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Final Rules › Clinical Laboratory Testing

Mintz - Health Care Viewpoints

FDA’s Backup LDT Enforcement Method: Specimen Collection Kits

Mintz - Health Care Viewpoints on

We have written at length about the U.S. Food and Drug Administration’s (FDA’s) actions to promulgate regulations specifying the agency’s authority to regulate laboratory developed tests (LDTs) as medical devices and to phase...more

Robinson+Cole Health Law Diagnosis

FDA Sued Over Laboratory Developed Tests Final Rule

Robinson+Cole Health Law Diagnosis on

The Food and Drug Administration (FDA) is being sued in two lawsuits after releasing its Final Rule on Laboratory Developed Tests (LDTs). The Final Rule requires laboratories to adhere to the same preapproval and...more

McDermott+

It’s Raining Regs: CMS Releases Major Laboratory-Developed Test Reg in Midst of Massive Reg Storm

McDermott+ on

Over the last several weeks, the Biden administration has released numerous final regulations in order to “beat the clock” before it ticks down to the Congressional Review Act (CRA) deadline. The CRA authorizes Congress to...more

Bass, Berry & Sims PLC

The End of an Era? FDA Finalizes LDT Rule But Grandfathers Many Existing LDTs

Bass, Berry & Sims PLC on

On May 6, 2024, the Food and Drug Administration (FDA) published its final rule for laboratory developed tests (LDTs). The final rule cemented the agency’s forecasted decision to increase the FDA’s regulatory oversight of...more

Bass, Berry & Sims PLC

Recent Updates to CLIA Proficiency Testing and Proposed Changes to Fees, Sanctions, and Other Requirements

Bass, Berry & Sims PLC on

This client alert highlights recent regulatory developments from the Centers for Medicare & Medicaid Services (CMS) relevant to clinical laboratories. CMS is implementing or considering implementing several updates to the...more

Hogan Lovells

FDA finalizes guidances for NGS-based tests

Hogan Lovells on

On April 12, 2018, the U.S. Food and Drug Administration (FDA or the Agency) finalized two guidances on the oversight of next generation sequencing (NGS)-based in vitro diagnostic tests. Unlike most IVDs that typically detect...more

Bradley Arant Boult Cummings LLP

CMS Releases Final Rule to Implement Major Changes in Medicare Clinical Laboratory Payment Policy

Bradley Arant Boult Cummings LLP on

On June 23, 2016, the Centers for Medicare and Medicaid Services (CMS) published a long-awaited final rule making major changes in the way Medicare will pay for clinical diagnostic laboratory tests (CDLTs). The changes were...more

King & Spalding

CMS Overhauls Clinical Laboratory Fee Schedule with Long-anticipated Final Rule

King & Spalding on

On June 17, 2016, CMS released a long-anticipated final rule revising the Medicare payment system for clinical diagnostic laboratory tests paid under the Clinical Laboratory Fee Schedule (CLFS) (the Final Rule). In 2018,...more

Mintz - Health Care Viewpoints

Delay in Final Rule Implementing PAMA: Sunshine Act Revisited?

Mintz - Health Care Viewpoints on

As reported in our 2015 Laboratory Industry Year in Review post, the laboratory industry began 2016 amid confusion regarding how to comply with the Protecting Access to Medicare Act of 2014 (PAMA), which made the most...more

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