News & Analysis as of

Food and Drug Administration (FDA) American Medical Association

ArentFox Schiff

Da Brat and The Latest (Rap) Battle: FDA Expected to Drop Sperm Donation Ban for Gay Men

ArentFox Schiff on

Under current US Food and Drug Administration (FDA) guidance, sexually active gay and bisexual men are prohibited from anonymously donating sperm. The FDA is expected to reverse this longstanding practice and adopt a system...more

Holland & Knight LLP

Holland & Knight Health Dose: February 6, 2024

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

McDermott Will & Emery

Remote Monitoring and Digital Therapies: CMS Updates Coverage and Payment Policies

McDermott Will & Emery on

In recent years, the Centers for Medicare & Medicaid Services (CMS) has expanded payment for remote monitoring services in an effort to pay for non-face-to-face services that improve care coordination for Medicare...more

Manatt, Phelps & Phillips, LLP

Access to Care for Justice-Involved Pregnant People With a Substance Use Disorder

There is a critical need to increase access to evidence-based care for justice-involved pregnant people with a substance use disorder (SUD)—and connect them to continued coverage and care upon release—according to national...more

Greenbaum, Rowe, Smith & Davis LLP

New Jersey Supreme Court Ruling Clarifies Standards for Punitive Damages in Medical Malpractice Actions

On August 25, 2022, the Supreme Court of New Jersey issued its decision in Rivera v. The Valley Hospital, Inc., reversing the trial judge’s interlocutory order denying the defendants’ motions to dismiss a claim for punitive...more

ArentFox Schiff

Triaging “Ivermania”: Recent Court Decisions Provide Guidance to Hospitals on Responding to Demands for Debunked COVID-19...

ArentFox Schiff on

As the COVID-19 pandemic continues, hospitals and other health care providers are facing a separate challenge: “Ivermania”—the wave of lawsuits filed against hospitals by guardians of COVID-19 patients seeking court orders...more

Benesch

Dialysis & Nephrology Digest - January 2022

Benesch on

Benesch reviews state, federal modifications to restrictive covenant laws - In a “Year-End Review,” Benesch points out there was considerable activity in trade secret and restrictive covenant law in 2021. Some of the...more

Womble Bond Dickinson

Here Comes the Sun — The Latest on Sunscreen Safety

Womble Bond Dickinson on

With all of the challenges to public health during the Summer of 2020, there is some comfort in the Centers for Disease Control’s (CDC) recommendation that fresh air and sunshine is beneficial. For decades, sunscreen has been...more

Akin Gump Strauss Hauer & Feld LLP

New CMS National Coverage Determination and FDA Regulatory Approach: the Next Generation for NGS Testing Policy?

• The new national Medicare coverage determination covers only FDA-authorized NGS tests with companion diagnostic indications, leaving NGS cancer tests without that specific indication to seek coverage from local Medicare...more

Patrick Malone & Associates P.C. | DC Injury...

Consumers beware: There’s lots of ugly in beauty products

The quest for beauty—whether skin deep or in the eye of the beholder—not only carries high costs. It also can be health risky. Jane Brody reminds us in the New York Times that due “to a lack of federal regulations, the...more

Morgan Lewis

FDA Issues Final Guidance for General Wellness Devices

Morgan Lewis on

The final guidance confirms FDA’s enforcement discretion for many fitness and wellness technologies but raises issues for certain testing services. On July 29, the US Food and Drug Administration (FDA) announced the...more

Patrick Malone & Associates P.C. | DC Injury...

Did drug maker fuel abuse by insisting that OxyContin works for 12 hours?

OxyContin in two decades not only has become a highly profitable, exceedingly popular prescription, it also has become one of the nation’s most abused painkillers-for a crucial reason, the Los Angeles Times says. The paper...more

Mintz - ML Strategies

Health Care Update - November 2015 #3

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Drug Pricing Issues Heat Up Following HHS Forum - Last week, the Department of Health and Human Services (HHS) hosted a forum on prescription drug costs which featured players from every corner of the industry, including...more

Foley & Lardner LLP

Navigating the Diagnostic Commercialization Process

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Guest Post By: Perry Dimas, Senior Vice President and General Manager for Premier Source, part of AmerisourceBergen The 2015 Business of Personalized Medicine Summit was an inspiring day with talented professionals. One...more

McGuireWoods LLP

Washington Healthcare Update

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This Week: House Energy and Commerce Subcommittee Holds Hearing on Legislation to Strengthen Medicaid Program Integrity and Fraud Controls... Bipartisan Senate Bill Introduced to Stop Anti-Competitive “Pay-For-Delay”...more

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