News & Analysis as of

Medical Devices Proposed Rules Health Care Providers

Benesch

CMS Proposes Overhaul of Skin Substitute Reimbursement Policy Beginning January 2026 - Implications for Providers, Manufacturers,...

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On July 16, 2025, the U.S. Department of Health and Human Services’ (HHS) Centers for Medicare & Medicaid Services (CMS) published its CY 2026 Medicare Physician Fee Schedule (PFS) Proposed Rule, which includes a sweeping...more

Alston & Bird

Health Care Week in Review | Trump Administration Releases FY 2026 Budget Proposal; CMS Launches Oversight Initiative on Medicaid...

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Alston & Bird

Health Care Week in Review | White House Issues Executive Orders on Biosecurity and Domestic Drug Production; House Committee...

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Benesch

Dialysis & Nephrology Digest - October 2024

Benesch on

The House Ways and Means Committee has postponed discussions on several healthcare bills, including those related to physician pay, due to scheduling conflicts and disagreements over legislative language. This delay affects...more

American Conference Institute (ACI)

[Event] Drug & Medical Device Litigation - December 5th - 6th, New York, NY

Hosted by American Conference Institute, the 28th Annual Conference on Drug & Medical Device Litigation returns for another exciting year with curated programming and networking opportunities with 400+ industry...more

Akin Gump Strauss Hauer & Feld LLP

ONC Proposes Sweeping Health IT Certification Program Requirements for “Predictive Decision Support Interventions”—Featuring...

On April 18, 2023, the U.S. Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology (ONC) published a far-reaching proposed rule, Health Data, Technology, and...more

McDermott Will & Schulte

CMS Clarifies Coverage and Payment for Remote Therapeutic Monitoring Services

On November 1, 2022, the US Centers for Medicare & Medicaid Services (CMS) released the calendar year (CY) 2023 final rule for services reimbursed under the Medicare Physician Fee Schedule (MPFS) (the Final Rule). The Final...more

Alston & Bird

Alston & Bird Health Care Week in Review - April 2022 #3

Alston & Bird on

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Alston & Bird

Alston & Bird Health Care Week in Review - January 2022 #3

Alston & Bird on

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and...more

Goodwin

Exactly One Year Later, CMS Reverses Course on Covering Innovative MedTech

Goodwin on

In September 2020, the Centers for Medicare & Medicaid Services (CMS) proposed a new rule that would expedite Medicare coverage for medical technology approved through the Food & Drug Administration’s (FDA’s) “Breakthrough...more

Troutman Pepper Locke

FDA Proposes Modified “Intended Use” Regulations

Troutman Pepper Locke on

In its latest effort to provide direction and clarity to regulated industry and stakeholders, on September 23, the U.S. Food and Drug Administration (FDA) published a proposed rule and preamble amending its medical product...more

Hogan Lovells

A bit more Sunshine: CMS proposes collecting additional information on manufacturer payments under the Open Payments program

Hogan Lovells on

Device and drug manufacturers got a small surprise in the annual Physician Fee Schedule proposed rule (at 40,713-16) issued late in July by the Centers for Medicare & Medicaid Services (CMS) – among many other things, the...more

Akin Gump Strauss Hauer & Feld LLP

CMS Issues Proposed Revisions to Open Payments/Sunshine Act Reporting Requirements

• On July 29, 2019, CMS released its proposed 2020 Physician Fee Schedule rule, which includes the much anticipated proposed regulatory changes to the Sunshine Act/Open Payments program (“Open Payments”). The proposed...more

Akin Gump Strauss Hauer & Feld LLP

CMS Proposes Several Changes to Reimbursement for Transformative Medical Technologies

• In recent proposed rulemaking, the Centers for Medicare and Medicaid Services (CMS) make several significant recommendations that incentivize innovation and break down patient barriers to accessing cutting-edge medical...more

Wilson Sonsini Goodrich & Rosati

CMS Proposes New Add-On Payment Pathway for Breakthrough Medical Devices

On April 23, 2019, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule, which describes CMS' efforts to transform "the healthcare delivery system through competition and innovation to provide patients...more

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