Focus On: Patient Access to Lab Test Results: Labs Have Flexibility in Developing Policies Under New Access Rule

Clinical and anatomic pathology laboratories have flexibility as to how to set up policies and procedures to respond to patient requests under a new rule requiring labs to provide patients with access … [Read more...]

Focus on: Electronic Health Records: Laboratory Professionals Have Key Role to Play In Developing Safer EHR Systems

Laboratory professionals can contribute to the development of safer electronic health record (EHR) systems through engagement, data integrity and usability, and innovation, according to a new white … [Read more...]

Stakeholder Group Calls for Reform of CLIA Waiver Process

A newly formed stakeholder group wants the Food and Drug Administration (FDA) to ease restrictions on where diagnostic tests can be performed. James Boiani, head of the Coalition for CLIA Waiver … [Read more...]

Focus On: Physician Fee Schedule: CMS Proposes Increase in FISH Payment, Review of LCD Process for Lab Tests

Independent clinical laboratories would see a 3 percent increase in their Medicare physician reimbursement under proposed changes to the Physician Fee Schedule (PFS) announced July 3. Pathologists, … [Read more...]

Focus On: Clinical Laboratory Fee Schedule: CMS Gets Pricing Advice for New 2015 CPT Lab Codes

Leading scientific advisory societies and national clinical laboratory groups gathered in Baltimore July 14 to make recommendations on Medicare pricing for new and revised lab testing codes that will … [Read more...]

Focus On: Clinical Laboratory Fee Schedule: Industry Groups Give Recommendations on 2015 Lab Test Codes

Leading lab and pathology groups recently made recommendations to the Centers for Medicare and Medicaid Services on new and revised codes that will be added to the Clinical Laboratory Fee Schedule … [Read more...]

FDA Plans to Regulate Lab-Developed Tests Could Increase Time and Cost of Development

While it’s too soon to say what effect the Food and Drug Administration (FDA) decision to move forward with plans to regulate lab-developed tests (LDTs) will have on clinical and anatomic pathology … [Read more...]

Lab Execs Air Concerns Over FDA Regulation of LDTs

The U.S. Food and Drug Administration (FDA) late last week officially issued its draft framework for how the agency plans to regulate laboratory-developed tests (LDTs). The 41-page framework, which … [Read more...]

Focus on: Lab Institute: Labs Need to Realign Approach to Diagnostic Services By Focusing on Physician, Patient Engagement

The future of the diagnostic laboratory industry was on everyone’s mind as more than 500 people from clinical and anatomic pathology laboratories and related industries gathered in Washington, D.C., … [Read more...]

Bostwick Laboratories Settles Whistleblower Case for $6 Million

Bostwick Laboratories (Uniondale, N.Y.) will pay more than $6 million to settle a whistleblower lawsuit alleging the lab inappropriately billed federal health programs for laboratory tests. The qui … [Read more...]