Mintz - Health Care Viewpoints

Health Care Enforcement Trends & 2025 Outlook

In our annual report, we examine health care enforcement trends, predict how health care enforcement may evolve, and offer practical guidance about what these trends and predictions mean for health care providers, payors, and…more

Compliance, Department of Justice (DOJ), Enforcement Actions, False Claims Act (FCA), Health Care Providers

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Mintz IRA Update — Fourth Edition: Q1 2025

Mintz’s Pharmacy Benefits and PBM Contracting Practice is pleased to present the ‘Fourth Edition: Q1 2025’ of our Mintz IRA Update, a regular publication that delves into developments of the Inflation Reduction Act of 2022 (IRA)…more

Drug Pricing, Inflation Reduction Act (IRA), Medicare, Medicare Part D, Pharmaceutical Industry

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PBM Policy and Legislative Update — Winter 2025

The PBM regulatory landscape is rapidly evolving at both federal and state levels, making it critical for our clients involved in the PBM space to stay apprised of developments in the industry as they happen. Our team actively…more

Compliance, Federal Trade Commission (FTC), Final Rules, Health Insurance, Healthcare

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ML Strategies Alert - FY2018 Massachusetts Budget Update: House Ways and Means Budget

On Monday, April 10th, the House Ways and Means Committee proposed a $40.3 billion budget for FY2018 that calls for increasing spending by 3.8 percent, or about $1.47 billion, above FY2017 levels. The spending increase is less…more

Economic Development, Educational Institutions, Employee Benefits, Energy Sector, Environmental Policies

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Health Care Enforcement Trends & 2025 Outlook

In our annual report, we examine health care enforcement trends, predict how health care enforcement may evolve, and offer practical guidance about what these trends and predictions mean for health care providers, payors, and…more

Compliance, Department of Justice (DOJ), Enforcement Actions, False Claims Act (FCA), Health Care Providers

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Massachusetts HPC Health Care Cost Trends Hearing: Key Takeaways

The Massachusetts Health Policy Commission (“HPC”) held its annual Health Care Cost Trends Hearing on October 16-17, 2018. The hearing covered a wide range of topics affecting the health care industry here in the Commonwealth…more

Electronic Medical Records, Health Care Providers, Health Insurance, Healthcare, Healthcare Costs

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Trump Administration Withdraws Proposed Rebate Rule

In an unexpected turn of events, the Trump administration has apparently reversed course and has withdrawn the proposed rule that would have amended the discount safe harbor under the Anti-Kickback Statute to eliminate…more

Anti-Kickback Statute, Drug Pricing, Executive Orders, Medicaid, Medicare

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Charting the Future of Premium Subsidies under the Affordable Care Act: Halbig v. Burwell and King v. Burwell

On July 22, 2014, two federal appellate courts issued conflicting decisions, within hours of each other, regarding the IRS final rule published on May 23, 2012 (the “IRS Rule”), intended to implement the exchange-related tax…more

Affordable Care Act, Halbig v Burwell, Healthcare, IRS, King v Burwell

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OCR Proposes Sweeping HIPAA Security Rule Amendments

Last fall at the Safeguarding Health Information: Building Assurance Through HIPAA Security 2024 conference, U.S. Department of Health & Human Services Office for Civil Rights (OCR) promised that before year’s end, it would…more

Compliance, Data Breach, Electronic Protected Health Information (ePHI), Food and Drug Administration (FDA), Hackers

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First Circuit Adopts “But-For” Causation Standard for False Claims Act Cases Based on Anti-Kickback Statute Violations

In United States v. Regeneron Pharmaceuticals, Inc., the First Circuit joined the emerging majority view that False Claims Act (FCA) claims based on violations of the Anti-Kickback Statute (AKS) require a showing of “but-for”…more

Anti-Kickback Statute, Causation, Compliance, Department of Justice (DOJ), Enforcement Actions

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Arkansas Law Takes Unprecedented Step to Prohibit PBM Ownership of Pharmacies

On April 16, 2025, Arkansas Governor Sarah Huckabee Sanders signed into law House Bill 1150, now Act 624 (the Act), making Arkansas the first state in the nation to prohibit pharmacy benefit managers (PBMs) from acquiring or…more

Acquisitions, Anti-Competitive, Competition, Drug Pricing, Healthcare

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CMS’s ACA Marketplace Integrity and Affordability Proposed Rule – What it may mean for Health Plans

Earlier this month, the Centers for Medicare & Medicaid Services (CMS) released its 2025 Marketplace Integrity and Affordability Proposed Rule (Proposed Rule), proposing a number of enrollment and eligibility policies impacting…more

Affordable Care Act, Biden Administration, Centers for Medicare & Medicaid Services (CMS), DACA, Department of Health and Human Services (HHS)

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Congress and the White House Continue Efforts to Respond to Coronavirus

The response to the coronavirus situation is fluid and fast-moving – particularly by Congress’ standards. In response to the coronavirus pandemic, the following legislation has been considered in Congress: Phase I: …more

Appropriation Act, Coronavirus/COVID-19, Families First Coronavirus Response Act (FFCRA), Financial Stimulus

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Mintz IRA Update — A Circuit Win and the End of Chevron Deference Could Shift Tides in Drug Price Negotiation Program Challenges

As detailed in our previous updates, the IRA’s Medicare Drug Price Negotiation Program (the Negotiation Program or Program), which enables the federal government to negotiate prices for some of the costliest Medicare Part D…more

Administrative Procedure Act, Centers for Medicare & Medicaid Services (CMS), Chevron Deference, Constitutional Challenges, Loper Bright Enterprises v Raimondo

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Health Law Diagnosed – Health Care Transaction Review Laws and the New Normal

In the latest episode of Health Law Diagnosed, host Bridgette Keller discusses the evolving legislative and regulatory landscape impacting health care transactions, particularly for private equities and hedge funds..…more

Acquisitions, Antitrust Provisions, California, Healthcare, Mergers

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Health Care Privacy and Security In 2024: Six Critical Topics to Watch

As we reflect on the flurry of activity in the health care data privacy and security space in 2023 and look ahead to what will continue to be a busy 2024, we are seeing the early stages of federal agency movement to align the…more

Artificial Intelligence, Cybersecurity, Data Breach, Data Security, Department of Health and Human Services (HHS)

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ML Strategies Alert - FY2018 Massachusetts Budget Update: House Ways and Means Budget

On Monday, April 10th, the House Ways and Means Committee proposed a $40.3 billion budget for FY2018 that calls for increasing spending by 3.8 percent, or about $1.47 billion, above FY2017 levels. The spending increase is less…more

Economic Development, Educational Institutions, Employee Benefits, Energy Sector, Environmental Policies

See all updates »

Ushering in a New Era: FDA Approves First Interchangeable Biosimilar

Has the Food and Drug Administration (FDA) finally ushered in a new era for the U.S. biosimilar marketplace? Many in the industry are hopeful after the Agency approved its first interchangeable biosimilar, Mylan’s Semglee…more

Biosimilars, Biosimilars Action Plan (BAP), Federal Trade Commission (FTC), Food and Drug Administration (FDA), Pharmaceutical Industry

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A Review of the Affordable Care Act at 10 Years, Part 4: Alternative Payment and Delivery Models

Today's post is the last in our series on the 10-year anniversary of the Affordable Care Act (ACA). While the Congress that passed the ACA recognized that health care delivery reform was necessary, the law included few…more

Affordable Care Act, Antitrust Provisions, Centers for Medicare & Medicaid Services (CMS), CMMI, Healthcare Reform

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Health Law Diagnosed – Health Care Transaction Review Laws and the New Normal

In the latest episode of Health Law Diagnosed, host Bridgette Keller discusses the evolving legislative and regulatory landscape impacting health care transactions, particularly for private equities and hedge funds..…more

Acquisitions, Antitrust Provisions, California, Healthcare, Mergers

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Garland Memo May Provide White Collar Defendants Increased Opportunity for Negotiation While Updated Corporate Enforcement Policy Highlights the Importance the Department of Justice Places on Self-Disclosure, Cooperation, and Remediation

In recent weeks, the Department of Justice has released key guidance in the form of a memorandum from Attorney General Garland regarding charging, pleas, and sentencing, in addition to an updated Corporate Enforcement Policy…more

Attorney General, Cooperation, Department of Justice (DOJ), FCPA Corporate Enforcement Policy (CEP), Mail Fraud

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CMS Issues Final Notice on Program for Breakthrough Device Reimbursement but Industry Looks to Congress for More Inclusive Solution

Obtaining Medicare coverage and reimbursement for medical devices is notoriously more difficult than for drugs or biologics, and any progress on expanding coverage pathways has been agonizingly slow for industry stakeholders. An…more

Centers for Medicare & Medicaid Services (CMS), Food and Drug Administration (FDA), MACs, Medical Devices, Medicare

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DOJ Announces it is Designing a Whistleblower Rewards Program

In early March 2024 at the American Bar Association’s 39th National Institute on White Collar Crime, Deputy Attorney General (DAG) Lisa Monaco’s keynote remarks previewed the development of new and significant Department of…more

American Bar Association (ABA), CFTC, Department of Justice (DOJ), False Claims Act (FCA), Foreign Corrupt Practices Act (FCPA)

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CMS’s 2026 Final Medicare Advantage Rule Focuses on Implementing the IRA and Deregulation

In April, CMS finalized its Contract Year (CY) 2026 Medicare Advantage and Part D Final Rule (Final Rule). With CMS releasing the 2026 Medicare Advantage and Part D Proposed Rule in December under the Biden Administration, the…more

Biden Administration, Centers for Medicare & Medicaid Services (CMS), Final Rules, Inflation Reduction Act (IRA), Medicare Advantage

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Health Law Diagnosed – New Year's Gratitude

In the latest episode of Health Law Diagnosed, host Of Counsel Bridgette Keller invites the Mintz Health Law team to reflect on what they’re grateful for as they prepare for the year ahead…more

Centers for Medicare & Medicaid Services (CMS), Health Insurance, Healthcare, Pharmacy Benefit Manager (PBM), Regulatory Requirements

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EnforceMintz — The Pandemic May Be Ending, But Fraud Prosecutions Will Keep Coming

The “epidemic” of COVID-19 related fraud continued unabated in 2022, and we expect to see the same in 2023. The Department of Justice (DOJ) appears poised to continue to aggressively investigate and prosecute COVID-19-related…more

Audits, Coronavirus/COVID-19, Department of Health and Human Services (HHS), Department of Justice (DOJ), Fraud

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Health Care Enforcement Trends & 2025 Outlook

In our annual report, we examine health care enforcement trends, predict how health care enforcement may evolve, and offer practical guidance about what these trends and predictions mean for health care providers, payors, and…more

Compliance, Department of Justice (DOJ), Enforcement Actions, False Claims Act (FCA), Health Care Providers

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FCC Seeks Big Role in Telemedicine with New Fund

$100 million in federal funds may soon become available to help health care providers cover the costs of broadband and connected care services. Earlier this month, the Federal Communications Commission (FCC) voted on a proposal,…more

Comment Period, FCC, Federal Pilot Programs, Health Care Providers, Healthcare Reform

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Health Law Diagnosed – New Year's Gratitude

In the latest episode of Health Law Diagnosed, host Of Counsel Bridgette Keller invites the Mintz Health Law team to reflect on what they’re grateful for as they prepare for the year ahead…more

Centers for Medicare & Medicaid Services (CMS), Health Insurance, Healthcare, Pharmacy Benefit Manager (PBM), Regulatory Requirements

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Seventh Circuit Adds to Circuit Split Over Standard for DOJ Dismissals in FCA Cases

The Seventh Circuit Court of Appeals recently decided a case that created a new standard to assess requests by the Department of Justice (DOJ) to dismiss declined qui tam (whistleblower) suits under the False Claims Act (FCA)…more

Collateral Order Doctrine, Department of Justice (DOJ), Dismissals, Equal Protection, False Claims Act (FCA)

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PBM Policy and Legislative Update — Winter 2025

The PBM regulatory landscape is rapidly evolving at both federal and state levels, making it critical for our clients involved in the PBM space to stay apprised of developments in the industry as they happen. Our team actively…more

Compliance, Federal Trade Commission (FTC), Final Rules, Health Insurance, Healthcare

See all updates »

Trump Administration Issues Drug Pricing Executive Order

On April 15, 2025, President Trump issued an Executive Order instructing federal agencies to implement a variety of drug pricing reforms. The Executive Order addresses drug pricing from several different angles, including…more

Department of Health and Human Services (HHS), Department of Labor (DOL), Drug Pricing, Executive Orders, Food and Drug Administration (FDA)

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Health Law Diagnosed – New Year's Gratitude

In the latest episode of Health Law Diagnosed, host Of Counsel Bridgette Keller invites the Mintz Health Law team to reflect on what they’re grateful for as they prepare for the year ahead…more

Centers for Medicare & Medicaid Services (CMS), Health Insurance, Healthcare, Pharmacy Benefit Manager (PBM), Regulatory Requirements

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White House Budget Documents Provide Additional Insights into the Trump Administration’s Priorities for HHS

Over the past few weeks, we have been closely following the Trump administration’s restructuring of the Department of Health and Human Services (HHS), the major reduction in the department’s workforce (RIF), and its broader…more

Budget Cuts, Centers for Disease Control and Prevention (CDC), Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services (HHS), Drug Pricing

See all updates »

Arkansas Law Takes Unprecedented Step to Prohibit PBM Ownership of Pharmacies

On April 16, 2025, Arkansas Governor Sarah Huckabee Sanders signed into law House Bill 1150, now Act 624 (the Act), making Arkansas the first state in the nation to prohibit pharmacy benefit managers (PBMs) from acquiring or…more

Acquisitions, Anti-Competitive, Competition, Drug Pricing, Healthcare

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Mintz IRA Update — From the Desk of ML Strategies: The Medicare Drug Price Negotiation Program Under the Second Trump Administration

The start of Donald Trump’s second presidency and Republican control in the 119th Congress raises questions about the future of the IRA’s Medicare Drug Price Negotiation Program (the Negotiation Program), which could be…more

Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services (HHS), Drug Pricing, Executive Orders, Medicare

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Health Care Enforcement Trends & 2025 Outlook

In our annual report, we examine health care enforcement trends, predict how health care enforcement may evolve, and offer practical guidance about what these trends and predictions mean for health care providers, payors, and…more

Compliance, Department of Justice (DOJ), Enforcement Actions, False Claims Act (FCA), Health Care Providers

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The AI Search Engine Doctor Is Always In: What Are the Regulatory and Legal Implications?

The information age in which we live is reaching a new milestone with the development and ready access to conversational artificial intelligence based on advanced transformer algorithms, or AI chatbots, including their upcoming…more

21st Century Cures Act, Algorithms, Artificial Intelligence, Food and Drug Administration (FDA), Medical Devices

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Health Care Enforcement Trends & 2025 Outlook

In our annual report, we examine health care enforcement trends, predict how health care enforcement may evolve, and offer practical guidance about what these trends and predictions mean for health care providers, payors, and…more

Compliance, Department of Justice (DOJ), Enforcement Actions, False Claims Act (FCA), Health Care Providers

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A First-of-its-Kind Telemedicine Criminal Prosecution: Key Takeaways

The indictment, arrest, and arraignment of Ruthia He, the founder, CEO, and clinical president of Done Global (Done), and David Brody, clinical president of Done and the sole shareholder of Done Health, P.C. (PC) in connection…more

Criminal Prosecution, DEA, Department of Justice (DOJ), Healthcare Fraud, Mental Health

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CMS’s 2026 Final Medicare Advantage Rule Focuses on Implementing the IRA and Deregulation

In April, CMS finalized its Contract Year (CY) 2026 Medicare Advantage and Part D Final Rule (Final Rule). With CMS releasing the 2026 Medicare Advantage and Part D Proposed Rule in December under the Biden Administration, the…more

Biden Administration, Centers for Medicare & Medicaid Services (CMS), Final Rules, Inflation Reduction Act (IRA), Medicare Advantage

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New York Department of Health Issues Long-Awaited FAQs for New York’s Disclosure of Material Transactions Law

The first quarter of 2025 has been eventful for New York’s Disclosure of Material Transactions Law. As discussed in our recent blog post, the proposed Fiscal Year 2026 New York State Executive Budget (FY 26 Executive Budget)…more

Acquisitions, Disclosure Requirements, Government Agencies, Health Care Providers, Healthcare Facilities

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Health Law Diagnosed – Health Care Transaction Review Laws and the New Normal

In the latest episode of Health Law Diagnosed, host Bridgette Keller discusses the evolving legislative and regulatory landscape impacting health care transactions, particularly for private equities and hedge funds..…more

Acquisitions, Antitrust Provisions, California, Healthcare, Mergers

See all updates »

Health Care Enforcement Trends & 2025 Outlook

In our annual report, we examine health care enforcement trends, predict how health care enforcement may evolve, and offer practical guidance about what these trends and predictions mean for health care providers, payors, and…more

Compliance, Department of Justice (DOJ), Enforcement Actions, False Claims Act (FCA), Health Care Providers

See all updates »

Health Law Diagnosed – New Year's Gratitude

In the latest episode of Health Law Diagnosed, host Of Counsel Bridgette Keller invites the Mintz Health Law team to reflect on what they’re grateful for as they prepare for the year ahead…more

Centers for Medicare & Medicaid Services (CMS), Health Insurance, Healthcare, Pharmacy Benefit Manager (PBM), Regulatory Requirements

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My Health, My Data! Washington State Enacts Broad Health Data Privacy Protection Law

Washington greatly expanded the protection for consumers’ identifiable health information by enacting the “My Health My Data Act” (MHMDA), in an effort to close the gap between HIPAA protections and the laws protecting the…more

Biometric Information Privacy Act, California Consumer Privacy Act (CCPA), Data Privacy, Disclosure Requirements, Employee Training

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Strategies to Unlock AI’s Potential in Healthcare Part 6: Commercialization of AI Tools in Healthcare – the Challenge of Securing Adequate Data Rights

As noted in previous posts in this series, AI tools hold great promise for applications in healthcare. To date, AI tools in healthcare primarily leverage machine learning technology – i.e., the machine’s ability to keep…more

Content Aggregators, Contract Terms, Cybersecurity, Data Collection, Data Privacy

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New York Proposes Regulatory Review and Approval of Material Health Care Entity Transactions

On February 1, 2023, New York Governor Kathy Hochul announced the Fiscal Year 2024 New York State Executive Budget (the Executive Budget). One component of the Executive Budget’s Health and Mental Hygiene Article VII Legislation…more

ACOs, Acquisitions, Anti-Competitive, Enforcement, Health Care Providers

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FCC to Award Additional $249+ Million in Funding for COVID-19 Telehealth Program

On March 29, 2021, the Federal Communications Commission (“FCC” or “Commission”) adopted an Order establishing rules and procedures for Round 2 of the COVID-19 Telehealth Program (the “Program”) to continue supporting telehealth…more

CARES Act, Consolidated Appropriations Act (CAA), Coronavirus/COVID-19, FCC, Health Care Providers

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OIG Expresses Concern about Laboratory Specimen Collection Payments to Hospitals in AO 22-09

Last week, the Office of Inspector General (OIG) for the Department of Health and Human Services (HHS) issued Advisory Opinion No. 22-09 (AO 22-09), which addresses a proposed arrangement pursuant to which the operator of a…more

Anti-Kickback Statute, Department of Health and Human Services (HHS), Department of Justice (DOJ), False Claims Act (FCA), Fraud

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Health Care Enforcement Trends & 2025 Outlook

In our annual report, we examine health care enforcement trends, predict how health care enforcement may evolve, and offer practical guidance about what these trends and predictions mean for health care providers, payors, and…more

Compliance, Department of Justice (DOJ), Enforcement Actions, False Claims Act (FCA), Health Care Providers

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Will New York Be Next to Regulate Specifically Personal Health Information to Further, and Possibly Re-Write, a New Paradigm of State-Level Health Data Regulation?

The New York legislature passed its version of Washington’s My Health My Data Act (“WA MHMDA”) on January 22, 2025. Currently awaiting action by Governor Kathy Hochul, the New York Health Information Privacy Act (“NY HIPA”)…more

Consent, Data Privacy, Enforcement, Health Insurance Portability and Accountability Act (HIPAA), Healthcare

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Protecting Health Information Post Roe – Part 2: Steps for Health Care Providers

State laws that restrict or criminalize abortions will require significant amounts of health information to enforce, putting new pressure on health care providers caught in the middle of competing obligations to their patients…more

Disclosure Requirements, Electronic Protected Health Information (ePHI), Health Care Providers, Health Insurance Portability and Accountability Act (HIPAA), HIPAA Breach

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Will New York Be Next to Regulate Specifically Personal Health Information to Further, and Possibly Re-Write, a New Paradigm of State-Level Health Data Regulation?

The New York legislature passed its version of Washington’s My Health My Data Act (“WA MHMDA”) on January 22, 2025. Currently awaiting action by Governor Kathy Hochul, the New York Health Information Privacy Act (“NY HIPA”)…more

Consent, Data Privacy, Enforcement, Health Insurance Portability and Accountability Act (HIPAA), Healthcare

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OIG Releases Semiannual Report to Congress

The Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) recently released its Semiannual Report to Congress (“Report”), summarizing OIG’s activities for the six-month period ending on March 31,…more

Department of Health and Human Services (HHS), Department of Homeland Security (DHS), Department of Justice (DOJ), False Claims Act (FCA), Healthcare

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FDA’s New Biosimilar Action Plan Represents the Next Step for Improving Drug Competition

On July 18, 2018, after months of alluding to the various aspects of an upcoming “Biosimilar Action Plan” as another prong within FDA’s broader Drug Competition Action Plan (DCAP), FDA finally unveiled its plan for stimulating…more

Anti-Competitive, Biosimilars, Competition, Drug Pricing, FDA Approval

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EnforceMintz — False Claims Act Statistical Year in Review

Health Care Cases Spur Largest FCA Recoveries - Mintz’s annual report on False Claims Act case activity analyzes data from DOJ and the firm’s Health Care Qui Tam Database, and explores the 2024 record high in FCA case…more

Coronavirus/COVID-19, Department of Justice (DOJ), Enforcement Actions, False Claims Act (FCA), Health Care Providers

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White House Budget Documents Provide Additional Insights into the Trump Administration’s Priorities for HHS

Over the past few weeks, we have been closely following the Trump administration’s restructuring of the Department of Health and Human Services (HHS), the major reduction in the department’s workforce (RIF), and its broader…more

Budget Cuts, Centers for Disease Control and Prevention (CDC), Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services (HHS), Drug Pricing

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Supreme Court Declines to Weigh in on False Claims Act Pleading Requirements

The Supreme Court recently denied petitions for writs of certiorari in three closely watched cases where parties asked the Court to clarify the heightened pleading standard governing fraud allegations under the False Claims Act…more

False Claims Act (FCA), Federal Rules of Civil Procedure, Fraud, FRCP 9(b), Petition for Writ of Certiorari

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Petition for Certiorari Filed in Supreme Court in False Claims Act Case Seeking Review of Whether “Willful” Under the Anti-Kickback Statute Requires Knowledge that the Conduct is Unlawful

The Supreme Court now has the opportunity to define “willfulness” under the federal criminal Anti-Kickback Statute (AKS). In a declined qui tam case filed against McKesson Corporation, a pharmaceutical wholesaler, the relator,…more

Anti-Kickback Statute, Corporate Misconduct, Criminal Prosecution, Dismissals, False Claims Act (FCA)

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First Circuit Adopts “But-For” Causation Standard for False Claims Act Cases Based on Anti-Kickback Statute Violations

In United States v. Regeneron Pharmaceuticals, Inc., the First Circuit joined the emerging majority view that False Claims Act (FCA) claims based on violations of the Anti-Kickback Statute (AKS) require a showing of “but-for”…more

Anti-Kickback Statute, Causation, Compliance, Department of Justice (DOJ), Enforcement Actions

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EnforceMintz — False Claims Act Statistical Year in Review

Health Care Cases Spur Largest FCA Recoveries - Mintz’s annual report on False Claims Act case activity analyzes data from DOJ and the firm’s Health Care Qui Tam Database, and explores the 2024 record high in FCA case…more

Coronavirus/COVID-19, Department of Justice (DOJ), Enforcement Actions, False Claims Act (FCA), Health Care Providers

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Congress Intensifies Tampon Safety Efforts and FDA Takes Steps to Respond

In its August 2024 issue, the journal Environmental International published an article called Tampons as a Source of Exposure to Metal(loid)s. The article reports on the results of a recent study by researchers from Columbia, UC…more

Contamination, Food and Drug Administration (FDA), PFAS, Proposed Legislation, Public Health

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Commissioner Chopra Releases Statement on Private Equity Physician Practice Roll-Ups with FTC/DOJ HSR Annual Report

On Wednesday, an FTC Commissioner used the occasion of a routine report to Congress to send a warning shot to private equity firms, especially those rolling up health care providers. Commissioner Rohit Chopra, an advisor to…more

Acquisitions, Antitrust Investigations, Competition, Department of Justice (DOJ), Federal Trade Commission (FTC)

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CMS’s 2026 Final Medicare Advantage Rule Focuses on Implementing the IRA and Deregulation

In April, CMS finalized its Contract Year (CY) 2026 Medicare Advantage and Part D Final Rule (Final Rule). With CMS releasing the 2026 Medicare Advantage and Part D Proposed Rule in December under the Biden Administration, the…more

Biden Administration, Centers for Medicare & Medicaid Services (CMS), Final Rules, Inflation Reduction Act (IRA), Medicare Advantage

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The Legal and Regulatory Landscape for Wellness Plans: The Affordable Care Act and Beyond

The Patient Protection and Affordable Care Act (the ‘‘Act’’) generally encourages employers to adopt wellness plans and programs in conjunction with their group health plans. Wellness plan vendors tout these arrangements with…more

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It’s Been a Long Time Coming: Massachusetts Health Care Market Review 2.0

The latest entrant in a national wave of policymakers enacting health care market oversight laws that have a significant impact on providers and investors, Massachusetts Governor Maura Healey has signed into law House Bill 5159,…more

Acquisitions, Compliance, Department of Justice (DOJ), False Claims Act (FCA), Health Care Providers

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Mintz Levin Health Care Qui Tam Update - Recent Developments & Unsealed False Claims Act (FCA) Cases: May 2014

Trends & Analysis: ..We have identified 58 health care–related qui tam cases that have been unsealed since our last Qui Tam Update. Of those, 33 cases were initiated after the start of 2012, with the remaining 25 cases…more

Clinical Laboratories, Diagnostic Imaging Services, Financial Conduct Authority (FCA), Healthcare, Hospitals

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Advance Regulatory Review of California Health Care Transactions by the New Office of Health Care Affordability to Begin in 2024

The health omnibus trailer SB-184, which created the Office of Health Care Affordability (OHCA), is set to usher in a significant change in California’s health care regulatory landscape. Beginning in 2024, certain health care…more

Anti-Competitive, California, Confidential Information, Health Care Providers, Healthcare

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OCR Proposes Sweeping HIPAA Security Rule Amendments

Last fall at the Safeguarding Health Information: Building Assurance Through HIPAA Security 2024 conference, U.S. Department of Health & Human Services Office for Civil Rights (OCR) promised that before year’s end, it would…more

Compliance, Data Breach, Electronic Protected Health Information (ePHI), Food and Drug Administration (FDA), Hackers

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ARPA-H Commits $100 Million to Accelerate Women’s Health Research through Sprint for Women’s Health

On February 21, 2024, the Advanced Research Projects Agency for Health (ARPA-H) announced a $100 million commitment to research and development in women’s health through Sprint for Women’s Health, a first-of-its-kind effort…more

Medical Devices, Medical Research, Women's Preventable Healthcare Mandates

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Health Law Diagnosed – Understanding the New Massachusetts Health Care Market Review Law

In the latest episode of Health Law Diagnosed, host Bridgette Keller discusses the new Massachusetts Health Care Market Review Law and what this means for health care providers, investors, and other key stakeholders. She is…more

Compliance, False Claims Act (FCA), Health Care Providers, Health Insurance, Healthcare

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PBM Policy and Legislative Update — Winter 2025

The PBM regulatory landscape is rapidly evolving at both federal and state levels, making it critical for our clients involved in the PBM space to stay apprised of developments in the industry as they happen. Our team actively…more

Compliance, Federal Trade Commission (FTC), Final Rules, Health Insurance, Healthcare

See all updates »

FCC to Award Additional $249+ Million in Funding for COVID-19 Telehealth Program

On March 29, 2021, the Federal Communications Commission (“FCC” or “Commission”) adopted an Order establishing rules and procedures for Round 2 of the COVID-19 Telehealth Program (the “Program”) to continue supporting telehealth…more

CARES Act, Consolidated Appropriations Act (CAA), Coronavirus/COVID-19, FCC, Health Care Providers

See all updates »

New York Department of Health Issues Long-Awaited FAQs for New York’s Disclosure of Material Transactions Law

The first quarter of 2025 has been eventful for New York’s Disclosure of Material Transactions Law. As discussed in our recent blog post, the proposed Fiscal Year 2026 New York State Executive Budget (FY 26 Executive Budget)…more

Acquisitions, Disclosure Requirements, Government Agencies, Health Care Providers, Healthcare Facilities

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Health Care Enforcement Year-in-Review and 2020 Outlook: Civil Fraud Enforcement Developments and Trends

As discussed in our article recently published by Law360, 2019 brought yet another year of robust health care enforcement activity, and the False Claims Act (FCA) remains the government’s most powerful civil health care…more

Department of Justice (DOJ), Dismissals, Enforcement Actions, False Claims Act (FCA), Health Care Providers

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Ebola Exclusions from Commercial Insurance Policies

Last week we wrote about a new business interruption insurance policy that is being rolled out to healthcare providers which will provide specific coverage for various ebola-related losses. This week we note that some business…more

Business Interruption, Commercial Insurance Policies, Ebola

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New California Mental Health and Addiction Treatment Laws

The COVID-19 pandemic has coincided with worsening mental health across the country, and California is no exception. Not surprisingly, Governor Gavin Newsom signed into law multiple pieces of mental health treatment related…more

California, Comprehensive Addiction and Recovery Act of 2016 (CARA), Coronavirus/COVID-19, Governor Newsom, Mental Health

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ICYMI: Biosimilars and FDA Regulatory Webinar

Our Biosimilar webinar series continued this month with Linda Bentley and Joanne Hawana’s Biosimilars FDA/Regulatory Overview presentation. Linda and Joanne discussed statutory provisions related to FDA’s authority to approve…more

Biosimilars, BPCIA, FDA Approval, Food and Drug Administration (FDA), Pharmaceutical Industry

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Trump Administration Issues Drug Pricing Executive Order

On April 15, 2025, President Trump issued an Executive Order instructing federal agencies to implement a variety of drug pricing reforms. The Executive Order addresses drug pricing from several different angles, including…more

Department of Health and Human Services (HHS), Department of Labor (DOL), Drug Pricing, Executive Orders, Food and Drug Administration (FDA)

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PBM Regulatory Roundup (Summer 2022): States Continue PBM Oversight Activities

2022 continues to see a surge in state-led PBM enforcement efforts. This roundup provides a brief summary of Louisiana’s complaint against United Healthcare and OptumRx related to its Medicaid program and recent state…more

Breach of Contract, Louisiana, Medicaid, Pharmacy Benefit Manager (PBM), Regulatory Oversight

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Arkansas Law Takes Unprecedented Step to Prohibit PBM Ownership of Pharmacies

On April 16, 2025, Arkansas Governor Sarah Huckabee Sanders signed into law House Bill 1150, now Act 624 (the Act), making Arkansas the first state in the nation to prohibit pharmacy benefit managers (PBMs) from acquiring or…more

Acquisitions, Anti-Competitive, Competition, Drug Pricing, Healthcare

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Heritage Pharmaceuticals Admits to Generic Drug Price Fixing Scheme

In the latest development in the Department of Justice (DOJ) Antitrust Division’s ongoing investigation into the generic pharmaceutical industry, Heritage Pharmaceuticals, Inc. has entered into a deferred prosecution agreement…more

Anticompetitive Behavior, Criminal Conspiracy, Criminal Convictions, Criminal Penalties, Deferred Prosecution Agreements

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Commissioner Chopra Releases Statement on Private Equity Physician Practice Roll-Ups with FTC/DOJ HSR Annual Report

On Wednesday, an FTC Commissioner used the occasion of a routine report to Congress to send a warning shot to private equity firms, especially those rolling up health care providers. Commissioner Rohit Chopra, an advisor to…more

Acquisitions, Antitrust Investigations, Competition, Department of Justice (DOJ), Federal Trade Commission (FTC)

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Pharma Distributors Trade Association Sued for Conspiracy to Exclude Competition for its Track and Trace Software

On October 23, 2017, a company that developed software to track and trace pharmaceuticals filed a complaint against a pharmaceutical distributors trade association that currently dominates the market for such software, alleging…more

Anti-Competitive, Antitrust Violations, Coercion, Contract Solicitation, Life Sciences

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Strategies to Unlock AI’s Potential in Health Care, Part 1: Common Pitfalls to Avoid When Getting a Patent

As in any area of technology, it is important to consider patent protection early in the development of an AI-related invention. However, AI and other digital health inventions raise a number of particular issues that, if not…more

Artificial Intelligence, CLS Bank v Alice Corp, Design Patent, Digital Health, Emerging Technology Companies

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Seeking FCC Flexibility on the Sale of Wireless Medical Devices During COVID-19

We’ve written previously about the role of the Federal Communications Commission (FCC) in regulating wireless medical devices, chiefly in determining the operating frequency and certain technical rules that ensure co-existence…more

Certification Requirements, Emergency Waivers, FCC, General Electric, Medical Devices

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Will New York Be Next to Regulate Specifically Personal Health Information to Further, and Possibly Re-Write, a New Paradigm of State-Level Health Data Regulation?

The New York legislature passed its version of Washington’s My Health My Data Act (“WA MHMDA”) on January 22, 2025. Currently awaiting action by Governor Kathy Hochul, the New York Health Information Privacy Act (“NY HIPA”)…more

Consent, Data Privacy, Enforcement, Health Insurance Portability and Accountability Act (HIPAA), Healthcare

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Biden Administration Throws Down Its First Gauntlet on 340B

On May 17, 2021, the Biden Administration took its first major action impacting the 340B Drug Discount Program. In a forceful statement, the Administration made plain its views on a major controversy that has pitted drug…more

Biden Administration, Drug Pricing, HRSA, Pharmaceutical Industry, Prescription Drugs

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Is Your Website Collecting PHI Under OCR's New Tracking Technologies Bulletin?

Covered Entities and Business Associates should promptly and carefully review their use of online tracking technologies on their websites and mobile apps following a bulletin (Bulletin) published by the U.S. Department of Health…more

Class Action, Compliance, Data Collection, Dobbs v. Jackson Women’s Health Organization, Health Insurance Portability and Accountability Act (HIPAA)

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Health Law Diagnosed – Understanding the New Massachusetts Health Care Market Review Law

In the latest episode of Health Law Diagnosed, host Bridgette Keller discusses the new Massachusetts Health Care Market Review Law and what this means for health care providers, investors, and other key stakeholders. She is…more

Compliance, False Claims Act (FCA), Health Care Providers, Health Insurance, Healthcare

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PBM Policy and Legislative Update — Winter 2025

The PBM regulatory landscape is rapidly evolving at both federal and state levels, making it critical for our clients involved in the PBM space to stay apprised of developments in the industry as they happen. Our team actively…more

Compliance, Federal Trade Commission (FTC), Final Rules, Health Insurance, Healthcare

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Health Care Enforcement Trends & 2025 Outlook

In our annual report, we examine health care enforcement trends, predict how health care enforcement may evolve, and offer practical guidance about what these trends and predictions mean for health care providers, payors, and…more

Compliance, Department of Justice (DOJ), Enforcement Actions, False Claims Act (FCA), Health Care Providers

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HRSA Demands Repayment from Providers that Failed to Comply with Provider Relief Fund Reporting Requirements

Under the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), the Health Resources and Services Administration (HRSA) of the Department of Health and Human Services (HHS) is authorized to distribute funds from its…more

CARES Act, Coronavirus/COVID-19, Department of Health and Human Services (HHS), HRSA, Medicare

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It’s Not Really ”Repeal and Replace”; It’s Transition

For the last six years, Republicans have talked about repeal and replacement of the Affordable Care Act. The election outcome now puts Republicans in a position of authority to take action on the Affordable Care Act. As we…more

Affordable Care Act, Healthcare Reform, Presidential Elections, Trump Administration

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HHS Finalizes Highly Anticipated Final Rules Amending AKS and Stark Law Regulations, Part III: Value-Based Arrangements

As promised, our team has been studying the two final rules published by the Department of Health & Human Services (HHS) (one by the Office of Inspector General (OIG) and one by the Centers for Medicare & Medicaid Services…more

Anti-Kickback Statute, Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services (HHS), DMEPOS, Final Rules

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OIG Issues Another Favorable Advisory Opinion on Patient Recruitment Efforts by Community Health Centers

The Office of Inspector General for the Department of Health and Human Services (OIG) recently issued a favorable Advisory Opinion on a proposed arrangement by a community health center (Health Center) designated under Section…more

Advisory Opinions, Anti-Kickback Statute, Compliance, Health Care Providers, Healthcare Fraud

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A Texas Federal Court Sides with Laboratories, But There May Be Unintended Consequences for FDA

The obvious result of the legal shootout between the U.S. Food & Drug Administration (FDA) and clinical laboratory trade associations, the American Clinical Laboratory Association and the Association for Molecular Pathology, in…more

Appeals, CLIA, Clinical Laboratories, Federal Food Drug and Cosmetic Act (FFDCA), Final Rules

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Flagging Judgment: Medical Necessity as a Focus of Fraud and Abuse Enforcement Actions

Physician judgment and medical necessity increasingly are a focus of fraud and abuse enforcement actions, with statistical analysis of procedure volumes used to flag potential cases. Last week, the Atlantic published this recent…more

Enforcement Actions, False Claims Act (FCA), Fraud and Abuse, Health Care Providers, Healthcare Fraud

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