First COVID-19 Breathalyzer Test Authorized By FDA

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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.

 

Feds Charge Three People For Multi-Million Dollar Scheme to Defraud Medicare, HIPAA Violations

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

In October 2020, Massachusetts federal prosecutors charged three people for their alleged roles in a multi-million dollar plot to defraud Medicare. Two individuals allegedly collected patient data and sold it to the purported mastermind, who used it to submit $109 million in false claims.

The two individuals who allegedly obtained the patient information were both located in Florida, wouldn’t ya know. They were each charged with one count of receiving more than $1.6 million kickbacks in connection with a federal health care program. Prosecutors charged the third individual with criminal violations of the Health Insurance Portability and Accountability Act (HIPAA).

Fraudulently Collecting & Using Private Patient Information.

According to court documents, both individuals in Florida owned marketing companies that enlisted foreign call centers to contact Medicare beneficiaries. Using a prepared script, they allegedly asked the patients they called if they would be interested in receiving durable medical equipment (DME) such as knee braces or compression sleeves “at little to no cost.”

The call centers would then collect information, including the patient’s name, address, insurance number, Medicare number, and doctor’s name and address, prosecutors said. The information was then sold to the third individual, who filed fraudulent Medicare claims for DME that were never prescribed and not medically necessary.

According to court records, the alleged co-conspirators used the same patients’ information repeatedly through a different shell company each time. More than 1,000 of the claims were made under the names of deceased beneficiaries. Click here to view the criminal information in this case.

Read the DOJ’s press release on this case for additional information.

Also, you can read one of my prior blogs on a similar case in Florida.

Don’t Wait Until It’s Too Late; Consult with a Health Law Attorney Experienced in Medicare Issues Now.

The attorneys of The Health Law Firm represent durable medical equipment (DME) suppliers and other health care providers in Medicare audits, ZPIC audits, MAC audits, and RAC audits throughout Florida and across the U.S. They also health care providers in qui tam or False Claims Act (whistleblower) litigation and in other complex medical litigation. They also represent DME suppliers, physicians, medical groups, nursing homes, home health agencies, pharmacies, hospitals, and other healthcare providers and institutions in Medicare and Medicaid investigations, audits, recovery actions, and termination from the Medicare or Medicaid programs, They represent health care providers in formal and informal administrative hearings, federal or state.

For more information please visit our website at www.TheHealthLawFirm.com or call (407) 331-6620 or toll-free (888) 331-6620.

Sources:

Sinay, Reenat. “Feds Charge 3 In Alleged $109M Medicare Fraud Scheme.” Law360. (October 2, 2020). Web.

Szaniszlo, Marie. “Three charged in multi-million dollar fraud scheme.” Sentinel Enterprise. (October 2, 2020). 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 the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Avenue, Suite 1000, Altamonte Springs, FL 32714, Phone: (407) 331-6620 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 © 2021 The Health Law

2021-02-24T10:55:49-05:00May 19th, 2021|Categories: Nursing Law Blog|Tags: , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |0 Comments

Feds Charge Three For Role in Multi-Million Dollar Scheme to Defraud Medicare, HIPAA Violations

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

In October 2020, Massachusetts federal prosecutors charged three people for their alleged roles in a multi-million dollar plot to defraud Medicare. Two individuals allegedly collected patient data and sold it to the purported mastermind, who used it to submit $109 million in false claims.

The two individuals who allegedly obtained the patient information were both located in Florida, wouldn’t ya know. They were each charged with one count of receiving more than $1.6 million kickbacks in connection with a federal health care program. Prosecutors charged the third individual with criminal violations of the Health Insurance Portability and Accountability Act (HIPAA).

Fraudulently Collecting & Using Private Patient Information.

According to court documents, both individuals in Florida owned marketing companies that enlisted foreign call centers to contact Medicare beneficiaries. Using a prepared script, they allegedly asked the patients they called if they would be interested in receiving durable medical equipment (DME) such as knee braces or compression sleeves “at little to no cost.”

The call centers would then collect information, including the patient’s name, address, insurance number, Medicare number, and doctor’s name and address, prosecutors said. The information was then sold to the third individual, who filed fraudulent Medicare claims for DME that were never prescribed and not medically necessary.

According to court records, the alleged co-conspirators used the same patients’ information repeatedly through a different shell company each time. More than 1,000 of the claims were made under the names of deceased beneficiaries. Click here to view the criminal information in this case.

Read the DOJ’s press release on this case for additional information.

Also, you can read one of my prior blogs on a similar case in Florida.

Don’t Wait Until It’s Too Late; Consult with a Health Law Attorney Experienced in Medicare Issues Now.

The attorneys of The Health Law Firm represent durable medical equipment (DME) suppliers and other health care providers in Medicare audits, ZPIC audits, MAC audits, and RAC audits throughout Florida and across the U.S. They also health care providers in qui tam or False Claims Act (whistleblower) litigation and in other complex medical litigation. They also represent DME suppliers, physicians, medical groups, nursing homes, home health agencies, pharmacies, hospitals, and other healthcare providers and institutions in Medicare and Medicaid investigations, audits, recovery actions, and termination from the Medicare or Medicaid programs, They represent health care providers in formal and informal administrative hearings, federal or state.

For more information please visit our website at www.TheHealthLawFirm.com or call (407) 331-6620 or toll-free (888) 331-6620.

Sources:

Sinay, Reenat. “Feds Charge 3 In Alleged $109M Medicare Fraud Scheme.” Law360. (October 2, 2020). Web.

Szaniszlo, Marie. “Three charged in multi-million dollar fraud scheme.” Sentinel Enterprise. (October 2, 2020). 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 the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Avenue, Suite 1000, Altamonte Springs, FL 32714, Phone: (407) 331-6620 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 © 2021 The Health Law

2021-02-24T10:52:53-05:00April 28th, 2021|Categories: Pharmacy Law Blog|Tags: , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |0 Comments

Three People Charged For $109 Million Scheme to Defraud Medicare & HIPAA Violations

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

In October 2020, Massachusetts federal prosecutors charged three people for their alleged roles in a multi-million dollar plot to defraud Medicare. Two individuals allegedly collected patient data and sold it to the purported mastermind, who used it to submit $109 million in false claims.

The two individuals who allegedly obtained the patient information were both located in Florida, wouldn’t ya know. They were each charged with one count of receiving more than $1.6 million kickbacks in connection with a federal health care program. Prosecutors charged the third individual with criminal violations of the Health Insurance Portability and Accountability Act (HIPAA).

Fraudulently Collecting & Using Private Patient Information.

According to court documents, both individuals in Florida owned marketing companies that enlisted foreign call centers to contact Medicare beneficiaries. Using a prepared script, they allegedly asked the patients they called if they would be interested in receiving durable medical equipment (DME) such as knee braces or compression sleeves “at little to no cost.”

The call centers would then collect information, including the patient’s name, address, insurance number, Medicare number, and doctor’s name and address, prosecutors said. The information was then sold to the third individual, who filed fraudulent Medicare claims for DME that were never prescribed and not medically necessary.

According to court records, the alleged co-conspirators used the same patients’ information repeatedly through a different shell company each time. More than 1,000 of the claims were made under the names of deceased beneficiaries. Click here to view the criminal information in this case.

Read the DOJ’s press release on this case for additional information.

Also, you can read one of my prior blogs on a similar case in Florida.

Don’t Wait Until It’s Too Late; Consult with a Health Law Attorney Experienced in Medicare Issues Now.

The attorneys of The Health Law Firm represent durable medical equipment (DME) suppliers and other health care providers in Medicare audits, ZPIC audits, MAC audits, and RAC audits throughout Florida and across the U.S. They also health care providers in qui tam or False Claims Act (whistleblower) litigation and in other complex medical litigation. They also represent DME suppliers, physicians, medical groups, nursing homes, home health agencies, pharmacies, hospitals, and other healthcare providers and institutions in Medicare and Medicaid investigations, audits, recovery actions, and termination from the Medicare or Medicaid programs, They represent health care providers in formal and informal administrative hearings, federal or state.

For more information please visit our website at www.TheHealthLawFirm.com or call (407) 331-6620 or toll-free (888) 331-6620.

Sources:

Sinay, Reenat. “Feds Charge 3 In Alleged $109M Medicare Fraud Scheme.” Law360. (October 2, 2020). Web.

Szaniszlo, Marie. “Three charged in multi-million dollar fraud scheme.” Sentinel Enterprise. (October 2, 2020). 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 the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Avenue, Suite 1000, Altamonte Springs, FL 32714, Phone: (407) 331-6620 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 © 2021 The Health Law

2021-02-24T10:50:35-05:00April 7th, 2021|Categories: Mental Health Law Blog|Tags: , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |0 Comments

Three Charged For Roles in $109 Million Medicare Fraud Scheme, HIPAA Violations

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

In October 2020, Massachusetts federal prosecutors charged three people for their alleged roles in a multi-million dollar plot to defraud Medicare. Two individuals allegedly collected patient data and sold it to the purported mastermind, who used it to submit $109 million in false claims.

The two individuals who allegedly obtained the patient information were both located in Florida, wouldn’t ya know. They were each charged with one count of receiving more than $1.6 million kickbacks in connection with a federal health care program. Prosecutors charged the third individual with criminal violations of the Health Insurance Portability and Accountability Act (HIPAA).

Fraudulently Collecting & Using Patient Information.

According to court documents, both individuals in Florida owned marketing companies that enlisted foreign call centers to contact Medicare beneficiaries. Using a prepared script, they allegedly asked the patients they called if they would be interested in receiving durable medical equipment (DME) such as knee braces or compression sleeves “at little to no cost.”

The call centers would then collect information, including the patient’s name, address, insurance number, Medicare number, and doctor’s name and address, prosecutors said. The information was then sold to the third individual, who filed fraudulent Medicare claims for DME that were never prescribed and not medically necessary.

According to court records, the alleged co-conspirators used the same patients’ information repeatedly through a different shell company each time. More than 1,000 of the claims were made under the names of deceased beneficiaries. Click here to view the criminal information in this case.

Read the DOJ’s press release on this case for additional information.

Also, you can read one of my prior blogs on a similar case in Florida.

Don’t Wait Until It’s Too Late; Consult with a Health Law Attorney Experienced in Medicare Issues Now.

The attorneys of The Health Law Firm represent durable medical equipment (DME) suppliers and other health care providers in Medicare audits, ZPIC audits, MAC audits, and RAC audits throughout Florida and across the U.S. They also health care providers in qui tam or False Claims Act (whistleblower) litigation and in other complex medical litigation. They also represent DME suppliers, physicians, medical groups, nursing homes, home health agencies, pharmacies, hospitals, and other healthcare providers and institutions in Medicare and Medicaid investigations, audits, recovery actions, and termination from the Medicare or Medicaid programs, They represent health care providers in formal and informal administrative hearings, federal or state.

For more information please visit our website at www.TheHealthLawFirm.com or call (407) 331-6620 or toll-free (888) 331-6620.

Sources:

Sinay, Reenat. “Feds Charge 3 In Alleged $109M Medicare Fraud Scheme.” Law360. (October 2, 2020). Web.

Szaniszlo, Marie. “Three charged in multi-million dollar fraud scheme.” Sentinel Enterprise. (October 2, 2020). 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 the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Avenue, Suite 1000, Altamonte Springs, FL 32714, Phone: (407) 331-6620 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 © 2021 The Health Law

 

 

2021-02-24T11:01:27-05:00February 24th, 2021|Categories: Health Facilities Law Blog, In the News|Tags: , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |0 Comments
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