Policy & Compliance
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August 06, 2024
Fed. Circ. Told Edwards Safe Harbor IP Suit Was Malicious
The Federal Circuit rightfully held Meril Life Sciences was protected by a patent safe harbor when bringing its preapproval transcatheter heart valve system to an industry conference and that Edwards Lifesciences' attempts to prove otherwise are just delay tactics, Meril told the full court.
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August 06, 2024
Ohio Judge Upholds Law Limiting Gender Care, Sports Access
An Ohio judge on Tuesday allowed the state to begin enforcing a law that restricts gender-affirming care for minors and bans transgender girls' participation in female sports, siding with the state and determining that the law is a legitimate attempt to protect children.
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August 06, 2024
Cancer Doc In Bitter Firing Dispute Loses At Mont. High Court
A Montana oncologist's firing from his longtime hospital in Helena prompted an outcry among his former patients. A recent ruling by the Montana Supreme Court in favor of his former employer closed a chapter in an ongoing legal saga.
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August 06, 2024
NC Hospital Gets New Shot At Emergency Dept. Plan Approval
A state appellate panel on Tuesday unraveled a decision overturning approval for a freestanding emergency department in rural North Carolina, ruling that an administrative law judge misapplied precedent when deciding whether a state agency's failure to hold a public hearing prejudiced the decision-making process.
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August 07, 2024
Dinsmore Adds 5-Atty Litigation Group From Bricker Graydon
Dinsmore & Shohl LLP announced Tuesday that a five-person litigation team led by a healthcare partner with over 30 years of experience joined the firm's Columbus, Ohio, office from Bricker Graydon LLP.
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August 06, 2024
Alabama Calls Its Gender Care Law A Rational Policy Choice
Alabama lawmakers acted out of a desire to protect children — not discriminatory intent — when they passed legislation that restricted gender-affirming care for minors, easily clearing the legal standard required to uphold the law, the state has told a federal judge.
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August 06, 2024
CMS Signals States Can Dump Medical Debt After NC Consent
After the U.S. Centers for Medicare & Medicaid Services approved North Carolina's plan to offer enhanced Medicaid reimbursements for hospitals that forgive medical debts, other states could follow its lead. Some have questioned whether the state agency implementing the program can legally carry it out.
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August 06, 2024
Ethical, Legal Challenges Await La. Surgical Castration Law
Physicians in Louisiana may be forced to confront unusual ethical questions under a first-in-the-nation state law allowing judges to order the surgical castration of some sex offenders.
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August 06, 2024
5 More Podcasts For Health, Life Sciences Attorneys
As the days get hotter and the start of the school year gets closer, health and life sciences practitioners might need a respite. If you've been there and done that with Law360's first five recommended podcasts, here are five more to take you into the fall and beyond.
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August 05, 2024
Indivior Accused Of Overstating Prospects Of 3 Opioid Drugs
Drugmaker Indivior PLC has been hit with a proposed investor class action in Virginia federal court over claims it overstated the financial prospects of its drugs used to treat opioid use disorders and the company's ability to forecast such financial projections.
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August 05, 2024
Chinese Drug Co. Says Sanctions In Valsartan MDL Too Harsh
Chinese drug firm Zhejiang Huahai Pharmaceutical Co. Ltd. told a New Jersey federal court Friday that sanctions authorizing two adverse jury instructions in multidistrict litigation over generic drugs contaminated with carcinogens should be overturned, arguing the plaintiffs did not allege the bad faith required for such a harsh penalty.
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August 05, 2024
Mich. Says HHS Can't Get Back $195M Medicaid Payments
The state of Michigan is asking a D.C. federal judge to bar the federal government from seeking repayment for $195 million in Medicaid payouts made to two state-operated hospitals that provided psychiatric services to state criminal defendant inmates, saying the government's payment withdrawal decision was made years too late and without proper notice.
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August 05, 2024
Mich. AG Defends Judge's Block Of Abortion Waiting Period
A Michigan judge's suspension of several state abortion regulations should be upheld, Michigan Attorney General Dana Nessel told appellate judges, saying the restrictions don't pass constitutional muster because they don't serve to protect women's health.
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August 05, 2024
Insurer Must Face Pa. Trans Firefighter's Surgery Claim
A Pennsylvania federal judge has refused to toss a suit from a transgender Philadelphia firefighter suing Independence Blue Cross for discrimination over the insurer's denial of coverage for facial feminization surgery, finding that claims under federal healthcare law could proceed, but not the Title VII claims.
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August 05, 2024
Nursing Home Flubs Make Reports Fair Game, NJ Justices Say
Two Garden State healthcare facilities failed to follow state regulations in after-incident reviews, making the normally privileged reports accessible to plaintiffs, the New Jersey Supreme Court ruled Monday.
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August 05, 2024
7th Circ. Backs Insurer's Win In Family's Autism Claims Fight
The Seventh Circuit on Monday affirmed a win for a Wisconsin health insurer in a family's dispute over coverage for autism therapies, finding that the insurer's denials of speech therapy to treat autism for a minor child were valid under a policy exclusion for treatments that weren't evidence-based.
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August 05, 2024
Fla. Man Gets 44 Months For $5M MilliporeSigma Export Scam
A Florida federal judge sentenced a Taiwanese citizen who lives in the Sunshine State to three years and eight months in prison for his role in a $5 million scheme to defraud life sciences company MilliporeSigma and the U.S. government by illegally exporting MilliporeSigma products to China.
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August 02, 2024
5th Circ. Upholds Challenge To Surprise Medical Billing Rule
The Fifth Circuit on Friday affirmed wins for plaintiffs challenging provisions of a federal surprise medical billing rule that relate to payment fights between out-of-network providers and health insurers, agreeing with a Texas federal judge that the rule places "a thumb on the scale" in insurers' favor.
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August 02, 2024
Fla.'s Trans Healthcare Ban Violates Title VII, Judge Says
A Florida federal judge has ruled the state's Department of Management Services illegally excluded gender-affirming treatment for transgender employees under state-sponsored health benefits plans, finding the state's exclusion only applies to trans individuals and is facially discriminatory under Title VII of the Civil Rights Act.
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August 02, 2024
Split 2nd Circ. Orders Partial Redo In Docs', Attys' Injury Scam
A divided Second Circuit panel on Friday upheld the convictions of three men who recruited patients for a more than $31 million trip-and-fall fraud scam that personal injury lawyers and doctors orchestrated, but remanded the case for further findings on the number of bogus accidents involved in the scheme.
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August 02, 2024
2nd Circ. Backs Conviction Over Fake-Therapy Scheme
The Second Circuit on Friday refused to overturn the conviction of a therapist who was found guilty of bilking a New York state program for developmentally disabled children, saying the trial court didn't err in declining to excuse a juror who had loose ties to a government witness.
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August 02, 2024
Family Denied Quick Win In Insurer's $2M Nursing Home Suit
An insurer for a now-bankrupt Georgia nursing home doesn't have to cover a $2.1 million judgment awarded to the family of a woman who died in the facility's care, a federal judge ruled Friday, finding an agreement between the facility and the family released the facility from all liability.
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August 02, 2024
Rehab Center Fired Nurse Over Sleeping Disorder, EEOC Says
A rehabilitation and assisted living facility fired a nurse after refusing to rework her schedule to accommodate a sleep disorder that keeps her awake at night and asleep during the day, the U.S. Equal Employment Opportunity Commission told a Texas federal court.
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August 01, 2024
Utah High Court Upholds Pause On State Abortion Ban
The Utah Supreme Court on Thursday upheld a pause on the state's near-total abortion ban while a constitutional challenge to the law proceeds, agreeing with a lower court's conclusion that the Planned Parenthood Association of Utah had standing to bring its challenge.
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August 01, 2024
Novo Nordisk Loses Challenge To Medicare Drug Price Talks
Another challenge to a Medicare drug price negotiation program has failed after a New Jersey federal judge ruled once again that the program is voluntary and rejected claims that it violates the constitutional rights of pharmaceutical giant Novo Nordisk.
A 'Watershed' DOJ Tipster Program Eyes Private Payer Fraud
A U.S. Department of Justice pilot program promising payouts to qualifying whistleblowers who tip off investigators about schemes at private healthcare payers marks a big shift in federal fraud enforcement efforts, and a significant new liability risk for providers.
Medicare Rules Face Double Punch From High Court Cases
A pair of administrative law decisions from the U.S. Supreme Court this past term will equip ambitious plaintiffs with more ammo to challenge regulations implementing federal healthcare programs.
Dead Or Not Quite: Hospitals Weigh Shared Definition Of DOA
What does it mean to be dead on arrival? Standardizing the definition is vital to the nation's hospital emergency departments, which are partly evaluated on patient mortality rates. In New York, the push to define DOA ignited a debate touching on how hospitals are reimbursed, risk-adjusted mortality figures, and the use of emergency procedures intended to save patients without a pulse.
Expert Analysis
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A Primer On EU's Updated Human Substance Regulations
The European Union's updated standards regarding quality and safety of substances of human origin meant for human application carry significant implications for companies that work with cells and tissues, and U.S. companies active in the EU market should pay particular attention to the import and export rules, say Geneviève Michaux and Georgios Symeonidis at King & Spalding.
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CFPB's Medical Debt Proposal May Have Side Effects
The Consumer Financial Protection Bureau’s recent proposal to prevent medical debt information from appearing on consumer reports and creditors from basing lending decisions on such information may have initial benefits for some consumers, but there are potential negative consequences that should also be considered, say attorneys at Cooley.
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15 Areas That Would Change Under Health Data Rule Proposal
If finalized, the Office of the National Coordinator for Health Information Technology's proposed rule will significantly progress its efforts to advance interoperability, respond to stakeholder concerns and clarify compliance with the health IT certification program, say attorneys at Ropes & Gray.
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3 Healthcare FCA Deals Provide Self-Disclosure Takeaways
Several civil False Claims Act settlements of alleged healthcare fraud violations over the past year demonstrate that healthcare providers may benefit substantially from voluntarily disclosing potential misconduct to both the U.S. Department of Justice and the U.S. Department of Health and Human Services, say Brian Albritton and Raquel Ramirez Jefferson at Phelps Dunbar.
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Takeaways From High Court's Tribal Health Admin Cost Ruling
The U.S. Supreme Court's recent determination that the government must reimburse two Native American tribes for administrative healthcare costs will help tribes maintain equal footing with the Indian Health Service when administering programs, and continues a pattern of how the current court aligns on tribal concerns, say attorneys at Lewis Roca.
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FTC Focus: Private Equity Investments In Healthcare
As the Federal Trade Commission is tightening its scrutiny of private equity investment in healthcare, the agency is finding novel grounds to challenge key focus areas, including rollup acquisitions, the flip-and-strip approach and minority investments in rival providers, say attorneys at Proskauer.
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High Court's Expert Ruling May Help Health Fraud Defendants
The U.S. Supreme Court's decision in Diaz v. U.S. appears to give the government a powerful new tool in calling its own agents as expert witnesses, but it could also benefit defense counsel in criminal healthcare fraud and other white collar criminal cases that arise in complex legal or regulatory environments, say attorneys at Holland & Knight.
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Unpacking HHS' Opinion On Cell Therapy Refund Programs
A recent advisory opinion from the U.S. Department of Health and Human Services, determining that a biopharma company's refund program for its cell therapy will not be penalized, indicates an encouraging willingness to engage, but the regulator's assumptions about the program's limited term warrant a closer look, says Mary Kohler at Kohler Health.
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DOJ Innovasis Settlement Offers Lessons On Self-Disclosure
The recent $12 million settlement with Innovasis and two of its executives demonstrates the U.S. Department of Justice's continued prioritization of Anti-Kickback Statute enforcement amid the growing circuit split over causation, and illustrates important nuances surrounding self-disclosure, say Denise Barnes and Scott Gallisdorfer at Bass Berry.
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How Orange Book Antitrust Scrutiny Is Intensifying
Pharmaceutical patent holders should be reviewing Orange Book listing practices, as the Federal Trade Commission takes a more aggressive antitrust approach with actions such as the Teva listing probe, and the U.S. Food and Drug Administration calls attention to potentially improper listings, say attorneys at McDermott.
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After Chevron: Slowing Down AI In Medical Research
The U.S. Supreme Court's recent decision overturning the Chevron doctrine may inhibit agencies' regulatory efforts, potentially slowing down the approval and implementation of artificial intelligence-driven methodologies in medical research, as well as regulators' responses to public health emergencies, say Ragini Acharya and Matthew Deutsch at Husch Blackwell.
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FDA's Multifaceted Role On Display In MDMA Therapy Scrutiny
Ongoing deliberations at the U.S. Food and Drug Administration regarding MDMA-assisted therapy for post-traumatic stress disorder serves as a window into the intricate balance of scientific innovation and patient safety oversight, and offers crucial insights into regulatory nuances, say Kimberly Chew at Husch Blackwell and Kevin Lanzo at Pharmaka Clinical Consulting.
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Analyzing FDA Draft Guidance On Clinical Trial Diversity
In light of the U.S. Food and Drug Administration's draft guidance on clinical trial diversity action plans, there are several important considerations for sponsors and clinical researchers to keep in mind to prevent delay in a drug or device application, say attorneys at Crowell & Moring.