CMS Approves Additional State Medicaid Waivers; Clinical Laboratory Improvement Amendments Guidance

The Centers for Medicare and Medicaid Services have released the following updates on March 27:

CMS Approves Additional State Medicaid Waivers and Amendments to Give States Flexibility to Address Coronavirus Pandemic

CMS approved an additional 6 state Medicaid waiver requests under Section 1135 of the Social Security Act (Act), bringing the total number of approved Medicaid Section 1135 waivers to 29.  These waivers were approved within days of states’ submitting them, and offer states new flexibilities to focus their resources on combatting the COVID-19 outbreak and providing the best possible care to Medicaid beneficiaries in their states. These waivers support President Trump’s commitment to a COVID-19 response that is locally executed, state managed and federally supported.  The states that were approved today are:

  • New York
  • Colorado
  • Hawaii
  • Idaho
  • Massachusetts
  • Maryland

In addition, keeping with its commitment to ensure states have the necessary tools to respond to the 2019 Novel Coronavirus (COVID-19) pandemic, CMS approved 1 additional state request for a tool states may use during emergency situations. Colorado’s request was approved today.  CMS has approved a total of 7 state requests for these tools to date.

Section 1135 Waivers

Appendix K Waivers

Clinical Laboratory Improvement Amendments (CLIA) Guidance During COVID-19 Emergency

CMS issued important guidance ensuring that America’s clinical laboratories are prepared to respond to the threat of the 2019 Novel Coronavirus (COVID-19.) CMS is committed to taking critical steps to ensure America’s clinical laboratories are prepared to respond to the COVID-19 threat and other respiratory illnesses by implementing flexibilities around requirements for a Clinical Laboratory Improvement Amendments (CLIA) certificate during public health emergencies.

While there is no formal waiver authority under CLIA, CMS continue to exercise flexibilities under current regulations and through enforcement discretion to address temporary and remote testing sites, use of alternate specimen collection devices, and implementation of laboratory developed tests.  Our hope is that this guidance provides the steps needed for all U.S. Labs wanting to apply for a CLIA certificate to test for COVID-19.

Guidance

FAQ

To keep up with the important work the White House Task Force is doing in response to COVID-19, click here www.coronavirus.gov. For information specific to CMS, please visit the CMS News Room and Current Emergencies Website.

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