Texas Hospital’s COVID-19 Vaccine Mandate Upheld by Federal Court

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

As some states lift COVID-19 restrictions, the business community is still grappling with the dynamic between the COVID-19 vaccine and workplace operations. To address this, some U.S. employers have elected to adopt mandatory vaccination policies. These policies, in essence, require that, subject to a few exceptions, all employees must receive the COVID-19 vaccine as a condition of continued employment.

Not surprisingly, we see various legal challenges to mandatory COVID-19 vaccination policies across the country. On June 12, 2021, a federal court in Texas became the first to rule on the permissibility of such policies enforced by private employers. In a landmark ruling, the court stated that mandatory workplace vaccination policies are lawful under Texas and federal law and may be enforced as a condition of continued employment.


The Court’s Ruling on Mandatory Vaccination Policies.

The lawsuit, Bridges v. Houston Methodist Hospital, was initially filed on behalf of 117 employees after their employer, Houston Methodist Hospital, instituted a policy requiring employees to receive a COVID-19 vaccine as a condition of continued employment. Employees who were not vaccinated by the deadline were to be placed on a two-week unpaid suspension to allow them to comply with the policy. Under the policy, those who ultimately did not comply would be terminated.

In the law suit challenging the employer’s policy, the Plaintiffs asserted: (1) the employees whose employment was terminated as a result of this policy were wrongfully terminated in violation of Texas law, and (2) the vaccine mandate violated public policy of the state of Texas.

Texas Wrongful Termination Claim.

Under Texas law, the court found that firing an employee who is unwilling to comply with an employer’s mandatory COVID-19 vaccine policy does not constitute wrongful termination. Texas law only protects employees who are fired for refusing to commit an illegal act at the request of their employer. The court reasoned that receiving the vaccine is not an illegal act given the U.S. Supreme Court’s rulings upholding involuntary quarantines and mandatory vaccines.

Violation of Public Policy.

The court dismissed the plaintiffs’ public policy arguments because, according to the court, Texas law does not recognize a public policy exception to the at-will employment doctrine. Additionally, the court noted that a mandatory vaccine requirement is consistent with public policy. The Supreme Court has previously held that state-imposed quarantine and vaccination requirements do not violate due process of law.

The court held that the plaintiffs were not being coerced to get the vaccine but were being given a basic choice by its employer: get the vaccine so the hospital could safely continue its business of saving lives or seek employment elsewhere.

Lastly, the court also cited recent Equal Employment Opportunity Commission (EEOC) guidance in its decision. The guidance states that employers can require employees to be vaccinated, subject to the obligation to provide reasonable accommodations to employees with legitimate medical or religious reasons for not being vaccinated. Click here to view.

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

Important Takeaway From This Court Decision.

While there are sure to be future legal challenges to mandatory workplace vaccination policies, this decision provides strong support for their use and permissibility. However, even with this ruling, employers with policies need to be mindful of their obligations and potentially provide reasonable accommodations to employees with disabilities or sincerely held religious beliefs that prevent them from receiving the COVID-19 vaccine. Of course, we will see numerous legal challenges of all kinds to these decisions.

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. We do NOT represent plaintiffs in COVID-19 injury suits, however.

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:

Downie, Alex. “Federal Court Upholds Employer’s COVID-19 Vaccine Mandate.” The National Law Review. (June 15, 2021). Web.

Brown, Amanda, Goldstein, Mark. “In first-of-its-kind decision, federal court rules that mandatory workplace COVID-19 vaccine policies are lawful.” Employment Law Watch. (June 16, 2021). 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, Florida 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.

 

Walgreens Accused of Providing Insufficient COBRA Notices, Class Action Lawsuit Says

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

On November 30, 2022, a group of former Walgreens workers filed a proposed class action in Florida federal court that accuses the pharmacy chain of sending confusing, incomplete COBRA notices. The former employees sued, saying the company purposely sent former employees “haphazard and piecemeal” information about their rights to continued insurance coverage under the federal COBRA law to save itself money.

As a result, the lawsuit claims, they lost access to their medical coverage when they were terminated and, therefore, had to pay out-of-pocket to cover medical expenses.

Details of the Class Action.

The plaintiffs filed the class action complaint against Walgreens Co. in the United States District Court Middle District of Florida, Tampa Division, alleging violations of the Employee Retirement Income Security Act (ERISA) and the Consolidated Omnibus Budget Reconciliation Act (COBRA). This federal law provides details on what employer-sponsored health plans must do.

The plaintiffs claim they were all terminated from Walgreens between 2018 and 2020 for reasons not related to gross misconduct, they said in their complaint. After their termination, they received COBRA notices that are required to be written in a manner that an average plan participant could understand. However, rather than receiving one document clearly outlining that information on their post-employment COBRA benefits, they received multiple separately mailed documents that lacked critical information, according to the complaint.

The lawsuit claims the first notice failed to include an address indicating where COBRA payments should be mailed. “It also fails to explain how to enroll in COBRA, nor does it bother including a physical election form,” the lawsuit alleges.

The lawsuit states that a second notice contained some but not all of the required information.

The insufficient COBRA notices confused and misled the plaintiffs and caused them economic injuries in the form of lost health insurance and informational injuries, they claim.

Similar Suits Against Walgreens.

Because similar lawsuits alleging deficient COBRA notices have been filed against Walgreens before, the pharmacy chain was aware that its notices were inconsistent with the Department of Labor’s model, alleged the workers. Therefore, they claim its choice to use a non-compliant notice was in “deliberate or reckless disregard” of the workers’ rights.

The plaintiffs seek to represent a class of all Walgreens health care plan participants and beneficiaries who were sent similar COBRA notices during the applicable statute of limitations period and did not elect to continue coverage.

The plaintiffs seek reinstatement of their right to coverage, damages, fees, and costs. Click here to read the complaint.

Contact Health Law Attorneys Experienced in Representing Health Care Professionals and Providers.

At the Health Law Firm, we provide legal services for pharmacists and pharmacies, as well as 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 other healthcare providers. 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 or Toll-Free (888) 331-6620 and visit our website at www.ThehealthLawFirm.com

Sources:

Edwards, Jesse. “Walgreens class action claims company fails to provide legal COBRA notices.” Top Class Actions. (December 5, 2022). Web.

Freedman, Emily. “Walgreens Provides Deficient COBRA Notices, Suit Says.” Law360. (December 1, 2022). 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 or Toll-Free: (888) 331-6620.

Current Open Positions with The Health Law Firm. The Health Law Firm always seeks qualified individuals interested in health law. Its main office is in the Orlando, Florida, area. If you are a current member of The Florida Bar or a qualified professional who is interested, please forward a cover letter and resume to: PAlexander@TheHealthLawFirm.com or fax them to (407) 331-3030.

“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 © 2023 The Health Law Firm. All rights reserved.

Walgreens Accused of Providing Insufficient COBRA Notices, Class Action Says

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

On November 30, 2022, a group of former Walgreens workers filed a proposed class action in Florida federal court that accuses the pharmacy chain of sending confusing, incomplete COBRA notices. The former employees sued, saying the company purposely sent former employees “haphazard and piece-meal” information about their rights to continued insurance coverage under the federal COBRA law to save itself money.

As a result, they lost access to their medical coverage when terminated and therefore had to pay out of pocket to cover medical expenses.

Details of the Class Action.

The plaintiffs filed the class action complaint against Walgreen Co. in the United States District Court Middle District of Florida Tampa Division, alleging violations of the Employee Retirement Income Security Act (ERISA) and the Consolidated Omnibus Budget Reconciliation Act (COBRA).

They were all terminated from Walgreens between 2018 and 2020 for reasons not related to gross misconduct, they said in their complaint. After their termination, they received COBRA notices that needed to be written in a manner that an average plan participant could understand. However, rather than receiving one document outlining that information on COBRA, they received multiple separately mailed documents that lacked critical information, according to the complaint.

The first notice fails to include an address indicating where COBRA payments should be mailed. “It also fails to explain how to actually enroll in COBRA, nor does it bother including a physical election form,” the lawsuit alleges.

A second notice sent contains some but not all of the required information, the lawsuit states.

The insufficient COBRA notices confused and misled the plaintiffs and caused them economic injuries in the form of lost health insurance and informational injuries, they claim.

Similar Suits Against Walgreens.

Because similar lawsuits alleging deficient COBRA notices have been filed against Walgreens before, the pharmacy chain was aware that its notices were inconsistent with the Department of Labor’s model, alleged the workers. Therefore, they claim that its choice to use a non-compliant notice was in “deliberate or reckless disregard” to the workers’ rights.

The plaintiffs seek to represent a class of all Walgreens health care plan participants and beneficiaries who were sent similar COBRA notices during the applicable statute of limitations period and did not elect to continue coverage.

The plaintiffs seek reinstatement of their right to coverage, damages, fees, and costs. Click here to read the complaint.

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 pharmacists, pharmacies, physicians, nurses, dentists, psychologists and any other healthcare provider. We represent health facilities, individuals, groups, and institutions in contracts, sales, mergers and acquisitions, and in complex litigation. The lawyers of The Health Law Firm are experienced in complex litigation and both formal and informal administrative hearings. We also represent pharmacists 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:

Edwards, Jesse. “Walgreens class action claims company fails to provide legal COBRA notices.” Top Class Actions. (December 5, 2022). Web.

Freedman, Emily. “Walgreens Provides Deficient COBRA Notices, Suit Says.” Law360. (December 1, 2022). 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 or Toll-Free: (888) 331-6620.

Current Open Positions with The Health Law Firm. The Health Law Firm always seeks qualified individuals interested in health law. Its main office is in the Orlando, Florida, area. If you are a current member of The Florida Bar or a qualified professional who is interested, please forward a cover letter and resume to: PAlexander@TheHealthLawFirm.com or fax them to (407) 331-3030

“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 © 2022 The Health Law Firm. All rights reserved.

Is the DEA Knocking on Your Door? What You Need to Know Right Now!

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

Is the Drug Enforcement Administration (DEA) knocking at your door or, even worse, going through your files inside your office?

This is what you need to know right now!

YES, you do have the right to call your attorney. Call your attorney right now. If you cannot, ask one of your employees or spouse to call your attorney. Get your attorney involved right now!

NO, do not sign a document to relinquish or voluntarily give up your DEA registration number. If you do so, this will probably be the biggest mistake you make of your life.

NO, do not sign a document waiving your right to a grand jury investigation before the DEA is authorized to charge you. Why would you want to voluntarily give up one of your most important constitutional rights?


Don’t be fooled by what the DEA agents tell you.

The DEA has the reputation (and, in my experience, deservedly so) of making false statements to individuals about what will happen to them or not happen to them if they do not “Cooperate” with the DEA by giving up their rights.

Often they will handcuff the pharmacist or the physician who is the subject of their raid, search warrant, or subpoena as a method of intimidating them. Then they will threaten the person by arresting them and jailing them immediately if they do not sign a “voluntary” relinquishment of their DEA registration. Yet once you do this, your DEA registration is gone, and you will most likely never get one again.

We have even had the report from a physician recently where the DEA agents, during executing a search warrant (not an arrest warrant, by the way), of having the doctor sign a document waiving her right to having a grand jury hearing on any charges she may have been facing. The threat was that she needed to waive her rights or be arrested on the spot and taken to jail. She signed without consulting an attorney.

If you are a pharmacist or pain management physician, or you own or operate a pain management practice, or if you prescribe or dispense opioids, you must have the name and phone number of a good health lawyer and a good criminal lawyer on hand and post at all times! It is only a matter of time before you need to use it.

Have this information in your wallet and taped to every telephone and computer in your office. But use it right away. Call your attorney right away. Your attorney will come over or brief you on what to do or not do.

Contact Health Law Attorneys Experienced in Representing Pharmacies and Pharmacists.

The Health Law Firm represents pharmacists and pharmacies in DEA, DOH, and FDA investigations, qui tam and whistleblower cases, regulatory matters, licensing issues, litigation, administrative hearings, inspections, and audits. 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, call (407) 331-6620 or toll-free (888) 331-6620 and visit our website at www.TheHealthLawFirm.com.

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.

Current Open Positions with The Health Law Firm. The Health Law Firm always seeks qualified individuals interested in health law. Its main office is in the Orlando, Florida, area. If you are a current member of The Florida Bar or a qualified professional who is interested, please forward a cover letter and resume to: PAlexander@TheHealthLawFirm.com or fax them to (407) 331-3030.

“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 © 2022 The Health Law Firm. All rights reserved.

2022-12-07T20:12:50-05:00December 7th, 2022|Categories: Pharmacy Law Blog|Tags: , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |0 Comments

Centene Will Pay $19 Million to Washington State For Medicaid Fraud Allegations

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

On August 24, 2022, managed healthcare company, Centene Corporation, agreed to pay $19 million to the State of Washington to settle fraud allegations. Centene owns and operates Sunshine State Health Plan, d/b/a Sunshine Health, in Florida. In addition, it has been reported that Centene/Sunshine Health reportedly has over $31 billion in contracts with the state of Florida alone. Click here to learn more.

The agreement with Washington State resolves allegations that it overcharged its Medicaid program for pharmacy benefit management services, Washington Attorney General Bob Ferguson announced in a press release.

Under the deal, in addition to the $19 million payment to Washington State, the federal government will receive $13.3 million related to the settlement, according to the Attorney General’s office. In addition, a whistleblower who sued the company on behalf of the state will also receive $1 million. It is the second-largest Medicaid fraud settlement in Washington’s history.

An Investigation and a Whistleblower.

According to the press release, the Washington AG’s office began investigating pharmacy benefit managers in 2019 after a whistleblower said the company failed to disclose actual pharmacy benefits and service costs. Furthermore, Centene allegedly failed to pass on discounts it received to the state Medicaid program, causing inflated fees, according to the release.

Washington sued Centene in July 2022, alleging the company and a subsidiary, Coordinated Care of Washington, violated the state’s Medicaid False Claims Act. Coordinated Care of Washington contracts with Washington’s Health Care Authority to manage its Medicaid program, Apple Health.

Shelling Out Big Bucks For Settlements.

Centene did not admit to any wrongdoing in this case, as is usual with settlement agreements. “This no-fault agreement reflects the significance we place on addressing their concerns and our ongoing commitment to making healthcare delivery local, simple and transparent,” Centene’s spokesperson said.

But, while denying any wrongdoing, it has settled claims over similar alleged conduct in ten other states for more than $260 million. Additionally, it said last year that it was still in negotiations with more states and had set aside $1.25 billion to settle such claims. Click here to learn more. 

To view the settlement agreement in full, click here. 

Similar Patterns of Misconduct?

We need to ask: “Is this the business model of Centene and its different owned subsidiary companies?” We note that on March 22, 2022, the Centers for Medicare and Medicaid Services (CMS) assessed civil monetary penalties (CMP) against Centene Corporation for similar alleged wrongful activities involving the states of California, South Carolina, Texas, Ohio, Michigan, and others.  And in a letter dated March 11, 2022, the Florida Agency for Health Care Administration issued a $9.1 million fine over Centene/Sunshine Health’s improper failure to pay benefits to Florida’s neediest, sick children.  We have not found any report that Centene challenged or appealed either government penalty.

When multiple billions of dollars in government contracts are handed out to one contractor, and it is the subject of so many allegedly wrongful acts, one must ask if it is just treating such penalties and fines as the routine costs of doing business. Considering that $9.1 million is less than three (3) hundredths of a percent (.0003) of its $31 billion in contracts with the state of Florida, this cost may not even be significant enough for it to post on its profit ad loss statements.

Contact Health Law Attorneys Experienced with Medicare and Medicaid Audits, Healthcare Audits, and Insurance Payment Disputes.

The attorneys of The Health Law Firm represent counselors, therapists, physicians, healthcare providers and healthcare facilities in defense of Medicare and Medicaid audits, audits by insurance companies and managed care, and demands for repayment of overpayments. They represent healthcare providers in audits, audit appeals and repayment disputes against Centene Corporation and Sunshine Sate Health Plan d/b/a Sunshine Health. They also represent healthcare providers in defense against allegations of false billing, overbilling, False Claims Act violations and civil monetary penalties (CMP).

Our attorneys represent physicians, mental health counselors, behavior therapists, professional counselors, occupational therapists, social workers, medical groups, home health agencies, pharmacies, pharmacists, home nursing care providers, and other healthcare providers and institutions.

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

Sources:

Redmond, Nell. “Centene to pay $33.3 million to settle Washington Medicaid fraud claims.” Reuters. (August 25, 2022). Web.

Elletson, Grace. “Centene Strikes $33M Deal To End Wash. Medicaid Fraud Suit.” Law360. (September 2, 2022). Web.

Health Law Weekly. “Centene Will Pay $19 Million to Resolve Medicaid Fraud Allegations.” AHLA. (September 2, 2022). 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

Attorney Positions with The Health Law Firm. The Health Law Firm is always looking for qualified attorneys interested in the practice of health law. Its main office is in the Orlando, Florida, area. If you are a member of The Florida Bar and are interested, forward a cover letter and your resume to: PAlexander@TheHealthLawFirm.com or fax to: (407) 331-3030.

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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 © 2022 The Health Law Firm. All rights reserved.

2022-10-14T14:52:30-04:00November 29th, 2022|Categories: Pharmacy Law Blog|Tags: , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |0 Comments

When the DEA Comes Knocking: 15 Tips For a “Routine” DEA Inspection

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

As the United States continues to open back up from the COVID-19 shutdown, the Drug Enforcement Agency (DEA) is resuming on-site routine inspections.  Therefore, healthcare professionals must ensure compliance and regulatory efforts are in place.

This is part 1 of a 2-part blog series. Check back for part 2 of this blog series soon!

DEA Inspections and Site Visits:  Subpoenas.

DEA agents are often pushy, demanding, and intimidating.  They will try to use subpoenas (which are merely requests for documents that afford you at least ten days to produce the requested documents) as search warrants.  THEY ARE NOT.  They will try to use an administrative subpoena to obtain documents and get your testimony immediately. YOU DO NOT HAVE TO PRODUCE THEM RIGHT AWAY. A copy of a sample subpoena used by the DEA is on our website for reference here.

Not Just a Routine Audit, Inspection, or Investigation.

Beware the “Notice of Inspection of Controlled Premises” (DEA Form 82).   Although the DEA often treats it as one, it is not a search warrant.  Also, it is probably NOT a “Routine Inspection.”  IT WILL NOT TAKE ONLY 15 TO 20 MINUTES.

We have had several clients who have had to close down their businesses all day to try to accommodate the demands of the agents performing their “routine inspection.”  The DEA should not cause you to shut down or should not cause you to turn away patients.  It should not interfere with your patient services or your ability to provide them.  You can ask them to come back at a later date.

The DEA often refers to “routine audits” as “Accountability Investigations” and requires the pharmacy or registrant to be given certain rights in connection with it. For example, DEA Form 82 states you are given the following rights:

1.    The constitutional right not to have an administrative inspection without an Administrative Inspection Warrant (AIW),
2.    Has the right to refuse consent to such an inspection,
3.    Presented with a Notice of Inspection,
4.    Given consent voluntarily, without threats of any kind,
5.    May withdraw consent at any time during the course of the inspection, and
6.    Incriminating evidence may be seized and used in criminal prosecution.

Although the DEA agent may tell you that the site visit is “completely random,” do not believe it.  If the DEA agent has brought a list of records to obtain from you, try to keep a copy of it, as your lawyer may find it very useful later when they are defending you.


What to Do When Confronted with a DEA Inspection or Site Visit.

1.    Notify the owner right away.  If you are not the owner, don’t sign anything, give permission, or agree to anything. You probably have no authority to do so.

2.    Call your health lawyer and get them over immediately.  This is an emergency!

3.    Yes, you have the right to consult with your attorney;  do not believe them if they say you can’t (which they may do, believe it or not).

4.    Request photo identification from everyone to ensure the individuals are who they say they are.  No identification? No access. Federal agents, including DEA agents, will always have their photo ID.

5.    Obtain a business card from each person present.  DEA agents always carry business cards.  If they do not have one, you will have to write all contact information for that agent from their photo id card (or photocopy, if they will allow you to do so).

6.    Do the same as the above for anyone else the DEA brings, whether they claim to be a federal or state investigator, Department of Health investigator, or local police. Please note that our experience has been that the DEA and state agencies contend that they don’t go on joint inspections or investigations (however, we don’t believe this to be true).  Therefore, get all parties’ information at the very start, or you may never get it until they testify against you.

7.    DO NOT SIGN A VOLUNTARY AGREEMENT TO RELINQUISH YOUR DEA REGISTRATION.  Agents may try to pressure and intimidate you into signing one by telling you it will be easier if you sign it. They might even try to scare you by warnings of criminal prosecution unless you sign it.  Yes, you have the right to consult with an attorney before deciding whether or not to sign it (they may falsely tell you that you don’t). However, once you sign it, it is gone.  If you are a prescribing physician or health professional, your authority to prescribe is gone forever.  If you are a pharmacy/pharmacist, your ability to order or fill any controlled substances is forever gone. So go ahead and put a sign on the door that says “CLOSED-Out of Business.”

8.    Before the inspection begins, you should be given a form to read and sign. If not, request it. It will usually be a DEA Form 82 “Notice of Inspection of Controlled Premises” Form. Before the inspection, it should be read, explained, agreed to, and signed, not during or after.

9.    Read the form carefully. You have the right to fax it, scan and e-mail it, or call and read it to your attorney before you sign it. If it says you have the right to refuse the inspection, consider putting it off until a later date. Especially if you are busy and have patients you must serve.

10.    Obtain a copy of the form (inspection form or subpoena) at the beginning and keep it.  You will need this later.

11.    Obtain a complete, detailed receipt for any documents, prescriptions, or other items taken by the agents. Again, since this is not a search warrant, the DEA does not have the authority to take your only originals and leave you without a copy.

12.    You may or may not be in serious trouble and subject to future criminal charges or administrative action to revoke your DEA registration. Your attorney should be able to evaluate this and advise you. Don’t bother to ask the agents, as they will not tell you what is in your own best interest to know.

13.    If you don’t have an attorney who is experienced in health law and DEA defense,  get one NOW.  You should begin preparing now.  It often takes the DEA a year or more to work up charges against you.  Once you are served with charges, you will only have a very short time to prepare your defense.  It is a completely unfair system for the subject of charges as the government will have longer to prepare its case against you than you have to prepare your defense.  Take advantage of the time you have. Do not waste it.

14.    Be polite and do not argue with a DEA agent.

15.    Do not volunteer information, but never tell a lie. Making a false statement to any federal agent is a felony criminal offense. A subpoena for documents is not an authorization to interrogate you.  A search warrant is not an authorization to interrogate you.

Lastly, don’t forget to check back to read part 2 of this blog series.

Please remember: This blog’s statements are opinions based on our experience.  If you do not agree with it, then you are probably the DEA.

Contact Health Law Attorneys Experienced with Investigations of Health Professionals and Providers.

The attorneys of The Health Law Firm provide legal representation to physicians, pharmacists, pharmacies, medical groups, nurses, nurse practitioners, CRNAs, dentists, psychologists and other health providers in Department of Health (DOH) investigations, Drug Enforcement Administration (DEA) investigations, FBI investigations, Medicare investigations, Medicaid investigations and other types of investigations of health professionals and providers.

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

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 or Toll-Free: (888) 331-6620.


Current Open Positions with The Health Law Firm.  The Health Law Firm always seeks qualified individuals interested in health law.  Its main office is in the Orlando, Florida, area.  If you are a current member of The Florida Bar or a qualified professional who is interested, please forward a cover letter and resume to: PAlexander@TheHealthLawFirm.com or fax them to (407) 331-3030.


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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 © 2022 The Health Law Firm. All rights reserved.

2022-11-12T21:34:46-05:00November 28th, 2022|Categories: Pharmacy Law Blog|Tags: , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |0 Comments

Follow These Steps If You Receive an OIG Subpoena from the DOH

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

The U.S. Department of Health and Human Services (HHS) issues investigative subpoenas through the Office of the Inspector General (OIG). This agency investigates allegations of fraud, waste, and abuse against Medicare, Medicaid, and other federally funded healthcare programs. These subpoenas are very broad, usually requiring the production of thousands of pages of documents. Click here to see a sample of a subpoena duces tecum issued by the OIG.

Immediate Action to Take If the OIG Issues a Subpoena.

Immediately review the subpoena in detail to see what it requests and from whom. A subpoena may be issued to or served on the wrong person or organization. If so, have your attorney contact the issuer and attempt to resolve the matter. Document everything in writing. Whatever you do, do not ignore it.

A review of the requested documents will give you and your experienced healthcare attorney an idea of what type of case is being investigated by the OIG. That is one reason that it is important to immediately retain the services of a healthcare attorney experienced in responding to such subpoenas and dealing with the OIG’s Office and the U.S. Attorney’s Office.

Many Different Scenarios Can Lead to Investigations and Subpoenas.

If someone has filed a False Claims Act (FCA) complaint or lawsuit, also known as a whistleblower or qui tam suit, this may be why the OIG is investigating. Suspicion of violating Medicare and Medicaid participation rules, including the Conditions of Participation or the Conditions for Payment (Federal Regulations), can also lead to investigations and subpoenas. If you have committed violations of program requirements such that the government can seek Civil Monetary Penalties, this may give rise to such investigation. If you are suspected of Medicare fraud, including upcoding or billing for medically unnecessary supplies or services, this may lead to an investigation. A patient complaint about not receiving services or equipment billed to Medicare is a surefire way to investigate. Regardless, the matter is serious, so you should retain experienced health care counsel.

Follow These Helpful Steps to Ease the Process:

1. Immediately review the subpoena to ensure you know the expected delivery date of the requested documents. Be sure to respond in writing via a reliable courier or another method of tracking your sending of the documents and their receipt.

2. Immediately retain the services of an experienced healthcare attorney to start dealing with the OIG or the U.S. Attorney’s Office involved in the case.

3. Immediately start assembling the requested documents in the subpoena so they may be reviewed by your attorney before they are organized, labeled, numbered, and produced. This will take longer than you think.

4. Request an extension of time to respond, if needed, before the due date for the production of the documents. These are routinely given, especially for large document productions. Document the extension of time in writing.

5. Completely read the instructions given in the subpoena regarding how documents produced are to be organized, page-numbered, labeled, copied, and delivered. It is essential to produce them this way.

6. If documents are archived, in storage, require the reinstallation of old software to reproduce, or otherwise will take a long time to produce, you may request a “rolling production.” This is an agreement to produce the documents as you obtain them.

7. In reviewing the documents, attempt to determine precisely what the OIG and U.S. Attorney may be investigating. This will afford you time to begin preparation for your defense and will allow you to request a modification of what it is necessary to produce in many instances.

8. It is preferable for you not to personally communicate with OIG special agents, FBI agents, other investigators, or attorneys working for the OIG or U.S. Attorney’s Office. Anything you say to them, orally or in writing, can be used against you in the case. Also, any incorrect or false information you provide, orally or in writing, can result in a felony charge under 18 U.S.C. Sect. 1001. Have your attorney do all communication.

9. Remember, you do not have to produce any documents in your custody. Likewise, you do not have to create documents to produce.

10. Never alter, destroy, or create documents for which the subpoena is issued after you have received the subpoena. Consider all documents to be “frozen” in time. Also, immediately notify whoever is in charge of your document retention or document destruction program (if you have one) to ensure no further documents are destroyed or deleted.

11. If you do not have a document destruction program for obsolete documents as you read this, you need to create one (subject to number 10 immediately above). Make sure it addresses e-mails, electronically stored documents, and paper copies. Do not keep any documents for longer than you are required to keep them by law (including Federal Regulations).

12. Provide an explanation for any documents or categories of records that you should have but were destroyed by natural disasters, fires, etc. Include documentation (fire department, police report, insurance company appraisal, etc.) that shows this. Do not ever lie or exaggerate it.

For additional information, read one of our recent blogs on preparing for a healthcare audit request.

Contact Health Law Attorneys Experienced in Handling Medicaid and Medicare Audits.

The Health Law Firm’s attorneys routinely represent physicians, medical groups, clinics, pharmacies, durable medical equipment (DME) suppliers, home health agencies, nursing homes, and other healthcare providers in Medicaid and Medicare investigations, audits, and recovery actions.

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.

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 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 © 2022 The Health Law Firm. All rights reserved.

Florida Pharmacy Owner Pleads Guilty For Role in $8.3 Million Medicare Fraud Scheme

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

On September 27, 2022, a Florida pharmacy owner pled guilty to conspiring to commit healthcare fraud in an $8.3 million scheme. The scheme involved securing orders for medically unnecessary prescriptions billed to Medicare and paying bribes and kickbacks, the Department of Justice (DOJ) announced. Read the DOJ’s press release here. Read the DOJ’s press release here.

The Fraudulent Scheme.

Michael Murphy allegedly invested in Cure Pharmacy in Jacksonville, Florida, and two other pharmacies participated in the Medicare program. From around November 2019 through March 2021, the government alleged, Murphy and his co-conspirators paid kickbacks and bribes to telemarketing companies to recruit Medicare beneficiaries to accept prescriptions for various medications. According to court documents, the medicines were mainly topical creams, which the beneficiaries usually did not want or need.

Additionally, they paid kickbacks and bribes to telemedicine companies that employed or contracted with physicians who signed the prescriptions. According to court documents, the physicians typically signed the prescriptions after a cursory telephone conversation or without contact with beneficiaries. After obtaining Medicare beneficiary information and the signed medications, the pharmacy owner and co-conspirators submitted claims to Medicare, sometimes through multiple pharmacies they owned and controlled in practice known as “recycling.”
In total, they were reimbursed $8.3 million by Medicare Part D.

The Repercussions of the Guilty Plea to Conspiracy to Commit Health Care Fraud.

Murphy pleaded guilty to one count of conspiracy to commit healthcare fraud. He faces a maximum of 10 years in prison. According to the DOJ, a federal district court judge will determine his actual sentence after considering the U.S. Sentencing Guidelines and other statutory factors.

Click here to read about a similar case involving a Florida pharmacy owner.

Contact Health Law Attorneys Experienced in Representing Pharmacies and Pharmacists.

The Health Law Firm represents pharmacists and pharmacies in DEA, DOH, and FDA investigations, qui tam and whistleblower cases, regulatory matters, licensing issues, litigation, administrative hearings, inspections, and audits. 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, call (407) 331-6620 or toll-free (888) 331-6620 and visit our website at www.TheHealthLawFirm.com.

Sources:

American Health Law Association. “Pharmacy Owner Pleads Guilty in $8.3 Million Fraud Scheme.” AHLA Health Law Weekly. (September 30, 2022). Web.

“Pharmacy Owner Pleads Guilty in $8.3 Million Fraud Scheme.” Bloomburg Law. (September 30, 2022). 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.

Attorney Positions with The Health Law Firm. The Health Law Firm is always looking for qualified attorneys interested in the practice of health law. Its main office is in the Orlando, Florida, area. If you are a member of The Florida Bar and are interested, forward a cover letter and your resume to: PAlexander@TheHealthLawFirm.com or fax to: (407) 331-3030.

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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 © 2022 The Health Law Firm. All rights reserved.

Florida Law Aimed at Healthcare Professional Background Screening Passed

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.

Florida Legislation Allows Pharmacy Technicians to Administer Immunizations

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

On July 1, 2022, Florida passed HB 1209, allowing registered pharmacy technicians to administer immunizations to patients. The new law utilizes pharmacy technicians to seek certification to provide immunizations and become “Certified Registered Pharmacy Technicians.” These pharmacy technicians will then be allowed to administer all vaccines listed by the CDC in the Adult Immunization Schedule or recommended by the CDC for international travel. Additionally, it includes vaccines authorized by the FDA under an emergency use authorization or by the Florida Board of Pharmacy in response to a state of emergency declared by the Governor.

This is a big step in medicine, once again broadening the ability of health professionals to provide more efficient and less expensive health care. In the past, properly qualified pharmacists were allowed to administer vaccines, but even then, there was a shortage.

Certification Requirements.

To become certified by the Florida Board of Pharmacy, a registered pharmacy technician must complete six hours of approved immunization-related training. As a renewal condition, an additional two hours of approved continuing education must be completed each cycle, according to the Board of Pharmacy website. For more information, click here.

In comparison, for certification, registered pharmacists must have 20 hours of education to administer vaccines. Registered pharmacist interns (persons with five years of college) who are also under the supervision of a certified pharmacist must take the same 20-hour immunization course that the pharmacists take to become certified to administer immunizations.

While this new Florida law seems to adopt a substantial lessening in training requirements, remember the 20-hour course allows pharmacists to administer vaccines independently. The six-hour course is for pharmacy technicians to administer vaccines under the pharmacist’s supervision. The technician certification program or programs authorized will have to be approved by the Florida Board of Pharmacy in consultation with the Florida Board of Medicine and the Florida Board of Osteopathic Medicine.

Stay Informed and Prepared.

The Board of Pharmacy has the authority to adopt rules to add new vaccines as added by the Centers for Disease Control (CDC) and the Food and Drug Administration (FDA), but it often takes many months to do so. Pharmacies and the pharmacists, pharmacist interns, and pharmacy technicians who are responsible need to monitor these situations closely.

Pharmacies should print a copy of the CDC adult immunization schedule, the CDC’s recommended vaccines for international travel, and the FDA’s list of vaccines with emergency use authorizations and have this readily available for its staff to review. They should also update this list at least once a month. This will help the pharmacy staff keep on top if either of these federal agencies, the CDC or the FDA, changes its list of immunizations. As we’ve seen from the COVID-19 pandemic, keeping track of vaccine schedules and emergency use authorization changes can be very confusing.

Click here to read Florida HB 1209 – Administration of Vaccines, in full.

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

We routinely provide legal representation to pharmacists, pharmacies, and other health professionals who have received complaints against their licenses, notices of investigations, Medicare or Medicaid audits, Drug Enforcement Administration (DEA) audits, investigations, subpoenas, search warrants, and orders to show cause (OSC) or who are facing formal or informal administrative hearings.

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.

Sources:

Dix, Martin. “A Jump Forward For Fla. Pharmacy Technicians’ Vax Authority.” Law360. (August 19, 2022). Web.

Sexton, Christine. “Checking the pulse of Florida health care news and policy.” Florida Politics. (August 16, 2022). Web.

Dix, Martin. “Florida Legislation Authorizing Pharmacy Technicians to Administer Vaccines Contains Some Surprises.” Akerman. (July 28, 2022). 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 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 © 2022 The Health Law Firm. All rights reserved.

 

 

 

 

 

 

2022-09-28T10:23:19-04:00September 28th, 2022|Categories: Pharmacy Law Blog|Tags: , , , , , , , , , , , , , , , , , , , , , , , |0 Comments
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