| 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. |