Policy & Compliance
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October 02, 2024
Lab Co. Settles Bogus Testing Claims With Feds For $27M
Precision Diagnostics Toxicology Lab, one of the nation's largest drug testing laboratories, has agreed to pay $27 million to resolve allegations that it billed Medicare and other federal healthcare programs for medically unnecessary tests, federal prosecutors announced Wednesday.
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October 02, 2024
Pfizer Didn't Warn Of Tumor Risks In Depo-Provera, Suit Says
Pfizer Inc. faces a product liability and negligence suit filed Tuesday in California federal court alleging it distributed the hormonal contraceptive drug Depo-Provera without adequately warning patients and doctors about the risk of brain tumors associated with its use, a danger that has been widely published in scientific journals for years.
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October 02, 2024
Colo. Judge Sees No Injuries In Health Data Breach Class Suit
A Colorado federal judge has dismissed a proposed class action alleging a software company waited nearly three months to tell data breach victims about hackers accessing personal and medical information for more than 250,000 people, concluding the plaintiffs' allegations weren't enough to give them standing.
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October 02, 2024
Abortion Clinic To Get Early Discovery In Patient Spying Case
A Massachusetts federal judge said Wednesday that an abortion clinic should get expedited discovery into its claims that a neighboring "pregnancy resource center" illegally infiltrated its patient communications in an attempt to derail appointments.
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October 01, 2024
CFPB Warns On Collecting 'Invalid,' Unverified Medical Debt
The Consumer Financial Protection Bureau on Tuesday cautioned debt collectors about significant potential compliance risks when working in the medical debt market, issuing guidance that identified a number of practices as illegal and capable of triggering "strict liability" under federal law.
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October 01, 2024
Judge Backs Louisiana 340B Law In Loss For Pharma Lobby
A Louisiana federal court has issued a sweeping loss to Big Pharma's top lobbying group and two pharmaceutical companies that argued a state law improperly expands the scope of the federal drug discount program.
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October 01, 2024
Ga. County Urges Full 11th Circ. To Nix Trans Deputy's Win
A Georgia county told the Eleventh Circuit on Monday that a health plan coverage exclusion for gender-affirming surgery is comparable to other exclusions in coverage and does not violate federal anti-discrimination laws.
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October 01, 2024
9th Circ. Revives FCA Claims Against Dermatology Practice
A Ninth Circuit panel on Monday revived the claims of a former employee who accused a Nevada dermatology practice of retaliation under the False Claims Act and other wrongdoing, reversing the practice's early win and sending the case back for trial.
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October 01, 2024
Novel FCA Decision Amplifies Voices Of Whistleblower Critics
A Florida federal judge's characterization of whistleblowers as self-appointed "special prosecutors" when they file lawsuits on the federal government's behalf amplifies the voices of critics questioning the constitutionality of a key enforcement tool for fighting fraud, while threatening to create a circuit split.
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October 01, 2024
Biotech Investors Reach $32.5M Deal Over Failed COVID Test
A class of Talis Biomedical Corp. investors accusing the company of inflating their stock price in the run-up to its IPO and then failing to launch a COVID-19 diagnostic test asked a California federal judge on Monday to preliminarily approve their $32.5 million settlement, citing Talis' shrinking cash reserves and imminent plans to file for bankruptcy.
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October 01, 2024
Gov't Looks To High Court To Preserve Free Preventive Care
The federal government has taken a fight over the Affordable Care Act's requirements for cost-free preventive care to the U.S. Supreme Court.
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October 01, 2024
Doctors Were 'Bamboozled' By $160M Health Fraud, Jury Told
A Houston man accused of defrauding the government out of $160 million by submitting false claims for diabetes medication is only guilty of creating a competitive business model, his attorney said Tuesday, telling a Texas federal jury it was "ridiculous" to say doctors across the country were "bamboozled" by an alleged scheme.
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October 01, 2024
FDA Chief Talks Shortages, Food Labels, Reorganization
Pharmaceutical supply chain challenges. A major agency reorganization. Rare disease research. These issues were top of mind for U.S. Food and Drug Administration Commissioner Robert Califf in a recent "fireside chat" with the Alliance for a Stronger FDA, a group of trade associations, pharmaceutical companies, health-focused nonprofits and other stakeholders.
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October 01, 2024
Nostrum Labs Hits Ch. 11 A Year After Medicaid Settlement
Nostrum Laboratories, a New Jersey drugmaker that paid millions to settle allegations that it underpaid Medicaid drug rebates for its bladder infection drug after it hiked the price more than 400%, filed for Chapter 11 protection with nearly $68.3 million in debt.
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October 01, 2024
'Unsworn' Actors Sink Qui Tam Provision, Fla. Judge Rules
A Florida federal judge on Monday ruled that the provision of the False Claims Act allowing whistleblowers to bring suits on behalf of the federal government is unconstitutional, dismissing a closely watched Medicare Advantage fraud case and potentially upending a key federal enforcement tool.
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September 30, 2024
Calif. Sues Eureka Hospital For Denying Emergency Abortion
California on Monday sued Providence of St. Joseph Hospital in Eureka for denying an emergency abortion to a woman it diagnosed with a serious pregnancy complication and sending her off to a small community hospital with a bucket and towels.
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September 30, 2024
Takeda End Payors, Direct Buyers Win Antitrust Class Cert.
A New York federal judge Monday adopted a magistrate judge's recommendation to certify two classes of direct purchasers and end payors in consolidated antitrust actions accusing Takeda Pharmaceuticals Co. of unlawfully inflating the price of its diabetes treatment Actos by delaying entry of generic alternatives.
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September 30, 2024
Ga.'s 'Heartbeat' Abortion Ban Struck Down Once Again
Georgia residents had their legal access to abortion temporarily restored Monday as the state's so-called heartbeat abortion ban was again struck down by a judge whose previous move to block the 2019 law had been reversed by the state's highest court.
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September 30, 2024
J&J Backs Off 340B Rebate Plan Following Feds' Objections
Johnson & Johnson abandoned its plan Monday to offer rebates rather than upfront discounts for two medications under the 340B drug pricing law, contending it had no choice after a federal agency threatened to impose excessive penalties.
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September 30, 2024
Physician Assistant Seeks Lenient Term In $10M Fraud Case
A North Carolina physician assistant is looking to spend just one year behind bars after a federal jury in Charlotte found him guilty of rubber-stamping bogus prescriptions for genetic testing, marking a far cry from prosecutors' requested nine-year prison sentence.
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September 27, 2024
Texas AG Wants Austin's Abortion Travel Fund Shut Down
Texas Attorney General Ken Paxton on Friday accused the city of Austin of illegally using taxpayer funds to cover travel costs for people traveling out of the Lone Star State to get abortions, claiming that the city is misappropriating the funds in violation of the state constitution.
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September 27, 2024
Kappos' Bayh-Dole Warning To Clients Draws Debate
An advocate for lowering drug prices squared off Friday against a former U.S. Patent and Trademark Office director about the potential risk of accepting government funds to develop drugs, as part of a discussion at New York University School of Law.
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September 27, 2024
Acadia To Pay $19.9M For Alleged Inpatient Billing Scheme
Acadia Healthcare will pay $19.85 million to settle allegations it billed false claims to the federal government for medically unnecessary behavioral health services provided to patients who weren't even eligible for treatment, the U.S. Department of Justice announced.
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September 27, 2024
Why Many Drugs Remain Pricey 40 Years After Hatch-Waxman
In the four decades since Congress passed the Hatch-Waxman Act in an effort to make generic drugs more available, the pharmaceutical industry has used patent thickets, "evergreening" and pay-for-delay tactics to block competition and keep prices of life-saving specialty drugs astronomical, several legal experts told Law360, while the industry argues other parties shoulder more of the blame.
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September 27, 2024
MetLife's 3rd Circ. Win Won't Stop ERISA Health Fee Suits
The Third Circuit's recent decision upholding MetLife's escape from a lawsuit accusing the company of pocketing $65 million in pharmacy rebates instead of using the funds to lower employee healthcare costs hands additional authority over to employers facing a new wave of class action litigation over excessive health fees, attorneys say.
11th Circ. Hearsay Ruling May Open Door To Top Court Review
An Eleventh Circuit decision to allow co-conspirator statements under a hearsay rule exclusion in a $400 million health insurance fraud case could stretch the scope of federal fraud law and might draw the attention of the U.S. Supreme Court.
In Florida, Regulators Eye Brazilian Butt Lift Industry
A spate of patient deaths following a gluteal fat graft — otherwise known as a Brazilian butt lift — has the attention of lawmakers and regulators in Florida, the epicenter of a booming plastic surgery business. The state’s moves may ripple through other parts of the country if the procedure continues to grow in popularity.
Henrietta Lacks' Family Still Seeks Justice For 'Immortal' Cells
Seven decades have passed since a doctor at a Baltimore hospital took, without permission, a sample of cells from a Black woman suffering from cervical cancer. While the durable strain of human cells known as "HeLa" has fueled a handful of lawsuits against drug companies accused of profiting from stolen genetic material, more are likely on the way.
Expert Analysis
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Plan Sponsors Must Prep For New Mental Health, Drug Rules
To comply with newly published health insurance rules requiring parity between access to mental health and substance use services compared to medical and surgical services, employers with self-insured plans will need to update third-party administrator agreements and collect data, among other compliance steps, say attorneys at Kilpatrick.
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A Primer On Navigating The Conrad 30 Immigration Program
As the Conrad 30 program opens its annual window to help place immigrant physicians in medically underserved areas, employers and physicians engaged in the process must carefully understand the program's nuanced requirements, say Andrew Desposito and Greg Berk at Sheppard Mullin.
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Class Actions At The Circuit Courts: September Lessons
In this month's review of class action appeals, Mitchell Engel at Shook Hardy identifies practice tips from four recent class certification rulings involving denial of Medicare reimbursements, automobile insurance disputes, veterans' rights and automobile defects.
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Proposed Legislation May Crack Down On Online Drug Ads
A bill recently proposed in Congress could serve as a sea change in how the U.S. Food and Drug Administration regulates drug-related speech, with significant trickle-down effects on various corners of not only the drug industry but also on consumers and providers themselves, say Dominick DiSabatino and Arushi Pandya at Sheppard Mullin.
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What To Expect From Calif. Bill Regulating PE In Healthcare
A California bill currently awaiting Gov. Gavin Newsom's approval, intended to increase oversight over private equity and hedge fund investments in healthcare, is emblematic of recent increased scrutiny of investments in the space, and may affect transactions and operations in California in a number of ways, say attorneys at Ropes & Gray.
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Vertex Suit Highlights Issues For Pharma Fertility Support
Vertex Pharmaceuticals' recent lawsuit challenging the U.S. Department of Health and Human Services' interpretation of the Anti-Kickback Statute is influenced by a number of reproductive rights and health equity issues that the Office of Inspector General should address more concretely, including in vitro fertilization and fertility preservation programs, says Mary Kohler at Kohler Health Law.
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CMS' New 'Breakthrough' Device Policy Shows Little Promise
The Centers for Medicare & Medicaid Services’ recent procedural notice outlining a new Medicare coverage pathway for breakthrough medical devices will, at best, be a failed experiment and, at worst, result in Medicare beneficiaries denied access to innovative treatments, say attorneys at King & Spalding.
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A Preview Of AI Priorities Under The Next President
For the first time in a presidential election, both of the leading candidates and their parties have been vocal about artificial intelligence policy, offering clues on the future of regulation as AI continues to advance and congressional action continues to stall, say attorneys at Mintz.
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Managing Community Health Needs Assessments: A Checklist
Excerpt from Practical Guidance
To guide nonprofit hospitals and health systems through their required community health needs assessment every three years, this checklist outlines the steps for 12 phases of the process.
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Pa. Health Employers Must Prep For Noncompete Restrictions
Newly enacted legislation in Pennsylvania prohibits certain noncompete covenants for healthcare practitioners in the state beginning next year, creating compliance challenges that both employers and employees should be aware of, say attorneys at Buchanan Ingersoll.
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FTC Focus: What Access To Patent Settlements Would Mean
Settling parties should adopt a series of practice tips, including specifying rationales to support specific terms, as the Federal Trade Commission seeks to expand its access to settlements before the Patent Trial and Appeal Board, say Shannon McGowan and David Munkittrick at Proskauer.
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Agencies Should Reward Corporate Cyber Victim Cooperation
The increased regulatory scrutiny on corporate victims of cyberattacks — exemplified by the U.S. Securities and Exchange Commission's case against SolarWinds — should be replaced with a new model that provides adequate incentives for companies to come forward proactively and collaborate with law enforcement, say attorneys at McDermott.
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Strategies To Defend Against Healthcare Nuclear Verdicts
The healthcare industry is increasingly the target of megaclaims, particularly those alleging medical malpractice, but attorneys representing providers can use a few tools to push back on flimsy litigation and reduce the likelihood of a nuclear verdict, says LaMar Jost at Wheeler Trigg.