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Health Administrative Agency

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

Senior Living Alert: Senior Care Impact — Results From 2024 Elections

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The 2024 elections brought significant shifts and challenges at both state and national levels, with senior care emerging as a key focus in some regions while remaining underemphasized in others. From California’s ongoing...more

Bond Schoeneck & King PLLC

Changes Are Likely on the Horizon for the Federal Healthcare Portfolio in Areas Including Cybersecurity and Regulatory Enforcement

Federal healthcare administration undoubtedly will look different in 2025 than it does as we close 2024. In the aftermath of the Republican party victories during this month’s Federal elections – and if the past is...more

Groom Law Group, Chartered

DOL & Treasury Extend Certain ERISA-Related Deadlines for Helene and Milton Impacted Areas

On November 8, the Departments of Labor and Treasury (the “Departments”) issued guidance extending certain deadlines related to retirement, health, and welfare plans in response to Hurricane Helene, Tropical Storm Helene, and...more

Dinsmore & Shohl LLP

Deadline Approaching for Compliance with New HIPAA Reproductive Health Care Privacy Rule

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The deadline for compliance with the Department of Health and Human Services Office of Civil Rights’ (“OCR”) recent update to the HIPAA Privacy Rule is December 22, 2024 -- less than thirty days away. Last spring, OCR...more

Rivkin Radler LLP

Third-party biller fraud may hook your practice, unless you protect yourself

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A November 25 article in Part B News, “Third-party biller fraud may hook your practice, unless you protect yourself,” discussed the federal government’s recent fraud investigation of a medical biller in New York State and...more

Dentons

Ep. 41 – Remind Employees of Your Gift Policy

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Holiday gifts are a common marketing tool used by many businesses; however, in healthcare, they can create compliance issues. Most healthcare providers have a gift policy that limits the type of gifts and other business...more

Manatt, Phelps & Phillips, LLP

CMS Approves New 1115 Waiver Demonstrations for Continuous Coverage

On November 14, the Centers for Medicare & Medicaid Services (CMS) announced approval of Section 1115 demonstration amendments for Colorado, Hawaii, Minnesota, New York, and Pennsylvania —all of which will provide multi-year...more

Manatt, Phelps & Phillips, LLP

J&J Sues HRSA Over Agency’s Challenge of its Rebate Model

On November 12, Johnson & Johnson (J&J) filed suit against the Health Resources and Services Administration (HRSA) in D.C. federal district court, arguing that the 340B statute explicitly provides flexibility for...more

Holland & Knight LLP

CDPAP Fiscal Intermediary Takes Aim at DOH's Competitive Bidding Process

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Another day, another legal challenge to New York's overhaul of the Consumer Directed Personal Assistance Program (CDPAP). In an emergency petition filed Nov. 25, 2024, by the state's largest fiscal intermediary (FI), Freedom...more

Smart & Biggar

Health Canada releases notice on aligned reviews between Health Canada and health technology assessment organizations

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On November 5, 2024, Health Canada released the Notice to industry: Aligned reviews between Health Canada and health technology assessment organizations.According to the notice, effective immediately, the option for aligned...more

Knobbe Martens

FDA Provides Perspective on Goals and Challenges for Regulation of Artificial Intelligence in Medical Devices, Drug Design, and...

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A recent article authored by Haider J. Warraich, MD; Troy Tazbaz; and Robert M. Califf, MD in the Journal of the American Medical Association, reviews the history of artificial intelligence (AI) regulation by the U.S. Food...more

Ballard Spahr LLP

Michigan Legislature Introduces Reproductive Health Privacy Bill

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On November 7, 2024, Michigan lawmakers in the Senate introduced the Reproductive Data Privacy Act (“RDPA”), also known as Senate Bill 1082 (SB 1082).  The bill aims to strengthen privacy protections for sensitive...more

Quarles & Brady LLP

Are You Ready for Massachusetts Non-Resident Pharmacy Licensure?

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On November 19, 2024, the Massachusetts Board of Registration in Pharmacy (the “Board”) published several memoranda that described the impending non-resident pharmacy licensure requirements and the anticipated timeline for...more

BakerHostetler

What a Second Trump Administration Could Mean for Tobacco Industry Regulations

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As the tobacco industry anticipates a second Trump administration, it’s banking on what some public health experts describe as his unpredictable approach to regulation. Trump’s history of abrupt policy shifts makes tobacco...more

Mitchell, Williams, Selig, Gates & Woodyard,...

National Association of Insurance Commissioners (NAIC) Fall 2024 Meeting Summary

The Mitchell Williams Insurance Regulatory team of attorneys recently attended the National Association of Insurance Commissioners (NAIC) Fall 2024 National Meeting which was held in Denver, Colorado. We have prepared a...more

Rothwell, Figg, Ernst & Manbeck, P.C.

Defining an Orange Book ‘Drug’

The Federal Circuit heard oral argument on November 8, 2024, grappling with the issue of what patent claims may properly be listed in the Orange Book. In late 2023, Teva filed a complaint for patent infringement in response...more

Epstein Becker & Green

New Jersey General Assembly Passes Legislation Prohibiting Sale of Diet Pills, Weight Loss/Muscle Building Supplements to Minors

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As the dietary supplement industry continues to draw attention from Congress, state attorneys general, and class action lawyers, now comes another state law prohibiting the sale of over-the-counter (“OTC”) dietary supplements...more

Burr & Forman

COVID Immunity Upheld to Protect Health Care Providers

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On October 4, 2024, the Alabama Supreme Court issued an opinion confirming and upholding the validity of not only the Governor’s Executive Order of May 8, 2020, providing immunity from negligence claims during the COVID-19...more

Mandelbaum Barrett PC

The Role of Veterinary Telemedicine in Today’s Practices: Evolving Legal and Practical Considerations

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As an attorney representing veterinarians and veterinary practices, I have seen firsthand how rapidly the veterinary field has adapted to technological advancements, particularly telemedicine. The COVID-19 pandemic...more

Stotler Hayes Group, LLC

Leading Age Seeks Action on Senior Matters Before End of Congressional Session

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Leading Age, a community of nonprofit aging service providers, including long-term care organizations and hospices, is seeking congressional action before the swearing in of the incoming 119th Congress (on January 3, 2025),...more

Akin Gump Strauss Hauer & Feld LLP

National Institutes of Health Develops AI Algorithm to Identify Potential Volunteers for Clinical Trials

Researchers from the National Institutes of Health (NIH) have developed an algorithm that harnesses AI to help accelerate the process of matching potential volunteers for relevant clinical research trials. The algorithm,...more

Akin Gump Strauss Hauer & Feld LLP

FDA Announces Plan to Speed Up Public Notification About Potentially High-Risk Device Recalls

On November 21, 2024, FDA’s Center for Devices and Radiological Health (CDRH) announced a pilot program aimed at improving public notice about potentially high‑risk medical device recalls. The pilot seeks to reduce the time...more

Akin Gump Strauss Hauer & Feld LLP

AdvaMed, Releases AI White Paper

AdvaMed, the world’s largest medical technology association representing device, diagnostics and digital technology companies, released a white paper that reviews the current landscape of artificial intelligence (AI)-based...more

Davis Wright Tremaine LLP

CMS Finalizes Changes to the Medicare Parts A and B Overpayment Rule

In the Calendar Year 2025 Medicare Physician Fee Schedule, the Centers for Medicare & Medicaid Services (CMS) finalized changes to the Medicare Parts A and B Overpayment Rule that were proposed in two prior rulemakings. This...more

Holland & Hart LLP

The New HIPAA Reproductive Health Rule: What You Need to Know

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Healthcare providers must comply with the new HIPAA Reproductive Health Rule (the “Rule”) by December 23, 2024. Here is what you need to know and do before then. Overview. In the wake of Dobbs v. Jackson Women’s Health...more

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