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Reporting Requirements Hospitals Pharmaceutical Industry

Robinson+Cole Health Law Diagnosis

HHS Publishes 340B Guidance Proposing Rebate Pilot Program

On July 31, 2025, the Department of Health and Human Services (HHS) announced a much-anticipated 340B Rebate Model Pilot Program (Pilot Program) via guidance (Guidance) that will be formally published on August 1, 2025. The...more

ArentFox Schiff

Medicare 2026 Proposed Rules, Major Drug Pricing Updates, and What Stakeholders Need to Know

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Every July, the Centers for Medicare & Medicaid Services (CMS) publishes two proposed rules that set Medicare reimbursement and shape the administration of the Medicare Part B program for the upcoming calendar year. These...more

Holland & Knight LLP

CMS Releases CY 2026 Outpatient Prospective, ASC Payment System Proposed Rule

Holland & Knight LLP on

The Centers for Medicare & Medicaid Services (CMS) on July 15, 2025, issued the Hospital Outpatient Prospective Payment (OPPS) and Ambulatory Surgical Center (ASC) Payment Systems proposed rule, which proposes updates to the...more

Bass, Berry & Sims PLC

Indiana Enacts Legislation Affecting Health Care Transactions and Imposing Ownership Reporting Requirements

Bass, Berry & Sims PLC on

On May 6, 2025, Indiana Governor Mike Braun signed Indiana HB 1666 into law. This new law grants Indiana’s attorney general authority to investigate market concentration of health care entities, modifies existing requirements...more

McGuireWoods Consulting

Senate Health Education Labor and Pensions Committee Releases Report on 340B Program and Recommendations for Change

When Sen. Bill Cassidy became Chairman of the U.S. Senate Health, Education, Labor and Pensions Committee this year, he stated one of his priorities was reforming the 340B Program. On April 24, 2025, he released a majority...more

Cornerstone Research

5 Questions with Sayeh Nikpay: The 340B Drug Pricing Program

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A periodic feature by Cornerstone Research, in which our affiliated experts, senior advisors, and professionals, talk about their research and findings. We interview Professor Sayeh Nikpay of the School of Public Health,...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 18, Number 6. In This Month’s E-News: June 2021

Report on Research Compliance 18, no. 6 (June 2021) - Clemson University is pushing back against recommendations by auditors for the National Science Foundation Office of Inspector General (OIG) that it repay $276,440,...more

Bass, Berry & Sims PLC

Significant Change to ClinicalTrials.gov Reporting Requirements: Ten Years' Worth of Back Data Owed

The National Institutes of Health (NIH) has warned clinical trial sponsors – including not only drug and device companies, but also universities and hospitals with investigator-initiated trials – to submit significant...more

K&L Gates LLP

K&L Gates Triage: Recent Developments in the 340B Drug Pricing Program

K&L Gates LLP on

In this episode, Richard Church, Andrew Ruskin, and Victoria Hamscho discuss recent developments in the 340B Drug Pricing Program, including recent actions by drug manufacturers to limit contract pharmacy access to 340B...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

Mitchell, Williams, Selig, Gates & Woodyard,...

Hazardous Waste Enforcement: U.S. Environmental Protection Agency and San Antonio, Texas Medical Facility Operator...

The United States Environmental Protection Agency (“EPA”) and Gastroenterology Consultants of San Antonio, P.A. (“GCS”) entered into a Consent Agreement and Final Order (“CA”) addressing alleged Resource Conservation and...more

Mintz - Health Care Viewpoints

Front End Changes and, Again, More DIR Columns

Since the beginning of the Medicare Part D program, CMS has introduced many reporting mechanisms for trying to understand drug pricing, price concessions, and the cost of providing services to Part D members. The tool CMS...more

Polsinelli

You Are Now on the Clock — Sunshine Act Dispute Window Now Open

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Beginning Monday, July 14, 2014, the review, dispute and correction process outlined the National Physician Payment Transparency Program (also known as the "Sunshine Act") opens on CMS's Open Payments website. Physicians and...more

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