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Medical Devices › Beneficiaries

King & Spalding

Transitional Coverage for Emerging Technologies: CMS’s Latest, But Not Necessarily Greatest, Coverage with Evidence Approach

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On August 7, 2024, the Centers for Medicare & Medicaid Services (“CMS” or the “Agency”) issued a final procedural notice (“Notice”) outlining a new Medicare coverage pathway, aimed at achieving timelier and predictable access...more

Sheppard Mullin Richter & Hampton LLP

OIG Permits Medical Device Manufacturer’s Cost-Sharing Subsidies for Medicare Beneficiaries in Clinical Trial

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Last month, in the last advisory opinion issued by the Office of Inspector General (“OIG”) in 2023 – Advisory Opinion No. 23-11 (the “Opinion”) – OIG “blessed” an arrangement involving a medical device manufacturer (the...more

Paul Hastings LLP

Buyers Take Note: OIG Opinion Provides Insights on Physician-Owned Entities & Their Technologies

Paul Hastings LLP on

PART I- On April 20, 2022, the Office of Inspector General (“OIG”) of the Department of Health and Human Services (“HHS”) issued Advisory Opinion, No. 22-07 (“Opinion 22-07”), an informative opinion regarding arrangements...more

King & Spalding

France - A Charter for the Promotion of Medical Devices (Including IVD)

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An ordinance (« arrêté ») was published in the French Official Gazette of 8 March 2022 that sets out a quality charter overseeing the professional practices of individuals responsible for the presentation of educational...more

Morrison & Foerster LLP - Left Coast Appeals

This Week at The Ninth: FCRA Dicta and Medicare Channeling

Morrison & Foerster LLP - Left Coast Appeals on

This week, we examine two decisions confronting novel procedural issues. In the first, the Ninth Circuit sought to promote development of the law by encouraging courts to alter how they address claims under the Fair Credit...more

Hinshaw & Culbertson LLP

SCOTUS Declines Review in Case Allowing Health Care Provider to Pursue State Law Misrepresentation Claims Against ERISA Health...

Hinshaw & Culbertson LLP on

The United States Supreme Court recently denied certiorari in a Fifth Circuit case, United Healthcare Insurance Co. v. Access Mediquip LLC, that allowed a health care provider to pursue state law misrepresentation claims...more

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