Statute
Clinical Laboratory Improvement Amendments
15 published works
Health Care Law Today
COVID-19 At-Home Tests: Do CLIA Requirements Apply and what do Health Care Providers Need to Know?
By Judith A. Waltz, Olivia R. King
Demand for COVID-19 tests, including over-the-counter at-home tests, has soared with the surge of the Omicron variant of the COVID-19 virus. However, health care providers, employers, and individuals have lacked…
Workforce Bulletin
New Guidance Clarifies Requirements for Onsite Workplace COVID-19 Testing
By Allen R. Killworth, Nancy Gunzenhauser Popper, Denise Merna Dadika, Nathaniel M. Glasser, Robert (Bob) R. Hearn
Important guidance regarding COVID-19 testing in the workplace was recently issued by the Centers for Medicare & Medicaid Services (“CMS”) in the form of Frequently Asked Questions regarding Over the…
Life Sciences Perspectives
Don’t Forget about the States! Understanding the Maze of State Billing Laws for Physicians and Laboratories Providing Anatomic Pathology Services
Laboratory tests play a critical part of the healthcare system. Ordering and billing for these tests, however, is not always cut-and-dry. Compliance with federal laws and rules (like the Clinical…
Health Care Law Matters
PA ASC Guidance Requires CLIA Certification for COVID-19 Testing
On May 23, 2020, the PA Department of Health (DOH) revised its guidance for ambulatory surgical facilities (ASFs) to require ASFs that intend to provide COVID-19 testing to patients and…
Health Law Diagnosis
Connecticut Governor Ned Lamont Issues Executive Order Allowing Pharmacists to Order COVID-19 Tests
By Robinson+Cole's Health Law Group
On May 7, 2020 Connecticut Governor Ned Lamont issued Executive Order 7KK allowing pharmacists to order COVID-19 tests. The order modifies Section 19a-36-D29 of the Regulations of Connecticut State Agencies…
Healthcare Law Blog
FDA Grants COVID-19 Diagnostic Emergency Use Authorizations, And Other Recent FDA Actions to Address COVID-19
The U.S. Food and Drug Administration (FDA) issued two Emergency Use Authorizations (EUA) for commercially distributed COVID-19 diagnostic tests at the end of last week. The first authorization was issued…
Health Industry Washington Watch
CMS Mulling Changes to CLIA Personnel, Proficiency Testing Referral Rules
CMS is requesting information from the public on potential changes to longstanding Clinical Laboratory Improvement Amendments of 1988 (CLIA) personnel, histocompatibility, and related policies, which have not been comprehensively updated…
Life Sciences Legal Update
FDA Advances LDT Dialogue with New Discussion Paper Containing Updated CMS/FDA Oversight Proposal
By Kevin Madagan, Catherine Brinkley
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…
Health Care and Life Sciences
Disruptor Meets Regulator, and Regulator Wins: Lessons Learned from Theranos
On July 7, 2016, the Centers for Medicare and Medicaid Services ("CMS") imposed several administrative penalties on Theranos, a clinical laboratory company that proposed to revolutionize the clinical laboratory business…
Health Industry Washington Watch
Individualized Quality Control Plan for CLIA Laboratory Non-Waived Testing (May 19)
CMS is hosting a provider call on May 19, 2014 regarding the Clinical Laboratory Improvement Amendments (CLIA) Individualized Quality Control Plan (IQCP), which is a new, voluntary quality-control option for laboratories…