CLIA

News & Analysis as of

Regulating Point of Care Diagnostics

Personalized medicine relies on diagnostic medicine to identify the best therapy for the patient at the right time. Tests that match a therapy to the patient fall into one of two categories. In vitro diagnostic devices or...more

Health Update - Feb 25, 2014

Integrating Physical and Behavioral Health: Strategies for Overcoming Legal Barriers to Health Information Exchange - A growing number of Medicaid officials believe that coordinating care across the physical and...more

HHS Rule Grants Patients Direct Access to Lab Test Results

The U.S. Department of Health and Human Services (HHS) recently published a Final Rule granting patients and their personal representatives access to the patient’s completed laboratory test reports directly from the lab...more

HHS Extends Patient Access To Laboratories

On February 6, 2014, the Department of Health and Human Services (HHS) published a Final Rule amending regulations implementing the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and the Health Insurance...more

Lab Results on Demand: CLIA/HIPAA Amendment Increases Patient Access

A new final rule (the “Final Rule”) from the Centers for Medicare and Medicaid Services, the Centers for Disease Control and Prevention, and the Office for Civil Rights (collectively, the “Agencies”) gives patients and their...more

Final Rule Expands Access to Laboratory Records

On February 6, 2014, the Department of Health and Human Services (HHS) released a Final Rule that amends the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and the Health Insurance Portability and Accountability...more

HHS Final Rule Allows Direct Patient Access to Laboratory Results

In a final rule published on February 6, 2014, the Department of Health and Human Services (HHS) amended the Clinical Laboratory Improvement Amendments (CLIA) regulations and the Health Insurance Portability and...more

New Privacy Rule Gives Patients Right To Access Lab Test Reports

On February 6, 2014, the Centers for Medicare and Medicaid Services (CMS) and the U.S. Department of Health and Human Services Office for Civil Rights (HHS OCR) issued a final rule amending the Clinical Laboratory Improvement...more

CMS Finalizes HIPAA and CLIA Amendments Intended to Increase Patient Access to Test Results

Yesterday the Centers for Medicare & Medicaid Services (CMS) finally published the long-awaited final rule amending the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and the Health Insurance Portability and...more

OCR Issues Guidance on HIPAA Refill Reminder Marketing Exception, and other Modifications to Privacy Protections

On September 19, 2013, the Office of Civil Rights of the Department of Health and Human Services (“OCR”) released guidance on a number of privacy protections, the most significant of which relates to the refill reminder...more

OCR Delays Required Changes to Notices of Privacy Practices for Laboratories

The HHS Office of Civil Rights (OCR) has granted certain clinical laboratories a temporary reprieve from the requirement to update their Notices of Privacy Practices (NPPs) by September 23, 2013, the deadline imposed by the...more

It's Never Too Late To Give Guidance: OCR Starts Releasing HIPAA Omnibus Rule Guidance In Anticipation Of September 23 Compliance...

This has been a busy week for the Department of Health and Human Services / Office for Civil Rights (HHS/OCR). It has started releasing guidance on various provisions of the Omnibus HIPAA final rule (the "Final Rule") in...more

CMS Issues Proposed Rule to Reform "Unnecessary, Obsolete, or Excessively Burdensome" Medicare Participation Standards

On February 4, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule to reform Medicare regulations that CMS views as unnecessary, obsolete, and/or excessively burdensome on hospitals and health care...more

CMS Proposes Changes to Overly Burdensome Rules

On February 4, 2013, CMS proposed certain reforms to Medicare regulations that would eliminate or change rules seen as unnecessary, obsolete, or excessively burdensome on hospitals and other health care providers. The...more

CMS Publishes Proposed Changes to CLIA’s Proficiency Testing Regulations

Yesterday the Centers for Medicare & Medicaid Services (CMS) filed a proposed rule (the Proposed Rule) that would make significant changes to existing regulations governing the proficiency testing (PT) process mandated by the...more

Proposed TEST Act May Provide Greater Flexibility to CMS

Since its enactment in 1992, the Certified Laboratory Improvement Amendments (CLIA) have imposed severe sanctions for the referral of a proficiency testing (PT) sample to an outside laboratory. PT is a test sent to a...more

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