This document does not reflect the intent or official position of the bill sponsor or House of Representatives.
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DATE: 6/29/2023
HOUSE OF REPRESENTATIVES STAFF FINAL BILL ANALYSIS
BILL #: CS/CS/HB 1471 Health Care Provider Accountability
SPONSOR(S): Health & Human Services Committee and Healthcare Regulation Subcommittee, Busatta
Cabrera and others
TIED BILLS: IDEN./SIM. BILLS:
FINAL HOUSE FLOOR ACTION: 115 Y’s
0 N’s GOVERNOR’S ACTION: Approved
SUMMARY ANALYSIS
CS/CS/HB 1471 passed the House on April 26, 2023, as amended. The bill was amended in the Senate on
May 4, 2023, and returned to the House. The House concurred in the Senate amendment and subsequently
passed the bill as amended on May 4, 2023.
The bill addresses health care provider accountability related to nursing home residents’ rights, unlicensed
facilities, and standards of care for certain office surgeries.
Section 400.022, F.S., establishes an extensive list of resident rights that a nursing home must afford to its
residents. The list includes, but is not limited to, the right to civil and religious liberties, the right to participate in
social and other activities that do not impact other residents’ rights, and the right to refuse medication and
treatment. The bill adds to the list of nursing home residents’ rights the right to be free from sexual abuse,
neglect, and exploitation.
The bill authorizes the Agency for Health Care Administration (AHCA) to seek an ex parte temporary injunction
to prevent continuing unlicensed activity by a provider who has been warned by the agency to cease such
unlicensed activity. The bill establishes the temporary injunction process, including petition requirements,
subsequent inspections to determine compliance, and a permanent injunction process if the provider is not
complying with the ex parte temporary injunction. This applies to any entity licensed by AHCA.
The bill establishes standards of practice for physicians performing gluteal fat grafting procedures in office
settings. The bill prohibits certain procedures in an office surgery setting, sets standards for performing such
grafting procedures, and includes inspection requirements to become registered to perform such office
surgeries.
The bill has an indeterminate, negative fiscal impact on AHCA and the Department of Health that can be
absorbed within existing resources. The bill has no fiscal impact on local government.
The bill was approved by the Governor on June 28, 2023, ch. 2023-307, L.O.F., and will become effective on
July 1, 2023.
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I. SUBSTANTIVE INFORMATION
A. EFFECT OF CHANGES:
Background
Nursing Home Resident Rights
Section 400.022, F.S., establishes rights that a nursing home must afford to each of its residents. The
section requires that all nursing home facilities adopt and make public a statement of the rights and
responsibilities of the residents and treat such residents in accordance with the provisions of that
statement. The statement must assure each resident has or receives:
The right to civil and religious liberties.
The right to private and uncensored communication.
Any entity or individual that provides health, social, legal, or other services to a resident has the
right to have reasonable access to the resident. The resident has the right to deny or withdraw
consent to access at any time by any entity or individual. Notwithstanding the visiting policy of
the facility, the section specifies that certain individuals, including immediate family members
and regulatory personnel, must be permitted immediate access to the resident.
The right to present grievances on behalf of himself or herself or others to the staff or
administrator of the facility, to governmental officials, or to any other person; to recommend
changes in policies and services to facility personnel; and to join with other residents or
individuals within or outside the facility to work for improvements in resident care, free from
restraint, interference, coercion, discrimination, or reprisal.
The right to organize and participate in resident groups in the facility and the right to have the
resident’s family meet in the facility with the families of other residents.
The right to participate in social, religious, and community activities that do not interfere with the
rights of other residents.
The right to examine, upon reasonable request, the results of the most recent inspection of the
facility conducted by a federal or state agency and any plan of correction in effect with respect
to the facility.
The right to manage his or her own financial affairs or to delegate such responsibility to the
licensee, but only to the extent of the funds held in trust by the licensee for the resident.
The right to be fully informed, in writing and orally, prior to or at the time of admission and during
his or her stay, of services available in the facility and of related charges for such services.
The right to be adequately informed of his or her medical condition and proposed treatment,
unless the resident is determined to be unable to provide informed consent under Florida law, or
the right to be fully informed in advance of any nonemergency changes in care or treatment that
may affect the resident’s well-being; and, except with respect to a resident adjudged
incompetent, the right to participate in the planning of all medical treatment, including the right to
refuse medication and treatment, unless otherwise indicated by the resident’s physician; and to
know the consequences of such actions.
The right to refuse medication or treatment and to be informed of the consequences of such
decisions, unless determined unable to provide informed consent under state law.
The right to receive adequate and appropriate health care and protective and support services,
including social services; mental health services, if available; planned recreational activities; and
therapeutic and rehabilitative services consistent with the resident care plan, with established
and recognized practice standards within the community, and with rules as adopted by the
Agency for Health Care Administration (AHCA).
The right to have privacy in treatment and in caring for personal needs; to close room doors and
to have facility personnel knock before entering the room, except in the case of an emergency
or unless medically contraindicated; and to security in storing and using personal possessions.
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The right to be treated courteously, fairly, and with the fullest measure of dignity and to receive
a written statement and an oral explanation of the services provided by the licensee, including
those required to be offered on an as-needed basis.
The right to be free from mental and physical abuse, corporal punishment, extended involuntary
seclusion, and from physical and chemical restraints, except those restraints authorized in
writing by a physician for a specified and limited period of time or as are necessitated by an
emergency.
The right to be transferred or discharged only for medical reasons or for the welfare of other
residents, and the right to be given reasonable advance notice of no less than 30 days of any
involuntary transfer or discharge, with certain exceptions.
The right to freedom of choice in selecting a personal physician; to obtain pharmaceutical
supplies and services from a pharmacy of the resident’s choice; and to obtain information about,
and to participate in, community-based activities programs, unless medically contraindicated as
documented by a physician in the resident’s medical record.
The right to retain and use personal clothing and possessions as space permits, unless to do so
would infringe upon the rights of other residents or unless medically contraindicated as
documented in the resident’s medical record by a physician.
The right to have copies of the rules and regulations of the facility and an explanation of the
responsibility of the resident to obey all reasonable rules and regulations of the facility and to
respect the personal rights and private property of the other residents.
The right to receive notice before the room of the resident in the facility is changed.
The right to be informed of the bed reservation policy for a hospitalization.
For residents of Medicaid or Medicare certified facilities, the right to challenge a decision by the
facility to discharge or transfer the resident, as required under 42 C.F.R. s. 483.12.
Each nursing home must orally inform the resident of the resident’s rights and provide a copy of the
statement to each resident or the resident’s legal representative at or before the resident’s admission to
a facility and to each staff member of the facility. Each licensee must prepare a written plan and provide
appropriate staff training to implement the provisions of the section.
The written statement of rights must include a statement that a resident may file a complaint with the
Agency for Health Care Administration (AHCA) or state or local ombudsman council. The statement
must be in boldfaced type and include the telephone number and e-mail address of the State Long-
Term Care Ombudsman Program and the telephone numbers of the local ombudsman council and the
Elder Abuse Hotline operated by the Department of Children and Families. The section specifies that
any violation of the resident’s rights constitutes grounds for licensure action.
Also, in order to determine whether the licensee is adequately protecting residents’ rights, the licensure
inspection of the facility must include private informal conversations with a sample of residents to
discuss residents’ experiences within the facility with respect to rights specified in this section and
general compliance with standards and consultation with the State Long-Term Care Ombudsman
Program. Any person who submits or reports a complaint concerning a suspected violation of the
resident’s rights or concerning services or conditions in a facility or who testifies in any administrative or
judicial proceeding arising from such complaint will have immunity from any criminal or civil liability for
that report, unless that person acted in bad faith, with malicious purpose, or if the court finds that there
was a complete absence of a justiciable issue of either law or fact raised by the losing party.
In addition to the rights listed in s. 400.022, F.S., federal law establishes rights for residents in Medicaid
and Medicare certified nursing homes. Many of the rights mirror rights established in s. 400.022, F.S. In
general, federal law guarantees the right to:
Be treated with respect;
Participate in activities;
Be free from discrimination;
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Be free from abuse and neglect;
Be free from restraints;
Make complaints;
Get proper medical care (including choosing one’s own personal physician);
Have representatives notified of certain occurrences;
Get information on services and fees;
Manage one’s own money;
Have proper privacy, property, and living arrangements;
Spend time with visitors;
Get social services;
Leave the nursing home;
Have protection against unfair transfers and discharges;
Form or participate in resident groups; and
Include family and friends.
1
This is an extensive list of rights to which nursing home residents are guaranteed, including the right to
be free from abuse and neglect. However, the list does not include express rights to be free from
sexual abuse, exploitation, or neglect.
Ex Parte Temporary Injunctions
An injunction is a court order prohibiting someone from doing a specified act or commanding someone
to undo some wrong or injury.
2
A temporary injunction may be granted without written or oral notice to
the adverse party only if:
It appears from the specific facts shown by affidavit or verified pleading that immediate and
irreparable injury, loss, or damage will result to the movant before the adverse party can be
heard in opposition; and
The movant's attorney certifies in writing any efforts that have been made to give notice and the
reasons why notice should not be required.
3
No evidence other than the affidavit or verified pleading can be used to support the application for a
temporary injunction unless the adverse party appears at the hearing or has received reasonable notice
of the hearing. Every temporary injunction granted without notice shall be endorsed with the date and
hour of entry and shall be filed forthwith in the clerk's office and shall define the injury, state findings by
the court why the injury may be irreparable, and give the reasons why the order was granted without
notice if notice was not given. The temporary injunction shall remain in effect until the further order of
the court.
4
Every injunction shall specify the reasons for entry, shall describe in reasonable detail the act or acts
restrained without reference to a pleading or another document, and shall be binding on the parties to
the action, their officers, agents, servants, employees, and attorneys and on those persons in active
concert or participation with them who receive actual notice of the injunction.
5
A petition for temporary injunction is immediately presented to a judge, who must review the petition. If
the petition is facially sufficient, the petition and related documents become public record. If it appears
to a court that an immediate and present danger exists, it may grant a temporary injunction ex parte.
6
A
1
42 CFR s. 483.10; for a summary of these rights please see: Your Rights and Protections as a Nursing Home Resident, Centers for
Medicare and Medicaid Services, available at https://downloads.cms.gov/medicare/your_resident_rights_and_protections_section.pdf
(last viewed on April 5, 2023).
2
Black’s Law Dictionary 540 (6th ed. 1995).
3
Fla. R. Civ. P. 1.610(a)(1)
4
Fla. R. Civ. P. 1.610(a)(2)
5
Fla. R. Civ. P. 1.610(c)
6
The judge may issue a temporary injunction based solely on information provided by the petitioner.
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hearing must be set at the earliest possible time after a petition is filed and the respondent must be
personally served with a copy of the petition.
7
The court may grant such relief as it deems proper.
8
Temporary injunctions cannot exceed 15 days.
9
The court may grant a continuance of the hearing for
good cause, which may include obtaining service of process.
10
A temporary injunction must be
extended, if necessary, during any period of continuance.
11
Current Florida law establishes a cause of action for an ex parte temporary injunction in several
criminal situations, such as domestic violence
12
; repeat violence, sexual violence, and dating violence
13
;
child abuse
14
; stalking and cyberstalking
15
; and exploitation of a vulnerable adult.
16
Unlicensed Activity
It is unlawful for any person or entity to own, operate, or maintain an unlicensed provider under s.
408.812, F.S. Unlicensed activity can cause harm that materially affects the health, safety, and welfare
of health care clients, and constitutes abuse and neglect. Current law authorizes AHCA or any state
attorney to bring an action for an injunction to restrain unlicensed activity, or to enjoin the future
operation or maintenance of the unlicensed provider or the performance of any services in violation of
applicable statutes, until compliance with statutes and rules has been demonstrated to the satisfaction
of AHCA.
17
In addition to injunctive relief, if AHCA determines that a person or entity is operating or
maintaining a provider without obtaining a license and determines that a condition exists that poses a
threat to the health, safety, or welfare of a client of the provider, the person or entity is subject to the
same actions and fines imposed against a licensee as specified in applicable statutes and rules.
18
The temporary injunction process in current law requires notice to an offending party, and follows a
procedure that can take time to result in an issued injunction. In cases where unlicensed activity
continues, despite notice from the agency to cease such activity, it presents an emergency situation
that threatens the health, safety, and welfare of persons, and the current injunction process may allow
such an emergency situation to remain in effect without any sufficient protection of the population.
Regulation of Office Surgeries
The Board of Medicine and the Board of Osteopathic Medicine (collectively, boards) have authority to
adopt rules to regulate practice of medicine and osteopathic medicine, respectively.
19
The boards have
authority to establish, by rule, standards of practice and standards of care for particular settings.
20
Such
standards may include education and training, medications including anesthetics, assistance of and
delegation to other personnel, sterilization, performance of complex or multiple procedures, records,
informed consent, and policy and procedures manuals.
21
7
S. 741.30(4), F.S.
8
S. 741.30(5), F.S.
9
S. 741.30(5)(c), F.S.
10
Id.
11
Id.
12
S. 741.30, F.S.
13
S. 784.046, F.S.
14
S. 39.504, F.S.
15
S. 784.0485, F.S.
16
S. 825.1035, F.S.
17
S. 408.812(2), F.S.
18
S. 408.812(6), F.S.
19
Chapter 458, F.S., regulates the practice of allopathic medicine, and ch. 459, F.S., regulates the practice of osteopathic medicine.
20
Ss. 458.331(v) and 459.015(z), F.S.
21
Id.
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The boards set forth the standards of care that must be met for office surgeries. An office surgery is any
surgery that is performed outside a facility licensed under ch. 390, F.S., or ch. 395, F.S.
22
There are
several levels of office surgeries governed by rules adopted by the boards, which set forth the scope of
each level of office surgeries, the equipment and medications that must be available, and the training
requirements for personnel present during the surgery.
Registration
The boards require a licensed physician who performs liposuction procedures in which more than 1,000
cubic centimeters of supernatant fat is removed, Level II procedures planned to last more than five
minutes, and Level III procedures to register the office with DOH.
23
A physician who performs surgery in
an office setting must ensure that the office is registered with DOH, regardless of whether other
physicians practice in the office or the office is not owned by a physician.
24
The registration requires a
physician to document compliance with transfer agreement
25
and training requirements. DOH must
annually inspect registered offices or the office must be accredited by a national accreditation
organization approved by the respective board.
26
Currently, there are 719 offices registered with
DOH.
27
Standards of Care
Prior to performing any surgery, a physician must evaluate the risk of anesthesia and of the surgical
procedure to be performed.
28
A physician must maintain a complete record of each surgical procedure,
including the anesthesia record, if applicable, and written informed consent.
29
The written consent must
reflect the patient’s knowledge of identified risks, consent to the procedure, type of anesthesia and
anesthesia provider, and that a choice of anesthesia provider exists.
30
Physicians performing office surgeries must maintain a log of all liposuction procedures in which more
than 1,000 cubic centimeters of supernatant fat is removed and Level II and Level III surgical
procedures performed, which includes:
31
A confidential patient identifier;
The time the patient arrives in the operating suite;
The name of the physician who provided medical clearance;
The surgeon’s name;
The diagnosis;
The CPT Codes for the procedures performed;
The patient’s ASA classification;
The type of procedure performed;
The level of surgery;
The anesthesia provider;
The type of anesthesia used;
22
Rules 64B8-9.009(1)(d) and 64B15-14.007(1)(d), F.A.C. Abortion clinics are licensed under ch. 390, F.S., and facilities licensed
under ch. 395, F.S., include hospitals, ambulatory surgery centers, mobile surgical facilities, and certain intensive residential treatment
programs.
23
SS. 458.309(3) and 459.005(2), F.S., see also Rules 64B8-9.0091 and 64B15-14.0076, F.A.C.
24
Rule 64B8-9.0091(1) and 64B15-14.0076(1), F.A.C.
25
A physician or the facility where a surgical procedure is being performed must have a transfer agreement with a licensed hospital
within a reasonable proximity or within 30 minutes transport time to the hospital. Rules 64B8-9.009 and 64B15-14.007, F.A.C.
26
Supra, FN 23.
27
Department of Health, License Verification – Office Surgery Registration, Practicing Statuses Only, March 21, 2023, available at
https://mqa-internet.doh.state.fl.us/MQASearchServices/HealthCareProviders (last visited April 5, 2023).
28
Rules 64B8-9.009(2) and 64B15-14.007(2), F.A.C.
29
Id. A physician does not need to obtain written informed consent for minor Level I procedures limited to the skin and mucosa.
30
Id. A patient may use an anesthesiologist, anesthesiologist assistant, another appropriately trained physician, certified registered
nurse anesthetist, or physician assistant.
31
Rules 64B8-9.009(2)(a) and 64B15-14.007(2)(a), F.A.C.
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The duration of the procedure;
The type of post-operative care;
The duration of recovery;
The disposition of the patient upon discharge;
A list of medications used during surgery and recovery; and
Any adverse incidents.
Such log must be maintained for at least six years from the last patient contact and must be provided to
DOH investigators upon request.
32
For elective cosmetic and plastic surgery procedures performed in a physician’s office:
33
The maximum planned duration of all planned procedures cannot exceed eight hours.
A physician must discharge the patient within 24 hours, and overnight stay may not exceed 23
hours and 59 minutes.
The overnight stay is strictly limited to the physician’s office.
If the patient has not sufficiently recovered to be safely discharged within the 24-hour period,
the patient must be transferred to a hospital for continued post-operative care.
Levels of Office Surgeries
Level I
Level I involves the most minor of surgeries, which require minimal sedation
34
or local or topical
anesthesia, and have a remote chance of complications requiring hospitalization.
35
Level I procedures
include:
36
Minor procedures such as excision of skin lesions, moles, warts, cysts, lipomas and repair of
lacerations, or surgery limited to the skin and subcutaneous tissue performed under topical or
local anesthesia not involving drug-induced alteration of consciousness other than minimal pre-
operative tranquilization of the patient;
Liposuction involving the removal of less than 4000cc supernatant fat; and
Incision and drainage of superficial abscesses, limited endoscopies such as proctoscopies,
skin biopsies, arthrocentesis, thoracentesis, paracentesis, dilation of urethra, cystoscopic
procedures, and closed reduction of simple fractures or small joint dislocations (i.e., finger and
toe joints).
Level II
Level II office surgeries involve moderate sedation
37
and require the physician office to have a transfer
agreement with a licensed hospital that is no more than 30 minutes from the office.
38
Level II office
surgeries, include but is not limited to:
39
32
Id.
33
Rules 64B8-9.009(2)(f) and 64B15-14.007(2)(f), F.A.C.
34
Minimal sedation is a drug-induced state during which the patient responds normally to verbal commands. Although cognitive function
and physical coordination may be impaired, airway reflexes, and ventilator and cardiovascular functions are not impaired. Controlled
substances are limited to oral administration in doses appropriate for the unsupervised treatment of insomnia, anxiety, or pain.
35
Rules 64B8-9.009(3) and 64B15-14.007(3), F.A.C.
36
Id.
37
Moderate sedation or conscious sedation is a drug-induced depression of consciousness during which a patient responds
purposefully to verbal commands, either alone or accompanied by light tactile stimulations. No interventions are needed to manage the
patient’s airway and spontaneous ventilation is adequate. Cardiovascular function is maintained. Reflex withdrawal from a painful
stimulus is not considered a purposeful response.
38
Rules 64B8-9.009(4) and 64B15-14.007(4), F.A.C.
39
Id.
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Hemorrhoidectomy, hernia repair, large joint dislocations, colonoscopy, and liposuction involving
the removal of up to 4,000cc supernatant fat; and
Any surgery in which the patient’s level of sedation is that of moderate sedation and analgesia
or conscious sedation.
A physician performing a Level II office surgery must:
40
Have staff privileges at a licensed hospital to perform the same procedure in that hospital as the
surgery being performed in the office setting;
Demonstrate to the appropriate board that he or she has successfully completed training directly
related to and include the procedure being performed, such as board certification or eligibility to
become board-certified; or
Demonstrate comparable background, training or experience.
A physician, or a facility where the procedure is being performed, must have a transfer agreement with
a licensed hospital within a reasonable proximity
41
if the physician performing the procedure does not
have staff privileges to perform the same procedure at a licensed hospital within a reasonable
proximity.
42
Anesthesiology must be performed by an anesthesiologist, a certified registered nurse anesthetist
(CRNA), or a qualified physician assistant (PA). An appropriately-trained physician, PA, or RN with
experience in post-anesthesia care, must be available to monitor the patient in the recovery room until
the patient is recovered from anesthesia.
43
Level IIA
Level IIA office surgeries are those Level II surgeries with a maximum planned duration of 5 minutes or
less and in which chances of complications requiring hospitalization are remote.
44
A physician,
physician assistant, registered nurse, or licensed practical nurse must assist the surgeon during the
procedure and monitor the patient in the recovery room until the patient is recovered from anesthesia.
45
The assisting health care practitioner must be appropriately certified in advanced cardiac life support, or
in the case of pediatric patients, pediatric advanced life support.
46
Level III
Level III office surgeries are the most complex and require deep sedation or general anesthesia.
47
A
physician performing the surgery must have staff privileges to perform the same procedure in a
hospital.
48
The physician must also have knowledge of the principles of general anesthesia.
40
Id.
41
Transport time to the hospital must be 30 minutes of less.
42
Supra, FN 38.
43
Id. The assisting practitioner must be trained in advanced cardiovascular life support, or for pediatric patients, pediatric advanced life
support.
44
Rules 64B-9.009(5) and 64B15-14.007(5), F.A.C.
45
Id.
46
Id.
47
Deep sedation is a drug-induced depression of consciousness during which a patient cannot be easily aroused but responds
purposefully following repeated or painful stimulation. The ability to independently maintain ventilatory function may be impaired. A
patient may require assistance in maintaining a patent airway, and spontaneous ventilation may be inadequate. Cardiovascular function
is usually maintained. General anesthesia is a drug-induced loss of consciousness during which a patient is not arousable, even by
painful stimulation. The ability to independently maintain ventilatory function is often impaired. Patients often require assistance in
maintaining a patent airway, and positive pressure ventilation may be required because of depressed spontaneous ventilation or drug-
induced depression of neuromuscular function. Cardiovascular function may be impaired. The use of spinal or epidural anesthesia is
considered Level III.
48
Rules 64B8-9.009(6) and 64B15-14.007(6), F.A.C. The physician may also document satisfactory completion of training directly
related to and include the procedure being performed.
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Only patients classified under the American Society of Anesthesiologist’s (ASA) risk classification
criteria as Class I or II
49
are appropriate candidates for Level III office surgery.
50
For all ASA Class II
patients above the age of 50, the surgeon must obtain a complete workup performed prior to the
performance of Level III surgery in a physician office setting.
51
If the patient has a cardiac history or is
deemed to be a complicated medical patient, the patient must have a preoperative EKG and be
referred to an appropriate consultant for medical optimization. The referral to a consultant may be
waived after evaluation by the patient’s anesthesiologist.
52
All Level III surgeries on patients classified
as ASA III
53
and higher must be performed in a hospital or an ambulatory surgery center.
54
During the procedure, the physician must have one assistant who has current certification in advanced
cardiac life support. Additionally, the physician must have emergency policies and procedures related
to serious anesthesia complications, which address:
Airway blockage (foreign body obstruction);
Allergic reactions;
Bradycardia;
Bronchospasm;
Cardiac arrest;
Chest pain;
Hypoglycemia;
Hypotension;
Hypoventilation;
Laryngospasm;
Local anesthetic toxicity reaction; and
Malignant hypothermia.
Adverse Incident Reporting
A physician must report any adverse incident that occurs in an office practice setting to DOH within 15
days after the occurrence any adverse incident.
55
An adverse incident in an office setting is defined as
an event over which the physician or licensee could exercise control and which is associated with a
medical intervention and results in one of the following patient injuries:
56
The death of a patient;
Brain or spinal damage to a patient;
The performance of a surgical procedure on the wrong patient;
If the procedure results in death; brain or spinal damage; permanent disfigurement; the fracture
or dislocation of bones or joints; a limitation of neurological, physical, or sensory functions; or
any condition that required the transfer of a patient, the performance of:
o A wrong-site surgical procedure;
49
An ASA Class I patient is a normal, healthy, non-smoking patient, with no or minimal alcohol use. An ASA Class II patient is a patient
with mild systemic disease without substantive functional limitations. Examples include current smoker, social alcohol drinker,
pregnancy, obesity, well-controlled hypertension with diabetes, or mild lung disease. See American Society of Anesthesiologists, ASA
Physical Status Classification System, (Oct. 15, 2014, last amended Dec. 13, 2020), available at https://www.asahq.org/standards-and-
guidelines/asa-physical-status-classification-system (last visited on April 5, 2023).
50
Supra, FN 48.
51
Id.
52
Id.
53
An ASA Class III patient is a patient with severe systemic disease who has substantive functional limitations and/or one or more
moderate to severe diseases. This may include poorly controlled diabetes or hypertension, chronic obstructive pulmonary disease,
morbid obesity, active hepatitis, alcohol dependence or abuse, implanted pacemaker, premature infant, recent history of myocardial
infarction, cerebrovascular disease, transient ischemic attack, or coronary artery disease.
54
Supra, FN 48.
55
Ss. 458.351 and 459.026, F.S.
56
Ss. 458.351(4) and 459.026(4), F.S.
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o A wrong surgical procedure; or
o A surgical repair of damage to a patient resulting from a planned surgical procedure
where the damage is not a recognized specific risk as disclosed to the patient and
documented through the informed consent process;
A procedure to remove unplanned foreign objects remaining from a surgical procedure; or
Any condition that required the transfer of a patient to a hospital from an ambulatory surgical
center or any facility or any office maintained by a physician for the practice of medicine which
is not licensed under ch. 395, F.S.
DOH must review each adverse incident report to determine if discipline against the practitioner’s
license is warranted.
57
Recent Statutory Changes
In 2019, the Legislature provided DOH and the boards additional enforcement authority for offices in
which physicians perform certain liposuction procedures and office surgeries.
58
Registration
Physicians must register offices where liposuction procedures in which more than 1,000 cubic
centimeters of supernatant fat is removed, Level II procedures lasting more than five minutes, and
Level III office surgeries register with DOH. The 2019 law applies the registration requirement to the
office where the surgical procedures are performed and makes all Level II office surgeries subject to
the requirement and not just those surgeries lasting more than five minutes.
Each registered office must designate a physician who is responsible for complying with all laws and
regulations establishing safety requirements for such offices. The designated physician must hold an
active and unencumbered Florida license to practice medicine or osteopathic medicine, and must
practice at the registered office. Within 10 days after termination of the designated physician, a
registered office must notify DOH of the identity of a new designated physician. If a registered office
does not have a designated physician, DOH may suspend its registration.
Each physician performing office surgery at a registered office must advise his or her respective board,
in writing, within 10 days of beginning or ending practice at a registered office.
DOH must inspect each registered office annually unless the office is accredited by a nationally
recognized accrediting agency approved by the respective board. Such inspections may be
unannounced.
Enforcement Authority
DOH may deny or revoke an office registration if any of its physicians, owners, or operators do not
comply with any office surgery laws or rules. Also, DOH may deny a person applying for a facility
registration if he or she was named in the registration document of an office whose registration is
revoked for five years after the revocation date.
DOH may impose penalties on the designated physician if the registered office is not in compliance with
safety requirements, including:
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Suspension or permanent revocation of a license;
Restriction of license;
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Ss. 458.351(5) and 459.026(5), F.S.
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Ss. 458.328 and 459.0138, F.S.
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S. 456.072(2), F.S.
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Imposition of an administrative fine not to exceed $10,000 for each count or separate offense. If
the violation is for fraud or making a false or fraudulent representation, the board, or the
department if there is no board, must impose a fine of $10,000 per count or offense.;
Issuance of a reprimand or letter of concern.
Placement of the licensee on probation for a period of time and subject to such conditions as
the board;
Corrective action;
Imposition of an administrative fine in accordance with s. 381.0261 for violations regarding
patient rights;
Refund of fees billed and collected from the patient or a third party on behalf of the patient; or
Requirement that the licensee undergo remedial education.
DOH can also issue an emergency order suspending or restricting the registration of a facility if there is
probable cause that:
The office or its physicians are not in compliance with the board rule on the standards of
practice; or
The licensee or registrant is practicing or offering to practice beyond the scope allowed by law
or beyond his or her competence to perform; and
Such noncompliance constitutes an immediate danger to the public.
The boards must adopt rules establishing the standards of practice for physicians who perform office
surgery. The boards must fine physicians who perform office surgeries in an unregistered facility $5,000
per day. Lastly, performing office surgery in a facility that is not registered with DOH is grounds for
disciplinary action against a physician’s license.
Effect of Proposed Changes
The bill addresses health care provider accountability related to nursing home residents’ rights,
unlicensed facilities, and standards of care for certain office surgeries.
Nursing Home Resident Rights
The bill adds to the list of nursing home residents’ rights the rights to be free from sexual abuse,
neglect, and exploitation. By adding these rights, the bill allows licensure and Medicare certification
disciplinary action against a nursing home facility for failing to protect a resident from these offenses.
The enumerated nursing home residents’ rights have also been used as the basis for civil litigation
against nursing homes, alleging that a facility has failed to protect a resident’s rights, leading to injury
and damages. As a result, the rights added by the bill may also be used as the basis of future civil
litigation.
Ex Parte Injunction Against Continued Unlicensed Activity
The bill permits AHCA to petition a circuit court for an ex parte temporary injunction against continued
unlicensed activity by a health care provider under chapter 408, F.S. A sworn petition seeking an ex
parte temporary injunction must allege:
The location of unlicensed activity,
The owners and operators of the unlicensed provider,
The type of services being provided that require a license, and
Specific facts that support the conclusion that the unlicensed provider is engaged in unlicensed
activity, including:
o The date, time, and location at which the unlicensed provider was told to discontinue
activity,
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o Whether the unlicensed provider prevented AHCA from conducting a follow up
investigation to determine if the provider was engaged in unlicensed activity,
o Any previous injunctive relief entered against the unlicensed provider, and
o Any previous AHCA determination that the unlicensed provider was previously identified
as engaging in unlicensed activity.
o AHCA personnel have verified through an onsite inspection that the provider continues
to advertise, offer, or provide services that require a license.
In a hearing for an ex parte temporary injunction, only verified pleadings or affidavits by AHCA
personnel with firsthand knowledge of alleged unlicensed activity may be used, unless the respondent
appears at the hearing. If the court determines that the unlicensed provider is engaged in unlicensed
activity and has not abided by AHCA’s notification to cease such activity, the court may grant the
petition, pending a full hearing, for a period not to exceed 30 days. The court may also award relief it
deems proper, including a temporary injunction to prevent the unlicensed provider from advertising,
offering, or providing services that require a license, and requiring the unlicensed provider to give
AHCA full access to personnel, records, and clients for future inspections. The grounds for denial of a
petition for an ex parte temporary injunction must be in writing.
The bill requires AHCA to reinspect the unlicensed provider’s premises within 20 days of obtaining the
ex parte temporary injunction to verify the provider’s compliance. If the unlicensed provider is found in
compliance, AHCA must voluntarily dismiss the injunction. If the unlicensed provider is noncompliant,
AHCA may file for a permanent injunction within 10 days of identifying the noncompliance, and a full
hearing must be set by the court for as soon as practicable. Pending the full hearing, AHCA is
authorized to apply for an extension of the ex parte temporary injunction until the hearing is held.
The bill specifically states that AHCA is not required to exhaust its’ administrative remedies before
seeking an ex parte temporary injunction. Lastly, the bill authorizes AHCA to provide any documents or
other materials to local law enforcement or state attorney’s office in the investigation of criminal
violations by unlicensed activity.
An ex parte temporary injunction process does not require notice to an offending party. In cases where
a person or entity has demonstrated an unwillingness to abide by statute or rule and cease unlicensed
activity, despite notice from the agency to cease such activity, the ex parte temporary injunction is a
mechanism that can alleviate an emergency situation that threatens the health, safety, and welfare of
persons quickly. It also allows AHCA to inspect an unlicensed person or entity to determine if an
emergency situation remains in effect, requiring a permanent injunction, or if the person or entity has
ceased the unlicensed activity, thereby protecting the populace.
Office Surgeries - Gluteal Fat Procedures
The bill establishes standards of practice for physicians performing gluteal fat grafting procedures in
office surgery settings. Office surgery is a surgery performed at an office that primarily serves as the
doctor’s office where he or she regularly performs consultations, presurgical exams, and postoperative
observation and care, and where patient medical records are maintained and available.
The bill requires DOH to inspect any office where office surgeries will be done before the office is
registered. If the office refuses such inspection, it will not be registered until the inspection can be
completed. If an office that has already been registered with DOH refuses inspection its registration will
be immediately suspended and remain suspended until the inspection is completed, and the office must
close for 14 days.
A physician providing gluteal fat grafting procedures must adhere to the standards of practice in statute
and in rule. The bill requires a physician or osteopathic physician performing such procedures to
conduct an in-person exam of the patient, while physically present in the same room as the patient, no
later than the day before the procedure.
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The bill requires that any duty delegated by the physician and performed during the gluteal fat grafting
procedure must be completed under the direct supervision of the physician. Gluteal fat injections and
fat extraction may not be delegated. Gluteal fat injections must be done under ultrasound guidance, or
guidance with other technology authorized by rule that equals or exceeds the quality of ultrasound, to
ensure the fat is injected into the subcutaneous space. Gluteal fat may only be injected into the
subcutaneous space and may not cross the fascia covering gluteal muscle. Intramuscular and
submuscular fat injections are prohibited.
If any procedure results in hospitalization, the incident must be reported as an adverse incident.
The bill prohibits office surgeries from:
Resulting in blood loss greater than 10 percent of blood volume in a patient with normal
hemoglobin;
Requiring major or prolonged intracranial, intrathoracic, abdominal, or joint replacement
procedures, excluding laparoscopy;
Involving a major blood vessel with direct visualization by open exposure of the vessel, not
including percutaneous endovascular treatment
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; or
Being emergent or life threatening.
The bill provides an effective date of July 1, 2023.
II. FISCAL ANALYSIS & ECONOMIC IMPACT STATEMENT
A. FISCAL IMPACT ON STATE GOVERNMENT:
1. Revenues:
None.
2. Expenditures:
The bill will have an indeterminate, negative fiscal impact on AHCA for bringing ex parte temporary
injunctions to prevent continued unlicensed activity, and prosecuting permanent injunctions, as
necessary. In addition, the bill will have an indeterminate negative fiscal impact on DOH due to
updating internal systems and board websites. The fiscal impact on AHCA and DOH from
provisions in the bill can be absorbed within existing resources.
B. FISCAL IMPACT ON LOCAL GOVERNMENTS:
1. Revenues:
None.
2. Expenditures:
None.
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Such treatment addresses conditions such a peripheral artery disease and other arterial blockages.
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C. DIRECT ECONOMIC IMPACT ON PRIVATE SECTOR:
The bill may have an indeterminate, negative impact on physicians who wish to perform office surgeries
due to administrative compliance with inspection and registration requirements, and complying with
delegation restrictions for gluteal fat grafting procedures.
D. FISCAL COMMENTS:
None.