Florida Law Aimed at Healthcare Professional Background Screening Passed

Attorney Michael L. SmithBy Michael L. Smith, R.R.T., J.D., Board Certified by The Florida Bar in Health Law

For several years, many healthcare professionals have been required to pass a Level II background check in order to work in most Florida healthcare facilities licensed by the Agency for Health Care Administration (AHCA). Many healthcare professionals are also required to pass a Level II background check in order to be licensed by the Florida Department of Health (DOH). In March 2020, the Florida Legislature passed House Bill 713, which will add the offenses of battery on a vulnerable adult and battery on a patient or resident of certain healthcare facilities (primarily nursing facilities) as a disqualifying offense. The law took effect on July 1, 2020. Previously, only felony battery and battery on a minor were disqualifying offenses for purposes of the Level II background screening.

More Details on the New Legislation.

A health professional who previously passed the Level II background check may nevertheless be deemed “not eligible” for employment in a licensed health facility on the next Level II background check. This would occur if the practitioner has been found guilty of, regardless of adjudication, or entered a plea of nolo contendere or guilty to battery of a vulnerable adult, or battery on a patient or resident of a healthcare facility. (This is the wording of the statute, not mine.)

A practitioner who is determined to be “not eligible” on a Level II background check due to a disqualifying offense must apply for an exemption from that disqualifying offense, in order to be permitted to work. The practitioner seeking an exemption has the burden of proving that the exemption should be granted. The provider must prove this with clear and convincing evidence, a standard that is higher and stricter than that in a civil trial.

Any health professional seeking an exemption from a disqualifying offense should seek the assistance of an experienced health law attorney familiar with the application process, and the types of evidence that can prove that the health professional should be granted an exemption.

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

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

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

About the Author: Michael L. Smith, R.R.T., J.D., is Board Certified by The Florida Bar in Health Law. He is an attorney with The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave. Suite 1000, Altamonte Springs, FL 32714, Phone: (407) 331-6620.

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

Florida Legislation Allows Pharmacy Technicians to Administer Immunizations

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

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

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

Certification Requirements.

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

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

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

Stay Informed and Prepared.

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

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

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

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

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

The lawyers of The Health Law Firm are experienced in both formal and informal administrative hearings and in representing physicians, physician assistants, and other health professionals in investigations and at Board of Pharmacy hearings. Call our office now at (407) 331-6620 or toll-free at (888) 331-6620 and visit our website www.TheHealthLawFirm.com.

Sources:

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

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

Dix, Martin. “Florida Legislation Authorizing Pharmacy Technicians to Administer Vaccines Contains Some Surprises.” Akerman. (July 28, 2022). Web.

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

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

 

 

 

 

 

 

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

DOJ Drops Charges in Appalachia Opioid Case After Supreme Court Ruling

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

On August 12, 2022, the U.S. Department of Justice (DOJ) announced that it dropped charges against the remaining defendants in a case against a former Ohio drug distributor. In 2019, Miami-Luken, two of its executives, and two pharmacists were charged with unlawfully conspiring to distribute millions of addictive painkillers across rural Appalachia.

The Original Indictment.

The DOJ issued an indictment against the five defendants in 2019 and charged all with conspiracy to distribute a controlled substance. It alleged Miami-Luken had sent millions of Class II and III narcotic painkillers to pharmacies that served rural towns in Appalachia. The indictment said that this occurred from about 2008 to 2015 when the opioid crisis was at its height.

During that time, the government alleged that Miami-Luken sent over “six million doses” of drugs to a West Virginia pharmacy and “regularly exceeded the internal threshold limit” set for that area. The charges were tied to alleged violations of the Controlled Substances Act. For more information about the charges, read the DOJ’s press release.

In a lengthy motion to dismiss, the former drug distributor said the claims were not clearly prohibited by the Controlled Substances Act and said the case was “the first time that the DOJ has relied on Drug Enforcement Administration (DEA) guidance letters interpreting a federal statute — the Controlled Substances Act — as the basis for a criminal prosecution.”

Pharmacy Fraud Cases using gavel and stethoscope with spilled opioid pills

As an aside, I note that the DEA (and when DOJ is representing it, DOJ adopts the same tactic) routinely engages in what I call “bean counting” to exaggerate the perception of the seriousness of the matter. They do this by counting the number of individual pills prescribed or dispensed when, overall, it really is not that significant. Let’s say a hypothetical patient suffering from chronic pain

is prescribed 20 mg of a narcotic medication thrice daily. Such prescriptions are normally written for a thirty (30) day supply. The DEA (and sometimes the DOJ) will multiply these out and allege the doctor prescribed 90 pills X 12 months or 1,080 pills. If the pharmacists did not have 20 mg size pills and filled it with 10 mg pills (doubling

the number of pills, but not the dosage), this doubles the number of pills to 2,160. It sounds like a tremendous number, but it is actually the average that would be prescribed for such a patient.

And then, when one considers that a pharmacy probably has thousands of patients each month who get their prescriptions filled, this greatly magnifies the number of individual pills. Then take it a step further, and consider a medical distributor that may be distributing medications to a hundred different individual drug stores. This multiplies out the number to a much greater one. Using a figure such as “six million pills distributed” sounds much more terrible than “three thousand patients received an average dosage of pills that were distributed through the drug distribution company.” Defense attorneys must do everything possible to eliminate or reduce the impact of such “bean counting” or “pill counting” in such cases.

In March 2021, U.S. District Judge Matthew W. McFarland of the Southern District of Ohio refused to toss the case, saying the motion was “premised on the mischaracterization of the crime.”

Unopposed Motion to Dismiss the Charges.

This time, Surprisingly, there was a motion by the DOJ to dismiss the case. Judge McFarland granted the government’s unopposed motion to dismiss the charges against the remaining defendants, including former Miami-Luken President Anthony Rattini, who died last year. Another former Miami-Luken executive had accepted a plea deal in December 2021.

View the government’s motion to dismiss the indictment without prejudice and stipulation.

View Judge McFarland’s order granting the motion to dismiss the indictment.

It’s important to note that the government did not specify why the charges were dropped; however, the move came shortly after a U.S. Supreme Court ruling that made such cases harder to prove. The decision in Ruan v. U.S. said that prosecutions under the Controlled Substances Act for excessive prescribing of opioids and other addictive drugs must show that doctors knew they lacked a legitimate medical purpose.

Click here to read my previous blog to learn more about this topic.

Contact Health Law Attorneys Experienced in the Representation of Health Professionals and Providers.

The Health Law Firm and its attorneys have represented physicians, pharmacists, nurses, clinics, dentists, pharmacies, health facilities, and other health care providers in cases involving allegations of over-prescribing narcotics and pain medications. These include criminal investigations by local police and law enforcement authorities, investigations by the U.S. Drug Enforcement Agency (DEA), U.S. Department of Justice (DOJ), complaints against professional licenses by the Florida Department of Health, investigations, and prosecutions by the Medicaid Fraud Control Units (MFCU), and other types of cases. Having attorneys familiar with the medical standards of care and guidelines for prescribing narcotics and having access to expert medical and pharmacy professionals who can testify as expert witnesses in such cases is also crucial. We have represented professionals in administrative investigations and hearings at state and federal levels.

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:

Weld, Elliot. “Appalachia Opioid Charges Dropped After High Court Ruling.” Law360. (August 12, 2022). Web.

Raymond Nate. “Opioid distributor Miami-Luken, execs seek dismissal of indictment.” Reuters. (May 1, 2020). Web.

Overley, Jeff. “DOJ Indicts Opioid Distributor, Execs Over Painkiller Sales.” Law360. (July 18, 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 Toll-Free: (888) 331-6620

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

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

2022-09-07T23:39:52-04:00September 7th, 2022|Categories: Pharmacy Law Blog|Tags: , , , , , , , , , , , , , , , , , , , , , , , , , , , , |0 Comments

Supreme Court Explores Doctor Intent in “Pill Mill” Criminal Prosecutions Under the Controlled Substances Act

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

Physicians and other healthcare professionals usually have broad scope to prescribe most drugs, including potentially dangerous ones. However, over the past decade, many limits, often imposed arbitrarily through criminal prosecutions or drastic administrative sanctions, have been used to impose limits.

The question was recently put before the U.S. Supreme Court as to how far a physician’s judgment can be allowed to go in the context of prescribing controlled substances before it becomes criminal. This was in the context of criminal prosecution of a physician for allegedly over-prescribing.

On March 1, 2022, the U.S. Supreme Court confronted the question of whether good faith is a defense for a doctor criminally prosecuted for unlawful distribution of controlled substances. For nearly 90 minutes, the Supreme Court heard oral arguments from both sides, struggling with the exact wording of the Controlled Substances Act (CSA), the clarity of the relevant federal regulation, and the proposition that a doctor who lacked subjective criminal intent could nevertheless go to jail for a substantial period of time, up to life imprisonment.

The two physicians whose cases are being considered are Xiulu Ruan, who was sentenced to 21 years in prison in 2017 for allegedly running a “pill mill,” and Shakeel Kahn, who was sentenced to 25 years in prison in 2019 for crimes including drug distribution of controlled drugs resulting in the death of a patient. The court consolidated their cases for the Supreme Court’s hearing.

Controversial Legal Standards Used to Convict.

The legal standard in question centers heavily on a disputed sentence in the Controlled Substances Act (CSA) that says, “Except as authorized by this subchapter, it shall be unlawful for any person knowingly or intentionally” to distribute controlled substances. The central question is how juries should assess the intentions of a doctor accused of prescribing narcotic painkillers outside “the usual course of his professional practice.”

The U.S. Department of Justice (DOJ) argued that the criminal intent standard is an objective one — or an “honest effort” to comply with professional norms. On the other hand, the attorneys for the doctors who were prosecuted argue that the standard must be subjective; that is did the doctor subjectively believe they were not prescribed for a legitimate medical purpose. This distinction gives rise to whether there is merely a violation of regulation as opposed to a crime having been committed.

Throughout the oral arguments, various justices seemed to cast doubt on whether deviating from mainstream standards on opioid prescribing is sufficient to throw physicians in jail, which could result in years or life in prison. In some states, this might even result in a death sentence, pretty drastic for what would otherwise be medical negligence.

How This Ruling Will Impact Future Prosecutions.

This case and the upcoming ruling raise alarms for healthcare providers and advocates for pain patients. Many fear that the ruling could enable even more aggressive prosecutions of opioid prescribers. They warn that such a decision could discourage doctors from providing opioids even when they’re fully warranted. In addition, the outcome could affect civil litigation accusing large pharmaceutical companies of recklessly selling prescription narcotics.

After hearing the oral arguments, the Supreme Court seemed likely to demand more substantial proof of intentional wrongdoing when the DOJ prosecutes opioid prescribers. A decision from the High Court is expected by late June 2022. The cases are Ruan v. U.S., case number 20-1410, and Kahn v. U.S., case number 21-5261, in the Supreme Court of the United States.

We will definitely keep you posted on the outcome of this case.

Click here to read one of my blogs about controlled substances and compliance.

Contact Health Law Attorneys Experienced in the Representation of Health Professionals and Providers.

The Health Law Firm and its attorneys have represented physicians, pharmacists, nurses, clinics, dentists, pharmacies, health facilities, and other health care providers in different cases involving allegations of over-prescribing narcotics and pain medications. These include criminal investigations by local police and law enforcement authorities, investigations by the U.S. Drug Enforcement Agency (DEA), U.S. Department of Justice (DOJ), complaints against professional licenses by the Florida Department of Health, investigations, and prosecutions by the Medicaid Fraud Control Units (MFCU), and other types of cases. Having attorneys familiar with the medical standards of care and guidelines for prescribing narcotics and having access to expert medical and pharmacy professionals who can testify as expert witnesses in such cases is also crucial. We have represented professionals in administrative investigations and administrative hearings at both the state and federal levels.

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:

Overley, Jeff. “High Court Poised To Make DOJ’s Job Harder In Opioid Cases.” Law360. (March 1, 2022.) Web.

Gluck, Abby. “In opioids “pill mill” case, justices grapple with physician intent.” SCOTUS Blog. (March 2, 2022). Web.

Joseph, Andrew. “Fight over opioid prescribing — and when it turns criminal — heads to Supreme Court.” STAT News. (February 28, 2022). Web.

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

2022-06-24T16:22:15-04:00June 24th, 2022|Categories: Pharmacy Law Blog|Tags: , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |0 Comments

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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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

 

 

 

 

 

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