Labs and the health industry have been waiting for years for some Stark Law and Anti-Kickback Statute (AKS) relief. Last October, HHS, CMS and the OIG finally unveiled the long-awaited plans to … [Read more...]
Reimbursement
OIG Medicare Lab Spending Report May Warn of Greater Scrutiny of Genetic and Automated Chemistry Tests
August 29, 2020
PAMA and market-based rate reductions for lab testing was supposed to save Medicare bundles of money. But according to a new OIG report, Medicare Part B spending on lab spending for 2018, the first … [Read more...]
Labs In Court
A roundup of recent cases and enforcement actions involving the diagnostics industry
July 2, 2020
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
July 2, 2020
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
June 1, 2020
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
May 27, 2020
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
May 24, 2020
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
May 24, 2020
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
May 2, 2020
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
May 2, 2020
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...]
