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Health Care Compliance Association (HCCA)

‘Waking Up With Panic Attacks’: NIH 15% Plan Caps Tumultuous Weeks Under New Administration

Health Care Compliance Association (HCCA) on

If NIH succeeds in imposing an across-the-board indirect cost rate of 15%, rough estimates indicate the University of Michigan could lose $119 million a year. Emory University could be down $75 million. For the University of...more

Akin Gump Strauss Hauer & Feld LLP

FDA Finalizes Guidance on Communication of Unapproved Uses of Approved or Cleared Medical Products

Akin Gump Strauss Hauer & Feld LLP on

On January 6, 2025, the FDA released final guidance for industry entitled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions...more

Akin Gump Strauss Hauer & Feld LLP

The Regulatory Race Is On: The Biden Administration Sprints to Issue Key Health Policies

Akin Gump Strauss Hauer & Feld LLP on

The upcoming election, and the approaching end of the President’s four-year term, introduce additional dynamics into the agencies’ rulemaking process and even the guidance process. From now through the November election, the...more

Sheppard Mullin Richter & Hampton LLP

AI’s Executive Order and Its Key Healthcare Implications 

Sheppard Mullin Richter & Hampton LLP on

Last week’s historic executive order (EO) on the development and use of artificial intelligence (AI) is teeming with urgency, both in caution and optimism, to keep pace with the technological advancements. The EO addresses...more

McDermott+

A Government Shutdown Is Likely on the Horizon: Will the Regulatory Process Also Hit Pause?

McDermott+ on

Passing the 12 annual appropriations bills that fund the federal government for the next fiscal year (which starts on October 1), or enacting a stopgap continuing resolution in the interim, seems to come down to the wire...more

Polsinelli

DEA to Extend Current Telemedicine Flexibilities

Polsinelli on

The Drug Enforcement Administration (DEA) is seeking approval from the White House to temporarily extend current COVID-19 Public Health Emergency (PHE) flexibilities for prescribing controlled substances via telemedicine....more

Polsinelli

Fall Congressional Forecast: Eye on Federal Funding and Health Care

Polsinelli on

Congress faces a crowded agenda this fall comprised of must-pass policy initiatives and potential political messaging opportunities in the lead up to the November midterm elections. With control of both chambers at stake, the...more

Mintz - ML Strategies

Health Care Update - July 2015 #2

Mintz - ML Strategies on

Congress Slowly Works on Budget Reconciliation; ACA Reform Proposals Still Up in the Air - The FY 2016 budget resolution, which was agreed to by Congress this past April, included broad reconciliation instructions...more

Mintz - ML Strategies

Health Care Update - May 2015 #2

Mintz - ML Strategies on

In This Issue: - 340B Drug Discount Program Guidance Nearing Finish Line - Implementation of the Affordable Care Act - Federal Regulatory Initiatives - Congressional Initiatives - Other...more

King & Spalding

Health Headlines: Also in the News - June 2014 #3

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MedPAC Recommends Short- and Long-Term ACO Changes – In a comment letter sent to CMS Administrator Marilyn Tavenner on June 16, 2014, the Medicare Payment Advisory Commission (MedPAC) outlined certain challenges associated...more

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