Laws & Regulations

Labs Urge Lawmakers to Rescind FDA Rule on Lab-Developed Tests
Regulatory & Compliance Labs Urge Lawmakers to Rescind FDA Rule on Lab-Developed Tests

The call for legislative intervention to overturn the FDA's final rule on the regulation of laboratory-developed tests (LDTs) has intensified. The Association for Diagnostics and Laboratory Medicine (ADLM) has been at the forefront, urging lawmakers to take action against the FDA's new rule. This

Biden Administration Expands Mental Health Coverage in Private Plans
Regulatory & Compliance Biden Administration Expands Mental Health Coverage in Private Plans

The Biden administration has taken a remarkable step forward in mental health care by finalizing rules that expand mental health coverage standards in private insurance plans. This bold move aims to address the longstanding disparities between mental and physical health benefits, ensuring millions

How Are Drug Distributors Contributing to the Opioid Crisis Settlement?
Regulatory & Compliance How Are Drug Distributors Contributing to the Opioid Crisis Settlement?

The opioid crisis has left an indelible mark on American society, thrusting numerous stakeholders, particularly drug distributors, into the spotlight. The recent $300 million settlement by McKesson, Cardinal, and Cencora represents one of the latest significant efforts to address the multifaceted

Will HHS's Appeal Change the Use of Online Trackers in Healthcare?
Regulatory & Compliance Will HHS's Appeal Change the Use of Online Trackers in Healthcare?

The recent decision by the U.S. Department of Health and Human Services (HHS) to appeal a district court ruling on the use of online tracking technologies in healthcare has sent ripples through the industry. This legal battle pits concerns about patient data privacy against the operational needs of

Medicare's Rising Costs: The Impact of Semaglutide Coverage Analysis
Regulatory & Compliance Medicare's Rising Costs: The Impact of Semaglutide Coverage Analysis

Medicare, the federal health insurance program designed to serve individuals aged 65 and older, faces substantial financial challenges that are growing increasingly severe. Recently, a spotlight has been placed on the potential repercussions of including semaglutide, a high-cost medication

J&J's 340B Drug Program Changes Spark Legal and Financial Concerns
Regulatory & Compliance J&J's 340B Drug Program Changes Spark Legal and Financial Concerns

Johnson & Johnson (J&J), one of the leading pharmaceutical companies globally, has announced significant changes to its participation in the 340B drug discount program. Effective October 15, the company will cease providing upfront discounts on two key drugs and move to a rebate system instead,

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