Policy & Compliance
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May 17, 2024
Allergan Says Deserted Drug Rule Weakens $680M Fraud Suit
Allergan drew a Maryland federal court's attention to the Centers for Medicare & Medicaid Services' abandonment of a regulation clarifying drug pricing, arguing the move undermined a whistleblower's claims that it overcharged Medicaid by over $680 million.
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May 17, 2024
Steward Health Ch. 11 Lifts Lid On PE In Healthcare
Steward Health's $9 billion Chapter 11 has come under scrutiny from state attorneys general seeking to uncover why a once-rapidly growing hospital network ended up buried in debt, with authorities taking the unusual tack of turning a special eye toward its former private equity owner Cerberus Capital Management, experts told Law360.
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May 17, 2024
OB-GYN Enough Like GYN Oncologist For Expert Witness Law
A Florida state appeals court on Friday revived a suit accusing a gynecological oncologist of performing an unnecessary surgery, saying the credentials of the patient's medical expert — an OB-GYN — satisfied the state's "same specialty" requirement.
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May 17, 2024
Jury Convicts NC Provider In Medicaid, COVID Fraud Scheme
A clinical social worker in North Carolina was found guilty Friday of defrauding South Carolina's Medicaid program and falsely obtaining COVID-19 relief checks following a nine-day trial in Charlotte's federal courthouse, prosecutors said.
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May 17, 2024
Hinshaw Bolsters Healthcare Team In NY With New Partner
Hinshaw & Culbertson LLP has added a healthcare-focused partner from New York healthcare and business firm Weiss Zarett Brofman Sonnenklar & Levy PC.
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May 17, 2024
Mass. Hospital Pays $24.3M To Settle Heart-Surgery FCA Case
Cape Cod Hospital will pay $24.3 million to settle claims it flouted Medicare billing rules for hundreds of heart-valve replacement surgeries in what's understood to be the largest recovery under the False Claims Act from a Massachusetts hospital.
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May 17, 2024
Many Plans Already In Front Of 11th Circ. Trans Health Ruling
The Eleventh Circuit's recent decision that a county health plan's coverage exclusion for gender transition surgery violated federal anti-discrimination law likely won't have a big impact on plans because they have already made adjustments for the U.S. Supreme Court ruling the appeals court applied, experts say.
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May 16, 2024
Ointment Scheme Conned Gov't Out Of Millions, Fla. Suit Says
Two Florida brothers and one of their former employees are accused of running a years-long fraudulent scheme billing government healthcare programs and receiving millions of dollars after paying kickbacks to generate prescriptions for ointments that were not needed, according to a False Claims Act lawsuit.
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May 16, 2024
3rd Circ. Shuns Teva's 'Novel' Appeal On Israeli Investor Class
The Third Circuit on Thursday turned away an appeal brought by Teva Pharmaceutical Industries Ltd., saying the class certification stage was not the right time to hear arguments over the "novel" question of the applicability of U.S. securities laws to Israeli-listed shares.
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May 16, 2024
FTC Deputy Director Rao On Healthcare Antitrust Agenda
The reason behind the Federal Trade Commission's changed attitude toward antitrust in healthcare in recent years isn't simple, according to Rahul Rao, deputy director of the FTC's Bureau of Competition.
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May 16, 2024
EPA Doctor Not A Whistleblower For Slamming Lead Plan
A former U.S. Environmental Protection Agency pediatrician and epidemiologist who publicly criticized the EPA's plan to reduce lead in drinking water as inadequate is not protected by federal whistleblower law, the Federal Circuit said Thursday.
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May 16, 2024
Fla. Seeks To Halt Biden's ACA Trans Discrimination Rule
Florida urged a federal court to stop recently finalized regulations clarifying gender identity-based discrimination under the Affordable Care Act from taking effect, saying the new rules would force the state to abandon its health and safety laws or lose funding from the federal government.
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May 15, 2024
Feds Urge Prison For Convicted Baby Formula Fraudster
Urging the judge to communicate the gravity of white collar crime, federal prosecutors in New York asked Wednesday that a Staten Island man get at least 2.25 years in prison after he pled guilty to forging baby formula prescriptions as part of a scheme to defraud insurers of $1.9 million.
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May 15, 2024
Anti-Trans Groups Fail To Block Wash. Youth Shelter Law
A federal judge on Wednesday threw out a lawsuit filed by two anti-transgender groups challenging a Washington state law intended to ensure shelter for teens seeking gender-affirming care or reproductive health services, ruling that speculating on possible injury was not enough to clear a standing hurdle.
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May 15, 2024
AstraZeneca Sales Reps Win Early Cert. In Gender Bias Suit
An Illinois federal judge on Tuesday granted a bid by workers to conditionally certify a collective in a lawsuit alleging AstraZeneca paid women less than men, giving the green light for notices to be sent out to female sales representatives who have worked at the pharmaceutical giant since late 2018.
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May 14, 2024
Hospitals Liable For Failing To Admit Killer, Pa. Justices Told
The Pennsylvania Supreme Court was reminded Tuesday, during oral arguments over whether someone can be officially treated at a hospital without filling out an application, that the case before them concerned a man who killed his girlfriend after he was turned away despite claiming homicidal and suicidal impulses.
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May 14, 2024
Vein Tech Maker Faces Investor Suit Over DOJ Kickback Probe
Vein disease device maker Inari Medical Inc. and three of its current and former executives face a proposed investor class action over claims that the company's share price fell after it disclosed an investigation into its compliance with federal anti-kickback laws.
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May 14, 2024
States Accuse EEOC Of 'Smuggling' Abortion Into PWFA Rule
Louisiana and Mississippi have sued the U.S. Equal Employment Opportunity Commission seeking to invalidate regulations implementing the Pregnant Workers Fairness Act, claiming the agency's stance that employers must provide workers accommodations if they get an abortion flouts U.S. Supreme Court precedent and the PWFA itself.
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May 14, 2024
White House Targets Kidney Transplant Bias Amid Lawsuits
A White House effort to reduce bias in the organ transplant system comes as some Black litigants are pressing legal claims against a national transplant network they say used a flawed, racially biased calculation to delay kidney transplants.
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May 14, 2024
Ariz. Justices Stay 1864 Abortion Ban To Allow For Appeal
Enforcement of Arizona's 1864 anti-abortion law will remain on hold for at least 90 days as state Attorney General Kris Mayes evaluates whether to ask the U.S. Supreme Court to take up the case.
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May 14, 2024
Mich. AG Says Eli Lilly 'Cherry-Picking' Enforcement Data
Michigan's attorney general has hit back against Eli Lilly's arguments that recent consumer protection law recoveries show her office is not being hampered in its investigations, as she seeks subpoenas in a probe of the pharmaceutical giant's pricing for an insulin drug.
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May 14, 2024
Holland & Knight Atty On 'Historic' Women's Health Moment
Julia Hesse, a veteran healthcare attorney who recently joined Holland & Knight LLP, talks about her multifaceted practice, pressing public policy issues, and why menopause care can be the next big thing in women's healthcare.
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May 14, 2024
Huge Payouts Pressure Hospitals To Address Doc Sex Abuse
A string of high-profile settlements and the conviction of a prominent urologist in New York are motivating more victims of sexual abuse to come forward and intensifying the legal scrutiny facing hospitals as they navigate a culture that grants doctors substantial authority.
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May 14, 2024
Convicted Fraudster Says Exchanges With Atty Are Privileged
A convicted fraudster who had his sentence commuted by then-President Donald Trump — now charged with launching another scam shortly after leaving prison — is embroiled in a fight with New Jersey federal prosecutors over his attempt to assert attorney-client privilege for communications with an Israeli attorney who allegedly participated in the scheme.
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May 14, 2024
BigLaw Attys Fight Sanctions Over Alleged Judge Shopping
Attorneys from Shook Hardy & Bacon LLP, Cooley LLP, Lightfoot Franklin & White LLC and prominent LGBTQ rights organizations did not engage in judge shopping when walking away from cases challenging an Alabama law banning certain medical procedures for transgender youth, the lawyers have told an Alabama federal court.
Expert Analysis
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Spartan Arbitration Tactics Against Well-Funded Opponents
Like the ancient Spartans who held off a numerically superior Persian army at the Battle of Thermopylae, trial attorneys and clients faced with arbitration against an opponent with a bigger war chest can take a strategic approach to create a pass to victory, say Kostas Katsiris and Benjamin Argyle at Venable.
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The Road Ahead For Florida's Drug Importation Program
Though the U.S. Food and Drug Administration approved Florida's drug importation program in January, a series of hurdles — including requisite buy-in from Canada — and potential legal challenges must be addressed before importation can begin, say attorneys at Ropes & Gray.
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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.