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Alston & Bird

Health Care Week in Review | Senate Finance Committee Releases Budget Reconciliation Text; SCOTUS Upholds TN Ban on...

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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

McDermott Will & Schulte

FDA Relaxes Critical Positions on Use of Scientific Information in Off-Label Communications

On January 6, 2025, the US Food and Drug Administration (FDA) published final guidance titled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical...more

Foley Hoag LLP

FDA Finalizes Guidance on Scientific Information on Unapproved Uses (SIUU) Communications

Foley Hoag LLP on

On January 6, 2025, FDA published a final version of its guidance document, “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products.” This...more

Womble Bond Dickinson

FDA Broadens Oversight of Lab-Developed Tests

Womble Bond Dickinson on

Lab-developed tests (LDTs) are laboratory tests where blood is drawn and placed in a test tube to help with identification, diagnosis, and treatment of diseases, conditions, and infections. Examples of LDTs are the COVID-19...more

Akin Gump Strauss Hauer & Feld LLP

FDA Finalizes Guidance on Communication of Unapproved Uses of Approved or Cleared Medical Products

On January 6, 2025, the FDA released final guidance for industry entitled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions...more

Ropes & Gray LLP

FDA Finalizes Guidance on Communication of Scientific Information on Unapproved Uses and Releases Updated First Amendment Analysis

Ropes & Gray LLP on

On January 7, 2025, FDA published a final guidance entitled Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products - Questions and Answers...more

Holland & Knight LLP

CMS Releases CY 2025 OPPS and ASC Final Rule

Holland & Knight LLP on

The Centers for Medicare & Medicaid Services (CMS) has released the calendar year (CY) 2025 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System Final Rule with comment...more

McDermott Will & Schulte

Remote Monitoring and Digital Therapies: CMS Updates Coverage and Payment Policies

McDermott Will & Schulte on

In recent years, the Centers for Medicare & Medicaid Services (CMS) has expanded payment for remote monitoring services in an effort to pay for non-face-to-face services that improve care coordination for Medicare...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

King & Spalding

AdvaMed Updates Code of Ethics on Interactions with HCPs: What’s the Impact on MedTech?

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On March 18, 2022, the Advanced Medical Technology Association (“AdvaMed”) announced revisions to its Code of Ethics on Interactions with Health Care Professionals (“Code”). The revised Code will take effect June 1, 2022. ...more

Hogan Lovells

After a long and winding road, FDA finalizes much-debated “intended use” rule

Hogan Lovells on

On August 2, 2021, the U.S. Food and Drug Administration (FDA) published a final rule to amend its “intended use” regulations, codified at 21 CFR § 801.4 for medical devices and 21 CFR § 201.128 for drugs. This updated final...more

Nilan Johnson Lewis PA

Anti-Kickback Statute and Stark Law Regulations: Final Rules Issued

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On November 20, 2020, the Department of Health and Human Services (HHS) published two final rules that aim to reduce regulatory barriers to care coordination and accelerate the transformation of the healthcare system to...more

Baker Donelson

Medicare Spreads Sunshine Act Coverage to New Categories of Payments, Recipients

Baker Donelson on

On November 15, 2019, the Centers for Medicare and Medicaid Services ("CMS") finalized changes to the Open Payments Program as part of the CY 2020 Physician Fee Schedule Final Rule....more

King & Spalding

CMS Publishes Final Rule for CY 2020 Hospital Outpatient Prospective Payment System

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n November 1, 2019, CMS posted the final rule establishing the payment rates for the Hospital Outpatient Prospective Payment System (OPPS) and the Ambulatory Surgery Center (ASC) Payment System for calendar year (CY) 2020...more

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