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Federal mental health parity proposed rules target health plans and issuers

Declaring that “too often” health plans and health insurance issuers are not complying with the Mental Health Parity and Addiction Equity Act of 2008 (“MHPAEA”), the ...

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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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A Break for Breakthrough Devices? CMS Issues Transitional Coverage for Emerging Technologies Notice

On June 22, 2023, the Centers for Medicare & Medicaid Services (CMS) released a Notice with Comment Period (Notice) proposing a new Transitional Coverage for Emerging Technologies...

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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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MEDCAC Coverage with Evidence Development meeting offers CMS guidance on CED study requirements

On February 13-14, 2023, the Centers for Medicare & Medicaid Services (CMS) convened a virtual panel of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) to...

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CMS issues Medicare Part B and Part D inflation rebate guidance

On February 9, 2023, the Centers for Medicare & Medicaid Services (CMS) published two “initial” guidance documents implementing the Medicare Part B and Part D inflation...

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Senate passes drug pricing legislation

On August 7, 2022, the Senate passed the proposed Inflation Reduction Act of 2022, which includes a number of significant drug pricing-related provisions. The bill generally revives...

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U.S. House passes drug pricing legislation

This morning, the U.S. House passed drug pricing legislation as part of the Build Back Better Act (BBBA) (specifically the Rules Committee version available here and the manager’s...

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Expedited breakthrough device coverage, “reasonable and necessary” definition delayed until Dec. 15

On May 14, 2021, the Centers for Medicare & Medicaid Services (CMS) released a display copy of a Final Rule (Final Rule) further delaying the effective date of the Medicare Coverage of...

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