HB 1127 2003
1	A bill to be entitled
2	An act relating to freestanding diagnostic imaging
3	facilities; creating pt. V of ch. 483, F.S., the Florida
4	Freestanding Diagnostic Imaging Facilities Law; creating
5	s. 483.95, F.S.; providing a popular name; creating s.
6	483.951, F.S.; declaring policy and purpose; creating s.
7	483.952, F.S.; providing exemptions from the act; creating
8	s. 483.953, F.S.; providing definitions; creating s.
9	483.954, F.S.; granting rulemaking authority, powers, and
10	duties to the Agency for Health Care Administration;
11	providing standards, fees, and licensing requirements;
12	creating s. 483.955, F.S.; providing for inspection of
13	facilities; creating s. 483.956, F.S.; providing for
14	licensing of facilities and requirements; providing for
15	licensing denials and revocations; creating s. 483.9565,
16	F.S.; providing for licensure application and application
17	requirements; creating s. 483.957, F.S.; requiring a
18	facility to have a medical director; providing
19	requirements for the director; creating s. 483.958, F.S.;
20	requiring facilities to display licenses; creating s.
21	483.959, F.S.; providing for disciplinary actions against
22	facilities in specified circumstances; creating s.
23	483.9591, F.S.; providing administrative penalties;
24	creating s. 483.9595, F.S.; providing for offenses;
25	creating s. 483.95955, F.S.; providing criminal penalties;
26	creating s. 483.9596, F.S.; authorizing injunctive actions
27	to be brought against unlicensed facilities; prohibiting
28	claims to be filed by unlicensed facilities; providing an
29	effective date.
30
31	Be It Enacted by the Legislature of the State of Florida:
32
33	Section 1. Part V of chapter 483, consisting of sections
34	483.95, 483.951, 483.952, 483.953, 483.954, 483.955, 483.956,
35	483.9565, 483.957, 483.958, 483.959, 483.9591, 483.9595,
36	483.95955, and 483.9596, Florida Statutes, is created to read:
37	PART V
38	FREESTANDING DIAGNOSTIC IMAGING FACILITIES
39	483.95 Popular name.--This part may be known by the
40	popular name "The Florida Freestanding Diagnostic Imaging
41	Facilities Law."
42	483.951 Declaration of policy and statement of
43	purpose.--The purpose of this part is to protect the health,
44	safety, and welfare of the people of this state from the hazards
45	of improper performance by freestanding diagnostic imaging
46	facilities. Diagnostic imaging facilities provide, among other
47	things, certain physician-ordered diagnostic imaging services,
48	including computerized axial tomography (CAT scan), magnetic
49	resonance imaging (MRI), ultrasound, and certain nuclear
50	medicine procedures, which are performed at the facility by
51	trained technicians under the supervision of physicians. Some
52	facilities utilize equipment that is obsolete or poorly
53	maintained. Images produced by such equipment lack sufficient
54	resolution and detail to enable a physician to render a
55	consistently reliable diagnosis or treatment decision. An
56	inaccurate diagnosis or treatment decision may cause unnecessary
57	anxiety, suffering, and additional financial expense for
58	individuals and their insurers and other third-party payors, or
59	may create a false and injudicious sense of security with
60	respect to the state of an individual's health, and may even
61	contribute directly to an individual's death. Improving the
62	quality of health care in the manner provided in this part will
63	have a positive effect upon the cost of professional liability
64	insurance for professionals and other providers. Therefore, the
65	Legislature finds and declares that the protection of the public
66	health requires the licensing of such facilities, the
67	establishment of certain minimum standards for the equipment and
68	professional staff used in such facilities, and other necessary
69	safeguards as authorized by this part.
70	483.952 Application of part; exemptions.--This part
71	applies to all freestanding diagnostic imaging facilities within
72	the state, but does not apply to:
73	(1) An entity operated by the United States Government,
74	the state, or any political subdivision of the state.
75	(2) An entity that limits screening to tests intended to
76	identify specific physical disorders or conditions and that
77	provides health services to the public free of charge or for a
78	donation to be used for charitable purposes.
79	(3) A hospital licensed under chapter 395.
80	(4) An ambulatory surgical facility licensed under chapter
81	395.
82	(5) A health maintenance organization certified under part
83	I of chapter 641.
84	(6) An office that is operated by a physician licensed
85	under chapter 458 or chapter 459.
86	483.953 Definitions.--As used in this part:
87	(1) "Agency" means the Agency for Health Care
88	Administration.
89	(2) “Computerized axial tomography” or “CAT scan” means a
90	series of X-ray images as slices of the human body that are
91	integrated by computer to create a two-dimensional image of the
92	body and its internal structures along various axes.
93	(3) "Consumer freestanding diagnostic imaging facilities"
94	are freestanding diagnostic imaging facilities that are open to
95	the general public.
96	(4) "Facility personnel" includes persons employed by a
97	facility, but does not include persons employed to perform
98	clerical or other administrative responsibilities.
99	(5) "Freestanding diagnostic imaging facility" or
100	"facility" means any fixed or mobile facility where computerized
101	axial tomography technology, magnetic resonance imaging,
102	ultrasound, or nuclear medicine is used to make diagnostic
103	images.
104	(6) “Magnetic resonance imaging” or “MRI” means a
105	procedure that uses magnetic signals, as opposed to X rays, to
106	create image slices of soft tissues, blood vessels, and other
107	body structures that are integrated by computer to create highly
108	detailed two-dimensional images of the human body along various
109	axes.
110	(7) “Nuclear medicine” includes a variety of medical
111	procedures including bone scans, scans of various internal
112	organs, cardiac stress tests utilizing radiopharmaceuticals, and
113	positron emission tomography (PET) scanning. Each of these
114	procedures involves introduction into the human body of low-
115	level radioactive material that is absorbed by the specific body
116	structure or diseased tissue to be studied. Specialized scanners
117	are then used to collect data regarding the concentrations of
118	radioactive material absorbed by the specific body structure or
119	tissue being studied.
120	(8) “Ultrasound” means a procedure that uses reflected
121	soundwaves, similar to sonar, transmitted and collected by a
122	transducer, which creates a real-time image of internal body
123	structures.
124	483.954 Powers and duties of the agency; rules.--The
125	agency shall adopt rules to implement this part, which rules
126	must include the following:
127	(1) LICENSING STANDARDS.--The agency shall license all
128	freestanding diagnostic imaging facilities meeting the
129	requirements of this part and shall prescribe standards
130	necessary for licensure.
131	(2) FEES.--The agency shall establish annual fees, which
132	shall be reasonable in amount, for licensing of facilities. The
133	fees must be sufficient in amount to cover the cost of licensing
134	and inspecting facilities.
135	(a) The annual licensure fee is due at the time of
136	application and is payable to the agency to be deposited in the
137	Health Care Trust Fund administered by the agency. The licensure
138	fee must be not less than $300 nor more than $1,000.
139	(b) The fee for the late filing of an application for
140	license renewal is $200 and is in addition to the licensure fee
141	due for renewing the license.
142	(3) ANNUAL LICENSING.--The agency shall provide for annual
143	licensing of facilities. Any facility that fails to pay the
144	proper fee or otherwise fails to qualify by the date of
145	expiration of its license is delinquent, and its license is
146	automatically canceled without notice or further proceeding.
147	Upon cancellation of its license under this subsection, a
148	facility may have its license reinstated only upon application
149	and qualification as provided for initial applicants and upon
150	payment of all delinquent fees.
151	(4) STANDARDS OF PERFORMANCE.--The agency shall prescribe
152	standards for the performance of freestanding diagnostic imaging
153	facilities.
154	(5) CONSTRUCTION OF FACILITIES.--The agency may adopt
155	rules to ensure that facilities comply with all local, county,
156	state, and federal standards for the construction, renovation,
157	maintenance, or repair of facilities, which standards must
158	ensure the conduct and operation of the facilities in a manner
159	that shall protect the public health.
160	(6) SAFETY AND SANITARY CONDITIONS WITHIN THE FACILITY AND
161	ITS SURROUNDINGS.--The agency shall establish standards relating
162	to safety and sanitary conditions within the facility and its
163	surroundings, including water supply, sewage, storage of
164	chemicals, workspace, fire safety, and general measures, which
165	standards must ensure the protection of the public health.
166	(7) EQUIPMENT.--The agency shall establish minimum
167	detailed quality-related standards for facility equipment
168	essential to the proper conduct and operation of the facility,
169	including the resolution of images generated by such equipment
170	and other requirements that recognize the importance of using
171	up-to-date technology. This may include requiring facilities to
172	use specified equipment and technology that is approved by the
173	FDA and is not obsolete.
174	(8) DIAGNOSTIC RECORDS.--The agency shall establish
175	minimum standards relating to the accuracy and retention of
176	medical records prepared and maintained by diagnostic imaging
177	facilities. This includes standards of review to determine
178	compliance.
179	483.955 Inspection of facilities.--The agency shall, at
180	least annually, inspect the premises and operations of all
181	facilities subject to licensure under this part, without prior
182	notice to the facilities, for the purpose of studying and
183	evaluating the operation, supervision, and procedures of such
184	facilities to determine their compliance with agency standards
185	and to determine their effect upon the health and safety of the
186	people of this state. This inspection shall include an
187	evaluation to determine that the facility’s equipment is meeting
188	specific standards of performance and is performing according to
189	the manufacturer’s specifications and an evaluation of accuracy
190	and timeliness of the diagnostic reports prepared by such
191	facilities.
192	483.956 Licensing of facilities.--
193	(1) A person may not conduct, maintain, or operate a
194	freestanding diagnostic imaging facility in this state without
195	obtaining a freestanding diagnostic imaging facility license
196	from the agency. The license is valid only for the person or
197	persons to whom it is issued and may not be sold, assigned, or
198	transferred, voluntarily or involuntarily. A license is not
199	valid for any premises other than the facility for which it is
200	issued. However, a new license may be secured for the new
201	location for a fixed facility before the actual change, if the
202	change is in compliance with this part and the rules adopted
203	under this part. A facility must be relicensed if a change of
204	ownership occurs. Application for relicensure must be made 60
205	days before the change of ownership.
206	(2) Each applicant for licensure must comply with the
207	following requirements:
208	(a) Upon receipt of a completed, signed, and dated
209	application, the agency shall require background screening, in
210	accordance with the level 2 standards for screening set forth in
211	chapter 435, of the managing employee, or other similarly titled
212	individual who is responsible for the daily operation of the
213	facility, and of the financial officer, or other similarly
214	titled individual who is responsible for the financial operation
215	of the facility, including billings for patient services. The
216	applicant must comply with the procedures for level 2 background
217	screening as set forth in chapter 435, as well as the
218	requirements of s. 435.03(3).
219	(b) The agency may require background screening of any
220	other individual who is an applicant if the agency has probable
221	cause to believe that he or she has been convicted of a crime or
222	has committed any other offense prohibited under the level 2
223	standards for screening set forth in chapter 435.
224	(c) Proof of compliance with the level 2 background
225	screening requirements of chapter 435 which has been submitted
226	within the previous 5 years in compliance with any other health
227	care licensure requirements of this state is acceptable in
228	fulfillment of the requirements of paragraph (a).
229	(d) A provisional license may be granted to an applicant
230	when each individual required by this section to undergo
231	background screening has met the standards for the Department of
232	Law Enforcement background check but the agency has not yet
233	received background screening results from the Federal Bureau of
234	Investigation, or a request for a disqualification exemption has
235	been submitted to the agency as set forth in chapter 435 but a
236	response has not yet been issued. A license may be granted to
237	the applicant upon the agency's receipt of a report of the
238	results of the Federal Bureau of Investigation background
239	screening for each individual required by this section to
240	undergo background screening which confirms that all standards
241	have been met, or upon the granting of a disqualification
242	exemption by the agency as set forth in chapter 435. Any other
243	person who is required to undergo level 2 background screening
244	may serve in his or her capacity pending the agency's receipt of
245	the report from the Federal Bureau of Investigation. However,
246	such person may not continue to serve if the report indicates
247	any violation of background screening standards and a
248	disqualification exemption has not been requested of and granted
249	by the agency as set forth in chapter 435.
250	(e) Each applicant shall submit to the agency, with its
251	application, a description and explanation of any exclusions,
252	permanent suspensions, or terminations of the applicant from the
253	Medicare or Medicaid program. Proof of compliance with the
254	requirements for disclosure of ownership and control interests
255	under the Medicaid or Medicare program may be accepted in lieu
256	of this submission.
257	(f) Each applicant shall submit to the agency a
258	description and explanation of any conviction of an offense
259	prohibited under the level 2 standards of chapter 435 by a
260	member of the board of directors of the applicant, its officers,
261	or any individual owning 5 percent or more of the applicant.
262	This requirement does not apply to a director of a not-for-
263	profit corporation or organization if the director serves solely
264	in a voluntary capacity for the corporation or organization,
265	does not regularly take part in the day-to-day operational
266	decisions of the corporation or organization, receives no
267	remuneration for his or her services on the corporation or
268	organization's board of directors, and has no financial interest
269	and has no family members with a financial interest in the
270	corporation or organization; provided that the director and the
271	not-for-profit corporation or organization include in the
272	application a statement affirming that the director's
273	relationship to the corporation satisfies the requirements of
274	this paragraph.
275	(g) A license may not be granted to an applicant if the
276	applicant or managing employee has been found guilty of,
277	regardless of adjudication, or has entered a plea of nolo
278	contendere or guilty to, any offense prohibited under the level
279	2 standards for screening set forth in chapter 435, unless an
280	exemption from disqualification has been granted by the agency
281	as set forth in chapter 435.
282	(h) The agency may deny or revoke licensure if the
283	applicant:
284	1. Has falsely represented a material fact in the
285	application required by paragraph (e) or paragraph (f), or has
286	omitted any material fact from the application required by
287	paragraph (e) or paragraph (f); or
288	2. Has had prior action taken against the applicant under
289	the Medicaid or Medicare program as set forth in paragraph (e).
290	(i) An application for license renewal must contain the
291	information required under paragraphs (e) and (f).
292	483.9565 Application for license.--
293	(1) Application for a license as required by s. 483.956
294	must be made to the agency on forms furnished by it and must be
295	accompanied by the appropriate license fee.
296	(2) The application shall contain:
297	(a) A determination as to whether the facility will be
298	fixed or mobile and the location for a fixed facility.
299	(b) The name and address of the owner if an individual; if
300	the owner is a firm, partnership, or association, the name and
301	address of every member thereof; or if the owner is a
302	corporation, its name and address and the name and address of
303	its medical director, officers, and each person having at least
304	a 10 percent interest in the corporation.
305	(c) The name of any person whose name is required on the
306	application under the provisions of paragraph (b) and who owns
307	at least a 10 percent interest in any professional service,
308	firm, association, partnership, or corporation providing goods,
309	leases, or services to the facility for which the application is
310	made, and the name and address of the professional service,
311	firm, association, partnership, or corporation in which such
312	interest is held.
313	(d) The name by which the facility is to be known.
314	(e) The name, address, and Florida physician's license
315	number of the medical director.
316	483.957 Medical director of facility.--Each facility
317	licensed under this part shall employ a medical director who is
318	a physician licensed under chapter 458 or chapter 459 and who is
319	a board certified radiologist or nuclear medicine physician.
320	483.958 Display of license.--The license of a facility
321	must specify, on its face, the names and addresses of the owner
322	and the medical director, the period for which the license is
323	valid, and, in the case of fixed facilities, the location at
324	which procedures are performed. The license must be displayed at
325	all times in a prominent place at the facility, where it is
326	visible to the public.
327	483.959 Grounds for disciplinary action against
328	facilities.--The following acts constitute grounds for which a
329	disciplinary action specified in s. 483.9591 may be taken
330	against a facility:
331	(1) Making a fraudulent statement on an application for a
332	license or on any other document required by the agency pursuant
333	to this part.
334	(2) Permitting unauthorized persons to operate a
335	freestanding diagnostic imaging center in violation of this
336	part.
337	(3) Rendering a report on the results of any test to a
338	person not authorized by law to receive such information.
339	(4) Knowingly having professional connection with, or
340	knowingly lending the use of the name of the licensed facility
341	or its medical director to, an unlicensed facility.
342	(5) Violating, or aiding and abetting in the violation of,
343	any provision of this part or the rules adopted hereunder.
344	(6) Failing to file any report required by the provisions
345	of this part or the rules adopted hereunder.
346	483.9591 Administrative penalties.--
347	(1)(a) The agency may deny, suspend, revoke, annul, limit,
348	or deny renewal of a license or impose an administrative fine,
349	not to exceed $500 per violation, for the violation of any
350	provision of this part or rules adopted hereunder. Each day of
351	violation constitutes a separate violation and is subject to a
352	separate fine.
353	(b) In determining the amount of the fine to be levied for
354	a violation, as provided in paragraph (a), the following factors
355	shall be considered:
356	1. The severity of the violation, including the
357	probability that death or serious harm to the health or safety
358	of any person will result or has resulted; the severity of the
359	actual or potential harm; and the extent to which the provisions
360	of this part were violated.
361	2. Actions taken by the licensee to correct the violation
362	or to remedy complaints.
363	3. Any previous violation by the licensee.
364	4. The financial benefit to the licensee of committing or
365	continuing the violation.
366	(c) All amounts collected under this subsection must be
367	deposited into the Health Care Trust Fund administered by the
368	agency.
369	(2) The agency may issue an emergency order immediately
370	suspending, revoking, annulling, or limiting a license when it
371	determines that any condition in the licensed facility presents
372	a clear and present danger to public health and safety.
373	483.9595 Offenses.--It is unlawful for any person to:
374	(1) Operate, maintain, direct, or engage in the business
375	of operating a freestanding diagnostic imaging facility unless
376	the person has obtained a license for the facility.
377	(2) Conduct, maintain, or operate a facility unless the
378	facility is under the direct and responsible supervision and
379	direction of a medical director who meets the qualifications
380	specified in s. 483.3957(1).
381	(3) Violate, or aid and abet in the violation of, any
382	provision of this part or the rules adopted under this part.
383	483.95955 Criminal penalties.--
384	(1) The performance of any of the acts specified in s.
385	483.3995 is a misdemeanor of the second degree, punishable as
386	provided in s. 775.082 or s. 775.083.
387	(2) Any use or attempted use of a forged license under
388	this part is a felony of the third degree, punishable as
389	provided in s. 775.082, s. 775.083, or s. 775.084.
390	483.9596 Unlicensed facilities.--
391	(1) INJUNCTION.--The operation or maintenance of an
392	unlicensed facility or the performance of any diagnostic imaging
393	procedures or operations in violation of this part is declared a
394	nuisance and inimical to the public health, welfare, and safety.
395	The agency, or any state attorney in the name of the people of
396	the state, may, in addition to other remedies provided in this
397	part, bring an action for an injunction to restrain such
398	violation, or to enjoin the future operation or maintenance of
399	any such facility or the performance of any health testing
400	procedures or operations in violation of this part, until
401	compliance with the provisions of this part or the rules adopted
402	under this part has been demonstrated to the satisfaction of the
403	agency.
404	(2) CLAIMS.--All charges or reimbursement claims made by
405	or on behalf of a facility that is required to be registered
406	under this section but that is not so registered are unlawful
407	charges and therefore are noncompensable and unenforceable.
408	Section 2. This act shall take effect upon becoming a law.