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

George IndestBy 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.

Mississippi Businessman Sentenced to 18 Years in Prison For $288 Million Tricare Fraud Scheme

George F. Indest III with 30+ years of experience, is Board Certified in Health LawBy George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

On January 15, 2021, a Mississippi man was sentenced to 18 years in prison by a federal judge for his role in a $287.6 million scheme to defraud the Tricare health benefits program. According to the U.S. Department of Justice (DOJ), he committed fraud by paying doctors and drug distributors kickbacks.

What is Tricare?

Tricare is the health care benefit program serving active-duty military personnel, military retirees, and their dependents worldwide. The program provides comprehensive coverage to all beneficiaries, including health plans, special programs, prescriptions, and dental plans. Learn more about Tricare here.

Conspiracy to Commit Health Care Fraud and Money Laundering.

In July 2020, he pled guilty to orchestrating a $287.6 million scheme to defraud Tricare by paying doctors and drug distributors kickbacks. The kickbacks were in exchange for unnecessary compounded medication prescriptions sent to his pharmacies. He admitted to tampering with drug formulas and bribing doctors to authorize prescriptions to rake in reimbursements from the federal benefits program. Read the complaint in full.

More Details of the Fraud Scheme.

According to the government, from 2012 to 2016, he used marketing companies, drug distributors, and compounding pharmacies that he owned to contract with other pharmacies to provide prescriptions for the medications.

He admitted to creating prescription pads with the drug formulas for doctors to push the expensive drugs onto patients easily. In exchange for participating in the fraud, doctors got a cut of the pharmacy benefits managers and programs’ reimbursements.

Additionally, he and his co-conspirators conducted illegal wire transfers of millions of dollars in illegally obtained cash to various companies and bank accounts. The government said he personally obtained more than $40 million from the scheme.

As part of his plea agreement, he is ordered to forfeit more than $50 million worth of property, luxury cars, and an airplane. He was also ordered Friday by U.S. District Judge Keith Starrett of the Southern District of Mississippi to pay $287,659,569 in restitution. Click here to view the plea agreement.

To read about a similar Tricare fraud case in Florida, click here to read one of my prior blogs.

Contact Health Law Attorneys Experienced in Representing Pharmacies and Pharmacists.

The Health Law Firm represents pharmacists, pharmacies, doctors, and medical groups in DEA, DOH, FDA, OIG, and DOJ investigations, qui tam and whistleblower cases, regulatory matters, licensing issues, litigation, administrative hearings, inspections, and audits. The Firm also represents both plaintiffs (whistleblowers or relators) and defendants in False Claims Act (whistleblower or qui tam) cases. The firm’s attorneys include those who are board-certified by The Florida Bar in Health Law as well as licensed health professionals who are also attorneys.

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

Sources:

Clough, Craig. “Miss. Businessman Gets 18 Years For $288M Tricare Fraud.” Law360. (January 15, 2021). Web.

Stawicki, Kevin. “Miss. Businessman Pleads Guilty To $288M Tricare Fraud.” Law360. (July 10, 2020). Web.

About the Author: George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law is an attorney with 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 Ave. Suite 1000, Altamonte Springs, Florida 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 © 2021 The Health Law Firm. All rights reserved.

 

HHS Makes Changes to Regulatory Process for Rulemaking

George Indest Headshot

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.

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

By Carole C. Schriefer, J.D.

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: Carole C. Schriefer is an attorney and former registered nurse. She practices with The Health Law Firm, which has a national practice. Its regional office is in the Northern Colorado, area. www.TheHealthLawFirm.com The Health Law Firm, 155 East Boardwalk Drive, Fort Collins, Colorado 80525. Phone: (970) 416-7456 or Toll-Free: (888) 331-6620. Its main office is in the Orlando, Florida area.

“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.

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.

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