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Baker Donelson

CMS Enacts New CLIA Regulations Effective January 2025

Baker Donelson on

On December 23, 2023, CMS issued its Final Rule, establishing new Clinical Laboratory Improvement Amendments (CLIA) regulations (the Final Rule). Several provisions only became effective December 28, 2024. CMS was driven to...more

Foley Hoag LLP

FDA Finalizes Guidance on Scientific Information on Unapproved Uses (SIUU) Communications

Foley Hoag LLP on

On January 6, 2025, FDA published a final version of its guidance document, “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products.” This...more

Womble Bond Dickinson

FDA Broadens Oversight of Lab-Developed Tests

Womble Bond Dickinson on

Lab-developed tests (LDTs) are laboratory tests where blood is drawn and placed in a test tube to help with identification, diagnosis, and treatment of diseases, conditions, and infections. Examples of LDTs are the COVID-19...more

Foley & Lardner LLP

Non-Competes: What the FTC’s Rule May Mean for Health Care & Life Sciences Providers

Foley & Lardner LLP on

On April 23, 2024, the U.S. Federal Trade Commission (FTC or Commission) finalized a rule, by a vote of 3-2, abolishing the vast majority of employee covenants not to compete across the United States (the Non-Compete Rule or...more

Epstein Becker & Green

SAMHSA Final Rule Regarding OTPs Expands Access, Increases Flexibility for Patients

Epstein Becker & Green on

On February 1, 2024, the Substance Abuse and Mental Health Services Administration (SAMHSA) issued a final rule revising 42 CFR Part 8, which regulates opioid treatment programs (OTPs). The final rule is the first update to...more

Quarles & Brady LLP

Key Considerations for Healthcare Providers Responding to Law Enforcement Requests

Quarles & Brady LLP on

Why is everyone talking about provider disclosures to law enforcement of late? The Senate Finance Committee authored a letter to Xavier Becerra, Secretary of the U.S. Department of Health and Human Services (HHS), outlining...more

Quarles & Brady LLP

California Follows the Lead of Other States in Heightening the Scrutiny of Health Care Transactions

Quarles & Brady LLP on

California is taking steps to broaden its regulatory oversight of health care related transactions, joining a growing list of states that have recently either attempted to or have been successful in enacting similar...more

Latham & Watkins LLP

Healthcare & Life Sciences: Drug Pricing Digest - November 2021

Latham & Watkins LLP on

Drug Pricing Initiatives: Late on Nov. 5, 2021, the House of Representatives passed H.R. 3684 (the Infrastructure Investment and Jobs Act). This $1 trillion infrastructure bill, which was passed earlier by the Senate, is part...more

Hogan Lovells

After a long and winding road, FDA finalizes much-debated “intended use” rule

Hogan Lovells on

On August 2, 2021, the U.S. Food and Drug Administration (FDA) published a final rule to amend its “intended use” regulations, codified at 21 CFR § 801.4 for medical devices and 21 CFR § 201.128 for drugs. This updated final...more

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