Mintz - Health Care Viewpoints

Challenge to False Claims Act Qui Tam Provisions Fails in an Initial Attempt to Revive Long-Dormant Arguments as to Constitutionality Under Article II

This July, we detailed the Supreme Court’s surprising revival in United States ex rel. Polansky v. Exec. Health Resources, No. 21-1052 (S. Ct. June 16, 2023) of the question of whether the qui tam provisions of the False Claims…more

Appointments Clause, Article II, Constitutional Challenges, Department of Justice (DOJ), False Claims Act (FCA)

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PBM Policy and Legislative Update — Summer 2024

Mintz’s PBM practice is pleased to present a 2024 year-to-date PBM Policy and Legislative Update. This edition builds upon prior issues and summarizes activity from January through June that impacts the PBM industry. It…more

Centers for Medicare & Medicaid Services (CMS), Drug Pricing, Pharmacy Benefit Manager (PBM), Prescription Drugs, Supply Chain

See all updates »

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 »

Acting U.S. Attorney Levy Forecasts False Claims Act COVID Cases Targeting Private Lenders Of CARES Act Loans That Failed In Their Obligation To Safeguard Government Funds

Acting U.S. Attorney Joshua Levy discussed the enforcement priorities for the Massachusetts U.S. Attorney’s Office (USAO) during a Q&A session on May 29, 2024, and made clear that the historical focus of the office remains the…more

Borrowers, BSA/AML, CARES Act, Coronavirus/COVID-19, False Claims Act (FCA)

See all updates »

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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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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Health Care Enforcement Year-in-Review and 2020 Outlook: Criminal Case Developments

As discussed in our article recently published by Law360, criminal health care enforcement in 2019 was in many ways a continuation of 2018, with opioid-related enforcement continuing to be the clear top priority for the…more

Bribery, Controlled Substances Act, Criminal Investigations, Criminal Prosecution, Department of Health and Human Services (HHS)

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Courts Continue to Grapple with the Causation Standard for False Claims Act Suits Based on Alleged Kickback Schemes, While the Supreme Court Stays on the Sidelines

A recent Massachusetts Federal District Court decision adds to divergent opinions deciding an important health care enforcement question: what causation standard applies to a False Claims Act (FCA) case based on a violation of…more

Causation, False Claims Act (FCA), Kickbacks, Medicare, SCOTUS

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PBM Policy and Legislative Update — Summer 2024

Mintz’s PBM practice is pleased to present a 2024 year-to-date PBM Policy and Legislative Update. This edition builds upon prior issues and summarizes activity from January through June that impacts the PBM industry. It…more

Centers for Medicare & Medicaid Services (CMS), Drug Pricing, Pharmacy Benefit Manager (PBM), Prescription Drugs, Supply Chain

See all updates »

Texas Challenges HHS’s HIPAA Rule Protecting Reproductive Health Information from State Investigative Bodies

Last week, Texas Attorney General Ken Paxton filed a complaint in federal district court against HHS and the Office for Civil Rights (OCR) challenging a recently issued rule strengthening protection of protected health…more

Abortion, Administrative Procedure Act, Department of Health and Human Services (HHS), Final Rules, Health Insurance Portability and Accountability Act (HIPAA)

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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 — IRA Litigation Update: Courts Begin to Address Legal Challenges to the Medicare Drug Price Negotiation Program

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 drugs, has been subject to several…more

AstraZeneca, Centers for Medicare & Medicaid Services (CMS), Constitutional Challenges, Dismissals, Drug Pricing

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2024 Pre-Election Analysis: Health Care Issues

In recent elections, health care has been one of the most hot-button issues with consequences for millions of Americans, and this election is no exception. The next administration and the 119th Congress have the potential to…more

Abortion, Affordable Care Act, Drug Pricing, Health Insurance, Healthcare

See all updates »

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)

See all updates »

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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California’s Health Care Transactions Review Law: Regulatory Revisions Effective Immediately

Effective immediately, on August 22, 2024, the Office of Health Care Affordability (OHCA) adopted revisions to the cost and market impact review (CMIR) regulations (Revised Regulations), which govern California’s pre-closing…more

Attestation Requirements, California, Confidentiality Policies, Documentation, Financial Transactions

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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

See all updates »

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)

See all updates »

PBM Policy and Legislative Update — Summer 2024

Mintz’s PBM practice is pleased to present a 2024 year-to-date PBM Policy and Legislative Update. This edition builds upon prior issues and summarizes activity from January through June that impacts the PBM industry. It…more

Centers for Medicare & Medicaid Services (CMS), Drug Pricing, Pharmacy Benefit Manager (PBM), Prescription Drugs, Supply Chain

See all updates »

California’s Health Care Transactions Review Law: Regulatory Revisions Effective Immediately

Effective immediately, on August 22, 2024, the Office of Health Care Affordability (OHCA) adopted revisions to the cost and market impact review (CMIR) regulations (Revised Regulations), which govern California’s pre-closing…more

Attestation Requirements, California, Confidentiality Policies, Documentation, Financial Transactions

See all updates »

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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The Supreme Court’s SuperValu Decision on the “Knowingly” Element in the False Claims Act: Protecting Against Liability When There is Regulatory Ambiguity

In a resounding unanimous 9-0 decision, the Supreme Court rejected the argument that a defendant’s subjective belief is irrelevant under the False Claims Act (FCA) when evaluating whether a defendant “knowingly” submitted a…more

Drug Pricing, False Claims Act (FCA), Pharmaceutical Industry, Pharmacies, Prescription Drugs

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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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Violations for Excessive Physician Compensation

The Department of Justice (DOJ) recently filed a complaint against Erlanger Health System (Erlanger), a county-owned public health system, and two of its Tennessee hospitals alleging that the health system systemically violated…more

Compensation, Compliance, Corporate Integrity Agreement, Department of Justice (DOJ), Fair Market Value

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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 — Summer 2024

Mintz’s PBM practice is pleased to present a 2024 year-to-date PBM Policy and Legislative Update. This edition builds upon prior issues and summarizes activity from January through June that impacts the PBM industry. It…more

Centers for Medicare & Medicaid Services (CMS), Drug Pricing, Pharmacy Benefit Manager (PBM), Prescription Drugs, Supply Chain

See all updates »

PBM Policy and Legislative Update — Summer 2024

Mintz’s PBM practice is pleased to present a 2024 year-to-date PBM Policy and Legislative Update. This edition builds upon prior issues and summarizes activity from January through June that impacts the PBM industry. It…more

Centers for Medicare & Medicaid Services (CMS), Drug Pricing, Pharmacy Benefit Manager (PBM), Prescription Drugs, Supply Chain

See all updates »

Acting U.S. Attorney Levy Forecasts False Claims Act COVID Cases Targeting Private Lenders Of CARES Act Loans That Failed In Their Obligation To Safeguard Government Funds

Acting U.S. Attorney Joshua Levy discussed the enforcement priorities for the Massachusetts U.S. Attorney’s Office (USAO) during a Q&A session on May 29, 2024, and made clear that the historical focus of the office remains the…more

Borrowers, BSA/AML, CARES Act, Coronavirus/COVID-19, False Claims Act (FCA)

See all updates »

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

See all updates »

PBM Policy and Legislative Update — Summer 2024

Mintz’s PBM practice is pleased to present a 2024 year-to-date PBM Policy and Legislative Update. This edition builds upon prior issues and summarizes activity from January through June that impacts the PBM industry. It…more

Centers for Medicare & Medicaid Services (CMS), Drug Pricing, Pharmacy Benefit Manager (PBM), Prescription Drugs, Supply Chain

See all updates »

2024 Pre-Election Analysis: Health Care Issues

In recent elections, health care has been one of the most hot-button issues with consequences for millions of Americans, and this election is no exception. The next administration and the 119th Congress have the potential to…more

Abortion, Affordable Care Act, Drug Pricing, Health Insurance, Healthcare

See all updates »

Recent DOJ Comments Shed Light on Expected Civil Enforcement of COVID-19 Cases

Comments made by Department of Justice (DOJ) attorneys during a recent webinar provided insight into the government’s civil enforcement priorities related to the coronavirus pandemic. In particular, government attorneys expect…more

CARES Act, Coronavirus/COVID-19, Department of Health and Human Services (HHS), Department of Justice (DOJ), Enforcement Actions

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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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FDA Releases Ambitious Action Plan for Further Reducing Children’s Exposure to Toxic Elements from Foods

The U.S. Food and Drug Administration (FDA), industry, policymakers, and consumers share a common goal of ensuring that the foods and beverages Americans eat and drink are safe, and the law has long prohibited the adulteration…more

Baby Products, Children's Products, Federal Food Drug and Cosmetic Act (FFDCA), Food and Drug Administration (FDA), Food Manufacturers

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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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California’s Health Care Transactions Review Law: Regulatory Revisions Effective Immediately

Effective immediately, on August 22, 2024, the Office of Health Care Affordability (OHCA) adopted revisions to the cost and market impact review (CMIR) regulations (Revised Regulations), which govern California’s pre-closing…more

Attestation Requirements, California, Confidentiality Policies, Documentation, Financial Transactions

See all updates »

New York City's Health Care Price Transparency Law Takes Effect

In summer of 2023, New York City Mayor Eric Adams signed Intro. 844-A (Local Law 844-A) and amended the New York City Charter. Local Law 844-A directs Mayor Adams to establish an Office of Healthcare Accountability that will…more

City of New York, Health Care Providers, Healthcare Facilities, IRS, Medicare

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PBM Policy and Legislative Update — Summer 2024

Mintz’s PBM practice is pleased to present a 2024 year-to-date PBM Policy and Legislative Update. This edition builds upon prior issues and summarizes activity from January through June that impacts the PBM industry. It…more

Centers for Medicare & Medicaid Services (CMS), Drug Pricing, Pharmacy Benefit Manager (PBM), Prescription Drugs, Supply Chain

See all updates »

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)

See all updates »

OIG Issues Advisory Opinion Nixing Purchased Services Arrangement Between Certain Anatomic Pathology Laboratories

Last week the Office of Inspector General for the U.S. Department of Health and Human Services (OIG) issued Advisory Opinion 23-06 (AO), which advised that a proposed arrangement between certain laboratories for the purchase of…more

Advisory Opinions, Billing, Carve Out Provisions, Clinical Laboratories, Competition

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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

See all updates »

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

See all updates »

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)

See all updates »

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

See all updates »

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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A Mintz Health Care Roundtable: Current Trends in State Health Care Transaction Review and What to Expect in 2024

States are increasingly exercising regulatory oversight of health care transactions by enacting laws requiring prior notice or approval of certain health care transactions. Currently, 15 states have enacted health care…more

Ambulatory Surgery Centers, Health Care Providers, Healthcare, Laboratories, Notice Requirements

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FDA Issues Guidance Intended to Diversify and Enhance Clinical Trial Participation

On June 28, 2024, the Food and Drug Administration (FDA) released draft guidance for industry, titled Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies (the Draft…more

Clinical Trials, Diversity, Food and Drug Administration (FDA), Medical Devices, New Guidance

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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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Courts Continue to Grapple with the Causation Standard for False Claims Act Suits Based on Alleged Kickback Schemes, While the Supreme Court Stays on the Sidelines

A recent Massachusetts Federal District Court decision adds to divergent opinions deciding an important health care enforcement question: what causation standard applies to a False Claims Act (FCA) case based on a violation of…more

Causation, False Claims Act (FCA), Kickbacks, Medicare, SCOTUS

See all updates »

Challenge to False Claims Act Qui Tam Provisions Fails in an Initial Attempt to Revive Long-Dormant Arguments as to Constitutionality Under Article II

This July, we detailed the Supreme Court’s surprising revival in United States ex rel. Polansky v. Exec. Health Resources, No. 21-1052 (S. Ct. June 16, 2023) of the question of whether the qui tam provisions of the False Claims…more

Appointments Clause, Article II, Constitutional Challenges, Department of Justice (DOJ), False Claims Act (FCA)

See all updates »

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

See all updates »

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)

See all updates »

Mintz IRA Update — The Consequences and Costs of Redesigning the Part D Program

The passage of the Inflation Reduction Act of 2022 (IRA) marked a significant milestone in Congress’s ongoing efforts to address escalating health care costs. While the IRA aims to rein in government spending on Medicare and to…more

Beneficiaries, Centers for Medicare & Medicaid Services (CMS), Drug Pricing, Health Insurance, Health Plan Sponsors

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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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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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Will Sustained Pressure on the 340B Program Finally Lead to Much Needed Reform?

As we enter into the final months of 2024, new developments in the administration of the 340B Drug Pricing Program signal that additional reform may be on the way. Although recent revisions to the 340B program’s administrative…more

Compliance, Consumer Protection Act, Dispute Resolution, Drug Pricing, Healthcare Reform

See all updates »

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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Texas Challenges HHS’s HIPAA Rule Protecting Reproductive Health Information from State Investigative Bodies

Last week, Texas Attorney General Ken Paxton filed a complaint in federal district court against HHS and the Office for Civil Rights (OCR) challenging a recently issued rule strengthening protection of protected health…more

Abortion, Administrative Procedure Act, Department of Health and Human Services (HHS), Final Rules, Health Insurance Portability and Accountability Act (HIPAA)

See all updates »

PBM Policy and Legislative Update — Summer 2024

Mintz’s PBM practice is pleased to present a 2024 year-to-date PBM Policy and Legislative Update. This edition builds upon prior issues and summarizes activity from January through June that impacts the PBM industry. It…more

Centers for Medicare & Medicaid Services (CMS), Drug Pricing, Pharmacy Benefit Manager (PBM), Prescription Drugs, Supply Chain

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 »

California’s Health Care Transactions Review Law: Regulatory Revisions Effective Immediately

Effective immediately, on August 22, 2024, the Office of Health Care Affordability (OHCA) adopted revisions to the cost and market impact review (CMIR) regulations (Revised Regulations), which govern California’s pre-closing…more

Attestation Requirements, California, Confidentiality Policies, Documentation, Financial Transactions

See all updates »

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

See all updates »

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

See all updates »

Will Sustained Pressure on the 340B Program Finally Lead to Much Needed Reform?

As we enter into the final months of 2024, new developments in the administration of the 340B Drug Pricing Program signal that additional reform may be on the way. Although recent revisions to the 340B program’s administrative…more

Compliance, Consumer Protection Act, Dispute Resolution, Drug Pricing, Healthcare Reform

See all updates »

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

See all updates »

PBM Policy and Legislative Update — Summer 2024

Mintz’s PBM practice is pleased to present a 2024 year-to-date PBM Policy and Legislative Update. This edition builds upon prior issues and summarizes activity from January through June that impacts the PBM industry. It…more

Centers for Medicare & Medicaid Services (CMS), Drug Pricing, Pharmacy Benefit Manager (PBM), Prescription Drugs, Supply Chain

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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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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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National Academics of Science, Engineering, and Medicine Issues Report on Inclusion of Pregnant and Lactating Persons in Clinical Research

Last month, the National Academies of Science, Engineering, and Medicine (“NASEM”) issued a report discussing the inclusion of pregnant and lactating people in clinical research and the health impacts of inadequate data from…more

Clinical Trials, Confidentiality Policies, Food and Drug Administration (FDA), Lactation Accommodation, National Institute of Health (NIH)

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PBM Policy and Legislative Update — Summer 2024

Mintz’s PBM practice is pleased to present a 2024 year-to-date PBM Policy and Legislative Update. This edition builds upon prior issues and summarizes activity from January through June that impacts the PBM industry. It…more

Centers for Medicare & Medicaid Services (CMS), Drug Pricing, Pharmacy Benefit Manager (PBM), Prescription Drugs, Supply Chain

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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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Violations for Excessive Physician Compensation

The Department of Justice (DOJ) recently filed a complaint against Erlanger Health System (Erlanger), a county-owned public health system, and two of its Tennessee hospitals alleging that the health system systemically violated…more

Compensation, Compliance, Corporate Integrity Agreement, Department of Justice (DOJ), Fair Market Value

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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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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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