Polsinelli

Who Would Have Predicted It? Polymarket Settles for Operating Unregistered Swap Execution Facility

On January 3, 2022, the Commodity Futures Trading Commission (CFTC) announced an order against and settlement with Polymarket, a blockchain-enabled prediction market that allows users to “bet” on the occurrence of certain future…more

Blockchain, CFTC, Designated Contract Markets (DCMs), Enforcement Actions, Financial Markets

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National Security Focus on Cybersecurity for Critical Infrastructure Sharpens

Last year Colonial Pipeline halted one of the United States’ largest pipeline systems due to a ransomware attack. Within days a state of emergency was declared in 17 states. A few days later the pipeline resumed service, and…more

Biden Administration, Critical Infrastructure Sectors, Cyber Attacks, Cybersecurity, Executive Orders

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Supreme Court Opens the Doors for States to Tax More Online Sales

On Thursday, June 21, 2018, The Supreme Court of the United States issued its decision in the landmark South Dakota v. Wayfair, Inc. case, drastically changing the law for e-commerce and remote sellers…more

Appeals, Commerce Clause, Constitutional Challenges, Internet Retailers, Interstate Commerce

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Generative Artificial Intelligence Leveraged to Deliver Healthcare - Legal Risks and Issues

With daily media reports citing to the explosion of interest in Artificial Intelligence (“AI”), AI start-ups have attracted a huge capital influx. During the last fiscal quarter of 2024 ending on December 31st, investors pumped…more

Artificial Intelligence, Compliance, Cybersecurity, Data Privacy, Data Protection

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New Form 5500 Rules Permit More Plans to Qualify for Audit Exemption

The Department of Labor, Internal Revenue Service, and Pension Benefit Guaranty Corporation recently issued final rules on employee benefit plan annual reporting requirements that are effective for plan years beginning on or…more

401k, 403(b) Plans, Compensation & Benefits, Department of Labor (DOL), Employee Benefits

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ESOP Transactions and the Duty to Monitor Revisited

Key Takeaways: Board’s Duty to Monitor the Trustee: A company’s board of directors has a fiduciary duty to monitor the ESOP trustee’s actions in an ESOP transaction, ensuring that the trustee is acting in the exclusive…more

Board of Directors, Compliance, Corporate Governance, Employee Benefits, ESOP

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Real or Ruse? IRS’s New Settlement Initiative for Syndicated Conservation Easements

The Internal Revenue Service (IRS) recently announced a new settlement initiative for Syndicated Conservation Easements (SCEs) that are currently under audit and have not reached the Tax Court. This new settlement initiative…more

Audits, Conservation Easements, Government Investigations, Investors, IRS

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The Polsinelli Pulse: Mitigating Litigation Risk at the Deal Table and Beyond - Vol. 3

Mergers & Acquisitions And Paycheck Protection Program: Proceed With Caution - In Spring 2020, Congress adopted the CARES Act, which authorized $350 billion for the Paycheck Protection Program (“PPP”). With an additional $310…more

Acquisition Agreements, C-Suite Executives, CARES Act, Coronavirus/COVID-19, Cyber Insurance

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OCR Proposes Regulatory Facelift to the HIPAA Security Rule: Addressing the Current Cybersecurity Environment with More Specificity and Additional Requirements

On January 6, 2025, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) published a “Notice of Proposed Rulemaking,” HIPAA Security Rule to Strengthen the Cybersecurity of Electronic Protected…more

Cybersecurity, Data Privacy, Data Security, Department of Health and Human Services (HHS), Electronic Protected Health Information (ePHI)

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Health Care Reimbursement and Payor Dispute Update Special Edition – Year End Regulatory Review

The Centers For Medicare & Medicaid Services Issues New Inpatient Prospective Payment System Final Rule - On September 3, 2020, the Centers for Medicare & Medicaid Services (CMS) issued the fiscal year (FY) 2021 Medicare…more

Centers for Medicare & Medicaid Services (CMS), Cramdown, Drug Pricing, Health Care Providers, Healthcare Reform

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A Vaccine is Coming: Can Employers Require Employees to Take it?

As clinical trials continue across the world for a COVID-19 vaccine, many employers are asking whether they will be able to require employees to take the vaccine when it becomes available in the United States. Like with so many…more

Americans with Disabilities Act (ADA), Best Management Practices, Civil Rights Act, Coronavirus/COVID-19, Employee Rights

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Supreme Court Confirms the AIA On-Sale Bar Covers Secret Sales—But Invites Controversy over What Is “Otherwise Available to the Public.”

The Supreme Court recently issued its closely-watched decision in Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc., which has direct implications regarding the scope of § 102 prior art under the America Invents Act…more

America Invents Act, Appeals, Assignment of Inventions, Confidentiality Agreements, Helsinn Healthcare SA v Teva Pharmaceuticals USA Inc

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Med-Staff Newsletter - October 2023 | VOL 12

Do the Right Thing — Reporting Voluntary Actions Taken While “Under Investigation” to the NPDB - Many health care entities struggle with the dilemma of whether and when to make reports to the National Practitioner Data Bank…more

Health Care Providers, Healthcare, Healthcare Reform, Healthcare Workers, Investigations

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FTC and DOJ Signal Greatly Increased Scrutiny of Private Equity Firms’ Acquisitions in Health Care

The top enforcers at the Federal Trade Commission (FTC) and Antitrust Division of the Department of Justice (DOJ) are sending strong signals that private equity (PE) firms are likely to be the next target in the Biden…more

Acquisitions, Antitrust Provisions, Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services (HHS), Department of Justice (DOJ)

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Mitigating Your Greatest Data Privacy Risk

Third-party vendors pose a significant risk - The greatest data privacy threat to companies is commonly thought to be that company’s employees. While employees can be a threat, the majority of data breaches and intrusions…more

Data Breach, Data Privacy, Data Protection, Information Security, Information Technology

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Silicon Valley Bank Receivership

1. What happened Friday? a. The California Department of Financial Protection and Innovation closed Silicon Valley Bank (SVB) and appointed FDIC as receiver…more

Banks, Deposit Accounts, Depository Institutions, Enforcement Actions, FDIC

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Technology Transactions & Data Privacy - 2025 Report

It is hard to believe that we are starting the 25th year of the 21st century. The rapid evolution that technology, privacy and data security have undergone these last 25 years is mindbending. Yet, as we enter 2025, it still…more

Class Action, Class Certification, Consumer Privacy Rights, Consumer Protection Laws, Critical Infrastructure Sectors

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The Devil's Dictionary of Bankruptcy Terms: Fraudulent Transfer

Fraudulent Transfer: A transfer by the debtor (including the incurring of an obligation by the debtor) voidable under Section 548 or under state law imported into the bankruptcy case through Section 544…more

Bankruptcy Code, Commercial Bankruptcy, Fraudulent Transfers, UFTA

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Technology Transactions & Data Privacy - 2025 Report

It is hard to believe that we are starting the 25th year of the 21st century. The rapid evolution that technology, privacy and data security have undergone these last 25 years is mindbending. Yet, as we enter 2025, it still…more

Class Action, Class Certification, Consumer Privacy Rights, Consumer Protection Laws, Critical Infrastructure Sectors

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What President Trump’s Energy Plan Means for the State Regulatory Environment, the Generation Mix and Electric Transmission

Signaling the prioritization of energy, President Donald Trump declared a national energy emergency on inauguration day. He issued several Executive Orders (EO) and Presidential Memoranda either unwinding the Biden…more

Clean Energy, Department of Energy (DOE), Energy Policy, Energy Sector, Environmental Policies

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SCOTUS Rejects Defense-Friendly Scienter Standard In Schutte Opinion

On June 1, 2023, the Supreme Court of the United States (SCOTUS) issued its much-anticipated opinion in United States ex rel. Schutte v. SuperValu Inc. and United States ex rel. Proctor v. Safeway, Inc. (Schutte), holding that a…more

Drug Pricing, False Claims Act (FCA), Fraud, Government Investigations, Healthcare

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CMS Spring Provider Enrollment Updates

Centers for Medicare & Medicaid Services (CMS) released several pieces of Medicare provider enrollment guidance this spring, both emphasizing current policy and requirements as well as providing guidance and clarification…more

Centers for Medicare & Medicaid Services (CMS), Disclosure Requirements, Medicaid, Medicare, New Guidance

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Med-Staff Newsletter - August 2022 | VOL 10

Whether you are new to medical staff leadership or have served in the past and have been called to serve again, there are times when you will need to consult a lawyer who specializes in medical staff matters. While there is…more

Abortion, ADEA, Coronavirus/COVID-19, Dobbs v. Jackson Women’s Health Organization, Employer Liability Issues

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Using Endowed Funds in a Crisis: Key Considerations

It goes without saying that we are living in uncertain times and are experiencing events that are reshaping our lives in ways that many of us believed only to exist in science fiction books and movies. Nevertheless, while we all…more

Charitable Organizations, Coronavirus/COVID-19, Endowment Funds

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COVID-19 Challenges Medical Equipment Supply Chains

The COVID-19 pandemic is significantly disrupting international trade as global and domestic supply chains grapple with declining trade volumes and inadequate supplies of medical goods, including personal protective equipment…more

Coronavirus/COVID-19, Customs and Border Protection, Export Controls, FEMA, Imports

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FDA Issues Exemptions from November 27, 2024 Compliance Deadline for Updated DSCSA Requirements

On Wednesday, the Food and Drug Administration (FDA) issued a statement granting additional exemptions from its November 27, 2024 deadline for compliance with certain product transaction requirements.  The exemptions followed…more

Compliance, Distributors, DSCSA, Food and Drug Administration (FDA), Manufacturers

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Key Takeaways from FDA's New Guidance for Prescription Drug Compounders

On April 15, 2016, the Food and Drug Administration (FDA) released draft guidance that describes the FDA's interpretation of drug compounding standards under Sections 503A and 503B of the Food Drug & Cosmetic Act (FD&C Act). The…more

Comment Period, Drug Compounding, Federal Food Drug and Cosmetic Act (FFDCA), Food and Drug Administration (FDA), Pharmaceutical Industry

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Top Questions Health Care Providers Should Consider in a Post-Chevron World – A Polsinelli Round Table Discussion

Health Care is one of the most regulated industries in the country, and for many years, one of the key administrative agencies overseeing health care in the United States, the Department of Health and Human Services’ (“HHS”)…more

Centers for Medicare & Medicaid Services (CMS), Chevron Deference, Healthcare, Healthcare Reform, Loper Bright Enterprises v Raimondo

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Pharmacy Benefit Managers Licensing and Compliance Developments

In response to calls for greater transparency in the prescription drug industry, 2021 continued a nationwide trend of increased state licensing and regulation of Pharmacy Benefit Managers (“PBMs”). In the last year, laws…more

Health Insurance, Insurance Regulations, Licensing Rules, New Legislation, Pharmaceutical Industry

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Design Patent Holders Rejoice, but Challengers Face an Uphill Battle

Design patent holders can rejoice, for now, as the Federal Circuit reinforces its stance on the invalidity of design patents based on obviousness. On January 20, 2023, the Federal Circuit upheld a decades old rule that governs…more

Design Patent, Intellectual Property Protection, Obviousness, Patent Infringement, Patent Invalidity

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CMS Extends Revalidation Deadline for Skilled Nursing Facilities to August 1, 2025

In its April 17 MLN Newsletter, the Centers for Medicare and Medicaid Services (CMS) once again extended the deadline for skilled nursing facilities (SNF) to submit their off-cycle revalidation from May 1 to August 1, 2025…more

Centers for Medicare & Medicaid Services (CMS), Filing Deadlines, Health Care Providers, Healthcare Facilities, Medicaid

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COVID-19 and Its Growing Impact on Commercial Contracts: How Should Contracting Parties Respond?

COVID-19 is causing a rapidly evolving public health crisis, and businesses face uncertainty about their commercial relationships. That uncertainty is raising questions about performance under contractual agreements that were…more

Business Interruption, China, Commercial General Liability Policies, Commercial Insurance Policies, Commercial Loans

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SEC Significantly Modifies Disclosure Rules for Mining Companies

On October 31, 2018, the United States Securities and Exchange Commission (SEC) amended its rules to revise and modernize disclosure requirements applicable to companies with mining properties or operations…more

Disclosure Requirements, Energy Sector, Gas Royalties, Mineral Exploration, Mining

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Federal Estate and Gift Tax Changes in 2026: What is on the Horizon, or Sunset Rather?

In 2017, the federal gift and estate tax exemption was $5.49 million. The Tax Cuts and Jobs Act of 2017 doubled the gift and estate tax exemption amount to $11.18 million in 2018, and that amount has been adjusted for inflation…more

Estate Planning, Estate Tax, Estate-Tax Exemption, Gift Tax, Tax Cuts and Jobs Act

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What is 13th Month Pay and Why Should Employers Care?

Most American employers run payroll twelve or twenty-four times across a calendar year. In some countries, there is a “thirteenth month” to think about…more

Bonuses, Employer Responsibilities, International Labor Laws, Payroll Taxes, Salaried Employees

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AI for GCs: What You Need to Know in 2025

During the course of 2024, interest in generative and other types of artificial intelligence, machine learning and predictive applications and services (collectively, AI) accelerated across industries. Some sectors, such as…more

Artificial Intelligence, Compliance, Contract Terms, Corporate Counsel, Corporate Governance

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EEOC Guidance on DEI-Related Discrimination in the Workplace

On March 20, 2025, the Equal Employment Opportunity Commission (EEOC) issued two key pieces of guidance: What To Do If You Experience Discrimination Related to DEI at Work and What You Should Know About DEI-Related…more

Disparate Treatment, Diversity and Inclusion Standards (D&I), Employees, Employer Liability Issues, Employment Discrimination

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Florida Legislative Session 2024: Health Care Highlights

The Florida Regular Legislative Session began on January 9, 2024, and ended on March 8, 2024. Below is a summary of relevant health care laws that will be effective July 1, 2024, if they are approved by Governor DeSantis…more

Cancer, Employee Benefits, Florida, Health Care Providers, Health Insurance

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Florida Legal Update: Laws of Interest Effective July 1, 2020

Business Legal Updates - Collegiate Student Athletes Can Now Receive Compensation - With the passing of Section 1006.74, F.S., effective July 1, 2020, intercollegiate athletes at a “postsecondary educational institution”…more

Assisted Living Facilities (ALFs), Fiduciary Duty, FinTech, Florida, Foreign Corporations

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Catching Judge Sontchi’s “Flurry of Opinions” PARTS 2-3 OF 3

In This Issue: - In re: Energy Future Holdings Corp., et al, 14-10979 (CSS) (CSC Trust Company of Delaware, as Indenture Trustee, v. Energy Future Intermediate Holdings Company LLC and EFIH Finance, Inc., Adv. Pro No:…more

Chapter 11, Commercial Bankruptcy, Debt, Debtors, Indenture Trustee

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Ninth Circuit Reverses Landmark Wit Case Addressing Behavioral Health Coverage

The President and his administration continue to tout their efforts to strengthen coverage for behavioral health care, including significantly increasing behavioral health spending and strengthening parity between physical and…more

Biden Administration, Denial of Insurance Coverage, Employee Retirement Income Security Act (ERISA), Health Insurance, Health Plan Sponsors

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Incoming Defense Contract Audit Agency Reorganization

On April 7, 2025, the Defense Contract Audit Agency (DCAA) announced a comprehensive reorganization plan aimed at consolidating its Region and Corporate Audit Directorates (CAD) into three primary Directorates in response to…more

Audits, Defense Contracts, Defense Sector, Department of Defense (DOD), Federal Acquisition Regulations (FAR)

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CISA and FDA Sound Alarm on Backdoor Cybersecurity Threat with Patient Monitoring Devices

Last week, the U.S. Cybersecurity and Infrastructure Security Agency (“CISA”) and the U.S. Food and Drug Administration (“FDA”) released warnings about an embedded function they found in the firmware of the Contec CMS8000, which…more

Cybersecurity, Data Breach, Data Privacy, Data Protection, Food and Drug Administration (FDA)

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The EU AI Act is Here, and the Clock is Ticking!

The EU AI Act is here, folks! Now that the Act has been officially published in the OJEU, it will go into force in 7 days on August 2, 2024. Now is the time to set your timers to align with the compliance calendar…more

Artificial Intelligence, Compliance, EU, European Commission, General Data Protection Regulation (GDPR)

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A Deepened Divide: Appellate Court Joins False Claims Act Circuit Split in Favor of Health Care Defendants

On February 18, 2025, the United States Court of Appeals for the First Circuit issued its opinion in United States v. Regeneron Pharmaceuticals Inc., finding that, in Anti-Kickback Statute (AKS) cases, the government must show a…more

Anti-Kickback Statute, Appellate Courts, Compliance, Department of Justice (DOJ), False Claims Act (FCA)

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Recent Federal Circuit Decisions Provide Mixed Messages on Patent Eligible Subject Matter

The Supreme Court’s Alice decision is now more than three years old, however, stakeholders, the courts and the U.S. Patent and Trademark Office are still struggling to understand Alice and, in particular, how to determine…more

CLS Bank v Alice Corp, Intellectual Property Litigation, Patent Infringement, Patent Invalidity, Patent Litigation

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Celsius Bankruptcy Case: February 2, 2023

As Celsius Network LLC, et al., Case Number: 22-10964 (MG), proceeds in the Bankruptcy Court for the Southern District of New York (the “Court”), the highly anticipated examiner report was released on January 31st…more

Bankruptcy Court, Chapter 11, Commercial Bankruptcy, Creditors, Examiners

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When ICE Knocks: Immigration Enforcement in the New Administration

Introduction - Since President Trump’s inauguration, the administration has underscored its commitment to prioritizing immigration enforcement. This shift includes an increase in U.S. Immigration and Customs Enforcement…more

Department of Homeland Security (DHS), Employer Responsibilities, Employment Eligibility Verification, Employment Policies, Form I-9

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Securities and Exchange Commission Modernizes Disclosure Requirements For Financial Institutions

On September 11, 2020, the Securities and Exchange Commission (the “SEC”) adopted final rules applicable to banks, bank holding companies, savings and loan associations and savings and loan holding companies that will, among…more

Corporate Governance, Disclosure Requirements, Financial Institutions, Financial Statements, GAAP

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Preparing for the Implementation of Missouri Paid Sick Time: Key Deadlines and Compliance Requirements

The earned paid sick time provisions of Proposition A are set to take effect on May 1, 2025. Missouri Proposition A requires employers to provide employees working in Missouri at least 1 hour of sick leave for every 30 hours…more

Constitutional Challenges, Employee Benefits, Employer Responsibilities, Employment Policies, Filing Deadlines

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A Scalpel, Not a Chainsaw: Supreme Court Drastically Limits the Telephone Consumer Protection Act’s Reach

In December, we reported on the oral argument in the U.S. Supreme Court in Facebook v. Duguid, which presented the question of what was required for equipment to qualify as an automatic telephone dialing system (“ATDS”) under…more

ATDS, Auto-Dialed Calls, Class Action, Facebook, Facebook Inc v Duguid

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Physician not a Hospital “Employee” for Purpose of Title VII Action

On May 8, 2019, the U.S. Seventh Circuit Court of Appeals reaffirmed its test to determine whether a worker qualifies as an “employee” as defined by and subject to Title VII protections. …more

Civil Rights Act, Employee Definition, Employer Liability Issues, Employment Litigation, Healthcare Facilities

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Complying with the ACA Disclosure Requirements Just Got a Whole Lot Easier!

New legislation liberalizing certain disclosure requirements under the Affordable Care Act (“ACA”) was passed at the end of 2024.  Effective for 2024 reporting, mailing a paper copy of Forms 1095-C/1095-B is no longer…more

Affordable Care Act, Benefit Plan Sponsors, Disclosure Requirements, Employee Benefits, Employer Group Health Plans

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Real or Ruse? IRS’s New Settlement Initiative for Syndicated Conservation Easements

The Internal Revenue Service (IRS) recently announced a new settlement initiative for Syndicated Conservation Easements (SCEs) that are currently under audit and have not reached the Tax Court. This new settlement initiative…more

Audits, Conservation Easements, Government Investigations, Investors, IRS

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What Honda's CCPA Penalty Means for Your Privacy Compliance

The California Privacy Protection Agency (CPPA) has reached a settlement with American Honda Motor Co., Inc. (Honda), as outlined in this Order of Decision. The Order is the CPPA’s first public enforcement action involving a…more

Automotive Industry, California Consumer Privacy Act (CCPA), California Privacy Protection Agency (CPPA), Compliance, Consumer Data Requests

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Department of Labor Proposes Rule to Increase Overtime Protections

On August 30, 2023, the U.S. Department of Labor (DOL) introduced a proposed rule that would increase the minimum salary required for an employee to be exempt under any of the so-called “White Collar Exemptions” from overtime…more

Department of Labor (DOL), Exempt-Employees, Fair Labor Standards Act (FLSA), Federal Labor Laws, Minimum Salary

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The NLRB Throws A Flag On The Northwestern Football Program

In a much awaited decision, the Regional Director for Region 13 of the National Labor Relations Board ("NLRB") has determined that grant-in-aid scholarship recipients on the Northwestern University football team are more than…more

College Athletes, NLRB, Unions

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‘Alkutkar v. Bumble’: Securing Active Consent for Updated Terms of Service

Overview - The District Court for the Northern District of California recently provided guidance in Alkutkar v. Bumble Inc., No. 22-CV-00422- PJH (N.D. Cal. Sept. 8, 2022), reconsideration denied, No. 22-CV-00422-PJH, (N.D…more

Advertising, Arbitration, Arbitration Agreements, B2B Transactions, Browsewrap Agreement

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Med-Staff Newsletter - August 2022 | VOL 10

Whether you are new to medical staff leadership or have served in the past and have been called to serve again, there are times when you will need to consult a lawyer who specializes in medical staff matters. While there is…more

Abortion, ADEA, Coronavirus/COVID-19, Dobbs v. Jackson Women’s Health Organization, Employer Liability Issues

See all updates »

The Devil's Dictionary of Bankruptcy Terms: Fraudulent Transfer

Fraudulent Transfer: A transfer by the debtor (including the incurring of an obligation by the debtor) voidable under Section 548 or under state law imported into the bankruptcy case through Section 544…more

Bankruptcy Code, Commercial Bankruptcy, Fraudulent Transfers, UFTA

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FTC Adopts Data Breach Notification Obligations for Non-Banking Financial Institutions

On October 27, 2023, the Federal Trade Commission (“FTC”) adopted an amendment to the FTC’s Safeguards Rule that will require non-banking financial institutions to notify the FTC within thirty days of discovering a data breach…more

Cyber Attacks, Cyber Incident Reporting, Cybersecurity, Data Breach, Data Protection

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Department of Labor Proposes Rule on Valuing Stock for ESOP Stock Purchase and Sale Transactions

On January 16, 2025, the Employee Benefits Security Administration (EBSA) at the Department of Labor (DOL) released drafts of long-awaited proposed regulations seeking to clarify the definition of “adequate consideration” as set…more

Department of Labor (DOL), Employee Benefits, Employee Retirement Income Security Act (ERISA), ESOP, Fiduciary Duty

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New Executive Order Rescinds the $17.75 Per Hour Federal Contractor Minimum Wage

n March 14, 2025, President Trump issued an Executive Order rescinding eighteen (18) prior executive orders and actions, including Executive Order 14026’s substantial increase to the minimum wage for federal government…more

Contract Terms, Department of Labor (DOL), Executive Orders, Federal Acquisition Regulations (FAR), Federal Contractors

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IRS Attacks Impact Investing With Flawed Logic: A Critical Review of the IRS Argument

On October 9th, the Internal Revenue Service released Private Letter Ruling 202041009 (the “Ruling”), which, in what many in the nonprofit community would have expected to be a relatively straight-forward exemption approval for…more

501(c)(3), Charitable Organizations, Investment, Investment Funds, IRS

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Florida Legal Update: Laws of Interest Effective July 1, 2020

Business Legal Updates - Collegiate Student Athletes Can Now Receive Compensation - With the passing of Section 1006.74, F.S., effective July 1, 2020, intercollegiate athletes at a “postsecondary educational institution”…more

Assisted Living Facilities (ALFs), Fiduciary Duty, FinTech, Florida, Foreign Corporations

See all updates »

Health Care Reimbursement and Payor Dispute Update Special Edition – Year End Regulatory Review

The Centers For Medicare & Medicaid Services Issues New Inpatient Prospective Payment System Final Rule - On September 3, 2020, the Centers for Medicare & Medicaid Services (CMS) issued the fiscal year (FY) 2021 Medicare…more

Centers for Medicare & Medicaid Services (CMS), Cramdown, Drug Pricing, Health Care Providers, Healthcare Reform

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HHS OCR Issues New, Post-Dobbs Guidance

In the wake of the Dobbs decision, the Department of Health and Human Services (HHS), Office for Civil Rights (OCR) issued new guidance regarding the privacy of patients seeking reproductive health care. The guidance…more

Abortion, Department of Health and Human Services (HHS), Dobbs v. Jackson Women’s Health Organization, Equal Protection, Health Insurance Portability and Accountability Act (HIPAA)

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What Did I Agree To? Importance of Reviewing Arbitration Provisions

Polsinelli recently defeated a motion to dismiss a client’s judicial review of an arbitration award, successfully arguing that adopted arbitration rules that waive appellate rights do not waive a party’s right to judicial review…more

Arbitration, Arbitration Agreements, Arbitration Awards, Business Litigation, Commercial Court

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Technology Transactions & Data Privacy - 2025 Report

It is hard to believe that we are starting the 25th year of the 21st century. The rapid evolution that technology, privacy and data security have undergone these last 25 years is mindbending. Yet, as we enter 2025, it still…more

Class Action, Class Certification, Consumer Privacy Rights, Consumer Protection Laws, Critical Infrastructure Sectors

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St. Luke's Health: Does Improving Patient Care Justify a Merger Under Antitrust Law? Ninth Circuit Says "No" and Orders Divestiture

Healthcare providers frequently consolidate to cut costs and improve patient care. These benefits can result from sharing administrative costs such as billing and electronic recordkeeping, eliminating excess capacity, better…more

Antitrust Provisions, Divestiture, Federal Trade Commission (FTC), Hospital Mergers, Hospitals

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AI for GCs: What You Need to Know in 2025

During the course of 2024, interest in generative and other types of artificial intelligence, machine learning and predictive applications and services (collectively, AI) accelerated across industries. Some sectors, such as…more

Artificial Intelligence, Compliance, Contract Terms, Corporate Counsel, Corporate Governance

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SEC Proposes Changes to Modernize and Simplify Equity Compensation Rules and Registration Obligations

On November 24, 2020, the Securities and Exchange Commission (“SEC”) proposed amendments to Rule 701 and Form S-8 (the “Proposals”) under the Securities Act of 1933, as amended (the “Securities Act”)…more

Disclosure Requirements, Form S-8, Publicly-Traded Companies, Rule 701, Securities and Exchange Commission (SEC)

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Department of Labor Proposes Rule on Valuing Stock for ESOP Stock Purchase and Sale Transactions

On January 16, 2025, the Employee Benefits Security Administration (EBSA) at the Department of Labor (DOL) released drafts of long-awaited proposed regulations seeking to clarify the definition of “adequate consideration” as set…more

Department of Labor (DOL), Employee Benefits, Employee Retirement Income Security Act (ERISA), ESOP, Fiduciary Duty

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The Applicability of Anti-Fraud Rules to Certain Statements and Information made by Obligated Persons of Municipal Securities – A Legal Bulletin ‘Reminder’ from the Office of Municipal Securities

On February 7, 2020, the Securities and Exchange Commission’s (the “SEC”) Office of Municipal Securities released its Legal Bulletin No. 21 (the “Bulletin”) regarding the applicability of the anti-fraud provisions of the federal…more

Anti-Fraud Provisions, Disclosure Requirements, Investment Opportunities, Municipal Securities Issuers, Municipal Securities Market

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Swing and a Miss: the Government Strikes Out in Pharmacy Executive Kickback Trial

Last week, the government submitted its decision to the federal court not to retry partially-acquitted pharmacy executive, Chad Beene, for conspiracy and illegal kickback allegations. At the end of last year, a New Jersey jury…more

Anti-Kickback Statute, Criminal Prosecution, Department of Justice (DOJ), Enforcement Actions, False Claims Act (FCA)

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CMS Encourages Continued Participation in Medicare Shared Savings Program with Final Rule

In This Issue: - ACO Eligibility Requirements - Establishing and Maintaining the ACO Participation Agreement - Data Sharing and Assignment of Beneficiaries - Shared Savings and Losses - Waivers of…more

ACO Participant Agreements, ACOs, Centers for Medicare & Medicaid Services (CMS), Data-Sharing, Electronic Health Record Incentives

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The OIG’s Concerns with Potentially Fraudulent Medicare Advantage Marketing

The HHS Office of Inspector General (“OIG”) released a Special Fraud Alert to inform health care professionals (“providers”) and Medicare Advantage Organizations (“MAOs”) about the OIG’s view of potentially abusive marketing…more

Compliance, Department of Health and Human Services (HHS), Fraud, Health Care Providers, Medicare

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ESOP Defendant Wins Partial Victory in Appeal to Fourth Circuit

The Fourth Circuit Court of Appeals has provided relief to a defendant who sold shares of company stock to an employee stock ownership plan (“ESOP”) by rejecting the district court’s legal conclusion concerning the calculation…more

Department of Labor (DOL), Employee Benefits, ESOP, Fair Market Value, Prohibited Transactions

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ESOP Defendant Wins Partial Victory in Appeal to Fourth Circuit

The Fourth Circuit Court of Appeals has provided relief to a defendant who sold shares of company stock to an employee stock ownership plan (“ESOP”) by rejecting the district court’s legal conclusion concerning the calculation…more

Department of Labor (DOL), Employee Benefits, ESOP, Fair Market Value, Prohibited Transactions

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Health Care Reimbursement and Payor Dispute Update Special Edition - Year End Regulatory Review

The end of 2021 brings positive indications of the continued acceptance of telehealth as an important clinical care approach post public health emergency (“PHE”). The Centers for Medicare and Medicaid Services (“CMS”), like…more

Ambulatory Surgery Centers, Centers for Medicare & Medicaid Services (CMS), Drug Pricing, Health Care Providers, Health Insurance

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Reminder: Upcoming Filing Deadlines for Fund Managers

With the new year comes a number of annual compliance obligations for evaluation by investment fund managers. In addition to the obligation for registered investment advisers to conduct an annual review of their compliance…more

Beneficial Owner, Filing Deadlines, Fund Managers, Hedge Funds, Investment Funds

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ESOP Transactions and the Duty to Monitor Revisited

Key Takeaways: Board’s Duty to Monitor the Trustee: A company’s board of directors has a fiduciary duty to monitor the ESOP trustee’s actions in an ESOP transaction, ensuring that the trustee is acting in the exclusive…more

Board of Directors, Compliance, Corporate Governance, Employee Benefits, ESOP

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Texas Offers State Low-Income Housing Tax Credits

Texas Governor Greg Abbott (R) recently signed Texas House Bill (H.B.) 1058, making Texas at least the 28th state, plus the District of Columbia, to offer state low-income housing tax credits to bridge the growing affordable…more

Affordable Housing, Community Development, Construction Project, Critical Infrastructure Sectors, LIHTC

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Court Provides Additional Guidance On When Notes Are Not Securities - The Kirschner Case

The loan market breathed an immense sigh of relief this spring with the ruling in Kirschner v. JPMorgan Chase Bank, N.A. 1 (“Kirschner”) affirming the prevailing market view that notes representing syndicated loans are not…more

Contract Terms, Investment Management, JPMorgan Chase, Leveraged Loans, Securities Regulation

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Back to Backlog? Polsinelli Shareholders Share Insight on how Terminations of DAB Attorneys and Potential Removal of Administrative Law Judges May Impact Medicare Appeals

As the new administration continues its efforts to contract and streamline the federal government, recent developments at the U.S. Department of Health and Human Services (“HHS”) and the Department of Justice (“DOJ”) hint at a…more

Administrative Law Judge (ALJ), Department of Health and Human Services (HHS), Department of Justice (DOJ), Government Agencies, Health Care Providers

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Texas Supreme Court Confirms Texas Home-Equity Lenders Are Entitled to Equitable Subrogation Irrespective of Failures to Correct Curable Constitutional Defects in Loan Documents

Last week, the Texas Supreme Court issued a significant decision in favor of Texas home-equity lenders in Federal Home Loan Mortgage Corporation v Zepeda, No. 19-0712, answering “yes” to the following certified question from the…more

Home Equity, Home Equity Line of Credit, Lenders, Loan Documentation, Mortgages

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IRS Attacks Impact Investing With Flawed Logic: A Critical Review of the IRS Argument

On October 9th, the Internal Revenue Service released Private Letter Ruling 202041009 (the “Ruling”), which, in what many in the nonprofit community would have expected to be a relatively straight-forward exemption approval for…more

501(c)(3), Charitable Organizations, Investment, Investment Funds, IRS

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Private Biometric Data: Union Consent to Collection

On June 13, 2019, the U.S. Seventh Circuit Court of Appeals in Miller v. Southwest Airlines, Co., Case 18-3476 (June 13, 2019), ruled that claims asserted under the Illinois Biometric Information Privacy Act (“BIPA”), in the…more

Appeals, Biometric Information, Biometric Information Privacy Act, Case Consolidation, Data Collection

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AFIDA Penalties Are Coming: Costs for Renewable Development May Be More Than You Think

When evaluating the all-in costs of a renewable development project, it is critical that costs associated with Agricultural Foreign Investment Disclosure Act (AFIDA) enforcement and compliance are considered. Since its enactment…more

Agricultural Sector, Disclosure Requirements, Energy Projects, Foreign Investment, Land Developers

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Loan Enforcement and Creditors’ Rights

At times, lenders lose the promissory notes on defaulted loans. Lost notes are problematic because, in order to have standing to foreclose, a lender may be required in many states, including in New York, to possess the original…more

Banking Sector, Commercial Loans, Default, ECOA, Foreclosure

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HRSA Aims for Swift Dispute Resolution with new 340B ADR Final Rule

On April 18, 2024, HRSA released its 2024 340B Administrative Dispute Resolution (ADR) Final Rule (2024 ADR Final Rule) and it is largely favorable to covered entities (CEs) with pending ADR claims against drug manufacturers…more

Claim Procedures, Covered Entities, Dispute Resolution, Drug Pricing, Healthcare

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Fantasy Sports Sites Win Challenge to Publicity Rights in Indiana

Recently, the Seventh Circuit affirmed that fantasy sports operators, such as FanDuel and Draft Kings, do not violate a student athlete’s right of publicity under Indiana law by using their name, image and likeness without their…more

DraftKings, FanDuel, Fantasy Sports, Gambling, Name and Likeness

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The Corporate Transparency Act and Agribusiness and Ag Tech Companies

From family farms and businesses to established agribusinesses to emerging ag tech companies, a new federal law requires business entities to disclose their owners’ and control persons’ personal information, and for many…more

Agribusiness, Beneficial Owner, Business Entities, Business Ownership, Compliance

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Energy Demand for AI Drives the Midwest’s Focus on Resource Adequacy

As presidential administrations change and policy priorities shift, the steady hum of electricity demand from artificial intelligence (AI) and data centers presses forward. Last week, the President signed several executive…more

Artificial Intelligence, Clean Energy, Data Centers, Electricity, Energy Efficiency

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QFC Rule and Resolution Stay Protocol

Clients who have engaged in Qualified Financial Contracts (QFCs)—which include derivatives, repurchase agreements and securities lending—with large financial institutions may have received, or may soon receive, a notice…more

Consumer Financial Products, Derivatives, Financial Institutions, ISDA, Qualified Financial Contracts (QFC)

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FDA Preemption of State Law for False Labeling Survives Appeal to Supreme Court

Manufacturers of dietary supplements, food, beverages, and even medical devices can breathe a little easier following the Supreme Court’s denial of certiorari this week in a case seeking to overturn a First Circuit decision…more

Denial of Certiorari, Dietary Supplements, False Advertising, Federal Food Drug and Cosmetic Act (FFDCA), Food & Drug Regulations

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Department of Labor Proposes Rule on Valuing Stock for ESOP Stock Purchase and Sale Transactions

On January 16, 2025, the Employee Benefits Security Administration (EBSA) at the Department of Labor (DOL) released drafts of long-awaited proposed regulations seeking to clarify the definition of “adequate consideration” as set…more

Department of Labor (DOL), Employee Benefits, Employee Retirement Income Security Act (ERISA), ESOP, Fiduciary Duty

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Federal Circuit Affirms District Court’s Obviousness Judgment on ImmunoGen Patent Application

1. Background: ImmunoGen’s Patent Application & Dispute - In 2014, ImmunoGen, Inc. (Immunogen) filed U.S. Patent Application No. 14/509,809 (the ’809 application)…more

Intellectual Property Litigation, Life Sciences, Obviousness, Obviousness-Type Double Patenting (ODP), Patent Applications

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Divided Illinois Supreme Court Holds that BIPA Claims Accrue with Each Scan, Potentially Opening the Door to Massive Damages Awards

In a recent 4-3 decision, the Illinois Supreme Court held that claims under sections 15(b) and 15(d) of Illinois’ Biometric Information Privacy Act (BIPA) accrue each time a private entity collects a biometric identifier (such…more

Accrual Requirements, Biometric Information, Biometric Information Privacy Act, Damages, Data Collection

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New York to Consider Rolling Back Liquidated Damages for Pay Frequency Violations

New York Governor Kathy Hochul’s proposed budget for fiscal year 2025 includes proposed legislation that would amend New York Labor Law to make clear that liquidated damages are not available as a remedy for certain pay…more

Employer Liability Issues, Employment Litigation, Labor Law Violations, Labor Reform, Liquidated Damages

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The MOAC Decision: Implications for DIP Lenders, Not Just for Asset Purchasers

The Supreme Court’s April 19, 2023, decision in MOAC Mall Holdings, LLC v. Transform Holdco, LLC, 598 U.S.­­­___, ___S. Ct.___, 2023 WL 2992693 (April 19, 2023) resolved an existing circuit split by holding that section 363(m)…more

363 Sales, Bankruptcy Code, Bankruptcy Court, Chapter 11, Commercial Bankruptcy

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25% Duties on U.S. Imports from Canada and Mexico Lifted for USMCA-Eligible Merchandise

Thursday, March 6, President Trump signed two Executive Orders significantly curtailing the scope of the emergency tariffs he imposed on Tuesday, March 4, impacting U.S. imports from Canada and Mexico. Effective today, U.S…more

Canada, Customs and Border Protection, Duties, Executive Orders, Imports

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Prop 15 is Ready to Rock Commercial Properties with the Split-Roll

On November 3, 2020, California voters will decide on Proposition 15, the citizen-initiated proposition that seeks to create a split-roll tax system in California. Also known as “The California Schools and Local Communities…more

Ballot Measures, Property Owners, Property Tax, Property Valuation, Real Estate Market

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New Texas Law Aims to Curb Local Prosecutorial Discretion

A new Texas law will go into effect on September 1, 2023 that is directly aimed at curbing the discretion of local prosecutors in deciding which classes or types of cases they choose not to pursue…more

Attorney Misconduct, Criminal Prosecution, District Attorneys, Healthcare, New Legislation

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SEC Cybersecurity Guidance: Key Takeaways for Your Business

The U.S. Securities and Exchange Commission (“SEC”) recently released interpretive guidance regarding issues and risks related to cybersecurity for the first time since 2011…more

Cybersecurity, Disclosure Requirements, Insider Trading, Investment Adviser, Securities and Exchange Commission (SEC)

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AI for GCs: What You Need to Know in 2025

During the course of 2024, interest in generative and other types of artificial intelligence, machine learning and predictive applications and services (collectively, AI) accelerated across industries. Some sectors, such as…more

Artificial Intelligence, Compliance, Contract Terms, Corporate Counsel, Corporate Governance

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Technology Transactions & Data Privacy - 2025 Report

It is hard to believe that we are starting the 25th year of the 21st century. The rapid evolution that technology, privacy and data security have undergone these last 25 years is mindbending. Yet, as we enter 2025, it still…more

Class Action, Class Certification, Consumer Privacy Rights, Consumer Protection Laws, Critical Infrastructure Sectors

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Not-For-Profits Gain Access to Historic Tax Credits with Enactment of Missouri HB 2062

On May 16, Missouri passed HB 2062 modifying the state’s existing Historic Tax Credit (HTC) program. The bill alters the program in several significant ways. The program will now feature a year-round application cycle, increased…more

Construction Project, Historic Preservation, Historical Landmarks, Historical Rehabilitation, Pending Legislation

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New Government Reporting Requirements That May Apply To You

If you or your trust owns an interest in a corporation, limited liability company, partnership, or other type of entity, subject to limited exceptions, you are likely required to provide certain information to the FinCEN…more

Anti-Corruption, Beneficial Owner, Corporate Transparency Act, Financial Crimes, FinCEN

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Federal Court Finds False Claims Act Penalty Unconstitutionally Excessive

On February 26, 2025, the U.S. District Court for the Northern District of Texas issued a significant False Claims Act (FCA) ruling in United States of America ex rel. Cheryl Taylor v. Healthcare Associates of Texas, LLC,…more

Constitutional Challenges, Damages, Department of Justice (DOJ), Eighth Amendment, False Claims Act (FCA)

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Polsinelli Obtains Favorable Decision in Challenge to Colorado’s Medicaid Funding Program

Medicaid is a shared federal and state program. Federal and state dollars are combined so states can furnish Medicaid health coverage to poor and disabled Coloradans including many who need nursing facility care…more

Constitutional Challenges, Federal Funding, Health Insurance, Medicaid, State and Local Government

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Technology Transactions & Data Privacy - 2025 Report

It is hard to believe that we are starting the 25th year of the 21st century. The rapid evolution that technology, privacy and data security have undergone these last 25 years is mindbending. Yet, as we enter 2025, it still…more

Class Action, Class Certification, Consumer Privacy Rights, Consumer Protection Laws, Critical Infrastructure Sectors

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Subscription Service Businesses Take Notice: Amendments to California’s Automatic Renewal Law Are Here

Subscription service providers should be aware of the various changes coming to California's automatic renewal law. California’s already stringent laws governing recurring subscription programs are about to become even more…more

Amended Legislation, Automatic Renewals, California, Cancellation Rights, Commercial Litigation

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California Bill Would Require Hospitals, Clinics and Other Health Facilities to Report Allegations of Patient Sexual Abuse to State Regulators

California Senate Bill 425, introduced in February 2019, would require health facilities and clinics to report any allegations of sexual abuse or sexual misconduct made against a clinician within 15 days of receiving the…more

Health Care Providers, Health Clinics, Healthcare Facilities, Internal Controls, Legislative Agendas

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IRS Says: New Goal is to Restore Fairness by Using Tax Dollars to Audit More Millionaires, Partnerships and Large Corporations

Following our initial reaction to the Internal Revenue Service's strategic operating plan to spend $80B in funding allocated from the Inflation Reduction Act, Polsinelli’s Tax attorneys continue to monitor the IRS’ compliance…more

Artificial Intelligence, High Net-Worth, Income Taxes, Inflation Reduction Act (IRA), Internal Revenue Code (IRC)

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COVID-19 Surge and Travel Restrictions and Advisories are Upending Thanksgiving Plans Across the Country

With more than 1 million cases reported in the United States over the last 7 days and cases rising, the U.S. Centers for Disease Control and Prevention (“CDC”) issued guidance on November 19, 2020 recommending Americans not…more

Centers for Disease Control and Prevention (CDC), Coronavirus/COVID-19, Emergency Management Plans, Infectious Diseases, International Travel

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Hydrocarbon Tax Policy Trends

As governments focus on clean energy and carbon reduction initiatives, their oil and gas taxation policies have increasingly come under scrutiny. Polsinelli’s attorneys review a few overarching themes concerning expected trends…more

Carbon Pricing, Energy Policy, Gas Royalties, Hydrocarbons, Infrastructure

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IRS Clarifies Requirements for Listing Providers in Financial Assistance Policies

On June 26, 2015, the Internal Revenue Service (IRS) released Notice 2015-46, which clarifies the requirement in the Treasury Regulations under Section 501(r)(4) that a hospital's financial assistance policy (FAP) must include a…more

Affordable Care Act, Compliance, Financial Assistance Policies, Health Care Providers, Healthcare

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Taking Care of Essential Business Despite Growing Number of Shelter in Place Orders — COVID-19

A growing number of states, six as of the publication date of this e-alert, along with the Puerto Rico, the Navajo Nation and a significant number of counties and municipalities, have issued mandatory “shelter in place” or “stay…more

Business Closures, Business Continuity Plans, Business Interruption, Coronavirus/COVID-19, Emergency Management Plans

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SCOTUS Appears Poised To Reject Defense-Friendly Safeco Scienter Standard In FCA Cases

On April 18, 2023, the Supreme Court of the United States (SCOTUS) heard oral arguments in a pair of monumental False Claims Act (FCA) cases to decide whether and when a defendant’s subjective understanding of an objectively…more

Drug Pricing, False Claims Act (FCA), Fraud, Healthcare, Oral Argument

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Energy Demand for AI Drives the Midwest’s Focus on Resource Adequacy

As presidential administrations change and policy priorities shift, the steady hum of electricity demand from artificial intelligence (AI) and data centers presses forward. Last week, the President signed several executive…more

Artificial Intelligence, Clean Energy, Data Centers, Electricity, Energy Efficiency

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Mastering Remote Work: Does Returning to the Office Mean Bringing Pets to Work?

With so much of the workforce going remote this past year, there has been a huge shift in the way many people view pet ownership. In fact, the national pet adoption rate jumped more than 30% at the beginning of the pandemic, and…more

Americans with Disabilities Act (ADA), Anti-Discrimination Policies, Business Continuity Plans, Coronavirus/COVID-19, Employment Policies

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Real or Ruse? IRS’s New Settlement Initiative for Syndicated Conservation Easements

The Internal Revenue Service (IRS) recently announced a new settlement initiative for Syndicated Conservation Easements (SCEs) that are currently under audit and have not reached the Tax Court. This new settlement initiative…more

Audits, Conservation Easements, Government Investigations, Investors, IRS

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Federal Circuit Clarifies AIA On-Sale Bar Provision Applies Where Existence of Sale Is Public

Yesterday, the Federal Circuit provided much-anticipated guidance on the scope of the America Invents Act’s “on-sale” bar provision. Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc., et al., Nos. 2016-1284, 2016-1787…more

Abbreviated New Drug Application (ANDA), America Invents Act, Generic Drugs, Hatch-Waxman, Intellectual Property Protection

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NLRB Overrules 2016 Decision Requiring Employers To Negotiate With Newly Certified Union Over Disciplinary Action

The National Labor Relations Board has overruled a previous Board’s 2016 Decision and reset an employer’s ability to discipline union-represented employees before reaching a first contract with the union…more

Collective Bargaining Agreements (CBA), Disciplinary Proceedings, NLRB, Retroactive Application, Unions

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The Privacy Survival Guide - August 2021

Virginia recently adopted a GDPR-inspired comprehensive data protection law for Virginia residents. What Are the Main Points Covered by Virginia’s Consumer Data Protection Act (CDPA)? …more

21st Century Cures Act, Biometric Information, Biometric Information Privacy Act, CDPA, Consumer Privacy Rights

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California Enacts New Franchise Broker Law

On Sept. 24, 2024, California Gov. Gavin Newsom signed Senate Bill 919, the California Franchise Broker Law, into law. Officially titled the “Franchise Investment Law: Franchise Brokers,” the California Franchise Broker Law…more

Broker-Dealer, California, Compliance, Disclosure Requirements, Franchise Agreements

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Virginia General Assembly Reverses Virginia Supreme Court on Requirement that Leases of more than Five Years be in the form of a Deed

In legislative action that will be welcomed by Virginia landlords and their mortgage lenders, the Virginia General Assembly, in its most recent session, amended the Virginia Statute of Conveyances (Va. Code Ann. § 55-2) to…more

Deeds, General Assembly, Landlords, Leases, Reversal

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PAGA Amendments Aim to Bring PAGA Litigation Under Control

California’s Private Attorneys General Act (“PAGA”) has undergone substantial, and arguably overdue, reform by way of dual legislative measures - Assembly Bill 2288 and Senate Bill 92. PAGA 2.0 will apply to PAGA civil…more

California, Employees, Employment Litigation, Labor Code, Labor Law Violations

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The NLRB Overturns Another Longstanding Rule Involving Employers Expressing Views on Unionization to a “Captive Audience”

On November 13, 2024, the National Labor Relations Board (“NLRB”) issued a sharply divided decision in Amazon.com Services LLC, overruling yet another decades-old rule and holding that captive-‍audience meetings violate national…more

Collective Bargaining, Employee Rights, Employer Liability Issues, Labor Regulations, Labor Relations

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Private Funds Rules Vacated

On June 5, 2024, the United States Court of Appeals for the Fifth Circuit (the “Court”) vacated the entire set of new Investment Advisers Act of 1940 (the “Advisers Act”) rules applicable to private fund advisers (the “Private…more

Administrative Procedure Act, Dodd-Frank, Investment Adviser, Investment Advisers Act of 1940, Private Funds

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Personal Jurisdiction Considerations for International Biosimilars Companies

The Federal Circuit recently issued decisions in a pair of appeals that provide guidance about when international filers of abbreviated Biologics License Applications (aBLAs) are subject to jurisdiction in the United States…more

Biologics, Biosimilars, Intellectual Property Litigation, Life Sciences, Patent Infringement

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New Section 232 Trade Investigations on Pharmaceutical and Semiconductor Imports Could Lead to Tariffs Mid-Year

On April 1, 2025, the Secretary of Commerce initiated, pursuant to President Trump’s directive, two new investigations under Section 232 of the Trade Expansion Act of 1962 (Section 232), one on imports of pharmaceuticals and…more

Executive Orders, Imports, National Security, Pharmaceutical Industry, Regulatory Requirements

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3rd Quarter 2024 Chapter 11, Healthcare, and Real Estate Distress Indices

Welcome to the 3rd Quarter 2024 Report for the Polsinelli | TrBK Distress Indices. The indices use filtered Chapter 11 filings as a proxy for distress in the overall U.S. economy and certain subsectors…more

Bankruptcy Plans, Chapter 11, Commercial Bankruptcy, Creditors, Debt Restructuring

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California Employers Must Know: Meal/Rest Premiums Are ‘Wages’

California reaffirms its reputation as the most employee-friendly state and raises potential liability for employers. On May 23, 2022, the California Supreme Court issued the long-awaited decision in Naranjo v. Spectrum Security…more

CA Supreme Court, Employer Liability Issues, Employment Litigation, Employment Policies, Labor Law Violations

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Tax Court Strikes out Smoltz and Klesko’s Big K SCE, but Provides Relief for Those Facing Fraud Allegations

In the late 1990s, former Atlanta Braves players John Smoltz and Ryan Klesko formed Big K Farms (“Big K”), a partnership that, over the years, acquired approximately 1,500 acres of land in Georgia for around $4 million. From…more

Appraisal, Charitable Donations, Conservation Easements, Internal Revenue Code (IRC), IRS

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DCGL Amendment May Breathe New Life Into Zombie Companies

On August 1, 2023, the Delaware General Corporation Law (DGCL) was amended to create an “insolvency exception” to Delaware’s long-standing requirement that a sale of all or substantially all of a Delaware corporation’s assets…more

Board of Directors, Business Ownership, Corporate Governance, Corporate Restructuring, Delaware General Corporation Law

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Lowering the Bar: The FTC Lowers HSR Premerger Reporting Thresholds for the First Time in a Decade

On February 2, 2021, the FTC published its annual changes to the thresholds for determining whether certain transactions must be reported to FTC and DOJ under the Hart-Scott-Rodino Act before closing can occur…more

Antitrust Provisions, Department of Justice (DOJ), Federal Trade Commission (FTC), Hart-Scott-Rodino Act, Interlocking Directorate

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Federal Estate and Gift Tax Changes in 2026: What is on the Horizon, or Sunset Rather?

In 2017, the federal gift and estate tax exemption was $5.49 million. The Tax Cuts and Jobs Act of 2017 doubled the gift and estate tax exemption amount to $11.18 million in 2018, and that amount has been adjusted for inflation…more

Estate Planning, Estate Tax, Estate-Tax Exemption, Gift Tax, Tax Cuts and Jobs Act

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Health Care Reimbursement and Payor Dispute Update Special Edition – Year End Regulatory Review

The Centers For Medicare & Medicaid Services Issues New Inpatient Prospective Payment System Final Rule - On September 3, 2020, the Centers for Medicare & Medicaid Services (CMS) issued the fiscal year (FY) 2021 Medicare…more

Centers for Medicare & Medicaid Services (CMS), Cramdown, Drug Pricing, Health Care Providers, Healthcare Reform

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Voting in the Celsius Bankruptcy Case

As we have been discussing in prior updates, the bankruptcy case of Celsius Network LLC is reaching an important milestone as most creditors now have the ability to vote on the Plan of Reorganization proposed by the Debtors (the…more

Bankruptcy Court, Commercial Bankruptcy, Creditors, Debt Restructuring, Debtors

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NASAA Shuts Down Use of Acknowledgments and Questionnaires in Franchise Sales Process

The North American Securities Administrators Association, Inc. (“NASAA”) has just adopted a new policy regarding the use of franchise questionnaires and acknowledgments in the franchise sales process. In its Statement of Policy…more

Franchise Disclosure Document, Franchise Laws, Franchisee, Franchises, NASAA

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Missouri Seeks to Limit Venue in Multi-Plaintiff Cases

In State ex rel. Johnson & Johnson v. The Honorable Rex M. Burlison, dozens of plaintiffs sought to bring their claims against Johnson & Johnson in the City of St. Louis, Missouri even though they were not residents of the city…more

Johnson & Johnson, Joinder, Mass Tort Litigation, Multi-Party Litigation, Non-Residents

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Expecting the Unexpected: Federal Procurement Under Trump

Federal contractors (and their lawyers) have spent much of the past two months trying to anticipate how federal procurement law and policy may change under the incoming Trump Administration. The first factor to note, which…more

Boeing, Federal Acquisition Regulations (FAR), Federal Contractors, Lockheed Martin, OFPP

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The PTAB and the Arthrex Decision: A Constitutional Question

The Appointments Clause of the U.S. Constitution1 provides that “principal officers” of the United States must be appointed by the President upon the advice and consent of the Senate. “Inferior officers,” on the other hand, do…more

Administrative Appointments, Administrative Authority, Administrative Patent Judges, Administrative Procedure Act, Administrative Proceedings

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Lender's Edge Newsletter: December 2016

Enforcement of a Commercial Loan After the Property Securing the Loan is Sold or Transferred - Enforcement of due-on-sale clauses started growing in popularity in the 1970s as a result of instability in the economy and rising…more

Banking Sector, Borrowers, Chapter 11, Commercial Bankruptcy, Commercial Loans

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Filing Fee for .sucks Top-Level Domain Names Really Sucks for Brand Owners

The recent top-level domain name explosion has been of great interest to existing brand owners and new market entrants alike. No longer is a business limited to deciding which of a few top-level domains, such as .com, .net,…more

Domain Names, Filing Fees, gTLD, ICANN, Trademarks

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Supreme Court Unanimously Clarifies Burden of Proof for FLSA Exemptions

On January 15, 2025, the Supreme Court of the United States issued a unanimous decision in E.M.D. Sales, Inc. v. Carrera, finally clarifying the standard of proof for employers to demonstrate an employee is properly exempt from…more

Burden of Proof, Department of Labor (DOL), Employment Litigation, Evidence, Exempt-Employees

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U.S. Federal Privacy Bill Unveiled

On April 5, 2024 members of U.S. Congress released a draft bipartisan, bicameral federal privacy bill, the American Privacy Rights Act. In a press release, the stated goal of this legislation is to be “a national data privacy…more

Consumer Privacy Rights, Data Brokers, Data Management, Data Privacy, Data Processors

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Technology Transactions & Data Privacy - 2025 Report

It is hard to believe that we are starting the 25th year of the 21st century. The rapid evolution that technology, privacy and data security have undergone these last 25 years is mindbending. Yet, as we enter 2025, it still…more

Class Action, Class Certification, Consumer Privacy Rights, Consumer Protection Laws, Critical Infrastructure Sectors

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Global Franchise & Supply Network - 2025 Report

While 2024 saw more stability in the financial markets than 2023, many challenges arose in 2024 for franchised businesses, manufacturers and retail chains, including bankruptcies of many large restaurant and retail chains,…more

Acquisitions, Bankruptcy Court, Chapter 11, Corporate Restructuring, Franchise Agreements

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Estate Planning Impact Of The Secure Act

The ‘Setting Every Community Up for Retirement Enhancement’ Act (the “SECURE Act”) was signed into law on December 20, 2019 and became effective January 1, 2020…more

401k, 403(b) Plans, Beneficiary Designations, Compensation & Benefits, Employee Benefits

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FCC's Decision on Net Neutrality Likely to Lead to Litigation

In a historic 3-2 vote on Thursday, February 26th, the Federal Communications Commission (FCC) voted to approve net neutrality rules aimed at governing Internet traffic. The FCC's decision would expand government oversight for…more

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Calling All SNFs… and All of Your Operational Associates – Get Ready Now: Sweeping New Disclosure Requirements Under The Updated 855A

Skilled Nursing Facilities and their operational associates need to prepare themselves now for new disclosure requirements that require much greater disclosure of ownership as well as disclosure from a much broader class of…more

Business Ownership, Centers for Medicare & Medicaid Services (CMS), Disclosure Requirements, Health Care Providers, Healthcare

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A Crypto-Tax Indictment Goes Viral

As reported in several recent entries on this blog, IRS has been engaged in ongoing efforts to enforce the taxation of cryptocurrency transactions.. These actions have run the gamut from educating investors,  miners and others…more

Criminal Prosecution, Cryptocurrency, Extradition, Financial Transactions, Indictments

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USPTO Announces New Artificial Intelligence Strategy

Synopsis: On January 14, 2025, the USPTO unveiled a new Artificial Intelligence (AI) Strategy, which outlines responsible implementation of AI within the agency and more generally across the intellectual property (IP) landscape…more

Artificial Intelligence, Collaboration, Compliance, Innovative Technology, Intellectual Property Protection

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BitBlog Bi-Weekly Update - May 2020

With the world slowly coming out of the COVID-19 lock down and the economy hopefully on the path to recovery there have been many developments in the blockchain / crypto space over the last few weeks…more

Bitcoin, Blockchain, CFTC, Cryptocurrency, Digital Assets

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Kansas Insurance Department Issues Data Call to All Third Party Administrators Licensed in Kansas

The Kansas Insurance Department (“Department”) recently issued a Data Call to all Third Party Administrators (“TPAs”) licensed in the state of Kansas. Pursuant to the Data Call, the Department has requested information regarding…more

Compliance, Data Collection, Department of Insurance, Employee Retirement Income Security Act (ERISA), Health Insurance

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IRS Identifies Monetized Installment Sales as a Listed Transaction

On August 4, 2023, the IRS published proposed regulations that, if finalized, would identify monetized installment sale transactions as a listed transaction. Sellers, intermediaries and other involved parties would be required…more

Installment Agreements, Internal Revenue Code (IRC), IRS, Proposed Regulation, Purchase Agreement

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Understanding How the Corporate Transparency Act Will Apply to the Delaware Statutory Trust Structure

What is the Corporate Transparency Act? In general terms, the Corporate Transparency Act (the “CTA”) requires reporting to the U.S. Department of Treasury’s Financial Crimes Enforcement Network (“FinCEN”) of personal direct…more

Anti-Corruption, Anti-Money Laundering, Beneficial Owner, Corporate Transparency Act, Financial Crimes

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What’s In a Name? – Labeling Alternatives to Meat Products

Manufacturers, producers and sellers of meat substitutes, including popular plant-based products and emerging cell-cultured products, can now be subject to criminal penalties in Missouri for calling their products “meat,” or by…more

Agricultural Sector, Food Labeling, Food Manufacturers, Food Safety, Food Supply

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Health Care Fraud and Abuse 2023 Year in Review

Introduction - Polsinelli proudly introduces the Health Care Fraud and Abuse 2023 Year in Review, a comprehensive examination of the evolving landscape surrounding the False Claims Act (“FCA”) and fraud & abuse enforcement…more

Anti-Kickback Statute, Department of Justice (DOJ), Enforcement Actions, False Claims Act (FCA), Fraud and Abuse

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“Outlook Not So Good” – An Employer’s Guide to the NLRB’s 2023 Agenda

“Should Employers have any hope for impartiality and good decisions from the National Labor Relations Board (“NLRB” or the “Board”) in 2023?”  Posed to the old Magic 8 Ball, the answer is “Don’t count on it.”…more

Collective Bargaining, Employer Liability Issues, Labor Reform, Labor Relations, Make-Whole Doctrine

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SEC Division of Examinations Announces 2022 Examination Priorities

Each year, the U.S. Securities and Exchange Commission’s (SEC) Division of Examinations (Division) prioritizes the examination of certain practices, products and services that it believes present potentially heightened risks to…more

Anti-Money Laundering, Capital Formation, Capital Markets, Investor Protection, Regulatory Agenda

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Federal Court Finds False Claims Act Penalty Unconstitutionally Excessive

On February 26, 2025, the U.S. District Court for the Northern District of Texas issued a significant False Claims Act (FCA) ruling in United States of America ex rel. Cheryl Taylor v. Healthcare Associates of Texas, LLC,…more

Constitutional Challenges, Damages, Department of Justice (DOJ), Eighth Amendment, False Claims Act (FCA)

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HCPF Makes Clarifications to Mandatory Facility-Based Professionals’ Reporting Requirements Under Colorado Hospital Discounted Care Law

What is Colorado Hospital Discounted Care? Colorado’s Hospital Discounted Care law, effective September 1, 2022, brought a detailed and comprehensive yet highly confounding overhaul to the way hospitals, freestanding…more

Colorado, Compliance, Health Insurance, Healthcare Facilities, Healthcare Reform

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Two Week Old DOJ COVID-19 Fraud Task Force Announces First Wave of Prosecutions—Many More Are Likely On The Horizon

Last week, in light of the Department of Justice’s newly-formed COVID-19 Fraud Enforcement Task Force, we cautioned that COVID-related prosecutions were likely imminent. And on the heels of this DOJ task force, we are already…more

Anti-Corruption, Coronavirus/COVID-19, Corruption, Department of Justice (DOJ), Enforcement Actions

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Top Questions Health Care Providers Should Consider in a Post-Chevron World – A Polsinelli Round Table Discussion

Health Care is one of the most regulated industries in the country, and for many years, one of the key administrative agencies overseeing health care in the United States, the Department of Health and Human Services’ (“HHS”)…more

Centers for Medicare & Medicaid Services (CMS), Chevron Deference, Healthcare, Healthcare Reform, Loper Bright Enterprises v Raimondo

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What the Health Care Industry Needs to Know About the Corporate Transparency Act

A new federal law requires health care business entities to disclose personal information and photographs of persons with ownership and control over their business. The Centers for Medicare & Medicaid (CMS) and other federal and…more

Beneficial Owner, Business Ownership, Centers for Medicare & Medicaid Services (CMS), Corporate Transparency Act, Disclosure Requirements

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Federal Estate and Gift Tax Changes in 2026: What is on the Horizon, or Sunset Rather?

In 2017, the federal gift and estate tax exemption was $5.49 million. The Tax Cuts and Jobs Act of 2017 doubled the gift and estate tax exemption amount to $11.18 million in 2018, and that amount has been adjusted for inflation…more

Estate Planning, Estate Tax, Estate-Tax Exemption, Gift Tax, Tax Cuts and Jobs Act

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SEC Proposes Amendments to Form PF to Drastically Expand Reporting Requirements for Private Fund Managers

On January 26, 2022, the Securities and Exchange Commission (the “SEC”) approved a proposal to amend Form Private Fund (“Form PF”) to (i) require additional reporting from advisers to large hedge funds and private equity funds,…more

Comment Period, Financial Regulatory Reform, Form PF, Hedge Funds, Investment Adviser

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CTA 2.0 – FinCEN Limits CTA’s Reporting Requirements to Certain Non-U.S. Entities and Non-U.S. Individuals

The Financial Crimes Enforcement Network (FinCEN) issued an interim final rule on March 21, 2025, that eliminates the Corporate Transparency Act (CTA) reporting requirements for U.S. entities and U.S. individuals. The rule is…more

Beneficial Owner, Business Entities, Business Ownership, Compliance, Corporate Transparency Act

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Enhancing Efficiency in Foreign Defense Sales: Key Takeaways from Recent Executive Order

On April 9, 2025, President Trump issued an Executive Order (EO) titled “Reforming Foreign Defense Sales to Improve Speed and Accountability.” This EO aims to reform the foreign defense sales (FDS) system, which encompasses U.S…more

Defense Contracts, Defense Sector, Department of Defense (DOD), Executive Orders, Export Controls

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Lender's Edge Newsletter - January 2019

A borrower’s request for a payoff letter on a secured commercial loan is typically a completely noncontroversial matter: an honest borrower has located a buyer for its property, or found another lender to refinance the…more

Commercial Loans, Consumer Financial Products, Financial Services Industry, Lenders, Payoff Requirements

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BitBlog Bi-Weekly Update - May 2020

With the world slowly coming out of the COVID-19 lock down and the economy hopefully on the path to recovery there have been many developments in the blockchain / crypto space over the last few weeks…more

Bitcoin, Blockchain, CFTC, Cryptocurrency, Digital Assets

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Tech Transactions & Data Privacy 2021 Report

As we bid farewell to 2020 and look toward the uncharted territory of 2021, it is hard not to take inventory of all that has changed in such a short period. No one at the beginning of 2020 would have predicted what transpired…more

Artificial Intelligence, California Consumer Privacy Act (CCPA), Communications Decency Act, Contact Tracing, COPPA

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Delaware Court of Chancery Rejects Lawyer-Driven Stockholder Books and Records Demand in Wilkinson v. Schulman

Stockholder books and records demands are investigatory tools that often are a prelude to litigation directed at corporate fiduciaries. In rejecting a stockholder books and records demand, the Delaware Court of Chancery recently…more

Books & Records, Business Litigation, Delaware General Corporation Law, Discovery, Evidence

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Tech Transactions & Data Privacy 2021 Report

As we bid farewell to 2020 and look toward the uncharted territory of 2021, it is hard not to take inventory of all that has changed in such a short period. No one at the beginning of 2020 would have predicted what transpired…more

Artificial Intelligence, California Consumer Privacy Act (CCPA), Communications Decency Act, Contact Tracing, COPPA

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Courts Split on How to Determine Statutory Damages for Copyright Infringement

The recent decision in Energy Intelligence Group, Inc. v. CHS McPherson Refinery, Inc. highlights a circuit split regarding how courts determine the statutory damages available for copyright infringement where multiple…more

Copyright, Copyright Infringement, Copyright Litigation, Intellectual Property Protection, Loss in Economic Value

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Swing and a Miss: the Government Strikes Out in Pharmacy Executive Kickback Trial

Last week, the government submitted its decision to the federal court not to retry partially-acquitted pharmacy executive, Chad Beene, for conspiracy and illegal kickback allegations. At the end of last year, a New Jersey jury…more

Anti-Kickback Statute, Criminal Prosecution, Department of Justice (DOJ), Enforcement Actions, False Claims Act (FCA)

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Federal Reserve Announces New Details for Term Asset-Backed Securities Loan Facility (TALF)

On March 23 the Federal Reserve announced the creation of the Term Asset-Backed Securities Loan Facility, or TALF to support the asset-backed securities (ABS) market.  The new facility (commonly referred to in the market as TALF…more

Asset-Backed Securities, CMBS, Collateral, Collateralized Loan Obligations, Federal Reserve

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Positive Momentum Behind Congressional Efforts to Avert Medicare Cuts

Health Care providers have been advocating for Congress to avert a series of impending Medicare reimbursement cuts slated to take effect in January of 2022 – an issue that has garnered bipartisan support. Congressional…more

Health Insurance, Healthcare, Healthcare Reform, Medicare, PAMA

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Reimbursement and Payor Dispute Update

Strategies for Complying with Price Transparency and Surprise Billing Laws - State legislatures and the federal government have been busy the past 12 months churning out laws that impose new disclosure and billing obligations on…more

Coronavirus/COVID-19, Health Care Providers, Health Insurance, Healthcare Reform, Infectious Diseases

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Medicare Continues its Updates to Provider Enrollment Policies as Part of Efforts to Enhance Program Integrity and Transparency

The Centers for Medicare & Medicaid Services (“CMS”) continued its efforts to increase oversight of the Medicare program by updating Medicare provider enrollment regulations and policies through recent regulatory and…more

Centers for Medicare & Medicaid Services (CMS), Enrollment, Health Care Providers, Health Insurance, Healthcare

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Harvard’s Tax-Exempt Status Dispute with the Trump Administration: Implications for Nonprofits

On April 16, 2025, President Donald Trump signaled a desire for Harvard University (Harvard or the University) to lose its tax-exempt status after the University refused several demands in the Trump Administration’s letter to…more

501(c)(3), Educational Institutions, Federal Funding, First Amendment, Harvard University

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FinCEN Issues a Notice to Financial Institution Customers on Beneficial Ownership Information Requirements

In its first step in linking CTA and banking laws, FinCEN recently posted a Notice to Financial Institution Customers regarding reporting beneficial ownership information under the CTA and banking regulations…more

Anti-Corruption, Beneficial Owner, Corporate Transparency Act, Financial Crimes, Financial Institutions

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Fall Congressional Forecast: Eye on Federal Funding and Health Care

Congress faces a crowded agenda this fall comprised of must-pass policy initiatives and potential political messaging opportunities in the lead up to the November midterm elections. With control of both chambers at stake, the…more

Abortion, Biden Administration, Continuing Resolution, Federal Funding, Food and Drug Administration (FDA)

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SEC Commissioner’s Public Comments May Signal Stiffer Corporate Stronger Misconduct Penalties on the Horizon

Earlier this week at a talk before the Council of Institutional Investors, U.S. Securities and Exchange (“SEC”) Commissioner, Caroline Crenshaw, argued that the enforcement must play a “central role” with regulators and require…more

Corporate Misconduct, Enforcement Actions, Investment, Penalties, Securities and Exchange Commission (SEC)

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Proposed Rules for Class VI UIC Permits through the Colorado Energy and Carbon Management Commission

On July 26, 2024, as part of the Colorado Energy and Carbon Management Commission’s (CECMC) ongoing efforts to obtain primacy to regulate Class VI wells for long term carbon sequestration under the U.S. Environmental Agency’s…more

Carbon Capture and Sequestration, Energy Policy, Energy Reform, Environmental Policies, Regulatory Agenda

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Swing and a Miss: the Government Strikes Out in Pharmacy Executive Kickback Trial

Last week, the government submitted its decision to the federal court not to retry partially-acquitted pharmacy executive, Chad Beene, for conspiracy and illegal kickback allegations. At the end of last year, a New Jersey jury…more

Anti-Kickback Statute, Criminal Prosecution, Department of Justice (DOJ), Enforcement Actions, False Claims Act (FCA)

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Regulatory Updates for Non-Hospital Quality Programs

The Washington Department of Health (DOH) has amended WAC 246-50, the rules applicable to coordinated quality improvement programs (CQIPs) for non-hospital organizations.  The amendments go into effect on May 21, 2021…more

Health Care Providers, Healthcare Reform, Physicians, Quality Incentive Program (QIP), Regulatory Agenda

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New SAMHSA Rule Expands Access to Medications for the Treatment of Opioid Use Disorder

On February 2nd, the U.S. Department of Health and Human Services (HHS) released a final rule expanding patient access to medications for the treatment of opioid use disorder (“OUD”). This new final rule implements changes that…more

Department of Health and Human Services (HHS), Final Rules, Health Care Providers, Healthcare, Healthcare Reform

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MACRA: Proposed Changes to the Merit-Based Incentive Payment System Track

The Centers for Medicare & Medicaid Services (CMS) published a proposed rule on the Medicare Quality Payment Program (QPP) in the Federal Register1 on June 30, 2017. This rule proposes the QPP program requirements for calendar…more

CEHRT, Centers for Medicare & Medicaid Services (CMS), Health Care Providers, Medicare, Medicare Access and CHIP Reauthorization (MACRA)

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Don't be Fooled by the Name... The Small BREW Act Could Have a Big Impact on Craft Breweries

The Small Brewer Reinvestment and Expanding Workforce Act, known as the "Small BREW Act", is bipartisan legislation introduced to Congress in early 2015. The overall goal of the Small BREW Act is to revamp the federal excise tax…more

Beer, Breweries, Business Taxes, Federal Taxes, Popular

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False Claims Act Recoveries During 2021

On February 1, 2022, the United States Department of Justice (DOJ) announced that it had recovered $5.6 billion from False Claims Act (FCA) Cases during fiscal year 2021. Each year, the DOJ publishes statistics about its…more

Department of Justice (DOJ), Enforcement Actions, False Claims Act (FCA), Fraud and Abuse, Healthcare

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CISA and FDA Sound Alarm on Backdoor Cybersecurity Threat with Patient Monitoring Devices

Last week, the U.S. Cybersecurity and Infrastructure Security Agency (“CISA”) and the U.S. Food and Drug Administration (“FDA”) released warnings about an embedded function they found in the firmware of the Contec CMS8000, which…more

Cybersecurity, Data Breach, Data Privacy, Data Protection, Food and Drug Administration (FDA)

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ASIC Bans Former BitConnect Front-man

John Louis Anthony Bigatton will not be providing financial services in Australia and likely not anywhere else, anytime soon. On Thursday, September 3, 2020, the Australian Securities and Investments Commission (“ASIC”)…more

ASIC, Australia, Bitcoin, Cease and Desist Orders, Cryptocurrency

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Stay Tuned… FTC Seeks to Breathe Life Back Into Non-Compete Ban

This past week, the FTC appealed a Texas federal court’s August ruling that blocked nationwide enforcement of the non-compete ban. The non-compete ban will remain blocked during the pendency of the appeal process. However, the…more

Employment Contract, Federal Bans, Federal Trade Commission (FTC), FTC Act, Non-Compete Agreements

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WARN-ings May Be Required Before a RIF or Shut Down

Recent layoffs at several high profile companies, and the putative class actions filed in their wake, highlight the importance of legal compliance when making and effecting these difficult decisions…more

Employer Liability Issues, Federal Labor Laws, Hiring & Firing, Layoff Notices, Layoffs

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The 80/20 Rule is Here: CMS Finalizes HCBS Care Worker Payment Requirements

In May 2023, the Centers for Medicare and Medicaid Services (“CMS”) proposed a series of rule changes intended to help promote the availability of home and community-based services (“HCBS”) for Medicaid beneficiaries. Chief…more

Centers for Medicare & Medicaid Services (CMS), Compensation & Benefits, Fair Labor Standards Act (FLSA), Health Care Providers, Healthcare Workers

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Health Care Reimbursement and Payor Dispute Update Special Edition – Year End Regulatory Review

The Centers For Medicare & Medicaid Services Issues New Inpatient Prospective Payment System Final Rule - On September 3, 2020, the Centers for Medicare & Medicaid Services (CMS) issued the fiscal year (FY) 2021 Medicare…more

Centers for Medicare & Medicaid Services (CMS), Cramdown, Drug Pricing, Health Care Providers, Healthcare Reform

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Technology Transactions & Data Privacy - 2025 Report

It is hard to believe that we are starting the 25th year of the 21st century. The rapid evolution that technology, privacy and data security have undergone these last 25 years is mindbending. Yet, as we enter 2025, it still…more

Class Action, Class Certification, Consumer Privacy Rights, Consumer Protection Laws, Critical Infrastructure Sectors

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Lender's Edge Newsletter: January 2018

Are Lenders Entitled to Insurance Proceeds When Foreclosing? A lender’s right to insurance proceeds after foreclosure depends on the type of loss payable clause contained in the insurance policy and the timing of the loss…more

Financial Services Industry, Foreclosure, Insurance Industry, Lenders, Mortgages

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Delaware Court of Chancery Rejects Lawyer-Driven Stockholder Books and Records Demand in Wilkinson v. Schulman

Stockholder books and records demands are investigatory tools that often are a prelude to litigation directed at corporate fiduciaries. In rejecting a stockholder books and records demand, the Delaware Court of Chancery recently…more

Books & Records, Business Litigation, Delaware General Corporation Law, Discovery, Evidence

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The OIG’s Concerns with Potentially Fraudulent Medicare Advantage Marketing

The HHS Office of Inspector General (“OIG”) released a Special Fraud Alert to inform health care professionals (“providers”) and Medicare Advantage Organizations (“MAOs”) about the OIG’s view of potentially abusive marketing…more

Compliance, Department of Health and Human Services (HHS), Fraud, Health Care Providers, Medicare

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Renewable News - Spring 2013

In This Issue: - Federal Policy Update - TradeWind and Alabama Power Announce PPA for Kansas Project - NextEra Energy Resources Finalized Purchase of Kansas Project - Incentives Announced for $66 Million…more

Biofuel, Energy Projects, Renewable Energy, Wind Power

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Contact Sports in the Era of COVID-19: How Schools and Amateur Sports Leagues May Face New Liability

This brief article explores some of the legal issues that may arise in the era of COVID-19 when restrictions are eased and participation in contact sports resumes in schools and amateur sports leagues…more

Assumption of the Risk, Athletes, Coronavirus/COVID-19, Educational Institutions, Liability

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Patient-Centered Sustainable Health Care

I. INTRODUCTION - Over the past two years, global events reshaped the health care industry by shifting the priorities of the industry’s key stakeholders. In the post-Covid-19 economy, quick responses to short-term problems…more

Healthcare, Healthcare Reform, Hospital Mergers, Patient-Specific, Patients

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Missouri Legislature Approves Six-Year Solar Rebate Phase-Out

As one of the final acts of the legislative session, on May 17th the Missouri legislature approved an amendment that will phase out the Missouri solar rebate between 2014 and 2020…more

Proposed Amendments, Rebates, Solar Energy

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New York’s Impending WARN Notice Requirement for Artificial Intelligence Related Layoffs Highlights Proliferating Nationwide Requirements

During her 2025 State of the State Address on January 14, 2025, New York Governor Kathy Hochul announced a plan to support workers displaced by Artificial Intelligence (AI) by requiring employers who engage in mass layoffs or…more

Artificial Intelligence, Disclosure Requirements, Employees, Employment Discrimination, Hiring & Firing

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Texas Federal Judge Blocks FTC Non-Compete Ban

This week, Judge Ada E. Brown of the U.S. District Court for the Northern District of Texas in Ryan v. The Federal Trade Commission upheld a challenge by business groups to the FTC’s non-compete ban. In addition to confirming…more

Administrative Procedure Act, Competition, Confidential Information, Employer Liability Issues, Employment Contract

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New Government Reporting Requirements That May Apply To You

If you or your trust owns an interest in a corporation, limited liability company, partnership, or other type of entity, subject to limited exceptions, you are likely required to provide certain information to the FinCEN…more

Anti-Corruption, Beneficial Owner, Corporate Transparency Act, Financial Crimes, FinCEN

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Technology Transactions & Data Privacy - 2025 Report

It is hard to believe that we are starting the 25th year of the 21st century. The rapid evolution that technology, privacy and data security have undergone these last 25 years is mindbending. Yet, as we enter 2025, it still…more

Class Action, Class Certification, Consumer Privacy Rights, Consumer Protection Laws, Critical Infrastructure Sectors

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NASAA Supports Reasonable Post-Term Non-Competes in Franchise Agreements

Last year saw non-compete agreements come under repeated scrutiny from the Federal Trade Commission. On April 23, 2024, the FTC issued a final rule banning non-compete agreements in most employment contracts…more

Compliance, Employment Contract, Federal Trade Commission (FTC), Final Rules, Franchise Agreements

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Global Franchise & Supply Network - 2025 Report

While 2024 saw more stability in the financial markets than 2023, many challenges arose in 2024 for franchised businesses, manufacturers and retail chains, including bankruptcies of many large restaurant and retail chains,…more

Acquisitions, Bankruptcy Court, Chapter 11, Corporate Restructuring, Franchise Agreements

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The Proposed Build Back Better Act Moves Forward After the House Passes a Revised Version of the Bill

Overview - Over the past year, several tax law changes have been proposed by the Biden administration and, in September 2021, draft legislative language was circulated, which set forth proposed changes to the Internal…more

Biden Administration, Capital Gains Tax, Corporate Taxes, Foreign Derived Intangible Income (FDII), Foreign Tax Credits

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California Reintroduces Legislation to Restrict Private Equity Management of Health Care Providers

The California legislature has introduced a bill that would implement some of the same restrictions on private equity health care investments as last year’s AB 3129…more

California, Corporate Practice of Dentistry, Corporate Practice of Medicine, Dentists, Health Care Providers

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HCPF Makes Clarifications to Mandatory Facility-Based Professionals’ Reporting Requirements Under Colorado Hospital Discounted Care Law

What is Colorado Hospital Discounted Care? Colorado’s Hospital Discounted Care law, effective September 1, 2022, brought a detailed and comprehensive yet highly confounding overhaul to the way hospitals, freestanding…more

Colorado, Compliance, Health Insurance, Healthcare Facilities, Healthcare Reform

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Health Reform + Related Health Policy News - January 2014, Issue 1

In This Issue: - Top News ..Congress Approves Budget Deal with Short-Term ‘Doc Fix' ..CMS “Two-Midnight” Rule delayed until March 31, 2014 ..Individuals with Canceled Insurance Policies May Apply for…more

Affordable Care Act, Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services (HHS), EHR, Exempt Organizations

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Health Care Reimbursement and Payor Dispute Update Special Edition – Year End Regulatory Review

The Centers For Medicare & Medicaid Services Issues New Inpatient Prospective Payment System Final Rule - On September 3, 2020, the Centers for Medicare & Medicaid Services (CMS) issued the fiscal year (FY) 2021 Medicare…more

Centers for Medicare & Medicaid Services (CMS), Cramdown, Drug Pricing, Health Care Providers, Healthcare Reform

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New Guidance on Employee-Owned Device Discovery

As technology continues to evolve, organizations are increasingly facing challenges concerning whether, and to what extent, they allow employees to utilize their own devices for work purposes. When employees use their own…more

Bring Your Own Device (BYOD), Discovery, Electronically Stored Information, Employer Liability Issues, Employment Policies

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Federal Circuit Addresses Obviousness of Polymorphs in Grunenthal GmbH v. Alkem Labs. Ltd., No. 2017-1153 (Fed. Cir. Mar. 28, 2019)

For the first time, on March 28, 2019, the Federal Circuit addressed obviousness of polymorph claims based on a known approach to polymorph screening, finding no reasonable expectation of success…more

Hatch-Waxman, Intellectual Property Litigation, Intellectual Property Protection, Obviousness, Pharmaceutical Industry

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Ninth Circuit Reverses Landmark Wit Case Addressing Behavioral Health Coverage

The President and his administration continue to tout their efforts to strengthen coverage for behavioral health care, including significantly increasing behavioral health spending and strengthening parity between physical and…more

Biden Administration, Denial of Insurance Coverage, Employee Retirement Income Security Act (ERISA), Health Insurance, Health Plan Sponsors

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Renewable News - Spring 2013

In This Issue: - Federal Policy Update - TradeWind and Alabama Power Announce PPA for Kansas Project - NextEra Energy Resources Finalized Purchase of Kansas Project - Incentives Announced for $66 Million…more

Biofuel, Energy Projects, Renewable Energy, Wind Power

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Regulatory Overreach/Litigation Remedies To Curtail Regulatory Excess by Federal Trade Commission

With the rise of large-scale, high-profile data breaches, the Federal Trade Commission has expressed its intent to hold companies accountable. (See “Consumer Financial Protection Circular 2022-04,” Consumer Financial Protection…more

Data Breach, Data Management, Data Security, Enforcement Actions, Federal Trade Commission (FTC)

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New York Targets Real Estate Owners in New LLC Transparency Law

Riding a wave of ownership disclosure laws began with the passage of the federal Corporate Transparency Act (CTA), on December 22, 2023, Governor Hochul signed New York’s own “LLC Transparency Act” (the NY-LLCTA), passed by the…more

Anti-Money Laundering, Beneficial Owner, Corporate Transparency Act, Financial Crimes, FinCEN

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Technology Transactions & Data Privacy - 2025 Report

It is hard to believe that we are starting the 25th year of the 21st century. The rapid evolution that technology, privacy and data security have undergone these last 25 years is mindbending. Yet, as we enter 2025, it still…more

Class Action, Class Certification, Consumer Privacy Rights, Consumer Protection Laws, Critical Infrastructure Sectors

See all updates »

Lender's Edge Newsletter: January 2018

Are Lenders Entitled to Insurance Proceeds When Foreclosing? A lender’s right to insurance proceeds after foreclosure depends on the type of loss payable clause contained in the insurance policy and the timing of the loss…more

Financial Services Industry, Foreclosure, Insurance Industry, Lenders, Mortgages

See all updates »

Technology Transactions & Data Privacy - 2025 Report

It is hard to believe that we are starting the 25th year of the 21st century. The rapid evolution that technology, privacy and data security have undergone these last 25 years is mindbending. Yet, as we enter 2025, it still…more

Class Action, Class Certification, Consumer Privacy Rights, Consumer Protection Laws, Critical Infrastructure Sectors

See all updates »

Cuts In Services May Leave Bigger Wounds

In a recent open letter, the Illinois Department of Financial and Professional Regulation (the "Department") advised providers of cuts in the Department's Medical Unit that will negatively impact the state's healthcare…more

Budget Cuts, Healthcare, Licenses, Physicians

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Southern District of New York Says Portions of Department of Labor’s FFCRA Final Rule “Jumped the Rail” and Are Vacated

On April 1, 2020, the United States Department of Labor (DOL) issued a Final Rule implementing the Families First Coronavirus Response Act (FFCRA).  Shortly thereafter, the State of New York filed suit against the DOL, arguing…more

Coronavirus/COVID-19, Department of Labor (DOL), Families First Coronavirus Response Act (FFCRA), Family and Medical Leave Act (FMLA), Relief Measures

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Department of Labor Proposes Rule on Valuing Stock for ESOP Stock Purchase and Sale Transactions

On January 16, 2025, the Employee Benefits Security Administration (EBSA) at the Department of Labor (DOL) released drafts of long-awaited proposed regulations seeking to clarify the definition of “adequate consideration” as set…more

Department of Labor (DOL), Employee Benefits, Employee Retirement Income Security Act (ERISA), ESOP, Fiduciary Duty

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Health Care Reimbursement and Payor Dispute Update - September 2022

Co-Location and the Provider-Based Rules – No News is…Good News? On July 15, the Centers for Medicare & Medicaid Services ("CMS") released the 2023 Outpatient Prospective Payment System proposed rule (“OPPS Proposed Rule”),…more

Centers for Medicare & Medicaid Services (CMS), Critical Access Hospitals, Health Care Providers, Health Insurance, Healthcare

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Top Issues in Behavioral Health for 2022

Behavioral Health M&A Will Remain Hot in 2022 - Behavioral health had its most active year in 2021, which came on the heels of very active years that preceded it. There are many factors that contributed to this and that…more

Centers for Medicare & Medicaid Services (CMS), Health Insurance, Healthcare, Healthcare Reform, Joint Venture

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SEC Proposes Changes to Modernize and Simplify Equity Compensation Rules and Registration Obligations

On November 24, 2020, the Securities and Exchange Commission (“SEC”) proposed amendments to Rule 701 and Form S-8 (the “Proposals”) under the Securities Act of 1933, as amended (the “Securities Act”)…more

Disclosure Requirements, Form S-8, Publicly-Traded Companies, Rule 701, Securities and Exchange Commission (SEC)

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Reopening Hospital Service Lines: A Playbook for Moving Forward

The COVID-19 pandemic has created severe financial and operational difficulties for hospitals. Rapidly responding to a novel pathogen within a declared Public Health Emergency (PHE), while experiencing decreased revenues as a…more

Coronavirus/COVID-19, Employer Liability Issues, Employer Responsibilities, Re-Opening Guidelines, Return-to-Work Agreements

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U.S. Court Of Appeals Decision Likely To Impact State Transmission And RES Policies

On June 7th, 2013, the U.S. Court of Appeals for the Seventh Circuit issued an opinion that could have significant impacts on transmission and renewable energy policies all across the country…more

FERC, MISO, Renewable Energy, RTO, Transmission Lines

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Environment, Energy & Infrastructure Landscape in 2023

THE PLAYERS - The Administration - While it is unusual for a President to enjoy four years of service from his cabinet leaders that oversee the Environmental Protection Agency and the Departments of Energy, the Interior, and…more

Administrative Appointments, Biden Administration, Congressional Committees, Critical Infrastructure Sectors, Energy Policy

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Understanding How the Corporate Transparency Act Will Apply to the Delaware Statutory Trust Structure

What is the Corporate Transparency Act? In general terms, the Corporate Transparency Act (the “CTA”) requires reporting to the U.S. Department of Treasury’s Financial Crimes Enforcement Network (“FinCEN”) of personal direct…more

Anti-Corruption, Anti-Money Laundering, Beneficial Owner, Corporate Transparency Act, Financial Crimes

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A Wait Until the Deal Closes: The Antitrust Agencies Send a Strong Message About the Dangers of Gun-Jumping

One of the most common questions clients have after a merger or acquisition has been signed is, “When can we start on combining the operations and doing business?” And one of the most challenging pieces of counseling is to help…more

Acquisitions, Antitrust Division, Antitrust Violations, Competition, Department of Justice (DOJ)

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Colorado Supreme Court to Rule on Yet Another Key Construction Defects Issue

On July 5, 2016, the Colorado Supreme Court announced it will consider the construction defects case of Forest City Stapleton, Inc., et al. v. Rogers. In this case the Colorado Court of Appeals, for the first time, imposed an…more

CO Supreme Court, Construction Defects, Construction Industry, Construction Litigation, Construction Project

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The Time is Now for Employers to Prepare for Illinois’ Paid Leave for All Workers Act

On January 1, 2024, Illinois will join Maine and Nevada as the only U.S. states to mandate that covered employers provide their employees with earned paid leave that can be used for any reason. Generally, the Paid Leave for All…more

Earned Sick Time, Employee Benefits, Employees, Employer Liability Issues, Illinois

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Meat Processing: COVID Liabilities

In the midst of the pandemic, meat processing facilities have struggled to meet demand while protecting employees. Governmental regulations, orders and guidelines often have seemed to be inconsistent with one another. Even…more

Centers for Disease Control and Prevention (CDC), Coronavirus/COVID-19, Defense Production Act, Farm Animals, Food Manufacturers

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California’s Amended Data Broker Registration Law

In October 2023, California Governor Gavin Newsom signed Senate Bill (S.B.) 362 into law, amending California’s data broker registration law. By January 31, 2024, qualifying data brokers must register with the California Privacy…more

California, California Consumer Privacy Act (CCPA), California Privacy Protection Agency (CPPA), Consumer Privacy Rights, Cybersecurity

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SECURE 2.0: Retirement Plan Rules Get a Makeover!

SECURE 2.0, which was signed into law on December 29, 2022 as part of the larger Consolidated Appropriations Act, is the most wide-sweeping retirement plan legislation enacted in more than a decade. It contains a myriad of…more

Compensation & Benefits, Consolidated Appropriations Act (CAA), Employee Benefits, New Legislation, Regulatory Reform

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Jury Verdict Invalidated a Patent Under Section 101

On September 12, 2019, after about six hours of deliberating, a jury in the United States District Court for the Eastern District of Texas determined that no infringement had been committed in a suit filed by PPS Data LLC…more

Financial Services Industry, Intellectual Property Protection, Patent Infringement, Patent Invalidity, Patent Litigation

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New York State’s Fashion Workers Act Effective Summer 2025

Governor Hochul signed legislation titled the “New York State Fashion Workers Act” (the “Act”), which has a widespread impact on the modeling industry as it relates to compensation, contractual restrictions, and other workplace…more

Compensation & Benefits, Department of Labor (DOL), Employment Contract, Employment Policies, Fashion Industry

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Top Questions Health Care Providers Should Consider in a Post-Chevron World – A Polsinelli Round Table Discussion

Health Care is one of the most regulated industries in the country, and for many years, one of the key administrative agencies overseeing health care in the United States, the Department of Health and Human Services’ (“HHS”)…more

Centers for Medicare & Medicaid Services (CMS), Chevron Deference, Healthcare, Healthcare Reform, Loper Bright Enterprises v Raimondo

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Patient-Centered Sustainable Health Care

I. INTRODUCTION - Over the past two years, global events reshaped the health care industry by shifting the priorities of the industry’s key stakeholders. In the post-Covid-19 economy, quick responses to short-term problems…more

Healthcare, Healthcare Reform, Hospital Mergers, Patient-Specific, Patients

See all updates »

George Costanza and the Supreme Court Align in Ruling This Week on Section 11 of the Securities Act of 1933

In a classic Seinfeld episode, George Costanza opined: "it's not a lie, if you believe it". In a ruling handed down on March 24th, the Supreme Court agreed with this sentiment as it concerned claims brought under Section 11 of…more

Material Misstatements, Omnicare v Laborers District Council, Registration Statement, SCOTUS, Securities Act of 1933

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New EDPB Guidance on International Transfers Following Schrems II

On November 10, the European Data Protection Board (“EDPB”) released its “Recommendations 01/2020 on measures that supplement transfer tools to ensure compliance with the EU level of protection of personal data” (the…more

Corporate Counsel, Cybersecurity, Data Protection, EU, European Data Protection Board (EDPB)

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Texas Supreme Court Confirms Texas Home-Equity Lenders Are Entitled to Equitable Subrogation Irrespective of Failures to Correct Curable Constitutional Defects in Loan Documents

Last week, the Texas Supreme Court issued a significant decision in favor of Texas home-equity lenders in Federal Home Loan Mortgage Corporation v Zepeda, No. 19-0712, answering “yes” to the following certified question from the…more

Home Equity, Home Equity Line of Credit, Lenders, Loan Documentation, Mortgages

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Survey of International Privacy Laws

Introduction - Recent years have brought a dramatic increase in the number of countries that have comprehensive privacy and data security laws. As the world has become increasingly digital, privacy and data protection have…more

Brazil, Canada, China, Cybersecurity, Data Privacy

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SCOTUS Overturns First, Fifth, Seventh, and Eleventh Circuits and Limits Scope of Computer Fraud and Abuse Act Prosecutions

In a 6-3 decision authored by the Court’s newest Justice, Amy Coney Barrett, the Court reversed and remanded Van Buren’s conviction. The majority, joined by Justices Breyer, Sotomayor, Kagan, Gorsuch, and Kavanaugh reasoned that…more

Computer Fraud and Abuse Act (CFAA), Databases, Police, SCOTUS, Unauthorized Access

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Subordinate Finance in Commercial Real Estate—The Current Landscape

Commercial real estate borrowers often need financing in amounts exceeding what traditional first mortgage lenders will provide. Profound changes in various forms of subordinate finance have occurred in the wake of the financial…more

Approval Requirements, CMBS, Commercial Real Estate Market, Equity Financing, Intercreditor Agreements

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State Wage Increases to Ring in the New Year (2025)

As 2024 comes to a close, employers should be aware of the hourly minimum wage rate increases set to take effect in various jurisdictions on January 1, 2025. 21 states and 48 local jurisdictions will “ring in” the New Year with…more

Corporate Counsel, Employees, Employer Liability Issues, Labor Reform, Minimum Wage

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Beyond the Blockchain: What’s Next for Digital Assets After Explosive Growth in 2024

Web3 represents the next evolution of the internet, characterized by decentralized networks and blockchain technology, enabling user-centric platforms and applications with enhanced security and data ownership. Digital assets, a…more

Asset Management, Blockchain, Cryptocurrency, Digital Assets, Enforcement Actions

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SEC Makes Moves to Step Up ESG Enforcement

As investor demand for socially responsible investing continues to rise, the U.S. Securities and Exchange Commission (SEC) has increased its focus on compliance practices of investment advisors and funds. After the change in the…more

Business Strategies, Capital Investments, Corporate Governance, Corporate Social Responsibility, Disclosure Requirements

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Lender's Edge Newsletter: January 2018

Are Lenders Entitled to Insurance Proceeds When Foreclosing? A lender’s right to insurance proceeds after foreclosure depends on the type of loss payable clause contained in the insurance policy and the timing of the loss…more

Financial Services Industry, Foreclosure, Insurance Industry, Lenders, Mortgages

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Funding Freeze for Health Care Providers – What You Need to Know

The Office of Management and Budget (“OMB”) released a memo directing federal agencies to take several actions impacting federal grant programs (outlined in greater detail below) that are resulting in real money consequences for…more

Centers for Medicare & Medicaid Services (CMS), Executive Orders, Federal Grants, Grants, Health Care Providers

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Analyzing the Proposed 2019 Stark Reforms

The United Stated Department of Health and Human Services (“HHS”) published a notice of proposed rulemaking (NPRM) containing proposed changes to the Physician Self-Referral Law (“Stark Law,” or “Stark”) on October 17, 2019…more

Anti-Kickback Statute, Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services (HHS), Health Care Providers, Healthcare Reform

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What’s up with Illinois’ BIPA

The Illinois Biometric Information Privacy Act, 740 ILCS 14/1 through 14/99, was enacted in 2008 to manage the promise of biometric technology for Illinois residents. BIPA seeks to encourage the development and use of biometric…more

Biometric Information, Biometric Information Privacy Act, BNSF Railway, Data Collection, Data Privacy

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Stop, Think, and Be Careful What You Ask For: Lessons and Opportunities Created by Recent Arbitration Ruling

On April 21, 2015, the Missouri Court of Appeals in City of Chesterfield v. Frederich Construction Inc. upheld an arbitration award that included substantial attorneys' fees to the prevailing party, in a construction case where…more

American Arbitration Association, American Rule, Appeals, Attorney's Fees, Construction Contracts

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Federal Circuit Clarifies AIA On-Sale Bar Provision Applies Where Existence of Sale Is Public

Yesterday, the Federal Circuit provided much-anticipated guidance on the scope of the America Invents Act’s “on-sale” bar provision. Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc., et al., Nos. 2016-1284, 2016-1787…more

Abbreviated New Drug Application (ANDA), America Invents Act, Generic Drugs, Hatch-Waxman, Intellectual Property Protection

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U.S. Supreme Court Holds That The Federal Arbitration Act Preempts California’s Rule Prohibiting Contractual Arbitration of Individual PAGA Claims

On June 15, 2022, the U.S. Supreme Court issued its highly anticipated opinion in Viking River Cruises, Inc. v. Moriana, which considered whether or not claims brought under the California Private Attorneys General Act (“PAGA”)…more

Arbitration, Arbitration Agreements, California, Class Action, Class Action Arbitration Waivers

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Don't Be Left On The Sidelines: CMS Is Seeking Applications For A New Hospice Demonstration Program

Currently, Medicare patients that wish to receive palliative hospice care have a tough choice to make—forgo any curative treatment or incur all hospice care costs. This could change, however, with the recent launch of CMS's…more

Centers for Medicare & Medicaid Services (CMS), Healthcare, Healthcare Reform, Hospice, Hospitals

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Med-Staff Newsletter - October 2023 | VOL 12

Do the Right Thing — Reporting Voluntary Actions Taken While “Under Investigation” to the NPDB - Many health care entities struggle with the dilemma of whether and when to make reports to the National Practitioner Data Bank…more

Health Care Providers, Healthcare, Healthcare Reform, Healthcare Workers, Investigations

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DOJ Announces Modest Increase in FCA Recoveries, Fueled Largely by Whistleblower Lawsuits

The Department of Justice (“DOJ”) recently announced a modest increase in monetary recoveries for 2024 from investigations and lawsuits under the False Claims Act (“FCA”), which is the Government’s primary tool for combating…more

Anti-Kickback Statute, Coronavirus/COVID-19, Department of Justice (DOJ), Enforcement Actions, False Claims Act (FCA)

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Member of an Arizona LLC? You May Have a Fiduciary Duty to the LLC

Arizona has finally resolved the issue of whether managers and members of an Arizona Limited Liability Company (LLC) owe a common law fiduciary duty to the LLC and whether an operating agreement can lawfully limit those…more

AZ Supreme Court, Business Litigation, Common Law Torts, Contract Terms, Duty of Care

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Illinois Amends Equal Pay Act to Prohibit Questions About Salary History

Recently, Illinois amended its Equal Pay Act to include a ban on salary-history inquiries, with the stated goal of reducing gender pay inequities.  Specifically, the amendments prohibit employers from asking questions regarding…more

Amended Legislation, Employer Liability Issues, Equal Pay, Equal Pay Act, Gender Equity

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New CMS Staffing Rules for Long Term Care Providers – What you need to know now

On May 10, 2024, the Centers for Medicare and Medicaid Services (“CMS”) published a final rule implementing mandatory hours per resident day (“HPRD”) requirements for various levels of nursing staff for skilled nursing…more

Centers for Medicare & Medicaid Services (CMS), Health Care Providers, Healthcare, Healthcare Workers, Long Term Care Facilities

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The Strategic Role of Systematic Health Care M+A in Remaking the Future of Health Care

This white paper analyzes the interplay of those middle market health care business mergers and acquisitions with the four-part, patient-care-centric conceptual framework of ownership, organization, payment and delivery that we…more

Acquisition Agreements, Business Model, Corporate Sales Transactions, Due Diligence, Health Care Providers

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Jury Sides with Hermès in Pivotal NFT Trademark Case

On February 8, 2023, a federal jury awarded Hermès International and Hermès of Paris, Inc. (“Hermès”) $133,000 in its trademark lawsuit against designer Mason Rothschild. Hermès sued Rothschild for selling non-fungible tokens…more

Artistic Works, Cybersquatting, Digital Assets, Dilution, Fashion Branding

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Vehicle Rental Laws: Road Blocks To Evolving Mobility Models?

The laws and regulations governing mobility are inconsistent and antiquated and should be modernized to encourage innovation as we prepare for an autonomous car future. The National Highway Traffic Safety Administration…more

Auto Lease, Automotive Industry, Car Rentals, Car-Sharing, Driverless Cars

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25% Duties on U.S. Imports from Canada and Mexico Lifted for USMCA-Eligible Merchandise

Thursday, March 6, President Trump signed two Executive Orders significantly curtailing the scope of the emergency tariffs he imposed on Tuesday, March 4, impacting U.S. imports from Canada and Mexico. Effective today, U.S…more

Canada, Customs and Border Protection, Duties, Executive Orders, Imports

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Health Care Reimbursement and Payor Dispute Update Special Edition – Year End Regulatory Review

The Centers For Medicare & Medicaid Services Issues New Inpatient Prospective Payment System Final Rule - On September 3, 2020, the Centers for Medicare & Medicaid Services (CMS) issued the fiscal year (FY) 2021 Medicare…more

Centers for Medicare & Medicaid Services (CMS), Cramdown, Drug Pricing, Health Care Providers, Healthcare Reform

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Temporary Food Labeling Policies in Light of the COVID-19 Pandemic

In the wake of the COVID-19 pandemic in the United States, the U.S. Food and Drug Administration in March relaxed its labeling requirements for food manufacturers and restaurants to aid the distribution and sale of food during…more

Agribusiness, Coronavirus/COVID-19, Department of Health and Human Services (HHS), Food and Drug Administration (FDA), Food Labeling

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Kansas Insurance Department Issues Data Call to All Third Party Administrators Licensed in Kansas

The Kansas Insurance Department (“Department”) recently issued a Data Call to all Third Party Administrators (“TPAs”) licensed in the state of Kansas. Pursuant to the Data Call, the Department has requested information regarding…more

Compliance, Data Collection, Department of Insurance, Employee Retirement Income Security Act (ERISA), Health Insurance

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A Long Time Coming: DOJ Issues First FCPA Advisory Opinion in Six Years

On August 14, 2020, the Department of Justice issued a Foreign Corrupt Practices Act (“FCPA”) Advisory Opinion—the first of its kind in nearly six years. The DOJ’s opinion advised a U.S. investment company that the transaction…more

Anti-Corruption, Corporate Counsel, Department of Justice (DOJ), Enforcement Guidance, Foreign Corrupt Practices Act (FCPA)

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Complying with the ACA Disclosure Requirements Just Got a Whole Lot Easier!

New legislation liberalizing certain disclosure requirements under the Affordable Care Act (“ACA”) was passed at the end of 2024.  Effective for 2024 reporting, mailing a paper copy of Forms 1095-C/1095-B is no longer…more

Affordable Care Act, Benefit Plan Sponsors, Disclosure Requirements, Employee Benefits, Employer Group Health Plans

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New Patent Office Guidance and Blockchain-based Patents

Recently, the Patent Office announced two new Guidance documents which although not targeted specifically to blockchain technology provide insight into strategies for the drafting and prosecuting of blockchain-based patents…more

Blockchain, Distributed Ledger Technology (DLT), Intellectual Property Protection, New Guidance, Patent Applications

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CMS Terminates and Scales Back Mandatory Bundled Payment Models

The Centers for Medicare & Medicaid Services (CMS) recently published a final rule that cancels the Episode Payment Models (EPMs) and the Cardiac Rehabilitation (CR) incentive payment model, each of which were slated to begin on…more

BPCI, Bundled Payments, Centers for Medicare & Medicaid Services (CMS), Episode Payment Models (EPM), Health Care Providers

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New Legislation Overhauls State and Local Regulations for Commercial Wind and Solar Farms

On January 27, 2023, Governor Pritzker signed a bill that will transform the way counties and municipalities in Illinois locally regulate the development and construction of commercial wind and solar energy generation…more

Energy Projects, Energy Reform, Illinois, Infrastructure, New Legislation

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New Executive Order Rescinds the $17.75 Per Hour Federal Contractor Minimum Wage

n March 14, 2025, President Trump issued an Executive Order rescinding eighteen (18) prior executive orders and actions, including Executive Order 14026’s substantial increase to the minimum wage for federal government…more

Contract Terms, Department of Labor (DOL), Executive Orders, Federal Acquisition Regulations (FAR), Federal Contractors

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For Whom the Whistle Blows

In This Issue: - Applicability and Protected Activity - Procedure Governing Section 402 Claims - Five Steps to Compliance - For More Information - Excerpt from Applicability and Protected…more

Chief Compliance Officers, Employer Liability Issues, Federal Food Drug and Cosmetic Act (FFDCA), Food Manufacturers, FSMA

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DCGL Amendment May Breathe New Life Into Zombie Companies

On August 1, 2023, the Delaware General Corporation Law (DGCL) was amended to create an “insolvency exception” to Delaware’s long-standing requirement that a sale of all or substantially all of a Delaware corporation’s assets…more

Board of Directors, Business Ownership, Corporate Governance, Corporate Restructuring, Delaware General Corporation Law

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3rd Quarter 2024 Chapter 11, Healthcare, and Real Estate Distress Indices

Welcome to the 3rd Quarter 2024 Report for the Polsinelli | TrBK Distress Indices. The indices use filtered Chapter 11 filings as a proxy for distress in the overall U.S. economy and certain subsectors…more

Bankruptcy Plans, Chapter 11, Commercial Bankruptcy, Creditors, Debt Restructuring

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Drug Pricing and Payment Executive Order Shows Trump Administration’s Cards

On April 15, 2025, President Trump signed the Lowering Drug Prices by Once Again Putting Americans First Executive Order (Executive Order). The Executive Order revives and expands several pharmaceutical pricing and payment…more

Drug Pricing, Executive Orders, Hospitals, Inflation Reduction Act (IRA), Medicaid

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Federal District Court Rules Qui Tam Whistleblower Enforcement of False Claims Act Unconstitutional

On September 30, 2024, Judge Mizelle, a federal judge in the Middle District of Florida, ruled that the False Claims Act’s (“FCA”) qui tam enforcement provision is unconstitutional, a ruling that, if followed by other courts,…more

Article II, Constitutional Challenges, False Claims Act (FCA), Qui Tam, Relators

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What is 13th Month Pay and Why Should Employers Care?

Most American employers run payroll twelve or twenty-four times across a calendar year. In some countries, there is a “thirteenth month” to think about…more

Bonuses, Employer Responsibilities, International Labor Laws, Payroll Taxes, Salaried Employees

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Eleventh Circuit Overturns FCC’s One-to-One Consent Rule

A 2023 Federal Communications Commission (FCC) Order interpreted the Telephone Consumer Protection Act as requiring that consumers provide specific one-to-one consent to receive robocalls. The purpose was to fill what the FCC…more

Chevron Deference, Consumer Privacy Rights, FCC, Regulatory Authority, Robocalling

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Technology Transactions & Data Privacy - 2025 Report

It is hard to believe that we are starting the 25th year of the 21st century. The rapid evolution that technology, privacy and data security have undergone these last 25 years is mindbending. Yet, as we enter 2025, it still…more

Class Action, Class Certification, Consumer Privacy Rights, Consumer Protection Laws, Critical Infrastructure Sectors

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How FinTech Could Reboot LIBOR

Part One of this two part E-alert looked at the challenges facing London Inter-Bank Offered Rate (LIBOR) LIBOR and how the syndicated loan market is dealing with the potential non-availability of these rates. Part two considers…more

Benchmarks, Blockchain, Distributed Ledger Technology (DLT), Financial Transactions, FinTech

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New Independent Contractor Test Increases Risk of Independent Contractor Misclassification

The U.S. Department of Labor is set to issue a Proposed Rule that will have a significant impact on the test used to determine whether someone is an independent contractor or an employee under the Fair Labor Standards Act…more

Biden Administration, Department of Labor (DOL), Employee Definition, Employer Liability Issues, Fair Labor Standards Act (FLSA)

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A Wait Until the Deal Closes: The Antitrust Agencies Send a Strong Message About the Dangers of Gun-Jumping

One of the most common questions clients have after a merger or acquisition has been signed is, “When can we start on combining the operations and doing business?” And one of the most challenging pieces of counseling is to help…more

Acquisitions, Antitrust Division, Antitrust Violations, Competition, Department of Justice (DOJ)

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Catching Judge Sontchi’s “Flurry of Opinions” PARTS 2-3 OF 3

In This Issue: - In re: Energy Future Holdings Corp., et al, 14-10979 (CSS) (CSC Trust Company of Delaware, as Indenture Trustee, v. Energy Future Intermediate Holdings Company LLC and EFIH Finance, Inc., Adv. Pro No:…more

Chapter 11, Commercial Bankruptcy, Debt, Debtors, Indenture Trustee

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Reopening Hospital Service Lines: A Playbook for Moving Forward

The COVID-19 pandemic has created severe financial and operational difficulties for hospitals. Rapidly responding to a novel pathogen within a declared Public Health Emergency (PHE), while experiencing decreased revenues as a…more

Coronavirus/COVID-19, Employer Liability Issues, Employer Responsibilities, Re-Opening Guidelines, Return-to-Work Agreements

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Courts Split on How to Determine Statutory Damages for Copyright Infringement

The recent decision in Energy Intelligence Group, Inc. v. CHS McPherson Refinery, Inc. highlights a circuit split regarding how courts determine the statutory damages available for copyright infringement where multiple…more

Copyright, Copyright Infringement, Copyright Litigation, Intellectual Property Protection, Loss in Economic Value

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Health Care Reimbursement and Payor Dispute Update Special Edition - Year End Regulatory Review

The end of 2021 brings positive indications of the continued acceptance of telehealth as an important clinical care approach post public health emergency (“PHE”). The Centers for Medicare and Medicaid Services (“CMS”), like…more

Ambulatory Surgery Centers, Centers for Medicare & Medicaid Services (CMS), Drug Pricing, Health Care Providers, Health Insurance

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Alabama To Offer State Tax Credit for Federal 4% LIHTC Projects

As affordable housing has continued to be a topic of concern across the United States, states are evaluating ways to spur and support affordable housing development. In response to affordable housing needs, Alabama became the…more

Affordable Housing, Alabama, Community Development, Construction Project, Critical Infrastructure Sectors

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Will the Red Wave Crash Down on the Estate Tax Sunset?

Prior to November 5th, most pundits on both sides of the aisle did not forecast Republicans gaining control of both the Senate and House of Representatives. With Donald Trump being elected to a second term, we now have a “red…more

Estate Planning, Estate Tax, Gift Tax, Tax Cuts and Jobs Act, Tax Liability

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California Privacy Rights Act: Latest Update, Impact and Next Steps

The California Privacy Rights Act (CPRA) is a ballot initiative that, if passed in November, will significantly amend the California Consumer Privacy Act (CCPA)…more

B2B Transactions, Ballot Measures, Behavioral Advertising, California Consumer Privacy Act (CCPA), California Privacy Rights Act (CPRA)

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Stark Law: What Providers Should Know About New CMS Form

The Centers for Medicare and Medicaid Services (CMS) has finalized Form CMS-10328 (the SRDP Form), a new OMB-approved information collection instrument that must be used by providers and suppliers utilizing the Stark Law…more

Affordable Care Act, Centers for Medicare & Medicaid Services (CMS), False Claims Act (FCA), Health Care Providers, OIG

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The NLRB Overturns Another Longstanding Rule Involving Employers Expressing Views on Unionization to a “Captive Audience”

On November 13, 2024, the National Labor Relations Board (“NLRB”) issued a sharply divided decision in Amazon.com Services LLC, overruling yet another decades-old rule and holding that captive-‍audience meetings violate national…more

Collective Bargaining, Employee Rights, Employer Liability Issues, Labor Regulations, Labor Relations

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Lance Armstrong Becomes Cautionary Tale on Risks of Arbitration

Arbitration is sometimes touted as less expensive and less risky for businesses than traditional courtroom litigation, especially when it comes to consumer disputes. But disgraced cyclist Lance Armstrong's most recent legal loss…more

Arbitration, Lance Armstrong

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Health Care Fraud and Abuse 2023 Year in Review

Introduction - Polsinelli proudly introduces the Health Care Fraud and Abuse 2023 Year in Review, a comprehensive examination of the evolving landscape surrounding the False Claims Act (“FCA”) and fraud & abuse enforcement…more

Anti-Kickback Statute, Department of Justice (DOJ), Enforcement Actions, False Claims Act (FCA), Fraud and Abuse

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Uncle Sam Wants to Protect Blockchain Technology

On August 27, 2020, the head of the U.S. Department of Justice’s Antitrust Division (“DOJ”), Makan Delrahim, spoke at the Thirteenth Annual Conference on Innovation Economics and emphasized that one of the DOJ’s top priorities…more

Anti-Competitive, Antitrust Division, Antitrust Provisions, Blockchain, Critical Infrastructure Sectors

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Drug Pricing and Payment Executive Order Shows Trump Administration’s Cards

On April 15, 2025, President Trump signed the Lowering Drug Prices by Once Again Putting Americans First Executive Order (Executive Order). The Executive Order revives and expands several pharmaceutical pricing and payment…more

Drug Pricing, Executive Orders, Hospitals, Inflation Reduction Act (IRA), Medicaid

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Federal Agencies Release a Final Rule Implementing the No Surprises Act’s Independent Dispute Resolution Process

On August 19, 2022, three federal agencies tasked with adopting regulations for the No Surprises Act (“NSA”) issued a highly anticipated Final Rule implementing key aspects of the NSA’s independent dispute resolution (“IDR”)…more

Biden Administration, Billing, Dispute Resolution, Final Rules, Health Care Providers

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Health Care “Prime” The Shaping of Health Care in America Through M+A and Innovation

This is a notable period for the modern health care industry in America. The health care ecosystem is evolving at an accelerating pace. How health care is owned, organized, delivered and paid for in the future will be different…more

Acquisitions, Analytics, Health Care Providers, Health Insurance, Healthcare Reform

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Federal Circuit Delays Sandoz Biosimilar Launch

In a closely-watched case between Amgen and Sandoz regarding the first biosimilar approved (Zarxio), the Federal Circuit interpreted key Biologics Price Competition and Innovation Act (BPCIA) provisions regarding Sandoz's…more

Amgen, Biologics, Biologics Price Competition and Innovation Act of 2009, Biosimilars, BPCIA

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Technology Transactions & Data Privacy - 2025 Report

It is hard to believe that we are starting the 25th year of the 21st century. The rapid evolution that technology, privacy and data security have undergone these last 25 years is mindbending. Yet, as we enter 2025, it still…more

Class Action, Class Certification, Consumer Privacy Rights, Consumer Protection Laws, Critical Infrastructure Sectors

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Securities and Exchange Commission Modernizes Disclosure Requirements For Financial Institutions

On September 11, 2020, the Securities and Exchange Commission (the “SEC”) adopted final rules applicable to banks, bank holding companies, savings and loan associations and savings and loan holding companies that will, among…more

Corporate Governance, Disclosure Requirements, Financial Institutions, Financial Statements, GAAP

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Illinois Announces Extension of Stay at Home Order and Phased Reopening of State, Including Authorizing Health Care Facilities to Resume Elective Procedures

On April 23, 2020, Illinois Governor JB Pritzker announced during his daily press conference that he would issue an executive order next week extending Illinois’ stay at home order through May 30, 2020…more

Coronavirus/COVID-19, Critical Infrastructure Sectors, Executive Orders, Personal Protective Equipment, Shelter-In-Place

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Missouri Protects Health Care Providers from Civil Actions Relating to COVID-19 Exposure

On July 7, 2021, Missouri Governor Mike Parson signed SB 51 into law, which protects health care providers from being held liable in civil actions for COVID-19 exposure (the “Act”)…more

Civil Liability, Coronavirus/COVID-19, Health Care Providers, Immunity, Infectious Diseases

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SEC Division of Examinations Announces 2022 Examination Priorities

Each year, the U.S. Securities and Exchange Commission’s (SEC) Division of Examinations (Division) prioritizes the examination of certain practices, products and services that it believes present potentially heightened risks to…more

Anti-Money Laundering, Capital Formation, Capital Markets, Investor Protection, Regulatory Agenda

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Here We Grow Again: Discover the legal issues fast-growing businesses confront.

Fast-growing businesses often encounter unique and accelerated business-related issues, such as a shortage of capital and human resources, due to their rapid expansion. Proactively dealing with the legal ramifications of these…more

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Health Care Reimbursement and Payor Dispute Update - September 2022

Co-Location and the Provider-Based Rules – No News is…Good News? On July 15, the Centers for Medicare & Medicaid Services ("CMS") released the 2023 Outpatient Prospective Payment System proposed rule (“OPPS Proposed Rule”),…more

Centers for Medicare & Medicaid Services (CMS), Critical Access Hospitals, Health Care Providers, Health Insurance, Healthcare

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Federal Reserve Announces New Details for Term Asset-Backed Securities Loan Facility (TALF)

On March 23 the Federal Reserve announced the creation of the Term Asset-Backed Securities Loan Facility, or TALF to support the asset-backed securities (ABS) market.  The new facility (commonly referred to in the market as TALF…more

Asset-Backed Securities, CMBS, Collateral, Collateralized Loan Obligations, Federal Reserve

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Technology Transactions & Data Privacy - 2025 Report

It is hard to believe that we are starting the 25th year of the 21st century. The rapid evolution that technology, privacy and data security have undergone these last 25 years is mindbending. Yet, as we enter 2025, it still…more

Class Action, Class Certification, Consumer Privacy Rights, Consumer Protection Laws, Critical Infrastructure Sectors

See all updates »

The Corporate Transparency Act and Pandora’s Papers

With the recent release of the “Pandora Papers,” renewed attention is focused on corporate ownership transparency. Earlier this year, Congress passed the Corporate Transparency Act (“CTA”). The CTA was enacted to combat the use…more

Corporate Transparency Act, Financial Fraud, FinCEN, International Consortium of Investigative Journalists (ICIJ), Money Laundering

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Congress Clears Major Agreement to Avert Debt Default

Deal Includes Significant New Regulatory Provisions - Days ahead of the Treasury Department’s projected default date, the U.S. House and Senate cleared a bipartisan package to raise the debt ceiling, extend the country’s…more

Biden Administration, Debt Ceiling, Federal Budget, Global Market, Government Shutdown

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AI for GCs: What You Need to Know in 2025

During the course of 2024, interest in generative and other types of artificial intelligence, machine learning and predictive applications and services (collectively, AI) accelerated across industries. Some sectors, such as…more

Artificial Intelligence, Compliance, Contract Terms, Corporate Counsel, Corporate Governance

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Technology Transactions & Data Privacy - 2025 Report

It is hard to believe that we are starting the 25th year of the 21st century. The rapid evolution that technology, privacy and data security have undergone these last 25 years is mindbending. Yet, as we enter 2025, it still…more

Class Action, Class Certification, Consumer Privacy Rights, Consumer Protection Laws, Critical Infrastructure Sectors

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Relax Jack...It’s Only a Joke!

Jack Daniel’s Properties, Inc. v. VIP Products LLC. (Docket 22-148) On March 22, 2023, VIP Products LLC told the Supreme Court that its parody Bad Spaniels whiskey-bottle-shaped dog toys do not violate the Lanham Act…more

First Amendment, Free Speech, Intellectual Property Protection, Jack Daniels Properties Inc v VIP Products LLC, Lanham Act

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SEC Adopts Cybersecurity Incident and Risk Management Disclosure Rules

On July 26, 2023, the Securities and Exchange Commission (the “SEC”) adopted new rules requiring public companies to disclose within four business days material cybersecurity incidents they experience and to disclose annually…more

Cyber Attacks, Cybersecurity, Data Breach, Data Protection, Data Security

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The Strategic Role of Systematic Health Care M+A in Remaking the Future of Health Care

This white paper analyzes the interplay of those middle market health care business mergers and acquisitions with the four-part, patient-care-centric conceptual framework of ownership, organization, payment and delivery that we…more

Acquisition Agreements, Business Model, Corporate Sales Transactions, Due Diligence, Health Care Providers

See all updates »

Harvard’s Tax-Exempt Status Dispute with the Trump Administration: Implications for Nonprofits

On April 16, 2025, President Donald Trump signaled a desire for Harvard University (Harvard or the University) to lose its tax-exempt status after the University refused several demands in the Trump Administration’s letter to…more

501(c)(3), Educational Institutions, Federal Funding, First Amendment, Harvard University

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APEX – An Alternative Patent Resolution Procedure on Amazon

APEX – Amazon’s Solution to Patent Dispute Resolution - With the traffic Amazon generates, the e-commerce giant has become an essential, and perhaps even mandatory, marketplace for many companies to sell their products…more

Amazon, Dispute Resolution, Intellectual Property Protection, Patent Infringement, Patent Litigation

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California Court of Appeal Invalidates Headless PAGA Actions

In a decision with significant impact for employers defending Private Attorney General Act (PAGA) cases, a California 2nd District Court of Appeal panel ruled on December 30, 2024, that plaintiffs cannot circumvent arbitration…more

Appeals, Appellate Courts, Arbitration, California, Employee Rights

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Utah Passes Innovative DAO Legislation

On March 1, 2023, the Utah Legislature passed HB 357, the “Utah Decentralized Autonomous Organizations” Act (the “Utah DAO Act”). This was a combined effort of the Utah Legislature’s Blockchain and Digital Innovation Task Force,…more

Blockchain, Business Formation, Decentralized Autonomous Organization (DAO), Digital Assets, Innovative Technology

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Health Care Fraud and Abuse 2023 Year in Review

Introduction - Polsinelli proudly introduces the Health Care Fraud and Abuse 2023 Year in Review, a comprehensive examination of the evolving landscape surrounding the False Claims Act (“FCA”) and fraud & abuse enforcement…more

Anti-Kickback Statute, Department of Justice (DOJ), Enforcement Actions, False Claims Act (FCA), Fraud and Abuse

See all updates »

Proposed Regulatory Changes to Safe Harbor Warning Provisions

All consumer products and food products sold or distributed into the State of California may soon be subject to new scrutiny for chemical exposure warnings Revisions to a critical environmental law regarding warnings for…more

OEHHA, Product Labels, Proposition 65, Regulatory Agenda, Safe Harbors

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Judge Connolly (D. Del.) Overturns $96 Million Molecular Diagnostics Jury Verdict, Finds Patents Invalid Under § 112

Synopsis: In a case with implications for the litigious molecular diagnostics space and written description law, Chief Judge Connolly of the District of Delaware reversed a $96 million jury verdict in favor of Natera, Inc…more

Biotechnology, Intellectual Property Litigation, Intellectual Property Protection, Life Sciences, Patent Infringement

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SEC Adopts Amendments to MD&A and Other Financial Disclosure Requirements in Regulation S-K

On November 19, 2020, the Securities and Exchange Commission (the “SEC”) adopted final rule amendments to modernize, simplify, and enhance Management’s Discussion & Analysis of Financial Condition and Results of Operations…more

Corporate Governance, Disclosure Requirements, Financial Regulatory Reform, Financial Statements, MD&A Statements

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Federal District Court Rules Qui Tam Whistleblower Enforcement of False Claims Act Unconstitutional

On September 30, 2024, Judge Mizelle, a federal judge in the Middle District of Florida, ruled that the False Claims Act’s (“FCA”) qui tam enforcement provision is unconstitutional, a ruling that, if followed by other courts,…more

Article II, Constitutional Challenges, False Claims Act (FCA), Qui Tam, Relators

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Judge Connolly (D. Del.) Overturns $96 Million Molecular Diagnostics Jury Verdict, Finds Patents Invalid Under § 112

Synopsis: In a case with implications for the litigious molecular diagnostics space and written description law, Chief Judge Connolly of the District of Delaware reversed a $96 million jury verdict in favor of Natera, Inc…more

Biotechnology, Intellectual Property Litigation, Intellectual Property Protection, Life Sciences, Patent Infringement

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Med-Staff Newsletter - October 2023 | VOL 12

Do the Right Thing — Reporting Voluntary Actions Taken While “Under Investigation” to the NPDB - Many health care entities struggle with the dilemma of whether and when to make reports to the National Practitioner Data Bank…more

Health Care Providers, Healthcare, Healthcare Reform, Healthcare Workers, Investigations

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SEC Proposes Changes to Modernize and Simplify Equity Compensation Rules and Registration Obligations

On November 24, 2020, the Securities and Exchange Commission (“SEC”) proposed amendments to Rule 701 and Form S-8 (the “Proposals”) under the Securities Act of 1933, as amended (the “Securities Act”)…more

Disclosure Requirements, Form S-8, Publicly-Traded Companies, Rule 701, Securities and Exchange Commission (SEC)

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APEX – An Alternative Patent Resolution Procedure on Amazon

APEX – Amazon’s Solution to Patent Dispute Resolution - With the traffic Amazon generates, the e-commerce giant has become an essential, and perhaps even mandatory, marketplace for many companies to sell their products…more

Amazon, Dispute Resolution, Intellectual Property Protection, Patent Infringement, Patent Litigation

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Illinois Rolls Out a 5-Phase Reopening Plan as Health Care Facilities Prepare to Resume Elective Surgeries

On May 5, 2020, Illinois Governor J.B. Pritzker unveiled “Restore Illinois,” a 5-phase public health plan to reopen Illinois. The plan endeavors to best support Illinoisans’ health and health care systems and save the most…more

Coronavirus/COVID-19, Critical Infrastructure Sectors, Health Care Providers, Healthcare Facilities, Re-Opening Guidelines

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California Pay Data Reporting Update

As we previously reported, on September 27, 2022, Governor Gavin Newsom approved SB 1162 to significantly expand the pay data reporting and pay scale requirements for California employers. These requirements became effective…more

California, Employer Liability Issues, Labor Reform, New Legislation, Pay Data

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Prop 15 is Ready to Rock Commercial Properties with the Split-Roll

On November 3, 2020, California voters will decide on Proposition 15, the citizen-initiated proposition that seeks to create a split-roll tax system in California. Also known as “The California Schools and Local Communities…more

Ballot Measures, Property Owners, Property Tax, Property Valuation, Real Estate Market

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What Honda's CCPA Penalty Means for Your Privacy Compliance

The California Privacy Protection Agency (CPPA) has reached a settlement with American Honda Motor Co., Inc. (Honda), as outlined in this Order of Decision. The Order is the CPPA’s first public enforcement action involving a…more

Automotive Industry, California Consumer Privacy Act (CCPA), California Privacy Protection Agency (CPPA), Compliance, Consumer Data Requests

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USPTO Announces New Artificial Intelligence Strategy

Synopsis: On January 14, 2025, the USPTO unveiled a new Artificial Intelligence (AI) Strategy, which outlines responsible implementation of AI within the agency and more generally across the intellectual property (IP) landscape…more

Artificial Intelligence, Collaboration, Compliance, Innovative Technology, Intellectual Property Protection

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Filling the Void: Colorado Advances Wetlands Rules That Will Have Major Impacts on Development

Colorado authorities recently published proposed regulations that will have major implications for construction and development projects that impact state waters. The regulations establish a permitting system for projects that…more

Clean Water Act, Construction Project, Jurisdiction, Proposed Regulation, Real Estate Development

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The EU AI Act is Here, and the Clock is Ticking!

The EU AI Act is here, folks! Now that the Act has been officially published in the OJEU, it will go into force in 7 days on August 2, 2024. Now is the time to set your timers to align with the compliance calendar…more

Artificial Intelligence, Compliance, EU, European Commission, General Data Protection Regulation (GDPR)

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ESOP Transactions and the Duty to Monitor Revisited

Key Takeaways: Board’s Duty to Monitor the Trustee: A company’s board of directors has a fiduciary duty to monitor the ESOP trustee’s actions in an ESOP transaction, ensuring that the trustee is acting in the exclusive…more

Board of Directors, Compliance, Corporate Governance, Employee Benefits, ESOP

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Are You Ready for the New Telemarketing Lead Generation Rules?

In December 2023, the Federal Communications Commission (“FCC”) adopted new rules in an effort to close the “lead generator loophole” it believed existed with respect to consumer consent to receive telemarketing calls and texts…more

Auto-Dialed Calls, FCC, Prior Express Consent, TCPA, Telecommunications

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Kansas Insurance Department Issues Data Call to All Third Party Administrators Licensed in Kansas

The Kansas Insurance Department (“Department”) recently issued a Data Call to all Third Party Administrators (“TPAs”) licensed in the state of Kansas. Pursuant to the Data Call, the Department has requested information regarding…more

Compliance, Data Collection, Department of Insurance, Employee Retirement Income Security Act (ERISA), Health Insurance

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California Reintroduces Legislation to Restrict Private Equity Management of Health Care Providers

The California legislature has introduced a bill that would implement some of the same restrictions on private equity health care investments as last year’s AB 3129…more

California, Corporate Practice of Dentistry, Corporate Practice of Medicine, Dentists, Health Care Providers

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HHS Finalizes Appeals Backlog Rule in Wake of Judicial Order

The U.S. Department of Health and Human Services (HHS) released a Final Rule aimed at reducing and eventually eliminating the backlog of more than 650,000 claims currently awaiting adjudication by an administrative law judge…more

Adjudicatory Process, Administrative Law Judge (ALJ), Amount in Controversy, Centers for Medicare & Medicaid Services (CMS), Decision-Making Process

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Employee Retention Tax Credits Update: IRS Warns Taxpayers to Beware

On October 19, 2022, the Internal Revenue Service (“Service”) issued news release IR-2022-183, which was intended to warn employers using third-party promoters of Employee Retention Tax Credits (“ERTCs”).  ERTCs were created by…more

CARES Act, Coronavirus/COVID-19, Corporate Counsel, Employee Retention, Internal Revenue Code (IRC)

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Med-Staff Newsletter - February 2023 | VOL 11

Structure of AMCs - While every AMC is unique, there are some common characteristics that many share: (1) the hospital and school are often tethered together from an organizational, governance and/or legal perspective; (2)…more

Accreditation, Coronavirus/COVID-19, Credentialing, Health Care Providers, Healthcare

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OFCCP Publishes Notice of New FOIA Request for Certain EEO-1 Reports and Calls for Government Contractor Objections by December 9, 2024

On October 29, 2024, the Office of Contract Compliance Programs (“OFCCP”) published a notice in the Federal Register about a request for Type 2 Consolidated EEO-1 Reports (the “Consolidated Reports”) for 2021. (The request is…more

EEO-1, Equal Employment Opportunity Commission (EEOC), Federal Contractors, FOIA, OFCCP

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ACGME is Instituting New Mandatory Medical, Parental and Caregiver Leave Requirements for Residency and Fellowship Programs: Are You Ready?

Organizations overseeing physician training (like ABMS and ACGME) have recently demonstrated a renewed commitment to supporting physicians’ holistic development by adopting new mandatory leave requirements for…more

Employee Training, Forced Leave of Absences, Healthcare, Physicians, Policies and Procedures

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The Approaching School Year Brings Renewed Focus on Workplace Policies

While elected-officials determine the feasibility of reopening America’s classrooms and workplaces, there is little certainty as to what life will look like in the fall for employers and employees alike. Will students be in…more

Coronavirus/COVID-19, Employer Liability Issues, Employer Responsibilities, Families First Coronavirus Response Act (FFCRA), Re-Opening Guidelines

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Third Party Administrator Update - TPA Licensing and Compliance: Vermont Issues Proposed Regulation Adopting DECEMBER 2020 Licensing and Regulatory Requirements for TPAs

In the fall of 2019, we reported that Vermont enacted Senate Bill 41, which granted the Commissioner of the Vermont Department of Financial Regulation (the “Department”) jurisdiction over entities that administer one or more…more

Employee Benefits, Flexible Spending Accounts, Health Insurance, Health Savings Accounts, TPAs

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Catching Up With the Times: CMS Reforms Long-Term Care Facility Requirements - Part I

On Oct. 4, CMS published the biggest overhaul to federal long-term care regulations since 1991. The lengthy Final Rule reforms the requirements for long-term care facilities participating in Medicare and Medicaid. CMS…more

Arbitration, Arbitration Agreements, Binding Arbitration, Centers for Medicare & Medicaid Services (CMS), Contract Terms

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Delaware Court of Chancery Establishes Duty of Oversight Extends to Officers

In a significant and far-reaching development in Delaware corporate law, the Delaware Court of Chancery recently held in In re McDonald’s Corporation Stockholder Derivative Litigation, C.A. No. 2021-0324-JTL (Del. Ch. Jan. 25,…more

Board of Directors, Breach of Duty, Caremark claim, Corporate Culture, Corporate Officers

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With Prejudice: Judge Dismisses FCA Claim and Orders Sanctions Against Attorney

On October 16, 2014, United States Magistrate Judge Jeremiah McCarthy of the Western District of New York issued a Report and Recommendation to District Judge William Skretny in which he recommended dismissal with prejudice as a…more

Attorney Misconduct, False Claims Act (FCA), Rule 11, Sanctions, Whistleblowers

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Rhode Island State LIHTC: Another Step Towards Affordable Housing

Rhode Island joins 26 other states in offering state low-income housing tax credits to bridge the growing affordable housing gap in the United States. Rhode Island Governor Daniel McKee recently signed the FY24 RI Ready…more

Affordable Housing, Community Development, Construction Project, Financing, LIHTC

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Blockchain+ Bi-Weekly; Highlights of the Last Two Weeks in Web3 Law: April 10, 2025

The past two weeks have been relatively quiet, with stablecoins being the most prominent focus on the regulatory front. Stablecoin legislation now appears likely this year, with a bill to regulate stablecoins advancing out of…more

Cryptocurrency, Digital Assets, Financial Regulatory Reform, New Legislation, Proposed Legislation

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Med-Staff Newsletter - August 2022 | VOL 10

Whether you are new to medical staff leadership or have served in the past and have been called to serve again, there are times when you will need to consult a lawyer who specializes in medical staff matters. While there is…more

Abortion, ADEA, Coronavirus/COVID-19, Dobbs v. Jackson Women’s Health Organization, Employer Liability Issues

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Swing and a Miss: the Government Strikes Out in Pharmacy Executive Kickback Trial

Last week, the government submitted its decision to the federal court not to retry partially-acquitted pharmacy executive, Chad Beene, for conspiracy and illegal kickback allegations. At the end of last year, a New Jersey jury…more

Anti-Kickback Statute, Criminal Prosecution, Department of Justice (DOJ), Enforcement Actions, False Claims Act (FCA)

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2024 Recap of Franchise Developments and 2025 Trends to Watch

There were a number of important and potentially impactful developments in 2024 that we predict will continuing developing and trending in 2025. Some of these topics are also discussed in other articles in this annual update…more

Disclosure Requirements, Enforcement Actions, Federal Trade Commission (FTC), Franchise Agreements, Franchises

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“No Concrete Harm, No Standing” – Supreme Court Finds Class Members Who Were Not Personally Harmed by Statutory Violations Lack Article III Standing

On June 25, 2021, the Supreme Court issued a landmark decision in TransUnion v. Ramirez. The Court ruled that class members whose inaccurate credit reports were not shared with third parties lacked standing to sue TransUnion for…more

Article III, Class Action, Class Members, Credit Reporting Agencies, Credit Reports

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Harvard’s Tax-Exempt Status Dispute with the Trump Administration: Implications for Nonprofits

On April 16, 2025, President Donald Trump signaled a desire for Harvard University (Harvard or the University) to lose its tax-exempt status after the University refused several demands in the Trump Administration’s letter to…more

501(c)(3), Educational Institutions, Federal Funding, First Amendment, Harvard University

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10 Steps to Better Managing Mass Tort Litigation

From the now decades old asbestos litigation to pharmaceuticals and product liability cases to the newly developing PFAS or “forever chemical” lawsuits, mass tort litigation has increasingly become the tool of choice by which…more

Access to Legal Counsel, Class Action, Client Services, Commercial Litigation, Corporate Liability

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Technology Transactions & Data Privacy - 2025 Report

It is hard to believe that we are starting the 25th year of the 21st century. The rapid evolution that technology, privacy and data security have undergone these last 25 years is mindbending. Yet, as we enter 2025, it still…more

Class Action, Class Certification, Consumer Privacy Rights, Consumer Protection Laws, Critical Infrastructure Sectors

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Strategic Growth: Is a Merger of Equals Right for Your Organization?

In today’s complex regulatory and business environment, many community banks are considering either growing through acquisition or selling to a larger institution. As an alternative to these transactions, we are seeing an…more

Banks, C-Corporation, IRS, Mergers, S-Corporation

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Will a New Wave of Lawsuits Roll Into a Nationwide Tsunami? Wiretapping Litigation for Website Analytics

2022 has seen a new wave of class action lawsuits targeting companies that use technology to track consumers’ interfaces on their websites. These lawsuits generally allege that the use of technologies such as session replay…more

Bots, Data Collection, Data Privacy, Electronic Communications, Electronic Monitoring

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Technology Transactions & Data Privacy - 2025 Report

It is hard to believe that we are starting the 25th year of the 21st century. The rapid evolution that technology, privacy and data security have undergone these last 25 years is mindbending. Yet, as we enter 2025, it still…more

Class Action, Class Certification, Consumer Privacy Rights, Consumer Protection Laws, Critical Infrastructure Sectors

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Court Rules that the FTC Rule Banning Non-Competition Clauses in Employment Agreements is Unlawful and Order Has “Nationwide Effect”: Impact on Franchisors

On August 20, 2024, the Northern District of Texas in the case of Ryan, LLC v. Federal Trade Commission granted summary judgment to the Plaintiff Ryan, LLC, enjoining the FTC from implementing its rule banning non-compete…more

Competition, Confidential Information, Employer Liability Issues, Employment Contract, Federal Trade Commission (FTC)

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Med-Staff Newsletter - February 2023 | VOL 11

Structure of AMCs - While every AMC is unique, there are some common characteristics that many share: (1) the hospital and school are often tethered together from an organizational, governance and/or legal perspective; (2)…more

Accreditation, Coronavirus/COVID-19, Credentialing, Health Care Providers, Healthcare