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Gardner Law

From Discretion to Regulation: FDA's New Path for LDTs

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Earlier this year, we reported on the expected U.S. Food and Drug Administration (FDA) ruling concerning Laboratory Developed Tests (LDTs). The FDA has consistently shown a commitment to regulating LDTs. On May 6, 2024, the...more

McDermott Will & Emery

Private Investors and Digital Health Attracting OIG Attention: General Compliance Program Guidance to Watch

McDermott Will & Emery on

On November 6, 2023, the US Department of Health and Human Services (HHS) Office of Inspector General (OIG) published the General Compliance Program Guidance (GCPG) as a revised reference guide for the healthcare compliance...more

Foley & Lardner LLP

FDA Laboratory Developed Test Oversight: What Stakeholders Need to Know About Proposed Overhaul

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After years of enforcement discretion, the U.S. Food and Drug Administration (FDA) published a proposed rule on October 3, 2023 under which the agency articulated its intent to increase regulatory oversight of laboratory...more

Foley & Lardner LLP

Remote Patient Monitoring (RPM) and Remote Therapeutic Monitoring (RTM): A Deep Dive into Proposed Medicare Changes

Foley & Lardner LLP on

On July 13, the Centers for Medicare & Medicaid Services (CMS) released its annual Proposed Rule updating the Medicare Physician Fee Schedule (PFS) for calendar year (CY) 2024, which includes various proposed changes related...more

McDermott Will & Emery

Top Takeaways | How to Succeed in CMMI Payment Models

In this session, McDermott Will & Emery partner Matthew Perreault moderated a panel that discussed the current state of value-based care in original Medicare and lessons learned from the panelists’ experiences with various...more

Rivkin Radler LLP

Partners, S Corp. Shareholders And Biden’s 2022 Revenue Proposal: No More Business As Usual

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What A Ride- No one anticipated that the Administration’s proposed tax increases would fly through Congress easily – at least no one residing in a state in which the recreational use of marijuana has not been legalized....more

Seyfarth Shaw LLP

Update: Paycheck Protection Program and Health Care Enhancement Act Increases Funds Available to Hospitals and Health Care...

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On April 24, 2020, the Paycheck Protection Program and Health Care Enhancement Act was signed into law, appropriating $75 billion for hospitals and other eligible health care providers for health care related expenses or lost...more

Jones Day

Focus on Health Care Provider Bankruptcies

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The next few years are expected to see a significant increase in the volume of bankruptcy cases filed by health care providers. Thus far in 2017, the number of bankruptcies in health care-related sectors, including hospitals,...more

McDermott Will & Emery

Congress Approves Legislation Extending and Changing Medicare Programs

On March 31, 2014, the U.S. Senate approved comprehensive Medicare legislation reauthorizing and extending dozens of Medicare payment enhancements, but also making several substantive changes that will profoundly impact...more

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