Tag: Coronavirus

COVID-19 Activities and Actions Update

As part of the ongoing White House Coronavirus Task Force efforts, the Centers for Medicare and Medicaid Services (CMS) and other agencies have issued several resource documents, refocused activities related to state survey agencies and accrediting o...

National Health Quality Roadmap Released

The Department of Health and human Services (HHS), Department of Defense (DoD) and Department of Veterans Affairs (VA) has published the National Health Quality Roadmap. This new guidance is in response to President Trump’s Executive Order (EO),

CMS announces MAC pricing for COVID-19 serology testing

CMS has announced pricing for the two new serology CPT codes (86769 and 86328) created last month. MAC pricing is as follows:

  • $42.13 for 86769
  • $45.23 for 86328
These prices will remain until a national Medicare paymen...

FDA updated its FAQ document

FDA continues to regularly update its FAQ regarding COVID-19 testing. In terms of EUAs, the FDA has issued 75 for commercial laboratories and/or manufacturer test kits. It has also issued 28 EUAs for high complexity, molecular based LDTs. Coronavir...

FDA approves the first antigen test for diagnosing COVID-19

On May 8, 2020, the FDA issued its first Emergency Use Authorization for an antigen test for the diagnosis of COVID-19. This test is authorized in moderate and high complexity labs as well as at point-of-care testing. Coronavirus (COVID-19) Update: ...

FDA approves the first diagnostic test using at-home saliva collection

The FDA announced today its issuance of an Emergency Use Authorization for its first laboratory diagnostic test using at-home collected saliva samples. Currently, this is the only authorized test using saliva samples. Coronavirus (COVID-19) Update:...

Pandemic Response Accountability Committee Launches Fund Tracker Site

Established by the Coronavirus Aid, Relief, and Economic Security (CARES) Act, the Pandemic Response Accountability Committee (PRAC) has launched a site to track how the $2.4 trillion in federal dollars are being distributed to support industries acr...

FDA updates its FAQs on COVID-19 testing and approves new EUAs

The FDA continues to update its FAQs on COVID-19 testing. As of April 21, 2020, the FDA had 43 EUAs for test kits manufacturers and commercial laboratories. In addition, the FDA granted EUAs for 17 high complexity molecular-based laboratory develope...

CMS announces higher pricing for certain COVID-19 tests

CMS has increased pricing for COVID-19 lab tests that use high-throughput technologies to rapidly diagnose large numbers of potential COVID-19 cases. Effective April 14, 2020, CMS will pay $100 (nearly double the current price) for COVID-19 clinical ...

HHS Distributes $30 Billion to FFS Medicare Providers

On April 10, 2020, the US Department of Health and Human Services (HHS) began distributing $30 billion from the $100 billion Public Health and Social Services Emergency Fund to Medicare fee-for-service (FFS) providers. The Coronavirus Aid, Relief, an...

AMA is expediting another code for novel coronavirus test

The AMA is holding a special CPT Editorial Panel meeting today to consider another code for novel coronavirus tests. If created through this expedited process, the new code would facilitate “he reporting, measuring, analyzing, researching, and benc...

FDA continues to update its FAQ on COVID-19 testing and gives EUA to additional tests

FDA continues to regularly update its FAQ regarding COVID-19 testing. FDA continues to issue additional Emergency Use Authorizations for diagnostic tests for COVID-19 with ten additional EUAs over the past week. In addition, six LDTs have received ...

AMA revised one code and created two new codes for COVID-19 antibody testing

Following its CPT Editorial Panel meeting, the AMA created two  new codes for COVID-19 antibody testing: 86328 Immunoassay for infectious agent antibody(ies), qualitative or semiquantitative, single step method (eg, reagent strip); severe acute res...

HHS Announces Plan to Use $1 billion from CARES Act Funding to Treat Uninsured COVID-19 Patients

The Secretary of Health and Human Services (HHS) announced on Friday, April 3, 2020, during the daily briefing of the White House Coronavirus Task Force that Administration’s current plan is to use a portion of the $100 billion CARES Act funding to...

CMS Issues Recommendations to Nursing Homes, State and Local Governments

On April 2, 2020, the Centers for Medicare and Medicaid Services (CMS) issued recommendations to state and local governments, as well as nursing homes, to help mitigate the spread of the 2019 Novel Coronavirus (COVID-19) in nursing homes. The recomme...

COVID-19 Activities and Actions Update

As part of the ongoing White House Coronavirus Task Force efforts, the Centers for Medicare and Medicaid Services (CMS) and other agencies have issued several resource documents, refocused activities related to state survey agencies and accrediting o...

MedPAC Releases Agenda for Closed-door April Meeting

The Medicare Payment Advisory Commission (MedPAC) posted the agenda for the next meeting scheduled for April 2. Due to the coronavirus outbreak, the Commission has announced that the April meeting will not be open to the public. MedPAC will post a tr...

CMS issues guidance on broad waivers and flexibilities related to COVID-19.

On March 30,CMS announced a broad range of waivers and flexibilities for providers as the country is faced with the COVID-19 public health emergency. CMS has developed provider specific fact sheets on the flexibilities during this PHE. Laboratories...

FDA updates its FAQ on COVID-19 testing and gives EUA to additional tests

On March 28, FDA again updated its FAQ regarding specimen collection for COVID-19 testing. FDA continues to issue additional Emergency Use Authorizations for diagnostic tests for COVID-19 including an additional point-of-care test. As of the morning...

COVID-19 Activities and Actions Update

As part of the ongoing White House Coronavirus Task Force efforts, the Centers for Medicare and Medicaid Services (CMS) and other agencies have issued several resource documents, refocused activities related to state survey agencies and accrediting o...

CMS Approves 11 Additional Medicaid Section 1135 Waivers

This announcement from the Centers for Medicare and Medicaid Services (CMS) brings the total number of approved Section 1135 waivers for states to 13. On March 13, 2020, President Trump declared the COVID-19 situation a national emergency which enabl...

FDA gives EUA for first point-of-care COVID-19 test

Since March 19, the FDA announced four additional Emergency Use Authorizations granted for diagnostic tests for COVID-19 including the first point-of-care test. Coronavirus Disease 2019 (COVID-19) Emergency Use Authorizations for Medical Devices Co...

FDA issues guidance on unauthorized fraudulent COVID-19 test kits

On March 20, the FDA issued new guidance alerting consumers about the unauthorized, fraudulent COVID-19 test kits. Coronavirus (COVID-19) Update: FDA Alerts Consumers About Unauthorized Fraudulent COVID-19 Test Kits...

FDA gives EUA to additional tests for diagnostic testing for COVID-19

Since March 17, the FDA announced three additional Emergency Use Authorizations granted for diagnostic tests for COVID-19. As of the morning of March 19, nine tests now have received EUAs. Coronavirus Disease 2019 (COVID-19) Emergency Use Authorizat...

FDA gives EUA to additional tests and issues policy on diagnostic testing for COVID-19

Since March 13, the FDA announced three additional Emergency Use Authorizations granted for diagnostic tests for COVID-19. As of the morning of March 17, six tests now have received EUAs. The FDA also issued guidance to provide a policy to help acce...

LOINC special use codes created for SARS-CoV-2

In response to the emergent health situation, special use codes have been developed for SARS-CoV-2 testing. These codes are in “pre-release” and may evolve prior to public release. As of March 16, 29 special use codes have been created. SARS-Co...

AMA created a new code for novel coronavirus testing

Following its CPT Editorial Panel meeting, the AMA created a new code for novel coronavirus testing: 87635 Infectious agent detection by nucleic acid (DNA or RNA); severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [CO...

FDA took two additional steps in response to the coronavirus (COVID-19) outbreak

On March 12, 2020, the FDA took two additional steps to address the coronavirus (COVID-19) outbreak. First, the FDA issued enforcement discretion and is not objecting to the New York State Department of Health (NYSDOH) authorizing certain laboratori...

FDA is allowing for high complexity laboratory developed tests for COVID-19 testing.

Based on its review of the evidence, FDA has concluded that molecular-based laboratory developed tests (LDTs) that are authorized for use by the singular developing laboratory are appropriate to protect the public health or safety. The FDA will issu...

Pricing Announced for the Two New HCPCS Codes for Coronavirus Testing

CMS has announced that the two new HCPCS codes created for coronavirus testing – U0001 (for tests developed by the CDC) and U0002 (for non-CDC laboratory tests) – will be priced by the local Medicare Administrative Contractors. Prices will be as ...

AMA is Expediting Code Development for Novel Coronavirus Test

The AMA is holding a special CPT Editorial Panel meeting this week to consider a code for novel coronavirus tests. If created through this expedited process, the new code would facilitate “he reporting, measuring, analyzing, researching, and benchm...

Bipartisan Bill Relaxes Federal Telehealth Requirements in the Wake of COVID-19

On March 6, 2020, President Trump signed the Coronavirus Preparedness and Response Supplemental Appropriations Act of 2020 (P.L. 116-123) into law. This bill takes important steps to allow healthcare providers to deploy telehealth resources in respon...

CMS Develops a Second HCPCS Code for Coronavirus Testing

On March 5, 2020, CMS created a second HCPCS code that providers and laboratories may use to report Coronavirus lab testing. Code U0001 will be for the CDC testing laboratory tests for patients with SARS-CoV-2. The new test is for non-CDC laboratory ...

FDA Posts a Number of New Items Related to Coronavirus

On February 29, 2020, the FDA issued a new guidance document (immediately in effect) on its policy for diagnostic testing in laboratories certified to perform high complexity testing under CLIA prior to Emergency Use Authorization (EUA) for Coronavir...

CMS Develops New HCPCS Code for Coronavirus Testing

Today, CMS created a new HCPCS code that providers and laboratories may use to report Coronavirus lab testing. This code (U0001) allows labs to bill for the specific CDC 2019 Novel Coronavirus Real-Time RT-PCR Diagnostic Test Panel rather than using ...