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Coronavirus/COVID-19 › Clinical Laboratories › Virus Testing

Read guidance, analysis, and updates on the myriad issues arising from the global response to the COVID-19 pandemic. Updated hourly every day, the insights published here are written by leading lawyers and law firms... more +
Read guidance, analysis, and updates on the myriad issues arising from the global response to the COVID-19 pandemic. Updated hourly every day, the insights published here are written by leading lawyers and law firms helping to make sense of insurance, employment, tax, securities, M&A, risk management, and every other consideration touched by this crisis. Follow the channel for a daily email brief of the latest and best updates. less -
Rivkin Radler LLP

NYC Man Pleads Guilty in $3.5 Million COVID-19 Kickback Scheme

Rivkin Radler LLP on

On February 26, David Weathers of the Bronx pleaded guilty in federal court in New Jersey for his role in a COVID-19 kickback conspiracy. The government had charged Weathers with soliciting kickbacks in return for referrals...more

K&L Gates LLP

COVID-19: A Roadmap to Fraud Investigations: Office of Inspector General Targets Labs for Billing COVID-19 Add-On Tests

K&L Gates LLP on

Introduction - On 6 December 2022, the Department of Health and Human Services Office of Inspector General (HHS-OIG) issued a report (Report) that summarized findings of HHS-OIG’s review of laboratories with questionably high...more

Robinson & Cole LLP

Clinical ColLABorative - Legal Insights in Laboratory Compliance

Robinson & Cole LLP on

What To Do When The Government Knocks On Your Lab’s Door - The volume of federal enforcement actions involving laboratories has increased dramatically over the last few years. Not a month seems to pass without a press...more

Womble Bond Dickinson

What to Expect as OIG and CMS Audits Focus on COVID-19 Testing?

Womble Bond Dickinson on

The COVID-19 pandemic has caused an enormous need for testing and has spawned the creation of new labs and specimen collection agencies to (try to) meet that need. In 2020 alone, Medicare spent $1.5 billion on COVID-19 tests....more

Robinson & Cole LLP

COVID-19 Testing — Additional Considerations

Robinson & Cole LLP on

At the start of the COVID-19 pandemic, each state and the federal government announced various states of public health emergencies which enabled them to suspend or modify various laws, rules, and regulations to accommodate...more

Oberheiden P.C.

Compliance Concerns for Respiratory and Clinical Labs Performing COVID-19 Testing

Oberheiden P.C. on

The tragedy of the COVID-19 pandemic is something we all agree we wish we could have avoided. However, the fact of the matter is that many respiratory and clinical labs have seen a boon to their bottom line due to the...more

Oberheiden P.C.

Key Elements of an OIG Compliance Program That Respiratory and Clinical Labs Need to Know

Oberheiden P.C. on

Clinical laboratories such as respiratory and clinical labs that bill Medicare, Department of Health and Human Services (“DHHS”) programs, and other federal programs are subject to oversight by the Office of Inspector General...more

Fox Rothschild LLP

COVID-19 and Clinical Laboratories: Licensing Requirements For Diagnostic Testing

Fox Rothschild LLP on

Clinical laboratories across the country have ramped up their diagnostic testing capabilities to meet the critical need for COVID-19 testing, which is essential to mitigating the spread of the virus. Many labs are responding...more

Mintz - Health Care Viewpoints

FDA in 2020: What a Year!

Mintz - Health Care Viewpoints on

What a year for the Food and Drug Administration! FDA, an agency with regulatory oversight of 20-25% of products on which consumers spend, including food and medicines, but which typically stays out of the limelight, was...more

K&L Gates LLP

K&L Gates Triage: CMS Cease and Desist Letters to COVID Labs and Reimbursement Dispute

K&L Gates LLP on

In this episode, Stephen Bittinger discusses the recent announcement that cease and desist letters from the Centers for Medicare & Medicaid Services (CMS) have been sent to 171 facilities testing for COVID-19 without proper...more

Jackson Walker

CMS Implements Stricter COVID-19 Testing Regulations on Nursing Homes

Jackson Walker on

As part of a broader Trump administration announcement made on August 25, 2020, the Centers for Medicare & Medicaid Services (CMS) issued sweeping oversight changes in the form of an Interim Final Rule with Comment Period...more

Bass, Berry & Sims PLC

Reimbursement and Liability Implications of Not Pursuing an Emergency Use Authorization for COVID-19 Laboratory-Developed Tests

Bass, Berry & Sims PLC on

In an unprecedented move touted as necessary to address the COVID-19 testing shortage, the U.S. Department of Health and Human Services (HHS) made a brief statement on August 19 that effectively rescinded the federal Food and...more

Bass, Berry & Sims PLC

Penalties for COVID-19 Reporting Failures and Other New CMS Rules on Mandatory Testing and Ordering Limits

Bass, Berry & Sims PLC on

Anyone conducting COVID-19 testing – whether using point of care or high complexity tests – should take note. On August 25, the Centers for Medicare & Medicaid Services (CMS) released an Interim Final Rule with comment period...more

King & Spalding

HHS OIG Permits Labs to Offer Free COVID-19 Antibody Tests and Oncology Practices to Offer Free Lodging in Certain Circumstances

King & Spalding on

OIG has updated its FAQs regarding the application of its administrative enforcement authorities to arrangements directly connected with COVID-19 with the addition of two new FAQs. On August 4, 2020, the OIG issued an FAQ...more

Foley Hoag LLP

New Massachusetts Bulletin Makes COVID Testing Reimbursement Easier

Foley Hoag LLP on

In an effort to make it easier for laboratories to be reimbursed by insurers for COVID-19 testing, the Massachusetts Division of Insurance has issued a bulletin stating that it expects “carriers to relax” restrictions on...more

Hogan Lovells

FDA updates FAQ on COVID-19 tests and validation

Hogan Lovells on

Last week, on 23-25 June 2020, the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) updated the responses to six of the Frequently Asked Questions related to laboratories and...more

Mintz - Health Care Viewpoints

CMS Allows Pharmacies and Other Suppliers to Bill Medicare for COVID-19 Testing

Mintz - Health Care Viewpoints on

In an effort to address the need to increase the availability of COVID-19 testing, the Centers for Medicare & Medicaid Services (CMS) has issued guidance notifying pharmacies and other Medicare-enrolled suppliers that they...more

Health Care Compliance Association (HCCA)

CMS reveals new HCPCS code for coronavirus lab tests

Health Care Compliance Association (HCCA) on

Compliance Today (May 2020) - The Centers for Medicare & Medicaid Services (CMS) announced on March 6, 2020, in a special edition of MLN Connects[1] that the agency has taken “additional actions to ensure America’s...more

Foley Hoag LLP

What Clinical Diagnostic Laboratories and Manufacturers Need to Know about the CARES Act

Foley Hoag LLP on

On March 27, 2020, Congress passed the Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”), the third and by far the largest stimulus package passed by Congress to respond to the COVID-19 outbreak. As discussed...more

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