Victoria Wallace on Medicare

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

5/28/2025 / Artificial Intelligence , Centers for Medicare & Medicaid Services (CMS) , Health Insurance , Health Technology , Hospitals , Medical Coding , Medical Devices , Medicare , Physicians

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

4/22/2025 / Artificial Intelligence , Health Care Providers , Health Insurance , Medicare , Regulatory Requirements

CMS Proposes Guidance on Use of Real World Data for Coverage with Evidence Development

Real world data (RWD), which is data from actual patient treatments, provides valuable information on safety and effectiveness of innovative new health technologies, often at significantly lower cost than evidence generated...more

2/5/2025 / Centers for Medicare & Medicaid Services (CMS) , Data Collection , Health Technology , Medical Devices , Medicare , New Guidance

Breaking News for Breakthrough Devices: CMS Finalizes Transitional Coverage for Emerging Technologies Pathway

On August 7, 2024, the Centers for Medicare & Medicaid Services (CMS) released a Final Notice for Transitional Coverage for Emerging Technologies (TCET) (Final Notice). The long-anticipated Final Notice on the TCET pathway...more

8/14/2024 / Centers for Medicare & Medicaid Services (CMS) , Food and Drug Administration (FDA) , Health Care Providers , Medical Devices , Medicare

Tortoise and Hare: Congress may overtake CMS in years-long race to set Medicare breakthrough device coverage

On June 27, 2024, the Ensuring Access to Breakthrough Products Act of 2024 (H.R. 1691) was marked up and reported out of the House Ways and Means Committee. This action brings Medicare beneficiaries one step closer to timely...more

7/3/2024 / Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Medical Devices , Medicare , Medicare Administrative Contractors (MAC)

Reform urged to facilitate payment & coverage of AI medical services in the U.S.

We recently hosted our 3rd annual AI Health Law & Policy Summit in Washington, DC where government and industry representatives joined members of the Hogan Lovells team to discuss new and emerging global health care AI...more

5/30/2024 / Artificial Intelligence , Health Care Providers , Hospitals , Medicare

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 (TCET) pathway. 88 Fed. Reg. 41,633 (Jun. 27,...more

6/28/2023 / Centers for Medicare & Medicaid Services (CMS) , Food and Drug Administration (FDA) , Medical Devices , Medicare

When being a little bit square is a good thing: CMS AppliedVR decision shows how innovative technology can secure a payment...

While the Medicare statute provides access to healthcare services for our nation’s elderly and disabled populations, it also can serve to foreclose access for those populations when an item or service does not fall within one...more

3/28/2023 / Biologics , Centers for Medicare & Medicaid Services (CMS) , HCPCS , Health Care Providers , Innovative Technology , Medicare , Virtual Reality

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 evaluate changes to the criteria for clinical...more

2/23/2023 / Centers for Medicare & Medicaid Services (CMS) , Health Care Providers , Medicare

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

5/18/2021 / Centers for Medicare & Medicaid Services (CMS) , Health Insurance , Medical Devices , Medicare , Medicare Part A , Medicare Part B , Reasonable and Necessary Expenses

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

On March 17, 2021, the Centers for Medicare & Medicaid Services (CMS) published a notice in the Federal Register delaying the effective date of the final rule titled, “Medicare Program; Medicare Coverage of Innovative...more

3/18/2021 / Centers for Medicare & Medicaid Services (CMS) , Comment Period , FDA Approval , Food and Drug Administration (FDA) , Innovative Technology , Life Sciences , Medical Devices , Medicare , Pharmaceutical Industry

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

9/2/2020 / Centers for Medicare & Medicaid Services (CMS) , Food and Drug Administration (FDA) , Health Insurance , Healthcare Reform , Medical Devices , Medicare , Medicare Program Integrity Manual (MPIM) , Pharmaceutical Industry , Regulatory Standards , Scope of Coverage

U.S. Supreme Court ruling expands scope of Medicare notice-and-comment requirement

On 3 June 2019 the U.S. Supreme Court held in Azar v. Allina Health Services that Medicare interpretive guidance must go through notice-and-comment if it establishes or changes a substantive legal standard governing payment,...more

6/10/2019 / Administrative Procedure Act , Azar v Allina Health Services , Department of Health and Human Services (HHS) , Hospitals , Low-Income Issues , Medicare , Medicare Advantage , Medicare Part A , Medicare Part C , Notice and Comment , Pay Reductions , Provider Payments , Reaffirmation , Retroactive Application , SCOTUS , Substantive Rule , Vacated

Victoria Wallace

Hogan Lovells

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