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

George Indest Headshot

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.

KeyWords: healthcare employment law representation, legal representation for physicians, doctor defense legal representation, legal representation for healthcare professionals, complex health care litigation attorney, complex civil litigation attorney, complex healthcare litigation lawyer, complex medical litigation lawyer, representation for complex medical litigation, representation for healthcare business litigation matters, business insurance representation, business interruption insurance claims defense, COVID-19 business insurance claim representation, The Health Law Firm, reviews of The Health Law Firm Attorneys, The Health Law Firm attorney reviews, legal representation for physicians and health care professionals, attorney for physician suits against insurers, complex medical business litigation against health insurers

“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.

 

CVS Fined for Prescription Errors and Poor Staffing at Oklahoma Pharmacies

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 July 16, 2020, the Oklahoma State Board of Pharmacy fined CVS, the nationwide pharmacy chain, $125,000, after auditors found safety issues and “chaotic” scenes at four of its pharmacies. State regulators in Oklahoma cited and fined the nation’s largest retail pharmacy chain for conditions including inadequate staffing and errors made in filling prescriptions. Hopefully, this was isolated to the few stores involved.

Pharmacy Complaints.

In four separate administrative orders, the Oklahoma State Board of Pharmacy said that auditors responded to complaints at each of the pharmacies for issues including long waiting times, wrong information on prescription refills, and dosage mistakes. The state board inspected the four pharmacies from mid-2019 to early 2020. In one case, the complaint said the pharmacy had put someone on hold on multiple occasions, sometimes as long as an hour. In another case, a woman said that when she got her medication refilled, the name and other information on the bottle she received was for someone else.

The pharmacy chains have pushed back on customer and employees’ complaints, saying staffing is sufficient and errors are rare.

Pharmacy Audits.

On multiple occasions, state auditors visiting the pharmacies said they found understaffed facilities, with the phone continuously ringing, employees working around unopened (and, we assume, un-inventoried) delivery boxes, and long lines at the drive-through windows. According to the orders, one pharmacy stated that it was normal for them to be as much as two weeks behind in filling prescriptions as a result of understaffing. It should be noted that the audits took place predominantly before the COVID-19 crisis.

Additionally, in letters to state pharmacy boards and in interviews, pharmacists working for CVS allegedly admitted that they struggled to keep up with an increasing number of tasks including filling prescriptions, giving flu shots, tending the drive-through window, answering phones, and calling patients. According to the orders, many said they also struggled to meet corporate performance metrics that they characterized as excessive and unsafe.

As a routine customer of CVS Pharmacy (not in Oklahoma, of course), I can sympathize with the pharmacists, pharmacy technicians, and clerks. In many places, pharmacists are now being required to administer a laundry list of vaccinations (literally, ten different vaccinations), practice medicine to a limited scope, contact prescribing physicians, constantly order out-of-stock drugs, order diagnostic tests, and answer all sorts of customer questions. Now, with the COVID-19 pandemic, there is a steady flow of coronavirus tests to administer to customers at the drive-through window. I see first-hand how difficult it is for these front-line healthcare professionals to keep up on a daily basis.

The Oklahoma Board said it “strongly recommended” that CVS follow through on nearly a dozen recommendations for all of its Oklahoma pharmacies, including increased training for technicians and changes to how staffing needs were determined. Additionally, the Oklahoma Board advised eliminating tasks that might overburden pharmacists and removing some metrics they are required to meet. For example, phone calls pharmacists often must make could be outsourced to a corporate call center.

In a statement, CVS Pharmacy said it agreed with the Board to settle the matter to avoid the lengthy and costly hearing process. The orders specify that CVS neither admits to nor denies the violations. The company agreed to pay the fines and to make other efforts to address the problems without contesting the allegations.

While the fine of $125,000 is relatively small for CVS, as it’s the country’s fifth-largest company, the move did validate the concerns raised at multiple drugstore chains by pharmacists who say workplaces are putting the public at risk.

You can read all four orders in this case here: CVS Order – Bartlesville, CVS Order – Choctaw, CVS Order – Moore, and CVS Order – Owasso.

Visit our Areas of Practice page on our website to learn more about Board of Pharmacy Representation and how we can assist Pharmacists and Pharmacies in these types of cases.

 

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

We routinely provide defense for pharmacists, pharmacies, and pharmacy technicians; defense to complaints filed against their licenses; defense to complaints filed by patients; defense in litigation against pharmacists, pharmacies, and technicians; legal representation and defense to DEA and Board of Pharmacy audits, investigations, and subpoenas; legal representation in depositions in criminal cases, negligence cases, civil cases, or disciplinary cases involving other health professionals. We have experience in dealing with HIPAA privacy complaints, audits, and investigations. We have experience in defending in Medicare, Medicaid, Tricare, and health insurance audits. We accept most professional liability insurance that pharmacists carry.

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

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 Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Avenue, Suite 1000, Altamonte Springs, Florida 32714, Phone: (407) 331-6620 or 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.

Major Florida Oncology Group Pays $100 Million to Settle Antitrust Charges

George Indest

Attorney Geroge F. Indest III

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

On April 30, 2020, the U.S. Department of Justice (DOJ) announced that a major Florida oncology group will pay $100 million to resolve a criminal charge that it conspired with competitors to divvy up cancer treatments in the area. This marks the first settlement in an ongoing oncology market allocation probe against Florida Cancer Specialists & Research Institute LLC (FCS).

Details of the Antitrust Complaint.

The oncology group, which is based in Fort Myers, Florida, admitted to a single felony antitrust charge under the agreement, the DOJ said. Additionally, FCS inked a civil antitrust settlement with the Florida attorney general requiring it to pay the state $20 million, plus interest.

According to the DOJ, federal prosecutors filed a one-count felony charge against the company in Florida federal court. Prosecutors allege the company of participating “in a criminal antitrust conspiracy” with unnamed oncology competitors in the southwest Florida counties of Lee, Collier, and Charlotte.

The antitrust complaint states: “FCS and its co-conspirators agreed not to compete to provide chemotherapy and radiation treatments to cancer patients in Southwest Florida. Beginning as early as 1999 and continuing until at least 2016, FCS entered into an illegal agreement that allocated chemotherapy treatments to FCS and radiation treatments to a competing oncology group.” Therefore, according to the DOJ, “This conspiracy allowed FCS to operate with minimal competition in Southwest Florida and limited valuable integrated care options and choices for cancer patients.”

We want to point out that the quotations above are statements that were made by the government in relation to this case and were not necessarily proven or agreed to by FCS.

The Settlement Agreement.

Under the settlement agreement, the Florida oncology company admitted to a conspiracy to divvy up the radiation and chemotherapy treatments. In addition to the $100 million, which is the statutory maximum, FCS will have to “cooperate fully with the Antitrust Division’s ongoing investigation” being run with the FBI’s Fort Myers satellite office and must keep up a compliance program aimed at stopping and ferreting out criminal antitrust violations.

Additionally, the deal also obliges FCS to follow a “non-compete waiver” under which it promises not to enforce any non-compete provisions with current and former oncologists. Other employees who open an oncology practice in southwest Florida or join one are also included in the provision, said the DOJ.

Criminal Antitrust Charges are Rarely Sought.

Criminal antitrust charges are rarely brought by the government, especially under the current administration. Anyone that has ever been involved in bringing or defending an anti-trust case knows that it is difficult enough to even have the government open a civil case or investigation, much less a criminal case.

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

To view the antitrust complaint about this case on our website, click here.

You can read the state of Florida’s deal with FCS here.

To learn more, click here and read one of my prior blogs on a similar antitrust case.

Contact Health Care Attorneys Experienced in Negotiating and Evaluating Physician’s Complex Business Litigation, and Transactions

At the Health Law Firm, we provide legal services for health professionals and facilities. This includes physicians, medical groups, nurses, pharmacists, pharmacies, dentists, psychologists, psychiatrists, mental health counselors, ambulatory surgical centers, pain management clinics, assisted living facilities, home health agencies, nursing homes, and any other health care provider.

The services we provide include representation in complex state and federal litigation, reviewing and negotiating contracts, preparing contracts, business transactions, professional license defense, opinion letters, representation in investigations, fair hearing defense, representation in peer review and clinical privileges hearings, litigation of restrictive covenant (covenants not to compete), Medicare and Medicaid audits, commercial litigation, and administrative hearings.

To contact The Health Law Firm, please call (407) 331-6620 or (850) 439-1001 and visit our website at www.TheHealthLawFirm.com

Sources:

Koenig, Bryan. “DOJ Cuts $100M Deal In Oncology Antitrust Probe.” Law360. (April 30, 2020). Web.

Office of Public Affairs. Press Release. “Leading Cancer Treatment Center Admits to Antitrust Crime and Agrees to Pay $100 Million Criminal Penalty.” U.S. Department of Justice. (April 30,2020). 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 Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Avenue, Suite 1000, Altamonte Springs, Florida 32714, Phone: (407) 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.
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