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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

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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

Fox Rothschild LLP

CMS Proposed Rule Decreases Physician Payments, Expands Telehealth, and Much More

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The comment period for the CMS CY 2025 Physician Fee Schedule (PFS) Proposed Rule recently closed on Monday, September 9th. Based on previous years, the Final Rule can be expected as soon as early November, taking effect...more

King & Spalding

CMS Issues Revised Guidance Regarding Enrollment and Conversion Process for Rural Emergency Hospitals

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On September 6, 2024, CMS released revised guidance regarding the process by which rural hospitals and outpatient facilities can participate in Medicare as a Rural Emergency Hospital (REH) rather than a Critical Access...more

Troutman Pepper

Preventative Medicine: Health Care AI Privacy and Cybersecurity – Part 2 — The Good Bot Podcast

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Join Troutman Pepper Partner Brett Mason for a podcast series analyzing the intersection of artificial intelligence (AI), health care, and the law. In this installment, Brett is joined by Partner Brent Hoard and Andrea...more

Maynard Nexsen

Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 207: Long COVID Research & Treatments with Dr. Kashyap...

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This episode, we welcome back one of our favorite guests, Dr. Kashyap Patel, a renowned practicing physician, author, and healthcare thought leader. Dr. Patel has been dedicating much of his attention to analyzing long COVID...more

Holland & Knight LLP

Novel Settlement Reached in Generative AI Deceptive Trade Practices Healthcare Investigation

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The state of Texas, by and through its Attorney General Ken Paxton, reached a first-of-its-kind settlement agreement with Pieces Technologies Inc. (Pieces) following an investigation into Pieces' alleged violations of the...more

ArentFox Schiff

investigations Newsletter: Walgreens Settles for $106.8 Million Over FCA Violations

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Walgreens Settles for $106.8 Million Over FCA Violations - On September 13, the US Department of Justice (DOJ) announced that Walgreens Boots Alliance Inc. and Walgreen Co. (collectively, Walgreens) agreed to pay $106.8...more

Hogan Lovells

CMS issues Final Rule adopting some but not all proposed changes to the Medicaid Drug Rebate Program

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On September 20, 2024, the Centers for Medicare & Medicaid Services (CMS) issued a final rule entitled: Misclassification of Drugs, Program Administration and Program Integrity Updates Under the Medicaid Drug Rebate Program....more

Kelley Drye & Warren LLP

Taking a ShOt at GLP-1 Weight Loss

As the demand for GLP-1 drugs like Ozempic and Wegovy increases with consumers eager to shed pounds, the supplement industry is weighing in. Dietary supplement companies have been considering ways to address this new demand...more

King & Spalding

Departments Finalize Rule on Mental Health Parity

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On September 9, 2024, the Department of Labor, the Department of the Treasury, and HHS (the Departments) jointly issued a final rule (the Final Rule) amending regulations implementing the Paul Wellstone and Pete Domenici...more

Napoli Shkolnik

Women Lack Access to Maternity Care. That’s Unacceptable.

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We live in a world where exciting medical research promises to cure cancer, prevent heart attacks, and push back the effects of aging. Sadly, we also live in a world in which “maternity care deserts” are growing across the...more

Husch Blackwell LLP

California Private Equity in Healthcare Legislation

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On August 31, the last day of its 2024 Legislative Session, the California Legislature approved Assembly Bill 3129 (Wood), which provides for notification to and review by the Attorney General of health care transactions...more

Kelley Drye & Warren LLP

The Eyes of Texas are on AI: Generative AI Settlement Reached

We have frequently written on AGs interest in AI. In what Texas calls the ​“first-of-its-kind healthcare generative AI” settlement, the state resolved its investigation into Pieces Technologies’ alleged misleading statements...more

Miles & Stockbridge P.C.

Are You Part of the TEAM? CMS Prepares for New, Mandatory Payment Model

The CMS Innovation Center (CMMI) continues to prepare for its next episode-based alternative payment model, the Transforming Episode Accountability Model, or TEAM for short. This five-year model will offer both incentive...more

Morgan Lewis - ML Benefits

CMS Disclosures Due October 15: Is Your Plan’s Rx Coverage Still Creditable?

The Inflation Reduction Act (IRA) made several changes to Medicare Part D that may impact whether employer-sponsored coverage will be creditable for the 2025 plan year. With open enrollment season about to begin, plan...more

Marshall Dennehey

Can Felons Pursue Damages Against Their Providers for Their Criminal Conduct? The Pennsylvania Supreme Court Says No

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Key Points: Pennsylvania Supreme Court recently evaluated the no felony conviction recovery rule. No felony conviction recovery rule bars medical malpractice and indemnification claims brought against murderer’s medical...more

McDermott Will & Emery

Trending in Telehealth: August 26 – September 17, 2024

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Trending in Telehealth highlights state legislative and regulatory developments that impact the healthcare providers, telehealth and digital health companies, pharmacists, and technology companies that deliver and facilitate...more

McDermott+

McDermott+ Check-Up: September 20, 2024

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Senate Judiciary Human Rights and the Law Subcommittee Holds Hearing on Georgia Abortion Ban. The field hearing examined how Georgia’s abortion ban impacts women’s health, and featured patient and physician witnesses. ...more

Hogan Lovells

New FDA clinical trials guidances promote efficient drug development, innovative designs, diversity

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The U.S. Food and Drug Administration (FDA) issued this week three guidance documents related to clinical trials: a draft guidance on multiregional trials in oncology, a draft guidance on integrating randomized controlled...more

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