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Health Tax

Read need-to-know updates, commentary, and analysis on Health issues written by leading professionals.
McDermott Will & Emery

This Week in 340B: September 17 – 23, 2024

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Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more

Greenbaum, Rowe, Smith & Davis LLP

Constitutional Challenge to New Jersey Residency Requirement in Medical Aid in Dying Act Rejected

On September 18, 2024, the Honorable RenéeMarie Bumb, the Chief Judge for the U.S. District Court for the District of New Jersey, filed a 59-page opinion along with an Order dismissing the complaint in Govatos challenging the...more

Gardner Law

Hiring Conflicts Result in FCA Violations

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A recent U.S. Department of Justice (DOJ) settlement highlights the importance of having (and following) a policy that prohibits conflicts of interest. In July 2024, the DOJ entered a nearly $1 million settlement with an...more

King & Spalding

HRSA Awards Multiple Contracts for Organ Procurement and Transplantation Network Activities

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On September 23, 2023, one year ago, President Biden signed the Securing the U.S. Organ Procurement and Transplantation Network Act into law, which allowed competitive bidding for various federal contracts under the Organ...more

Smith Gambrell Russell

Departments Release Final Mental Health Parity Rules with Significant Compliance Implications for Plan Sponsors and their Service...

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On September 9, 2024, the U.S. Departments of Health and Human Services, Labor, and the Treasury (collectively, the Departments) released much-anticipated final rules under the Mental Health Parity and Addiction Equity Act...more

Troutman Pepper

State AGs File Amicus Curae Brief in US Supreme Court Case Involving Flavored E-Cigarettes

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Earlier this month, 20 Democratic state attorneys general (AG) filed an amicus brief supporting the U.S. Food and Drug Administration’s (FDA) marketing denial orders (MDOs) of premarket tobacco applications (PMTAs) for...more

Foley & Lardner LLP

Research Misconduct: ORI Issues Final Rule with Modernized and Streamlined Regulations

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On September 17, 2024, the Office of Research Integrity (ORI) issued a final rule adopting changes to federal regulations governing research misconduct involving federally funded research (Final Rule). The regulations have...more

Manatt, Phelps & Phillips, LLP

Health AI Current “State” - All Eyes on California

Those following artificial intelligence (AI) legal developments are closely watching California, which currently has four bills pending the Governor’s signature that will impact AI development and use. California is at the...more

Robinson+Cole Health Law Diagnosis

South Dakota Hospital Settles False Claims Act Allegations for Over $14 Million Following Self-Disclosure

On September 18, 2024, the Department of Justice (DOJ) announced a settlement with Dunes Surgical Hospital and United Surgical Partners International, Inc. (USPI), an entity holding a partial ownership interest in Dunes, in...more

Epstein Becker & Green

Preparing for the Cybersecurity and Fraud Risks of Deepfakes: What Executive Teams Need to Know

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The widespread availability of Artificial Intelligence (AI) tools has enabled the growing use of “deepfakes,” whereby the human voice and likeness can be replicated seamlessly such that impersonations are impossible to detect...more

Manatt, Phelps & Phillips, LLP

Senate HELP Committee Examines Impact of Private Equity on Steward Health Care

On September 12, the Senate HELP Committee held a hearing that examined the bankruptcy of Steward Health Care, a nationwide health system that includes more than 30 hospitals in eight states. Members of the committee heard...more

Nelson Mullins Riley & Scarborough LLP

Providers Must Comply With Reproductive Health Amendment HIPAA Privacy Final Rule Soon

On April 22, the United States Department of Health and Human Services (HHS) Office for Civil Rights (OCR) released a Final Rule prohibiting the use and disclosure of protected health information (PHI) related to lawful...more

McDermott+

Healthcare Preview for the Week of: September 23, 2024

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One More Week Until Election Recess - The House and Senate are in Washington, DC, for one more week before leaving until after election day. Over the weekend, congressional leaders struck a deal on a continuing resolution...more

Holland & Knight LLP

CMS Releases Final Rule on the Medicaid Drug Rebate Program

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The Centers for Medicare & Medicaid Services (CMS) on Sept. 20, 2024, released the Misclassification of Drugs, Program Administration and Program Integrity Updates Under the Medicaid Drug Rebate Program (CMS-2434) Final Rule....more

Smart & Biggar

Supreme Court of Canada to hear method of medical treatment appeal

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On September 19, 2024, the Supreme Court of Canada granted Pharmascience leave to appeal a Federal Court of Appeal decision affirming a trial decision that upheld the validity of Janssen’s patent relating to paliperidone...more

Benesch

Dialysis & Nephrology Digest - September 2024

Benesch on

Appellate court ruling widens scope of NY fee-splitting law to include earnouts - The decision overturned a lower court ruling relating to the sale of part of a dental practice in 2015. The plaintiff agreed to sell...more

Wiley Rein LLP

Understanding Pharmacy Benefit Managers: The PBM Landscape Explained

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In this episode of Wiley’s Health Care Contracting Chronicles, hosts Jordan Ross and Brooke DeLoach introduce the complex world of Pharmacy Benefit Managers (PBMs) and their pivotal role in the healthcare industry. They...more

Fenwick & West LLP

New Regulatory Challenges for Private Equity and Hedge Fund Healthcare Transactions: Understanding the Impact of California’s AB...

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California’s healthcare ecosystem may soon experience significant regulatory changes as Assembly Bill 3129 (AB 3129) heads to Gov. Gavin Newsom's desk for approval....more

DLA Piper

Food and Beverage News and Trends - September 2024 #2

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This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal, and regulatory landscape....more

Kilpatrick

MHPAEA 2024 Final Rule Requires Action by Plan Sponsors

Kilpatrick on

I. Summary of the Final Rule - On September 9, 2024, the Departments of Treasury, Labor and Health and Human Services published the much-anticipated final rule implementing parts of the Mental Health Parity and Addiction...more

Rivkin Radler LLP

HRSA to J&J: Cease Implementation of New 340B Rebate Model

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As previously discussed , Johnson & Johnson (J&J) recently announced its intention to change its 340B Drug Pricing Program discount available to disproportionate share hospital (DSH) Covered Entities on purchases of STELARA...more

Baker Donelson

AI Firm Reaches Settlement With Texas Attorney General Over Misleading Accuracy Claims

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Texas Attorney General, Ken Paxton, (the Attorney General) announced on September 19, 2024, a landmark settlement with Pieces Technologies (Pieces) over allegations of false and misleading claims about the capabilities of its...more

Hall Benefits Law

Fifth Circuit Rules ACA Preventive Mandate Remains in Effect Nationwide – Except as to Plaintiffs

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The U.S. Court of Appeals for the Fifth Circuit has ruled in favor of Christian-owned businesses and individuals who sued over the Affordable Care Act (ACA) preventive care mandates. The appellate Court agreed with the...more

Health Care Compliance Association (HCCA)

HHS Abandons Appeal in Public Website Pixel Case, But CEs and BAs Should Expect Continued Scrutiny

The HHS Office for Civil Rights (OCR) has abandoned its appeal of a federal judge’s ruling overturning OCR’s guidance prohibiting covered entities (CEs) and business associates (BAs) from using the web-tracking technologies...more

Klein Moynihan Turco LLP

Medicare One-to-One Consent Rules Go Into Effect October 1!

Readers of this blog are aware of the fact that, beginning on October 1, 2024, the Medicare one-to-one consent rules will go into effect – requiring Third Party Marketing Organizations (“TPMOs”) who engage in Medicare-related...more

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