Clinical Laboratories

News & Analysis as of

Biodiagnostic Laboratory Services Sentenced; Another Physician Pleads Guilty

The long-running test-referral prosecution against Biodiagnostic Laboratory Services, LLC (“BLS”), a New Jersey clinical blood testing laboratory; its owner and employees; and BLS’s referring physicians recently reached...more

Summary: PAMA Final Rule

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 Finalizes Changes to Medicare Clinical Lab Test Payment Policy, Pushes Back Effective Date to 2018

On June 23, 2016, the Centers for Medicare & Medicaid Services (CMS) is publishing a major final rule to base Medicare clinical laboratory fee schedule (CLFS) reimbursement on private insurance payment amounts, as required by...more

At Long Last, CMS Issues Final Rule for Lab Fee Schedule Changes

Last Friday afternoon CMS released its eagerly anticipated final rule (the Final Rule) implementing the Protecting Access to Medicare Act of 2014 (PAMA), which, together with the Final Rule, will make sweeping changes to the...more

CMS Announces July 18 Public Meeting on 2017 Medicare Clinical Lab Fee Schedule

CMS has scheduled a July 18, 2016 public meeting on payment for new and substantially revised clinical diagnostic laboratory test codes for payment under the 2017 Medicare clinical laboratory fee schedule (CLFS). The meeting...more

Changing Time for Clinical Laboratories

As Bob Dylan wrote, ‘‘The times, they are a-changin’ ’’ While Dylan certainly had larger issues in mind than the state of the clinical laboratory industry, it still is a fair description of what is happening for laboratories...more

Highlights From The 2016 OIG Work Plan

The Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) has released its Work Plan for Fiscal Year 2016. The annual work plan can provide valuable insights into the OIG’s planned areas of...more

Agencies Extend Comment Period on Proposed Changes to Clinical Research Rules

Those wishing to comment on revisions to the Federal Policy for Protection of Human Subjects (known as the “Common Rule”) could add a 30-day comment period extension to the things they were grateful for at this year’s...more

FDA Commits to Moving Forward with LDT Regulation

Last Tuesday, Dr. Jeffrey Shuren, director of the Food and Drug Administration’s Center for Devices and Radiological Health, announced at a hearing before the House Energy and Commerce Committee’s Subcommittee on Health that...more

CMS Releases Final Medicare Clinical Lab Fee Schedule Determinations for 2016

CMS has announced its final 2016 Medicare clinical laboratory fee schedule (CLFS) payment determinations for new and reconsidered test codes, including...more

Genetic Testing, Genome Sequencing, and the FDA

In recent years, the Food and Drug Administration has been struggling with how to adapt the regulatory paradigm for in vitro diagnostic devices (IVDs) – any test that detects a disease, condition, or infection – to the...more

Three Pressing Challenges for Personalized Medicine

Personalized medicine can be described as the science of targeted therapies. Advances in diagnostic and molecular medicine have made it possible to more precisely identify alternative treatment options for patients based on...more

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

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

Dueling Records: Are Statements in Your 510(k) Putting Your Patents at Risk?

Laboratory developed test (LDT) providers, previously exempt from U.S. Food and Drug Administration (FDA) oversight, under a new FDA proposal, must now consider if their LDTs constitute moderate-risk (Class II) or high-risk...more

House Energy & Commerce Panel Releases Draft Bill to Regulate Diagnostic Lab Tests, Schedules November 17 Hearing

The House Energy and Commerce Health Subcommittee has scheduled a November 17, 2015 hearing on the regulation of diagnostic tests and laboratory operations. The hearing will feature FDA and CMS officials who will testify on...more

Nov. 10 CMS Call Will Review Clinical Lab Test Payment Proposed Rule

On November 10, 2015, CMS is hosting a public call to discuss its October 1, 2015 proposed rule that would make significant changes to the Medicare clinical diagnostic laboratory test payment system. Registration is required...more

CMS Takes First Step to Reduce Payments for Clinical Laboratory Tests

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

Navigating the Diagnostic Commercialization Process

Guest Post By: Perry Dimas, Senior Vice President and General Manager for Premier Source, part of AmerisourceBergen The 2015 Business of Personalized Medicine Summit was an inspiring day with talented professionals. One...more

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

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

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 Major Changes to Medicare Clinical Lab Test Payment Policy

On October 1, 2015, the Centers for Medicare & Medicaid Services (CMS) published its long-awaited proposed rule to base Medicare clinical laboratory fee schedule (CLFS) reimbursement on private insurance payment amounts...more

CMS Proposes Lab Data Collection Requirements to Update Fee Schedule

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 Releases Preliminary 2016 Determinations for New Clinical Lab Tests, Announces October 19 Open Meeting on Clinical Lab...

CMS has announced its preliminary 2016 clinical laboratory fee schedule (CLFS) payment determinations for new and reconsidered test codes. These preliminary determinations will be the subject of an October 19, 2015 meeting...more

CMS Releases Proposed Rule Reforming Medicare CLFS Payment Rates

The Centers for Medicare & Medicaid Services (“CMS”) released a proposed rule [CMS-1621-P] in accordance with Section 216 of the Protecting Access to Medicare Act of 2014 (“PAMA”), which establishes a new payment methodology...more

CMS Publishes Long-Awaited PAMA Proposed Rule

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

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