Policy & Compliance
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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.
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July 16, 2024
Union Fund Trustees Say Elevance Usurped Fiduciary Power
The trustees of two union health plans said Elevance Health Inc. and its subsidiaries violated federal benefits law when they overpaid themselves for administrative services and medical providers for patient care, arguing the insurer had significant control over the management of the plans and their assets.
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July 16, 2024
Ga. Denied Extension For Medicaid Work Requirement Plan
Georgia won't get extra time to administer a work requirement Medicaid expansion program in order to make up for federal regulators' illegal delaying of its rollout after a federal judge ruled Monday that the state didn't go through the proper channels in trying to extend the program's timeline.
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July 16, 2024
In Chevron's Fall, Attys See Conflicting Rulings, Circuit Splits
The end of Chevron deference, along with other U.S. Supreme Court decisions weakening the authority of federal agencies, may make the drug regulatory landscape more volatile — not less — as courts wrestle with new limits on federal power.
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July 16, 2024
The Risks And Promise Of Medical Debt Reporting Rule
A proposed federal rule would prevent medical debt from appearing on credit reports of tens of millions of Americans. Legal and debt experts are conflicted over whether it could backfire on some healthcare consumers and potentially kneecap healthcare providers who still need to collect unpaid bills.
Expert Analysis
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What Lawyers Must Know About Calif. State Bar's AI Guidance
Initial recommendations from the State Bar of California regarding use of generative artificial intelligence by lawyers have the potential to become a useful set of guidelines in the industry, covering confidentiality, supervision and training, communications, discrimination and more, say attorneys at Debevoise.
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Industry Must Elevate Native American Women Attys' Stories
The American Bar Association's recent research study into Native American women attorneys' experiences in the legal industry reveals the glacial pace of progress, and should inform efforts to amplify Native voices in the field, says Mary Smith, president of the ABA.
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White House Activity Is A Band-Aid For Regulating AI In Health
In the medium term, recent White House actions will have a greater impact on AI in the health care industry than Congress' sluggish efforts to regulate it, but ultimately legislation of AI's development and use in the health space will fall to Congress, say Wendell Bartnick and Vanessa Perumal at Reed Smith.
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Understanding Discovery Obligations In Era Of Generative AI
Excerpt from Practical Guidance
Attorneys and businesses must adapt to the unique discovery challenges presented by generative artificial intelligence, such as chatbot content and prompts, while upholding the principles of fairness, transparency and compliance with legal obligations in federal civil litigation, say attorneys at King & Spalding.
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How Mental Health Ruling Paves Road For Equal Coverage
The Tenth Circuit’s recent ruling in E.W. v. Health Net, which clarified the pleading requirements necessary to establish a Mental Health Parity and Addiction Equity Act violation, is a win for plaintiffs as it opens the door to those who have been denied coverage for behavioral health treatment to prove a mental health parity violation, says Mark DeBofsky at DeBofsky Law.
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ESG Around The World: Mexico
ESG has yet to become part of the DNA of the Mexican business model, but huge strides are being made in that direction, as more stakeholders demand that companies adopt, at the least, a modicum of sustainability commitments and demonstrate how they will meet them, says Carlos Escoto at Galicia Abogados.
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The Case For Post-Bar Clerk Training Programs At Law Firms
In today's competitive legal hiring market, an intentionally designed training program for law school graduates awaiting bar admission can be an effective way of creating a pipeline of qualified candidates, says Brent Daub at Gilson Daub.
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10 Takeaways From New HHS Federal Compliance Guidelines
The U.S. Department of Health and Human Services' recently issued general compliance program guidance is the first of its kind that would apply across all health care stakeholders, and signals the agency’s first step to improve and update existing compliance guidance, says Melissa Wong at Holland & Knight.
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2 HHS Warnings Highlight Anti-Kickback Risks For Physicians
Two recent advisory opinions issued by the U.S. Department of Health and Human Services' Office of Inspector General involve different scenarios and rationales, but together they illustrate the OIG's focus on and disapproval of contractual joint ventures and other revenue-maximizing physician arrangements, say Robert Threlkeld and Elliott Coward at Morris Manning.
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Attorneys Have An Ethical Duty To Protect The Judiciary
The tenor of public disagreement and debate has become increasingly hostile against judges, and though the legislative branch is trying to ameliorate this safety gap, lawyers have a moral imperative and professional requirement to stand with judges in defusing attacks against them and their rulings, says Deborah Winokur at Cozen O'Connor.
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Cross-Market Implications In FTC's Anesthesia Complaint
The Federal Trade Commission's recent complaint against a private equity firm's acquisition of anesthesiology practices highlights the controversial issue of cross-market harm in health care provider mergers, and could provide important insights into how a court may view such theories of harm, say Christopher Lau and Dina Older Aguilar at Cornerstone Research.
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AI Can Help Lawyers Overcome The Programming Barrier
Legal professionals without programming expertise can use generative artificial intelligence to harness the power of automation and other technology solutions to streamline their work, without the steep learning curve traditionally associated with coding, says George Zalepa at Greenberg Traurig.
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Preparing Law Students For A New, AI-Assisted Legal World
As artificial intelligence rapidly transforms the legal landscape, law schools must integrate technology and curricula that address AI’s innate challenges — from ethics to data security — to help students stay ahead of the curve, say Daniel Garrie at Law & Forensics, Ryan Abbott at JAMS and Karen Silverman at Cantellus Group.