Policy & Compliance

  • 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.

  • 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. 

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • August 12, 2024

    Big Tobacco To Pay $600M In 'Historic' Mass. Deal

    Philip Morris Inc. and RJ Reynolds Tobacco Co. will pay nine-figure sums as part of a $600 million settlement between Massachusetts and major tobacco companies that resolves yearslong disputes about how much the cigarette makers owe, the state attorney general announced Monday.

  • August 09, 2024

    Takeda Should Face Certified Antitrust Classes, Judge Says

    A New York federal judge on Friday recommended certifying 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.

  • August 09, 2024

    Valeant's Legal Gripe A Total 'Nothingburger,' Justices Told

    A lawyer who assembled a whistleblower lawsuit against a major pharmaceutical company using publicly available patent board filings says the larger legal question of whether he can do that is way too niche for the U.S. Supreme Court to bother thinking about.

  • August 09, 2024

    Medicare Drug Price Suit Nixed Over 'Forum Shopping' In Ohio

    The Department of Health and Human Services has notched yet another win in litigation challenging the constitutionality of the Medicare drug price negotiation program, securing the dismissal of a suit brought by several chambers of commerce.

  • August 09, 2024

    DC Circ. Pans Suit Claiming HHS Caused Health Aid Shortage

    The D.C. Circuit said Friday that a judge properly dismissed a proposed class action blaming the U.S. Department of Health and Human Services for a lack of home health aides willing to assist Medicare beneficiaries with chronic illnesses, saying the private providers aren't required to accept those patients.

  • August 09, 2024

    FDA Rejects Latest Effort To Treat PTSD With MDMA

    The U.S. Food and Drug Administration has rejected a new drug application to treat post-traumatic stress disorder with the psychedelic drug MDMA, an entactogen also known as ecstasy or molly, the company that backed the effort announced Friday.

  • August 09, 2024

    Aetna Illegally Axed Exec's Disability Benefits, Judge Says

    A California federal judge said Aetna was wrong to end an executive's disability benefits after it found he suffered from a mental illness instead of a physical disability, stating the insurer used flawed doctor opinions and may have been motivated by cutting costs.

Expert Analysis

  • How To Navigate The FTC's New Private Equity Frontier

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    The Federal Trade Commission's recent district court complaint against an anesthesia firm and its private equity partner tests key bounds of the agency's stand-alone authority, and defense strategies can include challenges to both the geographic and the service market fronts, say attorneys at Baker McKenzie.

  • Newman Suspension Shows Need For Judicial Reform

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    The recent suspension of U.S. Circuit Judge Pauline Newman following her alleged refusal to participate in a disability inquiry reveals the need for judicial misconduct reforms to ensure that judges step down when they can no longer serve effectively, says Aliza Shatzman at The Legal Accountability Project.

  • An Overview Of Congress' Proposed Drug Shortage Solutions

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    Recently, Congress has seen a number of bipartisan bills that seek to prevent and respond to national drug shortages, though disagreements over the right vehicle and timeline have slowed progress, says Miranda Franco at Holland & Knight.

  • SEC's Life Sciences Actions Utilize Novel Tools And Theories

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    Recent enforcement actions show that the U.S. Securities and Exchange Commission is employing new forms of data analytics and noteworthy applications of insider trading laws in its scrutiny of fraud within the life sciences and health industries, say Edward Imperatore and Jina Choi at MoFo.

  • ESG Around The World: Japan

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    Japan is witnessing rapid developments in environmental, social and corporate governance policies by making efforts to adopt a soft law approach, which has been effective in encouraging companies to embrace ESG practices and address the diversity of boards of directors, say Akira Karasawa and Landry Guesdon at Iwata Godo.

  • How And Why Your Firm Should Implement Fixed-Fee Billing

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    Amid rising burnout in the legal industry and client efforts to curtail spending, pivoting to a fixed-fee billing model may improve client-attorney relationships and offer lawyers financial, logistical and stress relief — while still maintaining profit margins, say Kevin Henderson and Eric Pacifici at SMB Law Group.

  • Potential Broader Effects Of FDA's Lab-Developed Test Rule

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    Though it's unclear whether the U.S. Food and Drug Administration's proposed rule for regulating lab-developed tests will ever go into effect, it nonetheless functions as a threatened hammer that may make legislative efforts to regulate such tests more palatable, say attorneys at King & Spalding.

  • Judicial Independence Needs Defense Amid Political Threats

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    Amid recent and historic challenges to the judiciary from political forces, safeguarding judicial independence and maintaining the integrity of the legal system is increasingly urgent, says Robert Peck at the Center for Constitutional Litigation.

  • 2 New Ways FDA Is Changing Lab-Developed Test Regulation

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    The U.S. Food and Drug Administration's recently announced rulemaking and voluntary pilot program signal the agency's dedication to ramping up oversight of lab-developed tests, which have been largely unregulated by the FDA until now, say attorneys at Sidley.

  • How Law Firms Can Use Account-Based Marketing Strategies

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    Amid several evolving legal industry trends, account-based marketing can help law firms uncover additional revenue-generating opportunities with existing clients, with key considerations ranging from data analytics to relationship building, say Jennifer Ramsey at stage LLC and consultant Gina Sponzilli.

  • AGs' Distaste For Food Bill May Signal Other State Issues

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    States' recent opposition to a proposed federal law that would block them from regulating out-of-state agricultural production could affect issues beyond this narrow debate, such as the balance of state and federal regulatory power, reproductive rights post-Dobbs, and energy production and water use, say Christopher Allen and Stephen Cobb at Cozen O'Connor.

  • Strategic Succession Planning At Law Firms Is Crucial

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    Senior partners' reluctance to retire, the rise of the nonequity partner tier and generational differences in expectations are all contributing to an increasing number of departures from BigLaw, making it imperative for firms to encourage retirement among senior ranks and provide clearer leadership pathways to junior attorneys, says Laura Leopard at Leopard Solutions.

  • What An NCAA Drug Test Change Could Mean For Cannabis

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    If the NCAA follows through with its decision to remove cannabis from its banned list of substances, it will affect college athletes, athletic directors, public relations employees, and marketing departments at universities and colleges, and it will have a significant economic effect on the cannabis industry, say Stanley Jutkowitz and Sydney Jenkins at Seyfarth.