HB 1331

CS

CHAMBER ACTION

1	The Judiciary Committee recommends the following:
2
3	Council/Committee Substitute
4	Remove the entire bill and insert:
5	A bill to be entitled
6	An act relating to mammography; providing legislative
7	findings and intent; amending s. 456.077, F.S.;
8	authorizing the Board of Medicine and the Board of
9	Osteopathic Medicine to issue citations and to require
10	additional education in certain circumstances; creating s.
11	766.119, F.S.; providing for informed consent prior to the
12	performance of a mammogram; creating a presumption that a
13	physician is operating within the appropriate standard of
14	care when obtaining informed consent; providing an
15	exception; providing limitations; providing a limitation
16	on the use of subsequent mammograms as evidence in certain
17	negligence actions; providing for severability; providing
18	applicability; providing an effective date.
19
20	WHEREAS, breast cancer is the second leading cause of
21	cancer deaths in women, and
22	WHEREAS, breast cancer affects all of us through our
23	spouses, mothers, daughters, sisters, aunts, nieces, friends,
24	and neighbors, and
25	WHEREAS, there are three main tools available to detect
26	breast cancer: breast examinations by a health care
27	practitioner, breast self-examinations, and screening
28	mammograms, and
29	WHEREAS, although mammography is an imperfect screening
30	tool, it is still the best method available to detect breast
31	cancer, and
32	WHEREAS, early detection of breast cancer decreases
33	mortality by 30 percent, and
34	WHEREAS, screening mammograms need to be widely available
35	to all women at risk regardless of geographic location, race,
36	type of or nonexistence of insurance, or socioeconomic status,
37	and
38	WHEREAS, the Workgroup on Mammography Accessibility created
39	by the Legislature under Senate Bill 2306 in the 2004 Regular
40	Session found that population growth combined with a growing
41	shortage of interpreting radiologists will have an adverse
42	effect on the future availability of mammography services, and
43	WHEREAS, radiologists are reluctant to provide screening
44	mammography services because of the high cost of obtaining
45	professional liability insurance in comparison to the low
46	reimbursements received and the fear of a medical malpractice
47	lawsuit being brought against a radiologist who is not able to
48	detect every single instance of a cancerous or precancerous
49	condition, and
50	WHEREAS, in 2004, the Legislature directed the Office of
51	Program Policy Analysis and Government Accountability to study
52	issues relating to mammography services in the state, and
53	WHEREAS, the Office of Program Policy Analysis and
54	Government Accountability found that one of the factors limiting
55	access to mammography services in the state is the fear of
56	medical malpractice lawsuits which is causing some radiologists
57	to limit the number of mammograms they interpret, and
58	WHEREAS, the Department of Health conducted a survey and
59	found that 17 percent of the facilities surveyed had appointment
60	wait times exceeding 28 days for screening mammograms, and
61	WHEREAS, the Workgroup on Mammography Accessibility found
62	that mammography facilities in the state have high-quality
63	personnel and equipment and a high level of compliance with
64	safety and other standards of care, as demonstrated by the
65	results of inspections by the United States Food and Drug
66	Administration, and
67	WHEREAS, the Workgroup on Mammography Accessibility found
68	that national data show that most defendants in alleged medical
69	malpractice claims involving breast cancer are radiologists and
70	that only claims for neurologically impaired newborns are more
71	expensive than breast cancer in terms of indemnity dollars, and
72	WHEREAS, the Legislature has previously recognized that two
73	other medical specialists, obstetricians and emergency room
74	physicians, have such a high risk of liability claims that
75	access to these services is in jeopardy without statutory
76	protection limiting the damages available to patients and their
77	families, and
78	WHEREAS, funds from professional liability insurance are
79	not an appropriate or adequate substitute for health insurance,
80	disability insurance, or life insurance, and
81	WHEREAS, breast cancer is not caused by physicians, and
82	WHEREAS, the Legislature must take action to protect the
83	advancements made in the diagnosis, treatment, and awareness of
84	breast cancer through the tireless efforts of groups such as the
85	Susan B. Komen Foundation, the American Cancer Society, the
86	American College of Radiology, and others, and
87	WHEREAS, the Workgroup on Mammography Accessibility made
88	eight recommendations to the Legislature to ensure that
89	mammography will continue to be available to women in Florida,
90	that there are enough radiologists available to interpret
91	mammograms, that the fear of lawsuits or high medical liability
92	insurance premiums does not deter physicians from entering the
93	field of radiology and the interpretation of mammograms, and
94	that utilization of mammography is increased in medically
95	underserved populations, NOW, THEREFORE,
96
97	Be It Enacted by the Legislature of the State of Florida:
98
99	Section 1.  Legislative findings.--
100	(1)  The Legislature finds that it is of the utmost public
101	importance that quality mammography services and other
102	diagnostic tools remain available to detect and treat breast
103	cancer.
104	(2)  The Legislature finds that the current litigious
105	environment and low reimbursement rates threaten the
106	availability of mammography services for all women in the state.
107	(3)  The Legislature finds that the rapidly growing
108	population and the changing demographics of the state make it
109	imperative that medical students continue to choose this state
110	as the place they will receive their medical educations,
111	complete their residency requirements, and practice radiology.
112	(4)  The Legislature finds that radiologists providing
113	mammography services are in a unique class of physicians who
114	have little or no direct patient contact and generally have no
115	established physician-patient relationship.
116	(5)  The Legislature finds that the State of Florida is
117	among the states with the highest medical malpractice insurance
118	premiums in the nation.
119	(6)  The Legislature finds that the cost of medical
120	malpractice insurance has increased dramatically during the past
121	decade and both the increase and the current cost are
122	substantially higher than the national average.
123	(7)  The Legislature finds that the increase in medical
124	malpractice liability insurance rates is forcing physicians,
125	including radiologists, to practice medicine without
126	professional liability insurance, to leave the state, to not
127	perform high-risk procedures such as mammograms, or to retire
128	early from the practice of medicine.
129	(8)  The Legislature finds that the 2003 Governor's Select
130	Task Force on Healthcare Professional Liability Insurance has
131	established that a medical malpractice crisis exists in the
132	state which can be alleviated by the adoption of legislatively
133	enacted comprehensive reforms.
134	(9)  The Legislature finds that making high-quality health
135	care, including mammography services, available to the citizens
136	of the state is an overwhelming public necessity.
137	(10)  The Legislature finds that ensuring that physicians
138	continue to practice radiology in the state is an overwhelming
139	public necessity.
140	(11)  The Legislature finds that ensuring the availability
141	of affordable professional liability insurance for physicians is
142	an overwhelming public necessity.
143	(12)  The Legislature finds that, based upon the findings
144	and recommendations of the Workgroup on Mammography
145	Accessibility, the Governor's Select Task Force on Healthcare
146	Professional Liability Insurance, the Office of Program Policy
147	Analysis and Government Accountability, and the various study
148	groups throughout the nation and based on the experience of
149	other states, the overwhelming public necessity of making
150	quality health care, including mammography services, available
151	to the citizens of the state, ensuring that physicians continue
152	to practice radiology in the state, and ensuring that those
153	physicians have the opportunity to purchase affordable
154	professional liability insurance cannot be met unless
155	limitations on medical malpractice lawsuits are imposed.
156	(13)  The Legislature finds that the high cost of medical
157	malpractice claims can be substantially alleviated by imposing
158	limitations on medical malpractice lawsuits relating to
159	mammography services.
160	(14)  The Legislature further finds that there is no
161	alternative measure for alleviating the high cost of medical
162	malpractice claims without imposing even greater limits upon the
163	ability of persons to recover damages for medical malpractice.
164	(15)  The Legislature finds that the provisions of this act
165	are naturally and logically connected to each other and to the
166	purpose of making quality mammography services available to the
167	women of the state.
168	(16)  The Legislature finds that each provision of this act
169	is necessary to alleviate the crisis relating to mammography
170	accessibility in the state.
171	Section 2.  Subsection (7) is added to section 456.077,
172	Florida Statutes, to read:
173	456.077  Authority to issue citations.--
174	(7)  The Board of Medicine and the Board of Osteopathic
175	Medicine may issue a citation in lieu of disciplinary action for
176	the first allegation brought against a physician alleging a
177	failure to diagnose breast cancer through the interpretation of
178	a mammogram. The board, in issuing the citation, may impose up
179	to 10 additional hours of continuing education in mammography
180	interpretation.
181	Section 3.  Section 766.119, Florida Statutes, is created
182	to read:
183	766.119  Actions relating to mammograms.--
184	(1)  This section applies to any civil action brought
185	pursuant to this chapter against a physician licensed in this
186	state pursuant to chapter 458 or chapter 459 for any action or
187	omission arising from the performance of his or her duties
188	relating to mammograms and to any facility that provides
189	mammography services.
190	(2)(a)  Prior to the performance of any radiologic test for
191	the screening of breast cancer, a physician or entity may
192	request that the patient read and execute a form giving written
193	informed consent to the physician and facility to administer the
194	screening. The written informed consent shall include a fair
195	explanation of the screening, including its purpose and
196	limitations, shall be evidenced in writing, and shall be validly
197	signed by the patient or another legally authorized person. A
198	valid signature is one which is given by a person who under all
199	the surrounding circumstances is mentally and physically
200	competent to give consent.
201	(b)  A physician or entity is presumed to have acted within
202	the appropriate standard of care in the interpretation of a
203	mammogram if the physician or entity obtains informed consent
204	from a patient as provided in this section, unless the physician
205	or entity interpreting the mammogram fails to detect an
206	abnormality that is clear and obvious to a reasonable physician
207	with the same level of mammography training and experience who
208	is provided the same information about the patient's medical
209	history and condition known at the time of the mammogram by the
210	interpreting physician who is alleged to have failed to detect
211	the abnormality.
212	(c)  The written informed consent used under this section
213	shall include the following language in at least 10-point type:
214	"Mammography is a screening tool, not a test, used to detect
215	some breast cancers. While not perfect, it is the best tool
216	available for the early detection of breast cancer. Knowing that
217	not all breast cancers are detected by mammography, it is
218	essential that you also perform a monthly breast self-
219	examination and have your breasts examined yearly by a
220	physician."
221	(d)  The written informed consent used under this section
222	shall include the following language in at least 10-point type
223	at the end of the document but before the signature line: "I
224	have read this information about detecting breast cancer and
225	while I understand that a normal mammogram is reassuring, I also
226	realize that not all cancers may be detected by mammography."
227	(e)  In no event shall a physician's or entity's
228	noncompliance with the provisions of this section create a
229	presumption of negligence on the part of the physician or entity
230	for any action or omission arising from the performance any duty
231	relating to mammograms.
232	(3)  The protections and limitations provided by this
233	section apply only if:
234	(a)  The mammography is performed in concordance with the
235	Mammography Quality Standards Act regulations in a facility that
236	has an active and valid certificate issued by the United States
237	Food and Drug Administration, meets the quality standards
238	required by the United States Food and Drug Administration, and
239	is accredited by an approved accreditation body or other entity
240	as designated by the United States Food and Drug Administration.
241	(b)  The interpreting physician has a minimum of 60 hours
242	of documented medical education in mammography, which shall
243	include instruction in the interpretation of mammograms and
244	education in basic breast anatomy, pathology, physiology,
245	technical aspects of mammography, and quality assurance and
246	quality control in mammography.
247	(c)  The mammography equipment used meets the Mammography
248	Quality Standards Act final rule as published by the United
249	States Food and Drug Administration and is specifically designed
250	for mammography and is certified pursuant to s. 1010.2 of the
251	Federal Register as meeting the applicable requirements of ss.
252	1020.30 and 1020.31 of the Federal Register in effect at the
253	date of manufacture. Radiographic equipment designed for general
254	purpose or special nonmammography procedures, including systems
255	that have been modified or equipped with special attachments for
256	mammography, shall not be used for mammography.
257	(d)  The radiographic equipment used for mammography is
258	specifically designed for mammography and is certified pursuant
259	to s. 1010.2 of the Federal Register as meeting the applicable
260	requirements of ss. 1020.30 and 1020.31 of the Federal Register
261	in effect at the date of manufacture.
262	(e)  The facility performing the mammography screening
263	conducts daily, weekly, monthly, quarterly, and annual quality
264	control tests as required by the United States Food and Drug
265	Administration.
266	(f)  The facility performing the mammography screening has
267	established and maintained a quality assurance program to ensure
268	the safety, reliability, clarity, and accuracy of mammography
269	services performed at the facility.
270	(g)  The facility performing the mammography screening has
271	established and maintained a mammography medical outcomes audit
272	program to ensure the reliability, clarity, and accuracy of the
273	interpretation of mammograms.
274	(4)  A subsequent mammogram may not be used by an expert
275	witness or a finder of fact in determining the failure to
276	diagnose breast cancer when the subsequent mammogram was
277	performed more than 3 months after the mammogram that is alleged
278	to have been incorrectly interpreted.
279	Section 4.  If any provision of this act or its application
280	to any person or circumstance is held invalid, the invalidity
281	does not affect other provisions or applications of the act
282	which can be given effect without the invalid provision or
283	application, and to this end the provisions of this act are
284	severable.
285	Section 5.  It is the intent of the Legislature to apply
286	the provisions of this act to prior medical incidents, to the
287	extent such application is not prohibited by the State
288	Constitution or the United States Constitution, except that the
289	changes to chapter 766, Florida Statutes, shall apply only to
290	any medical incident for which a notice of intent to initiate
291	litigation is mailed on or after the effective date of this act.
292	Section 6.  This act shall take effect July 1, 2005.

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