News & Analysis as of

Prescription Drugs Emergency Response

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

California’s Occupational Safety and Health Standards Board Votes on Naloxone Requirement

On June 20, 2024, the California Occupational Safety and Health Standards Board partially adopted Petition 602—a proposal to require employers to provide opioid overdose reversal medications (e.g., naloxone) at all worksites...more

Bass, Berry & Sims PLC

HRSA Clarifies Use of 340B Drugs in New Hospital Clinics, Ends COVID "Waiver"

Bass, Berry & Sims PLC on

On October 26, the Health Resources and Services Administration (HRSA) issued a notice clarifying the registration requirements for offsite hospital outpatient facilities under the 340B drug pricing program. The Notice, which...more

K&L Gates LLP

K&L Gates Triage: 340B Update - Hospitals Request Eligibility Flexibilities Amid COVID-19 Pandemic

K&L Gates LLP on

In this episode, Richard Church and Victoria Hamscho discuss recent developments in the 340B Drug Pricing Program, including recent COVID-19 guidance by the Health Resources and Services Administration and hospital requests...more

Bass, Berry & Sims PLC

Specialty Pharmacy Compliance During COVID-19 Pandemic

Bass, Berry & Sims PLC on

The recent Centers for Medicare & Medicaid Services (CMS) memorandum to all Medicare Advantage Organizations, Part D Sponsors, and Medicare-Medicaid Plans (CMS Memo) does not provide any express relief for specialty...more

Goodwin

COVID-19 Pandemic May Impact Biosimilars

Goodwin on

The COVID-19 pandemic has introduced new challenges for the pharmaceutical industry, including makers of biosimilars.  In response, the FDA has asked pharmaceutical makers to closely monitor their supply chains and...more

McDermott Will & Emery

FDA Update: COVID-19 Testing, Vaccine Development and Other Impacts

McDermott Will & Emery on

In response to the United States’ rapidly evolving public health situation, the US Food and Drug Administration (FDA) recently released guidance on high-complexity in vitro diagnostic (IVD) tests for COVID-19. This article...more

Holland & Knight LLP

CMS Offers Additional COVID-19 Guidance for Medicare Advantage and Part D Plans

Holland & Knight LLP on

The Centers for Medicare and Medicaid Services (CMS) continues to offer guidance related to the coronavirus (COVID-19) outbreak. On March 10, CMS issued a memo to all Medicare Advantage (MA) organizations and Part D sponsors...more

Downs Rachlin Martin PLLC

News From the Vermont Statehouse - An Analysis from DRM’s Government & Public Affairs Team - March 2017 #3

Paid Family Leave Could Be Costly - The House Committee on Ways and Means took up H.196, the Paid Family Leave bill this week after it passed out of the House Committee on General, Housing and Military Affairs over...more

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