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.
CMS has issued temporary waivers and new rules to help the American health care system address the increased need for health care services caused by COVID-19. Among the waivers, CMS is allowing hospitals to set up services in alternative sites to accommodate increased patient census. Hospitals may be allowed to use ASCs, inpatient rehab hospitals, hotels and dormitories for non-COVID-19 patients or patients not requiring critical inpatient services. Hospitals are also being encouraged to increase staffing, allowing hospitals to increase staff through hiring of local and non-local providers/practitioners as long as they are appropriately licensed in the same state as the hospital or another state. However, even though CMS has created flexibility for rendering services during this pandemic, use of alternative “hospital” sites and expansion of hiring staff must comport with a state’s emergency preparedness or pandemic response plan. read more
COVID is proving to be so burdensome on employers that we are seeing lay-offs and furloughs all over the country. As the virus curve bends back in a positive direction and physician and patient concerns for safety wane, patients will stream back to office. But what happens to the laid off (or furloughed) employees and contractors with non-competes? Will they come back or will they have moved on, possibly in a way that violates their noncompetes? And will a court think a noncompete has been violated when an employee or contractor was let go and there is no specific provision in their written contract that allows the employer to immediately let someone go without notice due to this type of situation? How will the COVID based lay-offs and furlough affect noncompetes? The short answer is we don’t yet know, but widespread lay-offs and furloughs may result in a flood of cases being filed because (1) many have been let go, (2) there likely isn’t a provision in their contract with the employer that specifically authorizes that sort of termination, and (3) a contract’s “breach” (e.g. no contract based allowance for the prompt termination) is traditionally a defense to an action to enforce a noncompete.
The COVID Issue
Though there is an exception for unusual specialties or where there is essentially a community need, noncompetition covenants are generally enforceable in Florida with respect to doctors and other healthcare professionals. Many people think doctors in particular can’t be restricted from practicing medicine under any circumstances. That is just not true.
Getting to the bone of the issue, noncompetes are enforceable in Florida if: read more
When the Governor issued Executive Order 20-72, essentially shutting down any healthcare service that isn’t urgent, it sent the entire Florida healthcare industry into a tail spin. In recognition of that fact, many industry trade groups circled back to Florida government and sought clarification. Attached is one report of such a clarification issued by the Florida Medical Association.
The FMA interpretation of Executive Order 20-72 is that only medically unnecessary, non-urgent or non-emergency procedures or surgeries are prohibited. This has been confirmed by staff at the Florida Department of Health in communications to the FMA this morning.
The Department of Health also confirmed that Physicians can continue to see patients for purposes of evaluation and management. Telemedicine visits can continue unabated. Primary care practitioners can continue to see and treat patients with chronic and acute conditions, perform wellness exams, and provide mental health services, that do not consume personal protective equipment. Specialists can see patients for follow-up care and other non-surgical purposes.
The medical care prohibited under this order is: • elective or non-medically necessary surgical procedures • surgical procedures that can be postponed without putting the patient’s immediate health, safety or well-being at risk • medical procedures that would consume personal protective equipment, that can be postponed without putting the patient’s immediate health, safety or well-being at risk
Physicians should consult the CMS recommendations for additional guidance. We understand the negative impact this will have on countless physicians and their patients. The FMA will be here to help guide you through this unprecedented event. If you have any questions please contact the FMA General Counsel’s office at email@example.com or call 850 224-6496.
CMS has rolled out a telehealth/telemedicine tool kit to assist medical professionals with health care delivery during the current COVID-19 public health emergency.
The toolkit contains information and links concerning:
1135 Waivers – allows the Secretary of HHS to temporarily waive or modify certain Medicare, Medicaid, and Children’s Health Insurance Program (CHIP) requirements to ensure sufficient health care services and items are available to meet the needs of individuals enrolled in Social Security Act programs during the emergency and that providers who provide services in good faith can be reimbursed and exempted from sanctions (provided there is no determination of fraud and abuse). 1135 waiver or modifications include:
Conditions of participation and other certification requirements;
Program participation and similar requirements;
State licensing requirements where services are rendered as long as the provider has equivalent licensing in another State (for Medicare, Medicaid, CHIP reimbursement only; State licensing still controls whether a non-Federal provider may provide services in a state he/she is not licensed in);
EMTALA sanctions for redirection for medical screening, as long as redirection is not the result of discrimination on the basis of a patient’s source of payment or ability to pay;
Stark self-referral sanctions;
Adjustment (not waiver) to performance deadlines and timetables;
Limitations on payment to permit Medicare enrollees to use out of network providers in an emergency situation.
Florida’s Governor passed an Executive Order Friday which essentially shuts down all elective medical treatment. The Order (20-72) only allows “non-urgent or non-emergency procedure or surgery which, if delayed, does not place a patient’s immediate health, safety, or wellbeing at risk, or will, if delayed, not contribute to the worsening of a serious or life-threatening medical condition.” read more
Join Florida Healthcare Law Firm Attorney Chase Howard on our free webinar titled “How can you transform your business to be prepared for future situations like COVID-19?”
Faced with the reality of remote operation, we’ll talk about how your business prepare to thrive in a similar scenario in the future.
What to do with remote staff when it comes to contracts, operations and patient privacy.
How do Federal regulations impact telework.
Could expanded telehealth laws ease the transition to remote care in a future crisis.
Presenter:Chase Howard, Esq. is an Attorney at the Florida Healthcare Law Firm and has focused his legal practice on health law, medical malpractice defense, business law, and contracts. He deploys crucial skills gained through hands-on business experience in the medical tech world to service clientele such as medical spas, medical practices, medical technology businesses, healthcare business entities, physicians, chiropractors, and dentists. Chase’s experience working in University of Miami Health System’s Risk Management Department provided him with a strong understanding of legal compliance in the healthcare world as well as experience in liability assessment, prevention and defense. With his multi-specialty background, Chase’s practice focuses on all aspects of transactional Health Law, MedSpa Start-up and consulting, general business law, and MedTech.
Up until now, Medicare has been fairly structured in how telehealth services are reimbursed. Medicare would pay for telehealth services only if certain, very narrow criteria were met. These rules covered the patient, the patient’s location, the provider, the types of services rendered, the telehealth equipment used and the way the services are coded. Those rules can now be relaxed under recent federal legislation.
On March 6, 2020, President Trump signed the Coronavirus Preparedness and Response Supplemental Appropriations Act of 2020 into law. That law relaxes the current Medicare criteria, in order to expand the use of telehealth as a resource against COVID-19. Pursuant to this law, the Secretary of HHS has the authority to waive the “site” requirements for telehealth services provided to Medicare beneficiaries who are located in an identified “Emergency Area” during an “Emergency Period.” Since the whole country is currently is experiencing a public health emergency, as declared by both the President and the Secretary of HHS, the Emergency Period and Emergency Area requirements are met on a nation-wide basis.
Botox. Fillers. Lasers. The aesthetic options for patients today are endless with more and more treatments available all the time. The “MedSpa” world is booming, and anyone can get in on the expected growth, including dentists. If you’re a dentist and you’re thinking about adding aesthetic treatments to your practice, you should first consider the following:
Scope of Practice. While most medspas provide full body aesthetic treatments, Dentists are limited to providing treatments that are with her or his scope of practice. For example, Botulinum Toxin-A may be prescribed by a dentist, but is limited to the face and neck of patients. This also means that for nurse practitioners working under the supervision of a dentist, they too are limited in practice. While certain other treatments don’t require any specific medical license or training, dentists should evaluate the type of treatments they wish to provide or supervise to ensure it is within their scope of practice.
Ownership. While medspas may be owned by anyone, including non-licensed providers, Dentists must be careful if taking on business partners due to corporate practice of dentistry. Under Florida law, no person other than a Florida licensed dentist, nor any entity other than a professional corporation or limited liability company composed of dentists may employ a dentist in the operation of a dental office. While most aesthetic services are not dental services, a non-dentist may not directly employ a dentist. Violation of these laws will subject the dentist to disciplinary action. If you’re a dentist in Florida, you can legally add limited aesthetic treatments to your practice. If you’re opening a new business with non-dentist partners, however, you will need to be cautious of these laws.
Keeping Things Separate. Adding aesthetics to your practice carries not only financial risk, but also professional risk. It’s recommended that rather than operate and bill for aesthetic services under your dental practice entity, incorporate a new entity to keep your new business separate from traditional practice.
Regulatory Compliance. Although aesthetic treatments are primarily elective and paid in cash, certain Florida laws still apply to dentists, patients, and marketing and referral arrangements. Dentists must maintain compliance with the Florida Patient Brokering Act when it comes to marketing or referral arrangements. Understanding these laws and exceptions is significant when it comes to avoiding scrutiny.
HIPAA. While it may seem obvious, many believe that because aesthetic services are elective, patient confidentiality does not apply. That is simply not true and providers must maintain compliance with HIPAA, even for such elective treatments.
Training. Anytime a medical business is expanded with the addition of new services, it is vitally important to be well-trained and educated in delivering such treatments. Even if you are not individually performing a treatment that you supervise, it is highly recommended that you be trained in such procedures. Aesthetic and elective services are just as highly litigated by unhappy patients and patients that feel as though a treatment resulted in negative outcomes. Even as a supervising providing, your license is at risk.
While there are many more considerations to adding aesthetic services to your dental practice, the above stated would be sufficient to get a dentist in Florida started on the path to adding a new line of business to their traditional practice.
With the legalization of medical marijuana, I could not help but think, could a medical marijuana practice be the next “pill mill” and how could that be possible with the strict requirements set forth in Section 381.986, Florida Statutes. Turns out, only a handful of physicians are prescribing the majority of medical marijuana. While this may at first blush indicate a problem, keep in mind that marijuana, even medical marijuana is still outlawed under federal law and many physicians are not willing to risk a DEA license or possibly a state license to become a physician that certifies a patient for using medical marijuana. If a physician does become a qualified physician and issues medical marijuana certifications, certain practices and behaviors should be avoided.
A Practice with Similarities to a Pill Mill
In May 2019, Department of Health filed an administrative complaint against a “qualified physician” for basically over-certifying the use of medical marijuana. Pursuant to Section 381.986, there are only 13 medical conditions for which medical marijuana may be recommended. Of those 13 medical conditions, one is a bit of a “catch-all” as it is for medical conditions of the same kind or class as or comparable to a list of ten specific conditions, i.e., cancer, epilepsy, glaucoma, positive status for HIV, AIDS, PTSD, ALS, Crohn’s disease, Parkinson’s disease, and MS. This is where the physician ran into a problem. read more
On October 23, 2019, the U.S. Department of Health and Human Services has imposed a civil money penalty of over $2 million against Jackson Health System in Florida for repeated HIPAA violations.
The HIPAA violations mentioned in the HHS Press Release include: 1-Loss of paper patient records in December 2012; 2-Loss of additional paper patient records in January 2013; 3-A media report containing patient information (a photo shared on social media); 4-Employees accessing the information of one patient without a job related purpose; 5- An employee’s improper access and sale of patient records in 2011.
“OCR’s investigation revealed a HIPAA compliance program that had been in disarray for a number of years,” said OCR Director Roger Severino. The state of the compliance program allowed for the failure of several HIPAA requirements, including provision of timely and accurate HIPAA breach notifications, performance of regular risk assessments, investigation of identified risks, audits of system activity records, and imposing appropriate restrictions on workforce members’ access to patient information. The government’s final determination is available here.
When a HIPAA breach is discovered and reported, the government will often take the time to review a covered entity’s history of compliance or non-compliance. This may include an investigation into prior issues, effectiveness of policies and procedures, and employee issues. Overlooking one suspected breach may result in the imposition of sanctions on any later breach. This is why it’s so important for a healthcare business to understand its HIPAA obligations and take them seriously.
When was the last time your business conducted a security risk assessment to understand its potential risk areas for security breaches? If you’ve never had one, or haven’t had one recently, the time is now to conduct one. “When was your last security risk assessment?” is often the first thing that the government will ask in response to a breach.
Federal fines for noncompliance with HIPAA are based on the level of negligence perceived by the Federal government at the time of the breach. Fines and penalties range from $100 to $50,000 per violation (or per record), with a maximum penalty of $1.5 million. Simply put, your healthcare business can’t afford to bury its head and hope that it won’t be hit.