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
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.
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May 14, 2024
Medicaid Work Mandates Resurface In Legal, Political Fights
Work requirements can help solve the tricky politics of expanding Medicaid in some states. But the job mandates can also trigger regulatory and legal challenges that make them tough to carry out.
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.
Why Midwives Are Fighting Practice Limits Across The US
Heather Swanson has long hoped to use her training to help pregnant people in Nebraska give birth safely in their homes but is blocked by state law. Today, she’s among a number of midwives battling laws they say unduly restrict skilled healthcare providers while maternity care "deserts” proliferate across the U.S.
'Global' Budgets May Fix Hospital Spending. Will States Try It?
An ambitious experiment is underway that could shake up healthcare spending by moving providers away from a traditional fee-for-service model in favor of "global" hospital budgets. But with deadlines looming, the voluntary, "total cost of care" model can't deliver without state buy-in.
Expert Analysis
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FTC Noncompete Rule's Impact On Healthcare Nonprofits
Healthcare entities that are nonprofit or tax-exempt and thus outside of the pending Federal Trade Commission noncompete rule's reach should evaluate a number of potential risk factors and impacts, starting by assessing their own status, say Ben Shook and Tania Archer at Moore & Van Allen.
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Key Takeaways From FDA Final Rule On Lab-Developed Tests
Michele Buenafe and Dennis Gucciardo at Morgan Lewis discuss potential consequences of the U.S. Food and Drug Administration's recently finalized rule regulating lab-developed tests as medical devices, and explain the rule's phaseout policy for enforcement discretion.
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Assessing HHS' Stance On Rare Disease Patient Assistance
The U.S. Department of Health and Human Services' recent advisory opinion, temporarily blessing manufacturer-supported copay funds for rare disease patients, carves a narrow path for single-donor funds, but charities and their donors may require additional assistance to navigate programs for such patients, says Mary Kohler at Kohler Health Law.
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Are Concessions In FDA's Lab-Developed Tests Rule Enough?
Although the U.S. Food and Drug Administration's new policy for laboratory-developed tests included major strategic concessions to help balance patient safety, access and diagnostic innovation, the new rule may well face significant legal challenges in court, say Dominick DiSabatino and Audrey Mercer at Sheppard Mullin.
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8 Questions To Ask Before Final CISA Breach Reporting Rule
The Cybersecurity and Infrastructure Security Agency’s recently proposed cyber incident reporting requirements for critical infrastructure entities represent the overall approach CISA will take in its final rule, so companies should be asking key compliance questions now and preparing for a more complicated reporting regime, say Arianna Evers and Shannon Mercer at WilmerHale.
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Mid-2024 FCA Enforcement And Litigation Trends To Watch
Reviewing notable False Claims Act trends and enforcement efforts in the last year and a half reveals that healthcare is a key enforcement priority for the U.S. Department of Justice, and the road ahead may bring clarification on Anti-Kickback Statute causation and willfulness standards, along with increased focus on private equity, cybersecurity and self-disclosure, say attorneys at Epstein Becker.
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Online Portal Helps Fortify Feds' Unfair Health Practices Fight
The Federal Trade Commission, U.S. Justice Department and the U.S. Department of Health and Human Services recently launched an online portal where the public can report potentially unfair healthcare practices, effectively maximizing enforcers' abilities to police anti-competitive actions that can drive up healthcare costs and chill innovation, say attorneys at Seyfarth.
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McKesson May Change How AKS-Based FCA Claims Are Pled
The Second Circuit’s analysis in U.S. v. McKesson, an Anti-Kickback Statute-based False Claims Act case, provides guidance for both relators and defendants parsing scienter-related allegations, say Li Yu at Dicello Levitt, Ellen London at London & Stout, and Erica Hitchings at Whistleblower Law.
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9th Circ. Ruling Puts Teeth Into Mental Health Parity Claims
In its recent finding that UnitedHealth applied an excessively strict review process for substance use disorder treatment claims, the Ninth Circuit provided guidance on how to plead a Mental Health Parity and Addiction Equity Act violation and took a step toward achieving mental health parity in healthcare, says Mark DeBofsky at DeBofsky Law.
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Breaking Down DOJ's Individual Self-Disclosure Pilot Program
The U.S. Department of Justice’s recently announced pilot program aims to incentivize individuals to voluntarily self-disclose corporate misconduct they were personally involved in, complementing a new whistleblower pilot program for individuals not involved in misconduct as well as the government's broader corporate enforcement approach, say attorneys at Paul Weiss.
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FDA Warning Letter Tightens Reins On 'Research Only' Labels
A recent warning letter from the U.S. Food and Drug Administration to Agena Bioscience alleged the company’s diagnostic devices were labeled for research use only, but improperly promoted for human clinical purposes, signifying a reinforcement — and a potential narrowing — of the agency's policy on products labeled “research only,” say attorneys at Sheppard Mullin.
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First 10b5-1 Insider Trading Case Raises Compliance Issues
The ongoing case against former Ontrak CEO Terren Peizer is the U.S. Department of Justice's first insider trading prosecution based primarily on the filing of 10b5-1 plans, and has important takeaways for attorneys reviewing corporate policies on the possession of material nonpublic information, say attorneys at Cadwalader.
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Policy Misrepresentations Carry Insurance Rescission Risks
The Second Circuit's recent decision in Medical Mutual v. Gnik, finding that material misrepresentation in a clinic's insurance applications warranted policy rescission, is a clear example of the far-reaching effects that misrepresentations can have and provides a reminder that policyholders should employ relatively straightforward steps to decrease risks, say attorneys at Hunton.