HB 0871

1
A bill to be entitled
2An act relating to independent diagnostic testing
3facilities; creating part XIV of chapter 400, F.S.;
4providing a popular name; providing legislative findings;
5providing definitions; providing licensing requirements;
6providing application requirements and deadlines;
7providing for temporary licensure; requiring background
8screening of all applicants; restricting the issuance of
9licenses under certain circumstances; providing for fees;
10providing for inspections of facilities by the Agency for
11Health Care Administration; providing for emergency
12suspension of licenses; providing for administrative fines
13and investigation fees; requiring license renewal and
14providing requirements thereof; requiring application for
15change of ownership under certain circumstances and
16providing requirements thereof; restricting transfers of
17licenses; providing for provisional licenses in certain
18circumstances; requiring the agency to adopt rules;
19requiring the agency to calculate certain fees; providing
20requirements; providing for deposit of collected fees in
21the Health Care Trust Fund; providing that it is unlawful
22to own, operate, or maintain a facility without a license;
23providing criminal penalties; providing for fines;
24providing penalties for health care providers who fail to
25report unlicensed facilities under certain circumstances;
26requiring the president, director, medical director, or
27chief executive officer of each independent diagnostic
28testing facility to accept certain responsibilities;
29requiring new independent diagnostic testing facilities to
30apply for licensure within a certain timeframe;
31restricting eligibility of certain claims; providing
32penalties for unlicensed activity; providing penalties for
33health care providers in violation; providing authority to
34the agency to suspend or revoke licenses issued; providing
35for investigations for compliance; providing for exemption
36from licensure under certain circumstances; requiring
37independent diagnostic testing facilities to display
38licenses; requiring accreditation for licensure; granting
39full faith and credit to magnetic resonance imaging
40independent diagnostic testing facilities under certain
41circumstances; authorizing the agency to pursue injunctive
42relief under certain circumstances; providing criteria;
43providing for a standard of review for agency actions;
44authorizing administrative penalties and providing
45criteria thereof; providing for procedures to correct
46violations; providing for interest on administrative
47fines; providing fines; providing for plans of corrective
48action in certain circumstances; providing for deposit of
49administrative fines in the Health Care Trust Fund;
50providing an effective date.
51
52Be It Enacted by the Legislature of the State of Florida:
53
54     Section 1.  Part XIV of chapter 400, Florida Statutes,
55consisting of sections 400.9970, 400.9971, 400.9972, 400.9973,
56400.9974, 400.9975, 400.9976, 400.9977, 400.9978, 400.9979, and
57400.9980, Florida Statutes, is created to read:
58     400.9970  Popular name; legislative findings.--
59     (1)  This part may be referred to by the popular name the
60"Independent Diagnostic Testing Facility Act."
61     (2)  The Legislature finds that the regulation of
62independent diagnostic testing facilities must be strengthened
63to prevent significant cost and harm to consumers. The purpose
64of this part is to provide for the licensure, establishment, and
65enforcement of basic standards for independent diagnostic
66testing facilities and to provide for the administrative
67oversight of such testing facilities by the Agency for Health
68Care Administration.
69     400.9971  Definitions.--As used in this part:
70     (1)  "Agency" means the Agency for Health Care
71Administration.
72     (2)  "Applicant" means an individual, partnership,
73corporation, or other business entity that owns or controls 5
74percent or more of an interest in the independent diagnostic
75testing facility, but does not include the limited partners in
76limited liability partnerships or an individual who is
77responsible for the day-to-day operation or financial operation
78of the independent diagnostic testing facility.
79     (3)  "Independent diagnostic testing facility" means an
80individual, partnership, corporation, or other business entity
81that performs the technical components of magnetic resonance
82imaging, static radiographs, computer tomography, and position
83emission tomography, and provides the professional components of
84such services, in a fixed facility that is accredited by the
85Joint Commission on Accreditation of Healthcare Organizations
86and the American College of Radiology within 1 year after
87licensure and:
88     (a)  Does not accept patient referrals prohibited by s.
89456.053(5).
90     (b)  Does not directly or indirectly provide therapy or
91treatment services to patients for whom it also provides
92diagnostic imaging services.
93     (c)  Does not include any entity which has an investor as
94defined by s. 456.053(3) or include any one of the following:
95     1.  Any individual or entity that is directly or indirectly
96an investor in a clinic; or
97     2.  Any individual or entity that directly or indirectly
98provides services to a clinic if such services include the
99referral of patients to any provider of diagnostic imaging
100services as defined in s. 456.053(3).
101     (d)  Is not a clinic as defined in s. 400.9905.
102     400.9972  License requirements; background screenings;
103prohibitions.--
104     (1)  Each independent diagnostic testing facility shall be
105licensed and maintain a valid license with the agency. Each
106independent diagnostic testing facility location shall be
107licensed separately even if the independent diagnostic testing
108facility is operated under the same business name or management
109as another independent diagnostic testing facility.
110     (2)  The initial independent diagnostic testing facility
111license application shall be filed with the agency by all
112independent diagnostic testing facilities on or before March 1,
1132005. An independent diagnostic testing facility license shall
114be renewed biennially.
115     (3)  Applicants that submit an application on or before
116March 1, 2005, which meets all requirements for initial
117licensure shall receive a temporary license until the completion
118of an initial inspection verifying that the applicant meets all
119requirements in the rules authorized by s. 400.9975. However, a
120clinic engaged in magnetic resonance imaging services may not
121receive a temporary license unless it presents evidence
122satisfactory to the agency that such clinic is making a good
123faith effort and substantial progress in seeking accreditation
124required under s. 400.9935.
125     (4)  Application for an initial independent diagnostic
126testing facility license or for renewal of an existing license
127shall be notarized on forms furnished by the agency and shall be
128accompanied by the appropriate license fee as specified in s.
129400.9975. The agency shall take final action on an initial
130license application within 60 days after receipt of all required
131documentation.
132     (5)  The application shall contain information that
133includes, but need not be limited to, the name, residence and
134business addresses, phone numbers, social security number, and
135license number of each applicant and each licensed medical
136provider employed or under contract with the independent
137diagnostic testing facility.
138     (6)  The application shall include satisfactory proof that
139the independent diagnostic testing facility is in compliance
140with this part and applicable rules, including the number and
141discipline of each professional staff member to be employed.
142     (7)  Upon receipt of a completed, signed, and dated
143application, the agency shall require background screening of
144the applicant, in accordance with the level 2 standards for
145screening set forth in chapter 435. Proof of compliance with the
146level 2 background screening requirements of chapter 435 which
147has been submitted within the previous 5 years in compliance
148with any other health care licensure requirements of this state
149is acceptable in fulfillment of this subsection.
150     (8)  Each applicant shall submit with the application a
151description and explanation of any exclusions, permanent
152suspensions, or terminations of an applicant from the Medicare
153or Medicaid program. Proof of compliance with the requirements
154for disclosure of ownership and control interest under the
155Medicaid or Medicare program may be accepted in lieu of this
156submission. The description and explanation may indicate whether
157such exclusions, suspensions, or terminations were voluntary or
158involuntary on the part of the applicant.
159     (9)  A license may not be granted to an independent
160diagnostic testing facility if the applicant has been found
161guilty of, or has entered a plea of nolo contendere or guilty
162to, any offense prohibited under the level 2 standards for
163screening set forth in chapter 435, or a violation of insurance
164fraud under s. 817.234, within the past 5 years. If the
165applicant has been convicted of an offense prohibited under the
166level 2 standards or insurance fraud in any jurisdiction, the
167applicant shall show that his or her civil rights have been
168restored prior to submitting an application.
169     (10)  The agency may deny or revoke licensure if the
170applicant has falsely represented any material fact or omitted
171any material fact from the application required by this part.
172     (11)  Requested information omitted from an application for
173licensure, license renewal, or transfer of ownership shall be
174filed with the agency within 21 days after receipt of the
175agency's request for omitted information or the application
176shall be deemed incomplete and withdrawn from further
177consideration.
178     (12)  The failure to file a timely renewal application
179shall result in a late fee charged to the independent diagnostic
180testing facility in an amount equal to 50 percent of the current
181license fee.
182     400.9973  Independent diagnostic testing facility
183inspections; emergency suspension; costs.--
184     (1)  An authorized officer or employee of the agency shall
185make inspections of the independent diagnostic testing facility
186as part of the initial license application or renewal
187application. The application for an independent diagnostic
188testing facility license or renewal issued under this part
189constitutes permission for an appropriate agency inspection to
190verify the information submitted in connection with the
191application or renewal.
192     (2)  An authorized officer or employee of the agency may
193make unannounced inspections of independent diagnostic testing
194facilities licensed pursuant to this part as are necessary to
195determine that such facilities are in compliance with this part
196and with applicable rules. A licensed independent diagnostic
197testing facility shall allow full and complete access to the
198premises and to billing records or information to any
199representative of the agency who makes an inspection to
200determine compliance with this part and with applicable rules.
201     (3)  Failure by an independent diagnostic testing facility
202licensed under this part to allow full and complete access to
203the premises and to billing records or information to any
204representative of the agency who makes a request to inspect the
205independent diagnostic testing facility to determine compliance
206with this part constitutes grounds for emergency suspension of
207the license by the agency pursuant to s. 120.60(6).
208     (4)  In addition to any administrative fines imposed, the
209agency may assess a fee equal to the cost of conducting a
210complaint investigation.
211     400.9974  License renewal; transfer of ownership;
212provisional license.--
213     (1)  An application for license renewal shall contain
214information as required by the agency.
215     (2)  An application for license renewal shall be submitted
216to the agency 90 days before the expiration date of the license.
217     (3)  The independent diagnostic testing facility shall file
218with the license renewal application satisfactory proof that it
219is in compliance with this part and applicable rules.
220     (4)  When transferring the ownership of an independent
221diagnostic testing facility, the transferee shall submit an
222application for a license at least 60 days before the effective
223date of the transfer. An application for change of ownership of
224an independent diagnostic testing facility is required only when
22545 percent or more of the ownership, voting shares, or
226controlling interest of an independent diagnostic testing
227facility is transferred or assigned, including the final
228transfer or assignment of multiple transfers or assignments over
229a 2-year period that cumulatively total 45 percent or more.
230     (5)  The license may not be sold, leased, assigned, or
231otherwise transferred and is valid only for the independent
232diagnostic testing facility owners and location for which
233originally issued.
234     (6)  An independent diagnostic testing facility against
235whom a revocation or suspension proceeding is pending at the
236time of license renewal may be issued a provisional license
237until final disposition by the agency of such proceedings. If
238judicial relief is sought from the final disposition, the agency
239may issue a temporary license for the duration of the judicial
240proceeding.
241     400.9975  Rulemaking authority; license fees.--
242     (1)  The agency shall adopt rules necessary to administer
243the independent diagnostic testing facility administration,
244regulation, and licensure program, including rules establishing
245the specific licensure requirements, procedures, forms, and
246fees. The agency shall adopt rules establishing a procedure for
247the biennial renewal of licenses. The agency may issue initial
248licenses for less than the full 2-year period by charging a
249prorated licensure fee and specifying a different renewal date
250than would otherwise be required for biennial licensure. The
251rules shall specify the expiration dates of licenses and any
252other conditions of renewal.
253     (2)  License application and renewal fees shall be
254reasonably calculated by the agency to cover the agency's costs
255in carrying out the agency's responsibilities under this part,
256including the cost of licensure, inspection, and regulation of
257independent diagnostic testing facilities, and shall be of such
258amount that the total fees collected do not exceed the cost of
259administering and enforcing compliance with this part.
260Independent diagnostic testing facility licensure fees are
261nonrefundable and may not exceed $2,000. The agency shall adjust
262the license fee annually by not more than the change in the
263Consumer Price Index based on the 12 months immediately
264preceding the increase. All fees collected under this part shall
265be deposited in the Health Care Trust Fund for the
266administration of this part.
267     400.9976  Unlicensed independent diagnostic testing
268facilities; penalties; fines; verification of licensure
269status.--
270     (1)  It is unlawful to own, operate, or maintain an
271independent diagnostic testing facility without obtaining a
272license under this part.
273     (2)  Any person who owns, operates, or maintains an
274unlicensed independent diagnostic testing facility commits a
275felony of the third degree, punishable as provided in s.
276775.082, s. 775.083, or s. 775.084. Each day of continued
277operation is a separate offense.
278     (3)  Any person who violates subsection (2) a second or
279subsequent time commits a felony of the second degree,
280punishable as provided in s. 775.082, s. 775.083, or s. 775.084.
281Each day of continued operation is a separate offense.
282     (4)  Any person who owns, operates, or maintains an
283unlicensed independent diagnostic testing facility due to a
284change in this part or a modification in agency rules within 6
285months after the effective date of such change or modification
286and who, within 10 working days after receiving notification
287from the agency, fails to cease operation or apply for a license
288under this part commits a felony of the third degree, punishable
289as provided in s. 775.082, s. 775.083, or s. 775.084. Each day
290of continued operation is a separate offense.
291     (5)  Any independent diagnostic testing facility that fails
292to cease operation after agency notification may be fined for
293each day of noncompliance pursuant to this part.
294     (6)  Any person aware of the operation of an unlicensed
295independent diagnostic testing facility shall report that
296facility to the agency.
297     (7)  Any health care provider who is aware of the operation
298of an unlicensed independent diagnostic testing facility shall
299report that facility to the agency. Failure to report an
300independent diagnostic testing facility that the provider knows
301or has reasonable cause to suspect is unlicensed shall be
302reported to the provider's licensing board.
303     (8)  The agency may not issue a license to an independent
304diagnostic testing facility that has any unpaid fines assessed
305under this part.
306     400.9977  Independent diagnostic testing facility
307responsibilities.--
308     (1)  The president, director, medical director, or chief
309executive officer of each independent diagnostic testing
310facility shall agree in writing to accept legal responsibility
311for the following activities on behalf of the independent
312diagnostic testing facility:
313     (a)  Ensuring that all practitioners providing health care
314services or supplies to patients maintain a current active and
315unencumbered Florida license.
316     (b)  Reviewing any patient referral contracts or agreements
317executed by the independent diagnostic testing facility.
318     (c)  Ensuring that all health care practitioners at the
319independent diagnostic testing facility have active, appropriate
320certification or licensure for the level of care being provided.
321     (d)  Serving as the independent diagnostic testing facility
322records owner as defined in s. 456.057.
323     (e)  Ensuring compliance with the recordkeeping, office
324surgery, and adverse incident reporting requirements of chapter
325456, the respective practice acts, and rules adopted under this
326part.
327     (f)  Conducting systematic reviews of independent
328diagnostic testing facility billings to ensure that the billings
329are not fraudulent or unlawful. Upon discovery of an unlawful
330charge, the medical director or independent diagnostic testing
331facility director shall take immediate corrective action.
332     (2)  Any business that becomes an independent diagnostic
333testing facility after commencing operations shall, within 5
334days after becoming an independent diagnostic testing facility,
335file a license application under this part and shall be subject
336to all provisions of this part applicable to an independent
337diagnostic testing facility.
338     (3)  All charges or reimbursement claims made by or on
339behalf of an independent diagnostic testing facility that is
340required to be licensed under this part but that is not so
341licensed, or that is otherwise operating in violation of this
342part, are unlawful charges and therefore are noncompensable and
343unenforceable.
344     (4)  Any person establishing, operating, or managing an
345unlicensed independent diagnostic testing facility otherwise
346required to be licensed under this part, or any person who
347knowingly files a false or misleading license application or
348license renewal application, or false or misleading information
349related to such application or department rule, commits a felony
350of the third degree, punishable as provided in s. 775.082, s.
351775.083, or s. 775.084.
352     (5)  Any licensed health care provider who violates this
353part is subject to discipline in accordance with this chapter
354and his or her respective practice act.
355     (6)  The agency may fine, or suspend or revoke the license
356of, any independent diagnostic testing facility licensed under
357this part for operating in violation of the requirements of this
358part or the rules adopted by the agency.
359     (7)  The agency shall investigate allegations of
360noncompliance with this part and the rules adopted under this
361part.
362     (8)  Any person or entity providing health care services
363which is not an independent diagnostic testing facility may
364voluntarily apply for a certificate of exemption from licensure
365under its exempt status with the agency on a form that sets
366forth its name, or names and addresses, a statement of the
367reasons it cannot be defined as an independent diagnostic
368testing facility, and other information deemed necessary by the
369agency.
370     (9)  The independent diagnostic testing facility shall
371display its license in a conspicuous location within the
372independent diagnostic testing facility readily visible to all
373patients.
374     (10)(a)  In order to remain licensed, an independent
375diagnostic testing facility shall be accredited by the Joint
376Commission on Accreditation of Healthcare Organizations and the
377American College of Radiology within 1 year after licensure.
378However, an independent diagnostic testing facility may request
379a single, 6-month extension if it provides evidence to the
380agency establishing that, for good cause shown, such independent
381diagnostic testing facility cannot be accredited within 1 year
382after licensure and that such accreditation will be completed
383within the 6-month extension. After obtaining accreditation as
384required by this paragraph, each such independent diagnostic
385testing facility shall maintain accreditation as a condition of
386renewal of its license.
387     (b)  The agency may disallow the application of any entity
388formed for the purpose of avoiding compliance with the
389accreditation provisions of this subsection and whose principals
390were previously principals of an entity that was unable to meet
391the accreditation requirements within the specified timeframes.
392The agency may adopt rules as to the accreditation of magnetic
393resonance imaging independent diagnostic testing facilities.
394     (11)  The agency shall give full faith and credit
395pertaining to any past variance and waiver granted to a magnetic
396resonance imaging independent diagnostic testing facility from
397Rule 64-2002, Florida Administrative Code, by the Department of
398Health, until September 1, 2004. After that date, such
399independent diagnostic testing facility shall request a variance
400and waiver from the agency under s. 120.542.
401     400.9978  Injunctions.--
402     (1)  The agency may institute injunctive proceedings in a
403court of competent jurisdiction in order to:
404     (a)  Enforce the provisions of this part or any minimum
405standard, rule, or order issued or entered into pursuant to this
406part if the attempt by the agency to correct a violation through
407administrative fines has failed; if the violation materially
408affects the health, safety, or welfare of independent diagnostic
409testing facility patients; or if the violation involves any
410operation of an unlicensed independent diagnostic testing
411facility.
412     (b)  Terminate the operation of an independent diagnostic
413testing facility if a violation of any provision of this part,
414or any rule adopted pursuant to this part, materially affects
415the health, safety, or welfare of independent diagnostic testing
416facility patients.
417     (2)  Such injunctive relief may be temporary or permanent.
418     (3)  If action is necessary to protect independent
419diagnostic testing facility patients from life-threatening
420situations, the court may allow a temporary injunction without
421bond upon proper proof being made. If it appears by competent
422evidence or a sworn, substantiated affidavit that a temporary
423injunction should be issued, the court, pending the
424determination on final hearing, shall enjoin operation of the
425independent diagnostic testing facility.
426     400.9979  Agency actions.--Administrative proceedings
427challenging agency licensure enforcement action shall be
428reviewed on the basis of the facts and conditions that resulted
429in the agency action.
430     400.9980  Agency administrative penalties.--
431     (1)  The agency may impose administrative penalties against
432independent diagnostic testing facilities of up to $5,000 per
433violation for violations of the requirements of this part. In
434determining whether a penalty is to be imposed and in fixing the
435amount of the fine, the agency shall consider the following
436factors:
437     (a)  The gravity of the violation, including the
438probability that death or serious physical or emotional harm to
439a patient will result or has resulted, the severity of the
440action or potential harm, and the extent to which the provisions
441of the applicable laws or rules were violated.
442     (b)  Actions taken by the owner, medical director, or
443independent diagnostic testing facility director to correct
444violations.
445     (c)  Any previous violations.
446     (d)  The financial benefit to the independent diagnostic
447testing facility of committing or continuing the violation.
448     (2)  Each day of continuing violation after the date fixed
449for termination of the violation, as ordered by the agency,
450constitutes an additional, separate, and distinct violation.
451     (3)  Any action taken to correct a violation shall be
452documented in writing by the owner, medical director, or
453independent diagnostic testing facility director and verified
454through followup visits by agency personnel. The agency may
455impose a fine and, in the case of an owner-operated independent
456diagnostic testing facility, revoke or deny an independent
457diagnostic testing facility's license when an independent
458diagnostic testing facility medical director or independent
459diagnostic testing facility director fraudulently misrepresents
460actions taken to correct a violation.
461     (4)  For fines that are upheld following administrative or
462judicial review, the violator shall pay the fine, plus interest
463at the rate as specified in s. 55.03, for each day beyond the
464date set by the agency for payment of the fine.
465     (5)  Any unlicensed independent diagnostic testing facility
466that continues to operate after agency notification is subject
467to a $1,000 fine per day.
468     (6)  Any independent diagnostic testing facility whose
469owner fails to apply for a change-of-ownership license in
470accordance with s. 400.9974 and operates the independent
471diagnostic testing facility under the new ownership is subject
472to a fine of $5,000.
473     (7)  The agency, as an alternative to or in conjunction
474with an administrative action against an independent diagnostic
475testing facility for violations of this part and adopted rules,
476shall, prior to written notification, make a reasonable attempt
477to discuss each violation and recommended corrective action with
478the owner, director, or medical director of the independent
479diagnostic testing facility. The agency, instead of fixing a
480period within which the independent diagnostic testing facility
481shall enter into compliance with standards, may request a plan
482of corrective action from the independent diagnostic testing
483facility which demonstrates a good faith effort to remedy each
484violation by a specific date, subject to the approval of the
485agency.
486     (8)  Administrative fines paid by any independent
487diagnostic testing facility under this section shall be
488deposited into the Health Care Trust Fund.
489     Section 2.  This act shall take effect July 1, 2004.


CODING: Words stricken are deletions; words underlined are additions.