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Health Care Compliance Association (HCCA)

The CMS Interoperability and Prior Authorization Rules

Healthcare lives on data. Getting it to the patient and providers is essential for delivering quality care, but that can be a challenge. As Eden Avraham-Katz, Vice President, Legal and Compliance at 1upHealth explains in...more

Ogletree, Deakins, Nash, Smoak & Stewart,...

What the Final Mental Health Parity Rules Mean for Employers

The wait is over, and now the work begins for health plan sponsors. Much-anticipated final rules implementing the Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Equity Act of 2008 (MHPAEA) were...more

Baker Botts L.L.P.

23andMe’s $30M Settlement: What It Means for Companies Handling Genetic and Genomic Data

Baker Botts L.L.P. on

The recent $30 million settlement between 23andMe and 6.4 million users following a major data breach offers important lessons for businesses dealing with sensitive genetic and genomic information....more

Keating Muething & Klekamp PLL

Benefits Monthly Minute - September 2024

The September Monthly Minute highlights the DOL’s extension of existing cybersecurity guidance to health and welfare plans and also addresses the new HIPAA reproductive health privacy rule....more

Goodwin

Celltrion Wins Brazilian Federal Tender for Trastuzumab for Fifth Consecutive Year

Goodwin on

On September 13, 2024, Celltrion announced that its Brazilian subsidiary won the Federal Government of Brazil’s bid to supply HERZUMA (trastuzumab-pkrb) for the fifth consecutive year, with around 660,000 vials to be...more

MG+M The Law Firm

The Chevron Ruling Shake Up: US Air Force Avoids PFAS Water Clean Up

MG+M The Law Firm on

The overturning of the “Chevron Doctrine” is already making waves. The US Air Force is refusing to comply with an EPA clean-up order, claiming federal regulators lack authority. In brief, here is the timeline of events: •...more

Husch Blackwell LLP

Texas Attorney General Reaches Generative AI Settlement

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Keypoint: The Texas Attorney General reaches a first-of-its-kind settlement with a healthcare company that provides generative AI products. On September 18, 2024, the Texas Attorney General announced that it had reached a...more

Vicente LLP

Ongoing Delta-8 THC Legal Battle Moves to the Texas Supreme Court

Vicente LLP on

The Delta-8 THC ("D8") battle in Texas continues, with the arena now moving to the Texas Supreme Court. On August 21, 2024, the Texas Department of State Health Services (DSHS) filed an opening brief with the Texas Supreme...more

Harris Beach PLLC

Paging All Nurses – Wherever in the World You Are: Immigration Options for Foreign Nurses

Harris Beach PLLC on

As hospitals and medical centers continue to face enormous challenges in staffing, employers are looking for alternatives to meet these seemingly unfillable positions. The high demand for foreign nurses has contributed to a...more

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

Foley & Lardner LLP on

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

Troutman Pepper on

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

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?

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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

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

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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

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