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HRSA issues 340B Program final rule modifying administrative dispute resolution process

On April 19, 2024, the Health Resources and Services Administration (HRSA) published a final rule (Final Rule) in the Federal Register adopting several changes to the current administrative ...

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CMS finalizes regulation specifying all covered prescriptions drugs are essential health benefits

On April 2, 2024, the Centers for Medicare & Medicaid Services (CMS) released the 2025 Notice of Benefit and Payment Parameters (NBPP) final rule (Final Rule), finalizing policies...

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Court rules for PhRMA in challenge to Oregon drug price transparency law

On February 16, 2024, the U.S. District Court for the District of Oregon issued a ruling in Pharmaceutical Research and Manufacturers of America (PhRMA) v. Stolfi, granting in part...

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CMS Issues Revised Medicare Part B and Part D Inflation Rebate Guidance

On December 14, 2023, the Centers for Medicare & Medicaid Services (CMS) published two “revised” guidance documents implementing the Medicare Part B and Part D inflation...

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CMS Issues Final Guidance on the Inflation Reduction Act (IRA) Drug Price Negotiation Program

On July 3, 2023, the Centers for Medicare & Medicaid Services (CMS) issued its final guidance on the Drug Price Negotiation Program established by the IRA. CMS showed some willingness...

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NY physician practice, MSO, and other health care transactions affected by new reporting rules

The New York legislature recently enacted new reporting requirements that will affect health care transactions across the state. Effective August 1, 2023, certain “material”...

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NY physician practice, MSO, and other health care transactions affected by new reporting rules

The New York legislature recently enacted new reporting requirements that will affect health care transactions across the state. Effective August 1, 2023, certain “material”...

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CMS issues initial guidance on Drug Price Negotiation Program

On March 15, 2023, the Centers for Medicare & Medicaid Services (CMS) issued initial guidance on the Drug Price Negotiation Program, which was established under the Inflation Reduction...

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After the Public Health Emergency: Implications for Medicare and U.S federal health care policies

On January 30, 2023, the Biden Administration announced that it intends to allow the COVID-19 national emergency and public health emergency (collectively, “PHE”) to expire...

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