News & Analysis as of

Health Tax

Read need-to-know updates, commentary, and analysis on Health issues written by leading professionals.
Health Care Compliance Association (HCCA)

Compliance Program Effectiveness: Keep it Streamlined and Strategic

KISS takes on a new meaning in this podcast: Keep it Streamlined & Strategic. Keeping it streamlined and strategic is also the topic of a session at the 2025 HCCA Compliance Institute...more

Knobbe Martens

FDA Publishes Case Studies and User Guide for Rare Disease Drug Developers

Knobbe Martens on

Drug development programs face unique challenges in demonstrating the safety and effectiveness of drugs for treating rare diseases. The FDA’s Accelerating Rare disease Cures (ARC) Program started the Learning and Education to...more

Knobbe Martens

Two Bills Introduced to Target “Patent Thickets” and “Product Hopping”

Knobbe Martens on

On March 17, 2025, a bipartisan group of senators introduced two bills intended to decrease the cost of prescription drugs. The sponsors include Chuck Grassley (R-Iowa), John Cornyn (R-Texas), Richard Blumenthal (D-Conn.),...more

Knobbe Martens

National Institutes of Health (NIH) Announces Plan to Centralize Peer Review Process

Knobbe Martens on

On March 6, 2025, the National Institutes of Health (NIH) announced plans to centralize peer review of all applications for grants, cooperative agreements and research and development contracts within its Center for...more

Ballard Spahr LLP

Republican Senators seek to use CRA to void medical debt rule

Ballard Spahr LLP on

Republican senators have introduced a Congressional Review Act resolution to nullify the rule that bans banks and credit unions from including medical debt on credit reports and generally prohibits the use of medical...more

Husch Blackwell LLP

Litigation Looms: ERIC Seeks Stay on 2024 Mental Health Parity Rule Enforcement

Husch Blackwell LLP on

On February 20, 2025, the ERISA Industry Committee (ERIC) announced that its legal counsel submitted a letter to the U.S. Departments of Labor (DOL), Health and Human Services (HHS) and Treasury, requesting a stay of...more

Warner Norcross + Judd

OCR Enforcement Intensifies: Key Takeaways on Risk Analysis and Right of Access

Warner Norcross + Judd on

The Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services has renewed its focus on two critical areas of HIPAA compliance: risk analysis and individual right of access. These enforcement...more

Axinn, Veltrop & Harkrider LLP

Compounding Problems: Recent Decisions on Tirzepatide Highlight Interplay Between FDA Anti-Compounding Enforcement and Private...

Earlier this month, a federal district court denied the Outsourcing Facilities Association’s preliminary injunction motion, which sought to preclude FDA from taking enforcement action against compounded tirzepatide...more

Ropes & Gray LLP

Hospital & Health System Reimbursement Check Newsletter - MARCH 2025

Ropes & Gray LLP on

In the short time since taking office on January 20, President Donald Trump has taken executive actions calling for sweeping changes affecting the health care sector. While new administrations always bring changes, the speed...more

Husch Blackwell LLP

Eliminating the GRAS “Loophole”: Implications for Functional Foods and Beverages

Husch Blackwell LLP on

On March 10, 2025, the U.S. Department of Health and Human Services (HHS) announced that U.S. Secretary of HHS Robert F. Kennedy Jr. directed the U.S. Food and Drug Administration (FDA) to explore closing the GRAS...more

King & Spalding

NY Department of Health Issues Clarifying FAQs on Healthcare Transaction Notice Law

King & Spalding on

Earlier this month, the New York State Department of Health (DOH) released its first formal guidance under Public Health Law (PHL) Article 45-A, the state’s recently enacted healthcare transaction notice law. Issued in the...more

Davis Wright Tremaine LLP

Stay ADvised: 2025, Issue 6

Reckitt Benckiser Tastes Sweet Success as Mucinex Honey False Ad Dismissed - Plaintiffs alleging that Reckitt Benckiser falsely advertised certain Mucinex products as containing honey failed to sufficiently allege that the...more

Holland & Hart LLP

Healthcare in the West Is on Life Support: Legislative and Immigration Barriers Leave Physician Gaps Unfilled

Holland & Hart LLP on

Across the Mountain West—Colorado, Idaho, Montana, New Mexico, Utah, and Wyoming—physician shortages are straining healthcare systems, particularly in rural and frontier communities. In response, state legislatures in the...more

King & Spalding

Saudi Arabia Permits Foreign Investment in Pharmacies

King & Spalding on

The Kingdom of Saudi Arabia issued Royal Decree number M/195 dated 03/09/1446H (corresponding to 03/03/2025G) (the “Royal Decree”), allowing foreign investment in retail pharmacies. This is a significant development as...more

Epstein Becker & Green

Telehealth Cliff Averted, for Now (But September is Six Months Away)

Epstein Becker & Green on

The potential plunge off the telehealth cliff that we warned you about in our March 3, 2025, blog post has been averted, for now....more

Akerman LLP - HR Defense

Hospital Leaders: Are You Fully Prepared For the Rising Wave of H-1B Onsite Inspections in Healthcare Systems Nationwide? Let’s...

In recent months, hospitals and healthcare systems across the country have seen an increase in random and unannounced worksite inspections by immigration officers, particularly targeting H-1B nonimmigrant worker visa holders....more

Robins Kaplan LLP

The Robins Kaplan Justice Report - Vol. 19, No. 1 - March 2025

Robins Kaplan LLP on

A recent $2.75 million settlement by Robins Kaplan LLP has drawn attention to a troubling case of deliberate indifference to medical needs at Anoka County Jail (the “Jail”). Deyonta Green, who struggled with addiction issues,...more

Nelson Mullins Riley & Scarborough LLP

Gold Dome Report - Legislative Day 35 - March 2025

Much like construction happening with the legislative offices, gutting and stuffing began in earnest today — the 35th day of the legislative session. But we aren’t talking about the Georgia Capitol renovations that are...more

Arnall Golden Gregory LLP

Step by Step: FDA Cracks Down on Unauthorized Medical Device Modifications

The Food and Drug Administration recently issued a Warning Letter concerning unauthorized modifications made to a previously cleared medical device (i.e., 510(k)). ...more

McDonnell Boehnen Hulbert & Berghoff LLP

Newman v. Moore -- Down to a "Battle of the Experts"?

The dispute between the Judicial Council of the Federal Circuit and The Honorable Pauline Newman, Circuit Judge for the U.S. Court of Appeals for the Federal Circuit has been waging for more than a year (see links below). The...more

Hogan Lovells

HHS Secretary Directs FDA to Explore Rulemaking to Eliminate Self-GRAS Pathway

Hogan Lovells on

The Secretary of the U.S. Department of Health and Human Services (HHS), Robert F. Kennedy, Jr., recently issued a press release directing the Food and Drug Administration (FDA) to take steps to explore possible rulemaking to...more

McGuireWoods Consulting

Health Care Executive Orders And Legal Actions: Part Five

This is part five in a series of executive orders related to health care. Trump Recission of Biden Administration Executive Orders - Medicaid and the Affordable Care Act (ACA)...more

Knobbe Martens

Boston Scientific Agrees to Acquire Sonivie Ltd. For up to $540 Million

Knobbe Martens on

Boston Scientific recently announced it entered into a definitive agreement to acquire SoniVie Ltd. According to the press release, SoniVie is a privately held medical device company that developed the TIVUS Intravascular...more

McDermott+

2026 Medicare Advantage and Part D Final Rate Notice: What to Expect

McDermott+ on

Key Takeaways - - CMS is expected to issue the 2026 final rate notice for Medicare Advantage (MA) and Part D plans by April 7, 2025. - The January 2025 advance notice proposed policies that would increase payments to MA...more

Holland & Knight LLP

Holland & Knight Health Dose: March 25, 2025

Holland & Knight LLP on

Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more

56,308 Results
 / 
View per page
Page: of 2,253

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide