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.

 

By |2024-04-21T20:00:10-04:00April 23, 2024|Categories: Pharmacy Law Blog|Tags: , , , , , , , , , , , , , , , , , , , , , , , , , |Comments Off on Texas Hospital’s COVID-19 Vaccine Mandate Upheld by Federal Court
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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: [email protected] 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.

By |2024-04-17T20:00:37-04:00April 19, 2024|Categories: Pharmacy Law Blog|Tags: , , , , , , , , , , , , , , , , , , , , , , , , , , , |Comments Off on Walgreens Accused of Providing Insufficient COBRA Notices, Class Action Lawsuit Says
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Florida Man Agrees to Plead Guilty in $110 Million Telemedicine Medicare Fraud Scheme

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

On February 16, 2024, a Parkland, Florida, man agreed to plead guilty to organizing a Medicare fraud scheme worth $110 million. The federal prosecution is taking place in the U.S. District Court for the District of Massachusetts. The fraud was allegedly perpetrated through two Florida companies the man owned, Expansion Media, LLC, and Hybrid Management Group, LLC. According to federal prosecutors in Boston, the scheme involved utilizing telemedicine and telemarketing enterprises to create fabricated orders for medical equipment, particularly knee braces. The scheme allegedly lasted from March 2016 to January 2023.

Specifics on this Medicare Fraud Scheme.

The Florida businessman and owner of Expansion Media, LLC, and Hybrid Management Group, LLC, allegedly sold medically unnecessary Durable Medical Equipment (D.M.E.) to medical staffing companies. According to the government, he used telemedicine and telemarketing companies to create false leads. The telemarketers would pay the Florida man’s companies to generate orders for the medical groups that signed off on them, even though they had no contact with any of the Medicare beneficiaries. The medical devices ordered resulted in $110 million in fraudulent claims, of which Medicare paid $52.5 million.

Prosecutors say the Florida man took many steps to conceal the scheme, including changing his business names, creating fictitious e-mails tied to those companies, and using third-party pass-through payment options.

The Florida man was ordered by the court to pay back $15.7 million and a laundry list of expensive jewelry purchases, such as multiple Patek Philippe watches and Tiffany & Co. jewelry. He agreed to plead guilty, and his deal includes a ten-year prison sentence with supervised releases for three years and fines up to $250,000.

No mention was made about what happened to the Patek Phillippe watches or the Tiffany jewelry, but I have asked the FBI to keep me advised. I have an anniversary coming up.

To view the press release from the U.S. Attorney’s Office, District of Massachusetts, click here.

Florida Man: Joyfully Spreading Florida’s Crime All Over the Place

This blog relates one of my biggest pet peeves. That scurrilous, underhanded Florida Man. Now he has spread his disease of fraud and theft all the way up to the beautiful city of Boston. Why don’t they finally lock him up once and for all?

Is Florida really going to make Florida Man the official state bird, replacing the beautiful Northern Mockingbird? Maybe that’s what he was doing up north in Massachusetts, mocking them.

This case also points out Florida’s reputation as a state which shelters and promotes the use of shell corporations and limited liability companies used to defraud the public and its protection of conmen and fraudsters.

Don’t Wait Until It’s Too Late; Consult with a Health Law Attorney Experienced in Medicare and Health care Fraud Issues Now.

The attorneys of The Health Law Firm represent physicians, pharmacists, durable medical equipment (DME) suppliers, and other health care providers in Medicare audits, investigations and subpoenas, Medicaid audits and subpoenas, Medicare and Medicaid investigations, Department of Health (DOH) subpoenas and investigations, Department of Health and Human Services (DHHS), Office of Inspector General (OIG) and Centers for Medicare and Medicaid Services (CMS) subpoenas and investigations, and Medicaid Fraud Control Unit (MFCU) subpoenas, audits and investigations, in Florida, Colorado, Louisiana, the District of Columbia, Virginia, and across the U.S. They also represent healthcare providers in actions to terminate billing privileges, termination from the Medicare or Medicaid programs, and state and federal administrative hearings and litigation.

For more information please visit our website at www.TheHealthLawFirm.com or call (407) 331-6620 or toll-free (888) 331-6620.

Sources:

DOM. (February 16, 2024). Owner of telemedicine companies charged with $110 million medicare fraud scheme. United States Attorney’s Office. Retrieved from https://www.justice.gov/usao-ma/pr/owner-telemedicine-companies-charged-110-million-medicare-fraud-scheme#:~:text=BOSTON%20%E2%80%93%20The%20owner%20of%20Expansion,as%20back%20and%20knee%20braces.

Dowling, B. (February 16, 2024). Telemedicine exec admits $110 Medicare fraud scheme. Law360. Retrieved from https://www.law360.com/articles/1803737/telemedicine-exec-admits-110m-medicare-fraud-scheme

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 Avenue, 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: [email protected] or fax 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 © 2024 George F. Indest III, The Health Law Firm. All rights reserved. No part of this work may be reproduced in any way in any medium without the written permission of the copyright owner. The author of this work reserves the right to have his name associated with any use or publication of this work or any part of it.

By |2024-03-14T09:59:08-04:00April 15, 2024|Categories: Pharmacy Law Blog|Tags: , , , , , , , , , , , , , , , , , , , , , |Comments Off on Florida Man Agrees to Plead Guilty in $110 Million Telemedicine Medicare Fraud Scheme
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Medicare Final Rule Decreased Physician Payments But Expands Coverage to Counselors

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

On November 2, 2023, the Centers for Medicare and Medicaid Services (CMS) issued a final rule that decreased overall payment rates for services provided under the Physician Fee Schedule (PFS). However, the final rule increased payment rates for outpatient services and expanded telehealth services. The rule went into effect January 1, 2024.

Physician Fee Schedule Rate Reductions; Counselors Added.

The overall payment rates under the 2024 PFS were reduced by 1.25 percent for 2024. The conversion factor is $32.74, which is a $1.15 decrease from 2023. Physicians’ Medicare reimbursements will fall by 3.4 percent under the PFS in 2024.

However, in a piece of good news, the 2024 final rule allows marriage and family therapists and mental health counselors, including addiction counselors, to enroll in Medicare and bill the program, for the first time ever.

Telehealth Expansions.

The PFS 2024 final rule expanded telemedicine and established that telehealth providers will be paid the non-facility rate for telehealth services. Under the rule, CMS will temporarily add health and well-being coaching services to the Medicare Telehealth Services List in 2024. Social Determinants of Health Risk Assessments will also be permanently added to the Telehealth Services List. The final rule also expanded the types of telehealth practitioners to include occupational therapists, physical therapists, speech-language pathologists, and audiologists.

The final rule allows all diabetes self-management training services via telehealth. It also enables teaching physicians to be present using telecommunications when a resident furnishes telehealth services.

Finally, the rule established that rural health clinics and federally qualified health centers will continue receiving payment for telehealth services.

Outpatient Program Payment Increases.

CMS increased Medicare payments for hospital outpatient departments and ambulatory surgical centers by 3.1 percent for 2024. Stipulations in the Outpatient Prospective Payment Program final rule require hospitals to display standard charge information that conforms to a CMS template. Hospitals have been required to post the prices of services online since 2021, but compliance could be better.

Consult with a Health Law Attorney Experienced in Medicare and Medicaid Issues Now.

The lawyers of The Health Law Firm routinely represent physicians, medical groups, clinics, pharmacies, durable medical equipment (DME) suppliers, home health agencies, nursing homes and other healthcare providers in Medicare and Medicaid investigations, audits and recovery actions. They also represent them in preparing and submitting corrective action plans (CAPs), requests for reconsideration, and appeal hearings, including Medicare administrative hearings before an administrative law judge. Attorneys of The Health Law Firm represent health providers in actions initiated by the Medicaid Fraud Control Units (MFCUs), in False Claims Act cases, in actions initiated by the state to exclude or terminate from the Medicaid Program or by the HHS OIG to exclude from the Medicare Program.

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:

“Calendar Year (CY) 2024 Medicare Physician Fee Schedule Final Rule.” CMS.gov Newsroom. (2 November 2023) https://www.cms.gov/newsroom/fact-sheets/calendar-year-cy-2024-medicare-physician-fee-schedule-final-rule

“CY 2024 Medicare Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System Final Rule (CMS 1786-FC).” CMS.gov Newsroom. (2 November 2023) https://www.cms.gov/newsroom/fact-sheets/cy-2024-medicare-hospital-outpatient-prospective-payment-system-and-ambulatory-surgical-center-0

“CMS issues CY 2024 physician fee schedule final rule.” American Hospital Association. (2 November 2023) https://www.aha.org/news/headline/2023-11-02-cms-issues-cy-2024-physician-fee-schedule-final-rule

“CMS Issues Physician Fee Schedule Final Rule with Payment Rate Cut.” American Health Law Association Health Law Weekly. (3 November 2023) https://www.americanhealthlaw.org/content-library/health-law-weekly/article/e144866d-b571-4b10-98d0-530c46f3f5e7/CMS-Issues-Physician-Fee-Schedule-Proposed-Rule-wi?Token=fe443b47-6081-4bae-bc4a-936ffe203608

HHS Press Office. “CMS Finalizes Physician Payment Rules that Advances Health Equity.” United States Department of Health and Human Services. (2 November 2023) https://www.hhs.gov/about/news/2023/11/02/cms-finalizes-physician-payment-rule-advances-health-equity.html

“Medicare Payments for Hospital Outpatient Services to Increase 3.1% in 2024.” American Health Law Association Health Law Weekly. (3 November 2023) https://www.americanhealthlaw.org/content-library/health-law-weekly/article/dcc44d7b-c122-49fd-9e5a-9918549f2c44/Medicare-Payments-for-Hospital-Outpatient-Services

Pifer, Rebecca. “CMS finalizes 2024 Medicare hospital, doctor payments, 340B fix and price transparency requirements.” Healthcare Dive. (3 November 2023) https://www.healthcaredive.com/news/cms-medicare-hospital-doctor-rates-2024-340b-transparency/698706/

Vaidya, Anuja. “New PFS Rule Includes Telehealth Payment, Address Reporting Wins.” mHealth Intelligence Healthcare Media. (3 November 2023) https://mhealthintelligence.com/news/new-pfs-rule-includes-telehealth-payment-address-reporting-wins

About the Authors: 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.

Hartley Brooks is a law clerk with The Health Law Firm.

The Health Law Firm’s main office is in the Orlando, Florida area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Avenue, 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: [email protected] 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 © 2024 George F. Indest III, The Health Law Firm. All rights reserved. No part of this work may be reproduced by anyone in any medium without the author’s express written permission. The author reserves the right to have his name associated with this work at all times.

By |2024-03-14T09:59:08-04:00April 15, 2024|Categories: Pharmacy Law Blog|Tags: , , , , , , , , , , , , , , , , , , , , , |Comments Off on Medicare Final Rule Decreased Physician Payments But Expands Coverage to Counselors
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Florida Pharmacy Sues Claiming HHS Wrongly Terminated it from Federal PrEP Program

Attorney and Author 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 March 25, 2024, a pharmacy in Celebration, Florida, alleged HHS abruptly terminated it from a federal program that provides free access to preexposure prophylaxis HIV-prevention (PrEP) medication. Turner Brothers Inc., which does business as Turner Drugs, filed a motion in its lawsuit in the U.S. District Court for the District of Columbia for a temporary restraining order and preliminary injunction.  In the motion, Turner Drugs asked a D.C. federal judge to force the U.S. Department of Health and Human Services (HHS) and two contractors to reinstate it to the program. To view the motion, click here.
The pharmacy says it is owed $3.1 million for nearly 1,500 already-approved prescriptions, but the payments have been withheld following its termination. The lawsuit accuses HHS, Mercalis Inc., and Pharmacy Data Management Inc. (PDMI) of breaching a contractual obligation to give participating pharmacies 40 days to fix any alleged breach before terminating them.  Additionally, the suit contends the allegedly overdue payments constitute a breach of contract.
The “Ready, Set, PrEP” Program. 
Turner Drugs, in Celebration, Florida, is a pharmacy providing services to underprivileged patients that need access to free medications, including HIV medication.  Turner Drugs was contracted with a Florida nonprofit, Advanced Health Access Inc., and Continuous Care LLC to operate free medical clinics.  The pharmacy alleges in the motion that it was suddenly terminated from the “Ready, Set, PrEP” program on March 12, 2024. The national program provides people without prescription drug coverage access to HIV-prevention medication as part of an HHS initiative to end the HIV epidemic in the United States.
Details of the Lawsuit.
Even though Turner Drugs claims it has diligently complied with its contractual terms, on March 12, 2024, it was suddenly terminated from the program without warning or written notification. The pharmacy claims it first learned of the termination because its requests for PrEP prescription approvals were denied based on their “nonparticipation” in the program, much to its surprise!
The pharmacy later learned from an attorney at PDMI that it had been “blocked due to suspicious activity” and would be audited at a later date. The alleged suspicious activity was possibly due to Turner Drugs being acquired by Advancing Health as its in-house pharmacy.  The pharmacy said this resulted in an uptick in Ready, Set, PrEP prescriptions.
“Turner Drugs [claims it] attempted to negotiate an amicable resolution by responding to an audit of prescriptions in only one day, offering to make all its records and procedures available to defendants for inspection, and to cooperate with defendants in any other manner they might request,” the complaint states. When the defendants made no attempt to explain the alleged “suspicious activities” and no resolution could be reached, Turner Drugs claims it had “little choice but to prepare” the lawsuit and the motion and file them.
To view the complaint in this case, click here.
For more information on the “ready, Set, prEP” program, click here. 
Consult With A Health Law Attorney Experienced in the Representation of Pharmacists and Pharmacies.
The attorneys of The Health Law Firm routinely provide legal representation to pharmacists, pharmacies, physicians, medical clinics, and other health providers 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 complex healthcare litigation in both state court and federal court, and in both formal and informal administrative hearings, and represent pharmacists, physicians, physician assistants, nurse practitioners, and other health professionals in investigations and at Board of Pharmacy, Board of Medicine and Board of Nursing hearings. 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:
Florida Health. “PrEP/PEP Program.” The Florida Department of Health. (August 15, 2024). https://www.floridahealth.gov/diseases-and-conditions/aids/PrEP/index.html
U.S. Department of Health and Human Services. “Ready, Set, PrEP: Find Out If You Qualify to Enroll for Free PrEP Medications.”  https://readysetprep.hiv.gov/#how-to-enroll
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 Avenue 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: [email protected] 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 © 2024 George F. Indest III, The Health Law Firm. All rights reserved. No part of this work may be reproduced in any way in any medium without the written permission of the copyright owner. The author of this work reserves the right to have his name associated with any use or publication of this work or any part of it.
By |2024-04-09T13:21:22-04:00April 9, 2024|Categories: Pharmacy Law Blog|Tags: , , , , , , , , , , , , , , , , , , , , , , , , , , , , |Comments Off on Florida Pharmacy Sues Claiming HHS Wrongly Terminated it from Federal PrEP Program
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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: [email protected] 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.

By |2024-03-20T20:01:55-04:00March 22, 2024|Categories: Pharmacy Law Blog|Tags: , , , , , , , , , , , , , , , , , , , , |Comments Off on Walgreens Accused of Providing Insufficient COBRA Notices, Class Action Says
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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: [email protected] 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.

By |2024-03-14T09:59:11-04:00March 2, 2024|Categories: Pharmacy Law Blog|Tags: , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |Comments Off on Is the DEA Knocking on Your Door? What You Need to Know Right Now!
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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: [email protected] 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.

By |2024-03-14T09:59:11-04:00February 23, 2024|Categories: Pharmacy Law Blog|Tags: , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |Comments Off on Centene Will Pay $19 Million to Washington State For Medicaid Fraud Allegations
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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: [email protected] 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.

By |2024-03-14T09:59:11-04:00February 22, 2024|Categories: Pharmacy Law Blog|Tags: , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |Comments Off on When the DEA Comes Knocking: 15 Tips For a “Routine” DEA Inspection
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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.

By |2024-03-14T09:59:13-04:00January 22, 2024|Categories: Pharmacy Law Blog|Tags: , , , , , , , , , , , , , , , , , , , |Comments Off on Follow These Steps If You Receive an OIG Subpoena from the DOH
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“The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A.
The Health Law Firm, a Florida professional service corporation, since 1999.
Copyright © 2022 The Health Law Firm. All rights reserved.
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