First COVID-19 Breathalyzer Test Authorized By FDA

Author Headshot

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

On April 14, 2022, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization for the first Covid-19 diagnostic test that uses breath samples. The test, made by Texas-based company, InspectIR Systems, is authorized for those patients 18 and older.

InspectIR expects to produce approximately 100 testing instruments per week, which can each be used to evaluate approximately 160 samples per day. At this level of production, testing capacity using the InspectIR COVID-19 Breathalyzer is expected to increase by about 64,000 samples per month, according to the FDA’s statement.

The Testing Requirements.

The test can only be performed in environments where the patient’s specimen is collected and analyzed, such as doctor’s offices, hospitals, and mobile testing sites.

Additionally, the test must be performed by a qualified, trained operator under the supervision of a licensed health care provider or authorized by state law to prescribe tests. The test detects chemicals associated with the virus that causes the disease in a breath sample in less than three minutes. If it’s positive, it should be followed up by a molecular test, the agency said in a statement.

“Today’s authorization is yet another example of the rapid innovation occurring with diagnostic tests for Covid-19,” Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said.

Read the FDA’s press release and get even more information.

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

At the Health Law Firm, we provide legal services for all health care providers and professionals. This includes physicians, nurses, dentists, psychologists, psychiatrists, mental health counselors, home health agencies, hospitals, ambulatory surgical centers, pain management clinics, nursing homes, and any other healthcare provider. It also includes medical students, resident physicians, and fellows, as well as medical school professors and clinical staff. We represent health facilities, individuals, groups, and institutions in contracts, sales, mergers, and acquisitions. The lawyers of The Health Law Firm are experienced in complex litigation and both formal and informal administrative hearings. We also represent physicians accused of wrongdoing, patient complaints, and in Department of Health investigations.

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

Sources:

Helsel, Phil. “FDA authorizes first Covid-19 breath test.” NBC News. (April 14, 2022). Web.

Muller, Madison. “Breathalyzer Test for Covid-19 Wins Approval From FDA.” Bloomberg. (April 14, 2022). Web.

Mckinney, Jim. “Coronavirus (COVID-19) Update: FDA Authorizes First COVID-19 Diagnostic Test Using Breath Samples.” U.S. Food and Drug Administration. (April 14, 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 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.

“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.

 

COVID Uninsured Provider Relief Fund Expected To Run Out of Money Soon If Congress Doesn’t Act

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

In 2020, the U.S. Department of Health and Human Services (HHS) created the “Provider Relief Fund” (PRF) to help support healthcare providers in the battle against the COVID-19 pandemic. The federal program has served as a lifeline to frontline healthcare workers who’ve experienced revenue losses and increased demand for their services during the pandemic.

To date, it has allocated more than $178 billion in payments to over 410,000 providers across the United States. Click here to learn more.

COVID-19 Uninsured Relief Fund.

Let’s start with some good news: Under the COVID-19 relief funding, HHS created the “uninsured relief fund.” This program provides claims reimbursement to health care providers for testing, treating, diagnosis, and administering vaccines to uninsured individuals for COVID-19. It has paid out more than $17 billion throughout the pandemic. It has paid out more than $17 billion throughout the pandemic.

Of the $17 billion, HHS has distributed nearly $10 billion for testing, more than $6 billion reimbursed for treatment, and the remainder covered vaccinations. Read more on the statistics here.

Running Out of Money.

Now for the bad news: According to an HHS spokesperson, there’s only $7.6 billion left, and the money will run out in the coming months. Congress isn’t currently considering making more funding available, meaning providers and patients are likely to have soon to bear the costs themselves.

Therefore, many hospitals and healthcare organizations urge Congress to replenish the PRF. “One of the most helpful and patient-oriented uses of the PRF was to help those people who for whatever reasons are uninsured and suffer from COVID-19,” said Federation of American Hospitals CEO Chip Kahn. “It meant that no one should have any reluctance to go to the hospital if they have COVID but no insurance.”

Additionally, on February 9, 2022, the American Hospital Association released a statement urging readers to contact lawmakers to get Congress to provide another $25 billion for the PRF in the government funding package. Read the AHA’s action alert here.

As we approach nearly two years since HHS declared COVID-19 a national public health emergency, PRF has been a lifeline to hospitals, health systems, and medical professionals. It has been helping to keep doors open during the pandemic to continue providing essential care to patients and communities. However, if the program runs out of money and Congress doesn’t appropriate more, hospitals could be left footing the bill, which will hurt both providers and patients in the end.

Read one of my previous blogs on a similar case regarding a Florida Dentist’s COVID-19 Business Interruption Insurance Claim to learn even more.

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

At the Health Law Firm, we provide legal services for all health care providers and professionals. This includes physicians, nurses, dentists, psychologists, psychiatrists, mental health counselors, home health agencies, hospitals, ambulatory surgical centers, pain management clinics, nursing homes, and any other healthcare provider. It also includes medical students, resident physicians, and fellows, as well as medical school professors and clinical staff. We represent health facilities, individuals, groups, and institutions in contracts, sales, mergers, and acquisitions. The lawyers of The Health Law Firm are experienced in complex litigation and both formal and informal administrative hearings. We also represent physicians accused of wrongdoing, patient complaints, and in Department of Health investigations.

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

Sources:

Hellmann, Jessie. “HHS running out of money to pay providers for treating uninsured COVID-19 patients.” Modern Healthcare. (February 8, 2022). Web.

HRSA. “Covid Uninsured Claim.” Health Resources & Services Administration. (February 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 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.

Psychiatric Practice to Pay $310,000 in FCA Settlement for Employing Doctor on OIG Exclusion List

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

On February 23, 2022, a psychiatric practice and its owner agreed to pay $310,874 to resolve allegations they improperly hired and employed a physician who was excluded from federal healthcare programs. The physician who was hired was on the OIG’s exclusion list, the “List of Excluded Individuals and Entities” (LEIE). As a result, the government took the position that claims for services the physician provided filed against government programs were illegal pursuant to the false Claims Act (FCA). Details were disclosed in a Press Release by the U.S. Attorney for the District of Connecticut.

Geriatric & Adult Psychiatry, LLC (GAP), along with the owner, entered into a civil settlement agreement to resolve their liability under the federal and state False Claims Acts, the U.S. Department of Justice (DOJ) said in a press release.

Past Conviction Overlooked.

In 2006, the physician had been convicted in the Southern District of Florida of conspiracy to commit healthcare fraud. Because of his conviction, the Office of the Inspector General (OIG) excluded him from all federal healthcare programs. Such an exclusion includes Medicare, Medicaid, Tricare, Veterans Administration (V.A.), and Indian Health Service (I.H.S.) programs.

When the OIG excludes an individual or entity from federal health care programs, no payments may be made for items or services furnished by that excluded individual. Additionally, the law prohibits any person or organization that receives such funds from employing or contracting with a person on the LEIE, in any way. To avoid potential liability, it advised that health care providers check the List of Excluded Individuals/Entities (LEIE) on the OIG website: http://oig.hhs.gov/exclusions.

In addition, the OIG has issued a Special Advisory Bulletin to providers who might employ or contract with an excluded individual or entity to provide guidance. To review this OIG Bulletin, click here.

For more helpful information, click here.

Despite this, to medical group hired the former physician as the clinical director in 2016 where he served in that position until 2021. During that time, both the practice and its owner billed and sought reimbursements from Medicare, Medicaid, TRICARE, and the Railroad Retirement Medicare Program. Additionally, GAP’s reimbursements were used to pay the physician’s salary and benefits.

Payment Prohibition & Civil Monetary Penalties (CMPs).

Health care providers receiving funds from federal health care programs must check to see if potential employees and contractors are excluded by searching the LEIE to ensure that person is not listed. Providers have mistakenly assumed that exclusion does not apply to an individual or entity that provides services that extend beyond direct patient care; this is wrong. Payment prohibition extends to anyone who chooses to employ or contract with an excluded individual or entity in any capacity. Providers who violate this prohibition are required to pay back all federal health care program funds inappropriately received and may also be subject to civil monetary penalties (CMPs) and action under the False Claims Act (FCA).

Furthermore, payment of an excluded individual’s salary, benefits, or expenses, directly linked to federal health care program funds is expressly prohibited. Click here to read my prior blog and learn more about this.

Little Known Fact: You Must Actively Apply to Get Taken Off the LEIE.

A little-known fact, often overlooked, is that a person or entity on the LEIE must actually apply to be removed from it, no matter how short the period of exclusion. Thus if a person is excluded and placed on the LEIE for only two years, they must apply to the OIG after that period of time, completing its detailed, notarized application, and be removed from the list. Removal is not automatic.

Contact Health Law Attorneys Experienced in Defending Against Action to Exclude an Individual or Business from the Medicare Program and Assisting in Reinstatement Applications.

The attorneys of The Health Law Firm have experience in dealing with the Office of the Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS), and defending against action to exclude an individual or business entity from the Medicare Program, in administrative hearings on this type of action, in submitting applications requesting reinstatement to the Medicare Program after exclusion, and removal from the List of Excluded Individuals and Entities (LEIE).

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:

Yankowski, Peter. “Officials: Hamden psychiatric practice to pay $310,000 settlement over employee who lost medical license.” Stamford Advocate. (February 23, 2022). Web.

Health Law Weekly. “Psychiatric Practice, Owner Pay $310K for Employing “Excluded” Individual.”American Health Law Association (AHLA). (February 25, 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 Avenue, Suite 1000, Altamonte Springs, FL 32714; Phone: (407) 331-6620; Toll-Free: (888) 331-6620.

 

“The Health Law Firm” is a registered fictitious business name of and a registered service mark of The Health Law Firm, P.A., a Florida professional service corporation, since 1999.
Copyright © 2022. The Health Law Firm. All rights reserved.

 

 

2022-03-22T18:28:42-04:00April 13th, 2022|Categories: Pharmacy Law Blog|Tags: , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |0 Comments

CMS Using Medicare Termination to Squash Doctors Involved in Overprescribing Opioids

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

Recently it has come to our attention that there may be a nationwide effort by the Centers for Medicare and Medicaid Services (CMS) Medicare Administrative Contractors (MACs) to squelch physicians who prescribe opioids and other narcotic medications. We have seen letters sent out by CMS MACs to physicians notifying them that their Medicare program billing privileges have been terminated because CMS has identified them as a provider who is overprescribing.


Nationwide Effort to Run “Pill Mills” Out of Business.

We are well aware of efforts by the various law enforcement authorities at the state and federal level to prosecute and put out of business physicians identified as “pill mills” and the pharmacies that fill their prescriptions.  These include surprise audits and inspections, followed by administrative actions or criminal prosecutions, by the Drug Enforcement Administration (DEA), the state Attorney General’s Office, the Department of Health, statewide task forces, and local sheriff’s offices and police departments.

However, this new heavy-handed tactic hits physicians in the pocketbook. It takes advantage of an arcanely-complex system of administrative appeals that is heavily weighted in favor of the government.

If You Receive a Letter from CMS Regarding Termination of Your Medicare Billing Privileges, Act Immediately.

Do not hesitate or wait if you receive a letter notifying you that CMS is terminating your billing privileges. You must get an experienced health care attorney to represent you right away and appeal the decision through a “request for reconsideration.”  You must also ask that the termination not go into effect while the appeal is pending and provide reasons why it should not.  Often you only have a few days to do this.

In Truth, There May Be No Oversprescribing.

In one recent case, we represented a physician who received such a letter stating she was terminated from Medicare. She was not a pain management physician, and she had over 2,000 patients. She only prescribed a handful (literally, less than ten) of these patients opioids, but the medical necessity was present and well-documented. However, because Medicare was aware of the prescriptions, it terminated her because it was paying for them.

Consequences of a Medicare Privileges Termination.

There are many, many seriously adverse consequences of a termination of Medicare privileges. Often we refer to this as a “death sentence.” It could be the death of your medical practice and possibly your medical career.

Consequences include:

1.    A waiting period of ten (10) years before you can even reapply.

2.    Placement on the OIG’s List of Excluded Individuals and Entities (LEIE).

3.    Having to notify hospitals and other health facilities where you are on the staff so that your medical staff privileges can be terminated.

4.    Being terminated from your state’s Medicaid Program.

5.    Being placed on the exclusion list for all federal contracts and contractors.

6.    Being terminated from the provider panels of all health insurers.

7.    Being excluded from any job or any position, including contractor or subcontractor for any organization that receives and government funding.

8.    Possible loss of medical license or non-renewal of medical license because of #1, #2 and #4 above (in most states).

 

Act Fast; Don’t Delay!

Act fast if you receive such a letter. Do not delay.  Retain the services of a health lawyer experienced in Medicare appeals and federal administrative hearings.

Don’t Wait Too Late; 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.

Call now at (407) 331-6620 or Toll-Free (888) 331-6620 or visit our website 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 Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave. Suite 1000, Altamonte Springs, FL 32714, Phone: (407) 331-6620 Toll-Free: (888) 331-6620.

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“The Health Law Firm” is a registered fictitious business name of and a registered service mark of The Health Law Firm, P.A., a Florida professional service corporation, since 1999.
Copyright © 2022 The Health Law Firm. All rights reserved.

2022-02-11T10:37:09-05:00February 11th, 2022|Categories: Pharmacy Law Blog|0 Comments

Court Rules NY Doctor Can Subpoena Yelp for User Info in Defamation Suit

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

On October 7, 2021, the United States District Court for the Southern District of New York ruled that Yelp is subject to a subpoena to reveal the names of anonymous users who left negative reviews for a doctor and his medical practice. The federal court judge found that the statements in the reviews made on Yelp contained factual claims that the doctor did have a legal right to contest in court. This is a factor that is usually missing in such cases. Accordingly, a motion for expedited discovery filed by the plaintiff physician was granted by the federal judge.

A Litigious History of Lawsuits.

The embattled physician has reportedly filed other lawsuits against reviewers for defamation. The doctor himself says he’s won or reached settlements with three of the negative reviewers, forcing them to take down their “false” reviews and paying an undisclosed amount of money.

Most recently, the physician filed suit in November 2020 against nine anonymous Yelp account-holders. According to the complaint, from November 2019 to August 2020, the users posted several reviews that contained statements that harmed his practice by making untrue and libelous comments.

In the present case we are discussing filed against the Yelp reviewer, the judge found that statements such as the physician “diluted” injectables and deceived patients about pricing to be factual statements. (The physician is apparently one who performs cosmetic procedures on patients like using botox and fillers.) Therefore, if they were false statements, as the physician alleged, this establishes a prima facie claim for defamation that courts have the authority to hear. According to the court’s order: “Because Plaintiff has alleged a prima facie case . . . and they cannot identify John Doe[s] without a court-ordered subpoena, the Court agrees that there is good cause to allow for early discovery.”  Click here to view the court’s opinion on our website.

I see this as a positive occurrence. Too often reviewers on Yelp, Google, Glass Door, and other such websites post egregious comments amounting to character assassination and libel, because they believe they can remain anonymous. And the owners of the websites fight tooth and toenail to avoid any liability and to avoid any co-operation when justice is sought by those harmed by their actions. We have had a number of cases we have handled where a “reviewer” uses a phony name and creates a phony user account just for the purpose of making a libelous, damaging review. Then, if caught, they just create a new phony account and re-post the same thing again. If the major carriers and websites like Yelp, Google, Bing, AOL, and Glass Door, want to remain free of liability, then they should co-operate when a person has to hire a lawyer and pursue legal action in order to obtain justice.

Is This Abusing the Legal System in An Effort to Stifle Free Speech?

Yelp reportedly warns users of the physician’s previous attempts to sue over negative reviews in a “Consumer Alert” pop-up notice on the doctor’s review page. Additionally, it reminds users, “reviewers who share their experiences have a First Amendment right to express their opinions on Yelp.”

Unlike a newspaper or television outlet, Yelp, Google, Glass Door, and other Internet carriers and websites enjoy immunity from liability for what they allow to be posted because of a federal law that protects them. Why are they given such a big advantage over more traditional media outlets? Why should they be?

In a separate lawsuit, a judge denied the effort by the same doctor to reveal the anonymous reviewer who wrote: “Cheap product and he’s absolutely not experienced nor does he care!!!!!” Yelp argued that the review is not defamatory as there is no statement of fact that can be proven true or false. The court agreed and found that the review used a “loose, figurative tone,” suggesting that the author expressed opinions rather than facts based on a negative experience.

Therefore, according to the court, the plaintiff was not able to make “a sufficient showing of prima facie defamation.” Click here to read the judge’s order in full in that case.

I disagree with the court’s ruling, however. Whether or not the physician has any experience is certainly a fact. It can easily be proven or disproven. It seems that if a doctor hung up a sign that said “Absolutely no Experience,” this would be perceived by most reasonable people to be a negative thing. I doubt that many people would be attracted to that doctor or his practice.

Key Takeaway From the Case.

The key takeaway from this case is that contrary to what Yelp’s pop-up notice implies, Yelp’s users have “implicitly agreed” to the release of their personal data if ordered by a court.

To learn more about fighting negative reviews on websites like Yelp as a healthcare professional, click here to read my prior blog.

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

At the Health Law Firm, we provide legal services for all health care providers and professionals. This includes physicians, nurses, dentists, psychologists, psychiatrists, mental health counselors, Durable Medical Equipment suppliers, medical students and interns, hospitals, ambulatory surgical centers, pain management clinics, nursing homes, and any other healthcare provider. We represent facilities, individuals, groups, and institutions in contracts, sales, mergers, and acquisitions.

The lawyers of The Health Law Firm are experienced in both formal and informal administrative hearings and in representing physicians in investigations and at Board of Medicine and Board of Osteopathic Medicine hearings. We represent physicians accused of wrongdoing, in patient complaints and in Department of Health investigations.

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

Sources:

Capriel, Jonathan. “Doc Can Subpoena Yelp User Info In Botox Defamation Suit.” Law360. (October 7, 2021). Web.

Marza, Mike. “Manhattan doctor sues over Yelp reviews he says are false.” ABC 7NY. (November 19, 2019). Web.

About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Suite 1000, Altamonte Springs, FL 32714, Phone: (407) 331-6620 or Toll-Free: (888) 331-6620.

“The Health Law Firm” is a registered fictitious business name of and a registered service mark of The Health Law Firm, P.A., a Florida professional service corporation, since 1999.
Copyright © 2021 The Health Law Firm. All rights reserved.

 

 

Humana Agrees To Pay $11.2 Million Settlement in Nursing Overtime Suit

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

On September 27, 2021, Humana agreed to pay $11.2 million to end claims that the health insurance company denied a group of nurses overtime pay by misclassifying them as exempt employees. A Wisconsin federal judge approved the deal with Humana, and a group of more than 200 nurses reached, securing a $36,000 average payment for each nurse involved in the suit.

A Violation of the Fair Labor Standards Act (FLSA).

This dispute stems from a class-action lawsuit filed in 2017 alleging that Humana misclassified its clinical nurse advisers as exempt employees and denied them overtime compensation, violating the Fair Labor Standards Act.  Many professionals and supervisors or managerial employees are considered to be exempt from overtime laws.

In the suit, the company faced allegations from nurses who claimed they were never paid for overtime even though they were required to work more than 40 hours per week to meet Humana’s production goals and expectations.

The Settlement.

The settlement agreement will allocate almost $3 million to cover attorney fees and costs. Additionally, the 221 nurses that are part of the settling class will get nearly $8 million based on the number of full-time weeks the nurses worked. According to the motion, the average payment per nurse for unpaid overtime and liquidated damages will be over $36,000.

The case is O’Leary v. Humana Insurance Co., et al., case number 17-cv-1774, in the U.S. District Court for the Eastern District of Wisconsin. Click here to view the court’s brief in full.

To read about another case dealing with alleged pay discrimination in the healthcare field, click here to read one of my prior blogs.

Contact Health Law Attorneys Experienced in Representing Nurses and Other Healthcare Professionals.

The Health Law Firm’s attorneys routinely provide legal representation to nurses, pharmacists, pharmacy technicians, dentists, dental assistants, physicians, physician assistants, mental health counselors, and other health providers. We also provide legal representation for employers in EEOC complaints, workplace discrimination complaints, and suits involving harassment or discrimination complaints. We also provide legal representation in Department of Health, Board of Medicine, Board of Nursing investigations and complaints, DORA investigations and complaints. We provide litigation services in state and federal courts and state and federal administrative hearings. We provide legal representation across the U.S., not just in Colorado, Florida, Louisiana, Virginia, and Washington, D.C.

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:

Spezzemonte, Irene. “Humana To Pay $11.2M To End Nurses’ Misclassification Suit.” Law360. (September 27, 2021). Web.

Webster, Katherine. “Court OKs $11.2M Overtime Settlement Between Humana, Nurses.” Top Class Actions. (September 30, 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 Ave. Suite 1000, Altamonte Springs, FL 32714, Phone: (407) 331-6620 Toll-Free: (888) 331-6620.

 

The Health Law Firm” is a registered fictitious business name of and a registered service mark of The Health Law Firm, P.A., a Florida professional service corporation, since 1999.
Copyright © 2021 The Health Law

 

 

 

 

 

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.

 

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.

Former University of Florida Professor and Researcher Charged With Fraud and Hiding China Ties

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

On February 3, 2021, a former University of Florida professor was indicted on allegations of fraudulently obtaining a federal grant from the U.S. by concealing his ties with the Chinese government. He is accused of fraudulently obtaining $1.75 million in federal grant money from the National Institutes of Health (NIH). He was able to do this by concealing support he received from the Chinese government and a company that he founded in China to profit from that research, according to the U.S. Department of Justice (DOJ).

The former professor is charged with six counts of wire fraud and four counts of making false statements to an agency of the United States.

A Scheme to Defraud National Institutes of Health and the University of Florida.

According to the indictment, the ex-professor obtained a $1.75 million grant from NIH to support his development work on an imaging informatics tool for muscles known as “MuscleMiner.” Additionally, he served as the principal investigator for the grant between September 2014 and July 2019. According to prosecutors, he was required to disclose any foreign research support and any financial conflicts of interest, including financial connections to foreign companies, but he failed to do so.

The indictment alleges that he concealed the information in order to keep his job at the University of Florida and continue to receive NIH grant money. Additionally, the ex-professor signed a document from UF’s College of Engineering in 2019 that said he had no affiliation with any business, business entity, or university in China. Prosecutors said that he left the United States in August of 2019 for China and has not returned.

Each wire fraud count carries a maximum penalty of 20 years in prison and a $250,000 fine. The maximum penalty for each count of making a false statement is five years in prison and a $250,000 fine. You can read the complaint in this case here.

To read the press release issued by the DOJ, click here.

Research Fraud, Grant Application Fraud, and Scientific Misconduct Allegations Have Serious Consequences.

An accusation, even if later proven to be unfounded, may unfairly tarnish the personal and professional reputation of any scientific, medical, or clinical researcher. It can cause the researcher to lose grants, bonuses, and promotions; his or her employment may be terminated; and, as in this case, he or she may face criminal prosecution for fraud, theft, or other applicable crimes.

To learn more on clinical research fraud and misconduct, click here to visit our Areas of Practice Page on our website and read one of my prior blogs here.

Contact Health Law Attorneys Experienced in Defending Against Allegations of Clinical Research Fraud and Misconduct.

The Health Law Firm and its attorneys have experience in representing researchers, investigators, academicians, and clinicians who are the subject of clinical research fraud and misconduct allegations. The Health Law Firm and its attorneys also have experience in representing students, employees, researchers, investigators, and “whistleblowers” who report such matters including those who become the victim of reprisals and retaliation by the person against whom the report is made.

Don’t wait. Obtain the advice and counsel of experienced attorneys who are familiar with such matters and can assist you before it is too late.

If you are facing allegations of research misconduct, research fraud, medical investigation misconduct, please visit our website for more information at www.TheHealthLawFirm.com or call The Health Law Firm at (407) 331-6620 or toll-free (888) 331-6620.

Sources:

Clough, Chris. “Former Fla. Professor Charged With Fraud, Hiding China Ties.” Law360. (February 3, 2021). Web.

Swirko, Cindy. “Former Florida professor indicted for fraudulently obtaining $1.75M federal grant.” The Gainesville Sun. (February 5, 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 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 © 2021 The Health Law Firm. All rights reserved.

2021-03-10T11:46:09-05:00May 18th, 2021|Categories: Pharmacy Law Blog|Tags: , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |0 Comments

Impaired Practitioner Programs: What You Need to Know if You’ve Been Accused

Attorney 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

In an industry that revolves around helping others physicians and other health professionals sometimes find that they are the ones being pushed toward a treatment program. Long hours, heavy workloads, and stress among health care professionals can sometimes lead to unsafe, unprofessional behavior and impairment allegations.

We routinely work with pharmacists and other health professionals who are accused by employers, hospitals, competitors, or terminated employees of impairment due to drug or alcohol abuse, or mental impairment, of being a “disruptive physician” or of sexual boundary issues. However, not all health professionals who are referred to a health program are in actual need of rehabilitation services.


What is the Impaired Practitioners Program?

The Florida Department of Health’s (DOH) Impaired Practitioners Program (IPN), Section 456.067, Florida Statutes, is administered by the Intervention Project for Nurses or “IPN” (for nurses and nurse practitioners) and by the Professionals Resource Network or “PRN” (for physicians, dentists, pharmacists, and all other health professionals). IPN is responsible for all nurses and works with and through the Florida Board of Nursing. PRN works with and through the Florida Board of Medicine, Board of Dentistry, Board of Pharmacy, and other Department of Health Professional Boards.


You’re told You Need to Report Yourself to IPN; What Now?

These types of allegations discussed above made against a pharmacist, nurse, physician, or other health professional are extremely serious because they are usually treated by the DOH as “Priority 1” or “Fast Track” offenses. This means that the charges against the individual will usually be automatically considered for an Emergency Suspension Order (ESO) issued by the Florida Surgeon General at the request of the Department of Health. Unless a qualified, experienced health care attorney is able to immediately produce reliable documentation and evidence showing the health professional is not impaired, the Surgeon General will usually issue an ESO. Click here to read one of my prior blogs to learn more.

Even in cases where the individual may actually have committed an offense, there are a number of administrative and procedural measures that may be used to avoid a suspended license. For the innocent health professional, an experienced attorney familiar with such matters may be able to obtain additional drug testing, polygraph (lie detector) testing, medical examinations, scientific evidence, expert witnesses, evaluations by certified addictions professionals, character references, or other evidence which may help to show innocence and lack of impairment.


Call an Attorney Immediately, Before Making Any Decisions or Calls!

If you are accused of wrongdoing, especially accusations involving drug or alcohol abuse or impairment, even if you are threatened with being reported to the DOH or the Board of Pharmacy, then it may be much better to defend yourself and fight such charges instead of trying to “take the easy way out.” This is especially true if you are being falsely accused. There are many problems that you can avoid by having good legal advice before you make a stupid mistake. We are often consulted and retained by clients when, after they have made the mistake of talking to the wrong people about the wrong things, they are in a situation they could have avoided.

Our firm has extensive experience in representing pharmacists, physicians, and other professionals accused of drug abuse, alcohol impairment, mental impairment, and sexual boundary issue, as well as in dealing with the IPN and the PRN, their advantages and disadvantages, their contracts, their policies and procedures, and their requirements.

The bottom line is: if you are accused of drug impairment, alcohol impairment, drug diversion, sexual boundary issues, sexual misconduct, or of being mentally or physically impaired, immediately contact an attorney experienced with IPN and PRN and with the Board of Pharmacy, Board of Medicine, Board of Dentistry, and other professional boards. Don’t risk losing your livelihood by just taking the apparently easy way out without checking into it. There may be other options available for you, especially if you are innocent and not impaired.

To read one of my prior blogs about the recent changes to Florida’s Impaired Practitioners Program, click here.

Contact Experienced Health Law Attorneys in Matters Involving PRN & IPN.

The Health Law Firm’s attorneys routinely represent pharmacists, nurses, physicians, dentists, and other health professionals in matters involving PRN or IPN. Our attorneys also represent health providers in Department of Health investigations, before professional boards, in licensing matters, and in administrative 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:

Masterson, Les. “Physician wellness, quality of care go hand-in-hand, analysis finds.” Healthworks Collective. (September 10, 2018). Web.

Maria Panagioti, Keith Geraghty, Judith Johnson. “Association Between Physician Burnout and Patient Safety, Professionalism, and Patient Satisfaction.” Journal of American Medical Association (JAMA). (September 4, 2018). Web.

About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

“The Health Law Firm” is a registered fictitious business name of and a registered service mark of The Health Law Firm, P.A., a Florida professional service corporation, since 1999.
Copyright © 2021 The Health Law Firm. All rights reserved.

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