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Foley & Lardner LLP

Medicare Advantage: A Circuit Court Addresses What is (or is not) Material in False Claims Act Cases

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Friday the 13th is not all bad luck. On September 13, 2024, the United States Court of Appeals for the Eighth Circuit’s published its much-anticipated decision in United States ex rel. Holt v. Medicare Medicaid Advisors,...more

Snell & Wilmer

Arizona Supreme Court Decides Cipro’s Black Box Warning Cannot Replace an Expert Opinion

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In Arizona, civil claims against health care professionals must be accompanied by a certified statement regarding whether “expert opinion testimony is necessary to prove the health care professional’s standard of care or...more

Brownstein Hyatt Farber Schreck

As Election Looms, Headwinds Brewing for Private Equity Health Care Dealmaking

As this fall’s election approaches, headwinds have been brewing in DC and state legislatures for private equity health care dealmaking, many of them with bipartisan support. While a key Senate committee scrutinized patient...more

Bennett Jones LLP

Proposed Changes to the Guidance on Recognized Standards for Medical Devices in Canada

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Changes affecting the approval of medical devices in Canada are coming. Health Canada has released a notice on Proposed Changes to the Guidance on Recognized Standards for Medical Devices along with a Draft List of Recognized...more

Foley & Lardner LLP

Final Mental Health Parity Rules – Top Five Changes to the Status Quo

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The Mental Health Parity and Addiction Equity Act and its implementing regulations and guidance (MHPAEA) prohibit health insurance policies and group health plans that cover mental health and substance use disorder (MH/SUD)...more

Troutman Pepper

Antitrust Considerations in Long-Term Care — Assisted Living and the Law Podcast

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Assisted Living and the Law, hosted by Troutman Pepper attorneys Cal Stein and Emma Trivax, offers timely insights and practical advice on navigating the complex and evolving legal landscape of the long-term care industry. ...more

Manatt, Phelps & Phillips, LLP

Biden Administration Finalizes Mental Health Parity Rules and Priorities

On September 9, the U.S. Departments of Labor, Health and Human Services, and the Treasury (collectively, the Departments) released a final rule to strengthen implementation of the Mental Health Parity and Addiction Equity...more

Sheppard Mullin Richter & Hampton LLP

Ubrelvy Untitled Letter – A Double Fault for AbbVie? Or Makeup Misread for FDA?

On August 29, 2024, the U.S. Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) issued an untitled letter to AbbVie, Inc. (AbbVie) regarding a promotional, direct-to-consumer (DTC) television...more

McDermott Will & Emery

Landmark Mental Health Parity Final Rule: What Plan Sponsors and Insurers Need to Know

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The US Departments of the Treasury, Labor, and Health and Human Services (the Departments) recently issued much-anticipated final regulations under the Mental Health Parity and Addiction Equity Act (MHPAEA). The newly issued...more

McDermott+

HHS, Labor, and Treasury Finalize Mental Health Parity Rule

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On September 9, 2024, the US Departments of Health and Human Services (HHS), Labor, and the Treasury (collectively, the Departments) finalized a rule titled Requirements Related to the Mental Health Parity and Addiction...more

Maynard Nexsen

Resources and Practical Response Tips

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After a lengthy absence, the South Carolina Department of Health and Human Services (“SCDHHS”) announced on September 10, 2024, that its Medicaid Recovery Audit Contractor (“RAC”) program was resuming on October 1, 2024. ...more

Faegre Drinker Biddle & Reath LLP

Recent Legislative Developments Impacting Pharmacy Benefit Managers, Health Plans & More

As prescription drug costs remains a significant, and largely bipartisan, issue for state and federal legislators, we continue to see activity focused on pharmacy benefit managers (PBMs) as we approach the last quarter of...more

McGuireWoods LLP

Ounce of Prevention: Are You Providing Free Translators for Individuals with Limited English Proficiency?

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Applicable Provider Types: All - Is Your Entity in Compliance? Recent regulatory language makes clear that most healthcare providers must provide free translators or interpreters for patients with limited English...more

Womble Bond Dickinson

FDA and the Fountain of Youth: Regulatory Hurdles in the Longevity Biotech Community

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With every major advancement in the field of aging biology, humankind is one step closer to turning back the clock and restoring our youth. In our previous longevity blog, we highlighted several novel therapeutics that have...more

Foley & Lardner LLP

The 340B Drug Pricing Program: Top Five Things to Know

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The 340B Drug Pricing Program continues to provide critical support for covered entities, although the program is subject to ongoing scrutiny and congressional, judicial, and industry pressures. Certain key guidance documents...more

Proskauer - Employee Benefits & Executive...

Final Mental Health Parity Regulations Released, with Plan Sponsor Action Required by 2025

Last week, the Departments of Labor, Treasury, and Health and Human Services finalized regulations implementing the Mental Health Parity and Addiction Equity Act of 2008 (MHPAEA). Although the final regulations step back...more

Mintz - Health Care Viewpoints

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...more

Faegre Drinker Biddle & Reath LLP

New Investment Opportunity in China’s Health Care Sector Following Recent Legal Reforms

Policy Announcements - On September 6, 2024, the People’s Republic of China’s (PRC) National Development and Reform Commission and the PRC Ministry of Commerce issued the “Special Administrative Measures for Foreign...more

Woodruff Sawyer

Healthcare’s Ever-Evolving Privacy Landscape: Litigation, Regulation, and the Perpetual Data Breach Risk

Woodruff Sawyer on

This webinar focuses on the privacy, security, regulatory, and litigation landscape that the healthcare sector is facing in in the privacy and cybersecurity arena. Leveraging Polsinelli’s experience working with healthcare...more

Goodwin

WHO Prequalifies Bavarian Nordic’s MVA-BN as First Vaccine Against Mpox

Goodwin on

On September 13, 2024, the World Health Organization (WHO) announced that it added the first vaccine against monkeypox (mpox) to its prequalification list. The vaccine, MVA-BN, is manufactured by Bavarian Nordic A/S....more

Smith Anderson

North Carolina Medical Board Links Physician Supervision to Corporate Practice of Medicine and Reiterates Concerns Regarding...

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On August 30, 2024, the North Carolina Medical Board (the “Board”) published online guidance titled, "Lessons from NCMB’s Disciplinary Committee: Are you aiding the unlicensed practice of medicine?” (the “Guidance”). The...more

Maynard Nexsen

Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 206: Supporting Patient Care with Darra Coleman of...

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Hosts Heather and Lauren are joined by Darra Coleman, former host of the podcast and Maynard Nexsen health care attorney and current Senior Associate General Counsel at Prisma Health. Darra joins the show to discuss how her...more

Manatt, Phelps & Phillips, LLP

Community Reinvestment: Forging New Partnerships in Medicaid

At least 10 states have implemented, or are in the process of implementing, a community reinvestment requirement in which Medicaid managed care organizations (MCOs) are required to reinvest in the communities they serve to...more

Manatt, Phelps & Phillips, LLP

Unhealthy Alliance: Hospitals Sharing Senior Leadership Increases Antitrust Risk

Collusion among rivals has long been considered the “supreme evil of antitrust.” It is not surprising, therefore, that antitrust scrutiny was applied to one hospital’s decision to employ the Chief Executive Officer of its...more

Holland & Knight LLP

Massachusetts Board of Pharmacy to Take a Big Step: Licensing Nonresident Pharmacies

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In a move that could reshape the regulatory landscape for pharmacies servicing Massachusetts residents, the Massachusetts Board of Pharmacy has announced that it will soon begin licensing nonresident pharmacies and requiring...more

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