Policy & Compliance
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August 15, 2024
2023 Rule Revising Hospital Payments Struck Down
A Texas federal judge on Thursday sided with about a dozen hospitals challenging a federal regulation that they say will curtail their payments for treating low-income patients, declaring the rule unlawful and setting it aside.
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August 15, 2024
Matthew Perry's Assistant And 2 Drs. Charged In Actor's Death
The former personal assistant for actor Matthew Perry and two doctors have been criminally charged in connection with the "Friends" star's death last year from an overdose of ketamine, according to a criminal complaint unsealed Thursday in California federal court.
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August 15, 2024
9th Circ. Judges Seem To Split On Wash. Abortion Coverage
A Ninth Circuit judge asked Thursday how a church could be harmed by a Washington law requiring employee health plans to cover abortions, since none of its workers had ever actually sought one, while another judge asked if tossing the case would slam the door on religious objections.
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August 15, 2024
CMS Posts Final Costs For 1st Set Of Drugs After Negotiations
The federal government released on Thursday the final prices of the first 10 drugs negotiated by Medicare under the Inflation Reduction Act, in a long-anticipated move set to shape the future of drug price negotiations.
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August 15, 2024
Ill. Health Center Challenges NLRB Constitutionality
An Illinois health center on Wednesday filed the latest constitutional challenge to the National Labor Relations Board, urging an Illinois federal judge to block an NLRB prosecution over its decision to fire employees who allegedly provided fake Social Security numbers when they were hired.
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August 15, 2024
Del. Chancery OKs $175M Judgment Against Insys Founder
The convicted founder of drugmaker Insys has told Delaware's Chancery Court he agreed to accept a $175 million judgment as part of a settlement with the company's liquidation trust over his role in an opioid kickback scheme that drove the firm into bankruptcy.
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August 15, 2024
Full 11th Circ. To Weigh Georgia Deputy's Trans Health Win
The Eleventh Circuit agreed Thursday to a full-court rehearing of an appeal from Georgia county officials looking to overturn a deputy's win in her suit alleging a health plan coverage exclusion for gender-affirming surgery violated federal anti-discrimination law.
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August 14, 2024
HHS Eyes 2025 For New Medicare Appeal Rule
In response to a Connecticut federal judge's stern demand for quicker progress, the U.S. Department of Health and Human Services has said in a court filing that it should be able to implement a new rule creating an avenue for Medicare beneficiaries to appeal their hospitalization status by Jan. 1.
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August 14, 2024
Hospital Groups Tell High Court HHS 'Stingy' In SSI Pay Row
Six of the nation's leading hospital associations told the Supreme Court on Wednesday that the U.S. Department of Health and Human Services is being "stingy" when miscalculating a formula that could cost hospitals treating low-income patients more than a billion dollars in special payments each year.
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August 14, 2024
Texas Sues HHS Over 'Arbitrary' Nursing Home Staffing Rule
The state of Texas on Wednesday challenged a new federal rule that sets minimum staffing standards at nursing homes, contending the Biden administration overstepped its statutory authority and crafted a rule almost impossible to meet because of nursing shortages.
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August 14, 2024
HHS Calls For More Research, Planning To Combat Heat Risks
Citing a sharp increase in deaths from extreme heat, the Biden administration unveiled a national strategy Wednesday that calls for better communicating the health risks of hot weather to the public and taking other steps to protect people from life-threatening heat waves.
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August 14, 2024
1st Circ. Revives Vax Refusal Suit Against Beth Israel
The First Circuit on Tuesday revived a suit against health facility system Beth Israel Lahey Health Inc. from an office manager who was fired over her refusal to be vaccinated against COVID-19, disagreeing with a lower court that said she hadn't shown a genuine religious belief meriting a vaccine exemption.
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August 14, 2024
Medical Device Maker Pleads Guilty To $2.4M Tax Evasion
A man who made millions of dollars on medical devices and sold one purporting to eradicate viruses by using sound waves pled guilty to evading $2.4 million in taxes in a trust scheme involving his girlfriend, according to Florida federal court documents.
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August 13, 2024
CMS Takes Baby Steps In New 'Breakthrough' Device Policy
The Centers for Medicare and Medicaid Services recently finalized highly anticipated guidance providing a new pathway for Medicare coverage of breakthrough medical devices, but attorneys worry the agency's plans to accept just five products each year will blunt the program's impact.
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August 13, 2024
Test-Makers See Way Out Of FDA Rule With Chevron Reversal
This spring, despite widespread industry opposition, the U.S. Food and Drug Administration granted itself oversight of laboratory-developed diagnostic tests. Now, industry groups say they're facing a costly and convoluted agency approval process — one they hope they can dismantle based on the Supreme Court's recent decision to overturn Chevron deference.
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August 13, 2024
Wash. Social Media Ban Violates Workers' Free Speech
The Washington State Court of Appeals has said a state law barring injured workers from posting videos of their state workers' compensation medical exams on social media is an unconstitutional violation of free speech rights.
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August 13, 2024
Biotechs Walk Tightrope On Drug Price Negotiation Messaging
Biotech companies whose products have been affected by Medicare price negotiations under the Inflation Reduction Act largely reassured investors on recent earnings calls of their success, even as they argue in court that the program could upend their businesses and the larger industry.
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August 13, 2024
NC Lawmakers Ask 4th Circ. To Restore Abortion Drug Limits
North Carolina Republican lawmakers want the Fourth Circuit to reinstate restrictions on the abortion drug mifepristone, telling the court the new rules concerning the medication are not preempted by U.S. Food and Drug Administration regulations.
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August 13, 2024
NY, NJ And Conn. Score $4.5M Penalty Over Enzo Data Breach
Molecular diagnostics company Enzo Biochem Inc. has agreed to pay a $4.5 million penalty after an investigation found that the company failed to implement recommended security protocols ahead of a data breach that affected millions of patients, New York's attorney general announced Tuesday.
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August 13, 2024
Janssen Wants New FCA Trial As Relators Seek $1.85B Win
Janssen has urged a New Jersey federal judge to toss a jury's $150 million False Claims Act verdict that found the pharmaceutical company illegally profited from the off-label marketing of popular HIV medications, while whistleblowers have asked the court for a whopping $1.85 billion judgment consisting of trebled damages and statutory penalties.
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August 13, 2024
FTC Makes 2nd Request In Review Of Medical Device Co. Deal
Medical device company Surmodics Inc. disclosed Monday that federal regulators are taking a closer look at its agreement to be acquired by private equity giant GTCR in a $627 million deal.
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August 13, 2024
As Attacks Rise, OSHA Lags On Health Workplace Protections
State and federal lawmakers are considering legislation to combat the growing issue of healthcare workplace violence, but legal experts say the Occupational Safety and Health Administration still lacks specific rules for healthcare workplaces even as it brings claims against them for failing to protect workers.
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August 12, 2024
9th Circ. Won't Rethink Upending Sutter Health Antitrust Win
The Ninth Circuit refused Monday to reconsider a panel's split decision overturning Sutter Health's defeat of insurance plan purchasers' $400 million antitrust suit, summarily rejecting hospital system arguments that the court wrongly put in play corporate "purpose" and decades-old communications.
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August 12, 2024
Paragard IUD Makers Gearing Up For Defect Dismissal Bid
Teva Pharmaceuticals and The Cooper Cos. have five days to reach out to plaintiffs who may be included in a motion to dismiss the sprawling litigation over alleged defects in the Paragard IUD, a Georgia federal judge said Monday.
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August 12, 2024
NJ Hospital Ex-Worker's Tactics Doom Class Cert., Court Told
A former employee of a New Jersey healthcare network who seeks to certify a class of employees alleging they were denied proper overtime didn't comply with deposition requests, the company told a federal court, arguing that the certification request should be denied.
Expert Analysis
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FDA's Data Monitoring Guidance Reveals Future Expectations
As the world of clinical research grows increasingly complex, the U.S. Food and Drug Administration's recent draft guidance on the use of data monitoring committees in clinical trials reveals how the agency expects such committees to develop, say Melissa Markey and Carolina Wirth at Hall Render.
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FDA Warning Indicates Scrutiny Of Regenerative Health Cos.
The U.S. Food and Drug Administration's recent warning letter to Akan Biosciences is a quintessential example of the agency's enforcement priorities for certain products involving human cells and tissues, and highlights ongoing scrutiny placed on manufacturers, say Dominick DiSabatino and Cortney Inman at Sheppard Mullin.
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2 Regulatory Approaches To Psychedelic Clinical Trials
Comparing the U.S. and Canada's regulatory frameworks for clinical trials of psychedelic drugs can be useful for designing trial protocols that meet both countries' requirements, which can in turn help diversify patient populations, bolster data robustness and expedite market access, say Kimberly Chew at Husch Blackwell and Sabrina Ramkellawan at AxialBridge.
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'Food As Health' Serves Up Fresh Legal Considerations
The growth of food as medicine presents a significant opportunity for healthcare organizations and nontraditional healthcare players to improve patient outcomes and reduce costs, though these innovative programs also bring compliance considerations that must be carefully navigated, say attorneys at McDermott.
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DC Circ. Ruling Heightens HHS Contract Pharmacy Challenges
The D.C. Circuit's recent ruling that the Section 340B program does not bar manufacturers from restricting deliveries of discounted drugs to contract pharmacies represents a second strike against the U.S. Department of Health and Human Services' current contract pharmacy policy and raises the stakes surrounding an upcoming Seventh Circuit ruling on the same issue, say attorneys at Foley Hoag.
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FTC Focus: Exploring The Meaning Of Orange Book Letters
The Federal Trade Commission recently announced an expansion of its campaign to promote competition by targeting pharmaceutical manufacturers' improper Orange Book patent listings, but there is a question of whether and how this helps generic entrants, say Colin Kass and David Munkittrick at Proskauer.
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3rd Circ.'s Geico Ruling May Encourage Healthcare Arbitration
The Third Circuit's recent decision in Geico v. Mount Prospect, finding that claims under New Jersey's Insurance Fraud Prevention Act can be arbitrated, strengthens arbitration as a viable alternative to litigation, even though it is not necessarily always a more favorable forum, say Khaled Klele and Jessica Osterlof at McCarter & English.
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Proposed Cannabis Reschedule Sidesteps State Law Effects
The U.S. Department of Justice's recent proposal to move cannabis to Schedule III of the Controlled Substances Act provides certain benefits, but its failure to address how the rescheduling would interact with existing state cannabis laws disappointed industry participants hoping for clarity on this crucial question, says Ian Stewart at Wilson Elser.
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A Changing Regulatory Landscape For Weight Loss Drugs
As drugs originally approved to treat diabetes become increasingly popular for weight loss purposes, federal and state regulators and payors are increasing their focus on how these drugs are prescribed, and industry participants should pay close attention to rapidly evolving compliance requirements, say attorneys at Goodwin.
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Opioid Suits Offer Case Study In Abatement Expert Testimony
Settlements in the opioid multidistrict litigation provide useful insight into leveraging expert discovery on abatement in public nuisance cases, and would not have been successful without testimony on the costs necessary to lessen the harms of the opioid crisis, says David Burnett at DiCello Levitt.
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How HHS Discrimination Rule Affects Gender-Affirming Care
The U.S. Department of Health and Human Services' new final rule, which reinterprets the Affordable Care Act's anti-discrimination provision, greatly clarifies protections for gender-affirming care and will require compliance considerations from sponsors and administrators of most group health plans, say attorneys at McDermott.
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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.