1 | The Health & Families Council recommends the following: |
2 |
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3 | Council/Committee Substitute |
4 | Remove the entire bill and insert: |
5 | A bill to be entitled |
6 | An act relating to medical records; amending s. 456.057, |
7 | F.S.; providing definitions; requiring a health care |
8 | practitioner's employer who is a records owner and a |
9 | records custodian to comply with specified requirements |
10 | for confidentiality and disclosure; amending s. 456.42, |
11 | F.S.; providing requirements for prescriptions of |
12 | medicinal drugs by health care practitioners that are |
13 | electronically generated and transmitted; creating s. |
14 | 456.43, F.S.; regulating electronic prescribing for |
15 | medicinal drugs; providing restrictions for electronic |
16 | prescribing software; providing definitions; authorizing |
17 | electronic prescribing software to show information |
18 | regarding a payor's formulary under certain circumstances; |
19 | providing that payors or providers are not limited from |
20 | implementing utilization management tools; amending s. |
21 | 465.025, F.S.; specifying requirements for a prescriber to |
22 | prevent generic substitution for brand name drugs when a |
23 | prescription is electronically transmitted and generated; |
24 | amending s. 381.028, F.S.; correcting a cross-reference; |
25 | providing an effective date. |
26 |
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27 | Be It Enacted by the Legislature of the State of Florida: |
28 |
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29 | Section 1. Present subsections (3) through (19) of section |
30 | 456.057, Florida Statutes, are renumbered as subsections (5) |
31 | through (21), respectively, and new subsections (3) and (4) are |
32 | added to that section to read: |
33 | 456.057 Ownership and control of patient records; report |
34 | or copies of records to be furnished.-- |
35 | (3) As used in this section, the term "records custodian" |
36 | means any person or entity that: |
37 | (a) Maintains documents that are authorized in subsection |
38 | (2); or |
39 | (b) Obtains medical records from a records owner. |
40 | (4) Any health care practitioner's employer who is a |
41 | records owner and any records custodian shall maintain records |
42 | or documents as provided under the confidentiality and |
43 | disclosure requirements of this section. |
44 | Section 2. Section 456.42, Florida Statutes, is amended to |
45 | read: |
46 | 456.42 Written prescriptions for medicinal drugs.--A |
47 | written prescription for a medicinal drug issued by a health |
48 | care practitioner licensed by law to prescribe such drug must be |
49 | legibly printed or typed so as to be capable of being understood |
50 | by the pharmacist filling the prescription; must contain the |
51 | name of the prescribing practitioner, the name and strength of |
52 | the drug prescribed, the quantity of the drug prescribed in both |
53 | textual and numerical formats, and the directions for use of the |
54 | drug; must be dated with the month written out in textual |
55 | letters; and must be signed by the prescribing practitioner on |
56 | the day when issued. However, a prescription that is |
57 | electronically generated and transmitted must contain the name |
58 | of the prescribing practitioner, the name and strength of the |
59 | drug prescribed, the quantity of the drug prescribed in |
60 | numerical format, and the directions for use of the drug and |
61 | must be dated and signed by the prescribing practitioner only on |
62 | the day issued, which signature may be in an electronic format |
63 | as defined by s. 668.003(4). |
64 | Section 3. Section 456.43, Florida Statutes, is created to |
65 | read: |
66 | 456.43 Electronic prescribing for medicinal drugs.-- |
67 | (1) Electronic prescribing shall not interfere with a |
68 | patient's freedom to choose a pharmacy. |
69 | (2) Electronic prescribing software shall not use any |
70 | means or permit any other person to use any means, including, |
71 | but not limited to, advertising, instant messaging, and pop-up |
72 | ads, to influence or attempt to influence, through economic |
73 | incentives or otherwise, the prescribing decision of a |
74 | prescribing practitioner at the point of care. Such means shall |
75 | not be triggered or in specific response to the input, |
76 | selection, or act of a prescribing practitioner or his or her |
77 | agent in prescribing a certain pharmaceutical or directing a |
78 | patient to a certain pharmacy. |
79 | (a) The term "prescribing decision" means a prescribing |
80 | practitioner's decision to prescribe a certain pharmaceutical. |
81 | (b) The term "point of care" means the time that a |
82 | prescribing practitioner or his or her agent is in the act of |
83 | prescribing a certain pharmaceutical. |
84 | (3) Electronic prescribing software may show information |
85 | regarding a payor's formulary as long as nothing is designed to |
86 | preclude or make more difficult the acts of a practitioner in |
87 | prescribing any particular pharmaceutical or a patient in |
88 | selecting a particular pharmacy. |
89 | (4) This section does not limit a payor or provider from |
90 | implementing utilization management tools, including, but not |
91 | limited to, utilization review, a quality assurance program, a |
92 | continuity of care system, a disease management system, step |
93 | therapy, or prior authorization system. |
94 | Section 4. Subsection (2) of section 465.025, Florida |
95 | Statutes, is amended to read: |
96 | 465.025 Substitution of drugs.-- |
97 | (2) A pharmacist who receives a prescription for a brand |
98 | name drug shall, unless requested otherwise by the purchaser, |
99 | substitute a less expensive, generically equivalent drug product |
100 | that is: |
101 | (a) Distributed by a business entity doing business, and |
102 | subject to suit and service of legal process, in the United |
103 | States; and |
104 | (b) Listed in the formulary of generic and brand name drug |
105 | products as provided in subsection (5) for the brand name drug |
106 | prescribed, |
107 |
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108 | unless the prescriber writes the words "MEDICALLY NECESSARY," in |
109 | her or his own handwriting, on the face of a written |
110 | prescription; or unless, in the case of an oral prescription, |
111 | the prescriber expressly indicates to the pharmacist that the |
112 | brand name drug prescribed is medically necessary; or unless, in |
113 | the case of a prescription that is electronically generated and |
114 | transmitted, the prescriber makes an overt act when transmitting |
115 | the prescription to indicate that the brand name drug prescribed |
116 | is medically necessary. When done in conjunction with the |
117 | electronic transmission of the prescription, the prescriber's |
118 | overt act indicates to the pharmacist that the brand name drug |
119 | prescribed is medically necessary. |
120 | Section 5. Paragraph (c) of subsection (7) of section |
121 | 381.028, Florida Statutes, is amended to read: |
122 | 381.028 Adverse medical incidents.-- |
123 | (7) PRODUCTION OF RECORDS.-- |
124 | (c)1. Fees charged by a health care facility for copies of |
125 | records requested by a patient under s. 25, Art. X of the State |
126 | Constitution may not exceed the reasonable and actual cost of |
127 | complying with the request, including a reasonable charge for |
128 | the staff time necessary to search for records and prevent the |
129 | disclosure of the identity of any patient involved in the |
130 | adverse medical incident through redaction or other means as |
131 | required by the Health Insurance Portability and Accountability |
132 | Act of 1996 or its implementing regulations. The health care |
133 | facility may require payment, in full or in part, before acting |
134 | on the records request. |
135 | 2. Fees charged by a health care provider for copies of |
136 | records requested by a patient under s. 25, Art. X of the State |
137 | Constitution may not exceed the amount established under s. |
138 | 456.057(18)(16), which may include a reasonable charge for the |
139 | staff time necessary to prevent the disclosure of the identity |
140 | of any patient involved in the adverse medical incident through |
141 | redaction or other means as required by the Health Insurance |
142 | Portability and Accountability Act of 1996 or its implementing |
143 | regulations. The health care provider may require payment, in |
144 | full or in part, before acting on the records request. |
145 | Section 6. This act shall take effect July 1, 2006. |