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

McDermott Will & Emery on

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

McDermott+ on

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

Maynard Nexsen on

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?

McGuireWoods LLP on

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

Womble Bond Dickinson on

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

Foley & Lardner LLP on

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...

Smith Anderson on

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...

Maynard Nexsen on

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

Holland & Knight LLP on

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

Morgan Lewis

Federal Agencies Release Final MHPAEA Regulations: Navigating the Key Changes

Morgan Lewis on

The US Departments of Health and Human Services, Labor, and the Treasury (collectively, the Departments) released their much anticipated final rules implementing the Paul Wellstone and Pete Domenici Mental Health Parity and...more

Hogan Lovells

Life Sciences Procurement Update: FY2025 NDAA Would Changes to Rules of Origin for Drugs

Hogan Lovells on

In July, the Senate Armed Services Committee passed its version of the FY 2025 National Defense Authorization Act (NDAA), which would make substantial changes to the rules for determining the “country of origin” of drugs for...more

Morgan Lewis

CMS Defers Low Wage Index Hospital Policy Changes in FY 2025 IPPS Final Rule Despite DC Circuit Holding

Morgan Lewis on

The Centers for Medicare and Medicaid Services (CMS) has deferred taking immediate action on its low wage index hospital policy in light of the US Court of Appeals for the DC Circuit’s decision in Bridgeport Hospital v....more

Oberheiden P.C.

Ozempic Lawsuit Update: New Study Links Semaglutides to Increased Risk of Vision Loss

Oberheiden P.C. on

More plaintiffs are continuing to join the diabetes drug Ozempic lawsuits against Novo Nordisk; and, until a couple of weeks ago, some court watchers were estimating that the total number of federal lawsuits involving Ozempic...more

Stotler Hayes Group, LLC

My Bar Exam: Three Strokes and You’re OUT!

I had always planned to attend law school, but life events delayed my entry until my kids had both started high school. I was 43 years old. Fortunately, my very supportive law school allowed me to stretch the coursework over...more

Sheppard Mullin Richter & Hampton LLP

Solving for Physician Burnout: How Organizations Can Deploy AI Solutions to Effectively Support Physician Workloads and Avoid...

This series explores legal issues related to physician burnout and potential solutions. Our first post addressed how healthcare organizations can foster the psychological safety and emotional wellbeing of their physicians....more

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