First COVID-19 Breathalyzer Test Authorized By FDA

Author Headshot

By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

On April 14, 2022, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization for the first Covid-19 diagnostic test that uses breath samples. The test, made by Texas-based company, InspectIR Systems, is authorized for those patients 18 and older.

InspectIR expects to produce approximately 100 testing instruments per week, which can each be used to evaluate approximately 160 samples per day. At this level of production, testing capacity using the InspectIR COVID-19 Breathalyzer is expected to increase by about 64,000 samples per month, according to the FDA’s statement.

The Testing Requirements.

The test can only be performed in environments where the patient’s specimen is collected and analyzed, such as doctor’s offices, hospitals, and mobile testing sites.

Additionally, the test must be performed by a qualified, trained operator under the supervision of a licensed health care provider or authorized by state law to prescribe tests. The test detects chemicals associated with the virus that causes the disease in a breath sample in less than three minutes. If it’s positive, it should be followed up by a molecular test, the agency said in a statement.

“Today’s authorization is yet another example of the rapid innovation occurring with diagnostic tests for Covid-19,” Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said.

Read the FDA’s press release and get even more information.

Contact Health Law Attorneys Experienced in Representing Health Care Professionals and Providers.

At the Health Law Firm, we provide legal services for all health care providers and professionals. This includes physicians, nurses, dentists, psychologists, psychiatrists, mental health counselors, home health agencies, hospitals, ambulatory surgical centers, pain management clinics, nursing homes, and any other healthcare provider. It also includes medical students, resident physicians, and fellows, as well as medical school professors and clinical staff. We represent health facilities, individuals, groups, and institutions in contracts, sales, mergers, and acquisitions. The lawyers of The Health Law Firm are experienced in complex litigation and both formal and informal administrative hearings. We also represent physicians accused of wrongdoing, patient complaints, and in Department of Health investigations.

To contact The Health Law Firm, please call our office at (407) 331-6620 or toll-free at (888) 331-6620 and visit our website at www.ThehealthLawFirm.com.

Sources:

Helsel, Phil. “FDA authorizes first Covid-19 breath test.” NBC News. (April 14, 2022). Web.

Muller, Madison. “Breathalyzer Test for Covid-19 Wins Approval From FDA.” Bloomberg. (April 14, 2022). Web.

Mckinney, Jim. “Coronavirus (COVID-19) Update: FDA Authorizes First COVID-19 Diagnostic Test Using Breath Samples.” U.S. Food and Drug Administration. (April 14, 2022). Web.

About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law; he is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Avenue, Suite 1000, Altamonte Springs, FL 32714, Phone: (407) 331-6620 or Toll-Free: (888) 331-6620.

“The Health Law Firm” is a registered fictitious business name of and a registered service mark of The Health Law Firm, P.A., a Florida professional service corporation, since 1999.
Copyright © 2022 The Health Law Firm. All rights reserved.

 

From the archives: COVID Uninsured Provider Relief Fund Expected To Run Out of Money Soon If Congress Doesn’t Act

Previously published on April 19, 2022
Attorney and Author HeadshotBy George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

In 2020, the U.S. Department of Health and Human Services (HHS) created the “Provider Relief Fund” (PRF) to help support healthcare providers in the battle against the COVID-19 pandemic. The federal program has served as a lifeline to frontline healthcare workers who’ve experienced revenue losses and increased demand for their services during the pandemic.

To date, it has allocated more than $178 billion in payments to over 410,000 providers across the United States. Click here to learn more.

COVID-19 Uninsured Relief Fund.

Let’s start with some good news: Under the COVID-19 relief funding, HHS created the “uninsured relief fund.” This program provides claims reimbursement to health care providers for testing, treating, diagnosis, and administering vaccines to uninsured individuals for COVID-19. It has paid out more than $17 billion throughout the pandemic. It has paid out more than $17 billion throughout the pandemic.

Of the $17 billion, HHS has distributed nearly $10 billion for testing, more than $6 billion reimbursed for treatment, and the remainder covered vaccinations. Read more on the statistics here.

Running Out of Money.

Now for the bad news: According to an HHS spokesperson, there’s only $7.6 billion left, and the money will run out in the coming months. Congress isn’t currently considering making more funding available, meaning providers and patients are likely to have soon to bear the costs themselves.

Therefore, many hospitals and healthcare organizations urge Congress to replenish the PRF. “One of the most helpful and patient-oriented uses of the PRF was to help those people who for whatever reasons are uninsured and suffer from COVID-19,” said Federation of American Hospitals CEO Chip Kahn. “It meant that no one should have any reluctance to go to the hospital if they have COVID but no insurance.”

Additionally, on February 9, 2022, the American Hospital Association released a statement urging readers to contact lawmakers to get Congress to provide another $25 billion for the PRF in the government funding package. Read the AHA’s action alert here.

As we approach nearly two years since HHS declared COVID-19 a national public health emergency, PRF has been a lifeline to hospitals, health systems, and medical professionals. It has been helping to keep doors open during the pandemic to continue providing essential care to patients and communities. However, if the program runs out of money and Congress doesn’t appropriate more, hospitals could be left footing the bill, which will hurt both providers and patients in the end.

Read one of my previous blogs on a similar case regarding a Florida Dentist’s COVID-19 Business Interruption Insurance Claim to learn even more.

Contact Health Law Attorneys Experienced in Representing Health Care Professionals and Providers.

At the Health Law Firm, we provide legal services for all health care providers and professionals. This includes physicians, nurses, dentists, psychologists, psychiatrists, mental health counselors, home health agencies, hospitals, ambulatory surgical centers, pain management clinics, nursing homes, and any other healthcare provider. It also includes medical students, resident physicians, and fellows, as well as medical school professors and clinical staff. We represent health facilities, individuals, groups, and institutions in contracts, sales, mergers, and acquisitions. The lawyers of The Health Law Firm are experienced in complex litigation and both formal and informal administrative hearings. We also represent physicians accused of wrongdoing, patient complaints, and in Department of Health investigations.

To contact The Health Law Firm, please call our office at (407) 331-6620 or toll-free at (888) 331-6620 and visit our website at www.ThehealthLawFirm.com.

Sources:

Hellmann, Jessie. “HHS running out of money to pay providers for treating uninsured COVID-19 patients.” Modern Healthcare. (February 8, 2022). Web.

HRSA. “Covid Uninsured Claim.” Health Resources & Services Administration. (February 2022). Web.

About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law; he is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave. Suite 1000, Altamonte Springs, FL 32714, Phone: (407) 331-6620 or Toll-Free: (888) 331-6620.

“The Health Law Firm” is a registered fictitious business name of and a registered service mark of The Health Law Firm, P.A., a Florida professional service corporation, since 1999.
Copyright © 2022 The Health Law Firm. All rights reserved.

COVID-19 Provider Relief Fund Expected To Run Out of Money If Congress Doesn’t Act Soon

Attorney and Author HeadshotBy George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

In 2020, the U.S. Department of Health and Human Services (HHS) created the “Provider Relief Fund” (PRF) to help support healthcare providers in the battle against the COVID-19 pandemic. The federal program has served as a lifeline to frontline healthcare workers who’ve experienced revenue losses and increased demand for their services during the pandemic.

To date, it has allocated more than $178 billion in payments to over 410,000 providers across the United States. Click here to learn more.

COVID-19 Uninsured Relief Fund.

Let’s start with some good news: Under the COVID-19 relief funding, HHS created the “uninsured relief fund.” This program provides claims reimbursement to health care providers for testing, treating, diagnosis, and administering vaccines to uninsured individuals for COVID-19. It has paid out more than $17 billion throughout the pandemic. It has paid out more than $17 billion throughout the pandemic.

Of the $17 billion, HHS has distributed nearly $10 billion for testing, more than $6 billion reimbursed for treatment, and the remainder covered vaccinations. Read more on the statistics here.

Running Out of Money.

Now for the bad news: According to an HHS spokesperson, there’s only $7.6 billion left, and the money will run out in the coming months. Congress isn’t currently considering making more funding available, meaning providers and patients are likely to have soon to bear the costs themselves.

Therefore, many hospitals and healthcare organizations urge Congress to replenish the PRF. “One of the most helpful and patient-oriented uses of the PRF was to help those people who for whatever reasons are uninsured and suffer from COVID-19,” said Federation of American Hospitals CEO Chip Kahn. “It meant that no one should have any reluctance to go to the hospital if they have COVID but no insurance.”

Additionally, on February 9, 2022, the American Hospital Association released a statement urging readers to contact lawmakers to get Congress to provide another $25 billion for the PRF in the government funding package. Read the AHA’s action alert here.

As we approach nearly two years since HHS declared COVID-19 a national public health emergency, PRF has been a lifeline to hospitals, health systems, and medical professionals. It has been helping to keep doors open during the pandemic to continue providing essential care to patients and communities. However, if the program runs out of money and Congress doesn’t appropriate more, hospitals could be left footing the bill, which will hurt both providers and patients in the end.

Read one of my previous blogs on a similar case regarding a Florida Dentist’s COVID-19 Business Interruption Insurance Claim to learn even more.

Contact Health Law Attorneys Experienced in Representing Health Care Professionals and Providers.

At the Health Law Firm, we provide legal services for all health care providers and professionals. This includes physicians, nurses, dentists, psychologists, psychiatrists, mental health counselors, home health agencies, hospitals, ambulatory surgical centers, pain management clinics, nursing homes, and any other healthcare provider. It also includes medical students, resident physicians, and fellows, as well as medical school professors and clinical staff. We represent health facilities, individuals, groups, and institutions in contracts, sales, mergers, and acquisitions. The lawyers of The Health Law Firm are experienced in complex litigation and both formal and informal administrative hearings. We also represent physicians accused of wrongdoing, patient complaints, and in Department of Health investigations.

To contact The Health Law Firm, please call our office at (407) 331-6620 or toll-free at (888) 331-6620 and visit our website at www.ThehealthLawFirm.com.

Sources:

Hellmann, Jessie. “HHS running out of money to pay providers for treating uninsured COVID-19 patients.” Modern Healthcare. (February 8, 2022). Web.

HRSA. “Covid Uninsured Claim.” Health Resources & Services Administration. (February 2022). Web.

About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law; he is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave. Suite 1000, Altamonte Springs, FL 32714, Phone: (407) 331-6620 or Toll-Free: (888) 331-6620.

“The Health Law Firm” is a registered fictitious business name of and a registered service mark of The Health Law Firm, P.A., a Florida professional service corporation, since 1999.
Copyright © 2022 The Health Law Firm. All rights reserved.

Go to Top