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.

 

 

 

 

 

 

By |2024-03-14T09:59:15-04:00December 23, 2023|Categories: Pharmacy Law Blog|Tags: , , , , , , , , , , , , , , , , , , , , , , , |Comments Off on Florida Legislation Allows Pharmacy Technicians to Administer Immunizations

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: [email protected] or fax to: (407) 331-3030.

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

By |2024-03-14T09:59:16-04:00December 2, 2023|Categories: Pharmacy Law Blog|Tags: , , , , , , , , , , , , , , , , , , , , , , , , , , , , |Comments Off on DOJ Drops Charges in Appalachia Opioid Case After Supreme Court Ruling

Iowa Appellate Court Reverses $6 Million Nursing Home Negligence Decision Because of Hearsay Testimony

Author HeadshotBy George F. Indest III, J.D., M.P.A, LL.M., Board Certified by The Florida Bar in Health Law and Hartley Brooks, Law Clerk, The Health Law Firm
On June 21, 2023, the Iowa Court of Appeals overturned the verdict in a nursing home negligence case that awarded $6 million in compensation and damages to the plaintiff. The case was reversed and remanded for a new trial because the trial court judge admitted inadmissible hearsay testimony into evidence. The testimony being appealed was that of staff members who claimed to have heard “reports” and “rumors” of alleged abuse by a nurse on staff toward not only the resident in question but other residents.
Hearsay in Iowa law is defined as “a statement, other than one made by the declarant while testifying at the trial or hearing, offered to prove the truth of the matter asserted.” Click here to read the Iowa Rules of Evidence concerning hearsay. This is the same definition used by the federal and most other courts.
Essentially, hearsay is when someone repeats something they heard from another person and presents it as if they know it to be true. Hearsay is often equated to rumor. Hearsay is not admissible due to the nature of speculation required in making such a statement, the fact that such statements are inherently unreliable and that the actual witness is not in court to answer questions about it. Thus there is no way for a party or the judge to test the credibility of the actual witness or determine facts that may have influenced the observation and statement.
Hearsay is considered unreliable because the person who knows what happened (who saw what happened or heard what happened) is not to be questioned about it. Therefore, there is no way to know what really happened for sure.
Details of the Case. 
In this case, the estate of the former nursing home resident, who succumbed to her injuries after a fall in the nursing home, claimed adult abuse and that negligence caused a wrongful death. In its defense, the nursing home focused on the alleged abuse by a nurse on the staff. The statements challenged in the appeal included testimony made by six nursing home staff members that residents, other unnamed employees, and an Iowa Department of Inspections and Appeals surveyor told them that the nurse in question had been physically rough with and swore at residents.
The employees testifying did not actually witness any such incidents. They were only testifying about someone else’s words (“hearsay”). 
The trial court admitted these statements, allegedly not for their truth, but in an attempt to show that abuse had been reported and there had not been any follow-up investigation. The appellate court stated that this was not a valid reason to admit inadmissible hearsay into evidence because the estate must prove that the conduct existed to prevent the jury from engaging in rampant speculation based on unreliable hearsay evidence.
People in today’s society, yes, even judges, often forget this basic principle of law. With all of the fabricated lies being put out as “news” on some news channels, Internet rumors running rampant, and politicians making egregiously false statements, it’s often hard to remember how to distinguish a fact from an unreliable rumor or hearsay.
This is one of the problems with hearsay. It is often just gossip and rumor, which change from person to person. Especially egregious conduct, criminal activity, and salacious acts become increasingly exaggerated with each retelling. The founding fathers in English and American law realized the inherently unreliable nature of such “evidence.”
Under the hearsay rule, the Court of Appeals agreed with the nursing home that the statements being challenged were inadmissible hearsay evidence that influenced the jury’s verdict. Due to this, the court reversed the verdict and remanded the case for a new trial. To read the court’s opinion in full, click here.
Contact Experienced Health Law Attorneys.
The Health Law Firm routinely represents health professionals and health facilities in civil and administrative litigation. We also represent physicians, nurses, and other health providers in investigations, regulatory matters, licensing issues, board hearings, inspections, and audits involving the DEA, Department of Health (DOH), and other law enforcement agencies. Its attorneys include those who are board-certified by The Florida Bar in Health Law as well as licensed health professionals who are also attorneys.  We represent medical students, interns, resident physicians, and fellows in disputes with their graduate medical education (GME) programs.  We represent clinical professors and instructors in contract disputes, employment disputes, clinical privileges matters, and other disputes with their employers.  We often act as the physician’s personal counsel in medical malpractice litigation.
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.
Source: 
About the Authors: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law; he is the President and Managing Partner of The Health Law Firm, which has a national practice. Hartley Brooks is a law clerk with the health law firm. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Avenue, Suite 1000, Altamonte Springs, FL 32714, Phone: (407) 331-6620 or Toll-Free: (888) 331-6620.
Attorney Positions with The Health Law Firm. The Health Law Firm always seeks qualified attorneys interested in health law practice. Its main office is in the Orlando, Florida, area. If you are a member of The Florida Bar and are interested, forward a cover letter and your resume to: [email protected] or fax to: (407) 331-3030.
“The Health Law Firm” is a registered fictitious business name of and a registered service mark of The Health Law Firm, P.A., a Florida professional service corporation, since 1999.
Copyright © 2023 The Health Law Firm. All rights reserved.

How to Find a Lawyer Who Accepts HPSO Insurance to Defend Healthcare Providers

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

Healthcare professionals such as pharmacists, licensed mental health counselors, advanced registered nurse practitioners (ARNPs), and massage therapists often struggle to find experienced lawyers in Florida who will accept their professional liability insurance after receiving complaints from the Department of Health (DOH). Specifically, in this blog, the insurance provider in question is Healthcare Providers Service Organization (HPSO) Insurance.

Advantages of Having HPSO Insurance.

The medical professionals HPSO Insurance covers can give a sigh of relief knowing they have excellent insurance coverage. HPSO Insurance provides professional liability coverage that protects them in the event of a lawsuit or negligence claim.

However, it’s not just the significant cases that HPSO covers. More often than not, healthcare professionals receive a notice of an investigation, a subpoena for a deposition in someone else’s case, a demand because of an allegation of sexual harassment or sexual impropriety, a complaint because of a breach of medical records confidentiality, or a Health Insurance Portability and Accountability Act (HIPAA) Privacy complaint, or some other administrative type of action. These situations can be incredibly stressful and time-consuming, but HPSO provides excellent coverage.

For example, if the individual receives a subpoena for a deposition, HPSO currently reimburses up to $10,000 in legal fees and expenses just for representation at the deposition. This means that the professional can focus on their work and not worry about the legal costs of a deposition. Additionally, the provider receives a notice of investigation or complaint from the DOH or Agency for Health Care Administration (AHCA). HPSO currently reimburses up to $25,000 in legal fees and expenses for their defense. The peace of mind that comes with knowing that they have this kind of coverage can be invaluable.

Finally, suppose a health professional is facing a complaint or investigation regarding a breach of medical confidentiality. In that case, HPSO reimburses up to $25,000 in legal fees and expenses for their legal representation in defense.

Whether you’re a nurse, physician, psychologist, or other healthcare professional, knowledgeable and skilled attorneys can assist you with legal issues.

Free Legal Advice: Get Insurance Right Away.

As a healthcare professional, it is essential to understand the importance of carrying insurance that covers any investigation, complaint, or administrative hearing that may be filed or opened against your license. Many healthcare professionals mistakenly believe their employer will cover them in such situations, but this is not always true.

Suppose you are still determining whether your employer will provide legal defense for any matters arising during employment. In that case, asking for a written statement confirming this is crucial. Without such a statement, you may find yourself without any legal support in the event of a complaint or investigation.

Unfortunately, in many cases, the employer terminates an employee and then files a complaint with the Department of Health (DOH). This can result in the DOH opening an investigation against the healthcare professional, leaving them vulnerable to potential legal action. In such cases, the employer is unlikely to pay for the healthcare professional’s legal defense costs, leaving the professional in a difficult position.

If you find yourself in this situation, you may be out of work, out of money, and facing an investigation and complaint that could result in your professional license and career termination. Taking proactive steps to protect yourself and your career is essential by investing in insurance that covers legal defense costs.

HPSO Insurance is both inexpensive and reliable. By purchasing this insurance, while you can afford it, you can rest assured that you will have the legal support you need in case of a complaint or investigation.

We Recommend That You Seek the Services of an Experienced Attorney in the Event of Any Notice of an Investigation.

If you work in the healthcare industry, you must be aware of the potential legal issues that could arise. One such issue is disciplinary action or licensure investigations. If you find yourself in this situation, seeking an experienced health law attorney is crucial. Don’t speak with investigators or provide documents or statements without seeking legal advice.

It’s important to remember that investigators and other professionals involved in the investigation are not on your side. They are looking for evidence against you, so don’t take any advice from them. Instead, rely on the guidance of a skilled attorney who can protect your rights and interests.

Another important consideration is insurance coverage. If you have good insurance, it can help cover the costs of legal expenses from the outset. However, not all insurance policies cover disciplinary complaints and licensure investigations. Be sure to check your policy carefully and ensure this type of coverage is included. If not, consider purchasing a separate policy that provides this coverage. It may cost extra, but it’s worth protecting yourself in case of a legal issue. It is worth it!  Please do it!

Contact Experienced Health Law Attorneys Who Represent Healthcare Professionals and Providers.

Our firm specializes in providing legal representation to a wide range of healthcare professionals, including pharmacists, massage therapists, mental health counselors, registered nurses, and more. We offer a variety of services, such as representing clients before their professional board, handling DOH investigations, conducting administrative hearings, defending against malpractice claims, assisting with professional licensing matters, and addressing allegations related to HIPAA privacy violations and medical record breaches.

We also handle DEA actions and other legal matters. Our team frequently defends physicians, dentists, nurse practitioners, and others against malpractice claims, civil lawsuits, administrative complaints, peer review actions, and audits by Medicare and Medicaid. If a healthcare professional has liability insurance that covers these types of claims, we will work to obtain coverage and seek reimbursement for legal fees. In some cases, we may accept an assignment of insurance policy proceeds to directly submit our bills to the insurance company.

We also defend health professionals and health facilities in general litigation matters and business litigation matters.

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.

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.

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

“The Health Law Firm” is a registered fictitious business name of and a registered service mark of The Health Law Firm, P.A., a Florida professional service corporation, since 1999.
Copyright © 2023 George F. Indest III. All rights reserved.

By |2024-03-14T09:59:19-04:00October 2, 2023|Categories: Pharmacy Law Blog|Tags: , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |Comments Off on How to Find a Lawyer Who Accepts HPSO Insurance to Defend Healthcare Providers

Florida Attorney Says AHCA Must Put Medicaid Final Orders Online

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

Florida’s Agency for Health Care Administration (AHCA) has come under fire for failing to make Medicaid final orders accessible to the public. On April 11, 2023, an attorney asked a Florida appeals court to revive her suit against AHCA, trying to force AHCA into compliance with state public records laws.

Attorney Nancy Wright says the AHCA orders fall under a state law that requires all proceedings determined by a state agency to be placed into a centralized electronic database accessible to the public. This would allow citizens and healthcare providers more accessible access to those decisions and transparency when understanding Medicaid policies and decisions made by AHCA.

Access to Medicaid Final Orders.

The plaintiff’s attorney argued before a three-judge panel of the court of appeal that she should not be required to pay hundreds of dollars to gain access to Medicaid final orders to prepare for clients’ Medicaid hearings when the law requires the agency to publish these. The attorney further argued that this fee was an unfair and unjustified barrier to justice and that she should be given free access to these orders to ensure that she could provide the best possible representation for her clients.

More Details of the Case.

The Florida Health Justice Project and the National Health Law Program filed the lawsuit against AHCA on behalf of Wright in December 2020 in the First District Court of Appeal of Florida.
“[Medicaid law’s] notorious complexity and rapid regulatory changes put even lawyers on edge,” she said in a statement at the time she filed her suit. “AHCA’s unwillingness to make their [sic] final orders accessible means that I am not able to fully advise my clients on how and why decisions on services are being made. For the many enrollees who are unrepresented, this lack of transparency makes a complicated system almost impossible to navigate.”

Click here to view the press release from The Florida Health Justice Project.

However, the trial court sided with AHCA and granted summary judgment to the agency.

The Appeal.

The Elder Law Section of the Florida Bar expressed their support for Wright and submitted an amicus brief on appeal. They highlighted that the Florida Department of Children and Families regulates Medicaid eligibility proceedings with the same law that provides authority to AHCA. Furthermore, the Department publishes its final orders in an electronic database, making them readily available to the public.

However, accessing these same orders on Medicaid coverage requires a public records request which can be costly and time-consuming. The Elder Law Section argued in its brief that this disparity is unfair as it burdens those attempting to gain access to said records. The brief further suggested that upholding the trial court’s summary judgment would only perpetuate this inequality of access to public records.

To learn more, read the complaint in full here.

Contact Health Law Attorneys Experienced in Handling Medicaid Audits, Investigations, and other Legal Proceedings

Physicians, therapists, counselors and other health professionals who accept Medicaid are routinely audited by the Medicaid Program to detect any overpayments or fraudulent claims. Medicaid fraud is a serious crime and is vigorously investigated by the state Medicaid Fraud Control Unit (MFCU), the Agency for Healthcare Administration (AHCA), Program Integrity Contractors (PICs), the FBI, and the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services (DHHS). Often other state and federal agencies, including the U.S. Postal Service (USPS), and other law enforcement agencies may also participate. Don’t wait until it’s too late. If you are concerned of any possible violations and would like a confidential consultation, contact a qualified health law attorney familiar with medical billing and audits today. Often Medicaid fraud criminal charges arise out of routine Medicaid audits, probe audits, or patient complaints.

The Health Law Firm’s attorneys routinely represent physicians, dentists, orthodontists, medical groups, clinics, pharmacies, mental health counselors, therapists, home health care agencies, nursing homes, group homes and other healthcare providers in Medicaid and Medicare investigations, audits and recovery actions.

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

About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law; he is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in 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.

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

“The Health Law Firm” is a registered fictitious business name of and a registered service mark of The Health Law Firm, P.A., a Florida professional service corporation, since 1999.
Copyright © 2023 The Health Law Firm. All rights reserved.

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

Previously published on June 24, 2022
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.

By |2024-03-14T09:59:20-04:00September 18, 2023|Categories: Pharmacy Law Blog|Tags: , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |1 Comment

Locating an HPSO or Pharmacists Mutual Insurance Attorney to Defend You in a Complaint Against Your Pharmacist License

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

All healthcare professionals, including pharmacists and pharmacies, should know the importance of good professional liability insurance. These policies protect them from the financial burden of legal expenses in case of any complaints or lawsuits filed against them. Healthcare Providers Service Organization (HPSO) Insurance and Pharmacists Mutual Insurance Company (PMIC) are both popular insurance companies that offers professional liability insurance to pharmacists and their pharmacies at a low and affordable rate. However, many pharmacists may need to realize the full extent of coverage that their policy offers.

Under a policy with either insurance company, the insurer company will pay the legal fees and other costs related to your defense or legal representation. However, you must seek out and retain the appropriate attorney to represent you.

Essential Things to Look For When Retaining an Attorney to Defend You.

1.The primary qualification for any attorney you hire to represent you should be their experience working with healthcare professionals in the same field, in this case pharmacies and pharmacists. Suppose the attorney is unfamiliar with the practice of pharmacy, the type of legal proceeding you have, or the board of pharmacy, Division of Regulatory Agencies (DORA) or the health department.  In that case, it may be difficult for that attorney to represent you properly.

2.If you consult with an attorney who claims they will help you make a statement to the investigator or assist you in the investigation but will not agree to appear and represent you in hearings, this is the wrong attorney. You need an attorney who can represent you from start to finish.

3.Seek and retain an attorney who accepts the insurance that you have, whether it’s HPSO Insurance, Pharmacists Mutual Insurance Company (PMIC), CPH & Associates Insurance, Philadelphia Insurance, Firemans Fund, or another national company. This will ensure that you have an attorney who will give you the lower rates the insurance company has negotiated and will establish a good working relationship with your insurance company. If an attorney with our firm cannot represent you, we will try to find you an attorney who will.

4.You should also retain the services of an attorney who has appeared before your professional board or professional licensing authority in investigations and hearings, especially in formal administrative hearings.

5.Often, you will encounter an attorney who only wants you to accept a consent order, stipulation, or settlement agreement. Remember that these are all merely “plea bargains,” and you will be pleading “guilty” to whatever offenses are charged. This is the easy way out. Often, the easy way is not the right way. If you plead guilty, then, from that point on, you are guilty. In most cases, however, you will be innocent of the charges and need a formal administrative hearing to prove this.

6.You don’t necessarily need an attorney who resides in your city, state, or location. Your attorney can complete the majority of casework by telephone, e-mail, Zoom video or other means. You usually have only one meeting or hearing; depending on what type of hearing it is, it could be located in various locations. Our attorneys will travel to those locations for meetings and hearings.

7.Beware of attorneys who hold themselves out in Internet advertising as health attorneys or professional licensed defense attorneys but are really some other type of attorneys. We see this a lot from medical malpractice attorneys, criminal defense attorneys, and attorneys who sue insurance companies. Be sure you get an attorney who concentrates their practice on defending those in the pharmacy specialty and board of pharmacy complaints, investigations, and formal and informal administrative hearings.

8.If you can’t find an attorney to meet your immediate needs through our firm or an Internet search, you may contact your insurance company or professional association and ask if they have a list of attorneys who can do the legal work you require.

For example, you may reach Healthcare Providers Service Organization (HPSO) at (800) 982-9491;  you can reach Pharmacists Mutual Insurance Company (PMIC) at (800) 247-5930;  you can reach CPH & Associates at (800) 875-1911 or (312) 987-9823.
When negative accusations arise that could affect a pharmacist’s license or the license of a pharmacy, having insurance is essential. This coverage offers a strong defense against potential harm and covers a variety of situations, including subpoenas for record release, depositions, and violations of HIPAA or medical confidentiality.

Connect With Health Law Attorneys Who Are Experienced in Investigations of Pharmacists and Pharmacies.

The attorneys of The Health Law Firm provide legal representation to pharmacists, pharmacies, prescribing physicians, dispensing physicians and nurse practitioners, and other health providers in pharmacy board complaints and investigations, Department of Health (DOH) investigations, Colorado DORA investigations, Drug Enforcement Administration (DEA) investigations, Medicare and Medicaid audits, Medicaid Fraud Control Unit (MFCU) investigations, Food and Drug Administration (FDA) actions, and other types of investigations of pharmacies and pharmacists.

In cases in which the pharmacist or pharmacy has professional liability insurance or general liability insurance that provides coverage for such matters, we will seek to obtain coverage by your insurance company and will attempt to have your legal fees and expenses covered by your insurance company. If allowed, we will agree to take an assignment of your insurance policy proceeds in order to be able to submit our bills directly to your insurance company.

We also defend health professionals and health facilities in general litigation matters and business litigation matters, Medicaid and Medicare complaints and hearings, and DEA Orders To Show Cause (OTSC) and 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.


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

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

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

Copyright © 2023 The Health Law Firm. All rights reserved.
By |2024-03-14T09:59:22-04:00August 23, 2023|Categories: Pharmacy Law Blog|Tags: , , , , , , , , , , , , , , , , , , , , , , , , , , , |Comments Off on Locating an HPSO or Pharmacists Mutual Insurance Attorney to Defend You in a Complaint Against Your Pharmacist License

Medicare Revocation and the Collateral Damage It Can Cause Health Care Providers

Attorney and Author George F. Indest III HeadshotBy George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law
Many healthcare professionals are unaware of the adverse long-term collateral effects of Medicare revocation or exclusion on their careers and future employment. However, if you are a physician, dentist, nurse, mental health counselor, psychologist, pharmacist, physician assistant, nurse practitioner, massage therapist, or other licensed health professional whose license is revoked or suspended, there may still be hope.
Lasting Consequences of Medicare Revocation. 
A revocation or exclusion from Medicare is often a severe consequence of license discipline on a professional license and can devastate a provider’s career. The Centers for Medicare & Medicaid Services (CMS) can revoke a healthcare provider’s agreement to participate in Medicare. When this occurs, their Medicare billing privileges are terminated.  Their legal authority to write prescriptions, referrals or orders for tests paid by Medicare also vanishes.
Additionally, the exclusion can last for many years. This can be a career-ending move for many healthcare providers especially physicians, as Medicare revocation is reported to the National Practitioner Databank (NPDB). In addition, it can potentially affect their opportunities to work in hospitals with other Medicare providers, or on health insurance panels.
For this reason, healthcare providers need to retain a health law attorney with experience in licensing issues who can help them navigate the complex legal system Medicare presents. A skilled attorney can review the facts of the case, develop a strategy for defending the provider’s license, recommend actions to avoid or mitigate the damages, and represent them in administrative hearings or proceedings in court. In some cases, an effective legal strategy may minimize the impact of discipline or even prevent Medicare revocation or exclusion. However, the best way to protect against license discipline and its consequences is to ensure that you are in compliance with Medicare standards, regulations and procedures.

To learn more, read one of my prior blogs here.

Contact Experienced Health Law Attorneys in Healthcare Licensing Issues.

If you have had a license suspended or revoked, or you are facing imminent action against your license, it is imperative that you contact an experienced healthcare attorney to assist in defending you.  Remember, your license is your livelihood. It is not recommended that you should not attempt to pursue these matters without the assistance of an experienced health care attorney. The Health Law Firm routinely represents physicians, dentists, nurses, medical groups, clinics, and other healthcare providers in Medicare issues and in defense of actions in personal and facility licensing actions.

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

Sources:

Hollender, Allison and Wortley, Mackenzie. “Collateral Consequences of Medicare Revocations.” AHLA. (March 9, 2021). Web.

Simas, Steven. “Collateral Consequence of Healthcare License Discipline – Medicare Exclusion.” SIMAS & Associates. (October 3, 2017). 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 or Toll-Free: (888) 331-6620.

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

“The Health Law Firm” is a registered fictitious business name of and a registered service mark of The Health Law Firm, P.A., a Florida professional service corporation, since 1999.
Copyright © 2023 The Health Law Firm. All rights reserved.
By |2024-03-14T09:59:24-04:00July 26, 2023|Categories: Pharmacy Law Blog|Tags: , , , , , , , , , , , , , , , , , , , , , , , , , , |Comments Off on Medicare Revocation and the Collateral Damage It Can Cause Health Care Providers

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.

 

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