News & Analysis as of August 15, 2025

Manufacturers

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Medicaid is a partnership program between states and the federal government to provide healthcare coverage for lower income individuals, people with disabilities, older people, and certain families with... more +

Dialysis & Nephrology Digest - June 2025

Benesch on 6/16/2025

Byonyks, a medical device company focused on advancing dialysis care, today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the Byonyks X1 APD Cycler, an automated peritoneal...more

OIG Approves Pharmaceutical Manufacturer’s Proposed Travel-Related Subsidies

Arnall Golden Gregory LLP on 1/24/2025

The Department of Health and Human Services, Office of Inspector General (“OIG”) recently released a favorable advisory opinion, OIG Advisory Opinion No. 24-13 (the “Opinion”) to a pharmaceutical manufacturer (the...more

FDA Issues Proposed Rule and Draft Guidance on Drug Importation

King & Spalding on 1/7/2020

In late December 2019, the Food and Drug Administration (FDA), an agency operating within the Department of Health and Human Services (HHS), issued two documents—a Proposed Rule and a Draft Guidance—intended to establish two...more

FDA Guidance on HCEI and Communications to Payors of Unapproved Products and Uses

Holland & Knight LLP on 6/15/2018

On June 12, 2018, the U.S. Food and Drug Administration (FDA) released draft guidance entitled "Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities - Questions and Answers"...more

Healthcare Law Update: May 2018

Holland & Knight LLP on 5/30/2018

Enforcement - OIG Issues Advisory Opinion on Provision of Samples by a Device Distributor - On April 30, 2018, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued a...more

New Medicaid Rebate Agreement

Blank Rome LLP on 3/27/2018

On March 23, 2018, the Centers for Medicare & Medicaid Services (“CMS”) announced the introduction of a new Medicaid National Drug Rebate Agreement. The new Agreement incorporates legislative and regulatory changes,...more

Healthcare Fraud & Abuse Review 2017

Bass, Berry & Sims PLC on 3/13/2018

A LOOK BACK... A LOOK AHEAD - While the uncertainty associated with legislative efforts to repeal the Patient Protection and Affordable Care Act (PPACA) dominated most of the headlines for the healthcare industry last year,...more

White House Unveils Proposal on Drug Pricing

Holland & Knight LLP on 2/13/2018

On Feb. 9, 2018, the Trump Administration released a 30-page report analyzing domestic and global factors influencing drug pricing. The report by the Council of Economic Advisers (CEA) is expected to inform the HHS' Fiscal...more

Ohio Legislature Concludes 131st General Assembly in Marathon Session Lasting Until 3:30 AM Last Friday

Roetzel & Andress on 12/12/2016

After a whirlwind final week of the lame duck session, where the Legislature passed various, often times emotion-evoking measures (including gun rights, abortion, unemployment compensation fund changes, municipal minimum wage...more

Washington Healthcare Update

McGuireWoods LLP on 10/18/2016

1. Congress - Senate - FDA Supports Expanded Authority Over Cosmetics - In an Oct. 5 letter to Senator Dianne Feinstein (D-CA), the Food and Drug Administration (FDA) says its current legal authority over...more

The EpiPen Controversy Signals Intensifying Scrutiny of Drug Classification Under Medicaid Rebate Program

Foley & Lardner LLP on 9/21/2016

Price increases threatening the availability of EpiPen® and EpiPen Jr® Auto-Injectors (“EpiPen”) have touched off the latest firestorm over drug pricing. Lost amid the public outcry, however, is a thorny regulatory issue:...more

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