Florida Judge Won’t Toss Lawsuit Filed By Family of Publix Employee Who Died of Coronavirus

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

On February 5, 2021, a judge in Florida refused to dismiss a lawsuit filed by the family of a Publix Super Markets deli worker who died after allegedly catching COVID-19 from a coworker. Judge Carlos Lopez announced that he would not dismiss the lawsuit filed by Gerardo Gutierrez’s family, who died on April 28, 2020, from complications caused by coronavirus. The suit was filed in the Florida Circuit Court for the Eleventh Judicial Circuit of Miami-Dade County, Florida, in November 2020.

Publix Accused of Failing Its Workers & the Miami Beach Community.

The suit alleged that on March 27 and 28, 2020, 70-year-old deli worker Gerardo “Gerry” Gutierrez worked at a Publix supermarket alongside a coworker who showed signs of COVID-19. Unfortunately, at that time, according to the complaint, Publix had made a decision to prohibit its employees from wearing masks and other personal protective equipment (PPE).

On April 2, Gutierrez was told by his supervisors to isolate at home; but by April 7, he tested positive for Covid-19, the complaint says. He died on April 28, 2020.

The family says in its complaint that Publix, a Florida-based grocery store chain, breached its duty to keep its employees safe. It knowingly failed to take proper precautions and prohibited its workers from wearing masks for fear it would “incite panic” among customers, claims the suit. The lawsuit echoes findings from an earlier Tampa Bay Times report that took the position that Publix lagged behind competitors in adopting employee and customer safety protections (such as employee PPE) during the early days of the pandemic.
Click here to learn more.

Additionally, the suit also references several Occupational Safety and Health Administration (OSHA) complaints, where employees repeatedly reported the grocer prohibited mask and glove use.

To view the family’s complaint, click here.

Publix Defends Itself.

In response to the lawsuit, Publix filed a motion to dismiss, calling the suit an attempt to circumvent the worker’s compensation process. Publix also argued that the claims in the case needed to be filed in the Florida Division of Administrative Hearings. The worker’s compensation system in Florida requires that employees of a corporation must file workers compensation claims for injuries sustained on the job. Civil litigation is prohibited against the employer, with a number of exceptions. The judge in the civil case disagreed with Publix, ruling in favor of the estate of the worker.

According to the complaint, it wasn’t until March 2020, after the realization set in that the spread of COVID-19 presented a major national crisis for Publix to post a statement on its website. In the statement, Publix CEO Todd Jones said the company had remained in close contact with the Centers for Disease Control and Prevention (CDC) and would “continue to focus on keeping [its] associates [employees] healthy—and [its] stores open and stocked—to serve and support all our communities.”

Click here to read the statement in full.

Despite the arguments, the family’s attorney Michael Levine said, “Publix has never taken any responsibility for its unthinkable decision to prohibit its employees from wearing masks as COVID-19 swept through Florida. Our case will make sure Publix is held accountable for its reckless decision. We look forward to uncovering the documents behind the mask prohibition and deposing its senior personnel.”

One problem that we see with this case is that many Publix employees work part-time. We had one working for our law firm, for example. By not allowing employees to wear proper PPE, and not requiring them to abide by other protective measures, the employer caused a far wider exposure of others, even many non-customers, and their families, to the COVID virus.

The case is Gutierrez v. Publix Super Markets Inc., case number 2020-025168-CA-01, and you can read the judge’s order in full here.

Read one of my prior blogs about OSHA previously handing out citations for COVID-19 PPE violations.

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:

Bolado, Carolina. “Fla. Judge Won’t Ax Suit Over Publix Worker’s COVID-19 Death.” Law360. (February 5, 2021). Web.

Toropin, Konstantin. “Family files suit over Publix employee’s death. It says company failed to protect him from Covid-19.” CNN. (November 23, 2020). Web.

DiNatale, Sara. “A Publix employee died from COVID-19. Now his family is suing over his death.” Tampa Bay Times. (November 23, 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 © 2021 The Health Law Firm. All rights reserved.

Florida Judge Sides With AdventHealth, Allows Fraud Claims Over Soured Multi-Million Dollar PPE Deal to Move Forward

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

On February 23, 2021, a federal court in Orlando, Florida, ruled that Adventist Health System Sunbelt (now known as AdventHealth, and which owns Florida Hospital, among others) could pursue claims it has over a bad $57.5 million deal to buy personal protective equipment (PPE). The defendants whom the hospital system is suing include Tomax Capital Management, Inc. (“Tomax”), a California corporation; a California attorney and his law firm; and others.

U.S. District Judge Paul G. Byron said the hospital system provided sufficient evidence that Tomax failed to deliver the promised PPE and then conspired to keep the $2 million which was not returned.

The PPE Contract.

According to the complaint in the case, the contract was for AdventHealth to purchase 10 million 3M N95 ventilator masks, according to the May 2020 complaint. Under the terms of the contract, the hospital was to pay a total of $57.5 million for 10 million 3M N95 masks to protect its workers during the Coronavirus pandemic. AdventHealth paid the $57.5 million into a California lawyer’s trust account. The 10 million masks were to be delivered to AdventHealth’s hospital in Orlando, Florida, by April 18, 2020. However, the masks never arrived.

Now, I just have to jump in and point out something. I don’t claim to have ironclad proof of it, but I have seen and read enough about 3M N95 masks on television and in the press while trying to purchase my own. I may be totally off on this figure, but I seem to remember around the beginning of the Coronavirus pandemic that 3M was only manufacturing approximately 1 million masks a month. So where someone would be able to come up with 10 million of these specific masks is mind-boggling to me. Let’s just say that this is my own opinion.

When the hospital system requested a refund of the $57.5 million it had paid, it claims it was only refunded $55.5 million, with $2 million missing in action. According to the complaint, AdventHealth never saw the remaining $2 million despite assurance from the attorneys involved in the deal that AdventHealth would get it back. Hence, the present lawsuit.

I mean, if you can’t trust an attorney nowadays, who can ya’ trust?

A Civil Conspiracy?

In its suit, AdventHealth makes various claims of breach of contract, conversion, and civil conspiracy and requests actual damages, punitive damages, and prejudgment interest. The conspiracy would involve the allegation that the attorney and law firm conspired with Tomax and others to deprive AdventHealth of the $2 million. Because AdventHealth alleged that it suffered damages in Florida, it was able to bring its case to the federal court here in Orlando.

Read the complaint filed in the U.S. District Court for the Middle District of Florida for more details.

Granted, $2 million isn’t a lot of money to some people, but it was obviously enough money to get these Defendants sued in federal court.

Judge Sides With the Hospital System’s Position on Motion to Dismiss Complaint.

The federal court judge denied a motion to dismiss the complaint filed by Tomax. In his order, the judge stated: “Plaintiff sufficiently pleads facts supporting the existence of a civil conspiracy that caused injury in Florida.” In addition to allowing the claims of the hospital system to move forward, the judge also ruled that the court has the authority to exercise personal jurisdiction over the attorney and law firm that was involved, under the state’s long-arm statute. To obtain more details, read the judge’s order denying the motion to dismiss.  Click here to visit our Areas of Practice page and learn more on how The Health Law Firm can assist you in legal cases like this.

PPE a “Hot Issue.”

In another recent pandemic-related case, OSHA began issuing fines to health care systems over PPE violations such as lack of proper equipment for their employees. We have also read a number of reports about companies and individuals being fined and injunctions being obtained by the Federal Trade Commission and the Food and Drug Administration over phony PPE being sold to Americans over the Internet.

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. The lawyers of The Health Law Firm are experienced in complex litigation in state and federal courts.

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:

Hale, Nathan. “AdventHealth’s Fraud Claim Over $57M PPE Deal Advanced.” Law360. (February 23, 2021). Web.

Bolado, Carolina. “AdventHealth Sues Attorney Over Failed $57.5M Masks Deal.” Law360. (May 29, 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 © 2021 The Health Law Firm. All rights reserved.

Multiple Settlements with HHS for HIPAA Security Rule Violations & Data Breaches

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

In September 2020, the Department of Health and Human Services (HHS) announced three settlements to resolve alleged violations of the Health Insurance Portability and Accountability Act (HIPAA) Privacy and Security Rules. The settlements, totaling $10.6 million, stem from data breaches in which hackers were able to access and obtain individuals’ protected health information (PHI) from U.S. health providers. Combined, the three hacking incidents compromised the health information of more than 16 million patients.

Summary of the HIPAA Security Rule Settlements.

On September 21, 2020, the Office of Civil Rights, or OCR, the division of HHS which receives and investigates HIPAA complaints, announced a settlement with an orthopedic clinic in Georgia. The clinic agreed to pay $1.5 million after a 2016 hacking incident that compromised over 200,000 patient records. Part of the settlement included a Corrective Action Plan, or CAP, which the clinic agreed to adopt, to help prevent future breaches of privacy. Click here to view the resolution agreement and Corrective Action Plan (CAP).

On September 24, 2020, the OCR publicized a settlement with an information technology (IT) and health information management company. The business agreed to pay $2.3 million to settle claims of systemic security rule violations relating to a 2014 hacking incident impacting the personal health information (PHI) of more than 6 million individuals. Click here to read the settlement agreement.

Days later, the OCR released information about a $6.85 million settlement with Premera Blue Cross, the largest health plan in the Pacific Northwest. The settlement, the second largest to date, related to a 2015 cyber-attack which exposed the health information of more than 10 million individuals. To read the resolution agreement in full, click here.

In regard to these settlements, the OCR alleged that the following security rule violations had occurred:

1. Failure to conduct an adequate and thorough risk analysis;

2. Failure to implement sufficient mechanisms to record and examine system activities;

3. Failure to enter into business associate agreements with vendors with access to electronic protected health information;

4. Failure to implement reasonable security measures to reduce risks and vulnerabilities;

5. Failure to respond to and document a known security incident;

6. Failure to implement technical policies and procedures regarding access; and

7. Failure to implement procedures to regularly review system activity logs and reports.

Readers could use the above as a compliance checklist to make sure their own systems of records are being properly protected.

Consequences of HIPAA Rule Noncompliance.

The HIPAA Security Rule establishes a set of national standards for confidentiality, integrity, and availability of e-PHI. HHS is responsible for administering and enforcing these standards, along with enforcement of the HIPAA Privacy Rule. Therefore, the agency may conduct complaint investigations and compliance reviews. To learn more details about the HIPAA Security Rule, click here.

HHS looks for systems failures, prior breaches, missing risk analyses, or absence of or inadequate HIPAA policies. Without question, any compliance violations will result in an enforcement action. And as these three settlements have demonstrated, enforcement can be costly.

Don’t Wait Until It’s Too Late, Protect Yourself from HIPAA Security Rule Compliance Violations.

Businesses and organizations need to acknowledge the need to act and create a HIPAA security rule compliance plan. Locating existing security policies and the last completed risk analysis is an essential step in compliance. If it’s been over a year, perform or update risk analysis to identify risks or vulnerabilities on all systems that contain any e-PHI. Security rule compliance requires regular attention and detailed records. Take steps now to help protect e-PHI from data breaches, and avoid millions of dollars in settlements or fines.


Contact a Health Law Attorney Experienced in Defending HIPAA Complaints and Violations.

The Health Law Firm represent physicians, medical groups, nursing homes, home health agencies, pharmacies, hospitals, and other healthcare providers and institutions to investigate and defend alleged HIPAA complaints and violations and prepare Corrective Action Plans (CAPs). Our attorneys regularly defend OCR HIPAA audits, defend in HIPAA complaint investigations, assist in preparing a HIPAA Risk Analyses, defend in federal administrative actions and administrative hearing cases, and defend in civil or administrative litigation of HIPAA/breach of medical confidentiality law suits.

For more information about HIPAA violations, electronic health records or corrective action plans (CAPs) please visit our website at www.TheHealthLawFirm.com or call (407) 331-6620 or toll-free (888) 331-6620.

Sources:

Kraus, Anna and Carrier, Tara. “HHS Announces Multiple HIPAA Settlements Related to Data Breaches and the Right of Access Initiative.” Lexology. (October 6, 2020). Web.

Castricone, Dena. “The Crushing Cost Of HIPAA Security Rule Noncompliance.” Law360. (October 1, 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 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 © 2021 The Health Law

New Florida Law Aimed at Healthcare Professional Background Screening

Attorney Michael L. SmithBy Michael L. Smith, R.R.T., J.D., Board Certified by The Florida Bar in Health Law

For several years, many healthcare professionals have been required to pass a Level II background check in order to work in most Florida healthcare facilities licensed by the Agency for Health Care Administration (AHCA). Many healthcare professionals are also required to pass a Level II background check in order to be licensed by the Florida Department of Health (DOH). In March 2020, the Florida Legislature passed House Bill 713, which will add the offenses of battery on a vulnerable adult and battery on a patient or resident of certain healthcare facilities (primarily nursing facilities) as a disqualifying offense. The law took effect on July 1, 2020. Previously, only felony battery and battery on a minor were disqualifying offenses for purposes of the Level II background screening.

More Details on the New Legislation.

A health professional who previously passed the Level II background check may nevertheless be deemed “not eligible” for employment in a licensed health facility on the next Level II background check. This would occur if the practitioner has been found guilty of, regardless of adjudication, or entered a plea of nolo contendere or guilty to battery of a vulnerable adult, or battery on a patient or resident of a healthcare facility. (This is the wording of the statute, not mine.)

A practitioner who is determined to be “not eligible” on a Level II background check due to a disqualifying offense must apply for an exemption from that disqualifying offense, in order to be permitted to work. The practitioner seeking an exemption has the burden of proving that the exemption should be granted. The provider must prove this with clear and convincing evidence, a standard that is higher and stricter than that in a civil trial.

Any health professional seeking an exemption from a disqualifying offense should seek the assistance of an experienced health law attorney familiar with the application process, and the types of evidence that can prove that the health professional should be granted an exemption.

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

About the Author: Michael L. Smith, R.R.T., J.D., is Board Certified by The Florida Bar in Health Law. He 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, FL 32714, Phone: (407) 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.

Board of Pharmacy Must Hand Over Patient Identifying Data to DEA in Colorado

George Indest HeadshotBy George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law
On April 22, 2020, a federal judge ordered the Colorado Board of Pharmacy to give the U.S. Drug Enforcement Administration (DEA) prescription drug monitoring program data on two pharmacies that the DEA is investigating. The data includes patient identifying information of more than 14,000 patients. The state must turn over the data by May 15, 2020, according to the order.

Pharmacy Investigations.

Citing concerns about the two pharmacies’ handling of controlled-substance prescriptions, the DEA issued subpoenas under the Controlled Substances Act in 2019. The DEA requested the information as part of an investigation into whether the two unnamed pharmacies broke the law in dispensing opioids and other drugs.

Clash Over Patient Privacy.

The DEA’s requested information is kept under the state’s Prescription Drug Monitoring Program or PDMP. For controlled-substance prescriptions, Colorado pharmacies and pharmacists are required by state law to report information that includes the names of patients, their doctors, and pharmacies.

Colorado state officials refused to release the data citing patient privacy concerns. The DEA’s “overly broad, undifferentiated demand for access would violate the Fourth Amendment right to privacy guaranteed to more than 14,000 patients whose medical data is at issue,” the state said.

According to the order, the Colorado statute allows the prescription-monitoring data to be disclosed but only to specific recipients including in response to law enforcement subpoenas. However, the state argued that the Colorado statute only applies to a “bona fide investigation of a specific individual.”

To read about a similar case involving a DEA investigation into pharmacy prescription practices, click here to read my prior blog.

The Decision.

U.S. District Judge Raymond P. Moore denied Colorado’s objections to the DEA’s subpoenas for the prescription data including patients’ information such as names, birth dates, and addresses. The judge said the DEA has shown that the requested information is relevant and needed for the ongoing investigation of the two pharmacies, and no warrant is needed to obtain it. The order directs the Colorado Board of Pharmacy and Patty Salazar, Executive Director of the Colorado Department of Regulatory Agencies (DORA) to provide the data to the DEA no later than May 15, 2020.

To read the court’s order in full, click here.

For more information, click here to read the press release issued from the United States Attorney’s Office for the District of Colorado.

States Must Act to Protect the Integrity of Such Programs.

State prescription drug monitoring programs (PDMPs) were sold to pharmacists and physicians based on a promise that they were solely for the purpose of protecting patients from overdoses and preventing “doctor shopping” by dishonest, drug-seeking patients. Inherent in these programs was the promise that they would not be used for the purpose of prosecuting or charging physicians or pharmacists, in criminal proceedings or administrative proceedings, based on their contents. Most of the state laws that authorized the creation of PDMPs specifically forbid their use in such cases. This was required in order to get physicians and state medical societies to buy off on them.

Yet here we are. We see this over and over. the Federal government and federal agencies obtaining copies of these reports from the state and using them as direct evidence against physicians, pharmacists, nurse practitioners, and pharmacies, despite the prohibition of the state statutes.

Moreover, not only does this subvert the purpose behind creating such databases, but then it runs afoul of the Fifth Amendment of the U.S. Constitution and similar provisions of most state constitutions. The doctor or pharmacist is required by law to report the prescriptions to the PDMP, but then the federal agency turns right around and uses it as evidence against the individual who reported it.

The feds take the position: “We do not care why you, the state, authorized it or what its purpose was supposed to be. If we want to take that information and use it for something else, something that was specifically prohibited by the state, then we will do it.”

Until state pharmacy associations and medical associations do something to tighten up the state legislation that created the PDMPs, this situation is not likely to change. The feds will continue to use the state PDMPs to prosecute and to take administrative actions to revoke the DEA registrations of physicians, pharmacists, pharmacies, and other health professionals.

Consult With A Health Law Attorney Experienced in the Representation of Pharmacists and Pharmacies.

We routinely provide legal representation to pharmacists, pharmacies, physicians and other health providers. We defend in state and federal administrative hearings, investigations, and litigation. We represent health professionals in formal and informal administrative hearings. We have a great deal of experience in defending against DEA actions.

The lawyers of The Health Law Firm are experienced in both formal and informal administrative hearings and in representing physicians, physician assistants and other health professionals in investigations and at Board of Pharmacy hearings. Call now or visit our website www.TheHealthLawFirm.com.

Sources:

Zegers, Kelly. “Colo. Must Give DEA Pharmacy Data With Patient Info.” Law360. (April 20, 2020). Web.

Ingold, John. “Why the DEA is suing Colorado’s pharmacy board as part of an opioid investigation.” The Colorado Sun. (November 11, 2019). Web.

Pazanowski, Mary Ann. “Colorado Pharmacy Board Must Give DEA Patient-Identifying Info.” Bloomberg Law. (April 22, 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 Avenue, Suite 1000, Altamonte Springs, FL 32714, Phone: (407) 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.

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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.

 

DOJ Charges 345 People Allegedly Involved in More Than $6 Billion in Healthcare Fraud, Mostly Related to Telemedicine and Opioid Prescriptions

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

In September 2020, federal prosecutors charged 345 doctors, nurses, and other medical professionals allegedly involved in more than $6 billion in healthcare fraud. It is considered the largest Health Care Fraud and Opioid Enforcement Action in the Department of Justice’s history (DOJ). The schemes were related to telemedicine, illegal opioid distribution, and durable medical equipment, the DOJ said.

A National Fraud Operation.

According to the DOJ, the 345 defendants were responsible for submitting false and fraudulent claims that cost more than $6 billion to federal health care programs and private insurers. It included $4.5 billion related to telemedicine fraud, $1.5 billion connected to sober homes, and over $806 million linked to illegal opioid distribution and other forms of Medicare fraud.

Telemedicine fraud charges made up the bulk of the nationwide bust. A total of 86 defendants were telehealth executives who allegedly paid medical professionals to order unnecessary amounts of durable medical equipment, genetic tests, and pain medications.

The sober homes cases include charges against more than 12 defendants for allegedly submitting false claims for tests and treatments for patients with drug and alcohol problems. The defendants allegedly paid illegal kickbacks and bribes for the referral of hundreds of patients to substance abuse treatment facilities.

Similarly, included in the charges were health professionals and others involved in distributing more than 30 million doses of opioids and other prescription narcotics. These charges have already resulted in guilty pleas by more than 240 of the defendants.

The historic law enforcement action was put in motion in April 2020 and aimed to crack down on classic health care fraud schemes. The DOJ executes “takedowns” every year to spotlight concerns about fraud in certain areas by grouping similar schemes together. Since its establishment in 2007, it has charged more than 4,200 defendants who defrauded Medicare for more than $19 billion, the agency said.

Click here to read the press release issued by the DOJ.

To read about a similar record-breaking telehealth fraud case in Florida, click here.

Contact Health Law Attorneys Experienced in Handling Medicare Audits, Investigations and other Legal Proceedings.

The attorneys of The Health Law Firm represent healthcare providers in defending audits and investigations by the Department of Health and Human Services, the Department of Justice, The Drug Enforcement Administration (DEA), the Florida Department of Health (DOH), the Colorado Department of Regulatory Agencies, Medicaid Fraud Control Unit (MFCU), state boards of medicine, state boards of pharmacy, and state boards of nursing. They also represent health professionals and providers in administrative litigation (state and federal) and civil litigation (state and federal). They represent physicians, nurses, medical groups, nursing homes, home health agencies, pharmacies, dentists, pharmacies, assisted living facilities, and other healthcare providers and institutions in recovery actions and termination from Medicare and Medicaid Programs.

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

Sources:

Allen, Jackie. “DOJ charges 345 people involve in more than $6 billion healthcare fraud.” USA Herald. (October 3, 2020). Web.

Stawicki, Keven. “DOJ Charges 345 In Health Fraud Schemes Topping $6B.” Law360. (September 30, 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 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 © 2021 The Health Law Firm. All rights reserved.

 

Non-physician Pill Mill Owners in Tampa Sentenced To Prison Time For Illegal Distribution Of Opioids

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

On October 7, 2020, two owners of a medical practice in Tampa, Florida, were sentenced to federal prison time for their roles in the illegal distribution of opioids. U.S. District Judge Mary S. Scriven sentenced Ernest Gonzalez to 46 months and Rosa Colon to 24 months in federal prison for conspiracy to distribute and dispense controlled substances for no legitimate medical purpose.

Plot to Illegally Distribute Controlled Substances.

According to court documents, Gonzalez served as the president and owner of Health and Pain Center (HPC), a Tampa pain management clinic. In June 2011, he transferred his executive title and ownership of HPC to Colon. The Drug Enforcement Administration (DEA) obtained a warrant in October 2016, while both were active participants of the administration and management of HPC.

The two owners allegedly hired physicians at HPC, who routinely prescribed controlled substances to patients eeking pain mediciations. Federal authorities always allege that such prescriptions are “outside the scope of professional (medical) practice.” Additionally, the owners are alleged to have participated and facilitated the physicians’ illegal prescribing practices by instructing employees to overlook failed urinalysis screens that help to detect drug abusers.

According to court papers, the owners also obtained MRI studies and other documents that the physicians used to justify the high volume of opioid prescriptions. According to court documents, the owners operated HPC as a cash-only business with little to no medical equipment on-site and staff with no medical training.

The owners pled guilty on September 11, 2018. It is unclear as to why they were not sentenced until October 7, 2020. As part of their sentences, the court entered money judgments of $47,780.96 against Gonzalez and $765,356.76 against Colon. This was in addition to the prison time stated above.

The facts above are typical of those in other state and federal prosecutions against physicians, pharmacists, and clinic owners. If you are a physician who is working for a clinic owned by non-physicians, you need to be very careful that you are working for a legitimate organization. If you are being pressured to write prescriptions for narcotics for patients, you need to be very careful about what you do and why you do it. Often physicians who work for pill mills just bury their heads in the sand and rationalize why they are writing and refilling the same prescriptions for opioids month after month.

For the past ten years, in Florida, the DEA, the Department of Health, the state Attorney General, and multi-jurisdictional task forces have been targeting physicians who write prescriptions for narcotics and pharmacies that fill such prescriptions. There are very few left. The cross-hairs of the regulators and law enforcement are now targeting those who are involved in only very small quantities. Watch out, it could be you next!

View the press release issued by the U.S. Attorney’s Office for the Middle District of Florida.

Read my prior blog and learn more about pill mills, here.

Contact Health Law Attorneys Experienced with DEA Cases.

The attorneys of The Health Law Firm are experienced in handling Drug Enforcement Administration (DEA) cases, board of medicine cases, and board of pharmacy case, Department of Health (DOH) investigations, and Department of Regulatory Agencies (DORA) investigations, regarding allegations of over-prescribing and illegal prescribing. If you are currently being investigated or facing other adverse actions by the DEA or a state licensing board, contact one of our attorneys by calling (407) 331-6620 or toll-free at (888) 331-6620. You can also visit our website for more information at www.TheHealthLawFirm.com.


Sources:

“Tampa Pill Mill Owners Sentenced To Prison For Illegal Distribution Of Opioids.” Tampa Free Press. (October 11, 2020). Web.

Otero, Sebastian. “Tampa pill mill owners sentenced to prison for illegal distribution of opioids.” ABC 7 WWSB. (October 8, 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 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.

 

Florida Dentist’s COVID-19 Business Interruption Insurance Claim Dismissed

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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 September 3, 2020, a Florida federal judge dismissed a suit for business interruption insurance payments by a Florida dentist. The dentist claimed he sustained damages caused by the COVID-19 pandemic and related civil authority shutdowns of dental services. The dismissal freed Allied Insurance Company of America from having to pay the dentist’s for COVID-19 related losses, holding that the policy’s “virus exclusion” barred coverage of the insurance claim made.

Insurance Coverage for COVID-19 Related Losses.

The dentist sued his insurance carrier for damages that he argued were “caused by or result[ing] from a Covered Cause of Loss.” The causes of the alleged loss, he maintained, included the COVID-19 virus’s impact on his dental practice and the Florida governor’s emergency declaration that limited dental services during a period of time. Specifically, he claimed that he incurred costs to decontaminate his dental office and lost valuable income because of the governor’s dental services limitation. The dentist alleged that Allied breached the insurance contract by denying coverage in April.

Allied’s insurance policy provides coverage “for direct physical loss or damage to covered property at the [plaintiff’s] premises” that is “caused by or result[s] from any Covered Cause of Loss.” Allied argued that there was no direct physical loss or damage to covered property at the clinic due to appointment cancellations or the closure of the dental practice.

Dismissal of the Law Suit.

U.S. District Court Judge John Badalamenti, for the Middle District of Florida, dismissed the case. He found that the dental practice’s loss or damage asserted was “not due to a covered cause of loss.” More importantly, he found that the policy contained an exclusion for loss or damage caused “directly or indirectly,” by “[a]ny virus, bacterium or other microorganisms that induces or is capable of inducing physical distress, illness or disease.”

According to the judge’s order, in order for the insurer to provide coverage, losses from business suspension must be caused by direct physical loss or damage. He ruled that the dentist failed to demonstrate what the policy required in order to be a covered loss. To read the order in full, click here.

With such a specific exclusion as this policy contained, it was difficult for the judge in the case to rule any other way.

Litigation on Whether Insurance Policies Should Cover Losses Due to Coronavirus Closures.

This recent Florida dismissal is another in a string of cases where insurers have prevailed in Coronavirus business loss cases, because of similar exclusions in their policies. In a similar case, a Michigan federal judge sided with the insurance company saying it didn’t have to cover a chiropractic office’s COVID-19 claimed losses. Like the case above, the judge said the business failed to allege physical loss and, therefore, the policy’s virus exclusion barred coverage. Click here to read the judge’s order in this case.

According to insurance experts and regulators, most businesses and professionals will probably find it difficult to obtain an insurance payout because of policy changes made after the 2002-2003 SARS outbreak. SARS, which infected 8,000 people, led to millions of dollars in business-interruption insurance claims. As a result, many insurers added exclusions to standard commercial policies for virus losses. The added policy language potentially allows insurance companies to avoid hundreds of billions of dollars in business-interruption claims because of the Covid-19 pandemic.

Since a wide-scale virus outbreak is such a rare event, most policy purchasers overlooked this exception. There certainly wasn’t any concerted effort to make insureds aware of the exclusion nor to offer them the opportunity to purchase specific virus outbreak insurance coverage.

A global pandemic presents unique problems for insurance companies. After the SARS outbreak at the beginning of this millennium, many insurance companies realized they would not be able to cover such a broad-scale event causing massive losses. Such an event could have damages greater than those sustained in the largest hurricane to strike the U.S. The insurance industry argued to state regulators that such policy exclusions were necessary, considering the overwhelming number of claims that might arise from a single disease outbreak.

This foresight on the part of the insurance companies saved their shareholders billions, if not trillions, of dollars. Unfortunately business and professionals have had to shoulder the losses.

So, it begs the question: Did insurers actually know the potential damage a viral pandemic could wreak on businesses and, therefore, purposefully exclude coverage? Disputes over the precise wording of business insurance policies will most likely continue to generate court battles like those discussed above.

Read my prior blog on this subject to learn more.

Recommendation for the Future.

There are several options that businesses and state insurance regulators should consider to try to prevent such massive losses from going uncompensated in the future.

First would be to create and provide virus damage insurance similar to that provided for flood insurance by the National Flood Insurance Program (NFIP). The biggest problem would be that losses could easily exceed the largest hurricane that one could imagine. However, the NFIP has shown this type of plan works.

Second would be similar programs provided at the state level. At the present time, many states, have captive insurance companies to fund losses from wind damage caused by storms. In Florida, the Citizens Property Insurance Corporation (CPIC) provides such coverage.

The biggest problem I see with both of the above is that short-sighted and selfish people don’t want to purchase such insurance and, thereby, make it less expensive for all involved. They figure that the government will bail them out anyway in such an event, so why should they pay. Therefore, either making it paid for completely with taxpayer money or a requirement of obtaining a business license or professional license or some combination, may be a way to finance it.

Creating a trust fund with assessments to employers and employees, similar to what is currently done for social security, would be another option. Creating a large trust fund that could cover such tragic events might work best. However, this would have to be made “raider safe” so that Congress does not come back and raid these funds and use them for other purposes like it has done to the United States Postal Service (USPS).

At the very least, some type of universal virus pandemic business loss insurance should be mandated by law or, at least, partially funded by the government. Making it mandatory means making it cheaper and making it work.

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. 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 (407) 331-6620 or toll-free (888) 331-6620 and visit our website at www.ThehealthLawFirm.com

Sources:

Zhang, Daphne. “Fla. Dentist’s Bid For COVID-19 Loss Coverage Axed.” Law360. (September 3, 2020). Web.

Zhang, Daphne. “State Farm Needn’t Cover Chiropractor’s COVID-19 Losses.” Law360. (September 3, 2020). Web.

Frankel, Todd. “Insurers knew the damage a viral pandemic could wreak on businesses. So they excluded coverage.” The Washington Post. (April 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 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.

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“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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