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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.

KeyWords: Florida Board of Pharmacy defense representation, legal defense for pharmacists, pharmacist defense lawyer, Board of Pharmacy defense lawyer, Board of Pharmacy hearing legal representation, pharmacy license disciplinary charges defense attorney, legal representation for pharmacist, legal representation for pharmacy, pharmacy defense lawyer, pharmacy audit defense representation, pharmacy audit defense attorney, board representation for pharmacists, board representation for pharmacies, board representation for physicians, Board of Pharmacy investigation representation, legal representation for board investigations, The Health Law Firm, administrative hearing defense attorney, DEA order to show cause (OSC) defense lawyer, legal representation for administrative hearings, DEA hearing defense attorney, reviews of The Health Law Firm, The Health Law Firm attorney reviews

“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.
Copyright © 2020 The Health Law Firm. All rights reserved.

New Florida Law Allows Limited Pharmacist Medical Practice with Practice Agreements

Attorney Michael L. SmithBy Michael L. Smith, R.R.T., J.D., Board Certified by The Florida Bar in Health Law
A new Florida law allows pharmacists to practice medicine to a certain extent underwritten collaborative practice agreements with physicians who are licensed to practice medicine or osteopathic medicine in Florida. The new law, signed by Governor DeSantis, took effect on July 1, 2020. However, the initial 20-hour course required by the law has not been approved as of July 22, 2020. Also, the Florida Board of Pharmacy has not adopted the formulary of approved medicinal drugs that are required by the law, as of this writing on July 22, 2020.

What Pharmacists Need to Know About the New Law.

Pharmacists practicing under a collaborative practice agreement with a physician will be permitted to test, screen for, and treat some nonchronic health conditions. The nonchronic health conditions a pharmacist is permitted to treat under a collaborative practice agreement are influenza, streptococcus, lice, skin conditions, and minor infections.

Pharmacists will also be able to initiate, modify, or discontinue drug therapy for chronic health conditions under a written collaboration agreement with a physician. The chronic conditions a pharmacist will be able to treat are arthritis, asthma, COPD, type-2 diabetes, HIV or AIDS, and obesity. The collaborative practice agreement for chronic health conditions must be specific to a patient, or patients, of the supervising physician.

A pharmacist must be certified by the Florida Board of Pharmacy before practicing under a collaborative practice agreement. In order to be eligible for certification, the pharmacist must hold an unencumbered license to practice as a pharmacist in Florida. The pharmacist must also have a doctor of pharmacy degree or 5-years of experience as a licensed pharmacist.

Every pharmacist seeking certification to practice under a collaborative practice agreement will be required to complete an initial 20-hour course approved by the Board of Pharmacy, and complete additional continuing education hours for each license renewal. Pharmacists practicing under collaborative practice agreements will also be required to maintain professional liability coverage of at least $250,000.

Pharmacists will not be permitted to prescribe controlled substances. The new law requires the Florida Board of Pharmacy to adopt a formulary of medicinal drugs that pharmacists may prescribe under collaborative practice agreements with physicians.

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

We routinely provide deposition coverage to pharmacists, pharmacies, and other health professionals being deposed in criminal cases, negligence cases, civil cases, or disciplinary cases involving other health professionals.

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: 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.

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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.

Insurer Faces Possible Class Action Over Failing to Pay COVID-19 Related Claims

Headshot of The Health Law Firm's 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 April 14, 2020, several companies announced they are considering a class action lawsuit against Hiscox Insurance over its failure to pay business interruption claims relating to the coronavirus lockdown. Hiscox, sold policies before COVID-19 hit. The policies allegedly stated that they would cover claims related to businesses being forced to shut owing to a notifiable disease. Business owners have reportedly filed claims with Hiscox and other commercial insurance companies, only to be told that their policies don’t cover the losses related to the pandemic.

The Policy Wording.

The company’s policy wording says business interruption claims can be made if a public authority makes the business premises unusable due to “an occurrence of any human infectious or human contagion disease.”

Hiscox claims the policy’s coverage would only be triggered by “certain specific events at, or local to, the premises.” The insurer said its policies were not designed to cover the extraordinary circumstances caused by the pandemic. In a statement, the company said, “We understand that these are incredibly difficult times for businesses affected by COVID-19. At Hiscox, we strive to pay claims that are covered by the policies fairly and quickly. However, general business interruption policies across the industry, including Hiscox’s, were not designed to cover these extraordinary circumstances. Like terrorism and flood, which have government-backed insurance schemes, pandemics like coronavirus are simply too large and too systemic for private insurers to cover,” it added.

Business Interruption Insurance.

Business interruption insurance usually provides protection against the closure of business because of damage to property. Multiple “non-damage” extensions can be added to standard policies, including those for denial of access because of communicable disease. A communicable disease extension or addendum will typically cover losses arising from closure resulting from an outbreak of a virus or bacteria on-site or nearby.

Many policies’ word also includes a defined list of diseases covered under the terms of the policy, which range from the SARS virus to smallpox. Others are less specific, offering coverage for any “notifiable disease” outbreak required by law to be reported to authorities. Additionally, sometimes communicable disease policy addendums contain exclusions, which state that an outbreak must have occurred on the business premises or within a defined vicinity.

The Problem With Policies?

The difficulty is that in the majority of cases, these policies cite “direct physical loss or damage” as a requirement to be triggered. Unfortunately, a quarantine, travel ban, shelter-in-place orders, or pandemic might make it impossible for a business to keep its doors open, but unfortunately may not constitute obvious “physical damage.” So, if the wording fits, as far as the insurance company is concerned, it’s not their problem!

Hiscox denied the claims made against them and responded that the clause was designed to cover losses “solely and directly” from restrictions imposed by a public authority. It would not apply in this case because losses would have still occurred even if businesses had not been closed, because of the government-imposed lockdown.

Legal Issues For Insurance Policies.

There are several important points to remember when dealing with insurance policies and claims made to an insurer.

First, insurance is governed by state law, so interpretations and policy coverage requirements may differ from state to state. Always check your state’s insurance laws and the cases that interpret them to see if the issue is governed by them.

Second, your insurance policy is a contract between you and the insurance company. Read the contract and see what it states. If it is vague or there is a doubt after you read it, you may have a good case. See the next step below.

Third, the insurance company wrote the policy. The insurance company had complete control over the wording of the policy. It was up to the insurance company to be definite and specific in what was covered or not covered. If there is doubt in the coverage that is provided in the policy, the courts will usually interpret this against the insurance company so as to provide coverage to the insured for the loss.

Fourth, when there is a problem with an insurance claim or a denied claim, immediately retain the services of one of the many attorneys who are experienced in suing insurance companies. These attorneys usually know what they are doing and will not charge you unless they obtain a recovery for you.

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 (407) 331-6620 and visit our website at www.ThehealthLawFirm.com

Sources:

Croucher, Martin. “Insurers Face Legal Tests Over Rejected Pandemic Claims.” Law360. (April 17, 2020). Web.

Croucher, Martin. “Hiscox Could Face Class Action Over COVID-19 Response” Law360. (April 14, 2020). Web.

Cox, Josie. “Coronavirus has exposed Britain’s insurance industry as a shambles.” The Guardian. (March 18, 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.

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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.

Emergency Order Allows Florida Pharmacists to Order and Administer COVID-19 Tests

Headshot of The Health Law Firm's 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 April 24, 2020, Florida Gov. Ron DeSantis announced he would expand the opportunities for people to obtain COVID-19 tests by allowing licensed pharmacists to order and administer them. For purposes of preparing for, responding to, and mitigating any effect of COVID-19, Emergency Order 20-006 was filed, suspending section 483.813, Florida Statutes. You can click on the link to read the entire Order.

According to the Order, it was necessary to waive certain statutes and rules of the Florida DOH in order to effectively respond to the emergency caused by COVID-19. Section 483.813, Florida Statutes, requires a pharmacist to be separately licensed to perform a clinical laboratory test. Additionally, section 465.003(13), Florida Statutes, has provisions that prohibit a pharmacist from ordering, administering, or reporting the results of COVID-19 tests, including serology tests, authorized by the United States Food & Drug Administration (FDA). The Emergency Order temporarily sidesteps the law to allow pharmacists to perform these functions.

This suspension of the applicable law applies until the expiration of Executive Order 20-52.

The full version of the Emergency Order may be found on the Florida Board of Pharmacy’s website here as well as on our website here.

It’s important to remember that as with all new guidance and policy changes, it is essential to understand how these changes fit into the existing regulatory frameworks that govern the health care industry.

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

We routinely provide deposition coverage to pharmacists, pharmacies, and other health professionals being deposed in criminal cases, negligence cases, civil cases, or disciplinary cases involving other health professionals.

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:

Gross, J. Samantha. “Florida pharmacists to be allowed to issue COVID-19 tests, DeSantis says.” Miami Herald. (April 24, 2020). Web.

“Pharmacists Authorized to Order and Administer COVID-19 Testing.” The National Law Review. (April 20,2020). 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.

KeyWords: Florida Board of Pharmacy defense representation, legal defense for pharmacists, pharmacist defense lawyer, Board of Pharmacy defense lawyer, Board of Pharmacy hearing legal representation, pharmacy license disciplinary charges defense attorney, legal representation for pharmacist, legal representation for pharmacy, pharmacy defense lawyer, pharmacy audit defense representation, pharmacy audit defense attorney, board representation for pharmacists, board representation for pharmacies, board representation for physicians, Board of Pharmacy investigation representation, legal representation for board investigations, The Health Law Firm, administrative hearing defense attorney, DEA order to show cause (OSC) defense lawyer, legal representation for administrative hearings, DEA hearing defense attorney, reviews of The Health Law Firm, The Health Law Firm attorney reviews, DEA order to show cause (OSC) defense attorney, Drug Enforcement Administration (DEA) defense attorney, Drug Enforcement Administration (DEA) investigation defense attorney, Drug Enforcement Administration (DEA) subpoena defense lawyer, Drug Enforcement Administration (DEA) inspection defense attorney, Drug Enforcement Administration (DEA) hearing defense attorney, Drug Enforcement Administration (DEA) order to show cause (OTSC) defense lawyer

“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.

Colorado Board of Pharmacy Ordered to Hand Over Patient Identifying Data to DEA

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.

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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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Question: Is Exposure to COVID-19 For Healthcare Workers, Causing Illness, Disability, or Death, Considered an Employment-Related Injury Under Workers’ Comp?

Attorney Amanda I. ForbesBy Amanda I. Forbes, J.D. and George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

In answering the question posed in the title of this blog, first, it should be noted that the World Health Organization (WHO) classifies COVID-19 as an “occupational disease.”  (Reference:  World Health Organization, “Coronavirus Disease (COVID-19) Outbreak: Rights, Roles and Responsibilities Of Health Workers. . . .”)

Click here to view the classification by the WHO on our website.

Most state workers’ compensation laws cover the worker for occupational diseases if the worker acquires it during the course and scope of their employment.  For example, Section 440.151(2), Florida Statutes, states:

Whenever used in this section the term “occupational disease” shall be construed to mean only a disease which is due to causes and conditions which are characteristic of and peculiar to a particular trade, occupation, process, or employment, and to exclude all ordinary diseases of life to which the general public is exposed, unless the incidence of the disease is substantially higher in the particular trade, occupation, process, or employment than for the general public. “Occupational disease” means only a disease for which there are epidemiological studies showing that exposure to the specific substance involved, at the levels to which the employee was exposed, may cause the precise disease sustained by the employee.

Section 440.151(2), Florida Statutes, (emphasis added).  Many other states have similar requirements to those of Florida.

Healthcare workers are at the front line of any outbreak response and as such are exposed to hazards that put them at an increased risk of infection with the COVID-19 virus.  Therefore, as COVID-19 meets the criteria as an “occupational disease.”

Moreover, Section 440.151(1)(a), Florida Statutes, states:

Where the employer and employee are subject to the provisions of the Workers’ Compensation Law, the disablement or death of an employee resulting from an occupational disease as hereinafter defined shall be treated as the happening of an injury by accident, notwithstanding any other provisions of this chapter, and the employee or, in case of death, the employee’s dependents shall be entitled to compensation as provided by this chapter, except as hereinafter otherwise provided; and the practice and procedure prescribed by this chapter shall apply to all proceedings under this section, except as hereinafter otherwise provided.  Provided, however, that in no case shall an employer be liable for compensation under the provisions of this section unless such disease has resulted from the nature of the employment in which the employee was engaged under such employer, was actually contracted while so engaged, and the nature of the employment was the major contributing cause of the disease. Major contributing cause must be shown by medical evidence only, as demonstrated by physical examination findings and diagnostic testing. “Nature of the employment” means that in the occupation in which the employee was so engaged there is attached a particular hazard of such disease that distinguishes it from the usual run of occupations, or the incidence of such disease is substantially higher in the occupation in which the employee was so engaged than in the usual run of occupations. In claims for death under s. 440.16, death must occur within 350 weeks after last exposure. Both causation and sufficient exposure to a specific harmful substance shown to be present in the workplace to support causation shall be proven by clear and convincing evidence.

Section 440.151(1)(a), Florida Statutes.

It is important to note that COVID 19 or any other communicable disease (TB, H1N1, etc.):  The employee has to test positive for the disease/contagion and it must be determined with a reasonable amount of certainty that their exposure to the virus occurred in the workplace and was not community-acquired.

In addition,  per Section 440.151(1)(c), Florida Statutes states:

Where an occupational disease is aggravated by any other disease or infirmity, not itself compensable, or where disability or death from any other cause, not itself compensable, is aggravated, prolonged, accelerated or in anywise contributed to by an occupational disease, the compensation shall be payable only if the occupational disease is the major contributing cause of the injury. Any compensation shall be reduced and limited to such proportion only of the compensation that would be payable if the occupational disease were the sole cause of the disability or death as such occupational disease, as a causative factor, bears to all the causes of such disability or death, such reduction in compensation to be effected by reducing the number of weekly or monthly payments or the amounts of such payments, as under the circumstances of the particular case may be for the best interest of the claimant or claimants. Major contributing cause must be demonstrated by medical evidence based on physical examination findings and diagnostic testing.

Section 440.151(1)(c), Florida Statutes, (emphasis added).

With regard to emergency medical technicians (EMTs) or paramedics Section 440.09(3), Florida Statutes, states:

If an emergency medical technician or paramedic is appointed or employed full time by a municipality, the state, or any political subdivision, is certified under chapter 401.23, in an emergency situation in this state, any such activities would be considered to be within the course of his or her employment and an emergency medical technician or paramedic and covered by the employer’s jurisdiction or area of responsibility, such activities are considered to be within the course of employment. The provisions of this subsection do not apply if the emergency medical technician or paramedic is performing activities for which he or she is paid by another employer of contractor.

Section 440.09(3), Florida Statutes (emphasis added).

Workers Compensation Benefits for Healthcare Professionals.

As of March 26, 2020, Florida has not issued any order or legislation explicitly stating that healthcare professionals exposed to COVID-19 will be entitled to Workers Compensation benefits.

By way of example, In the City of Phila. v. Workers’ Comp. Appeal Bd. (Sites), 889 A.2d 129 (Pa. Commw. Ct. 2005), a claimant was successful in proving that his hepatitis C was caused by his exposure to blood that occurred while working as a firefighter and emergency medical technician  (EMT).  Similar to COVID-19, hepatitis C was also classified as a compensable “occupational disease.”  Therefore, it is likely that a healthcare professional’s exposure to COVID-19 would result in viable workers’ compensation claim.

Federal workers’ compensation laws are similar to those quoted above. Therefore, federal health care providers and those working in federal facilities will also most probably be entitled to federal employment compensation (FECA) benefits under similar situations.

We want to emphasize that this is merely our preliminary opinion based on limited analysis and research.  It is provided for informational purposes only. It does not constitute the provision of legal advice.  Each state has different workers’ compensation laws and different case law, as does the federal government. Each individual set of circumstances may be different. Contact your local workers’ compensation plaintiff’s (claimant’s) attorney for advice and representation in your individual case.

For more information and more examples of employment compensation benefit cases for health care professionals, click here.

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, Durable Medical Equipment suppliers, medical students and interns, 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 student professors and clinical staff. We represent 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, in patient complaints, and in Department of Health investigations.

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

About the Authors:  Amanda I. Forbes, practices health law with The Health Law Firm in its Altamonte Springs, Florida, office.  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.

“The Health Law Firm” is a registered fictitious business name of and a registered service mark of The Health Law Firm, P.A., a Florida professional service corporation, since 1999.
Copyright © 2020 The Health Law Firm. All rights reserved.

By |2020-05-07T16:12:25-04:00May 25th, 2020|Categories: Pharmacy Law Blog|0 Comments

Florida Prosecutors Want Telehealth Suspect to Remain in Jail For $424 Million Fraud Scheme

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 March 19, 2020, federal prosecutors in New Jersey federal court pushed to keep a suspect involved in a $424 million telemedicine scheme in jail.  Authorities called him an “unrepentant conman” who carried out one of the largest health care fraud schemes in U.S. history and is likely to flee the country if released.

Telehealth Fraud & Illegal Kickback Scheme.

The defendant, who owns telehealth companies, has been locked up for nearly 11 months since he was charged last year with running an international fraud and kickback scam. He allegedly paid doctors to order unnecessary orthotic braces for Medicare beneficiaries and solicited bribes and kickbacks from brace suppliers in exchange for patient referrals.

Prosecutors say he went to great lengths to hide his scheme, including lying to obtain legal opinion letters bolstering his claim that he ran legitimate companies that profited from patient subscription fees. In reality, he was concealing the fact that most of those payments were kickbacks from brace suppliers.

Is He a Flight Risk?

In an opposition brief, prosecutors said that there aren’t any suitable bail conditions for the suspect, given his risk of flight and the danger he poses to the community. According to the government, he has a long history of deception and scheming involving foreign businesses, residences, and assets, including a $1 million yacht. Additionally, he claimed to control several foreign bank accounts and once told a cooperating witness that if the government started investigating him, he would flee to Venezuela.

The defendant argued that he’s not a flight risk because he has no criminal history and has close ties to his South Florida community.

Florida’s Involved in a Major Fraud Case, Shocker!

Another scenario that seems to be right out of a Carl Hiaasen or Tim Dorsey novel.  Why does Florida continue to attract and protect the assets fo fraudsters, conmen, and deadbeats?  Does it go back to our history of being the wintering ground for carnies and traveling circuses?

In 2019, the defendant was charged along with 23 other individuals in a crackdown on telehealth fraud schemes in New Jersey, Pennsylvania, South Carolina Texas, Florida, and California, involving over $1.2 billion in losses.

Given his close community ties and its reputation, it comes as no surprise that getting doctors to sign off on fraudulent prescriptions was a part allegedly played by telehealth company owners in Florida. Click here to view the indictment.

For years, Florida has been the home to health care fraudsters and ranked number one in terms of fraud cases. So, it’s not shocking that three Florida telehealth executives were also charged in what appears to be the biggest case in the takedown.
Click here to learn more about this case.

Therefore, to prevent flight and protect the public, prosecutors requested that the Court deny the
defendant’s motion to revoke the detention order and keep him detained. Click here to read the opposition brief.

To read about a similar telehealth case in Florida, click here to read my prior blog.

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, Durable Medical Equipment suppliers, medical students and interns, hospitals, ambulatory surgical centers, pain management clinics, nursing homes, and any other health care provider. We represent facilities, individuals, groups, and institutions in contracts, sales, mergers, and acquisitions.

The services we provide include reviewing and negotiating contracts, business transactions, professional license defense, representation in investigations, credential defense, representation in peer review and clinical privileges hearings, Medicare and Medicaid audits, commercial litigation, and administrative hearings. To contact The Health Law Firm, please call (407) 331-6620 or (850) 439-1001 or (970) 416-7456 or visit our website at www.TheHealthLawFirm.com.

Sources:

Bishop, Stweart. “Feds Push To Keep Telehealth Fraud Suspect Locked Up.” Law360. (March 19, 2020). Web.

Godoy, Jody. “Execs, MDs Charged In $1.2B Medicare Fraud Scheme.” Law360. (April 9, 2019). 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.

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The Health Law Firm” is a registered fictitious business name of The Health Law Firm, P.A., a Florida professional service corporation, since 1999, and is also a registered service mark.
Copyright © 2020 The Health Law Firm. All rights reserved

Hospital Countersues Whistleblower for Failing to Report Conduct Internally First

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 March 13, 2019, a West Virginia hospital facing a whistleblower lawsuit countersued a former employee who filed the False Claims Act (FCA) lawsuit against the health system. Wheeling Hospital alleges that the former executive, who is the whistleblower/relator in the lawsuit, breached his fiduciary duty to the company by failing to report the unlawful conduct internally, first. Instead, he used the information as the basis for his whistleblower claim. In the countersuit filed in the U.S. District Court for the Northern District of West Virginia, the Hospital accuses the former executive-turned-whistleblower of attempting to ‘extort a settlement’ and filing the FCA whistleblower suit as an act of revenge.

The Whistleblower’s Complaint.

The whistleblower, a former accountant, and senior executive at Wheeling Hospital, was discharged in August 2015. In December 2017, he filed a complaint under the qui tam provisions of the False Claims Act (FCA). He alleged the hospital violated the federal Anti-Kickback Statute (AKS) by paying kickbacks to physicians for patient referrals to the Hospital. Based on this, it is alleged, the claims for the services the hospital provided to the referred patients were false claims, subject to recoupment by the government.

The Hospital’s Countersuit.

In an unusual strategy, the Hospital filed a counter-suit against the whistleblower, alleging that he breached his fiduciary duty to the Hospital and abused the legal process. The Hospital’s case asserts that instead of carrying out his duty to the Hospital, instead, he capitalized on his alleged knowledge of the conduct to “extort a settlement” through a “false and frivolous” FCA suit as an act of revenge.

Additionally, the Hospital alleges that “at no time during his employment, or in his role as a partner at Deloitte, did he report any suspicions of fraud or violations of federal regulations to Wheeling Hospital’s compliance officer.”

You can read Wheeling Hospital’s countersuit against the whistleblower on our website in full.

The Significance of This Case: Unique Defense Strategy for Defending a Whistleblower Suit.

This case shows a unique, but legally valid, defense strategy that might be used in other future whistleblower cases. Often the information about false claims is produced by a high-ranking hospital or institutional employees whose job duties may have required them to report what they knew to the company as part of their job. The company should then have the opportunity to investigate and correct any improper billing or other misconduct that an errant employee might be carrying out on his own. By failing to do this, the employee may breach his duties to the company, may violate his employment contract, and may be subject to a suit or counter-suit over this. To the extent that the actions of the ex-employee cause the employer damages, the employer may be entitled to indemnification from the ex-employee.

However, the other side of the story is when an employee does make his or her superiors aware of suspected misconduct and false claims within the company and the company does nothing about it. This is often the case that we have when potential blowers contact us about filing a False Claims Act case. Often the whistleblower attempts to do the right thing by reporting it within the company and is stymied by his or her superiors. To us, this opens the door to legitimate whistleblower suits.

To read one of my prior blogs about South Florida Hospital reaching a settlement for similar FCA
claims, click here.

Click here to learn more about who can file a whistleblower/qui tam lawsuit and the reward programs for coming forward with a false claim.

Contact Health Law Attorneys Experienced with Qui Tam or Whistleblower Cases.

Attorneys with The Health Law Firm represent physicians, nurses and other health professionals who desire to file a False Claims Act (whistleblower or qui tam) case. However, the attorneys of The Health Law Firm also defend physicians, medical groups and health facilities that have been sued in False Claims Act (whistleblower or qui tam) cases or have had administrative or civil complaints filed against them to recover civil monetary penalties. We have developed relationships with recognized experts in health care accounting, health care financing, utilization review, medical review, filling, coding, and other services that assist us in such matters. We have represented doctors, nurses and others as relators in bringing qui tam or whistleblower cases, as well.

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

Sources:

Pearlman, Steve and Freeman, Meika. “Top 10 Whistleblowing And Retaliation Events Of The Year.” Law360. (December 20, 2019). Web.

Goldberg, Pinchos. “Hospital Sues Whistleblower for Failing to Report Information And Choosing Instead to Use As Basis for Claim.” JD Supra. (May 8, 2019). Web.

Commins, John. “HOSPITAL COUNTERSUES FALSE CLAIMS WHISTLEBLOWER.” Health Leaders. (May 9, 2019). 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.

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Walgreens Agrees to Pay $7.5 Million To End Lawsuit Over Unlicensed Pharmacist

George F. Indest III HeadshotBy George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law
On February 4, 2020, Walgreens agreed to pay $7.5 million to settle allegations that for more than a decade it let an unlicensed pharmacist handle hundreds of thousands of prescriptions. The pharmacy giant settled with authorities after an employee was criminally charged with impersonating a pharmacist in California. Prosecutors said that from 2006 through 2017, she used the license numbers of other registered pharmacists to dispense more than 745,000 prescriptions at Walgreens stores.

A Phony Pharmacist.

According to the lawsuit, Kim Thien Le worked for Walgreens for more than 15 years, first as an intern and then a pharmacist, despite never having her license. Le allegedly used the license of another person with the same first name to dispense more than 100,000 prescriptions for dangerous controlled substances. By using the license numbers of legitimate pharmacists, she was able to illegally impersonate and dispense highly regulated controlled substances, including prescription opioids such as fentanyl, oxycodone, hydrocodone, morphine, and codeine.

State Pharmacy Audit.

California state authorities discovered that she did not have a license during a pharmacy board audit in 2017. In California, as in most states, working as a pharmacist or pharmacist intern without a license from the state Board of Pharmacy is a crime. Le was criminally charged by the state with three felonies: false personation, identity theft, and obtaining money, labor or property by false pretenses. To read California Attorney General’s press release on this case, click here.

In a public statement, the Santa Clara County District Attorney’s Office announced the lawsuit against Walgreens alleging the company failed to properly safeguard against an unlicensed employee working for it as a pharmacist. Click here to view the press release in full.

The settlement also requires Walgreens to ensure licensure compliance by implementing a verification program, posting proof of licensure, conducting annual audits, and submitting an annual compliance report.

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

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

We routinely provide deposition coverage to pharmacists, pharmacies and other health professionals being deposed in criminal cases, negligence cases, civil cases or disciplinary cases involving other health professionals.

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:

“Walgreens to pay $7.5M in settlement over phony pharmacist.” AP News. (February 3, 2020). Web.

Zaveri, Mihir. “A Fake Pharmacist, 745,000 Prescriptions and a $7.5 Million Settlement.” The New York Times. (February 4, 2020). Web.

Clough, Craig. “Walgreens To Pay $7.5M To End Suit Over Fake Pharmacist.” Law360. (February 4, 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.

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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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