Policy & Compliance
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July 23, 2024
Healthcare Dealmaking Trends Of 2024: A Midyear Review
While each deal is unique, transactions don't occur in a vacuum. Here, Law360 Healthcare Authority reviews five trends that helped shape some of those deals and the wider healthcare industry so far this year.
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July 23, 2024
$680M Allergan FCA Suit Tossed After High Court Revival
A Maryland federal judge on Tuesday again tossed a False Claims Act suit accusing an Allergan unit of overcharging Medicaid, previously revived by the U.S. Supreme Court, saying a whistleblower still hadn't shown any deliberate wrongdoing by the company.
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July 23, 2024
6th Circ. Vows Careful Immunity Take In Prof's Retaliation Suit
The Sixth Circuit wrestled Tuesday with whether six University of Louisville officials were each rightly denied immunity from a former professor's suit alleging he was unconstitutionally pushed out because of his views on treating childhood gender dysphoria, with one judge promising meticulous assessments of each defendant.
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July 23, 2024
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.
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July 23, 2024
On Capitol Hill, PBM Execs Deny Role In High Drug Costs
Executives from the nation's three largest pharmacy benefit managers told members of a U.S. House committee on Tuesday that they lower drug costs while pointing the finger at pharmaceutical manufacturers.
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July 23, 2024
Hospital Cites Rare Doctrine In Colo. Trans Care Clash
A Colorado hospital accused of illegally refusing to provide gender-affirming surgery is turning to an unusual defense employed more often in foreign policy than healthcare litigation. While it's a rare effort to apply the "political question" doctrine to a healthcare dispute involving two private parties, it could influence other cases if employed successfully.
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July 23, 2024
PBMs Seek Safe Harbor Under Anti-Kickback Law
Pharmacy benefit managers are trying to stay one step ahead of federal regulators and lawmakers, undertaking aggressive restructuring and relying on the protection of safe harbor provisions under the anti-kickback statute.
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July 22, 2024
AbbVie Challenges Mo. Drug Discount Program Requirements
AbbVie Inc. on Monday asked a Missouri federal court to block a state law that adds requirements to participate in the federal drug discount program, claiming that the measure violates both the federal and Missouri constitutions.
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July 22, 2024
Groups Ask 3rd Circ. To Reverse Medicare Drug Price Rulings
A conservative group was one of several organizations to file amicus curiae briefs with the Third Circuit on Friday urging it to reverse a lower court's finding that Medicare's ability to negotiate drug prices with pharmaceutical companies does not run contrary to the companies' constitutional rights.
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July 22, 2024
1st Circ. Hints At Higher Bar For Feds In Anti-Kickback Cases
The First Circuit on Monday questioned the government's assertion that Congress intended to broaden the standard for liability in False Claims Act kickback cases when it passed a key amendment in 2010.
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July 19, 2024
House IP Committee Heads Unveil Drug Pricing Bill
Reps. Darrell Issa, R-Calif., and Hank Johnson, D-Ga., respectively the chair and top Democrat of the House intellectual property subcommittee, on Friday introduced a new bill that would change patent law to increase competition in the prescription drug market in order to lower patient costs.
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July 19, 2024
Ex-Pharma Sales Exec Denies Fake Prescription Scheme
The former vice president of sales for pharmaceutical company U.S. Compounding Inc. pled not guilty in Manhattan federal court Friday to forging fake horse drug prescriptions in order to juice revenues.
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July 19, 2024
Regeneron Rips DOJ's FCA Suit As 'Divorced From Reality'
Regeneron Pharmaceuticals Inc. has told a Massachusetts federal judge that a False Claims Act suit brought by the U.S. Department of Justice claiming the company withheld information about a drug's average sales price was "divorced from reality" and the practice the government was complaining about was commonplace.
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July 18, 2024
DaVita To Pay $34M In Medicare Kickback Whistleblower Suit
Dialysis company DaVita will pay more than $34 million to settle a Medicare fraud case over alleged kickbacks doctors received in exchange for patient referrals, after a whistleblower from the company's C-suite came forward, the U.S. Attorney's Office for the District of Colorado announced Thursday.
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July 18, 2024
6th Circ. Sees 'Fundamental' Shift Post-Chevron In Title X Row
The toppling of Chevron deference set the tone for a Sixth Circuit hearing on Thursday as the court contemplated Tennessee's arguments that the U.S. Department of Health and Human Services went beyond its statutory power when it introduced new requirements for family planning funding.
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July 18, 2024
9th Circ. Revives Fired Doctor's COVID Vax Religious Bias Suit
The Ninth Circuit revived a doctor's claims that Washington State University failed to accommodate his religious beliefs when it fired him from his residency for refusing the COVID-19 vaccine, ruling Thursday that U.S. Supreme Court precedent necessitates another look at his case.
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July 18, 2024
Feds Say Loper Bright Not Relevant In IVF Policy Suit
The U.S. Department of Defense urged a New York federal court Thursday to throw out a nonprofit's lawsuit challenging its in vitro fertilization coverage policy for service members, countering the group's argument that the agency can't shake the suit because the U.S. Supreme Court upended Chevron deference.
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July 18, 2024
PharMerica Inks $100M Deal In 13-Year-Old Whistleblower Suit
PharMerica Corp. has agreed to pay $100 million to settle a former New Jersey nursing home owner's long-running whistleblower litigation over an alleged drug kickback scheme, according to the plaintiff's law firm.
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July 17, 2024
Judge Warns HHS It's Not In 'Reasonable Compliance'
The Department of Health and Human Services appears not to be in "reasonable compliance" of an injunction ordering it to develop an avenue for Medicare beneficiaries to appeal their hospitalization status, a Connecticut federal judge said in a Tuesday notice.
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July 17, 2024
U. Miami Climate Leader Sees Chance For Innovation
With Miami often called the "ground zero" of the climate change crisis, the University of Miami in 2022 launched a Climate Resilience Academy to coordinate an interdisciplinary response. Nearly a year into his tenure, its leader reflects on the opportunity for midsize city innovation in infrastructure in the face of climate challenges.
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July 17, 2024
Burr & Forman Accused Of Aiding Health Insurance Fraud
Burr & Forman LLP has been hit with a malpractice suit in Georgia federal court by the liquidating trustees of two purported health insurance companies after the firm allegedly aided in a scheme to defraud customers by charging exorbitant fees and denying promised coverage, saying the attorneys helped create a web of LLCs to which it siphoned off millions.
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July 16, 2024
No Let-Up On DOJ Medicare Advantage Fraud Probes
Federal scrutiny of Medicare Advantage fraud is showing no signs of abating.
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July 16, 2024
Sanford-Marshfield Tie-Up Portends More Cross-Market Deals
A merger between two Midwest health systems is evidence of hospitals' desire to strike deals with players in other markets, according to experts in the space, who say the trend may be influenced by a tough antitrust environment and larger industry shift to value-based care.
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July 16, 2024
FDA Vet Joins Arnold & Porter As Counsel On Healthcare
After nearly a decade in high-level roles at the U.S. Food and Drug Administration, regulatory pro Andrew Zacher has joined the life sciences and healthcare team at Arnold & Porter.
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July 16, 2024
3rd Circ. Backs Tossing Over 1K Suits In Merck Vaccine MDL
The Third Circuit on Tuesday affirmed the dismissal with prejudice of 1,189 cases in multidistrict litigation alleging Merck & Co. Inc.'s shingles vaccine, Zostavax, caused the disease, saying the district court did not abuse its discretion by requiring medical tests to support the claims.
Expert Analysis
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FOIA Exemption Questions On Redacted HHS Cannabis Letter
The U.S. Department of Health and Human Services' recent recommendation letter concerning the rescheduling of cannabis was heavily redacted, and based on an analysis on the applicability of Freedom of Information Act Exemption 5 to the letter, it's likely that we will see successful legal challenges to those redactions, say attorneys at Troutman Pepper.
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A Primer On New Calif. Health Transaction Reporting Rules
New California regulations regarding the reporting of certain transactions involving healthcare entities, which took effect on Jan. 1, address some industry feedback about overly broad requirements but still leave several areas of concern, says Andrew Demetriou at Husch Blackwell.
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In The CFPB Playbook: Rulemaking Rush Before Election Year
In this quarterly Consumer Financial Protection Bureau activity recap by former bureau personnel, attorneys at McGuireWoods explain the regulator's recent push to finalize new rules about data aggregators, digital payment apps and more before the election-year Congressional Review Act window opens.
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What The Law Firm Of The Future Will Look Like
As the legal landscape shifts, it’s become increasingly clear that the BigLaw business model must adapt in four key ways to remain viable, from fostering workplace flexibility to embracing technology, say Kevin Henderson and Eric Pacifici at SMB Law Group.
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4 PR Pointers When Your Case Is In The News
Media coverage of new lawsuits exploded last year, demonstrating why defense attorneys should devise a public relations plan that complements their legal strategy, incorporating several objectives to balance ethical obligations and advocacy, say Nathan Burchfiel at Pinkston and Ryan June at Castañeda + Heidelman.
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Digging Into The Debate On FDA's Proposed Lab Test Rule
A proposed 10-word amendment from the U.S. Food and Drug Administration represents a sea change in device regulation as it would summarily end decades of FDA enforcement discretion for laboratory developed tests, and the public comments offer some insight into the future of this long-running saga, say attorneys at Mintz.
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Law Firm Strategies For Successfully Navigating 2024 Trends
Though law firms face the dual challenge of external and internal pressures as they enter 2024, firms willing to pivot will be able to stand out by adapting to stakeholder needs and reimagining their infrastructure, says Shireen Hilal at Maior Consultants.
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AI In Health Law: The Top Guest Articles Of 2023
As the use of artificial intelligence accelerated this year, Expert Analysis writers examined AI's significant impact on the healthcare sector, ranging from key compliance considerations for companies utilizing AI tools to regulators' efforts to keep up with rapidly evolving technologies.
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The Most-Read Legal Industry Law360 Guest Articles Of 2023
A range of legal industry topics drew readers' attention in Law360's Expert Analysis section this year, from associate retention strategies to ethical billing practices.
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Inside Higher Education's New FCA Liability Challenges
As the educational sector expands its use of government funding, schools are at increased risk under the False Claims Act, but recent settlements offer valuable lessons about new theories of liability they may face and specific procedures to reduce their exposure, say James Zelenay and Jeremy Ochsenbein at Gibson Dunn.
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AI Executive Order's Life Science, Healthcare Industry Effects
The recent White House executive order to manage risks associated with artificial intelligence includes provisions specific to healthcare and life sciences that merit special attention, including transparency, human oversight of AI output, and real world performance monitoring, say attorneys at Ropes & Gray.
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HHS Advisory Highlights Free Product Inducement Risks
A recent U.S. Department of Health and Human Services advisory opinion highlights concerns that valuable free products and other inducements may influence patients and providers to choose one manufacturer’s product over another, notwithstanding that such free healthcare products may be a benefit, say attorneys at Morgan Lewis.
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Attorneys' Busiest Times Can Be Business Opportunities
Attorneys who resolve to grow their revenue and client base in 2024 should be careful not to abandon their goals when they get too busy with client work, because these periods of zero bandwidth can actually be a catalyst for future growth, says Amy Drysdale at Alchemy Consulting.