News & Analysis as of

Clinical Laboratories

FDA Cleared First DTC Genetic Tests for Health Risks

by Hogan Lovells on

Last week, the U.S. Food and Drug Administration (FDA) granted marketing authorization for 23andMe’s Personal Genome Service (PGS) Test for 10 diseases or conditions. This was the first FDA authorization for a...more

CMS Give Clinical Labs Reporting Deadline Extension

by Dorsey & Whitney LLP on

Clinical laboratories have until May 30, 2017 to make required reports to the Centers for Medicare & Medicaid Services (“CMS”) regarding payment rates paid by private payors for certain diagnostic tests and the volume of such...more

Advertising Law - March 2017

FTC Fights Back in LabMD Suit - The Federal Trade Commission demonstrated its intention to fight for the power to regulate data security by filing a 111-page brief with the U.S. Court of Appeals for the Eleventh Circuit...more

FDA's 'Conversation Starter' Paper Suggests Altered Approach for Laboratories

by Polsinelli on

While a new U.S. Food & Drug Administration discussion paper neither serves as legal guidance nor effects any immediate policy changes, its issuance does suggest that the FDA may take a less stringent approach to regulating...more

FDA Advances LDT Dialogue with New Discussion Paper Containing Updated CMS/FDA Oversight Proposal

by Reed Smith on

On January 13, 2017, the Food and Drug Administration (FDA) released a discussion paper concerning an updated proposed framework for oversight of laboratory developed tests (LDTs). According to FDA, the updated proposal is...more

FDA Indefinitely Delays Action on Regulating Laboratory Developed Tests

by Ropes & Gray LLP on

On November 18, 2016, the Food and Drug Administration (FDA) notified industry groups that it no longer plans to finalize its draft guidance on laboratory developed tests (LDTs). FDA stated that it intends to work with the...more

OIG Releases 2017 Work Plan

On November 10, 2016, the Office of Inspector General (“the OIG”) of the U.S. Department of Health and Human Services (“DHHS”) is charged with ensuring the integrity of more than 100 programs administered by DHHS, including...more

CMS Posts Final 2017 Medicare Clinical Lab Payment Determinations

by Reed Smith on

CMS has released the final 2017 Medicare clinical laboratory fee schedule (CLFS) payment determinations for new and reconsidered test codes, including determinations regarding whether CMS will use crosswalking or gapfilling...more

CMS to Host November 2 Call on Clinical Diagnostic Lab Test Payment System Data Reporting

by Reed Smith on

CMS is hosting an educational call on November 2, 2016 to discuss reporting obligations under the June 23, 2016 Clinical Diagnostic Test Payment System final rule. As previously reported, under the Protecting Access to...more

OIG Raises Concerns Regarding Accuracy of New Clinical Laboratory Payment System

by King & Spalding on

On October 3, 2016, OIG released a report monitoring CMS’s progress on preparing for the implementation of the new payment system for clinical laboratory tests. The new payment system was mandated by the Protecting Access to...more

CMS Issues Preliminary 2017 Medicare Clinical Lab Payment Determinations, Final 2016 Gap Fill Amounts

by Reed Smith on

CMS has released the preliminary 2017 Medicare clinical laboratory fee schedule (CLFS) payment determinations for new and reconsidered test codes, including determinations regarding whether CMS will use crosswalking or...more

CMS Posts PAMA Clinical Lab Fee Schedule Data Reporting Template and User Guide

by Reed Smith on

In order to assist the clinical laboratory community in meeting new Medicare reporting requirements under the Protecting Access to Medicare Act of 2014 (PAMA), CMS has posted a Clinical Laboratory Fee Schedule Data Reporting...more

CMS Schedules Next Meeting of Advisory Panel on Clinical Diagnostic Laboratory Tests for September 12

by Reed Smith on

CMS has announced that the next meeting date of the Advisory Panel on Clinical Diagnostic Laboratory Tests will be September 12, 2016. The meeting is expected to cover...more

Game-Changing PAMA Rule Sets off Major Payment Shifts for Lab Tests

by Reed Smith on

The Centers for Medicare & Medicaid Services (CMS) recently published a major final rule that will base Medicare clinical laboratory fee schedule (CLFS) reimbursement on private insurance payment amounts, as required by the...more

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

by Foley Hoag LLP on

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

by Reed Smith on

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

by Reed Smith on

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

by Alston & Bird on

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

by McGuireWoods LLP on

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

by Reed Smith on

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

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