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Supreme Court affirms constitutionality of U.S. Preventive Services Task Force

On June 27, 2025, the Supreme Court in Kennedy v. Braidwood Management, Inc. upheld the structure of the U.S. Preventive Services Task Force (USPSTF, or “Task Force”), overturning a Fifth Circuit decision that had ruled that...more

AI Summit panelists offer tips for obtaining reimbursement for innovative health care technology

Hogan Lovells and the AI Health Care Coalition recently hosted their fourth annual AI Health Law & Policy Summit, where thought leaders and policymakers gathered to discuss a variety of topics including reimbursement issues...more

AI Health Law & Policy: Remote patient monitoring reimbursement & coding concerns

Remote patient monitoring (RPM) (oftentimes incorporating artificial intelligence (AI) to analyze data) uses technology to track a patient's physiologic data, such as vital signs, medication adherence, and activity levels,...more

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 Innovative Technology (MCIT) and...more

CMS finalizes “reasonable and necessary” definition, expedited breakthrough device coverage process

On January 14, 2021, the Centers for Medicare & Medicaid Services (CMS) published a final rule that, for the first time, adopts a regulatory standard for determining whether a particular item or service is “reasonable and...more

CMS proposes “reasonable and necessary” definition, expedited breakthrough device coverage process

On Tuesday, September 1, 2020, the Centers for Medicare & Medicaid Services (CMS) published a proposed rule addressing the Medicare coverage standard and expedited coverage for certain medical devices. If finalized, the...more

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