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Medical Devices › Biologics › Medicare

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

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in Q3 2023 and Beyond

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As the life sciences industry continues to expand and grow increasingly complex, so does its legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving and emerging laws and...more

Alston & Bird

Alston & Bird Healthcare Week in Review

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On November 15, 2017, the Food and Drug Administration (FDA) issued a draft guidance entitled, Assessing User Fees Under the Biosimilar User Fee Amendments of 2017. The Biosimilar User Fee Amendments of 2017 (BsUFA II)...more

Alston & Bird

A&B Healthcare Week in Review

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I. REGULATIONS, NOTICES, & GUIDANCE - On April 4, 2016, the Centers for Medicare & Medicaid Services (CMS) issued the Final Calendar Year (CY) 2017 Medicare Advantage Capitation Rates and Medicare Advantage (MA) and...more

Alston & Bird

A&B Healthcare Week in Review

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I. REGULATIONS, NOTICES, & GUIDANCE - On March 24, 2016, the Food and Drug Administration (FDA) issued a guidance entitled, “Draft Guidance for Industry: General Principles for Evaluating the Abuse Deterrence of Generic...more

Alston & Bird

A&B Healthcare Week in Review

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I. REGULATIONS, NOTICES, & GUIDANCE - On March 8, 2016, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule entitled, “Medicare Program; Part B Drug Payment Model.” The proposed rule seeks...more

McGuireWoods LLP

Washington Healthcare Update

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On Oct. 8, the House Republican caucus did not select a candidate for Speaker of the House and selection has been delayed. The current Speaker, John Boehner (R-OH), had announced that he would step down and retire from...more

McGuireWoods LLP

Washington Healthcare Update

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This Week: House E&C 21st Century Cures Bill Passes Unanimously Out of Committee... House Votes to Codify Permanent R&D Tax Credit... CMS Released Proposed Rule Concerning Medicaid and CHIP Plans....more

Wilson Sonsini Goodrich & Rosati

CMS Issues Final Rule for Implementing Sunshine Act

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On February 8, 2013, 16 months after the statutory deadline, the Centers for Medicare & Medicaid Services (CMS) published in the Federal Register the final regulation implementing the physician payment transparency...more

Perkins Coie

CMS Issues Final Physician Payment Sunshine Act Regulations

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On February 1, 2013, the Centers for Medicare and Medicaid Services (CMS) published the long-awaited final regulations implementing the Physician Payment Sunshine Act (Act or Sunshine Act). The Sunshine Act requires drug,...more

Mintz - Health Care Viewpoints

CMS Publishes Final Sunshine Act Rule

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This afternoon, the Centers for Medicare & Medicaid Services (CMS) released the long-awaited final rule (Final Rule) implementing the Physician Payments Sunshine Act (Sunshine Act). The Sunshine Act requires manufacturers of...more

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