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

By 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

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

By 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

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

By 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

By The Health Law Firm|2024-03-14T09:59:43-04:00April 7, 2021|Categories: Mental Health Law Blog|Tags: administrative hearing defense attorney, Anti-Kickback Statute (AKS) defense legal representation, Anti-Kickback Statute defense attorney, Centers for Medicare and Medicaid (CMS) defense representation, CMS defense lawyer, DME defense lawyer, durable medical equipment supplier (DMES) defense attorney, False Claim Act (FCA) defense lawyer, Fraudulent billing defense attorney, health care fraud defense attorney, healthcare overbilling legal representation, HIPAA complaint defense attorney, HIPAA complaint investigation defense lawyer, HIPAA violation risk assessment attorney, legal representation for Anti-Kickback Statute investigations, legal representation for CMS investigations audits, legal representation for informal administrative hearing, Legal representation for Medicare fraud, legal representation for submitting false claims, legal representation in Office of Civil Rights (OCR) HIPAA investigation, Medicare audit defense attorney, Medicare fraud defense lawyer, Medicare overbilling defense lawyer, Office of Civil Rights (OCR) HIPAA investigation defense attorney, representation for FCA violations, representation for medical equipment suppliers, representation for Medicare audits, representation for Medicare overbilling, reviews of The Health Law Firm attorneys, risk assessment attorney for HIPAA violation, risk assessment for HIPAA violation complaint investigation, the health law firm|Comments Off

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

By 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

New Changes to HHS Regulatory Process: Secretary Must Sign All Agency Rulemaking

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

In a September 15, 2020 memorandum, the current Secretary of the U.S. Department of Health and Human Services (HHS), Alex Azar, barred the Food and Drug Administration (FDA) and other federal health agencies under his authority from independently enacting any new federal regulations. The memo establishes that the Secretary must sign all agency rulemaking. This new policy affects all rules coming from all HHS agencies and offices, the department said, including the FDA, Centers for Medicare & Medicaid Services (CMS), and Office for Civil Rights. It doesn’t apply to guidance documents, emergency use authorizations, or vaccine or drug approvals.

How long this policy stands after President-elect Biden is sworn in is anybody’s guess. It is my guess that it won’t last long.

Why Make the Changes?

According to HHS, the new regulation-making procedures are to ensure consistency within HHS, compliance with congressional intent, the need to minimize the risk of litigation, and to provide public accountability. HHS regulations have been challenged in court based on the argument that officials who signed new regulations did not have the proper authority to do so.

The memo attempts to rationalize the change in the face of critics who claim that the move could negatively affect public trust in approval of COVID-19 vaccines and the entire approval process.

Rulemaking Process Before and After the Memo.

Before the policy change, the law and established departmental procedure required that all new regulations go through departmental and White House clearance and receive the Secretary’s approval. The regulations were typically signed by the Secretary and by the head of the agency involved. In some instances, other officials to whom authority had been delegated signed the new regulations.

Now, all HHS regulations will still go through departmental and White House clearance and will continue to be approved by the Secretary. But, the change effectively bars the FDA and other health agencies from signing off on any new regulations regarding the nation’s food, medicine, and other products under the HHS umbrella. The HHS Secretary himself must now sign all final regulations.

HHS released the following statement on this action:

“Before and after this action, no regulation issues from any part of HHS without the approval of the Secretary and the White House. The only change made by this memo is that, instead of the Secretary’s just approving all agency regulations, each regulation now also will be formally signed by him.”

Click here to read the HHS Statement on Regulatory Process.

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:

Stein, Shira. “HHS Secretary to Sign All Rules in Bid to Stem Litigation.” Bloomberg Law. (September 21, 2020). Web.

Keller and Heckman LLP. “A New Policy by HHS Secretary Alex Azar Will Prevent FDA and Other Health Agencies From Signing Final Rules.” National Law Review. (September 21, 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 Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave. 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 © 2020 The Health Law Firm. All rights reserved.

By The Health Law Firm|2024-03-14T09:59:50-04:00February 1, 2021|Categories: Pharmacy Law Blog|Tags: administrative procedure act lawyer, Centers for Medicare & Medicaid Services (CMS) investigation representation, CMS defense lawyer, complex health care litigation attorney, DEA hearing defense attorney, Department of Health defense attorney, DOH and DORA investigation attorney, Drug Enforcement Administration (DEA) complaint investigation hearing lawyer, Drug Enforcement Administration (DEA) order to show cause (OTSC) defense attorney, federal administrative and regulatory lawyer, federal administrative hearing litigation attorney, Florida health law attorney, Food and Drug Administration (FDA) complaint investigation defense attorney, Health law administrative lawyer, HHS defense lawyer, HHS investigation defense attorney, legal representation for DOH and DORA hearings, legal representation in administrative hearings, legal representation in Centers for Medicare & Medicaid Services (CMS) investigations, legal representation in Drug Enforcement Administration (DEA) investigations, legal representation in Food and Drug Administration (FDA) complaints, legal representation of health care providers, representation for healthcare business litigation matters, representation for HHS investigations, reviews of The Health Law Firm, The Health Law Firm attorney reviews|Comments Off

HHS Makes Changes to Regulatory Process for Rulemaking

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

In a September 15, 2020 memorandum, the current Secretary of the U.S. Department of Health and Human Services (HHS), Alex Azar, barred the Food and Drug Administration (FDA) and other federal health agencies under his authority from independently enacting any new federal regulations. The memo establishes that the Secretary must sign all agency rulemaking. This new policy affects all rules coming from all HHS agencies and offices, the department said, including the FDA, Centers for Medicare & Medicaid Services (CMS), and Office for Civil Rights. It doesn’t apply to guidance documents, emergency use authorizations, or vaccine or drug approvals.

How long this policy stands after President-elect Biden is sworn in is anybody’s guess. It is my guess that it won’t last long.

Why Make the Changes?

According to HHS, the new regulation-making procedures are to ensure consistency within HHS, compliance with congressional intent, the need to minimize the risk of litigation, and to provide public accountability. HHS regulations have been challenged in court based on the argument that officials who signed new regulations did not have the proper authority to do so.

The memo attempts to rationalize the change in the face of critics who claim that the move could negatively affect public trust in approval of COVID-19 vaccines and the entire approval process.

Rulemaking Process Before and After the Memo.

Before the policy change, the law and established departmental procedure required that all new regulations go through departmental and White House clearance and receive the Secretary’s approval. The regulations were typically signed by the Secretary and by the head of the agency involved. In some instances, other officials to whom authority had been delegated signed the new regulations.

Now, all HHS regulations will still go through departmental and White House clearance and will continue to be approved by the Secretary. But, the change effectively bars the FDA and other health agencies from signing off on any new regulations regarding the nation’s food, medicine, and other products under the HHS umbrella. The HHS Secretary himself must now sign all final regulations.

HHS released the following statement on this action:

“Before and after this action, no regulation issues from any part of HHS without the approval of the Secretary and the White House. The only change made by this memo is that, instead of the Secretary’s just approving all agency regulations, each regulation now also will be formally signed by him.”

Click here to read the HHS Statement on Regulatory Process.

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:

Stein, Shira. “HHS Secretary to Sign All Rules in Bid to Stem Litigation.” Bloomberg Law. (September 21, 2020). Web.

Keller and Heckman LLP. “A New Policy by HHS Secretary Alex Azar Will Prevent FDA and Other Health Agencies From Signing Final Rules.” National Law Review. (September 21, 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 Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave. 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 © 2020 The Health Law Firm. All rights reserved.

By The Health Law Firm|2024-03-14T09:59:52-04:00January 18, 2021|Categories: Medical Education Law Blog|Tags: administrative procedure act lawyer, Centers for Medicare & Medicaid Services (CMS) investigation representation, CMS defense lawyer, complex health care litigation attorney, DEA hearing defense attorney, Department of Health defense attorney, DOH and DORA investigation attorney, Drug Enforcement Administration (DEA) complaint investigation hearing lawyer, Drug Enforcement Administration (DEA) order to show cause (OTSC) defense attorney, federal administrative and regulatory lawyer, federal administrative hearing litigation attorney, Florida health law attorney, Food and Drug Administration (FDA) complaint investigation defense attorney, Health law administrative lawyer, HHS defense lawyer, HHS investigation defense attorney, legal representation for DOH and DORA hearings, legal representation in administrative hearings, legal representation in Centers for Medicare & Medicaid Services (CMS) investigations, legal representation in Drug Enforcement Administration (DEA) investigations, legal representation in Food and Drug Administration (FDA) complaints, legal representation of health care providers, representation for healthcare business litigation matters, representation for HHS investigations, reviews of The Health Law Firm, The Health Law Firm attorney reviews|Comments Off

HHS Changes Regulatory Process: Secretary Must Sign All Agency Rulemaking

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

In a September 15, 2020 memorandum, the current Secretary of the U.S. Department of Health and Human Services (HHS), Alex Azar, barred the Food and Drug Administration (FDA) and other federal health agencies under his authority from independently enacting any new federal regulations. The memo establishes that the Secretary must sign all agency rulemaking. This new policy affects all rules coming from all HHS agencies and offices, the department said, including the FDA, Centers for Medicare & Medicaid Services (CMS), and Office for Civil Rights. It doesn’t apply to guidance documents, emergency use authorizations, or vaccine or drug approvals.

How long this policy stands after President-elect Biden is sworn in is anybody’s guess. It is my guess that it won’t last long.

Why Make the Changes?

According to HHS, the new regulation-making procedures are to ensure consistency within HHS, compliance with congressional intent, the need to minimize the risk of litigation, and to provide public accountability. HHS regulations have been challenged in court based on the argument that officials who signed new regulations did not have the proper authority to do so.

The memo attempts to rationalize the change in the face of critics who claim that the move could negatively affect public trust in approval of COVID-19 vaccines and the entire approval process.

Rulemaking Process Before and After the Memo.

Before the policy change, the law and established departmental procedure required that all new regulations go through departmental and White House clearance and receive the Secretary’s approval. The regulations were typically signed by the Secretary and by the head of the agency involved. In some instances, other officials to whom authority had been delegated signed the new regulations.

Now, all HHS regulations will still go through departmental and White House clearance and will continue to be approved by the Secretary. But, the change effectively bars the FDA and other health agencies from signing off on any new regulations regarding the nation’s food, medicine, and other products under the HHS umbrella. The HHS Secretary himself must now sign all final regulations.

HHS released the following statement on this action:

“Before and after this action, no regulation issues from any part of HHS without the approval of the Secretary and the White House. The only change made by this memo is that, instead of the Secretary’s just approving all agency regulations, each regulation now also will be formally signed by him.”

Click here to read the HHS Statement on Regulatory Process.

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:

Stein, Shira. “HHS Secretary to Sign All Rules in Bid to Stem Litigation.” Bloomberg Law. (September 21, 2020). Web.

Keller and Heckman LLP. “A New Policy by HHS Secretary Alex Azar Will Prevent FDA and Other Health Agencies From Signing Final Rules.” National Law Review. (September 21, 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 Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave. 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 © 2020 The Health Law Firm. All rights reserved.

By The Health Law Firm|2024-03-14T09:59:53-04:00January 4, 2021|Categories: Health Facilities Law Blog, In the News|Tags: administrative procedure act lawyer, Centers for Medicare & Medicaid Services (CMS) investigation representation, CMS defense lawyer, complex health care litigation attorney, DEA hearing defense attorney, Department of Health defense attorney, DOH and DORA investigation attorney, Drug Enforcement Administration (DEA) complaint investigation hearing lawyer, Drug Enforcement Administration (DEA) order to show cause (OTSC) defense attorney, federal administrative and regulatory lawyer, federal administrative hearing litigation attorney, Florida health law attorney, Food and Drug Administration (FDA) complaint investigation defense attorney, Health law administrative lawyer, HHS defense lawyer, HHS investigation defense attorney, legal representation for DOH and DORA hearings, legal representation in administrative hearings, legal representation in Centers for Medicare & Medicaid Services (CMS) investigations, legal representation in Drug Enforcement Administration (DEA) investigations, legal representation in Food and Drug Administration (FDA) complaints, legal representation of health care providers, representation for healthcare business litigation matters, representation for HHS investigations, reviews of The Health Law Firm, The Health Law Firm attorney reviews|Comments Off