Labs In Court

A roundup of recent cases and enforcement actions involving the diagnostics industry

Case: CMS revoked an Arizona lab’s CLIA certification in 2000. Three unsuccessful appeals and one failed petition to the U.S. Supreme Court later—eight years in total—the seven CLIA deficiencies, … [Read more...]

Labs In Court

Arizona Lab’s 20-Year Quest to Regain CLIA Certification Comes Up Empty

Case: CMS revoked an Arizona lab’s CLIA certification in 2000. Three unsuccessful appeals and one failed petition to the U.S. Supreme Court later—eight years in total—the seven CLIA deficiencies, … [Read more...]

Medicare Reimbursement

CMS Waivers Expand COVID-19 Testing Coverage Rules

On May 1, CMS issued regulatory waivers temporarily expanding coverage and clarifying billing of COVID-19 testing for Medicare and Medicaid beneficiaries during the public health emergency (PHE). Here … [Read more...]

CORONAVIRUS

HHS Puts Information Blocking and EHI Operability on Hold Due to COVID-19 Crisis

On March 9, 2020, the HHS Office of the National Coordinator for Health Information Technology (ONC) and CMS issued but didn’t publish final rules designed to improve patient access to their own … [Read more...]

CARES Act

CMS Issues Guidance on Private Payor Reimbursement of COVID-19 Testing

If your lab is performing COVID-19 testing for patients covered by private insurance and health plans, you need to be aware of the reimbursement rules set out in the new COVID-19 relief legislation. … [Read more...]

Medicare Reimbursement

New CMS Waivers Dramatically Expand Coverage Rules for COVID-19 Testing

CMS doesn’t want the usual compliance red tape to stand in the way of desperately needed COVID-19 testing. So, on May 1, the agency issued regulatory waivers temporarily expanding coverage of testing … [Read more...]

CMS

Reimbursement of COVID-19 Testing: Private Payors

COVID-19 relief legislation, i.e., the Families First Coronavirus Response Act (FFCRA) and Coronavirus Aid, Relief, and Economic Security Act (CARES) require payors to cover COVID-19 testing without … [Read more...]

CMS

Reimbursement of COVID-19 Testing: Medicare

How about some good news for a change? On April 15, CMS announced that it was increasing reimbursements for high-throughput SARS-CoV-2 lab tests. Here are the three key takeaways. Which Tests … [Read more...]

Top of the News: CMS Issues New Guidance for Laboratories Performing Coronavirus Testing

On Feb. 4, the Food and Drug Administration (FDA) granted emergency use authorization (EUA) clearance for the first test approved in the US for detecting the novel coronavirus. Developed by the US … [Read more...]

Billing & Coding

New HCPCS Codes for COVID-19 Specimen Collection

CMS has established two new Level II HCPCS codes for COVID-19 specimen collection: G2023 - Specimen collection for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus … [Read more...]


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