Coronavirus Update #167
MDH Revised Orders, New CMS Toolkit, Reminders
CMS Releases New Tools to Streamline Certification for Labs Testing for COVID-19

On Friday, the Centers for Medicare & Medicaid Services (CMS) released new tools to reduce burdensome paperwork and authorization delays for laboratories seeking Clinical Laboratory Improvement Amendments (CLIA) certification to test for coronavirus disease 2019 (COVID-19). 

CMS’s quick-start guide helps laboratories with the application process for CLIA certification and includes information on the expedited review process implemented at the beginning of the public health emergency that allows labs to start COVID-19 testing before the official paper certificate arrives by postal mail. Laboratories also have a new option to pay CLIA certification fees on the CMS CLIA Program website. Online payments are processed overnight, which is substantially faster than hard-copy checks. 

CMS regulates all laboratory testing performed on humans for the purposes of diagnosis, prevention, or treatment in the U.S. through the CLIA program. To become CLIA-certified, laboratories must meet performance and quality assurance requirements aimed at ensuring they are able to deliver reliable and accurate test results for the purpose of proper diagnosis, prevention and treatment of diseases like COVID-19. This new guide provides laboratories with the resources they need to reduce paperwork and streamline the CLIA application and certification process. This quick-start guide outlines the steps laboratories must follow to apply for and receive CLIA certification, including ensuring the form is submitted to the correct state agency

Prior to receiving certification, laboratories must also pay a user fee to cover the costs of administering the CLIA program, which also includes inspection costs. Laboratories can now pay CLIA certification fees through a secure platform hosted by the Treasury Department on the CMS CLIA Program website. CLIA fees are based on the certificate requested by the laboratory (i.e., Certificate of Waiver, Provider-performed Microscopy, Accreditation, or Compliance) and, in some instances, the annual volume and types of testing performed. The CLIA Certificate Fee Schedule contains detailed information on costs. The actions announced today support continued efforts by CMS to promote access to safe and reliable testing during the COVID-19 public health emergency.
REMINDERS
MDH Webinar Recap

Last week, the Maryland Department of Health held a webinar call to update the long-term care sector on COVID-19 developments and best practices. The call was recorded, in case you were unable to join or would like to review the topics discussed, which included:

  • Review current situation of COVID-19
  • COVID-19 Epi Updates
  • CMS Updates
  • CDC Updates
  • Q&A


You can also view the webinar's Powerpoint presentation here.

If you have any questions, please email mdh.ipcovid@maryland.gov.
MDH Updates

Redetermination Extension

Last week, The Maryland Department of Health (MDH) shared that they requested and received additional approvals from the Centers for Medicare and Medicaid Services (CMS) and the Maryland Department of Budget and Management (DBM) to extend the deadline for renewal of Medicaid cases in Maryland, including Long-Term Care (L TC) Medicaid cases. 

Redetermination and renewal deadlines set for March 31, April 30, May 31, June 30, July 31, August 31, September 30, October 31, and November 30, 2020 have been extended to December 31, 2020. Cases that are due to close on those dates have been extended to December 31st. 

Please keep in mind that you are still encouraged to complete renewals as close to the scheduled redetermination date as possible. This extension does not extend past December 31, 2020. Click here to read the full memo.

Power Wheelchair Transmittal

Beginning November 1, 2020, Telligen, the Maryland Medicaid Program's Utilization Control Agent, will assume the responsibility for processing preauthorization requests for power wheelchairs (PWCs) for nursing facility residents. After this date, the Program will no longer accept requests from nursing facilities. Instead, requests must be submitted by a durable medical equipment (DME) provider that is an authorized Maryland Medicaid provider.

CMS Memo Reversing Nursing Home Restrictions

As you know, CMS announced changes regarding visitation. This new QSO memo (20-39-NH) greatly improves the ability for nursing home residents to receive visitors. In short, it allows for more outdoor and indoor visits, including parameters where indoor visits are required to be permitted.

Please note that on last week's webinar, MDH discussed the CMS changes and shared that they would be providing additional guidance on visitation; we will share this state guidance as soon as it becomes available.
This year, it’s more important than ever to get the flu shot

People who are 65 and older are at high risk of having serious health complications from the flu. Now more than ever, everyone needs to do their part to prevent the spread of illnesses like the flu.

Because of the COVID-19 pandemic, fewer people are getting vaccines which puts their communities at greater risk for other preventable diseases. When people with Medicare get the flu shot, it helps protect them and keep them from spreading the flu to others.  Getting a flu vaccine is a simple, easy, and powerful way to protect your health and the health of those around you.

Medicare covers the cost of the flu shot, which is available at most health care provider offices, local pharmacies, senior centers, health centers, and other places in the community.

This year, CMS is developing many new flu vaccination resources for people with Medicare, partners, providers, and others who can share our message. 

Consumer Resources on Medicare.gov

Partner & Provider Resources on CMS.gov
  • CMS developed a new page – cms.gov/flu – for one-stop shopping to help you find CMS’s flu vaccination information and resources.
  • Visit the Outreach & Media Materials page for flu vaccination materials you can share within your partner networks and use to reach people with Medicare, plus other audiences across our health care programs. We will continue to update this page with additional resources.
  • Use this social media toolkit with posts and graphics to spread the word about the importance of getting a flu shot this year (in English & Spanish).
  • For partners, CMS launched a Flu Vaccine Partner Toolkit with flu and other immunization resources. Multi-language fact sheets and much more here!
  • For health care providers, CMS launched a new website – cms.gov/flu-provider – with flu coverage and billing information.
Abbott BinaxNOW™ Assisted Living Webinar Follow-up

Abbott BinaxNOW recently held a webinar for assisted living facilities. Please click here to see the slides from the webinar.

​Skilled nursing facilities and assisted living communities who are receiving the Abbott BinaxNOW™ test kits can refer to the following resources from Abbott: 

Contact Information:  
  • To report shipping issues / order quality concerns (these should be sent to Abbott at: ARDxUSGovernmentSupport@abbott.com)  
  • For technical usage questions about the BinaxNOW™ test, contact Abbott directly at: Technical support: ts.scr@abbott.com or 1-800-257-9525 
  • For all other questions related to your distribution, please contact HHSBINAX@hhs.gov, this inbox was established to coordinate the distribution of government procured Abbott BinaxNOW™kits. This inbox should NOT be used to request kits for facilities not currently receiving these tests. 
  
For training videos & documentation and other important links, please refer the following information:  
  • For access to access training videos and documents, please visit the BinaxNOW™ COVID-19 Ag Card and NAVICA™ App Set-Up and Training portal.  
  • For CLIA FAQs and information, click here 
  • For policy regarding performance of antigen tests authorized by the FDA under an Emergency Use Authorization (EUA) at the point of care or in patient care settings operating under a CLIA Certificate of Waiver, please refer to CMS’s policy here and PREP Act guidance here
  • For FDA recommendations to health care providers who are ordering authorized tests outside their authorization (e.g., antigen tests for asymptomatic individuals), please see FDA’s FAQ on Testing for SARS-CoV-2.  
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from our federal and state partners.
Thank you.

We cannot thank you enough for the dedication and diligence in doing all that you can for the residents in your communities. HFAM continues to monitor the COVID-19 pandemic with our state and national partners and will do all we can to support you during this time.