News & Analysis as of

Health Care Providers › Manufacturers › Reporting Requirements

Husch Blackwell LLP

HHS Unveils 340B Drug Rebate Pilot Program

Husch Blackwell LLP on

On July 31, 2025, the U.S. Department of Health and Human Services (HHS) announced that it will conduct a pilot program testing out a rebate model for 340B drug purchases. Under the program, drug manufacturers will be allowed...more

Gardner Law

LDT Compliance: Countdown to May 2025

Gardner Law on

We previously reported on the FDA’s laboratory-developed test (LDT) rule published on May 6, 2024, which classifies LDTs as medical devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act). This shift marks the end...more

Mintz - Health Care Viewpoints

Connecticut Law Imposes New Requirements on Pharmaceutical Manufacturers, Defined to Include Device and Cosmetic Manufacturers,...

Mintz - Health Care Viewpoints on

Public Act No. 23-171: An Act Protecting Patients and Prohibiting Unnecessary Health Care Costs (Act) took effect in Connecticut on October 1, 2023. Under the Act, a pharmaceutical manufacturer (PM) that employs...more

K&L Gates LLP

COVID-19: FDA Warning Letters Address Fraudulent Products and Failures to Meet EUA Requirements

K&L Gates LLP on

In this week’s episode, Kenneth Kennedy discusses FDA’s ongoing focus on the issuance of warning letters to firms marketing fraudulent COVID-19 products, and to manufacturers who have failed to meet certain requirements under...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

Akin Gump Strauss Hauer & Feld LLP

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

Akin Gump Strauss Hauer & Feld LLP on

• 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

Cooley LLP

Blog: Federal Sunshine Act Reporting Requirements Expanded to Other Prescribers

Cooley LLP on

Currently, the federal Physician Payments Sunshine Act (Sunshine Act) requires certain manufacturers of drugs, biologics, medical devices and medical supplies for which payment is available under Medicare, Medicaid or the...more

Butler Snow LLP

Pro Te: Solutio Vol. 11 No. 1 – A Reflection on the First Ten Years

Butler Snow LLP on

It’s hard to believe a decade has passed since we delivered our first edition of Pro Te: Solutio to your door. Those years have brought enormous changes in the world and in our industry. Innovation has driven everything we...more

Mintz - Health Care Viewpoints

New Bill Would Expand the Sunshine Act to Cover Physician Assistants and Advance Practice Nurses

Mintz - Health Care Viewpoints on

Late last month, Senators Grassley (R-IA), Brown (D-OH), and Blumenthal (D-CT) introduced the Fighting the Opioid Epidemic with Sunshine Act, a bill that would expand Physician Payment Sunshine Act reporting requirements to...more

Fisher Phillips

What’s the Real Effect of OSHA’s Revamped Inspection Process, the “Enforcement Weighing System?”

Fisher Phillips on

On October 1, OSHA started its “Enforcement Weighing System,” which means that OSHA Compliance Officers and Area Offices will be under less pressure to complete a number of inspections and will receive credit for separate...more

10 Results
 / 
View per page
Page: of 1

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up Log in
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide