Reporting Requirements, Clinical Laboratories

A Regulatory Haze of Uncertainty Continues as the Clock Ticks Toward Phase One of FDA’s LDT Final Rule

Epstein Becker & Green on 2/27/2025

Clinical laboratories still face uncertainty and the difficult decision of whether to start the work needed to comply with the with Phase 1 expectations under FDA’s Laboratory Developed Tests Final Rule (the “LDT Final...more

CMS Implements First Major Updates to Lab Personnel Requirements in 30+ Years

McDermott Will & Emery on 2/3/2025

On December 28, 2024, a long-awaited Centers for Medicare & Medicaid Services (CMS) final rule became effective, significantly updating laboratory personnel requirements under Subpart M of the Clinical Laboratory Improvement...more

CMS Implements Stricter COVID-19 Testing Regulations on Nursing Homes

Jackson Walker on 9/4/2020

As part of a broader Trump administration announcement made on August 25, 2020, the Centers for Medicare & Medicaid Services (CMS) issued sweeping oversight changes in the form of an Interim Final Rule with Comment Period...more

Penalties for COVID-19 Reporting Failures and Other New CMS Rules on Mandatory Testing and Ordering Limits

Bass, Berry & Sims PLC on 9/1/2020

Anyone conducting COVID-19 testing – whether using point of care or high complexity tests – should take note. On August 25, the Centers for Medicare & Medicaid Services (CMS) released an Interim Final Rule with comment period...more

Potential Changes to PAMA Reporting in Medicare Physician Fee Schedule Rule

Mintz - Health Care Viewpoints on 7/30/2018

Clinical laboratories and hospitals should note the potential changes to the Protecting Access to Medicare Act of 2014 (“PAMA”) reporting requirements tucked into the 1,400 page Physician Fee Schedule Proposed Rule (the...more

Laboratory Group Challenges CMS’s Implementation of Clinical Laboratory Commercial Data Reporting Requirements

King & Spalding on 12/22/2017

On December 11, 2017, the American Clinical Laboratory Association (ACLA) filed suit on behalf of its membership against the Secretary of HHS, challenging the Secretary’s implementation of the Protecting Access to Medicare...more

Summary: PAMA Final Rule

Foley Hoag LLP on 7/5/2016

Market Based Payment for Clinical Diagnostic Laboratory Tests - Summary - On June 17, 2016 the Centers of Medicare & Medicaid Services (CMS) issued the long awaited Medicare Clinical Diagnostic Laboratory Tests...more

CMS Proposes Sweeping Changes to Medicare Reimbursement for Clinical Diagnostic Laboratory Tests

King & Spalding on 11/3/2015

First Data Collection Period for Clinical Laboratories Is July 1, 2015 to December 31, 2015 - In the October 1, 2015 Federal Register, the Centers for Medicare & Medicaid Services (CMS) published a proposed rule...more

CMS Takes First Step to Reduce Payments for Clinical Laboratory Tests

Baker Donelson on 10/20/2015

CMS recently published a proposed rule that would substantially revise the methodology used to pay for clinical laboratory tests that continue to be compensated separately by Medicare. Medicare Program; Medicare Clinical...more

Clinical Laboratories: Proposed Rule Implements Requirements for Reporting and Payment Based on Private Payer Rates

Foley & Lardner LLP on 10/12/2015

As required by a 2014 statute, CMS has issued proposed regulations (Proposed Rule) implementing new requirements for laboratory reporting of, and eventually basing Medicare payment on, rates for clinical laboratory services...more

New CMS Proposed Rule Provides Who/What/When for Clinical Laboratory Reporting Requirements Starting January 1, 2016

Dickinson Wright on 10/9/2015

Clinical laboratories will see significant changes to their Medicare payments for clinical diagnostic laboratory tests (CDLTs) starting January 1, 2017, but the basis for new payment rates will come from “applicable data”...more

CMS Proposes Lab Data Collection Requirements to Update Fee Schedule

King & Spalding on 10/7/2015

On September 25, 2015, CMS released proposed rulemaking that would extensively revise payment and reporting requirements for clinical diagnostic laboratory tests (CDLTs), as paid on the Clinical Laboratory Fee Schedule...more

CMS Publishes Long-Awaited PAMA Proposed Rule

Mintz - Health Care Viewpoints on 9/29/2015

On September 25, 2015, the Centers for Medicare & Medicaid Services (CMS) announced publication of the proposed rule (the “Proposed Rule”) implementing substantial changes to the Medicare Clinical Laboratory Fee Schedule...more

CMS Proposes Overhaul of Clinical Lab Payment Methodology: What You Need To Know

Polsinelli on 9/29/2015

On Friday, the Centers for Medicare & Medicaid Services (“CMS”) issued a long-awaited proposed rule that would drastically change the payment rates for clinical laboratory services beginning January 1, 2017 (the “Proposed...more

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