024
Texas, Mont. Sue HHS Over ACA Trans Discrimination Rule
Texas and Montana filed suit against the Biden administration seeking to halt its rule clarifying the application of the Affordable Care Act's nondiscrimination protections to gender identity, saying the new regulations infringe on states' autonomy and force them to violate their own laws.
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June 11, 2024
Judge Says Fla. Trans Medical Care Ban Is Unconstitutional
A Florida federal judge on Tuesday declared that a state law banning gender-affirming care for transgender minors and restricting it for adults is unconstitutional because it was motivated by animus for a specific group of people and serves no legitimate state interest.
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June 11, 2024
Fast Appeal In Hospital Merger Row A Sign Of Determined FTC
The Federal Trade Commission's quick appeal of its failed challenge to a North Carolina hospital merger suggests the agency remains committed to aggressive scrutiny of healthcare consolidation.
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June 11, 2024
High Court On Familiar Ground In Hospital Pay Row
Two years ago, the U.S. Supreme Court decided a case about federal formula for calculating disproportionate share hospital payments — commonly called "dish" payments — under Medicare Part A. A similar case set for high court review puts the justices back on familiar ground.
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June 11, 2024
10 Firms Seek $13M Fee For Effexor Antitrust Deal
Ten law firms asked a New Jersey federal judge on Monday to award $13 million in counsel fees and an additional $2.1 million in costs for representing direct buyers in a $39 million settlement with Pfizer Inc. unit Wyeth over an alleged scheme to delay generic competition for the antidepressant drug Effexor XR.
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June 11, 2024
CFPB Floats Rule To Take Medical Debt Off Credit Reports
The Consumer Financial Protection Bureau on Tuesday proposed a rule that would restrict how lenders and credit reporting companies can use consumers' medical debt information, a measure that the agency said could remove up to $49 billion in outstanding medical bills from millions of credit reports.
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June 11, 2024
Pivotal ERISA Case Stalls Amid Mental Health Crisis
A nationwide mental health crisis has emerged while a landmark case involving thousands of insurance claims denied by United Behavioral Health has wound its way through the courts. The dispute is hitting new headwinds at the Ninth Circuit.
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June 11, 2024
WilmerHale Lands Latham Atty To Help Lead Life Sciences
WilmerHale has added a partner in Palo Alto, California, who is an expert in complex strategic collaboration and licensing transactions, to co-chair its life sciences practice group, the firm said Tuesday.
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June 11, 2024
Rao Tracks His Journey From Stay-At-Home Dad To FTC
Rahul Rao said that every role he's taken on — from BigLaw attorney to stay-at-home dad to overseeing healthcare mergers at the Federal Trade Commission — has helped shape him into the lawyer he is today.
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June 11, 2024
FDA Urges 11th Circ. To Back E-Cig Ban Over High Nicotine
The U.S. Food and Drug Administration is urging the Eleventh Circuit to not let Bidi Vapor market an e-cigarette product that the agency claimed would expose users to nearly twice as much nicotine as a typical combustible cigarette.
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June 11, 2024
Next Wave Of Opioid Suits Targets Drug Biz 'Middlemen'
Communities ravaged by opioid addiction have secured billions of dollars in settlements with companies that make, market and dispense the drugs. A new target is now emerging in the next wave of litigation — pharmacy benefit managers.
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June 11, 2024
Beveridge & Diamond Hires DOJ Jan. 6 Litigator In DC
Beveridge & Diamond PC's new white collar principal, Louis Manzo, has worked on some of the highest-profile cases in the nation for the Justice Department, helping secure convictions for several January 6 insurrectionists charged with seditious conspiracy.
Expert Analysis
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Assessing CDC's Revised Guideline On Opioid Prescriptions
Kenneth Weinstein, Nicholas Van Niel and Kate Uthe at Analysis Group look at newly available data to evaluate the impact that the Centers for Disease Control and Prevention's revised opioid monitoring guideline have had on prescription trends in recent years, highlighting both specific and overall decreases.
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Valeant Ruling May Pave Way For Patent-Based FCA Suits
The Ninth Circuit’s recent ruling in Silbersher v. Valeant marks a significant development in False Claims Act jurisprudence, opens new avenues for litigation and potentially raises the stakes for patent applicants who intend to do business with the government, say Joshua Robbins and Rick Taché at Buchalter.
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Suits Against Insulin Pricing Are Driven By Rebate Addiction
A growing wave of lawsuits filed by states, cities and counties against insulin manufacturers and pharmacy benefit managers improperly allocate the blame for rising insulin costs, when in actuality the plaintiffs are partially responsible, says Dan Leonard at Granite Capitol Consulting.
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When Physician Retirement Arrangements May Be Legal
A recent advisory opinion from the Office of Inspector General regarding physician retirement arrangements sheds light on key considerations and mitigating factors that may be useful when attempting to balance healthcare operational needs with statutory conformity, says Magda Rodriguez at Day Pitney.
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ESG Around The World: Gulf Cooperation Council
The Gulf Cooperation Council is in the early stages of ESG policy implementation, but recent commitments by both states and corporations — including increases in sustainable finance transactions, environmental commitments, female representation on boards and human rights enforcement — show continuing progress toward broader ESG goals, say attorneys at Cleary.
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Navigating ACA Reporting Nuances As Deadlines Loom
Stephanie Lowe at Liebert Cassidy walks employers through need-to-know elements of Affordable Care Act reporting, including two quickly approaching deadlines, the updated affordability threshold, strategies for choosing an affordability safe harbor, and common coding pitfalls.
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Lessons From Rare Post-Verdict Healthcare Fraud Acquittal
A Maryland federal court recently overturned a jury verdict that found a doctor guilty of healthcare fraud related to billing levels for COVID-19 tests, providing defense attorneys with potential strategies for obtaining acquittals in similar prosecutions, says attorney Andrew Feldman.
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ChristianaCare Settlement Reveals FCA Pitfalls For Hospitals
ChristianaCare's False Claims Act settlement in December is the first one based on a hospital allegedly providing private physicians with free services in the form of hospital-employed clinicians and provides important compliance lessons as the government ramps up scrutiny of compensation arrangements, say attorneys at Sheppard Mullin.
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Patent Waiver For COVID Meds Would Harm US Biopharma
If the Biden administration backs the World Trade Organization in waiving patent rights on COVID-19 treatments, it would negatively affect the U.S. biopharmaceutical industry and help foreign competitors, without necessarily expanding global access to COVID-19 care, says clinical pathologist Wolfgang Klietmann.
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New CMS Rule Will Change Nursing Facility Disclosures
A new rule from the Centers for Medicare & Medicaid Services significantly expands disclosure requirements for nursing facilities backed by private equity companies or real estate investment trusts, likely foreshadowing increased oversight that could include more targeted audits, say Janice Davis and Christopher Ronne at Morgan Lewis.
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Skirting Anti-Kickback Causation Standard Amid Circuit Split
Amid the federal circuit court split over the causation standard applicable to False Claims Act cases involving Anti-Kickback Statute violations, which the First Circuit will soon consider in U.S. v. Regeneron, litigators aiming to circumvent the heightened standard should contemplate certain strategies, say Matthew Modafferi and Terence Park at Frier Levitt.
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Gilead Ruling Signals That Innovating Can Lead To Liability
A California appeals court's ruling last month in Gilead Life Sciences v. Superior Court of San Francisco that a drug manufacturer can be held liable for delaying the introduction of an improved version of its medication raises concerns about the chilling effects that expansive product liability claims may have on innovation, says Gary Myers at the University of Missouri School of Law.
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Health Policy Legislative Landscape May Remain Frozen
With Congress again delaying the full resolution of fiscal year 2024 federal spending legislation, there is now an additional window in which Congress could work through several priority issues for healthcare stakeholders, though these issues are unlikely to be resolved in time, say attorneys at Faegre Drinker.