Taylor Andelman

Jul 5, 2024 | mddionline.com | Donielle McCutcheon |Taylor Andelman

Recruiting and retaining study subjects remains a significant challenge for medical device companies that are innovating and sponsoring clinical trials, particularly when designing studies that reflect the diversity of the national population. Difficulties enrolling eligible study subjects can lead to significant study delays and can be costly for trial sponsors, extending the timeline that patients need to wait to obtain access to safe, effective, and important medical technologies.

Jul 1, 2024 | mddionline.com | Donielle McCutcheon |Taylor Andelman

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Apr 9, 2024 | lexology.com | Jon Zucker |Jaime L.M. Jones |Francesca R. Ozinal |George Maliha M.D |Taylor Andelman

The U.S. Centers for Medicare and Medicaid Services (CMS) published a final rule on April 4, 2024 that overhauls the regulations governing insurance agent and broker compensation rates and agreements for Medicare Advantage Plans (MAPs) and Medicare Part D Plans (PDPs). The final rule, which adopts the majority of the changes from the proposed rule that we previously discussed here, is intended to establish additional guardrails to protect beneficiaries and support competition within the industry.

Nov 21, 2023 | lexology.com | Jon Zucker |Meenakshi Datta |Taylor Andelman

The U.S. Centers for Medicare and Medicaid Services (CMS) published a proposed rule on November 15, 2023 that would overhaul the regulations governing insurance agent and broker compensation rates and compensation agreements for Medicare Advantage plans (MAPs) and Medicare Part D plans (PDPs). The proposal follows CMS’ final rule revising the regulations governing marketing by MAPs issued on April 5, 2023, which we covered in a prior Sidley Update here.

Jul 11, 2023 | lexology.com | Stephanie P. Hales |Meenakshi Datta |William A. Sarraille |Trevor L. Wear |Taylor Andelman

On June 22, 2023, the Centers for Medicare and Medicaid Services (CMS) released a Notice With Comment Period outlining a proposed Transitional Coverage for Emerging Technologies (TCET) pathway under Medicare that would be available for certain devices that the Food and Drug Administration (FDA) has designated as Breakthrough Devices. Comments are due by August 28, 2023.