Changes are coming to the way Electrologists in Florida may be supervised when performing laser hair removal. For years, direct, on-site supervision by a physician was required in order to allow an electrologist to perform laser hair removal. Recently, the Board of Medicine and Electrolysis Council agreed to a rule change, altering the method of supervision to include telehealth.
Almost two years after “Operation Brace Yourself” regarding purported telemedicine and orthotic bracing fraud made national headlines, on February 4, 2021 the Department of Justice Announced that a major player in that fraud – Florida businesswoman Kelly Wolfe – recently pled guilty to criminal health care and tax fraud charges.
Operation Brace Yourself was a 2019 crackdown on the illegal use of telemarketing and telemedicine to generate fraudulent claims for DME orders, whose reach spanned continents and ultimate implications defrauded taxpayers out of billions of dollars.
According to the Department of Justice Press Release and Settlement Agreement, Mr. Wolfe was seemingly a significant mastermind in establishing hundreds of DME companies that went on to defraud US taxpayers and Medicare beneficiaries.
Here are some highlights of the recently signed Settlement Agreement between the United States DOJ, Kelly Wolfe and her company Regency, Inc.
On June 30, 2020, State Surgeon General, Scott A. Rivkees, M.D., issued Emergency Order (“EO”) 20-011, which further extends EO 20-002 until the expiration of the Governor’s Executive Order No. 20-52, or any extensions thereof. Thus, EO 20-011 continues to allow out-of-state MDs, DOs, APRNs and PAs, to offer telehealth services to persons in Florida.
EO 20-011 continues to allow Florida licensed controlled substance prescribers (MDs, DOs, APRNs, PAs) to issue renewal prescriptions of controlled substances for non-malignant pain for existing patients. Additionally, EO 20-011 extends a qualified physician’s ability to recertify an existing qualified and certified patient’s continued use of medical marijuana using telehealth services. These further extensions are also tied to the expiration of Executive Order 20-52 and any extension thereof.
I recently wrote an article titled The Top Five Legal Concerns When Developing a Healthcare App, and I received some follow up questions, including technical queries about encryption and data sharing. To answer these questions, it is important to understand the current Healthcare App state of affairs. Various reporters, governmental agencies and privacy watchdogs have installed and monitored the flow of data from Healthcare Apps installed on smart phones. These journals, articles and enforcement actions taken together provide a roadmap for Do’s and Don’ts for the sharing of data.
Almost all Healthcare Apps are free and have some disclosures about how they share your data, and both iOS and Android require the user to give permission to the newly installed App, but who really pays attention to that? Almost no one. However, this doesn’t mean that an App developer shouldn’t embrace best practices to avoid liability and bad press.
There are numerous COVID-19 grants available from the United States Government, spanning the addiction treatment industry to assisted living, hospitals and providers. There’s money for workplace modernization and for telehealth funding. But how does one keep it all straight and avoid missing out? Join Florida Healthcare Law Firm Attorney Steven Boyne for this informative webinar designed to share an overview and strategy for determining how best your healthcare business can be supported during this unprecedented public health emergency.
Today no one can live without a smart phone, and we interact with the rest of the world through a series of apps that reside on our handheld devices. From the healthcare perspective many large healthcare institutions and private companies have developed a myriad of healthcare related apps that currently reside in Apple’s App Store and Googles Play Store. You can measure your heart rate, get clinical advice, view your records, check on your health insurance coverage, make appointments and virtually interact with many different types of healthcare providers. But even in today’s hyper-electronic society it took COVID-19 to really cause an explosion in telehealth, so what does that tell us? There is a lot more room for expanding electronic interactions with patients and clients through Apps. So, here are the top five legal concerns should you address when you develop a Healthcare App:
The COVID-19 virus has and will probably continue to change the way healthcare providers and business associates interact and help their patients. As many providers are aware, a HIPAA violation is a serious issue, and can cost a healthcare entity large amounts of time and money to respond to any regulatory investigation. Recognizing that the COVID-19 pandemic has strained every corner of the economy and is THE MOST IMPORTANT issue for almost every industry, the federal government has rolled back some HIPAA protections. It is unclear how long these rollbacks will last, and it is possible that some of them may be permanent, but for now healthcare providers and their business associates can take some comfort that they can focus on delivering care and not dealing with overly burdensome regulations and investigations. The major changes include:
Telehealth. Changes include allowing physicians and other healthcare providers to offer telehealth services across State lines, so State licensing issues should not be a concern. Additionally, Providers are essentially free to choose almost any app to interact with their patients, even if it does not fully comply with the HIPAA rules. The HHS allows the provider to use their business judgment, but of course, such communications should NOT be public facing – which means DO NOT allow the public to watch or participate in the visit!
Disclosures of Protected Health Information (PHI). A good faith disclosure of such information will not be prosecuted. Examples include allowing a provider or business associate to share PHI for such purposes as controlling the spread of COVID-19, providing COVID-19 care, and even notifying the media, even if the patient has not, or will not grant his or her permission.
Business Associate Agreement (BAA). As most healthcare providers know, a BAA agreement between a provider and an entity that may have access to PHI is required by law. During the COVID-19 pandemic, the lack of a BAA is not an automatic violation.
There are 116 specific COVID-19 grants available from the United States Government, spanning the addiction treatment industry to assisted living, hospitals and providers. There’s money for workplace modernization and for telehealth funding. But how does one keep it all straight and avoid missing out? Join Florida Healthcare Law Firm Attorney Steven Boyne for this informative webinar designed to share an overview and strategy for determining how best your healthcare business can be supported during this unprecedented public health emergency.
In my last post, I promised to keep you updated as to any new orders from the State Surgeon General that would further extend a practitioner’s ability to prescribe refills of non-malignant pain controlled substances using telehealth communications, or a qualified physician’s ability to recertify an existing qualified patient’s use of medical marijuana. The Surgeon General has extended the ability to continue assisting patients with these specific needs (as well as other needs) until May 31, 2020, through the issuance of Emergency Order 20-007 on May 9, 2020.
Keep in mind, that to prescribe a refill of a controlled substance for chronic non-malignant pain, the practitioner must be an MD, DO, APRN, or PA licensed in Florida and designated as a controlled substance prescribing practitioner. Further, to prescribe such controlled substances using telehealth communications during this public health emergency, the patient must be an existing patient of the prescribing practitioner.
Health law is the federal, state, and local law, rules, regulations and other jurisprudence among providers, payers and vendors to the healthcare industry and its patient and delivery of health care services; all with an emphasis on operations, regulatory and transactional legal issues.