| 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 | 
 | 
| 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 | 
 | 
| 108 | unless the prescriber writes the words "MEDICALLY NECESSARY," in | 
| 109 | her or his own handwriting, on the face of a written | 
| 110 | prescription; orunless, 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. |