Archive for: Coronavirus

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Diagnostics

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.

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Diagnostics

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.

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Diagnostics

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.

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Payment Innovation: COVID-19

Pandemic Response Accountability Committee Launches Fund Tracker Site

Established by the CARES Act, the PRAC has launched a site to track how the $2.4 trillion in federal dollars are being distributed to support industries across the nation during the current public health emergency.

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Payment Innovation: COVID-19

HHS Distributes $30 Billion to FFS Medicare Providers

On April 10, 2020, HHS began distributing $30 billion from the $100 billion Public Health and Social Services Emergency Fund to Medicare FFS providers

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Diagnostics

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.

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Diagnostics

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:

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Diagnostics

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.

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Payment Innovation: COVID-19

COVID-19 Activities and Actions Update

As part of the ongoing White House Coronavirus Task Force efforts, CMS and other agencies have issued several resource documents, refocused activities related to state survey agencies and accrediting organizations, and taken other related actions.

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Payment Innovation: COVID-19

CMS Issues Recommendations to Nursing Homes, State and Local Governments

On April 2, 2020, the 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.

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Payment Innovation: COVID-19

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

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 reimburse providers for treating uninsured patients with COVID-19.

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Payment Innovation: Other

MedPAC Releases Agenda for Closed-door April Meeting

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 transcript of the meeting by COB on Friday, April 3.

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Diagnostics

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.

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Diagnostics

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.

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Diagnostics

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

On March 23, FDA updated its FAQ regarding specimen collection for COVID-19 testing.

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Payment Innovation: COVID-19

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.

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Payment Innovation: COVID-19

COVID-19 Activities and Actions Update

As part of the ongoing White House Coronavirus Task Force efforts, CMS and other agencies have issued several resource documents, refocused activities related to state survey agencies and accrediting organizations, and taken other related actions.

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Diagnostics

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.

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Diagnostics

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.

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Diagnostics

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.

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Diagnostics

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.

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Diagnostics

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.

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Diagnostics

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.

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Diagnostics

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.

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Diagnostics

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.

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Diagnostics

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.

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Diagnostics

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.

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Payment Innovation: Other

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

President Trump signed the Coronavirus Preparedness and Response Supplemental Appropriations Act of 2020 (P.L. 116-123) into law.

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Diagnostics

CMS Develops a Second HCPCS Code for Coronavirus Testing

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.

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Diagnostics

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 EUA for COVID-19 during the public health emergency.

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Diagnostics

CMS Develops New HCPCS Code for Coronavirus Testing

CMS created a new HCPCS code that providers and laboratories may use to report Coronavirus lab testing.

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