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Dentons

Ep. 57 – Implementing Effective Drug Diversion Prevention Programs

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Drug diversion can pose serious risks to patients, employees, and organizations. Any provider who stores, transports, or dispenses controlled substances should have a robust program designed to deter drug diversion and to...more

Polsinelli

CMS Spring Provider Enrollment Updates

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Centers for Medicare & Medicaid Services (CMS) released several pieces of Medicare provider enrollment guidance this spring, both emphasizing current policy and requirements as well as providing guidance and clarification...more

Kelley Drye & Warren LLP

NAAG Attorney General Symposium 2025

Last week, the Kelley Drye State AG team attended the National Association of Attorneys General (NAAG) Attorney General Symposium. The panels included a number of topics of importance to state attorneys general including cell...more

Arnall Golden Gregory LLP

SNF Off-Cycle CMS-855A Reporting Delayed to August 1, 2025

Mandatory Medicare reporting for skilled nursing facilities (“SNFs”) has been delayed to August 1, 2025, to the relief of many in the industry. As a reminder, the Centers for Medicare & Medicaid Services (“CMS”) required the...more

Arnall Golden Gregory LLP

Court Strikes Down Nursing Home Minimum Staffing Rule

On April 7, 2025, the United States District Court for the Northern District of Texas ruled in favor of the American Health Care Association (“AHCA”) in its lawsuit against Health and Human Services (“HHS”) Secretary Robert...more

DLA Piper

Department of Commerce Announces Section 232 Pharmaceutical Investigation

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The Trump Administration issued a notice on Monday titled, “Notice of Request for Public Comments on Section 232 National Security Investigation of Imports of Pharmaceuticals and Pharmaceutical Ingredients,” which could serve...more

Alston & Bird

Commerce Seeks Comments on Section 232 Pharmaceutical Investigation

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Yesterday, April 16, 2025, the Bureau of Industry and Security (BIS), a bureau within the U.S. Department of Commerce, published a “Notice of Request for Public Comments on Section 232 National Security Investigation of...more

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

Federal Judge in Pennsylvania Reverses Dismissal of Medical Marijuana Cardholder’s Disability Discrimination Claim

On April 11, 2025, a federal judge for the U.S. Western District of Pennsylvania reversed his recent decision to dismiss a disability discrimination claim from a job applicant with a medical marijuana card who alleged he had...more

Holland & Knight LLP

CMS Moves Skilled Nursing Facility Revalidation Deadline to Aug. 1

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The Centers for Medicare & Medicaid Services (CMS) again has delayed the deadline for its mandatory provider revalidation program for skilled nursing facilities (SNFs), this time to Aug. 1, 2025. The change was made because...more

Venable LLP

Spotlight On: Lantus® / Lantus® SoloSTAR® (insulin glargine recombinant) / Basaglar® (insulin glargine) / Semglee® (insulin...

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Insulin Glargine Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple...more

Stark & Stark

What Every Parent Should Know About Childhood Concussions and Long-Term Learning

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We all know that childhood is full of bumps, bruises, and yes—sometimes concussions. A tumble off a bike, a collision on the soccer field—it happens. But what if those head injuries, even the “mild” ones, could echo into your...more

Benesch

Dialysis & Nephrology Digest - April 2025

Benesch on

ESRD ETC among value-based care models being ended early by CMS - This decision to end the ESRD ETC payment model and several others on Dec. 31 aligns with CMS’ goal to focus on models that demonstrate potential for...more

Knobbe Martens

An Alternative for Treating Mitral Regurgitation Receives Support for Ongoing Trial

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Mitral regurgitation is the most common form of valvular heart disease and affects around 10% of Americans over 75. It occurs when the mitral valve, which is located between the left atrium and the left ventricle, doesn’t...more

Downs Rachlin Martin PLLC

Mass General Brigham study offers promise that nasal spray targeting neuroinflammation could become an effective treatment for TBI

The secondary cascade, although a normal physiological response, can contribute to ongoing neuroinflammation, oxidative stress and axonal injury, continuing in some cases years after the initial insult.  There is no clearly...more

Fox Rothschild LLP

UPDATE: SNFs Receive Even More Time to Complete Off-Cycle Revalidation

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In October, we broke down the required off-cycle Medicare revalidation of all Skilled Nursing Facilities (SNFs) in an Alert and related blog post. We were happy to announce in November that CMS extended the deadline for SNFs...more

Wiley Rein LLP

Virginia Enacts Amendments to Consumer Protection Act

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Virginia recently amended its Consumer Protection Act (the Act) to provide enhanced protection for reproductive and sexual health information. These protections take effect on July 1, 2025. The amendment prohibits a...more

Axinn, Veltrop & Harkrider LLP

Federal Circuit Holds Generic’s Hatch-Waxman Litigation Expenses Deductible

A March 21 Federal Circuit decision in Actavis Laboratories FL, Inc. v. United States, No. 23-1320 (Fed. Cir. Mar. 21, 2025) marked a victory for generic drug developers, affirming that legal expenses incurred defending...more

Cozen O'Connor

Illinois Insights: An update from Cozen O'Connor (4/16)

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Gov. Pritzker, other Governors issue joint letter in response to CMS Proposed Rule - “Multiple governors, including Illinois Governor JB Pritzker, issued a join letter to the director of the Centers for Medicare & Medicaid...more

Morgan Lewis

FDA Drug Inspections Post–Workforce Reductions: Potential Implications and Practical Steps Forward

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The US Food and Drug Administration (FDA) is confronted with significant challenges in its inspection processes due to recent layoffs. Among other effects, the latest reduction in force of full-time FDA employees is raising...more

Sheppard Mullin Richter & Hampton LLP

CMS to Withdraw Federal Medicaid Match for Workforce, Social Needs, and Infrastructure: What States, Health Care Providers and...

In a move signaling a major shift in federal priorities, the Centers for Medicare & Medicaid Services (“CMS”) recently announced it will limit federal funding for state Medicaid initiatives that support services beyond direct...more

McDermott Will & Emery

New Rx for High Drug Prices? Senate Judiciary Committee Advances Six Bills With Heavy Dose of Options

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The US Senate Judiciary Committee advanced to the full Senate six bills intended to reduce pharmaceutical prices and enhance market competitiveness. The package collectively targets several aspects of the pharmaceutical...more

BCLP

PFAS Air Emissions Restrictions

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When evaluating legal risk relating to per- and polyfluoroalkyl substances (“PFAS”), most businesses typically consider wastewater, groundwater, or soil impacts, not air emissions. However, state and federal regulatory...more

Husch Blackwell LLP

Navigating Compliance Risks in Laboratory Operations—Key Lessons from a Recent FCA Case

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A recent False Claims Act (FCA) litigation—Jensen ex rel. United States of America v. Genesis Laboratory—highlights critical compliance risks for laboratories. This case reinforces the need for laboratories to ensure...more

MG+M The Law Firm

Masks on for Spring Cleaning: New Study Reveals Household Dust may be an Additional PFAS Exposure Source

MG+M The Law Firm on

A new study from the North Carolina State University’s GenX Exposure Study has detected airborne “forever chemicals” in everyday household dust in communities along the Cape Fear River Basin, North Carolina area. These...more

Pierce Atwood LLP

OSHA in 2025: Observations and Expectations

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The beginning of the second Trump administration has left employers asking myriad questions with respect to the Occupational Safety and Health Administration (OSHA). Are there plans to eliminate OSHA? Will inspections and...more

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