Can You Afford Not to Comply?
By CHAIRES, BROODERSON & GUERRERO
As discussed in last month’s issue, a doctor’s office can be many things these days - a laboratory, a pharmacy, a beauty salon, a weight loss clinic; and contain surgical office suites where procedures can be performed. Office surgery has been around for many years and has continued to expand in scope and operation over the course of the last several years. The Florida Board of Medicine promulgated the Office Surgery Rule years ago to provide guidance on how such office-based surgery facilities must operate and has amended it periodically since its inception.
Like many things in health care, the business world got creative in what procedures could be performed in the office setting and where they could be performed. Concomitantly, concerned about multiple poor and sometimes fatal outcomes (especially in the field of plastic surgery), the Legislature took great interest in the matter, which lead to the passage of Senate Bill 732, and was signed into law by Governor DeSantis on June 25, 2019. Effective January 1, 2020, this law is codified in Sections 458.328 and 459.0138, Florida Statutes, and simply stated is a game changer in the regulation of office-based surgery.
So, what is office surgery? Further to Rule 64B8-9.009, F.A.C. (the Rule), surgery is defined as the manual or operative procedure, including the use of lasers performed upon the body of a living human being for the purposes of preserving health, diagnosing or curing disease, repairing injury, correcting deformity or defects, prolonging life, relieving suffering or any elective procedure for aesthetic, reconstructive or cosmetic purposes. Under the Rule, office surgery is anything performed outside of an ASC, which in and of itself is a licensed and regulated facility.
Who has to register?
A physician office which has a physician that performs a liposuction procedure in which more than 1,000 cubic centimeters of supernatant fat is removed, a Level II office surgery, or a Level III office surgery must register with the Department of Health (the Procedures). A Level II procedure is one where any surgery in which the patient’s level of sedation is that of moderate sedation and analgesia or conscious sedation occurs. A Level III procedure is one in which the patient’s level of sedation is that of deep sedation and analgesia or general anesthesia.
Designated Physician and Physician Notification?
Each physician office location that wishes to perform office surgery that meets the above thresholds, must register by January 1, 2020. That includes any office that is currently registered. In other words, all physician facilities must re-register. At the time of registration, the office must designate a physician who is responsible for the office’s compliance with all applicable rules regarding the office’s health and safety requirements. The designated physician must have a full, active, and unencumbered license under Medical Practice Act or the Osteopathic Practice Act. Further, each physician that practices at a registered office must, within ten (10) calendar days, notify the Florida Department of Health in writing of starting or ending his or her practice at a registered office.
Financial Responsibility Requirement
As a condition of registration, each office must establish financial responsibility by demonstrating it has met and continues to maintain, at a minimum, the same financial responsibility requirements applicable to physicians. Further each physician practicing at a registered office must meet the financial responsibility requirements under the appropriate practice act.
Traditionally, the Florida Department of Health has registered office surgery locations and inspected such facilities annually. When deficiencies have been identified in such practices at the time of inspection, the physician office has submitted a Corrective Action Plan that addressed the deficiencies, resolving the matter. However, over the last couple of years, there was a push by the Florida Department of Health and the Florida Board of Medicine to hold the physicians associated with the office surgery locations responsible for violations of the Rule, though there were challenges in that regard. SB 732 was intended to address some of the glaring issues and challenges experienced in prior years. It is important to note, that there will continue to be annual inspections of such office facilities by the Florida Department of Health, and now such inspections may be unannounced except in limited circumstances, unless the office is accredited by a nationally recognized accrediting agency approved by the Florida Board of Medicine.
Penalties for Violation
The Florida Department of Health may suspend or revoke an office surgery registration in which Procedures or registration of any office in which Procedures are performed for failure of any of its physicians, owners, or operators, to comply with Section 458.328 and Section 459.0138, Florida Statutes, or any rule adopted thereunder. Importantly, if an office’s registration is revoked, the Department may deny any person named in the registration documents of the office, including those that own or operate the office, from registering an office to perform procedures or office surgeries for five (5) years after the registration date. In essence, a five (5) year suspension.
In addition, under the new law, the Florida Department of Health has independent authority to impose penalties against a designated physician for failure of an office to comply, which includes suspension or revocation of a license. This can be effectuated independently of the Florida Board of Medicine, the body that has had the exclusive authority to discipline a physician’s medical license prior to this new law. Thus, the Florida Department of Health can theoretically revoke a designated physician’s license, whether the Florida Board of Medicine agrees or not.
The new law also provides that the Florida Board of Medicine is required to impose a fine of $5,000 per day on a physician who performs a procedure or surgery in an office that is not registered. This could be the designated physician (if he or she performs procedures), or any other physician affiliated with an office that performs Procedures. It is incumbent on any physician that intends to perform Procedures that such physician ensures that an office is properly registered, and that the physician is properly registered at that office location. That penalty is significant and mandatory but may not be the only penalty a physician incurs.
It is critical that all offices that perform Procedures register or re-register prior to the end of 2019 and designate a physician that is responsible for the compliance of the office. It is important that compliance be something that is done on an ongoing basis, since the Department may now perform inspections unannounced. It is critical that physicians that perform Procedures at offices ensure that the office location is properly registered and that the physician performing the Procedures is registered at the applicable office location. The penalties are significant, and the risk of non-compliance simply is not worth it.
We would encourage any office that performs procedures to visit the Florida Board of Medicine’s website and review its “Frequently Asked Questions” section concerning compliance with SB 732. We would also encourage any physician that performs Procedures at an office, become aware of the requirements of the rule. Ignorance of the new law or its rules will not be a defense, and certainly ignorance of whether an office is properly registered, will not serve a physician well. The non-permissive penalty that must be imposed by the Board of Medicine can be financially devastating. As always, any practitioner or office requiring assistance or further information is encouraged to contact their health care attorney.
While this articles touches on the new statute that is taking place on January 1, 2020, regarding office based surgery, it is not a comprehensive review of all the relevant statutes, rules and laws that govern the delivery of such health care services in the office setting and thus, is not, nor should it be construed as, legal advice. Compliance will require analysis of multiple statutes and rules, including the Board of Medicine’s Office Surgery rule which is currently being revised further to the new statute discussed in this article.
Attorneys Gregory A. Chaires, Dr. Richard J. Brooderson and JoAnn M. Guerrero are attorneys and advisors serving health care providers. We are happy to assist in providing legal services concerning office-based surgery that you may have. Visit www.chlawyers.com