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Regulatory Requirements › Healthcare › Comment Period

Tucker Arensberg, P.C.

CMS Unveils 2026 Physician Fee Schedule Proposal: Key Changes Ahead

Tucker Arensberg, P.C. on

On July 14, the Centers for Medicare & Medicaid Services (CMS) released its proposed rule for the 2026 Physician Fee Schedule. As expected, there are several meaningful updates that providers, practices, and health systems...more

BakerHostetler

HHS Issues a Request for Information on Deregulation and Innovation: Considerations for Legal and Compliance Teams

BakerHostetler on

On May 14, 2025, the U.S. Department of Health and Human Services (HHS) issued its Request for Information (RFI) “Ensuring Lawful Regulation and Unleashing Innovation To Make American Healthy Again,” which HHS describes as...more

Polsinelli

CMS Issues Request for Public Input on Hospital Pricing Transparency

Polsinelli on

Key Takeaways - 1. Centers for Medicare & Medicaid Services (CMS) Aims to Strengthen Enforcement - The agency is evaluating how to better enforce hospital price transparency rules under the Executive Order....more

Sheppard Mullin Richter & Hampton LLP

CMS Proposes Medicare Payment Policies for Hospital Inpatient Services for Federal Fiscal Year 2026

Sheppard Mullin Richter & Hampton LLP on

The Centers for Medicare & Medicaid Services (CMS) recently published the fiscal year (“FY”) 2026 proposed rule for Hospital Inpatient Prospective Payment Systems (IPPS) (the “Proposed Rule”). Comments to the Proposed Rule...more

DLA Piper

Key Takeaways from FDA’s Draft Guidance on Use of AI in Drug and Biological Life Cycle

DLA Piper on

The US Food and Drug Administration (FDA) recently issued its draft guidance, Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products, on January 6, 2025. ...more

Mayer Brown

Private Equity in Healthcare: Increased Scrutiny from FTC, DOJ, and HHS

Mayer Brown on

Private equity acquisitions in healthcare will likely face increased scrutiny from multiple federal departments, as well as from state antitrust enforcement officials....more

Foley Hoag LLP

FDA Publishes Long-Awaited In Vitro Diagnostics Proposed Rule – Medical Device Regulations Would Apply to Laboratory Developed...

Foley Hoag LLP on

FDA published a proposed rule that would regulate IVDs, including LDTs, as medical devices, drastically altering the regulatory landscape for LDTs. The proposed rule would update the definition of IVDs in 21 CFR § 809.3 to...more

Polsinelli

Triaging Health Risks in the Cosmetic World: FDA Says Let’s Start with Tattoo Inks

Polsinelli on

Last month, the FDA’s Office of Cosmetics and Colors issued a Draft Guidance encouraging tattoo ink manufacturers and distributors to recognize situations in which these products may become contaminated with microorganisms,...more

Quarles & Brady LLP

The Clock is Ticking: Comments to Proposed Federal Rules For Wholesalers and 3PLs are Due June 6th and Here’s What We Think

Quarles & Brady LLP on

On February 4, 2022, the FDA released its long-awaited proposed national standards for the licensure of third party logistics providers (3PLs) and wholesale drug distributors. The draft rules were years over-due and the delay...more

King & Spalding

CMS Releases FY 2020 Medicare IPPS and LTCH PPS Proposed Rule and Proposes Key Changes to Several Regulatory Requirements

King & Spalding on

On April 23, 2019, CMS issued its annual Hospital Inpatient Prospective Payment System (IPPS) and Long-Term Care Hospital (LTCH) Prospective Payment System Proposed Rule for FY 2020 (the Proposed Rule), which will affect...more

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