Stuart Langbein on Medical Devices

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)

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

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 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

1/18/2021 / Centers for Medicare & Medicaid Services (CMS) , Health Insurance , Health Technology , Healthcare Reform , Medical Devices , Reasonable and Necessary Expenses

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

CMS proposes changes to new-technology add-on payment amounts and criteria in the inpatient prospective payment system proposed...

On 23 April 2019 the Centers for Medicare & Medicaid Services (CMS) issued the inpatient prospective payment system (IPPS) and long-term care hospital (LTCH) prospective payment system proposed rule for fiscal year (FY) 2020...more

4/29/2019 / Add-ons , Centers for Medicare & Medicaid Services (CMS) , Health Care Providers , Inpatient Prospective Payment System (IPPS) , Life Sciences , Long Term Care Facilities , Medical Devices , Payment Systems , Regulatory Agenda , Request For Information , Rulemaking Process

Stuart Langbein

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