News & Analysis as of

Centers for Medicare & Medicaid Services (CMS) Over The Counter Drugs (OTC)

Ogletree, Deakins, Nash, Smoak & Stewart,...

Stocking Naloxone in the Workplace: What Employers Need to Consider

It is well known that opioid overdoses have occurred at epidemic levels in the United States for years. According to the U.S. Centers for Disease Control and Prevention (CDC), opioid overdose deaths have increased from 21,089...more

McDermott+

McDermottPlus Check-Up: October 6, 2023

McDermott+ on

THIS WEEK’S DOSE - Uncharted Territory in the House: The House voted to remove Rep. McCarthy (R-CA) as Speaker of the House, then recessed until at least October 11, when the House is slated to reconvene to elect a new...more

Nelson Mullins Riley & Scarborough LLP

The Drive for Equitable Healthcare Access: Departments Seek Public Input on Over-the-Counter Preventive Services

On September 29, the Centers for Medicare & Medicaid Services (CMS) reported that the federal Departments of Health and Human Services, Labor, and the Treasury departments are seeking public input on the possibility of...more

McDermott Will & Emery

Healthcare Regulatory Check-up Newsletter | July 2023 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for July 2023. We discuss several criminal and civil enforcement actions that involve violations of the False Claims Act...more

Mintz - Health Care Viewpoints

First Nonprescription Birth Control Pill Approved for Marketing by FDA: A Milestone for Reproductive Health

As we previously reported, Perrigo Company’s subsidiary HRA Pharma submitted an application to the Food and Drug Administration (FDA) in the summer of 2022 to switch an existing prescription-only progestin birth control pill...more

BakerHostetler

Government Scrutiny Expected of Providers That Furnished OTC COVID-19 Tests to Medicare Patients

BakerHostetler on

In April 2022, CMS announced an initiative to pay for Medicare beneficiaries to receive free OTC COVID-19 test kits. Specifically, Medicare established a demonstration project to pay various eligible healthcare providers to...more

King & Spalding

Major Shift in Best Price Proposed in Grab Bag of MDRP Reforms

King & Spalding on

The title of CMS’s May 26 proposed rule, “Misclassification of Drugs, Program Administration and Program Integrity Updates Under the MDRP,” buries the lede. Amid twenty Medicaid Drug Rebate Program-related proposals—some...more

Mintz - Health Care Viewpoints

An Update on FDA’s Contribution to COVID-19 Diagnostic Testing

Back in the early days of the COVID-19 pandemic, we published a post outlining the different kinds of diagnostic tests that were being marketed and the different roles of the two main federal regulators that oversee the...more

Arnall Golden Gregory LLP

AGG Food & Drug Newsletter - November 2019

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

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