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FDA Finalizes LDT Regulation, with Significant Exceptions: Enforcement of Requirements Will Phase In over Four Years

On April 29, 2024, the Office of the Federal Register placed on display the Food and Drug Administration’s (FDA) final rule on the regulation of laboratory developed tests (LDTs). Set to be officially published on May 6, this...more

Analysis: CY 2025 Revisions to Medicare Advantage and Part D Rules Governing Agent, Broker and Third Party Compensation

On April 4, the Centers for Medicare & Medicaid Services (CMS) released the Contract Year (CY) 2025 Medicare Advantage (MA) and Medicare Part D Policy and Technical Changes final rule (“Final Rule”), which included revisions...more

Friday Evening Health Care Regulatory Blitz!

Happy Thanksgiving everyone. In a pre-holiday flurry, the Trump Administration has released four long-awaited health care policies impacting a wide range of health industry participants. On the drug pricing front, the...more

Interoperability and Information Blocking: What Providers, Payers and IT Developers Need to Know about New Enforcement Timelines

- On May 1, 2020, the ONC Interoperability, Information Blocking, and Health IT Certification Program Final Rule and the CMS Interoperability and Patient Access Final Rule were published in the Federal Register, marking the...more

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