Print Page | Contact Us | Sign In | Join Now
News and Press: Industry News

CMS Releases New Waived Tests

Monday, August 5, 2019   (0 Comments)
Posted by: Kyle Simon

Courtesy of the National Association for Home Care & Hospice (NAHC)

There are some new tests that fall into the Clinical Laboratory Improvement Amendments (CLIA) waived testing category. The Centers for Medicare & Medicaid Services (CMS) made the announcement in Transmittal 4336/Change Request (CR) 11354, New Waived Tests. Home health agencies and hospices may perform some of these tests, most of which are related to  testing. If a home health or hospice agency is performing any of the laboratory tests in the waived testing category, the agency must have a CLIA Certificate of Waiver. The full list of all waived tests is available at the end of the transmittal. Information about obtaining a CLIA waiver is handled by each state.

The new tests that fall into the waived category are:

  • 80305QW, December 13, 2018, Shenzhen Bioeasy Biotechnology Co., Ltd, BIOEASY Multi-Drug Test Cup;
  • 80305QW, April 18, 2019, Mercedes Scientific Inc., Platinum+ Multi-Drug Urine Test Cup;
  • 80305QW, April 18, 2019, Mercedes Scientific Inc., Platinum+ Multi-Drug Urine Test Dip Card;
  • 87880QW, May 9, 2019, McKesson Consult Strep A Test Cassette;
  • 87502QW, May 28, 2019, Alere ID NOW Instrument {Nasal and Nasopharyngeal swabs}, for Influenza A/B; and,
  • 87634QW, May 29, 2019, Alere ID NOW Instrument {Nasopharyngeal swabs}, for respiratory syncytial virus.

Associate Members